Citations
- 669 F. Supp. 2d 227
Full opinion text
CLAIM CONSTRUCTION OPINION
WILLIAM I. GARFINKEL, United States Magistrate Judge.
Plaintiffs Gary A. Lamoureux and Richard A. Terwilliger are the named co-inventors of U.S. Patent No. 6,554,760 (the '760 Patent) (attached hereto as “Appendix A”), issued on April 29, 2003, and entitled “Pre-Loaded Needle Assembly.” The '760 Patent claims an invention for a preplugged and pre-loaded needle assembly for the implantation of therapeutic elements into the body for the treatment of cancer. On August 11, 2003, they, along with World Wide Medical Technologies, LLC, the then-exclusive licensee of the patent, filed suit against Genesis Pharmacy Services, Inc., doing business as Custom Care Pharmacy, alleging, inter alia, various claims of patent infringement. Plaintiffs were granted leave to amend their complaint twice, ultimately resulting in the filing of a Corrected First Amended Complaint on October 21, 2005, with owners and/or licensees Advanced Care Pharmacy LLC, Advanced Care Pharmacy, Inc., Advanced Care Medical, Inc., and IdeaMatrix, Inc., named as additional plaintiffs, and AnazaoHealth Corporation, formerly known as Genesis Pharmacy Services, Inc., named as the sole Defendant (hereinafter “AnazaoHealth” or “Defendant”).
Plaintiffs Lamoureux, World Wide Medical Technologies, LLC, Advanced Care Medical, Inc., Advanced Care Pharmacy, Inc., and Advanced Care Pharmacy LLC (collectively “the World Wide Plaintiffs”) have asserted that Claims 1, 2, 3, 9,10,16, 17, 18, and 21 of the '760 Patent have been infringed by Defendant. Plaintiffs Richard A. Terwilliger and IdeaMatrix, Inc., (collectively “the Terwilliger Plaintiffs”) have asserted a patent infringement claim relating solely to Claim 9.
Following the submission of initial and responsive claim construction memoranda by all parties, the Court held a full-day Markman hearing, at which the parties were given the opportunity to submit internal and external evidence in support of their proffered claim constructions. Additionally, the Court received supplemental briefs from the World Wide Plaintiffs and Defendant concerning the issuance of a certificate of correction to the '760 Patent subsequent to the filing of the original complaint. After due consideration of all of briefs and evidence, the Court now renders this Claims Construction Ruling.
Background
As an alternative to general surgery, brachytherapy is a method of cancer treatment whereby a pattern of radioactive seeds is implanted in the vicinity of a cancerous tumor to destroy cancer cells with low-dose radiation. ('760 Patent col. 1,11.14-17.) Because optimal treatment of the patient depends on the proper spacing and location of the radioactive seeds, physicians must carefully position the radioactive seeds in a patient’s body. This is accomplished by using multiple hollow needles, also referred to as “cannula,” which act as holders and carriers of the seeds. Id. at col. 1,11. 18-22. Prior to insertion of the cannula into a predetermined area of the body, a solid wire stylet is axially introduced into the proximal end of the cannula and rests on the stack of seeds and spacers. Id. at col. 1, 11. 52-54. The cannula is then inserted into the body to the proper position. Id. at col. 1,11. 55-57. The stylet is held firmly and the cannula is moved axially toward the proximal end of the stylet. Id. at col. 1, 11. 56-58. This motion deposits the radioactive seeds and spacers into the body in a predetermined track or line as the cannula is pulled back. Id. at col. 1,11. 58-60. The seeds remain in the body as the radioactive dose decays over the treatment time. Id. at col. 1, 11. 23-25. As many as 25 needles or more may be used for each procedure. Id. at col. 1,11. 26-27.
Two principal types of radioactive seeds are used: “free” seeds, which are individual radioactive seeds that are loaded into the cannula with small non-radioactive cylindrical spacers stacked between them, and a pre-manufactured “strand” of radioactive seeds encapsulated in a biodegradable material that spaces the seeds apart from one another. Id. at col. 1, 11. 61-67. Typically, a physicist or the physician had to pre-load the radioactive seeds into the needles prior to the procedure, which was both time-consuming and risked exposure to radiation. Id. at col. 1,11. 27-29; col. 2, 11. 25-26.
Prior art needle assemblies disclosed a cannula with a sharpened distal tip and an inner solid wire stylet used to push the radioactive seeds into the body. Id. at col. 1, 11. 36-38. The proximal end of the cannula consisted of a plastic or metal hub that allowed the loading of the radioactive seeds into the cannula. Id. at col. 1,11. 38-40. The proximal end of the stylet was a plastic or metal handle for manipulation of the stylet. Id. at col. 1,11. 41-42.
The prior art devices were prepared for use by plugging the end of the cannula with bone wax. Id. at col. 1, 11. 43-44. The bone wax extended into the first 2 mm. to 5 mm. of the distal tip of the cannula to contain the seeds and to prevent body fluids from entering the cannula before deployment of the seeds. Id. at col. 1,11. 44^47. The bone-wax plugged cannula was then loaded with radioactive seeds held apart by short non-radioactive spacers that positioned the seeds in the body to achieve an even distribution to treat the suspected cancer in vivo. Id. at col. 1, 11. 47-51.
The complications involved in the prior art stemmed from the use of bone wax or other materials to plug the cannula prior to loading the radioactive seeds. Id. at col. 2, 11. 2-4. Bone wax could not be applied in a manner that assured a consistent positioning of the first seed, and the amount of bone wax varied from needle to needle. Id. at col. 2, 11. 5-9. Bone wax was also sticky and could cause the first few seeds deployed to stick to the end of the cannula as it was being withdrawn, thus displacing them from their intended position in the treated tissue. Id. at col. 2, 11. 9-14. Further, if the seeds and spacers had to be removed after the initial loading to change the pattern of seeds and spacers in a given needle, the bone wax prevented the unloading of seeds that came in contact with the wax. Thus, the needle could not be reused in the procedure. Id. at col. 2, 11.16-20.
The pre-loaded needle assembly that is disclosed by the '760 patent comprises a needle that is pre-plugged and pre-loaded with radioactive seeds on the order of a physician. Id. at col. 2, 11. 23-26. Once assembled, the needle is sterilized and shipped to the facility where the brachytherapy treatment will take place. The invention addresses the problem of having to load the brachytherapy needles in the operating room prior to the procedure, which, as noted above, was time-consuming and risked exposing the physician or physicist to radiation. Id. at col. 2, 11. 25-26. Additionally, the needle assembly of the '760 Patent uses an end plug that exactly locates the first seed a repeatable and known distance from the distal end of the cannula, thus improving the accuracy of placing the radioactive seeds in the body, which is important to the efficacy of the cancer treatment. Id. at col. 2, 11. 27-31.
Discussion
I. The Impact of the Certificate of Correction
Initially, the Court must determine whether additional wording added to the '760 Patent by the certificate of correction issued on November 25, 2003, should be considered in this infringement action, which was filed prior thereto. Defendant asserts that the certificate of correction should have no impact on this case because, under 35 U.S.C. § 254, a certificate of correction has no effect on causes of action instituted prior to the issuance of the certificate. Defendant maintains that the patent in suit must stand or fall without the correcting language, citing E.I. Du Pont De Nemours & Co. v. MacDermid Printing Solutions, LLC, 525 F.3d 1353, 1362 (Fed.Cir.2008), Novo Indus., L.P. v. Micro Molds Corp., 350 F.3d 1348, 1356 (Fed. Cir.2003), and Southwest Software, Inc. v. Harlequin, Inc., 226 F.3d 1280, 1295-96 (Fed.Cir.2000).
Plaintiffs respond that Defendant has ignored the basic distinction between the commencement of a lawsuit and the accrual of a cause of action for infringement, citing STMicroelectronics, Inc. v. Motorola, Inc., 327 F.Supp.2d 687, 700 (E.D.Tex.2004) (holding that under Southwest Software the relevant inquiry is the date the cause of action arose, not when suit was filed). Plaintiffs concede that the certificate of correction cannot be applied to causes of action accruing prior to its issuance but argue that, as to all causes of action accruing after November 25, 2003, the certificate of correction is to be treated as part of the original patent, citing Southwest Software, 226 F.3d at 1295. Because each act of infringement gives rise to a separate cause of action, see E.I. Du Pont De Nemours, 525 F.3d at 1362, Plaintiffs assert that they may rely on the certificate of correction for all acts of infringement occurring after November 25, 2003, which are encompassed in their First Amended Complaint. See LG Elecs., Inc. v. Quanta Computer Inc., 566 F.Supp.2d 910, 912 (W.D.Wisc.2008) (holding that the certificate of correction would not be effective for purposes of enforcement unless the plaintiff filed a new lawsuit or amended its complaint).
The Patent Act, 35 U.S.C. § 254, provides:
Whenever a mistake in a patent, incurred through the fault of the Patent and Trademark Office, is clearly disclosed by the records of the Office, the Director may issue a certificate of correction stating the fact and nature of such mistake, under seal, without charge, to be recorded in the records of patents. A printed copy thereof shall be attached to each printed copy of the patent, and such certificate shall be considered as part of the original patent. Every such patent, together with such certificate, shall have the same effect and operation in law on the trial of actions for causes thereafter arising as if the same had been originally issued in such corrected form.
(Emphasis added).
It is undisputed that, at the time the original complaint was filed, the certificate of correction had not been issued. Three months after suit was filed, the Patent and Trademark Office (“PTO”) issued the certificate of correction on November 25, 2003, to insert the phrase “frietionally held” in Claim 1, Column 5, Line 46, following “including a.” Thus, Claim 1 of the '760 Patent (col. 5, 11. 43-51) now reads:
1. For implanting therapeutic elements, a needle assembly comprising a cannula having a wall and a sharpened distal end, a line of elements in the cannula extending rearward from the distal end, yieldable means, including a frietionally held plug, for positioning an element more proximate the distal end a predetermined distance from the distal end, and a stylet reciprocable in the cannula and having a distal end engaging an end of the line of elements more remote from the distal end of the cannula.
The prosecution history reveals that this correction was the result of a telephone interview between the patent examiner and the applicants’ attorney regarding Claim 1, wherein the applicants gave their permission to this amendment to avoid a conflict with prior art. A notice of allowability was then mailed on January 24, 2003, including the examiner’s amendment, inserting the phrase “frietionally held.” ('760 Patent, Prosecution History, Ex. C, W0420, W0492-W0494.) Unfortunately, however, due to a printing error at the PTO, the issued patent did not include this language.
The certificate of correction was first referenced in this litigation as part of the Corrected First Amended Complaint, which attached the certificate of correction to the '760 Patent and which was filed as an exhibit to the complaint.
The statute itself provides that a certificate of correction will have prospective effect only “for causes thereafter arising." 35 U.S.C. § 254. Accordingly, in Southwest Software, the Federal Circuit held that a “certificate of correction is only effective for causes of action arising after it was issued.” 226 F.3d at 1294 (emphasis added). In that case, because the cause of action arose before the certificate of correction issued, the certificate of correction was not given effect. Id. This holding was reiterated in Novo Industries, 350 F.3d at 1356, wherein the court noted that sections 254 and 255 “deal only with the authority of the PTO to make prospectively effective corrections, and the PTO was given no authority to correct the claims retroactively.” Thus, the court held that for causes of action arising before the certifícate became effective, “the patent must be considered without the benefit of the certificate of correction.” Id. Likewise, in STMicroelectronics, 327 F.Supp.2d at 700, the court emphasized that the relevant inquiry for considering a certificate of correction is the date the cause of action arose rather than the date the suit was filed. Most recently, in E.I. Du Pont De Nemours, 525 F.3d at 1362, the court found a certificate of correction was effective only as to prospective infringement occurring after the issuance of the certificate.
Based on the holdings of Southwest Software, Novo Industries, STMicroelectronics, and E.I. Du Pont De Nemours, the Court finds that the critical date for purposes of determining whether the certificate of correction applies is the date the cause of action arose, i.e., the date the infringing conduct occurred, and not the date the complaint was filed. See also Rohm Co. v. Nichia Corp., No. Civ. A. 00-6379, 2003 WL 22844207, at *2 (E.D.Pa. Nov. 26, 2003) (holding that a certificate of correction is only effective as to causes of action arising after it was issued). In the instant case, unlike Southwest Software, Plaintiffs are suing for acts of infringement taking place both before and after the certificate of correction issued. Plaintiffs filed a Corrected First Amended Complaint that included the certificate of correction and encompassed acts of infringement arising after the certificate of correction had issued. As to all acts of infringement occurring after November 25, 2003, and, thus, as to all causes of action arising after November 25, 2003, the Court holds that the '760 Patent must be read to include the certifícate of correction.
II. Claim Construction Analysis
A. General Principles of Claim Construction
An infringement analysis involves two steps. The first step requires the court to determine, as a matter of law, the meaning and scope of the patent claims alleged to have been infringed. Mark-man, 52 F.3d at 979. The second step requires the fact finder to compare the properly construed claim to the accused device in order to determine whether all of the claim limitations are present in the accused device, either literally or by a substantial equivalent. Markman, 52 F.3d at 976-9.
At this stage of the proceedings, this Court is concerned only with the first step, the construction of the disputed patent claims, which is a matter of law exclusively for the Court. See Markman, 52 F.3d at 970.
“It is a ‘bedrock principle’ of patent law that ‘the claims of a patent define the invention to which the patentee is entitled the right to exclude.’ ” Phillips v. AWH Corp., 415 F.3d 1303 (Fed.Cir.2005) (en banc) (quoting Innova/Pure Water Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed.Cir.2004)), cert. denied, 546 U.S. 1170, 126 S.Ct. 1332, 164 L.Ed.2d 49 (2006). Courts construe claims to resolve disputes about claim terms and to assign fixed, unambiguous, legally operative meaning to the claim, so that a patentee’s right to exclude is clearly defined. Liquid Dynamics Corp. v. Vaughan Co., 355 F.3d 1361, 1367 (Fed.Cir.2004). However, claims are to be construed without the objective of capturing or excluding the accused device. NeoMagic Corp. v. Trident Microsystems, Inc., 287 F.3d 1062, 1074 (Fed.Cir.2002).
The words of a claim “are generally given their ordinary and customary meaning.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir.1996). “[T]he ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips, 415 F.3d at 1313. Where such meaning is “readily apparent even to lay judges, ... claim construction ... involves little more than the application of the widely accepted meaning of commonly understood words. In such circumstances, general purpose dictionaries may be helpful.” Id. at 1314 (citations omitted). In many cases, however, the meaning of a term is not “readily apparent” and “determining the ordinary and customary meaning of the claim requires examination of terms that have a particular meaning in a field of art.” Id. The inquiry into how a person of ordinary skill in the art would understand a claim term is based on the common understandings that inventors are generally skilled in the field of their invention and that patents are addressed to and intended to be read by others who are skilled in the art in question. Id.
The person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim at issue, but also in the context of the entire patent, including the specification and prosecution history. Id. (citing Medrad, Inc. v. MRI Devices Corp., 401 F.3d 1313, 1319 (Fed.Cir.2005)). “This last tenet derives from the fact that claims do not stand alone but rather ‘are part of a fully integrated written instrument consisting principally of a specification that concludes with the claims.’ ” ICU Med., Inc. v. Alaris Med. Sys., Inc., 558 F.3d 1368, 1374 (Fed.Cir.2009) (quoting Phillips, 415 F.3d at 1315). “The close kinship between the written description and the claims is enforced by the statutory requirement that the specification describe the claimed invention in ‘full, clear, concise, and exact terms.’ ” Phillips, 415 F.3d at 1316 (quoting 35 U.S.C. § 112).
Thus, it is well-settled that, in interpreting an asserted claim, the court should first consider the intrinsic evidence of record, i.e., the patent itself, including the claims, the specification, and, if in evidence, the prosecution history. Vitronics, 90 F.3d at 1582. The rationale for relying on the intrinsic evidence is that this evidence is a matter of public record, a record on which the public is entitled to rely. Id. at 1583.
The court examines the intrinsic evidence seriatim. Liquid Dynamics Corp., 355 F.3d at 1367. First, the court must first consider the words of the claims themselves to define the scope of the patented invention. Bell Commc’ns Research, Inc. v. Vitalink Commc’ns Corp., 55 F.3d 615, 620 (Fed.Cir.1995). Although words in a claim are generally given their ordinary and customary meaning, a patentee may choose to be his own lexicographer and use a term in a manner other than its ordinary meaning. However, in such a case, the special definition must be clearly stated in the specification or prosecution history. Hoechst Celanese Corp. v. BP Chems. Ltd., 78 F.3d 1575, 1578 (Fed.Cir.), cert. denied, 519 U.S. 911, 117 S.Ct. 275, 136 L.Ed.2d 198 (1996); Markman, 52 F.3d at 980.
Second, the court must review the specification, which contains a written description of the invention that must be clear and complete to enable one of ordinary skill in the art to make and use the invention. Markman, 52 F.3d at 979. The specification is “always highly relevant to the claim construction analysis” and is “the single best guide to the meaning of a disputed term.” Vitronics, 90 F.3d at 1582. The Federal Circuit has cautioned, however, that because the claims define the invention, limitations from the specification should not be read into those claims. Rather, a claim should be read in light of the specification. Comark Commc’ns, Inc. v. Harris Corp., 156 F.3d 1182, 1186-87 (Fed.Cir.1998). Third, the court looks to the patent’s prosecution history, if in evidence, which is also a matter of public record. Id. The prosecution history consists of the complete record of the proceedings before the PTO, including the prior art cited during the patent examination and the applicant’s acquiescence with regard to the prior art, which indicates what the claims do not cover. Phillips, 415 F.3d at 1317; Liquid Dynamics Corp., 355 F.3d at 1367. However, since the prosecution history represents ongoing negotiations between the inventor and the PTO rather than the final product of the negotiation process, it often lacks the clarity of the specification and may be less useful in the claims construction process. Phillips, 415 F.3d at 1317; United Techs. Corp. v. PerkinElmer, Inc., 537 F.Supp.2d 392, 398 (D.Conn.2008).
In most cases, an analysis of the intrinsic evidence alone will resolve any ambiguity in a disputed claim term, and in such cases, it is improper to rely on extrinsic evidence. Only if there is some genuine ambiguity in the claim after consideration of all the intrinsic evidence may the court consider extrinsic evidence. Vitronics, 90 F.3d at 1583.
Extrinsic evidence is that evidence which is external to the patent and file history and includes expert and inventor testimony, dictionaries, and learned treatises and articles. Markman, 52 F.3d at 980. Extrinsic evidence is generally considered to be less reliable than intrinsic evidence because it is not part of the patent and was not created at the time of the patent’s prosecution for the purpose of explaining the patent’s scope and meaning. Phillips, 415 F.3d at 1318. While extrinsic evidence may be used by the court to explain terminology, to aid the court in understanding the state of the art at the time of the invention, and to help the court in understanding scientific principles, it may not be used to vary or contradict the claim language. Id. at 981. Moreover, the use of extrinsic evidence is discretionary. The court may accept evidence that it finds useful and reject other evidence as unhelpful. See Robert L. Harmon, Patents and the Federal Circuit § 6.1 at 307 (8th ed. 2007) (hereinafter “Harmon”). “Thus, although construction may be enlightened by such extrinsic evidence as is helpful, it is still based upon the patent and its prosecution history.” Id.
The Federal Circuit in Phillips, 415 F.3d at 1303-04, also cautioned against reliance on the dictionary definition of disputed claim terms, which focuses on the abstract meaning of the words rather than their meaning in the context of the patent. Although the court may consult dictionaries in order to better understand the underlying technology and the commonly understood meaning of a word, the dictionary definition may not contradict any definition found in or ascertained by a reading of the patent documents. Vitronics, 90 F.3d at 1584 n. 6. “In sum, ... it is ‘[t]he construction that stays true to the claim language and most naturally aligns with the patent’s description of the invention [that] will be, in the end, the correct construction.’ ” United Techs., 537 F.Supp.2d at 399 (quoting Phillips, 415 F.3d at 1316) (emphasis in original).
The parties do not dispute these general tenets of claim construction. Rather, their disagreement arises from the application of these principles to the claim terms at issue in this case.
B. The ' 760 Patent
The '760 Patent describes Plaintiffs’ invention in 21 Claims. Claims 1, 9, 17, and 18 are independent claims. The remaining seventeen claims are dependent. The World Wide Plaintiffs have alleged infringement by AnazaoHealth of nine claims. The World Wide Plaintiffs and AnazaoHealth dispute the construction of terms in each of the claims allegedly infringed: Claims 1, 2, 3, 9, 10, 16, 17, 18, and 21. The Terwilliger Plaintiffs allege infringement of Claim 9 and seek construction only as to this claim.
The claims at issue in this case are as follows:
1. For implanting therapeutic elements, a needle assembly comprising a cannula having a wall and a sharpened distal end, a line of elements in the cannula extending rearward from the distal end, yieldable means, including a frictionally held plug, for positioning an element more proximate the distal end a predetermined distance from the distal end, and a stylet reciprocable in the cannula and having a distal end engaging an end of the line of elements more remote from the distal end of the cannula.
2. A needle assembly as claimed in claim 1 wherein the means for positioning includes an absorbable plug.
3. An assembly as claimed in claim 1 wherein the line of elements is encapsulated in a biodegradable material, the seeds being held in spaced relation by the biodegradable material.
9. For implanting a therapeutic element, a needle assembly comprising a cannula having a wall and having a sharpened distal end, a generally cylindrical end plug frictionally held in the distal end having a rearward end extending from the distal end a predetermined distance, a line of elements in the cannula contacting the plug and extending rearward thereform, and a stylet reciprocable in the cannula and having a distal end engaging an end of the line of elements more remote from the distal end of the cannula.
10. An assembly as claimed in claim 9 wherein the line of elements is encapsulated in a biodegradable material, the seeds being held in spaced relation by the biodegradable material.
16. An assembly as claimed in claim 9 wherein said end plug seals the distal end of the needle assembly and wherein the needle assembly is pre-loaded with said line of elements and is sterile.
17. A method of making a needle assembly for implanting radiation seeds, comprising the steps of:
a. providing a cannula having a sharpened distal end and a generally cylindrical plug,
b. forcing the plug into the sharpened distal end of the cannula to frictionally reside there.
18. A method of making a needle assembly for implanting therapeutic elements, comprising the steps of:
a. providing a cannula having a wall and having a sharpened distal end and providing a generally cylindrical plug,
b. placing the plug into the sharpened distal end of the cannula to reside there, and
c. modifying the diameter of the plug to enhance its frictional engagement with the wall of the cannula.
21. A method as claimed in claim 18 wherein the diameter of the plug is modified by mechanical distortion.
1. Claim 1
The World Wide Plaintiffs and/or AnazaoHealth have identified six terms in Claim 1 as requiring construction: “wall,” “element/elements,” “yieldable means,” “plug,” “predetermined distance,” and “frictionally held.”
a. Wall”
AnazaoHealth has identified the term “wall” in Claim 1 (and also in Claims 9 and 18) as requiring construction because it lacks any antecedent basis in the '760 Patent. It maintains that while “having a wall” is claimed as a discrete element of the invention, presumably as a characteristic of the cannula, it is not clear from the claim or specification what this “wall” element is supposed to be — other than, perhaps, the cannula itself, which only renders the claim language even more ambiguous. AnazaoHealth argues that this ambiguity runs afoul of 35 U.S.C. § 112, ¶ 2, which mandates that claims particularly point out and distinctly claim the subject matter which the applicant regards as his invention. Because this claim is “insolubly ambiguous,” AnazaoHealth argues that it is invalid as a matter of law.
The World Wide Plaintiffs respond that the claim language and the intrinsic record apprise those skilled in the art of the meaning of this term. It is common for patent drafters to expressly state a component that is inherent in a limitation of an apparatus, especially if that component is useful for describing how other aspects of the claimed invention interact with the limitation. Here, they assert, it was useful to identify the cannula wall — which is inherent in the definition of cannula — because, as later claimed, the plug may interact with the cannula wall. The World Wide Plaintiffs urge the Court to reject AnazaoHealth’s attempt to create indefiniteness by injecting an ambiguity into a claim.
Claim 1 recites “a needle assembly comprising a cannula having a wall and a sharpened distal end.... ” (Emphasis added). The specification of the '760 Patent does not define the term “wall” but it does refer to the end plug (32 in Fig. 2) adhering to the inside of the cannula wall. ('760 Patent col. 4, 11. 8-11.) It also refers to a bridge (364 in Figs. 7a, 7b, and 7c) in the cannula wall between the openings that is deflected inward to frictionally engage the plug and hold the plug yieldably in place. Id. at col. 5, 11. 22-25. The Preamble also speaks of a distortion of the wall of the cannula.
As the World Wide Plaintiffs point out, a cannula, which is a tube that can be inserted into the body, inherently has a wall that defines the hollow center. For purposes of this Patent, however, at times the patentees referred to the wall of the cannula (Claims 1, 5, 6, 7, 8, 9, 12, 13, 14, 18a) and at other times to the distal and/or proximal ends of the cannula (Claims 1, 5, 9, 12,17a, 17b, 18a, 18b). Indeed, even in Claim 1, they draw a distinction between the wall of the cannula and the sharpened distal end. To equate the term “wall” with “cannula” ignores the distinction in the claims between the different parts of the cannula. Moreover, AnazaoHealth’s construction would create a redundancy in Claim 1, “a cannula having a ‘cannula’.” The Court rejects this construction.
The prosecution history, which was introduced into evidence at the Markman hearing, reveals that the phrase “having a wall” was added to Claim 1 by the patentees in response to an objection by the Primary Patent Examiner that the term “wall” in Claims 5, 6, 7, 12, and 17 lacked an antecedent basis. (W0467-W0469, W0480.) When the claim term “wall” is read in the context of the rest of the Patent, which describes distortions in the cannula wall to enhance the frictional hold on the plug (e.g., an irregularity, inward hump, or tab in the wall that holds the plug), and which distortions are clearly depicted in the drawings, Figures 1 through 7c, it is clear the term “wall” is intended to have its common and ordinary meaning. There is nothing in the claims of the Patent or the specification to suggest that the inventors intended to impart a novel meaning to the term “wall.” See Miken Composites, LLC v. Wilson Sporting Goods Co., 515 F.3d 1331, 1337 (Fed. Cir.2008).
It is abundantly clear to this Court from the specification, preamble, and drawings — all of which depict a cannula as a hollow tube with walls, a sharpened distal end, and a proximal end — that a person of ordinary skill in the art would understand the term “wall” as having its ordinary and customary meaning. The Court finds that this term is not indefinite, and that no further construction is needed. See Phillips, 415 F.3d at 1313; see also U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed.Cir.) (holding that claim construction is to resolve disputed meanings, to clarify, and when necessary to explain what is covered by a claim, but it is not an “obligatory exercise in redundancy”), cert. denied, 522 U.S. 950, 118 S.Ct. 369, 139 L.Ed.2d 287 (1997).
b. “Element/Elements”
The World Wide Plaintiffs and AnazaoHealth have proposed two constructions of the term “element” as used in Claim 1, which differ primarily in the breadth to be ascribed to this term. The World Wide Plaintiffs ask the Court to construe this term as meaning “anything intended for use in brachytherapy, including radioactive seeds and/or spacers.” The World Wide Plaintiffs argue that “seeds,” “spacers,” and “radioactive seeds” were simply illustrative examples of elements that might be used in a brachytherapy procedure. Instead, they maintain that if an object, material or device used in connection with the treatment of cancer is designed to fit inside a needle and is implantable, it should be included in the definition of “element.”
AnazaoHealth proposes a more narrow definition of “elements,” that is limited to “radioactive seed(s), spacer(s) and/or drug(s).” AnazaoHealth asserts that the language of the specification indicates that the “therapeutic elements” contained within the needle and implanted in the body are radioactive seeds and spacers. AnazaoHealth argues that the World Wide Plaintiffs’ definition is overly broad and would encompass every aspect of brachytherapy treatment, including ultrasound probes or x-rays used to identify where the radioactive seeds were deposited or the materials used pre- and postoperatively to assist in a patient’s treatment. It further submits that the term should not be construed to include “markers,” which do not appear anywhere in the intrinsic evidence, and there is no indication that markers formed any part of the alleged invention. It maintains that there is no basis in the intrinsic record to conclude that the patentees had anything in mind other than radioactive seeds and spacers.
Claim 1 refers to “therapeutic elements” and “a line of elements.” ('760 Patent col. 5, 11. 43, 45, 50-51.) Additionally, the term “element” appears in Claims 3, 9, 10, 11, and 16, which refer to a “line of elements,” (id. at col. 5, 11. 54-55; col. 6, 11. 14-15, 17-18, 19-20, 23-24, 41), and in Claims 9 and 18, which refer to “therapeutic element(s).” Id. at col. 6,11. 9, 51. A person of ordinary skill in the art is deemed to read a claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification. Phillips, 415 F.3d at 1313. The purpose of the specification is to teach and enable those skilled in the art to make and use the invention and to provide a best mode for so doing, which is often done by example. Id. at 1323. The specification has been described by the Federal Circuit as the “single best guide to the meaning of a disputed term [and] the primary basis for construing the claims.” Id. at 1315.
Here, the specification speaks in terms of “a line of therapeutic elements, for instance, radioactive seeds.” ('760 Patent col. 3, 11. 56-57 (emphasis added).) The specification makes clear that radioactive seeds are but one type of therapeutic element that might be implanted in a brachytherapy procedure using the patented device. Although several of the claims use the term “seeds” rather than “elements,” from which one might infer that “elements” should be limited to “seeds,” id. at col. 5,11. 56; col. 6,11. 21, 44, even AnazaoHealth concedes that the term “element” must encompass more than seeds and spacers and could include drugs. The Court finds no basis for including drugs yet excluding other substances or materials used in connection with the treatment of cancer and which are designed to fit inside a needle assembly for implantation into a patient. The invention itself relates to the device for implanting therapeutic elements. It is not limited to certain types of therapeutic elements. Thus, the Court rejects AnazaoHealth’s definition that limits “elements” to radioactive seeds, spacers, and drugs.
When the term “element” is read in the context of the entire patent, the claims and specification make clear that an “element” within the needle assembly is something more than seeds and spacers and is something that is intended for implantation in the body for the purpose of treating cancer. See Phillips, 415 F.3d at 1321; Visto Corp. v. Sproqit Techs., Inc., 445 F.Supp.2d 1104, 1112 (N.D.Cal.2006). The World Wide Plaintiffs’ definition includes the limitation “intended for use in braehytherapy.” Therefore, the Court adopts the construction urged by the World Wide Plaintiffs, that being “anything intended for use in braehytherapy, including radioactive seeds and/or spacers.”
c. “Yieldable Means”
The third term in Claim 1 on which the parties seek construction is “yieldable means.” Claim 1 recites “a needle assembly comprising a cannula ..., a line of elements, yieldable means, including a frictionally held plug.” ('760 Patent col. 5, II. 43 — 46.) The World Wide Plaintiffs construe this phrase as a “means capable of yielding, or giving way, under force.” AnazaoHealth proffers a more restrictive construction, that is “a plug used to position the first seed in the needle at an exact distance from the distal tip of the needle and that is capable of holding and giving way under force.”
It appears from the two proposed definitions that the parties do not have a meaningful disagreement over the construction of the word “yieldable.” The primary disagreement involves whether “yieldable mean” should be construed as a means-plus-function term under 35 U.S.C. § 112, ¶ 6. If section 112, ¶ 6 is found to apply, then the claim term is construed by identifying the “function” associated with the claim language, and them identifying the corresponding “structure” in the speeification associated with the function. The claim is then construed as limited to that structure and its equivalents. DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 469 F.3d 1005, 1023 (Fed.Cir.2006), cert. denied, 552 U.S. 940, 128 S.Ct. 58, 169 L.Ed.2d 243 (2007). AnazaoHealth insists that the phrase must be construed as a “means-plus-function” limitation with the “structure” limited to a plug, which could perform the stated function and which was also disclosed as the preferred embodiment for positioning the element a “predetermined distance from the distal end.” ('760 Patent col. 3, 1. 60-col. 4, 1. 67.)
The World Wide Plaintiffs respond that the means-plus-function analysis applies only to purely functional limitations that do not provide any structure for performing the recited function. Here, they maintain, sufficient structure is disclosed to perform the recited function of “positioning an element ... a predetermined distance from the distal end.” AnazaoHealth replies that the World Wide Plaintiffs have failed to explain how a “yieldable means” could encompass anything other than a plug and, to the extent that this claim is interpreted more broadly, it would be invalid in light of prior art references that disclosed various “yieldable means.” (W0470, W0476-W0482.)
(i). “Means-Plus-Function”
The determination of whether a claim term is written in a means-plus-function format is a question of law for the court. Linear Tech. Corp. v. Impala Linear Corp., 379 F.3d 1311, 1318 (Fed. Cir.2004). “Means-plus-function claiming applies only to purely functional limitations that do not provide the structure that performs the recited function.” DePuy Spine, Inc., 469 F.3d at 1023 (quoting Phillips, 415 F.3d at 1311). “If the word ‘means’ appears in a claim element in association with a function,” there is a rebuttable presumption that section 112, paragraph 6 applies. See Callicrate v. Wadsworth Mfg., Inc., 427 F.3d 1361, 1368 (Fed.Cir.2005); see also Greenberg v. Ethicon Endo-Surgery, Inc., 91 F.3d 1580, 1584 (Fed.Cir.1996). This presumption may be rebutted, however, when the claim element recites a sufficiently definite structure to perform the claimed function. See Phillips, 415 F.3d at 1311; Callicrate, 427 F.3d at 1368. The Federal Circuit has held that in determining whether sufficient structure is recited by a term used in a claim limitation, the court may inquire into whether the “term, as the name for structure, has a reasonably well understood meaning in the art.” Greenberg, 91 F.3d at 1583.
The Court agrees with the World Wide Plaintiffs that sufficient structure is disclosed in Claim 1, which recites “yieldable means, including a frictionally held plug,” to rebut the aforesaid presumption. See Phillips, 415 F.3d at 1311 (holding that a claim limitation stating “means disposed inside the shell for increasing its load bearing capacity comprising internal steel baffles” provided sufficient structure so as not to invoke § 112, ¶ 6); Cole v. Kimberly-Clark Corp., 102 F.3d 524, 531 (Fed.Cir.1996) (holding that “perforation means ... for tearing” did not require construction as a means-plus-function term because the claim described the structure for tearing— i.e., perforations — as well as its location and extent. “An element with such a detailed recitation of its structure, as opposed to its function, cannot meet the requirements of the statute.”), cert. denied, 522 U.S. 812, 118 S.Ct. 56, 139 L.Ed.2d 20 (1997).
Here, although Claim 1 uses the term “means” in the phrase “yieldable means,” creating a rebuttable presumption of a “means-plus-function” limitation, the claim then specifically identifies a structure, i.e., a frictionally held plug, capable of entirely performing the function of “yielding.” The Federal Circuit has held that “[m]eansplus function claiming applies only to purely functional limitations that do not provide the structure that performs the recited function,” Phillips, 415 F.3d at 1311, which is not the case here. See also Watts v. XL Systems, Inc., 232 F.3d 877, 880-81 (Fed.Cir.2000) (holding that the focus is whether the claim recites a sufficiently definite structure, but noting that the claim limitation need not connote a precise physical structure).
(ii). Limiting “Yieldable Means” to a “Plug”
AnazaoHealth argues that even if section 112, paragraph 6 does not apply, “yieldable means” must still be limited to a plug. The Court disagrees. By defining the “yieldable means” as limited to a plug, AnazaoHealth ignores the broader language in the specification and claims, which contemplate other means for achieving the recited function in Claim 1. The claim itself states “yieldable means, including a frietionally held plug.” The Federal Circuit has repeatedly recognized that use of the term “including” is an open term, synonymous with “comprising,” thereby permitting the inclusion of unnamed components. See Hewlett-Packard Co. v. Repeat-O-Type Stencil Mfg. Corp., 123 F.3d 1445, 1451 (Fed.Cir.1997), cert. denied, 523 U.S. 1022, 118 S.Ct. 1304, 140 L.Ed.2d 470 (1998); Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1301 (Fed.Cir.1999); Altiris, Inc. v. Symantec Corp., 318 F.3d 1363, 1376 (Fed.Cir.2003).
Additionally, the specification states, “The positioning means for the first seed may take one of a variety of forms, all of them yieldable to permit the seed to be pushed past the distal end in the implantation.” ('760 Patent col. 2, 11. 30-33 (emphasis added).) “The needle assembly of the invention may include a bioeompatable end plug....” Id. at col. 2, 11. 34-35 (emphasis added). Thus, the specification makes clear that a plug is not the exclusive manner in which to attain the recited function in Claim 1. In fact, the '760 Patent expressly discloses an alternate embodiment where the yieldable means comprise the combination of a plug and a resilient tongue formed in the cannula wall. Id. at col. 5, 11. 1-20 & fig. 6d. Nothing in the prosecution history suggests otherwise. Moreover, AnazaoHealth’s proposed definition that limits the yieldable means to a plug is redundant of the language already recited in the claim, “including a ... plug.” Id. at 5:46 — 18.
The Court finds that the World Wide Plaintiffs’ proposed construction comports with the customary and ordinary meaning when viewed in the context of the intrinsic record. The Description of the Preferred and Other Embodiments discusses what the patentees meant by “yield-able means:”
In all embodiments, no matter by what means, the end plug is yieldably held in precise position and may be forced outward as the cannula is drawn backward on the stylet. The position of the end plug 32 in the cannula 12 is yieldable. Before yielding, the plug seals the needle and keeps the seeds from spilling out the needle or body fluids from entering the needle prematurely.
Id. at col. 4,11. 17-21; see also id. at col. 2, 11. 31-34. The only construction that is consistent with the claim language and the entire disclosure in the specification is one that construes the phrase as “means capable of yielding, or giving way under force.”
d. “Plug”
The next disputed term in Claim 1 is “plug.” Claim 1 provides in relevant part, “a needle assembly comprising a cannula, ... a line of elements, ... yieldable means, including a frictionally held plug, for positioning an element more proximate the distal end a predetermined distance from the distal end, ...” ('760 Patent col. 5, 11. 43-38.) This term also appears in Claim 2, which speaks of an “absorbable plug,” id. at col. 5, 1. 53; Claims 5 and 7, which refers to “said plug,” id. at col. 5, 1. 63, col. 6, 1. 4; Claim 9, which discusses both “the plug” and “a generally cylindrical end plug,” id. at col. 6, 11. 12-13, 14; Claim 16, which refers to “said end plug seals the distal end of the needle assembly,” id. at col. 6, 11. 39-40; Claims 17 and 18, which refer to “a generally cylindrical plug,” and “the plug,” id. at col. 6, 11. 47-48, 53-55, 57; and Claim 21, which refers to “the diameter of the plug.” Id. at col. 6, 11. 64-65.
The World Wide Plaintiffs define “plug” as “an object or material used to fill or seal an opening.” AnazaoHealth construes this term to mean “a separate ejectable member of predetermined dimensions comprised of material other than bone wax.”
AnazaoHealth argues that the breadth of the World Wide Plaintiffs’ construction encompasses the prior art plugging materials denigrated by the '760 Patent and the plug claimed in the Mercereau patent that formed a basis for the examiner’s rejection of the original claims of the '760 Patent. The World Wide Plaintiffs respond that AnazaoHealth’s construction improperly imports limitations from the specification that unnecessarily narrow the scope of the claim and improperly seeks to define the term “plug” by what it does not mean rather than by what it does mean. The discussion of the use of bone wax in the prior art focused on problems with the manner in which it was used. They maintain that the term “plug” should not be construed based upon its composition where there is no restriction in the claim language regarding the material composing the plug.
The competing constructions offered by the parties present several issues: (1) whether the Court should construe the term “plug” to cover only embodiments that do not include bone wax in light of the disclaimers in the specification; (2) whether the World Wide Plaintiffs’ construction is so broad as to encompass prior art; and (3) whether the limitations in AnazaoHealth’s proposed construction are necessary to preserve the validity of the '760 Patent.
(i). Exclusion of Bone Wax
The specification discusses complications in the prior art that “stem from the use of bone wax or other materials that are used to plug the cannulas prior to the loading of the radioactive seeds.” ('760 Patent col. 2, 11. 1-3 (emphasis added).) The specification then lists four drawbacks associated specifically with the use of bone wax. Id. at col. 2, 11. 4-20. Elsewhere, the specification describes the invention as including a “biocompatable end plug which may be made of a variety of materials including absorbable or non-absorbable suture materials either in a braided or monofilament configuration or molded biocompatable polymers.” Id. at col. 2, 11. 35-39 (emphasis added). Repeatedly thereafter, the specification refers to a “biocompatable end plug” without further limitation as to the composition of the end plug. Id. at col. 2, 11. 53, 58. In the Description of the Preferred Embodiments section, the material of the end plug is described as
biocompatable and biodegradable. It may be formed, for instance, of processed collagen (catgut), Nylon or various other organic substances. A preferred material is polyglactin acid (PGA) available under the trademark POLYGLACTIN 910.
Id. at col. 4, 11. 2-7. This section also recites the exact positioning of the end plug as a significant advantage over “the haphazard positioning of the more proximate end of a bone wax material as used in the needle assemblies of the prior art.” Id. at col. 4, 11. 36-38 (emphasis added). The inventors note that other variations of the invention are contemplated. Id. at col. 5,11. 29.
The Federal Circuit has repeatedly cautioned against importing limitations from the specification into claim terms. See, e.g., Phillips, 415 F.3d at 1323-24; Callicrate, 427 F.3d at 1368; North Am. Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 1348 (Fed.Cir.2005). At the same time, if the specification makes clear that the invention does not include a particular feature, that feature is deemed outside the claims of the patent even though the claims might otherwise be considered broad enough to encompass that particular feature. SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1342 (Fed.Cir.2001).
Based on a review of the intrinsic evidence, the Court concludes that the term “plug” should not be construed so as to limit the composition of the plug to materials other than bone wax. Although the specification does discuss the disadvantages associated with the manner in which prior art used bone wax to plug cannulas prior to loading the radioactive seeds, the specification discloses that the end plug may be composed of any material that is suitable for brachytherapy operations. While it lists specific examples of preferred materials, it does not limit or foreclose the use of any other materials. Nothing in the intrinsic evidence to suggest that the inventors intended to exclude or disavow any particular material from the scope of the claim, if that material was suitable for use in brachytherapy and could be fashioned in such a manner as to create a plug that could be inserted into the cannula a predetermined distance from the distal end. Statements in the specification discussing the disadvantages of pri- or art do not necessarily require a limiting construction, particularly where the language of the claim and the presumption of claim differentiation call for the opposite conclusion. See Acumed LLC v. Stryker Corp., 483 F.3d 800, 805 (Fed.Cir.) (rejecting the alleged infringer’s reliance on the discussion in the specification of the disadvantages of certain features of prior art to limit the claim of the asserted invention), cert. denied, 552 U.S. 1022, 128 S.Ct. 615, 169 L.Ed.2d 393 (2007).
(ii). Distinguishing the Claimed Invention from the Prior Art
AnazaoHealth also cites to the prosecution history as limiting the breadth of the term to something that is a “separate ejectable member” and of “predetermined dimensions.”
Clearly, statements made during prosecution may also affect the scope of a claim. Computer Docking Station Corp. v. Dell, Inc., 519 F.3d 1366, 1374 (Fed.Cir. 2008). “Specifically, a patentee may limit the meaning of a claim term by making a clear and unmistakable disavowal of scope during prosecution.” Id. (internal citation and quotation marks omitted). For example, a patentee might clearly characterize an invention in a particular way to try to overcome a rejection based on prior art. Id.
As AnazaoHealth points out, the prosecution history reveals that Claim 1 was rejected initially as being anticipated by prior art, the Mercereau Patent, et al. (U.S. Patent No. 6,450,937), which showed two different yieldable means. (W0470.) The patentees then revised Claim 1 of the '760 Patent to add “including a plug” after yieldable means (and later “frictionally held”). The Remarks submitted with the revision describe Mercereau as showing a lubricious coating, some of which was allowed to accumulate by surface tension in the end of the tube to form a web. This was formed by dipping the tube into a vat of coating material, where capillary action and surface tension caused a small quantity of the coating material to remain in the forward end of the tube. The quantity of lubricious material entering the tube was “notoriously unreliable” and would extend over different distances, varying from one tube to the next. Additionally, the web was comprised of solid polymers that were not absorbable or biodegradable. (W0481.) In the second version of Mercereau, the lubricious coating was allowed to accumulate by capillary action and surface tension to form a “plug” that was “not a separate ejectable member,” as described in the '760 Patent. Rather it was the solidified overflow into the distal end of the cannula by capillary action when the cannula was dipped into a vat. This embodiment of the prior art was considered even more unreliable in terms of the distance the material would extend into the cannula. Id.
The patentees asserted that an essential feature of their invention was the
yieldable means for positioning the element a pre-determined distance from the distal end includes a plug of predetermined dimensions with a rearward end that is positioned an exact length back from the extreme distal end of the beveled point. This distance is critical and does not vary from assembly to assembly.... Since Mercereau clearly does not include a plug which positions an element a predetermined distance from the distal end, Mercereau does not anticipate Claim 1.
(W0481-W0482 (first emphasis added, second emphasis in original).)
According to AnazaoHealth, these statements constitute a clear and unambiguous disavowal by the patentees that the plug of their invention was anything other than one of predetermined dimensions that was separate and ejectable. The Court agrees that these statements, as well as the specification and other claims of the Patent, support AnazaoHealth’s interpretation that the plug must be ejectable. However, that requirement is already included in Claim 1, which describes a “plug” as an example of a “yieldable means,” i.e., “means capable of yielding, or giving way under force.” Therefore, to include the limitation that the plug must be ejectable would be redundant.
The Court disagrees, however, that the these statements in the prosecution history constitute a clear disavowal of a plug being anything other than of predetermined dimensions. While the remarks describe features of the claimed invention, including a plug of predetermined dimensions, which differentiate it from Mercereau, they do not expressly disavow all other embodiments of a plug for positioning an element a predetermined distance from the distal end of the cannula. See Northern Telecom Ltd. v. Samsung Elecs. Co., 215 F.3d 1281, 1294 (Fed.Cir.2000) (refusing to limit scope of claim where statements in the prosecution history did not exclude the possibility of using a particular process); Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1458 (Fed.Cir.1998) (holding that statements in prosecution history distinguishing prior art could not properly be interpreted as precluding coverage for every type of external reservoir). In fact, the specification and other claims in the '760 Patent describe methods of changing the size of the plug to enhance its frictional engagement with the wall of the cannula, which contradicts the requirement that the plug must be of predetermined dimensions. See, e.g., Claims 18-21. Rather, the critical distinction between the '760 Patent and Mercereau was the ability of the claimed invention to position an element a “predetermined distance from the distal end,” not that the plug itself was of predetermined dimensions. The court declines to include the limitation that of “predetermined dimensions” in the definition of “plug.”
(iii). Invalidity of Plaintiffs’ Construction
Lastly, AnazaoHealth argues that Plaintiffs’ attempts to construe “plug” in a manner than extends to bone wax renders the patent invalid for want of enablement under 35 U.S.C. § 112, ¶ 1, because the Patent does not enable the full scope of the invention claimed. AnazaoHealth asserts that Plaintiffs’ position puts this case squarely within the holding of AK Steel Corp. v. Sollac and Ugine, 344 F.3d 1234 (Fed.Cir.2003).
As AnazaoHealth correctly observes, when claims are amendable to more than one construction, they should be interpreted to sustain their validity if reasonably possible. See Rhine v. Casio, Inc., 183 F.3d 1342, 1345 (Fed.Cir.1999). Claims, however, “can only be construed to preserve their validity where the proposed claim construction is ‘practicable,’ is based on sound claim construction principles, and does not revise or ignore the explicit language of the claims.” Generation II Orthotics Inc. v. Med. Tech., Inc., 263 F.3d 1356, 1365 (Fed.Cir.2001). In Phillips, 415 F.3d at 1327, the Court acknowledged this “maxim,” but noted that it had not been applied broadly nor had the Federal Circuit endorsed “a regime in which validity analysis is a regular component of claim construction.” Instead, this principle has been limited to cases in which “the court concludes, after applying all the available tools of claim construction, that the claim is still ambiguous.” Id. (quoting Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 911 (Fed.Cir.), cert. denied, 543 U.S. 925, 125 S.Ct. 316, 160 L.Ed.2d 223 (2004)). “In such cases, [the Federal Circuit has] looked to whether it is reasonable to infer that the PTO would not have issued an invalid patent, and that the ambiguity in the claim language should therefore be resolved in a manner that would preserve the patent’s validity.” Id.
The first paragraph of section 112 provides in relevant part that the specification shall describe “the manner and process of making and using [the invention], in such clear and concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use [the invention].” The enablement requirement is met when one skilled in the art could, after reading the specification, practice the full scope of the claimed invention without undue experimentation. AK Steel, 344 F.3d at 1244. “That is not to say,” however, “that the specification itself must necessarily describe how to make and use every possible variant of the claimed invention, for the artisan’s knowledge of the prior art and routine experimentation can often fill gaps, interpolate between embodiments, and perhaps even extrapolate beyond the disclosed embodiments, depending on the predictability of the art.” Id. (citing Genentech, Inc. v. Novo Nordisk AJS, 108 F.3d 1361, 1366 (Fed.Cir.), cert. denied, 522 U.S. 963, 118 S.Ct. 397, 139 L.Ed.2d 310 (1997)).
In AK Steel, the Court held that the patent was invalid because the specification failed to enable the full scope of the patent claims where the patentee had made it clear that a specific type of material would not work with the invention, yet this material was encompassed within the construction of the claim. Id. at 1244. Here, however, as discussed above, unlike AK Steel, the patentees have not disavowed the use of any specific material, including bone wax, as a plugging material. Rather, they have disavowed the manner in which bone wax and other plugging materials were used or applied in the prior art. The Court does not find the Patent invalid for failure to meet the enablement requirement of section 112, paragraph 1.
The Court concludes that, in light of the specification, the words of the claims themselves, and the prosecution history, a person of ordinary skill in the art would interpret the claim term “plug” to mean “an object or material used to fill or seal an opening,” as urged by the World Wide Plaintiffs. Thus, Claim 1 would read in relevant part, “a needle assembly comprising a cannula ..., a line of elements ..., yieldable means, including a frictionally held object or material used to fill or seal an opening, for positioning an element more proximate the distal end a predetermined distance from the distal end.... ”
e. “Predetermined Distance”
The fif