DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 9, 2026 has been entered.
Claims 14-15 and 18-20 have been canceled. Claims 1-13 and 16-17 are pending and have been considered on the merits. All arguments have been fully considered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 and 16-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1, line 8, the recitation of “the collagen fiber” is indefinite. Claim 1 recites a plurality of isolated collagen fibers before the limitation “the collagen fiber”. It is unclear what / which collagen fiber is referred to on line 8. Applicant may amend claim 1 line 8 to recite “the plurality of isolated collagen fibers” to overcome the rejection.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 1 is directed to a bioprosthetic heart valve leaflet comprising a plurality of isolated collagen fibers having at least 95% collagen proteins, having collagen from bovine or porcine pericardial tissue, and having an average length of 10 mm or greater. The claimed isolated collagen fibers are naturally occurring, because natural collagen fibers have at least 95% collagen proteins and have a length of 10 mm or greater, both bovine and porcine pericardial tissues are composed primarily of wavy collagen fibers. There is no indication in the instant specification that the claimed isolated collagen fibers have any characteristics that are different from the naturally occurring collagen fibers. In addition, claim 1 recites a preparation method. However, the preparation method does not result in collagen fibers that are different from the naturally occurring collagen fibers. Finally, claim 1 recites a bioprosthetic heart valve leaflet in the preamble (an intended use limitation, which does not limit the isolated collagen fibers). A heart valve leaflet is a naturally occurring biological structure primarily composed of collagen fibers. The heart valve leaflet is a natural product, and does not add significantly more to the exception. Thus, said isolated collagen fibers do not have markedly different characteristics from their natural counterpart in their natural state, and are “product of nature” exception. Accordingly, claim 1 is directed to an exception. Therefore, claim 1 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claims 2-13 recite limitations regarding the preparation method. These limitations do not result in collagen fibers that are different from the naturally occurring collagen fibers, and do not add significantly more to the exception. Therefore, claims 2-13 do not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-13 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Lauritzen et al (US 2011/0262515 A1; 10/27/2011.).
The instant claims recite a bioprosthetic heart valve leaflet for implantation, comprising a plurality of isolated collagen fibers, wherein the plurality of isolated collagen fibers comprise at least 95% collagen proteins, wherein the plurality of isolated collagen fibers comprise collagen from bovine or porcine pericardial tissue, wherein the plurality of isolated collagen fibers has an average length of 10 mm or greater, and wherein the collagen fiber is produced by a method comprising: at least partially decellularizing a collagenous tissue from bovine or porcine pericardial tissue, without proteolytic enzymes; homogenizing the decellularized collagenous tissue to provide a homogenized suspension; separating a plurality of collagen fibers from the homogenized suspension; and exposing at least a portion of the plurality of collagen fibers to an acidic solution before or after separating, wherein the bioprosthetic heart valve leaflet is produced by weaving, knitting, or wrapping the isolated collagen fibers around each other, or fabricating a non-woven material from the isolated collagen fibers.
Lauritzen teaches collagen fibers having greater than about 98% purity, purified collagen fibers means that the fibers are treated, cleansed, or made suitable for implantation and for use as medical devices (para 0078), collagen strands having a length spanning hundreds of feet (para 0107, 0110), and Fig. 10 shows a prosthetic coated with the collagen fibers (para 0049).
The limitation of a “bioprosthetic heart valve leaflet for implantation” is regarded as intended use limitation. The claiming of a new use, function or unknown property does not necessarily make the composition patentable. The intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103. (MPEP 2112) In addition, Lauritzen does teach the purified collagen fibers means that the fibers are treated, cleansed, or made suitable for implantation and for use as medical devices (para 0078), and Fig. 10 shows a prosthetic coated with the collagen fibers (para 0049).
Furthermore, the limitation of “wherein the plurality of isolated collagen fibers comprise collagen from bovine or porcine pericardial tissue” merely identify the source of the collagen fiber, and not the collagen fiber itself. It has been well settled that the source of a product does not limit the product, unless the applicant provides evidence establishing an unobvious difference between the claimed product and the prior art product. (MPEP 2113)
The method-related limitations are regarded as product by process type limitations. The patentability of a product does not depend on its method of production. If the claimed product is the same or obvious from a product in the prior art (i.e. the product disclosed in the cited reference), the claim is unpatentable even though the reference product was made by a different process. When the prior art discloses a product which reasonably appears to be identical with or slightly different than the claimed product-by-process, rejections under 35 U.S.C 102 and/or 35 U.S.C 103 are proper. (MPEP 2113)
Therefore the reference anticipates the claimed subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Lauritzen et al (US 2011/0262515 A1; 10/27/2011.) as applied to claims 1-13 above, further in view of Li et al (IOVS. 2012;53(9):5675-5685.).
Lauritzen does not teach the collagen fibers comprise glycerol and have a water content of about 5% by weight or less (claim 16).
However, Lauritzen does teach glycerol is added to the collagen product (para 0187). Li teaches glycerol, a dehydrating agent, has excellent antibacterial, antifungal, and antiviral properties (p.5680 col right – para 1), and corneas preserved in 95% glycerol under vacuum ensured an anhydrous state (p.5684 col left – para 2).
The limitation of “wherein the method further comprises treating the portion of collagen fibers with a solution comprising glycerol” is regarded as a product by process type limitation. The patentability of a product does not depend on its method of production. If the claimed product is the same or obvious from a product in the prior art (i.e. the product disclosed in the cited reference), the claim is unpatentable even though the reference product was made by a different process. When the prior art discloses a product which reasonably appears to be identical with or slightly different than the claimed product-by-process, rejections under 35 U.S.C 102 and/or 35 U.S.C 103 are proper. (MPEP 2113)
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to obtain collagen fibers comprise glycerol and have a water content of about 5% by weight or less, since Lauritzen discloses that glycerol is added to a collagen product, and Li discloses that glycerol is a dehydrating agent having excellent antibacterial, antifungal, and antiviral properties. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to obtain collagen fibers comprise glycerol and have a water content of about 5% by weight or less, with a reasonable expectation of success.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Lauritzen et al (US 2011/0262515 A1; 10/27/2011.) as applied to claims 1-13 above, further in view of Parker et al (WO 2015/112839 A1; 7/30/2015.).
Lauritzen does not teach the bioprosthetic heart valve leaflet is glutaraldehyde-fixed (claim 17).
Parker teaches bioprosthetic valves are generally made from naturally-derived xenogeneic tissues fixed with glutaraldehyde-based processes, and bioprosthetic valves are constructed by constructing valve leaflets using pericardial sac, such as bovine-derived pericardium (p.2 para 1).
The limitation of “wherein the method further comprises treating the portion of collagen fibers with a solution comprising glutaraldehyde” is regarded as a product by process type limitation. The patentability of a product does not depend on its method of production. If the claimed product is the same or obvious from a product in the prior art (i.e. the product disclosed in the cited reference), the claim is unpatentable even though the reference product was made by a different process. When the prior art discloses a product which reasonably appears to be identical with or slightly different than the claimed product-by-process, rejections under 35 U.S.C 102 and/or 35 U.S.C 103 are proper. (MPEP 2113)
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to obtain a bioprosthetic heart valve leaflet that is glutaraldehyde-fixed, since Parker discloses that bioprosthetic valves are generally fixed in glutaraldehyde. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to obtain a bioprosthetic heart valve leaflet that is glutaraldehyde-fixed with a reasonable expectation of success.
Response to Arguments
Applicant argues that the claimed article is a bioprosthetic heart valve leaflet tissue produced by weaving, knitting, or wrapping isolated collagen fibers around each other, or fabricating a non-woven material from the isolated collagen fibers, that the claimed isolated collagen fibers have an average length of 10 mm or greater, that the claimed isolated collagen fibers comprise at least 95% collagen proteins and comprise collagen from bovine or porcine pericardial tissue, that the decellularization is performed without proteolytic enzymes, and that the specification defines "collagen fibers" as used herein to include collagen that is precipitated in a fibrous form.
These arguments are not found persuasive because: First, the limitation of a “bioprosthetic heart valve leaflet” is regarded as intended use limitation. The claiming of a new use, function or unknown property does not necessarily make the composition patentable. The intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. Second, claimed method steps including “produced by …” and “decellularization” are regarded as a product by process type limitation, the patentability of a product does not depend on its method of production, if the claimed product is the same or obvious from a product in the prior art (i.e. the product disclosed in the cited reference), the claim is unpatentable even though the reference product was made by a different process. Third, natural collagen fibers have a length of 10 mm or greater, at least 95% collagen proteins and comprise collagen from bovine or porcine pericardial tissue. Fourth, the instant specification does not disclose a clear definition of the term “collagen fibers”, instead, the instant specification provides examples of collagen fibers. Finally, applicant may amend claim 1 to include limitations from claims 16 and/or 17 to overcome 101 rejections.
Applicant argues that amended claim 1 recites a specific article of manufacture, a bioprosthetic heart valve leaflet, together with multiple structural and compositional product limitations that define the claimed article, that Lauritzen does not disclose collagen fibers comprising at least 95% collagen proteins, that Lauritzen does not disclose collagen fibers comprising collagen from bovine or porcine pericardial tissue, that amended claim 1 requires that the plurality of isolated collagen fibers has an average length of 10 mm or greater, that Lauritzen's enzymatic processing produces structurally different fibers from those claimed, and that Lauritzen's Fig. 10 does not disclose the claimed bioprosthetic heart valve leaflet tissue.
These arguments are not found persuasive because: First, the limitation of a “bioprosthetic heart valve leaflet” is regarded as intended use limitation. The claiming of a new use, function or unknown property does not necessarily make the composition patentable. The intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. Second, claimed method steps are regarded as a product by process type limitation, the patentability of a product does not depend on its method of production, if the claimed product is the same or obvious from a product in the prior art (i.e. the product disclosed in the cited reference), the claim is unpatentable even though the reference product was made by a different process (for instance, Lauritzen's enzymatic processing). Third, Lauritzen does teach collagen fibers having greater than about 98% purity suitable for implantation (as one skill in the art understands that collagen fibers used for implantation require high purity of the collagen protein) (para 0078), and collagen strands having a length spanning hundreds of feet (para 0107, 0110). Fourth, the limitation of “collagen fibers comprise collagen from bovine or porcine pericardial tissue” merely identify the source of the collagen fiber, and not the collagen fiber itself. It has been well settled that the source of a product does not limit the product. In addition, Lauritzen does teach pericardium may be used as starting material (para 0061), and Li does teach that bioprosthetic valves are constructed by constructing valve leaflets using pericardial sac, such as bovine-derived pericardium.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached on (571)272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759
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