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 .
Applicant’s amendment and response filed on 1/23/2026 have been received and entered into the case. Claims 18-19 have been canceled. Claims 1-17 and 20 are pending and have been considered on the merits. All arguments have been fully considered.
Withdrawn Rejections
Rejections of Claim 7 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in view of applicant’s amendments.
Rejections of Claims 18-19 under 35 U.S.C. 101 are withdrawn in view of applicant’s amendments – Claims 18-19 have been canceled.
Rejections of Claim 18 under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Lauritzen et al (US 2011/0262515 A1; 10/27/2011.) are withdrawn in view of applicant’s amendments – Claim 18 has been canceled.
Rejections of Claim 19 under 35 U.S.C. 103 as being unpatentable over Lauritzen et al (US 2011/0262515 A1; 10/27/2011.) in view of Alavi et al (Ann Biomed Eng. 2013;41(3):547-561.) are withdrawn in view of applicant’s amendments – Claim 19 has been canceled.
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 1-17 and 20 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 2, the recitation of “the collagen fiber” is indefinite as it is unclear what / which collagen fiber is referred to by the term “the collagen fiber”. Applicant may amend claim 1 to recite “the 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 1-17 and 20 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 isolated collagen fibers having about 95% or greater purity. The claimed isolated collagen fibers are naturally occurring. 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. Claim 1 also recite a preparation method. However, the preparation method does not result in collagen fibers that are different from the naturally occurring collagen fibers. Thus, the 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 2-17 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 2-17 do not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 20 recites a heart valve leaflet made from the naturally occurring collagen fibers. Thus, the heart valve leaflet is a natural product, and does not add significantly more to the exception. Therefore, claim 20 does 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 1-17 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 tissue for implantation, comprising isolated collagen fibers having about 95% or greater purity, wherein the collagen fiber is produced by a method comprising: at least partially decellularizing a collagenous tissue; 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 tissue is produced by weaving, knitting, or wrapping the collagen fibers around each other, or fabricating a non-woven material from the collagen fibers.
Lauritzen teaches collagen fibers having about 95% or greater purity, 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).
The limitation of a “bioprosthetic tissue 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).
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 20 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 1-17 above, further in view of Alavi et al (Ann Biomed Eng. 2013;41(3):547-561.).
Lauritzen does not teach a heart valve leaflet (claim 20).
Alavi teaches bioprosthetic heart valve leaflets are formed from collagen fibers where collagen fibers reinforce the tissue and provide structural integrity (Abstract, p.7 para 3).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to form a bioprosthetic heart valve leaflet from collagen fibers, since it is a routine practice in the art to do so, as evidenced by Alavi. In addition, Alavi discloses that collagen fibers reinforce the tissue and provide structural integrity of the bioprosthetic heart valve leaflet. 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 form a bioprosthetic heart valve leaflet from collagen fibers with a reasonable expectation of success.
Response to Arguments
Applicant argues that claimed multiple steps of process (i.e, decellularization, homogenization, acid treatment) result in an isolated collagen fiber having different property than naturally occurring collagen fiber.
These arguments are not found persuasive because the claimed isolated collagen fiber after a series of treatment steps is still a collagen fiber that is not different from the naturally occurring collagen fiber. If there is a different property, Applicant may either point to the specification for support or recite the different property in the claims.
Applicant argues that Lauritzen does not disclose a bioprosthetic tissue form from the collagen fiber.
These arguments are not found persuasive. Please see above new rejections in view of applicant’s amendments.
Applicant argues that Alavi does not teach or suggest an implantable bioprosthetic tissue "artificially" produced from the isolated and processed collagen fibers, as claimed in claim 1.
These arguments are not found persuasive because Alavi is relied upon to demonstrate a bioprosthetic heart valve leaflet. Lauritzen does teach collagen fibers having about 95% or greater purity that are suitable for implantation.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Lynn Y Fan/
Primary Examiner, Art Unit 1759