Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 1-4 and 18 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/30/2025.
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.
The term “weak” in claim 5 is a relative term which renders the claim indefinite. The term “weak” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 17 recites the limitation "the softening agent". There is insufficient antecedent basis for this limitation in the claim.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 5-7, 10 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (CN110101911).
Regarding claim 5, Wang teaches that it is known to endothelialize a biological heart valve (Example 1) by exposing it to a glutaraldehyde solution for crosslinking and thereafter cleaning the valve and thereafter exposing the material to a neutral or weakly alkaline solution comprising VEGF to the valve.
Regarding claim 6, grafting is optional in claim 5.
Regarding claim 7, the cleaning of Wang is performed to remove additional glutaraldehyde after the crosslinking reaction.
Regarding claim 10, the examples of Wang generally teach using growth factors in the amounts claimed.
Regarding claim 12, the phosphorylcholine compound of Example 1 is considered to be a phosphate buffer.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (CN110101911) as applied to claims 5-7, 10 and 12 above.
Regarding claim 13, the teachings of Wang are as shown above. Wang is silent as to the particular amount of desired endothelium present at the end of his reaction although his reaction is inherently ended. However, those of ordinary skill in the art would readily recognize that the amount of time which the process was allowed to continue would directly affect the total amount and density of the endothelial material formed. Therefore, in the absence of criticality of the specific content range of the current claims, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to control the reaction time of Wang in order to control the amount of endothelial tissue present on the final product of his invention. Discovery of optimum value of result effective variable in known process is ordinarily within skill of art. In re Boesch, CCPA 1980, 617 F.2d 272, 205 USPQ215.
Regarding claim 14, the teachings of Wang are as shown above. Wang fails to teach the timeframe for his reaction of the current claims. However, those of ordinary skill in the art would readily recognize that the amount of time which the process was allowed to continue would directly affect the total amount and density of the endothelial material formed. Therefore, in the absence of criticality of the time range of the current claims, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to control the reaction time of Wang in order to control the amount of endothelial tissue present on the final product of his invention. Discovery of optimum value of result effective variable in known process is ordinarily within skill of art. In re Boesch, CCPA 1980, 617 F.2d 272, 205 USPQ215. Further, Wang teaches the use of temperature in the range of the current claims as cited above. Further, in claiming both static and dynamic contact in the claim 16, the applicant has reasonably claimed all possible types of contact implying that Wang necessarily reads upon one of the other of these two types of contact.
Claim(s) 8-9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (CN110101911) as applied to claims 5-7, 10 and 12 above and further in view of Trantina-Yates et al. (“Mitigation of bioprosthetic heart valve degeneration through biocompatibility: in vitro versus spontaneous endothelialization”, Biomaterials (2001), 22, pp. 1837-1846).
Regarding claims 8-9, the teachings of Wang are as shown above. Wang fails to teach exposing the crosslinked glutaraldehyde composition to a capping agent. However, Trantina-Yates teaches that it is known to expose post glutaraldehyde treated implant material with a composition including a capping agent such as sodium borohydride for the purpose of detoxifying the implant material (see Section 2.2). Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to expose the glutaraldehyde treated implant of Wang with the detoxifying step of Trantina Yates comprising a capping agent for the purposes of detoxifying the implant of Wang as guided by Trantina-Yates.
Regarding claim 11, the teachings of Wang are as shown above. Wang fails to teach wherein the solution for endothelialization comprises amino acid and polypeptide. However, Trantina-Yates teaches that it is known to incorporate pooled serum (which contains both polypeptides and amino acids) into the endothelialization composition provided to implants that have already been glutaraldehyde treated. Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to include the improvement of the addition of pooled serum of Trantina-Yates to the similar glutaraldehyde treated implant of Wang as a simple improvement of similar products in the same way and wherein the results of said improvement would have been predictable based upon the teachings of Trantina-Yates.
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (CN110101911) as applied to claims 5-7, 10 and 12 above and further in view of Allred et al. (USPGPub 2023/0079298).
Regarding claim 15, the teachings of Wang are as shown above. Wang fails to teach exposing the tissue based implant to a softening solution prior art implant. However, Allred teaches that is known to expose medical implants to a softening solution prior to implantation in order to increase the flexibility of the components [0849] which may comprise glycerin and water and may further comprise PEG if desired. Further Allred supports the adding of ingredients by soaking the implantable material in the components to be added [0857]. Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to expose the implant material of Wang to the softening agent solution of Allred in order to provide flexibility to the implant of Wang as guided by Allred.
Regarding claims 16, the teachings of Wang in view of Allred are as shown above. Wang in view of Allred fails to state the percentage of glycerin present in the composition, although Allred explicitly teaches a desired amount of plasticizer in the final product. However, those of ordinary skill in the art would readily recognize that the amount of glycerin present in the soaking solution would directly affect the amount of glycerin present in the final product of Wang in view of Allred. Therefore in the absence of criticality of the specific volume percentage range of the current claims, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of glycerin in the treatment composition of Wang in view of Allred in order to control the amount of glycerin present in the final product of Wang in view of Allred.
Regarding claim 17, Wang generally teaches a final step of the production process is a drying/dehydration step (see Examples).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J BOWMAN whose telephone number is (571)270-5342. The examiner can normally be reached Mon-Sat 5:00AM-11:00AM.
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/ANDREW J BOWMAN/Examiner, Art Unit 1717