DETAILED ACTION
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 .
Priority
This application is a CONTINUATION of U.S. Patent Application No. 16/849,694, filed 08/10/2024. Acknowledgement is made of the applicant’s claim for benefit to prior-filed U.S. patent applications 16/849,694, which was filed 04/15/2020.
Claim Objections
Claims 20-23 are objected to because of the following informalities:
The formality of alphabetic sequencing in claims 20, 22 and 23 is not consistent. For instance, claims 20 recites step f), while claim 22 recites step (f) in line 2.
Claim 21 recites “€” should be “e)”.
Claim 23 recites step h) after step j), it should be step k) in line 10.
Appropriate correction is required.
Claim Interpretation
Instant claims are directed to a bioprosthetic heart valve assembly (a product), the bioprosthetic heart valve assembly has a plurality of leaflets, wherein each of the plurality of leaflets is a collagen-based pericardial tissue made by a process as recited in instant claims. The claims are product-by-process claims. MPEP 2113 states: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In instant case, the disclosure of the structure is a bioprosthetic heart valve assembly comprising a plurality of leaflets, wherein each of the plurality of leaflets is a collagen-based pericardial tissue (having glutaraldehyde crosslinking).
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.
(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 20-23 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Cali et al. (US 2012/0035720 A1), as evidenced by Sizeland et al. (Biomed Res Int. 2014;2014:189197).
As stated above, claims 20-23 are product-by-process claims, which are directed to a bioprosthetic heart valve assembly (a product), the bioprosthetic heart valve assembly has a plurality of leaflets, wherein each of the plurality of leaflets is a collagen-based pericardial tissue (having glutaraldehyde crosslinking).
Cali et al. teach a prosthetic heart valve assembly comprises a plurality of leaflets configured to replace the function of a native heart valve. Each leaflet comprises laminar pericardium tissue (Abstract).
Regarding claims 20-23, Cali et al. teach a prosthetic heart valve assembly comprises a plurality of leaflets configured to replace the function of a native heart valve (Abstract), which is a replacement heart valve having one or more leaflets that are cut from a source material and assembled to form the valve (parag 0021). This teaching reads on “a bioprosthetic heart valve assembly having a plurality of leaflets” as recited in instant claims. Cali et al. teach leaflets can be formed from the flexible material comprises equine pericardium that has been crosslinked and fixed in a low-concentration, buffered glutaraldehyde solution (see parag 0030). Pericardium is a collagen-based tissue, which is evidenced by Sizeland et al.. Sizeland et al. teach pericardium is a fibrous collagen extracellular matrix material with structural similarities to skin and other tissues (p1, left column). This teaching reads on “each of the plurality of leaflets is a collagen-based pericardial tissue” as recited in instant claims. Therefore Cali et al. anticipate the bioprosthetic heart valve assembly having a plurality of leaflets, wherein each of the plurality of leaflets is a collagen-based pericardial tissue, as recited in instant claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 20-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. US 12,083,009 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims render obvious the instant claims.
Instant claims 20-23 are directed to a bioprosthetic heart valve assembly having a plurality of leaflets, wherein each of the plurality of leaflets is a collagen-based pericardial tissue made by a method comprising steps a) to k) as recited in instant claims. Patent claims 1-4 teach a method for preparing a collagen-based pericardial tissue that is used for a bioprosthetic heart valve assembly comprising the method as recited in steps a)-k). It would have been prima facie obvious to one of ordinary skill in the art to be motivated by the method in the patent and produce the bioprosthetic heart valve assembly as recited in instant claims. There would be a reasonable expectation of success of producing the bioprosthetic heart valve assembly as recited in instant claims since the patent teaches the method of making said product.
Conclusion
No claims are allowed.
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/Q.G./Examiner, Art Unit 1633
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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