DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Claims 45-58 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/1/2-26.
Claim Objections
Claims 59 and 60 are objected to because of the following informalities: “stretching under tension” appears to be worded in an awkward manner; it appears as though it would read slightly better if it was “stretches under tension.” Appropriate correction is required.
Applicant is advised that should claim 59 be found allowable, claim 60 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof (see the 35 USC 112(b) rejection below for the interpretation of the claim limitations, and why the Examiner perceives these claims as “duplicate”). When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 59 and 60 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 59 and 60 recites the limitation "the cellular infiltration" in the second line. There is insufficient antecedent basis for this limitation in the claim. When considering the claim language, it seems inappropriate for the claim to use the article “a” as in “a cellular infiltration;” however, if the article “the” was removed from both claims, and replaced with nothing, the claim would read properly and not include insufficient antecedent support.
Claim 60 is further indefinite because it is unclear if the claim is limited to the crosslinked soft tissue graft, per se, or if the composition must further comprise cells. When considering the claim language, “wherein the soft tissue graft is seeded with cells prior to implantation,” it would suggest that the cell seeding takes place after the graft is acquired by the artisan, and is a directive to the ordinary artisan to apply cells to the crosslinked graft. That is to say, the claim is drawn to an acellular soft tissue graft, wherein the artisan must add cells prior to implantation, it is not drawn to a crosslinked soft tissue graft that includes seeded cells. If this is an incorrect assessment of the claim limitation, the Applicant should amend the claim to something similar to the following:
60. A crosslinked soft tissue graft for implantation and tissue defect repair, wherein the soft tissue is seeded with cells, resistant to enzymatic degradation, and stretches under tension, wherein cellular infiltration after implantation is maintained.
The above assessment of claims drawn to an acellular graft seem reasonable, because the only discussion of cell seeding in the instant specification is provided in paragraph [0030], wherein there is no clear mention that the claimed composition must contain cells, only that the artisan must apply cells prior to implantation. Furthermore, all of the applied examples in the specification provide for acellular tissue grafts, further bolstering this assessment.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claim(s) 59-64 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Zeeman, et al (Journal of Biomedical Materials Research, 46, 424-433, 1999) and evidenced by Hiles, et al (Surgical Innovations, 16, 26-37, 2009). Zeeman teaches crosslinked dermal sheep collagen. See page 424, “Abstract” section. Zeeman explicitly teaches the claimed crosslinked soft tissue graft, but does not describe physical properties, like enzymatic degradation, stretching under tension, or the amount of cellular infiltration. Since it appears as though Zeeman teaches an identical graft, Zeeman’s graft must inherently possess identical physical properties. See MPEP 2112. As such, it appears as though the claimed graft is identical to the crosslinked soft tissue graft of Zeeman. However, since the claims provide for such a broadly claimed graft, the claimed graft may be an obvious variant of Zeeman’s.
It is also noted that the claim provides for a use, like tissue and hernia repair. However, these limitations are more drawn to an intended use, and do not necessarily further define structural or compositional elements of the claimed crosslinked soft tissue graft. Regardless, Hiles provides a review paper that indicates that decellularized soft tissue grafts, including those that have been crosslinked, are known to be used for tissue repair, including hernia repair. See page 26, “Abstract” Section. It should also be noted that several crosslinked soft tissue grafts are already commercially available. See page 27, Table 1.
With respect to claims 59 and 60, Zeeman teaches a crosslinked soft tissue graft that appears identical to the claimed soft tissue graft.
With respect to claim 61, Zeeman teaches a dermal matrix, while Hiles provides for a number of sources, including many of those claimed. See Table 1.
With respect to claims 62 and 63, although Zeeman does not appear to explicitly teach the degree of polymerization, Zeeman teaches the same crosslinking agent as provided in the applied examples in the instant specification, the di-epoxide: 1,4-butanediol diglycidyl ether (BDDGE). Zeeman also provides the crosslinking agent at a concentration range that overlaps with the range provided in the instant specification. See page 425, “Crosslinking” section. Although Zeeman does not explicitly teach the degree of crosslinking, based upon the amount of agent used, and comparing that to the amount provided in the applied examples, would suggest that Zeeman provides for a graft with crosslinking within the same range.
With respect to claim 64, although Zeeman teaches sheep dermis, Hiles makes it clear that there are a number of similar soft tissue grafts that are based upon human tissue. See Table 1.
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 59-64 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,561,762. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent provides for a soft tissue graft that overlaps in scope with the claimed soft tissue graft. The claimed soft tissue graft provides for “crosslinked soft tissue,” wherein a dependent claim describes the level of crosslinking. The patent provides for the same “crosslinked soft tissue,” but explicitly describes the degree of crosslinking to be between 10-40%, which overlaps with the range provided in the instant claims. The instant claims are significantly broader than the patent, wherein the patented graft would anticipate the claims of the instant graft.
Claims 59-64 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,318,228. Although the claims at issue are not identical, they are not patentably distinct from each other because the method of the patent would provide for the instantly claimed composition. Since there is no bar on double patenting rejections between inventions of different statutory categories, this rejection is appropriate. As long as the claimed invention can be anticipated by the claims of the patent, the instant claims can be considered double patenting with the patent.
Claims 59-64 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,097,305. Although the claims at issue are not identical, they are not patentably distinct from each other because the method of the patent would provide for the instantly claimed composition. Since there is no bar on double patenting rejections between inventions of different statutory categories, this rejection is appropriate. As long as the claimed invention can be anticipated by the claims of the patent, the instant claims can be considered double patenting with the patent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651
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