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 .
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.
Election/Restrictions
Applicant’s election without traverse of group IV, claims 87-92, 94, 97-98 in the reply filed on 1/7/26 is acknowledged.
Claims 69-83, 87-92, 94-98 are currently pending.
Claims 69-83, 95-96 are withdrawn as directed to non-elected inventions.
Claims 87-92, 94, 97-98 are elected and examined on the merits.
Priority
The present application claims priority to prior-filed application, Application Nos. 62/220,227 and 62/334,440. The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed application, Application No. 62/220,227, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The earliest support for an unseparated amnion/chorion sheet having a hemoglobin content of less than about 10 ng per mg of dry mass of the sheet appears in application 62/334,440 filed 5/10/16. Consequently, independent claims 88, and by extension its dependents, claims 89-92, 94, 97-98, are accorded an earliest priority date of 5/10/16.
Information Disclosure Statement
Six IDS were received on 11/29/22, 11/29/22, 11/29/22, 1/16/25, 10/3/25, and 1/7/26. All references have been considered; however, due to the voluminous number of references in the IDS, and the limited time available for review, they have been only briefly considered. It is noted that the cloaking of a relevant reference by inclusion in a long list of citations may not comply with the Applicant’s duty of disclosure. Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948 (S.D. Fla. 1972). Therefore, the applicant is encouraged to present a concise statement as to the relevance of any particular documents known to be material for patentability as defined by 37 C.F.R. § 1.56.
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 87-92, 94, 97-98 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.
The term “substantially” in claim 87 is a relative term which renders the claim indefinite. The term “substantially” 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 88 contains the limitation “wherein the amnion, intermediate layer, and/or chorion”. The use of “and/or” renders the claim unclear as to which tissues are recited in the alternative. For examination purposes, this limitation is interpreted as “wherein at least one of the amnion, intermediate layer, and[[/or]] chorion is detached”.
Claim 94 contains the limitation “comprises nucleated… metalloproteinases, and/or hyaluronic acid”. The use of “and/or” renders the claim unclear as to which components are recited in the alternative. For examination purposes, this limitation is interpreted as “comprises at least one component selected from the group consisting of nucleated… metalloproteinases, and[[/or]] hyaluronic acid”..
The term “substantially” in claim 97 is a relative term which renders the claim indefinite. The term “substantially” 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 98 recites the limitation "the hemoglobin content". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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) 87 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Horton et al., US Publication No. 2013/0136773 (cited on IDS dated 7/6/20, hereinafter Horton).
Regarding claim 87, Horton discloses therapeutic placental membrane compositions, methods of making, and methods of use thereof (Abstract). Horton discloses dissecting a placenta cleaning the placenta to remove residual blood by washing ([0019]; removing residual blood is interpreted substantially removing blood remnants). In some embodiments, the placenta is then freeze-dried (i.e., dehydrated) ([0019]). Horton explains that the disclosed compositions may be useful for a variety of conditions, such as wounds and other conditions which are typical not considered for placental membrane treatment ([0005], [0021], [0025], [0031]-[0032], claims 39, 49).
Horton does not explicitly disclose that the placental sheet includes an intermediate layer between the amnion and chorion. However, this is a feature of a naturally occurring placenta. As Horton does not disclose separating or removing any portion of the placental membrane, it is inherent that, in at least in some embodiments, the placental membrane of Horton includes an intermediate layer.
Therefore, every limitation of claim 87 is present in Horton, and the subject matter is anticipated.
Claim(s) 87 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brahm, T., US Patent No. 10,905,800 (hereinafter Brahm).
Regarding claim 87, Brahm disclose ocular grafts fabricated from human birth tissues, and methods of making thereof (Abstract, col 4 ln 43-55). Brahm discloses obtaining human birth tissue material and removing placental globe, umbilical cord, other gelatins, fluids, cells, and extracellular matrix (col 5 ln 46-55). Brahm discloses that excess blood and fluids may be removed from the membrane by stirring or swirling the fluid, or by placing a basin on a shaker (col 6 ln 44-54; removing excess blood is interpreted substantially removing blood remnants). The membrane may be treated with an alcohol solution (i.e., dehydrated), air-dried and terminally sterilized (col 2 ln 18-26, col 7 ln 18-col 8 ln15).
Brahm does not explicitly disclose that the unseparated amnion chorion tissue comprises an intermediate layer. However, this is a feature of a naturally occurring placenta. As Brahm discloses utilizing an intact placental membrane comprising an amnion and chorion, it is inherent that the placental membrane of Brahm includes an intermediate layer.
Therefore, every limitation of claim 87 is present in Brahm, and the subject matter is anticipated.
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, 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) 88-92, 94, 97-98 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brahm as applied to claim 87 above.
Brahm does not explicitly disclose that the unseparated amnion chorion tissue comprises an intermediate layer. However, this is an inherent feature of a naturally occurring placenta. As Brahm discloses utilizing an intact placental membrane comprising an amnion and chorion, it is inherent that the placental membrane of Brahm includes an intermediate layer. Similarly, it is inherent that in an unmodified placental membrane, the intermediate layer would have a mean thickness in the range of about 5 µm to about 200 µm.
Brahm does not disclose that the composition has a hemoglobin content of less than about 10 ng/mg dry mass of the composition. Brahm also does not disclose that the composition has a certain dry mass, total protein content, water absorption potential, ore reduction in hemoglobin content. The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not the placental tissue sheet of the prior art differs, and if so to what extent, from applicant’s placental tissue sheet. The prior art discloses a placental tissue sheet which is similar to applicant’s placental tissue sheet for these reasons: Brahm discloses an unseparated placental membrane comprising the amnion and chorion, which is devoid of residual blood. Where an examiner cannot determine whether or not the reference inherently possesses properties which anticipate, or render obvious, the claimed invention a rejection under §103 is appropriate. See MPEP §§ 2112-2112.02. The cited art taken as a whole demonstrates a reasonable probability that the placental membrane of Horton is either identical or sufficiently similar to the claimed unseparated amnion/chorion sheet that whatever differences exist, they are not patentably significant. Therefore, the burden of establishing novelty or unobviousness by objective evidence is shifted to applicants. See MPEP § 2112(v). Clear evidence that placental sheet of the cited prior art does not possess a critical characteristic that is possessed by the claimed placental tissue sheet would advance prosecution and might permit allowance of claims to applicant’s claims. Applicant is requested to specifically point out the support for any amendments made to the disclosure and arguments in response to this Office Action, including the claims. See MPEP §§ 714.02 and 2163.06. Applicant is also requested to refer to pages and line numbers in the as-filed specification. It is noted that other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Regarding claim 91, Brahm discloses that the amniotic and chorionic membranes may be utilized alone or in various combinations to form a layered composition (col 4 ln 63-col 5 ln 10).
Regarding claim 94, Brahm discloses that the membrane may be coated or treated with optional components to aid in treatment such as cytokines and growth factors (col 9 ln 66-col 10 ln 15).
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 88, 91-92 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim18 of U.S. Patent No. 11, 413,372. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are all directed to a method of treating a wound of a subject by applying an unseparated amnion/chorion sheet, wherein the at least one unseparated amnion/chorion sheet comprises an intermediate layer having a mean thickness of greater than about 5 μm, and wherein the composition has a hemoglobin content of less than about 5 ng per mg of dry mass of the composition, wherein the composition is dehydrated, and wherein the unseparated amnion/chorion is detached from the placental disc and umbilical cord.
Claims 88, 91-92 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 27 of U.S. Patent No. 11,116,871. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are all directed to a method of treating a wound of a subject by applying an unseparated amnion/chorion sheet, wherein the at least one unseparated amnion/chorion sheet comprises an intermediate layer having a mean thickness of greater than about 5 μm, and wherein the composition has a hemoglobin content of less than about 5 ng per mg of dry mass of the composition, wherein the composition is dehydrated, and wherein the unseparated amnion/chorion is detached from the placental disc and umbilical cord. The ‘871 patent differs in that the amnion/chorion sheet comprises a perforation. However, the narrower scope of the ‘871 patent anticipates the broader composition of the present claims.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632