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.
Claim Status
Claims 87-92, 94, 97, 99-104 are currently pending and examined on the merits.
Claims 87-8, 94, 97 are currently amended.
Claims 99-104 are newly added.
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.
Claim Rejections - 35 USC § 102/103
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.
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) 87, 101-102 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Horton et al., US Publication No. 2013/0136773 (cited on IDS dated 7/6/20, hereinafter Horton).
Regarding claims 87, 101, 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).
Regarding claim 102, Horton discloses that the membrane retains various growth factors, trophic factors, and hyaluronic acid ([0004]).
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.
Horton is silent as to hemoglobin content of dry mass of the composition. 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: Horton 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 §§102/103 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.
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 claim 18 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.
Response to Arguments
Applicant’s arguments and amendments dated 6/30/26 have been fully considered but are moot in part due to the new grounds of rejection necessitated by applicant’s amendments, and not persuasive in part.
Claims 88, 91-92 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 11, 413,372. 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.
Applicant has advanced no arguments against the rejection and asked for the rejection to be held in abeyance (Response p11). The claims are considered to be in condition but for the rejections under nonstatutory double patenting. Therefore, the rejection is maintained.
Allowable Subject Matter
Claims 99-100, 103-104 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 87-92, 94, 97, 101-102 are rejected. Claims 99-100, 103-104 are objected to.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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.
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, Peter Paras can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632
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