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 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5 May, 2026 has been entered.
Election/Restrictions
Applicants elected treating a recipient of an ovary transplant (ovary, cells, or tissue) with SEQ ID 1 and no other therapy without traverse in the reply filed on 31 March.
Claims Status
Claims 4-21 are pending.
Claim 21 is new.
Claims 7, 9-11, 14, 15, and 18 have been withdrawn due to an election restriction requirement.
Withdrawn Rejections
The provisional rejection of claims 4-6, 8, 12, 13, 16, 17, 18, and 19 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/210,454 (US 20210244789) in view of Soleimani et al (PLoS ONE (2011) 6(4) e19475) is hereby withdrawn due to the amendment of the competing claims.
Maintained/Modified Rejections
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.
Claims 4-6, 8, 12, 13, 16, 17, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Barnea (US 20150125886) in view of Soleimani et al (PLoS ONE (2011) 6(4) e19475).
Applicant’s elected invention is a method of restoring endocrine function with an ovarian tissue transplant comprising administering a PIF peptide after transplantation.
Barnea discusses modulating the immune system (title). PIF peptides inhibit activated immunity but not basal immunity (abstract), and allows for tolerance of foreign tissue in a different context than claimed by applicants (paragraph 2). They can be used to reduce inflammation and to treat immune mediated disorders (paragraph 32), including an animal model of graft vs. host disease (paragraph 110-116). This suggests that it will help prevent attack of an immune system vs. a foreign tissue implant, as both cases are tolerance of a mismatch between the immune system and a tissue. In animal models, low doses (0.1-1 mg/kg/day) and higher doses (2.73 and 5 mg/kg/day) proved effective, with even higher doses less effective or not effective at all (paragraph 76). Dosing is not particularly limited, with intravenous, oral, ocular, by inhalation, injectable, and various other methods explicitly mentioned (paragraph 92, for example). The material provided a long term effect, much longer than the pharmacokinetics of the peptide would suggest (paragraphs 82-84). Examples using an animal model of graft vs. host disease used an implanted pump in the back of the mice the day of the of transplant (i.e., administered after the transplant) (paragraph 110). Note that the sequence used is identical to that of SEQ ID 1 of the instant claims (paragraph 108), applicant’s elected species, and at least one example uses no other drug (paragraph 112). Pharmaceutical formulations are discussed (paragraph 94).
The difference between this reference and the examined claims is that this reference does not discuss ovarian tissue transplant.
Soleimani et al discuss ovarian tissue transplantation (title). Currently, this is performed with only genetically identical tissue, but when safer immune suppression agents become available, it can be performed between non-identical individuals (5th page, 2nd column, 3d paragraph).
Therefore, it would be obvious to use the PIF peptide of Barnea in the ovarian tissue transplant of Soleimani et al, to reduce the rejection of non-identical tissue. As Soleimani et al state that this process should work with effective immune suppression agents, and Barnea teaches that the peptide will induce immune tolerance, an artisan in this field would attempt this therapy with a reasonable expectation of success.
Soleimani et al discuss ovarian tissue transplantation using immunosuppressants with lower side effects. Barnea shows that PIF peptide will treat immune issues. Note that there is no point in transplanting ovarian tissue except for fertility reasons or for the hormones it releases – i.e. endocrine function. Thus, the combination of references renders obvious claims 4 and 5.
Barnea has at least one example of inducing transplant tolerance with treatment with just the peptide, rendering obvious claims 6, 18, and 12.
Barnea discusses long term activity, rendering obvious claim 13.
Barnea gives an example where administration occurs after transplant, rendering obvious claims 14 and 15.
While Barnea does not discuss the mechanism of action, this is the same drug used to treat the same patient population, so it will necessarily have the same mechanism of action. Thus, the combination renders obvious claims 16 and 17.
Barnea discusses pharmaceutical formulations, rendering obvious claims 18 and 19.
Barnea has an example where only the peptide is used, rendering obvious claim 21.
response to applicant’s arguments
Applicant argues that the failure described by Soleimani et al teach away from the invention, that there is no reasonable expectation of success, that Barnea does not discuss ovarian transplantation, and argue unexpected results of long term non-rejection in a primate model.
Applicant's arguments filed 5 May, 2026 have been fully considered but they are not persuasive.
Applicant argues that the failure of the experiment described by Soleimani et al teaches away from the invention. Yet the reference clearly states that the approach can be successful with improved therapies, as mentioned in the rejection. That is not a document that will lead a person of skill in the art away from the combination.
Applicant points to a number of different phenomenon that happen with tissue rejection to argue that there is no reasonable expectation of success. Yet all these phenomenon are tied to the immune system attacking the transplant; a phenomenon that Barnea strongly suggests will be reduced or eliminated by treatment with the peptide of SEQ ID 1.
Applicant argues that Barnea does not discuss ovarian transplantation. Note that if it did, the reference would anticipate the claims. However, as a rejection under 35 USC 103, there is no need for any one reference to describe every limitation of the claims; in this case, Suleimani et al makes up that lack.
Applicant argues the unexpected result of success in a primate model because Soleimani et al show failure. However, Barnea shows that the peptide stops immune rejection, even after the peptide has been cleared from the system. This makes applicant’s results expected. Note that unexpected results are compared to the closest prior art (MPEP 716.02(e)), which is assumed to be the primary reference (Barnea).
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
first rejection
Claims 4-6, 8, 12, 13, 16, 17, and 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 7,723,290 in view of Soleimani et al (PLoS ONE (2011) 6(4) e19475).
Competing claim 1 describes treatment of graft vs. host disease, comprising administering SEQ ID 13, identical with SEQ ID 1 of the examined application.
The difference between the competing claims and the examined claims is that the competing claims do not list ovarian transplant.
Soleimani et al discuss ovarian tissue transplantation (title). Currently, this is performed with only genetically identical tissue, but when safer immune suppression agents become available, it can be performed between non-identical individuals (5th page, 2nd column, 3d paragraph).
Therefore, it would be obvious to use the peptide of the competing claims to treat the ovarian transplant of Soleimani et al, as both references are discussing mitigating the effect of an immune system on tissue. As this is the same effect in both cases, an artisan in this field would attempt this treatment with a reasonable expectation of success.
response to applicant’s arguments
Applicants have repeated the same arguments as with respect to the rejection under 35 USC 103, which were answered above.
second rejection
Claims 4-6, 8, 12, 13, 16, 17, and 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8,454,967 in view of Soleimani et al (PLoS ONE (2011) 6(4) e19475).
Competing claim 1 describes treatment of an immune related disorder, comprising administering SEQ ID 13, identical with SEQ ID 1 of the examined application.
The difference between the competing claims and the examined claims is that the competing claims do not list ovarian transplant.
Soleimani et al discuss ovarian tissue transplantation (title). Currently, this is performed with only genetically identical tissue, but when safer immune suppression agents become available, it can be performed between non-identical individuals (5th page, 2nd column, 3d paragraph).
Therefore, it would be obvious to use the peptide of the competing claims to treat the ovarian transplant of Soleimani et al, as the immune rejection of Soleimani et al is a subgenus of the immune disorders of the competing claims. As the competing claims list a large number of disparate immune disorders (claim 5), an artisan in this field would attempt this therapy with a reasonable expectation of success.
response to applicant’s arguments
Applicants have repeated the same arguments as with respect to the rejection under 35 USC 103, which were answered above.
third rejection
Claims 4-6, 8, 12, 13, 16, 17, and 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,806,771 in view of Soleimani et al (PLoS ONE (2011) 6(4) e19475).
Competing claim 1 describes treatment of graft vs. host disease, comprising administering SEQ ID 13, identical with SEQ ID 1 of the examined application.
The difference between the competing claims and the examined claims is that the competing claims do not list ovarian transplant.
Soleimani et al discuss ovarian tissue transplantation (title). Currently, this is performed with only genetically identical tissue, but when safer immune suppression agents become available, it can be performed between non-identical individuals (5th page, 2nd column, 3d paragraph).
Therefore, it would be obvious to use the peptide of the competing claims to treat the ovarian transplant of Soleimani et al, as both references are discussing mitigating the effect of an immune system on tissue. As this is the same effect in both cases, an artisan in this field would attempt this treatment with a reasonable expectation of success.
response to applicant’s arguments
Applicants have repeated the same arguments as with respect to the rejection under 35 USC 103, which were answered above.
fourth rejection
Claims 4-6, 8, 12, 13, 16, 17, and 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, and 16 of U.S. Patent No. 11,096,987 in view of Soleimani et al (PLoS ONE (2011) 6(4) e19475).
Competing claim 1 describes a series of PIP peptide analogs. Competing claim 7 specifies treating an autoimmune disorder, while competing claim 16 specifies treatment of graft vs. host disease, comprising administering the PIP peptide analogs.
The difference between the competing claims and the examined claims is that the competing claims do not list ovarian transplant.
Soleimani et al discuss ovarian tissue transplantation (title). Currently, this is performed with only genetically identical tissue, but when safer immune suppression agents become available, it can be performed between non-identical individuals (5th page, 2nd column, 3d paragraph).
Therefore, it would be obvious to use the peptide of the competing claims to treat the ovarian transplant of Soleimani et al, as both references are discussing mitigating the effect of an immune system on tissue. As this is the same effect in both cases, an artisan in this field would attempt this treatment with a reasonable expectation of success.
response to applicant’s arguments
Applicants have repeated the same arguments as with respect to the rejection under 35 USC 103, which were answered above.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
Examiner interviews are available via telephone 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, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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