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 .
DETAILED ACTION
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.
Election/Restrictions
Applicant’s election without traverse of Invention II, claims 23-30, in the reply filed on Jun. 18, 2026 is acknowledged.
Claims 1-30 remain pending in the current application, claims 1-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
The requirement for the restriction of Inventions I and II is still deemed proper and is therefore made FINAL.
Claims 23-30 have been considered on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) and 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). 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 applications, Application No. 63/492,210, 17/846,725 and 17/846,845, fail 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 provisional Appl. No. 63/492,210 does not provide support for the composition of claim 23 containing an excipient and does not provide support for a composition containing 10,000 to 100,000 ovarian support cells as recited in claims 23 and 26. Appl. No. 63/492,210 only provides support for 100,000 support cells, but not for the claimed range. Appl. No. 63/492,210 does not provide support for the cells heterologously expressing RUNX1 as recited in claims 24 and 27. Appl. No. 63/492,210 does not provide support for the concentration ranges disclosed in claim 30 of the cell culture medium components. Accordingly, claims 23-25, 27, and 30 are not entitled to the benefit of Appl. No. 63/492,210. The subject matter disclosed in in claims 23-30 is not provided in Appl. Nos. 17/846,725 and 17/846,845. Accordingly, claims 23-20 are not entitled to the benefit of Appl. Nos. 17/846,725 and 17/846,845.
This application repeats a substantial portion of prior Appl. Nos. 17/846,725 and 17/846,845, both filed Jun. 22, 2022, and adds disclosure not presented in the prior application. For instance the specification has expanded from 35 pages to 133 pages and the drawings, Fig. 1B, Fig. 2C, Fig. 3B, Fig. 6C, Fig. 6D, Fig. 7B, and Figs. 9-24 are new. Because this application names the inventor or at least one joint inventor named in the prior application, it may constitute a continuation-in-part of the prior application.
Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Status of the Claims
Claims 1-30 are currently pending.
Claims 1-22 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 23-30 have been considered on the merits.
Drawings
The disclosure is objected to because of the following informalities:
The drawings are objected to because of the following informalities: illegible text in Figures 22D and 24.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
The disclosure is objected to because of the following informalities: minor grammatical error in claims.
Claims 23, 24, 25 and 29 are objected to because of the following informalities: the first time an acronym is utilized in a claim-set, said acronym should be spelled out in its entirety followed by said acronym in parenthesis (e.g. germinal vesicle (GV)-stage, meiosis I (MI)-stage, forkhead box protein L2 (FOXL2), nuclear receptor subfamily 5 group A member 1 (NR5A1), GATA binding protein 4 (GATA4), Runt-related transcription factor 1 (RUNX1), Runt-related transcription factor 2 (RUNX2), nuclear receptor subfamily 2 group F member 2 (NR2F2), follicle stimulating hormone (FSH), human chorionic gonadotropin(hCG)).
Claim 25 is objected to for missing either “and/or”, “and” or “or” between options (a) and (b).
Appropriate corrections are appreciated.
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.
(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 23-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoshino et al. (Science, 2021) (ref. of record).
With respect to claims 23, 24, 26 and 27, Yoshino teaches an ex vivo composition containing a population of ovarian support cells expressing FOXL2 and NR5A1 (pg. 3 Col. 2 para. 2 and Fig. 2). Yoshino teaches the composition containing 75,000 or 100,000 Nr5a1-h CD271 positive cells or fetal ovarian somatic cell-like cells (FOSLCs) with pluripotent stem cell-derived primordial germ cell-like cells (PGCLCs) (pg. 3 Col. 3 last para.). Yoshino teaches the composition containing FOSLCs with MI-stage oocytes (Fig. 4 and pg. 9 para. 2). Further with respect to claims 23 and 26, Yoshino teaches the culturing the cells which one of ordinary skill in the art would readily recognize that the composition contains medium or a diluent (pg. 9 para. 2).
With respect to claims 25 and 28, Yoshino teaches the Nr5a1-h CD271 positive cells include FoxL2-positive granulosa cells and stromal cells (pg. 4 Col. 2 para. 1 and pg. 7 Col. 1 para. 1). It is noted that claims 25 and 28 recite that the ovarian granulosa cells optionally can be steroidogenic and the term “optionally” does not require that the ovarian granulosa cells be steroidogenic.
Therefore, the reference anticipates the claimed subject matter.
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.
Claims 23-30 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshino et al. (Science, 2021) (ref. of record) in view of Mohsenzadeh et al. (Reproduction, 2001).
With respect to claims 23, 24, 26 and 27, Yoshino teaches an ex vivo composition containing a population of ovarian support cells expressing FOXL2 and NR5A1 (pg. 3 Col. 2 para. 2 and Fig. 2). Yoshino teaches the composition containing 75,000 or 100,000 Nr5a1-h CD271 positive cells or fetal ovarian somatic cell-like cells (FOSLCs) with pluripotent stem cell-derived primordial germ cell-like cells (PGCLCs) (pg. 3 Col. 3 last para.). Yoshino teaches the composition containing FOSLCs with MI-stage oocytes (Fig. 4 and pg. 9 para. 2). Further with respect to claims 23 and 26, Yoshino teaches the culturing the cells which one of ordinary skill in the art would readily recognize that the composition contains medium or a diluent (pg. 9 para. 2).
With respect to claims 25 and 28, Yoshino teaches the Nr5a1-h CD271 positive cells include FoxL2-positive granulosa cells and stromal cells (pg. 4 Col. 2 para. 1 and pg. 7 Col. 1 para. 1). It is noted that claims 25 and 28 recite that the ovarian granulosa cells optionally can be steroidogenic and the term “optionally” does not require that the ovarian granulosa cells be steroidogenic.
Yoshino is silent with respect to components of the medium and does not teach the cell culture medium containing the components recited in claims 29 and 30.
However, Mohsenzadeh teaches an IVM (in vitro maturation) medium containing 100 mIU/ml of hCG, 75 mIU/ml of FSH, and human serum albumin (pg. 151 para. 1). Mohsenzadeh further teaches that the media that they tested was associated with good outcomes (pg. 156 last para.).
Accordingly, at the effective time of filing of the claimed invention one of ordinary skill in the art would have been motivated to modify the composition of Yoshino so that the cell culture medium contains 100 mIU/ml of hCG, 75 mIU/ml of FSH, and human serum albumin for the benefit of using a known medium for IVM as taught by Mohsenzadeh. It would have been obvious to one of ordinary skill in the art to use medium known in the art for IVM in the composition containing ovarian support cells and GV-stage or MI-staged oocytes taught by Yoshino, since Yoshino is directed to developing oocytes in culture (abstract). One ordinary skill in the art would have had a reasonable expectation of success in making such a modification to Yoshino, since cell cultures containing 100 mIU/ml of hCG, 75 mIU/ml of FSH, and human serum albumin where known to be used successfully to mature oocytes in culture as taught by Mohsenzadeh (abstract and Table 2).
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claims 29 and 30 are rejected under 35 U.S.C. 103(a) as being unpatentable over Yoshino in view of Mohsenzadeh (as applied to claims 23-30 above), and further in view of de Prada et al. (Fertility and Sterility, 2009) as evidenced by Ince (US 2014/0170693 A1).
The teachings of Yoshino and Mohsenzadeh can be found in the previous rejection above.
Neither Yoshino or Mohsenzadeh teach the claimed composition where the medium contains androstenedione or androstenedione at a concentration of 495-505 ng/ml as recited in claims 29 and 30, respectively.
However, de Prada teaches a composition containing cumulus-oocyte complex (COC) a medium containing bovine calf serum, 0.03 IU/ml hFSH and 1 µg/mL androstenedione for the maturation of the oocytes (pg. 2044 Col. 2 para. 1). One of ordinary skill in the art would have been motivated to modify the composition taught by combined teachings of Yoshino and Mohsenzadeh to include androstenedione for its known use in cell culture media used for maturing oocytes in culture with support cells as taught by de Prada. Furthermore, it would have been obvious to one of ordinary skill in the art to modify the composition taught by the combined teachings of Yoshino and Mohsenzadeh to include the combination of hormones, proteins, and steroids replicates the intrafollicular environment. Additionally, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification, since Yoshino and Mohsenzadeh teach cell culture media for culturing and developing oocytes along with support cells in culture and de Prada teaches a similar composition containing androstenedione for maturing oocytes.
Although de Prada does not teach the exact ranges recited in claim 30, one of ordinary skill in the art would recognize that the concentration of androstenedione in a cell culture medium is a result effective variable and that the concentration of androstenedione would be matter of routine optimization as evidenced by Ince. Ince teaches that the concentration of a given ingredient in a cell culture medium is routinely optimized for specific cell types (0070). The concentrations of media components are routinely adjusted in cell culture compositions depending on such factors such as the cell types, the culture conditions and the desired outcomes.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached on 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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/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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