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
The Amendments filed on 3/24/2026 has been received and entered.
Claims 16, 19-29, and 31-36 are pending. Claims 16, 19, 23, 26-29, and 31-36 examined on the merits. Claims 20-22, and 24-25 are withdrawn.
Election/Restrictions
Claims 20-22, and 24-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/24/2026.
Applicant's election with traverse of the species treating ovarian insufficiency, cyclophosphamide and busulfan, decreasing follicle stimulating hormone level in the reply filed on 3/24/2026 is acknowledged. The traversal is on the ground(s) that the cell-free fat extract is novel. This is not found persuasive because the election of species is not dependent on whether the invention is novel.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/11/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 16, 19, 23, 26-29, and 31-36 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.
Regarding claim 16 (1), the parenthesis with for example in "(eg. with physiological saline)" and (3) the phrase within the parenthesis “(that is, the fat layer containing fat cells) render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
In Claim 28, the term “naturally” obtained renders the claims vague and indefinite because one does not know what origin or process would make something "naturally" as opposed to not being "naturally". Some sort of extract process was performed to make each extract and thus it is unclear how those processes would be "naturally" versus not being "naturally". Therefore, the term “naturally” makes the claims unclear.
Claims dependent on a rejected claim are rejected for failing to cure the indefiniteness.
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.
Claim(s) 16, 19, 23, 26-29, and 31-36 are rejected under 35 U.S.C. 103 as being unpatentable over Horrobin et al. (BG 63892 B1) in view of Yu et al. (2018, Stem Cell Research & Therapy, 9: 294, pages 1-14), Gordon et al. (2011, Menopause, Vol. 18, No. 11:1244-1248), and Tilly (ES 2547953 T3).
Horrobin et al. teaches a method of treating any gonadal steroid for the treatment of any disease, but especially estrogens and progestogens for the treatment of ovarian insufficiency (l) with fat emulsion (1. Preparation of 20% emulsion of GLA and EPA diester with 1,3-propanediol). A subject in need would be patients with ovarian insufficiency. The method of promoting recovery of ovarian function by decreasing follicle stimulating hormone level would inherently occur because the fat emulsion would function the same when used for the same purpose.
However, Horrobin et al. does not teach the cell-free fat extract, ovarian insufficiency caused by chemical damage, and an injection.
Yu et al. teaches an adipose tissue is inherently rich with a variety of bioactive factors that might be directly isolated for clinical application without the cell isolation or cultivation process (page 2, right column, lines 4-7). Human liposuction aspirates were obtained from female donors (page 2, Methods, FE preparation). The lipoaspirate was first rinsed with saline to remove red blood cells and then centrifuged at 1200 × g for 3 min. After the first spin, the superior oily and inferior fluid layers were discarded, and the middle fat layer was collected and mechanically emulsified. The emulsification was achieved via 30 passes of shifting the fat between two 10-cm3 syringes connected by a female-to-female Luer-Lok connector (B. Braun Medical Inc., Melsungen, Germany). The emulsified fat was then frozen at − 80 °C and thawed at 37 °C for further disruption of the fat tissue. After one cycle of the freeze/thaw process, the fat was again centrifuged at 1200× g for 5 min. After a second spin, the fat was separated into four layers. The upper layer of oil was discarded; the second layer of unbroken fat and the fourth layer of debris was discarded; and the third aqueous layer, namely the FE, was carefully aspirated without contamination of the bottom pellet. The final extract was produced by passing it through a 0.22-μm filter (Corning Glass Works, Corning, NY, USA) for sterilization and removal of cell debris (page 3, left column, paragraph 1 and Fig. 1). There is no other debris; therefore, the limitation of Claims 26-27 are met. The fat emulsion is administered by injection (page 3, right column, middle of paragraph 1).
Gordon et al. teaches chemical damage due to chemotherapy-induced ovarian failure (CIOF) occurs in approximately 50%-70% of premenopausal women who receive adjuvant chemotherapy for breast cancer (page 1244, left column, lines 5-7). Chemotherapy agents include cyclophosphamide, methotrexate, and fluorouracil, and 15 (35%) received cyclophosphamide and doxorubicin with or without fluorouracil or paclitaxel, tamoxifen (Results, paragraph 2).
Tilly et al. teaches the long-term outcome of cancer treatment in women's ovarian function shows chemotherapy regimens containing busulfan resulted in an almost total incidence of premature ovarian insufficiency (page 34, image 22).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use the fat emulsion of Yu et al. because Yu et al. teaches an adipose tissue from female is inherently rich with a variety of bioactive factors that might be directly isolated for clinical application without the cell isolation or cultivation process (page 2, right column, lines 4-7) and Horrobin et al. teaches a method of treating ovarian insufficiency (l) with fat emulsion (1. Preparation of 20% emulsion of GLA and EPA diester with 1,3-propanediol). One would have been motivated to make a fat emulsion from female fat for the expected benefit of treating ovarian insufficiency. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to treat ovarian insufficiency caused by chemical damage because Gordon et al. teaches chemical damage due to chemotherapy-induced ovarian failure (CIOF) received cyclophosphamide, methotrexate, and fluorouracil, and 15 (35%) received cyclophosphamide and doxorubicin with or without fluorouracil or paclitaxel, tamoxifen (Results, paragraph 2) and Tilly et al. teaches the long-term outcome of cancer treatment in women's ovarian function shows chemotherapy regimens containing busulfan resulted in an almost total incidence of premature ovarian insufficiency (page 34, image 22). One would have been motivated to use cell free fat extract for the expected benefit of treating those with ovarian dysfunction due to chemical damages after chemotherapy. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached on Monday-Friday 9-5:30 PM.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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