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 .
Status of the Claims
Claims 1-20 are pending (claim set as filed on 08/01/2023).
Priority
This application filed on 08/01/2023 has a provisional application no.: 63/395,252 filed on 08/04/2022.
Information Disclosure Statement
No Information Disclosure Statement (IDS) has been filed in this application. Applicant is reminded that each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the U.S. Patent and Trademark Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability (see 37 C.F.R. §1.56).
Drawings
No drawings were filed in this application.
Claim Interpretation
Regarding the claim’s recitation of “optionally”, the MPEP 2111.04 states that “a claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”.
Claim 9 contains limitations that pertain to steps of making, preparing, or obtaining growth factors. However, its base claim 1 is drawn to a methodology treatment of infertility. Thus, the interpretation of claim 9 is analogous to a product-by-process limitation (MPEP 2113) wherein the claimed invention as a whole is a method of use and not the process of making the composition. Therefore, the preparation steps have been considered but the emphasis of examination is based on the administration of growth factors.
Claim Rejections - 35 USC §112, Indefinite
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.
Claims 1-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 1, the recitation of “b) administering a regenerative cell population in a manner to stimulate ovarian functionality; c) administering a regenerative cell population in a manner to stimulate ovarian functionality” is rejected as being indefinite because it is not clear if step c) was an inadvertent duplicate entry or whether it was intended as a repetition step. If the latter was intended, it is suggested that step c) recites repeating the administration of a regenerative cell population. Appropriate clarification is requested.
Furthermore, claim 1 recites the phrase “an agent or plurality of agents which alter the host in order to enhance ability of administered regenerative cells to provide a therapeutic benefit” is deemed to be indefinite. The MPEP 2173.05(g) states that “A claim term is functional when it recites a feature “by what it does rather than by what it is” (e.g., as evidenced by its specific structure or specific ingredients)” and “When a claim limitation employs functional language, the Examiner’s determination of whether the limitation is sufficiently definite will be highly dependent on context (e.g., the disclosure in the specification and the knowledge of a person of ordinary skill in the art)”. However, in the instant case, the claimed term of “an agent” is considered to be broad and vague because one of ordinary skill in the art cannot envisage the structure of the compound/molecule wherein the instant specification provides no definition of said phrase and no guidance as to what said agents are. The MPEP 2173.05(g) further states that “The primary inquiry is whether the language leaves room for ambiguity or whether the boundaries are clear and precise” and therefore, in this case, the scope of the claims are unclear as it could be alleged that any agent may alter the host to provide a therapeutic benefit.
Regarding claim 2, which recites “The method of claim 1, wherein said mesenchymal stem cells” wherein MSCs were not previously introduced in its base claim. Thus, there is insufficient antecedent basis for this limitation in the claim.
Regarding claim 18, the phrase “(e.g.,)” means for example which renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention (MPEP 2173.05(d): Exemplary Claim Language).
Regarding claims 19-20, which recites “The method of claim 1, wherein the autologous regenerative cells” wherein autologous cells were not previously introduced in its base claim. Thus, there is insufficient antecedent basis for this limitation in the claim.
Regarding claim 20, which appears to recite brand name or trademark/trade name fertility hormones. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name.
Claims 3-17 are rejected because they are dependent claims that do not overcome the deficiencies of the rejected claim from which they depend.
Claim Rejections - 35 USC §102, Anticipation
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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim (US 2018/0296608 A1).
Kim’s general disclosure relates to “a pharmaceutical composition containing spheroidal cell aggregates for improving ovarian functions and a method of preparing the same and more particularly to a pharmaceutical composition which is applicable to relieving or treating early ovarian failure, infertility/subfertility, early menopausal, menopausal and climacteric symptoms by producing placenta derived mesenchymal stem cells in the form of spheroidal cell aggregates” (see abstract & ¶ [0001], [0009]).
Kim teaches “In addition, regarding the use for preparation of the pharmaceutical composition for improving ovarian functions, the pharmaceutical composition for improving ovarian functions may be formulated in the form of an injection” (see ¶ [0024], [0030]).
Regarding claims 2-4 pertaining to the mesenchymal stem cells, Kim teaches placenta-derived mesenchymal stem cells (see ¶ [0029], [0044]-[0047], [0125]-[0131]).
Claim Rejections - 35 USC §103, Obviousness
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 non-obviousness.
Claims 5-11, 16-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kim as applied to claims 1-4 above, and in view of Cheng (Extracorporeal Shock Wave Therapy Combined with Platelet-Rich Plasma during Preventive and Therapeutic Stages of Intrauterine Adhesion in a Rat Model, 2022).
Kim’s teaching is discussed above as it pertains to a method for treatment of infertility comprising administering mesenchymal stem cells to stimulate ovarian functionality.
However, Kim does not teach: administration of extracorporeal shock waves (claims 5-8); or administering platelet-rich-plasma (PRP) growth factors (claims 9-16).
Cheng discloses that intrauterine adhesion is a major cause of female infertility (see abstract & page 1: Introduction).
Cheng teaches the combination of extracorporeal shock wave therapy and platelet-rich-plasma (PRP) for the treatment of intrauterine adhesion (see abstract). Cheng teaches using autologous PRP (see page 3: Section 2.4) wherein “PRP releases growth factors and cytokines, such as vascular endothelial growth factor (VEGF), platelet-derived growth factor, epidermal growth factor (EGF), transforming growth factor (TGF), and other cytokines that modulate angiogenesis, affect recruitment proliferation and stimulate cell differentiation and growth. Thus, PRP therapy of the uterus and other tissues is a research hotspot for endometrial regeneration” (see page 2, 2nd full ¶). Cheng teaches using shock wave ranging of ESWT (0.1 mJ/mm2, 200 pulses) applicator (see page 3: Section 2.6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ the combination of extracorporeal shock wave therapy and platelet-rich-plasma (PRP) such as taught by Cheng in the method of Kim. The ordinary artisan would have been motivated to do so because Cheng teaches such combination was beneficial for treatment of intrauterine adhesion and infertility.
Regarding claims 17 and 20, Cheng discloses “Treatment with human umbilical cord mesenchymal stem cell-extracellular vesicles (UCMSC-EVs) alone or combined with estrogen significantly decreased not only inflammatory cytokines, such as TNF-α and IL-6, but also fibrosis markers, such as TGF-β, COL1α1, and VEGF. Xavier et al. have reported a pilot cohort study in which autologous CD133+ bone marrow-derived stem cells offered a safe and efficient therapeutic approach for patients with refractory Asherman’s syndrome, improving endometrial cavity and endometrial thickness” (see page 14, 2nd full ¶). Thus, the use of autologous, bone-marrow cells, and fertility agent is prima facie obvious.
Conclusion
No claims were allowed.
Correspondence Information
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653