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 .
Claim status
In the reply on 27 March 2026 Applicant has amended claim 6; cancelled claims 7-12 and added new claims 14-27. Therefore, claims 3-6 and 13-27 are pending.
To expedite the compact prosecution, the Examiner is pursuing the amended claims dated 11/15/2023, in which applicant; canceled claims 1-8; and added claims 9-17. Therefore, claims 9-17 are pending in the application.
Election/Restrictions
Applicant’s election without traverse of Group 2 claims 13-15 drawn to a method for treating spinal cord injury in the reply filed on 27 March 2026 is acknowledged.
Claims 8-12 and 16-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 13-15 are under current examination.
Priority
This application was filed 11/15/2023 and is a National Stage entry of PCT/JP2022/021676 filed on 05/27/2022, which claims benefit to the foreign application 2021-089367 filed on 05/27/2021.
Filing of a certified untranslated copy of the JP2021-089367, filed 11/15/2023 is acknowledged. MPEP 2304.01(c) states: Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action, 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Thus, the earliest possible priority for the instant application is 05/27/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/15/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner and the signed and initialed PTO Forms 1449 are mailed with this action.
Claim Rejections - 35 USC § 112 (a)
(Written description)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter that was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor, at the time the application was filed, had possession of the claimed invention.
Under the written description guidelines (see MPEP 2163), the Examiner is directed to determine whether one skilled in the art would recognize that the Applicant was in possession of the claimed invention as a whole at the time of filing. The following considerations are critical to this determination.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail so that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Accordingly, to satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.
Claim 13 encompasses (via claim 9) a genus of any [Symbol font/0x67]-secretase inhibitor. However, the specification doesn't have adequate support in the disclosure for the any [Symbol font/0x67]-secretase inhibitor. The specification discloses that the neurite outgrowth promotion kit comprises a [Symbol font/0x67]-secretase inhibitor, wherein the neurospheres were cultured for 24 hours in the presence of each 10 [Symbol font/0x67]-secretase inhibitor. Each inhibitor was added to a culture medium of the neurosphere so that the final concentration was 10 μM for DAPT, 1 μM for Compound 34, 10 μM for L-685,458, 10 μM for LY411575, 10 μM for Sulindac, and 5 μM for Compound E. In addition, a control group cultured in the absence of a [Symbol font/0x67]-secretase inhibitor was also prepared (see SPEC [0053]). Furthermore, Fig. 2 revealed that neurite outgrowth is particularly promoted in the DAPT-treated and Compound 34-treated groups among the [Symbol font/0x67]-secretase inhibitor (see SPEC [0057]). However, specification does not disclose the method for producing a neurosphere using the neurite outgrowth promotion kit comprises any [Symbol font/0x67]-secretase inhibitor. Therefore, the specification fails to identify the any [Symbol font/0x67]-secretase inhibitor.
The genus of [Symbol font/0x67]-secretase inhibitors is very large, including many small molecule inhibitors (FDA approved and otherwise), as well as antibodies, aptamers, etc. and any moiety capable of inhibiting gamma-secretase function. For example, antibody inhibitors are known in the art as per Takagi-Niidome et al. (Inhibition of [Symbol font/0x67]-secretase inhibitors by a monoclonal antibody against the extracellular hydrophilic loop of presenilin 1. Biochemistry, 52(1), pp.61-69, 2013; cited in PTO892). Small molecule inhibitors can be found in several review articles, including: McCaw et al. (Oncologist. 2021 Jan 2;26(4):e608–e621; cited in PTO892) and Gamma Secretase Inhibitors and Modulators from RugBankc Inc. (attached the PDF),
With these additional evidences, the method for producing a neurosphere using the neurite outgrowth promotion kit comprises any [Symbol font/0x67]-secretase inhibitor is not well established at the time of filling and the ordinary artisan cannot predictably identify any [Symbol font/0x67]-secretase inhibitor in a subject. Therefore, one of skill in the art would neither expect nor predict appropriate method for producing a neurosphere using the neurite outgrowth promotion kit comprises the instantly claimed genus of any [Symbol font/0x67]-secretase inhibitor.
Therefore, it concludes that the claimed genus of any [Symbol font/0x67]-secretase inhibitor the neurite outgrowth promotion kit doesn't have an adequate written description. It concludes that a skilled artisan would find the specification inadequately described. Therefore, the Applicant did not sufficiently possess the broader invention as claimed in claims 13-14.
Claim Rejections - 35 USC § 112 (b)
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 14-15 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 pre-AIA the applicant regards as the invention.
Regarding claims 14-15, the term “compare with a control” in the claim is a relative term which renders the claim indefinite. The term “a control” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what control is used for comparison in determining the expression level is increased, this claim limitation does not define the control. MPEP 2145 states that “Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).”
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.
Claim 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Okubo et al. (Stem cell reports, 7(4), pp.649-663, 2016; cited in PTO892; hereinafter “Okubo-2016”).
Regarding claim 13-15, Okubo-2016 teaches human induced pluripotent stem cells (hiPSCs)-derived neurospheres (i.e. aggregates of 253G1 and 201B7 hiPSC-NS/PCs) cultured in a medium comprising a [Symbol font/0x67]-secretase inhibitor (GSI) including DAPT at 10uM for 1 day (24 hours) for treatment of spinal cord injury and transplantation. (see p. 649 results to p.651, 1st col., 2nd paragraph, p. 650, figure 1A-1B; p. 655-660; p. 659, 2nd col. section: Experimental Procedures to p.661, 1st col.; p. 672, Supplemental Experimental Procedures). Furthermore, Okubo-2016 discloses a significant increases in the levels of p53-dependent genes (vector), such as GADD45G, was detected (Figures 3E and 3F). Okubo-2016 teaches that GSI-treated hiPSCs-derived neurospheres are differentiated more mature neuronal cell types (p.651, 1st col.) and transplantation of GSI-treated hiPSCs-derived neurospheres maintained and enhanced motor functional recovery after spinal cord injury (p. 653, 2nd col., last paragraph to p. 655, 1st col.; p. 655-p. 659).
Accordingly, Okubo-2016 anticipates the instant claims 13-15.
Pertinent References
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure is the following:
Okubo et al. (Effects of Gamma-secretase Inhibitor on Neural Stem/Progenitor Cells Derived from Tumorigenic Human Induced Pluripotent Stem Cells; ORS 2016 Annual Meeting Poster No. 1711; cited in PTO892) teaches Notch signaling plays a role in the maintenance of immature state of neural stem cells, its inhibition with Gamma-secretase inhibitor (GSI) may promote neuronal induction of hiPSC-NS/PCs with limited proliferation. Here we present the effects of GSI on proliferation and differentiation of hiPSC-NS/PCs in vitro. Furthermore, Okubo observed in the levels of p53-dependent genes, such as CDKN1C and GADD45G. RT-PCRs showed that the expression of Notch signaling target genes, such as HES5, Notch1 were almost abolished by GSI, indicating that Notch signaling was efficiently inhibited in vitro (see result ¶).
Deyts et al. (Deyts et al. eLife 2016;5:e15645. DOI: 10.7554/eLife.15645; cited in PTO892) observed that neurons treated with [Symbol font/0x67]-secretase inhibitor did not exhibit axonal or dendritic outgrowth in the absence of amyloid precursor protein (APP) expression (Fig.1-b1 and b2 of Deyts), suggesting that APP is the main contributing factor in g-secretase-mediated neurite outgrowth (p. 3 1st ¶ of Deyts).
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is 571-272-0196. The examiner can normally be reached M-F 8-5 (EST).
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/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684
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