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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/13/2026 has been entered.
No claim is amended.
Claim Objections
Claim 15 is objected to because of the following informalities: the term “least” should read “least” at line 2. Appropriate correction is required.
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(s) 12,15,23-27,29 and 30 remain rejected under 35 U.S.C. 102a1 as being anticipated by Hu et al. (BMC Cancer 2011, 11:82, 13 pages) as evidenced by Aubert (PNAS September 30, 2003 vol. 100 suppl. 1, 11836–11841). The inclusion of claim 14 in this rejection is withdrawn as claim 14 depends from claim 13.
Claim 1 is drawn to a method comprising culturing neural stem cells in a differentiation medium for a time and under conditions to for neuronal cells wherein the differentiation medium comprises a serum-free neural stem cell culture medium and a serum-free supplement comprising at least on gamma secretase inhibitor. The claim also recites wherein cell clumping is reduced by at least 65% compared to culture without inclusion of a gamma secretase inhibitor.
Hu taught isolating of neural stem cells from brains of mouse embryos. Single cells were primarily plated in serum-free Dulbecco’s modified Eagle’s medium (DMEDM)/F12 medium containing 20 ng/ml basic fibroblast growth factor, 20 ng/ml epidermal growth factor (EGF), B-27 neural supplement and were fed every 3 days by adding fresh medium supplemented with gamma secretase inhibitor (GSI), see page 3. Hu taught that NSCs normally proliferate and form neurospheres but in the presence of a GSI, proliferation and neurosphere formation is decreased. Hu did not teach that the cells exhibited reduced clumping in the presence of the GSI. Hu does not teach how much neurosphere formation (cell clumping) was decreased (claim 12, 65% and claim 15, 75%). However, because Hu teaches carrying out the method steps as claimed, it is held that the effect would be inherent to the method.
The specification, at para 73, teaches that the clumping is the result of higher cell density due to increased proliferation that occurs in the absence of GSI. Accordingly, Hu taught GSI led to augmented differentiation and attenuated proliferation, which is consistent with reduced clumping.
With regard to claims 25-27,29 and 30, Hu taught use of both 0.25 and 25 micromolar GSI (see supplementary materials).
Applicant argues that Hu fails to teach the claimed specific quantitative reduction in cell clumping and that the inherency position is not sufficient. Applicant references the MPEP supporting that the fact that a result may occur is not sufficient and that the Rxaminer must provide a basis in fact or technical reaonsing that the alleged inherent characteristic necessarily flows from the teachings in the prior art.
In response, the technical reasoning is that every method step limitation recited in claim 12 is met by the prior art. If the recited reduction in clumping necessarily results from the methods as claimed, then it is reasonable and logical that the same methods taught in the prior art would lead to the same result.
See Integra Life Sciences I Ltd. V. Merck KGaA, 50 USPQ2d 1846 (DC SCalif, 1999) which teaches that a reference teaching a process may anticipate claims drawn to a method comprising the same process steps, despite the recitation of a different intended use in the preamble or the later discovery of a particular property of one of the starting materials or end products.
By arguing that the methods of Hu, which meet the recited method step limitations, does not result in a reduction of cell clumping of at least 65%, Applicant is essentially arguing that the method, as claimed, does not result in a reduction of cell clumping of at least 65%.
Applicant argues that the rejection does not establish that Hu measured the same phenomenon required by the claims and that Hu measured neurosphere formation, not cell clumping. In response, Hu would still be applied as being anticipatory absent the data showing a reduction in neurosphere formation. Each active method step limitation is met and thus, it would be logically expected that any and all observable, resulting characteristics would be the same regardless of whether they are taught in the prior art reference. If Applicant’s method differs from that of Hu, they are invited to add differentiating limitations to the claims.
Applicant references the notion that Hu teaches reduced proliferation and the examiner’s connection to the teachings in the specification (para 73) that that the clumping is the result of higher cell density due to increased proliferation that occurs in the absence of GSI. This is pointed out in support of the rejection and technical reasoning that there is a reasonable expectation that reduced clumping occurs.
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 rejection of claim(s) 12,13-14,28 under 35 U.S.C. 103 as being unpatentable over Hu et al. (BMC Cancer 2011, 11:82, 13 pages) as evidenced by Aubert (PNAS September 30, 2003 vol. 100 suppl. 1, 11836–11841) in view of Groth (Seminars in Cell & Developmental Biology, Volume 23, Issue 4, June 2012, Pages 465-472) is withdrawn in view of Applicant’s arguments.
Claims 13-14 and 28 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALARIE BERTOGLIO whose telephone number is (571)272-0725. The examiner can normally be reached on M-F 6AM-2:30PM.
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/VALARIE E BERTOGLIO/ Primary Examiner, Art Unit 1632
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