DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I, presently claims 1-9, in the reply filed on 7/01/2026 is acknowledged. The traversal is on the ground(s) that there would be no serious search burden on the examiner to search all the claims. This is not found persuasive because search burden is not a consideration in a finding of lack of inventive unity; rather, according to M.P.E.P. §1850, the only consideration is whether the inventions share a special technical feature and none of Applicant’s arguments at this time persuasively set forth that the different groups of inventions as set forth in the Restriction requirement dated 4/02/2026 possess unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 11, 12, 20, 23, 25, 27, 46, 48, 49, 54, and 55 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/01/2026.
Claims 1-9 are under consideration on the merits.
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 1-9 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 claims 1, 4, 6-9, the phrase “e.g.” (being synonymous for the phrase "for example") renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. Similarly and regarding claims 1 and 7, the phrase "such as" renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Correction is required.
In so much that claims 2-9 depend from claim 1 and do not resolve the point of confusion, these claims must be rejected with claim 1 as indefinite.
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.
Claims 1, 2, and 5-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prah et al. (Neurosci Methods. 2019 May 15;320:50-63; provided in the IDS dated 10/23/2024) as evidenced by chemicalbook.com (“The applications of sodium pyruvate” 2019; Reference U).
Prah teaches a chemically-defined and serum-free culture media capable of culturing astrocytes termed "ABM" and comprising DMEM and neurobasal medium in a 1:1 w/v ratio, glucose and 1mM sodium pyruvate (e.g. an energy sources), glutmax (sic) (a typo for GlutaMAX, comprising L-alanyl-L-glutamine and being a source of L-glutamine), L-glutamine, transferrin (e.g. an iron carrier), putrescine dihydrochloride (e.g. a polyamine), progesterone (e.g. a hormone which activates the progesterone receptor), 40 ng/ml sodium selenite (e.g. an antioxidant), and FGF-basic (i.e. FGF2), EGF, or their combination (e.g. species of trophic factors), and 5 mg/ml N-acetylcysteine (subheading 2.2 on page 51; Fig. 1B for FGF2, EGF, and their combination improving astrocyte survival), wherein the resting astrocytes cultured in the media express stellate morphology (Fig. 2A and 2B, right panels), express GLAST and GLT-1 (Fig. 8B and 8C, and subheading 3.5), anticipating claim 1, the embodiment of FGF2 and/or EGF for claim 2, and claims 5-7.
Regarding claim 8, Prah is silent regarding any generic growth factor facilitating the utilization of glucose and amino acids) However, chemicalbook.com teaches that sodium pyruvate is an intermediate in glycolysis (see the 1st paragraph under “Applications”). Therefore, the sodium pyruvate of Prah inherently facilitates utilization of glucose as evidenced by chemicalbook.com; see M.P.E.P. § 2112.
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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Prah et al. (Neurosci Methods. 2019 May 15;320:50-63; provided in the IDS dated 10/23/2024) in view of Puschmann et al. (J. Neurochem. (2014) 128, 878-889; Reference V) and as evidenced by chemicalbook.com (“The applications of sodium pyruvate” 2019; Reference U).
The teachings of Prah as evidenced by chemicalbook.com are relied upon as set forth above in rejecting claims 1, 2, and 5-8 as anticipated under 35 U.S.C. § 102.
Regarding claim 3, Prah does not teach the embodiment of heparin binding EGF like growth factor (i.e. HBEGF). Regarding claims 4 and 9, Prah does not teach HBEGF.
Puschmann teaches an astrocyte culture medium comprising 10 ng/ml HB-EGF which is advantageous to increase cell proliferation and wherein HG-EGF can be advantageously used as a fetal calf serum (FCS) replacement in astrocyte culture systems, (Abstract; page 879, subheading “HB-EGF treatment of astrocyte cultures”) reading on claims 3, 4, and 9.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to add the HBEGF of Puschmann to the astrocyte culture medium of Prah. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Puschmann and Prah are directed towards astrocyte culture medium compositions and their associated methods of use thereof. The skilled artisan would have been motivated to do so because Puschmann teaches that the addition would be particularly advantageous to increase astrocyte to increase cell proliferation, and so the addition would predictably improve upon Prah’s astrocyte culture medium.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at 571-272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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