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 .
Claims 1-17 are pending in this application.
Election/Restrictions
Applicant’s election of Group III (Claims 5 and 6) in the reply filed on 08/26/2026 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 1-4 and 7-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/26/2026.
Claims 5-6 were examined on their merits.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. The abstract of the disclosure is objected to because it is too short to describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The use of the term GLUTAMAX™, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Interpretation
The preamble of Claim 5 recites, “A hindbrain region cancer cell culture formulation”. This appears to be the purpose or intended use of the formulation which will be evaluated to determine whether or not the recited purpose or intended use (A hindbrain region cancer cell culture) results in a structural difference between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See the MPEP at 2111.02, II. Claim 6 merely further limits the preamble of Claim 5.
Therefore, if Claim 5 is determined to not result in a structural difference and not limit the claim, Claim 6 will also be construed thusly.
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 5 and 6 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.
Claim 5 recites, “A hindbrain region cancer cell culture formulation comprising a basal medium supplemented with recombinant FGF, recombinant FGF-19, and recombinant stromal cell-derived factor 1 alpha (SDF-1-α)” while Claim 6, recites, “The hindbrain region cancer cell culture formulation of claim 5, wherein the hindbrain region comprises cerebellum tumor”. It is unclear if the composition comprises only a basal medium supplemented with recombinant FGF, recombinant FGF-19, and recombinant stromal cell-derived factor 1 alpha (SDF-1-α) or if the composition comprises a hindbrain region cancer cell culture and a basal medium supplemented with recombinant FGF, recombinant FGF-19, and recombinant stromal cell-derived factor 1 alpha (SDF-1-α).
The claim is indefinite because the ordinary artisan would not appreciate the metes and bounds of the claim. For purposes of examination, the Examiner has interpreted the claim as being drawn to a basal medium supplemented with recombinant FGF, recombinant FGF-19, and recombinant stromal cell-derived factor 1 alpha (SDF-1-α). Claim 6 is rejected as being dependent upon rejected Claim 5 and for failing to rectify the indefiniteness thereof.
Claim 5 also recites, “…stromal cell-derived factor 1 alpha (SDF-1-α)”. It is unclear if the parenthetical subject matter is intended as a claim limitation or not.
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.
Claim(s) 5-6 are rejected under 35 U.S.C. § 103 as being unpatentable over Lago et al. (05/29/2023).
Lago et al. teaches recombinant FGF-basic, FGF-19 and SDF-1α (Pg. 2155, Lines 27-29);
a method for differentiating hiPSCs into cerebellum organoids, comprising a basal medium (CDDM1) containing FGF-basic and FGF19 and a second basal medium comprising SDF-1α (CDDM2) (Pg. 2149, Fig. 1A).
The teachings of Lago et al. were discussed above. With regard to Claims 5 and 6, due to the indefiniteness issue discussed above, the preamble recitation has been determined to not result in a structural difference between the claimed invention and the prior art.
Lago et al. did not teach a single basal medium supplemented with recombinant FGF, FGF-19 and SDF1α, as required by Claim 5.
It would have been obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Lago et al. comprising two separate basal media comprising recombinant growth factors into a single basal media because this would eliminate the need for two separate media formulations and treatment steps. See the MPEP at 2144.06, I. and 2143, I., A., citing KSR. Those of ordinary skill in the art would have been motivated to make this modification in order to prepare a single basal medium composition suitable for differentiating hiPSCs into cerebellum organoids. There would have been a reasonable expectation of success in making this modification because the reference separately teaches the claimed elements.
Claim(s) 5 and 6 are rejected under 35 U.S.C. § 103 as being unpatentable over Mugurama et al. (2015).
Mugurama et al. teaches sequentially culturing human embryonic stem cells (hESC) in separate basal media comprising FGF2, FGF19 and SDF1 to generate cerebellum neurons (Pg, 546, Figs. E and Y);
wherein exposure of mouse ESC to FGF2 induced formation of isthmic organizer-like tissue (Pg. 537, Column 2, Lines 16-18);
and wherein addition of FGF19 promotes spontaneous formation of hindbrain neural-tube-like NE structures with dorsal-ventral (D-V) polarity and sequential addition of FGF19 and SDF1 induces the generation of continuous cerebellar plate neuroepithelium (CPNE) that differentiates into a multilayered structure as seen in the cerebellar ontogenesis (Pg. 537, Column 2, Lines 34-40).
The teachings of Mugurama et al. were discussed above. With regard to Claims 5 and 6, due to the indefiniteness issue discussed above, the preamble recitation has been determined to not result in a structural difference between the claimed invention and the prior art.
Mugurama et al. did not teach a single basal medium supplemented with recombinant FGF, FGF-19 and SDF1α, as required by Claim 5.
It would have been obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Mugurama et al. comprising three separate basal media comprising distinct recombinant growth factors into a single basal media because this would eliminate the need for two separate media formulations and treatment steps. See the MPEP at 2144.06, I. and 2143, I., A., citing KSR. Those of ordinary skill in the art would have been motivated to make this modification in order to prepare a single basal medium composition suitable for differentiating hiPSCs into cerebellum organoids. There would have been a reasonable expectation of success in making this modification because the reference separately teaches the claimed elements.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm EST.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Sharmila G 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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/PAUL C MARTIN/Examiner, Art Unit 1653 09/09/2026
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