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 .
Election/Restrictions
Claims 1-17 and 19-20 are pending.
Claims 17 and 20 are newly amended.
Applicant’s election without traverse of Group III, claims 14-17 and 20, in the reply filed on 08/28/2026 is acknowledged.
Claims 1-13 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/28/2026.
Claims 14-17 and 20 have been examined on their merits.
Claim Objections
Claims 14 and 17 are objected to for the following informalities: the claim uses en dashes to visually separate limitations (e.g., “- between 9 and 11 mM nicotinamide”), not grammatically to represent a span or range. MPEP 608.01(m), requires that a claim be a single sentence. Therefore, en dashes is not grammatically correct. Additionally, they are used inconsistently, as claim 20 does not use this convention. Simply removing the en dashes would be ameliorative.
Claim 20 is objected to for the following informalities: the claim recites “N-acetyl-cysteine (NAC).” However, claim 17 already establishes this abbreviation and it is therefore redundant in claim 20. Reciting “N-acetyl-cysteine” would be ameliorative.
Claims 17 and 20 are objected to because of the following informalities: the concentrations of A83-01 and SB202190 which were previously reported as measured in µM concentrations, have been amended to be reported in “pM” concentrations, but the claims have not been marked to identify these amendments. It is noted that the Remarks (08/28/2026) also does not identify these claims as amended. Amended claims must be properly annotated (see MPEP 714). It is noted that the amendments appear to be typographical errors. However, because “pM” is an actual concentration measurement, it has been given its plain meaning.
Appropriate correction is required.
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 17 and 20 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.
Claims 17 and 20 contains the trademark/trade name “B27”. 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) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). 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. In the present case, the trademark/trade name is used to identify/describe a neural cell media supplement and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 112(a)
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 17 and 20 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(s) contains subject matter which 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 17 and 20 recite concentrations of “pM A83-01” and “pM SB202190” (e.g., “between 0.45 and 0.55 pM A83-01” and “between 9 and 10 pM SB202190 in claim 17, and “0.5 pM A83-01” and “10 pM SB202190” in claim 20). Previously, these reagents were reported in concentrations as measured by µM (e.g., “between 0.45 and 0.55 µM A83-01” etc). The application lacks either explicit or implicit disclosure for the instant clamed concentrations.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cox et al. (Journal of Endocrinology, 2019, on IDS 12/03/2024).
Regarding claim 14, regarding the effect of the preamble of a medium “for the development, growth and culture of epithelial organoids from human tooth tissue”, this is an intended use of the composition. This intended use does not result in a structural difference in the composition, and therefore, is not considered limiting.
For further clarification, Applicant is directed to MPEP 211.02. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"). See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963) (The claims were directed to a core member for hair curlers and a process of making a core member for hair curlers. The court held that the intended use of hair curling was of no significance to the structure and process of making).
Turning to the art, Cox discloses a medium (referred to as PitOM) comprising Wnt agonist RSPO-1, NAD+ intermediate nicotinamide, Alk inhibitor A83-01, p38 MAPk inhibitor SB202190, BMP inhibitor Noggin, an FGF (e.g., FGF2), an IGF (e.g., IGF1), free-radical scavenger NAC, hedgehog signaling agonist SHH, adenylate-cyclase-CAMP agonist cholera toxin, L-glutamine, and N2 (Table 1, p290).
Regarding claim 15, Cox discloses that the media is serum-free (Table 1, p290).
Regarding claim 16, Cox discloses embodiments wherein HB-EGF (Heparin-Binding Epidermal Growth Factor-Like Growth Factor also referred to as diphtheria toxin receptor, DTR) replaces EGF (Different organoid phenotypes from normal and damaged pituitary, p294; Supp Fig. 3D) in PitOM (and therefore, embodiments wherein the medium does not comprise EGF).
Therefore, Cox anticipates the invention as claimed.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Cox et al. (Journal of Endocrinology, 2019, on IDS 12/03/2024).
Cox anticipates claim 1 as discussed above.
Regarding claims 17 and 20, Cox teaches that the media has the following reagents and compositions.
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The medium of Cox overlaps with all concentration ranges (claim 17) or specific concentrations (claim 20), except for the concentrations of A83-01 and SB202190 (noted in bold, 0.5 µM and 10 µM, respectively compared to the pM ranges in claims 17 and 20).
However, a person of ordinary skill in the art could have arrived at the claimed concentrations by routine optimization and the disclosure does not point to a criticality in these concentrations (see MPEP 2144.05(II)(A). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”). In the instant case because both A83-01 and SB202190 are results-effective variables, a person of ordinary skill in the art could have arrived at the claimed concentrations by routine optimization with predicable results and a reasonable expectation of success.
Therefore, the teachings of Cox render the invention unpatentable as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH (PAUL) MIANO whose telephone number is (571)272-0341. The examiner can normally be reached Mon-Fri from 8:30am to 5:30pm.
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/JOSEPH PAUL MIANO/Examiner, Art Unit 1631
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