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 1-19 are pending as originally filed and are presently considered.
Formalities:
The drawings are objected to (see below).
The specification of 8/29/24 is accepted.
The IDS filing of 7/30/26 and references therein have been considered on the basis of the English translations for foreign documents. A signed copy of the IDS is provided herewith.
Applicant’s priority is noted to be:
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Drawings
The drawings are objected to.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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 4, 17 and 19 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 4 and 17 each contain the trademark/trade name Matrigel. 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 the second hydrogel and, accordingly, the identification/description is indefinite.
Claim 19 recites “detecting a pathological event”, however, there no requirement to detect anything. Thus, it is not clear what is being claimed.
Claim Rejections - 35 USC § 112
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.
Claim 19 is 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.
Claim 19 is generic for induction of pathological events comprising ALS, MG and peripheral neuropathies.
The specification teaches that the pathological mechanisms underlying most NMDs remain unclear (e.g., paragraph 4), but does provide antecedent basis for the generic claim language (e.g., paragraph 25). It does also state that the NMJs made can be useful for studying pathological conditions (e.g., paragraph 93). This is the extent to which “pathological event[s]” are described by the specification.
The Art also recognizes that the causes of these diseases are also unknown. For example Hu, et al. (2024 – published online 8/14/2023) “Pathological mechanisms of amyotrophic lateral sclerosis”, Neural Regeneration Research, 19(5): 1036-44 recognizes “Amyotrophic lateral sclerosis refers to a neurodegenerative disease involving the motor system, the cause of which remains unexplained despite several years of research. Thus, the journey to understanding or treating amyotrophic lateral sclerosis is still a long one. According to current research, amyotrophic lateral sclerosis is likely not due to a single factor but rather to a combination of mechanisms mediated by complex interactions between molecular and genetic pathways.” (ABSTRACT.)
Thus, the Artisan would not know what pathological event is required in each case, or even if more than one event is required, as the diseases appear to be multi-factorial and producing just one of the events, even if known, may not be sufficient to get a proper response.
Hence, the Artisan would not have understood Applicant to have been in possession of the invention.
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.
Claim(s) 1, 3, and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 116999622 to Zhejiang University School of Medicine (hereinafter “Zhejiang”) (translation provided by Applicant on 7/30/26, 8 pages long).
Claim 1: Zhejiang teaches engineer muscle with two layers, a first and second neuromuscular layer, with a vascular layer disposed between (e.g., Claim 2). This necessarily yields muscle cells and nerve cells in each layer, which means that the first comprises muscle, and the second comprises neurons. The disclosure teaches that these comprise hydrogels (e.g., Disclosure of the Invention, paragraph 4). Further it is taught to pattern parallel grooves with an interval of between 29-32 micrometers (p. 4). This necessarily yields the structure claimed.
Claims 3 and 6: The grooves yield a pattern of 29-32 micrometers in the grooves (p. 4).
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.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin, et al. (2022) “CRABP1-CaMKII-Agrn regulates the maintenance of neuromuscular junction in spinal motor neuron”, Nature Cell Death & Differentiation, 29: 1744-56.
Claim 1: Lin teaches the two-layer hydrogel with wells patterned for the muscle cells and upper layer with neurons (e.g., Figure 4)).
Claim 2: gelatin is taught (e.g., Id.).
Claim 3: 10 micrometer depth is taught (e.g., Id.).
Claim 4: The medium, being a motor differentiation medium, allowing further differentiation is a basement-membrane like matrix (e.g., Figure 4).
Claim 5: Applicant having made the composition, is the position to tell if the second layer is between 1 micrometer and 10mm, but it seems it must be somewhere between these (e.g., Figure 4).
Claim 6: Applicant having made the composition, is in the position to tell if the micro grooves are between 2 and 100 micrometers and/or the depth is 2-40 micrometers, but it seems they are about 10 micrometers in depth (e.g., p. 1743, col. 2, paragraph 5).
Allowable Subject Matter
Claims 18 is 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.
Art Made of Record
Applicant’s publication Lin, et al. (2023) “A novel 3D bilayer hydrogel tri-culture system for studying functional motor units”, Cell & Bioscience, 13: 168 (14 pages) is made of record. The subject matter post-dates Applicant’s priority and discloses the invention presently claimed, being the first known art to do so as far as the Examiner could determine.
Conclusion
Claims 7-16 and 18 are objected to.
Claims 1-6, 17 and 19 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638
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