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 .
Applicant's election without traverse of Group II, claims 16, 17, and 21, and the species ASAH2, in the reply filed on 12 February 2026 is acknowledged. With the election of Group II, and upon further search and consideration, the species of ASAH1, ACER1, ACER2, and ACER3 are rejoined and examined on the merits.
Claims 1-15, 22, and 24 have been withdrawn. Claims 16, 17, and 21 are currently pending and under examination.
This Application claims priority to U.S. Provisional Application No. 63/305457, filed February 2, 2022.
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 16, 17, and 21 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 16 recites that the system comprises the modified non-human cell of “any of claim 1.” This limitation is indefinite, because it is unclear what “any of” a single claim is intended to refer to.
Further, it is noted that claim 1 is a non-elected and withdrawn claim. As such the dependency of claim 16 are unclear. For the purposes of examination, the modified non-human cell of any of claim 1 is interpreted to include a “modified non-human cell deficient in the expression of one or more endogenous ceramidase genes and comprising one or more nucleic acids encoding a human ceramidase.”
Additionally, the term “deficient” from the language of claim 1 interpreted as being required in claim 16 is a relative term which renders the claims indefinite. The term “deficient” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bound of the claims are indefinite, as it is unclear what amount of deficiency in expression of the ceramidase genes is intended to be included in, or excluded from, “deficient” expression.
Lastly, the language of claim 1 interpreted as being required in claim 16, that the modified non-human cell deficient in the expression of one or more endogenous ceramidase genes comprises “one or more nucleic acids encoding a human ceramidase,” is indefinite. As currently written, it appears that only a single nucleic acid is required to be present; it is unclear how a single nucleic acid is intended to be determined to encode a human ceramidase, and how this single nucleic acid would provide a system for detecting the specificity and/or potency of a ceramidase, as claimed in claim 16.
Claims 17 and 21 are included in this rejection, as these claims depend from above rejected claim 16 and fail to remedy the noted deficiencies.
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.
Claims 16, 17, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Doyle et al. (The Construction of Transgenic and Gene Knockout/Knockin Mouse Models of Human Disease, Transgenic Res., Vol. 21, No. 2 (2012), pp. 327-349), in view of Duarte et al. (Elusive Roles of the Different Ceramidases in Human Health, Pathophysiology, and Tissue Regeneration, Cells, Vol. 9, No. 1379 (2020), pp. 1-20).
With regard to claims 16, 17, and 22, Doyle et al. teach that the genetic and physiological similarities between mice and humans allow for rodents to be used as models for human disease (Abs.). Knockout/knockin mice include cells where expression of an endogenous gene is replaced by a corresponding human gene of interest to provide a model to study the human disease (p. 7, The producing of knockout/knockin mice: deleting and/or modifying endogenous mouse genes, para. 1 to p. 11, para 2).
Doyle et al. do not teach that the endogenous gene removed and replaced with a human gene is specifically a ceramidase gene.
Duarte et al. teach that five ceramidases, encoded by the specific genes ASAH1, ASAH2, ACER1, ACER2, and ACER3, play roles in various diseases including various cancers, Alzheimer’s disease, alopecia, and Farber disease, when the genes are mutated, overexpressed, or inhibited (Abs.; p. 2, para. 2; Fig. 2, 4).
It would have bene obvious to one of ordinary skill in the art to combine the teachings of Doyle et al. with Duarte et al., because both teach the modification of genes and relation to human diseases. The genes ASAH1, ASAH2, ACER1, ACER2, and ACER3, which play roles in various diseases when the genes are mutated, overexpressed, or inhibited, are known in the art as taught by Duarte et al. The use of the knockout/knockin mouse model system of Doyle et al. to remove an endogenous ceramidase gene and replace it with the human ASAH1, ASAH2, ACER1, ACER2, or ACER3 gene to provide an alternative disease model, amounts to the simple substitution of one known gene for another, and would have been expected to predictably and successfully provide a mouse model for the study of the human diseases caused by the mutation, overexpression, or inhibition of ASAH1, ASAH2, ACER1, ACER2, or ACER3 genes.
Further, use of the knockout/knockin mouse model system of Doyle et al. to study genetic mutations in ASAH1, ASAH2, ACER1, ACER2, and ACER3 genes, respectively, would have been expected to predictably improve the system, by allowing for additional uses, including providing mouse cells with each of the ceramidase genes as taught by Duarte et al. for study of the diseases resulting from mutation, overexpression, or inhibition of each of the inserted human genes. The removal and replacement of one, or all, of the ceramidase genes can be accomplished using the knockout/knockin mouse model system of Doyle et al. The choice of which ceramidase gene(s) to remove and replace is dependent on the desired end use of the model system, as guided by the teachings of Duarte et al. regarding gene/disease relationships.
Taken together, Doyle et al. and Duarte et al. render obvious the system as claimed, including the components as claimed. As the system cannot be separated from its properties, the system as rendered obvious would necessarily be capable of being used for detecting the specificity and/or potency of a ceramidase.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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