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 .
This office action is in response to the amendment filed on November 25, 2025. Claims 48-58 are currently pending. Claims 48-50 and 57 have been withdrawn previously. Claims 51-56 and 58 are currently under examination.
Withdrawal of Rejections
The rejection of claims 52 and 58 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for lack of antecedent basis is withdrawn based on the amendment to the claims to recite ABL1 kinsae.
Pending Rejections
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 51-56 and 58 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 51-56 and 58 are rejected for failing to disclose the nucleic acid sequence from which to make the substitutions in the amino acid protein. There is no SEQ ID NO: identifier for the claimed nucleic acid molecule to know the frame of reference for the positions recited in the substitutions. The nucleic acid structure is unclear and the mutant ABL1 human kinase is unclear. Clarification is requested as to the structure being claimed. The attached PDF of NCBI Reference Sequence NP_009297.2; Tyrosine-protein kinase ABL1 isoform b [Homo sapiens] does not have phenylalanine (F) at position 493 to make a F493L substitution as claimed. Clarification is requested as to the parent structure.
Claims dependent on a rejected claim are rejected for failing to cure the indefiniteness.
Response to Remarks
Applicant’s state that UniProt: P00519 is the human tyrosine protein kinase ABL1 used as reference sequence. Applicant's arguments filed November 25, 2025 have been fully considered but they are not persuasive. The claim does not identify the mutant human kinase ABL1 sequence with a SEQ ID NO: identifier. The name does not identify a particular isoform as remarked. The claim does not identify the kinase with a SEQ ID NO: to clarify the mutant isoform 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.
Claims 51-56 and 58 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.
The claims are rejected for failing to describe the genus of nucleic acids for the claimed mutant ABL1 kinase with the substitutions envisioned. There is no parent SEQ ID NO: provided to ascertain the structure to make the modification as claimed. The ABL1 kinase is not one amino acid sequence.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. The courts have stated:
"To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966." Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
MPEP § 2163 further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163 does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
As stated supra, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad genus. The claims are rejected for failing to describe the genus of nucleic acids for the claimed mutant ABL1 kinase with the substitutions envisioned. There is no parent SEQ ID NO: provided to ascertain the structure to make the modification as claimed. The ABL1 kinase is not one amino acid sequence.
Since the MPEP states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.") Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Response to Remarks
Applicant’s state that one of skill in the art would immediately appreciate the known sequence of human tyrosine kinase ABL1 as provided in the remarks as UniProt: P00519. Applicant's arguments filed November 25, 2025 have been fully considered but they are not persuasive. The claim does not identify the mutant human kinase ABL1 sequence with a SEQ ID NO: identifier. The name does not identify a particular isoform as remarked. There is no parent SEQ ID NO: provided to ascertain the structure to make the modification as claimed. The ABL1 kinase is not one amino acid sequence.
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.
Claim(s) 51-56 are rejected under 35 U.S.C. 103 as being unpatentable over NCBI Reference Sequence NP_009297.2; Tyrosine-protein kinase ABL1 isoform b [Homo sapiens].
The NCBI Reference sequence discloses an ABL1 kinase with position 448 having a leucine amino acid (L) (see PDF attachment at position 448 of the amino acid sequence provided). It would have been obvious to the person having ordinary skill in the art to make a nucleic acid sequence from the amino acid sequence based on the standard molecular biology genetic code. It was not inventive to transform host cells with nucleic acids to recombinantly express an amino acid polymer.
Therefore, it would have been prima facie obvious to the person having ordinary skill in the art to make a nucleic acid encoding a mutant human ABL1 kinase with a substation at position 448 with a leucine, because the art has shown a human ABL1 kinase isoform b with leucine at position 448.
Response to Remarks
Applicant’s state that one of skill in the art would immediately appreciate the known sequence of human tyrosine kinase ABL1 as provided in the remarks as UniProt: P00519. Applicant's arguments filed November 25, 2025 have been fully considered but they are not persuasive. The claim does not identify the mutant human kinase ABL1 sequence with a SEQ ID NO: identifier. The name does not identify a particular isoform as remarked. The ABL1 kinase is not one amino acid sequence; NP_009297.2 is a human ABL1 kinase with a leucine at position 448. It would have been obvious to the person having ordinary skill in the art to make a nucleic acid sequence from the amino acid sequence based on the standard molecular biology genetic code. It was not inventive to transform host cells with nucleic acids to recombinantly express an amino acid polymer.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655