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 .
DETAILED ACTION
1. Claims 1-10 are pending.
2.Applicant’s election without traverse of Group I, claims 1-3 in the reply filed on 10/28/25 is acknowledged.
Claims 4-10 are withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 1-3 read on a mutation complex comprising BMPR2 E376K mutant and ACVR1-R206H mutant are under consideration in the instant application.
3, Applicant’s provision of the foreign priority document Korea KR10-2020-0075327 and KR 10-2020-0075332 is acknowledged. However, an English translation has not been provided in accordance with 37 CFR 1.55. See MPEP § 201.15.
4. 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.
5. 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.
6. Claims 1-3 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 1 s indefinite and ambiguous in the recitation BMPR2 E376K mutant and ACVR1-R206H mutant. Recitation of a protein without providing SEQ ID NO for the protein is indefinite and ambiguous because different laboratories may have the same name for a different proteins .
7. 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.
8. Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20250333492 and 20210061898 in view of Miyata et al. ( J Mol. Evol. 1979, v.12 pages 219-236) and US patent Application 20100151529 and US Patent Application 20040077043.
US Patent Application ‘492 teaches a complex comprising ACVR1 and BMPR2 antigen-binding molecules ( see entire document, paragraphs 0154, 0155, 0326 0628). US Patent Application ‘492 teaches that antigen-binding molecules can comprising amino acid conservative substitutions including glutamic acid and arginine (see paragraphs 0309, 0319,0320, 0394)
US Patent Application ‘898 teaches a complex comprising ACVR1 and BMPR2 antigen-binding molecules ( see entire document, paragraphs 0002, US Patent Application ‘492 teaches that antigen-binding molecules can comprising amino acid conservative substitutions including glutamic acid and arginine to histidine ( see paragraphs 0003 , 0005, 0021, 0055 in particular))
US Patent Application ‘492 and US Patent Application ‘898 do not explicitly teaches a conservative amino acid substituting wherein glutamic acid is mutated to lysin in BMPR2 and arginine to histidine in ACVR1,
Miyata et al., teach a list of conservative amino acid substitution in recombinant protein that can effect the stability and affinity of mutated antigen-binding molecule, including glutamic acid to lysin and arginine to histidine ( see entire document, Table 2 in particular).
US Patent Application ‘529 teaches that conservative substitution of arginine to histidine increase the stability of engineered protein ( see entire document paragraphs 0022, 0035 and 0043 in particular).
US Patent Application ‘043 teaches that conservative substitution of arginine to histidine increase the stability of engineered protein ( see entire document paragraphs 0053 in particular).
All the claimed elements were known in the prior art and one skill in the art could have combine the elements as claimed by known methods with no change in their respective function and the combination would have yield predictable results to one of ordinary skill in the art at the time of the invention ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
Thus it would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to mutate glutamic acid to lysin in BPPR2 protein and arginine to histidine in ACVR1 with a reasonable expectation of success because the prior art suggests that conservative amino acid substitution was well know in the art that can increase the stability and affinity of the recombinant protein.
Claim 3 in included because the instant claims are drawn to the product a mutant complex comprisng BMPR2 and ACVR1. A product is a product irrespective of its intendent use in the absence of evidence of structural and/or functional difference.
Thus, it is the Examiner’s position that preamble of claim 3 only limits the claim to the extent that the prior art must be capable of performing the purpose or intended use.
From the combined teaching of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
9. No claim is allowed.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Daniel Kolker can be reached on 571/ 272-3181
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644