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 2-21 are pending.
2. Applicant’s election with traverse of Group I, claims 2-18 in the reply filed on 10/23/25 is acknowledged.
Applicant traverse the Restriction Requirement on the grounds that the search of Groups I-II together would not constitute a serious search burden on the examiner and that search of the claims of Group I would provide useful information for the claims of Group II
This is not found persuasive because the MPEP 803 (August 2001) states that “For purposes of the initial requirement, a serious burden on the examiner may be prima facie shown if the examiner shows by appropriate explanation either separate classification, separate status in the art, or a different field of search”. The Restriction Requirement enunciated in the previous Office Action meets this criteria and therefore establishes that serious burden is placed on the examiner by the examination of more than one Group. The Inventions are distinct for reasons elaborated in paragraphs 3-5 of the previous Office Action and above
The requirement is still deemed proper and is therefore made FINAL.
3. Claims 19-21 are withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 2-18 read on a nucleic acid comprising nucleic acid sequence encoding a nerve growth factor (NGF) mutant are under consideration in the instant application.
4. Applicant’s provision of the foreign priority document CN20161015303.7 is acknowledged. Certified copy of the priority documents have been received in the parent Application 16/085977.
5. The first sentence of the Specification should be amended to reflect the status of the parent case,17/455,870, now abandon.
6. 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.
7. Claims 2-18 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20240131114 and US Patent Application 20250320522 in view of Miyata et al. ( J Mol. Evol. 1979, v.12 pages 219-236) and US patent Application 20210166784
US Patent Application’114 teaches a nucleic acid encoding a NGF. US Patent Application’114 teaches that said NGF comprises an amino acid sequence that is 100% identical to the instantly recited SEQ ID NO2 ( see sequence alignment). US Patent Application’114 teaches an expression vector comprising said nucleic acid, a host cells expressing said vector and a method of expressing said vector in the host cells. US Patent Application’114 teaches that said vector can be DNA vector or virus vector. US Patent Application’114 teaches a pharmaceutical composition comprising said nucleic acid ( see entire document, Abstract and paragraphs 0010, 0014, 0041-45, 0051 ).
US Patent Application’522 teaches a nucleic acid encoding a NGF. US Patent Application’522 teaches that said NGF comprises an amino acid sequence that is 100% identical to the instantly recited SEQ ID NO:2 ( see sequence alignment US Patent Application’522 teaches an expression vector comprising said nucleic acid, a host cells expressing said vector and a method of expressing said vector in the host cells. US Patent Application’522 teaches that said vector can be DNA vector or virus vector. US Patent Application’522 teaches a pharmaceutical composition comprising said nucleic acid ( see entire document, Abstract and paragraphs 0011, 0012, 0015, 0019, 0034, 0044).
US Patent Application’114 and US Patent Application’522 do not explicitly teaches a NGF mutant wherein said mutant comprising substitution of Phe12 Glu with reference to the wild type NGF.
Miyata et al., teach a list of conservative amino acid substitution in recombinant protein that can effect the stability and affinity of mutated recombinant polypeptide , including Phe to Glu substitution. ( see entire document, Table 2 in particular).
US Patent Application ‘784 teaches that conservative substitution of Phe to Glu increase the stability of engineered protein ( see entire document paragraphs 0053, 0212 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 substitute Phe to Glu in a nucleic acid encoding a NGF taught by US Patent Application’114 and US Patent Application’522 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 polypeptide.
Claim 7 is included because the recited nucleic acid sequence of SEQ ID N:22 is a conservative mutant substitution of nucleic acid encoding Phe to Glu with reference to the nucleic acid encoding wild type NGF ( see sequence alignment).
As has been discussed supra, it is the Examiner;s position that it would be conventional and within the skill of the art to : (i) identify the exact position for substitution for Phe to Glu in NGF 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 polypeptide.
Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP § 2144.05 part II A.
It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious).
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.
8. No claim is allowed.
9. 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