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 .
RESPONSE TO APPLICANT’S AMENDMENT
1. The finality of the previous Office Action, mailed on 07/08/26 is hereby withdrawn.
2. Applicants amendment filed on 04/30/26 is acknowledged.
3. Claims 1-3,5-9,11,14,15,17,20,23,25 and 30 are pending.
4. Claims 25 and 30 stand withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 1-3, 5-9,11,14,15, 17 read on a recombinant nucleic acid encoding truncated EGFR ( tEGFR) are under consideration in the instant application.
5. 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.
6. Claims 1-3, 6-9, 11, 14,15,17, 20 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20190276801 in view of US Patent 8,158361
US Patent’801 teaches a nucleic acid encoding a tEGFR wherein said tEGFR comprises EGFR domain IV and does not comprise an EGFR domain III. US Patent’801 teaches that said tEGFR does not comprise an EGFR domain I and EGFR domain II. US Patent’801 teaches a nucleic acid further comprising a sequence encoding CAR comprising antibody region and transmembrane domain. US Patent’801 teaches an expression vector comprising said nucleic acid . US Patent’801 teaches that said nucleic acid comprising sequence encoding a self-cleaving peptidyl sequence. US Patent’801 teaches that said tEGFR can be used for various non-immunogenic selection tools. ( see entire document, Abstract and paragraphs 0008, 0012, 0014,0021,0047, 0049, 0052, 0063, 0070 and 0080 and claim 1 in particular) .
US Patent Application ‘ 801 does nor explicitly teach a nucleic acid encoding a tEGFR wherein said tEGFR does not comprise EGFR domain III.
US Patent 8,158361, teaches a tEGFR without extracellular domain III and can be used for various non-immunogenic selection tools.( see entire document, paragraphs 7, 9 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 use nucleic acid that encodes a tEGFR without extracellular domain III taught by US Patent 8,158361 in generating recombinant nucleic acid taught by US Patent Application ‘ 801 with a reasonable expectation of success because the prior art suggests each of said tEGFR can be used for various non-immunogenic selection tools
Claims 6 and 7 are included because said functional properties would be an obvious properties of the tEGFR without EGFR domain III because said tEGFR would comprise EGRG domain IV that is capable of binding to anti-domainIV EGFR antibody and would not have EGFR domain III and thus would not be able to bind to anti-domain III EGFR antibody.
From the teachings of the references, it was 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.
7. Claims 1,2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20190276801 in view of US Patent 8,158361 as apply to the claims 1-3, 6-9, 11, 14,15,17, 20 and 23 above and further in view of US Patent 11,118168
The teaching of US Patent Application 20190276801 and US Patent 8,158361 have been discussed above.
US Patent’801 and US Patent’ 361 do not explicitly teaches a nucleic acid comprising a sequence encoding a tGFR of SEQ ID N:276.
US Patent’168 teaches a nucleic acid encoding truncated EGFR of SEQ ID NO: 202 that is 100% identical to the instantly claimed SEQ ID NO: 276. US Patent’168 teaches a nucleic acid encoding said tEGFR can be used in generation CARs for immunotherapy ( see entide document, paragaphs 17, 19, 22, 38 and sequence alignment).
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 use a nucleic acid encoding truncated EGFR of SEQ ID NO: 202 that is 100% identical to the instantly claimed SEQ ID NO: 276 and substitute it for a nucleic acid encoding a tEGFR taught by US Patent’801 and US Patent 361 with a reasonable expectation of success because the prior art suggests each of said tEGFR can be used for generation CAR for immunotherapy.
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 teachings of the references, it was 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, Gregory Emch can be reached on 571/ 272-8149.
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
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