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. Applicants amendment filed on 04/30/26 is acknowledged.
2. Claims 1-3,5-9,11,14,15,17,20,23,25 and 30 are pending.
3. Claims 25 and 30 stand withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.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.
4. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
5. Claims 1-3, 6-9, 11, 14,15,17, 20 and 23 stand rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by US Patent Application 20190276801 for the same reasons set forth in the previous Office Action, mailed on 01/30/26.
Applicant’s arguments filed on 04/30/26 have been fully considered but have not been found convincing.
Applicant asserts that that US Patent Application ’801 does not teach tEGFR polypeptide that does not comprise an EGFR domain III.
The examiner does not agree with Applicant’s interpretation of the whole teaching of US Patent Application’ 801. The paragraphs pointed by Applicant only disclosed preferred embodiment. Nowhere does US Patent Application’ 801 teach that tEGFR should always comprise extracellular EGFR III domain. ( emphases added). Moreover, US Patent Application’801 explicitly teaches that truncated EGFR that does not comprise extracellular domain can be used for various non-immunogenic selection tools ( see Abstract and paragraphs 0005 in particular)
In this regard it is noted that according to MPEP § 2123, “[d]isclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). ‘A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.' In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994)…”
As is evidence from the teaching of US Patent 8,158361, the EGFR without extracellular domain III was well know in the art and was used for various non-immunogenic selection tools.( see entire document, paragraphs 7, 9 in particular).
As has been stated previously, 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. ( see entire document, Abstract and paragraphs 0008, 0012, 0014,0021,0047, 0049, 0052, 0063, 0070 and 0080 and claim 1 in particular).
Claims 6 and 7 are included because said functional properties would be an inherent properties of the references tEGFR because the referenced and instantly claimed tEGFR are the same.
See MPEP § 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).” Also, “Products of identical chemical composition can not have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada's polymer latexes for lack of novelty.").”
The reference teaching anticipates the claimed invention.
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 1,2 and 5 stand rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20190276801 in view of US Patent 11,118168 for the same reasons set forth in the previous Office Action, mailed on 01/30/26.
Applicant’s arguments filed on 04/30/26 have been fully considered but have not been found convincing.
Applicant asserts that since US Patent Application ’801 is not prior art reference it can not be used for rejection under 35 U.S.C. 103.
Contrary to Applicant’s assertion, as has been stated above, it is the Examiner’s position that US Patent Application ’801 is a prior art reference.
As has been stated previously, US Patent’801 does 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 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. THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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 extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no, however, event will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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