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 .
Applicant’s response (amendments, arguments) is acknowledged.
See also Interview Summary attached.
After amendment, claims 1, 6-8, and 22-24 remain pending and examined on the merits and claims 10-21 withdrawn (some of which may be eligible for rejoinder later, which applicant may discuss with their overseas client (Japan)).
The examiner remains open to further interview to advance prosecution.
Election/Restrictions-Maintained as to Group, Not Species Based on Amendment to SEQ’s 1-4
Applicant's election with traverse of Group I, claim 1-9 and the species Subgenus 1-A-LE-B, with any of peptide SEQ ID NOS: 5, 6, 8-99, and 108 attached thereto, in the reply filed on 9/29/23 is acknowledged. The traversal is on the ground(s) that:
Species: patentable distinctness of the species has not been established. This is not found persuasive for the reasons of record and that at a minimum the non-overlapping amino acid sequence structures for attachment to Subgenus 1 render such distinct.
Group: For the reasons of record, distinctness or independence of the respective structures within each Group is set forth in each Group description as bearing additional or missing structures distinct or independent to each, altering the search of the art thereto, with a serious burden search and analyze the search of all collectively.
The requirement is still deemed proper and is therefore made FINAL.
Allowable Subject Matter-Previously Noted
The examiner undertook a search of the fully defined peptide of SEQ ID NOS: 11-14, which were found to be free of the art and now positively amended into the pending claims under examination:
Formula (I) A-LE-B (found free of the art (STN structure search):
PNG
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210
452
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Greyscale
; bound to any one of the peptides SEQ ID NOS: 11-14 (found free of the art by sequence database search):
FNMQQ0RRFYEALHDPNLNEEQRNARIRSIRDD (SEQ [D NO: 11)
FNMOCORRFYEALNDPNLNEEORNARIRSIRDDC (SEQ ID NO: 12},
beta-Ala-NMOOORRPYEALHDPNLNEEORNARIRSIRDD (SEO ID NO: 13} of
beta -Ala-NMOCORRFYEALHDPNLNEEOQRNARIRSIRDDC (SEQ ID NO: 14},
As previously noted, these claims would be in condition for allowance, pending the final updated search bearing the interference search, and addressing the 35 USC 112(b) rejection below and potential claim rejoinder of withdrawn claims.
Claim Rejections - 35 USC § 112(a) – Written Description, New Matter
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.
Claims 1, 6-8, 22-24 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.
A thorough review of the instant application (U.S. Patent Publication 20210139541, through KWIC search thereof) was undertaken as the amended claims employing the term “configured” in multiple locations throughout the pending claims under examination. This term is not found in the specification as filed; lacking ipsis verbis support. Furthermore, without a clear associated definitional support thereof, other language was explored and agreed to and the examiner open to supplemental amendment, to address this new matter issues; however, such could not be resolved as applicant was unable to be reached in a timely fashion and after nearly a week the Office action had to be processed. Upon review, the supported language to address this rejection has been agreed to by the examiner and applicant’s representative, pending applicant’s approval thereof. (See Interview Summary attached).
Prior Art Made of Record But Not Relied Upon – Previously Noted
U.S. Patent Publication 20200181196 to Ito et al.
SITE-SPECIFIC RADIOISOTOPE-LABELED ANTIBODY USING IgG-BINDING PEPTIDE
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/MAURY A AUDET/Primary Examiner, Art Unit 1654
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