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) filed with the RCE is acknowledged.
After amendment, claims 1, 6-8, and 22-24 are pending and examined on the merits and claims 10-21 withdrawn (some of which may be eligible for rejoinder which applicant will discuss with their overseas client (Japan), see attached Interview Summary).
An interview summary is attached and the examiner remains open to further interview.
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(b) – Indefiniteness, New
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.
Claims 1, 6-8, and 22-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Per the Interview Summary of record:
After a thorough review of the amended claims by the examiner and applicant's representative, a new issue arose as to whether the formula identifier E is a linker or not as the relevant definitions/description thereto do not expressly identify such as nor is such positively claimed, which bears relevance on the claim scope interpretation of dependent claim 24, which though not claimed, may itself contain language that needs to also be incorporated into the claim language to identify such as a linker (see e.g. specification page 4, line 23). Applicant's representative was unable to reach a senior partner to further discuss. The examiner conveyed this may have to be addressed in writing (amendments and/or arguments) to confirm the intended claim scope and interpretation thereof.
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
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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