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 .
Election/Restrictions and Claim Status
Applicants’ amendments and arguments filed 5/29/26 are acknowledged. Any rejection or objection from the 12/29/25 office action that is not addressed below is withdrawn based on the amendments.
Previously, Group 2 and the species of SEQ ID NO:10 (as the ELP) and SEQ ID NO:17 (as the therapeutic agent) were elected.
The examiner called applicants representative on 7/16/26 and left a message proposing an examiner’s amendment. On 7/22/26 the examiner spoke with applicants’ representative but no agreement was reached. The interview summary is attached.
Claims 2, 5-10 and 12-25 have been cancelled.
Claims 1, 3-4 and 11 are being examined.
Priority
This application is a CON of 14/917,460 03/08/2016 PAT 10081667 which is a 371 of PCT/US14/58640 10/01/2014 which claims benefit of 61/885,300 10/01/2013.
Claim Rejections - 35 USC § 112
Claim 4 was previously rejected under 35 USC 112(b)/2nd. Since claim 4 has been amended, the rejection is updated to correspond to the instant claim.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is 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.
Claim 4 recites NF-kappaB inhibitory peptide (SEQ ID NO:15) or an NADPH oxidase inhibitory peptide (SEQ ID NO:16).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation NF-kappaB inhibitory peptide, and the claim also recites SEQ ID NO:15 which is the narrower statement of the range/limitation. Claim 4 recites the broad recitation NADPH oxidase inhibitory peptide, and the claim also recites SEQ ID NO:16 which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In addition, SEQ ID NO:15 is 840 amino acids long and the sequence listing describes it as ‘Synthetic SynB1-ELP-p50 sequence’ and SEQ ID NO:16 is 839 amino acids long and the sequence listing describes it as ‘synthetic SynB1-ELP-NOX sequence’. Thus, the sequences recited appear to correspond to more than just the therapeutic agent. The claim recites ‘drug delivery system consisting of’. When the therapeutic agent is SEQ ID NO:15 for example, it is unclear if an additional ‘ELP drug carrier’ is required (since SEQ ID NO:15 appears to already include an ELP). When the therapeutic agent is SEQ ID NO:16 for example, it is unclear if an additional ‘ELP drug carrier’ is required (since SEQ ID NO:16 appears to already include an ELP).
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 RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
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