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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/10/25 has been entered.
Election/Restrictions and Claim Status
Applicants’ amendments and arguments filed 8/11/25 are acknowledged. Any rejection or objection from the 4/10/25 office action that is not addressed below is withdrawn based on the amendments.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.
A telephone call and voice message with left with applicants representative on 12/12/25 in which the examiner proposed amendments to get the application in condition for allowance. Since the telephone message was not returned after more than 120 hours this office action was prepared.
Claims 2, 9-10 and 12-25 have been cancelled.
Claims 1, 3-8 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
The rejections below are new rejections.
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.
Claims 1, 3-8 and 11 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.
Claims 1 and 4 recite ‘cell penetrating peptide chosen from penetratin, Tat, SynB1, Bac, polyArg, MTS, Transportan, pVEC’. It is unclear if this is a closed or open list. There is no word ‘or’ in between the last options so it is unclear if additional peptides are possible. Claim 1 line 4 and claim 4 line 4 previously recite ‘consisting of’ so it should be clear what can or cannot be included within the scope of the claim. None of the dependent claims clarify the claim scope.
Claim 4 recites NF-kappaB inhibitory peptide selected from the group of amino acid sequences consisting of SEQ ID NO:15 and an NADPH oxidase inhibitory peptide consisting of SEQ ID NO:16. The claim language is confusing and unclear for numerous reasons. First, the claim recites ‘NF-kappaB inhibitory peptide’ selected from the group but then only recites a single option for NF-kappaB inhibitory peptide (SEQ ID NO:15). A group is to include more than one option. Further, the claim language ‘consisting of SEQ ID NO:15’ and ‘consisting of SEQ ID NO:16’ suggest closed language but the claim goes on to recite additional possible components. If the peptide consists of a particular sequence than it would not contain additional sequences. 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 therapeutic agent appears to consist of more than just an NF-kappaB inhibitory peptide or an NADPH oxidase inhibitory peptide. It is unclear if 2 ELP sequences are required. Claim 4 line 5 recites an ELP drug carrier and each of SEQ ID NO:15 and SEQ ID NO:16 include an ELP.
Claim 7 refers to Table 1. MPEP 2173.05(s) recites: ‘claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim’. There is no indication that the instant case is an exceptional circumstance. Further, it appears that Table 1 includes trademarks. MPEP 2173.05(u) states ‘If the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). See also Eli Lilly & Co. v. Apotex, Inc., 837 Fed. Appx. 780, 784-85, 2020 USPQ2d 11531 (Fed. Cir. 2020)’.
Claim 8 recites ‘regarded as harmful’. The term “regarded as harmful” is a relative term which renders the claim indefinite. The term “regarded as harmful” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5-8 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 1 has been amended to recite that the therapeutic agent is a VEGF therapeutic agent. Claims 5-8 refer to categories or descriptions that are broader than VEGF therapeutic agent. Further, there is not adequate evidence on the record that any known VEGF therapeutic agent would fit into the multiple categories as in claims 5-8.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
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.
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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