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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/2/2026 has been entered.
Claim Status
Claims 1-10 are pending. Claims 1 and 3-4 have been amended. Claims 1-4 are being examined in this application. In the response to the restriction requirement, Applicants elected Group I. Claims 5-10 are withdrawn as being drawn to a nonelected invention.
Claim Objections
Claims 1 and 4 are objected to because of the following informalities: Claim 1 should be amended to recite “….. injury regeneration at a nerve injury site in a mammal comprising: introducing, at the nerve injury site, a polypeptide, wherein the polypeptide comprises between 15 and 20 amino acids of SEQ ID NO: 2, ID NO: 2 further comprises, after said introducing:
. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The rejection of claims 1-4 under 35 U.S.C. 112(b) is withdrawn in view of the amendments to the claims.
The rejection of claims 3-4 under 35 U.S.C. 112(d) is withdrawn in view of the amendments to the claims.
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.
This rejection has been modified.
Claims 1-4 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.
Claim 1 recites “a prophylactic method for accelerating nerve recovery treating nerve injury regeneration at a nerve injury site in a mammal….”. It is unclear whether Applicants intended to claim: 1) “a prophylactic method for accelerating nerve recovery; or 2) “a prophylactic method for treating nerve injury.
Furthermore, the phrase “treating nerve injury regeneration” is unclear. How can nerve injury regeneration be treated?
Claims 2-3, which depend from claim 1, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as these claims incorporate by dependency the indefiniteness of claim 1.
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 recitations “activates intra-axonal mRNA translation” and “increases axon growth in neurons”, and the claim also recites “activating intra-axonal mRNA translation at the nerve injury site” and “increasing axon growth in neurons at the nerve injury site” which are the narrower statements 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.
Response to Arguments
Applicant’s arguments filed 7/2/2026 have been fully considered but they are not persuasive.
Applicant argues that the claims as amended are definite.
Applicant’s arguments are not persuasive.
As discussed in the rejection above, it is unclear whether Applicants intended to claim: 1) “a prophylactic method for accelerating nerve recovery; or 2) “a prophylactic method for treating nerve injury.
Furthermore, the phrase “treating nerve injury regeneration” is unclear.
Moreover, as discussed above, claim 4 recites the broad recitations “activates intra-axonal mRNA translation” and “increases axon growth in neurons”, and the claim also recites “activating intra-axonal mRNA translation at the nerve injury site” and “increasing axon growth in neurons at the nerve injury site” which are the narrower statements of the range/limitation. Thus, claim 4 is indefinite.
For the reasons stated above the rejection is maintained.
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.
This rejection is maintained.
Claims 2-4 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. Claims 3-4 are drawn to inherent properties of the polypeptide, which once administered would inherently disrupt G3BP1 function in axonal stress granule structures. Therefore, claims 3-4 fail to further limit the subject matter of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Response to Arguments
Applicant’s arguments filed 7/2/2026 have been fully considered but they are not persuasive.
Applicant argues that the claims as amended incorporate by reference all limitations of the claims from which they depend, and specify further limitations of the subject matter claimed.
Applicant’s arguments are not persuasive.
As discussed above, claims 2-4 fail to further limit the subject matter of claim 1 because they are clearly drawn to inherent properties of the polypeptide. The claimed polypeptide inherently disrupts G3BP1 function in axonal stress granule structures once it is administered, and such administration is already claimed in instant claim 1.
Therefore, claims 2-4 fail to further limit the subject matter of claim 1.
For the reasons stated above the rejection is maintained.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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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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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
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