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
Claim Status
Claims 1-10 are pending. Claims 2-3, 5 and 7 have been amended. Claims 1-4 are being examined in this application. In the response to the restriction requirement, Applicants elected Group I.
Newly amended claims 5-7 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claim 5 is directed to a method of disrupting G3BP functions, wherein disruption of G3BP functions is accomplished via transfection of siRNA to promote siRNA-mediated knockdown of G3BP1; whereas the elected invention of claims 1-4 is directed to a completely different method. Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 5-10 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 112
The rejection of claim 2 under 35 USC 112(d) is withdrawn in view of the amendments to the claim.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.
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.
This is a new rejection.
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 3 recites the broad recitation “disrupts G3BP functions”, and the claim also recites “disrupting G3BP1 function in axonal stress granule structures” 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.
This rejection is maintained.
Claim 1 recites “a prophylactic method for accelerating nerve recovery treating nerve injury in a mammal….”. It is unclear whether Applicants intended to claim: 1) “a prophylactic method for accelerating nerve recovery by treating nerve injury in a mammal….”; or 2) “a prophylactic method for accelerating nerve recovery or for treating nerve injury in a mammal….”. Furthermore, it is unclear whether the claimed method is a prophylactic method or a treatment method. Moreover, in the sentence “wherein the polypeptide is amino acid sequence SEQ ID NO: 2, comprising between 15 and 20 amino acids…”, the word “is” implies that the polypeptide consists of SEQ ID NO: 2, thus, said polypeptide is 19 amino acids long, NOT between 15 and 20 amino acids.
Claims 2-4 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.
Response to Arguments
Applicant’s arguments filed 4/10/2026 have been fully considered but they are not persuasive.
Applicant argues that “[w]hen claim 1 is read as a whole and in light of the specification, a person of ordinary skill in the art would understand the claim to be directed to a method in which a polypeptide is introduced at a nerve injury site in a mammal to accelerate nerve recovery. The body of claim 1 immediately supplies the operative context by requiring introduction of the polypeptide "at a nerve injury site in the mammal" and by reciting acceleration of nerve regeneration "at a nerve injury site in the mammal." The specification is consistent with that understanding. The Summary of the Invention describes introducing a polypeptide to a nerve injury site in a mammal, and the embodiment corresponding to Figure 19 likewise describes introduction of a polypeptide to a nerve injury site in the mammal to interfere with stress granule function and increase intra-axonal translation needed for regeneration. In that context, the metes and bounds of claim 1 are reasonably clear”.
Applicant also argues that “[A] person of ordinary skill in the art would understand claim 1 to require the specific polypeptide identified by SEQ ID NO: 2, which falls within the expressly recited 15-20 amino acid range disclosed in the specification for the claimed polypeptides. The claim therefore does not leave the reader uncertain as to what peptide is encompassed. At most, the claim recites a specific species together with the genus range within which that species falls. That does not create uncertainty in scope”.
Applicant’s arguments are not persuasive.
As discussed in the rejection above, the phrase “a prophylactic method for accelerating nerve recovery treating nerve injury in a mammal….” is unclear.
One of ordinary skill in the art would not understand whether the method is for accelerating nerve recovery by treating nerve injury in a mammal, or for accelerating nerve recovery or for treating nerve injury in a mammal.
Furthermore, it is unclear whether the claimed method is a prophylactic method or a treatment method.
With respect to the sentence “wherein the polypeptide is amino acid sequence SEQ ID NO: 2, comprising between 15 and 20 amino acids…”, the word “is” implies that the polypeptide consists of SEQ ID NO: 2, thus, said polypeptide is 19 amino acids long, NOT between 15 and 20 amino acids. It is unclear whether the polypeptide claimed consists of or comprises SEQ ID NO: 2. Tus the claim 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 3-4 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 4/10/2026 have been fully considered but they are not persuasive.
Applicant argues that “[C]laim 2 depends from claim 1 and further limits claim 1 by requiring that the polypeptide specifically targets mRNA storage sites in neurons at the nerve injury site and increases rates of neuron regeneration after introduction to the nerve injury site in the mammal. Claim 3 depends from claim 1 and further limits claim 1 by requiring that the polypeptide disrupts G3BP functions by disrupting G3BP 1 function in axonal stress granule structures. Claim 4 depends from claim 3 and further narrows claim 3 by requiring activation of intra-axonal mRNA translation, increased axon growth in neurons, and acceleration of nerve regeneration in vivo in the peripheral nervous system. The Office Action's position that these recitations are "inherent properties" does not establish noncompliance with § 112(d). Even assuming arguendo that the Office Action believes certain results would naturally follow from administration of the claim 1 polypeptide, that view does not alter the fact that claims 2-4 each recite additional narrowing limitations. The test under § 112(d) is not whether the added limitation is, in the Office Action's view, significant or noninherent. Rather, the test is whether the dependent claim includes the limitations of the parent claim and further narrows the scope. Claims 2-4 do exactly that”.
Applicant’s arguments are not persuasive because claims 3-4 do NOT further limit the subject matter of claim 1.
It is noted that the rejection of claim 2 has been withdrawn because the claim as amended requires a step to be performed (i.e. introduction to the nerve injury site).
However, claims 3-4 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.
Terminal Disclaimer
The terminal disclaimer filed on 4/10/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US10668128 and US11382947 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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 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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