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
Claims 31-37 and 50-52 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 40-50, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Upon further consideration, SEQ ID NOs: 36, 39, 40, and 49 in claim 31 and claim 32 have been rejoined with the elected species and examined..
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 6/25/25 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
The non-elected species in claim 33 were cancelled in the amendment filed on 4/13/26
Specification
The use of the term LASIK and LASEK, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Response to Arguments
Applicant’s arguments, see pages 7-8, filed 4/13/26, with respect to the rejection(s) of claims 33-39 and 51-52 under 102 and 103 based on Dey (US 20210171957) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn because applicant asserts that not later than the effective filing date of the claimed invention, the subject matter disclosed in the Dey application and the claimed invention were subject to an obligation of assignment to the same person. Both Dey and the instant application were subject to an obligation of assignment to MicroCures, Inc., as the assignments by the inventors thereof show.. However, upon further consideration, a new ground(s) of rejection is made in view of the rejoinder of non-elected invention directed to method claims.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 40-49 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating a wound in a skin graft or skin grafting site or skin in a subject in need thereof; help a patient recover erectile function post-surgery involving radical prostatectomy by implanted into surgical site proximal to the cavernous nerves; or improve regeneration of injured axons using the composition in claim 36, does not reasonably provide enablement for treating a wound or inhibition, reducing, or preventing scar in a subject. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The claimed method embraces treating, inhibiting, reducing or preventing a scar in a variety of tissues or organs in a subject. Each method would require a different patient and possibly a different route of administration of the siRNA.
The prior art does not teach that it was routine in the art to use fidgetin-like 2 (FL2) siRNA for treating any wound or inhibiting, reducing or preventing any scar in a subject.
US 20130022667, cited on an IDS, disclose that skin wounds in a human subject can be treated using FL2 siRNA or shRNA.
US 20210171957 (of record) disclose FL2 is involved in T cell therapies.
The art (US 20230203495, of record) disclose topically administration of a fidgetin-like 2 siRNA to the healing site of a skin draft in a porcine burn model.
Matamoros et al. (Journal of Neurosci. 39:20141-2024, 2019) disclose that knockdown of FL2 improved regeneration of injured axons by a microtubule-based mechanism.
The prior art appears to teach that FL2 siRNA can be used to improve regeneration of injured axons or treat skin wounds.
Pages 32-37 of the specification contemplate the claimed methods. The specification does not provide a working example of preventing a scar in a subject using the composition of claim 36. The specification discloses improved cell migration in two human cell lines using SEQ ID NO: 17/18 siRNA. The specification states that SEQ ID NO: 17/18 implanted into surgical site proximal to the cavernous nerves help a patient recover erectile function post-surgery involving radical prostatectomy. The specification provides a prophetic example of excisional wound healing using the claimed siRNA (paragraphs 192-205). FL2 appears to be a human enzyme that slows that rate of which skin cells migrate to wound to heal them.
With respect to inhibition or preventing a scar in a subject, neither the specification nor the prior art teach how carry out this method without an undue amount of experimentation. The working examples in the specification or prior art are directed to the subject already having the wound or scar. The broadest reasonable interpretation of the claimed method steps embrace preventing a scar from every forming. See paragraph 137 “In some embodiments, a compound of the disclosure treats or prevents neuropraxia.” The prior art does not teach what level of FL2 is required to be reduced to inhibit or prevent a scar in a subject that experiences neuropraxia. FL2 would have to expressed at a certain level for the scar to form. Other than in a controlled environment (e.g., surgery or inducing the wound or scar), the specification does not teach how to identify what subject would require FL2 siRNA outside a hospital setting or surgery before the scar is formed or how to determine if inhibition or prevention of the scar occurred or did not occur for another reason. The specification does not appear to fully enabling as of the filing date. See MPEP 2164.05(a).
In addition, even though the prior art teaches improved/enhanced regeneration of injured axons using FL2 siRNA and could result in restoring neural function, but there is nothing of record to teach the skilled artisan that it would result in enhancing neural function.
With respect to this scope of enablement, the method would require direct administration of the siRNA to the wound because neither the prior art nor the as-filed specification teach how to use a genus of administration routes to successfully deliver the siRNA to observe a therapeutic effect without an undue amount of experimentation. See Vicentini et al. (Pharm Res 2013, 30:915-931).
Also, a search of the prior art does not result in any teaching that FL2 expression is involved in a wound or scar in an eye, peripheral nervous system, cardiac tissue, blood vessel, tendon, ligament, muscle, oral cavity, lips, palate, an internal organs, abdominal cavity, pelvic cavity or thoracic cavity. The skilled artisan would look for guidance for how to carry out the claimed method involving these tissues or organs and would not find the guidance needed to the practice the claimed for these organs or tissues. See also MPEP 2164.05(a).
Furthermore, other than contemplating the methods; providing limited examples in cell lines’ and one patient with erectile dysfunction after radical prostatectomy, the specification of the application does not disclose how to use the full scope of claimed invention. See Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 clearly states: "Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 148 USPQ 689, 696 (1966) (stating, in context of the utility requirement, that "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.") Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention." Applicant cannot rely on the knowledge of one skilled in the art to supply information on the novel aspects of the claimed invention. Thus, in view of the reasons set forth above, it would take an undue amount of experimentation for one of skill in the art to practice the full scope of the invention.
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 42 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 42 contains the trademark/trade name LASIK and LASEK. Where a 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 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe LASIK surgery and LASEK surgery and, accordingly, the identification/description is indefinite.
Claims 31-39 and 50-52 are in condition for allowance. See reasons for allowance for the claimed product in the non-final rejection.
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.
See attached PTO-326 for disposition of claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian Whiteman whose telephone number is (571)272-0764. The examiner can normally be reached on Monday thru Friday; 6:00 AM to 3:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached at (571)-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN WHITEMAN/ Primary Examiner, Art Unit 1636
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