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
This Office Action is in response to Applicants’ Amendment and Remarks filed on 1/12/2026 in which claims 1 and 4-6 are cancelled, claims 2, 3 and 7-12 are amended and claim 13 is newly added.
Claims 2, 3 and 7-13 are examined on the merits herein.
Applicants’ declaration submitted on 1/12/2026 under 37 CFR 1.130, is acknowledged and will be further discussed below.
Priority
This application is a National Stage Application of PCT/JP2021/041978, filed on 11/15/2021. The instant application claims foreign priority to JP 2020-191266 and JP 2021-004576 filed on 11/17/2020 and 1/14/2021, respectively. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application on 5/16/2023. A certified copy of the foreign priority document accompanied by an English translation and statement of translation accuracy was made of record on 1/12/2026. Thus, foreign priority has been perfected. The effective filing date of the instant application is 11/17/2020.
Information Disclosure Statement
The information disclosure statements (IDS) dated 9/19/2025 and 1/12/2026 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits.
Withdrawn Rejections
All rejection(s) of record for claim(s) 1 and 4-6 is/are hereby withdrawn due to the cancellation of said claim(s) rendering said rejection(s) moot.
Applicant’s amendment, filed on 1/12/2026, with respect to the rejection of: 1) claims 2, 3 and 7-11 under 35 U.S.C. 102 as being anticipated by Hijiya et al. (US 5,627,157; 1997) or 2) claims 2, 3 and 7-11 under 35 U.S.C. 102 as being anticipated by Kambe et al. (US 2017/0081354; 2017), has been fully considered and is persuasive. Neither Hijiya nor Kambe disclose a method of adjusting lens hardness in the eye. The rejections are hereby withdrawn.
Applicant’s amendment and response, filed on 1/12/2026, with respect to the rejection of claims 2, 3, and 7-12 as being unpatentable over Nakazawa et al. (Open Med., 2016, PTO-892), in view of VanAken et al. (US 2021/0030780 A1, pub 2/4/2021, filed 1/28/2019), has been fully considered and is persuasive. Nakazawa 2016 does not teach administering alpha-glucosyl hesperetin, orally or otherwise, and VanAken does not remedy the deficiency of Nakazawa 2016. The rejection is hereby withdrawn.
Applicant’s response, filed on 1/12/2026, with respect to the rejection of claims 2, 3, and 7-12 as being unpatentable over Nakazawa et al. (Mol. Med. Rep., 1/14/2020), in view of VanAken et al. (US 2021/0030780 A1, pub 2/4/2021, filed 1/28/2019), has been fully considered and is persuasive. Applicant has filed a declaration showing that Nakazawa 2020 was commonly owned at the time of filing. Therefore Nakazawa 2020 does not qualify as prior art. The rejection is hereby withdrawn.
Applicant’s response, filed on 1/12/2026, with respect to the rejection of claims 2, 3 and 7-9 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-5 of US 11,453,694, has been fully considered and is persuasive. The claims of ‘694 are directed to a composition and do not anticipate nor render obvious the instantly claimed method.
Rejections Necessitated by Amendment
The following are new ground(s) or modified rejections necessitated by Applicants' amendment, filed on 1/12/2026, wherein instant independent claims 11 and 12 are amended to alter the breadth and scope of the claim, wherein the remaining pending claims depend from said independent claims. Therefore, new grounds of rejection have been made.
New Grounds of Rejection
Claim Rejections - 35 USC § 112(a) - Enablement
The following is a quotation 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.
Claims 2, 3 and 7-13 are rejected under 35 U.S.C. 112(a), because the specification, while being enabling for alleviating or improving hardening of the lens or alleviating or improving poor focus and/or decline of near visual acuity, does not reasonably provide enablement for preventing hardening of the lens or preventing focus loss and/or decline of near visual acuity. 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. With respect to the claimed method, attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. All of the Wands factors have been considered and those most relevant to the cited claims are discussed below. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below. Nature of the invention: The rejected invention is drawn to a methods of adjusting hardness of a lens or preventing, alleviating or improving poor focus and/or decline of near visual acuity, by orally administering alpha-glucosyl hesperidin. Claim 9 recites that the scope of adjusting hardness of a lens includes preventing, alleviating or improving hardening of the lens. Relative skill of those in the art: The relative skill of those in the art is high. Breadth of claims: The claims are broad with respect to the concepts of prevention. The specification does not define the term “prevention” or “preventing”. Thus, the term “prevention” is assumed to take on the customary meaning known to those skilled in the art. Specifically, “prevention” is defined according to the Institute for International Medical Education (Wojtczak, 2002, PTO-892) as: the goals within the field of medicine to promote health, to preserve health, to restore health when it is impaired, and to minimize suffering and distress. Customarily prevention is sub-classified as primary (the protection of health by personal and community wide effects), secondary (the measures available to individuals and populations for the early detection and prompt and effective intervention to correct departures from good health) and tertiary (the measures available to reduce or eliminate long-term impairments and disabilities, minimize suffering caused by existing departures from good health, and to promote the patient's adjustment to irremediable conditions). Tertiary prevention is most relevant as used in the context of the instant invention. Thus, the intent of the claimed method, as interpreted by a skilled practitioner of the medical or pharmaceutical arts, would include that which eliminates hardening of the lens or eliminating focus loss and/or decline of near visual acuity.
Amount of guidance/Existence of working examples:
The instant specification provides data via the working examples, at ¶044-0096, that oral administration of alpha-glucosyl hesperidin is effective for alleviating or improving hardening of the lens or alleviating or improving poor focus and/or decline of near visual acuity. However, there is no data supporting that oral administration of alpha-glucosyl hesperidin is effective to eliminate hardening of the lens or eliminate focus loss and/or decline of near visual acuity
Quantity of experimentation: One of skill in the art would have to conduct a myriad number of experiments comprising trial and error administration of the claimed alpha-glucosyl hesperidin compositions to both healthy individuals and individuals having hardening of the lens, to determine if the claimed compositions can be used in the fully claimed scope to prevent, include eliminate, lens hardening. Genetech, 108 F.3d at 1366, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent 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”. Therefore, in view of the Wands factors as discussed above, e.g., the breadth of the claims, the amount of guidance provided, and the lack of working examples, one of skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims, with no assurance of success.
Claim Rejections - 35 USC § 112(a) – New Matter
The following is a quotation of 35 U.S.C. 112(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.
Claims 2, 3 and 7-13 are rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The rejected claims recite administering “alpha-glucosyl hesperetin” (emphasis added). However, there is no written description support for the compound “alpha glucosyl hesperetin” in the specification. The working examples support administering “alpha glucosyl hesperidin” (emphasis added).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new and/or modified 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 extension fee 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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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/DALE R MILLER/Primary Examiner, Art Unit 1693