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
Claims 1, 19-24, 27-32 and 34-37 are pending in the application. Claims 1, 19-24, 27-32 and 34-37 are rejected.
Response to Amendments
Objections and rejections made in the Office Action mailed April 6, 2026 that do not appear below have been overcome by Applicant’s amendments to the claims and have been withdrawn.
Response to Arguments - 35 USC § 103
In reply, Applicant traverses the claim rejections under 35 U.S.C. § 103 as presented in the Final Rejection mailed April 6, 2026. The newly applied 35 U.S.C. § 103 rejection of claims 1, 19-24, 27-32 and 34-37 has been necessitated by Applicant’s amendment filed on June 22, 2026. The previously presented rejection under 35 U.S.C. § 103 in the Office Action mailed April 6, 2026 has been withdrawn and replaced with the rejection(s) below. Applicant’s remarks, dated June 22, 2026, relevant to the newly applied 35 U.S.C. § 103 are addressed below.
Applicant argues that “the ‘960 patent at most discloses or teaches that bendazac lysine can prevent lens lesions on the basis that it belongs to an aldose reductase inhibitor.” See page 11 of Applicant’s Remarks dated June 22, 2026. Regardless, the ‘960 patent invention is generally drawn towards an “eye refreshing drop for quickly repairing eyesight.” See e.g., page 7. Therefore, a person of ordinary skill in the art would have a reasonable expectation of success that administering the prior art eye drop to an individual would likely result in improved eyesight for the individual. Furthermore, for instance, a person of ordinary skill would recognize that an individual with improved eyesight would be far less inclined to experience “blurred vision when looking at distant objects” or “squinting or partially closing eyelids to see distant objects clearly” (as recited in instant claim 1). Therefore, by administering the prior art eye drop solution to an individual, a person of ordinary skill would effectively be preventing at least certain myopia-related symptoms. In addition, considering that the prior art eye drop solution comprises bendazac lysine, administering the prior art eye drop solution to an individual in this situation entails administering an effective amount of bendazac lysine to the individual. The fact that bendazac lysine is not administered as a sole active ingredient or as a main active ingredient in the ‘960 patent is addressed below in the newly amended claim rejection under 35 U.S.C. § 103.
Applicant further argues that “the ‘960 patent fails to present experimental data demonstrating the alleged vision-restoration effects.” See page 12 of Applicant’s Remarks dated June 22, 2026. However, the prior art is presumed to be operable or enabling. MPEP 2121 (I) states: “When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980).” Furthermore, a “[c]onclusive proof of efficacy is not required to show a reasonable expectation of success.” OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019).
Applicant also argues that “Silvestrini’s rationale is based on the premise that bendazac protects retinal tissue through antioxidant and anti-photooxidative mechanisms” and, therefore, does not align with methods for treating myopia. See page 13 of Applicant’s Remarks dated June 22, 2026. It is noted that both Silvestrini and the instant disclosure are drawn towards the same bendazac compound. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP § 2112.01(II).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. § 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 19-24, 27-32 and 34-37 are rejected under 35 U.S.C. § 103 as being unpatentable over Chinese Publication No. CN109549960A (April 2, 2019) in view of Silvestrini et al. (U.S. Patent No. 4,554,288; November 19, 1985).
Determining the scope and contents of the prior art (See MPEP § 2141.01)
Chinese Publication No. CN109549960A (herein after ‘960) teach an eye-drop solution (100 mL) for “quickly repairing eyesight” and “pre-myopia prevention” which includes the following components (see e.g., pages 7-9 of attached machine translation):
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Regarding instant claims 1, 20, 27-32 and 34-37, the instantly required bendazac lysine is listed as the fifth component from top in the above prior art formulation. Note that “pre-myopia prevention” as taught in the prior art entails the prevention of myopia forming in an individual- regardless of the type of myopia. Further note that, according to paragraph [0018] of the instant specification, a “vitamin” is considered a “drug.” Therefore, “Vitamin B1” as taught by ‘960 (the eighth component listed from top in the above prior art formulation) correlates to the instantly recited “one or more other drugs” as recited, for instance, in instant claims 20 and 29. In addition, administering the above prior art formulation to an individual would necessarily entail the simultaneous administration of the various components (e.g., bendazac lysine and vitamin B1) contained within the formulation as required, for instance, by instant claim 28. Furthermore, ‘960 teaches 0.2-0.5 g of bendazac lysine in a 100 mL aqueous solution which correlates to a maximum bendazac lysine mass/volume concentration of 0.50% which meets the mass/volume concentration requirement of instant claim 34.
Regarding instant claims 19 and 24, ‘960 teaches that the common pathogenesis of myopia includes increased intraocular vitreous chamber, extended axis oculi (i.e., axial myopia/axial elongation) and corneal curvature variation. See e.g., page 7 of attached machine translation.
Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
Regarding instant claims 1 and 21-23, ‘960 does not teach administering an effective amount of bendazac lysine or bendazac to an individual, such as an individual with myopia or a tendency to develop myopia. However, the invention of ‘960 is generally drawn towards methods for the treatment and prevention of myopia. See e.g., pages 7 and 8 of attached machine translation.
Regarding instant claim 1, ‘960 does not teach administering bendazac lysine or bendazac as a sole active ingredient or as a main active ingredient. However, Silvestrini et al. teach “method[s] for the treatment of retinitis pigmentosa in a human which comprises administering to said human a therapeutically effective amount of bendazac” as the sole active ingredient. See e.g., claim 1 in column 3. Silvestrini et al. also teach “bendazac orally in the form of lysine salt, available data on this drug indicate that it is capable of affecting retinitis pigmentosa in other salt forms, pharmaceutical forms, or eye-drops.” See e.g., column 2, lines 63-68. In addition, Silvestrini et al. discloses that “Retinitis pigmentosa is a retinal degeneration characterized by the following manifestations: night blindness, progressive loss of peripheral vision, eventually leading to total blindness.” See e.g., column 1, lines 5-9. Accordingly, the manifestations of retinitis pigmentosa as taught by Silvestrini et al. are encompassed by the instantly claimed “myopia-related symptoms” as recited in instant claim 1. Furthermore, Silvestrini et al. teach administering bendazac lysine salt to patients ranging from 28-65 years of age. See e.g., Table 1.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 1 and 21-23, it would have been obvious to a person of ordinary skill in the art to employ the bendazac-containing eye drop formulation of ‘960 in methods of treating or preventing myopia (i.e., administering the eye drop to an individual). Considering that ‘960 teach a formulation for “pre-myopia prevention” (see e.g., page 8), a person of ordinary skill would have been motivated to employ the instantly claimed methods (i.e., of preventing myopia or myopia related symptoms).
Further regarding instant claim 1, it would have been obvious to a person of ordinary skill in the art to administer bendazac lysine or bendazac as the sole/main active ingredient based on the teachings of ‘960 in view of Silvestrini et al. Considering that Silvestrini et al. teach “improvement in visual acuity” and “a significant increase in visual field” in patients after being administered bendazac lysine, a skilled artisan would be motivated to apply the bendazac eye-drops taught by Silvestrini et al. in methods of treating/preventing myopia or myopia related symptoms (e.g., night blindness, loss of peripheral vision, blindness) and, thereby, employ the instantly claimed method. See e.g., column 2, lines 53-58.
Conclusion
No claims are allowed.
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 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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/D.M.S./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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