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 .
Priority
The instant application, filed 10/15/2024, is a national stage entry of PCT/CN2023/088387, filed 04/14/2023, which claims priority to Chinese Patent Application No. CN202210397171.7, filed on 04/15/2022. Receipt is acknowledged of certified copies of papers required by 37 CFR § 1.55. No certified translation of the priority application, CN202210252930.0, has been received.
Status of Claims
Claims 1-11 were originally presented on 10/15/2024. The preliminary amendments to the claims also received on 10/15/2024 are acknowledged and entered. The second set of preliminary amendments to the claims received on 07/24/2026 are acknowledged, entered, and are the instant claims under examination.
Accordingly, claims 12-15 of the claim set dated 07/24/2026 are pending.
Information Disclosure Statement
The Information Disclosure Statements received on 10/15/2024 and 04/29/2026 are acknowledged and found to be in compliance with the provisions of 37 CFR § 1.97. Accordingly, the Information Disclosure Statements have been considered.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 12 Anticipated by US’944 as evidenced by US’076
Claim 12 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US’9441 as evidenced by US’076.2
Claim 12 recites:
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Claim 12 (emphasis on metabolite added).
By broadly claiming the administration of “metabolite[s]” and “prodrug[s]” of the active recited in claim 12, the instant claim is anticipated by at least US’944, which teaches that lanosterol may be administered to treat presbyopia. As evidenced by US’076, the active recited in the instant claim 12 metabolizes to lanosterol. Thus, claim 12 recites the administration of lanosterol.
For example, US’944 at 21, claim 57 teaches:
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US’944 at 21(emphasis on lanosterol added).
US’944 at 2 explains:
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US’944 at 2.
As evidenced by US’076, lanosterol is a metabolite of the compound recited in the instant claim 12. See US’076 at Abstract:
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US’076 at Abstract.
See US’076 at col. 2 (providing the chemical structure of lanosterol):
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US’076 at col. 2.
The active recited in instant claim 12 is designated “Embodiment 8” of US’076 at col. 42, compare left panel below (embodiment 8 of US’076) and right panel (active of instant claim 12):
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US’076 at col. 42, embodiment 8.
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Active recited in instant claim 12
See US’076 at col. 22, explaining that the compounds of the invention are prodrugs of lanosterol and convert to lanosterol in vivo:
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US’076 at col. 22.
See US’076 beginning at col. 50, Bioactivity data, and continuing to Table 6 (teaching that the active recited in instant claim 12 converts in vivo to lanosterol):
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US’076 at cols. 52-53, Table 6.
Accordingly, claim 12, which simply requires the administration of a metabolite of the active it recites, is anticipated by US’944 as evidenced by US’076, because the active recited metabolizes into lanosterol, which US’944 teaches may be administered to treat presbyopia.
Therefore, claim 12 is anticipated by US’944 as evidenced by US’076.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 12-15 Obvious over US’944 in view of US’076
Claim(s) 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US’944 in view of US’076.
The rejection of claim 12 under 35 U.S.C. 102(a)(1) as being anticipated by US’944 as evidenced by US’076 is incorporated herein.
Claim 12 was discussed previously. Claim 13 appears to limit the active administered in the claimed method to just the compound, and not the “stereoisomer, tautomer, nitrogen oxide, solvate, metabolite, pharmaceutically acceptable salt or prodrug of the compound”. See instant claim 13:
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Instant claim 13.
As discussed, US’944 at 2 explains:
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US’944 at 2 (emphasis added).
While US’944 does not exemplify the administration of the instantly claimed active, one of ordinary skill in the art at the time of filing would have had a reasonable expectation of success in administering the claimed active for treating presbyopia because
As suggested by US’944, the claimed active is an ester derivative of lanosterol, and
US’076 teaches that it functions as a prodrug of lanosterol that metabolizes into lanosterol.
For example, see US’076 at col. 42, embodiment 8, teaching the ester derivative of lanosterol that functions as a prodrug of lanosterol.
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US’076 at col. 42, embodiment 8.
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Active recited in instant claim 12
See also, US’076 beginning at col. 50, Bioactivity data, and continuing to Table 6 (teaching that the active recited in instant claim 12 converts in vivo to lanosterol):
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US’076 at cols. 52-53, Table 6.
Accordingly, claims 12-13 were obvious at the time of filing.
Regarding claim 14, it recites standard excipients for ocular drug delivery:
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Claim 14.
One of ordinary skill in the art at the time of filing would have had a reasonable expectation of success in administering US’076 embodiment 8 in a method of treating presbyopia, wherein the US’076 embodiment 8 is formulated with hydroxypropyl methylcellulose, Poloxamer 407, Poloxamer 188, and water, because US’076 taught a pharmaceutical composition comprising US’076 embodiment 8 formulated with hydroxypropyl methylcellulose, Poloxamer 407, Poloxamer 188, and water, suitable for administration to subjects:
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US’076 at col. 50 (emphasis added).
New Zealand white rabbits are accepted preclinical models of ocular disease. US’076 demonstrated that US’076 embodiment 8 could be formulated with hydroxypropyl methylcellulose, Poloxamer 407, Poloxamer 188, and water, and administered to a subject. Being a suitable set of excipients for ocular delivery, the person of ordinary skill in the art at the time of filing had a reasonable expectation of success in selecting the same excipients in the instantly claimed method. Further, US’076 at claim 5, col. 59, teaches the same active, and claims 6-13 teach its pharmaceutical composition suitable for a subject in need. Subjects in need in the context of US’076 were humans. See US’076 at col. 1.
Accordingly, claim 14 was obvious at the time of filing.
Regarding claim 15, it recites specific amounts of excipients:
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Claim 15.
Some maths are required and the significant figures are unclear because the instant claim 15 suggests just 1 significant figure. However, the active recited has a CAS Reg. No. of 2241299-91-0. CAS states the compound has a molecular weight of 546.82 g/mol. US’076 taught its administration at a concentration of 5 mM. The below table (right column) shows the pharmaceutical composition comprising this active taught in US’076 at col. 50 converted to parts per mass. These are the same values as the instant claim 15:
From US’076
Converted to parts per mass
Active
5 mM
27.3 (27.3 mg)
hydroxypropyl methylcellulose
1.2%
120
Poloxamer 407
20.5%
2050
Poloxamer 188
1.6%
160
water
10,000 (10 mL)
Any differences between the claimed composition and the one expressly taught in US’076 would be obtained by simple routine experimentation and optimization of the formulation, a process that was well within the skills of an ordinary chemist at the time of filing.
Therefore, claim 15 was obvious for the same reasons claim 14 was obvious at the time of filing, and for the reasons stated above.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
NSDP to US’763 in view of US’944
Claims 12-15 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 14-16 of U.S. Patent No. 12,329,763, hereinafter “US’763”, in view of US’944. US’944 is the same reference discussed throughout this office action.
US’763 at claim 1 recites a composition comprising the same active of the instant claims. See claim 1 of US’763:
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Claim 1 of US’763.
See, e.g., instant claim 12:
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Instant claim 12.
Claims 14-16 of US’763 recite this active in a very specific eye-drop formulation in a volume of 10 mL of water. See claims 14-16 of US’763:
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Claims 14-16 of US’763.
Instant claim 15 recites the intended use of the same formulation of claims 14-16 of US’763.
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Instant claim 15.
The claims of US’763 do not expressly teach the indication for treating presbyopia of this compound formulated in this very specific way.
However, one of ordinary skill in the art at the time of filing, and in possession of the subject matter of claims 1 and 14-16 of US’763, would have had a reasonable expectation of success in administering the same formulation of claims 1 and 14-16 of US’763 for treating presbyopia because US’944 taught that lanosterol and ester derivatives thereof may be used for treating presbyopia, and the active recited was an ester derivative of lanosterol.
For example, US’944 at 2 explains:
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US’944 at 2.
Accordingly, instant claims 12-15 were obvious over claims 1 and 14-16 of US’763 in view of US’944.
Prior Art Cited but not Applied
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Short 20083 teaches standard prodrug formulation parameters for ocular drug delivery.
Shah 20194 teaches background on animal models for ocular disease research.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christopher Evan Redwood whose telephone number is (571) 272-8882. The examiner can normally be reached Monday - Friday 6:15 AM - 4:45 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.E.R./ Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/ Supervisory Patent Examiner, Art Unit 1629
1 Piraee; Mahmood, “Combinations Of Lanosterol Or 25-Hydroxycholesterol Including Derivatives Thereof Useful In The Treatment Of Lens Disorders”, U.S. Patent Publication No. US 20200281944 A1, published 2020-09-10, hereinafter “US’944”.
2 Liu; Yizhi, et al. “Lanosterol Prodrug Compound And Preparation Method Therefor And Use Thereof”, U.S. Patent No. US 10738076 B2, published 2020-08-11, hereinafter “US’076”.
3 Short, Brian G. "Safety evaluation of ocular drug delivery formulations: techniques and practical considerations." Toxicologic pathology 36.1 (2008): 49-62, hereainfter “Short 2008”.
4 Shah, Mihir, et al. "Translational Preclinical Pharmacologic Disease Models for Ophthalmic Drug Development: Mihir et al." Pharmaceutical research 36.4 (2019): 58, hereinafter “Shah 2019”.
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