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 .
The examiner acknowledges receipt of preliminary amendment filed 02/07/2024 and IDS filed 09/29/2025, 06/12/2025 and 02/07/2024.
Claims 1-16 are canceled.
New claims 17-33 are added and pending.
Priority
This application is a 371 of PCT/CN2022/113025 filed 08/17/2022 and which claims benefit of CHINA application 202110951364.8 filed 08/18/2021.
Information Disclosure Statement
The IDS filed 09/29/2025, 06/12/2025 and 02/07/2024 have been considered by the examiner.
Claim Rejections - 35 USC § 112
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 19, 25-26 and 28-29 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.
Claims 19, 25-26 and 28-29 recite preferably to narrow a preceding broader rang to a narrower range.
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, the claims recite the broad recitation 0.01-4 mg/ml (claim 19), particle size of formula 1 of <90 mm (claim 25 and 28), suspension (claims 26 and 29), and the claims also recite 0.1, 0.2, … 4 mg/ml (claim 19), < 50 mm (claims 25 and 28), emulsion (claims 26 and 29), which represent 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.
Correction is respectfully requested.
Further, for claim 19, concentration is the first occurrence in claim 19 and does not derive antecedent support from claim 18.
For claim 25 and 28, particle size is the first occurrence and does not derive antecedent support form claim 17 and claim 27 respectively.
For claims 26 and 29, dosage form is the first occurrence and does not derive antecedent support from claims 17 and 27 respectively.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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.
Claim(s) 17-24, 26-27 and 29-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over ZHENG et al. (CN 106344587 A, English translation of the description on PE2E and the CHINA version of WO 2018036522 A1) in view of LIU et al., (EP 3828193 A1).
ZHENG discloses composition comprising lanosterol (see the whole Eng. Trans, pages 4-5 of the translation), one or more carriers selected from the group consisting or water, solubilizer, surfactant, thickening agent, osmotic pressure regulator, buffer, preservative, chelating agent (pages 7 and 8) and the composition is in the form of solution or emulsion or suspension (page 6, paragraphs 5, 6; page2, third paragraph) with the suspension or emulsion meeting claims 26 and 29. In one embodiment, the thickening agent is hydroxypropyl methylcellulose (HPMC), methylcellulose (MC), povidone (PVP), chitosan, gelatin, sodium carboxymethyl cellulose (CMC-Na) or combination (third paragraph of page 9), the buffer is citrate buffer (first paragraph of page 10), and the osmotic pressure regulator is a salt compound that is boric acid or potassium chloride or sodium chloride (paragraphs 5 and 7 or page 9) with the boric acid and citrate meeting the limitation of pH regulator of claims 17 and 20. The preservative is benzalkonium bromide, nautisan, parabens, sorbic acid, antibiotic or combination (2nd paragraph of page 10) and in another embodiment the composition comprises benzalkonium chloride, chelating agent EDTA, lanosterol particles (first paragraph of page 24) with the benzalkonium chloride meeting the benzalkonium chloride of claim 17. The solubilizer is a polyol namely glycerol, beta-cyclodextrin, hydroxypropyl-beta-cyclodextrin (page 8) meeting claims 21 and 23.
Thus for claims 17, 20, 21, 23 and 26, ZHENG teaches all the elements of these claims. ZHENG differs from these claims by teaching lanosterol instead of the compound of formula I
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254
354
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which is a prodrug of Lanosterol
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356
433
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, and the prodrug compound I is known to have good permeability and is effectively converted to lanosterol in the body which greatly improves the drug utilization rate of lanosterol (see paragraphs [0016], [0022] of LIU) and in paragraphs [0003] and [0004] and [0005], LIU teaches that lanosterol can reverse the condition of cataract and bring about clarification and transparency of the crystalline lens in vivo.
Therefore, before the effective date of the invention, the artisan guided by the teaches of LIU would have been motivated to use lanosterol prodrug in the composition of ZHENG with reasonable expectation that the prodrug would have good permeability and be effectively and predictably be converted in the body to lansosterol for effective and predictable treatment of cataract and clarification and transparency of the crystalline lens.
For claims 30 and 31, ZHENG prepares the composition in the form of solution or emulsion or suspension by mixing the sterol lansosterol/lansosterol prodrug with pharmaceutically acceptable carriers (first and second paragraphs of page 13; page 7) and the carriers comprise hydroxypropyl methylcellulose (HPMC) thickening agent (third paragraph of page 9), solubilizer, preservative and citrate of boric acid buffer as pH regulator, benzalkonium chloride preservative and glycerol, beta-cyclodextrin or hydroxypropyl-beta-cyclodextrin solubilizer (page 8).
For claim 32 and 33, ZHENGH teaches that the ophthalmic formulation is used to treat cataract (3rd paragraph of page 22).
For claims 18 and 24 and 27, the composition is at a pH of 6-8 (4th paragraph of page 11) and the composition comprises 5-250 mM of the sterol compound (1st paragraph of page 5), 0.1-5% (2nd paragraph of page 11), 0-1% benzalkonium chloride preservative (2nd paragraph page 10), citrate/sorbic acid pH regulator at 0.1% (page 10, 2nd and 4th paragraphs). The parts by parts are not the exact claimed part. It is reasonable to expect that the ordinary skilled artisan desiring for a composition that could reverse the condition of cataract and bring about clarification and transparency of the crystalline lens in vivo would be motivated to use a composition having the appropriate amounts of the compound, HPMC, benzalkonium chloride preservative and boric acid and citrate pH regulator.
For claim 19, the sterol (lanosterol) is at 5-250 mM (first paragraph of page 5) and at 250 mM, the sterol which is the compound, is at 0.11 g/ml which is species of the claimed amount of 0.01-4 mg/ml and which meets the 0.1 mg/ml of claim 19.
For claim 22, the solubilizer is polyol (2nd paragraph of page 8) and is present at 0.1-50 wt% (7th paragraph of page 10) which overlaps the claimed range of 10-50 parts with the disclosed range allowing for 10-50 parts.
Therefore, ZHENG in view of LIU renders claims 17-24, 26-27 and 29-33 prima facie obvious.
Claim(s) 17, 25, 27 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over ZHENG et al. (CN 106344587 A, English translation of the description on PE2E and the CHINA version of WO 2018036522 A1) in view of LIU et al., (EP 3828193 A1) as applied to claims 17 and 27, and further in view of Nagai et al., “The Intravitreal Injection of Lanosterol Nanoparticles Rescues Lens Structure Collapse at an Early Stage in Shumiya Cataract Rats” in International Journal of Molecular Sciences, Vol 21, Issue 3, Feb 2020.
Claim 25 depends on claim 17. Claim 28 depends on claim 27.
ZHENG in view of LIU has been described above to render claims 17 and 27 prima facie obvious.
ZHENG while teaching that lanosterol is in the form of particles (2st paragraph of page 24), ZHENG differs from claims 25 and 28 by not teaching the particle size of lanosterol.
However, according to Nagai, Lanosterol particles having sizes of about 50-400 nm have been used for treating cataract (see the whole document with emphasis on the abstract, section 2.1). Therefore, before the effective date of the invention, the ordinary skilled artisan would reasonably expect the particle size of the lanosterol to be 50-500 nm (0.05- 0.4 mm) which is less than 50 mm.
Therefore, ZHENG in view of LIU and further in view of Nagai renders claims 25 and 28 prima facie obvious.
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613