DETAILED ACTION
Status of Application
The response filed 05/06/2026 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claims 8, 11, 13 have been amended.
Claims 2, 9-10, 12 has been cancelled.
Claims 1, 3-8, 11, 13 are pending.
Claims 8, 11, 13 are present for examination at this time.
Applicant had previously elected Group II in response to restriction requirement and elected species of eye disorder of diabetic retinopathy which was expanded to include age-related macular degeneration.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
All grounds not addressed in the action are withdrawn as a result of amendment.
New grounds of rejection are set forth in the current office action as a result of amendment.
New Grounds of Rejection
Due to the amendment of the claims the new grounds of rejection are applied:
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.
Claims 8, 11, 13 are rejected under 35 U.S.C. 103 as being unpatentable over Ma et al. (U.S. Pat. 2020/0297651) in view of Baranowski et al. (Ophthalmic Drug Dosage Forms: Characterisation and Research Methods-Topical Ophthalmic Drug Forms).
The claim recites a method of treatment with a fibrate nanoparticle by a product by process recitation which is treated as a product (fibrate particle from 10-300nm in an eyedrop) for the method for treatment.
Rejection:
Ma et al. teaches treating an eye condition including diabetic retinopathy with an eyedrop nanoparticle composition comprising an peroxisome proliferator-activated receptor α (PPARα) agonist such as a fibrate like fenofibrate, and a biodegradable polymer like methylcellulose, hydroxypropylmethylcellulose, and poly (lactic acid-co-glycolic acid) (PLGA) (claims 12-13, 16, 19, Abstract, [33, 51-52, 62, 68, 88-89]). The nanoparticle size includes sizes from about 1nm-about 1000nm (solid nanoparticle, [46, 48]), and exemplified with fenofibrate at about 250nm (solid nanoparticles, [116-117] Table 2). The ocular formulation can include viscosity modifiers, tonicity agents like mannitol, stabilizing agent, wetting agents; and other adjuvant/excipients that improve solubility, deliverability, and stability ([44, 64-65], see full document specifically areas cited).
Wherein while Ma et al. does not exemplify treating diabetic retinopathy or AMD with the fibrate nanoparticle eyedrop, Ma et al. does expressly teach treating these eye conditions with the fibrate nanoparticle eyedrop and exemplifies fenofibrate nanoparticle formulation wherein it would be prima facie obvious to exemplify the teachings of Ma et al. with a reasonable expectation of success. It would also be prima facie obvious to utilize the taught polymers like methylcellulose and excipients like tonicity agents in the formulation with a reasonable expectation of success absent evidence of criticality for the claimed polymer or tonicity agent.
Ma et al. does not expressly recite the inclusion of a cyclodextrin but does teach the method of treatment with eyedrops and the inclusion of adjuvants/excipients that improve solubility and deliverability of the compounds.
Baranowski et al. teaches that known modification of liquid ophthalmic forms include the additions of substances like cyclodextrins (section 2.1.4), and the most often used cyclodextrin is 2-hydroxyproyl-beta-cyclodextrin (section 2.1.8).
Wherein it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a cyclodextrin like 2-hydroxyproyl-beta-cyclodextrin as suggested by Baranowski et al. and produce the claimed invention; as the inclusion of a known useful excipient for its known purpose is prima facie obvious with a reasonable expectation of success. It is noted that the instant claims are set forth in the form of product-by-process for the composition used in the method, which are considered a product for use in the method by the Office. Applicants are reminded that process limitations cannot impart patentability to a product being used that is not patentably distinguished over the prior art.
Response to Arguments
Applicant's arguments are centered on the assertion that Ma does not teach or suggest an eyedrop comprising solid nanoparticles; that the solid nanoparticles are a wet-ground product of fibrate obtained by wet-grinding a mixture of fibrate, cellulose based thickener, a cyclodextrin, mannitol and water; the assertion of unexpected results citing the working examples and Figure 6-10.
This is fully considered but not persuasive.
Contrary to Applicant’s assertion, Ma does teach solid nanoparticles of a fibrate like fenofibrate in an eyedrop composition and exemplified the nanoparticle with fenofibrate at about 250nm. The assertion that the nanoparticle is a wet-ground product of fibrate from fibrate, cellulose, cyclodextrin, water and mannitol is a product by process limitation which is not persuasive as it is a product by process recitation for the resulting fibrate nanoparticle which is considered as a product in the final composition for the claimed utility by the Office absent evidence of criticality of the process step to produce a materially different product for the recited utility. As for the assertion of unexpected results, this is not persuasive as the examples of the specification are not commensurate in scope with the claims which are broader, and the examples are to a single formulation (2%w/v fenofibrate, 0.005% w/v benzalkonium chloride, 0.5%w/v mannitol, 0.5%w/v methylcellulose, 5% 2-hydroxypropyl-beta-cyclodextrin) administered 2x/day to a single condition depicted by a diabetic mice model (i.e. diabetic retinopathy). The working examples are also not unexpected as the formulation is compared to a control that is merely a vehicle (no active, 0.005% w/v benzalkonium chloride, 0.5%w/v mannitol, 0.5%w/v methylcellulose, 5% 2-hydroxypropyl-beta-cyclodextrin) and not to a fibrate nanoparticle composition as presented in the prior art rejection wherein it does not demonstrate evidence of critically for the product by process recitation to yield a materially different product, as the prior art establishes that the fibrate nanoparticle eyedrop would be expected to be useful for the treatment of the eye condition.
Accordingly, the rejection stands.
Conclusion
Claims 8, 11, 13 are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
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