DETAILED ACTION
Election/Restrictions
Applicant’s election of Group II and the species of eye disorder of diabetic retinopathy in the reply filed on 10/20/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Upon review, the eye disease is expanded to include age-related macular degeneration.
Status of Application
Applicant has elected Group II in response to restriction requirement and elected species of eye disorder of diabetic retinopathy for the examination. Upon review, the eye disease is expanded to include age-related macular degeneration.
Due to restriction, based on election of Group II, claims 1-7 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-13 are pending.
Claims 8-13 are present for examination at this time.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement filed 5/16/2023 and 08/02/2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because there is no English translation for the reference cited. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
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.
Claim 8 is 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.
The independent claim 8 recites “the method comprising administering the eyedrop comprising nanoparticles including a fibrate to a subject” wherein it refers to “the eyedrop” wherein it is unclear what eyedrop it is referring to as it is an independent claims (verses a dependent claim referring to the independent claim) and does not recite an eyedrop formulation to which is “the eyedrop”.
For purposes of examination, it is treated as “the method comprising administering an eyedrop comprising nanoparticles including a fibrate to a subject”.
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Wassel et al. (U.S. Pat. 2014/0275263).
The claim recites a method of treatment with a product by process recitation which is treated as a product (any particle from 10-300nm) for the method for treatment.
Rejection:
Wassel et al. teaches treatment of eye conditions including diabetic retinopathy and age-related macular degeneration (AMD) with topical administration to the eye of an oil-in-water microemulsions comprising an active that is fenofibrate or fenofibric acid, and surfactants (abstract, [7, 19-24, 31-34, 45, 88-90, 97-99, 127-131, 133]. The topical administration can be eyedrops [133] and suitable modifications and adaptations are readily apparent in view of information known to the ordinary skilled artisan [134]. The fenofibrate and fenofibric acid eyedrops were topically administered to the eyes of rabbits with a particle size of 137+/- 40.3nm (falling within the instant particle range of 10-300nm, Example 11 [155-156], see full document specifically areas cited).
Wherein while Wassel et al. does not exemplify treating diabetic retinopathy or AMD with the fibrate eyedrop, Wassel et al. does expressly teach treating the eye conditions with the fenofibrate and fenofibric acid eyedrops which were exemplified and topically administered to the animal model wherein it would be prima facie obvious to exemplify the teachings of Wassel et al. 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.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Wassel et al. (U.S. Pat. 2014/0275263) as applied to claim 8, in view of Winfield (Formulation of Eye Drops-Viscosity enhancers).
Rejection:
The teachings of Wassel et al. are addressed above.
Wassel et al. does not expressly recite the inclusion of a thickener but does teach the method with eyedrops and that modifications are readily apparent in view of information known to the ordinary skilled artisan.
Winfield teaches that eyedrops are known to be formulated with components like viscosity enhancers (thickeners) to increase residence time of the drop to increase penetration and therapeutic action of the drug, and viscosity enhancers include hypromellose and polyvinyl alcohol.
Wherein it would be obvious to incorporate a viscosity agent like hypromellose as suggested by Winfield and produce the claimed invention; as it is prima facie obvious to incorporate known components like viscosity agents for their known purpose to attain the desired therapeutic profile with a reasonable expectation of success (i.e. increase residence time of the drop to increase penetration/therapeutic action of the drug).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Wassel et al. (U.S. Pat. 2014/0275263) in view of Winfield (Formulation of Eye Drops-Viscosity enhancers) as applied to claims 9-10 above, further in view of Rowe et al. (Hypromellose).
Rejection:
The teachings of Wassel et al. in view of Winfield are addressed above.
Wassel et al. in view of Winfield do not expressly recite the viscosity agent to be methylcellulose but does recite the inclusion of viscosity/thickening agents like hypromellose.
Rowe et al. teaches that hypromellose and methylcellulose are functionally equivalent celluloses (Related substances).
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 methylcellulose as suggested by Rowe et al. and produce the claimed invention; as simple substitution of known cellulose viscosity agent for another is prima facie obvious with a reasonable expectation of success absent evidence of criticality for the claimed cellulose.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Wassel et al. (U.S. Pat. 2014/0275263) as applied to claim 8, in view of Baranowski et al. (Ophthalmic Drug Dosage Forms: Characterisation and Research Methods-Topical Ophthalmic Drug Forms).
Rejection:
The teachings of Wassel et al. are addressed above.
Wassel et al. does not expressly recite the inclusion of a cyclodextrin but does teach the method with eyedrops and that modifications are readily apparent in view of information known to the ordinary skilled artisan.
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.
Claims 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ma et al. (U.S. Pat. 2020/0297651).
The claim recites a method of treatment with a product by process recitation which is treated as a product (any particle from 10-300nm) 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, 52, 62, 68, 88-89]). The nanoparticle size includes sizes from about 1nm-about 1000nm [46, 48], and exemplified with fenofibrate at about 250nm [116-117] Table 2). The ocular formulation can include viscosity modifiers, 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 in the formulation with a reasonable expectation of success absent evidence of criticality for the claimed polymer. 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.
Claims 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ma et al. (U.S. Pat. 2020/0297651) as applied to claims 8-11 above, in view of Baranowski et al. (Ophthalmic Drug Dosage Forms: Characterisation and Research Methods-Topical Ophthalmic Drug Forms).
Rejection:
The teachings of Ma et al. are addressed above.
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.
Conclusion
Claims 8-13 are rejected.
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