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 .
Claims 41-67 and 78 are presented for examination.
The amendments and remarks filed on 02/05/2026 have been received and entered.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 41-67 and 78 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
First, the claimed invention must be to one of the four statutory categories. 35 U.S.C. 101
defines the four categories of invention that Congress deemed to be the appropriate subject matter of a
patent: processes, machines, manufactures and compositions of matter. The latter three categories
define "things" or "products" while the first category defines "actions" (i.e., inventions that consist of a
series of steps or acts to be performed). See 35 U.S.C. 100(b) ("The term 'process' means process, art, or
method, and includes a new use of a known process, machine, manufacture, composition of matter, or
material."). See MPEP § 2106.03 for detailed information on the four categories.
Second, the claimed invention also must qualify as patent-eligible subject matter, i.e., the claim
must not be directed to a judicial exception unless the claim as a whole includes additional limitations
amounting to significantly more than the exception. The judicial exceptions (also called "judicially
recognized exceptions" or simply "exceptions") are subject matter that the courts have found to be
outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas,
laws of nature and natural phenomena (including products of nature). Alice Corp. Pty. Ltd. V. CLS Bank
Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Ass'n for Molecular Pathology V. Myriad
Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013). See MPEP § 2106.04 for detailed
information on the judicial exceptions.
The claims are drawn to an ophthalmic composition wherein it comprises a polyphenolic
compound and a terpenoid, or their respective pharmaceutically acceptable salts or crystalline forms, in
therapeutically effective amounts, wherein the polyphenolic compound is in a ratio of 1:10 10 10:1 regarding the terpenoid.
Analysis of the flowchart:
Step 1, is the claim to a process, machine, manufacture or composition of matter?
Yes. The claim is drawn to a composition of matter.
Step 2A. Prong one: Is the claim directed to a law of nature, a natural phenomenon (product of nature),
or an abstract idea? Yes, Claims are drawn to an ophthalmic composition wherein it comprises a polyphenolic compound and a terpenoid, or their respective pharmaceutically acceptable salts or
crystalline forms, in therapeutically effective amounts.
Step 2A. Prong two: Does the claims recite additional elements that amount to significantly
more than the judicial exception?
No. The claim(s) of do not include additional elements that are sufficient to amount to significantly more than the judicial exception, as there is no indication that extraction has caused the component of an natural compound that comprises the claimed compositions to have any characteristics that are different from the naturally occurring component of an natural compound. Claim 52 requires an excipient being present in the composition. However, there is no indication that the excipient claimed in the compositions result in a markedly different characteristic for the composition as compared to the components that occur in the nature. For the reasons described above, the claimed compositions are not markedly different from their closest naturally occurring counterparts and thus are product of nature judicial exceptions. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any additional elements beyond the claimed compositions themselves. Also, this is a product claim and since there are no claimed method steps, there are no additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception themselves. Therefore, the claims do not recite something significantly more thana judicial exception and are thus deemed patent ineligible subject matter.
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.
Claim(s) 41-67 and 78 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 10,471,076) in view of EP2346520 and further in view of Davis et al. (Topical Curcumin Nanocarriers are
Neuroprotective in Eye Disease).
Zhang teaches a method of treating or preventing vision disorders, the method comprising
administering to an individual in need thereof an effective amount of a lanosterol; and a prodrug or
pharmaceutically acceptable salt thereof. See column 1, lines 25-30. The vision disorder is taught to be
a disorder of the eye that affects function, clarity and/or structure of the lens of the eye. Such eye
diseases include, but are not limited to, cataracts of the eye, presbyopia of the eye, and nuclear sclerosis
of the eye lens. In addition, vision disorders refer to retinal degeneration, such as Refsum disease,
Smith-Lemli-Opitz syndrome (SLOS) and Schnyder crystalline corneal dystrophy (SCCD),
abetalipoproteinemia and familial hypobetalipoproteinemial. See column 2, lines 30-35. Zhang teaches
the use of a composition for the preparation of medicament to treat cataract or blindness/impaired
vision in a subject, said composition comprises a pharmaceutically acceptable ophthalmic carrier and a
pharmaceutically effective amount of lanosterol, wherein said lanosterol dissolves lens crystallin protein
aggregate(s) in the eye of said subject; wherein the lens crystallin protein is any of α-crystallin, ß-crystallin or y-crystallin. The above mentioned composition may be formulated as an ophthalmic
solution, an ophthalmic ointment, an ophthalmic wash, an intraocular infusion solution, a wash for
anterior chamber, an internal medicine, an injection, or preservative for extracted cornea. See column
3, lines 33-45. Zhang teaches that the present invention relate to an ophthalmic pharmaceutical
composition comprising sterol in an ophthalmic pharmaceutically acceptable carrier. In certain
embodiments of the invention, the pharmaceutically acceptable carrier is water, a buffer or a solution of
sodium chloride. See claim 13. In some embodiments, the pharmaceutically acceptable carrier is
sterile. In other embodiments, the pharmaceutically carrier is an ointment. In still other embodiments,
the pharmaceutically acceptable carrier is a gel. Gels can be formulated using gel formulating materials
that are well known in the art, including but not limited to, high viscosity carboxymethylcellulose,
hydroxypropyl methyl cellulose, polyethylene oxide and carbomer. In some aspects of the composition,
the pharmaceutically acceptable ophthalmic carrier is a cyclodextrin. In one embodiment, the
cyclodextrin is (2-hydroxypropyl)-β-cyclodextrin. See column 2, lines 4-22. Zhang teaches that the
compound of the inventive method or composition is lanosterol; a prodrug or pharmaceutically
acceptable salt thereof. In one embodiment, the compound is lanosterol. In another embodiment, any
prodrug or pharmaceutically acceptable salt of the above compounds are contemplated to be within the
scope of the invention. The addition to a buffer, isotonizers can be added to eye drops to make the
preparation isotonic with the tear. Isotonizers include, but are not limited to, sugars such as dextrose,
glucose, sucrose and fructose; sugar alcohols such as mannitol and sorbitol; polyhydric alcohols such as
glycerol, polyethylene glycol and propylene glycol; and salts such as sodium chloride, sodium citrate,
benzalkonium chloride, phedrine chloride, potassium chloride, procaine chloride, chloram phenicol, and
sodium succinate. Isotonizers are added in an amount that makes the osmotic pressure of the eye drop
equal to that of the tear. See column 16, lines 11-21. Zhang teaches that lanosterol is administered in a
sufficient amount and duration to dissolve amyloid-like fibrils of crystallin proteins. See claim 7. The different routes of administration is taught to be topically, subconjunctivally, retrobulbarly, periocularly,
subretinally, suprachoroidally, or intraocularly. See column 11, lines 42-48. The use of phosphatidyl
choline is taught in column 21, lines 57-60.
Zhang differs from the claimed invention in the presence of curcumin and the composition being in
nanoemulsion.
EP ('520) teaches an aqueous ophthalmic composition comprising natural curcuminoids, such as
curcumin, bisdemethoxycurcumin, desmethoxycurcumin and synthetically derived bis-o-desmethyl
curcumin and/or other demethylated curcuminoids either alone or in combinations, suitable surfactants
and co-solvents as permeation enhancers along with other ophthalmic excipients, useful for the
treatment of ocular diseases or disorders. See Para [0001]. EP ('520) teaches that ophthalmic eye drop
or eye gel formulation comprising natural curcuminoids, such as curcumin, bisdemethoxycurcumin
desmethoxycurcumin and synthetically derived bis-o-desmethyl curcumin and/or other demethylated
curcuminoids either alone or in combination together with nonionic surfactant, cosolvent and optionally
cyclodextrin along with suitable ophthalmic excipients. See para [0028]. EP ('520) teaches that the
drug and non-ionic surfactants can be combined with acceptable carriers to formulate a stable
ophthalmic preparation with enhanced bioavailability and stability. These carriers include
pharmaceutically acceptable excipients and additives known to a person skilled in the art, for example,
especially carriers, stabilizers, tonicity enhancing agents buffer substances, preservatives, thickeners,
complexing agents and other excipients. See Para [0035]. The non-ionic surfactant is not restricted to
the following, selected from polysorbate 80 and 20, polyethylene glycol esters, glycerol ethers or
mixtures of those compounds. See Para [0036]. The co-solvents are selected from polyhydric alcohols
such as polyethylene glycol, polypropylene glycol. See Para [0037]. The treatment of ocular conditions,
such as, Bechet’s disease, retinal disorders, diabetic retinopathy, cataract, conjunctival diseases, corneal
diseases including macular degeneration and glaucoma is taught in claim 8.
Davis et al. teach the use of a nanocarrier for increased solubility of curcumin in treating ophthalmic
disorders. See the abstract.
It would have been obvious to a person skilled in the art to incorporate a polyphenolic compound into
the composition of Zhang, motivated by the teachings of EP ('520), which teaches the use of
polyphenolic compounds, such as, curcuminoids for the treatment of ophthalmic conditions as old and
well known. It would have been obvious to combine compositions being for the same purpose.
Applicant's attention is drawn to In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980),
he court states that "It is prima facie obvious to combine two compositions each of which is taught by
the prior art to be useful for the same purpose, in order to form a third composition to be used for the
very same purpose... [T]he idea of combining them flows logically from their having been individually
taught in the prior art." In the instant case to combine two compositions being individually used for the
treatment of certain disorders flows logically for being used for the same purpose. The use of
nanocarriers for compounds, such as curcumin is taught by Davis et al. To obtain lanosterol or curcumin
from different sources does not create a patentably distinct composition in the absence of evidence to
the contrary. The use of the deionized water instead of water taught by the prior art does not create a
patentably distinct composition in the absence of evidence to the contrary.
Response to arguments
Applicant’s arguments regarding 35 U.S.C 101 have been noted. Applicant in his remarks argues that “the ophthalmic composition as claimed in the amended claims is not a mere product of nature, but a man-made product, since it is not possible to find the specific combination of a polyphenolic compound and a terpenoid, formulated in therapeutically effective amounts, in the specific claimed ratios which are required to achieve an unexpected synergistic effects”. It is the examiner’s position that the presented data are not commensurate in scope with the claimed language. The data is drawn to a couple of compounds at a couple of concentrations for treating cataracts. However, the claims are not drawn to only a couple of compounds at a couple of concentrations and treatment of one disease. Furthermore, the claimed components exist in nature. Therefore, the resulting product must have different characteristics, function or structures than the individual products in their natural state. Applicant’s arguments regarding the obviousness have been noted. Applicant in his remarks argues that from the teachings of prior art, a person of ordinary skill in the art would not have any motivation to combine
a polyphenolic compound and a terpenoid, in the claimed specific ratio, for treating cataracts, since a
great number of administrations of the formulation over a long period would be required to observe
only a slight improvement in the animals treated.
Therefore, it is surprising that with only two applications, one week apart, of the compositions
made under the principles of the instant application, a significant reduction of the cataracts was
achieved, reversing in some cases almost all the opacity of the lens for some of the formulations, as
shown in Example C of the instant application. In fact, the Examiner fails to consider the entire body
of examples of the application, where it is clearly shown that both, curcumin and lanosterol by
themselves do not achieve the same level of reversion of cataracts that the synergistic combination of
both compounds, demonstrating that the substantial reversal of cataracts was not the result of the mere
addition of the individual components' known effects. These unexpected results cannot be inferred from
the prior art at all. In other words, those skilled in art would not have expected to revert cataracts beyond
the action of the compounds alone and there is nothing in the prior art suggesting that the combination
of two known compounds will have a better effect than that of the compounds alone without undue
experimentation, as it is possible that the opposite effect occurs and that the combination of two
compounds may lead to a detrimental effect rather than synergistic”. It is the examiner’s position that the presented data are not commensurate in scope with the claimed language. The data uses a couple of compounds at a couple of concentrations for treating cataracts. However, the claims are not drawn to only a couple of compounds, a couple of concentrations and treatment of one disease.
THIS ACTION IS MADE FINAL. 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 ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617