DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 5, 14-16, 21-24, 29, and 40-49 have been canceled.
Claims 1-4, 6-13, 17-20, 25-28, and 30-39 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-4, 6-13, 17-20, and 25, and of species ranpirnase, oxymetazoline, viral conjunctivitis, and human adenovirus B, in the reply filed on 9/17/2025 is acknowledged.
Claims 9, 26-28 and 30-39 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and species, there being no allowable generic or linking claims.
Claims 1-4, 6-8, 10-13, 17-20, and 25 are being examined in this application, insofar as they read on the elected species of ranpirnase, oxymetazoline, viral conjunctivitis, and human adenovirus B.
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 1-4, 6-8, 10-13, 17-20, and 25 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 pre-AIA the applicant regards as the invention.
Claim 1, line 5, the recitation of “the additional therapeutic agent” is indefinite since the product combination comprises one or more additional therapeutic agent, it is unclear what / which additional therapeutic agent if more than one is referred by the recitation of “the additional therapeutic agent”. Applicant may amend the limitation to recite “the one or more additional therapeutic agent”.
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.
Claims 1-3, 6, 10-13 and 17-20 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.
Claim 1 is directed to a product combination comprising: a therapeutically effective amount of one or more ribonuclease (RNase); and a therapeutically effective amount of one or more additional therapeutic agent, wherein the additional therapeutic agent is a vasoconstrictor, an antibiotic, an immunomodulatory compound, a steroid, or a combination thereof. This limitation recites a natural product because RNase such as ranpirnase and an immunomodulatory compound such as vitamin C occur naturally. Claim 1 does not recite additional elements. Thus, claim 1 does not amount to significantly more than the product of nature. Accordingly, claim 1 is not eligible and should be rejected under 35 U.S.C. § 101.
Claims 2-3, 6, 10-13 and 18-20 do not recite additional elements. Claim 17 recites one or more pharmaceutically acceptable carrier. This limitation recites a natural product because a pharmaceutically acceptable carrier such as water occur naturally. Claims 2-3, 6, 10-13 and 17-20 do not amount to significantly more than the product of nature. Accordingly, claims 2-3, 6, 10-13 and 17-20 are not eligible and should be rejected under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102
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 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 10-13, 17-18, and 20 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Strem (US 2017/0087223 A1; 3/30/2017.).
The instant claims recite a product combination that inhibits or slows an ocular infection, wherein the product combination comprises: a therapeutically effective amount of one or more ribonuclease (RNase); and a therapeutically effective amount of one or more additional therapeutic agent, wherein the additional therapeutic agent is a vasoconstrictor, an antibiotic, an immunomodulatory compound, a steroid, or a combination thereof.
Strem teaches a pharmaceutical composition comprising ranpirnases for treating a viral conjunctivitis (para 0006), or delaying or preventing in an individual the onset of a clinical symptom of a viral conjunctivitis (para 0095), wherein the viral conjunctivitis is an epidemic keratoconjunctivitis, a pharyngoconjunctival fever, a nonspecific sporadic follicular conjunctivitis, or a chronic papillary conjunctivitis, caused by a Human adenovirus B (para 0006). Ranpirnases can be co-formulated with immunomodulatory drugs or antibiotics to increase the overall therapeutic effect of the treatment (therefore, a therapeutically effective amount of one or more additional therapeutic agent) (para 0139). Use of said ranpirnases is in an amount sufficient to treats the viral conjunctivitis (para 0055), the actual effective amount of ranpirnases can be determined by a person of ordinary skill in the art, variations in dosage levels can be adjusted using standard empirical routines of optimization, which are well-known to a person of ordinary skill in the art (para 0057, 0129). The pharmaceutical composition may include a pharmaceutically-acceptable carrier (para 0086). The pharmaceutical composition is formulated using an ophthalmic route of administration (para 0088, 0126). The formulation may be a simple one or as part of a more complex drug delivery system, said ranpirnases may be formulated by itself in a pharmaceutical composition, or may be formulated together with one or more other therapeutic compounds in a single pharmaceutical composition (para 0089). Ranpirnases is in an amount of 25 µM (para 0227).
Therefore the reference anticipates the claimed 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 of this title, 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 3-4, 6-8 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Strem (US 2017/0087223 A1; 3/30/2017.) as applied to claims 1-2, 10-13, 17-18, and 20 above, further in view of Terrie (Pharmacy Times. 2009;1-5.).
Strem does not teach the claimed additional therapeutic agent being oxymetazoline (claim 4) as well as the claimed amount of ranpirnases and oxymetazoline (claims 3, 6-8 and 25).
However, Strem does teach the pharmaceutical composition is used for treating a viral conjunctivitis, the actual symptoms associated with the viral conjunctivitis are well known and include ocular itching, burning eyes, and increased tear production. Strem does teach the pharmaceutical composition may be combined with other supplementary active ingredients, agents, drugs or hormones (para 0053). Terrie teaches that oxymetazoline is an ophthalmic decongestant on the market, and has been shown to improve the symptoms of burning, itching, and tearing associated with allergic conjunctivitis (p.3 para 2). Commonly used oxymetazoline hydrochloride is 0.025% (p.3 para 3).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate oxymetazoline into the pharmaceutical composition of Strem, since Strem discloses the pharmaceutical composition is used for treating a viral conjunctivitis, the actual symptoms associated with the viral conjunctivitis include ocular itching, burning eyes, and increased tear production, and Terrie discloses that oxymetazoline improves the symptoms of burning, itching, and tearing. In addition, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to optimize the concentration of ranpirnases and oxymetazoline, since Strem discloses ranpirnases is in an amount of 25 µM, Terrie discloses oxymetazoline hydrochloride is 0.025%, and Stren also discloses that variations in dosage levels can be adjusted using standard empirical routines of optimization, which are well-known to a person of ordinary skill in the art. Generally, differences in concentration will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. (MPEP 2144.05 II) Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to incorporate an optimized amount of ranpirnases and oxymetazoline with a reasonable expectation for successfully obtaining a pharmaceutical composition.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Strem (US 2017/0087223 A1; 3/30/2017.) as applied to claims 1-2, 10-13, 17-18, and 20 above.
Strem does not teach the one or more RNase is in a first composition and the one or more additional therapeutic agent is in a second composition, and wherein the first composition is separate from the second composition (claim 19).
However, Strem does teach the formulation may be a simple one or as part of a more complex drug delivery system, said ranpirnases may be formulated by itself in a pharmaceutical composition, or may be formulated together with one or more other therapeutic compounds in a single pharmaceutical composition (para 0089).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to separate ranpirnases in a first composition from an additional therapeutic agent in a second composition, since Strem discloses that the formulation comprises ranpirnases and additional therapeutic agents, and ranpirnases can be formulated by itself. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to separate ranpirnases in a first composition from an additional therapeutic agent in a second composition with a reasonable expectation of success.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759