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 .
DETAILED ACTION
The amended claim set of 29 Jan 2026 has been entered and reviewed.
Claims 4 and 15 have been amended.
Claims 1-19 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-6, 8 and 15, drawn to an aqueous topical ophthalmic solution, in the reply filed on 29 Jan 2026 is acknowledged. Applicants also elected that the moisturizing agent is propylene glycol, the osmolarity protectant is betaine, and the aqueous biocide is PHMB in response to the species election requirement.
Claims 7, 9-14 and 16-19 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-6, 8 and 15 are under consideration to the extent of the elected species, i.e., that the moisturizing agent is propylene glycol, the osmolarity protectant is betaine, and the aqueous biocide is PHMB.
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.
Claim 8 recites “the topical ophthalmic solution manufactured by the process of claim 7.” The claim clearly requires “the” solution produced by the method of claim 7 and thus improperly combines separate statutory classes of a product and a process. A claim that improperly mixes, for example, a product and a process in the same claim fails to clearly point out he invention and is indefinite.
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 1-4 and 8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
Claim interpretation: Under the broadest reasonable interpretation, the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111.
The claims are directed to an aqueous topical ophthalmic solution for treating an eye having keratoconjuctivitis sicca.
The composition of claim 1 requires, at minimum, cyclosporin dissolved in an organic alcohol and water.
Claim 2 further defines the alcohol as ethanol, isopropyl alcohol or benzyl alcohol. Claim 3 requires the inclusion of a moisturizing agent, osmolarity protectant or an aqueous biocide and claim 4 recites specific compounds for each of these components. Claim 8 requires the solution manufactured by the process of claim 7 which includes cyclosporin A, an alcohol, and water.
In accordance with the 2019 Revised Patent Subject Mater Eligibility Guidance (aka 2019 PEG), the following analysis is based on the flowchart found in MPEP §2106(III) and is used when considering whether or not a claimed invention recites eligible subject matter.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, claims 1-4 and 8 are directed to a composition of matter.
Step 2A: Is the claim directed to a judicial exception (i.e. a law of nature, a natural phenomenon (product of nature) or an abstract idea)?
Analysis of Step 2A is divided into two prongs.
Step 2A Prong One: Does the claim recite an abstract idea, law of nature or natural phenomenon?
This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04(II), a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim.
The claims are directed to an ophthalmic solution comprising cyclosporin, an alcohol, and water. Cyclosporin, water and alcohols such as ethanol are all naturally occurring compounds. Claims 3 and 4 require the addition of a component such as an osmolarity protectant such as betaine, which is a naturally occurring compound. Thus, each of the components as recited in the claims are natural in origin.
Since the composition contains products which are naturally-occurring, the claim is ‘directed to’ a nature-based product. Since the claims recite a nature-based product limitation, the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. MPEP 2106.04(c)(I). The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. MPEP 2106.04(c)(II). Here, the closest natural counterpart is naturally occurring cyclosporin, water, ethanol, and betaine as they occur separately in nature. There is no indication that mixing the components would change the structure, function or other characteristics of the individual components in any way. Rather, when mixed, each of the individual components would retain its naturally-occurring structure and function.
The claims recite that the solution is for treating keratoconjunctivitis sicca and is effective in treating keratoconjunctivitis sicca but these are merely intended uses and effects resulting from the composition and do not impart markedly different qualities of the components from their natural counterparts.
Claim 8 recites that the ophthalmic solution manufactured by the process of claim 7 and is thus a product-by-process claim. For a product-by-process claim, the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart (MPEP 2106.04(c)B). The process includes dissolving and heating steps and there is no indication that these would result in structural or functional characteristics distinct from what would occur from a natural mixing of components.
Therefore, claims 1-4 and 8 recite a product of nature exception. Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013) (naturally occurring things are “products of nature” which cannot be patented). Accordingly, the claim recites a judicial exception, and the analysis must therefore proceed to Step 2A Prong Two.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d)II.
Claims 1-4 and 8 do not recite an additional element beyond the natural components of cyclosporing, ethanol, water and betaine. As described above, the dissolving and heating processes do not impart any distinct qualities or characteristics to the components. Thus, claims 1-4 and 8 do not present elements or components in addition to the judicial exception that could be interpreted as imposing a meaningful limitation over the claim scope. Accordingly, the claims do not integrate the recited judicial exception into a practical application and the claims are therefore directed to the judicial exception.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As discussed with respect to Step 2A Prong Two, claims 1-4 and 8 do not recite an additional element beyond the natural components of the composition and the product by process limitation of claim 8. Therefore, the claims do not include any additional element which would amount to ‘significantly more’ than the judicial exception itself and thus the claims as a whole do not amount to significantly more than the judicial exception.
Conclusion: Claims 1-4 and 8, which are directed toward an opthalmic composition comprising the natural components of cyclosporin, water, ethanol and an osmolarity protectant such as betaine, are not markedly different in structure or function as compared to the closest naturally-occurring counterpart. Subsequently, the claims are directed toward a judicial exception under 35 USC 101. Claims 1-4 and 8 do not recite any element which would be considered to provide ‘significantly more’ than the judicial exception.
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 (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 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.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stringer (US 2009/0286718, 19 Nov 2009).
Claims 1 and 2 require an aqueous topical solution comprising cyclosporine dissolved in water and an opthalmically safe organic alcohol such as ethanol and effective in treating keratoconjuctivitis sicca. The limitation that the solution is “for treating an eye of a human having keratoconjuctivitis sicca” is an intended use which carries no patentable weight for a product claim. See MPEP 2111.02. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation").
Stringer teaches stable aqueous cyclosporin compositions for ophthalmic use (title, [0002]). Stringer teaches examples where cyclosporin is dissolved in ethanol ([0057], Table 1) and added to an aqueous solution ([0056]-[0058]). Thus, Stringer anticipates the solution of claims 1 and 2. The limitation that the solution is effective in treating keratoconjunctivitis sicca describes a property that would be inherently present in the composition of Stringer. Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. The cyclosporin composition taught by Stringer is the same as the composition of the claim and would have the feature of being effective in treating keratoconjuctivitis sicca.
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.
Claims 1-4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Stringer (US 2009/0286718, 19 Nov 2009) as evidenced by Mazzei (Sergio Mazzei Wound Care, The use of PHMB in wound care a powerful antimicrobial agent).
Stringer teaches stable aqueous cyclosporin compositions for ophthalmic use (title, [0002]). Stringer teaches ophthalmic compositions comprising cyclosporin and ethanol ([0014]) and teaches examples where cyclosporin is completely dissolved in ethanol ([0057], Table 1) and added to an aqueous solution ([0056]-[0058]). Stringer teaches that the composition is a topical composition ([0046]) and may be used for treating keratoconjuctivitis ([0047]). Stringer teaches that the cyclosporin may be cyclosporin A ([0018]). Stringer teaches that the compositions may include non-ionic tonicity adjustment agents such as propylene glycol ([0022]), rendering obvious the moisturizing agent of claims 3 and 4. It is noted that the osmolarity protectant such as betaine of claims 3 and 4 is optional and not required per the claims. Stringer teaches the inclusion of an antimicrobial preservative agent such as polyhexanide ([0032]), rendering obvious the aqueous biocide of PHMB as in claims 3 and 4. As evidenced by Mazzei, polyhexanide is PHMB (page 2 top paragraph). Stringer teaches heating as part of the formulation process ([0059]).
Stringer does not expressly teach selecting the propylene glycol and polyhexanide and cyclosporin A discussed above as part of the ophthalmic solutions with sufficient specificity to rise to the level of anticipation.
However, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have formed a topical ophthalmic solution comprising cyclosporin A, ethanol, water, propylene glycol and polyhexanide (PHMB) that is effective in treating keratoconjunctivitis sicca. One of ordinary skill in the art would have been motivated to do so as stable aqueous cyclosporin compositions for ophthalmic use are taught by Stringer for treating keratoconjunctivitis sicca and each of these components are known as suitable for such ophthalmic compositions. One of ordinary skill in the art would have a reasonable expectation of successfully forming an aqueous ophthalmic cyclosporin composition with ethanol, propylene glycol and polyhexanide, as taught by Stringer, since the modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions.
Regarding claim 8, the language “manufactured by the process of claim 7” is a product-by-process limitation. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). In the instant case, the ophthalmic solution comprising completely dissolved cyclosporin A, rendered obvious by Stinger, appears to be the same product claimed.
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Stringer.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Stringer (US 2009/0286718, 19 Nov 2009) as evidenced by Mazzei (Sergio Mazzei Wound Care, The use of PHMB in wound care a powerful antimicrobial agent) as applied to claims 1-4 and 8 above and in view of Bayardo et al. (WO2004096261, published 11 Nov 2004).
The teachings of Stringer are described supra.
Stringer teaches the inclusion of surfactants ([0026]) but does not teach sodium lauryl sulfate. This deficiency is made up for in the teachings of Bayardo.
Bayardo teaches aqueous solutions of cyclosporin A (title) that reduces inflammation of the conjunctiva of the eye (page 3 paragraph 2). Bayardo teaches compositions of cyclosporin A comprising ethyl alcohol and a surfactant such as sodium lauryl sulfate (page 3 paragraph 4).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have included sodium lauryl sulfate in the ophthalmic compositions rendered obvious by Stringer. Similar aqueous ophthalmic compositions comprising cyclosporin and components such as ethanol and surfactants are known from both Stringer and Bayardo. It is known from Bayardo that sodium lauryl sulfate is a suitable surfactant for such compositions. Thus, one of ordinary skill would have a reasonable expectation of success in including sodium lauryl sulfate in the compositions as it merely represents a known prior art surfactant element used in a composition it is known to be suitable for, namely aqueous ophthalmic cyclosporin compositions.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Stringer (US 2009/0286718, 19 Nov 2009) as evidenced by Mazzei (Sergio Mazzei Wound Care, The use of PHMB in wound care a powerful antimicrobial agent) in view of Bayardo et al. (WO2004096261, published 11 Nov 2004) as applied to claims 1-6 and 8 above and further in view of Chapin et al. (US 2010/0311688, 09 Dec 2010)
The teachings of Stringer and Bayardo are described supra.
Stringer teaches that the cyclosporin in present in an amount of about 0.001% (i.e. 10ppm) to about 1% (i.e. 10,000 ppm) ([0012]), rendering obvious the 100 ppm of cyclosporin A as in claim 15. Bayardo teaches that cyclosporin is soluble in methanol (page 2 paragraph 2) but Stringer and Bayardo do not teach the inclusion of talc. This deficiency is made up for in the teachings of Chapin.
Chapin teaches ophthalmic formulations useful for treating signs and symptoms of dry eye disease and are useful as a moisturizing and lubricating eye drop ([0006]). Chapin teaches the inclusion of carriers for such formulations ([0067]) and teaches talc as a pharmaceutically acceptable carrier ([0113).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have used methanol and talc in forming and ophthalmic composition with about 0.001% (i.e. 10ppm) to about 1% (i.e. 10,000 ppm) cyclosporin. Cyclosporin is used in amounts ranging from about 0.001% (i.e. 10ppm) to about 1% (i.e. 10,000 ppm), as taught by Stringer and is known from Bayardo to be soluble in methanol, rendering methanol an obvious solvent for use with cyclosporin preparations. Ophthalmic formulations for treating dry eye disease are known from Chapin and talc is known as a suitable carrier for such formulations as taught by Chapin. Thus, it would have been obvious to one of ordinary skill to include talc as it is a known carrier for ophthalmic compositions and one would have a reasonable expectation of success as it is known to be pharmaceutically acceptable for ophthalmic compositions.
Regarding the method of manufacturing steps in claim 15, these limitations are a product-by-process limitation. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). In the instant case, the ophthalmic solution comprising dissolved cyclosporin A, methanol, sodium lauryl sulfate and talc, rendered obvious by Stinger, Bayardo and Chapin, appears to be the same product claimed.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/E.C.M./Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600