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
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 26 Feb 2026 has been entered.
Claims 1, 3, 4, 6, 7, 9-15, 17, 18, and 20-22 remain pending in the application.
Claims 1-6, and 8-15 are amended.
Claims 2, 5, 8, 16, and 19 are cancelled.
Claims 20-22 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1, 3, 4, 6, 7, 9-15, 17 and 18 are under consideration to the extent of the elected species, i.e., that the preservative is benzalkonium chloride, the chelating agent is EDTA, the anti-oxidant is sodium metabisulfite, the polymer is hydropropylmethylcellulose, the buffering agent is phosphate buffers, the tonicity agent is sodium chloride and the pH adjusting agent is sodium hydroxide.
Objections Withdrawn
Objections to the Specification
The specification objections set forth in the Non-Final Office Action mailed 30 Sep 2025 are hereby withdrawn in light of applicant’s amendments of the specification.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 112
The rejections pursuant to 35 U.S.C. 112(b) set forth in the Non-Final Office Action mailed 30 Sep 2025 are hereby withdrawn in light of applicants amendment of the claims.
Rejections Maintained
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, 3, 4, 6, 7, 9, 10, 12-15, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Buono (US 2004/0013729, published 22 Jan 2004, listed in IDS filed 29 June 2023) in view of Matsumura (US 20180161438, published 14 Jun 2018).
Buono teaches single drop multiple agent compositions for topical delivery to the eye (title). Buono teaches that the compositions include mydriatic agents such as phenylephrine ([0014]) and cycloplegic agents such as atropine ([0015]). Buono teaches that the phenylephrine may be at 2.5% ([0042]), rendering obvious the amount of phenylephrine in claims 3 and 4. Buono teaches example compositions such as composition B which include cyclopentolate at 0.1%. Cyclopentolate is an alternative cycloplegic agent to atropine ([0015]). Buono teaches that the components come in solution form and can be combined together ([0042]), rendering obvious that the composition is in the form of a solution, as in instant claim 17. Buono teaches that the compositions are at physiologically acceptable pH ([0042]). Buono teaches the inclusion of a viscoelastic polymer such as hydroxypropylmethylcellulose (HPMC) ([0017]), rendering obvious claim 12.
Buono does not teach that the pH of the solutions is between 3.5 to 8.5 or that the atropine is at 0.01 as in claim 7 or the inclusion of excipients such as benzalkonium chloride, EDTA, phosphate buffers, sodium chloride and sodium hydroxide. These deficiencies are made up for in the teachings of Matsumura.
Matsumura teaches aqueous ophthalmic compositions (title). Matsumura teaches the compositions may have phenylephrine ([0126]). Matsumura teaches that the ophthalmic composition have a pH within a medically pharmacologically acceptable range such as 4.0 to 9.5 ([0170]), rendering obvious the pH range of claim 1. Matsumura teaches that atropine sulfate may be in the composition from 0.0001 to 0.01 w/v% ([0122]-[0125]). Matsumura teaches the inclusion of components including preservatives such as benzalkonium chloride ([0030]) and chelating drugs such as EDTA ([0182]), rendering obvious claims 9 and 10. Matsumura teaches the inclusion of a buffer such as a phosphoric acid buffer such as dipotassium phosphate ([0160]-]0162]), rendering obvious claim 13. Matsumura teaches the inclusion of inorganic salts such as sodium chloride ([0010], [0024]), rendering obvious claim 14. Matsumura further teaches the inclusion of sodium hydroxide in appropriate amounts ([0209] Table 3), rendering obvious claim 15.
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 formed the composition of Buono with phenylephrine at 2.5%, atropine from 0.001 to 0.01%, the pH from 4.0 to 9.5 and to have included HPMC, benzalkonium chloride, EDTA, phosphoric acid buffers such as dipotassium phosphate, sodium chloride and sodium hydroxide. Compositions for the eye with at multiple agents such as 2.5% phenylephrine and atropine and also HPMC are known from Buono. Including atropine in low amounts such as 0.1% is obvious as Buono indicates other cycloplegic agents such as cyclopentolate are at 0.1%. It is further known that atropine sulfate may be included in opthlamic compositions ranging from 0.0001 to 0.01 w/v% by Matsumura. Thus one would have a reasonable expectation of success in including the atropine from 0.0001 to 0.01 w/v% as Buono indicates low percentages of cycloplegic agents and the specific range of 0.0001 to 0.01% is known as suitable for ophthalmic compositions. Having the compositions at physiological pH is indicated by Buono and physiological pH includes pH levels from 4.0 to 9.5, as taught by Matsumura. Thus, it would have been obvious to have the compositions from pH 4.0 to 9.5 as this is a known physicological pH range indicating that it would be compatible for a patient. The inclusion of HPMC in the compositions is known from Buono and benzalkonium chloride, EDTA, phosphoric acid buffers such as dipotassium phosphate, sodium chloride and sodium hydroxide are likewise known as suitable components for ophthalmic compositions rendering it obvious to one of ordinary skill to include them as they are known to be suitable for ophthalmic compositions and their inclusion thus merely represents the use of known prior art elements for their intended purpose in a similar composition.
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.
Response to Arguments
Applicant's arguments filed 26 Feb 2026 have been fully considered but they are not persuasive. Applicant states that there is no direction or hint to specifically choose phenylephrine and atropine (page 10 of remarks). Applicant argues that Buono uses tropicamide and cyclopentolate with phenylephrine in examples and does not have experiments with phenylephrine and atropine (pages 10-11 of remarks). This is not persuasive as the rejection was made under 35 U.S.C. 103 which requires that “a patent for a claimed invention may not be obtained… if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been prima facie 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.” “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at ___, 82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At, 82 USPQ2d at 1396. While Buono may not provide a specific embodiment of the instantly claimed invention, an embodiment is not necessary and the examiner maintains that the combination of phenylephrine and atropine as claimed is nonetheless made obvious over Buono. The invention of Buono includes one or more mydriatic agent and one or more cycloplegic agent ([0005-0006]) and Buono identifies phenylephrine and atropine as a suitable mydriatic agent and cycloplegic agent, respectively, providing one of ordinary skill in the art a reasonable expectation of success in their combination. It is not necessary for the art to embody every combination for such as combination to be rendered as obvious. Applicant argues that Buono teaches the inclusion of a polymer but the claimed invention has a polymer as an optional component and is not required (page 11 of remarks). The examiner is not persuaded by this as the claims are open to the inclusion of a polymer and the polymer is even required in claim 12. Listing the polymer in claim 1 as an optional ingredient does not distinguish the invention from the prior art, even if the art has the polymer as a required component and not an optional component. Applicant argues that Buono dose not teach the inclusion of other excipients such as the preservative, chelating agent and buffering agent (page 11 of remarks). The examiner notes that Buono was not relied upon for the obviousness of including these components but their inclusion is obvious from the additional teachings of Matsumura.
Applicant argues against the obviousness of including the additional components such as the preservative, chelating agent, buffer component and salts, as Matsumura does not specifically disclose the components in an example (pages 11-12 of remarks). This is not persuasive for the same reasoning provided above concerning Buono that it is not necessary for the art to teach each of the components in a specific embodiment for the combination of the components to be obvious. Applicant further argues that Matsumura is directed to an ophthalmic composition capable of reducing ocular discomfort and uncomfortable feeling instead of pupil dilation (page 11 of remarks). The examiner does not find this argument persuasive. Matsumura is directed to ophthalmic compositions that can include components such as atropine sulfate ([0122]) and phenylephrine ([0125]). Thus, Matsumura teaches compositions for similar application, namely ophthalmic use, with the same components taught by Buono, namely phenylephrine and atropine. Matsumura further teaches the inclusion of components including preservatives such as benzalkonium chloride ([0030]), chelating drugs such as EDTA ([0182]), a buffer such as a phosphoric acid buffer such as dipotassium phosphate ([0160]-]0162]), inorganic salts such as sodium chloride ([0010], [0024]), and sodium hydroxide ([0209] Table 3). Thus, each of these components are known to be suitable for ophthalmic compositions and based on their inclusion together in the teachings of Matsumura one of ordinary skill would understand them to be obvious components for ophthalmic compositions and have a reasonable expectation of success in combining them together in an ophthalmic composition. Additionally, as noted by the applicant, Matsumura teaches compositions capable of reducing ocular discomfort and uncomfortable feeling ([0007]). Instead of providing a disconnect between Buono and Matsumura, this instead can serve as a further connection between the teachings as one of ordinary skill in the art would thus recognize each of these components as compatible with ophthalmic compositions that have reduced discomfort, which is a desirable feature. Ultimately, however, each of these components merely represent standard components that may be included in ophthalmic compositions and it would be obvious to include them for their known properties such as preservation, chelation and buffering. It is well understood that pharmaceutical type formulations, in addition to the active components, include components that improve properties such as storage and delivery of the formulation. Components of preservatives, chelating agents, buffering agents and other excipients are specifically known for use in ophthalmic compositions from Matsumra and thus merely represent the use of known prior art elements for their known function (e.g. preservation, chelation, buffering) in a similar composition for ophthalmic use. The applicant has not established that the combination of the components, especially as they are broadly recited (e.g. preservative, chelating agent, buffering agent), offer anything beyond what one would normally expect from their combination.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Buono (US 2004/0013729, published 22 Jan 2004, listed in IDS filed 29 June 2023) in view of Matsumura (US 20180161438, published 14 Jun 2018) as applied to Claims 1, 3, 4, 6, 7, 9, 10, 12-15, 17 and 18 above and further in view of Ostrow et al. (US 2015/0366854, published 24 Dec 2015)
The teachings of Buono and Matsumura are described supra. Buono and Matsumura do not teach the inclusion of sodium metabisulfite. This deficiency is made up for in the teachings of Ostrow.
Ostrow teaches ophthalmic compositions (title). Ostrow teaches the inclusion of components such as atropine and atropine sulfate ([0003]) from 0.001 to about 0.02 wt% ([0010]) further supporting the obviousness of the concentration of atropine described in the rejection above. Ostrow teaches the inclusion of ophthalmically acceptable antioxidants, such as sodium metabisulfite, to enhance chemical stability ([0139]).
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 metabisulfite into the composition obvious over Buono and Matsumura. Similar compositions as Buono and Matsumura for ophthalmic use and comprising atropine are taught by Ostrow. Sodium metabisulfite is a known antioxidant suitable for such compositions and offers benefits such as enhancing chemical stability. Thus, it would have been obvious to include sodium metabisulfite in the compositions for its use as an antioxidant and ability to enhance chemical stability.
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.
Response to Arguments
Applicant's arguments filed 26 Feb 2026 have been fully considered but they are not persuasive. Applicant states that the examiner has not provided a reason as to why one would specifically select sodium metabisulfite as the examples of Ostrow fail to show the use of antioxidants and their impact on stability (page 12 of remarks). This is not persuasive as it is not necessary for Ostrow to demonstrate the performance of every component for that component to be obvious to use. Ostrow teaches that antioxidants such as sodium metabisulfite are known to enhance chemical stability ([0139]) which is sufficient to provide one of ordinary skill motivation for including the component. Further, Ostrow is directed to ophthalmic compositions and teaches the inclusion of components such as atropine, further providing a reasonable expectation of success in using the sodium metabisulfite in the ophthalmic composition of Buono. Applicant argues that Ostrow requires deuterated water but the instant claims do not require deuterated water (page 13 of remarks). This is not persuasive. First, the examiner notes that the instant claims are open to the inclusion of deuterated water due to the use of the open ended comprising language. Ultimately though, Ostrow is not relied upon for deuterated water and it would not be necessary to include deuterated water for the sodium metabisulfite to be obvious. The sodium metabisulfite is a known antioxidant component and it would be obvious to include it for enhanced chemical stability. Applicant further argues that Ostrow is focused on preventing myopia development, which is a different focus from the present invention (page 13 of remarks). This is not persuasive as Ostrow is directed to compositions for similar applications of ophthalmic use and is only relied upon for the obviousness of including the antioxidant sodium metabisulfite in such compositions. Even if the ophthalmic composition of Ostrow has a different intended use than Buono or the instant invention, it is known from Ostrow that antioxidants such as sodium metabisulfite provide enhanced chemical stability and may be used in ophthalmic compositions and it would be obvious to take a generic antioxidant component and include it for improved stability.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
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
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