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
Pursuant to the amendment dated 11/04/2025, claims 1 and 23 are amended. Claims 1-17, 19, 21, 23, 25, 30, 32 and 39 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/US2021/044518, filed on 08/04/2021 and claims benefit of 63/060,829 filed on 08/04/2020.
Withdrawn Rejections
Applicant’s amendment, filed on 11/04/2025, with respect to the rejection of claims 10 and 11 under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA ), fourth paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends, has been fully considered and is persuasive. Applicant has amended claim 23 to change N-acetyl-L-alanine to N-acetyl-D-alanine. Claim 23 now includes all the limitations as the claim upon which it depends, claim 15. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 11/04/2025, with respect to the rejection of claim 1-3, 11-14, 25, 30, 32 and 39 under 35 U.S.C. 102(a)(1)(a)(2) as being anticipated by Chen et al. (US 2017/0304396 Al, published 10/26/2017, see IDS dated 08/14/2024) has been fully considered and is persuasive. Chen does not exemplify a composition comprising both a glycopeptide antibiotic and an aminoglycoside antibiotic. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 11/04/2025, with respect to the rejection of claims 1 and 4-10 under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 2017/0304396 Al, published 10/26/2017, see IDS dated 08/14/2024) and Rowe et al. (US 2017/0087117 A1, published 03/30/2017, see PTO-892 dated 08/05/2025) has been fully considered and is persuasive. Applicant has amended claim 1 to require a composition comprising both a glycopeptide antibiotic and an aminoglycoside antibiotic. Chen does not teach the combination of a glycopeptide antibiotic and an aminoglycoside antibiotic. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 11/04/2025, with respect to the rejection of claims 1, 15-17, 19, and 21under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 2017/0304396 Al, published 10/26/2017, see IDS dated 08/14/2024) and Perkins et al. (WO 2014/085526 A1, published 06/05/2014, see PTO-892 dated 08/05/2025) has been fully considered and is persuasive. Applicant has amended claim 1 to require a composition comprising both a glycopeptide antibiotic and an aminoglycoside antibiotic. Chen does not teach the combination of a glycopeptide antibiotic and an aminoglycoside antibiotic. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 11/04/2025, with respect to the rejection of claims 23 under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 2017/0304396 Al, published 10/26/2017, see IDS dated 08/14/2024) and Perkins et al. (WO 2014/085526 A1, published 06/05/2014, see PTO-892 dated 08/05/2025) as applied to claims 1, 15, and 16 above, and further in view of Goto et al. (Current Topics in Peptide & protein Research, published 01/01/2011, see PTO-892 dated 08/05/2025) has been fully considered and is persuasive. Applicant has amended claim 1 to require a composition comprising both a glycopeptide antibiotic and an aminoglycoside antibiotic. Chen does not teach the combination of a glycopeptide antibiotic and an aminoglycoside antibiotic. The rejection is hereby withdrawn.
Rejections Necessitated by Amendment
The following are new ground(s) necessitated by Applicants' amendment, filed on 11/04/2025, wherein instant independent claims 1 was amended to alter the breadth and scope of the claim, and wherein the remaining pending claims 2-17, 19, 21, 23, 25, 30, 32 and 39 depend from said independent claim.
New Grounds of Rejection
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 1-5, 11-14 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 2017/0304396 Al, published 10/26/2017, see IDS dated 08/14/2024) and Jacob et al. (WO 2011/053841 A1, published 05/11/2011, see PTO-892).
Chen is drawn to aqueous solutions compositions of vancomycin that are stable, ready for use and do not require reconstitution. The compositions are useful for the treatment of infections (abstract). Chen teaches a solution composition containing vancomycin, tryptophan, and water (claim 1). Chen teaches the vancomycin is present at about 0.05% w/v to about 5% w/v in the composition (claim 3) and in example 4 exemplifies vancomycin at 1% w/v and Tryptophan from 0.3% w/v to 1.5% w/v in a solution with a pH ranging from 4.81 to 5.25 (paragraph 0112). Chen teaches that vancomycin composition may be administered to a human or animal subject into the eyes (claim 12).
Chen does not teach the ophthalmic composition wherein the composition also comprises a therapeutically effective quantity of an aminoglycoside antibiotic.
Jacob is drawn to a method of forming an ocular delivery device that includes exposing a solid, shaped cellulose polymer to a solution including an active pharmaceutical ingredient (API) and a solvent capable of solubilizing the API, wherein the polymer absorbs at least a portion of the solution, including the API and solvent. A variety of APIs may be used, including cyclosporine, tobramycin and vancomycin. The ocular delivery devices prepared by the methods taught by Jacob may be used to treat a variety of eye disorders (abstract). Jacob teaches that the therapeutically effective amount of the API included in the ocular delivery device is about 1 µg to about 7.5 mg (paragraph 0021). Jacob teaches Jacob teaches that fortified tobramycin and vancomycin eye drops are often used to treat bacterial infections of the corneal stroma (paragraph 0004). Jacob teaches the ocular delivery device wherein the API is a mixture of vancomycin and tobramycin (claim 27).
It would have been prima facie obvious to combine the teachings of Chen and Jacob before the effective filing date of the claimed invention by including tobramycin as taught by Jacob in the composition comprising vancomycin taught by Chen to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to include tobramycin as taught by Jacob in the vancomycin composition taught by Chen because Jacob teaches that tobramycin and vancomycin are often used together to treat bacterial infections. One of ordinary skill in the art would have a reasonable expectation of success because Jacob teaches combining tobramycin and vancomycin for the treatment of bacterial infections of the corneal stroma and Chen teaches the administration of the vancomycin composition for for treatment of infections.
Regarding instant claims 11 and 12, it would have been prima facie obvious to combine the teachings of Chen and Jacob before the effective filing date of the claimed invention by optimizing the concentration of vancomycin to be between 1-10 mass % and tobramycin to be between 1-5 mass % to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to optimize the concentration of vancomycin to be between 1-10 mass % and tobramycin to be between 1-5 mass % because Chen teaches vancomycin is present at about 0.05% w/v to about 5% w/v in the composition and Jacob teaches tobramycin to be 1 µg to about 7.5 mg total. One of ordinary skill in the art would have a reasonable expectation of success by optimizing the concentration of the vancomycin and tobramycin in the ophthalmic composition taught by Chen because Chen teaches vancomycin is present at about 0.05% w/v to about 5% w/v in the composition and Jacob teaches tobramycin to be 1 µg to about 7.5 mg total. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Regarding instant claims 13 and 14, it would have been prima facie obvious to combine the teachings of Chen and Jacob before the effective filing date of the claimed invention by optimizing the pH composition to be between 5.1 and 5.3 arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to optimize the pH composition to be between 5.1 and 5.3 because Chen exemplifies a composition comprising vancomycin with a pH ranging from 4.81 to 5.25. One of ordinary skill in the art would have a reasonable expectation of success by optimizing the concentration of the vancomycin and tobramycin in the ophthalmic composition taught by Chen because Chen exemplifies a composition comprising vancomycin with a pH ranging from 4.81 to 5.25. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Claims 4-10 are rejected under 35 U.S.C. 103 as being unpatentable Chen et al. (US 2017/0304396 Al, published 10/26/2017, see IDS dated 08/14/2024) and Jacob et al. (WO 2011/053841 A1, published 05/11/2011, see PTO-892) as applied to claim 1 above, and further in view of Rowe et al. (US 2017/0087117 A1, published 03/30/2017, see PTO-892 dated 08/05/2025).
Claim 1 is rejected as discussed above.
The combined teachings of Chen and Jacob are discussed above.
The combined teachings of Chen and Jacob do not teach the ophthalmic composition that further comprises at least one anesthetic compound.
Rowe is drawn to compositions for providing anesthesia to the eye, for treating or preventing inflammatory disorders in the eye, or for treating or preventing ocular infections (abstract). Rowe teaches a method of treating an ocular microbial infection, comprising topically administering a composition comprising a glycosaminoglycan and an active ingredient to a patient in need, wherein the active ingredient is an antimicrobial agent selected form the group consisting of antibiotics, antivirals, and antifungals (claim 16). The compositions can be administered alone or in combination with one or more additional active agents suitable for providing anesthesia, treating or preventing inflammation, or treating or preventing ocular infections (paragraph 0021). The active agents are administered in a therapeutically effective amount to repress or retard the infection (paragraph 0044). Rowe teaches the composition may contain antibiotics such as vancomycin and tobramycin (paragraph 0092). Rowe teaches that the anesthetic that may be used could be lidocaine (paragraph 0085). The lidocaine concentration is typically between 0.1 to 2% for fluid compositions (paragraph 0082). Rowe teaches that topical anesthesia such as lidocaine are often used for quick procedures and to minimize pain following surgery (paragraph 0140).
It would have been prima facie obvious to combine the combined teachings of Chen and Jacob with the teachings of Rowe before the effective filing date of the claimed invention by adding 1% lidocaine as taught by Rowe to the ophthalmic composition taught by Chen and Jacob to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to modify the ophthalmic composition taught by Chen and Jacob by further adding an anesthetic such as 1% lidocaine as taught by Rowe because Rowe teaches an ophthalmic composition with additional anesthetics to minimize pain. One of ordinary skill in the art would have a reasonable expectation of success by adding 1% lidocaine to the ophthalmic composition taught by Chen and Jacob because Rowe teaches the addition of 0.1 to 2% anesthetic to the ophthalmic compositions containing antibiotics. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Claims 15-17, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable Chen et al. (US 2017/0304396 Al, published 10/26/2017, see IDS dated 08/14/2024) and Jacob et al. (WO 2011/053841 A1, published 05/11/2011, see PTO-892) as applied to claim 1 above, and further in view of Perkins et al. (WO 2014/085526 A1, published 06/05/2014, see PTO-892 dated 08/05/2025).
Claim 1 is rejected as discussed above.
The combined teachings of Chen and Jacob are discussed above.
Chen further exemplifies the aqueous compositions containing vancomycin and other amino acids such as cysteine and alanine in concentrations ranging from 0.60-1.37% w/v, but is silent on the stereoisomers, amino acid derivatives, and the use of L-glycine and L-lysine (paragraph 0112).
The combined teachings of Chen and Jacob do not teach a composition wherein the amino acid is selected from the group consisting of L-glycine, L-cysteine, or L-lysine.
Perkins is drawn to a stabilized lipid-based glycopeptide antibiotic composition (abstract). Perkins teaches that the composition comprises a lipid component a glycopeptide antibiotic, and an amino acid or a derivative thereof. The antibiotic may be vancomycin (paragraph 0005). The amino acid increases the half-life, efficacy and/or bioavailability of the glycopeptide antibiotic in the composition. The amino acids in the compositions may be L- or D-amino acids (paragraph 00044). Perkins teaches the amino acid can be glycine, lysine, or alanine. Perkins teaches that an “amino acid derivative” refers to a moiety having both an amine functional group, either as a NH2, NHR, or NR2, and a carboxylic acid functional group. The term “amino acids” encompasses both natural and unnatural amino acids.
It would have been prima facie obvious to combine the combined teachings of Chen and Jacobs with the teachings of Perkins before the effective filing date of the claimed invention by substituting the amino acid, tryptophan, in the composition taught by the combined teachings of Chen and Jacob by selecting a different amino acid or amino acid derivative as taught by Perkins to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to substitute the amino acid used to stabilize the vancomycin in the composition taught by the combined teachings of Chen and Jacob to be L-glycine, L-cysteine, or L-lysine because Chen exemplifies cysteine and Perkins teaches that the amino acids such as glycine and lysine, in both L and D stereoisomers, and their derivatives may be used to stabilize the vancomycin in a formulation. One of ordinary skill in the art would have a reasonable expectation of success because both Chen and Perkins teaches that amino acids may be used to stabilize vancomycin in a formulation.
It would have been prima facie obvious to combine the combined teachings of Chen and Jacobs with the teachings of Perkins before the effective filing date of the claimed invention by selecting amino acids taught by Perkins and the amino acid concentrations in the pharmaceutical composition to be between 0.1mass % and about 1.5 mass % as taught by Chen to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to optimize the amino acid concentrations to be between 0.1 mass % and about 1.5 mass % because Chen teaches that the amino acid concentration may be 0.1% w/v to about 2.5% w/v. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Claim 15, 16, and 23 are rejected under 35 U.S.C. 103 as being unpatentable Chen et al. (US 2017/0304396 Al, published 10/26/2017, see IDS dated 08/14/2024) and Jacob et al. (WO 2011/053841 A1, published 05/11/2011, see PTO-892) as applied to claim 1 above, and further in view of Jasprica et al. (US 10,188,697 B2, published 01/29/2019, see PTO-892).
Claims 1, 15, and 16 are rejected as discussed above.
The combined teachings of Chen and Jacob are discussed above.
The combined teachings of Chen and Jacob do not teach a composition wherein the amino acid is N-acetyl-D-alanine and wherein the N-acetyl-D-alanine has a concentration in the ophthalmic pharmaceutical composition of between about 0.25 mass % to about 1.5 mass %.
Jasprica is drawn to solutions comprising a glycopeptide antibiotic, such as vancomycin and an amino acid or amino acid derivative such as N-acetyl-D-alanine. The solutions are stable or stabilized for long-term periods at conditions of normal use and storage and can be formulated as pharmaceutical solutions for use in subjects (abstract). Jasprica teaches a pharmaceutical composition wherein the concentration of the glycopeptide antibiotic is about 0.5-15% w/V and wherein the molar ration of the N-acetyl-D-alanine to the glycopeptide antibiotic is about 1:1 to about 40:1 (claim 23).
It would have been prima facie obvious to combine the combined teachings of Chen and Jacob with the teachings of Jasprica before the effective filing date of the claimed invention by modifying the amino acid, tryptophan, in the composition taught by Chen to be N-acetyl-alanine as taught by Jasprica to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to modify the amino acid used to stabilize the vancomycin in the composition taught by Chen to be N-acetyl-L-alanine because Jasprica teaches acetyl-L-alanine may be used to stabilize the vancomycin in a formulation. One of ordinary skill in the art would have a reasonable expectation of success because both Chen and Jasprica teaches that amino acids may be used to stabilize vancomycin in a formulation and Jasprica specifically teaches that acetyl-L-alanine may be used to stabilize glycopeptide antibiotics such as vancomycin.
It would have been prima facie obvious to combine the combined teachings of Chen and Jacob with the teachings of Jasprica before the effective filing date of the claimed invention by optimize the concentration of N-acetyl-D-alanine in the pharmaceutical composition to be between 0.25 mass % and about 1.5 mass % as taught by Chen to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to modify the amino acid concentrations to be between 0.25 mass % and about 1.5 mass % because Chen teaches that the amino acid concentration may be 0.1% w/v to about 2.5% w/v and Jasprica teaches that the ratio of N-acetyl-D-alanine to the glycopeptide antibiotic is between 1:1 and 40:1. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Claims 25, 30 and 32 rejected under 35 U.S.C. 103 as being unpatentable Chen et al. (US 2017/0304396 Al, published 10/26/2017, see IDS dated 08/14/2024) and Jacob et al. (WO 2011/053841 A1, published 05/11/2011, see PTO-892) as applied to claim 1 above, and further in view of Rosasco et al. (J. of Applied Pharmaceutical Science, published 12/27/2015, see PTO-892).
Claim 1 is rejected as discussed above.
The teachings of Chen are discussed above.
Chen further exemplifies the stability of the vancomycin and tryptophan composition stored at 2-8°C over 12 months (paragraph 0132).
The teachings of Jacob are discussed above.
The combined teachings of Chen and Jacob do not teach the stability of the combination comprising vancomycin, tobramycin, and tryptophan.
Rosasco is drawn to the study of the chemical stability of various formulations of tobramycin eye-drops (title). Rosasco shows that across six preservation systems, the tobramycin compositions had shelf lives of 1.58 years to greater than 5 years when stored in a refrigerator (2-8°C) (Table 1 and page 011).
It would have been prima facie obvious to combine the combined teachings of Chen and Jacob with the teachings of Rosasco before the effective filing date of the claimed invention by optimizing the composition comprising vancomycin, tobramycin, and an amino acid to be stable stored at 2-8°C over 12 months as taught by Chen and Rosasco to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to optimize the composition comprising vancomycin, tobramycin, and tryptophan because Chen teaches that tryptophan stabilizes vancomycin for at 2-8°C over 12 months and Rosasco teaches that tobramycin can be stabile in pharmaceutical compositions 2-8°C over 12 months.
Response to Arguments
Applicant's arguments filed 11/04/2025 have been fully considered in so much as they apply to the amended claims but they are not persuasive.
Applicant argues that Rowe is directed to compositions that include a glycosaminoglycan, such as hyaluronic acid, in a concentration suitable for achieving a desired viscosity and that while Rowe teaches that the composition may include an active agent, that the active agent includes anesthetics, anti-inflammatory agents, antivirals, antibacterials, antifungals, and anti-allergic agents. The applicant argues that at best Chen teaches that the compositions of Rowe could possibly be combined with the composition of Chen, which is not sufficient to establish a prima facie case of obviousness. The argument is not persuasive. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art.”); In re Sneed, 710 F.2d 1544, 1550, 218 USPQ 385, 389 (Fed. Cir. 1983). "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR, 550 U.S. at 421, 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. at 420, 82 USPQ2d at 1397. 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 418, 82 USPQ2d at 1396 (see MPEP 2145 II(c)). Rowe teaches that the active agent is an antibiotic (claim 16) and gives a non-exhaustive list of antibiotics that included vancomycin and tobramycin. In the rejection for the amended instant claims 4-10, Jacob was relied upon to teach to combine both vancomycin and tobramycin for the treatment of an eye infection, Chen to teach the addition of an amino acid to improve the stability of vancomycin in an ophthalmic composition, and Rowe to teach that a composition for treating an eye infection that includes antibiotics such as vancomycin or tobramycin may also include lidocaine in the claimed amounts.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 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.
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/SAMANTHA LYNN SCHACHERMEYER/Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693