DETAILED ACTION
This office action is in response to the Applicant’s filing dated May 18th, 2026.
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 .
Notice of Change of Examiner
Please note that the Examiner prosecuting this application has been changed to Examiner Christopher Johnson of Art Unit 1691. Please address all future correspondences to Examiner Johnson.
Status of Claims
Claims 1, 3, 5-6, 8, 14-19 and 21-22 are pending in the instant application. Acknowledgement is made of Applicant’s remarks and amendments filed on May 18th, 2026. Acknowledgment is made of Applicant’s amendment of claims 1, 3, 5 and 14; the cancelation of claims 2, 4, 7, 9-13 and 20; and the addition of new claims 21-22.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on May 18th, 2026 is acknowledged.
Claims 14-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 18th, 2026.
Claim Rejections - 35 USC § 112(b)
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 1 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.
Regarding claim 1, in line 5 spanning into line 7 the claim recites “a topical anesthetic comprising proparacaine, tetracaine, cocaine, procaine, hexylcaine, bupivacaine, lidocaine, benoxinate, mepivacaine, prilocaine, etidocaine;” which renders the metes and bounds of the claim unclear; because due to the absence of “and” or “or” between “prilocaine” and “etidocaine”, it is not clear whether or not all of the recited topical anesthetics must be present.
In the interest of compact prosecution, the Examiner will examine this claim as if “or” was present between “prilocaine” and “etidocaine” indicating only one topical anesthetic must be present.
Claim Rejections - 35 USC § 103
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 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, 5, 8 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Sanad et al (Journal of Natural Science, Biology and Medicine, (2023), 14(2), 151-163); as evidenced by Rowe et al (Propylene Glycol, Handbook of Pharmaceutical Excipients, (2009), 6th Edition, Pharmaceutical Press, 592-594), cited for evidentiary purposes only.
Regarding claims 1, 5, 8 and 21, Sanad teaches pharmaceutical compositions, used for wound healing, in the form of hydrogels comprising 0.01% moxifloxacin dissolved in distilled water and 2% lidocaine dissolved in propylene glycol (page 151, Abstract; page 152, left column, last paragraph; page 152, Table 1). Sanad discloses that moxifloxacin is a fluoroquinolone compound that has a broad range of antibacterial activity, and lidocaine is a painkiller that is efficacious in the control of localized pain throughout the process of wound healing (page 152, left column, first and second paragraphs). Propylene glycol reads on an excipient and preservative as evidenced by Rowe (pages 592, Applications in Pharmaceutical Formulation or Technology), cited for evidentiary purposes only.
Sanad does not explicitly disclose the concentration range of the inactive portion of the composition being about 99.3%-99.7%; or the volumetric ratio of antibiotic to anesthetic present in the composition being from about 5:1 to about 15:1.
It would have been prima facie obvious to one of ordinary skill in the art to utilize the amounts of moxifloxacin and lidocaine taught by Sanad as a starting point for optimizing the amounts of moxifloxacin and lidocaine in the pharmaceutical composition since Sanad teaches that moxifloxacin is useful to provide broad spectrum antibiotic activity in wound healing, and lidocaine is useful in controlling localized pain throughout the process of wound healing, and when combined in a hydrogel they are useful in treating wound conditions. One of ordinary skill in the art would have recognized the relative concentrations of moxifloxacin and lidocaine in the pharmaceutical composition as result-effective variables, i.e. variables that achieve a recognized result, because their respective concentrations affect the antibacterial and local anesthetic effects of the composition. Therefore, the determination of the optimum or workable concentrations would have been well within the practice of routine experimentation by the skilled artisan. Because adjustment of the relative concentrations of the active components necessarily results in a corresponding adjustment of the concentration of the inactive portion of the composition, optimization of the concentrations of moxifloxacin and lidocaine would likewise result in optimization of the concentration of the inactive portion. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed concentration range, the determination of the optimum or workable concentrations given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Moreover, regarding the use of the claimed pharmaceutical composition for the treatment of a corneal abrasion, such a limitation of the instant claims fails to patentably distinguish the instant claims over the cited prior art because such a limitation is an intended use of the pharmaceutical composition (i.e. an intent to use the disclosed pharmaceutical composition as treatment for corneal abrasion), which does not impart any physical or material characteristics to the pharmaceutical composition that is not already present in the cited prior art. 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. See Pitney Bowes Inc. v. Hewlett-Packard Co., 182 F.2d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 378, 42 USPQ2d 1550, 1554 and MPEP § 2112.02(II). In the instant case, the claims are directed to a pharmaceutical composition and, thus, would be reasonably expected to be capable of performing the intended use as instantly claimed, absent factual evidence to the contrary and further absent any apparent structural difference between the pharmaceutical composition of the prior art and that of the instant claims.
Taken together, all of this would result in the composition of instant claims 1, 5, 8 and 21 with a reasonable expectation of success.
Claims 3 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Sanad et al (Journal of Natural Science, Biology and Medicine, (2023), 14(2), 151-163); as evidenced by Rowe et al (Propylene Glycol, Handbook of Pharmaceutical Excipients, (2009), 6th Edition, Pharmaceutical Press, 592-594), cited for evidentiary purposes only; in view of Shahinian (US 5760077 A).
Regarding claims 3 and 22, Sanad renders obvious the composition of claims 1, 5, 8 and 21 as described in the above rejection.
Sanad does not teach proparacaine hydrochloride as the anesthetic present in the pharmaceutical composition.
Shahinian teaches the use of lidocaine and proparacaine to treat corneal abrasion pain in patients. Shahinian teaches that proparacaine was reported to provide therapeutic anesthetic effect at a lower disclosed concentration than lidocaine when administered to patients with corneal abrasions in the cited cases. Specifically, 0.001% proparacaine in Case B8 and 0.005% lidocaine in Case B10 was required respectively to achieve “good pain relief” (column 16, lines 51-63; column 17, line 50 to column 18, line 3; column 18, Table 2).
It would have been prima facie obvious to a person of ordinary skill in the art to substitute proparacaine for lidocaine as the anesthetic in the pharmaceutical composition of Sanad, because Shahinian teaches both lidocaine and proparacaine are effective topical anesthetics for relieving pain associated with corneal abrasions and further demonstrates successful pain relief with proparacaine at a lower disclosed concentration than lidocaine in the reported cases. Accordingly, one of ordinary skill in the art would have recognized proparacaine as a known alternative to lidocaine for providing local anesthesia in the treatment of corneal abrasion pain and would have had reason to select proparacaine in order to obtain the same recognized anesthetic function, providing effective pain relief at comparatively lower concentrations. The substitution of one known local anesthetic for another performing the same function would have represented no more than the predictable use of prior art elements according to their established function, with a reasonable expectation that proparacaine would likewise provide local anesthesia.
“[T]he rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395.
Taken together, all of this would result in the composition of instant claims 3 and 22 with a reasonable expectation of success.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Sanad et al (Journal of Natural Science, Biology and Medicine, (2023), 14(2), 151-163); as evidenced by Rowe et al (Propylene Glycol, Handbook of Pharmaceutical Excipients, (2009), 6th Edition, Pharmaceutical Press, 592-594), cited for evidentiary purposes only; in view of Witham et al (US 2017/0290786 A1).
Regarding claim 6, Sanad renders obvious the composition of claims 1, 5, 8 and 21 as described in the above rejection.
Sanad does not expressly disclose the pharmaceutical composition packaged in a 0.01 oz vial or a 2 mL bottle.
Witham teaches a pharmaceutical composition that is packaged in plastic or glass bottles that are 2 mL (page 7, claims 22-23).
It would have been prima facie obvious to a person of ordinary skill in the art to package the pharmaceutical composition of Sanad in the 2 mL bottle taught by Witham, because Witham teaches that 2 mL plastic or glass bottles are suitable containers for packaging pharmaceutical compositions. The use of a known pharmaceutical container for its established purpose of storing and dispensing a pharmaceutical composition would have represented no more than the predictable use of a prior art element according to its established function, with a reasonable expectation that the 2 mL bottle would suitably contain and dispense the pharmaceutical composition.
“[T]he rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395.
Taken together, all of this would result in the composition of instant claim 6 with a reasonable expectation of success.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 5, 8 and 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 21-23 of copending Application No. 18/629,882 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because reference application ‘882 is directed to a pharmaceutical composition comprising a topical antibiotic (specifically moxifloxacin, reference claim 4), topical anesthetic (specifically proparacaine, reference claims 2 and 22) and an excipient (specifically a preservative, reference claim 23) in the same volumetric ratios of antibiotic to anesthetic present in the composition being from about 5:1 to about 15:1 (reference claim 1).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 3, 5-6, 8 and 21-22 are rejected.
No claim is allowed.
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/C.L.J./Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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