DETAILED ACTION
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 .
Applicant should note that the instant application has been reassigned to a new examiner and art unit.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/28/2026 has been entered.
Claim Status
Claims 25, 27, 29, and 34-76 are pending. Claims 1-24, 26, 28, and 30-33 were previously cancelled. Claims 25, 27, 29, 41-55, and 73-75 are withdrawn as being directed to a non-elected invention.
Claims 34-40, 56-72, and 76 are under current examination.
Claim Objections
Applicant is advised that should claims 56-64 be found allowable, claims 65-72 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claims 34-40, 56-72, and 76 are rejected under 35 U.S.C. 103 as being unpatentable over Dang et al. (International Application Published Under the PCT WP 2007/061454 A1; Published 31 May 2007; of record) in view of Chae et al. (The Use of Intranasal Sphenopalatine Ganglion Blockade for the Treatment of Post-Traumatic Headache: A Case Series; Heechin Chae, et al.; Archives electronic page Peer-reviewed poster presentation: Pain rehabilitation; Volume 87, Issue 11, e39; November 2006; of record) and Kulkarni et al. (Formulation and characterization of nasal sprays; Vitthal Kulkarni and Charles Shaw; Inhalation; June 2012; of record).
The claims are directed to a sprayable composition comprising a histamine antagonist such as azelastine hydrochloride, a local anesthetic such as lidocaine hydrochloride, one or more pharmaceutically acceptable excipients such a cellulose derivative, and the pH of the composition being no less than 4.4 and no greater than 4.7.
Dang et al. teach a nasal solution composition comprising azelastine hydrochloride and a viscosity-increasing agent, such as carboxymethylcellulose, administered by a metered dose spray pump (paragraphs 0009 and 1218-1219). The pH of the composition is between 4.5 and 7.5 (paragraph 0087). The composition further comprises additional active ingredients (abstract). Adverse events associated with nasal administration of azelastine hydrochloride includes headaches (paragraphs 1267-1269).
Dang et al. lacks a teaching wherein the composition further comprises lidocaine in an amount ranging from about 0.25% to about 2.0% w/w of the composition. Further, Dang et al. lacks a teaching wherein the composition contains a cellulose derivative in an amount ranging from about 0.01% to about 4.0% w/w of the composition.
Chae et al. teach that 2% intranasal lidocaine is an efficient method for pain reduction in headaches (abstract).
Kulkarni et al. teach that microcrystalline cellulose and/or carboxymethylcellulose sodium (both cellulose derivatives) are known excipients for use in nasal spray formulations, and that the FDA IIG (inactive ingredient guidance) suggests limiting the concentration of these excipients to <2% w/w (table 2).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the filing of the instant application to include a micronized cellulose or carboxymethylcellulose sodium in a concentration less than 2% w/w in the composition of Dang et al. and have a reasonable expectation of success. One would have been motivated to do so since Dang et al. teach that the composition comprises cellulose derivatives as a viscosity-increasing agent, and Kulkarni et al teach that microcrystalline cellulose and/or carboxymethylcellulose are known excipients in nasal sprays, and that their concentrations should be less than 2% w/w. Additionally, it is the examiner’s position that the instantly claimed excipient concentration of “about 0.01% to 4.0% w/w” includes any lower limit greater than 0% w/w.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the filing of the instant application to add lidocaine to the composition of Dang et al. and have a reasonable expectation of success. One would have been motivated to do so in order to concurrently prevent and/or treat headaches associated with the nasal administration of the azelastine composition.
It would have been prima facie obvious for one of ordinary skill in the art at the time of the filing of the instant application to create a composition having a pH of 4.5 and have a reasonable expectation of success. One would have been motivated to do so since Dang et al. suggest the pH of the composition can be 4.5.
Claim 76 is directed to the limitation that the composition be capable of forming a gel at a temperature greater than ambient temperature. The instant composition and the prior art composition are structurally indistinguishable, therefore it would inherently be expected to gel at temperatures higher than ambient temperature.
Response to Arguments
Applicant's arguments as well as the declaration, both filed 01/28/2026, have been fully considered but they are not persuasive.
On pages 8-10, Applicant asserts that there is no motivation and argues that there is no reasonable expectation of success that one could combine Chae with Dang, citing the Declaration as arguing that Chae constitutes only observational data of two particular patients and that Chae does not describe spray administered lidocaine.
These arguments are not persuasive for the reasons detailed in the “Response to Declaration” section below.
Response to Declaration:
Declarant argues on pages 3-4 that Chae is a case study and thus not able to isolate a particular effect from the patient’s physiology. Declarant argues that it is difficult to base hypotheses on future results based solely on a case study. Declarant argues that it is well-settled that the pharmaceutical arts are highly unpredictable and that Chae teaches sphenopalatine ganglion block rather than intranasal spray to deliver lidocaine.
The examiner respectfully disagrees that one having ordinary skill would lack a reasonable expectation of success in the instant case either in terms of treating headache a recognized anesthetic (i.e. a drug that blocks sensation) or that lidocaine could be delivered intranasally when the prior art teaches sphenopalatine ganglion block. See MPEP 2143.02 which states, inter alia:
Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")).
In the instant case, reasonable expectation of success is found for the using intranasal lidocaine to block headache pain in that it was effective in patients having different causes of headache, in that lidocaine was an extremely well-known sensation blocker used for pain management as of the instant effective filing date, and in that intranasal delivery was recognized as a highly effective means for drug delivery to the surface of the nasal passages. The examiner does not consider the obviousness standard under 35 USC 103 to require the expectation of success associated with a clinical trial in this instance for the foregoing reasons.
On para 17, Declarant argues that “there would be no reason based on [the cited prior art] to believe that intranasally administered lidocaine would work for a different indication, particularly to induce a temporary suppression of appetite”
Insomuch as this may be an assertion of unexpected results, please refer to MPEP 716.02(b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims.
Declarant’s arguments regarding unexpected results are cumulative and Declarant is directed to the Response to Arguments section in the Office action mailed 08/28/2025, which are replicated herein for convenience as well as to the interview summary. Previous response to argument:
Applicant further argues that the prior art does not teach or suggest the unexpected effect of the administration of the instantly claimed composition would result in anosmia to suppress appetite. Applicant’s argument has been fully considered but found not to be persuasive. A showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997) (conclusory statements regarding unusually low immune response or unexpected biological activity that were unsupported by comparative data held insufficient to overcome prima facie case of obviousness). In the instant case Applicant has not provided any data or evidence that the combination of lidocaine and azelastine results in anosmia to suppress appetite.
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 34-40 and 76 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18849767 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the ‘767 application embrace a composition for intranasal delivery comprising a histamine antagonists, specifically azelastine or salts thereof, and a local anesthetic, specifically lidocaine or salts thereof, and excipients chosen from pectin methylcelluloses, blends of microcrystalline cellulose/sodium carboxymethylcellulose, glycerol esters of hydrogenated rosin, and combinations thereof in amounts overlapping with the amounts required by the instant claims. The excipients are gel-forming and therefore fall within the scope of instant claim 76.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 56-72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18849767 (reference application) as applied to claims 34-40 above, and further in view of Dang et al. (International Application Published Under the PCT WP 2007/061454 A1; Published 31 May 2007; of record).
The relevant limitations of the copending ‘767 claims are set forth above. The copending claims are silent with respect to the pH of the composition.
Dang et al. teach a very similar nasal solution composition comprising azelastine hydrochloride and a viscosity-increasing agent, such as carboxymethylcellulose, administered by a metered dose spray pump (paragraphs 0009 and 1218-1219). The pH of the composition is between 4.5 and 7.5 (paragraph 0087).
It would have been prima facie obvious to formulate the claims of the ‘767 application to have a pH within the range of 4.5 to 7.5 because one having ordinary skill would have recognized this pH as suitable for the composition embraced by the copending claims. See MPEP 2144.07.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617