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
Reissue: Non-Final Office Action
Status of the Claims
On 02/08/2022 US Patent 11,241,477 issued to Newman et al. with claims 1-20. Claims 1-52 are currently pending. Claims 21-52 are newly presented in the instant reissue application. Non-elected claims 21-47 are withdrawn from consideration. Claims 1-20 and 48-52 are the subject of this Office Action. This is the first Office Action on the merits of the claims in reissue Application 18/437,141.
Maintenance Fees
Applicant is reminded of the requirement to pay all applicable maintenance fees on the original patent. See MPEP § 1415.01.
Ongoing Duty To Disclose
Applicant(s) is/are reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent 11,241,477 is or was involved. These proceedings would include any trial at the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Election/Restrictions
Newly presented claims 21-47 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The inventions of claims 1-20 and 48-52 (Group I) are distinct from the inventions of claims 21-47 (Group II), each from the other because of the following reasons:
Inventions I and II are directed to related products and/or methods. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have a materially different design. Specifically, the claims of Group I all require oxytocin, while claims 21-47 are all directed to an analog or derivative of oxytocin, which makes these Groups mutually exclusive. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Since applicant has received an action on the merits for the originally presented invention (i.e., in application 17/007,518), this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 21-47 (Group II) are withdrawn from consideration as being directed to a constructively non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. Claims 1-20 and 48-52 are under examination on their merits.
Applicant may file a divisional reissue application directed to the constructively non-elected invention.
Applicant is advised that if the original patent claims are found allowable and no error (other than the failure to present the non-elected claims) is being corrected in the reissue application under examination, and a divisional application has been filed for the non-elected claims, further action in the application will be suspended, pending resolution of the divisional application. Otherwise, the claims to the original patented invention will continue to be examined and the non-elected claims (to any added invention(s)) will be held in abeyance in a withdrawn status. The non-elected claims will only be examined if filed in a divisional reissue application.
Information Disclosure Statement
The references cited on the information disclosure statement(s) were considered and have been made of record to the extent that each was provided.
Official Gazette Publication
The Official Gazette (O.G.) publication date for this reissue application was 07/09/2024.
Claim Objections
The amended claim set filed 02/08/2024 is improper for the following reasons:
A. The amendment does not comply with 37 CFR 1.173 which sets for the manner of making amendments in reissue applications. Specifically, the claim set uses double brackets to show deletions in claims 19 and 20, instead of single brackets as required by 37 C.F.R. 1.173(d).
While the improper amendment has been entered and considered, a supplemental paper correctly amending the reissue application is required. An amendment filed after final rejection that fails to comply with 37 CFR 1.173 will not be entered.
B. Pursuant to 37 CFR 1.173(c), each claim amendment must be accompanied by an explanation of the support in the disclosure of the patent for the amendment (i.e., support for all changes made in the claims, whether insertions or deletions, including claims added by amendment). In the remarks dated 02/08/2024, applicants have pointed to col. 1, line 66 to col. 2, line 24, which appears to be relevant to support for the analog/derivative language in claims 21-47. However, applicants have not pointed to where support can be found in the specification for methods lacking intranasal administration, which is relevant to claims 48-52.
Appropriate correction is required.
Defective Declaration/Oath
A. The reissue oath/declaration filed with this application is defective because the error identified (failure to include claims explicitly directed to methods of treating tinnitus comprising administering … an analog or derivative of oxytocin) no longer applies in light of the election by original presentation. Thus, the declaration fails to identify at least one error which is relied upon to support this reissue application. See 37 CFR 1.175 and MPEP § 1414.
B. The declaration is also objected to because the title of the application is cut off and is incomplete.
Broadening Reissue
The instant reissue application was filed on 02/08/2024, which is within two years of the issue date of US Patent 11,241,477 (issued on 02/08/2022); has a broadened claim (e.g., claim 21); and has clear intent to broaden the claim.
The broadening in this Reissue Application does not recapture claimed subject matter that was deliberately added, or argued to overcome a rejection in the original application or an application in the patent family.
Original Patent
The following is a quotation of the first paragraph of 35 U.S.C. 251:
(a) IN GENERAL.—Whenever any patent is, through error, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. No new matter shall be introduced into the application for reissue.
Claims 48-51 are rejected under 35 U.S.C. 251, for claiming subject matter that does not meet the original patent requirement.
MPEP 1412.01 states that the reissue claims must be for the same invention as that disclosed as being the invention of the original patent. MPEP 1412.01 further provides guidelines for determining whether the reissue claims are "for the invention disclosed in the original patent" as:
(A) the claims presented in the reissue application are described in the original patent specification and enabled by the original patent specification such that 35 U.S.C. 112, first paragraph is satisfied; and
(B) nothing in the original patent specification indicates an intent not to claim the subject matter of the claims presented in the reissue application.
(C) the newly claimed invention is clearly and unequivocally disclosed in the specification as a separate invention with the claimed combination of features.
The presence of the disclosure in the original patent should evidence that applicant intended to claim or that applicant considered the material now claimed to be the invention.
Further, the Federal Circuit addressed the “original patent” requirement of 35 USC 251 in Antares Pharma, Inc. v. Medac Pharma Inc. and Medac GMBH, 771 F.3d 1354, 112 USPQ2d 1865 (Fed. Cir. 2014). In Antares the reissue claims covered embodiments of injection devices (not restricted to jet-injection devices) which the Applicant admitted was a different invention from what was originally claimed. Id. at 1356. The Federal Circuit adopted the Supreme Court's explanation of the “same invention” requirement as “if the original patent specification fully describes the claimed inventions, but not if the broader claims ‘are [] merely suggested or indicated in the original specification’ ”. Id. at 1359. The Federal Circuit further stated that although wording in 35 USC 251 was changed from “same invention” to “original patent” no change in substance was intended. Id. at 1360.
Based on Antares a review of the specification is necessary to determine whether the original specification adequately discloses the invention of the reissue claims.
In the instant case, the original patent required intranasal administration in all claims, the specification discussed oxytocin delivery solely in the context of intranasal administration (e.g., see the abstract, Summary of the Disclosure, and Description of the Disclosure at cols. 1-2), and the original application never clearly and unequivocally disclosed a method lacking intranasal administration, let alone any other route of administration. In fact, the dosages claimed (e.g., claim 1) appear to have been specifically developed for intranasal delivery (e.g., col. 3, lines 56 to col. 4, line 3; col. 4, lines 42-55; Examples). Therefore, eliminating intranasal delivery from the claims also raises enablement issues (see the 112(a) rejection below).
Thus, claims 48-51, which are directed to a method of treating tinnitus without requiring intranasal administration do not satisfy the “original patent” requirement, and are rejected under 35 USC 251 for not claiming subject matter directed to the invention disclosed in the original patent.
Claim Rejections - 35 USC § 112(a) or (pre-AIA )
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Scope of Enablement
Claims 48-51 are rejected under 35 U.S.C. 112, first paragraph or 35 U.S.C. 112(a), as failing to comply with the enablement requirement.
This rejection is made over the scope of claims 48-51 that includes non-intranasal delivery.
Claims 48-51 are rejected under 35 U.S.C. 112, first paragraph, or 35 U.S.C. 112(a), because the specification, while being enabling for treatment of tinnitus intranasally, does not reasonably provide enablement for treatment of tinnitus by any other route of administration. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. Specifically, treatment of tinnitus by administration via any route other than intranasally has not been sufficiently taught to enable the full scope of the claims.
In this regard, the application disclosure and claims have been compared per the factors indicated in the decision In re Wands, 8 USPQ 2d 1400 (Fed. Cir., 1988) as to undue experimentation. The factors include:
1) the nature of the invention;2) the scope or breadth of the claims;3) the state of the prior art;4) the predictability or unpredictability of the art; 5) the relative skill of those skilled in the art; 6) the presence or absence of working examples; 7) the amount of direction or guidance presented and,8) the quantity of experimentation necessary.
The relevant factors are addressed below on the basis of comparison of the disclosure, the claims and the state of the prior art in the assessment of undue experimentation.
Scope or breadth of the claims: Instant claim 48 and dependent claims thereon recite:
"A method of treating tinnitus comprising administering to an individual in need of treatment from 50 to 260 IU of oxytocin over a 24 hour period."
However, the instant specification as originally filed lacks adequate guidance, direction, or discussion to apprise the skilled artisan of how to treat tinnitus by administration of oxytocin by any route other than intranasally.
State of the prior art: While the prior art recognizes intranasal delivery of oxytocin to treat tinnitus, the state of the art with regard to treating tinnitus by administering oxytocin other routes (e.g., topical, i.v., etc.) is essentially non-existent. In fact, non-intranasal systemic administration of oxytocin is known to target the kidneys, not the central nervous system (e.g., tinnitus) (e.g., see Tuğtepe, H., et al. Regulatory Peptides (2007), 140; 101-108). Further, it is known in the art that administration by different routes requires specialized formulations and dosages to allow appropriate delivery and activity of the active ingredient(s).
Degree of predictability or unpredictability in the art: The pharmaceutical arts are generally considered unpredictable, requiring detailed clinical studies to demonstrate efficacy of each different drug and formulation thereof. Further, small changes in a given pharmaceutical formulation have the potential to significantly affect the characteristics of the drug delivery and bioavailability in ways that are often not predictable without significant experimentation.
Relative skill possessed by those in the art: The level of skill in the art is high and is at least that of a medical doctor or Ph.D. scientist with several years of experience in the field(s) of drug formulation, the design of drug delivery systems, and pharmaceutics.
Presence of working examples/Amount of guidance or direction provided: No working examples, guidance, or direction were provided for treatment of tinnitus by any route other than intranasal administration.
Quantity of experimentation required to make and use the invention: In view of the state of the art with regard to treating tinnitus with oxytocin, the complexity and unpredictability of formulating a given drug to treat a specific condition, and the absence of working examples, the skilled artisan would have been required to undertake undue experimentation to determine the exact conditions and manner and/or process of execution to arrive at those conditions and dosages allowing treatment of tinnitus by administering oxytocin by any route other than intranasally. In the absence of detailed guidance to this effect, and absent direction or discussion as to how the skilled artisan would go about practicing the claimed method, one of ordinary skill in the art would have no alternative recourse but to undertake an exhaustive, and, thus, unduly burdensome search of conditions and dosages to practice the claimed method.
Claim Rejections - 35 USC § 112(b) or (pre-AIA ) 35 USC § 112 (2nd Par.)
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.
Claims 6, 15, 18, and 51 are 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 pre-AIA the applicant regards as the invention.
The claims are indefinite in the recitation "said thickener having a viscosity of from 4,000 to 12,000 cps". First, viscosity depends on a variety of factors, including the temperature, pressure, concentration of the thickener (e.g., a mucoadhesive polymer), and the nature and amount of other compounds (e.g., solutes) in the fluid (e.g., solution) in question. Since the claim fails to specify any of these parameters, it is indefinite for this reason alone. Second, intranasal formulations are typically characterized by their viscosity overall, not the viscosity of individual components. The viscosity of an individual thickening component, without also specifying the amount or concentration thereof, is a relatively meaningless way to describe a formulation containing a thickener. Third, thickening agents (e.g., mucoadhesive polymers such as chitosan, polyacrylic acid, etc.) are solids, and do not inherently have a viscosity per se. Rather, they must be dissolved in a solvent (usually water) in order to measure the viscosity of the solution, which varies with the concentration of the dissolved polymer (and the claim fails to specify the concentration). Thus, it is not clear if the intent of the claim is to require a thickener that is inherently a liquid (i.e., to the exclusion of solid thickeners dissolved in water) or something else. In light of these factors, the claim overall is indefinite.
For the purposes of this Office Action, this term/phrase will be interpreted to be met by any thickening agent (solid or liquid) that could have the claimed viscosity when dissolved in water under any conditions (e.g., any concentration, temperature, pressure, etc.).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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, 8-13, and 48-50 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over AZEVEDO (Azevedo, A. A., et al. Front. Neurol. (2017), 8; article 494; 1-7; on IDS) in view of PEDERSEN (US 2013/0085106; Pub. Apr. 4, 2013; on IDS).
This rejection addresses the embodiments in which the administration is intranasal.
Azevedo discloses tinnitus treatment by administering intranasal oxytocin (title; abstract; Introduction; Experimental Procedure). Azevedo reports a significant reduction in tinnitus using this method (abstract; Results, Discussion). The dose of oxytocin administered in in Azevedo’s studies was 4 oxytocin IU per nostril two times per day, for a total daily dose of 16 IU (Experimental Procedure). Thus, Azevedo differs from the instant claims by using a lower dosage than that claimed.
Pedersen discloses methods and formulations for treatment of various medical disorders with intranasal oxytocin (title; abstract). Intranasal administration is taught to be particularly advantageous as it is non-invasive and facilitates self-administration outside of a clinical setting (abstract; [0021], [0120]). Pedersen teaches any suitable dosage of oxytocin can be administered to give the desired response. Dosages of pharmaceutically active compounds can be determined by methods known in the art. Specifically, the dosage of oxytocin ranges from at least about 0.05 international units (IU) of oxytocin to less than about 1000 IU of oxytocin for a typical (i.e., 70 kg) human subject. See [0109]. Pedersen specifically exemplifies a dosage regimen where 24 IU oxytocin is insufflated intranasally 6 times (alternating between nostrils), for a total of 144 IU oxytocin ([0163], [0182]), which may be repeated twice daily, for a total of 288 IU oxytocin ([0255]).
In light of these teachings, 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 treat tinnitus by administering an intranasal dose within the instantly claimed range. One would have been motivated to do so since Azevedo teaches intranasal oxytocin can reduce tinnitus and since the claimed dosages overlap with known dosages for intranasal oxytocin. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claim 4, Azevedo teaches delivery 4 times (Experimental Procedure). Moreover, a range can be disclosed in multiple prior art references instead of in a single prior art reference. See MPEP § 2144.05(I). Pedersen teaches intranasal administration of oxytocin up to 6 times daily ([0163], [0182], [0283]).
Regarding claim 5, the prior art renders obvious the dosages and number of administrations as discussed above. It is within the skill of an artisan in this field to determine how to divide the dose to deliver the proper total amount.
Applicants are advised that should claim 1 be found allowable, claim 52 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).
Claims 1-6, 8-20, and 48-52 are rejected under 35 U.S.C. 103 as being unpatentable over AZEVEDO (Azevedo, A. A., et al. Front. Neurol. (2017), 8; article 494; 1-7) in view of PEDERSEN (US 2013/0085106; Pub. Apr. 4, 2013; on IDS), BALAKRISHNAN (Balakrishnan, P., et al. Molecules (2015), 20; 4124-4135), optionally as evidenced by Carbopol 934P Product Specification.
The teachings of Azevedo and Pedersen are presented supra, and are incorporated herein. Pedersen teaches the formulations may contain thickening agents ([0150]), but does not expressly state that such are mucoadhesive polymers or teach the viscosity of the agents.
Balakrishnan reports on thermoreversible gel formulations for intranasal drug delivery (title; abstract). Balakrishnan teaches that thermoreversible gels would improve intranasal drug delivery since it remains a liquid at room temperature and gels at body temperature (p. 4125). Balakrishnan teaches Carbopol is a thickener and mucoadhesive polymer used in intranasal formulations (p. 4126). Balakrishnan teaches a thermoreversible gel comprising Carbopol 934P (C934P), which has a viscosity that overlaps that recited in claim 6 (Fig. 1). See also the Carbopol 934P Product Specification, which lists the viscosity of Carbopol 934P as overlapping that claimed.
In light of these teachings, 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 use a thickener such as Carbopol 934P having a viscosity and in an amount within the instantly claimed ranges. One would have been motivated to do so to prepare a thermoreversible gel for improved intranasal drug delivery. Moreover, it is within the skill of the ordinary artisan to adjust the amounts of the thickener to prepare a formulation having the desired properties for intranasal delivery.
Regarding claims 17-20, the amount of drug is a result effective variable that must be determined based on a variety of factors including the age, body weight, and health of the patient, the condition(s) to be treated and their severity, the route(s) of administration, the particular drug(s) used, adverse drug effects or toxicity, clinical response to treatment, etc., and is routinely optimized by the skilled artisan. Applicants are advised that recitation of dosages, without more, is generally insufficient to patentably distinguish over the prior art. Further, Pedersen teaches dosage of oxytocin ranges from at least about 0.05 international units (IU) of oxytocin to less than about 1000 IU of oxytocin for a typical (e.g., 70 kg) human subject ([0109]). Pedersen also teaches the concentration of the active compound(s) in the pharmaceutical formulations can vary widely, e.g., from less than about 0.01% or 0.1% up to at least about 2% to as much as 20% to 50% or more by weight, and will be selected primarily by fluid volumes, viscosities, etc. ([0132]). Pedersen teaches spray vials designed to deliver 0.1 ml metered doses per insufflation ([0163]). Thus, one of skill in the art could determine the appropriate concentration of oxytocin per ml in light of the guidance provided by Azevedo and Pedersen.
Claims 1-5, 7-13, and 48-52 are rejected under 35 U.S.C. 103 as being unpatentable over AZEVEDO (Azevedo, A. A., et al. Front. Nerurol. (2017), 8; article 494; 1-7; on IDS) in view of PEDERSEN (US 2013/0085106; Pub. Apr. 4, 2013; on IDS) and YEOMANS (US 2012/0322736; Dec. 20, 2012).
The teachings of Azevedo and Pedersen are presented supra, and are incorporated herein. Pedersen teaches headaches are associated with the conditions described as treatable with oxytocin ([0007], [0088]), but does not expressly teach treatment of migraines.
Yeomans discloses treatment of headaches, including migraines with intranasal oxytocin (title; abstract; [0002], [0022]). The amount of oxytocin administered as a unit dose depends upon the specific formulation, but can be about 0.1-150 IU ([0094], [0097], [0099]), which can be delivered in multiple doses (e.g., up to ten times daily) ([0098]).
In light of these teachings, 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 treat a patient having tinnitus and/or migraine headache by administering intranasal oxytocin. One would have been motivated to do so, and would have had a high expectation of success since oxytocin was known to treat both tinnitus and migraines in the prior art.
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 obviousness-type 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); and 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
US Patent Application 19/299,582
Claims 1-20 and 48-52 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-20 of copending Application 19/299,582 in view of RENZE (Renze, M. Int. Tinnitus J. (2017), 21(1); 74-75). Although the conflicting claims are not identical, they are not patentably distinct from each other because the scope of the '582 claims renders obvious that of the instant claims.
The difference between the two claim sets is that the '582 claims recite a method of treating visual snow syndrome by intranasally administering the same amount of oxytocin as instantly claimed. However, Renze teaches ~63% of patients with visual snow syndrome (VSS) also suffer from tinnitus, and that VSS may be related to other sensory processing disorders like tinnitus via a common pathophysiological mechanism (abstract; p. 75). Thus, 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 treated either tinnitus or VSS with intranasal oxytocin, and the '582 claims recite an obvious variation of the instant claims.
Conclusion
Claims 1-20 and 48-52 are rejected. No claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kevin S Orwig whose telephone number is (571)270-5869. The examiner can normally be reached Mon.-Fri. 8AM-5PM.
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/Kevin S Orwig/Patent Reexamination Specialist, Art Unit 3991
Conferees:
/LBD/Patent Reexamination Specialist, Art Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991
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