DETAILED ACTION
Status of Claims
The amendment submitted January 6, 2026 has been entered.
Claims 1, 5-16, 24-25, and 30-34 are pending and under consideration.
Claims 2-4, 26, and 29 are cancelled by Applicant.
Claims 30-34 are new.
Claims 1, 5-16, 24-25, and 30-34 are under consideration in the instant office action as explained below in the Election/Restriction section
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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 5-16 and 24-25 drawn to a method of treating rhinosinusitis in a subject in the reply filed on January 6, 2026 is acknowledged.
New claims 30-34 are also drawn towards a method of treating rhinosinusitis and depend on claim 1; therefore, are also elected.
The examiner notes that Claims 2-4, 26, and 29 comprising Groups II-IV are presently cancelled by Applicant.
Therefore, claims 1, 5-16, 24-25, and 30-34 are under consideration and the subject of this Office Action.
Information Disclosure Statement
Ten information disclosure statements (IDS) submitted on February 8, 2023; March 6, 2023; February 2, 2024; May 16, 2024; July 24, 2024; August 15, 2024; November 26, 2024; June 12, 2025; September 17, 2025; January 6, 2026 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to because Figure 5 is fuzzy and the axis labels are illegible and similarly, Figures 6A and 6B are also fuzzy and axis labels hard to read.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Abstract Objections
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because the abstract is less than 50 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5 and 30-34 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Bleier (US-PGPUB 2017/0348384 A1).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 1, Bleier teaches the method of claim 1 for “treating rhinosinusitis in a subject, the method comprising: identifying a subject having rhinosinusitis; and administering to the subject an effective amount of verapamil and mometasone.”
Specifically, claims 1, 3, and 21-22 of Bleier teaches “A method of treating rhinosinusitis in a subject, the method comprising
identifying a subject having rhinosinusitis;
administering to the subject an effective amount of a P-glycoprotein inhibitor,” and “wherein the P-glycoprotein inhibitor is R-verapamil,” “wherein the P-glycoprotein inhibitor is administered in combination with one or both of a corticosteroid and an antibiotic,” and “wherein the corticosteroid is selected from…mometasone.”
At page 1, paragraph [0009] of Bleier also teaches “In one aspect, a subject with rhinosinusitis is treated with a P-gp inhibitor in an amount sufficient to inhibit P-gp expression and/or activity. The P-gp inhibitor could be a first-generation compound, e.g. verapamil, cyclosporin A, anti-hypertensive, reserpine, quinidine or yohimbine, tamoxifen, or toremifena. Preferably, the P-gp inhibitor is a second or third generation compound, e.g. PSC 833, R-verapamil, VX-710, GF120918, MS-209, R101933, LY335979, OC144093, XR9051, or XR9576.”
Additionally, for combination therapy, at page 1, paragraph [0016], Bleier teaches “In some embodiments, the P-glycoprotein inhibitor is administered in combination with one of both of a corticosteroid and/or an antibiotic. The corticosteroid can be, e.g., selected from dexamethasone, prednisone, prednisolone, triamcinolone, cortisol, budesonide, mometasone, fluticasone, flunisolide, and betamethasone.”
Consequently, Bleier teaches combination therapy using the identical P-gp inhibitor and corticosteroid combination as instant invention, including in combination with an antibiotic.
As per MPEP 2131.02, “A genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990).”
Regarding claim 5, Bleier teaches “wherein the subject has chronic rhinosinusitis or CRS with nasal polyps.”
Specifically, Bleier teaches as per claim 2 “wherein the subject has chronic rhinosinusitis.”
Bleier additionally teaches subjects as per page 1, paragraph [0013] “In some embodiments, when a subject with rhinosinusitis has nasal polyps, surgical removal of such nasal polyps can be performed in addition to administration of a P-gp inhibitor to the subject. Thus, a subject with rhinosinusitis may undergo both surgery and treatment with a P-gp inhibitor,” and page 1, paragraph [0015], “In some embodiments, a subject continues to experience symptoms of chronic sinusitis after a sinus surgery, and a P-gp inhibitor-eluting implant, stent, or spacer is used to maintain sinus patency in the subject.”
Consequently, Bleier teaches the identical patient population as instant invention.
Regarding claims 30-34, Bleier teaches “wherein the subject having rhinosinusitis was identified by endoscopy or computed tomography,” “wherein the subject having rhinosinusitis was identified by observing the subject's symptoms and duration of symptoms, “further comprising monitoring the efficacy of the treatment,” “wherein monitoring the efficacy of treatment comprises using endoscopy or computed tomography,” and “wherein monitoring the efficacy of treatment comprises observing the subject's symptoms and duration of symptoms.”
In the abstract, Bleier specifically teaches “The subject having rhinosinusitis can be identified by one of skill in the art based on known methods, e.g., based on detection of the presence of symptoms, by endoscopy, or by computed tomography. The efficacy of the treatment can be monitored by methods known in the art, e.g., by monitoring symptoms, by endoscopy or computed tomography.”
Claims 12-17 of Bleier additionally teach “wherein the subject having rhinosinusitis was identified by endoscopy,” “wherein the subject having rhinosinusitis was identified by computed tomography,” “wherein the subject having rhinosinusitis was identified by observing the subject's symptoms and duration of symptoms,” “further comprising monitoring the efficacy of the treatment by endoscopy,” “further comprising monitoring the efficacy of the treatment by computed tomography,” and “further comprising monitoring the efficacy of the treatment by observing the subject's symptoms and duration of symptoms.”
Bleier provides further guidance at page 5, paragraph 70 pertaining subject identification, and monitoring efficacy of treatment: “In some embodiments, a subject having rhinosinusitis is identified and treated by administering to the subject an effective amount of a P-gp inhibitor. The subject having rhinosinusitis may be identified by one of skill in the art based on known methods, e.g., based on detection of the presence of symptoms, by endoscopy, or by computed tomography. The efficacy of the treatment may be monitored by methods known in the art, e.g., by monitoring symptoms, by endoscopy or computed tomography. Improvements of the subject include a better symptom score, e.g. a better SNOT-22 or VAS score; a reduction in inflammation or nasal polyp burden as revealed by endoscopy, e.g. a better Lund-Kennedy score; or a reduction in mucosal thickening or sinus opacification as revealed by computed tomography (CT), e.g. a better Lund-Mackay score.”
Therefore claims 1, 5 and 30-34 are anticipated by Bleier.
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.
Claims 1, 5-16, 24-25 and 30-34 are rejected under 35 U.S.C. 103 as being unpatentable over Bleier (US-PGPUB 2017/0348384 A1).
The teachings of Bleier are applied as set forth above.
As aforementioned, Bleier teaches methods of treatment using the identical combination of verapamil and mometasone.
Bleier does not explicitly teach methods of administration for mometasone; however, does teach methods for verapamil as per instant invention and developing such methods for administration would be obvious and routine for an ordinarily-skilled artisan to optimize the method of treatment based on patient and patient needs.
As per MPEP 2144.05, II. A: Generally, 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).
Regarding claim 6, Bleier teaches similar methods “wherein the verapamil and mometasone are administered systemically.”
At page 6, paragraph [0073], Bleier specifically teaches “In some embodiments, the P-gp inhibitor is administered systemically, e.g., orally, intravenously, intradermally, or subcutaneously.”
As aforementioned, Bleier does not explicitly teach systematically administering mometasone; however, such a method would be routine experimentation to a person of ordinary skill in the art in optimizing the method of treatment.
Regarding claims 7-8, Bleier teaches similar methods “ wherein the verapamil and mometasone are administered locally to the subject's nasal passage and sinuses,” and “wherein the verapamil and mometasone are delivered to the subject's nasal passage and sinuses by nasal irrigation.” As aforementioned, Bleier does not explicitly teach administration for mometasone.
At page 1, paragraphs 11-12 of Bleier specifically teaches “In some embodiments, the P-gp inhibitor is administered systemically. In other embodiments, the P-gp inhibitor is administered locally to the subject's nasal passage and sinuses by an inhalation device, by flushing, spraying, irrigation, nebulization, atomization, or a drug eluting vehicle.”
Regarding claims 14-15, Bleier teaches similar methods “wherein the verapamil and mometasone are administered to the subject as a verapamil and mometasone eluting implant placed in the subject's nasal passage or sinuses,” and “wherein the implant is bioabsorbable.” As aforementioned, Bleier does not explicitly teach administration for mometasone.
Specifically, Claims 10-11 Bleier teach “wherein the P-glycoprotein inhibitor is administered to the subject as a P-glycoprotein inhibitor eluting implant surgically placed in the subject's nasal passage or sinuses,” and “wherein the P-glycoprotein inhibitor eluting implant is bioabsorbable.”
Additionally, page 1, paragraph 15 Bleier teaches “In some embodiments, a subject continues to experience symptoms of chronic sinusitis after a sinus surgery, and a P-gp inhibitor-eluting implant, stent, or spacer is used to maintain sinus patency in the subject. The P-gp inhibitor eluting device can be made from bioabsorbable material so that the implant will be absorbed within a short period of time after the implantation and no surgical removal of the implant is necessary. The P-gp inhibitor eluting device can be in the form of solid, semisolid, gel, polymer, or particle.”
Bleier does not teach the elements of claims 7-13 “wherein the nasal irrigation is high volume, low positive pressure nasal irrigation.”
Regarding claims 24-25, Bleier teaches similar methods “wherein the verapamil and mometasone are administered in combination with an antibiotic,” and “wherein the antibiotic is selected from erythromycin or a pharmaceutically acceptable salt thereof, doxycycline or a pharmaceutically acceptable salt thereof, tetracycline or a pharmaceutically acceptable salt thereof, penicillin or a pharmaceutically acceptable salt thereof, beta-lactam or a pharmaceutically acceptable salt thereof, macrolide or a pharmaceutically acceptable salt thereof, fluoroquinolone or a pharmaceutically acceptable salt thereof, cephalosporin or a pharmaceutically acceptable salt thereof, and sulfonamide or a pharmaceutically acceptable salt thereof.”
Specifically, claims 21 and 23 of Bleier teach “wherein the P-glycoprotein inhibitor is administered in combination with one or both of a corticosteroid and an antibiotic,” and “wherein the antibiotic is selected from erythromycin, doxycycline, tetracycline, penicillin, beta-lactam, macrolide, fluoroquinolone, cephalosporin, and sulfonamide.”
At page 1, Paragraph [0016] of Bleier additionally teaches “In some embodiments, the P-glycoprotein inhibitor is administered in combination with one of both of a corticosteroid and/or an antibiotic. The corticosteroid can be, e.g., selected from dexamethasone, prednisone, prednisolone, triamcinolone, cortisol, budesonide, mometasone, fluticasone, flunisolide, and betamethasone. The antibiotic can be, e.g., selected from erythromycin, doxycycline, tetracycline, penicillin, beta-lactam, macrolide, fluoroquinolone, cephalosporin, and sulfonamide.”
Therefore, it would have been prima facie obvious for one of ordinary skill in the art to have modified the original methods taught by Bleier because Bleier teaches combination therapy using verapamil and mometasone and/or an antibiotic to treat identical patient population using identical methods of diagnosis and monitoring efficacy excepting specific embodiments pertaining mometasone administration.
Consequently, a person of ordinary skill in the art would have been motivated to optimize the administration methods for the combination therapy based on optimizing the treatment plan for the individual patient as is routine in the art of pharmacology. Applicant has additionally failed to provide support demonstrating criticality of the administration methods for instant invention to suggest such administration methods would be non-routine.
Therefore, a person of ordinary skill in the art would have arrived at the instant methods as a predictable result with a reasonable expectation of success based on the beneficial teachings of Bleier.
Therefore, Claims 1, 5-16, 24-25 and 30-34 are rejected as being obvious.
Conclusion
Claims 1, 5-16, 24-25 and 30-34 are under consideration and are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN L. LADD whose telephone number is (703)756-5313. The examiner can normally be reached M-Th, 7:00 am to 5:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H. Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.L.L./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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