DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
The instant claims 1,4-11 and 14-24 are granted the benefit of priority 12/3/20 as the viral infections limitations of the instant claims are not described in the disclosures of the parent applications.
Claims and Previous Objections/Rejections Status
Claims 1,4-11 and 14-24 are pending in the application.
Any objections and/or rejections from previous office actions that have not been reiterated in
this office action are obviated.
Response to Arguments
Applicant’s arguments, see REMARKS, filed 3/26/26, with respect to the rejection(s) of claim(s) 1,4-11 and 14-24 under 35 U.S.C. 103(a) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Cohen et al. (US 2015/0017099A1) in view of Prendergast (WO2007/052242A1), Engels et al. (US 1,741,761) and Seeler et al. (J. Infect. Diseases, Sep.-Oct., 1946, Vol 79, No. 2, pp.156-158) and in further view of Altmeyer et al. (US 2011/0201665A1) and Desrosiers et al. (Otolaryngology-Head and Neck Surgery September 2001, p265-269).
New Grounds of Rejection
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1,4-11 and 14-24 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable
over Cohen et al. (US 2015/0017099A1) in view of Prendergast (WO2007/052242A1), Engels et al. (US 1,741,761) and Seeler et al. (J. Infect. Diseases, Sep.-Oct., 1946, Vol 79, No. 2, pp.156-158) and in further view of Altmeyer et al. (US 2011/0201665A1) and Desrosiers et al. (Otolaryngology-Head and Neck
Surgery September 2001, p265-269).
Cohen et al. (US 2015/0017099A1) discloses the methods for treatment of respiratory tract
infections, especially upper respiratory tract, by administering a composition comprising a bitter receptor agonist in a pharmaceutically acceptable carrier to the respiratory tract (abstract; p1, [0011-
0012]; p5, [0069]; p7, [0093]; claims 1 and 14) that encompasses the method of treating a viral infection in a subject having an upper respiratory infection of the instant claims.
The upper respiratory tract encompasses the upper respiratory tract of the instant claims.
The preferred composition comprising the bitter tase agonists are topical compositions that are administered by direct or indirect means to the upper respiratory tract via nasal sprays, nasal lavage, inhalers via atomization or spraying (p7, [0090],[0093]; claim 10) that encompasses dispersing the bitter taste agonist to the mucosal surface of an upper respiratory cavity of the subject of the instant claims.
The nasal sprays, nasal lavage, inhalers, etc. encompass the nasal delivery devices of the instant claims.
The method comprises administering the bitter receptor agonist (e.g. quinine) that stimulates
an innate microbial response (i.e. antimicrobial activity to produce peptides) in the respiratory tract of a subject (p2, [0019]; p6, [0070],[0072],[0080]; p7, [0083],[0094]) or stimulating nitric oxide (NO) production in sinonasal epithelial cells of the subject, thereby treating the respiratory infection and associated disease or disorder (p2, [0021-0022],[0024]; p6, [0079]; p12, [0138]; p22, [0223]).
The quinine encompasses the quinine of the instant claims.
The NO production encompasses the NO production of the instant claims.
The stimulation of an innate microbial response (i.e. antimicrobial activity to produce peptides)
encompasses the stimulation of an antimicrobial peptide production of the instant claims.
The quinine may be administered as any variety of physiologically acceptable salt form (p12,
[0142]), not excluding quinine sulfate dihydrate.
The T2R38 is shown to express at the apical membrane and cilia of sinonasal airway epithelial cells in primary human sinonasal airway liquid interface (ALI) cultures (p3, [0056]) that encompasses differentiating the sinonasal epithelial cells of the instant claims.
Cohen et al. further discloses that bitter taste receptor agonists denatonium and absinthin were
used to stimulate antimicrobial activity in sinonasal cell cultures to kill both Pseudomonas aeruginosa and MRSA (FIG. 5). The kill assay applies ASL from cultures treated with 50% PBS alone (unstimulated), 10 mM denatonium, and 300 µM absinthin. Airway surface liquid was tested against both Pseudomonas aeruginosa and MRSA. PBS, denatonium, and absinthin solutions alone had no effect on Pseudomonas or MRSA growth (not shown). No growth (0 CFUs) was observed when bacteria were mixed with airway surface liquid from cultures stimulated with denatonium or absinthin.
Other bitter tase agonists include denatonium benzoate, homoserine lactone, PTC, etc. (p6,
[0072]; p7, [0084],[0086]). The denatonium benzoate, homoserine lactone and PTC encompass the
denatonium benzoate, homoserine lactone and PTC of the instant claims.
The composition is used as a weekly treatment and may be administered as a single dose, two
consecutive doses or in repeat administrations (p8-9, [0094]; p12, [0142]) that encompasses repeating the dispersing and applying steps three times per day continued for four weeks of the instant claims.
Cohen et al. does not disclose the viral infections are those of the instant claims.
Prendergast (WO2007/052242A1) discloses the method for the treatment of viral infection wild type A Influenza using a camelid heavy chain antibody and quinine sulfate (abstract; p10, lines 14-19; p11, lines 4-8; 12, lines 11-15; claims 32,35).
Engels et al. (US 1,741,761) discloses that quinine bisalicylosalicylate is used for the treatment of influenza (p1, left column, lines 27-31).
Seeler et al. (J. Infect. Diseases, Sep.-Oct., 1946, Vol 79, No. 2, pp.156-158) discloses that quinine sulfate appears to have an effect on the course of influenza (p156, left column, second paragraph; Table 2; p158, Summary).
At the time of the invention it would have been obvious to one of ordinary skill in the art that quinine sulfate is effective for treating influenza A with a reasonable expectation of success as Prendergast, Engels et al. and Seeler et al. teach of the use of quinine for the method of
treating influenza, such as Influenza A.
Cohen et al. does not explicitly disclose reducing vial load.
Altmeyer et al. (US 2011/0201665A1) discloses a method for treating viral infections (e.g. an infection caused by an influenza virus) wherein treating is generally meant to measurably slow or stop the replication of a virus or to measurably decrease the load of a virus in a cell (abstract; p3, [0029]). The slow in replication or decrease in viral load is at least 90%,95% or 99% as determined by using a suitable
assay as compared to in the absence of agent (p3, [0029]).
At the time of the invention it would have been obvious to one of ordinary skill in the art that
Cohen et al. envisioned reducing the viral load as Cohen et al. teaches of the administration of bitter taste receptor agonists to kill both the Pseudomas and MRSA bacteria until they are undetectable and therefore, the purpose of the treatment method of Cohen et al. is the reduction of an infection that extends to viral or bacterial infections with a reasonable expectation of success.
Altmeyer et al. teaches of treating viral infections and measuring the decrease the load of a virus in a cell by administering an agent and comparing the load in the absence of the agent. Therefore, it would have been predictable to one of ordinary skill in the art to examine/detect the decrease in the viral load via the method of treating of Cohen et al. to determine the diminishment of the extent of a viral infection of the upper respiratory tract. The determination of the decrease in the vial load of the viral infection encompasses the method of detecting viral infection of nasal epithelium of the instant claims.
Therefore, Cohen utilized airway surface liquid tests to detect infections and the purpose of the treatment of Cohen is the reduction of an infection, such as a decrease in the bacteria via stimulating or enhancing the secretion of the body’s microbial defense as a therapeutic strategy for the upper respiratory tract that predictably extends to viral and/or bacterial infections with a reasonable expectation of success.
Although Cohen et al. doesn’t exemplify reducing the viral load of a viral infection, each bitter taste receptor agonist of Cohen et al. does not need to be exemplified against every viral infection.
Cohen et al. does not disclose the quinine sulfate solution is formulated at a concentration of 1 mg/ml.
Desrosiers et al. (Otolaryngology-Head and Neck Surgery September 2001, p265-269) discloses quinine aerosol solutions of 1 mg/mL for administration to the nasal passages for the examination of the treatment of rhinosinusitis (abstract; p267, left column, first full paragraph).
At the time of the invention it would have been obvious and/or predictable to one of ordinary
skill in the art to administer quinine at various concentrations, such as 0.1 mg/ml via the aerosol to the
nasal passage to determine the effective dose for the method of treating an upper respiratory infection by stimulating of nasal epithelium cells as quinine aerosol solutions of 1 mg/mL is known in the prior art of Desrosiers et al.
Furthermore, it is obvious to vary and/or optimize the amount of quinine provided in the composition, according to the guidance provided by Cohen et al. to provide a composition having the desired properties such as the stimulation of nasal epithelium cells and stimulation of NO production. It is noted that “[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).
Applicant’s assertions with regards to Duan are moot as the references is not used in the instant rejection.
Applicant asserts that Pseudomonas and MRSA are both bacterial, and not viral and a skilled artisan will appreciate that the treatment of bacterial and viral organisms are not interchangeable due to the fundamental biological differences between them.
The reference of Cohen et al. envisioned reducing the viral load via administration of bitter taste receptor agonists to kill both the Pseudomas and MRSA bacteria until they are undetectable and therefore, the purpose of the treatment method of Cohen et al. is the reduction of an infection via stimulating or enhancing the secretion of the body’s microbial defense as a therapeutic strategy for the upper respiratory tract that predictably extends to viral and/or bacterial infections with a reasonable expectation of success.
Applicant asserts that Altmeyer does not disclose the reduction in viral infection consequent to
dispersing as particulate a formulation of a bitter taste receptor agonist and applying the dispersed formulation onto the mucosal surface of an upper respiratory cavity of the subject, and at best, Altmeyer provides an alleged method of measuring viral content. Applicants submit while Altmeyer might teach methods of measuring viral content, Altmeyer does not provide teach or suggest a method of reducing viral load with the claimed methods. Applicants accordingly submit that Altmeyer does not provide a skilled artisan with a reasonable expectation of successfully reducing a viral load through the claimed methods of dispersing as particulate a formulation of a bitter taste receptor agonist and applying the dispersed formulation onto the mucosal surface of an upper respiratory cavity of a subject with an upper respiratory viral infection. Cohen and Altmeyer do not teach or suggest a method of detecting viral infection, whatsoever and accordingly do not provide the skilled artisan with a reasonable expectation of obtaining a method to successfully detect viral infections.
The reference of Altmeyer was not used to teach of a method of reducing viral load of the claimed method but was used to teach that the purpose of treating viral infections is measuring the decrease of the load of a virus in a cell by administering an agent and comparing the load in the absence of the agent. Therefore, it would have been predictable to one of ordinary skill in the art to examine/detect the decrease in the viral load via the method of treating of Cohen et al. to determine the diminishment of the extent of a viral infection of the upper respiratory tract.
The reference of Cohen teaches that bitter taste receptor agonists denatonium and absinthin were used to stimulate antimicrobial activity in sinonasal cell cultures to kill both Pseudomonas aeruginosa and MRSA. The kill assay applies ASL from cultures treated with 50% PBS alone (unstimulated), 10 mM denatonium, and 300 µM absinthin. Airway surface liquid was tested against both Pseudomonas aeruginosa and MRSA. PBS, denatonium, and absinthin solutions alone had no effect on Pseudomonas or MRSA growth (not shown). No growth (0 CFUs) was observed when bacteria were mixed with airway surface liquid from cultures stimulated with denatonium or absinthin.
Therefore, Cohen utilized airway surface liquid tests to detect infections and the purpose of the treatment of Cohen is the reduction of an infection via stimulating or enhancing the secretion of the body’s microbial defense as a therapeutic strategy for the upper respiratory tract that predictably
extends to viral and/or bacterial infections with a reasonable expectation of success.
Applicant asserts that Altmeyer merely states that “the decrease in viral load, or reduction in the symptoms is at least 20%,30%,50%,70%,80%,90%,95% or 99%, as determined using a suitable assay. Altmeyer is in fact silent on methods of detecting viral infections of the nasal epithelium whatsoever, let alone methods of detecting viral infections of nasal epithelium using an air-liquid interface.
The reference of Altmeyer was used to teach that the purpose of treating viral infections (e.g. an infection caused by an influenza virus) is to measurably slow or stop the replication of a virus or to measurably decrease the load of a virus in a cell wherein the slow in replication or decrease in viral load is at least 90%,95% or 99% as determined by using a suitable assay as compared to in the absence of agent which can be applied to the method of Cohen with a reasonable expectation of success as they are drawn to analogous purposes of treating viral infections.
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 10,11,15-19 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6,8,10 and 14 of U.S. Patent No. 10,881,698B2 in view of Cohen et al. (US 2015/0017099A1) and Altmeyer et al. (US 2011/0201665A1).
The method of treating an upper respiratory infection of U.S. Patent No. 10,881,698B2 is analogous to the method of treating an upper respiratory infection of the instant claims as they both
comprise administering a bitter taste receptor agonist, such as quinine to a subject via inhalation using a spray, nebulae, etc.
The quinine of U.S. Patent No. 10,881,698B2 and the quinine of the instant claims have the
same properties and are capable of the same functions, such as cause bitter taste receptor signaling
resulting in NO production or stimulating antimicrobial peptide production.
U.S. Patent No. 10,881,698B2 does not disclose reducing the viral load of the instant claims.
Cohen et al. (US 2015/0017099A1) discloses the methods for treatment of respiratory tract infections, especially upper respiratory tract, by administering a composition comprising a bitter receptor agonist in a pharmaceutically acceptable carrier to the respiratory tract as well as that stated above.
Altmeyer et al. (US 2011/0201665A1) discloses a method for treating viral infections (e.g. an infection caused by an influenza virus) wherein treating is generally meant to measurably slow or stop the replication of a virus or to measurably decrease the load of a virus in a cell as well as that stated above.
At the time of the invention it would have been obvious to one of ordinary skill in the art that the method of treating an upper respiratory infection of U.S. Patent No. 10,881,698B2 reduces the viral load of an upper respiratory tract infection as Cohen et al. envisioned reducing the viral load via the administration of bitter taste receptor agonists (quinine, homoserine lactone, etc.) to kill both the Pseudomas and MRSA bacteria until they are undetectable and Altmeyer et al. teaches of treating viral infections and measuring the decrease the load of a virus in a cell by administering an agent and comparing the load in the absence of the agent. Therefore, it would have been predictable to one of ordinary skill in the art to examine the decrease in the viral load via the method of treating an upper respiratory infection of U.S. Patent No. 10,881,698B2 to determine growth or killing of the virus bacteria and ultimately the efficacy of the treatment.
U.S. Patent No. 10,881,698B2 does not disclose repeating three times per day using a nasal delivery device for four weeks.
Cohen et al. further discloses that the preferred composition comprising the bitter tase agonists are topical compositions that are administered by direct or indirect means to the upper respiratory tract via nasal sprays, nasal lavage, inhalers via atomization or spraying. The composition is used as a weekly treatment and may be administered as a single dose, two consecutive doses or in repeat administrations.
At the time of the invention it would have been obvious to one of ordinary skill in the art that to administer the bitter taste receptor agonist used for the method of treating an upper respiratory infection of U.S. Patent No. 10,881,698B2 via nasal sprays, nasal lavage, inhalers for the advantage of administration to the upper respiratory tract and consecutive doses and/or in repeat administrations for effective treatment as taught by Cohen et al.
U.S. Patent No. 10,881,698B2 does not disclose the method of detecting viral infection of nasal epithelium using an air-liquid interface of the instant claims 10 and 11.
Cohen et al. further discloses that bitter taste receptor agonists denatonium and absinthin were used to stimulate antimicrobial activity in sinonasal cell cultures to kill both Pseudomonas aeruginosa and MRSA (FIG. 5). The kill assay applies ASL from cultures treated with 50% PBS alone (unstimulated), 10 mM denatonium, and 300 µM absinthin. Airway surface liquid was tested against both Pseudomonas aeruginosa and MRSA. PBS, denatonium, and absinthin solutions alone had no effect on Pseudomonas or MRSA growth (not shown). No growth (0 CFUs) was observed when bacteria were mixed with airway surface liquid from cultures stimulated with denatonium or absinthin.
At the time of the invention it would have been obvious to one of ordinary skill in the art that to examine the bitter taste receptor agonist used for the method of treating an upper respiratory infection of U.S. Patent No. 10,881,698B2 via the airway surface liquid testing method of Cohen to determine the growth or killing of the virus bacteria and ultimately the efficacy of the treatment.
Claims 10,11,15-19 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1,7-11,15,37,38 and 41 of copending Application No. 17/111,158 in view of Cohen et al. (US 2015/0017099A1) and Altmeyer et al. (US 2011/0201665A1).
The method of treating an upper respiratory infection of copending Application No. 17/111,158
is analogous to the method of treating an upper respiratory infection of the instant claims as they both
comprise administering a bitter taste receptor agonist quinine to a subject via inhalation using a spray, nebulae, etc.
The quinine of copending Application No. 17/111,158 and the quinine of the instant claims have
the same properties and are capable of the same functions, such as cause bitter taste receptor signaling
resulting in NO production or stimulating antimicrobial peptide production.
Copending Application No. 17/111,158 does not disclose the not disclose reducing the viral load of the instant claims.
Cohen et al. (US 2015/0017099A1) discloses the methods for treatment of respiratory tract infections, especially upper respiratory tract, by administering a composition comprising a bitter receptor agonist in a pharmaceutically acceptable carrier to the respiratory tract as well as that stated above.
Altmeyer et al. (US 2011/0201665A1) discloses a method for treating viral infections (e.g. an
infection caused by an influenza virus) wherein treating is generally meant to measurably slow or stop the replication of a virus or to measurably decrease the load of a virus in a cell as well as that stated above.
At the time of the invention it would have been obvious to one of ordinary skill in the art that the method of treating an upper respiratory infection of copending Application No. 17/111,158 reduces the viral load of an upper respiratory tract infection as Cohen et al. envisioned reducing the viral load via the administration of bitter taste receptor agonists (quinine, homoserine lactone, etc.) to kill both the Pseudomas and MRSA bacteria until they are undetectable and Altmeyer et al. teaches of treating viral infections and measuring the decrease the load of a virus in a cell by administering an agent and comparing the load in the absence of the agent. Therefore, it would have been predictable to one of ordinary skill in the art to examine the decrease in the viral load via the method of treating an upper respiratory infection of copending Application No. 17/111,158 to determine the growth or killing of the virus bacteria and ultimately the efficacy of the treatment.
Copending Application No. 17/111,158 does not disclose repeating three times per day using a nasal delivery device for four weeks.
Cohen et al. further discloses that the preferred composition comprising the bitter tase agonists are topical compositions that are administered by direct or indirect means to the upper respiratory tract via nasal sprays, nasal lavage, inhalers via atomization or spraying. The composition is used as a weekly treatment and may be administered as a single dose, two consecutive doses or in repeat administrations.
At the time of the invention it would have been obvious to one of ordinary skill in the art that to administer the bitter taste receptor agonist used for the method of treating an upper respiratory infection of copending Application No. 17/111,158 via nasal sprays, nasal lavage, inhalers for the advantage of administration to the upper respiratory tract and consecutive doses and/or in repeat
administrations for effective treatment as taught by Cohen et al.
Copending Application No. 17/111,158 does not disclose the method of detecting viral infection of nasal epithelium using an air-liquid interface of the instant claims 10 and 11.
Cohen et al. further discloses that bitter taste receptor agonists denatonium and absinthin were used to stimulate antimicrobial activity in sinonasal cell cultures to kill both Pseudomonas aeruginosa and MRSA (FIG. 5). The kill assay applies ASL from cultures treated with 50% PBS alone (unstimulated), 10 mM denatonium, and 300 µM absinthin. Airway surface liquid was tested against both Pseudomonas aeruginosa and MRSA. PBS, denatonium, and absinthin solutions alone had no effect on Pseudomonas or MRSA growth (not shown). No growth (0 CFUs) was observed when bacteria were mixed with airway surface liquid from cultures stimulated with denatonium or absinthin.
At the time of the invention it would have been obvious to one of ordinary skill in the art that to examine the bitter taste receptor agonist used for the method of treating an upper respiratory infection of copending Application No. 17/111,158 via the airway surface liquid testing method of Cohen to determine the growth or killing of the virus bacteria and ultimately the efficacy of the treatment.
This is a provisional nonstatutory double patenting rejection.
Claims 1,4-11 and 14-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-19 of copending Application No. 17/996,853 in view of Altmeyer et al. (US 2011/0201665A1). The method of treating a viral infection in a subject having an upper respiratory infection of copending Application No. 17/996,853 comprises analogous method steps as the method of treating a viral infection in a subject having an upper respiratory viral infection of the instant claims.
The method of detecting viral infection of nasal epithelium using an air-liquid interface of copending Application No. 17/996,853 comprises analogous method steps as the method of detecting
viral infection of nasal epithelium using an air-liquid interface of the instant claims.
The bitter taste receptor agonists, such as quinine sulfate of copending Application No. 17/996,853 that generates NO production or stimulate antimicrobial peptide production that encompass the bitter taste receptor agonists, such as quinine sulfate that generates NO production or stimulate antimicrobial peptide production of the instant claims.
The viral infections, such as SARS-CoV-2 and influenza A of copending Application No. 17/996,853 encompass the viral infections, such as SARS-CoV-2 and influenza A, respectively of the instant claims.
The concentration of between 0.5 mg/ml and 1 mg/ml of bitter taste receptor agonists of copending Application No. 17/996,853 encompasses the 1 mg/ml of bitter taste receptor agonists of the instant claims.
The administration of the bitter taste receptor agonists via nasal delivery regimen of repeating three times a day for four weeks of copending Application No. 17/996,853 encompasses the administration of the bitter taste receptor agonists via nasal delivery regimen of repeating up to three times a day for up to four weeks of the instant claims.
Copending Application No. 17/996,853 does not disclose the not disclose reducing the viral load of the instant claims.
Altmeyer et al. (US 2011/0201665A1) discloses a method for treating viral infections (e.g. an infection caused by an influenza virus) wherein treating is generally meant to measurably slow or stop the replication of a virus or to measurably decrease the load of a virus in a cell as well as that stated above.
At the time of the invention it would have been obvious to one of ordinary skill in the art that to reduce the viral load in the upper respiratory tract as Altmeyer et al. teaches of treating viral infections and measuring the decrease the load of a virus in a cell by administering an agent and comparing the load in the absence of the agent. Therefore, it would have been predictable to one of ordinary skill in the art to examine the decrease in the viral load via the method of treating an upper respiratory infection of copending Application No. 17/996,853 to determine the growth or killing of the virus bacteria and ultimately the efficacy of the treatment.
This is a provisional nonstatutory double patenting rejection.
Applicants respectfully request that these rejections be held in abeyance because no claims have been allowed in the current application.
The rejections are maintained and not held in abeyance at this time.
Conclusion
No claims are allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA JEAN PERREIRA whose telephone number is (571)272-1354. The examiner can normally be reached M9-3, T9-3, W9-3, Th9-2, F9-2.
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/MELISSA J PERREIRA/ Examiner, Art Unit 1618
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