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 .
Priority
Application 18/583,611 filed February 21st, 2024 is a continuation of application 17/513,733 filed October 28th, 2021; which is a continuation-in-part of 16/167,108 and 16/167,131 filed October 22nd, 2018.
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 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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Lasser (US 2014/0079810 A1, published March 20th, 2014), in view of Clarot (US 7,597,901 B2, published October 6th, 2009), and in view of Gilbert (WO 2018/057914 A1, published March 29th, 2018)
Lasser teaches a method of treating a nasal allergic condition to a mammal in need comprising administration of zinc. In some embodiments, the composition includes a pharmaceutical carrier such as water or saline (p. 11, para. 0102). The reference teaches treatment may be formulated as an aerosol formulation using an inhaler or nebulizer. [0018]
The difference between the prior art and the instant claims is that Lasser is silent on a dosage of zinc between 1 to 30 mg instantly claimed. Clarot teaches a system for delivering a composition to a nasal membrane comprising ionic zinc (claim 1). In one embodiment, the application dosage ranges between “about 20 to about 100 mg of zinc” (col 11, lines 49-52). The nature of the invention is directed to “allergy relief compositions” (col 1, line 36).
Another difference between the prior art and the instant claims is that Lasser does not teach a composition further comprising probiotics. Gilbert teaches a method of administering a composition to a subject comprising Bifidobacteria (claim 1 and 8), as recited in the instant specification (p. 4, para. 0011). The method is directed towards treating an allergen hypersensitivity or inflammatory condition (p. 1, abstract).
It would have been prima facie obvious for the skilled artisan at the time of filing to arrive at a method of topically administering a composition comprising a probiotic and zinc. The skilled artisan would have been motivated to combine the zinc composition of Lasser with the probiotic composition taught by Gilbert because both a directed to treating non-infective nasal allergies and inflammation.
It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art. Based on the disclosure by these references that probiotics and zinc are useful ingredients in treating nasal allergies and nasal inflammation, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
The skilled artisan would have understood to adjust the amount of zinc in the composition to be between 20 to 100 mg, as taught by Clarot, which overlaps the instant claimed range of 1 to 30 mg. The skilled artisan would have been motivated to do so because of the similar composition and use of Clarot. The skilled artisan would have had a reasonable expectation of success given the working examples of Clarot and Lasser.
Response to Arguments
Applicant's arguments filed 11/26/2025 have been fully considered but they are not persuasive.
Applicant argues Gilbert does not teach intranasal and only mentions in a laundry list with not working examples or specific formulations.
This argument is unpersuasive since the instant claims do not claim any specific formulation. The instant claims are directed to topical nasal administration of a composition comprising zinc (or salt thereof), a probiotic, and aqueous diluent. The claims broadly recite “topically administering to a nasal cavity.”
WO also teaches probiotics for treatment of allergies in a pharmaceutical carrier. The art clearly teaches on page 17: Exemplary routes of administration to the human body can be through space under the arachnoid membrane of the brain or spinal cord (intrathecal), the eyes (ophthalmic), mouth (oral), skin (topical or transdermal), nose (nasal), lungs (inhalant), oral mucosa (buccal), ear, rectal, vaginal, by injection (e.g., intravenously, subcutaneously, intratumorally, intraperitoneally, etc.) and the like.” Note both administration to the nose and lung are taught and topical administration is taught.
Moreover page 31-32 WO teaches:
“Compositions may, for example, be in the form of tablets, resolvable tablets, capsules, bolus, drench, pills sachets, vials, hard or soft capsules, aqueous or oily suspensions, aqueous or oily solutions, emulsions, powders, granules, syrups, elixirs, lozenges, reconstitutable powders, liquid preparations, creams, troches, hard candies, sprays, chewing-gums, creams, salves, jellies, gels, pastes, toothpastes, rinses, dental floss and tooth-picks, liquid aerosols, dry powder formulations, HFA aerosols or organic or inorganic acid addition salts. The pharmaceutical compositions of embodiments of the invention may be in a form suitable for, e.g., rectal, oral, topical, buccal administration. Depending upon the disorder and patient to be treated and the route of administration, the compositions may be administered at varying doses.” Moreover, WO teaches it is within the skill of the ordinary artisan to determine dosage and route of administration based on the therapy needed. See page 18.
WO teaches how to formulate liquid compositions which may be in different forms including aqueous diluents. See page 33. Thus, WO clearly teaches the depending on the desired route, one may formulate the compositions for topical administration along with liquid preparations and liquid aerosols.
In order for applicant to persuasively argue that the prior art is not enabling, applicant must provide some evidence rather than mere assertions that the art only teaches a laundry list and does not exemplify the suggested embodiment. Note MPEP 2121: When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In instant case, applicant has not provided any evidence.
Note MPEP 2123” Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). In instant case, the fact that WO does not exemplify the suggested embodiment is not a teaching away from the broader disclosure. In fact, it is clearly suggested that the liquid compositions may comprise aqueous diluents just as instant claims.
Applicant has not provided any evidence of unobviousness to overcome the rejection of record based on combining two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. MPEPE 2144.06: COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE. Therefore, the rejection is maintained.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Dang (US 2006/0110331 A1, published May 25th, 2006), in view of Kovacs (WO 2009/066262 A1, May 28th, 2009), in view of Osbakken (US 2002/0061281 A1, published May 23rd, 2002), and in view of Clarot (US 7,597,901 B2, published October 6th, 2009) as referenced by Jamalkandi (“Oral and nasal probiotic administration for the prevention and alleviation of allergic diseases, asthma and chronic obstructive pulmonary disease” Nutrition Research Reviews 2021, 34, 1-16, published online on April 13th, 2020).
Dang teaches a composition comprising azelastine in the range of “0.005% to about 5.0% by weight” and a “pharmaceutically acceptable carrier” (claim 1). In some embodiments, the carrier is saline (p. 44, para. 1177) and the azelastine composition is “topically applied to the nasal passage, generally in the form of a nasal spray” (p. 46, para. 1194). In one embodiment, the solution is packaged in a “0.14 mL” volume spray pump and is administered via “two sprays…to each nostril two times per day” (p. 50, para. 1254). This embodiment delivers a total volume of 1.2 mL of the composition. Assuming a density near unity, this would correspond to a range of azelastine between 60 to 60,000 μg. Dang teaches a method of treating “allergic rhinitis, non-allergic vasomotor rhinitis and allergic conjunctivitis” by administration of the composition (claim 139).
The difference between the prior art and the instant claims is that Dang does not teach a composition further comprising probiotics, acetylcysteine, or zinc. Furthermore, Dang is silent on the use of this composition in a method of managing non-infective nasal-symptoms.
Kovacs teaches a respiratory preparation comprising a thickening agent and a benefit agent such as “probiotic” (claim 9). The probiotic is in the concentration of between 106 to 1012 cfu and may be “bacillus, bacteroides…enterococcus, lactobacillus” or “streptococcus” (p. 7, lines 11-27). In some embodiments, the composition contains a “antimicrobial metal salt” such as “zinc” in the amount of “0.01% to 10%” by weight (p. 11, lines 5-17).
Osbakken teaches a pharmaceutical composition consisting of a mucolytic agent (claim 1). In one embodiment, the formulation comprises acetylcysteine in “100 mg unit doses” as a “mucolytic” (p. 13, para. 0206). Osbakken teaches a method of treating “chronic sinusitis” comprising administration of the composition by “topical delivery of medications to the nasal cavity and sinuses by aerosolizing aqueous solutions or suspensions of these medications” (p. 6, para. 0081).
Clarot teaches a system for delivering a composition to a nasal membrane comprising ionic zinc (claim 1). In one embodiment, the application dosage ranges between “20 to about 100 mg of zinc” (col 11, lines 49-52). The nature of the invention is directed to “allergy relief compositions” (col 1, line 36).
It would have been prima facie obvious for the skilled artisan of the time of filing to combine elements known in the prior art to arrive at the instant claimed method of managing non-infective nasal symptoms comprising topical administration of the claimed composition. The skilled artisan would have been motivated to do so given that these elements are include in method of or compositions directed to nasal administration for the purpose of treating non-infective sinusitis such as from allergy. The amount of 20-100 mg of zinc within the composition overlaps the range of 1-30 mg instantly claimed, as taught by Clarot. The amount of azelastine within the composition within the composition, as taught by Dang, is within the range of 100 to 1000 μg instantly claimed. The amount of 100 mg acetylcysteine, as taught by Kovacs, is within range of 50 to 300 mg instantly claimed. The range of probiotic of 106-12 cfu within the composition encompasses the range of 1 to 9 billion cfu instantly claimed. The skilled artisan would have understood that zinc “enhances discharge of mucous and inhibits the generation of new mucous” (Clarot, col 7, lines 14-15) and would have a similar effect as mucolytic acetylcysteine and anti-histamine azelastine. The skilled artisan also would have understood that probiotics can “reduce the severity of allergic reactions”, as taught by Jamalkandi (p. 8). As such, the skilled artisan would have known to combine these elements in a composition for use in the method of Dang for topical application to the nasal passage to reduce inflammation arising from non-ineffective conditions such as allergies. The skilled artisan would have understood to use a carrier such as water or saline to better aerosolize the composition for use in a spray pump, as taught by Dang. One would have had a reasonable expectation of success, given the working examples of the prior art. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
The skilled artisan would have understood to adjust the amount of zinc in the composition to be between about 5 to about 15 mg of zinc since Clarot teaches the dosage may vary from about 20 to 100 mg, and instant specification teaches “Numbers modified by the term "about" are intended to include +/- 10% of the number modified.” [0121] which overlaps the instant claimed range of 1 to 30 mg and about 5 to about 15mg.
Response to Arguments
Applicant's arguments filed 11/26/2025 have been fully considered but they are not persuasive.
Applicant argues that Clarot does not teach nasal administration of zinc for treating non-infective nasal symptoms since Clarot teaches zinc creates a barrier which inhibits viral infection which is an infective condition.
Clarot teaches administering a medicament directly into the nasal cavity to ensure adequate therapeutic result. So as to not mischaracterize the teachings of Clarot, paragraph 30 is reproduced:
“In accordance with the various embodiments of the invention, composition 13 includes zinc. Zinc may act as a decongestant and/or provide other therapeutic and/or beneficial therapy. It is believed that zinc enhances discharge of mucous and inhibits the generation of new mucous. When a composition comprising zinc is applied to the nasal cavity, zinc ions diffuse from the composition into the mucous or mucous membrane in the nasal cavity. It is believed that the zinc concentration in the mucous or mucous membrane creates a barrier which inhibits viral infection of the nasal epithelial membrane”
Thus, Clarot teaches zinc can work to treat both infections and non-infective symptoms, i.e. works as a decongestant and enhances discharge of mucous along with protecting from viral infections by providing a barrier. The fact that the prior art teaches that an active may be used for treating both infective and non-infective is not a teaching away since the art is clearly teaching the active has multiple properties.
Applicant argues Kovacs does not teach nasal administration and is directed to oral administration to the mouth and throat to relieve cough. Applicant argues the minimum mention of inhalation devices is not enabling and does not constitute a meaningful teaching. Applicant argues that Kovac teaches the use of a thickening agent which would not be compatible with nasal administration and the reference does not teach an inhalation device.
Kovacs teaches respiratory preparation comprising a thickening agent, a benefit agent (suggested probiotic or zinc) in a delivery device. Page 2. The delivery device includes “droppers, pumps, sprayers, liquid dropper… pressurized sprayers, atomizers, air inhalations devices…The sprayers, atomizer, and air inhalations devices can be associated with a battery or electric power source.” All of which enable the topical administration to the nasal cavity. Kovacs teaches the actives and excipients and concentrations to formulate the respiratory preparation.
On page 12-13 Kovacs teaches the method of administering depends on the site that one may want to deliver the composition and method of making the compositions this is within the skill of an artisan.
The instant claims are directed to topical nasal administration of a composition comprising zinc (or salt thereof), a probiotic, and aqueous diluent. Applicant does not claim any specific formulation or delivery device. In fact the claims only require topical application to the nasal cavity which may be done via a sprayer or droppers.
In order for applicant to persuasively argue that the prior art is not enabling, applicant must provide some evidence rather than mere assertions that the art only teaches a laundry list and does not exemplify the suggested embodiment. Note MPEP 2121: “When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability.” In instant case, applicant has not provided any evidence. Rather applicant attacks the references individually.
Note MPEP 2123” Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). In instant case, the fact that WO does not exemplify the suggested embodiment is not a teaching away from the broader disclosure. In fact, the art suggests respiratory compositions comprising thickening agents, benefits agents which may be probiotics and zinc, and the administration is via inhalers, droppers, or sprayers. Therefore applicant’s arguments are not persuasive.
Regarding applicant’s argument that Kovan is directed to cough suppression, the instant claims are directed to managing non-infective nasal symptoms. The instant specification teaches examples of these symptoms include anosmia, sneezing, nasal congestion, and drippy or runny nose…”
On page 13 Kovacs teaches the delivery device may be “for runny nose, nasal or chest congestion, sneezing,…” Thus, the reference teaches the use of the respiratory preparation for managing non-infective nasal symptoms. Moreover, cough is also a non-infective nasal symptoms since mucus drip from the nose to the back of the throat triggers the cough reflex and allergies cause the airways to narrow triggering coughing reflex due to breathing constriction. Thus, the motivation is as outlined in MPEPE 2144.06: COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE. All the references teach treating non-infective symptoms.
Applicant argues that Jamalkandi teaches treating infective respiratory conditions.
Jamalkandi teaches probiotics are used to “modify microbiome constitution used to treat many diseases including respiratory diseases including COPD, asthma, and allergic rhinitis. Moreover the reference demonstrates the state of the art “many studies have evaluated the therapeutic efficacy of probiotic administration (mostly via the oral route and much lesser the nasal route).” Table 1 teaches the studies that have been done which include infective and non-infective disorders including sinusitis, asthma. The fact that the prior art teaches that an active may be used for treating both infective and non-infective is not a teaching away. Page 8, column 2 teaches nasal probiotics for allergies. Thus, applicant’s arguments are not persuasive.
Applicant has not provided any evidence of unobviousness to overcome the rejection of record based on combining two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. MPEPE 2144.06: COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE.
Therefore the rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARMILA G. LANDAU whose telephone number is (571)272-0614. The examiner can normally be reached Monday-Friday 7-3:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the supervisor, Jennifer Michener can be reached at 571-272-1424. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653