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. Claims 1-2, 8-12, 17, 19, 21, 25, 28, 31, 33-34, 39, 42, 46 and 52-53 are pending in the application. Preliminary amendment filed 07/25/2024. Priority This application is a 371 of PCT/ US22/31075 filed 05/26/2022 . This application claims the benefit of 63193952 filed 05/27/2021. The parent application 63193952 to which priority is claimed is seen to provide adequate support under 35 U.S.C. 112 for claims 1-2, 8-12, 17, 19, 21, 25, 28, 31, 33-34, 39, 42, 46 and 52-53 of this application. Drawings New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because in the drawings filed 11/20/2023 Figures 1-6 are very fuzzy . Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance. Specification The disclosure is objected to because of the following informalities: In the specification, the structural formulas at pages 7-8 are fuzzy. Clear structural formulas should be provided. Appropriate correction is required. Claim Objections Claims 25 and 28 are objected to because of the following informalities: Claim 25 recites ‘sugar selected a monosaccharide ,… ’. This should be replaced by the recitation ‘sugar selected from a monosaccharide ,…’ . Claim 28 depends from canceled claim 26. Claim 25 is examined as dependent from claim 25. Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112: 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. Claims 1-2, 8-12, 17, 19, 21, 25, 28, 31, 33-34, 39, 42, 46 and 52-53 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while enabling for a method of treatment and prevention of allergic rhinitis , does not reasonably provide enablement for a method of prevention of chronic nasal congestion as recited in claim 1 . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below. 1. The nature of the invention: The instant invention pertains to a method of treatment or prevention of chronic nasal congestion in a subject comprising administering to the subject a monophosphoryl lipid A compound . 2. The breadth of the claims and the predictability of the art : The pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 166 USPQ 18 indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. Instant claim 1 recites the term ‘preventi ng ’. The definition of prevent provided in the specification is (page 14, last full para): The term prevention also encompasses absolute prevention of chronic nasal congestion . In the instant case prevention means keeping the said chronic nasal congestion from happening in a subject and is interpreted to mean the complete and total blocking of chronic nasal congestion for an indefinite period of time. Prevention is seen to include the administration of the claimed compound to a healthy subject , and subsequent exposure to conditions that would cause the chronic nasal congestion , wherein the claimed compound prevents said exposure from manifesting itself in said subject so exposed. Any therapy which merely reduces the severity of chronic nasal congestion , or which is effective for a period shorter than the subject’s remaining lifespan, is considered to be ineffective at preventing. In general, prevention is not possible as any so-called preventive effects of a drug therapy are expected to cease when the drug is cleared from the patient’s system. More generally, prevention of chronic nasal congestion in the sense being used herein is not a recognized clinical outcome in the art, as no treatment is perfectly effective. According to Naclerio et al (Interna tional Journal of Internal Medicine, 2010, 3, 47-57) nasal congestion can also occur secondary to structural causes. Nasal mucosa reaction to venous changes that alter local blood flow, secondary compression of the neck veins or hydrostatic pressures may give rise to this phenomenon. The molecular mechanisms underlying the hyperresponsiveness are not fully understood but are though to involve actions of neurotrophins on sensory afferents (page 50, right col: sub-heading: Structural Problems through page 53, right col. first para). Therefore, based on the teachings of Naclerio one of ordinary skill in the art would consider it highly unlikely that the instant active agent will prevent chronic nasal congestion. 3 . The presence or absence of working examples: E xample 6 at page 20 in the specification discloses that it supports the amelioration of pro-inflammatory cytokines production for MPLA as a treatment of inflammatory conditions. Treating inflammatory conditions is not prevention. Example 2 discloses safety and tolerability of a formulation of PHAD in participants. T h e s e example s are not commensurate in scope with the claimed prevention of chronic nasal congestion . See MPEP § 716.02(d). Thus, the specification fails to provide sufficient support for the prevention of chronic nasal congestion as instantly claimed. Therefore, in view of the Wands factor and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test the instant active agents in preventive methods, with no assurance of success. 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. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claims 52 and 53 contain the trademark/trade name PHAD ® (see page 6, last para in specification). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph. See Ex parte Simpson , 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe glucopyranosyl lipid A and, accordingly, the identification/description is indefinite. Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis ( i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 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 as of the effective filing date of the claimed invention(s) 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 as of the effective filing date of the later invention 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. Claim (s) 1-2, 8-12, 17, 19, 21, 25, 28, 31, 33-34, 39, 42, 46 and 52-53 are rejected under 35 U.S.C. 103 as being unpatentable over Pfaar et al (Int Arch Allergy Immunol, 2011, 154(4), 336-344; cited in IDS filed 01/31/2024) in view of Baldridge et al (Vaccine, 2000, 18, 2416-2425) and further in view of Childers et al (Infection and Immunity, October 2000 , 5509-5516; cited in IDS filed 01/31/2024) , Crane (US 2002/0009456 A1) , Van Haren et al (US 2017/0224811 A1, Haren) and Yoshino et al (JP-H0597695 A , machine English translation, page 1-3 ) . Pfaar et al teaches that in a study of 80 subjects in treating allergic rhinitis , four groups of sixteen subjects each received monophosphoryl lipid A (MPLA) in combination with grass pollen allergen as a formulation in buffered aqueous glycerol via sublingual immunotherapy, and the other groups given placebo. The amount of MPLA administered is in the range of 9.45 m g to 52.5 m g. The results indicated that inclusion of monophosphoryl lipid A induced earlier immunological response, and that monophosphoryl lipid A potentiates interaction between allergens and oral dendritic cells (Abstract; page 338, left col., Methods; page 341-343; method and active agent as in claim 1; dosage as in claim 2; composition as in claim 8, aqueous liquid as in claim 11, concentration as in claim 12; glycerol is an organic sol v ent as in claim 17) . The MPLA compound is administered within 14 days of onset of symptoms of allergic rhinitis as in claim 39 and is administered within 14 days of known or suspected exposure of the subject to allergen as in claim 42). The artisan can adjust the frequency of administration as in claim 46 depending on the severity of the allergic rhinitis. Pfaar does not teach intranasal administration as in claim 1, and does not teach the limitations of claims 9-10, 19, 21, 25, 28, 31, 33-34, 46, 52 and 53. According to Baldridge, intranasal delivery of MPLA in combination with antigens enhanced mucosal and systemic immunity (Abstract; page 2417, part 2.2-2.3; page 2423, right col., last para; intranasal administration as in claim 1). According to Childers administration of MPLA via intranasal route was more effective (Abstract). Therefore, the artisan would choose intranasal administration of MPLA composition in the method of Pfaar. Crane teaches the use of solvents like alcohols for making the lipid A compositions. This renders obvious the use of the solvents as in claim 19. Haren teaches a composition comprising monophosphoryl lipid A (MPLA) or glucopyranosyl lipid A formulated as a nanoparticle, such as a liposome Abstract; (para 0206). According to the definition in the specification, at page 10, last two lines through page 11, line 3, colloid refers to any liquid or solid composition comprising multimolecular aggregate microstructures having diameters or lengths on the scale of 1nm to 10um. Such microstructures include liposomes. According to page 6, last para, PHAD is also known as glucopyranosyl lipid A or GLA (as in claims 52 and 53). Therefore, the composition of Pfaar can be formulated as a colloid having particle diameter having size of about 50nm to 1000nm diameter as in claims 9-10 , which would be ideal for intranasal administration and can also include PHAD . Haren teaches that its composition comprising MPLA can also have monosaccharides and disaccharides, which can be sucrose or maltose (para 0232 , 0235 and 0237; as in claims 25 and 28). Haren also teaches a composition wherein trehalose is used (para 0059). This renders obvious the use of trehalose as a disaccharide in combination with MPLA as in claim s 28 and 33 . In view of Haren one of ordinary skill in the art will find it obvious to use all the other components recited in claims 25 and 28. Haren teaches that its compositions can be in the form of powder (para 0122). This renders obvious to administer the instant composition in the form of a powder as in claim 21. Yoshino teaches the use of cyclodextrin for the purpose of enhancing the activity of macrophage activating factor, which are involved in biological defense systems such as allergic reactions. The cyclodextrins that can be used are b - and g -cyclodextrins (paras 0002 and 0004; as in claims 31 and 34). This also renders obvious the use of alpha-cyclodextrin as in claim 31. MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention." According to the rationale discussed in KSR above, the rationale in ( G) above is seen to be applicable here since based on the prior art teachings, MPLA and the other claimed components are known in the art to be useful for treating allergic rhinitis. Thus, it is obvious to arrive at the claimed method in view of the combined teachings of the prior art. Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. One of ordinary skill in the art will administer MPLA in a method of treating allergic rhinitis in a subject since Pfaar teaches the use of oral compositions for treating allergic rhinitis in a subject, and Baldridge teaches intranasal delivery of MPLA in combination with antigens enhanced mucosal and systemic immunity. Therefore, one of ordinary skill in the art will be motivated to use intranasal administration of MPLA in the claimed method. According to Pfaar monophosphoryl lipid A induced earlier immunological response. This provides motivation to use it as an active agent in the claimed method. Conclusion Pending claims 1-2, 8-12, 17, 19, 21, 25, 28, 31, 33-34, 39, 42, 46 and 52-53 Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT GANAPATHY KRISHNAN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0654 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8.30am-5pm . 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. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /GANAPATHY KRISHNAN/ Primary Examiner, Art Unit 1693