Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission has been entered.
This Office Action is in response to Applicant's amendment and response filed on 12/18/2025, in which claim 20 is cancelled, claims 17, 22, 24-33 and 36-38 are amended and claims 39-43 are newly added.
Claims 17, 22, 24-33 and 36-43 are pending in the instant application and are examined on the merits herein.
Priority
The application is a divisional of application 16/327659, now US 11,077,151, which is the National Stage entry of PCT/US2017/48665 filed on 8/25/2017, which claims priority to provisional application 62/379651 filed on 8/25/2016.
Information Disclosure Statement
The information disclosure statement (IDS) dated 12/18/2025 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS has been placed in the application file and the information therein has been considered as to the merits.
Withdrawn Rejections
All rejection(s) of record for claim(s) 20 is/are hereby withdrawn due to the cancellation of said claim(s) rendering said rejection(s) moot.
Applicant’s amendment, filed on 12/18/2025, with respect to the rejection of claims 17, 22, 24-33 and 36-38 are rejected under 35 U.S.C. 103 as being unpatentable over Choe et al. (US 2015/0018291A1), in view of Schmidt et al. (DE 10163602A1), further in view of Deshmukh et al. (US 2014/0348855A1), has been fully considered and is persuasive. The combined teachings of the prior art do not teach an oral suspension. The rejection is hereby withdrawn.
Applicant’s response with respect to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable US 11,464,810, has been fully considered and is persuasive. Patent ‘810 does not claim an oral suspension. The rejection is hereby withdrawn.
New Rejections
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 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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 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 17, 22, 24-33 and 36-43 are rejected under 35 U.S.C. 103 as being unpatentable over Choe et al. (US 2015/0018291A1, IDS), in view of Schmidt et al. (DE 10163602A1, 2003, reference of record), further in view of Deshmukh et al. (US 2014/0348855A1, reference of record), further in view of Velicelebi et al. (US 2009/0137659 A1, PTO-892).
Choe et al. discloses a composition comprising an ascaroside extracted from the nematode Nippostrongylus brasiliensis, specifically ascr#7, or a pharmaceutically acceptable salt or prodrug thereof, and a pharmaceutically acceptable carrier, for use in treating asthma, autoimmune diseases, celiac disease, chronic prostatitis, glomerulonephritis, Hypersensitivities, Inflammatory bowel diseases, pelvic inflammatory disease, reperfusion injury, rheumatoid arthritis, sarcoidosis, transplant rejection, vasculitis, interstitial cystitis, lupus, scleroderma, certain types of hemolytic anemia, type one diabetes, graves disease, multiple sclerosis, Goodpasture' s syndrome, pernicious anemia, some types of myopathy, seasonal allergy, mastocytosis, perennial allergy, anaphylaxis, food allergy, allergic rhinitis, atopic dermatitis, and/or autism. (¶0007, 0050, 0056)
Choe does not teach an oral suspension composition comprising ascr#7 and a corticosteroid, specifically budesonide or fluticasone, and a carrier comprising carboxymethylcellulose and microcrystalline cellulose.
Schmidt et al. discloses a composition comprising a nematode extract, including the nematode genus Nippostrongylus, in combination with an anti-inflammatory agent, specifically cortisone, for treating dermatitis, eczema, psoriasis, bronchial asthma, allergic rhinitis, rhinoconjunctivitis and food allergies.(Claims 1-6; pp. 27)
Deshmukh et al. discloses that, “Moderate asthma is currently treated with a daily inhaled anti-inflammatory-corticosteroid…Inhaled corticosteroids improve inflammation, airways hyperreactivity, and obstruction, and reduce the number of acute exacerbations. However, it takes at least a month before effects are apparent and up to a year for marked improvement to occur. The most frequent side effects are hoarseness and oral fungal infection, i.e., candidiasis. More serious side effects have been reported, e.g., partial adrenal suppression, growth inhibition, and reduced bone formation, but only with the use of higher doses. Beclomethasone, triamcinolone, and flunisolide probably have a similar potency; whereas budesonide and fluticasone are more potent and reportedly have fewer systemic side effects.” (¶0100) In addition to asthma, other diseases that may be treated by the formulations of inventions include allergy, autoimmune disease, or other inflammatory diseases. Other allergic diseases include allergic rhinitis, atopic dermatitis, food hypersensitivity and urticaria; immune-mediated skin diseases include bullous skin diseases, erythema multiform and contact dermatitis; autoimmune disease include psoriasis, rheumatoid arthritis, juvenile chronic arthritis; inflammatory bowel disease (i.e., ulcerative colitis, Crohn's disease); other diseases associated with ILl3 include idiopathic interstitial pneumonia, goblet cell metaplasia, inflammatory and fibrotic lung diseases such as cystic fibrosis , gluten-sensitive enteropathy, and Whipple's disease; immunologic diseases of the lung such as eosinophilic pneumonia, idiopathic pulmonary fibrosis and hypersensitivity pneumonitis; chronic obstructive pulmonary disease, RSV infection, uvelitis, scleroderma, osteoporosis, and Hodgkin's lymphoma. (¶0103)
Velicelebi et al. discloses compositions for treating conditions such as dermatitis, allergic rhinitis, asthma. (¶0104) Velicelebi further discloses that the composition may be formulated as an oral suspension comprising pharmaceutically acceptable additives including carriers (e.g. glycerin), binders (e.g. carboxymethylcellulose, microcrystalline cellulose), filling agents, suspending agents, flavoring agents, sweetening agents, disintegrating agents, dispersing agents, surfactants, lubricants, colorants, diluents (e.g. buffers or carbohydrates such as lactose, sucrose, dextrose), solubilizers, moistening agents, plasticizers (e.g. glycerin), stabilizers, penetration enhancers, wetting agents, anti-foaming agents, antioxidants (e.g. ascorbate), preservatives, or one or more combination thereof. (¶0557, 0588-0596, 0600, 0619, 0623-625, 0635)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Choe to add a corticosteroid. One would have been motivated to modify Choe in this manner because Schmidt teaches that cortisone may be combined with an extract containing active agents from Nippostrongylus, for treating the same conditions as Choe, including asthma, dermatitis, allergic rhinitis and food allergies. “It is prima facie obvious to combine 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.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (see also MPEP § 2144.06(I))
It would have been further prima facie obvious to replace cortisone with either fluticasone or budesonide, thereby arriving at the instant invention. One would have been motivated to perform such a replacement because Deshmukh teaches that when administering corticosteroids to treat the same diseases as Choe/Schmidt, such as asthma, allergic rhinitis, dermatitis, etc., fluticasone or budesonide are more potent and have fewer side effects.
It would have been further prima facie obvious that the composition of Choe/Schmidt/Deshmukh could be modified by the analogous art teaching of Velicelebi to be formulated as an oral suspension comprising carboxymethylcellulose and microcrystalline cellulose as binders, glycerin as either a carrier or plasticizer, carbohydrates as diluents, as well as any one or a combination of flavoring agents, sweetening agents, surfactants, antioxidants, buffers and preservatives. Velicelebi discloses well-understood, routine and conventional modifications in the art for formulating composition to treat the same diseases as Choe/Schmidt/Deshmukh. Thus, one would reasonably expect and predict that the formulations of Velicelebi could be applied to other art with the goal of formulating composition to treat dermatitis, allergic rhinitis, asthma. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
With respect to claim 17 and the limitation regarding the composition being formulated for preventing or treating an IL-6 and/or IL-1beta mediated disease, the cited recitations are considered an “intended use” of the claimed composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since such disclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting. Moreover, even if the recitations did provide a structural limitation to the composition, the limitation is still obvious over the cited prior. The combined prior art teaches treatment of diseases, which are identified by the instant claims as IL-6 and/or IL-1beta mediated diseases (i.e. claims 27-30, 36). Regardless of the prior art recognizing that the taught diseases are IL-6 and/or IL-1beta mediated, the teaching of diseases which are disclosed by the claims meets this limitation.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 17, 22, 24-33 and 36-43 of the instant application are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 5-8, 11, 12 of US 11,464,151, in view of Hill et al. (US 2012/0164080, reference of record). Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant composition is obvious over the composition administered in the method of ‘151, with the exception that the instant composition is in the form of an oral suspension and contains specific carriers. The obviousness of formulating a composition comprising a corticosteroid in numerous forms, including an oral suspension, is provided by Hill et al. Hill discloses that corticosteroid containing compositions may be administered in functionally equivalent forms including a solution, suspension, emulsion, syrup, slurry, dispersion, elixir, tonic, orally dissolving tablet, lozenge, powder, granules, micropellets, nanopellets, microparticles, nanoparticles, tablet, effervescent tablet, melting tablet, disintegrating tablet, orally disintegrating tablet, foam, gel, solid solution, solid formulation, solid disintegrating formulation, emulsion, liquid or semi-liquid solution, gum, wafer (e.g., dissolving or disintegrating), or a combination thereof, or a film or patch. (Claim 28) Hill further discloses that the composition may be formulated with excipients including microcrystalline cellulose and/or carboxymethylcellulose. (¶0101) Thus the addition of MCC and CMC to the composition of ‘151 is also obvious over in view of Hill. Moreover, although the instant claims are directed to a composition and the claims of ‘151 are directed to a method of treatment, the instant claims are an obvious variant of ‘151/Hill. This is due to the fact that in order to practice the method of ‘151/Hill, one must be in possession of a composition that is obvious to that instantly claimed. Regarding claims reciting intended use, the rationale for how these limitations are not given patentable weight is referenced as discussed above.
Claims 17, 22, 24-33 and 36-43 of the instant application are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 4, 13, 20 of US 11,464,810, in view of Hill et al. (US 2012/0164080, reference of record). Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant composition is obvious over the composition administered in the method of ‘810, with the exception that the composition of ‘810 is in the form of a slurry. The obviousness of formulating a composition comprising a corticosteroid in numerous forms, including a slurry or oral suspension, is provided by Hill et al. Hill discloses that corticosteroid containing compositions may be administered in functionally equivalent forms including a solution, suspension, emulsion, syrup, slurry, dispersion, elixir, tonic, orally dissolving tablet, lozenge, powder, granules, micropellets, nanopellets, microparticles, nanoparticles, tablet, effervescent tablet, melting tablet, disintegrating tablet, orally disintegrating tablet, foam, gel, solid solution, solid formulation, solid disintegrating formulation, emulsion, liquid or semi-liquid solution, gum, wafer (e.g., dissolving or disintegrating), or a combination thereof, or a film or patch. (Claim 28) Hill further discloses that the composition may be formulated with excipients including microcrystalline cellulose and/or carboxymethylcellulose. (¶0101) Thus the addition of MCC and CMC to the composition of ‘810 is also obvious over in view of Hill. Moreover, although the instant claims are directed to a composition and the claims of ‘810 are directed to a method of treatment, the instant claims are an obvious variant of ‘810/Hill. This is due to the fact that in order to practice the method of ‘810/Hill, one must be in possession of a composition that is obvious to that instantly claimed. Regarding claims reciting intended use, the rationale for how these limitations are not given patentable weight is referenced as discussed above.
Claims 17, 22, 24-33 and 36-43 of the instant application are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 and 11-16 of copending application 19/314492, in view of Hill et al. (US 2012/0164080, reference of record). Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant composition is obvious over that of ‘492, with the exception that the composition of ‘492 is in the form of a slurry. The obviousness of formulating a composition comprising a corticosteroid in numerous forms, including a slurry or oral suspension, is provided by Hill. Hill discloses that corticosteroid containing compositions may be administered in functionally equivalent forms including a solution, suspension, emulsion, syrup, slurry, dispersion, elixir, tonic, orally dissolving tablet, lozenge, powder, granules, micropellets, nanopellets, microparticles, nanoparticles, tablet, effervescent tablet, melting tablet, disintegrating tablet, orally disintegrating tablet, foam, gel, solid solution, solid formulation, solid disintegrating formulation, emulsion, liquid or semi-liquid solution, gum, wafer (e.g., dissolving or disintegrating), or a combination thereof, or a film or patch. (Claim 28) Hill further discloses that the composition may be formulated with excipients including microcrystalline cellulose and/or carboxymethylcellulose. (¶0101) Thus the addition of MCC and CMC to the composition of ‘492 is also obvious over in view of Hill. Regarding claims reciting intended use, synergism and inherent effect of an administered composition, the rationale for how these limitations are not given patentable weight is referenced as discussed above.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Modified Rejection
Claims 17, 22, 24-33 and 36-43 of the instant application are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 5, 6, 15 and 16 of copending application 17/941589, in view of Hill et al. (US 2012/0164080, reference of record). Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant composition is obvious over that of ‘589, with the exception that the composition of ‘589 is in the form of a slurry. The obviousness of formulating a composition comprising a corticosteroid in numerous forms, including a slurry or oral suspension, is provided by Hill. Hill discloses that corticosteroid containing compositions may be administered in functionally equivalent forms including a solution, suspension, emulsion, syrup, slurry, dispersion, elixir, tonic, orally dissolving tablet, lozenge, powder, granules, micropellets, nanopellets, microparticles, nanoparticles, tablet, effervescent tablet, melting tablet, disintegrating tablet, orally disintegrating tablet, foam, gel, solid solution, solid formulation, solid disintegrating formulation, emulsion, liquid or semi-liquid solution, gum, wafer (e.g., dissolving or disintegrating), or a combination thereof, or a film or patch. (Claim 28) Hill further discloses that the composition may be formulated with excipients including microcrystalline cellulose and/or carboxymethylcellulose. (¶0101) Thus the addition of MCC and CMC to the composition of ‘589 is also obvious over in view of Hill. Regarding claims reciting intended use, synergism and inherent effect of an administered composition, the rationale for how these limitations are not given patentable weight is referenced as discussed above.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claims are allowed.
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/DALE R MILLER/Primary Examiner, Art Unit 1693