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
Claims 1-29 are pending in the present application.
AMENDMENTS
The amendments filed January 02, 2026 have been acknowledged and entered in the present application file.
Previous Claim Rejections - 35 USC § 103
Claims 1, 4-18 and 25 were previously rejected under 35 U.S.C. 103 as being unpatentable over Bazan et al. (henceforth Bazan, WO 2018/175288 A1) , in view of Calderon (Calderón, Moisés A., et al. "A comparison of cytokine release from epithelial cells cultured from nasal biopsy specimens of atopic patients with and without rhinitis and nonatopic subjects without rhinitis." Journal of allergy and clinical immunology 99.1 (1997): 65-76.).
Applicant traverses the previous rejection on grounds the prior art does not disclose a method of treating an allergic inflammatory disease by administering a VLC-PUFA of hydroxylated derivative thereof, where a VLC-PUFA compound reduces IL-1β expression induced by allergen rather than oligomeric Aβ peptide, and the present application provides support for the treatment of allergic inflammatory disease – including where IL-10 cytokine, decreased due to allergen expression, was increased as a result of elovanoid addition.
The Examiner has considered the traversal fully but must disagree for the following reasons.
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998). See also MPEP 2123.
Bazan discloses the use of VLC-PUFA compounds (see pg. 46-57), including the present elected species (see pg. 48 for formula A2; (16Z,19Z,22Z,25Z,28Z,31Z)-tetratriaconta-16,19,22,25,28,31-hexaenoic acid), for the treatment of a number of diseases, including inflammatory diseases and eczema (see pg 32, ln. 1-6; pg 46, ln. 18-21 and pg. 60, ln. 7-11), an allergic inflammatory disease, which are mediated by, amongst other factors, chemokines and cytokines. Calderon discloses data from cultures of human nasal epithelial cells of patients with allergic rhinitis and where allergic rhinitis is indicated by an increase in production of pro-inflammatory chemokines and cytokines, including IL-8 and IL-1β. See abstract (methods section); page 66, column 1, paragraph 2 – column 2, paragraph 2. Bazan discloses data demonstrating where VLC-PUFA compounds reduce gene expression of IL-1β cytokine. See pg 17, ln. 13-14.
Conclusive proof of efficacy is not required to show a reasonable expectation of success. See MPEP 2143.02, Section I. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")).
The prior art does not need to disclose a method of treatment, which is completely effective, for an allergic inflammatory disease, to establish a reasonable expectation of success. Calderon discloses where allergic rhinitis is indicated by an increase in production of pro-inflammatory chemokines and cytokines, including IL-8 and IL-1β and Bazan discloses where VLC-PUFA compounds reduce gene expression of IL-1β cytokines.
It would be within the ability of the skilled artisan to develop a similar method of treatment as disclosed by Bazan, for an allergic inflammatory disease such as allergic rhinitis, as disclosed by Calderon.
As Calderon provides experimental data demonstrating the increased cytokine and chemokine production associated with allergic rhinitis and Bazan discloses where VLC-PUFA compounds reduce gene expression of IL-1β cytokine, there would be a reasonable expectation of success for one of ordinary skill in the art.
The previous rejection is maintained.
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.
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.
Claims 1, 4-18 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Bazan et al. (henceforth Bazan, WO 2018/175288 A1) , in view of Calderon (Calderón, Moisés A., et al. "A comparison of cytokine release fromepithelial cells cultured from nasal biopsy specimens of atopic patients with and without rhinitis and nonatopic subjects without rhinitis." Journal of allergy and clinical immunology 99.1 (1997): 65-76.).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Bazan discloses a method of alleviating a symptom of, treating, or preventing an inflammatory disease in a subject (pg 32 ,ln 1-6; pg 34, ln 3-8), the method comprising administering to the subject (pg 63 ,ln 31-37) a therapeutically effective amount (pg 59, ln 15-17) of a very-long-chain polyunsaturated fatty acid (VLC-PUFA; pg 1, ln 14-16).
Bazan discloses where the method comprises administration of the present elected species. See pg 90, last line and present claim 4.
Bazan discloses data demonstrating where VLC-PUFA compounds reduce gene expression of IL-1β cytokine. See pg 17, ln. 13-14 and present claims 13-15.
Bazan discloses elected species (pg. 90, last line). See present claim 4.
Bazan discloses pharmaceutical composition and compositions which may be administered intranasally and topically, further discloses formulation as cream (pg 28, ln 29-37). See present claims 6-9.
Bazan discloses the pharmaceutical formulation may further contain antioxidants (pg 59, ln 26-28). See present claims 11-12.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Bazan does not disclose or suggest a method of claim 1, wherein the allergic inflammatory disease is indicated by increased production of pro-inflammatory cytokines and chemokines by a cell as indicated in present claims 16-18 as well as present claims 22-24.
Bazan does not disclose or suggest a method of claim 1, wherein the VLC-PUFA or hydroxylated derivative thereof is administered prior to exposure to an allergen, at about the same time as exposure to an allergen, or after exposure to an allergen. See present claim 19.
Bazan also does not disclose wherein the allergen causes an allergic inflammatory disease in a subject or an increased production of pro-inflammatory cytokines and chemokines by a cell. See present claims 20-21.
Bazan does not disclose or suggest wherein the allergic inflammatory disease comprises allergic rhinitis, allergic conjunctivitis, allergic dermatitis, asthma. See present claim 25.
Finding of prima facie obviousness --- rationale and motivation (See
MPEP § 2142-2143)
Calderon discloses data from cultures of human nasal epithelial cells of patients with allergic rhinitis and where allergic rhinitis is indicated by an increase in production of pro-inflammatory chemokines and cytokines, including IL-8 and IL-1β. See abstract (methods section); page 66, column 1, paragraph 2 – column 2, paragraph 2. See instant claims 16-18 and 25.
Bazan discloses a method of alleviating a symptom of, treating, or preventing an inflammatory disease comprising a VLC-PUFA, where the VLC-PUFA comprises the presently elected species. Calderon discloses where human nasal epithelial cells from patients with allergic rhinitis, an allergic inflammatory disease, have increased levels of IL-1β cytokine, in addition to other cytokines and chemokines. It would have been obvious for one of ordinary skill in the art to administer the VLC-PUFA of Bazan in a method of treating an allergic inflammatory disease, such as allergic rhinitis. As Calderon provides experimental data demonstrating the increased cytokine and chemokine production associated with allergic rhinitis and Bazan discloses where VLC-PUFA compounds reduce gene expression of IL-1β cytokine, there would be a reasonable expectation of success.
Therefore, the method of claims 1, 4-18 and 25 are prima facie obvious.
Claims 19-24 are rejected under 35 U.S.C. 103 as being unpatentable over Bazan et al. (henceforth Bazan, WO 2018/175288 A1) , in view of Calderon (Calderón, Moisés A., et al. "A comparison of cytokine release fromepithelial cells cultured from nasal biopsy specimens of atopic patients with and without rhinitis and nonatopic subjects without rhinitis." Journal of allergy and clinical immunology 99.1 (1997): 65-76.) and Kett et al. (henceforth Kett; US 8,597,632 B2) .
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Bazan discloses a method of alleviating a symptom of, treating, or preventing an inflammatory disease in a subject (pg 32 ,ln 1-6; pg 34, ln 3-8), the method comprising administering to the subject (pg 63 ,ln 31-37) a therapeutically effective amount (pg 59, ln 15-17) of a very-long-chain polyunsaturated fatty acid (VLC-PUFA; pg 1, ln 14-16).
Bazan discloses where the method comprises administration of the present elected species. See pg 90, last line and present claim 4.
Bazan discloses data demonstrating where VLC-PUFA compounds reduce gene expression of IL-1β cytokine. See pg 17, ln. 13-14 and present claims 13-15.
Bazan discloses elected species (pg. 90, last line). See present claim 4.
Bazan discloses pharmaceutical composition and compositions which may be administered intranasally and topically, further discloses formulation as cream (pg 28, ln 29-37). See present claims 6-9.
Bazan discloses the pharmaceutical formulation may further contain antioxidants (pg 59, ln 26-28). See present claims 11-12.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Bazan does not disclose or suggest a method of claim 1, wherein the VLC-PUFA or hydroxylated derivative thereof is administered prior to exposure to an allergen, at about the same time as exposure to an allergen, or after exposure to an allergen. See present claim 19.
Bazan also does not disclose wherein the allergen causes an allergic inflammatory disease in a subject or an increased production of pro-inflammatory cytokines and chemokines by a cell. See present claims 20-21. Bazan does not disclose or suggest a method of claim 1, wherein the allergic inflammatory disease is indicated by increased production of pro-inflammatory cytokines and chemokines by a cell as indicated in present claims 22-24.
Finding of prima facie obviousness --- rationale and motivation (See
MPEP § 2142-2143)
Calderon discloses data from cultures of human nasal epithelial cells of patients with allergic rhinitis and where allergic rhinitis is indicated by an increase in production of pro-inflammatory chemokines and cytokines, including IL-8 and IL-1β. See abstract (methods section); page 66, column 1, paragraph 2 – column 2, paragraph 2. See instant claims 20-24.
Kett discloses anionic oligosaccharide conjugates as useful in the treatment inflammatory respiratory disorders including anaphylaxis, asthma, allergic respiratory disease, allergic rhinitis, subepithelial fibrosis in airway hyperresponsiveness, chronic sinusitis, perennial allergic rhinitis, allergic bronchopulmonary aspergillosis in cystic fibrosis patients, COPD, ARDS/ALI, eosinophilic bronchitis, bronchiectasis, bronchospasm, bronchial constriction, bronchial hyperreactivity, bronchial hypertrophy and bronchial inflammation. See cols. 6-7; col 12, lines 17-45.
Kett discloses the method for treating an allergic inflammatory disease comprising administration of anionic oligosaccharide conjugate agent prior to allergen exposure in nasal epithelial cell. See Example 16 in cols. 49-50 where Kett discloses treatment of allergic rhinitis where subjects are pretreated with anionic oligosaccharide conjugates 30 min prior to intranasal instillation of ovalbumin (OVA; allergen causing allergic rhinitis). See present claims 19-20.
Bazan discloses a method of alleviating a symptom of, treating, or preventing an inflammatory disease comprising a VLC-PUFA, where the VLC-PUFA comprises the presently elected species. Calderon discloses where human nasal epithelial cells from patients with allergic rhinitis, an allergic inflammatory disease, have increased levels of IL-1β cytokine, in addition to other cytokines and chemokines. Kett discloses where exposure to OVA (an allergen) can cause allergic rhinitis, and further discloses methods of treatment comprising administration of a therapeutic agent, anionic oligosaccharide conjugate agent, prior to OVA exposure. It would have been obvious for one of ordinary skill in the art to administer the VLC-PUFA of Bazan in a method of treating an allergic inflammatory disease, such as allergic rhinitis, prior to the exposure of an allergen which causes the allergic inflammatory disease. As Calderon provides experimental data demonstrating the increased cytokine and chemokine production associated with allergic rhinitis, Bazan discloses where VLC-PUFA compounds reduce gene expression of IL-1β cytokine and Kett discloses a method of treatment for allergic rhinitis comprising administration of a therapeutic agent prior to exposure to an allergen, there would be a reasonable expectation of success.
Therefore, the method of claims 19-24 are prima facie obvious.
Conclusion
Claims 1 and 4-25 are rejected.
Claims 2-3 and 26-29 are withdrawn.
THIS ACTION IS MADE FINAL. 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 QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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