CLAIMS 1-20 ARE PRESENTED FOR EXAMINATION
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 .
Applicant’s Information Disclosure Statement filed January 17, 2024 has been received and entered into the application. As reflected by the attached, completed copies of form PTO/SB/08, the cited references have been considered by the Examiner.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(I) Claims 1, 2, 4-6 and 10-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2006/024545 to Stichting Voor De Technische Wetenschappen (hereinafter, "Stichting", cited by Applicant).
Regarding Claim 1, Stichting discloses a method of inhibiting inflammation in a subject in need thereof (Fused bicyclic natural compounds and their use as inhibitors of parp and parp-mediated inflammatory processes, Title; preventing, treating and/or alleviating any of the diseases... is accomplished by the administration of a therapeutically effective amount of the compounds or compositions ... to a patient in need thereof, Pg. 19, lns. 13-16; the compounds and compositions described herein may be used for inhibiting an inflammatory response,
Pg. 18, Lns. 16-17) comprising administering to the subject a composition comprising about 2 mg to about 800 mg of paraxanthine (compounds or compositions ... are administered to a patient in need thereof, Pg. 19, Lns. 15-16; said PARP-1 inhibitor compounds is ... paraxanthine, Pg. 15, Lns. 28, 30; a medicament, (an additive in) a nutraceutical or a medical food for treating, preventing and/or alleviating a disease or disorder involving chronic or acute inflammatory processes comprising at least two compounds, wherein a first compound is a poly (ADP-ribose) polymerase (PARP-1) inhibitor compound chosen [to be] ... paraxanthine ... and is present in a dose of between about 50-500 mg, Pg. 20, Lns. 29-34, Pg. 21, Lns. 22-23).
Regarding Claim 2, Stichting discloses the method of claim 1, wherein paraxanthine is present in the composition in amount from about 50 mg to about 400 mg (a medicament ... a nutraceutical or a medical food for treating, preventing and/or alleviating a disease or disorder involving chronic or acute inflammatory processes comprising at least two compounds, wherein a first compound is a poly (ADP-ribose) polymerase (PARP-1) inhibitor compound chosen [to be] ... paraxanthine ... and is present in a dose of between about 50-500 mg, Pg. 20, Lns. 29-34, Pg. 21, Lns. 22-23).
Regarding Claim 4, Stichting discloses the method of claim 1, wherein the subject has been diagnosed with an inflammatory disease or condition (The compounds ... have. a weak to mild PARP-inhibitory activity and are therefore ideally suited for chronic use or for use by patients having specific diseases, Pg. 2, Lns. 19-20; use of any of the PARP-1 inhibitor compounds described herein to inhibit the formation of advanced glycation end products (AGEs) in patients with diabetes, Pg. 12, Lns. 32-34, See instant disclosure, claim 6, which states the subject has been diagnosed with diabetes).
Regarding Claim 5, Stichting discloses the method of any of claim 1, wherein the subject is at risk of developing inflammatory disease or condition (use ... for preventing acute inflammation, such as, for instance, acute inflammation due to or as a result of ischemia or
reperfusion damage, Pg. 13, Lns. 2-4; Patients in need of surgery may be treated daily with the medical foods in order to enhance recovery and reduction of time spent in the hospital. For instance, the patients may be treated before surgery with the medical foods, Pg. 27, Lns. 22-25).
Regarding Claim 6, Stichting discloses the method of claim 1, wherein the subject has been diagnosed with diabetes, Crohn's disease, rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, glomerulonephritis, scleroderma, or multiple sclerosis (use of any of the PARP-1·inhibitor compounds to inhibit the formation of advanced glycation end products (AGEs) in patients with diabetes, (Pg. 12, Lns. 32-34).
Regarding Claim 10, Stichting discloses a method of treating an inflammatory disease or condition in a subject in need thereof (Fused bicyclic natural compounds and their use as inhibitors of parp and parp-mediated inflammatory processes, Title; preventing, treating and/or alleviating any of the diseases is accomplished by the administration of a therapeutically effective amount of the compounds or compositions ... to a patient in need thereof, Pg. 19, Lns. 13-16) comprising administering to the subject a composition comprising about 2 mg to about 800 mg of paraxanthine (compounds or compositions are administered to a patient in need thereof, Pg. 19, Lns. 15-16; said PARP-1 inhibitor compounds is paraxanthine, Pg. 15, Lns. 28, 30; a medicament, (an additive in) a nutraceutical or a medical food for treating, preventing and/or alleviating a disease or disorder involving chronic or acute inflammatory processes comprising at least two compounds, wherein a first compound is a poly (ADP-ribose) polymerase (PARP-1) inhibitor compound chosen [to be] ... paraxanthine ... and is present in a dose of between about 50-500 mg, Pg. 20, lns. 29-34, Pg. 21, Lns. 22-23).
Regarding Claim 11, Stichting discloses the method of claim 10, wherein the i[lflammatory disease or condition is diabetes, Crohn's disease, rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, glomerulonephritis, scleroderma, or multiple sclerosis (use of any of the PARP-1 inhibitor compounds to inhibit the formation of advanced, glycation end products (AGEs) in patients with diabetes, Pg. 12, Lns. 32-34).
Regarding Claim 12, Stichting discloses the method of claim 10, wherein the composition further comprises second anti-inflammatory agent (NAD+-precursors as PARP-1 inhibitor compound, Pg. 2, Lns. 9-10; Patients suffering from chronic inflammatory diseases ... are treated with specific nutritional supplements or preparations that contain a combination of a NAD+-precursor and one or more of the PARP-inhibiting compounds, Pg. 31, Lns. 24-26; Addition of 2 or more PARP- inhibitors to the standard diet of diabetic mice significantly ... reduces plasma levels of pro-inflammatory cytokines, Pg. 35, Lns. 18-20).
Regarding Claim 13, Stichting discloses the method of claim 12, wherein the second anti-inflammatory agent exerts anti-inflammatory effects by: inhibiting prostaglandins, increasing macrophage mediated phagocytosis, suppressing cytokine-driven inflammation, inhibiting cytokines, inhibiting histone deacetylation, inhibiting kinases, stimulating PPAR and/or inhibiting proteases (Addition of 2 or more PARP- inhibitors to the standard diet of diabetic mice significantly ... reduces plasma levels of pro-inflammatory cytokines, Pg. 35, Lns. 18-20).
(II) Claims 1, 8, 15, 16, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2019/006427 to Juno Therapeutics Inc (hereinafter, "Juno", cited by Applicant).
Regarding Claim 1, Juno discloses a method of inhibiting inflammation in a subject in need thereof (the test agent, optionally the test dosage regimen of the test agent, is a candidate for ameliorating the toxicity and/or the sign, symptom, or outcome, Para. [0076]; if the comparison indicates the toxicity and/or the sign, symptom or outcome is ... reduced, in the presence of the test agent ... the test agent is identified as an agent for ameliorating toxicity, Para. [0077]; the toxicity is selected from increased inflammation, optionally systemic inflammation or neuroinflammation, Para. [00781) comprising administering to the subject a composition comprising about 2 mg to about 800 mg' of paraxanthine (test agents are administered to a mouse that-models toxicity described herein to determine if the test agent is a candidate agent for an intervention, Para. [0475]; the test agent, such as the additional agent, is an adenosine receptor antagonist, Para. '[0571]; Exemplary A2R antagonists include ... paraxanthine, Para. [0572]; the dose of the test agent is or includes between or between about 1 µg/kg and 1,000 mg/kg, Para. [04691).
Regarding Claim 8, Juno discloses the method of claim 1, wherein administration of the composition to the subject produces an increase in serum IL-1,0 levels in the subject from about 5% to about 20% relative to a control subject (the one or more cytokines and/or chemokines are increased by at least 10% ... IL-10 ... [is] increased by at least 10%, at least 20%, at least 30%, Para. [0390]; the increase in one or more cytokines and/or chemokines is in comparison with the level of one or more cytokines ... in control mice ... the increase in one or more cytokines ... is in comparison with the level of one or more cytokines and/or chemokines in a mouse that has not been administered the immunotherapy, Para. [0391]; the immunotherapy ... and... any test agents ... are provided as a composition, Para. [06241).
Regarding Claim 15, Juno discloses a method for enhancing immune function in a subject (the test agent is a second therapy or a test therapy, e.g., an immunotherapy, that may be administered in conjunction with an immunotherapy, for example, to treat the same disease as the immunotherapy, Para. [0474]; method of identifying and/or assessing one or more effects of an agent, e.g., a test agent, Para. '[0463]; the test agent, e.g., the additional agent, is an adenosine receptor antagonist ... antagonizing immunosuppressive adenosine receptors can augment, boost or enhance immune response, Para. [05701), comprising: providing the subject with a composition comprising about 2 mg to about 800 mg of paraxanthine (test agents are administered to a mouse that models toxicity ... to determine if the test agent is a candidate agent for an intervention, Para. [0475]; the test agent, such as the additional agent, is an adenosine receptor antagonist, Para. [0571]; Exemplary A2R antagonists include ... paraxanthine, Para. [0572]; the dose of the test agent is or includes between or between about 1 µg/kg and 1,000 mg/kg, Para. [04691).
Regarding Claim 16, Juno discloses the method of claim 15, wherein paraxanthine is present in the composition in amount from about 50 mg to about 400 mg (the test agent, such as the additional agent, is an adenosine receptor antagonist, Para. [0571]; Exemplary A2R antagonists include ... paraxanthine, Para. [0572]; the dose of the test agent is or includes between or between about 1 µg/kg and 1,000 mg/kg, Para. [04691).
Regarding Claim 19, Juno discloses the method of claim 15, wherein administration of the composition to the subject produces an increase in serum IL-2 levels in the subject from about•10% to about 30% relative to a control subject (the one or more cytokines and/or chemokines are increased by at least 10% ... IL-2 ... [is] increased by at least 10%, at least 20%, at least 30%, Para. [0390]; the increase in one or more cytokines and/or chemokines is in comparison with the level of one or more cytokines ... in control mice ... the increase in one or more cytokines ... is in comparison with the level of one or more cytokines and/or chemokines in a mouse that has not been administered the immunotherapy, Para. [0391]; the immunotherapy ... and ... any test agents ... are provided as a composition, Para. [0624]; the tissue sample is or comprises ... serum, Para. [0070]; the toxicity and/or the one or more signs, symptoms or outcomes is or is associated with altered-level, amount or expression or ratio thereof of one or more molecules in the serum, Para. [00791).
Regarding Claim 20, Juno discloses the method of claim 15, wherein the composition further comprises one or more compounds selected from the list consisting of: Cyclosporine, tacrolimus, rapamycin, Omega-3 fatty acids, Curcumin, S-adenosylmethionine, Zinc, Green tea extract, .Frankincense (Boswellia serrata resin), Capsaicin, Cat's claw (uncaria plants, including Uncaria tomentosa and Uncaria guianensis), Schizonepeta tenuifolia, Pomegranate, Moringa oleifera, Ecklonia cava, Limonene, Sunifiram, Sulforaphane, Angelica gigas, Ascophyllum nodosum, Scutellaria baicalensis, celery seed extract, Sesamin, Feverfew, Taurine, Rosmarinic Acid, Evodia rutaecarpa, Green Tea Catechins, Punicalagins, Artemisia iwayomogi, Pyrroloquinoline quinone, N-Acetylcysteine, King Oyster, Methylsulfonylmethane,..alpha-lipoic acid, pine pollen, Sophora flavescens, Ophiopogon japonicus, Stephania tetrandra, Crataegus pinnatifida, grape seed extract, Bladderwrack, Paederia foetida, Benfotiamine, Rubus coreanus, Punicic Acid, Sea Buckthorn, Hibiscus rosasinensis, Phellodendron amurense, Resveratrol, Quercetin, Rooibos, Olive leaf extract, Pterostilbene, Eucommia ulmoides, Diindolylmethane, Anatabine, Serrapeptase, Pelargonidin, watercress, Astaxanthin, Piceatannol, Fish Oil, Glutathione, Orthosiphon stamineus, Aronia melanocarpa, blueberry, Tripterygium wilfordii, Boerhaavia diffusa, Whey Protein, Bromelain, Panax ginseng, Aloe vera, cocoa extract, stinging nettle, garlic, Gentelia asiatica, Astragalus membranaceus, Dendrobium, Vitamin C, Spirulina, Berberine, Ganoderma lucidum, Vitamin C, Vitamin D, Vitamin E, lutein, leucine, dileucine, trileucine, tetraleucine Pau d'arco, AHCC, rhodiola ashwagandha, shitake, maitake, turkey tail, monolaurin, lysine, Ergothioneine, medium chain triglycerides (MCTs) and butyrate (one or more test agents can be used to assess or evaluate any of the additional agents ... that can be prepared and administered as a combination therapy, such as in pharmaceutical compositions comprising one or more agents of the combination therapy and·a pharmaceutically acceptable' carrier, Para. [0593]; Pharmaceutically acceptable carriers are generally nontoxic to recipients at the dosages and concentrations employed, and include ... amino acids such as ... lysine, Para. [0627]).
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.
(A) Claims 10, 11 and 14 are are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2015/0374703, (Leighton, cited by Applicant).
Regarding Claim 10, Leighton discloses a method of treating an inflammatory disease or condition in a subject in need thereof (Compositions and methods for treating symptoms of inflammatory related conditions using a combination of an antihistamine and a stimulant, Title; a method of treating symptoms associated with inflammation in a mammal in need thereof, Para. [0022]) comprising administering to the subject a composition comprising paraxanthine (administering to the mammal a pharmaceutically effective amount of a composition comprising: at least one stimulant and at least one anti-histamine composition or a pharmaceutically acceptable salt thereof; a carrier; and optionally, an additional active ingredient, Paras. [0022]-[0025]; the stimulant is a methyl xanthine, Para. [0026]; Non-limiting examples of stimulants that can be ... used ... include methyl xanthines, optionally including one or more of xanthines and methyl xanthines, which can optionally include ... paraxanthine, .Para. [0041]).
Leighton fails to explicitly disclose about 2 mg to about 800 mg of paraxanthine.
However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to include about 2 mg to about 800 mg of paraxanthine, because where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The motivation for doing so would be to provide a 5-1000 mg of a stimulant in a composition have an optimum therapeutic effect in a given patient in need thereof, (Leighton, Para. [0153]).
Regarding Claim 11, Leighton discloses the method of claim 10, wherein the inflammatory disease or condition is diabetes, Crohn's disease, rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, glomerulonephritis, scleroderma, or multiple sclerosis (Inflammation can result from a wide variety of diseases, conditions, syndromes, disorders, injuries and the like of the various anatomical systems, including ... rheumatoid arthritis, Paras. [0048]-[0049]) thus making the subject matter of present claim 11 clearly obvious to one or ordinary skill in the art.
Regarding Claim 14, Leighton discloses the method of claim 11, wherein the second anti-inflammatory agent is selected from aspirin, ibuprofen; naproxen, hyssop,.-ginger, turmeric, helenalin, cannabichromene, rofecoxib, celecoxib, paracetamol (acetaminophen), sirolimus (rapamycin), dexamethasone, dipyridamole, alfuzosin, statins, and glitazones (the additional active ingredient is [a] ... non-steroidal anti-inflammatory agent, Para [0125]; Representative examples of NSAIDs include; without limitation, aspirin, Para. [0128]). Because these are anti-inflammatory agents required in present claim 14, their selection would have clearly been obvious to one of ordinary skill in the art.
(B) Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Stichting, (as relied upon above for grounds of a rejection under section 102), for the reasons set forth above as applied to claim 1, which reasons are here incorporated by reference, in view of WO 2012/073025, (Vectura Limited et al., (“Vectura”, cited by Applicant).
It is further noted that Stichting teaches that the compositions useful for treating inflammation contain a second active agent which itself is anti-inflammatory, (see the abstract and pages 11-18).
The difference between the subject matter of claim 3 and the presently claimed subject matter lies in that Stichting fails to explicitly disclose wherein the composition further comprises an effective amount of dileucine.
However for the following reasons, it would have been obvious to include dileucine because of the teachings of Vectura. Vectura teaches subject matter in the field of the treatment of pulmonary inflammation (Title) and teaches wherein the compositions useful therefor further comprises an effective amount of dileucine (the use further comprises ... Methylxanthines, Pg. 22, first partial paragraph from top, Pg. 24, first partial paragraph from top; claim 33; advantageous for the additive material to comprise an amino acid ... A particular amino acid that ... is ... - dileucine, Pg. 50, first full paragraph from bottom; The term "effective amount" refers to an amount of a _compound, which confers a therapeutic effect on the treated patient , Pg. 31, first full paragraph from top).
(C) Claims 1, 7 and 9 are are rejected under 35 U.S.C. 103 as being unpatentable over Stichting, (as relied upon above for grounds of a rejection under section 102), for the reasons set forth above as applied to claim 1, which reasons are here incorporated by reference, in view of WO 2019/0064272012/073025, (Juno Thereapeutics, Inc., (“Juno”, cited by Applicant).
Regarding Claim 7, Stichting discloses the method of claim 1, wherein administration of the composition to the subject produces a decrease in IL-6 levels in the subject from about 5% to about 15% relative to a control subject (the PARP-1 compounds reduce the relative IL-6 concentration, Pg. 34, Ln. 8, Plasma IL-6 alpha (% of diabetic) ... Diabetic, Standard lab diet ... 100 ... Diabetic 3 PA.RP inhibitors added ... 70, Table 11).
Stichting fails to explicitly disclose specific serum levels.
However, Juno is in the field of markers for assessing, measuring, and/or quantifying inflammation (Para. [0604]) and teaches serum levels (llfle tissue sample is or comprises ... serum, Para. [0070]; the toxicity and/or the one or more signs, symptoms or outcomes is or is associated with altered level, amount or expression or ratio thereof of one or more molecules in the serum, Para. [0079]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Stichting by a marker as taught by Juno for the purpose of identifying an agent for use in the .treatment of Type I diabetes (Juno, Para. [0195]).
Regarding Claim 9, Stichting discloses the method of claim 1, wherein administration of the composition to the subject produces a decrease in inflammation markers in the subject from about 15% to about 30% relative to a control subject (the PARP-1 compounds reduce the relative IL-6 concentration, Pg. 34, Ln. 8, Plasma IL-6 alpha (% of diabetic) ... Diabetic, Standard lab diet ... 100 ... Diabetic 3 PARP inhibitors added ... 70, Table 11, See instant disclosure, Para. [038], which lists IL-6 as an example of an acceptable proinflammatory factor).
Stichting fails to explicitly disclose serum CRP levels.
However, Juno is in the field of markers for assessing, measuring, and/or quantifying inflammation (Para. [0604]) and teaches serum CRP levels (the toxicity comprises and/or the one or more signs, symptoms or outcomes associated with the toxicity is selected from increased inflammation, optionally systemic inflammation or neuroinflammation, Para. [0078]; the toxicity and/or the one or more signs, symptoms or outcomes is or is associated with altered level, amount or expression or ratio thereof of one or more molecules in the serum, Para. [0079]; inflammatory markers include ... C-reactive protein, Para. [0188]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Stichting by a marker as taught by Juno for the purpose of identifying an agent for use in the treatment of Type I diabetes (Juno, Para. [0195]).
(D) Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Juno, already of record, for the reasons of record as set forth above under the 102 heading as applied to at least claims 15-16, which reasons are here incorporated by reference, in view of Thida, Khine, (herein after “Thida”, cited by Applicant), "Does Caffeine Consumption before High-Intensity Intermittent Exercise Enhance Immunity?", Aukland University of Technology, 2016, 8-14, 48-54.
Regarding Claim 17, Juno discloses the method of claim 16, wherein administration of the composition to the subject produces an increase in serum markers (the toxicity and/or the one or more signs, symptoms or outcomes is or is associated with altered level, amount or expression or ratio thereof of one or more molecules in the serum, Para. [0079]).
Juno fails to explicitly disclose iricreasing Th2, Th17, and/or Tfh levels in the subject from about 350% to about 800% relative to a control subject.
However, Thida is a reference containing teachings in the field of caffeine for use in enhancing immunity (Title) and teaches increasing Th2, Th17, and/or Tfh levels iri the subject (Pre-supplement ... CD4+ cells (x109 cells.L-1)a... CAF... 0.69... Pre-exercise ... CD4+ cells (x109 cells.L:1)a□CAF...0.75 ... Pre-supplement ... CD4+ cells (x109 cells.L-1)a□PLA ... 0.74 ... Pre-exercise ... CD4+•cells (x109 cells.L-1)a□PLA 0.73, Table 4, where CAF = Caffeine and PLA = Placebo; TH (CD4+) cells are further subdivided into TH2, TH17, Pg. 12, first full paragraph from top; Similar to the circulating CD4+ and CD8+ cell numbers, caffeine raised the number of CD3-CD56+ cells following one hour of ingestion, Pg. 52, first full paragraph from bottom).
It would have been obvious to cine of ordinary skill in the art at !lie time of the invention to modify the method of Juno by a T-cell as taught by Thida for the purpose of enhancing immunity (Thida, Title). Further, it would have been obvious to one of ordinary skill in the art at the time the invention was made to increase levels from about 350% to about 800% relative to a control subject, since where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The motivation for doing so would be to enhance immunity in a subject (Thida, Title).
(E) Claims 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Juno, already of record, for the reasons of record as set forth above under the 102 heading as applied to at least claim 15, which reasons are here incorporated by reference, in view of Vectura, aleady cited above.
Juno fails to explicitly disclose wherein the composition further comprises an effective amount of dileucine.
Vectura is in the field of the treatment of pulmonary inflammation (Title) and teaches wherein the composition further comprises an effective amount of dileucine (the use further comprises methylxanthines, Pg. 22, first partial paragraph from top, Pg. 24, first partial
paragraph from top; claim 33; advantageous for the additive material to comprise an amino acid ... A particular amino acid ... is ... dileucine, Pg. 50, first full paragraph from bottom; The term "effective amount" refers to an amount of a compound, which confers a therapeutic effect on the treated patient, Pg. 31, first full paragraph from top).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Juno by dileucine as taught by Vectura for the purpose of treating inflammation caused by immune defects (Vectura, Pg. 9, first full paragraph from bottom).
Accordingly, for the above reasons, the claims are deemed properly rejected by the Examiner and none of rhe claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYMOND J HENLEY III whose telephone number is (571)272-0575. The examiner can normally be reached M-F 6-2:30pm EST.
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 examiner’s supervisor, Jeffrey S Lundgren can be reached at 571-272-5541. 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.
/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629 November 28, 2025