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 .
Status of Claims
The claims filed May 6, 2024 are acknowledged and entered. Claims 1-19 are pending.
Priority
This application is a CON of 18/082,622, now U.S. Patent No. 12,012,412 B2, filed December 16, 2022, which claims the benefit of 63/290,136, filed December 16, 2021.
Information Disclosure Statement
Acknowledgement is made of the Information Disclosure Statement filed on May 23, 2024. All references have been considered except where marked with a strikethrough.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
Claim Rejections - 35 USC § 112a
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 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 1-6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating heart failure in a subject, does not reasonably provide enablement for a method of generally treating or preventing of a cardiovascular disease or disorder in a subject. 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.
Applicant teaches that Compound X is an inhibitor PDE9 that is useful for treating cardiovascular disease (see [0145] and [0152]). However, inhibition of PDE9 is not known to be correlated with the treatment of the entire scope of conditions embraced by the claims or prevention of any condition embraced by the claims. Applicant’s disclosure is only enabling for the treatment of conditions which Applicant has demonstrated may be treated by the instant compound, and of conditions which the prior art is already aware may be treated by a compound with the disclosed activity (i.e. inhibition of PDE9) and for which Applicant has written support. Case law is clear on this point. In an unpredictable art, such as drug therapy to treat disease, models may be used for enablement only if there is a reasonable correlation between the activity in question and the asserted utility. Given the guidance provided by Applicant, one skilled in the art would not be able to practice the full scope of the invention without undue experimentation.
In evaluating the enablement question, several factors are to be considered. Note In re Wands, 8 USPQ2d 1400 and Ex parte Forman, 230 USPQ 546. The factors include: 1) The nature of the invention, 2) the state of the prior art, 3) the predictability or lack thereof in the art, 4) the amount of direction or guidance present, 5) the presence or absence of working examples, 6) the breadth of the claims, and 7) the quantity of experimentation needed. The determination that “undue experimentation” would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations.
Nature of the Invention and Breath of the Claims
Instant claim 1 is drawn to a method of treating or preventing a cardiovascular disease or disorder, comprising administering to a subject in need thereof a solid form of Compound X. The specification teaches Compound X is a PDE9 inhibitor (see paragraph [0145]: present disclosure provides method of inhibiting PDE9). Instant claims 2-5 depend from claim 1, recite Forms A-D, and include the limitations treating or preventing a cardiovascular disease or disorder.
Instant claim 6 depends from claim 1 and recites the cardiovascular disease or disorder is systemic hypertension, pulmonary hypertension, congestive heart failure, coronary artery disease, atherosclerosis, stroke, thrombosis, post-percutaneous transluminal coronary angioplasty, peripheral vascular disease, renal disease associated with cardiovascular issues, angina (including stable, UI1 stable, and variant (Prinzmetal) angina), aorta disease, Marfan syndrome, heart muscle disease, congenital heart disease, deep vein thrombosis, heart failure, pericardial disease, heart valve disease, or rheumatic heart disease.
The specification teaches “treating" describes the management and care of a patient for
the purpose of combating a disease, condition, or disorder, and includes the administration of a
compound of the present application to alleviate the symptoms or complications of a disease,
condition or disorder, or to eliminate the disease, condition or disorder (see [0162]).
The specification teaches the term “preventing” describes reducing or eliminating the onset of
the symptoms or complications of the disease, condition or disorder (see [0163]).
Subject is not defined in the specification but would reasonably include humans.
The nature of the invention is thus a method of treating or preventing a cardiovascular disease in a subject comprising administration of Compound X and wherein the cardiovascular disease is treated or prevented by inhibition of PDE9. The specification teaches the cardiovascular disease or disorder may include systemic hypertension, pulmonary hypertension, congestive heart failure, coronary artery disease, atherosclerosis, stroke, thrombosis, conditions of reduced blood vessel patency ( e.g. post-percutaneous transluminal coronary angioplasty), peripheral vascular disease, renal disease associated with cardiovascular issues, angina (including stable, Ull stable, and variant (Prinzmetal) angina), aorta disease,
Marfan syndrome, heart muscle disease, congenital heart disease, deep vein thrombosis, heart failure, pericardia! disease, heart valve disease, rheumatic heart disease, and any condition where improved blood flow leads to improved end organ function ([0153]); however, the specification does not provide a closed definition of conditions embraced by a cardiovascular disease or disorder. Cardiovascular disease or disorder includes any condition or disease that affects the blood circulatory system. The broadest reasonable interpretation of a cardiovascular disease or disorder would include any condition which the prior art regards as affecting the blood circulatory system, which includes veins, arteries, capillaries and the heart itself. The scope of the claims therefore is very broad.
The state of the prior art
Cardiovascular Disease
Clinical Guide to Cardiovascular Disease, 2016, by Friedewald teaches there are 99 primary and distinct adult cardiovascular disorders which are conditions effecting the heart and blood vessels (Front Matter, Contents, About this Book). The state of the prior art recognizes that cardiovascular diseases are extremely varied, and some conditions are the opposite of others. For example, the heart can beat too fast or too slow; blood pressure can be too high or too low; an artery may be duplicated or may be missing. Cardiovascular diseases, disorders or conditions include, but are not limited to, various forms of acute rheumatic heart disease, including acute rheumatic pericarditis, acute rheumatic endocarditis (including acute rheumatic valvulitis) and acute rheumatic myocarditis. There are chronic rheumatic heart diseases, which include rheumatic mitral valve diseases (mitral stenosis, rheumatic mitral insufficiency, mitral stenosis with insufficiency and other mitral valve diseases including mitral valve failure); rheumatic aortic valve diseases (including rheumatic aortic stenosis (which includes aortic Stenosis, including valvular aortic stenosis, idiopathic hypertrophic sub-aortic stenosis (IHSS), subvalvular aortic stenosis, and supravalvular aortic stenosis), rheumatic aortic insufficiency and rheumatic aortic stenosis with insufficiency); rheumatic tricuspid valve diseases (such as tricuspid stenosis, tricuspid insufficiency and tricuspid stenosis with insufficiency); multiple valve diseases (including disorders of both mitral and aortic valves; disorders of both mitral and tricuspid valves, disorders of both aortic and tricuspid valves and combined disorders of mitral, aortic and tricuspid valves); and assorted other rheumatic heart diseases, including rheumatic myocarditis, rheumatic diseases of endocardium, chronic rheumatic pericarditis (including rheumatic adherent pericardium, chronic rheumatic mediastinopericarditis and chronic rheumatic myopericarditis), rheumatic disease of pulmonary valve, and rheumatic carditis. There are some corresponding nonrheumatic mitral valve disorders, which include nonrheumatic mitral valve insufficiency, mitral valve prolapse (e.g. floppy mitral valve syndrome) and mitral valve stenosis. There are nonrheumatic aortic valve disorders, including nonrheumatic aortic valve stenosis, aortic valve insufficiency, and aortic valve stenosis with insufficiency. There are nonrheumatic tricuspid valve disorders, including nonrheumatic tricuspid valve stenosis, tricuspid valve insufficiency, and tricuspid valve stenosis with insufficiency. There are an array of hypertensive diseases including essential (primary) hypertension; hypertensive heart disease (including hypertensive heart failure); hypertensive renal disease (which includes for example arteriosclerosis of kidney arteriosclerotic nephritis and hypertensive nephropathy as well as nephrosclerosis and assorted combined hypertensive heart and renal diseases); and secondary hypertension, including renovascular hypertension, hypertension secondary to other renal disorders or to endocrine disorders. Hypotensive disorders include Chronic hypotension, maternal hypotension syndrome, Idiopathic hypotension, postural Hypotension, Orthostatic hypotension, neurogenic orthostatic hypotension, hypotension due to drugs, and cardiovascular collapse. The ischemic heart diseases include angina pectoris (such as various forms of unstable angina, including intermediate coronary syndrome and preinfarction syndrome; angina pectoris with spasm, including angiospastic angina and prinzmetal angina; angina of effort; stenocardia; anginal syndrome and ischemic chest pain); acute myocardial infarction (which includes acute transmural myocardial infarction of anterior wall, acute transmural myocardial infarction of inferior wall and acute transmural myocardial infarction of other sites); subsequent myocardial infarction (which can again be at the anterior wall, the inferior wall or at other sites); assorted complications following acute myocardial infarction (complications include hemopericardium, atrial septal defect (which comes in multiple forms, including ostium secundum atrial septal defect, ostium primum atrial septal defect, sinus venosus atrial septal defect, and common or single atrium), ventricular septal defect, rupture of cardiac wall , or of chordae tendineae of papillary muscle as well as thrombosis of atrium, auricular appendage, and ventricle, all as current complications following acute myocardial infarction); as well as other acute ischemic heart diseases, including transient myocardial ischemia of newborn and Dressler's syndrome. There are also a variety of chronic ischemic heart disease, including atherosclerotic heart disease (including coronary atheroma and sclerosis), heart aneurysm (mural or ventricular as well as acquired coronary arteriovenous fistula), ischemic cardiomyopathy, silent myocardial ischemia and more.
The state of the prior art is unaware of any single therapy or pharmaceutical agent that treats all varied forms of disease embraced by the term “cardiovascular disease”. Nor is the state of the prior art aware that any therapy prevents cardiovascular disease generally.
Cardiovascular Disease and PDE9
The state of the prior art recognizes that heart failure (HF) may be treated by inhibition of PDE9. Scott et al. (Journal of the American College of Cardiology 2019, Vol 74, No. 7, pages 889-901) teaches PDE9-I improves NP efficacy in conjunction with beneficial hemodynamic and renal effects in experimental HF. These results support a role for PDE9 in HF pathophysiology and suggest its inhibition may constitute a novel therapeutic approach to this disease (Title and Abstract).
The state of the prior, however, is not aware that inhibition of PDE9 is a general strategy for treating or preventing the highly varied conditions embraced as a “cardiovascular disease”.
The Level of One of Ordinary Skill
The level of skill in the art is high. The artisan using the claimed invention would be a person with medical training such as a medical doctor or physician with an MD degree or the equivalent
Predictability in the art
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved”. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is a reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
Amount of guidance/working examples
Applicant teaches a variety of physiological processes in the cardiovascular, nervous and immune systems are controlled by the NO/cGMP pathway, including ion channel conductance, glycogenolysis,
cellular apoptosis, and smooth muscle relaxation. In blood vessels, relaxation of vascular smooth
muscles leads to vasodilation and increased blood flow. By reducing or preventing the hydrolysis
of cGMP by PDE9, PDE9 inhibitors elevate the intracellular level of cGMP, thus enhancing or
prolonging its effects (paragraph [0003] of the specification).
Applicant further teaches the invention treats cardiovascular disease (see paragraphs [0145]-[0147] of the specification) including systemic hypertension, pulmonary hypertension, congestive heart failure, coronary artery disease, atherosclerosis, stroke, thrombosis, conditions of reduced blood vessel patency ( e.g. post-percutaneous transluminal coronary angioplasty), peripheral vascular disease, renal disease associated with cardiovascular issues, angina (including stable, Ull stable, and variant (Prinzmetal) angina), aorta disease, Marfan syndrome, heart muscle disease, congenital heart disease, deep vein thrombosis, heart failure, pericardia! disease, heart valve disease, rheumatic heart disease, and any condition where improved blood flow leads to improved end organ function (see paragraph [0153]).
However, Applicant has provided no data to show that Compound X treats any condition embraced by the claims. Moreover, no evidence is provided to show that PDE9 is associated with the entire scope of conditions embraced by the claims. Or that an increase in cGMP is associated with treating cardiovascular disease generally. Heart failure appears to be the only cardiovascular disease that is associated with PDE9 and heart failure does not represent the entire scope of conditions embraced by the claims.
As per “preventing”, there is no evidence in the record to suggest the claimed invention prevents any condition claimed. It is presumed “prevention” of the claimed disease would require a method of identifying those individuals who will develop the claimed diseases before they exhibit symptoms. Nothing in the specification teaches how one skilled in the art identifies a subject who’s disease will be prevented.
The quantity of experimentation needed:
MPEP 2164.01(a) states, "A conclusion of lack of enablement means that, based on theevidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)."
That conclusion is clearly justified here and one skilled in the art could not practice the full scope of the claimed invention without undue experimentation.
This rejection could be overcome by amending claims to recite a method of treating heart failure.
Claim Rejections - 35 USC § 112b
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 applicant regards as his invention.
Claims 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 6, the word "including" renders the claim indefinite because it is unclear whether the limitation(s) following “including” are part of the claimed invention. Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites the broad recitation “heart failure”, and the claim also recites “congestive heart failure” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,012,412. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the patent claims.
The instant claims are drawn to a method of treating or preventing a cardiovascular disease or disorder, including heart failure, comprising administering to a subject in need thereof a solid form of Compound X:
PNG
media_image1.png
585
925
media_image1.png
Greyscale
Patent claim 1 is drawn to a solid form of compound X.
PNG
media_image2.png
375
297
media_image2.png
Greyscale
Patent claims 2-19 depend form claim 1 and recite limitations of Forms A-D of Compound X.
Compound X and Forms A-D of the patent claims corresponds to the same Compound X and Forms A-D of the instant claims.
The patent claims do not recite a method of treatment. However, the patent specification teaches Compound X is useful for treating a cardiovascular disease or disorder including heart failure (col 25, lines 5-20; col 26, lines 25-40). In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See also Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008);Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
The difference between the patent claims and the instant claims is that the instant claims are drawn to a method of treating a cardiovascular disease or disorder comprising administering to a subject in need thereof a solid form of Compound X. However, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the instant application to use Compound X of the patent in a method of treating a cardiovascular disease or disorder, as claimed, because Compound X of the patent claims was disclosed to be useful for treating a cardiovascular disease or disorder.
One would have been motivated to use Compound X as a matter of practicing the patented invention which the patent taught was useful for treating a cardiovascular disease or disorder.
One would have had a reasonable expectation of success because the patent specification taught that Compound X was useful for treating a cardiovascular disease or disorder.
Claims 7-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,012,412 in view of Jones (Pharmaceutical Formulation, CH 1 Preformulation Studies, 2018, pages 1-20) (hereinafter “Jones”).
The instant claims are drawn to a pharmaceutical composition comprising a solid form of Compound X and a pharmaceutically acceptable excipient.
The patent claims and disclosed utility of Compound X were discussed above and are incorporated herein by reference.
The patent claims do not recite a pharmaceutical composition Comprising compound X and a pharmaceutically acceptable excipient. However, Jones teaches that during the development of a new medical product the candidate drug must be formulated into a dosage form that is appropriate for the intended study such as in vivo efficacy and safety studies in relevant animal species, first-in-human studies to determine the optimum drug to progress into clinical development, initial volunteer/patient studies and full-scale clinical trials. The nature and composition of the formulations will be different for each stage of development but the formulation chosen for full-scale clinical trials must, as far as possible, be the same as the product that is intended for marketing (page 1, paragraphs 2-3; page 2 Figures 1.1 and 1.2). Jones teaches to ensure that the various formulations are optimized for their intended use, pre-formulation studies should be conducted not only to evaluate the characteristics of candidate drugs but also potential formulation excipients, and their interactions with drug substances, in order to select appropriate formulation ingredients (page 2).
A drug candidate that is formulated into a dosage as disclosed by Jones corresponds to a pharmaceutical composition.
The difference between the patent claims and the instant claims is that the instant claims recite a pharmaceutical composition comprising Compound X and a pharmaceutically acceptable excipient. However, in view of Jones it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the patent claims into a pharmaceutical composition comprising Compound X and a pharmaceutically acceptable excipient because Compound X was reportedly useful for treating cardiovascular disease (patent specification) and it was known that pharmaceutically active compounds required formulation with excipients to create a dosage for further studies such as evaluation of the compound in in vivo efficacy and safety studies in relevant animal species or first-in-human studies to determine the optimum drug to progress into clinical development.
One would have been motivated as a matter of evaluating the use of Compound X in the treatment of a cardiovascular disease. One would have formulated Compound X into a pharmaceutical composition with a pharmaceutically acceptable excipient in order to study the use of the compound in in vivo efficacy and safety studies of cardiovascular disease or first-in-human studies to determine the optimum drug to progress into clinical development.
One would have had a reasonable expectation of success because Compound X was already claimed and was disclosed to be useful for treating cardiovascular disease, and it was known that a pharmaceutically active compound such as Compound X needed to formulated into an appropriate dosage for further evaluation.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN MARTIN whose telephone number is (571)270-0917. The examiner can normally be reached Monday - Friday 8 am - 5 pm.
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 Murray can be reached on (571) 272-9023. 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.
April 2, 2026
/KEVIN S MARTIN/Examiner, Art Unit 1624
Prosecution Insights