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 1-19 are pending and are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/02/2023 and 02/24/2023 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. See attached copy of the PTO-1449.
Priority
This application claims the benefit of and priority to U.S. Provisional Application Serial No. 63/047,546, filed on July 2, 2020, and to U.S. Provisional Application Serial No. 63/180,715, filed on April 28, 2021.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1,5 ,9 and 15 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated by Slominski et al. (US 2014/0200201 hereinafter Slominski, reference already of record)
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C.102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Instant claims are drawn to a pharmaceutical composition, comprising a therapeutically effective amount of an active agent or a pharmaceutically acceptable salt of the active agent, and a pharmaceutically acceptable carrier, to treat a condition, wherein the active agent is selected from the group consisting of: 9P,10a-cholesta-5,7-diene-38,24-diol, 9p,10a-cholesta-5,7-diene- 3P,25-diol, 9P,10a-cholesta-5,7-diene-38,22-diol, 9P,10a-cholesta-5,7-diene-38,20-diol, cholesta-5,7-dien-38,20-diol, cholesta-5,7-dien-38,22-diol, cholesta-5,7-dien-38,25-diol, 3P- hydroxypregna-5,7-dien-20-one, (3S,5Z,7E)-9,10-secocholesta-5,7,10(19)-trien-3, 20-diol, (3S,5Z,7E)-9,10-secocholesta-5,7,10(19)-trien-3, 20, 23-trio, and optionally(3S,5Z,7E)-9,10- secocholesta-5,7,10(19)-trien-1, 3, 20-triol, 9P,10a-cholesta-5,7-diene-38,20,22-triol, and 9P,10a-cholesta-5,7-diene-38,27-diol, , and combinations thereof (Claim 1) and A method of treating a condition comprising: administering to a subject in need thereof, a pharmaceutical composition, wherein the pharmaceutical composition includes a therapeutically effective amount of an active agent or a pharmaceutically acceptable salt of the active agent, and a pharmaceutically acceptable carrier, wherein the active agent is selected from the group consisting of: 9P,10a-cholesta-5,7-diene-38,24-diol, 9p,10a-cholesta-5,7-diene- 3P,25-diol, 9P,10a-cholesta-5,7-diene-38,22-diol, 9P,10a-cholesta-5,7-diene-38,20-diol, cholesta-5,7-dien-38,20-diol, cholesta-5,7-dien-38,22-diol, cholesta-5,7-dien-38,25-diol, 3P- hydroxypregna-5,7-dien-20-one, (3S,5Z,7E)-9,10-secocholesta-5,7,10(19)-trien-3, 20-diol, (3S,5Z,7E)-9,10-secocholesta-5,7,10(19)-trien-3, 20, 23-triol, and optionally(3S,5Z,7E)-9,10- secocholesta-5,7,10(19)-trien-1, 3, 20-triol, 9P,10a-cholesta-5,7-diene-38,20,22-triol, and 9P,10a-cholesta-5,7-diene-38,27-diol, and combinations thereof (Claim 9).
Slominski discloses a pharmaceutical composition (para [0102]), comprising a therapeutically effective amount of an active agent (para [0102}) or a pharmaceutically acceptable salt of the active agent, and a pharmaceutically acceptable carrier (para [0102}), to treat a condition (para [0103): "the compounds and ether and ester derivatives thereof of Tables 1A-1B and 2A-2B may be efficacious as therapeutics or adjuvant therapeutics for various diseases, disorders"), wherein the active agent is selected from the group consisting of: 9β, 10α-cholesta-5,7-diene-3β,24-diol, 9β, 10α-cholesta-5,7-diene-3β,25-dio!, 9β, 10α-cholesta- 5,7-diene-3β,22-diol, 9β, 10α-cholesta-5,7-diene-3β,20-diol (para [0093], Table 1, compound 3cL), cholesta-5,7-dien- 3β,20-diol, cholesta-5,7-dien-3bβ,22-diol, cholesta-5,7-dien-3β,25-diol, 3β-hydroxypregna-5,7-dien-20-one, (3S,5Z,7E)-9,10- secocholesta-5,7,10(19)-trien-3,20-diol, (3S,5Z,7E)-9, 10-secocholesta-5,7,10(19)-trien-3,20,23-triol, and optionally (3S,5Z,7E)-9,10- secocholesta-5,7,10(19)-trien-1,3,20-triol, 9β, 10α-cholesta-5,7-diene-3bβ,20,22-triol, and 9β, 10α-cholesta-5,7-diene- 3β,27-diol and combinations thereof. Regarding claim 9, Slominski discloses a method (para [0093)) of treating a condition (para [0103]) comprising: administering to a subject in need thereof (para [0069]), a pharmaceutical composition (para (0102]), wherein the pharmaceutical composition includes a therapeutically effective amount of an active agent (para (0102]) or a pharmaceutically acceptable salt of the active agent, and a pharmaceutically acceptable carrier (para [0102]), wherein the active agent is selected from the group consisting of: 9β, 10α-cholesta-5,7-diene-3β,24-diol, 9β, 10α-cholesta-5,7-diene-3β,25-dio!, 9β, 10α-cholesta- 5,7-diene-3β,22-diol, 9β, 10α-cholesta-5,7-diene-3β,20-diol (para [0093], Table 1, compound 3cL), cholesta-5,7-dien- 3β,20-diol, cholesta-5,7-dien-3bβ,22-diol, cholesta-5,7-dien-3β,25-diol, 3β-hydroxypregna-5,7-dien-20-one, (3S,5Z,7E)-9,10- secocholesta-5,7,10(19)-trien-3,20-diol, (3S,5Z,7E)-9, 10-secocholesta-5,7,10(19)-trien-3,20,23-triol, and optionally (3S,5Z,7E)-9,10- secocholesta-5,7,10(19)-trien-1,3,20-triol, 9β, 10α-cholesta-5,7-diene-3bβ,20,22-triol, and 9β, 10α-cholesta-5,7-diene- 3β,27-diol and combinations thereof. They further disclose wherein the treatment is suitable for human [0094]
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is also noted that, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430,433 (CCPA 1977). See also MPEP § 2112.01 with regard to inherency and product-by-process claims. In addition, it is also noted that “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). As such the instantly claimed mechanistic functions of the buffering agents such as sodium acetate, ammonium solution, ammonium carbamate etc. to have alkalinizing property which would increase the pH of the composition to above 7 would be present in these agents taught by Gambhire et al. as buffering agents and would therefore elicit these effects whenever it is administered.
Therefore the composition disclosed by Slominski fully anticipates instant claims 1 and 9.
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 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.
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 1-19 are rejected under 35 U.S.C. 103(a) as being unpatentable over by Slominski et al. (US 2014/0200201 hereinafter Slominski, reference already of record) in view of Grant et al ( Nutrients 2020, 12, 988;1-19) and Umhau (Infectious disease , March 2020, pages 1-4)
Instant claims are drawn to a pharmaceutical composition, comprising a therapeutically effective amount of an active agent or a pharmaceutically acceptable salt of the active agent, and a pharmaceutically acceptable carrier, to treat a condition, wherein the active agent is selected from the group consisting of: 9P,10a-cholesta-5,7-diene-38,24-diol, 9p,10a-cholesta-5,7-diene- 3P,25-diol, 9P,10a-cholesta-5,7-diene-38,22-diol, 9P,10a-cholesta-5,7-diene-38,20-diol, cholesta-5,7-dien-38,20-diol, cholesta-5,7-dien-38,22-diol, cholesta-5,7-dien-38,25-diol, 3P- hydroxypregna-5,7-dien-20-one, (3S,5Z,7E)-9,10-secocholesta-5,7,10(19)-trien-3, 20-diol, (3S,5Z,7E)-9,10-secocholesta-5,7,10(19)-trien-3, 20, 23-trio, and optionally(3S,5Z,7E)-9,10- secocholesta-5,7,10(19)-trien-1, 3, 20-triol, 9P,10a-cholesta-5,7-diene-38,20,22-triol, and 9P,10a-cholesta-5,7-diene-38,27-diol, , and combinations thereof (Claim 1) and A method of treating a condition comprising: administering to a subject in need thereof, a pharmaceutical composition, wherein the pharmaceutical composition includes a therapeutically effective amount of an active agent or a pharmaceutically acceptable salt of the active agent, and a pharmaceutically acceptable carrier, wherein the active agent is selected from the group consisting of: 9P,10a-cholesta-5,7-diene-38,24-diol, 9p,10a-cholesta-5,7-diene- 3P,25-diol, 9P,10a-cholesta-5,7-diene-38,22-diol, 9P,10a-cholesta-5,7-diene-38,20-diol, cholesta-5,7-dien-38,20-diol, cholesta-5,7-dien-38,22-diol, cholesta-5,7-dien-38,25-diol, 3P- hydroxypregna-5,7-dien-20-one, (3S,5Z,7E)-9,10-secocholesta-5,7,10(19)-trien-3, 20-diol, (3S,5Z,7E)-9,10-secocholesta-5,7,10(19)-trien-3, 20, 23-triol, and optionally(3S,5Z,7E)-9,10- secocholesta-5,7,10(19)-trien-1, 3, 20-triol, 9P,10a-cholesta-5,7-diene-38,20,22-triol, and 9P,10a-cholesta-5,7-diene-38,27-diol, and combinations thereof (Claim 9) where in the condition is COVID-19 or acute respiratory distress syndrome, administered in the form of inhalant or parenteral at dosage of 2-60 µg/kg wherein in the subject is human or domesticated animal.
Slominski discloses a pharmaceutical composition (para [0102]), comprising a therapeutically effective amount of an active agent (para [0102}) or a pharmaceutically acceptable salt of the active agent, and a pharmaceutically acceptable carrier (para [0102}), to treat a condition (para [0103): "the compounds and ether and ester derivatives thereof of Tables 1A-1B and 2A-2B may be efficacious as therapeutics or adjuvant therapeutics for various diseases, disorders"), wherein the active agent is selected from the group consisting of: 9β, 10α-cholesta-5,7-diene-3β,24-diol, 9β, 10α-cholesta-5,7-diene-3β,25-dio!, 9β, 10α-cholesta- 5,7-diene-3β,22-diol, 9β, 10α-cholesta-5,7-diene-3β,20-diol (para [0093], Table 1, compound 3cL), cholesta-5,7-dien- 3β,20-diol, cholesta-5,7-dien-3bβ,22-diol, cholesta-5,7-dien-3β,25-diol, 3β-hydroxypregna-5,7-dien-20-one, (3S,5Z,7E)-9,10- secocholesta-5,7,10(19)-trien-3,20-diol, (3S,5Z,7E)-9, 10-secocholesta-5,7,10(19)-trien-3,20,23-triol, and optionally (3S,5Z,7E)-9,10- secocholesta-5,7,10(19)-trien-1,3,20-triol, 9β, 10α-cholesta-5,7-diene-3bβ,20,22-triol, and 9β, 10α-cholesta-5,7-diene- 3β,27-diol and combinations thereof. Regarding claim 9, Slominski discloses a method (para [0093)) of treating a condition (para [0103]) comprising: administering to a subject in need thereof (para [0069]), a pharmaceutical composition (para (0102]), wherein the pharmaceutical composition includes a therapeutically effective amount of an active agent (para (0102]) or a pharmaceutically acceptable salt of the active agent, and a pharmaceutically acceptable carrier (para [0102]), wherein the active agent is selected from the group consisting of: 9β, 10α-cholesta-5,7-diene-3β,24-diol, 9β, 10α-cholesta-5,7-diene-3β,25-dio!, 9β, 10α-cholesta- 5,7-diene-3β,22-diol, 9β, 10α-cholesta-5,7-diene-3β,20-diol (para [0093], Table 1, compound 3cL), cholesta-5,7-dien- 3β,20-diol, cholesta-5,7-dien-3bβ,22-diol, cholesta-5,7-dien-3β,25-diol, 3β-hydroxypregna-5,7-dien-20-one, (3S,5Z,7E)-9,10- secocholesta-5,7,10(19)-trien-3,20-diol, (3S,5Z,7E)-9, 10-secocholesta-5,7,10(19)-trien-3,20,23-triol, and optionally (3S,5Z,7E)-9,10- secocholesta-5,7,10(19)-trien-1,3,20-triol, 9β, 10α-cholesta-5,7-diene-3bβ,20,22-triol, and 9β, 10α-cholesta-5,7-diene- 3β,27-diol and combinations thereof. They further disclose wherein the treatment is suitable for human [0094]. Slominski discloses that the UVB driven photolysis of the steroidal B ring of cholesta-5,7-dien-3.beta.-ol (7-dehydrocholesterol, 7DHC) with further rearrangement of the activated molecule (pre-D3) generates vitamin D3 ((5Z,7E)-9,10-secocholesta-5,7,10(19)-trien-3.beta.-ol, cholecalciferol, D3), tachysterol (6E)-9,10-secocholesta-5(10),6,8-trien-3.beta.-ol, T3) and luminosterol (9.beta.,10.alpha.-cholesta-5,7-dien-3.beta.-ol, L3) (1-3). Vitamin D3 (D3), the main product of the process plays a fundamental role in biology, serving as a precursor for the hormone 1,25-dihydroxyvitamin D3 ((5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-1.alpha.,3.beta.,25-triol, 1,25(OH).sub.2D3, calcitiol) with its most fundamental role in the regulation of body calcium homeostasis (2, 4-5) [0006]. They also disclose that mammalian cytochrome P450scc (CYP11A1), in addition to its role in the conversion of cholesterol to pregnenolone for steroid synthesis, can also metabolize vitamins D2 and D3, as well as their provitamin precursors ergosterol and 7-dehydrocholesterol (cholesta-5,7-dien-3.beta.-ol, 7DHC) (6-10). P450scc converts vitamin D3 to 20-hydroxycholecalciferol ((5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-3.beta.,20-diol, 20(OH)D3) and di- and tri-hydroxycholecalciferol in a sequential and stereospecific, manner with initial formation of 20(S)-hydroxycholecalciferol [0008]. They further disclose that the compounds of their invention may be used to treat an autoimmune disease or inflammatory processes caused by the action of NfkB against proliferating cells or immune cells [0099].
Slominski fails to disclose where in the condition is COVID-19 or acute respiratory distress syndrome, administered in the form of inhalant or parenteral at dosage of 2-60 µg/kg wherein in the subject is human or domesticated animal
However, Grant et al. discloses roles of vitamin D (and thus inherently metabolites of Vitamin D as instantly claimed) in reducing the risk of respiratory tract infections, knowledge about the epidemiology of influenza and COVID-19, and how vitamin D supplementation might be a useful measure to reduce risk. Through several mechanisms, vitamin D can reduce risk of infections. Those echanisms include inducing cathelicidins and defensins that can lower viral replication rates and reducing concentrations of pro-inflammatory cytokines that produce the inflammation that injures the lining of the lungs, leading to pneumonia, as well as increasing concentrations of anti-inflammatory cytokines. Several observational studies and clinical trials reported that vitamin D supplementation reduced the risk of influenza, whereas others did not. Evidence supporting the role of vitamin D in reducing risk of COVID-19 includes that the outbreak occurred in winter, a time when 25-hydroxyvitamin D (25(OH)D) concentrations are lowest; that the number of cases in the Southern Hemisphere near the end of summer are low; that vitamin D deficiency has been found to contribute to acute respiratory distress syndrome; and that case-fatality rates increase with age and with chronic disease comorbidity, both of which are associated with lower 25(OH)D concentration. To reduce the risk of infection, it is recommended that people at risk of influenza and/or COVID-19 consider taking 10,000 IU/d of vitamin D3 for a few weeks to rapidly raise 25(OH)D concentrations, followed by 5000 IU/d. The goal should be to raise 25(OH)D concentrations above 40–60 ng/mL (100–150 nmol/L) (abstract and the entire document).
Umhau discloses that lack of sun-induced vitamin D (and thus inherently metabolites of Vitamin D as instantly claimed) in the winter and early spring leads to epidemic (and this probably includes viruses like COVID-1) (page .2, 1st para). They disclose that vitamin D supplementation is safe and that it protects against acute respiratory tract infection and that there are several mechanisms by which vitamin D activity is critical for immune defense: vitamin D acts to maintain tight junctions, promote the effect of antimicrobial peptides (i.e., cathelicidin and defensins), and . (page 2, 3rd para to page 3, 1st paragraph)
As such it would have been prima facia obvious to a person of ordinary skill in the art to arrive at the instant claims motivated and guided by the combined teachings of Slominski, Grant et al. and Umhau. An ordinarily skilled artisan would be motivated from Slominski to utilize their inventive vitamin D3 metabolites in conditions such as cancer and other conditions where the patients are immune compromised. Grant et al. and Umhau provide motivation to use Vitamin D3 in the treatment of viral infections, and respiratory tract infection and COVID 19. The instantly claimed metabolites of Vitamin D3 would inherently have the same properties of Vitamin D3 in terms of its therapeutic potential and as such an ordinarily skilled artisan would be motivated to use the agents described by Slominski in the treatment of COVID-19 or acute respiratory infections, absence of evidence to the contrary.
With regards to instant claims 7, 10, 11, 14 and 17.Slominski teaches that their compounds or pharmaceutical compositions may be administered by any method standard in the art and suitable for administration to the subject [0101]. The compounds and composition thereof may be administered independently one or more times to achieve, maintain or improve upon a pharmacologic or therapeutic effect. It is well within the skill of an artisan to determine dosage or whether a suitable dosage comprises a single administered dose or multiple administered doses. An appropriate dosage depends on the subject's health, the progression or remission of the disease or disorder, the route of administration and the formulation used [0102]. As such absence of evidence to the contrary optimization of dosage, routes of administration and the treatment regimen for any drug is well within the purview of the person or ordinary skill in pharmaceutical and pharmacological arts and it would be obvious for them to arrive at the instant claims. Further with regards to dosage, It is noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With regards to instant claim 18, the combined teachings from the references above teach the utility of the instantly claimed compounds in treating viral infections for the various benefits they provide and as such a person of ordinary skill would be motivated to use the in conditions which are related to HIV, hepatitis or influenza as each of these conditions affect the subject’s immunity.
With regards to instant claims 6 and 16, the benefits provided by the treatment with the claimed compositions as taught by the combined teachings of the references above would motivate a skilled artisan to also use this in veterinary art to treat domesticated animals, absence of evidence to the contrary.
As such a person of ordinary skill in the art would be imbued with a reasonable expectation of success in treating all viral infections and acute respiratory distress syndrome with the instantly claimed compositions , absence of evidence to the contrary.
Conclusion
Claims 1-19 are rejected. No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAVITHA RAO whose telephone number is (571)270-5315. The examiner can normally be reached on Mon-Fri 7 am to 4 pm..
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dierdre (Renee) Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SAVITHA M RAO/Primary Examiner, Art Unit 1691