DETAILED ACTION
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 .
Priority
This application is a national stage entry of PCT/ES2021/070228 filed on 04/06/2021. Acknowledgment is made of applicant's claim for foreign priority based on an application filed in SPAIN (P202030281) on 04/06/2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Accordingly, the effective filing date is 04/06/2021.
Claim Objections
Claims 7-11 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n).
Claim Rejections - 35 USC § 112
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 9-11 are 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.
Claim 9 of the instant application claims the compound, the composition, or the combined preparation for use according to any of claims 1-8, wherein 2 capsules containing 266 mg of the compound of formula II (calcifediol) are administered at the start of the treatment, and 1 capsule is administered on days 3, 7, 15, and 30. Claim 9 is drawn to a product claim, however, the language of the claim is consistent with a process of using claim since it recites an administration step. Thus it is unclear if the claim should be treated as a product claim or a process claim. However, since all claims are drawn to product claims, including the claims in which claim 9 is dependent on, for the sake of compact prosecution, claim 9 is being interpreted as a product claim and examined herewith. Accordingly, the limitation, wherein 2 capsules containing 266 mg of the compound of formula II (calcifediol) are administered at the start of the treatment, and 1 capsule is administered on days 3, 7, 15, and 30 are interpreted as intended use and not afforded patentable weight.
Claims 10 and 11 recite the limitation "the antiviral” according to claim 2 or 3. There is insufficient antecedent basis for this limitation in the claim since claims 2 or 3 from which claims 10 and 11 depend do not recite antiviral.
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.
(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 1-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bishop et al. U.S. Publication No. 2021/0308151 A1 (earliest priority date of April 6, 2020).
Claims 1-11 of the instant application claim a compound of formula (II):
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which is calcifediol also known as 25-hydroxyvitamin D3, calcidiol, 25-hydroxycholecalciferol, and 25(OH)D3, and is the active form of vitamin D3 (cholecalciferol) wherein vitamin D3 has the following structure:
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, or any of the pharmaceutically acceptable salts, esters, tautomers, solvates, and hydrates thereof, or any combinations thereof, for the prevention, improvement, mitigation, or treatment of acute respiratory distress syndrome.
Bishop et al. teaches methods of treating COVID-19 in a subject in need thereof, comprising administering to the subject a 25-hydroxyvitamin D compound (abstract). Bishop et al. also teaches a hard capsule dosage form of 25-hydroxyvitamin wherein the 25-hydroxyvitamin D is administered as a controlled release formulation, optionally an extended release oral formulation, such as Rayaldee® extended release calcifediol capsules (abstract). Bishop et al. teaches methods of treating SARS-CoV-2 infection including reducing SARS-CoV-2 viral load and increasing an immune response (abstract). Bishop et al. teaches treatment of SARS-CoV-2 infection, more particularly, treatment of SARS-CoV-2 infection with calcifediol, including extended release calcifediol (ERC), and characterized by a target serum total 25-hydroxyvitamin D concentration threshold [0003]. Bishop et al. teaches methods of treating SARS-CoV-2 infection with calcifediol [0030].
Bishop et al. further teaches the administration of 25-hydroxyvitamin D and treatment of COVID-19 as described therein can be performed in the presence of additional therapies, for example, additional treatments for COVID-19 can include one or more compounds in the classes of, antivirals, antimalarials (chloroquine, hydroxychloroquine), and antibiotics [0146]. Bishop et al. teaches the anti-viral agents can include ribavirin, remdesivir etc. [0147].
Thus the cited claims of the instant application are anticipated since Bishop et al. specifically teaches a compound of formula (II):
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which is calcifediol also known as 25-hydroxyvitamin D3, calcidiol, 25-hydroxycholecalciferol, and 25(OH)D3. Moreover, even though the claims recite the compound is for the prevention, improvement, mitigation, or treatment of acute respiratory distress syndrome, wherein the acute respiratory distress syndrome is due to coronavirus infection specifically coronavirus 2, which is an intended use, Bishop et al. specifically teaches that the calcifediol compound useful in a method for treating COVID-19 or SARS-CoV-2 infection.
It is respectfully pointed out that a recitation of an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Thus since Bishop et al. teaches the same calcifediol compound, the compound of Bishop is inherently capable of the prevention, improvement, mitigation, or treatment of acute respiratory distress syndrome, wherein the acute respiratory distress syndrome is due to coronavirus infection specifically coronavirus 2 as claimed in the instant claims.
Claims 3-8, 10 and 11 are anticipated since Bishop et al. specifically teaches combining the calcifediol with antiviral agents including remdesivir or antimalarial agents including chloroquine and hydroxychloroquine [0146]-[0147]. Claim 9 is anticipated since Bishop et al. teaches the same compound as claimed and specifically teaches a capsule dosage form and as such said compound in capsule form is inherently capable of being administered as claimed in claim 9 of the instant application.
Thus the cited claims of the instant application are rejected in view of the teachings of Bishop et al.
Claims 1-2 and 7-9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Endo et al. JP-2018131423A (Machine English translation provided).
Claims 1-2 and 7-9 of the instant application claim a compound of formula (II):
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which is calcifediol also known as 25-hydroxyvitamin D3, calcidiol, 25-hydroxycholecalciferol, and 25(OH)D3, and is the active form of vitamin D3 (cholecalciferol) wherein vitamin D3 has the following structure:
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, or any of the pharmaceutically acceptable salts, esters, tautomers, solvates, and hydrates thereof, or any combinations thereof, for the prevention, improvement, mitigation, or treatment of acute respiratory distress syndrome.
Endo et al. teaches an oral composition for preventing or relaxing upper respiratory tract infection containing 25-hydroxycholecalciferol as an active ingredient (abstract and page 2). Endo et al. teaches that the present invention relates to an oral composition for preventing upper respiratory tract infection or relieving symptoms of upper respiratory tract infection using 25-hydroxycholecalciferol as an active ingredient, wherein 25-hydroxycholecalciferol is a compound also referred to as 25(OH)D3 (page 3). Endo et al. specifically teaches preparing oral compositions of calcifediol in the form of tablets or capsules (pages 3, 4, 5, 7, and 14-15).
Thus the cited claims of the instant application are anticipated since Endo et al. specifically teaches a compound of formula (II):
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which is calcifediol also known as 25-hydroxyvitamin D3, calcidiol, 25-hydroxycholecalciferol, and 25(OH)D3. Moreover, even though the claims recite the compound is for the prevention, improvement, mitigation, or treatment of acute respiratory distress syndrome, which is an intended use, Endo et al. specifically teaches that the calcifediol compound useful in a method for treating and preventing upper respiratory tract infection.
Furthermore, it is respectfully pointed out that a recitation of an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Thus since Endo et al. teaches the same calcifediol compound, the compound of Endo et al. is inherently capable of the prevention, improvement, mitigation, or treatment of acute respiratory distress syndrome, wherein the acute respiratory distress syndrome is due to coronavirus infection specifically coronavirus 2 as claimed in the instant claims.
"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).
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, a rejection under 35 USC 102 is proper. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Please note that the discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).
Claim 9 is anticipated since Endo et al. teaches the same compound as claimed and specifically teaches a capsule dosage form and as such said compound in capsule form is inherently capable of being administered as claimed in claim 9 of the instant application.
Thus the cited claims of the instant application are rejected in view of the teachings of Endo et al.
Claims 1-3 and 7-9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tabash et al. U.S. Patent No. 8,207,149 B2.
Claims 1-3 and 7-9 of the instant application claim a compound of formula (II):
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which is calcifediol also known as 25-hydroxyvitamin D3, calcidiol, 25-hydroxycholecalciferol, and 25(OH)D3, and is the active form of vitamin D3 (cholecalciferol) wherein vitamin D3 has the following structure:
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, or any of the pharmaceutically acceptable salts, esters, tautomers, solvates, and hydrates thereof, or any combinations thereof, for the prevention, improvement, mitigation, or treatment of acute respiratory distress syndrome.
Tabash et al. teaches a stable, controlled release formulation for oral dosing of vitamin D compounds wherein the formulation is prepared by incorporating one or more vitamin D compounds into a solid or semi-solid mixture of waxy materials and the oral dosage forms can be prepared by melt-blending the components described therein and filling gelatin capsules with the formulation (abstract).
Tabash et al. specifically teaches supplementation with a controlled release 25-hydroxyvitamin D3 capsule which avoids unacceptable side effects related to calcium and PTH metabolism (see examples 1-7 in columns 22-31). Tabash et al. further specifically teaches a controlled release, oral dosage form of 25-hydroxyvitamin D to reduce the subject's serum parathyroid hormone level by at least 30% while safely raising serum total 25-hydroxyvitamin D, comprising 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, or a combination of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 (see claims 1-11). Thus Tabash et al. further teaches a combination of calcifediol and an additional active ingredient.
Thus the cited claims of the instant application are anticipated since Tabash et al. specifically teaches a compound of formula (II):
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which is calcifediol also known as 25-hydroxyvitamin D3, calcidiol, 25-hydroxycholecalciferol, and 25(OH)D3.
With respect to the claimed intended use, it is respectfully pointed out that a recitation of an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Thus since Tabash et al. teaches the same calcifediol compound, the compound of Tabash et al. is inherently capable of the prevention, improvement, mitigation, or treatment of acute respiratory distress syndrome, wherein the acute respiratory distress syndrome is due to coronavirus infection specifically coronavirus 2 as claimed in the instant claims.
"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).
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, a rejection under 35 USC 102 is proper. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Please note that the discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).
Claim 9 is anticipated since Tabash et al. teaches the same compound as claimed and specifically teaches a capsule dosage form and as such said compound in capsule form is inherently capable of being administered as claimed in claim 9 of the instant application.
Thus the cited claims of the instant application are rejected in view of the teachings of Tabash et al.
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.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Zeicher WO 2016/059247 A1.
Claims 1-9 of the instant application claim a compound of formula (II):
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which is calcifediol also known as 25-hydroxyvitamin D3, calcidiol, 25-hydroxycholecalciferol, and 25(OH)D3, and is the active form of vitamin D3 (cholecalciferol) wherein vitamin D3 has the following structure:
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, or any of the pharmaceutically acceptable salts, esters, tautomers, solvates, and hydrates thereof, or any combinations thereof, for the prevention, improvement, mitigation, or treatment of acute respiratory distress syndrome, in combination with at least one additional active ingredient such as chloroquine or hydroxychloroquine.
Zeicher teaches a pharmaceutical composition or kit of parts comprising at least three ingredients from a HMG-CoA reductase inhibitor, a leukotriene antagonist, a proton pump inhibitor, melatonin or a melatonin receptor agonist, a bioavailable preparation of a curcuminoid, a calciferol derivative, a compound from the group consisting of metformin and phenformin, valproate, minocycline and chloroquine and one or more pharmaceutically acceptable carriers or excipients (abstract). Zeicher teaches advantageously, the present invention relates to a pharmaceutical composition or a pharmaceutical kit of part comprising, a calciferol derivative, melatonin, curcumin and one or more compounds selected from the group consisting of an HMG-CoA reductase inhibitor, a proton pump inhibitor, metformin, phenformin, valproate, minocycline and chloroquine (page 2). Zeicher teaches, preferably, the pharmaceutical composition or the pharmaceutical kit of the present invention comprises melatonin and/or curcumin, a calciferol derivative, an HMG-CoA reductase inhibitor, and one or more compounds selected from the group consisting of a proton pump inhibitor, metformin, phenformin, valproate, minocycline and chloroquine (page 2).
Zeicher specifically teaches the pharmaceutical composition or the pharmaceutical kit of the present invention comprises melatonin and/or curcumin, a calciferol derivative, chloroquine, and one or more compounds selected from the group consisting of an HMG-CoA reductase inhibitor, a proton pump inhibitor, metformin, phenformin, valproate and minocycline (page 3). Zeicher teaches the calciferol derivative of the pharmaceutical composition or the pharmaceutical kit of part of the present invention is selected from the group consisting of alfacalcidol, calcifediol, calcitriol, cholecalciferol, ergocalciferol, 22-dihydroergocalciferol and sitocalciferol (pages 4 and 9). Preferably, the calciferol derivative is selected from the group consisting of alfacalcidol, calcifediol, calcitriol, cholecalciferol (Vitamin D3), ergocalciferol, 22- dihydroergocalciferol and sitocalciferol (page 21).
Zeicher does not specifically exemplify a composition comprising chloroquine and calcifediol.
However, Examples 1 and 2 of Zeicher specifically exemplifies combining cholecalciferol (Vitamin D3) with chloroquine (pages 25-28). Moreover, Zeicher specifically teaches that calcifediol is a suitable alternative for cholecalciferol (Vitamin D3). Accordingly, prior to the effective filing date based on the teachings of Zeicher, a person of ordinary skill in the art would have been motivated to combine chloroquine and calcifediol in addition to or instead of cholecalciferol (Vitamin D3) with a reasonable expectation of similar success. Thus substituting calcifediol for cholecalciferol would have been seen as a suitable alternative to yield predictable results. Thus, although Zeicher includes calcifediol on a list that includes other calciferol derivatives a prima facie case of obviousness can still be established since picking one of a finite number of known solutions to a known problem is prima facie obvious. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007).
With respect to the intended use as claimed, it is respectfully pointed out that a recitation of an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Thus since Zeicher teaches the same calcifediol compound combined with chloroquine, said combination of Zeicher is necessarily capable of the prevention, improvement, mitigation, or treatment of acute respiratory distress syndrome, wherein the acute respiratory distress syndrome is due to coronavirus infection specifically coronavirus 2 as claimed in the instant claims.
"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).
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Claim 9 is rendered obvious since Zeicher teaches a combination comprising the same active agents as claimed in the instant claims and as such said combination is necessarily capable of being administered as claimed in claim 9 of the instant application.
Thus the cited claims of the instant application are rejected in view of the teachings of Zeicher et al.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Hyman, April 1, 2020 A Functional Medicine Approach to COVID-19 (https://drhyman.com/blogs/content/a-functional-medicine-approach-to-covid-19) in view of Tabash et al. U.S. Patent No. 8,207,149 B2.
Claims 1-11 of the instant application claim a compound of formula (II):
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which is calcifediol also known as 25-hydroxyvitamin D3, calcidiol, 25-hydroxycholecalciferol, and 25(OH)D3, and is the active form of vitamin D3 (cholecalciferol) wherein vitamin D3 has the following structure:
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, or any of the pharmaceutically acceptable salts, esters, tautomers, solvates, and hydrates thereof, or any combinations thereof, for the prevention, improvement, mitigation, or treatment of acute respiratory distress syndrome due to coronavirus specifically coronavirus 2 in combination with at least one additional active ingredient such as chloroquine or hydroxychloroquine or remdesivir.
Hyman discusses supplements and medicines that have been shown to be promising for the treatment of COVID-19 infection. Hyman teaches vitamin D3 1000-4000 IU per day supports the immune function (pages 7-8). Hyman further teaches that the most promising medicines useful against COVID-19 infection are chloroquine or hydroxychloroquine and remdesivir (pages 8-9).
Thus, prior to the effective filing date of the claimed invention vitamin D3 and chloroquine, hydroxychloroquine and remdesivir were being used to treat COVID-19 infection. Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine these components with a reasonable expectation of producing an improved treatment for COVID-19. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose ....[T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850,205 USPQ 1069, 1072 (CCPA 1980).
Hyman does not teach calcifediol.
Tabash et al. teaches that an alternative to vitamin D3 supplementation is supplementation with a controlled release 25-hydroxyvitamin D3 capsule which avoids unacceptable side effects related to calcium and PTH metabolism (see examples 1-7 in columns 22-31).
Accordingly, prior to the effective filing date of the claimed invention, based on the teachings of Tabash et al. it would have been obvious to a person of ordinary skill in the art to substitute 25-hydroxyvitamin D3 for vitamin D3 with a reasonable expectation of similar or improved results in supporting the immune function to treat COVID-19 infection as taught by Hyman. Thus combining and administering promising medicines useful against COVID-19 infection including chloroquine or hydroxychloroquine and remdesivir with 25-hydroxyvitamin D3 to support immune function to treat COVID-19 is rendered obvious in view of the cited prior art teachings.
Claim 9 is rendered obvious since the prior art renders obvious a combination comprising the same active agents as claimed in the instant claims and as such said combination rendered obvious over the prior art teachings is necessarily capable of being administered as claimed in claim 9 of the instant application.
Thus claims 1-11 are rendered obvious in view of the cited prior art teachings.
Conclusion
Claims 1-11 are rejected. Claims 7-11 are further objected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA R. MCMILLIAN whose telephone number is (571)270-5236. The examiner can normally be reached Tuesday-Friday 12:00 PM-6:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM