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 .
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on Feb. 11, 2026 has been entered.
Status of the Claims
Claims 77, 79-85, 88, 105-107, and 110 are pending in this application. Claims 1-76, 78, 86-87, 89, 90-104, 108-109, and 111 have been canceled by applicant.
Claim Objections
Claim 80 is objected to because of the following informalities:
Claim is missing a period “.” at the end.
Appropriate correction is required.
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 79-81 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 regards as the invention.
Claim 79 is indefinite because it is unclear how D-carnitine can comprise L-carnitine.
Claims 80-81 are rejected for depending upon the limitations of claim 79.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 77, 79-85, 88, 105-107, and 110 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mixture of natural products without significantly more.
The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to carnitine (a natural product) without significantly more. The claims recite the use of carnitine salts or L-carnitine or valeryl L-carnitine as an angiotensin-converting enzyme-2 (ACE-2) reducing nutritional supplement with an auxiliary substance and a carrier (which includes naturally occurring sugars, sugar alcohols, etc.). This judicial exception is not integrated into a practical application because any bodily fluid that carries carnitine (i.e., blood) comprises carnitine, sugars, and an excipient (i.e. water). The claim has been given the broadest reasonable interpretation consistent with the excipients known in the art (In re Hyatt, 211 F.3d1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000) (see MPEP 2111).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they are drawn to a natural product. In addition, claims 77, 79-85, 88, 105-107, and 110 encompass carnitine in a bodily fluid.
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.
Claims 77, 79-85, 88, 105-107, and 110 are rejected under 35 U.S.C. 103 as being unpatentable over Dahl et al. (WO 00/35460 – previously cited) (“Dahl”).
Applicant is advised, the claims are drawn to a nutritional composition comprising an ACE-2 reducing supplement and auxiliary substances or excipients, wherein the ACE-2 reducing supplement is L-carnitine, for use in the treatment, prevention, or delay of progression of infection in a mammal. Thus, if the prior art discloses the claimed composition, then the prior art is capable of performing the intended use.
Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). 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.
Applicant is further advised, a recitation of the intended use of the claimed invention, such as the use of L-carnitine as an ACE-2 reducing component in a nutritional supplement for use in the treatment, prevention, and/or delay of progression of infection in a mammal caused by a coronavirus which binds to ACE-2, in the instant application, 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. Note: MPEP 2111.02.
Regarding claims 77, 79-85, 88, 105-107, and 110, Dahl discloses a composition comprising L-carnitine tartrate, microcrystalline cellulose (carrier), and hydrogenated vegetable oil (lubricant and binder) (page 39, end).
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Regarding claims 82-85, 88, 106-107, and 110, the supplement of claims 77 and 105 is discussed above; each of these claims are directed to a use of the claimed supplement, and therefore do not further limit structural components of the claimed supplement.
However, regarding claims 82-83, 106-107, Dahl teaches oral administration of their carnitine formulation (page 8, line 5).
Therefore, regarding the instant composition comprising L/D-carnitine or a mixture thereof in an amount from about 1000 mg-10000 mg, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Dahl teaches their composition comprising 24 % w/w L-carnitine tartrate. While Dahl’s composition is in the form of a 125 mg tablet, a person of ordinary skill would have had a reasonable expectation of success in scaling up their composition to meet the instantly claimed range of 1-10 g of L-carnitine tartrate.
MPEP 2144.04 (IV)(A) states: "mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability”. Furthermore, Applicant is advised that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01). The courts have also found that where 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. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05-II.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Claims 77, 79, 82-85, 88 are rejected under 35 U.S.C. 103 as being unpatentable over Manning et al. (US 2006/0088574 A1) (“Manning”).
Applicant is advised, the claims are drawn to a nutritional composition comprising an ACE-2 reducing supplement and auxiliary substances or excipients, wherein the ACE-2 reducing supplement is L-carnitine, for use in the treatment, prevention, or delay of progression of infection in a mammal. Thus, if the prior art discloses the claimed composition, then the prior art is capable of performing the intended use.
Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). 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.
Applicant is further advised, a recitation of the intended use of the claimed invention, such as the use of L-carnitine as an ACE-2 reducing component in a nutritional supplement for use in the treatment, prevention, and/or delay of progression of infection in a mammal caused by a coronavirus which binds to ACE-2, in the instant application, 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.
Regarding claims 77, 79, 82-85, 88, Manning discloses a vitamin and mineral premix comprising L-carnitine, calcium carbonate (carrier), and folic acid (antioxidant – auxiliary substance) [0303].
Regarding claims 82-85, and 88, the supplement of claim 77 is discussed above; each of these claims are directed to a use of the claimed supplement, and therefore do not further limit structural components of the claimed supplement.
However, regarding claims 82-83, Manning teaches oral administration of their carnitine formulation (abstract, line 1).
Therefore, regarding the instant composition comprising L/D-carnitine or a mixture thereof in an amount from about 1000 mg-10000 mg, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Manning teaches their composition comprising 31 mg of L-carnitine for every 6000 mg of composition. Thus, a person of ordinary skill would have had a reasonable expectation of success in scaling up their composition to meet the instantly claimed range of 1-10 g of L-carnitine.
MPEP 2144.04 (IV)(A) states: "mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability”. Furthermore, Applicant is reminded that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. The courts have also found that where 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.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
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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 77, 79-85, 88, 105-107, and 110 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8-10, 14, 16, 19-21, 23, 26-27, 30, 32-34, 36, 38, 39, 42-44, and 46 of copending Application No. 17/765,156 (Copending ‘156). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 77, 79, and 105, Copending ‘156 claims a composition for ingestion comprising L-carnitine in an amount less than 500 mg comprising a liquid carrier (Copending ‘156 claims 27 and 30).
Regarding instant claims 80-81 and 105, Copending ‘156 claims to a composition for ingestion comprising L-carnitine or a derivative thereof (reading on L-carnitine tartrate, valeryl L-carnitine, isovaleryl L-carnitine, etc.) (Copending ‘156 claim 27)
Regarding instant claims 82-85, 88, 106-107, and 110, the supplements of instant claims 77 and 105 are discussed above. Each of instant claims 82-85, 88, 106-107, and 110 are directed to a use of the claimed supplement, and therefore do not further limit structural components of the claimed supplement.
Applicant is reminded, a recitation of the intended use of the claimed invention, such as the use of L-carnitine as an ACE-2 reducing component in a nutritional supplement for use in the treatment, prevention, and/or delay of progression of infection in a mammal caused by a coronavirus which binds to ACE-2, in the instant application, 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.
Applicant is reminded that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. The courts have also found that where 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.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 77, 79-85, 88, 105-107, and 110 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3, 5-8, 11-15, 18-19, 21-26, 29, 31, and 33 of Copending Application No. 17/765,173 (Copending ‘173). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 77, 79, and 105, Copending ‘173 claims a composition for ingestion comprising L-carnitine in a liquid carrier, wherein the carnitine is 80% w/w of the composition (Copending ‘173 claims 21 and 26).
Regarding instant claims 80-81 and 105, Copending ‘173 speaks to a composition for ingestion comprising L-carnitine or a derivative thereof (reading on L-carnitine tartrate, valeryl L-carnitine, isovaleryl L-carnitine, etc.) (Copending claim 21)
Regarding instant claims 82-85, 88, 106-107, and 110, the supplements of instant claims 77 and 105 are discussed above. Each of instant claims 82-85, 88, 106-107, and 110 are directed to a use of the claimed supplement, and therefore do not further limit structural components of the claimed supplement.
Applicant is reminded, a recitation of the intended use of the claimed invention, such as the use of L-carnitine as an ACE-2 reducing component in a nutritional supplement for use in the treatment, prevention, and/or delay of progression of infection in a mammal caused by a coronavirus which binds to ACE-2, in the instant application, 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.
Applicant is reminded that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. The courts have also found that where 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.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Claims
Claim amendments are acknowledged. No new matter has been introduced.
Claim Rejections - 35 USC § 112(b)
Applicant’s arguments, see page 6, filed 02/11/2026, with respect to the 35 USC § 112(b) rejection(s) of the claim(s) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of claim amendments.
Claim Rejections - 35 USC § 101
Applicant's arguments filed 02/11/2026 have been fully considered but they are not persuasive.
Applicant asserts that claim elements are sufficient to constitute significantly more than the judicial exception – specifically, a carrier (as recited in claim) and an auxiliary substance (as recited in claim). Applicant asserts these elements are intentionally added to their claimed formulation and not equivalent to naturally occurring bodily fluids, asserting that the Office’s broadest reasonable interpretation (BRI) is not consistent with the specification. Applicant states, the claims are drawn to a man-made formulation, structurally different from any natural product alone, and states the structural differences imparted by a carrier and auxiliary substance are sufficient to satisfy the “significantly more” requirement.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
In the present case, claims are drawn to a composition comprising L-carnitine, a carrier (which may be lactose or other sugars), and an auxiliary substance (which may be an excipient – since the term “excipient” is not defined in the specification, the term is interpreted to broadly encompass water, which is a known pharmaceutical excipient in the art). Therefore, the instant claim encompasses bodily fluids (such as blood), which may comprise L-carnitine, sugars, and water. Therefore, as stated herein, the claim does not satisfy the “significantly more” requirement to overcome the judicial exception.
In response to applicant’s argument that the Office’s BRI is not consistent with the specification. Applicant provides no definition of “excipients” in the specification; therefore, the BRI is applied in view of what is known in the art. Per MPEP 2111: “The Patent and Trademark Office ("PTO") determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction "in light of the specification as it would be interpreted by one of ordinary skill in the art." In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364[, 70 USPQ2d 1827, 1830] (Fed. Cir. 2004). Indeed, the rules of the PTO require that application claims must "conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description." 37 CFR 1.75(d)(1).
Thus, the BRI applied herein is appropriate, and claims stand rejected under 35 USC § 101.
Claim Rejections - 35 USC § 102
Applicant’s arguments, see pages 8-10, filed 02/11/2026, with respect to 35 USC § 102 rejections have been fully considered and are persuasive. The 35 USC § 102 rejection of the claims has been withdrawn.
Claim Rejections - 35 USC § 103
Applicant’s arguments, see pages 8-10, filed 02/11/2026, with respect to 35 USC § 103 rejections have been fully considered and are persuasive. The 35 USC § 103 rejection of the claims has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made.
Double Patenting
Applicant's arguments filed 02/11/2026 have been fully considered but they are not persuasive.
Applicant argues that amended claims overcome standing provisional NSDP rejections.
Applicant is reminded that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. The courts have also found that where 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.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Therefore, claims stand rejected over the provisional NSDP rejections of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627