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 .
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 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.
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 Objections
Claim amendments are acknowledged and have been entered. No new matter has been introduced. Claim objections of record have been withdrawn.
Claim Rejections - 35 USC § 112(b)
Applicant’s arguments, see page 6, filed 06/11/2026, 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.
Claim Rejections - 35 USC § 101
Applicant’s arguments, see page 6, filed 06/11/2026, with respect to the 35 USC § 101 rejection(s) of the claim(s) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Claim Rejections - 35 USC § 103
Applicant’s arguments regarding 35 USC § 103 rejections have been considered but are not persuasive. As an initial matter, rejections over Manning have been withdrawn to avoid redundance.
Applicant argues that Examiner’s conclusion that Dahl’s formulation may be scaled up is the result of a misinterpretation of the art and impermissible hindsight. Applicant argues Dhal provides no motivation to scale up. Applicant argues Dahl is solving a problem of stability, not a treatment with L-carnitine, and that a person of ordinary skill seeking to modulate ACE-2 would not consult Dhal, since they teach away from the use of high-dose of ingredients, with carnitine being optional in their composition. Applicant cites Dahl to say that “L-carnitine free base is hygroscopic and not a preferred diluent” (page 10, last 2 lines), which allegedly discourages it’s use – this excerpt from Dahl is included below for clarity of record:
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In fact, Dahl encourages inclusion of carnitine salts, such as tartrate, since they are non-hygroscopic.
Applicant argues that the Examiner’s conclusion of the obviousness of scaling up is factually unsupported by Dahl, stating that Dahl’s biggest dose contains about 360 mg of L-carnitine-L-tartrate, while the instant claims require a minimum of 1000 mg. Applicant states that while Dahl discloses 10 kg batches of material, these batches encompass thousands of individual dose units.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to Applicant’s arguments that Dahl offers no motivation to scale up, Applicant is advised that In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package "of appreciable size and weight requiring handling by a lift truck" were held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) ("mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled." 531 F.2d at 1053, 189 USPQ at 148.).
Furthermore, 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.
Thus, Applicant needs to demonstrate a special property of the claimed composition comprising 1-10 g of L-carnitine salts versus Dahl’s composition comprising 360 mg of L-carnitine.
In response to Applicant’s argument’s that Dahl is not directed to a composition that can modulate ACE-2, Applicant is reminded that 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. These arguments confer no patentable weight in the absence of unexpected results showing that Dahl’s composition is not capable of performing the same actions, while the instant composition can.
In response to Applicant’s arguments that Dahl teaches away from high doses of L-carnitine salts – Applicant is advised, per MPEP 2123(II): Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) Furthermore, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
In response to Applicant’s argument that Dahl discourages the use of L-carnitine free base due to hygroscopic properties, Dahl encourages the use of L-carnitine salts, such as tartrate salts (providing further motivation to arrive at the instant claims), since these are non-hygroscopic (see excerpt from Dahl above).
In the absence of unexpected results showing a special property of the claimed composition not present in Dahl’s composition, the instant claims stand rejected over the prior art of record. This action is final.
Double Patenting
Applicant's arguments filed 06/11/2026 have been fully considered but they are not persuasive.
Applicant requests rejections be held in abeyance. This is not persuasive, therefore, claims stand rejected over the provisional NSDP rejections of record.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone 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, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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