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 51-70 are pending.
Domestic Benefit
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Instant application is a continuation of PCT/US2023/060772, filed 01/17/2023. PCT/US2023/060772 claims benefit of U.S. Provisional Application 63/300,364, filed 01/18/2022. Therefore, the effective filing date is 01/18/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/15/2024, 12/20/2024, and 09/09/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Applicant is advised that should claims 62 and 68 be found allowable, claims 63 and 69, respectively, will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 51, 52, 54-59, 64, and 70 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the methods as described wherein the compound of Formula (I) is N-trans-caffeoyltyramine (NCT) or a compound listed in claim 53, does not reasonably provide enablement for the methods as described comprising administering any compound of Formula (I). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
3- the presence or absence of working examples,
4- the nature of the invention,
5- the state of the prior art,
6- the relative skill of those in the art,
7- the predictability of the art, and
8- the breadth of the claims
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention
The nature of the invention relates to methods comprising administering a compound of formula (I) in claims 51 and 64. Such compounds are useful for supporting mitochondrial function and increasing fatty acid oxidation.
Predictability of the art
The hypothetical compounds in claims 51 and 64 would be unpredictable in terms of one skilled in the art being able to synthesize every possible compound claimed in instant claim 51 and 64. In addition, the compounds of Formula (I) would be unpredictable in terms of their efficacy in the methods of the instant claims. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is a reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
Level of skill in the art
An ordinary artisan in the area of drug development would have experience in synthesizing and screening chemical compounds for particular activities, such as a medical doctor or chemist. Screening of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target, (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can often be employed, developing a therapeutic method, as claimed, is generally not well-known or routine, given the complexity of certain biological systems.
4. The breadth of the claims
The scope of the claims involves compounds of formula (I), shown below.
PNG
media_image1.png
309
526
media_image1.png
Greyscale
Claims 51 and 64 are very broad in the number of variables and the options of substituents for each variable. There is an extremely large amount of hypothetical compounds included in claims 51 and 64.
5. The amount of direction provided, the presence or absence of working examples, and the quantity of experimentation necessary
The specification only provides about 35 compounds listed as reading on Formula (I), and there are no synthesis methods provided for any of said compounds. Working examples are only provided for one compound, NCT. However, it would be assumed that the inventors are also enabled for the compounds of claim 53, since these compounds are similar in structure to NCT and would be expected to have similar reactivity.
Synthesis methods are not taught in the specification to provide for the aforementioned variables to include all of the possible substituents listed in the claims. The optional substituents in Formula (I), which are listed in the specification in paragraph [0050], would change the reactivity of the compounds, and therefore would require alternate synthesis methods. It could also be possible that some combinations of compounds may not be able to be synthesized due to their instability. It would require one skilled in the art, such as a chemist, to perform thousands of reactions to determine which compounds of Formula (I) can be prepared and would require synthesis methods other than those provided in the specification. In addition, one would then have to perform in vivo or in vitro tests to determine the physiological properties of said compounds of Formula (I) and to determine their efficacy in the instant method claims. This is undue experimentation given the limited guidance and direction provided by Applicants.
Accordingly, the instant claims do not comply with the enablement requirement of 35 U.S.C. 112(a), since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 60, 62, and 63 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 60, 62, and 63 teach that the compound of Formula (I) is N-trans-caffeoyltyramine. However, claim 53, from which claims 60, 62, and 63 depend, teaches that the compound is selected from N-cis-caffeoyltyramine, N-trans-feruloyltyramine, N-cis- feruloyltyramine, p-coumaroyltyramine, cinnamoyltyramine, sinapoyltyramine, and 5- hydroxyferuloyltyramine, which does not include N-trans-caffeoyltyramine. Therefore, claims 62 and 63 fail to include the limitations of the claim upon which they depend.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 51-59, 61, 64-67, and 70 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chae (US 20200368186 A1), published 26 November 2020, hereinafter referred to as Reference ‘186.
Reference ‘186 teaches, in claims 1, 2, and 8, a method of modulating metabolism comprising administering a compound of Formula (I), which reads instant claims 51, 59, and 64, wherein the compounds of reference claim 8 are those in instant claims 53 and 65. The composition is taught in claim 4 to be a pharmaceutical composition or medical food, as in instant claim 52. Figure 1 shows a composition comprising N-trans-caffeoyltyramine and a composition comprising N-trans-feruloyltyramine, as in instant claims 61 and 66-67.
Regarding “increasing fatty acid oxidation” and “supporting mitochondrial function”, MPEP 2112 I states: “[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).”
Therefore, "increasing fatty acid oxidation" and “supporting mitochondrial function” will inevitably flow from the teachings of the prior art (see above rejection), since the same composition (N-trans-feruloyltyramine or N-trans-caffeoyltyramine) is being administered to the same subjects (a subject in need of support in mitochondrial function). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
Table 2 shows the liquid oral administration of said compositions, as in instant claim 58. It is taught in paragraph [0079] that the composition can be prepared in solid dosage forms, as in instant claims 54 and 70. Paragraph [0080] teaches that the composition contains 0.1-99% of the compound, as in instant claim 55. Paragraph [0077] teaches that the composition comprises 0.01-5% of a preservative, as in instant claims 56 and 57.
Claims 51, 52, 55-59, 64, and 66 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olatunji et al. (Neuroprotective effect of trans-N-caffeoyltyramine from Lycium chinense against H2O2 induced cytotoxicity in PC12 cells by attenuating oxidative stress, Biomedicine & Pharmacotherapy, 2017, Vol. 93, pages 895–902), cited by Applicant in the IDS.
Olatunji et al. teaches, on page 900, that trans-N-caffeoyltyramine (TNC) prevents mitochondrial dysfunction by preventing the generation of reactive oxygen species (ROS). Concentrations of 0-40 μM TNC, which were dissolved in 0.1 % DMSO, were tested, as in instant claims 51, 52, 55-57, and 58.
Regarding instant claims 59, 64, and 66, MPEP 2112 I states: “[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).”
Therefore, "increasing fatty acid oxidation" will inevitably flow from the teachings of the prior art (see above rejection), since the same composition (trans-N-caffeoyltyramine) is being administered to the same subjects (a subject in need of support in mitochondrial function). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
Claims 51-53, 55-59, 61, 64, 65, and 67 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gao et al. (Effects of N-trans-feruloyltyramine isolated from laba garlic on antioxidant, cytotoxic activities and H2O2-induced oxidative damage in HepG2 and L02 cells, Food and Chemical Toxicology, 2019, Vol. 130, pages 130-141).
Gao et al. teaches, in the abstract, that N-trans-feruloyltyramine (FLA) prevents oxidative damage, by preventing the generation of ROS, and maintains the integrity of mitochondria. Gao et al. teaches, in section 3.2.1. on page 134, that oral administration of FLA was performed in mice at 300 mg/kg. FLA is taught in the abstract to be used in “functional foods”, and treatments were tested using 320μM FLA, as in instant claims 51-53, 55-58, 61.
Regarding instant claims 59, 64, 65, and 67, MPEP 2112 I states: “[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).”
Therefore, "increasing fatty acid oxidation" will inevitably flow from the teachings of the prior art (see above rejection), since the same composition (N-trans-feruloyltyramine) is being administered to the same subjects (a subject in need of support in mitochondrial function). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
Claims 51-59, 61, and 64-70 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by (US 20240158339 A1), with an effective filing date of 01/10/2018, hereinafter referred to as Reference ‘339.
The applied reference has a common inventor and applicant 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 in the reference 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.
Reference ‘339 teaches, in claims 1 and 12, an orally consumable composition comprising N-trans-feruloyltyramine and N-trans-caffeoyltyramine, wherein the composition further comprises a preservative at 0.01-1% by weight, as in instant claims 51, 53, 56, 57, 59, 61, and 64-69. Regarding “increasing fatty acid oxidation” and “supporting mitochondrial function”, MPEP 2112 I states: “[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).”
Therefore, "increasing fatty acid oxidation" and “supporting mitochondrial function” will inevitably flow from the teachings of the prior art (see above rejection), since the same composition (N-trans-feruloyltyramine and N-trans-caffeoyltyramine) is being administered to the same subjects (a subject in need of support in mitochondrial function). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
The oral composition is taught in claim 14 to be e medical food, as in instant claim 52. The composition is taught in paragraph [0115] to be in the form of tablets, as in instant claims 54 and 70. The composition is taught, in claim 20, to be in liquid form, as in instant claim 58. Reference ‘339 teaches, in paragraph [0121], that the compound comprises 0.1-99% of the composition, as in instant claim 55.
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 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 68 and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Chae (US 20200368186 A1), published 26 November 2020, hereinafter referred to as Reference ‘186, as applied to claims 51-59, 61, 64-67, and 70 above.
Reference ‘186 teaches a method of modulating metabolism comprising administering a composition comprising N-trans-caffeoyltyramine and a separate composition comprising N-trans-feruloyltyramine.
Reference ‘186 fails to teach a method of administering N-trans-caffeoyltyramine and N-trans-feruloyltyramine together in a composition.
However, MPEP 2144.06 I states: "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) (citations omitted)”.
Therefore, combining the two compositions taught by Reference ‘186 in order to use a third composition for the same purpose renders instant claims 68 and 69 prima facie obvious. One would have a reasonable expectation of success since the compositions are taught individually in the prior art to have the same effect.
Claims 53, 54, 65, and 70 are rejected under 35 U.S.C. 103 as being unpatentable over Olatunji et al. (cited above), as applied to claims 51, 52, 55-59, 64, and 66 above.
Olatunji et al. teaches a method of administering trans-N-caffeoyltyramine (TNC) to prevent mitochondrial dysfunction by preventing the generation of reactive oxygen species (ROS). See above rejection.
Olatunji et al. fails to teach the administration of cis-N-caffeoyltyramine, as in instant claims 53 and 65. Olatunji et al. fails to teach that the oral composition is a tablet, capsule, granule, or powder, as in instant claims 54 and 70.
It would be prima facie obvious to one of ordinary skill in the art to test cis-N-caffeoyltyramine in the prevention of mitochondrial dysfunction, when the prior art shows that trans-N-caffeoyltyramine is used for the same purpose. The compounds would be expected to have the same or similar physiological properties, since they are geometric isomers, having the same chemical formula and similar structure. One would have a reasonable expectation of success in testing a geometric isomer of a known compound in order to use it for the same purpose, namely, to prevent mitochondrial dysfunction.
It would be prima facie obvious to one of ordinary skill in the art, and it is common practice in the art, to formulate an oral composition in order to prepare a medicinal composition for human consumption. One would be motivated to do so in order to use the composition for the same purpose to treat humans, since most medicines are formulated in solid dosage form. One would have a reasonable expectation of success in formulating a solid oral dosage form, since this is common practice in the art, and it would not be expected to change the efficacy of the composition.
Claims 54 and 70 are rejected under 35 U.S.C. 103 as being unpatentable over Gao et al. (cited above), as applied to claims 51-53, 55-59, 61, 64, 65, and 67 above.
Gao et al. teaches, in the abstract, that N-trans-feruloyltyramine (FLA) prevents oxidative damage, by preventing the generation of ROS, and maintains the integrity of mitochondria. See above rejection.
Gao et al. fails to teach a solid oral dosage form, as in instant claims 54 and 70.
However, it would be prima facie obvious to one of ordinary skill in the art, and it is common practice in the art, to formulate an oral composition in order to prepare a medicinal composition for human consumption. One would be motivated to do so in order to use the composition for the same purpose to treat humans, since most medicines are formulated in solid dosage form. One would have a reasonable expectation of success in formulating a solid oral dosage form, since this is common practice in the art, and it would not be expected to change the efficacy of the composition.
Claims 68 and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Gao et al., further in view of Olatunji et al. (cited above), as applied to claims 51-59, 61, 64, 65, 67, and 70 above.
Gao et al. teaches, in the abstract, that N-trans-feruloyltyramine (FLA) prevents oxidative damage, by preventing the generation of ROS, and maintains the integrity of mitochondria. See above rejections.
Gao et al. fails to teach that FLA is administered in combination with N-trans-caffeoyltyramine, as in instant claims 68 and 69.
However, Olatunji et al. teaches a method of administering trans-N-caffeoyltyramine (TNC) to prevent mitochondrial dysfunction by preventing the generation of reactive oxygen species (ROS).
MPEP 2144.06 states: "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)”.
Therefore, instant claims 68 and 69 are rendered prima facie obvious in view of Gao et al. and Olatunji et al., since these claims consist only of combining two compositions, each independently taught to be used to prevent the generation of ROS and protect mitochondrial function, in order to use the composition for the same purpose.
Nonstatutory 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 51-54, 56, 58, 59, 61, and 64-70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 51-53 and 58 of copending Application No. 19/075,230 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Application ‘230 teaches a method for improving intestinal permeability comprising administering Formula (I) of instant claim 51. Claims 51-53 and 58 read directly on instant claims 51-53, 59, 61, and 64-69. The support of mitochondrial function and increase in fatty acid oxidation would be inherent properties of the method of Application ‘230. See MPEP 2112 I.
Claim 58 of Application ‘230 teaches that the composition is a pharmaceutical composition or medical food, which overlaps in scope with, and renders prima facie obvious, the composition formulations of instant claims 54, 56, 58, and 70.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 51-54, 56, 58, 59, 64, 66, and 70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 7, and 19 of copending Application No. 18/415,255 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Application ‘255 teaches, in claims 1, 2, 5, and 7, a method for increasing fatty acid oxidation and reducing mitochondrial stress comprising administering N-trans-caffeoyltyramine, as in instant claims 51-53, 59, 64, and 66. The composition is taught, in claim 19, to be administered orally, which overlaps in scope with, and renders prima facie obvious, the composition formulations of instant claims 54, 56, 58, and 70.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 51-54, 56, 58, 59, 61, and 64-70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 9 of copending Application No. 17/812,126 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Application ‘126 teaches, in claim 1, a method of administering a compound of Formula (I), which is Formula (I) of the instant claims, wherein the administration increases circulating free fatty acids, as in instant claims 51-53, 59, 61, and 64-69. The support of mitochondrial function and increase in fatty acid oxidation would be inherent properties of the method of Application ‘126. See MPEP 2112 I. Claim 9 reads directly on instant claims 53 and 65. The composition is taught, in claim 3, to be in a unit dosage form configured as a pharmaceutical composition or medical food, which overlaps in scope with, and renders prima facie obvious, the composition formulations of instant claims 54, 56, 58, and 70.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 51-59, 61, and 64-70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 10-13, 15, 16, and 19 of copending Application No. 19/190,308 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Application ‘308 teaches, in claims 8 and 19, a pharmaceutical composition comprising 0.1-99% Formula I and methods of treating a metabolic disorder comprising administering said composition, as in instant claims 51, 55, 59, and 64 (MPEP 2112 I). The compounds of claims 10-12 read directly on instant claims 53, 61, and 65-69. Claims 13 and 15 of App. ‘308 read directly on instant claims 56 and 57, respectively. The composition is taught in claim 16 to be a syrup or a capsule, as in instant claims 52, 54, 58, and 70.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 51-54, 56-59, 61, and 64-70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, and 12 of copending Application No. 18/419,387 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See also Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Here, the same compounds and compositions are recited in both the instant application and Application ‘387. Although the co-pending Application does not claim methods, the disclosure of Application ‘387 recites, in paragraphs [0086]-[0087], the administration of the composition in syrup or tablets. The composition is also described in the claims a “orally consumable”. Therefore, the ordinary artisan would recognize as obvious that administration is implicit in the co-pending claims in view of Sun Pharmaceutical Industries, LTD. v. Eli Lilly and Company which states the following: “Similarly, in Pfizer, the earlier patent claimed several compounds and the specification disclosed their use in treating inflammation and inflammation-associated disorders. 518 F.3d at 1363 & n.9; see 5,563,165 (“’165 patent”), at [57], col.1 11.11-14, col.3 11.3-27. The later patent then claimed a method of using these compounds for treating inflammation, inflammation-associated disorders, and specific inflammation-associated disorders, including arthritis, pain, and fever. Pfizer, 518 F.3d at 1363 & n.9; see U.S. Patent No. 5,760,068 (“’068 patent”) col.97 1.49- col. 108 1.29. After rejecting the patentee’s objection to our consideration of the specification of the earlier patent, we determined that the later patent “merely claims a particular use described in the [earlier] patent of the claimed compositions of the [earlier] patent.” Pfizer, 518 F.3d at 1363 & n.8. As such, we concluded that the asserted claims of the later patent were not “patentably distinct” from the claims of the earlier patent, and thus the later patent was invalid for obviousness-type double patenting. Id. at 1368.”
Claims 1, 11, and 12 of Application ‘387 teach an orally consumable composition comprising N-trans-caffeoyltyramine and N-trans-efruloyltyramine, in the form of a food or liquid, further comprising 0.01-1% of a preservative, as in instant claims 51-54, 56-59, 61, and 64-70. The support of mitochondrial function and increase in fatty acid oxidation would be inherent properties of the method of Application ‘387. See MPEP 2112 I.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 51-56, 58, 59, 61, and 64-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8-14 of U.S. Patent No. 11,382,880 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Patent ‘880 teaches, in claim 1, a method of treating a disease comprising administering a compound of Formula (I), which is Formula (I) in the instant claims, wherein the compound of Formula (I) comprises 10-99% of the oral composition, as in instant claims 51, 52, 55, 59, and 64. The support of mitochondrial function and increase in fatty acid oxidation would be inherent properties of the method of Application ‘387. See MPEP 2112 I. The compounds of claims 8-14 read on instant claims 53, 61, 65-69. The composition is taught, in claim 1, to be in an orally administrable pharmaceutical composition, which overlaps in scope with, and renders prima facie obvious, the composition formulations of instant claims 54, 56, 58, and 70.
Claims 51-56, 58, 59, 61, and 64-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7, and 8 of U.S. Patent No. 11,173,136 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Patent ‘136 teaches a method of treating a metabolic disorder comprising administering a compound of Formula (I), which is Formula (I) of the instant claims, wherein the compound comprises 10-99% of the composition, as in instant claims 51, 55, 59, and 64. The support of mitochondrial function and increase in fatty acid oxidation would be inherent properties of the method of Application ‘387. See MPEP 2112 I.
The compounds of Reference claim 7 read on instant claims 53, 61, and 65-69. Claim 4 teaches that the composition is formulated as a medical food or pharmaceutical composition, as in instant claim 52. The composition is taught in claims 4 and 8 to be an orally administrable pharmaceutical composition configured into a unit dosage form, which overlaps in scope with, and renders prima facie obvious, the composition formulations of instant claims 54, 56, 58, and 70.
Claims 51-59, 61, and 64-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-6 of U.S. Patent No. 11,642,323 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See also Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Here, the same compounds and compositions are recited in both the instant application and Patent ‘323. Although the co-pending Application does not claim methods, the disclosure of Patent ‘323 recites, in column 15, the administration of the composition in syrup or tablets. The composition is also described in the claims as a “compound for oral consumption”. Therefore, the ordinary artisan would recognize as obvious that administration is implicit in the co-pending claims in view of Sun Pharmaceutical Industries, LTD. v. Eli Lilly and Company which states the following: “Similarly, in Pfizer, the earlier patent claimed several compounds and the specification disclosed their use in treating inflammation and inflammation-associated disorders. 518 F.3d at 1363 & n.9; see 5,563,165 (“’165 patent”), at [57], col.1 11.11-14, col.3 11.3-27. The later patent then claimed a method of using these compounds for treating inflammation, inflammation-associated disorders, and specific inflammation-associated disorders, including arthritis, pain, and fever. Pfizer, 518 F.3d at 1363 & n.9; see U.S. Patent No. 5,760,068 (“’068 patent”) col.97 1.49- col. 108 1.29. After rejecting the patentee’s objection to our consideration of the specification of the earlier patent, we determined that the later patent “merely claims a particular use described in the [earlier] patent of the claimed compositions of the [earlier] patent.” Pfizer, 518 F.3d at 1363 & n.8. As such, we concluded that the asserted claims of the later patent were not “patentably distinct” from the claims of the earlier patent, and thus the later patent was invalid for obviousness-type double patenting. Id. at 1368.”
Patent ‘323 teaches, in claim 1, an oral composition comprising Formula (I), which is Formula (I) of the instant claims, wherein the compound comprises 0.1-99% of the composition. Claim 1 also teaches that the compounds in the composition are N-trans-caffeoyltyramine and N-trant-feruloyltyramine, as in instant claims 51, 53, 55, 59, 61, and 64-69. The support of mitochondrial function and increase in fatty acid oxidation would be inherent properties of the method of Application ‘387. See MPEP 2112 I.
The composition is taught, in claim 4, to be a tablet, as in instant claims 54 and 70. The composition is taught in claim 5 to be a medical food or pharmaceutical composition, as in instant claims 52 and 58. The composition is taught in claim 6 to comprise a preservative at 0.01-1% by weight, as in instant claims 56 and 57.
Claims 51-59, 61, and 64-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8-11 of U.S. Patent No. 12,285,392 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See also Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Here, the same compounds and compositions are recited in both the instant application and Patent ‘392. Although the co-pending Application does not claim methods, the disclosure of Patent ‘392 recites, in column 15, the administration of the composition in both solid and liquid forms, as in instant claims 54, 58, and 70. The composition is also described in the claims as an “oral composition”. Therefore, the ordinary artisan would recognize as obvious that administration is implicit in the co-pending claims in view of Sun Pharmaceutical Industries, LTD. v. Eli Lilly and Company. See citation above.
Patent ‘392 teaches, in claim 1, a composition comprising N-trans-caffeoyltyramine and N-trant-feruloyltyramine, wherein the composition is a liquid, as in instant claims 51, 53, 58, 59, 61, and 64-69. The support of mitochondrial function and increase in fatty acid oxidation would be inherent properties of the method of Application ‘387. See MPEP 2112 I.
It is taught, in claims 8 and 9, that the composition comprises a preservative at 0.01-1%, and in claim 10, that N-trans-caffeoyltyramine comprises 0.1-99% of the composition, as in instant claims 55-57. The composition is taught in claim 11 to be a medical food or pharmaceutical composition as in instant claim 52.
Conclusion
Claims 51-70 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RILLA M SAMSELL whose telephone number is (703)756-5841. The examiner can normally be reached Monday-Friday, 7-3.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
Prosecution Insights