DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
U.S. Pat. Appln. Ser. No. 18/708,426, Filed: 05/08/2024 is a 371 Nat.’l Stage Entry of WO 2023/090260A1 (i.e., PCT/JP2022/042016, Intern.’l Filing Date: 11/11/2022), which claims foreign priority to JP 2021-187227, Filed: 11/17/2021,
However, to overcome art rejections, while certified foreign documents were filed in the Japanese language, NO corresponding certified ENGLISH translation was filed with that Japanese language document; i.e., therefore the earliest priority or effective filing date (EFD) for prior art consideration is 11/11/2022 (i.e., PCT Filing Date, not 11/17/2021 to overcome art rejections)
Status
Acknowledgement is made of the May 27, 2025 Preliminary Amendment and corresponding documents.
Claims 5 and 7 are pending, claim 5 is original and claim 7 is new in the above-identified application.
Information Disclosure Statement
An Information Disclosure Statements (IDS) submitted on May 8, 2024 is in compliance with the provisions of 37 CFR 1.97.
Accordingly, Information Disclosure Statements have been considered by the Examiner.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Regarding rejections [3] to [10] as set forth in this section, the applied reference has a common assignee, a common applicant, or at least one common (joint) inventor 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.
[A] Relevant Claim to each 35 U.S.C. 102(a)(1) Rejection
In particular, the claimed invention relates to Claims 5 and 7 (i.e., which will be cited below in each additional 35 U.S.C. 102(a)(1) rejection [2] to [8] below):
PNG
media_image1.png
163
1046
media_image1.png
Greyscale
PNG
media_image2.png
19
504
media_image2.png
Greyscale
PNG
media_image3.png
101
1052
media_image3.png
Greyscale
[1] Claims 5 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Katsube et al. “Food-Derived Antioxidant Ergothioneine Improves Sleep Difficulties In Humans” (Suntory Global Innovation Ctr Ltd. Research Institute) Journal of Functional Foods (August 2022), 95,105165, https://doi.org/10.1016/j.jff.2022.
The present invention is directed to claims 5 and 7 are directed a method of inhibiting histamine-N-methyl transferase, which comprises administering L-ergothioneine to human subject(s)
Katsube discloses methods of improving sleep, which comprises administration of L- ergothioneine (L-EGT) to humans (i.e., which reads on claim 5 of the instant invention).
Katsube teaches that:
administration of L-EGT in human patients ameliorates sleeping difficulties and targeting assays revealed that EGT inhibits histamine N-methyltransferase (i.e., which is taught by the instant specification) aldehyde dehydrogenase activity and binding to α3β4 nicotinic acetylcholine receptor.
a study to evaluate effect of orally ingested L-ergothioneine (EGT) on improving sleep quality via a randomized placebo-controlled, double-blind, parallel-group comparison study ingestion of 20 mg L-EGT in human patients.
Given that:
Katsube reference discloses administration of L-ergothioneine or a salt thereof (i.e., carrying out the sole required and identical active step) to human subjects, then the function of the preamble use for improving sleep results.; and
the same compound (i.e., L-EGT is L-ergothioneine), then Katsube’s 20 mg example falls within the claimed range of 2–50 mg, the claim would be anticipated as per MPEP § 2131.03 rule — that “if the prior art discloses a point within the claimed range, the prior art anticipates the claim” — applies only when the prior art actually discloses that specific point and the claim is directed to a range.
“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art.” Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)) (emphasis in original) (Claims to titanium (Ti) alloy with 0.6-0.9% nickel (Ni) and 0.2-0.4% molybdenum (Mo) were held anticipated by a graph in a Russian article on Ti-Mo-Ni alloys because the graph contained an actual data point corresponding to a Ti alloy containing 0.25% Mo and 0.75% Ni and this composition was within the claimed range of compositions.). “If the prior art discloses a point within the claimed range, the prior art anticipates the claim.” UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). (i.e., see MPEP §2131.03 Anticipation of Ranges)
Therefore, Claims 5 and 7 of the instant application is anticipated under 35 U.S.C. §102(a)(1).
[2] Claims 5 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
Cheah et al., Administration of Pure Ergothioneine to Healthy Human Subjects: Uptake, Metabolism, and Effects on Biomarkers of Oxidative Damage and Inflammation, Antioxid Redox Signal. 2017 Feb 10;26(5):193-206. doi: 10.1089/ars.2016.6778. Epub 2016 Sep 7. (“”Cheah”)
Cheah teaches a proof of concept study detailing administration of pure L-ergothioneine to healthy human patients, i.e., provides insights into pharmacokinetic, physiological effects and safety effects. (i.e., which reads on claim 5 of the present invention) and potential application as a therapeutic agent for antioxidant therapies as a dietary supplement, oxidative stress-related conditions.
Given that the Cheah reference discloses administration of pure L-ergothioneine (i.e., carrying out the sole required and identical active step) to healthy human patients, then the effect of inhibiting histamine-N-methyltransferace, antioxidant activities or oxidative stress-related conditions will necessarily result.
Cheah also teaches oral administration of pure ET to healthy adults in doses of 5 mg/day and 25 mg/day for 7 days, followed by monitoring over 28 days, which appears to establishes safety, tolerability, and pharmacokinetics, arguably a range 5–25 mg/day determined from 2 dosing end points.
“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art.” Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)) (emphasis in original) (Claims to titanium (Ti) alloy with 0.6-0.9% nickel (Ni) and 0.2-0.4% molybdenum (Mo) were held anticipated by a graph in a Russian article on Ti-Mo-Ni alloys because the graph contained an actual data point corresponding to a Ti alloy containing 0.25% Mo and 0.75% Ni and this composition was within the claimed range of compositions.). “If the prior art discloses a point within the claimed range, the prior art anticipates the claim.” UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). (i.e., see MPEP §2131.03 Anticipation of Ranges)
Therefore, Claims 5 and 7 of the instant application is anticipated under 35 U.S.C. §102(a)(1).
[3] Claims 5 and 7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by
claims 5 and 7 of U.S. Pat. Pub. 2024/0189284A1, Filed: March 25, 2022 (i.e., having a foreign priority claim to Apr. 26, 2021 “U.S. ‘284 Pat. Pub.”).
As to Claims 5 and 7 of the claimed invention are anticipated by the prior art because the prior art U.S. ‘284 Pat. Pub.is directed to these method claims 5 and 7 of the shown below:
PNG
media_image4.png
2
371
media_image4.png
Greyscale
PNG
media_image4.png
2
371
media_image4.png
Greyscale
The U.S. ‘284 Pat. Pub. specification further teaches: the “amount of L-ergothioneine or a salt thereof in the composition per adult daily intake is 2 to 50 mg in terms of L-ergothioneine (i.e., see para. [0008] therein, which reads on the claimed invention)”.
U.S. ‘284 Pat. Pub. discloses L-ergothioneine or a salt thereof and its use for promoting lipolysis, and the preamble is a purpose/intended use statement that does not add new limitations beyond the body of the claim.
Therefore, Claims 5 and 7 of the instant application are anticipated under 35 U.S.C. §102(a)(2).
[4] Claims 5 and 7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by claims 9-12 and 17-20 of U.S. Pat. Pub. 2024/0180876 A1, Filed: March 25, 2022 (“U.S. Pat. ‘876 Pub”).
Claims 5 and 7 of the present invention cited under section: “[A] Present Invention: Relevant Claim to each 35 U.S.C. 102(a)(2) Rejection” and in [1] supra.
As to Claims 5 and 7 of the claimed invention are anticipated by the prior art because the prior art U.S. Pat. ‘876 Pub is directed to these method claims 9-12 and 17-20 of the shown below:
PNG
media_image5.png
2
460
media_image5.png
Greyscale
PNG
media_image5.png
2
460
media_image5.png
Greyscale
PNG
media_image5.png
2
460
media_image5.png
Greyscale
PNG
media_image5.png
2
460
media_image5.png
Greyscale
PNG
media_image6.png
5
695
media_image6.png
Greyscale
PNG
media_image6.png
5
695
media_image6.png
Greyscale
PNG
media_image7.png
90
783
media_image7.png
Greyscale
PNG
media_image6.png
5
695
media_image6.png
Greyscale
PNG
media_image8.png
6
699
media_image8.png
Greyscale
PNG
media_image8.png
6
699
media_image8.png
Greyscale
The U.S. Pat. ‘876 Pub. specification further teaches: the “amount of L-ergothioneine or a salt thereof in the composition per adult daily intake is 2 to 50 mg in terms of L-ergothioneine (i.e., see para. [0009] therein, which reads on the claimed invention)”.
U.S. Pat. ‘876 Pub. discloses L-ergothioneine or a salt thereof and its use for increasing at least one of red blood cell count or hemoglobin level, and the preamble is a purpose/intended use statement that does not add new limitations beyond the body of the claim.
Therefore, Claims 5 and 7 of the instant application are anticipated under 35 U.S.C. §102(a)(2).
[5] Claims 5 and 7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by claims 6 and 8 of U.S. Pat. Pub. 2024/0180877 A1, Filed: March 25, 2022 (“U.S. Pat. ‘877 Pub.”).
Claims 5 and 7 of the present invention cited under section: “[A]: Relevant Claim to each 35 U.S.C. 102(a)(2) Rejection” and in [1] supra.
As to Claims 5 and 7 of the claimed invention are anticipated by the prior art because the prior art U.S. Pat. ‘877 Pub. are directed to these method claims 6 and 8 of the shown below:
PNG
media_image9.png
203
710
media_image9.png
Greyscale
The U.S. Pat. ‘877 Pub. specification further teaches: the “amount of L-ergothioneine or a salt thereof in the composition per adult daily intake is 2 to 50 mg in terms of L-ergothioneine (i.e., see para. [0008] therein, which reads on the claimed invention)”.
U.S. Pat. ‘877 Pub. discloses L-ergothioneine or a salt thereof and its use for preventing or reducing an anxiety symptom, and the preamble is a purpose/intended use statement that does not add new limitations beyond the body of the claim.
Therefore, Claims 5 and 7 of the instant application are anticipated under 35 U.S.C. §102(A)(2).
[6] Claims 5 and 7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by claims 8 and 10 of U.S. Pat. Pub. 2024/0173298A1 Filed: March 25, 2022 (U.S. ‘298 Pat. Pub.).
Claims 5 and 7 of the present invention cited under section: “[A] Relevant Claim to each 35 U.S.C. 102(a)(2) Rejection” and in [1] supra.
As to Claims 5 and 7 of the claimed invention are anticipated by the prior art because the prior art U.S. ‘298 Pat. Pub.is directed to these method claims 8 and 9 of the shown below:
PNG
media_image10.png
123
1042
media_image10.png
Greyscale
PNG
media_image11.png
94
1063
media_image11.png
Greyscale
The U.S. ‘298 Pat. Pub. specification further teaches: the “amount of L-ergothioneine or a salt thereof in the composition per adult daily intake is 2 to 50 mg in terms of L-ergothioneine (i.e., see para. [0008] therein, which reads on the claimed invention)”.
U.S. ‘298 Pat. Pub. discloses L-ergothioneine or a salt thereof and its use for reducing renal function decline or ameliorating renal function, and the preamble is a purpose/intended use statement that does not add new limitations beyond the body of the claim.
Therefore, Claims 5 and 7 of the instant application are anticipated under 35 U.S.C. §102(a)(2).”
[7] Claims 5 and 7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by claims 8 and 10 of U.S. Pat. Pub.2024/0156785 A1 Filed: March 25, 2022 (U.S. ‘785 Pat. Pub.).
Claims 5 and 7 of the present invention cited under section: “[A] Relevant Claim to each 35 U.S.C. 102(a)(2) Rejection” and in [1] supra.
As to Claims 5 and 7 of the claimed invention are anticipated by the prior art because the prior art U.S. ‘785 Pat. Pub.is directed to these method claims 8 and 10 of the shown below:
PNG
media_image12.png
120
891
media_image12.png
Greyscale
PNG
media_image13.png
182
1045
media_image13.png
Greyscale
The U.S. ‘785 Pat. Pub. specification further teaches: the “amount of L-ergothioneine or a salt thereof in the composition per adult daily intake is 2 to 50 mg in terms of L-ergothioneine (i.e., see para. [0008] therein, which reads on the claimed invention)”.
U.S. ‘785 Pat. Pub. discloses L-ergothioneine or a salt thereof and its use for reducing renal function decline or ameliorating renal function, and the preamble is a purpose/intended use statement that does not add new limitations beyond the body of the claim.
Therefore, Claims 5 and 7 of the instant application are anticipated under 35 U.S.C. §102(a)(2).
[8] Claims 5 and 7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by claims 7-8 and 11-12 of U.S. Pat. Pub. 2024/0122899 A1 Filed: March 25, 2022 (“U.S. Pat. ‘899 Pub.”).
Claims 5 and 7 of the present invention cited under section: “[A] Relevant Claim to each 35 U.S.C. 102(a)(2) Rejection” and in [1] supra.
As to Claims 5 and 7 of the claimed invention are anticipated by the prior art because the prior art U.S. Pat. ‘899 Pub. is directed to these method claims 7-8 and 11-12 of the shown below:
PNG
media_image14.png
19
597
media_image14.png
Greyscale
PNG
media_image14.png
19
597
media_image14.png
Greyscale
PNG
media_image15.png
65
729
media_image15.png
Greyscale
PNG
media_image15.png
65
729
media_image15.png
Greyscale
The “U.S. Pat. ‘899 Pub. specification further teaches: the “amount of L-ergothioneine or a salt thereof in the composition per adult daily intake is 2 to 50 mg in terms of L-ergothioneine (i.e., see para. [0013] therein, which reads on the claimed invention)”.
“U.S. Pat. ‘899 Pub. discloses L-ergothioneine or a salt thereof and its use for promoting immune cell metabolism, and the preamble is a purpose/intended use statement that does not add new limitations beyond the body of the claim.
Therefore, Claims 5 and 7 of the instant application are anticipated under 35 U.S.C. §102(a)(2).
[9] Claims 5 and 7 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by claims 1 and 5 of WO 2021/085062 A1 (Intern.’l Pub. Date: May 6, 2021; “WO. ‘062 Appln.”).
Claims 5 and 7 of the present invention cited under section: “[A] Relevant Claim to each 35 U.S.C. 102(a)(2) Rejection” and in [1] supra.
As to Claims 5 and 7 of the claimed invention are anticipated by the prior art because WO. ‘062 Appln. is directed to these method claims 1 and 5 of the shown below (English Translation from Espacenet)
Claim 1. A sleep-improving composition containing L-ergothioneine or a salt thereof as an active ingredient.
Claim 5. A method for improving sleep by administering L-ergothioneine or a salt thereof.
The WO. ‘062 Appln. specification further teaches: the “in one embodiment, when the composition for sleep improvement of the present invention is parenterally administered to a human (adult), the dosage of L-ergothioneine or a salt thereof per 60 kg body weight per day in terms of L-ergothioneine is, for example, preferably 1 to 500 mg, more preferably 5 to 200 mg, still more preferably 10 to 100 mg, particularly preferably 10 to 50 mg. When the composition is parenterally administered to a human (adult), the dosage of L-ergothioneine or a salt thereof per 60 kg body weight per day in terms of L-ergothioneine may be 10 mg or more and less than 50 mg or may be 10 to 45 mg. (i.e., see para. [00613] therein, which reads on the claimed invention)”. Additional doses are further taught therein.
In the instant application, claim 7 recites a dosage range of 2 to 50 mg.
A claimed invention is anticipated by a prior art reference if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference (see MPEP § 2131). When a prior art reference discloses a broad numerical range and also explicitly teaches specific examples that fall within a narrower claimed range, those specific examples anticipate the narrower claim. Here, WO. ‘062 Appln. specific disclosed alternate dosages and ranges as identified supra all squarely within the claimed range of 2 to 50 mg. Because these specific examples are "clearly named" in WO. ‘062 Appln., they anticipate the claimed range regardless of whether WO. ‘062 Appln. also provides a broader broad genus or other species outside the claimed range (see MPEP § 2131.02).
WO. ‘062 Appln. discloses L-ergothioneine or a salt thereof and its use for improving sleep, and the preamble is a purpose/intended use statement that does not add new limitations beyond the body of the claim.
Therefore, Claims 5 and 7 of the instant application are anticipated under 35 U.S.C. §102(a)(2).
[10] Claims 5 and 7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by claims 7-9 and13-15 of U.S. Pat. Pub. 2024/0216335A1, Filed: March 25, 2022 (“U.S. ‘335 Pat. Pub.”).
Claims 5 and 7 of the present invention cited under section: “[A] Relevant Claim to each 35 U.S.C. 102(a)(2) Rejection” and in [1] supra.
As to Claims 5 and 7 of the claimed invention are anticipated by the prior art because the prior art U.S. ‘335 Pat. Pub.is directed to these method claims 7-9 and 13-15 of the shown below:
PNG
media_image16.png
762
712
media_image16.png
Greyscale
The U.S. ‘335 Pat. Pub. specification further teaches: the “amount of L-ergothioneine or a salt thereof in the composition per adult daily intake is 2 to 50 mg in terms of L-ergothioneine (i.e., see para. [0011] therein, which reads on the claimed invention)”.
U.S. ‘335 Pat. Pub. discloses L-ergothioneine or a salt thereof and its use for improving sleep, and the preamble is a purpose/intended use statement that does not add new limitations beyond the body of the claim.
U.S. ‘335 Pat. Pub. discloses L-ergothioneine or a salt thereof and its use for increasing at least one of leukocytes or basophils (i.e., claim 7), inhibiting epidermal growth factor receptor (i.e., claim 8) and/or activating innate immunity (i.e., claims 9-15), and the preamble is a purpose/intended use statement that does not add new limitations beyond the body of the claim.
Therefore, Claims 5 and 7 of the instant application are anticipated under 35 U.S.C. §102(a)(2).
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.
[1] Claims 5 and 7 are rejected on the ground of provisional nonstatutory double patenting as being unpatentable over claims 5 and 7 of U.S. Pat. Appln Ser. No. 18/286,446 (“U.S. ‘446 Appln.”, i.e., corresp. to U.S. Pat. Pub. 2024/0189284A1, Filed: 3-25, 2022).
In particular, the claimed invention relates to these two claims:
PNG
media_image1.png
163
1046
media_image1.png
Greyscale
,
PNG
media_image2.png
19
504
media_image2.png
Greyscale
PNG
media_image3.png
101
1052
media_image3.png
Greyscale
Although the conflicting claims are not identical, they are not patentably distinct from the U.S. ‘446 Appln. which is directed to the following method claims 5 and 7 of the shown below:
PNG
media_image4.png
2
371
media_image4.png
Greyscale
PNG
media_image4.png
2
371
media_image4.png
Greyscale
While each preamble recited in co-pending U.S. ‘446 Appln. recites a different indication or use “a method of promoting lipolysis”, the instant claims of the present invention are anticipated, because there is no differentiation in the patient population to whom “L-ergothioneine or a salt thereof” is administered, therefore, every patient administered the aforementioned compound would necessarily experience histamine-N-methyltransferase inhibition (i.e., even with specific dosing range of “2 to 50 mg in terms of L-ergothioneine).
Nonstatutory Double Patenting Rejections [2] to [8]
The above completely written out double patenting rejection [1] is representative of each of the provisional double patenting rejections [2] to [8], now consolidated for conciseness as follows:
The following statement is relevant to each rejection [2] to [8], the instant claimed invention relates to these two claims:
PNG
media_image1.png
163
1046
media_image1.png
Greyscale
,
PNG
media_image2.png
19
504
media_image2.png
Greyscale
PNG
media_image3.png
101
1052
media_image3.png
Greyscale
Although the conflicting claims are not identical, they are not patentably distinct from each of the cited patent applications:
[2] Claims 5 and 7 are rejected on the ground of provisional nonstatutory double patenting as being unpatentable over claims 9-12 and 17-20 of U.S. Pat. Appln Ser. No. 18/285,409 (“U.S. ‘409 Appln.”, i.e., corresp. to U.S. Pat. Pub. 2024/0180876 A1, Filed: 3-25, 2022).
Although the conflicting claims are not identical, they are not patentably distinct from the U.S. ‘409 Appln. which is directed to the following method claims 9 and 17 shown below:
PNG
media_image17.png
157
859
media_image17.png
Greyscale
PNG
media_image18.png
154
853
media_image18.png
Greyscale
While each preamble recited in co-pending U.S. ‘‘409 Appln.. recites a different indication or use “a method of increasing at least one of red blood cell count or hemoglobin level”, the instant claims of the present invention are anticipated, because there is no differentiation in the patient population to whom “L-ergothioneine or a salt thereof” is administered, therefore, every patient administered the aforementioned compound would necessarily experience histamine-N-methyltransferase inhibition (i.e., even with specific dosing range of “2 to 50 mg in terms of L-ergothioneine)
[3] Claims 5 and 7 are rejected on the ground of provisional nonstatutory double patenting as being unpatentable over claims 6 and 8 of U.S. Pat. Appln Ser. No. 18/285,521 (“U.S. ‘521 Appln.”, i.e., corresp. to U.S. Pat. Pub. 2024/0180877 A1, Filed: 3-25, 2022).
Although the conflicting claims are not identical, they are not patentably distinct from the U.S. ‘521 Appln. which is directed to the following method claims 6 and 8 shown below:
PNG
media_image19.png
144
973
media_image19.png
Greyscale
PNG
media_image20.png
6
445
media_image20.png
Greyscale
PNG
media_image20.png
6
445
media_image20.png
Greyscale
While each preamble recited in co-pending U.S. ‘521 Appln. recites a different indication or use “a method of preventing or reducing anxiety”, the instant claims of the present invention are anticipated, because there is no differentiation in the patient population to whom “L-ergothioneine or a salt thereof” is administered, therefore, every patient administered the aforementioned compound would necessarily experience histamine-N-methyltransferase inhibition (i.e., even with specific dosing range of “2 to 50 mg in terms of L-ergothioneine).
[4] Claims 5 and 7 are rejected on the ground of provisional nonstatutory double patenting as being unpatentable over claims 8 and 9 of U.S. Pat. Appln Ser. No. 18/552,715 (“U.S. ‘715 Appln.”, i.e., corresp. to U.S. Pat. Pub. 2024/0173298A1 Filed: 3-25, 2022).
Although the conflicting claims are not identical, they are not patentably distinct from the U.S. ‘715 Appln. which is directed to the following method claims 8 and 9 shown below:
PNG
media_image10.png
123
1042
media_image10.png
Greyscale
PNG
media_image11.png
94
1063
media_image11.png
Greyscale
While preamble recited in co-pending U.S. ‘715 Appln. recites a different indication or use
“a method of reducing renal function”, the instant claims of the present invention are anticipated, because there is no differentiation in the patient population to whom “L-ergothioneine or a salt thereof” is administered, therefore, every patient administered the aforementioned compound would necessarily experience histamine-N-methyltransferase inhibition (i.e., even with specific dosing range of “2 to 50 mg in terms of L-ergothioneine)
[5] Claims 5 and 7 are rejected on the ground of provisional nonstatutory double patenting as being unpatentable over claims 8 and 10 of U.S. Pat. Appln Ser. No. 18/552,718 (“U.S. ‘718 Appln.”, i.e., corresp. to U.S. Pat. Pub.2024/0156785 A1 Filed: 3-25, 2022).
Although the conflicting claims are not identical, they are not patentably distinct from the U.S. ‘718 Appln. which is directed to the following method claims shown below:
PNG
media_image12.png
120
891
media_image12.png
Greyscale
PNG
media_image13.png
182
1045
media_image13.png
Greyscale
While preamble recited in co-pending U.S. ‘718 Appln. recites a different indication or use “a method of improving blood cholesterol”, the instant claims of the present invention are anticipated, because there is no differentiation in the patient population to whom “L-ergothioneine or a salt thereof” is administered, therefore, every patient administered the aforementioned compound would necessarily experience histamine-N-methyltransferase inhibition (i.e., even with specific dosing range of “2 to 50 mg in terms of L-ergothioneine)
[6] Claims 5 and 7 are rejected on the ground of provisional nonstatutory double patenting as being unpatentable over claims 7-8 and 11-12 of U.S. Appln. No. 18/286, 634 (i.e., corresp. to U.S. Pat. Pub. 2024/0122899 A1 Filed: 3-25, 2022; U.S. ‘634 Appln.).
Although the conflicting claims are not identical, they are not patentably distinct from the U.S. ‘634 Appln. which is directed to the following method claims 7, 8, 11 and 12 shown below:
PNG
media_image21.png
15
476
media_image21.png
Greyscale
PNG
media_image21.png
15
476
media_image21.png
Greyscale
PNG
media_image22.png
56
790
media_image22.png
Greyscale
PNG
media_image22.png
56
790
media_image22.png
Greyscale
While each preamble recited in co-pending U.S. ‘899 Pat. Pub. recites a different indication or use “a method of promoting immune cell metabolism”, the instant claims of the present invention are anticipated, because there is no differentiation in the patient population to whom “L-ergothioneine or a salt thereof” is administered, therefore, every patient administered the aforementioned compound would necessarily experience histamine-N-methyltransferase inhibition (i.e., even with specific dosing range of “2 to 50 mg in terms of L-ergothioneine).
[7] Claims 5 and 7 are rejected on the ground of provisional nonstatutory double patenting as being unpatentable over claims 7-9 and13-15 of U.S. Pat. Appln Ser. No. 18/286,601 (“U.S. ‘601 Appln.”, Filed: 3/25/2022).
Although the conflicting claims are not identical, they are not patentably distinct from the U.S. ‘601 Appln. which is directed to the following method claims shown below:
PNG
media_image23.png
475
712
media_image23.png
Greyscale
PNG
media_image24.png
247
721
media_image24.png
Greyscale
While recited in co-pending U.S. ‘601 Appln. recites a different indication or use for increasing at least one of leukocytes or basophils (i.e., claim 7), inhibiting epidermal growth factor receptor (i.e., claim 8) and/or activating innate immunity (i.e., claims 9, 13-15), the instant claims of the present invention are anticipated, because there is no differentiation in the patient population to whom “L-ergothioneine or a salt thereof” is administered, therefore, every patient administered the aforementioned compound would necessarily experience histamine-N-methyltransferase inhibition (i.e., even with specific dosing range of “2 to 50 mg in terms of L-ergothioneine)
Summary Relevant Analysis to each of [1] to [7] above:
While the recited preamble of each of the above-identified U.S. patent applications provides a different indication than that of the claims of the present invention, each of the applications identified in each double patenting rejection below comprise the identification step of administration of an identical active method step: “L-ergothioneine or a salt thereof” in a specific dose range of “2 to 50 mg in terms of L-ergothioneine when administered to a human adult” each of the copending apps anticipate the instant claims of the present invention as the instant patient population is not limited; i.e., such that It includes anyone/anything with histamine-N-methyltransferase. Any time L-ergothioneine is administered, for example for the various uses in the copending applications, histamine-N-methyltransferase will necessarily be inhibited
Each of the U.S. provisional nonstatutory double patenting rejections supra remain provisional rejections as none of the aforementioned applications, respectively, have not yet issued as a U.S. Patents.
Appropriate action is required accordingly
CONCLUSION
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to GRACE C HSU whose telephone number is (571) 270-1689.
The Examiner can normally be reached Monday-Friday 7:30 am - 6 pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicants 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 on 571-270-5239. 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.
/G.C.H./
Examiner, Art Unit 1627
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
Prosecution Insights