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 Application
Receipt of the Preliminary amendment filed on November 19, 2024 is acknowledged.
Claims 7-16, 18-21 and 23-28 are pending in this application.
Claims 1-6 and 22 have been cancelled.
Claims 7-8, 10-16, 18, and 21 have been amended.
Claims 26-28 are new.
All pending claims are under examination in this application.
Claim Objections
Claims 23-24 are objected to because of the following informalities: the claims do not read well. The claims depend from claim 18. As such, the claims only require “providing” the composition and then the mental step of “identifying” as subject in need of the composition. After a review of the specification, it appears that the identification would include an assessment via cognitive testing. Therefore, it suggested the claims depend from claim 19. Appropriate correction is required.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 18 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as based on a disclosure which is not enabling. The disclosure does not enable one of ordinary skill in the art to practice the invention without administration of the composition, which is/are critical or essential to the practice of the invention but not included in the claim(s). See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976). Claim 18 recites the step of “providing to the individual a composition of claim 8”. The instant specification does not define the scope of “providing”. The common definition of such is “giving or furnishing something”. The act of giving the composition to an individual would not be able to satisfy the intended method of “improving cognitive ability and/or reducing blood alcohol concentration in an individual in need thereof who is suffering from or is suspected of suffering from cognitive impairment due to alcohol” without the essential step of “administration” which the instant application has identified to be a separate method step, as seen in claim 19 and the instant specification in at least paragraph 0010 which discloses the method comprises providing followed by administration. There is not discussion within the specification at simple osmosis of the composition through the skin while holding the composition would be adequate for the method effects to materialize.
Therefore, the claim recited in claim 18 is not enabled.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-16, 18-21, and 23-28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 7-8, the claim recites “synephrine (or synephrine HCl)”, it is unclear if the compound in parenthesis is an alternative or an example of synephrine. It is suggested the parenthesis be removed.
Claim 18 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: administration of the composition, as noted above, the instant specification does not define the scope of “providing”. The common definition of such is “giving or furnishing something”. The act of giving the composition to an individual would not be able to satisfy the intended method of “improving cognitive ability and/or reducing blood alcohol concentration in an individual in need thereof who is suffering from or is suspected of suffering from cognitive impairment due to alcohol” without the essential step of “administration” which the instant application has identified to be a separate method step, as seen in claim 19 and the instant specification in at least paragraph 0010 which discloses the method comprises providing followed by administration. There is not discussion within the specification at simple osmosis of the composition through the skin while holding the composition would be adequate for the method effects to materialize.
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 11, 13, 14, and 26-27 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. The claims are drawn to a composition of matter. The claims do not recite any additional components to be added but merely a necessary results/intended uses of the composition after administration. 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.
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 7-16, 18-21, and 23-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,156,878. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and the patented claims are both drawn to a composition for reducing blood alcohol concentration (BAC) in an individual impaired or suspected of being impaired by alcohol comprising an effective amount of:
theacrine;
methylliberine;
theobromine;
caffeine;
cdp choline;
synephrine;
Macuna pruriens;
apple pectin;
dandelion extract;
n-acetyl cysteine;
milk thistle; and
Ginseng, and/or derivations thereof; wherein said derivations include extracted ginsenosides.
The instant claims additionally recite one or more of:
a B vitamin;
N-acetyl tyrosine;
taurine;
cocoa extract;
phenylalanine;
Huperzine A;
magnesium citrate;
sodium citrate;
calcium citrate;
potassium chloride;
citric acid; and/or
glycine.
However, these components are listed in patented claim 3.
The instant claims recite the form of the composition as a tablet, capsule, caplet, pill, gel cap, dry powder, liquid, or suspension. However, these forms are routinely used in the preparation or oral formulations, therefore, it would have been obvious to one of ordinary skill in the art to prepare the composition of the patented claims in any of the recited forms.
The instant claims and the patented claims additionally recite further identical components, as well as dosage amounts in dependent claims.
Examiner’s Note
Claims 7-16, 18-21, and 23-28 are free of the prior art. The closest prior art is that of Lopez et al. (US 2015/0132280) in view of Parker (US2021/0220422) and Pilat (RU 2605767) and Yin (CN 1593395), as discussed in the parent application 18/395.565. However, as Applicant previous argues there are a large number of potential active ingredients and the lack of motivation/direction to elect specific components.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
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