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 .
Election/Restrictions
Claims 1-30 are pending in the instant application. Applicant’s election without traverse of Group I, Claims 1-17 in the reply filed on 5 December 2025 is acknowledged. Claims 18-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5 December 2025.
Claims 1-17 are being examined on the merits.
Information Disclosure Statement
The listing of references in the specification (e.g., [0009]-[0013]) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 112(a)
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 15 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor, at the time the application was filed, had possession of the claimed invention. This is a “written description” rejection, rather than an enablement rejection under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. Applicant is directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, first paragraph, "Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.
The claim is drawn to a dental composition for expediting recovery from anesthesia comprising Vitamin C, caffeine, and beet root extract wherein the Vitamin C counteracts the effect of anesthetic agents through opposing analgesic action. However, the specification only discloses that Vitamin C opposes analgesic action via specific neurochemical pathways (page 9, [0037]) without providing any supporting data or citations regarding this effect. Li et al. (J Pain Res, 2021, 2201-2208), however, teach that Vitamin C increases recovery time after administration of propofol and also acts as an adjuvant, reducing total anesthetic dosage (Li et al., Table 2, page 2205). Additionally, Hung et al. (Nutrients, 2020, 17 pages) teach that Vitamin C is known to exhibit analgesic functions (Hung et al., Introduction, page 2) and that perioperative use of Vitamin C reduces pain scores and opioid requirements (Hung et al., Abstract, page 1). Since the phrase “opposing analgesic action” is generally known to mean a substance that blocks the analgesic effect of another, and the prior art teaches that not only does Vitamin C act as an adjuvant for anesthetics, but is also a known analgesic, the present disclosure would not convey to one skilled in the relevant art that the inventor, at the time the application was filed, that the inventor had possession of Vitamin C which acts though opposing analgesic action to counteract the effect of all anesthetic agents.
Claim Rejections - 35 USC § 112(b)
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.
Claim 14 is 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.
Claim 14 indicates ingredients which the claimed composition is free of, however Claim 1 lists caffeine and beet root extract as components of the claimed composition. Caffeine is an extractable compound from both green tea and green coffee beans (see e.g., Kruse, EP 3646861 A1, Translation, page 5) and beet roots comprise alpha-lipoic acid, folate, and thiamine (see e.g., Ware, 2024, pages 3-4). It is therefore unclear whether the claim is limiting caffeine to a particular source, such as synthetic caffeine which was not obtained from tea leaves or green coffee beans, or whether the claim is restricting the inclusion of additional caffeine extracted from tea leaves or coffee beans. Additionally, it is unclear whether the claim is limiting the beet root extract to a specific (e.g., a specific compound such as betalain or a specific extract obtained via a specific method which excludes specific compounds) extract or whether the claim restricts the inclusion of alpha-lipoic acid, folate, nitrate, and thiamine in addition to that which is already found in a beet root extract. Nitrate, an ion, would naturally form complexes with compounds such as arginine, an amino acid, in an extract. Appropriate clarification is necessary.
For the purposes of compact prosecution, the claim is being interpreted as limiting the claimed composition from the inclusion of additional green tea extract, green coffee bean extract, alpha-lipoic acid, folate, nitrate, and thiamine outside of purified caffeine extractable from green tea or green coffee beans and beet root extract.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7 and 14-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1-7, 14, and 15-17 are directed to a natural product (i.e., a law of nature/a natural phenomenon). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception – i.e., as drafted, the claims read upon a product of nature (i.e., a law of nature/a natural phenomenon) for the following reasons:
Claims 1-7 and 14-17 are drawn to a composition (for the intended use as a dental composition for expediting recovery from dental anesthesia) formed entirely from natural ingredients (as disclosed on pages 9-10, paragraphs [0037]-[0039] of the instant specification) including Vitamin C (as an agent for counteracting the effect of anesthetic agents through opposing analgesic action), caffeine (as an agent for enhancing metabolism to facilitate anesthetic clearance), and beet root extract (as an agent for increasing blood flow to facilitate anesthetic clearance). The claimed composition is not markedly different from their naturally-occurring counterparts - Vitamin C obtainable from food such as citrus; caffeine obtainable from plants such as tea leaves and coffee beans; and beet root extract obtainable from beet roots - because there is no indication that the composition has any characteristics or properties that are different from the naturally-occurring counterparts (including the natural compounds found therein). The cited claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the amounts claimed are broad ranges and the intended effects of Claims 15-17 recite biological properties of the natural products themselves.
Furthermore, the claims do not integrate the composition into a distinguishing practical application (for example, do not broadly or specifically recite a specific dosage form and the therapeutically-effective amounts of the materials), but merely recites the natural materials themselves or a multiplicity of natural materials and their individual biological effects.
Therefore, the claimed composition is not deemed to be markedly different from what exists in nature in terms of structural and/or functional differences. In other words, the claims do not set forth a marked difference in terms of structural and/or functional differences (properties and/or characteristics) as compared to the naturally-occurring Vitamin C, caffeine, and beet root (see, e.g., Diamond v. Chakrabarty, 447 U.S. 303(1980)). Please note that combining natural materials/extracts (such as from two or more plants) does not remove the claims from reading upon a judicial selection (Funk Brothers Seed Col. V. Kalo Inoclulant Col. – 333 U.S. 127 (1948)) because, again, there is no evidence of a marked difference brought about by combining the instantly claimed herbal extracts/natural materials. Please also note that modifying the concentration (including amounts and proportions) of the product of composition is not sufficient to remove the claimed composition from a judicial exception (see, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 106 USPQ2d 1972 (2013)).
Thus, when the relevant factors are analyzed, they weigh against a significant difference between the claimed invention and a judicial exception. Therefore, the claimed invention is not considered to be patent eligible subject matter.
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.
Claims 1-7, 13, 14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kruse (EP 3646861 A1, Translation, 16 pages).
The instant claims are as of record, drawn to a dental composition for expediting recovery from dental anesthesia comprising 75-2,000 mg Vitamin C, 30-400 mg caffeine, and 250-7,000 mg beet root extract.
Kruse, however, anticipates the claims by teaching compositions comprising 10 to 5,000 mg nitrate obtainable from beet roots (beet root extract; Kruse, page 6; as required for instant Claims 1, 6, and 7), 1 to 1,500 mg caffeine (Kruse, page 7; as required for instant Claims 1, 4, 5, and 7), and 1 to 5,000 mg Vitamin C (Kruse, page 8; as required for instant Claims 1, 2, 3, and 7). In a specific example, the compositions consist of beet root juice (extract) containing nitrate, caffeine, Vitamin C, magnesium for treating a magnesium deficiency, and sulforaphane as an indirect antioxidant (e.g., magnesium and sulforaphane do not materially affect the basic and novel characteristics of the claimed invention, see MPEP § 2111.03; consists essentially of; in the absence of; Kruse, page 11; as required for instant Claims 13 and 14). The nitrate extractable from beet roots widens the blood vessels, which is associated with more efficient blood flow (e.g., increases blood flow; Kruse, page 4; as required for instant Claim 16). The composition is provided as pharmaceutical, medical, and food products, including dental care products (dental composition; Kruse, page 5).
With respect to the rejections above, please note that the intended use of the claimed composition (expediting recovery from dental anesthesia) does not patentably distinguish the composition, per se, since such undisclosed use is intrinsic to the composition reasonably suggested by the cited references, as a whole. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting (see, e.g., MPEP 2112).
Please note, since the Office does not have the facilities for examining and comparing
Applicants’ composition with the composition of the prior art, the burden is on applicant to show
a novel or unobvious difference between the claimed product and the product of the prior art.
See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67,
205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to
manufacture products by the myriad of processes put before it and then obtain prior art products
and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685,
688 (CCPA 1972).
Claim Rejections - 35 USC § 103
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 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.
Claims 1-7, 10-14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kruse (EP 3646861 A1, Translation, 16 pages) as applied to Claims 1-7, 13, 14, and 16 above, and further in view of DentalROI (Types of Anesthesia for Oral Surgery, 2023, 9 pages).
The instant claims and teachings of Kruse are as of record.
Kruse does not teach the various types of dental anesthesia of Claims 10-12.
DentalROI, however, teaches the various types of anesthesia used in oral surgery including local, injectable anesthetics such as lidocaine and bupivacaine (DentalROI, page 3; as required for instant Claim 10), inhalation minimal sedation such as nitrous oxide (DentalROI, pages 3-4; as required for instant Claim 11), and deep dental sedation drugs such as propofol, which can be given as a pill (oral anesthetic; DentalROI, page 4; as required for instant Claim 12).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to provide a composition with the intended use of expediting recovery from dental anesthesia wherein the anesthetics include those commonly used for various types of oral surgery. An artisan would be motivated to provide such a composition due to potential side effects of anesthesia and sedation such as nausea, headache, and fatigue (DentalROI, pages 4-5) and could do so with a reasonable expectation of success because the various anesthetics are well known in the field of oral surgery.
Claims 1-9, 13, 14, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kruse (EP 3646861 A1, Translation, 16 pages) as applied to Claims 1-7, 13, 14, and 16 above, and further in view of Davenport (What are some of the best caffeine pills?, 2022, 21 pages).
The instant claims and teachings of Kruse are as of record.
Kruse does not teach wherein the caffeine enhances metabolism or wherein the composition is formulated as a gelatin capsule.
Davenport, however, teaches that caffeine is a fast-working natural stimulant which can temporarily boost metabolism (enhances metabolism; Davenport, page 7; as required for instant Claim 17) and can be formulated as a gelatin capsule (Davenport, page 5; as required for instant Claims 8 and 9).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application that the caffeine of Kruse would provide the effect of enhancing metabolism because it is a well-known effect of the compound. Additionally, a skilled artisan would be motivated to provide the composition as a gelatin capsule because it is a known dosage form for providing natural compounds such as caffeine and is not an active ingredient (Davenport, page 5). A skilled artisan could therefore provide caffeine knowing that is enhances metabolism and also provide a gelatin capsule dosage form with a reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685,
688 (CCPA 1972).
Conclusion
No claims are allowed.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655