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 .
Claim Status
Applicant’s remarks and amendments, filed 11 May 2026 and 20 May 2026 in response to the non-final rejection mailed 9 February 2026, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 20 May 2026 replaces all prior versions and listings of the claims.
Claims 1-31 are pending. Claims 18-30 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claim 31 is newly added. Claims 1, 5, 7, and 13-16 are amended. Claims 1-17 and 31 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s arguments and amendments, on pages 7-8 of the reply filed 11 May 2026 with respect to the rejection of Claim 15 under 35 USC § 112(a) have been fully considered. The rejection of Claim 15 is withdrawn due to amendment of the claim.
Applicant’s arguments and amendments, on page 9 of the reply filed 11 May 2026 with respect to the rejection of Claim 14 under 35 USC § 112(b) have been fully considered. The rejection of Claim 14 is withdrawn due to amendment of the claim.
Applicant’s arguments and amendments, on pages 9-11 of the reply filed 11 May 2026 with respect to the rejection of Claims 1-7 and 14-17 under 35 USC § 101 have been fully considered. The rejections of Claims 1-7 and 14-17 are withdrawn due to amendment of Claim 1.
Applicant’s arguments and amendments, on pages 11-13 of the reply filed 11 May 2026 with respect to the rejection of Claims 1-7, 13, 14, and 16 under 35 USC § 102(a)(1) have been fully considered. The rejections of Claims 1-7, 13, 14, and 16 are withdrawn due to amendment of Claim 1.
Claim Rejections - 35 USC § 112(d)
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 8 and 9 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.
Claim 1 recites the limitation “wherein the composition is formulated as a gelatin capsule,” whereas Claim 8 recites the broader limitation of “wherein the composition is formulated as a capsule” and Claim 9, depending from Claim 8, recites the limitation “wherein the capsule is a gelatin capsule.” These limitations do not further limit the subject matter of Claim 1.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims complies with the statutory requirements.
Claim Rejections - 35 USC § 103
(grounds modified as necessitated by amendment)
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, 13-17, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Kruse (EP 3646861 A1, Translation, 16 pages) in view of Milano et al. (Phamaceutics, 2023, 34 pages), Fong et al. (Anesthesiology, 2018, 19 pages), and May (Subcell Biochem, 2012, 20 pages).
The instant claims are as of record, drawn to a dental composition for expediting recovery from dental anesthesia consisting essentially of 75-2,000 mg Vitamin C, 30-400 mg caffeine, and 250-7,000 mg beet root extract formulated as a gelatin capsule which have complementary mechanisms to expedite anesthesia recovery.
Kruse teaches 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, 7, and 31), 1 to 1,500 mg caffeine (Kruse, page 7; as required for instant Claims 1, 4, 5, 7, and 31), and 1 to 5,000 mg Vitamin C (Kruse, page 8; as required for instant Claims 1, 2, 3, 7, and 31). 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 1, 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; complementary mechanism; Kruse, page 4; as required for instant Claims 1, 16, and 31). The composition is provided as pharmaceutical, medical, and food products, including dental care products (dental composition; Kruse, page 5).
Kruse does not teach wherein the composition is formulated as a gelatin capsule, the complementary mechanisms of caffeine and Vitamin C, or expediting dental anesthesia recovery.
Milano et al. teach that gelatin-based drug delivery systems, such as capsules, are chemically versatile, are able to act as a carrier for many different types of drugs, have the ability to control release kinetics, have a low cost, are easily available and biodegradable, and have low immunogenicity (Milano et al., 3. Gelatin, page 5; as required for instant Claims 1 and 31).
Fong et al. teach that caffeine accelerates emergence from anesthesia administered intravenously by elevation of cAMP (expedite anesthetic clearance; metabolic acceleration; reduce duration of post-procedural dental numbness; Fong et al., Introduction, page 2; as required for instant Claims 1, 13, 17, and 31).
May teaches that Vitamin C is an important chemical in the central nervous system and provides antioxidant protection, peptide amidation, myelin formation, synaptic potentiation, and protection against glutamate toxicity (neurochemical activity; May, Abstract, page 1; as required for instant Claims 1, 15, 13, and 31).
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 the composition of Kruse in a gelatin capsule as taught by Milano et al. for anesthesia recovery as taught by Fong et al. with the known effects of Vitamin C as taught by May. A skilled artisan would know the biochemical effects of Vitamin C and beet root extract from Kruse and May and would additionally know from Fong et al. that caffeine accelerates anesthesia recovery, and would therefore be motivated to provide the composition of Kruse for such a purpose and could do so with a reasonable expectation of success because it was known that caffeine accelerates anesthesia recovery. A skilled artisan could therefore reasonably deduce that by accelerating anesthetic clearance and recovery, post-procedural numbness would also have a reduced duration. Additionally, a skilled artisan would have a reasonable expectation of success of providing the composition in a gelatin capsule rather than as a drinkable liquid because of the known advantages of such a drug delivery system as taught by Milano et al. and would therefore be motivated to provide the composition in a gelatin capsule.
Claims 1-7, 10-17, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Kruse (EP 3646861 A1, Translation, 16 pages) in view of Milano et al. (Phamaceutics, 2023, 34 pages), Fong et al. (Anesthesiology, 2018, 19 pages), and May (Subcell Biochem, 2012, 20 pages) as applied to Claims 1-7, 13-17, and 31 above, and further in view of DentalROI (Types of Anesthesia for Oral Surgery, 2023, 9 pages).
The instant claims and teachings of Kruse in view of Milano et al., Fong et al., and May are as of record.
Kruse in view of Milano et al., Fong et al., and May 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 the composition taught by Kruse, Milano et al., Fong et al. and May 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.
With respect to the USC 103 rejections above, please note that the intended use of the claimed composition as a dental composition for 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).
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).
Response to Arguments
Applicant's arguments filed 11 May 2026 and Declaration submitted under 37 CFR § 1.132 on 20 May 2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to Kruse in view of Davenport have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues that the inclusion of magnesium and sulforaphane in the composition of Kruse affects the basic and novel characteristics of the composition because they have biochemical mechanisms which are unrelated to dental anesthesia recovery and would therefore affect the mechanisms of beet root, caffeine, and Vitamin C. It is unclear, however, how inclusion of two additional ingredients with separate mechanisms would affect the unrelated mechanisms of action of beet root, caffeine, and Vitamin C. Without evidence to the contrary, indicating that the known mechanisms of action of beet root, caffeine, and Vitamin C as taught by the prior art and disclosed in the rejection above are not possible in the presence of magnesium and sulforaphane, the inclusion of these two additional ingredients has not been shown to affect the basic and novel characteristics of the composition.
Additionally, applicant argues that Kruse does not teach the intended use of dental anesthesia recover and the amended-in limitations of a gelatin capsule and reduction of anesthesia recovery time. The composition of Kruse, however, teaches the components of the instant composition and, along with Fong et al. and May, a skilled artisan would know the biochemical effects of Vitamin C and beet root extract and would additionally know that caffeine accelerates anesthesia recovery. Since the complementary mechanisms providing the synergistic effect of the three ingredients combined were known in the art, a skilled artisan would not only be aware of them, but it also indicates that absent evidence to the contrary, the composition of Kruse would also have that effect. Additionally, a skilled artisan could provide that composition for dental anesthesia recovery since caffeine was already known to accelerate anesthesia recovery, and could also provide the composition in a gelatin capsule due to the benefits of such a drug delivery system as taught by Milano et al.
Applicant also argues that the narrow ranges of new Claim 31 are not taught by Kruse, however the ranges are still overlapping and thus taught by the prior art.
Finally, applicant argues that the motivation for combining Kruse and DentalROI is legally insufficient because reducing the effect of post-anesthesia nausea, headache, and fatigue is an entirely different clinical problem from the one the claimed invention solves and are different from prolonged local numbness. The instant claims, however, are drawn to expediting anesthetic clearance and accelerated anesthetic recovery, and a skilled artisan could reasonably deduce that reducing the time it takes for an anesthetic to clear a patient’s system not only reduces the duration of post-procedural numbness, but also reduces additional side effects of those commonly used anesthetics such as nausea, headache, and fatigue.
Regarding the Declaration submitted under 37 CFR § 1.132, it is noted that the features upon which applicant relies (i.e., 39.05 min reduction in anesthesia recovery time at para. 23; statistically significant reduction in numbness duration compared to an untreated control group at para. 23; specific mechanisms of action on specific voltage-gated sodium channels in dorsal root ganglia) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Additionally, the mechanisms of action disclosed in the declaration (at para. 8 & 25(c)), were known in the art as disclosed above and there is no evidence to indicate that the beet root, Vitamin C, and caffeine of Kruse would not have those same known biochemical mechanisms of action. Finally, per applicant’s own disclosure on pages 8-11 of the disclosure, these mechanisms of action were well known in the art prior to the effective filing date of the instant application.
Conclusion
No claims are currently allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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