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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/20/2025 has been entered.
DETAILED ACTION
Status of Claims
The amendments and arguments filed on 05/20/2025 are acknowledged and have been fully considered. Claims 1 and 6-14 are now pending. Claims 2-5 and 15-22 are canceled; claim 1 is amended.
Claims 1 and 6-14 will be examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112
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 7 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 1 recites that the amount of vitamin B9 is in the composition in an amount of about 500 mcg and vitamin B12 is present in an amount of about 500 mcg, however dependent claim 7 recites that vitamin B9 is used in an amount from about 250 mcg to about 1000 mcg and vitamin B12 in an amount from about 250 mcg to about 1000 mg. The ranges given in claim 7 are broader than the amounts given in claim 1. It is not clear how the composition can have about 500 mcg of vitamin B9 and range from 250-1000 mcg (e.g. have 750 mcg) at the same time. For this reason, one with ordinary skill in the art would not understand the metes and bounds of the claims and the claim is indefinite. For purposes of search and consideration, claim 7 is understood to recite the same amounts for vitamins B9 and B12 as claim 1.
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.
Claims 1 and 6-14 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUG 20180125915 A1 (Mikhail, 2018) in view of US 20190069585 A1 (Haase, 2019) and Chen (2015).
In regards to claim 1, Mikhail teaches a composition for treating or preventing hangovers (see Mikhail, abstract; claim 1) comprising at least one of N-Acetyl L-Cysteine or L-glutathione (see Mikhail, paragraph 0012) and at least one B vitamin (see Mikhail, paragraph 0013; claims 1 and 10). It is taught that the composition comprises at least one B vitamin (see Mikhail, paragraph 0013) and lists vitamins B9 (folic acid) and B12 as possible B vitamins for use in the composition (see Mikhail, paragraphs 0065-0066; claims 10). It would be within the purview of one with ordinary skill in the art to formulate the composition of Mikhail with just one or both of these vitamins using the teachings of Mikhail. Further, Mikhail teaches an embodiment comprising the three ingredients specifically, as well as Hovenia Dulcis Fruit/resin extract and green tea leaf extract (see Mikhail, paragraph 0028; claim 10), which comprise dihydromyricetin and caffeine respectively (see Mikhail, paragraphs 0081 and 0083).
Further in regards to claims 1 as well as claims 6 and 13, Mikhail teaches examples (see Mikhail, Table 1, Batches 3-5) that comprise N-Acetyl L-Cysteine, L-glutathione, various vitamins, milk thistle, dihydromyricetin (in the Hovenia Dulcis Fruit extract 10:1, see Mikhail, paragraph 0083), and caffeine (in the green tea leaf extract, see Mikhail, paragraph 0081). Claim 10 also recites a combination of these compounds (see Mikhail, claim 10).
In regards to claims 7-8, it is taught that the amount of glutathione in the composition is about 5 mg to about 100 mg per unit dosage form (see Mikhail, paragraph 0049). In regards to claim 7, MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In regards to claims 9 and 11-12, the composition is taught to be a pill (i.e. a tablet or capsule) as well as a powder that is poured into a liquid (see Mikhail, claims 2, 9, and 12; paragraph 0014; caption below Table 1; paragraphs 0091-0096). It is taught that the powder is added to 8, 10, and 12 oz of water (see Mikhail, caption below Table 1; paragraphs 0091-0096). 8 oz of water is equal to about 237 mL of water. This amount is within the claimed volume of claim 11.
In regards to claim 10, it is taught in the specification as filed that a “shot” is to be understood as a liquid that a consumer is able to consume a single dose of the product quickly and continues to say that a single dose of a “shot” may be contained in from about 1 oz to about 5 oz (see page 5, paragraph 4 of the instant specification as filed). As such, the limitation of a shot is directed to the amount of liquid or volume that the final composition is present in. It is noted that it is taught that the amount of water that the powder composition is mixed in is important to the taste for the consumer (see Mikhail, caption below Table 1; paragraphs 0091-0096). As such, the amount of liquid used would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed amount of liquid cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the amount of liquid in Mikhail to obtain the desired balance between the taste of the final product as taught by Mikhail (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
The teachings of Mikhail are silent on the use of cannabidiol, the amount of dihydromyricetin, the specific amounts used of the compounds in claims 7-8, and the use of melatonin.
In regards to claims 7 and 14, Haase teaches a composition for oral micronutrients for optimal health (see Haase, paragraph 0167). It is taught that the composition comprises cannabinoids (i.e. cannabidiol, see Haase, paragraphs 0028 and 0138; tables 1-3), melatonin (see Haase, paragraph 0072), N-acetylcysteine in an amount from about 0.1 mg to 1500 mg (see Haase, paragraph 0058), vitamin B9 in an amount from 50 mcg to about 2000 mcg, and vitamin B12 in an amount from about 0.1 mcg to about 50 mcg (see Haase, paragraphs 0066-0067).
In regards to claim 1, Haase teaches that the primary dosage of cannabinoids is 15 mg in one embodiment (see Haase, example 10). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Chen teaches the use of 150 mg capsules of dihydromyricetin (see Chen, abstract and materials) to treat liver disease (see Chen, abstract, introduction, and page 80, column 1, paragraphs 1-3).
In regards to claims 1 and 6-14, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Mikhail with Haase as both references teach similar compounds to be used for improving overall health. "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). Further, the amounts used in Haase are taught to have “desired beneficial effects in humans of both genders and of wide age and weight cohorts. The basic classes of micronutrients to which the components of the present formulations belong is known to reduce oxidative damage and inflammation, support immune system function and neuroprotection and enhance optimal health” (see Haase, paragraph 0167). It would also be obvious to one with ordinary skill in the art to use the amount of dihydromyricetin of Chen with the composition of Mikhail and Haase as it is taught that the dihydromyricetin is able to protect liver function, improve insulin resistance, regulate glucose and lipid metabolism, and slow the progression of liver steatosis (see Chen, page 80, column 1, paragraph 3). As Mikhail is does not mention the amount of dihydromyricetin, one with ordinary skill in the art would look to Chen for the dosage amount, especially as Mikhail is drawn to compounds that prevent liver damage (see Mikhail, paragraphs 0075-0078, 0082, 0084-0086). One with ordinary skill in the art would be motivated to combine the teachings of Mikhail with the teachings of Haase and Chen according to the known method of making an oral composition (see Haase, paragraphs 0129-0130) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known method to yield predictable results.
Further, in regards to claims 1 and 7-8 , specifically the “about 500 mcg of vitamin B12”, it is noted that the amount of drug is clearly a result effective variable that must be determined based on a variety of factors including the age, body weight, and health of the patient, the condition(s) to be treated and their severity, the route(s) of administration, the particular drug(s) used, adverse drug effects or toxicity, clinical response to treatment, etc., and is routinely optimized by the skilled artisan. Applicant is advised that recitation of dosages, without more, is generally insufficient to patentably distinguish over the prior art.
Further, in regards to claim 8, specifically to the teaching of “about 150 mg of glutathione”, “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.").” One with ordinary skill in the art would reasonably expect that a composition comprising about 100 mg of glutathione would have the same properties as a composition comprising about 150 mg of glutathione. Further, it is noted that the instant specification does not set forth a specific definition of the term “about”, and thus the term is being broadly interpreted.
Response to Arguments
Applicant's arguments filed 05/20/2025 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
In regards to applicant’s argument that the art does not render obvious the amounts of vitamins B9 and B12, it is pointed out that it is taught that vitamin B9 in an amount from 50 mcg to about 2000 mcg (see Haase, paragraphs 0066-0067) and the amount of vitamin B12 is clearly a result effective variable that must be determined based on a variety of factors including the age, body weight, and health of the patient, the condition(s) to be treated and their severity, the route(s) of administration, the particular drug(s) used, adverse drug effects or toxicity, clinical response to treatment, etc., and is routinely optimized by the skilled artisan. Applicant is advised that recitation of dosages, without more, is generally insufficient to patentably distinguish over the prior art.
Applicant presents the declaration of Ajay Suman, MD to attempt to establish unexpected results to overcome the rejection. Examiner appreciates the declaration provided; however applicant is reminded that whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). In the instant case, the declaration does not provide specific data or evidence that the combination of the compounds in the amounts have unexpected results, rather points to anecdotal evidence and citations that explain what effects the compounds have on the body. Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) and MPEP § 716.02(d) - § 716.02(e). The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."). Looking at the points presented in the declaration, there is no reason to believe that the benefits of the composition would be more than the expected benefits of the compounds. "Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967). Further, if applicant believes that the unexpected results are due to the amount of the compounds present in the claims, then the criticality of the amounts has to be established. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). As such, the declaration is not enough to establish unexpected results.
As such the claims are rendered obvious as discussed in the rejection above.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYAAN A ALAM whose telephone number is (571)270-1213. The examiner can normally be reached M-F 8-5 EST.
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, Bethany Barham can be reached at 571-272-6175. 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.
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611