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 .
Applicants' arguments, filed 12/26/25, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. They constitute the complete set presently being applied to the instant application.
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.
Previous
1) Claim(s) 1-4, 7-8, 10-12, 14-15, 25, 27, 29, 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Yuka et al., (JP2011088939 w/translation, pub. 2011) and Prat (WO 2006/040189) in view of Hermelin et al., (US 2008/0193531) and further in view of Knowde.com (Hopsetiner Beta Bio 45%, published online Feb. 2021).
Yuka et al. teaches, stable internal pharmaceutical preparations (Abstract). “Specifically, the forms of internal preparations of the present invention include tablets (including orally disintegrating tablet, chewable tablets, effervescent tablets, troches, jelly-like drops, etc.), granules, fine granules, powders . . .” (6th page, 3rd paragraph).
Tablets are capable of performing the intended uses insofar as tablets are capable of being swallowed.
“Further, the internal preparation of the present invention can be provided as various foods (health supplement foods, foods for specified health use, nutritional functional foods, special use foods, etc.) in addition to pharmaceuticals and quasi drugs” (6th page, 4th paragraph).
Yuka et al. teaches a specific embodiment of a solid preparation comprising “Pirenzepine hydrochloride 45 parts by weight Aldioxa 150 parts by weight Magnesium hydroxide 450 parts by weight Precipitated calcium carbonate 900 parts by weight (calcium abrasive) Synthetic hydrotalcite 780 parts by weight Hop dry extract 33 parts by weight Hydroxypropyl cellulose 180 parts by weight Crystalline cellulose 256 parts by weight D-mannitol [nutrient source for microorganisms; natural sweetener] Suitable amount hydroxy 300 parts by weight propyl starch 15 parts by weight of light anhydrous silicic acid 3600 parts by weight” (7th page, Formulation Example 1, 4th paragraph), as per claim 1-2, 7-8.
Here, the amount of Natural Hops Extract comprises about 0.49% of the solid preparation, as per claim 1 and 13. The solid preparation is free of sucrose, as per claim 25.
Hops Extract comprises hops acids such as humulone, an alpha acid and lupulone, a beta acid, as per claim 3-4, as evidenced by Prat (see p. 3, lines 4-11 stating “Hop extracts such as hop acids (alpha acids also referred to as Humulone and Beta acids also referred as to Lupulone) present in hop have been long known and used for their bacteriostatic and bacteriocidal functions in the beer industry”).
Vitamins may also be including in the preparations of Yuka et al., wherein “such vitamins include vitamin C, vitamins B1, vitamins B6, vitamins B12, vitamins B2, vitamins E, vitamins A” including “retinol acetate” (a retinoid compound), as per claim 12 (5th page, 7th paragraph).
Amino acids, as per claim 14, may also be included insofar as the stable internal pharmaceutical preparation can include “glutamine” (Abstract).
The internal pharmaceutical preparations include “excipients (sucrose, starch, corn starch, crystalline cellulose, light anhydrous Silicic acid etc.), lubricants . . . disintegrating agents . . . foaming agents” as well as “antiseptic/preservative, antioxidant, a sweetening agent, a sour agent, a coloring agent, a fragrance/flavor, a flavoring agent, etc. these formulation” (6th page, 2nd paragraph).
Internal preparations also include “As astringents . . . tannic acid . . .” (5th page, 1st full paragraph). It is noted that the prior art is silent as to the amounts of astringent present in the composition that would be sufficient to administer to a subject the amounts of Applicant's claim 1; however, because the presence of the astringent is taught it would have been obvious to optimize the range of tannic acid. Accordingly, "where 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 MPEP 2144.05, II. A, quoting In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add tannic acid, sucrose, vitamins and amino acids, e.g. glutamine, to the compositions of Yuka et al. given their plain enumeration in the prior art.
Yuka et al. anticipates an edible oral composition comprising hops, calcium, and a nutrient source for microorganisms, wherein the edible oral composition is not a toothpaste, a dentifrice, or a mouthrinse.
Yuka et al. does not teach a source of hops extract comprising at least about 35% by weigh to hops beta and less than 1% hops alpha acid, calcium chloride or calcium citrate.
In addition to evidencing the content of hops acids in hops extract, Prat also teaches, “Beta acids from hop have been shown as demonstrating superior efficiency against development of gram + bacteria and claimed for use in food preservation” (p. 3, lines 27-29).
In view of this, it would have been obvious to utilize an extract of predominantly beta acids.
Knowde.com teaches a natural hops extract containing “the potassium salts of hop beta acids” called “Hopsteiner Beta Bio 45%” (p. 1), which can be used in “Food Applications” (top of 2nd page).
The extract comprises about 45% beta acids, and 0.4% alpha acids (less than 1%) (see Properties, 5th page).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to use Hopsteiner Beta Bio 45% of Knowde.com as the natural hops extract in the solid preparations of Yuka et al. for the advantage of superior efficiency against development of gram + bacteria, as taught by Prat.
Hermelin et al. teaches “pharmaceutical compositions and methods for improving the absorption of nutrients and/or drugs in the gastrointestinal tract of a subject”, wherein the pharmaceutical compositions include “one or more agents selected from a pH lowering agent, a vitamin, a mineral, and a drug” (Abstract).
Suitable forms for the pharmaceutical compositions “include a tablet, including a suspension tablet, a chewable tablet, and effervescent tablet or caplet; a pill; a powder such as a sterile packaged powder . . . the pharmaceutical compositions may be incorporated into a food product or powder for mixing with a liquid” (p. 15, para. [0081]).
Suitable minerals include “calcium chloride, calcium citrate” (p. 3, para. [0030]).
The compositions also comprise excipients such as “xylitol and sorbitol” (p. 6, para. [0056]), as well as arginine, as a buffering agent (Id., para. [0047]), which is an ammonia generating compound, as per claim 32. The prior art is silent concerning the amount of buffering agent; however, it would have been obvious to optimize a range based on its function.
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use (see MPEP 2144.07). Also, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function (see 2144.06).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s invention to add calcium chloride to the compositions of Yuka et al. for the advantage of providing minerals to the compositions, as taught by Hermelin et al.
It would have also been obvious to add xylitol, arginine and sorbitol to the compositions of Yuka et al. since the compositions of Yuka et al. comprise excipients and buffering agents (6th page, 2nd paragraph of Yuka et al.), and xylitol and sorbitol are recognized in the art as excipients, and arginine is recognized in the art as a buffering agent, as taught by Hermelin et al. The artisan would have been motivated to provide known excipients and buffering agents based on their art recognized suitability for their intended use.
2) Claim(s) 16-19 remain rejected under 35 U.S.C. 103 as being unpatentable over Yuka et al., (JP2011088939 w/translation, pub. 2011) and Prat (WO 2006/040189) in view of Hermelin et al., (US 2008/0193531) and further in view of Knowde.com (Hopsetiner Beta Bio 45%, published online Feb. 2021), as applied to claim 14 above in view of Bernard et al., (US 2006/0127343).
The combination of Yuka et al., Prat, Hermelin et al., and Knowde.com, which is taught above, differs from claims 16-19 insofar as it does not teach where the amino acid is a peptide.
Bernard et al. teaches a “cosmetic/pharmaceutical composition” for combating signs of cutaneous aging (Abstract).
The compositions “for ingestion . . . can be provided in the form of capsules, granules, syrups or tablets” (p. 3, para. [0052]).
The compositions include “active principles which stimulate the macromolecules of the dermis or prevent their degradation” (p. 4, para. [0067]) such as “the palmitoyl of lysine-threonine-threonine-lysine-serine pentapeptide” (pal-KTTKS) , and “retinoids” (Id. at para. [0073]).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add peptides to the solid preparations of Yuka et al. for the advantage of combating signs of cutaneous aging, as taught by Bernard et al.
Previous
4) Claim(s) 1-4, 7-12, 14-15, 20-25, 27, 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Beddie et al., (WO 2007/012080, cited in IDS) in view of Gyarmathy et al., (US 3,431,339) and further in view of Robinson et al., (US 2006/0134020).
Beddie et al. teaches oral care compositions containing “natural tree resins or acids or derivatives thereof, which inhibit undesirable bacteria that are known to cause dental caries, gingivitis and other periodontal diseases” (Abstract), wherein “[s]uch oral care compositions are advantageously combined with hop resins, hop extracts, hop acids or hop acid derivatives”, including “hop extract resins such as lupulone and humulone, from the hop plant humulus lupulus” (p. 2, lines 5-10).
“In one embodiment, the hop acids are beta acids selected from the group consisting of lupulone, colupulone, adlupulone and derivatives thereof” (p. 2, lines 15-17). The concentration hops acid can be “between about 0.001 and 0.1%” or “between about 1% and 99%” (Id. lines 19-21), as per claim 13.
Since the hops acids can be beta acids, it would have been obvious to have at least 35%, by weight of the hops, of hops beta acid, as per claim 5, even to the exclusion of hops alpha acids, as per claim 6.
Fluoride is taught in the reference (see p. 6, lines 1-2), but is not necessary for the practice of the invention. Accordingly, it would have been obvious to have less than about 0.7 ppm fluoride, as per claim 24.
“The oral care products or compositions of the present invention may include powders, pastes, gums, gels, solutions and the like for rinsing, brushing, washing, chewing or topical application in the oral cavity” (p. 5, lines 18-20). These forms satisfy the intended use of the claims insofar as they are capable of being swallowed intentionally.
Beddie et al. does not teach wherein the chewing composition comprises calcium abrasive or a biofilm modifier as per claims 1 and 32.
Gyarmathy et al. teaches a “Dental tablet for use in place of toothpaste” comprising “an intimate blend of water-soluble, anticaries fluorine containing agents, such as stannous fluoride or sodium monofluorophosphate, polishing agent, such as agent including insoluble sodium metaphosphate, foaming agent, such as sodium lauryl sulfate, and releasable matrix, such as a waxy polyethylene glycol” (Abstract). Note: stannous is also tin, as per claim 20. Gyamathy et al. further teaches, “It is within the scope of this invention to use other active ingredients together with the anticaries fluorine-containing agent such as stannous fluoride”, wherein suitable active agents include “urea” (see col. 2, lines 44-51), which is an ammonia generating compound, as per claims 1 and 32. Accordingly, it would have been obvious to add it to the tablets of Beddie et al.
The dental tablets are chewable insofar as Gyarmathy et al. teaches, “When the tablets of each of the examples are used, the average user naturally bites down on it with the posterior teeth, usually crushing the tablet between the first molar and either a bicuspid or another molar” (col. 6, lines 28-31).
Concerning calcium Gyarmathy et al. teaches that preferred polishing agents include calcium compounds such as “calcium pyrophosphate”, “tricalcium phosphate”, “dicalcium phosphate dihydrate, calcium carbonate, anhydrous dicalcium dihydrate” (col. 2, lines 57-67). Calcium carbonate is specifically mentioned as a cleaning abrasive “which will not scratch the enamel surface of the teeth or abrade the dentin” (Id.).
The prior art teaches a specific embodiment of a tablet comprising insoluble sodium metaphosphate, anhydrous dicalcium phosphate, polyethylene glycol, stannous fluoride, tetrasodium pyrophosphate, sodium salt of hydrogenated coco fatty acid monoglyceride, sodium lauryl sulfate, sodium carboxymethylcellulose, silica, flavoring oil, woodpulp cellulose, mannitol (nutrient source for microorganisms; natural sweetener), arrowroot starch, and Alabama talc (col. 5, Example 1, lines 10-42). This embodiment is free of sucrose, as per claims 25 and 28.
In regard to claim 30, the prior art teaches, “To contribute desirable sweetness to the taste of the flavor, a sweetening agent such as sodium saccharin or sodium, potassium and calcium salts of cyclohexsulfamic acid is advantageously added” (col. 4, lines 24-28).
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use (see MPEP 2144.07). Also, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function (see 2144.06).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s invention to add calcium to the chewable form of Beddie et al. since calcium is recognized in the prior art as suitable for adding to a chewable form of an oral care formulation, as taught by Gyarmathy et al. Note that the chewable form of Gyarmathy et al. includes nutrient sources for microorganisms, such as mannitol, and sweeteners such as saccharin. Accordingly, it would have been obvious to include them as well.
The combination of Beddie and Gyarmathy et al. does not teach calcium chloride, vitamins, amino acids, nor xylitol
Robinson et al. teaches “oral care compositions” comprising fluoride and a water-soluble calcium salt (Abstract).
The compositions may be in the form of “a dental tablet” (see p. 5, para. [0049]; see also para. [0043]).
Suitable calcium salts include “calcium chloride . . . calcium citrate” (p. 2, para. [0020]), which “help remineralize demineralized tooth enamel and prevent the development of dental caries” (Id. para. [0019]).
The compositions further comprise “xylitol”, as a sweetener (p. 7, para. [0057]), as per claim 27, and “a nutrient” (p. 8, para. [0072]), wherein suitable nutrients include “vitamins, minerals, amino acids, and mixtures thereof. Vitamins include Vitamins C and D, thiamine, riboflavin, calcium pantothenate, niacin, folic acid . . . and mixtures thereof” (Id.). Amino acids include “L-tryptophane, L-lysine, methionine, threonine, levocarnitine and L-carnitine” (Id.) See also “vitamin A” (p. 8, para. [0066]), which is a retinoid (i.e. retinol), as per claim 12.
Robinson et al. also teaches adding “an antiplaque (e.g., plaque disrupting) agent”, wherein suitable agents include “urea”, which is an ammonia generating compound, as per claims 1 and 32. It would have been obvious to add it to the compositions of Beddie et al. for the advantage of plaque disruption.
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use (see MPEP 2144.07). Also, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function (see 2144.06).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add the calcium chloride, calcium citrate, vitamins, urea, amino acids, and xylitol of Robinson et al. to the oral care formulation of Beddie et al. based on their art recognized suitability for their intended use in oral care compositions, as taught by Robinson et al. The artisan would have been further motivated to add the ingredients of Robinson et al. for the advantage of remineralizing demineralized tooth enamel and preventing the development of dental caries, as taught by Robinson et al.
5) Claim(s) 14, 16-19 remain rejected under 35 U.S.C. 103 as being unpatentable over Beddie et al., (WO 2007/012080, cited in IDS) in view of Gyarmathy et al., (US 3,431,339) and further in view of Robinson et al. (US 2006/0134020) as applied to claim 1 above, and further in view of Bernard et al., (US 2006/0127343).
The combination of Beddie et al. and Gyarmathy et al., which is taught above, differs from claims 14, 16-19 insofar as it does not teach amino acids as peptides.
Bernard et al. teaches a “cosmetic/pharmaceutical composition” for combating signs of cutaneous aging of the skin and/or mucous membranes (Abstract). Note: Mucous membranes also line the structures within the oral cavity limits known as the oral mucosa.
The compositions “can be provided in the form of capsules, granules, syrups or tablets” (p. 3, para. [0052]).
The compositions include “active principles which stimulate the macromolecules of the dermis or prevent their degradation” (p. 4, para. [0067]) such as “the palmitoyl of lysine-threonine-threonine-lysine-serine pentapeptide” (pal-KTTKS) (Id. at para. [0073]).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add amino acids as peptides, to the chewable formulations of Beddie et al. for the advantage of combating signs of cutaneous aging of the skin and/or mucous membranes, as taught by Bernard et al.
Technological Background
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure Yang et al., (Molecular Microbiology 2015). Yang et al. is pertinent for teaching, “Amino acids are one of the most valuable nutrient sources for bacteria and can be utilized as sole nitrogen, carbon or energy sources” (p. 2, para. [0019]).
Response to Arguments
i) Applicant argues, “The combination of Yuka, Prat, Hermelin and Knowde fails to teach or suggest a composition comprising a biofilm modifier as recited in pending clams 1 and 32”
The Examiner disagrees.
The compositions of Yuka are edible insofar as they are described as chewable tablets. Concerning the most recent amendments, Yuka et al. teaches adding tannic acid as astringent, and Hermelin et al. teaches adding arginine, as a buffering agent. Accordingly, it would have been obvious for the compositions to possess a biofilm modifier as claimed.
Robinson et al. also teaches adding urea as an antiplaque (e.g., plaque disrupting) agent. Accordingly, it would have been obvious for the compositions of Beddie to possess a biofilm modifier, as claimed.
“It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant” (see MPEP 2144, citing e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006)).
Furthermore, “[w]hen the claimed compositions are not novel they are not rendered patentable by recitation of properties, whether or not these properties are shown or suggested in the prior art.” In re Spada, 911 F.2d 705, 709 (Fed. Cir. 1990).
ii) Applicant argues that Table 3 of the instant specification provides evidence of unexpected synergistic results sufficient to overcome the art of record. Specifically, “in Table 3, the addition of the specific hops extract to a composition to a composition containing an ammonia-generating compound (arginine) resulted in a dramatic and unexpected improvement in acid inhibition” (p. 7).
The Examiner disagrees.
"[I]t is well settled that unexpected results must be established by factual evidence. Mere argument or conclusory statements in the specification does not suffice" (In re De Blauwe, 736 F.2d 699,705 (Fed. Cir. 1984)).
Table 3 of the instant specification demonstrates the benefit of hops acids in regard to acid production and acid inhibition in the oral cavity when combined with known chewable compositions. Regardless of the composition, the presence of hops reduced acid production and increased acid inhibition. Applicant states, “It was unexpected that by adding hops beta acid extract to the commercial edible compositions that it increased that antimicrobial efficacy of every composition” (p. 49-50, lines 20-2). When combined with a chew comprising arginine, despite showing the same kind of improvement, applicant stated, “This, unexpectedly, produced a synergistic effect and resulted in a more effectively stabilized biofilm pH than either ingredient could achieve on its own” (p. 10, lines 19-20).
Initially, the data of Table 3 is lacking in probative value insofar as it is not clear what ingredients were also present in the formulations besides what was mentioned by applicant, such as hops and arginine. It was also unclear whether or not the commercial chews were formulated to prevent acid production in the oral cavity. It is also unclear how much hops acid was added to each formulation, which may help shed light on the reason for the efficacious results.
Table 3 does not show evidence of synergy insofar as it does not show provide a showing of results with hops chew alone, without arginine. Synergy, by definition, is the interaction of two or more substances that produce a combined effect greater than the sum of their separate effects.
Moreover, 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) (MPEP 716.02(b)). It is unclear how applicant’s results are unexpected and unobvious and of both statistical and practical significance. There is no indication that comparisons were replicated, peer reviewed, or subject to robust statistical method, which would speak to reliability of the results.
Since hops acids are known and used for their antibiofilm activity and ability to provide antimicrobial properties against staphylococci (see Bogdanova et al.), one would have reasonably expected the addition of a known antibacterial agent to result in increased antibacterial effects. Bogdanova et al. teaches the antibiofilm activity of hop compounds humulone, lupulone and xanthumol and concluded, “All tested hop compounds were shown to possess antimicrobial properties against all tested staphylococci, both planktonic and biofilm-dwelling, with no significant difference between resistant and susceptible strains” (Abstract). Reduction in Staphylococcus aureus would have resulted in reduced acid production insofar as Staphylococcus aureus can produce acidic byproducts like lactate and acetate from sugar metabolism, contributing to the acidic oral environment.
Even if applicant’s data supported unexpected results, Appellant must demonstrate a difference between the claimed invention and the closest prior art. In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) (“[W]hen unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.”).
Applicants have not presented any experimental data comparing the claimed invention to the closest prior art, i.e. Yuka et al. or Beddie et al.. Due to the absence of tests comparing applicant’s articles with those of the closest prior art, applicant’s assertions of unexpected results constitute mere argument.
Nonstatutory Obvious-type Double Patenting--Previous
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
1) Claims 1-4, 7-8, 10-12, 14-25, 27, 29-31 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No. 17/704,027 (reference application). This rejection applies to newly added claim 32. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim an oral composition comprising hops and calcium. The compositions also comprise natural sweeteners, which suffices as a nutrient source for microorganisms.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
2) Claims 1-4, 7-8, 10-12, 14-25, 27, 29-31 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 17/485,553 (reference application). This rejection applies to newly added claim 32. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim an oral composition comprising hops and calcium. The compositions also comprise an amino acid, which suffices as a nutrient source for microorganisms.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
3) Claims 1-4, 7-8, 10-12, 14-25, 27, 29-31 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 17/485,552 (reference application). This rejection applies to newly added claim 32. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim an oral composition comprising hops and calcium. The compositions also comprise an amino acid, which suffices as a nutrient source for microorganisms.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
4) Claims 1-4, 7-8, 10-12, 14-25, 27, 29-31 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-41 of copending Application No. 17/485,550 (reference application). This rejection applies to newly added claim 32. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim an oral composition comprising hops and calcium. The compositions also comprise citrate, which suffices as a nutrient source for microorganisms.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
5) Claims 1-4, 7-8, 10-12, 14-25, 27, 29-31 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-8, 10-18, 54 of copending Application No. 17/037,776 (reference application). This rejection applies to newly added claim 32. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim an oral composition comprising hops and calcium. The compositions also comprise an amino acid, which suffices as a nutrient source for microorganisms.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
6) Claims 1-4, 7-8, 10-12, 14-25, 27, 29-31 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 7-18, 35-51, 55 of copending Application No. 17/037,766 (reference application). This rejection applies to newly added claim 32. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim an oral composition comprising hops and calcium. The compositions also comprise an amino acid, which suffices as a nutrient source for microorganisms.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
THIS ACTION IS MADE FINAL. 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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/WALTER E WEBB/ Primary Examiner, Art Unit 1612