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 .
DETAILED ACTION
Claim Status
Claims 1-5, 7, 9-14 and 16-25 are pending.
Claims 6, 8 and 15 are canceled.
Claims 11-13 and 18-23 are withdrawn.
Claim 25 has been added.
Claims 1-5, 7, 9, 10, 14, 16-17 and 24-25 have been examined.
Claims 1-5, 7, 9, 10, 14, 16-17 and 24-25 are rejected.
Acknowledgement of Receipt
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/13/2024 has been entered.
Withdrawn Objections/ Rejections
In light of Applicants amendment to contain the status identifier within the body of the numbered claim, the claim objections are withdrawn.
In light of the cancellation of claim 15 and the addition of new claim 25, the rejection of claim 15 under 35 U.S.C. § 112(d) as being of improper dependent form is withdrawn.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 (a) are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicants are advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 7, 9, 10, 14, 16-17 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Gabillet (US 2019/0216110, filed 09/25/2017, cited on IDS as WO 2018/058039), and Meador (US 2016/0361291, pub. 12/15/2016) evidenced by Doing (Doing Holdings Group, pub. 06/28/2018), in view of Roberts (US 2006/0013904, pub. 01/19/2006), evidenced by Guillaume (FR 3016168, pub, 07/10/2015). Citations from Guillaume are from the machine translation document provided.
Gabillet discloses a gelled feed composition for animals comprising a gelling agent comprising from 50 to 75% by weight of xanthan gum, from 12 to 37% by weight of guar gum, and from 0.5 to 13% by weight of locust bean gum (abstract, [0029], claim 1). Gabillet teaches that guar gum has viscosifying properties, that locust bean gum can serve as a thickener, and xanthan gum enhances viscosity ([0024]). Gabillet meets the one or more second viscosity adjustment components limitation by teaching xanthan gum ([0007], claims 1 and 10) to read on claim 1 and claim 7.
Gabillet discloses green tea extract as a nutrient in the feed from 0.001 to 0.05% ([0034], [0064], Example 3). Applicants describe green tea as a known source of caffeine (see Spec., pg. 2, last para.). As such, Gabillet necessarily teaches caffeine to read on the naturally occurring caffeine of claim 1. Additionally the green tea extract of Gabillet reads on claim 3 and claim 24.
Gabillet teaches that the feeds described herein are not limited for use with swine, and can be used for other animals, including other types of livestock and pets ([0027]).
Regarding the one or more second viscosity adjustment components comprising about 0.05-0.20% wt. of the supplement product limitation, Gabillet discloses that the gelling agent composition can allow binding with water and/or is capable of forming a matrix in which the feed nutrient is retained ([0032]). Gabillet discloses that in some embodiments, the total amount of the gelling agent (i.e., one or more second viscosity adjustment components) may be in a concentration of from about 0.5 to 3.0% by weight of the total weight of the unstructured gel feed ([0032]). MPEP 2144.05 states that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. The lower end of the range taught by Gabillet, 0.5% wt., is close to the upper range claimed, 0.2% wt. Additionally, Gabillet meets the limitation with Example 3 where the gelling agent is present from 0.1 to 2% of the gel feed ([0064]). MPEP 2144.05 states that a prima facie case of obviousness exists in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art. In addition, MPEP 2144.05 states that 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.
Gabillet teaches that in one aspect, the gel feed does not stick to skin of the animal being fed and that the liquid contained in the gel feed will not separate from the solids ([0022]). Gabillet teaches that the structure of the gelled feed can be adjusted depending on the feeding and palatability (i.e., texture) needs of the animal, suggesting a viscosity and consistency similar to a typical porridge ([0028]). Gabillet teaches that the gelled agent can include other materials (e.g., pectin) reduce the flowability (i.e., increase the consistency) and/or increase the stickiness of the final gel feed produced ([0031]).
Gabillet does not disclose 400-800 centipoise at 21 °C.
Meador discloses a nutritional composition including 20 to 2,000 mg of green tea extract per serving to the subject which may be an animal e.g., cow (abstract, [0027- 0028], [0034], [0038], claims 1, 23). Meador teaches that the green tea extract is a source of stimulation (i.e., stimulant) (of muscle protein synthesis) and provides example evaluations ([0060]; see Example 1,[0079]). A person of ordinary skill would immediately recognize that caffeine is typically found in the green tea extract, thus, is a source of non-synthetic caffeine.
Meador teaches corn syrup as an examples of a source of carbohydrate suitable for use in the nutritional compositions and shows this in Table 3 at 61.3% ([0054], [0072], claim 10). MPEP 2144.05 states that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Meador teaches guar, locust bean, and xanthan gum as examples of a source of carbohydrate suitable for use in the nutritional compositions ([0054]). Meador teaches that one skilled in the art would be able to select the appropriate carbohydrates to include in the nutritional compositions disclosed herein or otherwise contemplated ([0056]). Although Meador teaches corn syrup as a carbohydrate, as evidenced by Doing (circled text on pg. 2 of Corn Syrup document) the ingredient is well-known in the art of having the ability to thicken and being utilized as a thickener in a composition such as a supplement product.
Roberts discloses an oral dosage composition that is retained by the patient in the oral cavity for a time sufficient to allow absorption of the active e.g., parthenolide (a sesquiterpene lactone), by oral mucosal tissues (title, abstract, [0011], [0039], element c) of claim 1). Roberts teaches that the said patient may be an animal ([0039]). Roberts teaches a composition that comprises green tea extract ([0023], claim 6, 10). Roberts teaches that preferred thickening agents include guar gum, potato starch, and xanthan gum ([0033]).
Roberts teaches that most preferably, the compositions have a viscosity that is from about 100 cP (somewhat lower than the viscosity of olive oil) to about 50,000 (i.e., the viscosity of molasses), and more preferably from about 500 cP (the viscosity of SAE #10 motor oil) to about 5000 cP (approximately the viscosity of corn syrup), all measured at 25° C ([0034]).
Regarding claims 1 and claim 16, (i.e., green tea extract, xanthan/guar 0.05- 0.20%, corn syrup 50-60% wt., water, 400-800 centipoise), it would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to use the increased percentage of green tea extract and thickening agent taught by Meador in view of Roberts in the composition of Gabillet with expected results. One skilled in the art would be motivated do so because Meador discusses skeletal muscle loss characterized by dysphagia and impaired nutrient absorption ([0030]). Roberts teaches that compositions having higher viscosity enable better contact with the sublingual area, and the thickening agent retains the liquid composition sublingually improving absorption of the active ingredients in by the patient ([0032]). Absent evidence of the contrary, the prior art of Gabillet, Meador and Roberts would contribute to improved absorption and delivery of caffeine to oral mucosal environments.
Regarding the water limitation of clam 16, the references teach incorporating water (Gabillet [0033] water component, Meador [0071] Table 2 water Q.S., Roberts [0029-0031]). Particularly relevant to the neonatal calf of Applicants’ claimed invention is Gabillet’s teaching of a composition which exhibits excellent stability (for up to 2 years or more) to extend storage time, an invaluable advantage to breeders, and that the composition is soft, making it easier for young animals to consume ([0028]).
Regarding claim 2 (i.e., 500-650 cps), Roberts teaches a preferred viscosity of 500 cP ([0034]).
Regarding claim 4, Gabillet does not teach the 1-3% wt. of caffeine.
Meador teaches green tea extract present at 1.390% and 1.212% in an exemplary formulation (see Tables 2 and 3 respectively, [0071-0072]). MPEP 2144.05 states that a prima facie case of obviousness exists in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art.
Regarding claim 5 (i.e., glycerin), Gabillet teaches glycerin in the composition ([0064]).
Regarding claim 7 (i.e., second viscosity adjustment component, ascorbic acid), Gabillet teaches vitamin C (i.e., ascorbic acid) from 0.001 to 0.050% ([0064]) to further read on the lower limit of the claimed range of claim 1 (i.e., 0.05). In addition, Gabillet teaches citric acid from 0.2 to 1.5% of the gel feed ([0064]) to read on the upper limit of the claimed range of claim 1 (i.e., 0.20%). MPEP 2144.05 states that a prima facie case of obviousness exists in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art.
Regarding claim 9 (i.e., antioxidant), Applicants teach caffeine as functioning as an antioxidant (see Spec., pg. 8, last para.). Gabillet teaches Butylated hydroxytoluene as an antioxidant ([0034], [0053] see Antioxidant E321).
Regarding claim 10 (i.e., green tea), Gabillet and Meador teach green tea extract in the feed gel which is well-known in the art in natural antioxidant systems as evidenced by Guillaume, green tea extract provides oxidative stability to food and veterinary formulations (see Guillaume [0003], claim 15).
Regarding claim 14 (i.e., trisodium citrate dihydrate), Gabillet teaches trisodium citrate ([0035], [0053] Example 2,see E331 Trisodium Citrate; [0064] Example 3).
Regarding claim 17 (i.e., 1-3 % wt. green tea extract), as stated above, Meador discloses green tea extract at 1.390 % and 1.212 % in an exemplary formulation ([0071-0072] Tables 2-3).
Claims 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Gabillet and Meador evidenced by Doing, in view of Roberts evidenced by Guillaume as applied to claims 1-5, 7, 9, 10, 14 and 16-17 above, in further view of Guillaume (FR 3016168 A1, pub. 07/10/2015) and Perva-Uzunalić (Food Chemistry 96, 2006, 597-605). Citations from Guillaume are from the machine translation document provided.
The above teachings of Gabillet, Meador, in view of Roberts as evidenced by Guillaume are incorporated herein.
As mentioned above, Gabillet teaches green tea extract with Example 3 ([0034], [0064]).
Regarding the 10 - 40 ml liquid dose and 100 - 400 mg of claim 25, a conversion of the recited milligrams is provided below:
(100 mg/10 ml - 100 mg/40 ml) or (10 mg/ml - 2.5 mg/ml) or (1 wt.% - 0.25 wt.%); and (400 mg/40 ml - 400 mg/10 ml) or (10 mg/ml - 40 mg/ml) or (1.0 wt.% - 4.0 wt.%).
Guillaume discloses a composition comprising green tea extract to increase the oxidative stability of food or veterinarian formulations ([0009-0010], claim 15). Guillaume discloses the green tea extract includes 4% caffeine and that the extract can be obtained by techniques known to those skilled in the art, in particular by extraction of green tea leaves using solvents such as water or ethanol followed by a purification step by re-extraction/enzymatic treatment ([0009]). Guillaume teaches that a composition comprises preferably 1-3% by weight of green tea extract ([0009], claim 9) and provides exemplary formulation examples ([0021], [0028]).
As stated above, Meador teaches a composition to deliver 20-2000 mg of green tea extract (claims 1 and 23). As Guillaume teaches green tea extract may comprise 4% of caffeine ([0009]), therefore, approximately 80 mg of caffeine would be delivered (0.04 x 2000 = 80 mg).
Perva-Uzunalić discloses green tea extracts from green tea leaves (Fanning Belas, China) and concentrations thereof at 36 g caffeine/kg of material followed with extractions to provide a content of caffeine in the extract in the range of 75 g/kg with extraction efficiencies ranging from 62% to 76% (abstract). The study teaches that the content of caffeine was in the range of approximately 10-100 g caffeine/kg dry extract (see Conclusion, pg. 604).
The conversion is as follows: (10 x 1000)/40 ml = 250 mg of caffeine to fall within the claimed range.
In light of these teachings, it would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to apply the concentrated green tea extract taught by Perva-Uzunalić to the compositions of Gabillet and Meador in view of Roberts with expected results. One skilled in the art would be motivated do so because all of the references allow for the incorporation of dry powders (i.e., concentrated green tea extract) (Meador [0023], Gabillet [0033], Guillaume [0009]). Perva-Uzunalić further teaches that caffeine can be isolated from even decaffeinated green tea leaves (pg. 604, see Section 3.4.). Meador shows a concentration that is close to the claimed range and combined with the concentration teachings of Perva-Uzunalić a skilled artisan would achieve expected results. In addition, it would have been obvious to one of ordinary skill in the art to use optimization and experimentation to determine the desired amount of caffeine to be delivered. The adjustment of particular conventional working conditions (e.g., extraction, measuring effective amounts of the components beneficially taught by the cited references) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
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 1-5, 7, 9, 10, 14, 16, 17, 24 and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 13-15 of copending Application No. 18/976,650. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined application claim(s) is/are either anticipated by, or would have been obvious over the reference claims.
Copending application '650 discloses a neonatal dietary supplement for ruminant animals that delivers green tea extract as the source of non-synthetic caffeine at about 0.3-2.0% wt of the supplemental product.
Claim 1 of copending ‘650 anticipates the limitations of claims 1 and 25.
Claim 2 of copending ‘650 anticipates the limitations of claim 2.
Claim 3 of copending ‘650 anticipates the limitations of claim 3.
Claim 4 of copending ‘650 anticipates the limitations of claim 4.
Claim 5 of copending ‘650 anticipates the limitations of claim 5.
Claim 6 of copending ‘650 anticipates the limitations of claim 7.
Claim 7 of copending ‘650 anticipates the limitations of claim 24.
Claim 8 of copending ‘650 anticipates the limitations of claim 9.
Claim 9 of copending ‘650 anticipates the limitations of claim 10.
Claim 13 of copending ‘650 anticipates the limitations of claim 14.
Claim 14 of copending ‘650 anticipates the limitations of claims 16 and 25.
Claim 15 of copending ‘650 anticipates the limitations of claims 17 and 25.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 12/13/2024 have been fully considered but they are not persuasive.
Applicants argue Gabillet does not mention a condition more serious (than dehydration) (Remarks, pg. 11, para. 1, 4).
Applicants further argue the nutritional components of Gabillet’s product would not be able to be suspended in a liquid product (Remarks, pg. 12, para. 1).
In response to applicant's argument that Gabillet is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. In this case, Gabillet teaches that the feeds described herein are not limited for use with swine, and can be used for other animals, including other types of livestock and pets ([0027]).
In response to applicant's argument that Gabillet does not disclose more serious conditions than dehydration like bovine dystocia, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., suspended) 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. Notably, Gabillet discloses the gel feed exhibiting little or no syneresis (i.e., separation) ([0022]).
Green tea
Applicants argue Gabillet provides a long list of nutrient examples and green tea extract is far down in the list (Remarks, pg. 11, para. 3) and is in a trace amount while the instant claims require the caffeine ingredient be present at 1-3% wt of the supplement product (Remarks, pg. 13, para. 3).
Applicants argue Meador is relying upon epigallocatechin gallate (EGCg) to provide the 20-2000 mg green tea extract, the green tea extract of Meador can be decaffeinated or substantially free of caffeine, and Table 2 and Table 3 of Meador show green tea extract ingredients at 0.57% wt and 0.77% wt. Applicants further argue Meador can use very small amounts of the green tea extract because the EGCg extracted component constitutes “a very large presence in the green tea leaves” (Remarks, pg. 14, para. 1).
The Examiner, in response, respectfully submits that nonpreferred and alternative embodiments constitute prior art. A disclosure of what is most preferable does not prevent one from looking at another ingredient also disclosed. MPEP 2123(II.) states that examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use. Gabillet clearly discloses green tea extract as a nutritive element in a composition beneficial especially for young animals ([0002], [0034]).
Meador is brought in to teach green tea extract at an amount that falls within the claimed range ([0071-0072]). The rejected claims do not exclude EGCg. Applicants’ mention of Meador’s use of small amounts above, suggests enhanced efficiency which in turn would be a cost savings in the industry.
Viscosity
Applicants argue Gabillet discloses a gelling agent with components that have % wt amounts relative to the total weight of the gelling agent (Remarks, pg. 11, para. 2; pg. 13, para. 1-2).
Applicants argue Gabillet’s “typical porridge” exhibits inconsistent and varying viscosities; which contrasts with Applicants’ liquid supplement. Applicants state viscosity of the claimed invention is increased “just to the point that it can adhere to the calf’s mouth tissue” but not so much that the supplement product could not be delivered via a squeeze bottle (Remarks, pg. 12).
Applicants argue that the Gabillet’s teaching of xanthan and guar gum to meet the second viscosity adjustment component limitation at computed ranges fall outside the Applicants claimed range of 0.05-0.20% wt (Remarks, pg. 13, para. 2).
Gabillet discloses that in some embodiments, the total amount of the gelling agent (i.e., one or more second viscosity adjustment components) may be in a concentration of from about 0.5 to 3.0% by weight of the total weight of the unstructured gel feed ([0032]). MPEP 2144.05 states that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Further, the rejected claims do not recite delivery via a squeeze bottle or consistencies. The prior art teaches the range of centipoise recited.
The skilled artisan would expect to obtain a result that necessarily flows with the intended purpose and properties, i.e., effective to such that the “supplement is absorbed through the oral mucosal lining of the neonatal calf” (recited in rejected claim 1) without evidence to the contrary. Likewise, one of ordinary skill in the art would have been motivated to utilize the viscosity adjustment components to adjust the viscosity. Doing so is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Thickening agent
Applicants argue that the corn syrup in Meador’s overall product composition in Table 3 is below the 50-60% wt range for the thickening agent (Remarks, pg. 14, para. 2).
Applicants argue that Roberts’ supplement is kept under the tongue for 30-60 seconds to prevent the parthenolide/feverfew extract components from being broken down whereas the calf described in the instant claims would naturally swallow the 400-800 cps viscosity product into its gastrointestinal tract (Remarks, pg. 15, para. 1).
Meador as evidenced by Doing teaches the thickening agent (i.e., corn syrup) at 61.3% in the aforementioned Table 3 ([0072]). MPEP 2144.05 states that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.
Roberts teaches the thickening agent may assist in providing sublingual liquid retention for a time appropriate for proper absorption of the active ingredient by the patient, and also thereby may improve the clinical efficacy of the composition ([0033]). The rejected claims, as presented, do not recite a duration of delivery. The combined prior art teaches the viscosity range that would be obvious for supplements comprising beneficial components to be absorbed through the oral mucosal lining.
Caffeine
Applicants argue that Meador’s serving size being 296 ml (10 fluid oz.) is above the 10-40 ml range and therefore the concentration of caffeine is lower and that this is for the extreme 2000 mg end of Meador’s caffeine range for their product (Remarks, pg. 17, para. 2).
Applicants does not agree with the Perva-Uzunalić teaching of 250 mg of caffeine in 40 ml (Remarks, pg. 17, para. 3).
The rejected claim 25 recites the 100-400 mg caffeine to be delivered. Combining Meador’s teaching of a concentration which is close to the claimed range with the concentration teachings of Perva-Uzunalić, a skilled artisan would achieve expected results. In addition, it would have been obvious to one of ordinary skill in the art to use optimization and experimentation to determine the desired amount of caffeine to be delivered.
For these reasons, Applicants’ arguments are found unpersuasive.
Conclusion
Claims 1-5, 7, 9, 10, 14, 16, 17, 24 and 25 are rejected; no claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Karen Ketcham whose telephone number is (571)270-5896. The examiner can normally be reached 900-500 ET.
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/Karen Ketcham/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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