DETAILED ACTION
The receipt is acknowledged of applicants’ amendment and terminal disclaimer filed 01/09/2026.
Claims 1-17, and 21-22 are pending.
Claims 15-17 are withdrawn from further consideration without traverse as being drawn to a nonelected invention II.
Claims 1-14, and 21-22 are subject of this office 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 .
Terminal Disclaimer
The terminal disclaimer filed on 01/09/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,504,413, has been reviewed and is accepted. The terminal disclaimer has been recorded.
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.
Claims 21 and 22 are 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. Claims 21 and 22 are confusing because the claims recite the first and second component consists of “….each component in bulk form OR dose of …..”. The claims are interpreted as either: 1) each of the components comprises the claimed ingredients each in bulk form, OR 2) each of the components consists of 10-70 g protein, 1-5 g creatinine, 500-3000 IU vitamin D and 100-1000 mg calcium. In other words the if the components are present in bulk they do not have the claimed amounts.
The claims are further confusing regarding the amount of each component in the bulk? Are they in the same amount as in the dose? Are the bulk doses are provided separately, i.e. protein in bulk, creatine in bulk, etc.?
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 21 and 22 recites the broad recitation “each ingredient of the first component in bulk” and “each ingredient of the second component in bulk”, and the claim also recites “first component consists of 10-70 g of a protein, 1-5 g of creatine, 500-3000 IU of vitamin D and 100-1000 mg calcium”, and “second component consisting of doses of 100-2000 mg of DHA and 100-2000mg of EPA” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The boundaries of coverage is not imposed by the disclosure for a bulk form not comprising the claimed components. It is important that a person of ordinary skill in the art be able to interpret the metes and bounds of the claims so as to understand how to avoid infringement of the patent that ultimately issues from the application being examined. See MPEP § 2173.02.
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 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.
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. Applicant is 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 1-14 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Tsion (US 20160213728), Owoc (US 2015/0132440), Jourdan et al. (US 2013/10780), the article by Kelly et al. (Nutritional studies on dried functional food ingredients containing omega-3 polyunsaturated fatty acids), and Giordano et al. (US 2012/0121726), all references are cited on IDS filed 01/25/2023.
Applicant Claims
Claim 1 is directed to a kit consisting of a first composition consisting of 10-70 g of a protein, 1-5 g of creatine, 500-3000 IU of vitamin D, 100-1000 mg calcium and optionally at least one physiologically acceptable excipient, and a second composition consisting of 100-2000mg of DHA, 100-2000mg of EPA and optionally at least one physiologically acceptable excipient, wherein the first and second compositions are packaged separately.
Claim 21 is directed to a kit comprising a first component consisting of a protein, creatine, vitamin D and calcium, and optionally at least one physiologically acceptable excipient, wherein the first component consists of protein, creatine, vitamin D, and calcium, each in bulk form or the first component consist of doses of 10-70 g of a protein, 1-5 g of creatine, 500-3000 IU of vitamin D and 100-1000 mg calcium, and a second component consisting of DHA and EPA, and optionally at least one physiologically acceptable excipient, wherein the second component consists of DHA and EPS, each in bulk or the second component consists of doses of 100-2000mg of DHA and 100-2000 mg of EPA.
Claim 22 is directed to a kit to improve cognitive ability in an individual comprising a first component consisting of a protein, creatine, vitamin D and calcium, and optionally at least one physiologically acceptable excipient, wherein the first component consists of protein, creatine, vitamin D, and calcium, each in bulk form or the component consists of doses of 10-70 g of a protein, 1-5 g of creatine, 500-3000 IU of vitamin D and 100-1000 mg calcium, for use with a second component consisting of DHA and EPA, and optionally at least one physiologically acceptable excipient, wherein the second component consists of DHA and EPS, each in bulk or the second component consists of doses of 100-2000 mg of DHA and 100-2000mg of EPA.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Tsion teaches solid dietary supplement composition to protect the energy balance in the cells of the nervous system to achieve optimal brain function and to improve cognitive function including memory, concentration and focus, e.g. symptoms associated with attention deficient syndrome patients (ADD or ADHD) (abstract; ¶¶ 0033, 0056, 0092). The composition comprises 50-1000 IU vitamin D3, 50-500 mg calcium carbonate, 100-1100 mg EPA and 100-1100 mg DHA (¶¶ 0007, 0014, 0015, 0039, 0046, 0067, 0069, 0104; examples, and claims). The composition can be in a single formulation or in the form of a kit comprising two separate formulations, wherein one of the formulations is lipid and the other is solid (¶¶ 0018, 0024, 0035). The formulation comprises excipients, e.g. oils, emulsifiers, flavoring agents, colorant, etc. (¶¶ 0080-0082; 104-106).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Tsion teaches nutritional composition comprising vitamin D3, EPA, DHA and calcium suitable to improve cognitive function, the reference does not teach the nutritional composition comprising protein and creatine as claimed by claims 1, 21 and 22. While Tsion suggests kit, the reference does not explicitly teaches the claimed ingredients of each component of the kit as claimed by claims 1, 21, and 22, or the bulk that reads on powder as claimed by claims 21 and 22.
Owoc teaches nutritional composition that can be in the form of powder and used to ameliorate muscle wasting, enhance cognitive function and improve dementia and enhance quality of life (abstract; ¶¶ 0007, 0032, 0037, 0049). The composition comprises 1-100 gm protein including why protein isolate, omega-3 fatty acids, 2500 mg (2.5 g) creatine monohydrate, micellar casein, vitamin D3 (¶¶ 0040, 0050-0061, 0099, 0101, 0102, 0121, 0124; claims 2-7).
Jourdan teaches composition for treating loss of muscle mass and for improving activities of daily living (abstract; ¶¶ 0021, 0022, 0092). The composition comprising 0.5-20 g of creatine (¶¶ 0028, 0031-0032), micellar casein (¶ 0029), vitamin D2 or D3 in a preferred amount of 1,000 IU (¶¶ 0040-0043), 12-14 g of proteinaceous material such as whey protein isolate (¶¶ 0047-0053), EPA and DHA (¶ 0064) and calcium (¶ 0088). The composition can be in the form of powder (¶ 0095).
Kelly teaches powdered milk formula comprising encapsulated fish oil to provide acceptable taste and modest shelf life expectation and excellent stability when stored in air. The encapsulated fish oil is incorporated in the powder milk composition. The powdered formula comprises micellar casein and whey protein (see the entire document, and in particular main conclusion on page 3; page 13; pages14-15; table in page 16). Fish oil comprises omega-3 fatty acids: EPA and DHA as evidenced by Walser (page 457, left column).
Giordano teaches kit comprising elements packaged separately for co-administration to the patient. The reference teaches kit comprising first composition comprising vitamin D3 and second composition comprising mega-3 fatty acids, e.g. DHA, are separated, as well as any other vitamins and minerals that can have deleterious effect on DHA benefit and unappealing side effects (abstract; ¶¶ 0008, 0009, 0011). The first and second compositions can be in a different forms (¶ 0014). Vitamin D3 is present in an amount of 200-600 IU and DHA is present in amount of 125-375 mg, each in separate blister in an acceptable carrier (¶¶ 0028, 0032, 0033). Powder form is suggested at paragraph [0043], and capsule is suggested at paragraph [0047].
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide a solid nutritional composition useful to improve cognitive function and comprising 50-1000 IU vitamin D3, 50-500 mg calcium carbonate, 100-1100 mg EPA and 100-1100 mg DHA as taught by Tsion, and further add 1-100 gm protein including why protein isolate, 2.5 g creatine monohydrate, and micellar casein as taught by Owoc. One would have been motivated to do so because Owoc teaches suitability of 1-1000 g protein, 2.5 g creatine monohydrate, and micellar casein in a nutritional composition to enhance cognitive function, improve dementia, ameliorate muscle wasting, and enhance quality of life. One would reasonably expected formulating nutritional composition comprising vitamin D3, calcium carbonate, EPA and DHA, protein, and creatine monohydrate, all in the claimed amounts, and further comprises micellar casein wherein the composition enhanced cognitive function while improving muscle mass and the general quality of life.
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide a solid nutritional composition comprising the ingredients taught by the combination of Tsion and Owoc above, and produce the solid composition in the form of powder as taught by Jourdan. One would have been motivated to do so because Jourdan teaches that all the elements taught by the combination of Tsion and Owoc are suitable to be included in a powder composition useful to improve muscle mass and activity of daily living.
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide a powder nutritional composition comprising the ingredients taught by the combination of Tsion, Owoc and Jourdan, and separately encapsulate the omega-3 fatty acids (EPA and DHA) in the composition as taught by Kelly. One would have been motivated to do so because Kelly teaches that encapsulated fish oil incorporated into powder composition provides acceptable taste and modest shelf life expectation and excellent stability when stored at in air. One would reasonably expect formulating powdered composition comprising the above ingredients wherein EPA and DHA are encapsulated within the powder wherein the composition has acceptable taste and the extended shelf life and excellent stability even when stored in air.
Additionally, one having ordinary skill in the art would have been motivated to separately package vitamin D3 and omega-3-fatty acids as taught by Giordano and further separate the elements taught by the combination of Tsion, Owoc, Jourdan, and Kelly to form a kit separating any elements that may cause deleterious effect on each other or may provide unappealing composition as taught by Giordano.
Regarding the limitation of “kit” as claimed by claims 1, 21, and 22, the composition taught by the combination of the cited references is two components composition, powder part and encapsulated omega-3 fatty acids, which constitute two components composition, which reads on a kit. The claimed kit does not precisely define present structural attributes of interrelated component parts of the claimed kit. In any event Giordano teaches kit separating the elements that have deleterious effects on each other to form kit, particularly separating the omega-3- fatty acid from other ingredients in nutritional composition.
Regarding the amount of protein of 10-70 g as claimed by claims 1, 21 and 22, Owoc teaches 1-100 g that overlaps with the claimed amount, and Jourdan teaches 12-14 g that falls within the claimed amount.
Regarding the amount of creatine of 1-5 g as claimed by claims 1, 21 and 22, Owoc teaches 2.5 g that falls within the claimed amount and Jourdan teaches 5-20 g that overlaps with the claimed amount.
Regarding the amount of vitamin D of 500-3000 IU as claimed by claims 1, 21 and 22, Tsion teaches 50-1000 IU that overlaps with the claimed amount and Jourdan teaches 1000 IU that falls within the claimed amount.
Regarding the amount of calcium of 100-1000 mg as claimed by claims 1, 21, and 22, Tsion teaches 50-500 mg that overlaps with the claimed amount.
Regarding the amount of EPA and DHA each of 100-1500 mg as claimed by claims 1, 21, and 22, Tsion teaches 100-1100 mg that overlaps with the claimed amount.
Regarding all the above ranges of amounts of the ingredients, it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding claim 2 that the first composition is powder and the second composition is an oil, the combination of cited references teaches powder composition and encapsulated fish oil composition. Further, powder form and capsule form are suggested by Giordano.
Regarding the protein is why protein as claimed by claim 3, this is taught by Owoc, and Jourdan.
Regarding whey protein isolate claimed by claim 4, this is taught by Jourdan.
Regarding the amount of whey protein as claimed by claim 5 of 15-35 g, Owoc teaches 1-100 g that overlaps with the claimed amount, and Jourdan teaches 12-14 g that falls within the claimed amount.
Regarding casein claimed by claim 6, this is taught by Jourdan.
Regarding claim 7 that the composition comprises whey protein and casein, combination of the cited references teaches their combination in a composition.
Regarding creatine derivatives and creatine monohydrate claimed by claims 8 and 9, respectively, Owoc and Jourdan teach creatine, and Owoc teaches creatine monohydrate in powder composition.
Regarding vitamin D3 claimed by claims 10 and 11, it is taught by both Tsion and Jourdan.
Regarding calcium carbonate claimed by claim 12, Tsion teaches calcium carbonate.
Regarding the intended us of the composition for increasing cognitive ability in an individual as claimed by claims 13 and 22, this is taught by Tsion and Owoc. Note that the intended use of the composition does not impart patentability to composition claims.
Regarding excipients claimed by claim 14, they are taught by Tsion.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Response to Arguments
Applicant's arguments filed 01/09/2026 have been fully considered but they are not persuasive.
Claim Rejections under 35 USC 112(b)
Applicants argue that amended claims 21 and 22 are clear and in compliance with 35 USC 112(b). The claims have been amended to clarify that the bulk form of the first component consists of protein, creatine, vitamin D and calcium, each in bulk, and the second component consists of DHA and EPA, each in bulk.
In response to this argument, it is argued that the amendment created another 112/b rejection as set forth in this office action.
Claim Rejections under 35 USC 103
Applicants argue that the claimed kit does not read on compositions that include other ingredients.
In response to this argument, it is argued that the kit is a composition wherein ingredients are packaged as separate components.The claimed kit does not precisely define or present structural attributes of interrelated component parts of the claimed assembly/kit. The two claimed components are packaged and used separately.
Applicants disagree with the Examiner that it would have been obvious to provide a composition to improve cognitive function comprising certain components from Tsion (vitamin D, calcium carbonate, EPA and DHA), and certain components from Owoc (protein, creatine and micellar casein), and that one of skill in the art would have been motivated to do so because Owoc teaches the suitability of these components to enhance cognitive function. This is because the components of the claimed kit consist of particular active ingredients and are closed to the inclusion of other active ingredients.
In response to this argument, applicant’s attention is directed the scope of the present invention that is directed to a composition, and all the elements of the claimed composition are taught by combination of the cited references. Motivation to combine the references exists and reasonable expectation to achieve the present invention was presented. Regarding the expression “consisting of”, claims 21 and 22 recite the open language “kit comprising”, and claims 1, 21 and 22 all recite “physiologically acceptable carrier” in both first and second components that is embrace myriad of compounds in each component.
Applicants argue that the active ingredients in Tsion found to improve cognition are magnesium, Vitamin D3 and a botanical component selected from Valerian sp. and Salvia sp., and the active ingredients in Owoc that elicit beneficial effects are di- and/or tri- peptides having a branched chain amino acid. However, the additional ingredients: calcium carbonate, EPA, DHA, protein, creatine and micellar casein, that may be included in the Tsion or Owoc compositions are not required for the function of the composition to elicit a cognitive effect, and are excluded from many of the exemplary compositions in Tsion and Owoc.
In response to this argument, it is argued that the use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain. In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir 1983). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005). 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 purpose. The discovery of a new action underlying a known process does not make it patentable. MEHL/Biophile, 192 F.3d at 1365, 52 U.S.P.Q.2d at 1303. Also, it is irrelevant that the prior art observers did not recognize the property or function of the disputed claim; if the prior art inherently possessed that characteristic, it anticipates. See Verdeegal Brothers, lnc. v. Union Oil Co. of Cal., 814 F.2d 628, 633, 2 U.S.P.Q.2d 1051, 1054 (Fed. Cir. 1987). This is believed to be applicable here because anticipation is the epitome of obviousness. Further, the intended use of the ingredients do not impart patentability to composition claims. It is reiterated that the claims’ language permits the presence of plant extracts, and any other ingredients, active or inactive, even in major amounts.
Applicants argue that the Examiner appears to suggest that it would have been obvious for one of skill in art to remove the active ingredients from the Tsion and Owoc references, combine only optional arbitrary secondary components, and expect the resulting composition to be effective to improve cognition.
In response to this argument, it is argued that the intended use of the ingredients of a claimed composition do not impart patentability to the claims. Note that not all the claimed ingredients are shown by applicants to be effective to improve cognition. In any event, it has been decided by the Courts that even in a case where the reference does not teach the same use of the composition, the two different intended uses are not distinguishable in terms of the composition, see In re Thuau, 57 USPQ 324; Ex parte Douros, 163 USPQ 667; and In re Craige, 89 USPQ 393.
Applicants reminding the Examiner that when combining and modifying references to establish obviousness, the proposed modification cannot render the prior art unsatisfactory for its intended purpose. The modifications suggested by the Examiner to the Tsion and Owoc references to yield the claimed invention would clearly render the prior art compositions unsatisfactory for their respective intended purposes, i.e. removal of the primary active ingredient(s) in each case would not obviously yield a composition that retains function, namely, improvement of cognition.
In response to this argument, it is argued that Tsion is clearly directed to a composition to protect the energy balance in the cells of the nervous system to achieve optimal brain function and to improve cognitive function (¶¶ 0033, 0056, 0092); and Owoc clearly teach improving cognitive function (at least ¶¶ 0037, 0049). Therefore, combination of the cited references teaches the claimed ingredients used for the same purpose to improve cognitive function, and not render the prior art compositions unsatisfactory for their intended purposes. The rationale to modify the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art and the reason to modify the reference may often suggest what the applicant has done.
Applicants argue that the combination of references must result in a sufficient basis for a reasonable expectation of success. In this regard, modifying the Tsion and Owoc references to remove the primary active ingredients and retaining only optional ingredients as suggested by the Examiner to yield the claimed invention would not reasonably lead to a composition that retains a beneficial effect on cognition.
In response to this argument, it is argued that the combination of the cited references would not remove primary active ingredients from any references, because the references teach all the taught ingredients are suitable to improve cognition of subject. Therefore the combination of the references definitely provides reasonable expectation of success of obtaining composition improves cognitive function. Keeping in mind what is required is only reasonable expectation of success, and not absolute predictability. References are evaluated by what they would suggest to one having ordinary skill in the art rather than their specific disclosure.
Applicants argue that Tsion and Owoc teach a multitude of compounds that may optionally be included in their compositions, resulting in a myriad of potential combinations of ingredients. It would clearly require undue experimentation for one of skill in the art to particularly select the claimed combination from the teachings of Tsion and Owoc, and there would have been no expectation that such a combination would function effectively to increase cognitive ability, particularly if the active ingredients of Tsion (namely, magnesium, Vitamin D3 and a botanical component) and Owoc (di- and tri- peptides) are excluded as the Examiner appears to suggest.
In response to this argument, it is argued that disclosed examples and preferred embodiments do not constitute a teaching away from broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Furthermore, “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). Further, the comprising language and the presence of unidentified excipients in the claimed compositions, permits the presence of any ingredients taught by the cited references, active or inactive, even in major amounts.
Applicants argue that, regarding efficacy, neither Tsion nor Owoc provide any clinical evidence that their compositions actually provide any significant effect on cognitive function. Tsion loosely indicates that soldiers given a two component formulation felt a significant improvement in their alertness and ability to focus on a mission (see para. [0118]). This type of self-diagnosis, without any evidence of controls, lacks significance and validity with respect to cognitive effect. Owoc provides no evidence at all of the utility of their combinations on cognition.
The examiner respectfully disagrees because both references clearly desired to improve cognition function, as set forth in this office action. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005). Applicants did not show that the ingredients taught by the references, e.g. magnesium, would have negative impart on cognitive function.
Applicants argue that this is in contrast to the efficacy of the claimed kit to increase cognitive ability in a healthy individual which is significant as determined using established tests for this purpose, including The Montreal Cognitive Assessment (MoCA), the Rey Auditory Verbal Learning Test (RAVLT), the Go-No-Go task and the Simple Reaction Time task as known to those in the art and described at paragraphs [0067], and [0090] to [0094]. The tests confirmed the surprising results that a significant improvement in the composite score of cognition was observed for the SUPP group (group who took kit composition), but not the CON (control) group (see paragraphs [0116] and [0117]). Thus, the claimed kit was surprisingly determined to provide clinically significant improvement of cognition in comparison to controls, in contrast to the non-clinical effects of the prior art compositions.
In response to this argument, applicant’s attention is directed to the scope of the present invention that is directed to a composition, and the intended use of the composition to improve cognition, although taught by the cited references, does not impart patentability to composition claims. The results obtained by applicants are expected from the prior art kit/composition comprising the claimed elements in the claimed amounts, absent evidence to the contrary. Further, applicants did not compare the prior art composition comprising the same elements in the claimed amount that improves cognitive function with the present composition. In addition, regarding applicant's arguments of unexpected superior results in the instant specification, it is the examiner's position that the data in the specification regarding improving cognitive function are not unexpected results and therefore cannot rebut prima facie obviousness. The examiner directs applicant's attention to MPEP 716.02 (a). "A greater than expected result is an evidentiary factor pertinent to the legal conclusion of obviousness of the claims at issue." In re Corkhill, 711 F.2d 1496, 266 USPQ 1006 (Fed.Cir. 1985). In Corkhill, the claimed combination showed an additive result when a diminished result would have been expected. Furthermore, the MPEP states, "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).
Applicants argue that the teachings of Jourdan, Farmer and Giordano do not overcome the deficiencies in Tsion and Owoc to teach the claimed invention. While these references each teach compositions with multiple potential components, they do not provide teachings that would lead one of skill in the art to claimed invention with a reasonable expectation of success.
In response to this argument, it is noted that applicants admit these references each teach compositions with multiple potential components, and it is worthy to mention that it has been decided by the Courts that even in a case where the reference does not teach the same use of the composition, the two different intended uses are not distinguishable in terms of the composition, see In re Thuau, 57 USPQ 324; Ex parte Douros, 163 USPQ 667; and In re Craige, 89 USPQ 393. Motivation to combine the reference shad been provided, even if different from what applicants had done, with reasonable expectation to achieve the present invention had been presented.
Applicants argue that none of Jourdan, Farmer nor Giordano teach or suggest a kit consisting of the claimed components, or teach any effect of their composition on cognition. Accordingly, one of skill in the art would not have consulted the Jourdan, Farmer and Giordano references in the determination of ingredients for compositions useful to increase cognitive ability. Even if it would have been appropriate for one of skill in the art to consult these references, Jourdan, Farmer and Giordano teach many different ingredients, but no clear direction to select the particularly claimed components as useful to improve cognition. Thus, these references do not lead one of skill in the art to the claimed invention, nor provide any reasonable expectation of success with respect to the components that would yield the claimed kit.
In response to this argument, it is reiterated that all the elements of the claimed composition/kit are taught by combination of the cited references. The cited references are in the same field of endeavor and seek to solve the same problems as the instant application and claims, and one of skill in the art is free to select components available in the prior art, In re Winslow, 151 USPQ 48 (CCPA, 1966). Further, the examiner recognizes that references cannot be arbitrarily combined that there must be some reason why one skilled in the art would be motivated to make the proposed combination of primary and secondary references, In re Nomiya, 184 USPQ 607 (CCPA 1975). However, there is no requirement that a motivation to make the modification be expressly articulated. The cited references show that it was well known in the art at the time of the invention to use the claimed ingredients in compositions that improve cognitive function. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art. ln re Pinten, 459 F.2d 1053, 173 USPQ 801 (CCPA 1972); ln re Susi, 58 CCPA 1074, 1079-80) 440 F.2d 442, 445; 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21; 279 F.2d 274, 276-277; 126 USPQ 186, 188 (1960).
Based on the disclosure by the cited references that these elements are used in compositions to improve cognition, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in improving cognition. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See ln re Sussman, 1943 C.D. 518; In re Huellmantel 139 USPQ 496; ln re Crockett 126 USPQ 186.
Finally, obviousness does not require absolute predictability of success all that is required is a reasonable expectation of success. See In re Kubin, 561 F.3d at 1360. The Court has held that "the test of obviousness is not express suggestion of the claimed invention in any or all of the references but rather what the references taken collectively would suggest to those of ordinary skill in the art presumed to be familiar with them." See In re Rosselet, 146 USPQ 183, 186 (CCPA 1965). "There is no requirement (under 35 USC 103(a)) that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art." Motorola, Inc. V. Interdigital Tech. Corp., 43 USPQ2d 1481, 1489 (Fed. Cir. 1997). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR Int'l Co. V. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) ("The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.").
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached on Monday through Friday, 8:30 AM to 5:00 PM 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 on 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 an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Isis A Ghali/
Primary Examiner, Art Unit 1611 /I.G./
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