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 .
Status of Application
The Amendments and Remarks filed on 03/17/26 are acknowledged.
Claims 1, 7, 10, and 13 were amended.
Claims 1-21 are pending and are included in the prosecution.
Response to Amendments/Arguments
In light of the amendment of claim 1 to recite that a full serving of the composition comprises about 225 mg to about 275 mg of the Ginkgo biloba extract, Applicant’s arguments (Pages 7-12, filed 03/17/26) regarding the following rejections have been fully considered and are persuasive.
Rejection of claims 1, 5, 7-8, and 17-18 under 35 U.S.C. 102(a)(1) as being anticipated by Cohen (US 2018/0369306 A1)
Rejection of claims 1, 6-8, and 17-18 under 35 U.S.C. 102(a)(1) as being anticipated by BrainPillTM (first available on Amazon 28 July 2016, 11 pages total (date on page labeled 2/5))
Rejection of claims 1, 5-6, 8-9, 11-12, and 17-21 under 35 U.S.C. 102(a)(1) as being anticipated by Rabovsky et al. (US 2016/0193306 A1 – “Rabovsky”)
Rejection of claims 2-4, 10, and 13 under 35 U.S.C. 103 as being unpatentable over Cohen, or alternatively over BrainPillTM, in view of Rabovsky
Rejection of claims 14-16 under 35 U.S.C. 103 as being unpatentable over Cohen, or alternatively over BrainPillTM, or Rabovsky, each in view of Atsutoshi (JP 2011-157304 A – English Espacenet translation)
Since the cited references do not teach or suggest the newly added limitation of a full serving of the composition comprises about 225 mg to about 275 mg of the Ginkgo biloba extract, the rejections listed above are withdrawn.
However, upon further consideration of the amended claims, a new ground(s) of rejection is made in view of a new supporting reference Kattan (US 6,093,404).
Since the new grounds of rejection were necessitated by Applicant’s amendment, this action is made FINAL.
Notice for all US Patent Applications filed on or after March 16, 2013
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.
New Rejections Necessitated by Amendment
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 of this title, 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 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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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 1-13 and 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Cohen (US 2018/0369306 A1), BrainPillTM (first available on Amazon 28 July 2016, 11 pages total (date on page labeled 2/5)), Rabovsky et al. (US 2016/0193306 A1 – “Rabovsky”), in view of Kattan (US 6,093,404).
The claimed invention is a composition comprising phosphatidylserine (PS), a Ginkgo biloba extract, and a Bacopa monnieri extract, wherein the composition is formulated as a tablet, a capsule, or a soft gel.
Cohen discloses a composition for treating memory loss and diminished cognition comprising about 50 mg to about 650 mg of Bacopa monnieri; about 10 mg to about 160 mg of Ginkgo biloba, and about 10 mg to about 400 mg of PS (Abstract, [0024], [0047]-[0048], [0075]-[0076], claims 1, 8, and 16-17). The composition can be provided in the form of a capsule or tablet (Abstract, [0036], claims 3 and 4).
BrainPillTM is a supplement comprising 2 capsules per serving size and the following components:
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Rabovsky discloses multi-supplement compositions having combinations of dietary supplements (Abstract and claim 6). The multi-supplement composition comprises various Supplement Formulations (claim 6) and include PS ([0033] and claim 8), Ginkgo biloba (claim 9), and a Bacopa monnieri extract (claim 7). The multi-supplement composition can be in the form of a tablet, soft gelatin capsule, or a hard gelatin capsule ([0078]). The supplement formulations can include a coating to prevent moisture adsorption and to provide a formulation with good long term stability ([0083]). Coatings include methacrylate coatings, hydroxy propyl methyl cellulose phthalate coatings, hydroxy propyl methyl cellulose acetate succinate coatings, polyvinyl acetate phthalate coatings, cellulose acetate trimellitate coatings ([0084]).
Cohen, BrainPillTM, and Rabovsky do not expressly teach that a full serving of the composition comprises about 225 mg to about 275 mg of the Ginkgo biloba extract.
Kattan teaches a therapeutic composition taken in a single daily dose that contains Ginkgo biloba (Abstract and claim 1). A preferred range for the Ginkgo biloba is 166-249.75 mg and a most preferred dosage is 225 mg (Col. 4, line 21). In another embodiment a preferred range for the Ginkgo biloba is 175-262.5 mg and a most preferred dosage is 250 mg (Col. 4, line 33). Kattan teaches that Ginkgo biloba is obtained from the leaf of the ginkgo tree, and benefits include improved short and long term memory as well as improved metal clarity (Col. 3, lines 11-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a composition comprising PS, Ginkgo biloba, and Bacopa monnieri, as taught by each of Cohen, BrainPillTM, and Rabovsky, in view of the composition comprising about 166-249.75 mg and about 175-262.5 mg of Ginkgo biloba extract with preferred dosages of 225 mg and 250 mg of Ginkgo biloba, as taught by Kattan, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because all the references teach supplement compositions comprising Ginkgo biloba extract and it is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A). One of ordinary skill in the art would have found it obvious to use the dosage ranges taught by Kattan in the supplement compositions of Cohen, BrainPillTM, and Rabovsky, and have a reasonable expectation of success in producing a functional supplement composition that provides an effective amount of Ginkgo biloba extract for the improvement of memory and providing mental clarity.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claims 1, 10, and 13, the limitations of a composition comprising PS, a Ginkgo biloba extract, and a Bacopa monnieri extract would have been obvious over the composition for treating memory loss and diminished cognition comprising about 50 mg to about 650 mg of Bacopa monnieri; Ginkgo biloba, and about 10 mg to about 400 mg of PS (Abstract, [0024], [0047]-[0048], [0075]-[0076], claims 1, 8, and 16-17), as taught by Cohen; the BrainPillTM composition for faster recall, better short and long-term memory, inter alia, wherein the composition comprises 100 mg of PS, Ginkgo biloba extract, and 320 mg of SynapsaTM (Page 1/6), which is a Bacopa monnieri extract (Page 2/6), the multi-supplement composition comprising various Supplement Formulations (claim 6) which include PS ([0033] and claim 8), Ginkgo biloba (claim 9), and a Bacopa monnieri extract (claim 7), as taught by Rabovsky, in view of the 166-249.75 mg and 175-262.5 mg dosage range and most preferred dosages of 225 mg and 250 mg of Ginkgo biloba (Col. 4, lines 21 and 33), as taught by Kattan. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Regarding instant 1, 5, and 11, the limitations of the composition formulated as a tablet, a capsule, or a soft gel would have been obvious over the capsule or tablet (Abstract, [0036], claims 3 and 4), as taught by Cohen, the capsule of BrainPillTM (Page 1/6), the tablet, soft gelatin capsule, or a hard gelatin capsule ([0078]), as taught by Rabovsky.
Regarding instant claims 2-4, the limitations of the wt% of PS would have been obvious over the PS can be present in an overlapping range of from about 2 percent to about 20 percent by weight ([0235]), as taught by Rabovsky. Please see MPEP 2144.05.
Regarding instant claims 2-4, the limitations of the wt% of the Ginkgo biloba extract would have been obvious over the Ginkgo biloba can be present in an overlapping range of from about 0.5 percent to about 10 percent by weight ([0235]), as taught by Rabovsky, and the 10-15% by weight of Ginkgo biloba (Col. 3, line 37), as taught by Kattan. Please see MPEP 2144.05.
Regarding instant claims 2-4, the limitations of the wt% of the Bacopa monnieri extract would have been obvious over the Bacopa monnieri extract present at an overlapping level of least 10 percent (e.g., at least 15, 20 percent) ([0203]), as taught by Rabovsky. Please see MPEP 2144.05.
Regarding instant claim 6, the limitation of two capsules would have been obvious over the serving size of 2 capsules of BrainPillTM (Page 1/6).
Regarding instant claims 6 and 12, the limitations of two or three tablets in combination or two or three capsules in combination would have been obvious over the total daily dose in the form of one or more capsules or tablets (e.g., two capsules or tablets, three capsules or tablets) ([0181]), as taught by Rabovsky.
Regarding instant claim 7, the limitations of about 25 mg to about 1200 mg of PS, and about 100 mg to about 800 mg of the Bacopa monnieri extract would have been obvious over the composition comprising about 50 mg of PS, about 40 mg of Ginkgo biloba, and about 320 mg of Bacopa Monnieri (claim 16), as taught by Cohen; and BrainPillTM which comprises 100 mg of PS and 320 mg of SynapsaTM (Page 1/6), which is a Bacopa monnieri extract (Page 2/6). Please see MPEP 2144.05.
Regarding instant claim 8, the limitation of L-carnitine would have been obvious over the composition comprising acetyl-L-carnitine (Abstract, [0024]-[0025], [0053]-[0055], [0075]-[0076], claims 1, 11, 16, and 17), as taught by Cohen. The limitation of vitamin B12 would have been obvious over the vitamin B12 (Abstract, [0024]-[0025], [0056]-[0061], [0075]-[0076], claims 1, 12, 16, and 17), as taught by Cohen. The limitation of huperzine A would have been obvious over the huperzine A (Abstract, [0024]-[0025], [0051]-[0052], [0075]-[0076], claims 1, 10, 16, and 17), as taught by Cohen. Also, the limitations of vitamin B12, pyridoxine, and huperzine A would have been obvious over BrainPillTM which comprises vitamin B12 (as cyanocobalamin), vitamin B6 (as pyridoxine HCl), and huperzine A, respectively (Page 1/6). The limitations of L-carnitine and huperzine A would have been obvious over the acetyl-L-carnitine and huperzine A, respectively, (claim 7), as taught by Rabovsky. The limitations of vitamin B12, vitamin E, and pyridoxine would have been obvious over the vitamin B12, vitamin E, and pyridoxine, respectively ([0181]), as taught by Rabovsky.
Regarding instant claim 9, the limitations of calcium carbonate powder, microcrystalline cellulose (MCC), croscarmellose sodium, stearic acid, silicon dioxide, and magnesium stearate would have been obvious over the calcium carbonate, MCC, croscarmellose sodium, stearic acid, silicon dioxide, and magnesium stearate ([0305]), as taught by Rabovsky.
Regarding instant claims 10 and 13, the limitations of about 25 wt % to about 37 wt% and about 350 mg to about 450 mg of the calcium carbonate powder would have been obvious over the calcium carbonate ([0305]) ranging from 75 mg ([0119]), 200-1000 mg ([0180]), as taught by Rabovsky. The limitation of about 7 wt% to about 10 wt% and about 50 mg to about 150 mg of the MCC would have been obvious over the MCC ([0305]) present at 56 mg ([0304]), as taught by Rabovsky. The limitation of about 3.5 wt% to about 5.5 wt% and about 45 mg to about 75 mg of the croscarmellose sodium would have been obvious over the croscarmellose sodium ([0305]) present at 15 mg ([0304]), as taught by Rabovsky. The limitation of about 1 wt% to about 2 wt% and about 17.5 mg to about 30 mg of the stearic acid would have been obvious over the stearic acid ([0305]) present at 20 mg ([0304]), as taught by Rabovsky. The limitation of about 1 wt% to about 2 wt% and about 20 mg to about 30 mg of the silicon dioxide would have been obvious over the silicon dioxide ([0305]) present at 6 mg ([0304]), as taught by Rabovsky. The limitation of about 0.5 wt% to about 1 wt% and about 10 mg to about 15 mg of the magnesium stearate would have been obvious over the magnesium stearate ([0305]) present at 0.5 mg ([0304]), as taught by Rabovsky. One of ordinary skill in the art would have found it obvious to modify the concentration of these conventional pharmaceutically acceptable components based on the desired concentration of calcium source (calcium carbonate), bulk filler (MCC – [0095]), disintegrant (croscarmellose sodium - [0212]), glidant (silicon dioxide – [0382]), and lubricant (stearic acid and magnesium stearate - [0212]), and based on the desired attributes of hardness and stability of the finished tablet or capsule. The recited concentration ranges would have been obvious variants over the concentrations taught by Rabovsky unless there is evidence of criticality or unexpected results.
Regarding instant claims 17 and 18, the limitations of the tablet, capsule, or soft gel formulated to release the phosphatidylserine, Ginkgo biloba extract, and Bacopa monnieri extract in water in less than 60 minutes at a temperature of about 37°C and in 60 minutes or more at a temperature of about 37°C, respectively, would have been obvious over the composition comprising about 50 mg to about 650 mg of Bacopa monnieri; Ginkgo biloba, and about 10 mg to about 400 mg of PS (Abstract, [0024], [0047]-[0048], [0075]-[0076], claims 1, 8, and 16-17), wherein the composition is a capsule or tablet (Abstract, [0036], claims 3 and 4), as taught by Cohen, in view of BrainPillTM which comprises 100 mg of PS, Ginkgo biloba extract, and 320 mg of SynapsaTM (Page 1/6), which is a Bacopa monnieri extract (Page 2/6), the multi-supplement composition comprising various Supplement Formulations (claim 6) which include PS ([0033] and claim 8), Ginkgo biloba (claim 9), and a Bacopa monnieri extract (claim 7), as taught by Rabovsky, and the supplement containing 166-249.75 mg and 175-262.5 mg dosage range and most preferred dosages of 225 mg and 250 mg of Ginkgo biloba (Col. 4, lines 21 and 33), as taught by Kattan. The recited release parameters are intrinsic properties associated with the composition, which is taught by the prior art. One of ordinary skill in the art would have expected the composition taught by the prior art to have the same properties.
Regarding instant claims 19-21, the limitations of the pH-dependent coating comprising methacrylic acid copolymer would have been obvious over the methacrylate coatings, hydroxy propyl methyl cellulose phthalate coatings, hydroxy propyl methyl cellulose acetate succinate coatings, polyvinyl acetate phthalate coatings, and cellulose acetate trimellitate coatings ([0084]), as taught by Rabovsky, since these coating components will intrinsically provide the recited pH-dependent release.
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Cohen (US 2018/0369306 A1), BrainPillTM (first available on Amazon 28 July 2016, 11 pages total (date on page labeled 2/5)), Rabovsky et al. (US 2016/0193306 A1 – “Rabovsky”), in view of Kattan (US 6,093,404), as applied to claims 1-13 and 17-21 above, further in view of Atsutoshi (JP 2011-157304 A – English Espacenet translation) .
Instant claim 14 is drawn to the composition of claim 1, wherein the tablet, capsule, or soft gel comprises a coating, and wherein the coating comprises: cellulose, calcium carbonate powder, and carnauba wax.
The teachings of Cohen, BrainPillTM, Rabovsky, and Kattan are discussed in detail above.
Although Rabovsky teaches coatings ([0083]-[0084]), Rabovsky does not expressly teach that the coating comprises cellulose, calcium carbonate powder, and carnauba wax.
Atsutoshi teaches sugar-coated tablets wherein the coating agents include celluloses such as ethyl cellulose, carboxymethylethylcellulose, crystalline cellulose, low-substituted hydroxypropyl cellulose, and hydrophobized hydroxypropylmethylcellulose, calcium carbonate, and carnauba wax ([0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a composition comprising PS, Ginkgo biloba, and Bacopa monnieri, as taught by each of Cohen, BrainPillTM, and Rabovsky, in view of the composition comprising about 166-249.75 mg and about 175-262.5 mg of Ginkgo biloba extract with preferred dosages of 225 mg and 250 mg of Ginkgo biloba, as taught by Kattan, and the coating agents including cellulose, calcium carbonate, and carnauba wax, as taught by Atsutoshi, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because the coating provides an advantage of preventing moisture adsorption and minimizing the water activity of the final blend to provide a formulation with good long term stability ([0083]), as taught by Rabovsky. Furthermore, Atsutoshi teaches that the coated tablets do not crack and have excellent strength against external impacts ([0001]), [0009], [0012], [0067], [0079], [0091], [0095]).
Regarding instant claim 14, the limitations of the coating comprising cellulose, calcium carbonate powder, and carnauba wax would have been obvious over the coatings ([0083]-[0084]), as taught by Rabovsky, in view of the sugar-coated tablets wherein the coating agents include celluloses such as ethyl cellulose, carboxymethylethylcellulose, crystalline cellulose, low-substituted hydroxypropyl cellulose, and hydrophobized hydroxypropylmethylcellulose, calcium carbonate, and carnauba wax ([0029]), as taught by Atsutoshi.
Regarding instant claims 15 and 16, the limitations of the concentrations of cellulose, calcium carbonate powder, and carnauba wax in the composition would have been obvious over the coatings ([0083]-[0084]), as taught by Rabovsky, in view of the sugar-coated tablets wherein the coating agents include celluloses such as ethyl cellulose, carboxymethylethylcellulose, crystalline cellulose, low-substituted hydroxypropyl cellulose, and hydrophobized hydroxypropylmethylcellulose, calcium carbonate, and carnauba wax ([0029]), as taught by Atsutoshi. Since the recited concentrations are based on the composition, they would have been obvious variants since one of ordinary skill in the art would have found it obvious to use the coatings and the constituents taught by Rabovsky and Atsutoshi and modify the concentrations of the constituents based on the desired coating protection, crack prevention, and strength, unless there is evidence of criticality or unexpected results.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARADHANA SASAN whose telephone number is (571)272-9022. The examiner can normally be reached Monday to Friday from 6:30 am to 3:00 pm.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615
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