DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/08/2025 has been entered.
Previous Rejections
Applicant’s arguments, filed 10/08/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 - Obviousness
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.
Claim(s) 11-15 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Farber et al (WO 2004/009053 A2), in view of Nantong Huashan Pharmacy Co (CN111588696A), further in view of Dudrick et al (USP 5,026,721 A) and Anderson et al (US 2010/0086573 A1).
Farber taught an oral liposomal delivery system [title, abstract and claim 12] for encapsulating [page 8, lines 12-14; compounds contained in aqueous medium and entrapped within liposome taught at page 25, lines 8-10; see also page 31, lines 24-27] active agents. The liposomes comprised phosphatidylcholine (e.g., reads on a liposomal blend) [page 25, line 15]. The active agent, creatine, was taught as a nutritional supplement (e.g., reads on a supplemental amino acid) [page 32, line 25; claim 10].
Although Farber alluded to liposomes as carrier systems that increase absorption of the active agent and protects the active agent from the digestive degradative process page 1, line 14 to page 2, line 5], Farber was not explicit this functionality (e.g., increased absorption, protection from digestive degradative process) of liposomes, as recited in claim 11. Farber was silent the amounts of supplemental amino acid and liposomal blend, as recited in claim 11.
Nantong Huashan Pharmacy Co taught that liposomes protect encapsulated active agents from being damaged by gastric juice, bile, digestive enzymes and the like; improves the stability of the encapsulated active agent in the gastrointestinal tract; and, further increases the absorption and bioavailability of the active [abstract].
It would have been prima facie obvious to one of ordinary skill in the art to include the teachings of Nantong Huashan Pharmacy Co within those of Farber. The ordinarily skilled artisan would have been motivated to protect the encapsulated active agent from the digestive system, and to increase the absorption and bioavailability of the active in the small intestine, as taught by Nantong Huashan Pharmacy Co at the abstract.
The combined teachings of Farber and Nantong Huashan Pharmacy Co did not teach amounts of the supplemental amino acid and liposomal blend.
Dudrick taught an amino acid nutritional supplement for enhancing sound nutrition, comprising between 40 % to 100 % supplemental amino acids [col 2, lines 53-59]. Dudrick’s amino acid supplements and regimens were particularly advantageous in that they significantly enhanced physical performance through sound nutrition, without the deleterious side effects of pharmaceutical performance enhancers. The supplements were for oral consumption [col 2, lines 35-43].
Anderson taught, in the manufacture of liposomes, phosphatidylcholine as an exemplary phospholipid, present in an amount at about 1 % [0039 and 0041].
Since Farber generally taught amino acid nutritional supplements, it would have been prima facie obvious to one of ordinary skill in the art to include the amino acid acids at 40 % to 100 % within Farber, as taught by Dudrick. The ordinarily skilled artisan would have been motivated to significantly enhance physical performance through sound nutrition, as taught by Dudrick at col 2 and lines 35-43.
Since Farber taught liposomes comprising phosphatidylcholine, it would have been prima facie obvious to one of ordinary skill in the art to include the lipid, within Farber, in an amount at about 1 %, as taught by Anderson. The ordinarily skilled artisan would have been motivated to form the liposomal vesicle, as taught by Anderson [0039 and 0041].
The instant claim 11 recites about 90 % to about 99.99 % supplemental amino acid and about 0.01 % to about 0.99 % liposomal blend.
The instant claim 17 recites about 95 % to about 99.95 % supplemental amino acid and 0.05 % to about 0.99 % liposomal blend.
The instant claim 18 recites about 99.01 % supplemental amino acid and about 0.99 % liposomal blend.
Dudrick taught 40 % to 100 % amino acid. Anderson taught about 1 % lipid. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
Farber, in view of Dudrick and Anderson, reads on claims 11-12, 14-15 and 17-18.
Claim 13 is rendered prima facie obvious because Farber taught creatine monohydrate at Tables 1-5.
Claim 19 is rendered prima facie obvious because Farber taught that the system was especially suited for the delivery of biologically active agents with poor solubility [abstract].
Response to Arguments
Applicant's arguments filed 10/08/2025 have been fully considered but they are not persuasive.
Applicant argued that Farber does not teach a composition that is overwhelmingly amino acid rich (e.g., ≤ 90 %) with ≤ 1 % phospholipid, nor does it disclose encapsulation for intestinal absorption.
The Examiner responds that Farber was not relied upon to teach amounts of the amino acid and phospholipid, as those features were taught by the combination of the references. And one cannot show nonobviousness by attacking references individually, where the rejections are based on combinations of references. See MPEP 2145(IV). In the instant case, Farber taught the encapsulation of active agents (supplemental amino acid) within liposomes; Dudrick taught amounts of supplemental amino acids; and, Anderson taught amounts of phospholipids, in the manufacture of liposomes.
Concerning a teaching of liposomes for the increased absorption of the active agent, Farber alluded to liposomes as carrier systems that increase absorption of the active agent and protects the active agent from the digestive degradative process page 1, line 14 to page 2, line 5]. And, Nantong Huashan Pharmacy Co taught that liposomes protect encapsulated active agents from being damaged by gastric juice, bile, digestive enzymes and the like; improves the stability of the encapsulated active agent in the gastrointestinal tract; and, further increases the absorption and bioavailability of the active [abstract].
Applicant argued that Dudrick preferably teaches between about 60 wt. % to 75 wt. % amino acid, which is well below the instantly claimed 99.99 % to about 90 %.
The Examiner responds that Dudrick is not limited to the preferences therein, as Dudrick was relied upon as an entire disclosure. See MPEP 2123II. Furthermore, Dudrick’s preferable percentages between about 60 wt. % to 75 wt. %, do not render as less obvious the percentages that were taught as between 40 % to 100 %. The Applicant’s arguments over Dudrick are non-persuasive.
Applicant argued that Anderson taught 1 % phosphatidylcholine as an exemplary process parameter, not a teaching that the overall finished composition contains less than 1 % lipid.
The Examiner disagrees. Anderson taught that the phospholipids for use therein may be present in a collective amount ranging from about 1% to about 10% by weight of the aqueous liposomal solution prior to lyophilization or addition to the external phase composition [0041], where the liposomes were suspended in the external phase composition [abstract]. This is a teaching that the amount of the phospholipids is that amount which is contained in the final composition. The Applicant’s arguments over Anderson are non-persuasive.
Applicant further argued that achieving stable liposomes that encapsulate a supplemental amino acid at low lipid levels is not routine or result-effective, and that the formulation is unpredictable, for which the prior art provides no guidance or expectation of success.
The Examiner disagrees. The Applicant’s claims are not drawn to methods of formulating stable liposomes. The claims are drawn to liposomes encapsulating an agent, wherein the liposomes are composed of the phospholipids. The combined teachings of the prior art teach liposomes encapsulating a supplemental acid, as claimed. The combined teachings of the prior art also teach amounts of the supplemental acid and of phospholipids, wherein the prior art amounts either read on, or overlap, the claimed amounts. The combined teachings of the prior art teach the claimed composition, and directs the ordinarily skilled artisan to the said composition, with an expectation of success (e.g., liposomes that encapsulate supplemental amino acids).
Applicant argued that the rejection of claim 11 relied upon hindsight.
In response to the Applicant's argument that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See MPEP 2145. In the instant case, the rejection was based upon a combination of references, and the motivation, rather than hindsight reasoning, to combine those references. As was previously discussed, Farber taught the liposomal encapsulation of supplemental amino acids; Dudrick taught amounts of supplemental amino acids; and, Anderson taught amounts of vesicle-forming lipids, in the manufacture of liposomes.
Applicant argued that claim 11 is allowable, as are claims 12-20, based upon dependency.
The Examiner disagrees. Allowable subject matter has not been identified in the present application.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Farber et al (WO 2004/009053 A2), in view of Nantong Huashan Pharmacy Co (CN111588696A), further in view of Dudrick et al (USP 5,026,721 A) and Anderson et al (US 2010/0086573 A1) and further in view of Pitcher et al (US 2019/0240281 A1).
The 35 U.S.C. 103 over Farber, Nantong Huashan Pharmacy, Dudrick and Anderson was previously described.
Although Farber taught phosphatidylcholine, Farber did not teach its extraction from sunflowers.
Pitcher taught phospholipid liposome structures for the encapsulation of active agents [abstract], where the liposome was constructed from sunflower-based lecithin (e.g., phosphatidylcholine). The sunflower lecithin was provided for encapsulating and protecting the active component within the aqueous space [0045-0047, 0082].
It would have been prima facie obvious to one of ordinary skill in the art to include, within the combined teachings of Farber, Dudrick and Anderson, phosphatidylcholine extracted from sunflowers, as taught by Pitcher. The ordinarily skilled artisan would have been motivated to form the liposomal vesicle, for encapsulating and protecting the active component within the aqueous space, as taught by Pitcher at ¶s 0045-0047 and 0082.
Response to Arguments
Applicant's arguments filed 10/08/2025 have been fully considered but they are not persuasive.
Applicant argued that Pitcher did not teach or suggest using phosphatidylcholine extracted from sunflowers in the context of the Applicant’s amino-acid-dominant composition.
The Examiner responds that Pitcher was not relied upon to teach an amino-acid-dominant composition, as that limitation was taught by the combination of Farber and Dudrick. Farber generally taught liposomes made of phosphatidylcholine, and Pitcher was relied upon to teach liposomes constructed from sunflower-based lecithin (e.g., phosphatidylcholine).
Applicant argued that selecting Pitcher’s sunflower-derived phosphatidylcholine and transplanting it into the Applicant’s quantitatively and functionally distinct system would require a change in Pitcher’s dosage form (e.g., anaerobic liquid) and use (e.g., glutathione stability via oxygen exclusion).
The Examiner disagrees. The instant application does not appear distinct from the combined teachings of the prior art. Additionally, the claims do not exclude Pitcher’s teachings.
Applicant argued that Pitcher’s sunflower lecithin amounts are significantly greater than the Applicant’s, with Pitcher disclosing about 4 % to about 11 %, with an exemplary composition at about 10.5 %.
The Examiner responds that Pitcher was not relied upon to teach amounts of lipids, as that limitation was taught by Anderson. The Applicant is reminded against attacking references individually, where the rejection was based upon a combination of references. In the instant case, Pitcher was relied upon to teach sunflower-derived phosphatidylcholine. Pitcher taught that sunflower lecithin was provided for encapsulating and protecting the active component within the aqueous space of the liposome [0045-0047, 0082].
Nevertheless, for the purposes of argument only, and not as a basis of rejection, the Examiner responds that Pitcher’s disclosure of sunflower lecithin included amounts at 1 % [see Pitcher at ¶ 0151].
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Farber et al (WO 2004/009053 A2), further in view of Nantong Huashan Pharmacy Co (CN111588696A), in view of Dudrick et al (USP 5,026,721 A) and Anderson et al (US 2010/0086573 A1) and further in view of Mower et al (US 2006/0210688 A1).
The 35 U.S.C. 103 rejection over Farber, Nantong Huashan Pharmacy, Dudrick and Anderson was previously described.
The combined teachings of the art did not teach a powdered composition, as recited in claim 20.
Mower taught a dehydrated sports drink powder, for convenience of storage [0088]. According to another embodiment, was a sport drink that included a solution of the dehydrated powder and water [abstract and title]. Mower’s drink included amino acids [0026, 0081].
Since Farber generally taught nutritional supplements, it would have been prima facie obvious to have included, within Farber, formulation as powders, at least partially operative to dissolve in water, as taught by Mower. The ordinarily skilled artisan would have been motivated towards convenience of storage, as taught by Mower et al [abstract and ¶ 0088].
Response to Arguments
Applicant did not separately argue the rejection over claim 20.
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612