DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 14 April 2025 has been entered.
Priority
The application was filed 26 April 2021 and is the national stage entry of PCT/EP2019/079050 filed 24 October 2019. The Applicant claims priority to EP18203304.3 filed 30 October 2018. A translated copy of the foreign document has been provided. Therefore, the effective filing date of the application is 30 October 2018.
Examiner’s Note
The Applicant's arguments filed 14 October 2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. 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and/or objections not reiterated from previous office actions are hereby withdrawn.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. In the Applicant’s response, filed
14 October 2025, it is noted that no claims have been amended or added.
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.
Claim(s) 1, 3, 4, 19, 20, 24 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kirchen et al. (US 11,278,046 B2), iherb.com, and Daniels (US 2015/0104539 A1), as evidenced by apoteum.com and ift.org.
Kirchen et al. teach a multivitamin extrudate (entire teaching, title) that may comprise vitamin B9 (col. 3, ln. 21), a buffer (col. 6, ln. 58), fillers (col. 6, ln. 57), and water (example 1, col. 8, ln. 27). The composition may also comprise water-soluble vitamins, such as vitamins B1 and B2 (col. 3, ln. 1-3), addressing claims 3 and 4. The water content may be in an amount of 4-6 wt% (col. 8, ln. 32, col. 9, ln. 15, col. 10, ln. 28) or 0.1-92 wt% for an auxiliary agent (col. 6, lns. 59-62). In various examples, ascorbic acid fine powder may be included in the composition (tables). Kirchen also teaches the extrudate in the form of a strand (col. 7, ln. 37-39 and Examples 1-3). Fillers include wheat starch and durum wheat semolina (Table 1, Examples), addressing claims 24 and 25. The limitation of the pH buffer sufficient to retain at least 80% of the vitamin B9 after the extruded strand is dried to a water content of less than 10 weight% based on the total weight of the extruded strand, and stored in an aluminum bag for 3 months at 30°C and 65% humidity in claim 1 is interpreted as a product-by-process limitation and is given minimal patentable weight (see MPEP 2113(I)).
Kirchen et al. do not teach ascorbic acid and sodium ascorbate as a pH buffer in claim 1.
Iherb.com teaches that buffered vitamin C powder is made of ascorbic acid and a mineral salt (pg. 2). Buffered vitamin c powder resists changes in pH and is also an antioxidant (pg. 2), which is interpreted as a buffering system or buffering agent. Antioxidants are known in the art to increase the shelf life of compositions (ift.org, pg. 3). Buffered vitamin c is made of ascorbic acid and a mineral, such as sodium, to form sodium ascorbate (pg. 2), and is commonly found as a food additive, as evidenced by apoteum.com.
In regards to selecting a combination of vitamin B9, vitamin B1 and/or B2, fillers, water, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various
combination of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Kirchen et al. teach a multivitamin extrudate comprising vitamin B9, a buffer, fillers, and water, whereas the claimed invention is directed towards an extruded strand comprising vitamin B9, a pH buffer made of ascorbic acid a salt of ascorbic acid, a filler, and water. Since Kirchen teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Since Kirchen does not teach a pH buffer made of ascorbic acid and sodium ascorbate in claim 1, one of ordinary skill in the art would have been motivated to use the teaching of buffered vitamin C powder from iherb.com to address the deficiencies in Kirchen’s teachings. One of ordinary skill in the art would have been motivated to substitute the vitamin C fine powder for buffered vitamin C. Iherb.com also teaches that buffered vitamin C powder may manage pH changes and serve as an antioxidant, which is a similar function in Kirchen’s teaching (col. 6, ln 46-47). Therefore, iherb.com provides a reason and motivation to substitute and enhance the compositions and methods taught by Kirchen. The composition comprising buffered vitamin C addresses the limitation of a solid buffer in claim 1.
In regards to the weight ratio of ascorbic acid and sodium ascorbate in claim 1 and the weight % of water in claims 19 and 20, Kirchen teaches an auxiliary content of 0.1-92 wt% (col. 6, lns. 59-62) and Daniels teaches a citrate buffer as well as an ascorbate buffer (para. 28) for use in their extruded (para. 40) nutritional supplement composition comprising vitamins (claim 1). The citrate buffer may comprise about 10% sodium citrate and about 5% citric acid or 5-20% trisodium citrate and 2.5-15% citric acid (para. 23). It is therefore reasonable to expect and obvious to one of ordinary skill in the art to adjust the amount of buffer needed for their own composition. Therefore, the optimum or workable range for the weight ratio and weight % can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of ascorbic acid to sodium ascorbate and water as nonobvious.
Response to Arguments
Applicant's arguments filed 14 October 2025 have been fully considered but they are not persuasive.
The Applicant argues that the cited prior art teachings do not address a mixture of ascorbic acid and sodium ascorbate in claim 1 (Remarks, pg. 2).
Applicant’s argument is not found persuasive. Since Kirchen does not teach a pH buffer made of ascorbic acid and sodium ascorbate in claim 1, one of ordinary skill in the art would have been motivated to use the teaching of buffered vitamin C powder from iherb.com to with a reasonable expectation of success. A skilled artisan would have been led to use buffered vitamin c, as Kirchen describes use of a buffer and iherb.com teaches buffered vitamin c use in managing pH changes in food. Along with managing changes in pH, buffered vitamin c serves as an antioxidant, which is a similar function in Kirchen’s teaching (col. 6, ln 46-47). Therefore, iherb.com provides a reason and motivation to substitute and enhance the compositions and methods taught by Kirchen.
The Applicant argues that Kirchen does not describe an extruded strand with a buffer (Remarks, pg. 2).
Applicant’s argument is not found persuasive. Kirchen et al. teach a multivitamin extrudate (entire teaching, title) that may comprise vitamin B9 (col. 3, ln. 21), a buffer (col. 6, ln. 58), fillers (col. 6, ln. 57), and water (example 1, col. 8, ln. 27). The motivation to combine with iherb.com’s teaching of buffered vitamin c is stated above. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. Where an applicant’s reply establishes that each of the applied references fails to teach a limitation and addresses the combined teachings and/or suggestions of the applied prior art, the reply as a whole does not attack the references individually as the phrase is used in Keller and reliance on Keller would not be appropriate. This is because “[T]he test for obviousness is what the combined teachings of the references would have suggested to [a PHOSITA].” In re Mouttet, 686 F.3d 1322, 1333, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012).
The Applicant argues that the art does not teach buffered vitamin C as a weak acid and its conjugate base (Remarks, pg. 3).
Applicant’s argument is not found persuasive. Iherb.com teaches that buffered vitamin C powder is made of ascorbic acid combined with a mineral salt (pg. 2). Buffered vitamin c is made of ascorbic acid and a mineral, such as sodium, to form sodium ascorbate (pg. 2).
The Applicant argues that table 2 and example 3 in the instant specification show that ascorbate alone does not achieve improved stability compared to vitamin c buffer (Remarks, pg. 3).
Applicant’s argument is not found persuasive. Since it is known in the art that buffers help to stabilize the pH of solutions and therefore maintain stability of biological and chemical processes, it is not surprising that formulations with a buffer would have better overall stability compared to formulations without a buffer.
The Applicant reiterates arguments stated in the previously filed declaration. To summarize, the Applicant argues against the credibility of iherb.com and contends that the prior art references do not teach a buffer that is a combination of ascorbic acid and sodium ascorbate (Remarks, pgs. 4-9).
Applicant’s arguments are not found persuasive. As stated above, iherb.com teaches that buffered vitamin C powder is made of ascorbic acid combined with a mineral salt (pg. 2). Since iherb.com does not specify a mineral salt, Apoteum clarifies that buffered vitamin c is made of ascorbic acid and a mineral, such as sodium, to form sodium ascorbate (apoteum, pg. 2). A skilled artisan would have been led to apoteum’s teaching of sodium ascorbate in combination with ascorbic acid with a reasonable expectation of success.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613