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 .
This office action is in response to the reply filed 2/2/2026.
Election/Restrictions
Claims 1-16 and 21 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/12/2024.
Response to Arguments
All of Applicant’s arguments filed 2/2/2026 have been fully considered.
The 102(a)(1) rejection over claims 17 and 19-20 as presented in the office action mailed 10/9/225 has been withdrawn in view of the amendments. Arguments against these withdrawn rejections will not be addressed as they are moot.
On pages 18-19, Applicant argues that Fernandez example 2 does not teach magnesium oxide and while magnesium oxide is listed as a possible mineral for use, the selection of magnesium oxide cannot be don’t without impermissible hindsight. Applicant remarks that Fernandez teaches away from using magnesium oxide and argues against an obvious to try arguments.
Applicant’s arguments are not persuasives as Example 2 relied upon in the rejection below explicitly teaches magnesium oxide to be present in the composition.
Applicant argues that the invention achieves unexpected results which arise from the unique and synergistic combination of calcium ascorbate, high-DHA carrier and magnesium oxide. Table 1 teaches this explicit combination.
Applicant’s arguments are not persuasives they are unsupported by factual evidence. Applicant bears the burden of proving unexpectedly good results. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). When unexpected results are used as evidence of non-obviousness, the results must be shown to be unexpected compared with the closest prior art. In re Baxter Travenol Labs, 952 F.2d 388, 392, 21 USPQ2d 1281, 1285 (Fed. Cir. 1991); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196, (Fed. Cir. 1984). Here, applicants have failed to provide a side by side analysis between the claimed invention and the closest prior art (i.e. Fernandez.).
Furthermore, it is a fundamental requirement that any superior property be unexpected to be considered evidence of non-obviousness, however, other than statements by the attorney, Applicant provides no evidence that the results are unexpected. The cited location in the specification (i.e. table 1) does not use the terms “unexpected” or “surprising” and no declaration of affidavit has been submitted to shows that the results were unexpected or surprising. Outside of Attorneys statement, nothing in table 1 suggests “reducing soft gel fragility” is unexpected.
Applicant argues that Fernandez does not recognize the problem of long-term capsule fragility.
Applicant’s argument is not persuasive. While the prior art fails to teach reducing the fragility of a soft gel gelatin capsule, this is a property that results as a consequence of performing the claimed method. The prior art makes obvious the performance of the claimed active method steps defined by the claim to reduce the fragility (i.e. formulating a composition comprising vitamin c in the form of Ca ascorbate or Mg ascorbate, magnesium oxide and a carrier as claimed) as such the method is expected to reduce fragility of the capsule absent factual evidence to the contrary. The examiner would also like to note that the prior art need not be pertinent to the particular problem with which the inventor was concerned, so long as it is in the same field of the endeavor as the instant invention, in this case, both Fernandez and Lee are in applicant’s same field of endeavor (i.e. pharmaceutical composition comprising vitamin c in the form of Ca ascorbate or Mg ascorbate).
Modified/Maintained 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, 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.
Claim(s) 17 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fernandez (US 2017/0202802) and Lee (Korean J Physiol Pharmacol 2018;22(1):35-42).
Fernandez teaches composition for nutrition supplementation (Abs), reading on dietary composition, and teaches administration of the composition of Example 1 to subjects [0156].
Fernandez teaches preparing a composition comprising a soft shell capsule (Example 2) for use in a kit, the capsule comprising:
-Vitamin C in the form of ascorbic acid;
-Vitamin D;
-Vitamin B1 – reading on vitamin of instant claims 19 and 20;
-Zinc ;
-Magnesium oxide;
-Algal Oil blend which provides DHA – reading on a carrier of instant claim 1.
The capsule can be formulated with gelatin [0157].
Regarding claim 20: Fernandez teaches that vitamin D can be selected from vitamin D3 [0010].
While Example 2 teaches ascorbic acid, Fernandez teaches that vitamin c can also be provided in one or more forms which include calcium or magnesium ascorbate [0009].
Lee teaches calcium ascorbate and ascorbic acid to have similar antioxidant activity (Abs). Calcium ascorbate is taught to increase gastric pH without increasing the total acid output, thereby attenuating gastric symptoms (Pg. 38, col. 2). Lee determined that calcium ascorbate could act as an antioxidant substrate without acid-induced gastric high acidity, and (2) the rate of absorption and the maintenance of calcium ascorbate in the body were higher than those of ascorbic acid in vivo. Our observations suggest that calcium ascorbate could be used as an antioxidant substrate for individual health maintenance without gastric high acidity particularly for people with sensitive stomachs and illnesses such as indigestion, diarrhea, abdominal cramps/pain, and other gastric diseases (pg. 40-41, discussion).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Fernandez and replace the ascorbic acid in Example 2, partially or wholly, with calcium ascorbate as Lee teaches ascorbic acid and calcium ascorbate to have similar antioxidant activity without gastric high acidity and its beneficial for people with sensitive stomachs and illnesses such as indigestion, diarrhea, abdominal cramps/pain, and other gastric diseases. One of skill in the art would have a reasonable expectation of success as Fernandez teaches that the vitamin C source can be calcium ascorbate or ascorbic acid.
While the prior art fails to teach “reducing the fragility of a soft gel gelatine capsule”, this is a property that results as a consequence of performing the claimed method. The prior art makes obvious the performance of the claimed active method steps defined by the claim to reduce the fragility (i.e. formulating a composition comprising vitamin c in the form of Ca ascorbate or Mg ascorbate; magnesium oxide; and DHA and/or EPA) as such the method is expected to reducing fragility of the capsule absent factual evidence to the contrary.
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new/modified 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.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613