DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The amendment filed August 4, 2026 has been received and entered. The text of those sections of Title 35, U.S. Code, not included in this action can be found in a prior Office action. Any rejection set forth in a previous Office action that is not specifically set forth below is withdrawn.
3. Claims 1, 3-14, and 16 are pending.
Election/Restrictions
4. In the reply filed on February 10, 2026, applicant elected Group I, now claims 1, 3-6, 13, 14 and 16, and chromium for the species without traverse.
5. Claims 7-12 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claim 16 is now withdrawn because it has been amended to require the presence of non-elected species.
6. Claims 1, 3-6, 13, and 14 are examined on the merits in regards to the elected species.
Claim Rejections - 35 USC § 103
7. Claim(s) 1, 13, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang (US 2010/0143533) in view of DiSilvestro (Journal of Trace Elements in Medicine and Biology (2007), vol. 21, pp. 120-124).
Chang teaches a pharmaceutical composition comprising lemon bioflavonoids (lemon extract), orange bioflavonoids (C. sinensis fruit extract), chromium, and carriers (see paragraph 60). The reference does not teach that the chromium is chromium picolinate.
However, DiSilvestro teaches that chromium picolinate is a superior form of chromium for use in dietary supplements because it allows for the best absorption of the chromium in the subject (see abstract). Thus, an artisan of ordinary skill would reasonably expect that the supplement of Chang would be improved if chromium picolinate was used as the source of the chromium in the composition. This reasonable expectation of success would have motivated the artisan to modify Chang to include the use of chromium picolinate in the composition.
It is noted that in the response submitted August 4, 2026 applicant argues that Example 7 in the specification demonstrates unexpected synergistic results. However, the results shown in the specification are not considered to be sufficient to overcome this rejection. The results show that a combination of lemon extract, blood orange extract, and chromium picolinate functions superiorly to the individual ingredients. However, as discussed in MPEP section 716.02(e), unexpected results must be shown in comparison with the closest prior art. Chang teaches a combination of orange extract, lemon extract, and chromium. This combination is closer prior art than the individual ingredients as tested in the specification. Any unexpected result must stem from a difference between the claimed invention and the closest prior art. In this case the difference is the use of chromium picolinate. Applicant has not shown that the use of this specific chromium compound produces an unexpected result. Please note that MPEP section 716.02(d) also states that any unexpected results must be commensurate in scope with the claimed invention.
8. Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang (US 2010/0143533) in view of DiSilvestro (Journal of Trace Elements in Medicine and Biology (2007), vol. 21, pp. 120-124) as applied to claims 1, 13, and 14 above, and further in view of
Buysschaert (US 2010/0159100).
As discussed above, Chang and DiSilvestro teach a pharmaceutical composition comprising lemon bioflavonoids, orange bioflavonoids, chromium picolinate, and carriers. Chang does not teach that the orange extract is specifically from blood oranges or blonde oranges.
However, Buysschaert teaches that blood oranges and blonde oranges can be used as sources of citrus flavonoid extracts (see paragraphs 4 and 36). Thus, an artisan of ordinary skill would reasonably expect that either or both of blood and blonde oranges could be successfully used as a source of the orange bioflavonoid extract in the composition taught by Chang. This reasonable expectation of success would have motivated the artisan to modify Chang to include the specific use of blood orange extract and/or blonde orange extract.
9. Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang (US 2010/0143533) in view of DiSilvestro (Journal of Trace Elements in Medicine and Biology (2007), vol. 21, pp. 120-124) and Buysschaert (US 2010/0159100) as applied to claims 1, 3, 4, 13, and 14 above, and further in view of DE 202015102040 – English translation.
The teachings of Chang, DiSilvestro and Buysschaert are discussed above. The references do not teach that the composition contains the concentrations of flavonoids and hydroxycinnamic acids claimed by applicant in claim 5. However, Buysschaert does teach that the pharmaceutical activity of the flavonoid citrus extract is linked with the antioxidant activity of the extract (see paragraph 2). DE ‘040 teaches optimizing the concentration of flavonoids and hydroxycinnamic acid within a blood orange extract to increase the antioxidant capacity of the extract (see page 3 of the translation).
As discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” DE ‘040 teaches that the ingredients claimed by applicant in claim 5 are active within an antioxidant composition. Thus, varying the concentration of the active antioxidant flavonoids and hydroxycinnamic acid within the composition taught by the references is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the compounds produces an unexpected result. Therefore, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
10. Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang (US 2010/0143533) in view of DiSilvestro (Journal of Trace Elements in Medicine and Biology (2007), vol. 21, pp. 120-124) and Buysschaert (US 2010/0159100) as applied to claims 1 3, 4, 13, and 14 above, and further in view of Giuffre (International Journal of Food Properties (2017), vol. 20, no. S2, pp. S1930-S1943).
The teachings of Chang, DiSilvestro and Buysschaert are discussed above. The references do not teach that the composition contains the concentrations of hesperidin, eriocitrin, naringin, neoeriocitrin, neohesperidin, didymin, narirutin, and anthocyanins claimed by applicant in claim 6. However, Giuffre teaches that each of these compounds is present in blood orange juice and that the concentrations of these compounds influences the pharmaceutical activity and quality of the blood orange juice (see pages S1930-S1931, S1938-S1941).
As discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” Giuffre teaches that the concentration of the ingredients claimed by applicant in claim 6 impacts important characteristics of blood orange juice. Thus, an artisan would expect that the concentration of these compounds should be optimized to produce a product with the best quality and pharmaceutical properties. Therefore, varying the concentration of these ingredients is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the compounds produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
11. 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 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 Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
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, Anand Desai can be reached at 571-272-0947. 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.
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
