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 .
Claim Status
Applicant’s remarks and amendments, filed 10 August 2025 in response to the non-final rejection mailed 24 June 2026, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 10 August 2026 replaces all prior versions and listings of the claims.
Claims 1, 8, 9, 11, and 19-21 are pending. Claims 2-7, 10, and 12-18 are canceled by Applicant’s amendment. Claims 19-21 are newly added. Claims 1, 9, and 11 are amended. Claims 1, 8, 9, 11, and 19-21 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s amendment to Claim 11 and cancellation of Claim 10 has overcome the claims objection in regards to minor informalities. The objection to Claim 11 has therefore been withdrawn.
Applicant’s arguments and amendments, on page 5 of the reply filed 10 August 2026 with respect to the rejection of Claim 5 under 35 USC § 112(a) have been fully considered. The rejection of Claim 5 is withdrawn due to cancellation of the claim.
Applicant’s arguments and amendments, on pages 5-6 of the reply filed 10 August 2026 with respect to the rejection of Claims 5, 7, 9, and 12 under 35 USC § 112(b) have been fully considered. The rejections of Claims 5, 7, and 12 are withdrawn due to cancellation of the claims and the rejection of Claim 9 is withdrawn due to amendment of the claim.
Applicant’s arguments and amendments, on pages 6-7 of the reply filed 10 August 2026 with respect to the rejection of Claims 1-9, 12, and 13 under 35 USC § 101 have been fully considered. The rejections of Claims 2-7, 12, and 13 are withdrawn due to cancellation of the claims and the rejections of Claims 1, 8, and 9 are withdrawn due to amendment of Claim 1.
Applicant’s arguments and amendments, on page 7 of the reply filed 10 August 2026 with respect to the rejection of Claims 1-5 and 7-13 under 35 USC § 102(a)(1) have been fully considered. The rejections of Claims 2-5, 7, 10, 12, and 13 are withdrawn due to cancellation of the claims and the rejections of Claims 1, 8, 9, and 11 are withdrawn due to amendment of Claim 1.
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.
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.
Claims 1, 8, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Mithen et al. (WO 2010/001119 A2) in view of West et al. (J Agric Food Chem, 2004, 916-926) and Li et al. (Plant Physiol Biochem, 2005, 503-511).
The instant claims are as of record, drawn to a composition comprising broccoli seed extract, horseradish, and calcium carbonate in a mass ratio of 40:10:1.
Mithen et al. teach a pharmaceutical composition comprising an extract from one or more of the plants selected from a group consisting of broccoli (component 1) and radish (component 2; Mithen et al., pages 16-17, lines 30-31 and 1-8), and the glucosinolate in high glucosinolate broccoli extract comprises 4-methylsulfinylbutyl glucosinolate (glucoraphanin; Mithen et al., page 16, lines 6-21; as required for instant Claim 1). The pharmaceutical composition can be administered in the form of tablets (e.g., solid form) or capsules (Mithen et al., page 22, lines 1-5; as required for instant Claim 11) and additionally comprise calcium carbonate (calcium salt; Mithen et al., page 22, lines 7-8; as required for instant Claim 1) and a cyclodextrin (functional oligosaccharide; Mithen et al., page 20, lines 29-32; as required for instant Claims 8 and 9).
Mithen et al. do not teach wherein the broccoli extract is a seed extract, wherein the radish is horseradish, or the specific mass ratio of instant Claim 1.
West et al. teach that broccoli seeds have a high glucoraphanin content and can be used for the isolation of glucoraphanin (West et al., Conclusion, pg. 925).
Li et al. teach that myrosinase can be extracted from horseradish and can break down glucosinolates in a crude broccoli extract (Li et al., Abstract, pg. 503).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of Mithen et al., West et al., and Li et al. to arrive at the instantly claimed invention. A skilled artisan would be motivated to use broccoli seed extract as the broccoli of Mithen et al. because of its high glorcoraphanin content as taught by West et al., and also use horseradish as the radish of Mithen et al. because of its known myrosinase content and ability to break down glucosinolates in broccoli extracts as taught by Li et al. A skilled artisan would therefore have a reasonable expectation of success at using broccoli seed extract as a broccoli extract and horseradish as the radish as provided in Mithen et al. Regarding the weight ratios of instant Claim 1, based upon the overall beneficial teachings provided by the references regarding combinations of broccoli extracts, horseradish, and calcium carbonate, the adjustments of particular conventional working conditions (e.g., determining one or more suitable weight ratios), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Claim 1, 8, 9, 11, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Mithen et al. (WO 2010/001119 A2) in view of West et al. (J Agric Food Chem, 2004, 916-926) and Li et al. (Plant Physiol Biochem, 2005, 503-511) as applied to Claims 1, 8, 9, and 11 above, and further in view of Ibrahim (J Food Chem Nanotechnol, 2018, 65-76).
The claims and teachings of Mithen et al., West et al., and Li et al. are as of record.
Mithen et al., West et al., and Li et al. do not teach wherein the functional oligosaccharide is xylo-oligosaccharide or the other oligosaccharides of Claim 19.
Ibrahim teaches that xylo-oligosaccharides are naturally present in fruits and vegetables, are generally recognized as safe for use in food and pharmaceutical products, and have various benefits such as water solubility, low calories, antimicrobial properties, and have health benefits at a low daily intake (Ibrahim, Xylo-oligosaccharides, pg. 72).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of Mithen et al., West et al., Li et al., and Ibrahim to arrive at the instantly claimed invention. An artisan would have a reasonable expectation of success because xylo-oligosaccharide and cyclodextrin are both functional oligosaccharides and would be motivated to use it in the composition of Mithen et al. due to its various benefits such as water solubility, low calories, antimicrobial properties, and health benefits at a low daily intake as taught by Ibrahim.
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 was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685,
688 (CCPA 1972).
Response to Arguments
Applicant's arguments filed 10 August 2026 have been fully considered but they are not persuasive.
Applicant argues that because the claimed mass ratio is not taught by the prior art, there is no guidance which would lead a skilled artisan to modifying mass ratios of various ingredients to arrive at the instant invention and submits supplementary experimental data in a declaration under 35 CFR 1.132. Applicant also argues that the prior art does not recognize the burst release of sulforaphane from solid compositions containing glucoraphanin and myrosinase when dissolved in an aqueous solution and that the prior art is directed to a different technical problem. Finally, applicant argues that calcium carbonate is in a list of excipients and therefore is not contemplated as being part of the composition for a specific purpose as a functional component.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., burst release, controlled release, release kinetics, release stability, desirability of a controlled and balanced release profile) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Additionally, the broad comprising formulation does not exclude the inclusion of all of the excipients of Mithen et al., nor does the instantly claimed composition require any specific effect in relation to differing mass ratios. Simply calling the calcium carbonate of Mithen et al. an excipient does not change its chemical composition or effect, and therefore the calcium carbonate of Mithen et al. would have the same effect as the calcium carbonate in the instant composition. The additional data provided by applicant indicates that at the various ratios tested, a timed release occurs and merely defines some profiles as “excessively slow” or “too rapid” whereas the claimed ratio is an “optimal state” (Declaration, para. 8), however these are relative terms and it is therefore unclear how they relate to one another, nor are these features recited in the instant claims. It is additionally noted that excipients, such as calcium carbonate, are well known in the art as carriers or delivery mechanisms for drugs, such as in the controlled- and sustained-release applications noted by Mithen et al. (pg. 22). A skilled artisan could therefore reasonably modify ratios of the phytochemicals and excipients of Mithen et al. to arrive at a composition with an acceptable controlled- or sustained-release profile.
Conclusion
No claims are currently 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 JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 5:00am to 5:00pm EST.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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