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 .
DETAILED ACTION
Claims 1-20 are pending. Claims 1-7, 9, 12-14, and 17-18 are examined on the merits. Claims 8, 10-11, 15-16, and 19-20 are withdrawn.
Election/Restrictions
Applicant’s election of Group I (Claims 1-9, 12-18), the species maitake, glucan, breast cancer, quercetin in the reply filed on 6/1/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 8, 10-11, 15-16, and 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/1/2026.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6/3/2026, 12/19/2025, 11/4/2025, 4/14/2025, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 7, 12-14, and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bias (US 20100015109 A1).
Bias teaches a method of generating a high Oxygen Radical Absorbance Capacity (ORAC) value with a composition comprising at least about 125 mg broccoli sprout, at least about 50 mg maitake fruiting body, at least about 250 mg oat beta-glucan (Claim 20), a source of vitamin C (which is ascorbic acid) (Claim 1) and quercetin (Claim 5). The dietary supplement which has an oxygen radical absorbance capacity, as measured by known methods, of at least about 4,500 or the equivalent of at least about nine servings of fruits and/or vegetables. Generally, one serving of fruits and/or vegetables has an average ORAC value of about 500. An example of a high-ORAC value composition in accordance with the invention is a formulation which provides the antioxidant equivalent of twenty-four servings of fruits and/or vegetables, i.e., has an ORAC value of about 12,000 [0013]. A dietary supplement is taken orally. A subject in need thereof is everyone because oxidative stress has also been implicated in the process of aging. It is known that reactive oxygen species can damage biological molecules such as proteins, lipids, and DNA. While the human body has developed a number of systems to eliminate free radicals from a person's system, it is not 100% efficient [0003]. Broccoli extract would contain the limitations of Claims 2 and 3. A composition comprising at least about 125 mg broccoli sprout would inherently contain about 1-75% w/w of Claim 2.
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.
Claim(s) 1-7, 12-14, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Bias (US 20100015109 A1).
Bias teaches a method of generating a high Oxygen Radical Absorbance Capacity (ORAC) value with a composition comprising at least about 125 mg broccoli sprout, at least about 50 mg maitake fruiting body, at least about 250 mg oat beta-glucan (Claim 20), a source of vitamin C (which is ascorbic acid) (Claim 1) and quercetin (Claim 5). The dietary supplement which has an oxygen radical absorbance capacity, as measured by known methods, of at least about 4,500 or the equivalent of at least about nine servings of fruits and/or vegetables. Generally, one serving of fruits and/or vegetables has an average ORAC value of about 500. An example of a high-ORAC value composition in accordance with the invention is a formulation which provides the antioxidant equivalent of twenty-four servings of fruits and/or vegetables, i.e., has an ORAC value of about 12,000 [0013]. A dietary supplement is taken orally. A subject in need thereof is everyone because oxidative stress has also been implicated in the process of aging. It is known that reactive oxygen species can damage biological molecules such as proteins, lipids, and DNA. While the human body has developed a number of systems to eliminate free radicals from a person's system, it is not 100% efficient [0003]. Broccoli extract would contain the limitations of Claims 2 and 3. A composition comprising at least about 125 mg broccoli sprout would inherently contain about 1-75% w/w of Claim 2.
However, Bias does not teach enteric dosage form.
The reference also does not specifically teach formulating the composition in the forms claimed by applicant. These pharmaceutical forms are well known in the art to be acceptable means of administering a pharmaceutically active substance. Based on this knowledge, a person of ordinary skill in the art would have had a reasonable expectation that formulating the composition taught by the references in the claimed forms would be successful. Therefore, an artisan of ordinary skill would have been motivated to formulating the composition taught by the reference in the forms claimed by applicant.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7, 12-14, and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-14 of U.S. Patent No. 9421183 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the increase of NADPH:quinone oxidoreductase 1 (NQO-1), the amount of about 1-75% w/w broccoli extract, glucans are not taught.
U.S. Patent No. 9421183 B2 teaches:
9. A method of treating, preventing, reducing the occurrence of, decreasing the symptoms associated with, and reducing secondary recurrences of breast cancer, comprising administering to a subject in need thereof a composition comprising a synergistic combination of a sulforaphane precursor; a glucosidase enzyme capable of converting the sulforaphane precursor to sulforaphane; a cofactor of the enzyme; and a maitake mushroom extract or powder.
10. The method of claim 9, wherein the sulforaphane precursor comprises glucoraphanin.
11. The method of claim 9, wherein the enzyme capable of converting the sulforaphane precursor to sulforaphane comprises myrosinase.
12. The method of claim 9, wherein the enzyme cofactor comprises ascorbic acid.
13. The method of claim 9, comprising administration of glucoraphanin, myrosinase, ascorbic acid, and maitake mushroom extract.
14. The method of claim 9, comprising administering an enteric-coated dosage form.
The reference does not specifically teach adding the ingredients in the amounts claimed by applicant for the increase of NADPH:quinone oxidoreductase 1 (NQO-1), the amount of about 1-75% w/w broccoli extract. However, the reference does teach the composition for treating breast cancer, which is a type of oxidative stress disease. The amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[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). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to add glucan because glucan is in maitake mushroom. One would have been motivated to make the treatment for breast cancer with glucan for the expected benefit of glucan from mushrooms. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached on Monday-Friday 9-5:30 PM.
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 U Desai can be reached on 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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