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 .
Election/Restrictions
Claims 1-18 are pending in the instant application. Applicant’s election without traverse of Group I, Claims 1-13, drawn to a composition comprising glucoraphanin, myrosinase, and calcium salt in the reply filed on 5 May 2026 is acknowledged. Claims 14-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Newly submitted Claim 18 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The invention of elected Claims 1-13 and newly added Claim 18 are related as product and process of making. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the process as claimed can be used to make a materially different product which does not comprise glucoraphanin or myrosinase.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, Claim 18 is additionally withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 1-13 are being examined on the merits.
Claim Objections
Claims 10 and 11 are objected to because the phrase “which is in” should instead read --wherein the composition is in--. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 5 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
Claim 5 recites the phrase “flower bulbs,” however cruciferous vegetables do not have “bulbs,” which are short stems found underground and function as food storage for plants during dormancy (e.g., onion bulbs or daffodil bulbs; see Miller, 2018, 2 pages). The specification mentions “flower bulbs” in reference to broccoli in the specification at [0013]-[0015] and [0028], however no additional definition is given which would inform one skilled in the art of plant biology to understand what is meant by “flower bulb” in relation to broccoli.
The claim therefore contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5, 7, 9, and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 is indefinite because it is unclear what is meant by “flower bulbs” in relation to cruciferous vegetables, which do not have “bulbs,” which are short stems found underground which function as food storage for plants during dormancy (e.g., onion bulbs or daffodil bulbs). Additionally, in Claim 12, the phrase “broccoli curd lyophilized powder” is equally unclear; in the specification at [0021] the phrase “broccoli flower lyophilized powder” is used and it is therefore unclear what is meant by these phrases. For the purposes of advancing prosecution, “flower bulbs” in the context of broccoli (e.g., specification at [0013]-[0015] and [0028]) and “broccoli curd” are being interpreted as broccoli inflorescences.
Claim 7 recites “preferably” and “more preferably,” which are narrower limitations of the calcium salt Markush group and Claim 9 recites “especially selected from” and “particularly preferred,” which are narrower limitations of the functional oligosaccharide Markush group. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Additionally, Claim 9 recites the limitation “the functional oligosaccharide.” There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9, 12, and 13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1-9, 12, and 13 are directed to a natural product (i.e., a law of nature/a natural phenomenon). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception – i.e., as drafted, the claims read upon a product of nature (i.e., a law of nature/a natural phenomenon) for the following reasons:
Claims 1-9, 12, and 13 are drawn to a composition (for the intended use in the dosage forms of Claims 12 and 13) formed entirely from natural ingredients (as disclosed on pages 3-4 and paragraphs [0006] and [0011] of the instant specification) including broccoli (as a component providing glucoraphanin); a component 2 (such as horseradish, radish, or kale); a calcium salt (such as calcium carbonate, found naturally in rocks, shells, and pearls); and in some embodiments, further including a functional oligosaccharide (such as fructo-oligosaccharides, found naturally in foods such as bananas, onions, and garlic). The claimed composition is not markedly different from its naturally-occurring counterparts because there is no indication that the composition has any characteristics or properties that are different from the naturally-occurring counterparts (including the natural compounds found therein). The cited claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any additional elements.
Furthermore, the claims do not integrate the composition into a distinguishing practical application (for example, do not broadly or specifically recite dosage form(s) (e.g., Claims 10 and 11) and the therapeutically-effective amounts of the material), but merely recites the natural materials themselves or a multiplicity of natural materials. While Claim 6 requires certain ratios of components in the active ingredient or composition, there is no indication that the amounts claimed result in a markedly different characteristic for the composition as compared to components found in nature.
Therefore, the claimed composition is not deemed to be markedly different from what exists in nature in terms of structural and/or functional differences. In other words, the claims do not set forth a marked difference in terms of structural and/or functional differences (properties and/or characteristics) as compared to the naturally-occurring counterparts (see, e.g., Diamond v. Chakrabarty, 447 U.S. 303(1980)). Please note that combining natural extracts (such as from two or more plants) does not remove the claims from reading upon a judicial selection (Funk Brothers Seed Col. V. Kalo Inoclulant Col. – 333 U.S. 127 (1948)) because, again, there is no evidence of a marked difference brought about by combining the instantly claimed herbal extracts. Please also note that modifying the concentration of the product/composition is not sufficient to remove the claimed composition from a judicial exception (see, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 106 USPQ2d 1972 (2013)).
Thus, when the relevant factors are analyzed, they weigh against a significant difference between the claimed invention and a judicial exception. Therefore, the claimed invention is not considered to be patent eligible subject matter.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-5 and 7-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mithen et al. (WO 2010/001119 A2).
The instant claims are as of record, drawn to a composition comprising a component 1 providing glucoraphanin; a component 2 providing myrosinase; and a calcium salt.
Mithen et al., however, anticipate the claims by teaching a pharmaceutical composition comprising an extract from one or more of the plants selected from the group consisting of the cruciferous plants broccoli (component 1), rocket, watercress, cauliflower, kale (component 2), turnips, collards, Brussel sprouts, cabbage, radish (component 2), and turnip (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 Claims 1-3, 12, and 13). The extract is obtained by extracting the whole or part of the plant and preferably the broccoli inflorescences (e.g., flowers (interpreted as “flower bulbs”)) are used to obtain the extract (Mithen et al., page 16, lines 23-27 & page 17, lines 5-8; as required for instant Claims 4 and 5). 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 Claims 10 and 11) and additionally comprise calcium carbonate (calcium salt; Mithen et al., page 22, lines 7-8; as required for instant Claims 1 and 7) and a cyclodextrin (functional oligosaccharide; Mithen et al., page 20, lines 29-32; as required for instant Claims 8 and 9).
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 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Mithen et al. (WO 2010/001119 A2).
The instant claims are as of record, drawn to a composition comprising a component 1 providing glucoraphanin; a component 2 providing myrosinase; and a calcium salt.
Mithen et al., however, anticipate the claims by teaching a pharmaceutical composition comprising an extract from one or more of the plants selected from the group consisting of the cruciferous plants broccoli (component 1), rocket, watercress, cauliflower, kale (component 2), turnips, collards, Brussel sprouts, cabbage, radish (component 2), and turnip (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 Claims 1-3, 12, and 13). The extract is obtained by extracting the whole or part of the plant and preferably the broccoli inflorescences (e.g., flowers (interpreted as “flower bulbs”)) are used to obtain the extract (Mithen et al., page 16, lines 23-27 & page 17, lines 5-8; as required for instant Claims 4 and 5). 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 Claims 10 and 11) and additionally comprise calcium carbonate (calcium salt; Mithen et al., page 22, lines 7-8; as required for instant Claims 1 and 7) 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 the specific mass ratios of instant Claim 6.
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 modify the mass ratios of the various components of the composition because Mithen et al. teach that when formulated for oral delivery, the pharmaceutical composition can have varying doses of phytochemicals (e.g., extracts of cruciferous plants; Mithen et al., page 11, lines 10-20). Additionally, the pharmaceutical compositions are made by mixing the phytochemical and one or more suitable carriers, diluents, or excipients (e.g., calcium carbonate) using techniques known in the art (Mithen et al., page 26, lines 3-6). Based upon this overall beneficial teaching provided by this reference, the adjustments of particular conventional working conditions (e.g., determining one or more suitable ratios of individual components (as required for instant Claim 6)), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
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).
Conclusion
No claims are currently allowed.
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 11:00am 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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