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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-2 in the reply filed on 3/12/2026 is acknowledged.
Claims 3-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/12/2026.
Claim Objections
Claim 1 is objected to because of the following informalities: the phrase “composition of matter” should be deleted since all physical entities are compositions of matter. Appropriate correction is required.
Claims 1 and 2 are objected to because of the following informalities: the phrase “pyrrolizidine alkaloids, having concentration” is missing the article from before “having”. Also, the comma is not proper punctuation in this claim language construction and should be removed. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: the phrase “per liter extract” is missing the article from in front of “extract”. 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.
Claim(s) 1 and 2 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural composition of matter without significantly more.
Claims 1 and 2 recite a composition of matter extracted from the plant Tribulus terrestris comprising: i. at least 40% furostanol saponins and ii. pyrrolizidine alkaloids, having concentration of less than 400 µg per kilogram of said composition; and a Tribulus terrestris extract comprising: i. at least 10% furostanol saponins and ii. pyrilizidine alkaloids, having concentration of less than 80 µg per liter extract. Claims 1 and 2 recite an extract of Tribulus terrestris as the only ingredient. Claims 1 and 2 are drawn to an extract of Tribulus terrestris.
These instantly claimed limitations are drawn to a product of nature, namely naturally occurring compounds found in Tribulus terrestris. Tribulus terrestris contains the instantly compounds. Extraction of plants only concentrates and portions the naturally occurring compounds in the plants which are soluble or insoluble in the particular solvent. While the extract itself may not be found in the nature, the compounds which are present in the plant and soluble in the selected solvent are found in nature. The creation of a solvent extract only partitions and concentrates the molecules that are naturally in the plant. There is no evidence or reason to expect that any new compounds are formed. The extract itself is a mixture of the naturally occurring compounds that are simply soluble in a particular solvent. Thus, a claim to a solvent extract would tie up and monopolize a subset of compounds that are naturally present in the plant and are simply soluble in the selected solvent. Thus, the instantly claimed extract of Tribulus terrestris does not amount to an exception of the judicial exception, because isolation or purification does not result in a product which is ‘markedly different’ from the naturally-occurring component. Thus, while extraction of the compounds with the selected solvent (water and alcohol) would separate a portion of the plant matter away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally-found in the plant material; i.e., the compound is not inventive or “man-made.” Please note that in Myriad, excising DNA to isolate the DNA from its natural source did not constitute a product which was “markedly different” from the naturally occurring DNA even though the excised ends of the DNA were different in structure when compared to native DNA.
Thus, the claims are drawn to mixtures of naturally occurring products. Therefore, the claims are drawn to judicial exceptions. There are no structural limitations in claims 1 and 2 in addition to the extract containing naturally occurring ingredients.
Claim Rejections - 35 USC § 102/103
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 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.
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.
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 and 2 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Li et al. (N, CN 100478001 C, Translation provided herein).
A tribulus terrestris extract is a product extracted from tribulus terrestris fruits and comprises 55-60% of total tribulus terrestris saponin, wherein the total tribulus terrestris saponin basically comprises total spirostanol saponin of tribulus terrestris and total furostanol saponin of tribulus terrestris, the content of the total spirostanol saponin of tribulus terrestris is 15-40%, the content of the total furostanol saponin of tribulus terrestris 15-40% (which reads on at least 10% and at least 40%, since 40% is at least 40%)
Although Li does not expressly teach a composition of matter containing pyrrolizidine alkaloids having a concentration of less than 400 µg per kilogram of said composition or a Tribulus terrestris extract comprising pyrilizidine alkaloids having a concentration of less than 80 µg per liter extract, the amount of pyrilizidine alkaloids is inherent to the extract taught by Li because the ingredients are one and the same as disclosed in the instantly claimed invention of Applicant. Thus, the composition of matter containing pyrrolizidine alkaloids having a concentration of less than 400 µg per kilogram of said composition or a Tribulus terrestris extract comprising pyrilizidine alkaloids having a concentration of less than 80 µg per liter is inherent to the extract taught by Li. Therefore, the reference anticipates the claimed subject matter.
In the alternative, even if the claimed extract and composition of matter is not identical to the extract taught by the cited reference with regard to some unidentified characteristics, the differences between that which is disclosed and that which is claimed are considered to be so slight that the extract taught by the cited reference is likely to intrinsically possess the same characteristics (including with respect to the instantly claimed functional effects) of the claimed particularly in view of the similar characteristics which they have been shown to share. Thus, the claimed extract and composition of matter would have been obvious to those of ordinary skill in the art within the meaning of USC 103. Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the cited reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
With respect to the USC 102/103 rejection above, please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicant’s claimed extract and composition of matter is different and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Wang et al. (U).
Wang teaches isolating furostanol saponins from Tribulus terrestris (which reads on an extract and composition of matter from Tribulus terrestris).
Although Wang does not expressly teach a composition of matter containing at least 40% furostanol saponins and pyrrolizidine alkaloids having a concentration of less than 400 µg per kilogram of said composition or a Tribulus terrestris extract comprising at least 40% furostanol saponins and pyrilizidine alkaloids having a concentration of less than 80 µg per liter extract, the amount of pyrilizidine alkaloids is inherent to the extract taught by Wang because the Tribulus terrestris extract of isolated compounds would inherently be greater than 40% of the total composition and less than 400 µg per kilogram or less than 80 µg per liter extract of pyrilizidine alkaloids, since the compounds themselves are the only product and thus would necessarily be greater than 40% and have no or trace other compounds in the purified extract. Thus, the extract taught by Wang is one and the same as disclosed in the instantly claimed invention of Applicant. The composition of matter containing at least 40% furostanol saponins and pyrrolizidine alkaloids having a concentration of less than 400 µg per kilogram and a Tribulus terrestris extract comprising at least 40% furostanol saponins and pyrilizidine alkaloids having a concentration of less than 80 µg per liter is inherent to the extract taught by Li. Therefore, the reference anticipates the claimed subject matter.
In the alternative, even if the claimed extract and composition of matter is not identical to the extract taught by the cited reference with regard to some unidentified characteristics, the differences between that which is disclosed and that which is claimed are considered to be so slight that the extract taught by the cited reference is likely to intrinsically possess the same characteristics (including with respect to the instantly claimed functional effects) of the claimed particularly in view of the similar characteristics which they have been shown to share. Thus, the claimed extract and composition of matter would have been obvious to those of ordinary skill in the art within the meaning of USC 103. Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the cited reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
With respect to the USC 102/103 rejection above, please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicant’s claimed extract and composition of matter is different and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amy L. Clark whose telephone number is (571)272-1310. The examiner can normally be reached M-F 8:00am-5:00pm.
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/AMY L CLARK/ Supervisory Patent Examiner, Art Unit 1628
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