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
Applicant's election with traverse of the isomeric species corresponding to the compound 13 and the compound 16 for claims 7 and 14, respectively in the reply filed on January 26, 2026 is acknowledged. The traversal is on the ground(s) that searching all of the eight isomeric species present within both claims 7 and 14 would not present a serious search burden to the examiner. This is not found persuasive because each of the isomeric species found within claims 7 and 14 are very specific to some plant families, fungi, etc. In addition, some of the listed isomeric species are present under flavonoids, which are a very broad class that encompasses over three subclasses, in which, some, if not all the compounds stated within claims 7 and 14 are not guaranteed to be present within an extract of C. mimosoides as a result of some of the compounds having a greater natural presence in other plant families, fungi, etc.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-14 are examined on the merits in regards to the elected species.
Specification
The use of the term Witepsol (page 11), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
Claim(s) 1-3, 5-10, 12-14 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 1 is indefinite because it is unclear what “allergic respiratory disease” is. In page 2 of the specification, it only provides examples of “allergic respiratory diseases” and not a definition of “allergic respiratory disease”. Thus, the metes and bounds of the claim are unclear.
Claim 8 is indefinite because it is unclear what “allergic respiratory disease” is. In page 2 of the specification, it only provides examples of “allergic respiratory diseases” and not a definition of “allergic respiratory disease”. Thus, the metes and bounds of the claim are unclear.
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) 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. The pharmaceutical or health food “composition” comprising a C. mimoisoides extract of claims 1-14 encompasses naturally occurring substances.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim
is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a
statutory category of invention. Applicant’s claims are directed to a product; thus, the
answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a
product of nature. In this case, applicant’s claims recite an extract from Cassia mimosoides L. (C. mimosoides). Cassia mimosoides L. is a naturally occurring plant. Thus, the claims
do recite products of nature. MPEP § 2106.04(b) states that “When a claim recites a
nature-based product limitation, examiners should use the markedly different
characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based
product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not
naturally occurring, for example due to some human intervention, then the markedly
different characteristics analysis must be performed to determine whether the claimed
product limitation is a product of nature exception…”. To perform the markedly
different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different
characteristics analysis compares the nature-based product limitation to its naturally
occurring counterpart in its natural state. Markedly different characteristics can be
expressed as the product’s structure, function, and/or other properties…”.
In this case, extraction of plants only concentrates and portions the naturally occurring compounds in the plants which are soluble or insoluble in the particular solvent, such as ethanol. General extraction does not necessarily result in a markedly distinct change in the naturally occurring compounds from the plant. Thus, while a solvent 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, while extraction of the
compounds with the selected solvent (ethanol) 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.” Thus, the extract in turn is a mixture of the naturally occurring compounds found in the particular plant. The extract from the individual plant leads to a combination of the naturally occurring compounds from the plant. Thus, the claim is drawn to a mixture of naturally occurring products.
There is no indication that the specified extract as commensurate in scope with the stated claim changes the structure, function, or other properties of the extract in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for the extract is a mixture of the naturally occurring compounds that are present in the extract. Because, as discussed above, the plant extract contains only a mixture of the naturally occurring compounds found in the plant. The extract composition appears to maintain its naturally occurring structure and properties and is merely present in the combination. In addition, there is nothing to show that mixing the ingredients in the particular concentrations produces any sort of marked distinction. Thus, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites
additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant’s claims are directed to a composition with an intended use of treating allergic respiratory diseases. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements
that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this
evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the additional element in the claims is the presence of an extract. However, MPEP § 2106.05(d)
states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. The presence of specific compounds within the extract of C. mimosoides, such as (2S)-3',4,7-trihydroxylavan-(4ß->8)-catechin and (2S)-3',4,7-trihydroxyflavan-(4a-> 8)-catechin ([compounds 13 and 16 from claims 7 and 14 of the current invention, respectively]) as taught by Kojima et al (Nippon Shokuhin Kagaku Kogaku Kaishi, (Year: 2012), vol. 59, no. 6, pp. 279-283) that are also stated within claims 7 and 14 of the present invention does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
In addition, applicant’s intended use of treating allergic respiratory disease is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
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) 1-2, 4-9 and 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sato (U.S. Patent No. 6,054,129) with Kojima et al (Nippon Shokuhin Kagaku Kogaku Kaishi, (Year: 2012), vol. 59, no. 6, pp. 279-283) providing evidence of inherent characteristics of Sato.
Regarding claims 1-2, 4-6, 8-9, 11-13,
Sato teaches an extract from Cassia mimosoides L. (abstract). Sato also teaches [that it is] preferable that ethanol is [mixed] with water, preferably at a ratio of 50% to 50% (paragraph 0042). Sato teaches extraction solvents [such as] ethanol [and] ethyl acetate [and that it is] possible to optionally select one or more kinds of those solvents for preparation [like] ethanol [and] ethyl acetate (paragraph 0042). Sato teaches the extract may be filled into capsules or soft capsules, may also be formed in tablet type or granular type [or] extract may also be mixed into materials for all foods and drinks [such as] nutrition drinks ([e.g. a health functional food or a pharmaceutical composition]) (paragraph 0048).
The Sato reference does not specifically teach the treatment of allergic diseases. However, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claims 7 and 14,
The Sato reference does not explicitly state that the composition contains the two compounds (e.g. compounds 13 and 16) from claims 7 and 14 of the present invention. However, Kojima et al demonstrates that the two compounds: (2S)-3',4,7-trihydroxylavan-(4ß->8)-catechin and (2S)-3',4,7-trihydroxyflavan-(4a-> 8)-catechin ([compounds 13 and 16 from claims 7 and 14 of the current invention, respectively]) inherently occurs within the C. mimosoides extract (abstract, page 281 and figure 3).
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.
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.
Claim(s) 1, 3, 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Sato (U.S. Patent No. 6,054,129) with Kojima et al (Nippon Shokuhin Kagaku Kogaku Kaishi, (Year: 2012), vol. 59, no. 6, pp. 279-283) providing evidence.
The teachings of Sato and Kojima et al are above.
Sato does not teach that the fraction is an ethyl acetate fraction of a 60% (v/v) to 80% (v/v) ethanol extract of Cassia mimosoides (as stated within claims 3 and 10 of the present invention).
Regarding claims 3 and 10, the Sato reference teaches that both organic solvents, ethanol and ethyl acetate can be used for extraction with C. mimosoides.
However, 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).” Therefore, one would reasonably expect that the fraction(s) of organic solvents would be experimented with in order to find the ideal fraction in order to achieve the appropriate ethyl acetate fraction to the ethanolic extract of C. mimosoides.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U 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.
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NASHARA L MOREAUExaminer, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655