DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-11 are currently pending.
Claim Objections
3. Claim 7 is objected to because of the following informalities: “Heathy” should be “Heath”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
4. Claims 1-11 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.
The claims are indefinite because they are drawn to “use” type claims which are a non-statutory category of invention. Thus, it is unclear if applicant is intending to claim a composition with an intended use, a method of making a composition, or a method of using a composition. For the sake of examination, the claims are examined as a composition with an intended use. This is the broadest reasonable interpretation of the claims. Furthermore, the claims appear to be intended as composition claims because claim 1 does not contain any active method steps.
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.
5. Claims 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to “use” type claims which are a non-statutory category of invention.
6. Claims 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
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. As discussed above, the claims are interpreted as composition claims; 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 Lonicera japonica. Lonicera japonica 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 a plant only concentrates and portions the naturally occurring compounds in the plant which are soluble or insoluble in the particular solvent. 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 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 claims are drawn to mixtures of naturally occurring products.
There is no indication that extracting Lonicera japonica with water as claimed 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, each plant extract is 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. Thus, the claimed extract 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 enhancing the activity of mitochondria. 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 is the intended use of enhancing the activity of mitochondria. The intended use 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
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.
7. Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoon (US 2015/0044316).
This reference teaches a pharmaceutical composition comprising an extract from Lonicera japonica. The reference teaches that the extract contains 20% or 30% chlorogenic acid. In addition, the reference teaches that the extract is made by extracting the flowers in water and drying. The reference specifically teaches using 1.5 and 3 fold water to plant material (see paragraphs 11, 15, and 77-81).
The reference does not specifically teach that the composition has the same activities as claimed by applicant. 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. As discussed above, the reference composition is structurally the same as the claimed composition. Therefore, the reference composition should be capable of performing the claimed intended uses if applicant’s invention functions as disclosed.
8. Claim(s) 1-8 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hong (KR 20210037868 A – English translation).
this reference teaches a feed composition comprising an extract from Lonicera japonica. The reference teaches that the extract contains chlorogenic acid. In addition, the reference teaches that the concentration of the extract in the composition is 500 µg/mL (see claims).
The reference does not specifically teach that the composition has the same activities as claimed by applicant. 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. As discussed above, the reference composition is structurally the same as the claimed composition. Therefore, the reference composition should be capable of performing the claimed intended uses if applicant’s invention functions as disclosed.
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.
9. Claim(s) 1 and 11 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoon (US 2015/0044316).
The teachings of this reference are discussed above in paragraph 7. The reference does not specifically teach using the Lonicera japonica extract in the concentrations claimed by applicant. 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).” The reference teaches using the extract in a concentration from 16 µg/day to 1 mg/day (see paragraph 47). Varying the concentration of the extract within the range taught by the reference is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the extract produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
10. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Coe Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Terry McKelvey can be reached at 571-272-0775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSAN HOFFMAN/ Primary Examiner, Art Unit 1655