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
Response to Amendment
Acknowledgment is made of the receipt and entry of the amendment filed on 10/16/2025, wherein claim 1 is cancelled, new claims 25-27 are added, claims 4, 7-9, 11, 14-17, 19, 20 and 22 are amended to depend on new independent claim 25.
Status of Claims
Claims 4, 7-9, 11, 14-17, 19, 20, 22 and 25-27 are pending and currently under examination.
Action Summary/ Response to Arguments
Applicant's Remarks filed 10/16/2025 have been fully considered. Any objection and rejection found in the previous Office Action and not repeated herein has been withdrawn in view of amendment and Applicant’s remarks . The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 1 is cancelled, claims 4, 7-9, 11, 14-17, 19, 20 and 22 are amended to depend on new independent claim 25. As such, rejection of claim 1 and dependent claims 4, 7-9, 11, 14-17, 19, 20, 22 in the previous Office Action are withdrawn. As necessitated by amendment, following rejections are newly applied and/or reapplied, and made Final.
Newly applied and/or reapplied rejection necessitate by amendment :
Claims 9,11,16-17, 19-20 and 25-27 are rejected under 35 U.S.C. §112(a) as failing to comply with the written description requirement;
Claims 4, 7-9, 11, 14-17, 19, 20, 22 and 25-27 are rejected under 35 U.S.C.§ 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter;
Claims 4, 16-17, 19, 22, 25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more;
Claims 4, 7-9, 11, 14-17, 19, 20, 22 and 25 are rejected under 35 U.S.C. § 102(a)(1) and (a)(2) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as being obvious over Rosenfeld et al.;
Claims 4, 7-9, 11, 14-17, 19, 20, 22 and 25 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as being obvious over Yimam et al., evidenced by Rosenfeld et al.;
Claims 4, 7-9, 11, 14-17, 19, 20, 22 and 25 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by or, in the alternative, under 35 U.S.C. § 103 as being obvious over Kalman et. al. evidenced by Rosenfeld et al.;
Claims 4, 7-9, 11, 14-17, 19, 20, 22 and 25-27 are rejected under 35 U.S.C. § 103 as being unpatentable over Yimam in view of Rosenfeld.
As disclosed by instant specification (See page 13, line 4, page 53, line 2, etc.), instant claimed composition comprising an extract enriched for one or more phenylpropanoid acids and benzoxazinoids is known as UP165 derived from Zea mays(corn). UP 165 was available for public use for enhancing psychological well-being and in relieving symptoms of depression and anxiety as early as 2015 as taught by Kalman. Kalman teaches clinical study of UP 165 funded/supported by the Applicant, Unigen. UP165 (Maizinol®) disclosed by Yimam 2018 is a sleep aid product developed by Applicant, Unigen. UP 165 taught by Yimam 2018 and Kalman are considered as made in the same way as instant claimed Zae mays extract, therefore contains the same components of phenylpropanoid acids and the benzoxazinoids as instantly claimed extract, in absence of evidence to the contrary. For example, the efficacy of Up 165 in treating sleep disorder taught by Yimam 2018 in Table 2 and 3 are the same as instant Table 14 and 15, respectively. Thus, instant claims are considered as anticipated by UP165 taught by Yimam and Kalman under 35 U.S.C. §102 evidenced by Rosenfeld. With respect to 35 U.S.C. § USC 102/103 rejections, please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicant’s claimed extract composition from Zae mays (UP 165) are different, if so, to what extent, from UP165, Zae mays extract taught by prior art. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants. Applicant does not provide any evidence that instant claimed composition is any different from UP165 taught by Yimam and Kalman. As such, rejections of 4, 7-9, 11, 14-17, 19, 20, 22 and 25 under 35 USC§ 102/103 are newly reapplied/reiterated as necessitated by amendment.
Priority
This instant application 17/831,862 filed on 06/03/2022 claims benefit of US provisional applications 63/293,856 filed on 12/27/2021 and 63/196,398 filed on 06/03/2021.
Claim interpretation
New independent claim 25 recites: “a composition comprising an enriched extract, wherein the enriched extract is enriched for one or more phenylpropanoid acids and the enriched extract is further enriched for one or more benzoxazinoid glycosides, wherein the ratio of the one or more phenylpropanoid acids to the one or more benzoxazinoid glycosides in the enriched extract is 1:2 or 2:1”.
As disclosed by instant specification (See page 13, line 4, page 53, line 2, etc.), instant claimed composition comprising an extract enriched for one or more phenylpropanoid acids and benzoxazinoids is known as UP165 derived from Zea mays(corn). Applicant does NOT provide any evidence in the form of Affidavit or Declaration that instant claimed composition comprising an extract enriched for one or more phenylpropanoid acids and benzoxazinoids is different from UP165 taught by prior art on the record (e.g. Yimam and Kalman). UP165 taught by prior art (e.g. Yimam and Kalman) is considered as a composition comprising one and more enriched benzoxazinoids and phenylpropanoid acids in absence of evidence to the contrary, although Yimam and Kalman are silent about the ratio recited in new claim 25.
Claim 9 and 11 recites limitation directed to the extracting and enriching process. As stated in MPEP 2113, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
New claims 26 and 27 recited MT receptor binding activities. Claims 16-17 and 19 recite limitation, e.g. “wherein the one or more phenylpropanoid acids and one or more benzoxazinoids in the extract selectively binds to a MT2 receptor over a MT1 receptor” “wherein the one or more phenylpropanoid acids and one or more benzoxazinoids in the extract improves overall mental well-being measured by the Pittsburgh Sleep Quality Index (PSQI) and Profile of Mood States (POMS), provides positive mood support and enhances emotional well-being; maintains homeostasis of biomarkers - serotonin, melatonin, or GABA in formulation in a mammal”, “maintains homeostasis of cortisol that leads to improved symptoms of chronically high cortisol”. These limitations are construed as intended use/function which do not necessarily make contribution to the structural change of pharmaceutical composition. A composition and its properties are inseparable. "Products of identical chemical composition cannot have mutually exclusive properties." A recitation of the intended use/function of the claimed composition product must result in a structural difference between the claimed product and the prior art in order to patentably distinguish the claimed product from the prior art. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP 2112.01. If the prior art structure is capable of performing the intended use, then prior art meets the limitation.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o).
New independent claim 25 recites: “a composition comprising an enriched extract, wherein the enriched extract is enriched for one or more phenylpropanoid acids and the enriched extract is further enriched for one or more benzoxazinoid glycosides, wherein the ratio of the one or more phenylpropanoid acids to the one or more benzoxazinoid glycosides in the enriched extract is 1:2 or 2:1”.
Instant specification is required to provide support to the limitation which one or more phenylpropanoid acids and/or benzoxazinoid glycosides are enriched and the ratio of 1:2 or 2:1 is between which one or more phenylpropanoid acids and which one or more benzoxazinoid glycosides in the enriched extract.
Instant specification [See PGPub US 2022/0387366 A1 [0126]) disclosed: “ The MT2 receptor binding inhibition is either lost or reduced after purification, strongly indicating the potent efficacy is not from single type of actives but coming from a combination of two types of components, phenolic acids, specifically phenylpropanoid acids, and benzoxazinoid glycosides. EA-F5, with IC50 close to 2.5 μg/mL, which contains phenolic acids and benzoxazinoid glycosides in a ratio of 2:1 based on proton NMR analysis. EA-F4-2 showed potent inhibition with IC50 around 0.5 μg/mL concentration, containing phenolic acids and benzoxazinoids in a ratio of 1:2 based on the proton NMR analysis”. It's noted the EA-F5 or EA-F4-2 are fractions during the enrichment process while instant claims are directed to composition comprising final enriched extract enriched for one or more phenylpropanoid acids and benzoxazinoid glycosides.
Instant Examples 4 and 5 disclosed composition profile of Zea mays extract focusing on 6-MBOA without disclosing content /amount of other phenylpropanoid acids and/or benzoxazinoid glycosides. Instant specification does not identify/characterize the active one or more phenylpropanoid acids and/or the one or more benzoxazinoid glycosides enriched in the claimed ratio. An ordinary skilled artisan would not know which one or more phenylpropanoid acids and/or one or more benzoxazinoid glycosides are enriched in the claimed ratio and active for the intended function as recited in dependent claims 16-17 and 19. Instant specification failed to provide sufficient support for instantly claimed enriched one or more phenylpropanoid acids and one or more benzoxazinoid glycosides wherein the ratio of the one or more phenylpropanoid acids to the one or more benzoxazinoid glycosides in the enriched extract is 1:2 or 2:1.
Claim Rejections - 35 USC § 112
Claims 9,11,16-17, 19-20 and 25-27 are 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. The claim(s) 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 (newly applied as necessitated by amendment).
New independent claim 25 recites: “a composition comprising an enriched extract, wherein the enriched extract is enriched for one or more phenylpropanoid acids and the enriched extract is further enriched for one or more benzoxazinoid glycosides, wherein the ratio of the one or more phenylpropanoid acids to the one or more benzoxazinoid glycosides in the enriched extract is 1:2 or 2:1”. New claims 26 and 27 further recite limitation regarding MT2 receptor binding inhibition. Instant claims are directed to composition comprising variety of phenylpropanoid acids and benzoxazinoids within the extract that have different chemical structure, different physical property and different biological activity, etc. However, the active phenylpropanoid acids and/or benzoxazinoid glycosides binding to MT2 receptor are not identified/characterized/disclosed by instant specification. It’s not clear which specific phenylpropanoid acid and/or benzoxazinoid species are enriched for.
Instant specification [See PGPub [0126]) disclosed: “ The MT2 receptor binding inhibition is either lost or reduced after purification, strongly indicating the potent efficacy is not from single type of actives but coming from a combination of two types of components, phenolic acids, specifically phenylpropanoid acids, and benzoxazinoid glycosides. EA-F5, with IC50 close to 2.5 μg/mL, which contains phenolic acids and benzoxazinoid glycosides in a ratio of 2:1 based on proton NMR analysis. EA-F4-2 showed potent inhibition with IC50 around 0.5 μg/mL concentration, containing phenolic acids and benzoxazinoids in a ratio of 1:2 based on the proton NMR analysis”. It's noted the EA-F5 or EA-F4-2 are fractions during the enrichment process. Instant claims are directed to composition comprising final enriched extract enriched for one or more phenylpropanoid acids and benzoxazinoid glycosides. It’s not clear if the final enriched extract is EA-F5 or EA-F4-2, or any other fraction during the enrichment process or combination thereof.
Instant Examples 4 and 5 disclosed composition profile of Zea mays extract focusing on 6-MBOA without disclosing content /amount of other phenylpropanoid acids and/or benzoxazinoid glycosides. Instant Example 6 disclosed certain purified individual phenylpropanoid acids and/or benzoxazinoid glycosides, but none of the purified individual phenylpropanoid acids and/or benzoxazinoid glycosides showed inhibition against MT2 receptor binding, indicating the MT2 binding activity might be contribute to other naturally occurred phenylpropanoid acids and/or benzoxazinoid glycosides in the extract but not isolated/ identified/characterized. Instant specification (See Example 7) disclosed effect of composition comprising enriched extract for one or more phenylpropanoid acids and benzoxazinoids (UP 165, Lot # Lot #FP041019-01) on MT1 and MT2 and indicated that there were components/enriched for one or more phenylpropanoid acids and benzoxazinoids other than 6-MBOA that competitively bound to the MT1 or MT2 receptor (See [0128]- [0129]). However, the active phenylpropanoid acids and/or benzoxazinoid glycosides are not identified/defined by instant specification although phenylpropanoid acids and benzoxazinoid glycosides are disclosed as in a ratio of 2:1 or 1: 2 based on proton NMR analysis. It’s not clear which phenylpropanoid acids and benzoxazinoid glycosides contribute to the efficacy of inhibiting MT2 receptor. An ordinary skilled in the art would not know which enriched phenylpropanoid acids and/or benzoxazinoid glycosides components are the active ingredients for the intended function as recited in claims 16-17 and 19. For example, dependent claim 16 recites “wherein one or more phenylpropanoid acids and one or more benzoxazinoids in the composition selectively binds to MT2 over MT1 receptor”. It’s not clear which one or more phenylpropanoid acids or which one or more benzoxazinoids selectively binds to MT2 over MT1 receptor.
Instant specification does not identify/disclose specific combination comprising specific one or more phenylpropanoid acids and benzoxazinoid glycosides and it’s not clear which one or more phenylpropanoid acid and/or benzoxazinoid species, and combination thereof are enriched for with the ratio of 2:1 or 1: 2 . An ordinary skilled in the art would not know which one or more specific phenylpropanoid acid(s) and/or benzoxazinoid glycoside(s) with the ratio of 2:1 or 1: 2 exhibit the binding activity to MT2 receptor. As such, at the time the application was filed, the instant specification does not provide a sufficient written description for the enriched one or more phenylpropanoid acids and/or benzoxazinoid glycosides wherein the ratio of the one or more phenylpropanoid acids to the one or more benzoxazinoid glycosides in the enriched extract is 1:2 or 2:1.
Applicant is reminded that MPEP 2161 II makes clear that “ The written description requirement is separate and distinct from the enablement requirement”.
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 4, 7-9, 11, 14-17, 19, 20, 22 and 25-27 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 (newly applied or newly reapplied necessitated by amendment).
New independent claim 25 recites: “a composition comprising an enriched extract, wherein the enriched extract is enriched for one or more phenylpropanoid acids and the enriched extract is further enriched for one or more benzoxazinoid glycosides, wherein the ratio of the one or more phenylpropanoid acids to the one or more benzoxazinoid glycosides in the enriched extract is 1:2 or 2:1”. Instant claims are directed to composition comprising variety of phenylpropanoid acids and benzoxazinoids within the extract that have different chemical structure, different physical property and different biological activity, etc. However, the active phenylpropanoid acids and/or benzoxazinoid glycosides are not identified/defined in instant claims or disclosed by instant specification. It’s not clear which specific phenylpropanoid acid and/or benzoxazinoid species are enriched for. The ratio between components within the natural extract vary in different batches and different fractions of extract. It’s not clear the ratio is weight ratio or molar ratio. It’s not clear “the ratio of 1: 2 or 2:1” is between which specific phenylpropanoid acid and benzoxazinoid species. Or is the ratio between one, or two, or three phenylpropanoid acids and one or two benzoxazinoid glycosides? An ordinary skilled in the art would not know the scope of phenylpropanoid acids and/or benzoxazinoid glycosides as recited in claim 25. The lack of clarity renders the claims indefinite since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
Claim 4, 7-9, 11, 14-17, 19, 20, 22 and 26-27 are rejected due to their dependency on claim 25.
New claims 26 and 27 depend on claim 25 and recite “the MT2 receptor binding inhibition IC50”. There is no recitation of MT2 receptor in claim 25. There is insufficient antecedent basis for this limitation “MT2 receptor”. Further, it’s not clear which specific phenylpropanoid acid and/or benzoxazinoid species or combination thereof within the extract contribute to the MT2 binding inhibition. The MT2 binding inhibition could be the result of two phenylpropanoid acids binding to MT2 receptor and one benzoxazinoid binding to MT1 receptor, or three different phenylpropanoid acids binding to MT2 receptor? The lack of clarity renders the claims indefinite since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
Claim 11 recites “wherein the one or more phenylpropanoid acids and one or more benzoxazinoids in the extract are enriched by solvent precipitation, neutralization, solvent partition, ultrafiltration, enzyme digestion, column chromatograph with silica gel, XAD, HP20, LH20,C-18, alumina oxide, polyamide, ion exchange and CG161 resins”. Instantly claimed variety of phenylpropanoid acids and benzoxazinoids in the extract have different chemical structure, different physical property(e.g. solubility, affinity to enzyme, silica gel, column chromatograph, etc.) and might not be separated/enriched by different process. It’s not clear which phenylpropanoid acids and/or benzoxazinoids are enriched by what process.
Claim 15 is amended to depend on new claim 25 and recites “wherein the route of the administration is selected from the group consisting of oral, topical, suppository, intravenous, intradermic, intragastric, intramuscular, intraperitoneal, or intravenous”. New claim 25 does not recite administering the composition, thus there is insufficient antecedent basis for limitation “the administration”.
Claim 16 recites “wherein the one or more phenylpropanoid acids and one or more benzoxazinoids in the extract selectively binds to MT2 receptor over MT1 receptor”. Instant claims are directed to variety of phenylpropanoid acids and benzoxazinoids within the extract that have different chemical structure, different physical property and different biological activity, etc. It’s not clear which specific phenylpropanoid acid and/or benzoxazinoid species within the extract selectively binds to MT2 over MT1 receptor. The selective MT2 binding could be the result of two phenylpropanoid acid binding to MT2 receptor and one benzoxazinoid binding to MT1 receptor, or three phenylpropanoid acids binding to MT2 receptor and no phenylpropanoid acids/benzoxazinoid binding to MT1 receptor. The lack of clarity renders the claims indefinite since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
Claim 17 recites “wherein the one or more phenylpropanoid acids and one or more benzoxazinoids in the extract improves overall mental well-being measured by the Pittsburgh Sleep Quality Index (PSQI) and Profile of Mood States (POMS), provides positive mood support and enhances emotional well-being; maintains homeostasis of biomarkers - serotonin, melatonin, or GABA in formulation in a mammal”. The phrase " improves overall mental well-being... provides positive mood support and enhances emotional well-being " is vague and renders the claim indefinite. As stated in MPEP 2173.05: “Notwithstanding the permissible instances, the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear”.
Claim 19 recites “wherein the one or more phenylpropanoid acids and one or more benzoxazinoids in the extract maintains homeostasis of cortisol that leads to improved symptoms of chronically high cortisol” The phrase "improved" is vague and renders the claim indefinite because it is unclear what symptoms of chronically high cortisol are improved to what extent. As stated in MPEP 2173.05: “Notwithstanding the permissible instances, the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971).
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 4, 16-17, 19, 22, 25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
As disclosed in instant specification (page 13, line 4), instant composition enriched for one or more phenylpropanoid acids and benzoxazinoids is referred to as UP165. The claims recite a composition comprising an extract (e.g. from corn leaf or corn shoot), wherein the extract is enriched for one or more phenylpropanoid acids and one or more benzoxazinoids wherein the ratio of the one or more phenylpropanoid acids to the one or more benzoxazinoid glycosides in the enriched extract is 1:2 or 2:1. This judicial exception is not integrated into a practical application because intended use is not sufficient to integrate the judicial exception into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
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 are directed to extract from Zea mays(corn) leaf (or shoots). Zea mays(corn) 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. 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. 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/enriching is still a mixture of ingredients which are naturally-found in the plant material; i.e., the compound is not inventive or “man-made”.
Instant specification does not disclose any characteristic structural difference of instantly claimed phenylpropanoid acids and benzoxazinoids from the naturally occurred phenylpropanoid acids and benzoxazinoids. There is no indication that enriched extract made with instantly claimed process changes the structure, function, or other properties of the extract in any marked way in comparison with the closest naturally occurring counterpart. Instantly claimed enriched extract is only a mixture of the naturally occurring compounds found in the nature. The closest naturally occurring counterpart of the claimed extract is a mixture of the naturally occurring compounds that are present in the extract. Thus, the claimed extract as a whole does not display markedly different characteristics in comparison with the naturally occurring counterpart. 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 improving overall mental well-being in a mammal. 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 moves 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 instant case, the additional element in claims 16-17 and 19 are administrating natural extract for the intended use. 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. Administrating/mixing extract composition does not amount to significantly more than a combination of judicial exception because administering natural extract is well-understood, routine, and conventional in the field of treating sleep disorder with natural plant extract (See e.g. Guadagna et al, Evidence-Based Complementary and Alternative Medicine, Volume 2020, Article ID 3792390, 9 pages, https://doi.org/10.1155/2020/3792390, “Plant Extracts for Sleep Disturbances: A Systematic Review”). Further, applicant’s intended use is not considered to amount to significantly more than the judicial exception. 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.
As elaborated above, the additional elements are not considered to amount to significantly more than the judicial exception. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
Response to Argument
Applicant argues “even assuming that Step 2A is met, the claim does meet the test for Step 2B: "Does the claim recite additional elements that amount to significantly more than the judicial exception?" The Examiner must consider whether the enriched for combination has markedly different characteristics from any naturally occurring non-enriched for counterparts in their natural state. Where the combination itself does not exist in nature, the USPTO considers the combination a product of nature and compares the combination to the individual naturally occurring components...combination exhibited activity not seen in the individual components. (emphasis added)” (Remarks, page 8).
RESPONSE: Applicant’s argument is fully considered but NOT persuasive. Please note both phenylpropanoid acids and benzoxazinoid glycosides in general co-exist in the naturally Zea mays plant as taught by Rosenfeld. As such, instantly claimed extract comprising enriched phenylpropanoid acids and benzoxazinoid glycosides as an natural combination exist in the nature though the ratio might be different. More importantly, instant specification does not identify/disclose specific combination comprising one or more specific phenylpropanoid acids and benzoxazinoid glycosides and it’s not clear which specific phenylpropanoid acid(s) and/or benzoxazinoid glycoside(s) exhibit the binding activity to MT2 receptor or MT1 receptor. Instant specification (See Example 6) disclosed none of the purified individual phenylpropanoid acids and/or benzoxazinoid glycosides showed inhibition against MT2 receptor binding, indicating the MT2 binding activity might be contributed by other naturally occurred phenylpropanoid acids and/or benzoxazinoid glycosides in the extract but not identified/isolated/characterized. Instantly claimed activity exhibited by natural extract comprising phenylpropanoid acids and/or benzoxazinoid glycosides is not considered as synergistic artificially constructed combination since the active individual components of phenylpropanoid acids and/or benzoxazinoid glycosides are not fully identified/characterized/disclosed by instant specification.
Applicant argues “Examples 6-20, enriched extracts are compared with their conventional counterparts and shown to have synergistic results... These compounds are not the same as the ones found in nature and were experimentally derived. Once they were produced and evaluated, they were found to be more effective than the natural extracts alone. This active enriching of the extracts shows that it is in the category of a judicial exception. These are not "naturally occurring" but instead are modified so that they are enriched for one or more active constituents. This is an active modification made to a plant extract. This is not something found or done in nature, nor is it contemplated to be that (Remarks, page 10).
RESPONSE: Applicant’s argument is fully considered but NOT persuasive. It’s noted instant Examples 6-20 do not disclose individual active conventional counterparts from the Zea mays extract as Applicant argues. Instant Examples 4 and 5 disclosed composition profile of Zea mays extract focusing on 6-MBOA without disclosing content /amount of other phenylpropanoid acids and/or benzoxazinoid glycosides. There is no unexpected advantage over non-disclosed individual conventional counterparts. Applicant’s argument “ they were found to be more effective than the natural extracts alone” is NOT supported by instant specification and contradictory to instant Example 6 wherein none of the purified individual phenylpropanoid acids and/or benzoxazinoid glycosides showed inhibition against MT2 receptor binding.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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 4, 7-9, 11, 14-17, 19, 20, 22 and 25 are rejected under 35 U.S.C. 102(a)(1) and (a) (2) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Rosenfeld et. al. (US 6,667,308)(newly reapplied as necessitated by amendment).
Claim interpretation: Phenylpropanoids is also known as cinnamic acids. Instant specification (page 20) disclosed corn shoot or immature corn leaf extract is enriched for one or more phenolic acids, particularly phenylpropanoid acids, including one or combination of more but not limited to cinnamic acid, coumaric acid, ferulic acid, phloretic acid, as contemplated herein.
Regarding enriched phenylpropanoid acids and phenylpropanoid, Rosenfeld teaches composition comprising family of phenolic compounds including phenylpropanoid (e. g. 4-hydroxy cinnamic acid and 4-hydroxy-3-methoxy cinnamic acid) and benzoxazinoids (e.g. 6-MBOA) (see generalized chemical structures in Fig 1. Fig. 2; Col. 4, claims 1, 2), are obtained from plants in their early growth stages (e.g. immature leaves of Zea mays, corn plants) (See e.g. Example 4, claims 18, 22-27, 37) and processed at concentration suitable for human therapeutic use as antidepressant and mood enhancer (abstract, Col. 3, lines 26-67; Co. 5, lines 16-25, claims 1-52).
Rosenfeld teaches process of extracting/enriching immature corn leaf (no more than five weeks after planting) with solvents (e. g. water, dichloromethane), analysis of 6-MBOA and amount/concentration of phenolic compounds, for example, 6-MBOA at 10 mg/g (dry weight), cumulative total for cinnamic acids (i. e. phenylpropanoid acid) at 0.9-1.5 mg/gm (dry weight), and total phenols averaged greater than 17mg/gm (dry weight)(Example 4, Col. 9, lines 29-67, Col. 10, lines 1-5; Fig 4, claims 1-52).
Rosenfeld teaches embodiments may be ingested in the form of ground plant parts in which they naturally occur, or as a chemically synthesized compound in a pharmaceutically acceptable carrier(Col 5, lines 22-27). Rosenfeld teaches chemical composition is administered orally (in the form of tablets, capsules, suspensions, solutions and other means suitable for ingestion), or parenteral injection (in the form of subcutaneous, intramuscular, intravenous) and other administration route (Col 5, lines 28-44, claims 15, 30, 41, 52). Rosenfeld teaches a dose of 15-mg 6-methoxy-2-benzoxazolinone as effective daily amount for humans (See Col. 6, line 51 to 55). Rosenfeld also teaches composition as an admixture with other compounds to enhance absorption or to otherwise assist in achieving the desired effects (Col 5, lines 30-33).
Rosenfeld is silent about the limitation recited in claim 16-17 and 19 that are directed to intended use/function that do not necessarily make contribution to the structural change of pharmaceutical composition. The intended function of composition product (e.g. binding to MT receptor or maintains homeostasis of cortisol, etc.) are intrinsic property of active ingredients (e.g. phenylpropanoid, benzoxazinoids, 6-MBOA). 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. The composition taught by Rosenfeld are used for treating depressions/ mood disorder/sexual desire, arousal and performance in humans and would be capable of performing the intended use of improving mental well-being or other claimed use.
Rosenfeld collectively teaches Zea mays (corn) extract comprising phenolic compounds including phenylpropanoid (e. g. 4-hydroxy cinnamic acid and 4-hydroxy-3-methoxy cinnamic acid) and benzoxazinoids (e.g. 6-MBOA) content which is substantially identical to the claimed components, for treating mood disorder (e.g. anxiety, depressions, etc.), eating disorder, etc. for improving wellbeing in mammal/humans. The reference composition should be capable of performing the claimed intended use if applicant’s invention functions as claimed. Thus, instant claims are considered as anticipated by Zea mays (corn) extract taught by Rosenfeld under 35 U.S.C. §102.
In the alternative, even if instantly claimed composition comprises phenylpropanoid (e. g. 4-hydroxy cinnamic acid and 4-hydroxy-3-methoxy cinnamic acid) and benzoxazinoids in different ratio. Rosenfeld teaches Zae mays extraction comprising variety amount/concentration of phenolic compounds, for example, 6-MBOA at 10 mg/g , cumulative total for cinnamic acids (i. e. phenylpropanoid acid) at 0.9-1.5 mg/gm, and total phenols averaged greater than 17mg/gm. The weight ratio of the phenylpropanoid acids (cinnamic acids) to the benzoxazinoid (6-MBOA) is calculated to be about 1:6 to 1:7. Where 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/optimization. MPEP 2144.05.
Rosenfeld teaches 6-MBOA and other components in Zea mays (corn) extract are structurally similar and/or associated with melatonin, effective in bettering mood and as an adjunctive therapy for weight loss and substance abuse and addiction (See Col. 2 and 3). It would have been obvious to those of ordinary skilled 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 composition extract from Zae mays are different , if so, to what extent, from Zea mays (corn) extract taught by Rosenfeld. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Response to Argument
Applicant does not provide any evidence that instant claimed composition from Zae mays extract are different , if so, to what extent, from Zea mays (corn) extract comprising phenylpropanoid (e. g. 4-hydroxy cinnamic acid and 4-hydroxy-3-methoxy cinnamic acid) and benzoxazinoids taught by Rosenfeld. As such, this 102/103 rejection is newly reapplied as necessitated by amendment.
Claims 4, 7-9, 11, 14-17, 19, 20, 22 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Yimam et al. (Phcog Res 2018;10:156-60, published April 2018, “Effect of UP165, a Zea mays Leaf Extract Standardized for 6‑methoxybenzoxazolinone, as Sleep Adjunct”), evidenced by Rosenfeld et. al. (US 6,667,308) (newly reapplied as necessitated by amendment).
Claim interpretation: As disclosed in instant specification (page 13, line 4), instant composition enriched for one or more phenylpropanoid acids and benzoxazinoids is referred to as UP165. As evidenced by Rosenfeld (US 6,667,308), Zea mays extract from immature leaves comprise phenolic compounds including phenylpropanoid (e. g. 4-hydroxy cinnamic acid and 4-hydroxy-3-methoxy cinnamic acid) and benzoxazinoids (e.g. 6-MBOA, etc.).
Regarding instantly claimed extract composition, Yimam discloses UP165 (Maizinol), a Zea mays (commonly known as corn) leaf extract standardized for 6‑methoxybenzoxazolinone (6-MBOA) content, were evaluated on sleep latency and sleep time in pentobarbital‑induced mouse sleep model (Title, Abstract, Results). Yimam teaches “there are reasonable structural and biological cause and effect networks among 6‑MBOA, melatonin, and serotonin suggesting the possible application of UP165 for mood enhancement and sleep improvement” (left column, 4th paragraph, page 157)(6-MBOA content is species encompassed by benzoxazinoids recited in instant claim 8). Yimam teaches “The extract was orally administered at 250 mg/kg (low dose), 500 mg/kg (mid dose), and 1000 mg/kg (high dose) daily for 32 days” and “UP165 increased the sleep duration and incidence and could be used as an adjunct for sleep disorder”. (Abstract, Material and Methods, Summary, page 156, Figure 1, Tables 1-3, Conclusion).
Yimam explicitly teaches UP165, a brown and odorless powder, was extracted from immature corn leaf (Zea mays) with ethanol and standardized to contain at least 0.2% 6‑MBOA. UP165 was dissolved with sterile water for administration.
Regarding phenylpropanoid acid species recited in claim 7, as disclosed by instant specification, instant composition enriched for one or more phenylpropanoid acids and benzoxazinoids is referred to as UP 165 (page 13, line 4), and the extract obtained from Zea mays with ethanol/ alcohol or other suitable solvents is known to comprise instantly claimed phenylpropanoid acid species, e.g. cinnamic acid, etc. (see pages 19/20). Thus, UP 165, the immature corn leaf (Zea mays) extract with ethanol, taught by Yimam inherently contains the claimed phenylpropanoid acid and benzoxazinoids species that read on instant claimed components. Further, as evidenced by Rosenfeld (US 6,667,308), Zea mays extract from immature leaves comprise phenolic compounds including phenylpropanoid (e. g. 4-hydroxy cinnamic acid and 4-hydroxy-3-methoxy cinnamic acid) and benzoxazinoids (e.g. 6-MBOA).
Regarding the limitation and the limitations recited in claims 16-17, 19, they are construed as intended use/function which do not necessarily make contribution to the structural change of pharmaceutical composition. Yimam teaches UP 165 standardized for 6-MBOA is reported to demonstrate equivalency with S-adenosyl-methionine SAM-e in human clinical trial(See page 157, left column). Please note instant claims are directed to pharmaceutical composition comprising natural extract for intended function/use . The intended function of composition product (e.g. binding to MT receptor or maintains homeostasis of cortisol, etc.) are intrinsic property of active ingredients (e.g. phenylpropanoid, benzoxazinoids, 6-MBOA). If the prior art structure is capable of performing the intended use, then it meets the claim limitation.
Regarding claim 16, selective binding to MT receptor is property and/or direct result of composition comprising phenylpropanoid acid and benzoxazinoids. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding instant claims 17 and 19, Yimam teaches “there are reasonable structural and biological cause and effect networks among 6‑MBOA, melatonin, and serotonin suggesting the possible application of UP165 for mood enhancement and sleep improvement” (left column, 4th paragraph, page 157). The effect of UP165 (Maizinol) on increasing sleep duration and enhancing mood in the subject taught by Yimam are considered as read on maintaining homeostasis of biomarkers (melatonin, serotonin) and improving overall mental and emotional well-being in the subject.
Regarding the process limitation recited in amended claim 9 and 11 ( enriched, precipitation, etc.), instant claims are directed to composition product and construed as product-by-process claims. As stated in MPEP 2113, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01.
Yimam collectively teaches UP165 (Maizinol), a Zea mays (corn) leaf extract standardized for 6‑methoxybenzoxazolinone (6-MBOA) content along with other components from Zea mays. UP165 (Maizinol) is construed under BRI as a composition comprising one and more benzoxazinoids (e.g. 6-MBOA) and phenylpropanoid acid. UP 165 taught by Yimam 2018 is considered as made in the same way as instant claimed extract, therefore contains the same components of phenylpropanoid acids and the benzoxazinoids as instantly claimed extract. The efficacy of Up 165 in treating sleep disorder taught by Yimam 2018 in Table 2 and 3 are the same as instant Table 14 and 15, respectively. Thus, instant claims are considered as anticipated by UP165 taught by Yimam under 35 U.S.C. §102.
In the alternative, even if instantly claimed composition comprises phenylpropanoid (e. g. 4-hydroxy cinnamic acid and 4-hydroxy-3-methoxy cinnamic acid) and benzoxazinoids in different ratio, the differences between what is disclosed in prior art and what is claimed are considered to be within the meaning of 35 U.S.C. §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 composition extract from Zae mays are different , if so, to what extent, from UP165 taught by Yimam. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Claims 4, 7-9, 11, 14-17, 19, 20, 22 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Kalman et. al. (Foods. 2015, 4, 730-739, “A Prospective Randomized DoubleBlind Study Evaluating UP165 and S-Adenosyl-L-Methionine on Depression, Anxiety and Psychological Well-Being”), as evidenced by Rosenfeld et. al. (US 6,667,308) (newly reapplied as necessitated by amendment).
Claim interpretation: As disclosed in instant specification (page 13, line 4), instant composition enriched for one or more phenylpropanoid acids and benzoxazinoids is referred to as UP165. As evidenced by Rosenfeld (US 6,667,308), Zea mays extract from immature leaves comprise phenolic compounds including phenylpropanoid (e. g. 4-hydroxy cinnamic acid and 4-hydroxy-3-methoxy cinnamic acid) and benzoxazinoids (e.g. 6-MBOA).
Kalman et. al. teaches randomized double-blind study evaluating effects of UP 165 (derived from Zea mays L., commonly known as corn) on depression, anxiety and psychological well-being and indicates there may be benefit to UP 165 for mood enhancement in those with mild depression or anxiety (abstract, Experimental Section, Results). Kalman and its incorporated reference teaches UP165 contains naturally occurring substance 6-methoxybenzoxazolinone (6-MBOA) which has structural resemblance to melatonin and further teaches that structural and biological similarities between 6-MBOA and melatonin might be the mechanism that 6-MBOA demonstrate mood enhancing properties in relieving symptoms of depression and anxiety and enhancing psychological well-being(last paragraph, page 131) : 6-MBOA stimulates melatonin biosynthesis. 6-MBOA appears to act as a weak β-adrenergic agonist and seems to have affinity for melatonin receptors. It is also well established that serotonin is a precursor of melatonin
6-MBOA content is species encompassed by benzoxazinoids recited in instant claim 8.
Kalman teaches subjects were randomized to receive a dietary supplement of either UP165 (derived from Zea mays L.) 250 mg/day or SAMe 400 mg/day with mean body weight of 67 kg(second paragraph, page 132, Table 1)(which reads on instant claim 20).
Regarding the specific phenylpropanoid acid species recited in claim 7, as disclosed by instant specification, a composition enriched for one or more phenylpropanoid acids and benzoxazinoids is referred to as UP 165 (page 13, line 4), and the extract obtained from Zea mays with ethanol/ alcohol or other suitable solvents is known to comprise instantly claimed phenylpropanoid acid species, e.g. cinnamic acid, etc. (see pages 19/20). Thus, UP 165, the immature corn leaf (Zea mays) extract with ethanol, taught by Kalman inherently contains the claimed phenylpropanoid acid and benzoxazinoids species that read on instant claimed components. Further, as evidenced by Rosenfeld (US 6,667,308), Zea mays extract from immature leaves comprise phenolic compounds including phenylpropanoid (e. g. 4-hydroxy cinnamic acid and 4-hydroxy-3-methoxy cinnamic acid) and benzoxazinoids (e.g. 6-MBOA).
Regarding the limitation and the limitations recited in claims 16-17, 19, they are construed as intended use/function which do not necessarily make contribution to the structural change of pharmaceutical composition. Please note instant claims are directed to pharmaceutical composition comprising natural extract for intended function/use . The intended function of composition product (e.g. binding to MT receptor or maintains homeostasis of cortisol, etc.) are intrinsic property of active ingredients (e.g. phenylpropanoid, benzoxazinoids, 6-MBOA). If the prior art structure is capable of performing the intended use, then it meets the claim limitation.
Regarding claim 16, selective binding to MT receptor is property and/or direct result of composition comprising phenylpropanoid acid and benzoxazinoids. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding instant claims 17 and 19, the effect of UP165 on depression, anxiety and enhancing psychological well-being in the subject taught by Kalman are considered as read on improving overall mental and emotional well-being associated with maintaining homeostasis of biomarkers (melatonin, serotonin) in the subject.
Regarding the process limitation recited in amended claim 9 and 11, instant claims are directed to composition product and construed as product-by-process claims. As stated in MPEP 2113, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01.
Kalman collectively teaches UP165, a Zea mays (corn) leaf extract standardized for 6‑methoxybenzoxazolinone (6-MBOA) content along with other components from Zea mays. UP165 is construed under BRI as a composition comprising one and more benzoxazinoids (e.g. 6-MBOA), phenylpropanoid acid and further comprises other components from Zea mays extract. Thus, instant claims are considered as anticipated by UP165 taught by Kalman under 35 U.S.C. §102.
In the alternative, even if instantly claimed composition comprises phenylpropanoid (e. g. 4-hydroxy cinnamic acid and 4-hydroxy-3-methoxy cinnamic acid) and benzoxazinoids in different ratio, Kalman teach that UP165 is known to have structural similarity to melatonin which is known biomarker associated with mood (anxiety, depression, etc. ). The differences between what is disclosed in prior art and what is claimed are considered to be slight within the meaning of 35 U.S.C. §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 Office is not equipped to conduct experimentation in order to determine whether Applicant’s claimed composition extract from Zae mays are different , if so, to what extent, from UP165 taught by Kalman. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
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 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 non-obviousness.
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 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 4, 7-9, 11, 14-17, 19, 20, 22 and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Yimam et al. (Phcog Res 2018;10:156-60, “Effect of UP165, a Zea mays Leaf Extract Standardized for 6‑methoxybenzoxazolinone, as Sleep Adjunct”), in view of Rosenfeld et al. (US 6,667,308) (newly reapplied as necessitated by amendment).
The collective teachings of Yimam and Rosenfeld are elaborated in preceding 35 U.S.C. 102/103 rejection and applied as before. Yimam collectively teaches UP165 (Maizinol), a Zea mays (corn) leaf extract standardized/enriched for 6‑methoxybenzoxazolinone (6-MBOA) content along with other components from Zea mays for mood enhancement and sleep improvement . UP165 taught by Yimam is construed under BRI as a composition comprising one and more benzoxazinoids (e.g. 6-MBOA), phenylpropanoid acid and other components from Zea mays extract that read on instantly claimed composition.
Yimam is silent about phenylpropanoid acids and the ratio of the phenylpropanoid acids to the benzoxazinoids recited in new claim 25 and MT receptor inhibition as recited in new claims 26-27. Rosenfeld teaches Zae mays extraction comprising variety amount/concentration of phenolic compounds, for example, 6-MBOA at 10 mg/g , cumulative total for cinnamic acids (i. e. phenylpropanoid acid) at 0.9-1.5 mg/gm, and total phenols averaged greater than 17mg/gm. The weight ratio of the phenylpropanoid acids (cinnamic acids) to the benzoxazinoid (6-MBOA) is calculated to be about 1:6 to 1:7. Where 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/optimization. MPEP 2144.05.
It would have been prima facie obvious to one of the ordinary skill in the art before the effective filing date of instant invention to combine the teachings of composition of Zea mays (corn) extract comprising enriched phenylpropanoid acids and benzoxazinoids taught by Yimam and Rosenfeld for treating disease/disorder associated with melatonin. The skilled artisan would be motivated to combine the teachings of Yimam, Rosenfeld because both teachings are directed to composition of natural extract from Zea mays comprising 6-MBOA which is analog of melatonin. As for the MT receptor inhibition activity, a composition and its properties are inseparable. "Products of identical chemical composition cannot have mutually exclusive properties.". UP165 taught by Yimam is construed under BRI as a composition comprising one and more benzoxazinoids (e.g. 6-MBOA), phenylpropanoid acid and other components from Zea mays extract that read on instantly claimed composition. As such, UP165 taught by Yimam with further optimization is considered as capable of achieve instant claimed MT receptor inhibition in absence of evidence to the contrary.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the teachings of prior art, together with general knowledge of natural product. Therefore, the invention as a whole is 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.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/L.M./Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628