DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restriction
Applicant’s election without traverse of claim(s) 1-5 in the reply filed May 22, 2026 is acknowledged. Claim(s) 6-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim(s) 1-5 are examined on the merits.
Information Disclosure Statement (IDS)
The information disclosure statement (IDS) submitted on June 18, 2024 are being considered by the examiner. The signed IDS forms are attached with the instant office action.
Claim Objections
Claim(s) 2-3 are objected to because of the following informalities:
In claim 2, “C27H28O14” should read “C27H28O14”
In claim 3, “concentration 2.5 – 3.5” should read “concentration of 2.5 – 3.5”
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.
Claim(s) 1-5 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 “natural potassium” means. Moreover, it is unclear what range or limit encompasses “total polyphenols”. The specification does not further explain the terms above. Thus, the metes and bounds of the claim are unclear.
Claim 3 is indefinite because it is unclear what range or limit encompasses “total flavonoid content” and it is unclear what “total flavonoid content as Rutin” means; it is unclear if the “total flavonoid content” can only be Rutin. The specification does not resolve this issue; thus, the metes and bounds of the claim are unclear.
Claim 4 is indefinite because it is unclear what limit encompasses “total polysaccharides”. The specification does not resolve this issue. Thus, the metes and bounds of the claim are unclear.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 states that “the composition as claimed in claim 1, wherein the molecular formula of Maysin is C27H28O14, and the molecular weight of the Maysin is 576.” Claim 2, which is dependent on claim 1 is not further limiting because Maysin is a known and naturally occurring compound within a corn silk extract that would inherently possess the respective molecular formula and weight that is stated within claim 2.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1-5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. A composition comprising sweet corn silk (e.g. Stigma maydis) extract of claim(s) 1-5 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 claim 1 is drawn to a composition
that comprises a sweet corn silk extract (e.g. Stigma maydis). Sweet corn silk (Stigma maydis) 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. 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 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. In addition, the closest
naturally occurring counterpart for each ingredient is the ingredient itself. There is no indication
that the extract of sweet corn silk (Stigma maydis) as claimed changes the structure, function, or other properties of the components in any marked way in comparison with the closest naturally occurring counterpart. Thus, the claims are drawn directly to a product of nature. Thus, the claims are drawn directly to a product of nature. 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 as a medicine. 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 ingredient to be incorporated in the form of a medicinal composition. 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. Thus, mixing the ingredients together 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 a medicine 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 § 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) 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Liu (CN 101254011 A – English translation provided) in view of Hasanudin et al (Molecules, (Year: 2012), vol. 17, issue. 08, pp. 9697-9715).
Liu teaches a corn silk drink that comprises corn silk extract (abstract). Liu teaches that corn silk [is seen as a] safe and non-toxic substance and [that the] corn silk extract prepared [as a] medicine (page 2). Liu teaches 2 grams of vitamin C (page 3). Liu teaches that the polysaccharide content within the corn silk drink is 0.5 to 1.2 mg/ml (page 3).
Liu does not teach that the composition of a sweet corn silk extract for medicinal use that comprises: characterized in that: 0.25-0.50 percent weight of Maysin; 2.0-3.0 percent weight of natural potassium; 7.5-9.0 percent weight of total polyphenols; and 1.0-2.0 percent weight of vitamin C (as stated within claim 1 of the present invention). Liu does not teach the molecular formula of Maysin is C27H28O14, and the molecular weight of the Maysin is 576 (as stated within claim 2 of the present invention). Liu does not teach that the composition in claim 1 comprises total flavonoid content as Rutin, wherein the total flavonoid content as Rutin comprises a concentration 2.5-3.5 percent weight (as stated within claim 3 of the present invention). Liu does not teach the composition from claim 1 comprises 25-30 percent weight of total polysaccharides (as stated within claim 4 of the present invention). Liu does not teach that the composition stated within claim 1 comprises 2 to 5 percent weight of moisture content (as stated within claim 5 of the present invention).
Hasanudin et al teaches the presence of Rutin [(i.e. a flavonoid)] [within a corn silk (CS) extract] (pg. 9699). Hasanudin et al teaches [the presence of] potassium [within a CS extract] (pg. 9701). Hasanudin et al taches [the presence of] polyphenol [content within CS extract] (pg. 9702). Hasanudin et al teaches [multiple] Maysin [derivatives that can be found within the CS extract and also teaches that Maysin is found within a CS methanol extract] (figure 1, pp. 9699-9700).
The corn silk drink that contains the extract of corn silk, polysaccharides and vitamin C as taught by Liu can be modified to include additional information that the CS extract also possess Maysin compounds, flavonoid compounds such as Rutin, polyphenols and potassium all taught by Hasanudin et al. One of ordinary skill in the art and in general chemistry knows that the molecular formula of Maysin is C27H28O14 in which, after proper calculation, would result in a molecular weight of 576 grams of the Maysin molecule. In addition, one would reasonably expect to use Liu’s medicinal drink combined with additional teachings from Hasanudin et al that teaches that specific components and compounds are naturally occurring within sweet corn silk extract in order to create the optimal drink that contains a number of nutrients and sufficient moisture content in order to serve as a medicinal product for consumption.
Regarding claim(s) 1 and 3-5, the combined aforementioned references does not teach all of the percent weights in the amounts claimed by the applicant for each of the components or compounds listed across claim(s) 1 and 3-5. 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 references teach the use of each of the ingredients in a composition. Varying the concentration of ingredients within a composition 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 ingredients 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. One would reasonably expect to optimize the components and compounds needed within that of a sweet corn silk extract that would have a negligible amount of moisture that would lead to the ideal medicinal composition for use.
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
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