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/Restrictions
Applicant's election with traverse of Group II (claims 20, 21, 23, and 24, drawn to a composition for containing a hydrolysate of Scutellaria roots) in the reply filed on February 26th, 2026 is acknowledged. The traversal is on the grounds that no lack of unity was raised in the written opinion of the ISA (understood as International Search Authority), and because claim 20 is directed to a hydrolysate of the roots of the genus Scutellaria enriched and standardized in wogonin and baicalein. This is not found persuasive because lack of unity as determined by the USPTO is independent of the decision made by the ISA, and it is not clear from the applicant's response that the hydrolysate of the cited reference does not contain wogonin and baicalein in concentrations that would render it functionally distinct from the composition of instant claim 20. Claim 25 was amended by the applicant to depend on claim 20, and further modify the composition recited in claim 20. Claims 1-14, 26, and 27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s election without traverse of ‘Scutellaria baicalensis’ and ‘1,3-propanediol’ in the reply filed on 02/19/2025 is acknowledged. Election was made without traverse in the reply filed on 02/26/2025. Non-elected species are withdrawn.
The applicant has introduced new claims 28-39, of which 28-37 explicitly depend on claim 20, and further modifying the composition recited in claim 20.
Claims 20, 21, 23-25, and 28-39 are pending and were examined on the merits.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The priority date is March 4th, 2020.
Information Disclosure Statement
The IDSs filed 08/31/2022 and 01/16/2024 are acknowledged and presently considered.
Claim Interpretation and Examiner Notes
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
Claim 20 is representative of the pending claim scope, and the applicable claim interpretation is set forth below.
Claim 20 is drawn to a composition comprising a hydrolysate of Scutellaria roots that are enriched and standardized in wogonin and baicalein.
“Comprising” is an open-ended transitional term (see, e.g., MPEP § 2111.03(I)), wherein additional steps or components are not excluded. However, “‘[c]omprising’ is a term of art used in claim language which means that the named elements are essential” (see, e.g., Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997)).
Additional claim interpretations are set forth below.
Specification
The use of the terms R&D Systems, SAFAS, Xenius, and EXOCET, each of which is a trade name or a mark used in commerce, has been noted in this application. Each term should be accompanied by the generic terminology; furthermore, each term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because of the following informalities: the applicant appears to use the abbreviation "SBI" without previously reciting the full terminology for the abbreviation, implied as Systems Biosciences based on the context (page 20, line 16).
Appropriate correction is required.
Claim Objections
Claim 23 is objected to because of the following informalities: the applicant uses the term "adjuvant" without reciting examples. The term "adjuvant" has different meanings in different disciplines. Therefore, for clarity, claim 23 should recite examples of adjuvants with support from the instant specification. 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 20 is 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 substrate of hydrolysis is unclear. Although claim 20 recites performing an enzymatic hydrolysis of a dispersion, it is unclear what chemical compounds or class of chemical compounds is hydrolyzed. The meaning of the term “dry” in claim 20, step (v) is unclear. It is unclear if the dry extract contains a dihydric alcohol solvent, if there is a drying step not explicitly stated, and what materials and/or phases of matter are excluded from the extract rendering it “dry”.
Claims 38 and 39 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. Claims 38 and 39 recite the limitation "The hydrolysate of claim 38" in line 1 of each claim. There is insufficient antecedent basis for this limitation in the claims.
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 20, 21, 23, 24, and 28-37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claims recite a hydrolysate of roots of the genus Scutellaria enriched and standardized in wogonin and baicalein. This judicial exception is not integrated into a practical application because it is not clear that there are characteristic markedly differentiating the instantly claimed composition is different from that of the natural source materials of the composition. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the hydrolysate, as claimed, is not distinguishable from a composition of natural metabolites from the roots of the genus Scutellaria.
The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since claims 20, 21, 23, 24, and 28-37 are directed to a composition, the claims are directed to a composition.
Effective January 7, 2019, subject matter eligibility determinations under 35 U.S.C. § 101 follow
the procedure explained in the Federal Register notice titled 2019 Revised Patent Subject Matter
Eligibility Guidance (Federal Register, Vol. 84, No.4, 50-57), which is found at:
https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf. Applicants are kindly asked
to review this guidance as well as MPEP 2106.
The statutory categories of invention under 35 U.S.C. 101 are processes, machines,
manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject
matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The
Office released guidance on December 16, 2014 for the examination of claims reciting natural products
under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular
Pathology v. Myriad Genetics, Inc. (569 U.S. ___, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013)) and
Mayo Collaborative Services v. Prometheus Laboratories (566 U.S. ___, 132 S. Ct. 1289, 101 USPQ2d
1961 (2012)), Diamond v. Chakrabarty, 447 U.S. 303 (1980)) and Funk Brothers Seed Co. v. Kalo Inoculant Co. - 333 U.S. 127 (1948)). (inter alia). See eg. MPEP 2106.04(b)
The Supreme Court has explained that the judicial exceptions reflect the Court’s view
that abstract ideas, laws of nature, and natural phenomena are "the basic tools of scientific and
technological work", and are thus excluded from patentability because "monopolization of those
tools through the grant of a patent might tend to impede innovation more than it would tend to
promote it." Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980 (quoting Myriad, 133 S. Ct. at
2116, 106 USPQ2d at 1978 and Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S.
66, 71, 101 USPQ2d 1961, 1965 (2012)). The Supreme Court’s concern that drives this
"exclusionary principle" is pre-emption. Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980.
The Court has held that a claim may not preempt abstract ideas, laws of nature, or natural
phenomena; i.e., one may not patent every "substantial practical application" of an abstract
idea, law of nature, or natural phenomenon, even if the judicial exception is narrow.
While preemption is the concern underlying the judicial exceptions, it is not a standalone
test for determining eligibility. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119
USPQ2d 1370, 1376 (Fed. Cir. 2016). Instead, questions of preemption are inherent in and
resolved by the two-part framework from Alice Corp. and Mayo (the Alice/Mayo test referred to
by the Office as Steps 2A and 2B). It is necessary to evaluate eligibility using the Alice/Mayo
test, because while a preemptive claim may be ineligible, the absence of complete preemption
does not demonstrate that a claim is eligible.
Products of Nature: When a law of nature or natural phenomenon is claimed as a
physical product, the courts have often referred to the exception as a "product of nature".
Products of nature are considered to be an exception because they tie up the use of naturally
occurring things, but they have been labeled as both laws of nature and natural phenomena.
See Myriad 133 S. Ct. at 2116-17, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature
exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281
(1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and
"phenomena of nature"). Step 2A of the Office’s eligibility analysis uses the terms "law of
nature" and "natural phenomenon" as inclusive of "products of nature".
It is important to keep in mind that product of nature exceptions include both naturally
occurring products and non-naturally occurring products that lack markedly different
characteristics from any naturally occurring counterpart. Instead, the key to the eligibility of all
non-naturally occurring products is whether they possess markedly different characteristics from
its closest naturally occurring counterpart.
When a claim recites a nature-based product limitation, examiners 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. Nature-based products, as used herein,
include both eligible and ineligible products and merely refer to the types of products subject to
the markedly different characteristics analysis used to identify product of nature exceptions.
The Markedly Different Characteristics Analysis
The markedly different characteristics analysis is part of Step 2A, because the courts use this
analysis to identify product of nature exceptions. If the claim includes a nature-based product
that has markedly different characteristics, then the claim does not recite a product of nature
exception and is eligible. If the claim includes a nature-based product that does not exhibit
markedly different characteristics from its closest naturally occurring counterpart in its natural
state, then the claim is directed to a "product of nature" exception (Step 2A: YES), and requires
further analysis in Step 2B to determine whether any additional elements in the claim add
significantly more to the exception.
Nature-based Product Claim Analysis
Where the claim is to a nature-based product by itself, the markedly different
characteristics analysis should be applied to the entire product. Where the claim is to a nature-
based product produced by combining multiple components, the markedly different
characteristics analysis should be applied to the resultant nature-based combination, rather than
its component parts. Where the claim is to a nature-based product in combination with non-
nature based elements, the markedly different characteristics analysis should be applied only to
the nature-based product limitation. For a product-by-process claims, the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its
naturally occurring counterpart.
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, and are evaluated based
on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-
based product limitation does not exhibit markedly different characteristics, then that limitation is
a product of nature exception. If the analysis indicates that a nature-based product limitation
does have markedly different characteristics, then that limitation is not a product of nature
exception. Because the markedly different characteristics analysis compares the nature-based
product limitation to its naturally occurring counterpart in its natural state, the first step in the
analysis is to select the appropriate counterpart(s) to the nature-based product. When there are
multiple counterparts to the nature-based product, the comparison should be made to the
closest naturally occurring counterpart. When the nature-based product is a combination
produced from multiple components, the closest counterpart may be the individual nature-based
components of the combination. Because there is no counterpart mixture in nature, the closest
counterparts to the claimed mixture are the individual components of the mixture, i.e., each
naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281
(comparing claimed mixture of bacterial species to each species as it occurs in nature).
Markedly changed characteristics can include structural, functional, chemical changes.
In order to show a marked difference, a characteristic must be changed as compared to nature,
and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an
incidental change in a characteristic of the naturally occurring counterpart. Myriad, 133 S. Ct. at
2111, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, applicant must have
caused the claimed product to possess at least one characteristic that is different from that of
the counterpart. If there is no change in any characteristic, the claimed product lacks markedly
different characteristics, and is a product of nature exception.
Step 1: Determine if the claims are directed to one of the four statutory categories of patentable
subject matter identified by 35 U.S.C. 101: a process, machine, manufacture or composition of matter.
YES, the claims are directed to a composition of matter, which is a statutory category within at least one of the four categories of patent eligible subject matter.
Step 2A: PRONG ONE: Evaluate whether the claim recites a Judicial Exception (e.g., law of nature, natural phenomenon, or an abstract idea; see MPEP 2106.04). YES, the claims are product claims reciting something that appears to be a nature-based product (i.e., a hydrolysate of roots of the Scutellaria genus prepared using endogenous enzymes) which is not markedly different from the closest naturally-occurring counterpart (i.e., the individual nature-based products comprising the composition).
Because the claim states the nature-based products which are plant extracts the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claim recites the naturally occurring components wogonin and baicalein found within the roots of the genus Scutellaria (instant claim 20). This equates to a plant extract. The process of creating a plant extract is by partitioning the starting plant material into separate compositions based upon some property. The closest naturally occurring counterparts of extracted components are those same components when found existing in the plant in an unseparated form, even when purified and/or concentrated because they are chemically identical to the extracted compounds/components. All of these are naturally occurring in nature and are not markedly different from its naturally occurring counterpart in its natural state. The properties of the nature-based product as claimed are not markedly different than the properties of these naturally occurring counterparts found in nature as these activities would inherently be found in the plant they come from. The components which would give the activities claimed in the instant invention would inherently do the same in nature as there has been nothing done in the instant invention that would make them act in any different way.
Step 2A: prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a)
identifying whether there are any additional recited elements in the claim beyond the judicial exception
and (b) evaluating those additional elements individually and in combination to determine whether the
claim as a whole integrates the exception into a practical application.
This judicial exception is not integrated into a practical application because the plant extract
composition is only comprising the nature-based components. The claims do not integrate the judicial
exceptions into a practical application because in this context, such integration for a claimed product
would be a physical form of the specific practical application instead of a more general composition that
is not so limited.
The claims do not include additional elements that are sufficient to amount to significantly more
than the judicial exception because these components and their activity are already found naturally
occurring in nature and the addition of an intended use does not impart any added benefit to the
compounds or integrate the composition into a practical application.
Step 2B evaluates whether the claim as a whole, amounts to significantly more than the recited
exception, i.e., whether any additional element, or combination of additional elements, adds an
inventive concept to the claim (see MPEP § 2106.05(b)).
The claims as a whole do not amount to more than the recited exceptions because there aren’t
any other additional elements to consider, which does not add an inventive concept to the claims. Thus,
the claims are not eligible subject matter under current 35 U.S.C. 101 standards.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 20-21, 23-25 and 28-37 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. (Pharmaceutical Biology 2013, 51 (10), 1228-1235), and further in view of KR-2011/0104625-A (cited as Foreign Patent Document 1 on the information disclosure statement received August 31st, 2022).
The citations of Yu et al. in the rejection below refer to the attached Taylor & Francis manuscript. The page numbering in the citations below consider page 1228 of this manuscript as page 1, i.e. the page starting with the Abstract and Introduction. An additional NIH manuscript of Yu et al., with different text formatting, is attached and cited on the PTO-892 in case the watermark in the Taylor and Francis manuscript causes legibility problems.
Regarding claims 20, 21, 23-25, and 28-37 and a hydrolysate of the roots of Scutellaria baicalensis wherein the hydrolysate has a wogonin/baicalein weight ratio of at least 0.2, Yu et al. (2013) teaches a S. baicalensis derivative wherein the baicalein values are about 250-300 µmol/g and the wogonin values are about 50-65 µmol/g (see, e.g., Yu et al., p. 5-6, Figures 4-6, C and D).
Regarding claims 20, 21, 23-25, and 28-37 and a hydrolysate of the roots of Scutellaria baicalensis produced by:
activating endogenous enzymes by dispersion, under mechanical stirring and for a period of between 10 minutes and 1 hour. of said roots, in a root/water weight ratio of 0 .1 to 0.5
performing an enzymatic hydrolysis of the dispersion obtained in step (i) thermochemically, comprising:
adding a miscible organic solvent of the dihydric alcohol type in a solvent/water weight ratio of 1 to 5:
heat-treating the reaction medium obtained in step (ii/a) at a temperature of between 40 and 55°C, and for a period of between 20 hours and 50 hours
irreversibly inhibiting the enzymatic activity in the reaction medium obtained in step (ii) by heat treatment at a temperature of between 65°C and 90°C and for a period of between 1 hour and 3 hours
adjusting the pH to a value of between 3.5 and 5.5
adjusting the weight of crude hydrolysate by the addition of a solvent of the dihydric alcohol type to obtain a hydrolysate reduced to a dry extract with a content varying from 1.8 to 2.5%,
Yu et al. (2013) teaches the treatment of S. baicalensis with endogenous enzymes, shaken for 0-240 minutes in a root/water weight ratio of 0.1-0.2 (see, e.g., Yu et al.; Figure 1; p. 2, left column, lines 7-15; p. 2, right col., lines 21-30; p. 3, right col., lines 42-47). Further, Yu et al. (2013) teaches the further ethanol extraction of S. baicalensis treated with the endogenous enzymes, wherein the extract is at 25 °C for 30 minutes with 75% ethanol (see, e.g. Yu et al., p. 2, left column, lines 7-15; p. 2, right col., lines 1-4 form the bottom; p. 3 , left col., lines 1-3 from the top).
Regarding claims 20 and 28 and a hydrolysate of the roots of Scutellaria baicalensis wherein the roots are ground, pulverized, and optionally reduced to a powder, Yu et al. (2013) teaches grinding S. baicalensis roots (see, e.g. Yu et al., p. 2, left col., lines 24-26).
Regarding claims 20 and 31 and a hydrolysate of the roots of Scutellaria baicalensis wherein the wogonin/baicalein weight ratio in the hydrolysate obtained in step (v) is at most 0.4, Yu et al. (2013) teaches a S. baicalensis derivative wherein the baicalein values are about 250-300 µmol/g and the wogonin values are about 50-65 µmol/g (see, e.g., Yu et al., p. 5-6, Figures 4-6, C and D).
The primary reference differs from the pending claim scope as follows: Yu et al. (2013) fails to teach steps ii to v and the limitations of steps ii to v of the extraction methods and a composition comprising the S. baicalensis extract for cosmetic or dermatological purposes. However, these steps would have been obvious in view of the teachings of the prior art. Specifically, the art within KR’625.
Regarding claims 20, 21, 23-25, and 28-37 and a hydrolysate of the roots of Scutellaria baicalensis produced by:
performing an enzymatic hydrolysis of the dispersion obtained in step (i) thermochemically, comprising:
adding a miscible organic solvent of the dihydric alcohol type in a solvent/water weight ratio of 1 to 5:
heat-treating the reaction medium obtained in step (ii/a) at a temperature of between 40 and 55°C, and for a period of between 20 hours and 50 hours
irreversibly inhibiting the enzymatic activity in the reaction medium obtained in step (ii) by heat treatment at a temperature of between 65°C and 90°C and for a period of between 1 hour and 3 hours
adjusting the pH to a value of between 3.5 and 5.5
adjusting the weight of crude hydrolysate by the addition of a solvent of the dihydric alcohol type to obtain a hydrolysate reduced to a dry extract with a content varying from 1.8 to 2.5%,
KR’625 teaches the hydrolysis of an Scutellaria root extract with water at 40-50 °C for 4 hours (see, e.g., Trans’625, third paragraph under the heading [0006]) and homogenizing/stabilizing the dermal composition at 70-75 °C for 4 hours (see, e.g., Trans’625, fourth paragraph under the heading [0006]).
Regarding claims 20 and 23 and a hydrolysate of the roots of Scutellaria baicalensis wherein the administration is by cosmetic or dermo-cosmetic compositions, KR’625 teaches a composition comprising Scutellaria root hydrolysate extract for dermal improvement (see, e.g., Trans’625, para. [0001]; note: the term “gold” appears to be a mistranslation of Scutellaria Radix, see the text under the heading [0023]).
Regarding claims 20 and 23-24 and a composition comprising 0.05-5.0% hydrolysate of the roots of Scutellaria baicalensis, KR’625 teaches a composition comprising 5% Scutellaria root extract and 1% Scutellaria root extract (see, e.g., Trans’625, under heading [0083])
Regarding claims 20 and 25 and hydrolysate of the roots of Scutellaria baicalensis wherein the process defined in claim 20 is further limited by the following statements:
the heat treatment of step (ii/b) is carried out at a temperature of between 45 and 55°C;
the heat treatment of step (ii/b) is carried out for a period of between 20 hours and 30 hours
the heat treatment of step (iii) is carried out at a temperature of between 65 and 75 °C
the heat treatment of step (iii) is carried out for a period of between 1 hour 30 minutes and 2 hours 30 minutes
the pH is adjusted at 4.5 in step (iv)
KR’625 teaches the hydrolysis of an Scutellaria root extract with water at 40-50 °C for 4 hours (see, e.g., Trans’625, third paragraph under the heading [0006]) and homogenizing/stabilizing the dermal composition at 70-75 °C for 4 hours (see, e.g., Trans’625, fourth paragraph under the heading [0006]).
Regarding claims 20 and 37, a hydrolysate of the roots of Scutellaria baicalensis wherein the solvent used for step ii(a) in the extraction process is 1,3-propanediol, it is within the knowledge of one of skill in the art that 1,3-propanediol and ethanol, recited by Yu et al. (of record above), are both amphiphilic organic solvents, and that amphiphilic organic solvents predictably dissolve the amphiphilic organic compounds baicalein and wogonin. Therefore, one of skill in the art could have substituted the amphiphilic organic extraction solvent ethanol, recited by Yu et al., with 1,3-propanediol with the predictable effect of extracting the amphiphilic organic compounds baicalein and wogonin.
Regarding claims 20 and 25 and the adjustment of the pH of the hydrolysate to 3.5-5.5 (claim 20) or 4.5 (claim 25), this pH range is obvious over routine optimization. One of ordinary skill in the art could have adjusted the pH of the composition using sodium hydroxide, hydrochloric acid, and a laboratory pH probe. One of ordinary skill in the art could have tested the effects of compositions prepared with different pH adjustments, on the skin, by photographing the skin before and after treatment over a regular treatment regimen. Therefore, the adjustment of the pH of the hydrolysate to 3.5-5.5 is obvious to one of skill in the art over routine optimization.
Regarding claims 21 and 32-35, the adjustment of the wight contents of hydrolysate components baicalein, wogonin and wogonoside, these weight contents are obvious over routine optimization. One of ordinary skill in the art could have varied the amount of solvent added to the crude extract or separated these chemical components using HPLC and recombined them to adjust their weight contents. One of ordinary skill in the art could have tested the effects of compositions prepared with different weight contents of baicalein, wogonin and wogonoside, on the skin, by photographing the skin before and after treatment over a regular treatment regimen. Therefore, the adjustment of the weight contents of baicalein, wogonin and wogonoside is obvious to one of skill in the art over routine optimization.
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reasons:
The combination of elements from the prior art comprise all steps as claimed within the application. Yu et al. (2013) details the treatment of the plant extract with enzyme as well as solvent extraction, KR’625 teaches the hydrolysate product of an enzyme and extraction process. It would have been obvious to an artisan in the bioactive extraction arts to combine the methods of extraction to produce a hydrolysate product, especially considering all extraction and composition methods are directed towards Scutellaria baicalensis. Per MPEP 2143(I)(A), “[The claim is obvious if] all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art” (see Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 163 USPQ 673 (1969). Accordingly, the hydrolysate preparation, as stated in Yu et al. (2013), in combination with the methods and invention as claimed in KR’625 is obvious, predictable, and an obvious combination of elements that perform the same function as the elements do separately. Thus, absent of some demonstration of unexpected results from the combination of methodologies for the development of a S. baicalensis product, the combination of inventions from Yu et al. (2013), KR’625 would have been obvious before the effective filing date of applicant’s claimed invention.
Further, the prior art includes various ranges and values for experimental variables stated in the claims of the applications, ingredient ratios, temperatures, and time frames. However, instant claims 21 and 32-35 are distinguished from the prior art by reciting weight contents of wogonin, baicalein, and wogonoside that are not recited in the prior art. The differences in values or ranges is not sufficient for non-obviousness unless there is an unexpected result from the claimed values. Per MPEP 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).” Accordingly, varying the concentrations and environmental conditions of the experiment constitutes routine experimentation in the art, and is not considered to be non-obvious unless the specified values (pH, ingredient concentrations and ratios, temperatures, and time frames) produce an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of experimental variables would have been obvious before the effective filing date of applicant’s claimed invention.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)).
Yu et al. and KR-2011/0104625-A are relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teachings provided by the references with respect to providing the hydrolysate of the roots of the Scutellaria genus, the adjustments of particular conventional working conditions (e.g., the selection from among known components and determining one or more suitable ranges (amounts, proportions, ratios thereof) in which to provide the hydrolysate), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of Yu et al. in view of KR-2011/0104625-A, the invention as a whole, drawn to a hydrolysate of the roots of the genus Scutellaria as described in Claims 20-21, 23-25 and 28-37, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, and one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing
Applicants’ composition with the composition of the prior art, the burden is on applicant to show
a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
No claims are allowed.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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