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 .
Claims 1-10 are pending and were examined on the merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to because, in Figure 1, the oral condition of the subject animal is unclear without a color image of sufficient resolution to distinguish oral ulcers from non-ulcerous oral tissues. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
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 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more, and a method of preparing a soft gel comprising a product of nature. The claims recite a composition comprising plant materials from several plant genera. This judicial exception is not integrated into a practical application because the applicant has not provided evidence in the instant specification that the claimed soft gel composition significantly improves the therapeutic efficacy of the claimed product of nature (a modified prescription of Gancao Xiexin decoction). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the formulation of a soft gel comprising the claimed product of nature is merely a routine method of administration. The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since claim 1 is directed to a modified prescription of Gancao Xiexin decoction, the claims are directed to a composition. Since claim 10 is drawn to a method for preparing the soft gel, the claims are directed to a process.
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 and a process, which are statutory categories
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 modified prescription of Gancao Xiexin decoction) which is not markedly different from the closest naturally-occurring counterpart (i.e., the individual nature-based products).
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 found within several listed plant genera (instant claim 1). 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 § 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 5 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because the “use” claim attempt to claim a process without setting forth any steps involved in the process. "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 ").
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 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: the steps of preparing a product for treating oral ulcer using modified prescription of Gancao Xiexin decoction of claim 1 or an extract thereof.
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.
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 1, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Ru et al. (Front. Pharmacol. 2023, 13. 1078665) in view of Zhou et al. (Front. Pharmacol. 2022, 13. 974054) and Zhang et al. (Food Frontiers 2022, 3. 785–795).
Claim 1 recites “A modified prescription of Gancao Xiexin decoction, comprising, in parts by weight, 2-5 parts of Coptidis Rhizoma, 6-12 parts of Scutellariae Radix, 10-15 parts of Glycyrrhizae Radix et Rhizoma, 6-12 parts of Zingiberis Rhizoma, 5-12 parts of Jujubae Fructus, 10-15 parts of Citri Reticulatae Pericarpium, and 10-15 parts of Bolbostemmatis Rhizoma”. Claim 5 recites “Use of the modified prescription of Gancao Xiexin decoction of claim 1 or an extract thereof in the preparation of a product for treating oral ulcer”. Claim 6 recites “A product for treating oral ulcer, comprising the modified prescription of Gancao Xiexin decoction of claim 1 or an extract thereof”.
Ru et al. recites the Gancao Xiexin decoction including the root and rhizome of Glycyrrhiza uralensis, the root of Scutellaria baicalensis, the tuber of Pinellia ternata, the rhizome of Zingiber officinale, the rhizome of Coptis chinensis, and the fruit of Ziziphus jujuba (Table 1). Ru et al. also recites that the Gancao Xiexin decoction is used to treat oral ulcers (Abstract).
Zhou et al. recites the following when discussing Bolbostemma paniculatum: “So far, 96 compounds have been isolated from B. paniculatum, including triterpenoids, sterols, alkaloids and other components, of which triterpenoid saponins are the main bioactive components. The compounds isolated from B. paniculatum exhibit various pharmacological activities, such as anti-tumor, antiviral, anti-inflammatory, immunoregulatory, and so on” (Introduction, paragraph 2).
Zhang et al. recites the following when discussing a Citri Reticulatae Pericarpium (CRP) extract: “we confirmed that two major flavonoids, Hsd and Hst, were present in the CRP extract and that both compounds exhibited similar anti-inflammatory effects” (Conclusion). Ulcers are addressed with anti-inflammatory treatment in Western medicine (instant specification, paragraph [0003]).
Considering the anti-ulcer use of the Gancao Xiexin decoction, as recited by Ru et al., and the anti-inflammatory compounds in Bolbostemma paniculatum (Zhou et al.) and Citri Reticulatae Pericarpium (Zhang et al.), one of ordinary skill in the art would have been motivated to try combining these inventions to produce a decoction comprising the plant materials recited in instant claim 1, with the intent of producing an anti-ulcer composition, because the art has shown use of anti-inflammatory compounds for ulcer treatments (instant claims 5 and 6). Note, although instant claim 1 does not explicitly recite material from Pinellia ternate as Ru et al. does for the Gancao Xiexin decoction, Pinellia ternate material can be present in the composition recited in instant claim 1 because the composition is recited as “comprising” the recited plant materials.
Concerning the relative quantities of different plant materials recited in claim 1, these would have been obvious as routine optimization. One of ordinary skill in the art would have been able to prepare a composition with these relative quantities using an analytical balance. One of ordinary skill in the art could have arrived at these recited quantities by varying the relative masses of the recited plant materials and testing the resulting compositions for anti-ulcer therapeutic efficacy in subject animals (instant specification, Effect Example 1). 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).
Ru et al., Zhou et al., and Zhang et al. 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 quantities of different plant materials, 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 modified prescription of Gancao Xiexin decoction), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.).
Therefore, it 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, because Ru et al., Zhou et al., and Zhang et al. disclose the use of Gancao Xiexin decoction and anti-inflammatory compounds for ulcer treatments, especially in the absence of evidence to the contrary.
Claims 1, 2, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Ru et al. (Front. Pharmacol. 2023, 13. 1078665), Zhou et al. (Front. Pharmacol. 2022, 13. 974054), and Zhang et al. (Food Frontiers 2022, 3. 785–795) as applied to claims 1, 5, and 6 above, and further in view of Huang et al. (CN-104042991-A).
The claims and teachings of the cited references are as record above.
Claim 1 is drawn to a modification of Gancao Xiexin useful for the treatment of oral ulcers (see the above 35 U.S.C. 103 rejection of claims 1, 5, and 6).
Claim 2 recites “The modified prescription of Gancao Xiexin decoction of claim 1, further comprising, in parts by weight, 1-5 parts of Pogostemonis Herba, and 1-5 parts of Eupatorii Herba”.
Huang et al. recites a medicine for oral health care (Abstract) and “the invention provides a kind of medicine of anti-treating dental ulcer” (Summary of the Invention, paragraph 1, machine translation). Huang et al. further describes their invention: “For achieving the above object, according to one aspect of the present invention, provide a kind of medicine for oral cavity health, it is the medicament of being made by the raw material of following weight proportioning Herba Eupatorii 5～30 Herba Pogostemonis 1～10 …” (Summary of the Invention, paragraphs 2 and 3, machine translation). The terms “Herba Eupatorii” and “Herba Pogostemonis” recited by Huang et al. are understood as equivalent to the instantly recited terms “Eupatorii Herba” and “Pogostemonis Herba”, respectively. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a composition for treating oral ulcers by combining Eupatorii Herba and Pogostemonis Herba with the materials in the composition of instant claim 1, as recited in instant claim 2, because Huang et al. disclose the use of Eupatorii Herba and Pogostemonis Herba in a composition for oral health care, including treating dental ulcers, broadly understood as a type of oral ulcer.
Concerning the relative quantities of different plant materials recited in claims 1 and 2, these would have been obvious as routine optimization. One of ordinary skill in the art would have been able to prepare a composition with these relative quantities using an analytical balance. One of ordinary skill in the art could have arrived at these recited quantities by varying the relative masses of the recited plant materials and testing the resulting compositions for anti-ulcer therapeutic efficacy in subject animals (instant specification, Effect Example 1).
Ru et al., Zhou et al., Zhang et al., and Huang et al. 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 quantities of different plant materials, 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 modified prescription of Gancao Xiexin decoction), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. 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).
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.).
Therefore, it 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, because Ru et al., Zhou et al., and Zhang et al. disclose the use of Gancao Xiexin decoction and anti-inflammatory compounds for ulcer treatments and Huang et al. disclose the use of Eupatorii Herba and Pogostemonis Herba in a composition for oral health care, including treating dental ulcers, especially in the absence of evidence to the contrary.
Claims 1, 3-5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Ru et al. (Front. Pharmacol. 2023, 13. 1078665), Zhou et al. (Front. Pharmacol. 2022, 13. 974054), and Zhang et al. (Food Frontiers 2022, 3. 785–795) as applied to claims 1, 5, and 6 above, and further in view of Zhou (CN-104042947-A).
The claims and teachings of the cited references are as record above.
Claim 1 is drawn to a modification of Gancao Xiexin useful for the treatment of oral ulcers ( see the above 35 U.S.C. 103 rejection of claims 1, 5, and 6).
Claim 3 recites: “The modified prescription of Gancao Xiexin decoction of claim 1, further comprising, in parts by weight, 1-6 parts of Platycodonis Radix”. Claim 4 recites: “The modified prescription of Gancao Xiexin decoction of claim 3, further comprising, in parts by weight, 10-20 parts of Scrophulariae Radix, and 10-20 parts of Ophiopogonis Radix”.
Zhou, in the machine translation of CN-104042947-A, recites a composition comprising “Radix Scrophulariaes”, “Radix Ophiopogonis”, and “Radix Platycodoniss”, among other materials (Technical scheme of the present invention, paragraph 3). The terms “Radix Scrophulariaes”, “Radix Ophiopogonis, and “Radix Platycodoniss” are understood as respectively equivalent to the terms “Scrophulariae Radix”, “Ophiopogonis Radix”, and “Platycodonis Radix” (instant claims 3 and 4). Zhou recites the following properties of these plant materials:
“Radix Scrophulariae: property hardship is salty, cool, enters lung, kidney channel.Nourishing YIN to lower pathogenic fire.The throat that disappears is swollen, rushes down the fire of unrooted.
…
Radix Ophiopogonis: the sweet micro-hardship of property, cold, enter lung, stomach, heart channel.Nourishing YIN and moistening the lung, reinforcing stomach reg fluid.Control dryness of the lung dry cough, dry mouth and throat.
Radix Platycodonis: property toil, flat, enter lung, stomach warp.The evacuation of pus of eliminating the phlegm.Control laryngopharynx swelling and pain, aphtha of the mouth and tongue” (Zhou, machine translation of CN-104042947-A, page 4 of 23).
The anti-inflammatory (“lower pathogenic fire”) property of Scrophulariae Radix makes this material obvious to one in the art as applicable to the treatment of oral ulcers (instant specification, paragraph [0003]). The property of Ophiopogonis Radix of controlling dry mouth renders this material broadly applicable to maintaining the homeostasis of tissues in the oral cavity. The property of Platycodonis Radix of controlling aphtha of the mouth is broadly understood as controlling a type of oral ulcer.
It would be obvious to one of ordinary skill in the art to include Scrophulariae Radix, Ophiopogonis Radix, and/or Platycodonis Radix in a composition for oral health care, including treating dental ulcers, broadly understood as a type of oral ulcer, because Zhou (CN-104042947-A) discloses a composition for oral health care.
Concerning the relative quantities of different plant materials recited in claims 1, 3 and 4, these would have been obvious as routine optimization. One of ordinary skill in the art would have been able to prepare a composition with these relative quantities using an analytical balance. One of ordinary skill in the art could have arrived at these recited quantities by varying the relative masses of the recited plant materials and testing the resulting compositions for anti-ulcer therapeutic efficacy in subject animals (instant specification, Effect Example 1). 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 modified prescription of Gancao Xiexin decoction), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.).
Therefore, it 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, because Ru et al., Zhou et al., and Zhang et al. and Zhou (CN-104042947-A) disclose the use of Gancao Xiexin decoction, Eupatorii Herba and Pogostemonis Herba, Scrophulariae Radix, Ophiopogonis Radix, and/or Platycodonis Radix in a composition for oral health care, especially in the absence of evidence to the contrary.
Claims 1 and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Ru et al. (Front. Pharmacol. 2023, 13. 1078665), Zhou et al. (Front. Pharmacol. 2022, 13. 974054), and Zhang et al. (Food Frontiers 2022, 3. 785–795) as applied to claims 1, 5, and 6 above, and further in view of Luo et al. (Drug Design, Development and Therapy 2022, 16. 1383-1405) and Ru et al. (Front. Pharmacol. 2023, 13. 1078665).
The claims and teachings of the cited references are as record above.
Claim 7 recites: “The product of claim 6, wherein the extract is an aqueous extract of the modified prescription of Gancao Xiexin decoction”. Claim 8 recites: “The product of claim 7, wherein a preparation of the aqueous extract of the modified prescription of Gancao Xiexin decoction comprises following steps of: S1, taking medicinal materials according to the modified prescription, removing insects or metamorphic parts thereof, crushing the medicinal materials and sieving to obtain crude medicinal powder; S2, adding pure water to the crude medicinal powder obtained in the step S1 in a ratio of solid to liquid of 1:(10-40), heating, refluxing to extract, and obtaining an extract liquid; and S3, centrifuging the extract liquid obtained in the step S2, and concentrating a supernatant in vacuo to obtain the aqueous extract of the modified prescription of Gancao Xiexin decoction”.
For a preparation of Gancao Xiexin Luo et al. recites certain plant materials and their dosages for humans and mice; Luo et al. then recites following steps: “Decoction was soaked with distilled water for 30 min, decocted for 30 min”. From the context, it is assumed that Luo et al. is referring to the soaking of the recited plant materials (not the final decoction) with distilled water; because the act of soaking comes after the description of plant materials and before the act of decocting for 30 minutes, and the decoction would be a liquid and thus not an object that can be soaked. However, from this quote, it is evident that distilled water is understood by Luo et al. as an appropriate solvent for the preparation of Gancao Xiexin. Therefore, it would have been obvious to one of ordinary skill in the art to try preparing an aqueous extract of a modification of Gancao Xiexin using pure water (instant claims 7 and 8).
Ru et al. recites the following steps in an extraction procedure for Gancao Xiexin:
“12 g Glycyrrhiza uralensis Fisch., 9 g Scutellaria baicalensis Georgi, 9 g Pinellia ternata (Thunb.) Breit., 9 g Zingiber officinale Rosc., 3 g Coptis chinensis Franch., and 6 g Ziziphus jujuba Mill. were put into a round-bottom flask, and then added 2000 mL to soak for 30 min, then heated and refluxed for 2 h. The extracted solution filtered by gauze was concentrated through rotary evaporation under vacuum at 80°C.” (subheading 2.1, paragraph 2).
Although Ru et al., does not explicitly recite the limitations of instant claim 8 step 1, these would be obvious to one of ordinary skill in the art in preparing an extract of a modification of Gancao Xiexin for the following reasons. Gancao Xiexin is broadly understood as a plant composition (Ru et al., Luo et al.), thus rendering insects and metamorphic parts unnecessary. Crushing the medicinal materials would increase the surface area: volume ratio of plant materials, increasing the accessibility of these materials to extraction solvent. Sieving the crushed medicinal materials would remove debris, such as pieces of rock, that are unnecessary for the extraction process.
Ru et al. does not recite the identity of the solvent used in the extraction, but the quantity of 2000 mL, mixed with a total of 48 g of plant material. If water (density = 1 g/mL) were the solvent, as suggested by Luo et al., the resulting solid:liquid ratio would be 1:42, close to the range recited in instant claim 8 (1:(10-40)). Given how close the instant and reference solid: liquid ratios are, prima facie one of ordinary skill in the art would expect the instant and reference mixtures to have the same properties (MPEP 2144.05, I). Therefore, it would be obvious to one of ordinary skill in the art to try a solid: liquid ratio of 1:40 as recited in instant claim 8. Other solid:liquid ratios in the range of 1:(10-40) are obvious to one of skill in the art over routine optimization because one could vary this ratio using an analytical balance to weigh solid plant materials and the solvent and observe the therapeutic efficacy of the resulting composition when administered to a subject animal (instant specification, Effect Example 1).
Ru et al. recites a procedure comprising combining the plant materials with the liquid, heating, refluxing, and obtaining an “extracted solution” (instant claim 8 step 2). Ru et al. next recites filtration. Centrifugation (instant claim 8 step 3), is an obvious alternative to filtration as a means of separating liquid and solid phases in a mixture. Ru et al. recites concentrating the filtered extraction solution through rotary evaporation under vacuum (compare with instant claim 8 step 3).
It would have been obvious to one of ordinary skill in the art for preparing an extract of a modification of Gancao Xiexin before the effective filing date of the claimed invention, because Luo et al. and Ru et al. disclose the aqueous extract of Gancao Xiexin.
Therefore, it 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 aqueous extract invention, because Luo et al. and Ru et al. disclose the aqueous extract of Gancao Xiexin.
Claims 1, 5, 6, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Ru et al. (Front. Pharmacol. 2023, 13. 1078665), Zhou et al. (Front. Pharmacol. 2022, 13. 974054), and Zhang et al. (Food Frontiers 2022, 3. 785–795) as applied to claims 1, 5, and 6 above, and further in view of Young (CA-3004879-C), and Robinson et al. (CN-101495002-A; Google Patent English Translation provided).
The claims and teachings of the cited references are as record above.
Claim 9 recites: “A soft gel for treating oral ulcer, comprising an aqueous extract of the modified prescription of Gancao Xiexin decoction of claim 1”. Claim 10 recites: “A method for preparing the soft gel of claim 9, wherein after diluting the aqueous extract of the modified prescription of Gancao Xiexin decoction with water, adding sodium carboxymethyl cellulose, glycerol, and sucralose for heating and dissolving, and cooling to obtain the soft gel”.
Ru et al. and Zhou et al. disclose a modified Gancao Xiexin composition for oral administration. Although neither Ru et al. nor Zhou et al. recite a soft gel composition, Young recites a softgel capsule of rac- 1 -palmitoy1-2-linoleoy1-3-acetylglycerol (PLAG) (Example 2), where the overall invention of Young is directed toward “preventing or treating mucositis, for example oral mucositis (e.g., oral ulceration) and gastrointestinal mucositis” (Abstract).
Considering Young’s recited use of a softgel capsule for treating an oral ulceration condition, preparing a softgel comprising an extract of modified Gancao Xiexin for treating oral ulcers (instant claim 9) would have been obvious to one of ordinary skill in the art to try before the effective filing date of the claimed invention.
Robinson et al. recites a soft gel form of a tobacco product. “One representative tobacco product is in fluid form (eg, weak gel or soft gel). This can be achieved by mixing in water granulated or ground tobacco material, glycerin, glyceryl stearate, propylene glycol, kappa- carrageen, carmellose grade Ticalose 1500 from TIC Gums, and microcrystalline cellulose Elements (such as Ticacel HV of
TICG Company) provide the tobacco product, wherein the moisture content of the product is about 60-70% by weight” (Google Patents translation, pages 10 and 11 of 20), where Ticalose® is broadly understood in the art as a trade name for certain carboxymethylcellulose products (instant claims 9 and 10). Robinson et al. further recites “The resulting tobacco blend is further mixed with other components to form a tobacco product comprising: about 40 parts ground tobacco, … , about 4 parts of sweetener …” (Google Patents translation, Example 1), where sucralose is broadly understood in the art as a sweetener, and thus useful for increasing the palatability of a given composition (instant claim 10).
It would have been obvious to the person having ordinary skill in the art to prepare a modified Gancao Xiexin extract softgel by combining the extract with sodium carboxymethyl cellulose, glycerol, and sucralose, because both Young and Robinson et al. disclose the use of soft gel forms for oral administration. Furthermore, Young discloses the use of soft gels for oral ulceration conditions and Ru et al. and Zhou et al. disclose a modified Gancao Xiexin composition for oral ulcer treatment.
Art of Record
Examiner has provided applicant with a PE2E translated version and a Google Patents translated version of Robinson et al. (CN-101495002-A).
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