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 I (claims 1,2, and 5-13) in the reply filed on February 3rd, 2026 is acknowledged. The traversal is on the ground(s) that Group I and Group III inventions satisfy the unity-of-invention requirement, as they share a special technical feature over the prior art. This is not found persuasive because the special technical feature over the prior art is not stated by the applicant in the response.
The requirement is still deemed proper and is therefore made FINAL.
Claims 3,4, 14, and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on February 3rd, 2025.
Claims 1, 2 and 5-13 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, filed on January 18th, 2024. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on January 18th, 2024 and December 18th, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on January 18th, 2024. These drawings are acceptable.
Specification
The use of the terms CAPCELL PAK, SHISEIDO, Sigma-Aldrich, Duksan, Corning, and Molecular Devices, which are trade names or a mark used in commerce, has been noted in this application. Each term should be accompanied by the generic terminology; furthermore, the 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5, and 11-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for preparing a horse chestnut extract comprising avicularin and juglanin, does not reasonably provide enablement for preventing periodontal disease. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a composition for preventing or treating periodontal disease comprising horse chestnut extract as an effective component. Thus, the claims taken together with the specification imply that the composition comprising horse chestnut extract prevents periodontal disease.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
Kim et al. (J Vet Sci 2017, 18 (2), 245-251) recites improvement of clinical conditions upon treating subjects (beagles) with periodontal disease using a horse chestnut leaf extract (Abstract). However, Kim et al., does not experimentally demonstrate the prevention of periodontal disease.
Since the prevention of periodontal disease in beagle dogs remains largely unsolved, means for preventing periodontal disease in subject organisms, including humans, is highly unpredictable.
(5) The relative skill of those in the art:
The relative skill of those in the art is high. Kim et al. intentionally induced periodontal disease in subject organisms and treated it using a horse chestnut extract, but their experimental work does not demonstrate failure to induce periodontal disease in a subject if the subject is administered a horse chestnut extract.
Accordingly, one would have turned to the instant disclosure for additional direction and guidance.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided evidence that a horse chestnut extract inhibits the activity of tartrate-resistant acid phosphatase (TRAP), an osteoclast-specific marker, in a mouse macrophage cell line treated with receptor activator of nuclear factor-kappa B (RANKL). However, the specification does not provide that a horse chestnut extract prevents periodontal disease in a subject organism.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by Kim et al. and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to use a horse chestnut extract to prevent periodontal disease.
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, 2 and 5-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a horse chestnut extract without significantly more. The claims recite compositions comprising horse chestnut extract. This judicial exception is not integrated into a practical application because the applicant has not provided evidence in the instant specification that the claimed compositions significantly improve the therapeutic efficacy of the claimed product of nature (a horse chestnut extract). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed product of nature is embodied merely comprising routine compositions for oral administration (pharmaceutical composition, food, toothpaste, gargle solution, and oral spray). The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since claims 1, 2, and 5-13 are directed to compositions comprising horse chestnut extract as an effective component, the claims are directed to compositions.
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., compositions comprising horse chestnut extract as an effective component) which is not markedly different from the closest naturally-occurring counterpart (i.e., the nature-based product).
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 claims recite horse chestnut extract (instant claims 1, 2, 6, 7, 9, and 10). 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, and 5-13 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (J Vet Sci 2017, 18 (2), 245-251), and further in view of Zhang et al. (Front. Pharmacol., Sec. Inflammation Pharmacology 2021, 11, 596230), Ha et al. (Molecules 2014, 19 (4), 3940-3954), Hienz et al. (Journal of Immunology Research 2015, 2015, 615468), and Wu et al. (Analytical Biochemistry 2013, 433 (1), 48-55).
Claim 1 recites a pharmaceutical composition for preventing or treating periodontal disease comprising horse chestnut extract as effective component wherein the horse chestnut extract comprises avicularin and juglanin as active ingredients. Claim 2 recites the pharmaceutical composition of claim 1, wherein the horse chestnut extract comprises 0.1 to 4.0% by weight of avicularin and 0.1 to 3.0% by weight of juglanin as active ingredients based on the total weight of horse chestnut extract. Claim 5 recites: the pharmaceutical composition of claim 1, wherein the pharmaceutical composition inhibits tartrate-resistant acid phosphatase (TRAP), an osteoclast differentiation marker. Claim 6 recites obtaining the extract (claim 1) by extracting horse chestnut leaves with 10-50% (v/v) aqueous alcohol and concentrating. Claim 7 recites the horse chestnut extract (claim 1) is 10-90% of the pharmaceutical composition (by weight). Claim 8 recites the periodontal disease (claim 1) is selected from gingivitis, periodontis, alveolar pyorrhea, and peri-implantitis. Claim 9 recites a food composition comprising horse chestnut extract as effective component, wherein horse chestnut extract comprises avicularin and juglanin as active ingredients. Claim 10 recites the food composition of claim 9, wherein the horse chestnut extract comprises 0.1 to 4.0% by weight of avicularin and 0.1 to 3.0% by weight of juglanin as active ingredients based on the total weight of horse chestnut extract. Claim 11 recites a toothpaste comprising the pharmaceutical composition according to claim 1. Claim 12 recites a gargle solution comprising the pharmaceutical composition according to claim 1. Claim 13 recites an oral spray comprising the pharmaceutical composition according to claim 1.
Kim et al. recites a horse chestnut leaf extract “ALH-L1005” obtained by extracting 10 kg of horse chestnut leaves with 200 L of 25% aqueous ethanol for 2 hours, followed by filtration, vacuum concentration, then drying (Materials and Methods, Chemical preparation; instant claim 6). Kim et al. recites that periodontis was induced in beagles and that clinical conditions improved after 6 weeks of treatment with the horse chestnut extract “ALH-L1005” (Abstract; instant claims 1, 8, and 9). Therefore, it would have been obvious to one of skill in the art to try treating periodontal disease, especially periodontis, using a horse chestnut extract (instant claims 1, 8, and 11-13).
Regarding the embodiments of a pharmaceutical composition (instant claims 1, 2, and 5-7), a food composition (instant claims 9 and 10), a toothpaste (instant claim 11), a gargle solution (instant claim 12), and an oral spray (instant claim 13), one would have been motivated to try producing these embodiments because these are known in the art to achieve a therapeutic outcome in the oral cavity, whether through oral administration (Kim et al., Materials and Methods, Chemical preparation) as a pharmaceutical or food, or specifically application to the periodontal tissue as a toothpaste, gargle solution, or oral spray. One of skill in the art would have had reasonable expectation of success at formulating a horse chestnut extract into a pharmaceutical product such as a capsule (Kim et al., Materials and Methods, Chemical preparation), a food by mixing with food solids, a toothpaste by mixing with toothpaste materials, or as a gargle solution or oral spray, by mixing with a carrier liquid that would predictably dissolve it, such as an aqueous alcohol solution (instant claim 6).
Although Kim et al. does not recite avicularin and juglanin as active ingredients in a horse chestnut extract for treating periodontal disease (instant claims 1, 2, 9, and 10), both compounds are known in the art to have activity against osteoclast differentiation (juglanin: Zhang et al., Abstract; avicularin: Ha et al., Figure 1). Ha et al. recites the significance of osteoclast differentiation for bone health: “Bone is constantly remodeled through the removal of old bone by osteoclasts and the replacement of new bone by osteoblasts. Osteoclasts are multinucleated bone resorbing cells that are differentiated from monocyte/macrophage-lineage hematopoietic progenitor cells” (Introduction, paragraph 1). Periodontal disease is known in the art to involve bone resorption (Heinz et al., Abstract and Introduction); therefore, it would be obvious to use the compounds avicularin and juglanin, that inhibit the differentiation of bone resorbing cells (osteoclasts), as active ingredients in a composition for treating periodontal disease (instant claims 1, 2, 9, and 10). Even if avicularin and juglanin are not inherently present in a horse chestnut extract, one of skill in the art could have added them to a horse chestnut extract already known to treat periodontal disease, with the predictable effect of enhancing the activity of the extract against periodontal disease (Kim et al., Abstract; instant claims 1, 2, 9, and 10). The instantly claimed avicularin and juglanin weight percentages would have been obvious over routine optimization, as they could be controlled through the use of a laboratory scale for weight measurements and the resulting composition could be tested on a subject for efficacy against periodontal disease (Kim et al., Materials and Methods; instant claims 2 and 10). If avicularin and juglanin were extracted from horse chestnut material, their weight percentages could also be routinely optimized through varying extraction conditions (times, temperatures, and solvent species percentages) and calculated from data obtained through HPLC, before testing the composition for efficacy against periodontal disease (Kim et al., Materials and Methods; instant claims 2 and 10).
Although Kim et al. does not recite a horse chestnut extract inhibiting tartrate-resistant acid phosphatase (TRAP), Wu et al. recites the inhibition of TRAP by certain flavonoids (Flavonoids affecting the measurement of sTRAP activities, The screening of antiosteoclastic flavonoids). Considering TRAP inhibition recited by Wu et al., it would have at least been obvious for one of skill in the art to try inhibiting TRAP using a composition comprising the flavonoids juglanin and avicularin with a reasonable expectation of success (instant claim 5).
Although Kim et al. does not recite a pharmaceutical composition with a horse chestnut extract content of 10-90% by weight (instant claim 7), such a composition would be obvious to make to one of skill in the art over routine optimization. One of skill in the art could weigh the horse chestnut extract and other components of the pharmaceutical composition to be combined to control the content of horse chestnut extract by weight in the pharmaceutical composition. Compositions with differing content of horse chestnut extract, in terms of weight percent, could be tested for their efficacy for treating periodontal disease in a subject (Kim et al., Materials and Methods).
Kim et al., Zhang et al., Ha et al., Hienz et al., and Wu 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 utilities of horse chestnut extract, avicularin, and juglanin for treating periodontal disease, 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 avicularin and juglanin components of the instantly claimed compositions), 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 Kim et al. in view of Zhang et al., Ha et al., Hienz et al., and Wu et al., the invention as a whole, drawn to a composition comprising horse chestnut extract, in which avicularin and juglanin are active ingredients, as described in Claim 1, 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).
Relevant and Prior Art Made of Record
The relevant and/or prior art made of record and not relied upon is considered pertinent to applicant's disclosure, including the following:
Zou et al. (Phytomedicine 2021, 91, 153657).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand 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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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655