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 without traverse of species b (innate immunity (claim 15) in the reply filed on July 8th, 2026 is acknowledged. The species election between species a (claims 2 and 12-17) and species b (claims 2 and 8-10) is withdrawn for compact prosecution. For compact prosecution, the species election of IFN-γ instead of IL-2 and/or TNF-α is withdrawn (all three of these species are examined); however, IL-4, IL-10, IL-12, and IL-6 remain withdrawn from claim 15 as non-elected species.
Claims 1, 2, 8-10, and 12-17 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 effective filing date is June 21st, 2023.
Information Disclosure Statement
The information disclosure statement filed March 10th, 2025 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered for the references lined through. Foreign patent document 2 (KR 10-2017-0073058 A) lacks an English abstract or an explanation of relevance. References not lined through were considered.
The information disclosure statement (IDS) filed March 14th, 2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the documents cited therein, as supplied by the applicant, are illegible. In this case illegibility may result from text that is too small given the scanning resolution. The IDS has been placed in the application file, but the information referred to therein has not been considered as to the merits for the references lined through. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a). References not lined through were considered.
The information disclosure statement (IDS) submitted on April 24th, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on March 9th, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Although the supplied copy of the cited non-patent literature document Wang, J.; et al. (Carbohydrate Polymers 2022, 285, 118971) contains some illegible text in tables 1 and 2 and the References section, a fully legible copy of this document is retrievable over the internet (PMID: 35287839, DOI: 10.1016/j.carbpol.2021.118971).
Drawings
The drawings (received March 10th, 2025) are objected to because the vertical axis of Fig. 1 recites "Cell priliferation" when it should recite "Cell proliferation" for correct spelling. 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.
Specification
The disclosure is objected to because of the following informalities: the term "PMA" is only recited as an acronym, so its meaning is unclear.
Appropriate correction is required.
The use of the terms Millipore; Becton, Dickinson and Company (registered as Becton Dickinson); ADVIA; Siemens; JW Pharmaceutical; Thermo Fisher Scientific; Gibco; Merck; R&D Systems; TECAN; PRISM; and Graphpad; 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.
Claim Objections
Claim 1 is objected to because of the following informalities: the term "paeonia" should be capitalized and italicized to "Paeonia", the term "Angelica sinensis" should be completely italicized to "Angelica sinensis", and the term "Ligusticum chuanxiong" should be italicized to "Ligusticum chuanxiong" (lines 2 and 3 from the bottom). To avoid redundancy, the applicant should consider removing the term “angelica” in claim 1 line 2, where it is repeated consecutively, but keep the term “Angelica sinensis (Oliv.) Diels”. Appropriate correction is suggested.
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 1 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 term “hot” in claim 1 is a relative term which renders the claim indefinite. The term “hot” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The temperature of the water used for preparing the water extract is rendered indefinite by the use of the term "hot".
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, 8-10, and 12-17 rejected under 35 U.S.C. 101 because the claimed invention is directed to product of nature without significantly more. The claims recite a composition comprising an extract and precipitated polysaccharide of certain plant materials, a product of nature. This judicial exception is not integrated into a practical application because combining different naturally occurring plant materials does not. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the combination of naturally occurring materials is not claimed as having properties that markedly differentiate it from naturally occurring source materials, for example, a biological activity not present in the naturally occurring source materials.
The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since claims 1, 2, 8-10, and 12-17 are directed to a composition for enhancing immunity, 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 composition comprising a hot water extract of certain plant materials and an ethanol-precipitated polysaccharide thereof) 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 § 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, 8-10, and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (Evidence-Based and Complementary Alternative Medicine 2019, 2019, 3494806; non-patent literature document 1 on the IDS received on March 10th, 2025), abbreviated “Kim”; and further in view of Kim, Ryu, and Shin (KR 20010000062 A), abbreviated "Ryu".
Claim 1 recites “A composition for enhancing immunity, the composition comprising a mixture of a mixed hot water extract of angelica Angelica sinensis (Oliv.) Diels, Ligusticum chuanxiong Hort cnidium or Cnidium officinale, and paeonia, and an ethanol-precipitated polysaccharide thereof, isolated from the mixed extract or a fraction of the mixture as an effective ingredient; wherein the mixed hot water extract comprises Angelica sinensis (Oliv.) Diels, Ligusticum chuanxiong Hort or Cnidium officinale, and paeonia at a weight ratio of 1: 1.2 to 3:1.2 to 3; wherein the ethanol is 90% to 95% ethanol; and wherein the mixture comprises a hot water extract of Angelica sinensis (Oliv.) Diels, Ligusticum chuanxiong Hort or Cnidium officinale, and paeonia, and an ethanol-precipitated polysaccharide thereof at a weight ratio of 60 to 65 : 35 to 40”. Claim 2 recites “The composition according to claim 1, wherein the immunity is innate immunity, acquired immunity, or a combination thereof”. Claim 8 recites “The composition according to claim 1, wherein the fraction is a water or an ethanol fraction of the mixture”. Claim 9 recites “The composition according to claim 8, wherein the water fraction or ethanol fraction has T cell proliferation ability”. Claim 10 recites “The composition according to claim 8, wherein the water fraction or ethanol fraction has a T cell proliferation ability of 130% to 160% at a concentration of 400 to 500 μg/ml”. Claim 12 recites “The composition according to claim 1, wherein the mixture is contained at 0.001% to 90% by weight based on the total weight of the composition”. Claim 13 recites “The composition according to claim 1, wherein the mixture or a fraction of the mixture increases NK cell activity”. Claim 14 recites “The composition according to claim 1, wherein the mixture or a fraction of the mixture increases body weight, increases WBC count, restores spleen cell density, increases spleen cell proliferation ability, and increases immune-related cytokines”. Claim 15 recites “The composition according to claim 14, wherein the cytokine is any one or more selected from the group consisting of IL-2, IFN-γ, IL-4, IL-10, TNF-α, IL-12, and IL-6”. Claim 16 recites “The composition according to claim 1, which is a food composition”. Claim 17 recites “The composition according to claim 16, wherein the food composition is prepared as a powder, granule, tablet, capsule, syrup, or beverage”.
Kim recites a composition, “HemoHIM”, prepared by extracting Angelica gigas, Cnidium officinale, and Paeonia japonica in boiling water; half of the extract was precipitated by adding ethanol to obtain an ethanol-insoluble polysaccharide fraction; the final HemoHIM composition comprises 50% the non-precipitated water extract and 50% the polysaccharide fraction (Kim, Materials and Methods, 2.2 Preparation of HemoHIM; instant claims 1 and 8). Although Kim recites using Angelica gigas, instead of Angelica sinensis as instantly claimed, both species of Angelica are known in the art for enhancing cell immune function, as recited by Ryu: “Radix Angelicae Sinens is the root of Angelica Sinensis, Angelica Acutiloba, Angelica Gigas, and antibacterial, anti-blood, antioxidant, and anti-inflammatory effects. Because of its efficacy in enhancing cell immune function, it is a medicine widely used in the treatment of inflammatory diseases” (Ryu, Tech-Solution, paragraph 7, machine translation; instant claim 1). Therefore, it would have been obvious to one of skill in the art to substitute Angelica sinensis in place of Angelica gigas, with the predictable result of making a composition that can be used for enhancing immunity (instant claim 1).
Kim recites the composition HemoHIM enhancing innate immunity, including an increase in NK cell activity: “In this study, to examine the effect on the restoration of immune cells and balance in the immune system, we utilized a cisplatin-induced immunosuppression mouse model. Mice were injected intraperitoneally with cisplatin, an immunosuppressive anticancer, and then received oral doses of 100, 250, and 500 mg/kg of HemoHIM for 14 days. The HemoHIM prevented the cisplatin-induced loss of body and organ weight. In terms of innate immunity, natural killer (NK) cell activity and phagocytosis increased in the HemoHIM group compared to the cisplatin control group” (Abstract; instant claims 1, 2, and 13).
Kim further recites the effects of HemoHIM on the production of certain cytokines: “The HemoHIM group also showed a significantly higher expression of Th1-mediated cytokines (interferon gamma (IFN-γ), interleukin-2 (IL-2), and tumor necrosis factor alpha (TNF-α)) and inhibited the production of Th2-mediated cytokine interleukin-4 (IL-4) compared to cisplatin control group. These findings indicate that HemoHIM enhances immune activity by modulating immune cell activity and cytokine secretion in immune-suppressed mice” (Abstract; instant claims 1, 2, 14 and 15).
Kim recites the effects of HemoHIM on T-cells in cisplatin-treated mice: “The ratio of CD4+/CD8+ was not significantly different in between cisplatin treatment and HemoHIM treatment in both blood and splenocyte. However, CD4+ T lymphocytes tended to decrease in cisplatin group compared to control group (Table 2). The decreased CD4+ T lymphocytes were significantly alleviated by HemoHIM treatment at 250 and 500 mg/kg in splenocytes (p<0.05, p<0.01)” (Kim, subheading 3.4 and Table 2; instant claims 9 and 10). Considering that HemoHIM counteracts a decrease in CD4+ T lymphocytes, one of skill in the art would have had a reasonable expectation of success at administering HemoHIM with the resulting effect of increasing total T-lymphocytes, and white blood cell count, which encompasses T-lymphocytes (instant claims 9, 10, and 14). One of skill in the art would have been motivated to increase T-cell proliferation and total white blood cell count to restore immune function to subject suffering from depressed immune function from the administration of cisplatin or another immune system depressing drug (instant claims 9, 10, and 14).
Kim recites the effect of HemoHIM on body weight “Body weight significantly decreased after cisplatin treatment and did not recover until day 13 after treatment (Figure 1). However, HemoHIM treatment (250 and 500 mg/kg) inhibited the body weight loss in cisplatin-treated mice” (Kim, subheading 3.1). One of skill in the art would have had a motivation to increase body weight to restore organism homeostasis after cisplatin treatment (instant claim 14). Considering that HemoHIM lessened the effect of body weight loss of cisplatin treatment (Kim, Figure 1), HemoHIM effects body weight in the opposite direction as cisplatin. Therefore, one of skill would have a reasonable expectation of success at increasing body weight, after a cisplatin regimen, by administering HemoHIM, or a similar composition prepared according to optimized parameters (see arguments below) (instant claim 14).
Kim recites cisplatin treated mice shown reduced splenocyte proliferation; however, HemoHIM treatment restored splenocyte proliferation to the level of a control untreated with cisplatin (Kim, subheading 3.5 and Figure 5). One of skill in the art would have had a motivation to increase spleen cell proliferation to restore organism homeostasis during or after cisplatin treatment (instant claim 14). Considering that HemoHIM restored splenocyte proliferation to the control level in mice administered cisplatin (Kim, Figure 5), HemoHIM effects splenocyte proliferation in the opposite direction as cisplatin. Therefore, one of skill would have a reasonable expectation of success at increasing splenocyte proliferation by administering HemoHIM, or a similar composition prepared according to optimized parameters (see arguments below) (instant claim 14).
Although Kim does not explicitly recite that administering HemoHIM increases spleen cell density, one of skill in the art would have been motivated to increase spleen cell density after this density has been depleted resulting in decreased immune function (instant claim 14). One of skill in the art would have reasonable expectation of success at increasing spleen cell density by increasing spleen cell proliferation. Increasing spleen cell proliferation would help fill in gaps in the extracellular matrix of the spleen increasing spleen cell density. One of skill in the art would have a reasonable expectation of success at increasing spleen cell proliferation by administering HemoHIM (see arguments above), or a similar composition, prepared according to optimized parameters (see arguments below) (instant claim 14).
Although Kim does not explicitly recite using food and beverage compositions for administering HemoHIM, Kim recites oral administration of HemoHIM to mice (Materials and Methods, subheading 2.3), and it is within the knowledge of one of skill in the art to use food and beverage compositions for orally administering substances into the body (instant claims 16 and 17).
The instant claims are distinguished from Kim in that Kim does not explicitly recite the following parameters for HemoHIM:
A weight ratio of 1 : 1.2 to 3 : 1.2 to 3 for Angelica sinensis (Oliv.) Diels : Ligusticum chuanxiong Hort Cnidium officinale : Paeonia (claim 1)
An ethanol percentage of 90- 95% for precipitating polysaccharides (claim 1)
Weight ratio 60 to 65 : 35 to 40 for the water extract of Angelica sinensis (Oliv.) Diels, Ligusticum chuanxiong Hort or Cnidium officinale, and Paeonia : an ethanol-precipitated polysaccharide thereof (claim 1)
The water or ethanol fraction of the mixture, recited in claim 1, has a T cell proliferation ability of 130% to 160% at a concentration of 400 to 500 μg/mL (claim 10)
The mixture is contained at 0.001% to 90% by weight based on the total weight of the composition. (claim 12)
However, these parameters are obvious to one of skill in the art over routine optimization. Weight ratios can be adjusted by weighing different materials using a scale instrument before combining them (instant claims 1 and 12). The percentage of ethanol for precipitating polysaccharides can be adjusted by measuring ethanol in a graduated cylinder and diluting with purified water to a specific volume, such that the ethanol comprises a known volume percentage of the resulting solution. Concentrations of solutes can be adjusted by measuring the solute mass using an analytical balance and dissolving the solute in a solvent to make a solution of known volume, measured using volumetric glassware (instant claim 10). The T-cell proliferation ability of different compositions can be measured using flow cytometry as described by Kim (Materials and Methods, subheadings 2.1-2.3 and 2.7). Therefore, one of skill in the art could compare the T-cell proliferation resulting from administering different compositions, and adjust the composition to result in a target T-cell proliferation (instant claim 10). One of skill in the art could also compare different compositions, prepared according to variations on the parameters listed above, in terms of their effect on body weight (using a scale instrument), NK cell activity (Kim, Material and Methods, subheadings 2.1-2.4), and splenocyte proliferation (Kim, Materials and Methods, subheadings 2.1-2.3 and 2.8). By these means one of skill in the art could optimize the parameters listed above to make a composition for enhancing immunity, rendering these parameters obvious to one of skill in the art over routine optimization (instant claims 1, 10, and 12).
Kim and Ryu 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 composition for enhancing immunity, 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 composition for enhancing immunity), 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 in view of Ryu, the invention as a whole, drawn to a composition for enhancing immunity as described in Claims 1, 2, 8-10, and 12-17, 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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