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 .
Claim(s) 3, 5, 7-8 and 10-12 are currently pending.
Withdrawn Objections
Applicant’s arguments filed June 05, 2026 have been fully considered. In regards to the objection of the specification, applicant has elected to amend the specification as appropriate.
In regard to the objection of claim 6, applicant has elected to amend claim 6 as appropriate. Therefore, the objections of the specification and claim 6 have been withdrawn.
Withdrawn Rejections
Applicant’s arguments filed June 05, 2026 have been fully considered.
In regards to the rejection under 35 U.S.C. 112(a) for enablement, applicant has explained that the deposited microorganism, Irpex lacteus KACC 83046BP has been deposited with the International Deposit Authority, Korean Agricultural Culture Collection (KACC) with the assigned deposit ID KACC 83046BP and was made under the terms of the Budapest Treaty at the KACC and that all restrictions on the availability of the deposit to the public will be irrevocably removed upon the granting of a patent. Thus, the rejection of claim(s) 3, 5, 7 and 10 under 35 U.S.C. 112(a) for enablement has been withdrawn.
In regards to the rejection under 35 U.S.C. 112(b) for indefiniteness, applicant has elected to cancel claim 9 and amend claim 7 and 10 and therefore, the rejection of claim(s) 7 and 10 under 35 U.S.C. 112(b) for indefiniteness have been withdrawn.
In regards to the rejection under 35 U.S.C. 102(a)(1) for anticipation and 35 U.S.C. 102/103 for anticipation by or, in the alternative as being obvious, applicant has elected to cancel claim 2 and amend claim(s) 5 and 8 to depend from independent claim 3. Due to the amended claim 3, the rejection of claim 8 under 35 U.S.C. 102(a)(1) for anticipation and the rejection of claim 5 under 35 U.S.C. 102/103 for anticipation by or, in the alternative as being obvious have been withdrawn.
Pending Rejections
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.
Claim 3, 5, 7-8 and 10-12 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The response filed June 05, 2026 has introduced NEW MATTER into the claims. Amended claim 3 recites in part (iii) drying the concentrated culture, wherein the composition comprises beta-glucan in an amount of 30 wt% or more and extracellular polysaccharides in an amount of 40 wt% or more.
The response filed June 05, 2026 did not point out where support for newly added information across claim 3 could be found within the originally filed disclosure. Although
the PTO has the initial burden of presenting evidence or reasons why persons skilled in the art
would not recognize in the disclosure a description of the invention defined by the claims, when
filing an amendment an applicant should show support in the original disclosure for new or
amended claims. See MPEP 714.02 and 2163.06 (“Applicant should therefore specifically point
out the support for any amendments made to the disclosure.”). Instant claim 3 now recites
limitations, which were not clearly disclosed in the specification as filed, and now change the
scope of the instant disclosure as filed. Such limitations recited in amended claim 3, which
did not appear in the specification, as filed, introduce new concepts and violate the description
requirement of the first paragraph of 35 U.S.C 112. Applicant is required to provide sufficient
written support for the limitations recited in present claim 3 in the specification or claims,
as-filed, or remove these limitations from the claims in response to this Office Action.
More specifically, applicant should state where within the disclosure that support is provided for the proposed newly added limitations; in claim 3 part (iii), examiner has found that paragraph 0016 of the specification covers specific percentages but those specific percentages does not support the breadth of what is being claimed within claim 3 part (iii).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 3, 5, 7-8 and 10-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring Irpex lacteus without significantly more.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant's claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant's claims recite Irpex lacteus KACC 83046BP. Irpex species are a naturally occurring fungus. In addition, claim 5 is drawn to the pharmaceutical composition of claim 3 and a pharmaceutically acceptable excipient (i.e. water). Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that "When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A."
MPEP § 2106.04(c)(I) states that "if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception... To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states "The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product's structure, function, and/or other properties…". To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states "The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product's structure, function, and/or other properties…"
In this case, applicant's specification states that the claimed species, Irpex lacteus were collected from nature and selection was made of mushrooms exhibiting antidiabetic functions. Of them, one mushroom species was found to have an excellent antidiabetic function and identified as Irpex lacteus before deposition (page 4, lines 11-13).
Selection of a particular species of a naturally occurring organism does not create a markedly distinct organism. The selected microorganism would be the same as the identical microorganism because selection only occurs from what exists. Thus, the claims are drawn directly to a product of nature. Thus, the claimed Irpex lacteus KACC 83046BP cannot display markedly different characteristics in comparison with the naturally occurring counterpart because they are one in the same. In regards to product-by-process claims please note that MPEP § 2106.4(c)(I)( B) states "For a product-by-process claim (e.g., a claim to a cloned farm animal produced by a nuclear transfer cloning method), the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart " Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant's claims are directed to a composition with an intended use of a pharmaceutical or food composition for treating diabetes. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to "an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the 'treatment or prophylaxis' consideration." Therefore, applicant's intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by "Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself." In this case, the additional element in the claims is the combination of the I. lacteus with additional ingredients (i.e. a pharmaceutically acceptable excipient like water) to form pharmaceutical or food compositions with the culture of I. lacteus. However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. Thus, mixing the ingredients together does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
In addition, applicant's intended use of treating diabetes is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), "Generally linking the use of the judicial exception to a particular technological environment or field of use" is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3, 5, 7-8 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Sun (CN 107574124 A – English translation provided) in view of Shoseyov (CA Pub. No. 2382303 A1), Sugimoto (PH Patent No. 1/2008/500762), Ying (CN 107574193 A - English translation provided), Schnellbaecher et al (Biotechnology and Bioengineering, (Year: 2019), vol. 116, issue. 6, pp. 1537-1555), Teng (CN 102559513 A - English translation provided), Sica et al (Phytochemistry, (Year: 2017), vol. 143, pp. 45-53), Basu et al (Bioinformation, (Year: 2015), vol. 11, issue. 4, pp. 182-182), Ravimannan et al (Global Journal of Science Frontier Research: C Biological Science, (Year: 2016), vol. 16, issue. 3, vers. 1.0, pp. 75-78), Stamets et al (Integrative Medicine: A Clinician’s Journal, (Year: 2014), issue. 13, vol. 01, pp. 46-47) and Lamar (U.S. Patent No. 5,786,188). All references have been previously cited.
Sun teaches Irpex lacteus (abstract). Sun teaches that the composition containing the Irpex lacteus can be [added to] a food, health product (page 6). Sun teaches the composition containing Irpex lacteus to prepare active dietary fiber useful for regulating blood sugar levels and relieving diabetes symptoms (page 3).
Sun does not teach the Irpex lacteus KACC 83046BP is formulated into a composition and does not teach the steps associated with preparing the composition (as stated within claim 3 of the present invention). Sun does not explicitly teach that that the Irpex lacteus KACC 83046BP can be administered with a pharmaceutically acceptable excipient for the prevention or treatment of diabetes mellitus, wherein the composition has at least one of the functions of reducing a blood bAIc level (%), a blood insulin level, a blood c-peptide level, a blood glucose level, or an OGTT level (as stated within claim 5 of the present invention). Sun does not teach that the pharmaceutical composition is in a formulation selected from an oral dosage form, topical agents, suppositories and sterile injectable solutions (as stated within claim 7 of the present invention). Sun does not teach that the health functional food composition the composition of claim 2 for prevention or treatment of diabetes mellitus, wherein the composition has one of the functions of reducing a blood bAIc level (%), a blood insulin level, a blood c-peptide level, a blood glucose level, or an OGTT level (as stated within claim 8 of the present invention). Sun does not teach that the health functional food of claim 8, being in a form of any one selected from the group consisting of a tablet, a capsule, a pill, an extract, pulvis, granules, a liquid, a suspension, a tea, a jelly, and a beverage (as stated within claim 10 of the present invention). Sun does not teach the pharmaceutical composition of claim 7, wherein the oral dosage form is selected from pulvis, granules, tablets, capsules, suspensions, emulsions, syrups, or aerosols (as stated within claim 11 of the present invention). Sun does not teach the composition of claim 3, wherein the culturing is performed in a broth containing sucrose 0.2-2% (w/v), glucose 0.2-2% (w/v), starch 0.2-2% (w/v), soy flour 0.05- 1.5% (w/v), yeast extract 0.05-1.5% (w/v), soy peptone 0.05-1.5% (w/v), MgSO4 0.001-0.005% (w/v), KH2PO4 0.001-0.005% (w/v), K2HPO4 0.001-0.005% (w/v), biotin (B7) 0.001-0.005% (w/v), and pyridoxine (B6) 0.001-0.005% (w/v), based on the total volume thereof (as stated within claim 12 of the present invention).
Shoseyov teaches the [Irpex lacteus component can be formulated] as tablets, capsules, liquids, syrups for oral ingestion (page 28, lines 5-6). Shoseyov teaches [that the Irpex lacteus within the pharmaceutical composition can be] administered topically, orally (page 27, line 21). Shoseyov teaches [suitable pharmaceutically acceptable excipients such as] sucrose, mannitol (page 28, line 11). Shoseyov teaches [that the pharmaceutical composition can be] presented in unit dosage form (page 29, lines 35-36).
The Sugimoto reference teaches a culture containing 2% of glucose, 0.5% of yeast extract, [and] 0.2% of potassium dihydrogen phosphate ([KH2PO4]) (page 55, lines 8-10 and lines 20-21).
The Ying reference teaches that [Irpex lacteus] is inoculated into a medium at 25-28 degrees centigrade (page 3). Ying teaches potato extracted powder (page 3). Ying teaches culturing for 7 days (page 7).
Schnellbaecher et al teaches that the B vitamins that are considered essential for CCM (cell culture media) (page 1538). Schnellbaecher et al teaches the B vitamins are pyridoxine (B6), biotin (B7) (page 1539, table 1).
Teng teaches [the] white bag rake teeth bacteria (e.g. Irpex lacteus) within a culture medium [that contains] sucrose (page 5). Teng teaches [a method of culturing the white bag rake teeth bacteria such as] seed culturing method: the slant mother access liquid seed culture, in degrees centigrade, 120-160 r/min shaking culture for 6d. Shake flask fermentation culturing the seed liquid access to the liquid fermentation culture medium according to 5% inoculum (lactose 26-27 g/L, yeast extract 23- g/L, (MM) 2SO4: 0. 30-0. 35 g/L, KH2PO4: 0. 4- 5 g/L, MgSO4: 0. 4- 5 g/L, VB1: 0. 01-0. 15 g/L) carrying out liquid fermentation, fermentation culture medium is liquid quantity is shaking bottle of 250 mL mL, culturing temperature is degrees centigrade, speed of the shaking table is 150rpm, harvesting the mycelium after culturing for 5d (paragraphs 0012-0013).
Sica et al teaches that fresh [fungi] cultures were inoculated in a medium containing soy peptone (page 10).
Basu et al teaches growth of fungi at pH range of 5 to 6 (page 183).
Ravimannan et al teaches [that] soy flour can serve as a good nutrient source (abstract). Ravimannan et al teaches [that] soy flour has been used as some of the protein sources to formulate alternative culture media to grow fungi (page 75).
Stamets et al teaches mycelia [has] use in naturopathic medicine (page 47).
Lamar teaches the mycelium of Irpex lacteus (paragraph 0061). Lamar also teaches Irpex lacteus culture (paragraph 0039).
Regarding claim 3, claim 3 is considered a product-by-process claim and the product in this case (Irpex lacteus KACC 83046BP) is not limited by the method of making. Therefore, the method as taught by Teng is sufficient to reject this claim. "[T]he lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. 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). One of ordinary skill in the art would reasonably expect that the method as taught by Teng within Sun’s composition to obtain a culture of Irpex lacteus within a composition is sufficient to achieve the desired product, as stated within claim 3 of the present invention. In addition, one of ordinary skill within the field of microbiology would reasonably expect to optimize pH, temperature, aeration rate as well as a stirring rate and in addition, would effectively use the reverse osmosis technique in order to minimize the risk of contamination that can compromise culture quality. Thus, one of ordinary skill in the art would reasonably expect that the composition that contains Irpex lacteus would be an accurately concentrated culture.
Moreover, even if the reference microorganism (Irpex lacteus from the Sun reference) and the claimed microorganism (i.e. Irpex lacteus KACC 83046BP) are not one and the same and there is, in fact, no anticipation, the reference microorganism would, nevertheless, have rendered the claimed microorganism obvious to one of ordinary skill in the art at the time the claimed invention was made in view of the clearly close relationship between the microorganism as evidenced by their shared taxonomical classification and pharmaceutical characteristics. The selection of a specific strain of a known type of microorganism is considered to be prima facie obvious in the absence of sufficient, clear, and convincing evidence to the contrary.
Regarding claim(s) 3, 5, 7-8 and 10-12, one of ordinary skill in the art would reasonably expect to use a composition that can be in the form of a pharmaceutical composition or a health functional food (which is known in the art to contain components, vitamins and compounds that can have a positive effect on health) that would contain Sun’s fungus, Iprex lacteus, that could be within an oral dosage form such as a capsule or tablet as taught by Shoseyov that would have a positive effect on regulating blood sugar levels and relieving diabetes symptoms as taught by Sun when administered orally in which, the symptoms that can be relieved by Sun’s composition would encompass the limitations present in claim(s) 5, 7-8 and 10-11.
Regarding claim(s) 3 and 12, claim(s) 3 and 12 of the present invention addresses a few ingredients not covered by the references directly (e.g. aeration rate of 0.05-2 vvm, stirring rate of 25-100 rpm, MgSO4 0.001-0.005% (w/v), K₂HPO₄ ([e.g. dipotassium phosphate]) 0.001-0.005% (w/v) and starch 0.2-2% (w/v) - although the Ying reference as discussed above teaches potato extracted powder which is another form of a starch), one of ordinary skill in the art would be highly knowledgeable in the field of microbiology and the ideology behind cell culture mediums would reasonably expect to use those ingredients not addressed within the references within a culture medium in order to provide extra nutrients to help the fungus to grow, help to maintain or buffer the overall medium, provide oxygen and ideal pH levels to help facilitate growth (and mimic the fungal environment) and keep a consistent stirring rate to achieve a uniform medium. It is obvious to one skilled in the art that the purpose of specific ingredients within mediums is to prompt growth of specific organisms (e.g. a fungus) within a lab setting. In addition, as discussed in MPEP section 2144.05(II)(A), "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. '[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.' In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)." The references teach the use of each of the ingredients in a cell culture medium. Varying the concentration of ingredients within a cell culture is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant's claimed invention.
Response to Arguments
Applicant's arguments filed June 05, 2026 have been fully considered but they are not persuasive. The arguments regarding the rejection under 35 U.S.C. 101 for natural products and 35 U.S.C. 103 for obviousness are found to be non-persuasive.
In regards to the rejection under 35 U.S.C. 101 for natural products, applicant has amended claim 3 to be a product-by-process claim. Within the product-by-process claim (claim 3), applicant is reminded that product-by-process claims are not limited to the method of making; and in this case, based on applicant’s amendments and as stated above in the 35 U.S.C. 112(a) written description rejection, applicant must provide evidence within the disclosure to prove that the language “the composition comprises beta-glucan in an amount of 30% wt% or more and extracellular polysaccharides in an amount of 40 wt% or more” (as stated within page 10 of applicant arguments) is not new matter. In addition, Irpex lacteus is a naturally occurring fungus and it is known in the art to culture organisms as well as filtering out contaminants within a culture to obtain the purest form of the culture. Moreover, the inclusion of the dependent claims would be directed to a judicial exception as a result of preventing or treating diabetes mellitus through administering the composition that contains Irpex lacteus is considered to be natural in its form – it is natural for organs and cells to have a specific reaction to the ingestion of a composition containing Irpex lacteus in which, would lead to affecting blood glucose levels and even blood insulin levels (also stated within claim(s) 5 and 8 of the claims of the present invention); these underlying effects (that are discussed in claim(s) 5 and 8) would happen naturally because of the biochemical pathways involved with diabetes mellitus. To add on, administering a composition that contains Irpex lacteus in an oral form through liquid or syrup is also considered natural given that there are options in what form that the pharmaceutical composition can be present in (as stated within claim(s) 7 and 10-11 of the claims of the present invention). Furthermore, dependent claim 12 describes a routine culturing step and is well known in the art. Finally, the composition that contains the Irpex lacteus (as stated within claim 3) along with the dependent claims (claim(s) 5, 7-8 and 10-12) does not possess markedly distinct characteristics and does recite a product of nature exception which would be directed to a judicial exception making them ineligible at Pathway B. Overall, the present invention’s claimed composition that contains the fungus, Irpex lacteus is a product of nature and would not overcome the analysis covered within steps 2A and 2B and therefore, the rejection under 35 U.S.C. 101 for natural products is maintained.
Regarding applicant’s remarks for the 35 U.S.C. 103 rejection for obviousness wherein obviousness by Sun in view of Lamar, Shoseyov and Stamets et al fails to “[teach or suggest] a composition comprising 30 wt% or more of beta-glucan and 40 wt% or more of extracellular polysacchardies” (as stated within page 16 of applicant arguments). In addition, applicant goes on to further state specific teachings of Lamar, Shoseyov and Stamets et al on page 17 of applicant’s arguments and ends by stating “the cited references merely mention strains used for purposes (dietary fiber and soil bioremediation, respectively) where beta-glucan and polysaccharide content as claimed is not taught or suggested. A skilled artisan would have no basis to predict that culturing Irpex lacteus KACC 83046BP and concentrating/drying its culture would yield a composition comprising 30 wt% or more of beta-glucan and 40 wt% or more of extracellular polysaccharides. In fact, none of the cited references provides any process guidance for achieving the claimed composition”. Based on the new matter rejection under 35 U.S.C. 112(a) for written description, applicant is required to provide sufficient written support for the limitations recited in present claim 3 in the specification or claims, as-filed, or remove these limitations from the claims in response to this Office Action. More specifically, applicant should state where within the disclosure that support is provided for the proposed newly added limitations; in claim 3 part (iii), examiner has found that paragraph 0016 of the specification covers specific percentages but those specific percentages does not support the breadth of what is being claimed within claim 3. The proposed newly added limitations within claim 3 of the claims of the present invention is what applicant is using in order to prove that the new limitations overcome the combination of the aforementioned references under 35 U.S.C. 103 for obviousness by the examiner. Given the changes to claim 3 of the present invention and given that claim 3 is directed to a product-by-process claim, until there is further proof within the disclosure that would provide support for the newly added limitation in part (iii) of claim 3, applicant arguments based on specific percentages of beta-glucan and specific percentages of extracellular polysaccharides within the rejection under 35 U.S.C. 103 for obviousness will be rendered moot. In addition, based on amendments to claim 8, a new rejection under 35 U.S.C. 103 for obviousness was created; one of ordinary skill within the field of microbiology, biochemistry and molecular biology would have reasonably expected that the administration of a pharmaceutical composition or a health functional food composition that contains Irpex lacteus would intrinsically and positively affect the stated compounds/components that are found within the biochemical and cellular pathways associated with diabetes mellitus. Thus, one skilled within the field of microbiology, biochemistry and molecular biology would find that the combination of all of the aforementioned references overcomes the recent inventions amendments and the newly added claims and thus, the rejection under 35 U.S.C. 103 for obviousness is maintained.
No claims are allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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NASHARA L MOREAUExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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