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 .
Specification
The use of the term Witepsol (page 10) and Tween (page 10), which is a trade name or a mark used in commerce, has been noted in this application. The 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 Objections
Claim(s) 6 is objected to because of the following informalities:
In claim 6, “and an OGTT level” should read “or an OGTT level”
Appropriate correction is required.
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(s) 2-7, 9, and 10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Since the microorganism Irpex lacteus KACC 83046BP is recited in the claims, it is essential to the invention recited in those claims. It must therefore be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the microorganism is not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the microorganism.
Since a deposit has been made under the terms of the Budapest Treaty, then an affidavit or declaration by Applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney or record over his/her signature, and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 C.F.R. § 1.808.
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(s) 7 and 9-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 is indefinite due to the use of improper Markush language. The claim states that it is drawn is “at least one form selected from the group consisting of oral dosage forms including…”. The use of “including” in a Markush grouping is improper because it implies that there are other members of the group without stating what these members are (see MPEP section 2173.05(h).
Claim 9 is indefinite because the structural requirements of the claim are unclear. Claim 9 states that it is drawn to a food comprising “the Irpex lacteus KACC 83046BP of claim 2 and a mycelial culture thereof…”. This is unclear because the mycelial culture would appear to meet the requirement that the claim contains “the Irpex lacteus” because mycelium is a part of the Irpex lacteus. Thus, it is not clear if one or two l. lacteus ingredients are required.
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) 2-10 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. 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…”.
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. 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 to form pharmaceutical and foods and with the culture of the 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 § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claim(s) 2 and 5 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Sun (CN 107574124 A – English translation provided).
The Sun reference teaches a Irpex lacteus organism. The Sun reference teaches a microorganism which appears to be identical to the presently claimed microorganism, based on the fact that the both the reference microorganism and the claimed microorganism are from the same genus and species and have the same pharmaceutical properties (such as helping to prevent or treat diabetes as stated within page 4 of the specification of the current invention and within page 3 and 5 as taught by Sun – using the Irpex lacteus (e.g. white bag rake teeth) to prepare active dietary fiber useful for regulating blood sugar levels and relieving diabetes symptoms). Consequently, the claimed microorganism appears to be anticipated by the reference.
However, even if the reference microorganism and the claimed microorganism 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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 8 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sun (CN 107574124 A – English translation provided).
Regarding claim 8, 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).
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) 2-3, 5-7 and 9-10 and are rejected under 35 U.S.C. 103 as being unpatentable over Sun (CN 107574124 A – English translation provided) in view of Lamar (U.S. Patent No. 5,786,188), Shoseyov (CA Pub. No. 2382303 A1) and Stamets et al (Integrative Medicine: A Clinician’s Journal, (Year: 2014), issue. 13, vol. 01, pp. 46-47).
The teachings of Sun are above.
Sun does not teach the Irpex lacteus KACC 83046BP and does not teach a mycelial culture of Irpex lacteus KACC 83046BP.
Lamar teaches the mycelium of Irpex lacteus (paragraph 0061). Lamar also teaches Irpex lacteus culture (paragraph 0039).
Shoseyov teaches the [Irpex lacteus component can be formulated] as a capsule (page 26, line 5).
Stamets et al teaches mycelia [has] use in naturopathic medicine (page 47).
Regarding claims 2-3, 5-7 and 9-10, the Irpex lacteus that was taught by Sun can be modified to have the mycelium culture of Irpex lacteus as taught by Lamar, including that the composition that contains the Irpex lacteus can be administered in the form of a capsule as taught by Shoseyov with general information that mycelia are good for natural medicine as taught by Stamets et al.
One of ordinary skill in the art would know that a mycelial culture of the organism, I. lacteus involves the cultivation of fungal cells along with the knowledge that the mycelial culture of I. lacteus would have its intended use of treating or preventing diabetes mellitus. In addition, one would reasonably expect too that if diabetes mellitus is being treated with a mycelial culture of l. lacteus, it would encompass all of the features stated within claim 6 of the present invention, which is what is naturally affected within someone that has diabetes mellitus.
One of ordinary skill in the art would reasonably expect to combine all these references in order to achieve a composition, in this case, a health functional food in the form of a capsule that includes a mycelial culture of I. lacetus that serves as a holistic approach in medicine in terms of treating or preventing diabetes mellitus.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Sun (CN 107574124 A – English translation provided) in view of Lamar (U.S. Patent No. 5,786,188), Shoseyov (CA Pub. No. 2382303 A1) and Stamets et al (Integrative Medicine: A Clinician’s Journal, (Year: 2014), issue. 13, vol. 01, pp. 46-47) as applied to claim(s) 2-3, 5-7 and 9-10 above, and further in view of 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) and Ravimannan et al (Global Journal of Science Frontier Research: C Biological Science, (Year: 2016), vol. 16, issue. 3, vers. 1.0, pp. 75-78).
The Sugimoto reference teaches a culture containing 2% of glucose, 0.5% of yeast extract, [and] 0.2% of potassium dihydrogen phosphate (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).
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).
Regarding claim 4, claim 4 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 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.
Conclusion
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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NASHARA L MOREAUExaminer, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655