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 of Group III (claims 6-9), drawn to a method of treating a biofilm of Candida Albicans in the reply filed on February 24th, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 1-5, 14, and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claims 6-9 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 foreign priority date is October 18th, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) filed April 16th, 2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the citation of foreign patent document 2 in the IDS has an error in the document number which should be 2010-77028, per the document included in the file wrapper; and non-patent literature document 2 is illegible in certain areas, possibly because of inadequate scanning resolution. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. 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).
The following document has been retrieved by the examiner and cited on the PTO-892:
Alves, M.; et al. Frontiers in Pharmacology 2019, 10, 446.
The information disclosure statement (IDS) submitted on December 9th, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on April 16th, 2024. These drawings are acceptable.
Specification
The disclosure is objected to because of the following informalities:
scientific genus-species names such as "Candida albicans" should be italicized;
the specification contains the phrase "bacterial solution" to describe a fungal culture of Candida albicans (page 10, line 14, see paragraph [0036]). The phrase "bacterial solution" is incorrect and could be corrected to "fungal culture", "fungal cell culture", or "cell culture".
Appropriate correction is required.
The use of the terms Avantec and Cayman Chemical, 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, 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 6 is objected to because of the following informalities: the term "Candida albicans" should be italicized because it is a scientific genus-species name. Appropriate correction is suggested.
Claim 9 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: the steps of treating a biofilm of Candida albicans. If by “treating”, the applicant intends to recite applying an extract to a biofilm, then this step of applying an extract to a biofilm should be stated explicitly in the claim.
Claim Rejections - 35 USC § 112, Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6 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 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 instant.
The MPEP states that the purpose of the written description requirement is to ensure that the
inventor had possession, at the time the invention was made, of the specific subject matter claimed.
The courts have stated:
"To fulfill the written description requirement, a patent specification must describe an invention
and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor
invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41
USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618
(Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to
recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the
written description requirement "by describing the invention, with all its claimed limitations, not
that which makes it obvious," and by using "such descriptive means as words, structures,
figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at
1572, 41 USPQ2d at 1966." Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d
1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court
stated: "A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
MPEP § 2163 further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163 does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
The factors considered in the Written Description requirement are (1) level of skill and knowledge in the art, (2) partial structure, (3) physical and/or chemical properties, (4) functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the (5) method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient." MPEP § 2163.
In the instant case, the claims are drawn to a biofilm inhibition method, comprising: treating a biofilm of Candida albicans with a water-soluble extract of a spent mushroom bed after mushroom bed cultivation (claims 6-8).
(1) Level of skill and knowledge in the art:
Some mushroom species, such as portobello mushrooms (Agaricus bisporus) and shiitake mushrooms (Lentinula edodes), are broadly known as edible to humans. Others, such as Death Cap (Amanita phalloides) and Fly agaric (Amanita muscaria), are broadly known as toxic to humans. This example demonstrates that the same toxicity to a given species of organism cannot be assumed to hold across all species of mushroom.
(2) Partial structure:
Regardless of structural (specifically, anatomical) similarities between different mushroom species, these do not necessarily imply shared chemical properties, functional characteristics, or method of making the claimed invention.
(3) Physical and/or chemical properties:
Mushrooms from different species of organisms would not necessarily comprise the same proteins and enzyme-generated metabolites, in the same concentrations, because of different genetics and different levels of gene expression. Therefore, the chemical composition of the mushroom will vary from species to species.
(4) Functional characteristics:
Chelela, et al. (American Journal of Research Communication, 2014, 2 (9), 58-68) demonstrated that ethanol extract of Amanita muscaria had a minimum inhibitory concentration (MIC) of 0.78 mg/mL against Candida albicans, whereas the ethanol extract of Lactarius gymnocarpoides had a higher minimum inhibition concentration of 12.50 mg/mL (page 63, Table 2). Therefore, different mushroom species extracted using the same solvent do not necessarily have equivalent functionality for killing Candida albicans.
(5) Method of making the claimed invention:
The method of making the claimed invention would change depending on the type of mushroom cultivated because of different techniques required to grow different species of mushroom.
As stated supra, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad genus. Independent claim 6 and dependent claims 7 and 8 are broadly generic to all possible mushroom species encompassed by the claims. The possible variations are enormous to any class of mushroom species. Since the MPEP states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163. Here, though the claims may recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure of mushroom beyond those disclosed in the examples in the specification. Moreover, the specification lacks sufficient variety of species to reflect this variance in the genus since the specification does not provide any examples of Candida albicans biofilm inhibition using mushrooms other than shiitake mushrooms.
While having written description of shiitake mushrooms identified in the specification tables and/or examples, the specification is devoid of any mushrooms derived from any species of mushroom that qualify for the functional characteristics claimed.
The description requirement of the patent statue requires a description of an invention, not an
indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d
1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does
"little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the
invention will hopefully ameliorate.") Accordingly, it is deemed that the specification fails to provide
adequate written description for the genus of the claims and does not reasonably convey to one skilled
in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire
scope of the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at (571) 272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/
Supervisory Patent Examiner, Art Unit 1655
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