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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/04/2026 have been entered and being considered by the examiner.
Claims Status
Amendments filed 05/04/2026 are entered. Claims 1-42 are pending. Claims 15-40 are withdrawn. Claims 41-42 are new. Claims 1, 3, 6, 7, 9, and 12 are amended. Claims 1-14 and 41-42 are under examination.
Withdrawn Objections/Rejections
Claim Rejections - 35 USC § 112(a) Enablement
The previous enablement rejection for the biological deposit is withdrawn in response to the Declaration by the Applicant, filed 05/08/2026, providing the necessary information requested.
New Grounds of Objections/Rejections
Claim Rejections - 35 USC § 112(b)
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.
Claims 6 and 12 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.
In response to the Applicant’s amendments to claims 6 and 12, adding the limitation regarding the “organic solvent-extracted fraction,” these claims are newly rejected for indefiniteness because it is unclear whether the antifungal agent includes the organic solvent or some purified version thereafter, which is important in understanding the scope of the composition of the antifungal agent claimed. Is the organic solvent-extracted fraction the antifungal agent still in the organic solvent or after the organic solvent has been evaporated?
Maintained Objections/Rejections
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 1-14 and 41-42 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. laws of nature, physical phenomena, or abstract ideas) without significantly more. The claims recite naturally occurring bacteria and a naturally occurring antifungal agent, which are both products of nature, which are a judicial exception to eligible statutory classes. These judicial exceptions are not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for reasons that follow.
Step 1: Is the claim directed to a process machine, manufacture, or composition of matter?
Claims 1 and 6 are amended to add further limitations to the antifungal agent but remain directed to the antifungal agent. Claim 3 is amended to broaden the scope of potential bacteria sources of the antifungal agent, but remain directed to the antifungal agent.
Claims 1-6 remain reciting an antifungal agent derived from a bacterium.
Claims 41-42 recite an antifungal agent derived from a bacterium.
Claims 7, 9, and 12 are amended to add further limitations to the antifungal agent composition but remain directed to the antifungal agent composition.
Claims 7-13 remain reciting an antifungal composition comprising of an antifungal agent derived from a bacterium and a carrier.
Claim 14 remain reciting bacteria strains.
Thus, claims 1-14 remain directed to compositions of matter and new claims 41-42 are also directed to compositions of matter.
Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the judicial exception as a "product of nature". The Office’s eligibility analysis uses the term “product of nature” to refer to a "law of nature" or "natural phenomenon” claimed as a physical product. For example, see Myriad Genetics, Inc., 569 U.S. at 590-91, 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”). As explained in those decisions, products of nature are considered to be an exception to the statutory classes because they tie up the use of naturally occurring things, and they have been labeled as both laws of nature and natural phenomena. Products of nature are identified by the markedly different characteristics analysis according to MPEP 2106.04(c).
Claim 1 recites an antifungal agent derived from an Acidipila bacterium. The specification teaches that the claimed Acidipila bacterium is naturally occurring and is isolated from soil and naturally produces the antifungal agent (paragraph 64). The claimed bacterium is taught to be the wildtype bacterium isolated from soil. Claim 7 recites an antifungal composition comprising of an antifungal agent derived from an Acidipila bacterium and a carrier. The specification does not distinctly define a carrier. The specification teaches that the composition contains the antifungal agent as an effective ingredient (paragraph 58). A “dosage form” is not defined by the definition – only nonlimiting examples are given. The broadest reasonable interpretation of “dosage form” is a form that allows a measured quantity of the substance to be allocated. As such, the list of dosage forms encompasses the antifungal agent in water, such as the dosage forms solution, infusion, spray, and injection. The infusion, spray, and injection imply how the antifungal agent is administered, but still encompasses the antifungal agent in water, in addition to any non-nature-based products (e.g. syringe) that may be used to enable this infusion, spray, or injection of the antifungal agent. However, these non-nature based products are not considered in the markedly different characteristics analysis; only the nature-based products are included. There is no evidence in the specification that the antifungal agent exhibits any structural or functional differences in water as compared to in nature, and the water itself has no structural or functional changes. Accordingly, claims 1 and 7 encompass an antifungal agent or antifungal composition comprising of a naturally occurring antifungal agent and carrier that do not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, and therefore the antifungal agent and antifungal composition are directed to products of nature.
Claims 2-6, 8-13, and 41-42 depend on claims 1 or 7.
Claims 41 and 42 further limit the antifungal agent or antifungal composition to specific dosage forms that encompass dosage forms that are directed to products of nature for the same reasons recited for claims 1 and 7.
Claims 2 and 8 describe the natural antifungal function of the antifungal agent. Claims 3 and 9 name the naturally occurring strains of bacteria the antifungal agent is derived from. Claims 4, 5, 10, and 11 name the fungus genera that the antifungal agent naturally inhibits the growth of, as taught by Examples 3-4 of the specification (pages 23-24). The appropriate counterparts to compare these claimed bacterium and antifungal agent with for markedly different characteristics analysis are the naturally occurring bacterium and antifungal agent it produces. The appropriate characteristics to analyze for markedly different characteristics are their functional and structural characteristics. The specification teaches that these are innate properties of the naturally occurring antifungal agent observed by the applicant. MPEP 2106.04(C) states:
“The courts have emphasized that 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, 569 U.S. at 580, 106 USPQ2d at 1974-75.”
Accordingly, claims 2-5, 8-11, and 41-42 as a whole each recite a nature-based product that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, and therefore is directed to a product of nature.
Claims 6 and 12 is amended to recite that the antifungal agent is the organic solvent-extracted fraction of a culture or culture supernatant of the claimed bacterium. The appropriate counterparts to compare this claimed antifungal agent with for markedly different characteristics analysis is the naturally occurring antifungal agent in its natural state as produced by its source bacterium. There is no evidence provided that the antifungal agent in this fraction has any structural or functional differences from its naturally occurring counterpart.
Accordingly, claims 6 and 12 as a whole recite a nature-based product that does not exhibit markedly different characteristics from its naturally occurring counterpart, and therefore is directed to a product of nature.
Claim 13 is directed to the antifungal composition, wherein the composition is formulated as a pharmaceutical dosage form, a detergent, a food additive, a cosmetic, or a disinfectant. The specification provides examples but does not explicitly define nor limit the definition of these compositions. The specification broadly teaches the antifungal agent may be used anywhere inhibition of fungal growth is desired (paragraph 59). The claim is sufficiently broad to encompass the antifungal agent being formulated with a nature-based product, for example, water, to produce a pharmaceutical dosage form. There is no evidence that the antifungal agent exhibits any structural or functional differences in water as compared to in nature, and the water itself has no structural or functional changes.
Accordingly, claim 13 encompasses an antifungal composition comprising of a naturally occurring antifungal agent and carrier that do not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, and therefore the antifungal composition is directed to a product of nature.
Claim 14 recites four Acidipila bacteria strains. The specification teaches that the claimed Acidipila bacteria strains are naturally occurring, are isolated from soil (paragraph 64), and given names MT3 – MT6 (table 1 on p. 22). Therefore, claim 14 as a whole recites a naturally occurring nature-based product and therefore is directed to a product of nature.
Step 2A, Prong 2: If the claim is directed to a judicial exception, does the claim recite additional elements that integrate the judicial exception into a practical application? (MPEP 2106.05(a)-(c), (e)-(h))
Having determined that claims 1-14 and 41-42 recite a judicial exception, it is then determined whether the claims recite additional element that integrate the judicial exception into a practical application.
Claims 1 and 7 recite the additional element of the antifungal formulated as a specific dosage form. The specification teaches that the composition contains the antifungal agent as an effective ingredient (paragraph 58). The scope of the claim broadly encompasses dosage forms wherein the antifungal agent or composition is formulated with water. There is no evidence that the antifungal agent exhibits any structural or functional differences in these dosage forms, such as water, as compared to in nature, and the water itself has no structural or functional changes. The dosage forms can therefore be understood as an insignificant extra-solution activity, conventional in the arts, to carry the antifungal agent. The antifungal agent has no structural or functional changes from the wildtype and the additional elements recited do not amount to anything more than insignificant extra-solution activity.
Claim 14 does not include any additional elements to the product of nature, the bacteria strains.
Claims 2-6 and 41 depend on claim 1 and incorporate all its limitations. Claims 8-13 and 42 depend on claim 7 and incorporate all its limitations.
Claims 2-5 and 8-11 only describe the inherent and innate properties of the product of nature, the antifungal agent. The product of nature has no structural or functional changes from the wildtype.
Claims 41-42 narrow down the possible dosage forms but still include forms that could comprise of the antifungal agent with carriers, such as water, that do not make the claim as a whole amount to significantly more than the judicial exception, as explained previously.
Therefore, claims 2-5, 8-11, and 41-42 also do not include any additional elements to the antifungal agent of claim 1 and antifungal composition of claim 7, respectively.
Claims 6 and 12 recite the antifungal agent is the organic solvent-extracted fraction of a culture or culture supernatant of the Acidipila bacterium it is produced by. The specification teaches the medium used for culture may be any medium generally used for bacterial culture (p. 14, paragraph 0056). The specification further teaches that the concentration, extraction, and purification can be performed by conventional methods, and one such method is extraction with an organic solvent such as methanol (p. 14, para. 0057). MPEP 2106.05(g) states:
"The term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim. … As explained by the Supreme Court, the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978)."
The culture can therefore be understood as an insignificant extra-solution activity, conventional in the arts, to allow the bacteria to replicate so that it produces more of its naturally antifungal agent.
The extraction process can be understood as an insignificant extra-solution activity, conventional in the arts, after culturing, to then separate the cell lysate debris from the cell metabolites released into the cell culture.
There is no evidence the antifungal agent has any structural or functional changes from the wildtype and the additional elements recited do not amount to anything more than insignificant extra-solution activity added to the antifungal agent of claim 1 or antifungal composition of claim 7.
Claim 13 recites intended uses for the composition of claim 7, formulated as a pharmaceutical dosage form, a detergent, a food additive, a cosmetic, or a disinfectant. It does not amount to more than generally linking the use of the judicial exception to a particular technological environment or field of use, i.e. inhibiting fungal growth. Specifically in regards to the pharmaceutical dosage form, the MPEP 2106.04(d)(2) states, "If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration."
Therefore, claims 1-14 and 41-42 do NOT recite additional elements that integrate the judicial exception into a practical application.
Step 2B: If the claim is directed to a judicial exception, determine whether any additional element, or combination of additional elements, in the claim is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception. (MPEP 2106.05(d))
Having determined that claims 1-14 and 41-42 do not recite additional elements to the judicial exception or the additional elements recited do not integrate the judicial exception into a practical application, it is then determined whether any additional element in the claim is sufficient to ensure the claim as a whole amounts to significantly more than the judicial exception.
Claim 14 does not recite any additional elements to the judicial exception and therefore the claim as a whole does NOT amount to significantly more than the judicial exception.
Claims 1-13 and 41-42 recite elements that represent only well-understood, routine, conventional activity. Claim 1 and 7 encompass forms that do not amount to more than the judicial exception. The specification teach conventional culture and extraction methods, as is relevant to claims 6 and 12. The other dependent claims of Claim 1 and 7 only describe the inherent and innate properties of the product in claim 7. Claim 13 recites a well-understood, routine, and conventional use of an antifungal agent. It is well known in the art that antifungal agents could be used in a pharmaceutical dosage form, a detergent, a food additive, a cosmetic, or a disinfectant. Therefore, these limitation does not amount to an inventive concept.
As such, claims 1-14, and 41-42 do not recite any additional element in the claim that is sufficient to ensure that claim as a whole amounts to significantly more than the judicial exception.
Claim Rejections - 35 USC § 112(a) – Written Description
Claims 1-13 and 41-42 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 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.
Independent claims 1 and 7 are directed towards an antifungal agent derived from an Acidipila bacterium, or a composition comprising of this antifungal agent. The claims are therefore directed towards a genus of agents, an antifungal agent, derived from a genus of bacteria, Acidipila. The claims were amended to specify formulation forms and specify the agent comprising a secondary metabolite of the bacterium.
Dependent claims 2, 4-5, 8, 10-11 further describe the antifungal agent by its function, inhibiting the growth of filamentous fungus and/or yeast, and recites specific genera of fungus and/or yeast. Dependent claim 13 and 41-42 further recite the antifungal agent or composition in a specific formulation or dosage form.
Dependent claims 3 and 9 further describe the antifungal agent by the particular Acidipila bacteria strain it is isolated from, which is directed towards how the antifungal agent is made and narrows one embodiment of the invention to the particular species of antifungal agents produced by the claimed strains. Dependent claim 13 describes the antifungal agent formulated as a composition as a pharmaceutical, dosage form, a detergent, a food additive, a cosmetic, or a disinfectant, which is directed to the components in a composition around the antifungal agent.
Dependent claims 6 and 12 describe the antifungal agent as the culture or culture supernatant of the Acidipila bacterium, or some derivative thereof. As such, the limitations of claim 6, 12 are directed to both how the antifungal agent is made, by culturing the claimed bacteria, and to the components in a culture around the antifungal agent.
Regarding the antifungal agent itself, how it is made, and its function, the specification teaches that the claimed bacteria belonging to the genus Acidipila produced the antifungal agents (paragraph 8). The specification teaches the bacteria produces the antifungal agent when cultured (Examples 2-3, pages 22-24), specifically in the known Medium 1426 at 28°C for 14 days (paragraph 75) but that the culture conditions may be appropriately determined by a person skilled in the art depending on the emergence and growth of the bacterial cells (paragraph 54). Therefore, the culture conditions are selected from their ability to grow the desired bacteria. The specification teaches the natural functions of the antifungal agent is inhibiting the growth of specific fungi (Examples 3-4, pages 23-24).
Regarding the composition comprising of the antifungal agent, the specification teaches the medium used to culture the bacteria may be any medium generally used for bacterial culture (paragraph 56) or specifically the known Medium 1426 (paragraph 75). The specification teaches the composition comprising of the antifungal agent is formulated as a pharmaceutical dosage form, a detergent, a food additive, a cosmetic, or a disinfectant (paragraph 22) or any dosage form selected depending on purpose of use (p. 15, para. 0058). The specification provides examples of these compositions (paragraph 58), but does not explicitly define nor limit the definition of these compositions. The specification broadly teaches the antifungal agent may be used anywhere inhibition of fungal growth is desired (paragraph 59).
Written description is met for the limitations regarding the strains of Acidipila bacteria that could produce an antifungal agent, a method of culturing the bacteria to produce the antifungal agent using Medium 1426, and the antifungal activity against the fungi tested in Examples 3-4. Written description is met for some components of the antifungal composition, but not for the antifungal agent itself.
Regarding the species of antifungal agent itself, how it is made, and its function, the disclosure lacks written description for the structure of the antifungal agent and any correlation between its structure and its function, how it is made, or what bacteria it is derived from. The disclosure does not teach any partial or full structure or any physical or chemical properties of the antifungal agent. Although the disclosure teaches a functional characteristic, there is no described correlation between function and structure responsible for the function so that one skilled in the art can arrive at a structure based on the function.
The state of the art teaches that the structure and what constitutes an antifungal agent is not one that can be resolved by antifungal function alone as there is high and distinct structural diversity amongst compounds that have antifungal activity. For example, one genus (e.g. Barka et al, Table 3, Antifungal agent producers) or even subspecies of bacteria (for example, Streptomyces violaceusniger YCED9 in Barka et al, page 24) can produce structurally diverse antifungal agents. There is also high and distinct structural diversity amongst compounds that have antifungal activity against one fungus, and specifically against the claimed fungus. For example, numerous bacteria-derived antifungal agents against the Aspergillus has been reported (e.g. Yadav et al, Abstract and Vahedi-Shahandashti et al, section 5. Natural Products as Anti-Aspergillus Agents). There is also no common structure for antifungals. Although the art recognizes shared halogen atoms in some antifungal agents, it does not mean that all structures with halogen atoms are antifungals, and all antifungal agents have halogen atoms (Bouz et al, section Conclusions and Remarks).The state of the art teaches that clinically used antifungals can be classified according to their mechanism of antifungal function (Bouz et al, section 2. Clinically Used Antifungals); thus, knowing the agent's mechanism of action could narrow down the potential structure of the antifungal agent, but not completely resolve the structure. However, the specification does not provide any insight into the antifungal agents’ specific mechanism of action. In other words, the limitations that merely describe the bacteria source of the antifungal agent and the target fungus do not limit the structure of the antifungal agent to allow one skilled in the art to determine what antifungal agent structure the applicant is in possession of.
Regarding the composition comprising of the antifungal agent, the disclosure lacks written description for any correlation between the disclosed culture components and the antifungal agent that can be produced; and any correlation between the disclosed formulations and the structure of the antifungal agent that it can comprise.
Specifically, regarding the limitations directed to the antifungal agent in a composition formulated as pharmaceutical dosage form, a detergent, a food additive, a cosmetic, or a disinfectant, the specification does not teach any particular composition that distinctly limits the structure of the antifungal agent that it can comprise.
Specifically regarding the antifungal agent as the culture or culture supernatant of the claimed bacteria, The antifungal agent is considered a separate entity from the culture and supernatant. The specification teaches that the disclosed bacterium belonging to the genus Acidipila has the ability to produce an antifungal agent (page 13, paragraph 54). It is taught in the specification that the culture media is known and used to grow the bacteria. One skilled in the art would understand that the bacteria produces the antifungal agent into the culture and that the culture media provides the bacteria the necessary cofactors to grow and produce its secondary metabolites, such as those that have antifungal properties. It follows that although the claims recite that the antifungal agent is the culture, the specification teaches that the culture contains the antifungal agent. Therefore, the antifungal agent is a distinct and separate entity from the bacteria culture, produced by the bacteria into the culture media. From this, there is no disclosed correlation between the disclosed culture components and the antifungal agent that can be produced. The disclosure teaches a broad range of routine culture compositions and conditions, but does not teach any particular culture that limits the antifungal agent that could be produced by the claimed bacteria.
The state of the art teaches that there are structurally diverse antifungal agents in clinically used pharmaceutical formulas ((Bouz et al, section 2. Clinically Used Antifungal and Figures 1-2) and formulations under clinical development ((Bouz et al, Figures 3-17) and in preclinical development (Bouz et al, section 4. New Compounds as Potential Antifungals (In Preclinical Stages)). There is no disclosed or art-recognized correlation between the disclosed formulations and the structure of the antifungal agent that it can comprise. In other words, knowing the antifungal agent can be formulated as the broad class of pharmaceutical formulations, as claimed, does not distinctly limit the structure of the antifungal agent.
The state of the art teaches hat Medium 1426 (also known as SSE/HD 1:10 medium) is a known soil solution equivalent, commonly used to culture the broad group of bacteria that naturally grow in soil (Fiorini et al, section 4.2. Cultivation Strategies), which is applicable to the claimed strains of Acidipila bacteria found in soil, as taught by the specification. The state of the art teaches that selection of some components of culture medium and culture conditions, such as acidity, temperature, cultivation time, and media components such as carbon sources and nitrogen sources, do skew the production of certain families of metabolites, but they do not predict distinct structures of antifungal agent produced (Sidorova et al, Introduction, paragraphs 4-5). The specification discloses the culture conditions is chosen to grow the bacteria but does not disclose selection of the culture condition guided by any factors meant to skew the structure of the antifungal agent. Therefore, knowing the culture components and conditions disclosed does not limit the structure of the antifungal agent.
MPEP 2163(II)(A)(3)(a)(i) pertaining to claims drawn to a species or single embodiment states:
“Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention.”
Particularly regarding the claim limitations that teach what bacteria can make the antifungal agent and the function of the antifungal agent, MPEP 2163(I)(A) states:
“An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function.”
With the state of the art teaching the breadth of antifungal structures produced by a bacteria within the same genus, the inability to determine antifungal agent structure by how the bacteria is cultured or by what pharmaceutical formulation the antifungal agent is placed in, and the lack of disclosed or art-recognized function-structure correlation for antifungal agents; the lack if description in the disclosure directed towards the distinct structure of the antifungal agent claimed prevents one of ordinary skill in the art to reasonably conclude that the applicants is in possession of the structure of the claimed antifungal agent derived from Acidipila bacteria. The disclosure therefore lacks written description for any species of antifungal agent derived from Acidipila bacteria.
Regarding the claimed genus of antifungal agents, without written description for any species of an antifungal agent, the disclosure also lacks written support for the genus of antifungal agents derived from a Acidipila bacterium. agents derived from a Acidipila bacterium as they lack written description for any species, and therefore it is unclear whether their claimed invention are representative species of the claimed genus of antifungal agent.
The state of the art teaches that a genus of bacteria can produce broadly structurally diverse antifungal agents. For example, one genus (e.g. Barka et al, Table 3, Antifungal agent producers) or even subspecies of bacteria (for example, Streptomyces violaceusniger YCED9 in Barka et al, page 24) can produce structurally diverse antifungal agents. As such, a representative number of species for the genus would need to span this structural diversity. However, the disclosure lacks any structural information or identifying functional information that could narrow down the structure. The claimed genus lacks any reduction to drawings. The claimed genus lacks relevant, identifying characteristics sufficient to show the applicant was in possession of the claimed genus for the same reasons stated above for lack of written description for any one antifungal agent species.
Pertaining to claims drawn to a genus, MPEP 2163(II)(A)(3)(a)(ii) states:
“The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021). … A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014)”
With the state of the art teaching that antifungal agents even within a genus has a wide breadth of structural diversity and no distinct structures taught by the disclosure, and therefore no representative species of the claimed genus, one of ordinary skill in the art cannot reasonably conclude that the applicants is in possession of the genus of antifungal agents derived from Acidipila bacteria.
For all these reasons, the disclosure lacks adequate written description for the claimed antifungal agent and the claimed genus of antifungal agents, and one of skill in the art cannot reasonably conclude that applicant had possession of the invention, as claimed in claims 1-13, at the time the instant application was filed.
Response to Arguments
Applicant's arguments filed 05/04/2026 have been fully considered but they are not persuasive for the following reasons:
Claim Rejections - 35 U.S.C § 101
Regarding the rejection of claims 1-14 under 35 U.S.C. § 101, applicant amended independent claims 1 and 7 and added claims 41-42 to further limit the antifungal agent or antifungal composition.
Regarding the amendment that the antifungal agent is specifically a secondary metabolite of the Acidipila bacterium, this does not change the fact that this agent, regardless of the category of metabolite it belongs to, is still naturally produced by the bacteria in nature, and for the same reasons originally presented, is still a product of nature.
Regarding the further amendment that the antifungal agent is further formulated as a dosage form selected from a list of forms, the Examiner agrees that some amended dosage forms in the claimed list of forms changes the nature of the antifungal agent and amount to significantly more than the judicial exception. However, not all dosage forms claimed do, as explained in the rejection above, and because of those forms, the claim as a whole remains rejected under 35 USC § 101.
The Examiner agrees that the dosage forms that are analogous to the composition in the example cited by the Applicant, from Subject Matter Eligibility Examples: Life Sciences – Example 28 (“Vaccines”) (published May 2016), changes the nature of the antifungal agent and amount to significantly more than the judicial exception.
Regarding the preliminary argument by the Applicant regarding the broadest reasonable interpretation of “dosage forms”, the Examiner disagrees these forms reasonably eliminates a formulation in water and unequivocally necessitates additional parameters that would amount to significantly more than the judicial exception. A “dosage form” is not defined by the definition – only nonlimiting examples are given – and it is not explicitly limited to a dosage form that requires the argued sterility and carriers or other factors that would amount to significantly more. In claim 3 of the same example cited by the Applicant, from Subject Matter Eligibility Examples: Life Sciences – Example 28 (“Vaccines”) (published May 2016), even a “vaccine” is not considered to inherently nor implicitly have the claimed limiting broadest reasonable interpretation the Applicant purports for “dosage form”. Therefore, the broadest reasonable interpretation of “dosage form” also does not implicitly have the argued limitations and is considered to be any form that allows a measured quantity of the substance to be allocated at time and encompasses the antifungal agent in water, which, for the reasons outlined in the previous office action and in the explanation for claim 3 from Subject Matter Eligibility Examples: Life Sciences – Example 28 (“Vaccines”) (published May 2016), is still a product of nature.
By this maintained BRI, the dosage form that is a solution, a spray, an injection, or an infusion, which can comprise the antifungal agent in water, is still a product of nature. Taken as a whole, the amended claims 1 and 7 are still products of nature.
Applicant amended claims 3 and 9 to broaden the bacteria source the antifungal is from, and the amended parent claim does not eliminate the product of nature. Therefore, these claims still include the product of nature.
Applicant amended claim 6 and 12 to limit the antifungal agent to specifically the organic solvent-extracted fraction of the culture or a culture supernatant of an Acidipila bacterium, and argues that since this organic solvent-extracted fraction contains a different mixture of components than the closest natural analog – i.e. unextracted culture supernatant – the extracted fraction would display unique antifungal properties compared to the natural analog. The specification teaches the use of extraction specifically by methanol that is eventually evaporated away (para 0074).
MPEP 2106.04(c)(II)(A) states:
“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. For example, assume that applicant claims an inoculant comprising a mixture of bacteria from different species, e.g., some bacteria of species E and some bacteria of species F. 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.”
Furthermore, MPEP 2106.04(c)(II)(A) states:
“Although the selected counterpart should be in its natural state, examiners should take care not to confuse the counterpart with other material that may occur naturally with, or adjacent to, the counterpart. For example, assume that applicant claims a nucleic acid having a nucleotide sequence derived from naturally occurring gene B. Although gene B occurs in nature as part of a chromosome, the closest natural counterpart for the claimed nucleic acid is gene B, and not the whole chromosome.”
Accordingly, the appropriate counterpart for this antifungal agent is not the unextracted culture supernatant, as the Applicant argues, but rather the individual nature-based components of the extracted mixture. That includes the naturally occurring antifungal in its natural state, the naturally occurring components that co-exist and may be released by the bacteria with the antifungal, and other naturally occurring components in the culture media. The markedly different analysis does not include non-nature-based products. The markedly different analysis is then performed on each of these nature-based product components compared to their natural counterparts.
Therefore, Applicant’s argument between the difference in composition between the extracted and unextracted culture is moot because the analysis is not using the composition as a whole but rather the difference between the structure and/or function of each nature-based product in the composition to its naturally occurring counterpart in its natural state. As explained in the rejection, the antifungal agent maintains its natural antifungal function and there is no evidence that there is any structural changes to the antifungal agent itself.
Even if the comparison analysis was appropriately narrowed down to the components within the culture and the naturally occurring nature-based components, (1) there is no evidence or teaching of unique antifungal properties, and (2) if any component did exhibit this claimed unique property, and it is reasonably expected, then it is not an unexpected result, and therefore would not amount to a markedly different property. The Applicant essentially argues expected unexpected results. Finally, MPEP 2145(1) recites:
“Arguments presented by applicant cannot take the place of evidence in the record. See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984); In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) ("An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness.").”
It is reasonably likely that the antifungal agent is not the entirety of the culture, nor even the entirety of the organic solvent-extracted fraction of the culture, but some specific compound or compound(s) released into the culture. The Applicant has not provided any evidence that the other parts of the composition bear any significance to the structure or function of the antifungal agent itself nor that they are significantly different in structure or function than its naturally occurring counterpart. The Applicant has not provided any evidence or teachings that this/these antifungal agent has any markedly different functions or structures than its naturally occurring counterpart. Further, the Applicant has not provided any evidence or teachings of the argued purported unique and/or unexpected properties compared to the natural analog and these unique properties cannot be assumed. The extracted antifungal agent still functions as an antifungal agent. Even if there were purported increased antifungal potency, this would also be expected, as the extracted fraction likely contains a more purified or concentrated form of the antifungal agent.
Absent evidence from the Applicant that the extraction explicitly changed the structure and/or function of the antifungal agent - that is, the actual active compound - and not just the extraneous composition of compounds that co-exist with it and has no evidenced bearings on the structure and/or function of the antifungal agent, the claim as a whole does not amount to more than the judicial exception. Therefore, rejection of claims 6 and 12 under 35 USC 101 is maintained.
Claims 2, 4, 5, 8, 10, 11, and 13 are not amended nor argued and remain dependent on products of nature.
Claim 14 is independent and not amended nor argued.
Therefore, the rejection under 35 U.S.C. 101 is maintained for claims 1-14, and updated as necessary in response to Applicant’s amendments.
Applicant added claims 41 and 42 and specifically limit the antifungal agent or antifungal composition to specific dosage forms that still encompass forms that do not amount to significantly more than the judicial exception, for the reasons outlined for claim 1 and 7, which they depend upon. Therefore, new claims 41-42 are newly rejected under 35 USC 101.
Claim Rejections - 35 USC § 112(a) Written Description
Applicant amended independent claims 1 and 7 and argues the extra limitations overcomes the previous written description rejection.
Regarding the amendment that the antifungal agent is specifically a secondary metabolite of the Acidipila bacterium, this does not change the fact that the structure or distinctly identifying characteristic of this antifungal agent is unknown. The claim to a secondary metabolite of the Acidipila bacterium does not disclose which distinct secondary metabolite is instantly claimed and what the secondary metabolite is.
Regarding the amendment that the antifungal agent is further formulated as a dosage form selected from a list of forms or the various ways the culture containing the agent can be concentrated, the base antifungal agent, i.e. the active ingredient that makes the composition antifungal, is still unknown, even if the other parts of the composition can be envisioned, and therefore the full structure or distinctly identifying characteristic of the composition is also still unknown.
Regarding the written description requirement, MPEP 2163(I)(A) states:
“Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention.”
“An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function.”
“Written description issues may also arise if the knowledge and level of skill in the art would not have permitted the ordinary artisan to immediately envisage the claimed product arising from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not necessarily constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species)”.
The claims do not describe the structure or distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. The invention is described by a method of making when there is no described or art-recognized correlation and/or its function when there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. Therefore, the arguments and the amendments do not provide sufficient additional information for sufficient written description and the rejection is maintained for claims 1-13 and updated to include new claims 41-42 for the same reasons.
Conclusion
No claims are allowed.
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.
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/BONIRATH CHHAY/Examiner, Art Unit 1645
June 11, 2026
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 June 12, 2026
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