DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of claims 1-14 in the reply filed on 12/30/2025 is acknowledged.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claims Status
The claims filed 11/09/2023 have been entered. Claims 1-40 are pending. Claims 15-40 has been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/30/2025. Therefore, claims 1-14 are under examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Acknowledgment is made of applicant's claim for foreign priority. However, the foreign
priority document is not translated to English; therefore, the examiner cannot determine if it
discloses the presently claimed invention. Therefore, the effective filing date is 02/16/2023,
which is the PCT filing date.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/02/2023 and 04/11/2025 have been entered. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 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 1-6 recite an antifungal agent derived from a bacterium.
Claims 7-13 recite an antifungal composition comprising of an antifungal agent derived from a bacterium and a carrier.
Claim 14 recites bacteria strains.
Thus, claims 1-14 are 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. The claimed antifungal agent has no structural modifications from its naturally occurring counterpart and so the antifungal activity described in the specification, related to the drawing, is the innate function of the antifungal agent (Examples 3-4, pages 23-24). Therefore, Claim 1 as a whole recites a naturally occurring nature-based product and therefore is directed to a product of nature.
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). The scope of the claim therefore encompasses nature-based products, for example, water, as a carrier. 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, claim 7 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.
Claims 2-6 depend on claim 1 and incorporate all its limitations. Claims 8-13 depend on claim 7 and incorporate all its limitations.
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 and 8-11 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 recite that the antifungal agent is the culture or culture supernatant of the claimed bacterium, or a concentration, purification or extraction thereof or a mixture thereof. In other words, the scope of the claim encompasses the culture of the claimed bacteria. The specification teaches the medium used to culture the bacteria may be any medium generally used for bacterial culture (paragraph 56). The medium could therefore be a nature-based product, such as the soil it naturally occurs in. The culture components support the natural growth of the bacterium and natural production of its antifungal agent. The components together act as they would in nature. 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 in its natural state, 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.
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 recite a judicial exception, it is then determined whether the claims recite additional element that integrate the judicial exception into a practical application.
Claim 1 does not include any additional elements to the product of nature, the antifungal agent.
Claim 7 recites the additional element of a carrier in composition with the antifungal agent. The specification teaches that the composition contains the antifungal agent as an effective ingredient (paragraph 58) but does not distinctly define a carrier. The scope of the claim therefore broadly encompasses any carrier, which includes water. There is no evidence that the antifungal agent exhibits any structural or functional differences in its carrier, such as water, as compared to in nature, and the water itself has no structural or functional changes. The carrier 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 depend on claim 1 and incorporate all its limitations. Claims 8-13 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. Therefore, claims 2-5 and 8-11 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 a culture or culture supernatant of the Acidipila bacterium it is produced by, which includes the additional element of the culture medium as part of the antifungal agent. The specification teaches the medium used for culture may be any medium generally used for bacterial culture (paragraph 56). 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 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 added to the antifungal agent of claim 1 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 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 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.
Claims 1-5 and 14 do 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 6-13 recite elements that represent only well-understood, routine, conventional activity. The specification teach conventional culture, as is relevant to claims 6 and 12. Claim 7 does not amount to more than the conventional use of antifungal agents in a composition for its antifungal properties and claims 8-11 only describe the inherent and innate properties of the product in claim 7. Claim 13 simply 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. The specifications recite the use of conventional and known compositions of these formulations, but with using the claimed antifungal agent as the antifungal ingredient. Therefore this limitation does not amount to an inventive concept.
As such, claims 1-14 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)
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.
Written Description
Claims 1-13 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, 7, and 13 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.
Dependent claims 2, 4-5, 8, and 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 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). 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.
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:
“he 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.
Enablement Rejection
Claims 3, 9, and 14 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 claims contain 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. This is a biological deposit enablement rejection.
It is apparent that the bacterial strains represented by the NITE Deposit Numbers NITE BP-03614, NITE BP-03615, NITE BP-03616, and NITE BP-03617 are required in order to practice the invention since the claims directly claim the bacteria or the antifungal agent derived from these particular strains of bacteria. The deposit of biological organisms is considered by the Examiner to be necessary for the enablement of the current invention (see 37 CRF 1.808(a)). The examiner acknowledges the deposit of organisms under the NITE Deposit Numbers NITE BP-03614, NITE BP-03615, NITE BP-03616, and NITE BP-03617 in partial compliance with this requirement. However, said deposits are not in full compliance with 37 CFR 1.803-1.809.
If the deposit is made under terms of the Budapest Treaty, then an affidavit or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made under the terms of 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 CFR 1.808.
If a deposit is not made under the terms of the Budapest Treaty, then an affidavit, or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the following criteria have been met:
1) during the pendency of the application, access to the deposit will be afforded to one determined by the Commissioner to be entitled thereto;
2) 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; and
3) the deposits will be maintained for a term of at least thirty (30) years from the date of the deposit or for the enforceable life of the patent or for a period of at least five (5) years after the most recent request for the furnishing of a sample of the deposited material, whichever is longest; and
4) a viability statement in accordance with the provisions of 37 CFR 1.807; and
5) the deposit will be replaced should it become necessary due to inviability, contamination or loss of capability to function in the manner described in the specification.
In addition, the identifying information set forth in 37 CRF 1.809(d) should be added to the specification. See 37 CFR 1.803 – 1.809 for additional explanation of these requirements. To fulfill these requirements, Applicant must provide a statement ensuring 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, and provide the address of the depository.
Closest Prior Art
Barka, E. A., et al, Taxonomy, Physiology, and Natural Products of Actinobacteria, Microbiol Mol Biol Rev 80:1– 43, published 11/25/2015; hereafter referred to as Barka et al.
Barka et al teaches naturally occurring antifungal agents derived from Actinobacteria bacteria, which are ubiquitously and naturally found in aquatic and terrestrial ecosystems. The prior art differs from the instant application by the bacteria phylum the antifungal agent is derived from, Actinobacteria instead of the Acidobacteria phylum that the Acidipila bacterium of the instant application belongs to.
Crits-Christoph, A., et al, Novel soil bacteria possess diverse genes for secondary metabolite biosynthesis, Nature, vol 558, pages 440–444, published 06/13/2018; hereafter referred to as Crits-Christoph et al.
Crits-Christoph et al teaches newly identified members of the Acidobacteria, which is the most abundant bacteria phylum in soil biomes, from divergent lineages (Abstract), implying a broad representation of the phylum.
Furthermore, Crits-Christoph teaches that by genetic analysis, newly discovered Acidobacteria with divergent genomic lineages could produce secondary metabolites that are diverse and have been linked to antifungal activity. Each of these acidobacteria encoded an unusually large repertoire of gene clusters encoding biosynthetic enzymes (Abstract), such as NRPS and PKS that are of particular interest because the products of these enzymes include many secondary metabolites, such as antifungals (page 440, paragraph 5). Crits-Christoph further teaches that these gene clusters had high genetic diversity from one another, and that previous analyses have shown that structural divergence correlates strongly with genetic divergence (page 441, paragraph 3), implying potentially a broad range of unique compounds. The reference concludes that they uncovered extensive evidence for secondary metabolite synthesis by acidobacteria of compounds in which a large percentage isolated from other microbial sources, have antimicrobial activity (page 443, paragraph 4); and that these bacteria may be a source of natural products that can act as antibiotics (Abstract).
However, the prior art does not explicitly teach the bacteria is of the genus Acidipila within the phylum Acidobacteria. It also does not explicitly validate the product and antifungal function of the discovered gene clusters.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIRATH CHHAY whose telephone number is (571)272-0682. The examiner can normally be reached Mon-Thu 8AM-5PM EST.
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/B.C./
Examiner, Art Unit 1645
January 29, 2026
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645