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 .
Priority
The present invention is a 371 National Stage Entry of PCT/EP2022/065569 (filed on 06/08/2022) and claims priority to French application FR2106084 (filed on 06/09/2021).
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 1-6 and 8-14 are currently pending and have been examined on their merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/07/2023 is in compliance with the provisions of 37 C.F.R. 1.97. All references cited in this IDS have been fully considered.
Claim Objections
Claim 1 is objected to because the taxonomic name “Lactobacillus” should be introduced before using the abbreviation “L.”. Accordingly, it is recommended that claim 1 be amended to read “Lactobacillus casei SGC-K”.
Claim 8 is objected to because the conjunction “and” should be added before the final element of the list of subjects.
Appropriate correction is required.
Claim Interpretation
Applicant recites deposit numbers throughout the claim. The deposit numbers are arbitrary accession numbers assigned by the depository. Accordingly, they do not impart any meaningful structure on the composition (i.e., the bacterial strain) which has been deposited.
For the purpose of examination, the claims have been examined for the strain itself, not the deposit. In other words, prior art has been applied irrespective of whether the reference describes the accession number.
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 1-5 and 11-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature and natural phenomenon without significantly more.
The instant claims recites laws of nature and natural phenomena. These judicial exceptions (JEs) 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 as explained below:
Subject Matter Eligibility Guidance
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP § 2106:
Step (1): Is the claim directed to a process, machine, manufacture, or composition of matter?
Step (2A): Is the claim directed to a law of nature, natural phenomenon (product of nature), or an abstract idea?
Prong 1 – Does the claim recite a law of nature, natural phenomenon, or an abstract idea?
Product of Nature Definition
When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979.
The Markedly Different Characteristics Analysis
The first step in the analysis is to select the appropriate counterpart to the nature-based product. When the nature-based product is derived from a naturally occurring thing, then the naturally occurring thing is the counterpart. See MPEP § 2106.04(c)(II)(A).
The second step in the analysis is to identify appropriate characteristics to compare. Appropriate characteristics must be possessed by the claimed product, because it is the claim that must define the invention to be patented. Cf. Roslin, 750 F.3d at 1338, 110 USPQ2d at 1673. See MPEP § 2106.04(c)(II)(B).
The final step in the markedly different characteristics analysis is to compare the characteristics of the claimed nature-based product to its naturally occurring counterpart in its natural state, in order to determine whether the characteristics of the claimed product are markedly different. See MPEP § 2106.04(c)(II)(C).
Prong 2 – If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application?
Limitations that are indicative of integration into a practical application include:
Improvements to the functioning of a computer, or to any other technology or technical field. See MPEP § 2106.05(a);
Applying the judicial exception with, or by use of, a particular machine. See MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing. See MPEP § 2106.05(c);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. See MPEP § 2106.05(d);
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. See MPEP § 2106.05(e).
Step (2B). If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly different than the judicial exception such that they provide an inventive concept? This step includes evaluation of the same considerations under Step (2A), Prong 2, as well as two additional considerations:
Adding a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; and
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Analysis
Step (1)(direction to a process, machine, manufacture, or composition of matter):
Claims 1-5 and 11-14 are directed to a composition of matter, which is a statutory category.
Therefore, the answer to this step for claims 1-5 and 11-14 is yes.
Step (2A) Prong 1 (recitation of a law of nature, natural phenomenon, or an abstract idea):
Claims 1 and 11 are directed to compositions comprising Lactobacillus casei SGC-K.
Claim 2 further requires “one or more other probiotic bacterial strains”.
Claim 3 limits the “other probiotic bacterial strains” to be of the genera Bifidobacterium, Lactobacillus, Lactococcus, Enterococcus, Streptococcus, Kluyveromyces, Saccharomyces, Faecalibacterium, Blautia, Christensenella, Bacteroides, Eubacterium, Roseburia, Coprococcus, and combinations thereof. As discussed in the rejection under 35 U.S.C. § 112, this claim contains genera which are not “bacterial”. Nonetheless, they are also naturally occurring microorganisms.
Claims 4 and 12 limit the “other probiotic bacterial strains” to be specific species.
Claims 5 and 13-14 limit the composition to further comprise “one or more prebiotics”. Prebiotics are naturally occurring. See, for example, the list of prebiotics recited in p. 15, lines 3-6 of the specification.
Because the claims recite natural products (and combinations of natural product), the next relevant analysis is whether the natural products per se are markedly different from their natural counterparts or if the combinations of natural products, when viewed as a whole, are markedly different from the natural counterpart. The natural counterpart for each of these microorganisms and prebiotics are the microorganisms and prebiotics found in nature. There is no evidence that the strain SGC-K is markedly different from naturally occurring SGC-K. Moreover, there is no evidence that combining SGC-K with another microorganism (e.g., “one or more other probiotic bacterial strains”) or a prebiotic causes the combination to be markedly different in structure, property, or function.
Therefore, the answer to this prong for claims 1-5 and 11-14 is yes.
Step (2A) Prong 2 (recitation of additional elements that integrate the JE into a practical application):
Because the answer to 2A Prong 1 is yes, the next relevant analysis is whether the claims recite additional elements that integrate the JE into a practical application.
Claims 1-5 and 11-14 are merely directed to either the natural product per se or combinations of natural products. There is no evidence that formulating the bacterium per se or combining the bacterium with additional components such as other microorganisms or prebiotics cause the composition to be integrated such as by effecting a transformation or reduction of the JE to a different state or thing.
Therefore, the answer to this prong for claims 1-5 and 11-14 is no.
Step (2B)(recitation of additional elements that amount to significantly different than the JE such that they provide an inventive concept):
Because the answer to 2A Prong 2 is yes, the next relevant analysis is whether the claims recite additional elements that amount to significantly different such that they provide an inventive concept.
The closest prior art is Navarro López (US 2019/0282636 A1) which teaches probiotic compositions that modify the intestinal microbiota ([0022]). Navarro López teaches that Lactobacillus casei is a bacterium commonly used as a probiotic, found mostly in yogurt and other dairy products ([0030]). Navarro López teaches that probiotic compositions can comprise “other microorganisms in addition to…L. casei” including Lactobacillus, Streptococcus, Bifidobacterium, Saccharomyces, Kluyveromyces, and combinations therefore ([0056]).
Additionally, Kiely (US 2018/0360092 A1) teaches probiotic compositions comprising Lactobacillus casei (abstract). Kiely teaches that formulations comprising L. casei strains can further comprise “a prebiotic material” ([0013]) and “[t]he addition of one or more oligosaccharides, polysaccharides, or other prebiotics enhances the growth of lactic acid bacteria in the gastrointestinal tract” ([0124]).
Accordingly, the formulation of probiotics comprising L. casei including with other probiotic microorganisms and/or prebiotics were well-known and routine in the art and these limitations do not provide an inventive concept.
Therefore, the answer to step (2B) for claims 1-5 and 11-14 is no.
Conclusion
Claims 1-5 and 11-14 are directed to a judicial exception and do not qualify as eligible subject matter under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112:
(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.
(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.
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 1-5 and 8-14 are rejected under 35 U.S.C. 112(a), 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.
The specification lacks complete deposit information for the deposit of the following strains:
Lactobacillus casei SGC-K, deposited with CNCM under I-5663 (recited in claims 1 and 11; required by each of the pending claims);
Bifidobacterium longum NCC3001 (ATCC BAA-999)(recited in claims 4 and 12);
Bifidobacterium longum NCC2705 (CNCM 1-2618)(recited in claims 4 and 12);
Bifidobacterium longum NCC490 (CNCM 1-2170)(recited in claims 4 and 12);
Bifidobacterium lactis NCC2818 (CNCM I-3446)(recited in claims 4 and 12);
Bifidobacterium breve strain A (recited in claims 4 and 12);
Lactobacillus paracasei NCC2461 (CNCM 1-2116)(recited in claims 4 and 12);
Lactobacillus johnsonii NCC533 (CNCM 1-1225)(recited in claims 4 and 12);
Lactobacillus rhamnosus GG (ATCC53103)(recited in claims 4 and 12);
Lactobacillus rhamnosus NCC4007 (CGMCC 1. 3724)(recited in claims 4 and 12);
Enterococcus faecium SF 68 (NCC2768; NCIMB10415)(recited in claims 4 and 12).
Because it is not clear that the properties of these strains are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the best mode disclosed by the specification requires the use of these specific strains, a suitable deposit for patent purposes is required.
It is noted that applicant indicates that Lactobacillus casei SGC-K was deposited with the CNCM on March 8, 2021, under accession no. CNCM I-5661. It is not clear whether this deposit was made under the provisions of the Budapest Treaty.
There is no deposit information provided for any of the strains described in claims 4 and 12.
If the deposit has been made under the provisions of the Budapest Treaty, the deposit requirement may be fulfilled by filing an affidavit or declaration by applicants or assignees or a statement by an attorney of record who has authority and control over the conditions of the deposit over his or her signature and registration number averring that:
the deposit was made under the Budapest treaty and “all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent”.
This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR §1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring that:
“during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request”;
“all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application”;
“the deposits will be maintained in a public depository for a period of at least thirty years from the date of the deposit or for the enforceable life of the patent or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest”; and
“the deposits will be replaced if they should become non-viable or non-replicable”.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the cell line described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing of a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant's possession at the time the application was filed.
Applicant's attention is directed to In re Lundak, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR § 1.801-1.809 for further information concerning deposit practice.
Claim 6 is rejected under 35 U.S.C. 112(a) because the specification, while being enabling for maintaining muscle mass and/or function, does not reasonably provide enablement for increasing muscle mass and/or function.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors considered when determining if there is sufficient evidence to support that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue” include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. See In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). MPEP § 2164.04
further states that although the analysis and conclusion of a lack of enablement are based on these factors and the evidence as a whole, it is not necessary to discuss each factor in the enablement rejection.
With respect to the breadth of the claims and the nature of the invention, the claims are directed to the following:
Claim 6 is directed to a method for maintaining or increasing muscle mass and/or function in a subject in need thereof, in particular a malnourished subject, in an elderly subject, in particular a malnourished elderly subject, and in a subject performing intense physical exercise.
The above methods require administering to the subject the composition of claim 1.
With respect to the state of the prior art, the closest prior art is Navarro López (US 2019/0282636 A1) which teaches probiotic compositions that modify the intestinal microbiota ([0022]). Navarro López teaches that Lactobacillus casei is a bacterium commonly used as a probiotic, found mostly in yogurt and other dairy products ([0030]). Navarro López teaches that probiotic compositions can comprise “other microorganisms in addition to…L. casei” including Lactobacillus, Streptococcus, Bifidobacterium, Saccharomyces, Kluyveromyces, and combinations therefore ([0056]). Navarro López teaches that the probiotic composition can be used for the treatment and/or prevention of atopic dermatitis.
None of the prior art references teach or suggest the use of Lactobacillus casei SGC-K, especially for effects on muscle mass.
With respect to the existence of working examples and the amount of direction provided by the inventors, applicant teaches the use of Lactobacillus casei SGC-K on male Wistar rats aged 18-20 months (Example 1). Specifically, applicant found the restricted diet (R) and restricted diet + SGC-K (R+SGC-K) ingested 21.3 ± 0.1 g and 20.9 ± 0.1 g, respectively. Applicant teaches that “[t]he supplementation with L. casei SGC-K probiotics…did not have any specific effect during the restriction” (p. 28, lines 27-30). Applicant further teaches that the loss of lean body mass is significantly greater with the restriction in the R and R+ SGC-K animals in comparison with ad libitum (AL). Applicant states that “[t]hese results indicate that the ingestion of the probiotic L. casei SGC-K makes it possible to limit the loss of lean body mass which is caused by undernutrition” (p. 29, lines 4-5).
Next, applicant assessed the effect on muscle mass (B.3). Applicant reports that supplementation with L. casei SGC-K made it possible to maintain muscle mass of undernourished rats.
Finally, applicant teaches that proteins S6 and elF2a were stimulated by the bacteria strain SGC-K in the muscle in models of frail rats (p. 31, lines 6-10).
With respect to the level of one of ordinary skill in the art, a person having ordinary skill in the art is a person having an understanding of microbiology and/or pharmaceutical sciences.
With respect to the level of predictability and the quantity of experimentation needed, as discussed above, the prior art does not teach or suggest the use of L. casei SGC-K. Accordingly, a person having ordinary skill in the art could look only to applicant’s disclosure to enable the invention. Applicant has not demonstrated that the composition is capable of increasing muscle mass.
As such, there would be a low level of predictability that the L. casei strain could actually perform this function and there would be an undue amount of experimentation needed to determine which, if any, conditions result in increasing muscle mass.
Conclusion
Claim 6 is enabled for maintaining muscle mass and/or function in a subject in need thereof and but is not enabled for increasing muscle mass.
Claim 10 is rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement.
The claim contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention.
The factors considered when determining if there is sufficient evidence to support that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue” include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. See In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). MPEP § 2164.04
further states that although the analysis and conclusion of a lack of enablement are based on these factors and the evidence as a whole, it is not necessary to discuss each factor in the enablement rejection.
With respect to the breadth of the claims and the nature of the invention, the claims are directed to the following:
Claim 10 is directed to a method for the prevention or the treatment of inflammatory pathological conditions chosen from (i) irritable bowel syndrome or disease, inflammatory bowel diseases, (ii) chronic obstructive pulmonary diseases, or (iii) other pathological conditions linked to chronic inflammation, including chronic intestinal or kidney inflammation, such as long-term inflammation caused by a viral infection such as an infection by a SARS-COV-2 virus.
The above method requires administering to the subject the composition of claim 1.
Applicant has not provided any special definitions for “treatment” and “prevention”, which are therefore interpreted in their broadest reasonable form to include any alleviation of disease and complete reduction of the probability of developing the associated condition, respectively.
With respect to the state of the prior art, the closest prior art is, Kiely (US 2018/0360092 A1) which teaches probiotic compositions comprising Lactobacillus casei (abstract). Kiely teaches that formulations comprising L. casei strains can further comprise “a prebiotic material” ([0013]) and “[t]he addition of one or more oligosaccharides, polysaccharides, or other prebiotics enhances the growth of lactic acid bacteria in the gastrointestinal tract” ([0124]). Kiely teaches that the composition can be used for prophylaxis and/or treatment of obesity, non-alcoholic fatty liver disease, obesity related inflation, metabolic dysregulation, and blocking fat absorption ([0020]-[0026]).
None of the prior art references teach or suggest the use of Lactobacillus casei SGC-K.
With respect to the existence of working examples and the amount of direction provided by the inventors, applicant teaches the use of Lactobacillus casei SGC-K on male Wistar rats aged 18-20 months (Example 1). Specifically, applicant found the restricted diet (R) and restricted diet + SGC-K (R+SGC-K) ingested 21.3 ± 0.1 g and 20.9 ± 0.1 g, respectively. Applicant teaches that “[t]he supplementation with L. casei SGC-K probiotics…did not have any specific effect during the restriction” (p. 28, lines 27-30). Applicant further teaches that the loss of lean body mass is significantly greater with the restriction in the R and R+ SGC-K animals in comparison with ad libitum (AL). Applicant states that “[t]hese results indicate that the ingestion of the probiotic L. casei SGC-K makes it possible to limit the loss of lean body mass which is caused by undernutrition” (p. 29, lines 4-5).
Next, the insulin sensitivity of animals was evaluated (B.2). Applicant states that when comparing the value of HOMA-IR index (composite index integrating insulinemia and glycemia) at day 58, it is observed that dietary restriction tends to reduce the HOMA-IR for R+SGC-K compared to AL (p. 29, lines 8-14). Moreover, applicant asserts that glycemia of animals in the group R+SGC-K decreased significantly more rapidly suggesting that L. casei SGC-K causes an insulin-sensitizing effect (p. 29, lines 28-29).
Finally, applicant teaches that proteins S6 and elF2a were stimulated by the bacteria strain SGC-K in the muscle in models of frail rats (p. 31, lines 6-10).
None of applicant’s working examples assess the effects of the bacterial strain on treatment or prevention of inflammatory pathological conditions.
With respect to the level of one of ordinary skill in the art, a person having ordinary skill in the art is a person having an understanding of microbiology and/or pharmaceutical sciences.
With respect to the level of predictability and the quantity of experimentation needed, as discussed above, the prior art does not teach or suggest the use of L. casei SGC-K. Accordingly, a person having ordinary skill in the art could look only to applicant’s disclosure to enable the invention. Applicant has not demonstrated that the composition is capable of treating or preventing (i) irritable bowel syndrome or disease, inflammatory bowel diseases, (ii) chronic obstructive pulmonary diseases, or (iii) other pathological conditions linked to chronic inflammation, including chronic intestinal or kidney inflammation, such as long-term inflammation caused by a viral infection such as an infection by a SARS-COV-2 virus.
As such, there would be a low level of predictability that the L. casei strain could actually perform this function and there would be an undue amount of experimentation needed to determine which, if any, conditions result in treatment or prevention of the conditions recited in claim 10.
Conclusion
Claim 10 fully lacks enablement.
Claims 2-4, 6, 8-10, and 12 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 2 recites the phrase “…the bacteria of one or more other probiotic bacterial strains”. It is unclear what “bacteria” applicant is referencing. Therefore, the phrase lacks antecedent basis. In the interest of compact prosecution, this claim is interpreted as if applicant’s claim is limiting the composition to further comprise “one or more other probiotic bacterial strains”.
Claim 3 depends from claim 2 and recites that “the other probiotic bacterial strains” are chosen from a list of genera.
First, the claim from which this claim depends allows for “one or more” strains (inclusive of a single bacterial strain). Accordingly, this claim is unclear because it requires “the other probiotic bacterial strains” (plural). It is therefore unclear if this claim requires multiple bacterial strains. To clarify the claim, it is recommended that applicant amend the claim to refer to “the one or more other probiotic bacterial strains”.
Second, the claim recites genera which are not bacteria within the “bacterial strain” Markush group (see, for example, Kluyveromyces and Saccharomyces). Accordingly, the group is either improper or applicant is using the term “bacterial” contrary to its plain meaning.
Claims 4 and 12 are similarly indefinite because, for the reasons discussed above, the claims improperly recite fungal/yeast species in the group of “probiotic bacterial strains”.
Additionally, the claims recite indefinite exemplary language. Description of examples or preferences is properly set forth in the specification rather than the claims (MPEP § 2173.05(d)). If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim (Id.). In this case, it is unclear if the specific “preferable” strains recited in this claim are required or not. In the interest of compact prosecution, it is recommended that applicant remove any exemplary claim language as, for the reasons discussed above, the specification is the proper location for description of examples or preferences.
Finally, the claims recite Bifidobacterium breve strain A. It is not clear to what strain applicant is referring.
Claims 6, 8, 9, and 10 are similarly considered to be indefinite because they recites a “subject” followed by exemplary language including “in particular” or “such as”. Therefore, it is unclear which, if any, subjects or conditions are actually required by the claim.
Claims 3-4 and 12 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claims upon which they depend, or for failing to include all the limitations of the claims upon which they depend.
Claims 3-4 and 12 broaden, rather than narrow, the scope of the claims from which they depend because, as discussed above, these claims recite fungal/yeast genera and species but depend from claims which introduce the group as “bacterial”.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
Conclusion
No claim is allowed.
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/GRANT C CURRENS/Examiner, Art Unit 1651
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