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 .
Status of Claims
Claims 1-9 are pending.
Claims 1-9 are rejected.
Claims 1 and 7 are objected to.
Priority
Applicant’s claim for the benefit of a prior-filed application PCT/EP2022/068283 filed 01 July 2022 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Acknowledgment is made of applicant’s claim for foreign priority to EP21194475.6 filed 02 Sept. 2021 and PCT/CN2021/104588 filed 05 July 2021 under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Accordingly, the effective filing date of the claimed invention is 05 July 2021.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 02 Jan. 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the list of cited references was considered in full by the examiner.
Drawings
The Application does not include drawings.
Specification
References to Applicant’s specification are made with respect to the published version.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosure
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - The “Sequence Listing XML” has not been entered into the application because the required statement of no new matter, in accordance with 37 CFR 1.835(a)(4) or 1.835(b)(5), is missing.
While Applicant’s response to the pre-exam sequence notice indicates the support for the additions, deletions, or replacements of the sequence information with specific references to particular parts of the application as originally filed as required by 37 CFR 1.835(b)(4), Applicant’s response does not include a statement that the replacement "Sequence Listing XML" includes no new matter.
Required response - Applicant must submit a statement that the “Sequence Listing XML,” identified by the date the “Sequence Listing XML” was filed, includes no new matter.
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete
Required response - Applicant must:
• Provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Claim Objections
Claims 1 and 7 are objected to because of the following informalities:
Claim 1, line 8 recites “wherein identifying a first individual microbiome network comprises…”, which should recite “wherein identifying the first individual microbiome network” to increase clarity and use consistent terminology.
To increase readability in claim 1, the wherein clause in line 8 and subsequent sub-steps “(a) obtaining…; (b) obtaining…; and (c) determining…” should be moved under step “A) identifying…” and furthermore, Therefore, claim 1 should recite “A) identifying….skin assessment, wherein identifying….comprises the steps of: (a) obtaining…; (b) obtaining…; and (c) determining….; B) comparing…; and C) providing…”. Last, the substeps should be further indented than the steps of A) through C) in accordance with MPEP 608.01(m), and substep “(b)” should begin on a separate line than substep (a).
Claim 1 recites “(b)…a second populational microbiome network”, which should recite “a second population microbiome network”.
Claim 7 recites “wherein the benchmark individual microbiome network is obtained by selecting…; or finding…”, which is grammatically incorrect and should include a colon after “by” to recite “is obtained by: selecting…; or finding…”.
Appropriate correction is required.
Claim Interpretation
Claim 7 recites “wherein the benchmark individual microbiome network is obtained by selecting a group of benchmark persons…”. Claim 1, from which claim 7 depends, recites “…B) comparing the first individual microbiome network with a benchmark individual microbiome network”, but does not require a step of obtaining the benchmark individual microbiome network. Therefore, the limitation of claim 7 is interpreted to be a product by process limitation defining how the benchmark individual microbiome network was previously obtained. However, claim 7 does not require a step of obtaining the benchmark individual microbiome network. See MPEP 2113 I. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)
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.
Claims 1-9 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 1, and claims dependent therefrom, are indefinite for recitation of “a desired skin surface”. The term “desired” is a subjective term which renders the claim indefinite. The term “desired” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Furthermore, whether a skin surface is “desired” requires the exercise of subjective judgement without restriction, and the claims do not provide an objective standard for determining which skin surfaces are “desired”. As a result, it is not clear what embodiments of “a skin surface” are intended to fall within the metes and bounds of a “desired skin surface”. It is noted that claim 2 also recites “the desired skin surface” and therefore is indefinite for the same reasons. For purpose of examination, the claim is interpreted to mean “a skin surface of a person in need of skin assessment”.
Claim 1, and claims dependent therefrom, are indefinite for recitation of “the group of samples without the sample from the person”. There is insufficient antecedent basis for this limitation in the claim, because claim 1 previously recites “a group of samples consisting of N individuals including said person”, but does not recite a group of samples without the sample from the person. As a result, it is not clear if “the group of samples without the sample from the person” is referring to an entirely separate group of samples or if the group of samples is referring to the N individuals except for the person. For purpose of examination, the claim is interpreted to mean “a first group of samples consisting of N individuals and said person” and “a second group of samples consisting of the N individuals”.
Claim 2, and claims dependent therefrom, are indefinite for recitation of “generating a population microbiome network by representing microbial organism in each matrix as a network”. Claim 1, from which claim 2 depends, does not previously recite any matrices. As a result, it is not clear what matrices, “each matrix” is intended to refer to. Clarification is requested by claim amendment.
Claim 2, and claims dependent therefrom, are indefinite for recitation of “the group of samples”. Claim 1, from which claim 2 depends, recites “a group of samples…including said person” and “the group of samples without the sample from said person”. As a result, it is not clear if “the group of samples” is referring to the group of samples with or without the person. For purpose of examination, the limitation is interpreted to refer to either group.
Claim 5, and claims dependent therefrom, are indefinite for recitation of “the skin conditions of the desired skin surface…”. There is insufficient antecedent basis for “the skin conditions” of the desired skin surface because claims 1 and 4 do not previously recite any skin conditions. For purpose of examination, claim 5 is interpreted to mean “assessing skin conditions of the desired skin surface…”.
Claim 6 is indefinite for recitation of “The method according to claim 5 wherein the method further comprises a step of assessing the skin conditions of the desired skin surface and associating the first shift with the skin conditions”. Claim 5, from which claim 6 depends, already recites “The method according to claim 4 wherein the method further comprises a step of assessing the skin conditions of the desired skin surface and associating the first shift with the skin conditions”. It is not clear if claim 6 intends to require performing the exact same step in claim 5 a second time, or if these are intended to be the same limitation and the assessing and associating are only required once.
Claim 7 is indefinite for recitation of “the benchmark skin surface”. There is insufficient antecedent basis for the limitation in the claim because claims 1 and 7 do not previously recite a benchmark skin surface, and therefore it is not clear what skin surface is being referenced. The limitation is interpreted to mean “from a benchmark skin surface of the group…”.
Claim 8 is indefinite for recitation of “substantially the same”. The term “substantially” is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As a result, it is not clear how similar the identified first microbiome network and the benchmark individual microbiome network must be to be considered “substantially the same”.
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 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more.
The Supreme Court has established a two-step framework for this analysis, wherein a claim does not satisfy § 101 if (1) it is “directed to” a patent-ineligible concept, i.e., a law of nature, natural phenomenon, or abstract idea, and (2), if so, the particular elements of the claim, considered “both individually and as an ordered combination,” do not add enough to “transform the nature of the claim into a patent-eligible application.” Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016) (quoting Alice, 134 S. Ct. at 2355). Applicant is also directed to MPEP 2106.
Step 1: The instantly claimed invention (claim 1 being representative) is directed to a method of assessing skin. Therefore, the instantly claimed invention falls into one of the four statutory categories. [Step 1: YES]
Step 2A: First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in in Prong Two if the recited judicial exception is integrated into a practical application of that exception.
Step 2A, Prong 1: Under the MPEP § 2106.04, the Step 2A (Prong 1) analysis requires determining whether a claim recites an abstract idea, law of nature, or natural phenomenon.
Claim 1 recites the following steps which fall under the mental processes and/or mathematical concept grouping of abstract ideas:
A) identifying a first individual microbiome network of the a desired skin surface of a person in need of skin assessment, wherein identifying a first individual microbiome network comprises the steps of:
(a) obtaining a first population microbiome network from a group of samples consisting of N individuals including said person, wherein N is an integer of at least 20;
(b) obtaining a second populational microbiome network from the same group of samples without the sample from said person; and
(c) determining the first individual microbiome network of said person by subtracting the effects of the second population microbiome network from the first population microbiome network;
B) comparing the first individual microbiome network with a benchmark individual microbiome network; and
C) providing a cosmetic composition to change the first individual microbiome network toward the benchmark individual microbiome network,
The identified claim limitations falls into one of the groups of abstract ideas of mental processes and/or mathematical concepts for the following reasons. In this case, obtaining a first microbiome network and a second microbiome network from a group of samples with and without the person can be practically performed in the mind aided with pen and paper by analyzing generated microbiome data in the groups to determine correlations of amounts of different species across samples, and organizing the correlations into a network with nodes and edges, as discussed in Applicant’s specification at para. [0056]-[0062]). Furthermore, obtaining population microbiome networks further recites the mathematical concept of a mathematical relationship (i.e. correlations between microbial species), analogous to organizing information and manipulating information through mathematical correlations in Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014). Determining the first individual microbiome network by subtracting effects of the second population microbiome network from the first population microbiome network recites can be practically performed in the mind by comparing the first and second population microbiome networks to identify differences; furthermore, the subtracting step further recites the mathematical concept of a mathematical calculation (e.g. performing subtraction on effects between two networks). Comparing the first individual microbiome network to a benchmark network can be practically performed in the mind by performing data comparisons. Last, providing a cosmetic composition to change the first individual microbiome network can be practically performed in the mind by analyzing differences between the first individual network and the benchmark network to determine cosmetic agents capable of inducing particular effects. It is noted there is no requirement to physically administer a composition to a subject to actually induce the changes in the first microbiome network, and instead encompasses merely providing information of a cosmetic composition.
Dependent claims 2-9 further recite an abstract idea and/or are part of the abstract idea above. Dependent claim 2 further limits the abstract idea of obtaining a population microbiome network to include determining microbiome composition data (i.e. determining the composition of microbes from sequencing data) and generating a network for microbial organisms in matrices. Dependent claim 3 further limits the microbial composition data being obtained in claim 2 and therefore is part of the abstract idea of claim 2. Dependent claim 4 further recites the abstract idea of identifying a first shift of the first microbiome network toward the benchmark network. Dependent claims 5-6 further recite the mental process of assessing skin conditions of the skin surface and associating the first shift with the skin conditions. Dependent claim 7 defines the process in which the benchmark network was previously obtained, and therefore is part of the abstract idea of comparing the first network with the benchmark network of claim 1. Dependent claim 8 further recites the abstract idea of repeating steps (A), (B), and (C) until the first and benchmark networks are the same. Dependent claim 9 further limits the cosmetic composition being provided in claim 1, and therefore is part of the abstract idea of providing the cosmetic composition of claim 1. Therefore, claims 1-9 recite an abstract idea. [Step 2A, Prong 1: YES]
Step 2A: Prong 2: Under the MPEP § 2106.04, the Step 2A, Prong 2 analysis requires identifying whether there are any additional elements recited in the claim beyond the judicial exception(s), and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. This judicial exception is not integrated into a practical application for the following reasons.
Claims 1-9 do not recite any elements in addition to the judicial exception. Therefore, the claims as a whole do not integrate the abstract idea into practical application. Thus, claims 1-9 are directed to an abstract idea. [Step 2A, Prong 2: NO]
Step 2B: In the second step it is determined whether the claimed subject matter includes additional elements that amount to significantly more than the judicial exception. See MPEP § 2106.05.
The claims do not include any additional steps appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception because claims 1-9 do not recite any elements in addition to the judicial exception.
Thus, the claims as a whole do not amount to significantly more than the exception itself. [Step 2B: NO]
Therefore, the instantly rejected claims are not drawn to eligible subject matter as they are directed to an abstract idea (and/or natural correlation) without significantly more. For additional guidance, applicant is directed generally to the MPEP § 2106.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Apte (2018) in view of Sonawane (2019).
Cited references:
Apte et al., US 2018/0122514 A1; and
Sonawane et al., Microbiome-Transcriptome Interactions Related to Severity of Respiratory Syncytial Virus Infection, 2019, Scientific Reports, 9:13824, pg. 1-14.
Regarding claim 1, Apte discloses a method for diagnosing and treating cutaneous conditions of the skin (Abstract; [0017], e.g. condition pertains to skin), which comprises the following steps:
Apte discloses A) generating (i.e. obtaining) features including networks of represented taxonomic groups of microorganisms based on analysis of RNAs ([0063]-[0064]), wherein the features including the microbiome networks are generated from a sample of a subject to be characterized (i.e. thus generating a first individual microbiome network) ([0101]; [0106]), wherein the sample is collected via a swab configured to wipe a region of a subject’s body (i.e. the network is of a skin surface of the person in need of characterization) ([0022]).
Apte discloses B) comparing the features of the subject (i.e. first individual microbe network) to reference features representing an average individual not having or having a cutaneous condition (i.e. a benchmark individual microbiome network) ([0106]; FIG. 1B).
Apte discloses C) promoting a therapy for the subject, including topical medications such as ointments, creams, lotions, baths, soaks, foams, moisturizing agents, anti-inflammatory agents etc., to treat the cutaneous condition (i.e. to change the first network toward the benchmark/healthy network ([0015]; [0104], e.g. therapies that shift subject’s microbiome composition toward a desired equilibrium state).
Regarding claim 2, Apte discloses determining microbiome composition data for a population of subjects ([0026]).
Regarding claim 3, Apte discloses the microbiome composition data comprises at least Bacteroidetes (phylum), Staphylococcus (genus), Staphylococcaceae (family), and Actinobacteria (class) ([0098]).
Regarding claim 4, Apte discloses comparing the features of the subject (i.e. first individual microbe network) to reference features representing an average individual having a cutaneous condition (i.e. a benchmark individual microbiome network) which is used as a disease signature ([0106]). Apte further discloses using a cutoff or probability value determined from the reference features associated with the reference diseased individuals ([0106]), which is used to classify the subject as having the disease (i.e. identifying a first shift of the first network toward the benchmark network) ([0083])
Regarding claims 5-6, Apte discloses the method can be used to characterize skin conditions (i.e. assessing skin conditions) ([0017]), and further discloses utilizing cutoff or probability values for particular amounts of features associated with diseased individuals in order to classify the subject as having the disease (i.e. associating the first shift with the skin conditions) ([0083]; [0106]).
Regarding claim 7, as discussed above in claim interpretation, the limitation only serves to define the process in which the benchmark individual microbiome network was previously obtained. See MPEP 2113 I. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Therefore, because the benchmark individual microbiome network of Apte is the same as in the claims, this reads on claim 7 even if the benchmark microbiome network of Apte was determined by a different process.
Regardless, Apte does disclose the reference features represent an average individual not having or having a cutaneous condition (i.e. an averaged benchmark individual microbiome network) determined from a control population (i.e. benchmark persons) ([0106]; [0123]; FIG. 1B).
Regarding claim 8, Apte further discloses monitoring and/or adjusting therapies provided to a subject by reception, processing, and analysis of additional samples from a subject throughout the course of therapy (i.e. repeating the analysis (A), (B), and (C)). Apte further discloses a classification of the subject using the method may classify the subject as not having the condition ([0083]), and that treatments are determined for an individual having the condition ([0116]), which demonstrates the repeated analysis of additional samples for adjusting therapies during a course of therapy occurs until the subject is healthy (i.e. the first network is the same as the benchmark network).
Regarding claim 9, Apte discloses the cosmetic composition comprises one or more of ointments and moisturizing agents ([0115]).
Regarding instant claims 1-2, Apte does not disclose the following limitations:
Further regarding claim 1, Apte does not disclose: the identifying the first individual microbiome network comprises: identifying a first population microbiome network from a group of samples consisting of N individuals including said person, wherein N is an integer of at least 20: (b) obtaining a second populational microbiome network from the group of samples without the sample from said person; and (c) determining the first individual microbiome network of said person by subtracting effects of the second population microbiome network from the first population microbiome network.
Regarding claim 2, Apte further does not disclose generating a population microbiome network by representing microbial organisms in each matrix a network of a plurality of nodes corresponding to the group of samples.
However, regarding claim 1, Sonawane discloses a method for analyzing microbiome data of subjects in relation to the severity of a disease (Abstract), which comprises applying the LIONESS method to a network of α samples, Gα, with nodes corresponding to clades (i.e. taxonomic groups) and genes (i.e. the first population microbiome network) in order to construct a sample-specific microbiome network for a subject q (pg. 11, para. 7-8). Sonawane discloses the sample-specific microbiome network is determined by excluding sample q from the α samples to obtain a population network G(α -q) (i.e. the second population microbiome network), and then finding the sample-specific network for subject q Gq based on Gα - G(α -q) (i.e. subtracting effects of the second population microbiome network from the first population microbiome network) (pg. 11, para. 7-8; Table 2).
Regarding claim 2, Sonawane further discloses determining microbiome composition data from the microbiome (Table 2; pg. 5, para. 2), and generating the network Gα, by representing nodes as corresponding to clades (i.e. microbial organisms represented as a network of nodes) (pg. 11, para. 7). Sonawane further discloses constructing a weighted adjacency matrix for each of Gα and G(α -q) (i.e. the microbial organisms in each matrix are represented as nodes in the graph). (pg. 11, para. 7-8).
Last, Sonawane discloses networks derived using information from all samples cannot shed light on which relationships might be associated with differences in various phenotypic or clinical properties of the input samples, including disease severity, and that reverse engineering sample-specific networks allows for the reconstruction of separate networks for each subject and to relate clade principal components to clinical information for the subjects (pg. 5, para. 5-7; pg. 11, para. 8; Table 2; Figure 4(A)).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Apte to have determined the first individual microbiome network of the person according to the method of constructing a sample-specific network as shown by Sonawane above. One of ordinary skill in the art would have been motivated to combine the methods of Apte and Sonawane in order to provide an individual microbiome network informative of clinical information and disease severity of the subject, as shown by Sonawane (pg. 5, para. 5-7; pg. 11, para. 8; Table 2; Figure 4(A), thus facilitating the diagnosis of the person using the first individual microbiome network in Apte. This modification would have had a reasonable expectation of success given Apte discloses generating a network of represented taxonomic groups of microorganisms based on analysis of RNAs from the skin of the person as a feature that is then compared to a reference feature to make a diagnosis ([0063]-[0064]), and thus the method of identifying a sample-specific network of microbiome data of Sonawane is applicable to the method of Apte.
Therefore, the invention is prima facie obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 and 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/575,997 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant claim 1, reference claim 1 discloses the limitations of instant claim 1, wherein the second individual microbiome network of the reference claims corresponds to the baseline individual microbiome network of the instant claims. However, reference claim 1 is different in scope than instant claim 1 because reference claim 1 requires treating the skin surface with a cosmetic composition.
Regarding instant claim 2, reference claim 2 discloses this limitation.
Regarding instant claim 3, reference claim 3 discloses this limitation.
Regarding instant claim 7, the limitation only serves to define the process in which the benchmark network was previously obtained. Reference claim 1 discloses obtaining a second individual microbiome network of a treated skin surface (i.e. the benchmark network), which is the same product as the benchmark network in the instant claims, and thus reads on instant claim 7.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 4-6 and 8-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/575,997 (reference application) in view of Apte (2018).
Cited reference: Apte et al., US 2018/0122514 A1
Regarding instant claims 4-6 and 8-9, the reference claims disclose the limitations of instant claim 1, as applied above.
The reference claims do not disclose the limitations of instant claims 4-6 and 8-9.
However, regarding instant claims 4-6 and 8-9, Apte discloses a method for diagnosing and treating cutaneous conditions of the skin (Abstract; [0017], e.g. condition pertains to skin), which comprises generating (i.e. obtaining) features including networks of represented taxonomic groups of microorganisms based on analysis of RNAs of a skin surface ([0063]-[0064]; [0101]; [0106]; [0022]), comparing the features of the subject (i.e. first individual microbe network) to reference features representing an average individual not having or having a cutaneous condition (i.e. a benchmark individual microbiome network) ([0106]; FIG. 1B), and then promoting a therapy for the subject, including topical medications (i.e. cosmetic compositions) such as ointments, creams, lotions, baths, soaks, foams, moisturizing agents, anti-inflammatory agents etc., to treat the cutaneous condition ([0015]; [0104]).
Regarding instant claim 4, Apte further discloses comparing the features of the subject (i.e. first individual microbe network) to reference features representing an average individual having a cutaneous condition (i.e. a benchmark individual microbiome network) which is used as a disease signature ([0106]). Apte further discloses using a cutoff or probability value determined from the reference features associated with the reference diseased individuals ([0106]), which is used to classify the subject as having the disease (i.e. identifying a first shift of the first network toward the benchmark network) ([0083])
Regarding instant claims 5-6, Apte further discloses the method can be used to characterize skin conditions (i.e. assessing skin conditions) ([0017]), and further discloses utilizing cutoff or probability values for particular amounts of features associated with diseased individuals in order to classify the subject as having the disease (i.e. associating the first shift with the skin conditions) ([0083]; [0106]).
Regarding instant claim 8, Apte further discloses monitoring and/or adjusting therapies provided to a subject by reception, processing, and analysis of additional samples from a subject throughout the course of therapy (i.e. repeating the analysis (A), (B), and (C)). Apte further discloses a classification of the subject using the method may classify the subject as not having the condition ([0083]), and that treatments are determined for an individual having the condition ([0116]), which demonstrates the repeated analysis of additional samples for adjusting therapies during a course of therapy occurs until the subject is healthy (i.e. the first network is the same as the benchmark network).
Regarding instant claim 9, Apte further discloses the cosmetic composition comprises one or more of ointments and moisturizing agents ([0115]).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have modified the method of the reference claims to have identified and associated a shift of the first microbiome network toward the benchmark network with skin conditions, assessed the skin conditions of the skin surface, and repeated steps (A), (B), and (C) to monitor a course of therapy, as shown by Apte above, thus arriving at the inventions of instant claims 4-6 and 8-9. One of ordinary skill in the art would have been motivated to combine the methods of the reference claims with Apte in order to facilitate the treatment monitoring of a subject by providing a therapy for the subject that results in a shift in the subject’s microbiome to an equilibrium state and monitoring the shift over the course of the treatment ([0083]; [0015]; [0104]). This modification would have had a reasonable expectation of success given both the reference claims and Apte analyze microbiome data of a subject, and thus the analysis and treatment methods of Apte are applicable to the reference claims.
This is a provisional nonstatutory double patenting rejection.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kuijjer et al., Estimating Sample-Specific Regulatory Networks, 2019, iScience, 14, pg. 226-240.
Kuijjer discloses a method of estimating sample-specific regulatory networks from a network of a population of subjects as described in claims 1-2 (Abstract; Figure 1).
Conclusion
No claims are allowed.
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/KAITLYN L MINCHELLA/Primary Examiner, Art Unit 1685
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