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 .
DETAILED ACTION
Pursuant to a preliminary amendment, claims 1-9 are currently pending in the instant application.
Response to Election/Restriction
Applicant's election without traverse of Group I, claims 1 and 4-9, directed to a method detecting the presence of American foulbrood (AFB) in a beehive; and the election of:
Species (A): the election of up to ten (10) compounds incudes: dihydro-3-hydroxy-4,4-dimethyl-2(3H)-furanone; acetamide; 3-methyl-2-oxo-pentanoic acid methyl ester; 2,5-dimethyl-pyrazine; 2-methyl propenamide; 3-methyl-butanamide; butanamide; hexanamide; benzene-acetamide; 3-methyl-3-buten-1-ol (claim 1); and
Species (B): wherein the compounds are present in a relative amount of at least 2, 5, 10, 20, 50, 100, 500, 1000, 2000 or 3000 times more in an infected hive than a non-infected hive (claim 5), in the reply filed on September 2, 2025 is acknowledged.
Claims 2 and 3 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claim 4 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, there being no allowable generic or linking claim.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election of invention has been treated as an election without traverse (MPEP
§ 818.03(a)).
The restriction requirement is still deemed proper and is therefore made FINAL.
The claims will be examined insofar as they read on the elected species.
Therefore, claims 1 and 5-9 are under consideration to which the following grounds of rejection are applicable.
Priority
The present application filed March 11, 2022 is a 35 U.S.C. 371 national stage filing of International Application PCT/AU2020/051048, filed on October 1, 2020, which claims the benefit of
Australian Patent Application Nos. AU2019903716, filed October 3, 2019; and AU2020902277, filed July 3, 2020.
Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, International Application WO2021062474, filed October 1, 2020, fails to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for one or more claims of this application. The specific method steps recited in independent claim 1 does not have support for: “indole”. Therefore, the priority date for the presently claimed invention is March 11, 2022 the filing date of the instant application US17/642,594.
Applicants are invited to specifically indicate the location of the cited phrase pertinent to claim 1 of the instant application.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on March 6, 2023 and August 29, 2024 have been considered. Initialed copies of the IDSs accompany this Office Action.
Claim Objections/Rejections
Claim Objections
Claims 1, 8 and 9 are objected to because of the following informalities: Claims 1, 8 and 9 recite the abbreviation “CAS#” and “NIL”, where an abbreviation should be spelled out in the first encounter of the claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 5-9 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 applicant regards as the invention.
Claims 1, 8 and 9 are indefinite for the recitation of the terms “2(3H)-Furanone, dihydro-3-hydroxy-4,4-dimethyl-…Furan, 3-methyl-” such as recited in claim 1, lines 1-19 because many of the chemical names are not recited as they are commonly read, thus making it difficult to read and identify the IUPAC name. For example, the compound “2(3H)-Furanone, dihydro-3-hydroxy-4,4-dimethyl-“ should be recited as “dihydro-3-hydroxy-4,4-dimethyl-2(3H)-furanone” or as “3-hydroxy-4,4-dimethyldihydro-2(3H)-furanone” and, thus, the metes and bounds of the claim cannot be determined.
Claims 1, 8 and 9 are indefinite for the use of parentheses such as in the recitation of the term “2(3H)-Furanone, dihydro-3-hydroxy-4,4-dimethyl- (CAS# 52126-90-6)” in claim 1, lines 1-19 to comment on or qualify part of the sentences because it is unclear whether the limitations in parentheses are meant to be limitations in the claims, whether they are only suggestions, whether they are examples of a preferred embodiment, and/or whether they refer to some other feature or limitation. Accordingly, the metes and bounds of the claim are not clear.
Claim 1 is indefinite for the recitation of the term “C21 ketone or similar” in claim 1, line 8 because the compounds and structures encompassed by the term “C21 ketone or similar” is completely unclear. Moreover, the term “similar” is a relative term that renders the claim indefinite. The term “similar” is not defined by the claim, and the Specification does not provide a standard for ascertaining the requisite amount of ‘similarity’ as compared to some other compound or structure that qualifies as an “similar” to C21 ketones (e.g., C15 ketones, amides, alcohols, etc.), such that one of ordinary skill in the art would not be reasonably appraised of the scope of the invention.
Claims 1 and 8 are indefinite for the recitation of the term “AFB NIL 1, AFB NIL 6, AFB NIL 7, AFB NIL 8/ C16 alkene, AFB NIL 9” such as recited in claim 1, lines 18-19 because the claim does not particularly point out and distinctly claim the subject matter that Applicant regards as the invention. The Specification and claims do not identify the compounds encompassed by the terms including their structures, molecular formulas, molecular weights, functions, etc. and, thus, the metes and bounds of the claim cannot be determined.
Claims 1 and 5 are indefinite for the recitation of the terms “non-infected” and “infected” such as recited in claim 1, lines 21 because it is unclear what the hive is “infected” or “not infected” with, given that no infection is recited in claim 1 and, thus, the metes and bounds of the claim cannot be determined.
Claim 5 is indefinite for the recitation of the terms “hive” such as recited in claim 5, line 3 because
it is unclear whether the “hive” as recited in claim 5 refers to the beehive recited in claim 1, line 3 and, thus, the metes and bounds of the claim cannot be determined.
Claim 5 is indefinite for the recitation of the term “at least 2” such as recited in claim 5, line 2 because claim 5 depends from claim 1, wherein claim 1, line 21 recites the term “at least three times that of an non-infected hive” and, thus, the metes and bounds of the claim cannot be determined.
Claim 5 is indefinite for the recitation of the term “at least 2, 5, 10, 20…or 3000 times” such as recited in claim 5, line 2 because a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The instant claim broadly recites “at least 2”, while also reciting “at least 3000 times”, which is a narrower range or limitation of relative amounts and, thus, the metes and bounds of the claim cannot be determined.
Claim 5 is indefinite for the recitation of the term “infected hive” such as recited in claim 5, line 3 because claim 5 depends from claim 1, wherein claim 1 does not recite that the beehive is an “infected hive” and, thus, the metes and bounds of the claim cannot be determined.
Claim 7 is indefinite for the recitation of the term “detection means is a handheld, mobile, portable or point-of-use diagnostic tool” such as recited in claim 7, lines 1-2 because claim 7 depends from claim 1, wherein claim 1 does not recite a step of “detecting”, a means for detecting, and/or the use of a diagnostic tool. Additionally, claim 7 does not recite any specific means of detecting and/or diagnostic tools. Moreover, it is unclear as to the difference between a “mobile” device and a “portable” device and, thus, the metes and bounds of the claim cannot be determined.
Claim 6 is indefinite insofar as it ultimately depends from instant claim 1.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 5 and 7 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 claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 5 recites (in part): “wherein the compounds are present in a relative amount of at least 2, 5, 10, 20, 50, 100, 500, 1000, 2000 or 3000 times more in an infected hive than in a non-infected hive” in lines 1-2 because claim 5 depends from claim 1, wherein claim 1 does not recite the presence of an infected beehive. Moreover, claim 1 recites that the relative amount begins with ‘at least three times’ the relative amount of the compound, while the relative amount recited in claim 5 begins at “at least 2” times the relative amount of the compound. Thus, claim 5 is an improper dependent claims for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 7 recites (in part): “wherein the detection means is a handheld, mobile, portable or point-of-use diagnostic tool” in claim 7, lines 1-2 because claim 7 depends from claim 1, wherein claim 1 does not recite a step of detecting, a means for detecting, and/or the use of a diagnostic tool. Thus, claim 7 is an improper dependent claims for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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 and 5-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. An analysis with respect to the claims as a whole reveals that they do not include additional elements that are sufficient to amount to significantly more than the judicial exception. See Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 110 U.S.P.Q.2d 1976 (2014); Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116, 106 U.S.P.Q.2d 1972 (2013); Mayo Collaborative Svcs. v. Prometheus Laboratories, Inc., 132 S. Ct. 1289, 101 U.S.P.Q.2d 1961 (2012). See also 2014 Interim Guidance on Patent Subject Matter Eligibility, available at http://www.gpo.gov/fdsys/pkg/FR-2014-12-16/pdf/2014-29414.pdf (“2014 Interim Guidance”), and the Office’s examples to be considered in conjunction with the 2014 Interim Guidance in examination of nature-based products, available online at http://www.uspto.gov/patents/law/exam/mdc_examples_nature-based_products.pdf (“Nature-Based Products Examples”). This rejection is proper.
Analysis of subject-matter eligibility under 35 U.S.C. § 101 requires consideration of three issues: (1) whether the claim is directed to one of the four categories recited in §101; (2) whether the claim recites or involves a judicial exception (i.e., a law of nature, natural phenomenon, or natural product); and (3) whether the claim as a whole recites something that amounts to significantly more than the judicial exception. In the instant case, the claims are directed to a natural phenomenon and an abstract idea. Therefore, they must each be considered to determine whether, given their broadest reasonable interpretation, they amount to significantly more than the judicial exception.
The claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claims 1 and 5-9 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below.
In the instant case, the claims are broadly directed to a natural phenomenon and an abstract idea in the form of a method for detecting the presence of American foulbrood (AFB) in a beehive, the method comprising: (a) taking a sample from a beehive; and (b) testing the sample for compounds from the list comprising: 1-Decene; 2(3H)-Furanone, dihydro-3-hydroxy-4,4-dimethyl-; 2-Coumaranone; 2-Dodecanone; 2-Piperidinone; 3-Pentanone, 2,4-dimethyl-; 4-Hexen-3-ol; Acetamide; C21 ketone or similar; Trisulfide, dimethyl-; Disulfide, dimethyl-; Indole; N-(3-Methylbutyl)acetamide; Pentanamide, 4-methyl-; Pentanoic acid, 3-methyl-2-oxo-, methyl ester; Pyrazine, 2,5-dimethyl-; Pyrazine, trimethyl-; Propanamide, 2-methyl-; Butanamide, 3-methyl-; Butanamide; Hexanamide; 2-Tetradecanone; 2-Undecanone; Benzeneacetamide; Butanal, 2-methyl-; 2-Tridecanone; 2,3-Pentanedione; Butanal, 3-methyl-; AFB NIL 2; 2-Pentadecanone; AFB NIL 1; 3-Buten-1-ol, 3-methyl-; AFB NIL 6; AFB NIL 7; AFB NIL 8\ C16 alkene; AFB NIL 9; and Furan, 3-methyl-, wherein the presence of one or more of the compounds in a relative amount of at least three times that of a non-infected hive indicates the presence of AFB in the beehive.
Beginning with Step I of the analysis, which asks whether the claimed invention falls within a statutory category, such that the instant claims are directed to a process, thus, the instant claims are directed to a statutory category. Step I: [YES].
Proceeding to Step IIA – Prong One: of the analysis, which asks if the claimed invention is directed to a judicial exception. Instant claims 1 and 5-9 are drawn to a natural phenomenon in the form of naturally occurring volatile organic compounds given off within a beehive, such that when the specific compounds as listed are at least 3 times that observed within a non-infective hive is correlated to a beehive having a Paenibacillus larvae bacterium infection (American foulbrood); as well as, being directed to an abstract idea in the form of mathematical concepts (e.g., mathematical relationships, formulas or equations, and/or calculations) and mental process (e.g., observation, judgement and opinion) including testing the sample for the presence of the recited compounds; determining and comparing the relative amount of the compounds in a sample to a non-infected hive; relative to 2 to 3000 times more in a non-infected hive; and the use of a hand-held, mobile, portable, point-of-use diagnostic tool . The claims broadly recite a process and a system that can be carried out by a general computer carrying out generic computer functions. Step IIA – Prong One [YES].
Step IIA - Prong Two of the analysis asks whether the claim recites additional elements that integrate the exception into a practical application of the exception. In the instant case, the claims are directed to a judicial exception in the form of a natural phenomenon and an abstract idea. Claim 1 recites: “a method for detecting the presence of American foulbrood (AFB) in a beehive, the method comprising: (a) taking a sample from a beehive; and (b) testing the sample for compounds from the list” of compounds in lines 1-4; as well as, “wherein the presence of one or more of the compounds in a relative amount of at least three times that of a non-infected hive indicates the presence of AFB in the beehive” in lines 20-21; which resembles “obtaining and comparing intangible data” (i.e. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 99 U.S.P.Q.2d 1690 (Fed. Cir. 2011)), and are analogous to “organizing information through mathematical correlations” (i.e. Digitech Image Techs., LLC v Electronics for Imaging, Inc., 758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)); and are examples of “collecting information, analyzing it, and displaying certain results of the collection analysis” (i.e. Electric Power Group, LLC, v. Alstom, 830 F.3d 1350, 119 U.S.P.Q.2d 1739 (Fed. Cir. 2016)); and resembles “comparing information regarding a sample or test subject to a control or target data” (i.e. Univ. of Utah Research Found. v. Ambry Genetics Corp. (Also known as In re BRCA1– and BRCA2–Based Hereditary Cancer Test Patent Litigation), 774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014) or Association for Molecular Pathology v. USPTO (Also known as Myriad CAFC), 689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)). Hence, these limitations are akin to an “abstract idea itself” which was at issue in Alice Corp. and has been identified among non-limiting examples to be an abstract idea. Additionally, the dependent limitations of claims 5-9 also suffer from the same issue. In other words, the dependent limitations do not rectify the rejection of the independent claim. By way of example, the limitations of claim 5 provides, “wherein the compounds are present in a relative amount of at least 2, 5, 10, 20…or 3000 times more in an infected hive than in a non-infected hive”; and claim 7 recites, “wherein the detection means is a handheld, mobile, portable or point-of-use diagnostic tool”, which are analogous to “obtaining and comparing intangible data” (i.e. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 99 U.S.P.Q.2d 1690 (Fed. Cir. 2011)); “collecting information, analyzing it, and displaying certain results of the collection analysis” (i.e. Electric Power Group, LLC, v. Alstom, 830 F.3d 1350, 119 U.S.P.Q.2d 1739 (Fed. Cir. 2016)); and “comparing information regarding a sample or test subject to a control or target data” (i.e. Univ. of Utah Research Found. v. Ambry Genetics Corp. (Also known as In re BRCA1– and BRCA2–Based Hereditary Cancer Test Patent Litigation), 774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014) or Association for Molecular Pathology v. USPTO (Also known as Myriad CAFC), 689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)). Thus, the claims do not integrate the judicial exceptions into a practical application of the exceptions. Step IIA – Prong Two [NO].
Thus, the claims do not integrate the judicial exceptions into a practical application of the exceptions. Step IIA – Prong Two [NO].
Proceeding to Step IIB of the analysis: the question then becomes what element or what combination of elements is sufficient to amount to significantly more than the abstract idea? The Guidance provides the following examples of what may constitute significantly more in a claim:
• Improvement to another technology or technical field
• Improvement to functioning of computer itself
• Meaningful limitation beyond generally linking the use of an abstract idea to a particular technological environment.
What is NOT enough to qualify as "significantly more" under Alice v CLS Bank is:
• Adding words to apply it or instructions to implement the idea.
• Requiring no more than a general computer to perform generic computer functions that are well-known and conventional (what is instantly claimed is a general method and computer system for comparing and correlating data to diagnosis a genetic disease).
Proceeding to Step IIB of the analysis: the question then becomes what element or what combination of elements is sufficient to amount to significantly more than the abstract idea? The instant independent claim is recited at a high level of generality, such that substantially all practical applications of the judicial exception as related to the method of taking the sample (e.g., invasive, non-invasive, syringe, cutting, etc.); the sample taken (e.g., hive, bees, larva, honey, etc.); the method of testing the sample (e.g., GC/MS, electronic nose, MS, NMR, etc.); the specific combinations of biomarkers detected (e.g., decene, dimethyl-disulfide, hexanamide, Benzeneacetamide, etc.); the relative amounts of compounds in an infected hive; the relative amounts in a non-infected hive; the strain of Paenibacillus larvae bacterium; the level of compounds that indicates an on-going bacterial infection, etc., wherein the broadly recited method of detecting compound biomarkers including biomarkers in bees, beehives, and/or biomarkers of bacterial infections are well known, purely conventional or routine in the art. Step IIB: [NO].
For example, detecting relative VOC abundances of pathogenic bacteria is known in the art including visualizing abundances using a heatmap gradient red/yellow color scale, where dark orange/red represents a high abundance; and orange/yellow represents a low abundance, such that all bacterial strains—except for SEP.A—were successfully clustered with their respective species; and the Euclidean distance between the E. coli strains and the other bacteria tested was the greatest, verifying that the two E. coli strains had the most discriminative VOC signatures of all samples tested, wherein S. epidermidis strains emitted a lower number of VOCs in comparison to the other species and were clustered close to the media control as a result; S. aureus and P. aeruginosa both have clearly differentiated VOC signatures, which can be seen from the heatmap by the relatively high number of unique ‘red’ values including compounds such as decane, dimethyl disulfide, 2,5-dimethyl-pyrazine, dimethyl trisulfide, 2-decanone, indole, etc.; wherein Figure 4 shows that each bacteria comprise a changing VOC abundance of compound classes including alcohols, aldehydes, ketones, pyrazines, and acids as evidenced by Fitzgerald (Scientific Reports, 2020, 10, 1-12; pg. 2, last full paragraph; pg. 3, Figure 1; and pg. 6, Figure 4); and the effectiveness of detecting American foulbrood in bee colonies by a multi-sensor devices was known in the art, wherein different gas Bee-sensor units were tested for the detection of various chemical elements as evidenced by Bak (Sensor, 2022; pg. 2, last partial paragraph; and pg. 3, first full paragraph). Moreover, volatile and semi-volatile organic beehive compounds from a variety of beehive sources, wherein the beehive is not infected with by AFB including 2-butenal, acetamide, alkanes, alcohols, hydrocarbons, ketones, and amides is known in the art as evidenced by Smith (Volatile Organic Compounds in Beehives, Chapter 2, 2002, 12-41; pgs. 18-29, Tables 2.2-2.6); and identifying AFB volatile biomarkers that can be incorporated into a diagnostic gas sensor was known in the art, where gas chromatography (GC-MS) was used to identify volatile organic compounds in the headspace of healthy and AFB-diseased brood, wherein significant differences in the volatile profiles of healthy and AFB-disease honey bee larvae were identified as potential biomarkers for AFB, and the production of a heatmap of relative amounts of volatile compounds as potential AFB biomarkers; as well as, the production and use of a hand-held gas sensor or “beehive-breathalyzer” device is being developed to diagnose AFB without opening hives, to prevent the spread of spores via tools, to greatly reduce labor effort and cost, and to reduce AFB risk during pollination events as evidenced by Moran (Poster, 2019; pg. 1, Our Search for Smelly Biomarkers; Volatile Profiles of Healthy and AFB-Diseased Brood; Developing a Beehive Breathalyzer; and Figures 1-3). Furthermore, the detection of volatile compounds of honey samples, followed by multivariate analysis was known in the art, wherein 124 compounds were detected such as a variety of hydrocarbons, aldehydes, alcohols, ketones, acetates, benzenes and their derivatives, furan and pyran, norisopreoids, terpenes and their derivatives, sulfates, and cyclic compounds including methyl butanal, dimethyl disulfide, unknowns, dimethyl trisulfide, etc. as evidenced by Tananaki (Applied Sciences, 2021, 12, 264, 1-25; Abstract; pg. 1, Introduction; and Table 1). Thus, collecting a sample from a beehive, testing the sample for compounds including volatile organic compounds using a diagnostic tool; and determining the presence or absence of a bacterial infection from the tested sample was well known, purely conventional, or routine in the art including the detection and analysis of proteins associated with preeclampsia. Step IIA [YES].
In sum, when the relevant factors are analyzed, the claims as a whole do NOT recite additional elements that amount to significantly more than the judicial exception itself. Accordingly, claims 1 DOES NOT qualify as eligible subject matter.
Dependent claim(s) 5-9 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 101 because they do not add anything that makes natural product and the abstract idea recited in claim 1 significantly different. For example, claim 7 encompasses the method of claim 1, wherein the he detection means is a handheld, mobile, portable, or point-of-use diagnostic tool, but it does not add anything that makes the natural product in claim 1 significantly different.
Thus, the claims as a whole do NOT recite additional elements that amount to significantly more than the judicial exception itself.
In light of the above consideration and the new guidance, claims 1 and 5-9 are non-statutory. This rejection is newly recited as necessitated by the new Guidance set forth in the Memorandum of July 30, 2015 updating the June 25, 2014 guidance (see June 25, 2014 memorandum from Deputy Commissioner for Patent Examination Policy Andrew Hirshfeld titled Preliminary Examination Instructions in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. (Alice Corp. Preliminary Examination Instructions) and the Revised Patent Subject Matter Eligibility Guidance (See, Federal Register, vol. 84, No. 4, January 7, 2019).
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 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 may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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 and 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Moran et al. (hereinafter “Moran”) (Poster, Presented at the 46th Apimondia International Apicultural Congress, Montreal, Canada, Sept 8-12, 2019, 1) in view of Fitzgerald et. al. (hereinafter “Fitzgerald”) (Scientific Reports, 2020, 10:17971, 1-12).
Regarding claims 1 (in part), 5-7, 8 (in part) and 9 (in part), Moran teaches that American foulbrood (AFB) disease is he most fatal and costly established pest to the Australian honey bee industry, which is caused by the bacterium Paenibacillus larvae, such that AFB turns honey bee larvae into foul-smelling, glue-like mass and causes colonies to die out (FIG. 1); and that this research aims to identify AFB volatile biomarkers that can be incorporated into a diagnostic gas sensor (interpreted as a gas sample from the interior of the hive, claims 1 and 6) (pg. 1, Our Search for Smelly Biomarkers; and Figure 1). Figure 1 is shown below:
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Moran teaches that gas chromatography (GC-MS) was used to identify volatile organic compounds in the headspace of healthy and AFB-diseased brood, wherein significant differences in the volatile profiles of healthy and AFB-disease honey bee larvae were identified as potential biomarkers for AFB (Figs. 2 & 3), wherein Figure 2 is a PCA that shows volatile profiles of larvae are strongly influenced by AFB-disease status, while Figure 3 shows a heatmap of volatile compounds as potential AFB biomarkers (interpreting the Heatmap log10 and scaled compound abundance of -2 to 2 as a relative amount of at least 2 times, at least 3 times, and at least 3000 times more within an infected hive than in a non-infected hive, claims 1 and 5) (pg. 1, Volatile Profiles of Healthy and AFB-Diseased Brood; and Figures 2 & 3). Figures 2 and 3 are shown below:
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Moran teaches that volatile biomarkers for AFB have been successfully identified, and a hand-held gas sensor or “beehive-breathalyzer” device is being developed to diagnose AFB without opening hives, to prevent the spread of spores via tools, to greatly reduce labor effort and cost, and to reduce AFB risk during pollination events (interpreted sensing the interior of the beehive; and a hand-held, mobile, portable, or point-of-use diagnostic tool, claims 6 and 7) (pg. 1, Developing a Beehive Breathalyzer).
Moran does not specifically exemplify any of the compounds as recited in claims 1, 8 and 9 (claims 1, 8 and 9, all in part).
Regarding claims 1, 8 and 9 (all in part), Fitzgerald teaches that the detection of volatile organic compounds (VOC) emitted by pathogenic bacteria has been proposed as a potential non-invasive approach for characterizing various infectious diseases; as well as wound infections, wherein studying microbial VOC profiles in vitro allows the mechanisms governing VOC production and the cellular origin of VOCs to be deduced, such that inter-study comparisons of microbial VOC data remains a challenge due to the variation in instrumental and growth parameters across studies; and that in this work, multiple strains of pathogenic and commensal cutaneous bacteria were analyzed using headspace solid phase micro-extraction coupled with gas chromatography–mass spectrometry, wherein a kinetic study was also carried out to assess the relationship between bacterial VOC profiles and the growth phase of cells, such that comprehensive bacterial VOC profiles were successfully discriminated at the species-level, while strain-level variation was only observed in specific species and to a small degree (Abstract). Fitzgerald teaches that Figure 1 visualizes the clustering results coupled with a heatmap to show the different patterns in individual VOC abundances across all bacterial strains, wherein the heatmap contains 65 rows, which are labelled by each VOC, and listed in order of increasing retention time, wherein each column of the heatmap represents the mean VOC abundance recovered from each strain (n = 3); and Figure S5 in the S1 visualizes the inter-sample variation across each bacterial sample of each examined species and strain, wherein Figure S5 in compounds found in the TSB growth media; and in Fig. 1, the relative VOC abundances are visualized using a gradient red/yellow color scale, where dark orange/red represents a high abundance; and orange/yellow represents a low abundance, such that all bacterial strains—except for SEP.A—were successfully clustered with their respective species; and the Euclidean distance between the E. coli strains and the other bacteria tested was the greatest, verifying that the two E. coli strains had the most discriminative VOC signatures of all samples tested, wherein S. epidermidis strains emitted a lower number of VOCs in comparison to the other species and were clustered close to the media control as a result; S. aureus and P. aeruginosa both have clearly differentiated VOC signatures, which can be seen from the heatmap by the relatively high number of unique ‘red’ values including compounds such as decane, dimethyl disulfide, 2,5-dimethyl-pyrazine, dimethyl trisulfide, 2-decanone, indole, and including one or more of AFB NIL 6; AFB NIL 7; AFB NIL 8\ C16 alkene; and AFB NIL 9 (interpreted as detecting the compounds as recited in claims 1, 8 and 9) (pg. 2, last full paragraph; and pg. 3, Figure 1). Figure 1 is shown below:
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Fitzgerald teaches that Figure 4 shows that each bacteria comprise a changing VOC abundance of compound classes including alcohols, aldehydes, ketones, pyrazines, and acids (pg. 6, Figure 4). Figure 4 (in part), is shown below:
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It is prima facie obvious to combine prior art elements according to known methods to yield predictable results; the court held that, "…a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950)”. Therefore, in view of the benefits of using photolithographic synthesis and photoactive coupling formulations for the attachment of polymer or biomolecules to a substrate as exemplified by Rajasekaran, it would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of producing PNA-DNA chimera arrays including PNA-DNA chimeras comprising fluorescent dyes or other labels as disclosed by Egholm to include the photolithographic synthesis methods and photobase generators as taught by Rajasekaran with a reasonable expectation of success in the high efficiency one-step coupling of biomolecules including PNAs to a substrate; and/or in producing PNA-DNA chimera arrays that can be used in DNA sequencing, DNA fragment analysis, reverse transcription, mini-sequencing, chromosome labelling, amplification, and SNP detection.
Thus, in view of the foregoing, the claimed invention, as a whole, would have been obvious to one of ordinary skill in the art at the time the invention was made. Therefore, the claims are properly rejected under 35 USC §103 as obvious over the art.
Conclusion
Claims 1 and 5-9 are rejected.
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/AMY M BUNKER/Primary Examiner, Art Unit 1684