DETAILED ACTION
Status of the Claims
Claims 1, 4-6, 8, 11, 13-14, 17-19, 23, 25-29, 32-33, and 42 are currently pending and are the subject of this Office Action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 07/13/2022 and 06/28/2028 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Sequence Non-compliance
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 C.F.R. § 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 C.F.R. §§ 1.821(d) because the Application contains at least 3 nucleotide sequences of ten or more nucleotides which are not marked with "SEQ ID NOs", nor are there CRF depositions on file for them. For example, see Figure 26. The foregoing analysis should not to be deemed exhaustive, as there may be other polynucleotide or polypeptides disclosed which similarly require sequence identifiers. In accordance with 37 CFR 1.821(a), Nucleotide and/or amino acid sequences as used in § 1.821 through 1.825 are interpreted to mean an unbranched sequence of four or more amino acids or an unbranched sequence of ten or more nucleotides. See the attached Notice To Comply With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures. Applicant must comply with the requirements of the sequence rules (37 CFR 1.821 - 1.825).
Specific deficiency – Nucleotide and/or amino acid sequences appearing in Figure 26 are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, 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 Rejections - 35 USC § 112
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 8, 13-14, and 17-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 8 recites, in one embodiment, that the genetic barcode element comprises:
a) a first primer binding sequence;
b) at least one barcode region;
c) a Cas enzyme scaffold;
d) a transcription initiation site; and
e) a second primer binding sequence.
However, it is noted that as per [00141] of the specification: “[a] Cas enzyme scaffold is an RNA molecule”, but the transcription initiation site is reasonably a DNA molecule. Since the genetic barcode must be both an RNA molecule and a DNA molecule, the metes and bounds of the claim are unascertainable.
Claims 13-14 and 17-18 depend from claim 8 and are therefore similarly rejected.
Claim 13 recites the term “RPA”, which is not a common term that would be apparent to one of ordinary skill in the art without consulting the specification. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Acronyms or abbreviated terms should be spelled out fully upon their first appearance in the claims and can then later be shortened.
As per MPEP 2173: It is of utmost importance that patents issue with definite claims that clearly and precisely inform persons skilled in the art of the boundaries of protected subject matter. Therefore, claims that do not meet this standard must be rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph as indefinite. Further, as per MPEP 2173.02: If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. As currently written, the metes and bounds of the rejected claims are unascertainable for the reasons set forth above, thus the above claim(s) and all dependent claims are rejected under 35 USC 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Claim Rejections – 35 U.S.C. 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Giaever et al.
Claims 1, 4-6, 8, 11, 13-14, 19, 23, 25, and 27-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Giaever et al. (Nature, 2002, 418:387-391).
Regarding claim 1, Giaever discloses a Saccharomyces cerevisiae microorganism engineered to comprise at least one genetic barcode element (e.g., “two distinct 20-nucleotide sequences that serve as ‘molecular bar codes’ to uniquely identify each deletion mutant” as per the Deletion Strategy section on p. 387) and at least one of an inactivating modification of at least one essential gene or an inactivating modification of at least one germination gene (e.g., several deletion mutants made, including many essential genes, as per the Deletion Strategy section on pp. 387-388).
Regarding claim 4, Giaever discloses the above, wherein the microorganism is a yeast or a bacterium (e.g., Saccharomyces cerevisiae as per the Title).
Regarding claim 5, Giaever discloses the above, wherein the microorganism is a Saccharomyces yeast or a Bacillus bacterium (e.g., Saccharomyces cerevisiae as per the Title).
Regarding claim 6, Giaever discloses the above, wherein the microorganism is Saccharomyces cerevisiae, Bacillus subtilis, or Bacillus thuringiensis (e.g., Saccharomyces cerevisiae as per the Title).
Regarding claim 8, Giaever discloses the above, wherein the genetic barcode element comprises a first primer binding sequence, at least one barcode region, and a second primer binding sequence (e.g., as per Fig. 1).
Regarding claim 11, Giaever discloses the above, wherein the microorganism is engineered to comprise first and second barcode regions (e.g., “two distinct 20-nucleotide sequences that serve as ‘molecular bar codes’ to uniquely identify each deletion mutant” as per the Deletion Strategy section on p. 387). Note that regarding the limitations that the first barcode region indicates that an item on which the microorganism is detected is from one of a group of known sources, and the second barcode region indicates that an item on which the microorganism is detected is from a particular source of said group of sources, these limitations are functional limitations and/or intended uses of a product claim and a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02, citing In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus).
Regarding claim 13, Giaever discloses the above, wherein the first primer binding sequence and second primer binding sequence comprise sites for binding of PCR or RPA primers (e.g., PCR primers as per Fig. 1).
Regarding claim 14, Giaever discloses the above, wherein the barcode region comprises 20-40 base pairs (e.g., “two distinct 20-nucleotide sequences that serve as ‘molecular bar codes’ to uniquely identify each deletion mutant” as per the Deletion Strategy section on p. 387).
Regarding claim 19, Giaever discloses the above, wherein the at least one essential gene comprises an essential compound synthesis gene selected from an amino acid synthesis gene or a nucleotide synthesis gene a conditional essential gene (e.g., LYS2 labeled ORF YBR115C in the Supplementary Materials).
Regarding claim 23, Giaever discloses the above, wherein the at least one essential compound synthesis gene comprises a synthesis gene for threonine, methionine, tryptophan, phenylalanine, histidine, leucine, lysine, or uracil, or is selected from the group consisting of thrC, metA, trpC, pheA, HIS3, LEU2, LYS2, MET15, and URA3 (e.g., LYS2 labeled ORF YBR115C in the Supplementary Materials).
Regarding claim 25, Giaever discloses the above, comprising an inactivating modification of at least two or more essential compound synthesis genes (e.g., MET17, MET15, and MET25 labeled ORF YLR303W in the Supplementary Materials).
Regarding claim 27, Giaever discloses the above, comprising an inactivating modification of at least two or more germination genes (e.g., MET17, MET15, and MET25 labeled ORF YLR303W in the Supplementary Materials).
Koo et al.
Claims 1, 4-6, 8, 11, 13-14, 19, 23, and 25-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koo et al. (Cell Systems, 2017, 4:291-305, as cited in the IDS of 07/13/2022).
Regarding claim 1, Koo discloses Bacillus subtilis microorganisms engineered to comprise at least one genetic barcode element (e.g., “each mutant has two unique barcodes” as per the right column of p. 302) and at least one of an inactivating modification of at least one essential gene or an inactivating modification of at least one germination gene (e.g., several deletion mutants made, including many essential genes, as per Table 1).
Regarding claim 4, Koo discloses the above, wherein the microorganism is a yeast or a bacterium (e.g., Bacillus subtilis as per the Title).
Regarding claim 5, Koo discloses the above, wherein the microorganism is a Saccharomyces yeast or a Bacillus bacterium (e.g., Bacillus subtilis as per the Title).
Regarding claim 6, Koo discloses the above, wherein the microorganism is Saccharomyces cerevisiae, Bacillus subtilis, or Bacillus thuringiensis (e.g., Bacillus subtilis as per the Title).
Regarding claim 8, Koo discloses the above, wherein the genetic barcode element comprises a first primer binding sequence, at least one barcode region, and a second primer binding sequence (e.g., as per Fig. 1).
Regarding claim 11, Koo discloses the above, wherein the microorganism is engineered to comprise first and second barcode regions (e.g., “each mutant has two unique barcodes” as per the right column of p. 302). Note that regarding the limitations that the first barcode region indicates that an item on which the microorganism is detected is from one of a group of known sources, and the second barcode region indicates that an item on which the microorganism is detected is from a particular source of said group of sources, these limitations are functional limitations and/or intended uses of a product claim and a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02, citing In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus).
Regarding claim 13, Koo discloses the above, wherein the first primer binding sequence and second primer binding sequence comprise sites for binding of PCR or RPA primers (e.g., PCR primers as per Fig. 1).
Regarding claim 14, Koo discloses the above, wherein the barcode region comprises 20-40 base pairs (e.g., “barcode length was > 17bp,” as per the Quality Control of Library section on p. e5).
Regarding claim 19, Koo discloses the above, wherein the at least one essential gene comprises an essential compound synthesis gene selected from an amino acid synthesis gene or a nucleotide synthesis gene a conditional essential gene (e.g., lysP labeled SAOUHSC_01787 in the Supplementary Materials).
Regarding claim 23, Koo discloses the above, wherein the at least one essential compound synthesis gene comprises a synthesis gene for threonine, methionine, tryptophan, phenylalanine, histidine, leucine, lysine, or uracil, or is selected from the group consisting of thrC, metA, trpC, pheA, HIS3, LEU2, LYS2, MET15, and URA3 (e.g., lysP labeled SAOUHSC_01787 in the Supplementary Materials).
Regarding claim 25, Koo discloses the above, comprising an inactivating modification of at least two or more essential compound synthesis genes (e.g., lysP and cysE labeled SAOUHSC_01787 and SAOUHSC_00510 in the Supplementary Materials).
Regarding claim 26, Koo discloses the above, wherein the at least one germination gene is selected from the group consisting of cwlJ, sleB, gerAB, gerBB, and gerKB (e.g., gerAB labeled as locus BSU33060 as per the Supplementary Materials).
Regarding claim 27, Koo discloses the above, comprising an inactivating modification of two or more germination genes (e.g., gerAB and cwlJ labeled as loci BSU33060 and BSU02600 as per the Supplementary Materials).
Claim Rejections – 35 U.S.C. 103(a)
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.
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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Keinan et al., Buckley et al., Giaever et al., and/or Koo et al. and/or Hosseini et al.
Claims 1, 4-6, 8, 11, 13-14, 19, 23, 25-29, and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Keinan et al. (U.S. PGPub 2012/0082997 A1) in view of Buckley et al. (Applied and Environmental Microbiology, 2012, 78(23):8272-8280, as cited in the IDS of 07/13/2022) and further in view of Giaever et al. (Nature, 2002, 418:387-391) and/or Koo et al. (Cell Systems, 2017, 4:291-305, as cited in the IDS of 07/13/2022) as applied to claims 1, 4-6, 8, 11, 13-14, 19, 23, and 25-27 and/or Hosseini et al. (Applied and Environmental Microbiology, 2018, 84(3):e02334-17).
Keinan discloses methods of tagging materials with spores as a means to determine the source of said materials (e.g., as per the Abstract), wherein the materials comprise added spores that are uniquely associated with these materials (e.g., as per [0032]). Keinan recognizes that spores are useful in surviving “environmental assaults that would normally kill a micro-organism [such as] high temperature, high UV irradiation, desiccation, chemical damage and enzymatic destruction” (e.g., as per [0079]). Keinan discloses that the spore of the microorganism can be intentionally engineered to be barcoded (e.g., as per [0107]), wherein the barcode encodes for various information including a material’s provenance “using e.g., a universal alphanumeric or binary coding system” and is directly inserted into the genome of the microorganism (e.g., as per [0112]).
Keinan discloses a combinatorial approach to tagging substances using predetermined combinations of spores of 2, 3, 4, 5, 20, 100, or more different microorganisms (e.g., as per [0113]) to all for tagging and characterizing large number of materials. However, Keinan is silent regarding the different microorganisms used for combinatorial labeling differ from one another by the inserted barcode sequences.
Buckley discloses “creat[ing] a set of genetically heterogeneous yet phenotypically indistinguishable strains” of Bacillus thuringiensis subsp. kurstaki by “introducing small genetic signatures (‘barcodes’) into neutral regions of the genome” (e.g., as per the Abstract). Buckley, similar to Keinan, uses the different spores to monitor
It would have been prima facie obvious to a person of ordinary skill in the art prior to the effective filing date of the application to use the specific barcoding of Buckley in the tagging and tracking method of Keinan. One of ordinary skill in the art would have been motivated to do so, since Buckley teaches that “[u]ntil now, only very limited numbers of suitable strains existed, limiting the number of possible studies in any given area or time” (e.g., as per the left column of p. 8273).
One of ordinary skill in the art would have had a reasonable expectation of success as of the application’s effective filing date in combining the teachings of the prior art references to arrive at the invention as presently claimed since Buckley describes in detail the steps and materials needed to create the barcoded collections, including use of real-time PCR assays for specific and rapid detection, using microbiology and molecular biology techniques well within reach of the skilled artisan.
Keinan also discloses that the spores are made from microorganisms that are auxotrophic (e.g., such as for a nucleotide or amino acid synthesis as per [0101]) such as a yeast with a mutation making it unable to synthesize uracil (e.g., as per [0100]). However, Keinan is silent about the source of the mutation causing the auxotrophic phenotype.
Giaever and Koo disclose methods of engineering and characterizing auxotrophic strains of Saccharomyces and Bacillus, respectively, as detailed above.
It would have been prima facie obvious to a person of ordinary skill in the art prior to the effective filing date of the application to engineer auxotrophic strains of Saccharomyces and/or Bacillus, as per Giaever and/or Koo, for use in the tagging and tracking methods of Keinan. One of ordinary skill in the art would have been motivated to do so since Giaever and Koo each provides details to achieve the auxotrophic strains as sought by Keinan. In accordance with MPEP 2141 citing KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385,1395 (2007), "[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”, and as per MPEP 2143(I)(A), the rationale to support a conclusion that the 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 yielded nothing more than predictable results to one of ordinary skill in the art.
One of ordinary skill in the art would have had a reasonable expectation of success as of the application’s effective filing date in combining the teachings of the prior art references to arrive at the invention as presently claimed since Giaever and Koo each describes in detail the steps and materials needed to create such auxotrophic strains using microbiology and molecular biology techniques well within reach of the skilled artisan.
Alternatively, or in addition, to the teachings of Giaever and Koo, Hosseini discloses creation of auxotrophic strains of Bacillus subtilis as a means for biological containment (e.g., as per the Abstract). One of ordinary skill in the art would have been motivated to use these auxotrophic strains due to the increased safety associated with containing such spores of GMOs that would surely come in contact with humans (e.g., as per the Abstract).
Regarding claim 29, Keinan in view of Buckley, Giaever, Koo, and/or Hosseini discloses a method of determining the provenance of an item, the method comprising:
a) contacting an item with at least one engineered microorganism comprising a genetic barcode and having an inactivating modification in at least one essential gene (e.g., as per Keinan at [0034] and as detailed above),
b) isolating nucleic acid from the item (e.g., as per Keinan at [0112]);
c) detecting the genetic barcode element of the at least one isolated engineered microorganism (e.g., as per Keinan at [0112]); and
d) determining the provenance of the item based on the detected genetic barcode element of the at least one isolated engineered microorganism (e.g., as per Keinan at [0107]-[0108]).
Regarding claim 32, Keinan in view of Buckley, Giaever, Koo, and/or Hosseini discloses a method of determining the provenance of an item (e.g., as per Keinan at [0034] and as detailed above), the method comprising:
a) isolating nucleic acid from the item (e.g., as per Keinan at [0112]); and
b) detecting the presence of a genetic barcode element (e.g., as per Keinan at [0112]), wherein the presence of the genetic barcode element indicates the presence of at least one engineered microorganism comprising a genetic barcode element and an inactivating modification of at least one essential compound synthesis gene or an inactivating modification of at least one germination gene, wherein the presence of the at least one engineered microorganism determines the provenance of the item (e.g., as per Keinan at [0107]-[0108]).
Regarding claim 33, Keinan in view of Buckley, Giaever, Koo, and/or Hosseini discloses a method of marking the provenance of an item, the method comprising contacting the item with at least one engineered microorganism of claim 1 (e.g., as per Keinan at [0112]).
Keinan et al., Buckley et al., Giaever et al., and/or Koo et al. and/or Hosseini et al. and Gootenberg et al.
Claims 1, 4-6, 8, 11, 13-14, 17-19, 23, 25-29, and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Keinan et al. (U.S. PGPub 2012/0082997 A1) in view of Buckley et al. (Applied and Environmental Microbiology, 2012, 78(23):8272-8280, as cited in the IDS of 07/13/2022) and further in view of Giaever et al. (Nature, 2002, 418:387-391) and/or Koo et al. (Cell Systems, 2017, 4:291-305, as cited in the IDS of 07/13/2022) and/or Hosseini et al. (Applied and Environmental Microbiology, 2018, 84(3):e02334-17), further in view of Gootenberg et al. (Science, 2017, 356:438-442, cited in IDS of 07/13/2022).
Keinan in view of Buckley, Giaever, Koo, and/or Hosseini is relied on as above, however, the references are silent on the limitations of a Cas enzyme scaffold comprising a scaffold for Cas13 and a transcription initiation site comprising a T7 transcription initiation site, as set forth in claims 17-18.
Gootenberg discloses a rapid method of sensitive DNA detection using reporters comprising a Cas13 enzyme scaffold and a T7 transcription site.
It would have been prima facie obvious to a person of ordinary skill in the art prior to the effective filing date of the application to perform the rapid and sensitive DNA detection method as per Gootenberg in the methods of Keinan in view of Buckley, Giaever, Koo, and/or Hosseini. One of ordinary skill in the art would have been motivated to do so since Gootenberg teaches that their method of detection is isothermal, inexpensive to perform, has attomole sensitivity, and is appropriate for point-of-care or remote applications such as those that might involve the item tracking as per Keinan.
One of ordinary skill in the art would have had a reasonable expectation of success as of the application’s effective filing date in combining the teachings of the prior art references to arrive at the invention as presently claimed since Gootenberg discloses the method can be redesigned and synthesized in a matter of days for as little as $0.61 per test (e.g., as per the penultimate sentence of the paper).
Keinan et al., Buckley et al., Giaever et al., and/or Koo et al. and/or Hosseini et al. and Meadow et al.
Claims 1, 4-6, 8, 11, 13-14, 19, 23, 25-29, 32-33, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Keinan et al. (U.S. PGPub 2012/0082997 A1) in view of Buckley et al. (Applied and Environmental Microbiology, 2012, 78(23):8272-8280, as cited in the IDS of 07/13/2022) and further in view of Giaever et al. (Nature, 2002, 418:387-391) and/or Koo et al. (Cell Systems, 2017, 4:291-305, as cited in the IDS of 07/13/2022) and/or Hosseini et al. (Applied and Environmental Microbiology, 2018, 84(3):e02334-17) and further in view of Meadow et al. (U.S. PGPub 2018/0357365 A1).
Keinan in view of Buckley, Giaever, Koo, and/or Hosseini is relied on as above, however, the references are silent on the limitations of allowing the item or individual to contact the surface in a continuous or discontinuous path and determining the path of the item or individual across the surface based on the detected genetic barcode element of the at least two isolated engineered microorganisms, as set forth in claim 42.
Meadow discloses methods of tracing the paths of tagged items using detection of specific genetic barcodes (e.g., as per the Products in Distribution: The Analysis of Product Manufacturing and Distribution Networks section at [0183]+).
It would have been prima facie obvious to a person of ordinary skill in the art prior to the effective filing date of the application to trace the paths of objects in transit as per Meadow with the spore taggants as per Keinan in view of Buckley, Giaever, Koo, and/or Hosseini. One of ordinary skill in the art would have been motivated to do so since Meadow discloses a broader application of such tracking (e.g., as per Example 2). Furthermore, in accordance with MPEP 2141 citing KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385,1395 (2007), "[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”, and as per MPEP 2143(I)(A), the rationale to support a conclusion that the 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 yielded nothing more than predictable results to one of ordinary skill in the art.
Given the teachings of the prior art and the level of the ordinary skilled artisan at the time of the application’s effective filing date, it must be considered, absent evidence to the contrary, that said skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
Conclusion
No claims are allowed.
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/JEREMY C FLINDERS/
Primary Examiner, Art Unit 1684