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 .
Claim Status and Action Summary
This action is in response to the papers filed on April 30, 2026.
Applicant’s election without traverse of Group I (claims 1-2, 4, 6, 8-10, 30-31, 33, 36, 38-39, 44-46, and 151) in the reply filed on December 2, 2025 is acknowledged.
Claims 1, 6, 8-10, 30-31, 33, 36, 38-39, 44-46, 58-59, 104 and 151 are pending.
Claims 2 and 4, which were previously pending, have been canceled by applicant.
Claims 58-59 and 104 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1, 6, 8-10, 30-31, 33, 36, 38-39, 44-46, and 151 are under examination.
Any objections and rejections not reiterated below are hereby withdrawn.
The 112(b) and 112(d) rejections of record have been withdrawn in view of the amendments to the claims. The 112(b) and 112(d) rejections below are new grounds of rejection necessitated by the amendments to the claims.
Priority/Effective Filing Date
The present application, filed on April 25, 2023, is a 371 of PCT/US2021/056821, filed on October 27, 2021 and claims priority to U.S. Provisional Patent Application No 63/178864, filed on April 23, 2021 and U.S. Provisional Patent Application No 63/106292, filed on October 27, 2020.
Specification
The listing of references in the specification on pages 53-57 is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings filed on April 25, 2023 are acceptable.
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 6, 33, 38, and 151 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.
This is a new grounds of rejection necessitated by the amendments to the claims.
Claim 6 depends from claim 1. Claim 1, as amended, recites steps of: “performing in situ analysis of the gene expression in the cells by performing in situ single-cell transcriptome sequencing…” and “performing mapping of the gene expression in the cells”. Claim 6 recites: “The method of claim 1, wherein the step of performing mapping of the gene expression comprises performing transcriptomic mapping.” Claim 1, as amended, requires “mapping” “single-cell transcriptome [data]”. It is unclear whether and how “transcriptomic mapping” differs from “mapping gene expression” that comprises “single-cell transcriptome sequencing” data. Therefore, it is unclear what method steps are required by claim 6 in addition to those recited by claim 1.
Claim 33, as amended, recites “The method of claim [[4]], wherein the step…”. The deleted reference to claim 4 has not been replaced with any other preceding claim. Therefore, the claim appears to be incomplete and lacking in antecedent basis for “the step of performing in situ single cell transcriptomic sequencing” and it is unclear what steps are required by the claim.
Claim 151, as amended, recites a step of “identifying, based on the comparing, a candidate target for treating the disease”. Neither the claims nor the specification provide any methods for “identifying” a “candidate target for treating a disease” in addition to the comparing step. Therefore it is unclear whether this step is intended to require something more than identifying transcripts that are different in abundance in cells that are associated with different electrophysiological recording data between a first tissue and a second tissue (i.e. does the “identifying a target step” require something more than identifying differentially expressed genes in cells exhibiting different electrophysiological behavior between a first tissue and a second tissue, wherein the second tissue is an “engineered… disease model”? Put another way, are all differentially expressed genes in single cells with spatially correlated electrophysiological differences “candidate targets for treating the disease”?)
Claim 38 is additionally indefinite because it depends from, and thus includes the indefinite limitations of claim 6.
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.
Claims 6, 33, 38, and 45 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.
This is a new grounds of rejection necessitated by the amendments to the claims.
Claim 6 depends from claim 1. Claim 1, as amended, recites steps of: “performing in situ analysis of the gene expression in the cells by performing in situ single-cell transcriptome sequencing…” and “performing mapping of the gene expression in the cells”. Claim 6 recites: “The method of claim 1, wherein the step of performing mapping of the gene expression comprises performing transcriptomic mapping.” Claim 1, as amended, requires “mapping” “single-cell transcriptome [data]”. It is unclear whether and how “transcriptomic mapping” differs from “mapping gene expression” that comprises “single-cell transcriptome sequencing” data. Therefore, it is unclear what method steps are required by claim 6 in addition to those recited by claim 1.
Claim 33, as amended, recites “The method of claim [[4]], wherein the step…”. The deleted reference to claim 4 has not been replaced with any other preceding claim. Therefore, the claim appears to be incomplete and lacking in antecedent basis for “the step of performing in situ single cell transcriptomic sequencing” and it is unclear what steps are required by the claim.
Claim 45 was previously rejected under 112(b) as indefinite because of the limitation: “wherein the tissue is a tissue with electrical activity”. The claim as amended requires: “the tissue is a tissue with measurable electrophysiological activity”. The specification defines “As used herein, “electrophysiological activity” refers to the electrical properties of a biological system” and “involves measurements of voltage changes or electric current, and in particular the flow of ions.” (paragraph 0036). It is well known in the art that eukaryotic cells in tissues maintain electrochemical gradients (i.e. restrict the flow of ions; generate electrical potential differences (i.e. voltage changes)) at least across their plasma membrane and across the outer and inner mitochondrial membranes. These electrical properties of a biological system are therefore present and measurable in all eukaryotic cells. Therefore, given its broadest reasonable interpretation, the claim term “a tissue with measurable electrophysiological activity” appears to encompass any cell in any tissue because all eukaryotic cells regulate the flow of ions across their plasma membranes and inner and outer mitochondrial membranes that result in measurable electrical properties that change in response to environmental conditions within the tissue and/or cell (e.g. concentration of glucose, oxygen, second messengers such as cyclic adenosine monophosphate (cAMP), metabolites such as pyruvate or lactic acid, etc.). As such, the phrase “the tissue is a tissue with measurable electrophysiological activity” does not appear to limit “a tissue” because it appears that there are no tissues that do not have “measurable electrophysiological activity” as defined by the instant specification.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Interpretation
Claim 33 was rejected under 112(b) and 112(d) above due to the amendment: “The method of claim [[4]], wherein…” resulting in the creation of an apparent dependent claim that does not refer to a preceding claim establishing antecedent basis for the claim terms therein (see detailed rejections above). In the interest of compact prosecution, this claim has been given the broadest reasonable interpretation as a direct dependent of independent claim 1 (i.e. “The method of claim 1, wherein…”), which is the only preceding independent claim.
Claim 45 was previously rejected under 112(b) as indefinite because of the limitation: “wherein the tissue is a tissue with electrical activity”. The claim as amended requires: “the tissue is a tissue with measurable electrophysiological activity”. The specification defines “As used herein, “electrophysiological activity” refers to the electrical properties of a biological system” and “involves measurements of voltage changes or electric current, and in particular the flow of ions.” (paragraph 0036). It is well known in the art that eukaryotic cells in tissues maintain electrochemical gradients (i.e. restrict the flow of ions; generate electrical potential differences (i.e. voltage changes)) at least across their plasma membrane and across the outer and inner mitochondrial membranes. These electrical properties of a biological system are therefore present and measurable in all eukaryotic cells. Therefore, given its broadest reasonable interpretation, the claim term “a tissue with measurable electrophysiological activity” appears to encompass any cell in any tissue because all eukaryotic cells regulate the flow of ions across their plasma membranes and inner and outer mitochondrial membranes that result in measurable electrical properties that change in response to environmental conditions within the tissue and/or cell (e.g. concentration of glucose, oxygen, second messengers such as cyclic adenosine monophosphate (cAMP), metabolites such as pyruvate or lactic acid, etc.).
Claim Rejections - 35 USC § 103
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, 6, 8-10, 30-31, 33, 36, 38-39, and 44-46 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al., “Cyborg Organoids: Implantation of Nanoelectronics via Organogenesis for Tissue-Wide Electrophysiology” Nano Lett. 2019, 5781-5789 (published July 26, 2019) in view of Wang et al., “Three-dimensional intact-tissue sequencing of single-cell transcriptional states” Science 361, 380 (published July 27, 2018) and Disawal et al., US 2013/0292879 A1 (published November 7, 2013).
This rejection has been updated as necessitated by the amendments to the claims.
Regarding claim 1, Li et al. teach methods for measuring continuous electrophysiological activity (i.e. a continuous physical process) in cells in a tissue with single-cell and millisecond spatiotemporal resolution in a cardiac organoid (i.e. cells in a tissue) (Li et al., Abstract). Li et al. teach the method comprises: a) embedding nanoelectronic devices comprising multiple sensors in the tissue (Li et al., Figure 1A, reproduced below for clarity), wherein the device is labeled with the fluorescent dye rhodamine 6G (R6G)(Li et al., Figure 3),
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b) performing continuous tissue-wide electrophysical mapping (i.e. continuous physiological measurement), c) fixing the cyborg organoids (i.e. the nanoelectronics-tissue hybrid), d) performing in situ analysis of stage-specific marker expression (including protein markers TNT, alpha actinin and actin by immunostaining), and e) performing mapping of the protein expression on the cells (Li et al., figure 3).
Li et al. further teaches that each of the sensors in the device are individually addressable (Li et al., page 5781, column 1) and are fabricated in a photolithographic process (Li et al., page 5785, column 2, paragraph 2).
Li et al. further teach that the continuous physiological process comprises electrophysiological activity, wherein the measuring step comprises continuous electrophysiological recording (Li et al., figure 4).
Li et al. do not teach that the multiple sensors in the nanoelectronic device (Li et al., figure 1) each comprise a unique electronic barcode.
However, Disawal et al. teach that individual sensors in microelectronic devices (Disawal et al., paragraph 0067) can be individually labeled with unique barcodes using photolithography (Disawal et al., paragraph 0182) and that there is no particular limit to how small the lateral dimension (of the barcode) can be as long as the feature can be detected (with a microscope) and that barcodes in particular can vary from nanoscopic to microscopic (Disawal et al., paragraph 0187-0188). Disawal et al. teach that unique micron and nanoscale identifier features (such as barcodes) are useful for labeling objects including individual sensors or medical devices for purposes such as the prevention of counterfeiting such components (Disawal et al., paragraph 0229).
Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention for one of ordinary skill in the art to have modified the lithographically-fabricated, fluorescently-labeled nanoelectronic devices, taught by Li et al. to comprise individually labeled (i.e. “electronic barcod[ed]”) sensor components, encoded using the same fluorescent molecule taught by Li et al., by the methods taught by Disawal et al. comprising lithographic fabrication of nanoscopic barcode features. The ordinary artisan would have been motivated to utilize individually barcoded sensor components, fabricated by the lithographic processes taught by Disawal et al. and Li et al., because of the teaching of Disawal et al. that individually barcoded components beneficially prevent counterfeiting of products such as medical devices and sensors in microelectronic devices.
Li et al. and Disawal et al. do not teach performing cell segmentation to correlate an in situ analysis (of the expression of various gene expression markers) with a continuous physiological measurement (spatiotemporally-resolved electrophysiology).
However, Wang et al. teach methods comprising three-dimensional in situ sequencing of individual RNA molecules in intact single cells in intact tissues (Wang et al., Figures 1-2). Wang et al. further teach attributing the in situ analysis of gene expression to individual cells in an intact tissue by cell segmentation analysis (Wang et al., page 8, column 3). Finally, Wang et al. explicitly suggest that this method can be integrated with cell-type information with single-cell morphology, projection anatomy, and in vivo neural activity imaging and electrophysiology (Wang et al., page 9, column 2, paragraph 2).
Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention for one of ordinary skill in the art to have substituted the immunofluorescence methods of measuring in situ gene expression in cells in a tissue, taught by Li et al. with the single-cell, in situ gene expression analysis comprising in situ, single-cell RNA sequencing and cell segmentation analysis taught by Wang et al.
The ordinary artisan would have been motivated to substitute the method of Wang et al. into the methods taught by Li et al. because of the express suggestion of Wang et al. that single cell, in situ RNA sequencing can integrate in vivo neural activity electrophysiology (i.e. a continuous physiological process) with single cell gene expression analysis (i.e. an in situ analysis of a biomolecular process) in intact tissues. Furthermore, Wang et al. explicitly provide the motivation that: in situ transcriptomics exemplified by STARmap (i.e. single cell in situ RNA sequencing) can effectively link this imaging-based molecular information with complementary cellular-resolution datastreams describing anatomy, natural activity, and causal importance (e.g., electrophysiology), thus promising to fundamentally deepen our understanding of brain function and dysfunction (Wang et al., page 9, column 2, paragraph 2).
Regarding claim 6, Wang et al. teach the biomolecular process comprises gene expression, wherein the in situ analysis of gene expression comprises performing in situ single cell transcriptome sequencing (Wang et al., abstract) and mapping of the transcripts onto single cells (i.e. transcriptomic mapping) (Wang et al., abstract).
Regarding claim 8, Li in view of Disawal et al. teach that the “electronic barcode” is a fluorescent electronic barcode (see claim 1 above).
Regarding claim 9, Li et al. teach “The mesh nanoelectronics are highly scalable due to the photolithographic nature of the fabrication process” and “it is possible to further scale up to larger sensor arrays, 96, 128, or more without sacrificing the geometries and mechanics that are essential for integration via organogenesis (Li et al., page 5785, column 1-2 bridging paragraph). Even more, Li et al. teach the method “is scalable for integrating a larger number of sensors and stimulators” (Li et al., page 5787, column 2, paragraph 3).
Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention for one of ordinary skill in the art to have scaled up the number of sensors arrayed in the nanoelectronic device to comprise over 1000 sensors. The ordinary artisan would have been motivated to increase the number of sensors in the device to predictably increase the spatial resolution of signals detected by the sensor array. Furthermore, the ordinary artisan would have been reasonably confident that an increased number of sensors would have been easily integrated into the device, given the express teaching/suggestion of Li et al. that the device is scalable for integrating a larger number of sensors without any observed practical trade-off. Furthermore, the courts have previously held that duplication of parts taught by the prior art “has no patentable significance unless a new and unexpected result is produced” (see In re Harza, below). In this case, given the predictable benefit of increased spatial resolution provided by an increased number of sensors in a device comprising a sensor array and the teaching of Li et al. that the number of sensors in such a device may be scaled up without compromising the integration of the device, it is the position of the examiner that one of ordinary skill in the art would have been motivated to increase the number of sensors in the array with a reasonable expectation of success.
In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.).
Regarding claim 10, Li et al. teach the cells in the tissue comprise over 1,000,000 (i.e. 1x106 cells (Li et al., Materials and methods, page 6, section 2.4 “3D culture of cyborg organoids”).
Regarding claim 30, Li et al. teach the nanoelectronic device comprises electrical sensors (i.e. an electrical device) and stimulators (Li et al., page 5781, column 2, paragraph 2 and page 5787, column 2, paragraph 2).
Regarding claim 31, Li et al. teach the step of embedding the device comprises transferring the device onto a 2D sheet of cells and allowing the cells to aggregate, proliferate, and migrate, leading to device compression and embedding within the tissue (Li et al., Figure 1).
Regarding claim 33, Wang et al. teach the step of performing in situ single cell transcriptome sequencing comprises: constructing cDNA amplicons in situ by probe hybridization, enzymatic amplification of the cDNA amplicons, and immobilization of the amplified cDNA in a hydrogel network (Wang et al., Figure 1, reproduced below for clarity and convenience).
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Regarding claim 36, Wang et al. teaches the step of performing in situ single cell transcriptome mapping comprises “STARmap” (Wang et al., page 1, column 3).
Regarding claim 38, Wang et al. teaches mapping over 1000 genes simultaneously (Wang et al., abstract).
Regarding claim 39, Wang et al. and Li et al. teach imaging the tissues using confocal microscopy (Wang et al., page 8, column 3; Li et al., materials and methods, page 36, figure S23). Li et al. further teach determining the structure and position of the stretchable mesh nanoelectronics using confocal microscopy (Li et al., materials and methods, page 36, figure S23) (i.e. in combination with Disawal et al., see claim 1 above, identifying the position of the electronic barcode).
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Regarding claim 44, Li et al. and Wang et al. teach that the tissue is three dimensional (Li et al., Figure 1; Wang et al., Figure 1).
Regarding claims 45 and 46, Li et al. teach the tissue is a cardiac organoid (i.e. a tissue with measurable electrophysiological activity; heart tissue; muscle tissue; developing tissue) (Li et al., abstract).
Claim 151 is rejected under 35 U.S.C. 103 as being unpatentable over Li et al., “Cyborg Organoids: Implantation of Nanoelectronics via Organogenesis for Tissue-Wide Electrophysiology” Nano Lett. 2019, 5781-5789 (published July 26, 2019) in view of Wang et al., “Three-dimensional intact-tissue sequencing of single-cell transcriptional states” Science 361, 380 (published July 27, 2018) and Disawal et al., US 2013/0292879 A1 (published November 7, 2013) as applied to claims 1-2, 4, 6, 8-10, 30-31, 33, 36, 38-39, 44-46 above, and further in view of Lee et al., “Engineered Cardiac Organoid Chambers: Toward a Functional Biological Model Ventricle” Tissue Engineering: Part A Volume 14, Number 2, 2008.
Regarding claim 151, as described for claim 1 above, the methods of Li et al. in view of Wang et al., and Disawal et al. teach the method steps (a) through (g) recited by claim 151. Li et al. further suggests that cardiac cyborg organoids may be applied to study cardiac development, diseases, and therapeutics (Li et al., page 5787 , column 2, paragraph 3). Li et al. in view of Wang et al., and Disawal et al. do not teach performing the method comprising steps (a) through (g) (i.e. the steps recited by claim 1) on a second tissue, wherein the second tissue is engineered as a disease model, and comparing the single cell transcriptome data and electrophysiological recording data from the first (i.e. control) tissue and the second (i.e. disease model) tissue.
However, Lee et al. teach engineered cardiac organoid chambers comprising an engineered cryoinjured organoid model of myocardial infarction (i.e. a disease model). Lee et al. teach comparing contractile function between the first (control) organoid and a second (injured/diseased) organoid (Lee et al., Figure 7). Lee et al. further teach that the contractile function is driven by electrophysiological activity, as measured by electrophysiology measurements (Lee et al., page 217, column 1 and page 221, column 1-2 bridging paragraph).
Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention for one of ordinary skill in the art to have combined the methods for correlating single cell transcriptome data with electrophysiological activity in cyborg cardiac organoids, taught by Li et al. in view of Wang et al. and Disawal et al. with the engineered cardiac organoid model of myocardial infarction taught by Lee et al.
The ordinary artisan would have been motivated to combine the cyborg cardiac organoid system and method with the engineered cardiac organoid disease model taught by Lee et al. because of the suggestion of Li et al. that cardiac cyborg organoids may be applied to study cardiac development, diseases, and therapeutics (Li et al., page 5787 , column 2, paragraph 3) and the teaching of Lee et al. that experimental cryoinjury, previously established as a controllable model of myocardial infarction in rat animal models, was implemented in an organoid model (Lee et al., page 217, column 2, paragraph 2) and exhibited similar changes in physiology to those observed in the animal model (Lee et al., page 223, paragraph 1). Finally, Lee et al. suggests that engineered cardiac organoids can reduce the use of experimental animals for cardiac research. The ordinary artisan would have been reasonably confident that the relatively straightforward disease model applied by Lee et al. (i.e. cryoinjury of cardiac organoid tissue) would have been readily applied to the cardiac cyborg organoids and methods taught by Li et al. in view of Wang et al. and Disawal et al.
Response to arguments
The response asserts:
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The response identifies differences between the cited prior art and the claimed invention, particularly that the nanoelectronic device recited by the claimed invention differs from that taught by Li et al. in that the claimed invention comprises a unique fluorescent barcode on the at least one sensor of the at least one nanoelectronic device and a step of cell segmentation to correlate the mapping of electrophysiological measurements with in situ gene expression data. The response further identifies that the secondary references likewise differ from the claimed invention (to summarize: Wang et al. does not teach embedded nanoelectronic sensors; and Disawal does not teach an electrophysiology/transcriptomics platform).
Regarding the individual differences between the cited prior art in the 103 (obviousness-type) rejections above, In response to applicant's arguments against the references individually, it is noted that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Finally, the response asserts:
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In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, as described in the 103 rejection above, motivation for combining the methods of Li et al. and Wang et al. is “because of the express suggestion of Wang et al. that single cell, in situ RNA sequencing can integrate in vivo neural activity electrophysiology (i.e. a continuous physiological process) with single cell gene expression analysis (i.e. an in situ analysis of a biomolecular process) in intact tissues. Furthermore, Wang et al. explicitly provide the motivation that: in situ transcriptomics exemplified by STARmap (i.e. single cell in situ RNA sequencing) can effectively link this imaging-based molecular information with complementary cellular-resolution datastreams describing anatomy, neural activity, and causal importance (e.g., electrophysiology), thus promising to fundamentally deepen our understanding of brain function and dysfunction (Wang et al., page 9, column 2, paragraph 2).
Regarding the assertion that the ordinary artisan would not have looked to the individual component labeling methods taught by Disawal et al., “seeking to improve Li’s electrophysiology/transcriptomics platform” because the teachings of Disawal et al. are not taught in the context of, or applied to identifying embedded physiological sensors in a tissue by Disawal, this argument has been thoroughly reviewed and is not persuasive for at least (but not limited to) the following reasons:
MPEP 2144 (IV) states: “The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant.”
The assertion that the ordinary artisan would not have been motivated to optically label the individual components of the sensors taught by Li et al. as taught by Disawal et al. because Disawal et al. does not explicitly apply the labeling to the components in the systems taught by Li et al. i) constitutes a piecemeal analysis of the references, and ii) is not persuasive additionally because it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY MARK TURPIN whose telephone number is (703)756-5917. The examiner can normally be reached Monday-Friday 8:00 am - 5:00 pm.
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/Z.M.T./Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682
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