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/Action Summary
This action is in response to the papers filed on December 5, 2025.
Claims 1-13 are under examination. No other claims are currently pending in the present application.
Applicant's arguments filed December 5, 2025 have been fully considered but they are not persuasive, as detailed following the rejections below.
Priority
The present application, filed on March 24, 2023, is a 371 of PCT/US2021/044011, filed on July 30, 2021, which claims the benefit of U.S. Provisional Application No. 63/085,319, filed on September 30, 2020.
Drawings
The drawings filed on March 24, 2023 are acceptable.
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.
Claims 8-9 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
This rejection has been updated as necessitated by the amendments to the claims.
Claim 8 recites the limitation “the electric field is applied at a strength and for a time sufficient to expose the DNA.” It is unclear to what “sufficient to expose the DNA” refers. The claim may be interpreted as “sufficient to release DNA [from the nucleus or from the cell]” or alternatively, “sufficient to expose the DNA to the one or more detectable nucleic acid probes”.
Claim 9 is also indefinite because it depends on claim 8 and therefore includes the indefinite limitation of claim 8.
Response to Arguments
The response asserts that the 112(b) rejection of record is believed to be moot in light of the amendments to claims 8 and 9 reciting “the target polynucleotide” and “500 V/mm”. It is noted that the response does not address the ambiguous claim term “sufficient to expose the DNA”, identified in the 112(b) rejection of record. Therefore, the rejection has been updated in view of the amendments to the claims and is maintained with respect to this indefinite claim term.
Applicant is reminded that no new matter may be added.
Claim Rejections - 35 USC § 102
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.
Claims 1-8, 10, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Frenz, US 2020/0277664 A1, published September 3, 2020.
This rejection has been updated as necessitated by the amendments to the claims.
Regarding claim 1, Frenz teaches methods for analyzing the spatial distribution of nucleic acid molecules in a cell (i.e. a sample comprising a target polynucleotide), wherein the introduction of a detectable nucleic acid probe is facilitated by electroporation (i.e. applying an electric field to the sample while contacting the sample with detectable nucleic acid probes) (Frenz, paragraph 1128) (i.e. the electric field is applied during nucleic-acid exposure (i.e. permeabilization of the cell), during which the nucleic acid probes bind to the target polynucleotide).
Regarding claims 2-6, Frenz teaches the sample is a paraffin-embedded tissue specimen, wherein the specimen comprises whole tissue samples, slices of tissue samples, cultured cell pellets, or touch imprints (i.e. cell smears) (Frenz, paragraphs 0209, 0215-0217, and 0221)
Regarding claim 7, Frenz teaches the sample comprises cells and the target polynucleotide is within a nucleus of the cells (Frenz, paragraphs 0119 and 0194-0195).
Regarding claim 8, Frenz teaches “With electroporation, a biological analyte by a molecule (e.g., a nucleic acid molecule) having a barcode (e.g., a spatial barcode) and a capture domain can enter a cell through one or more pores in the cellular membrane formed by applied electricity. The pore of the membrane can be reversible based on the applied field strength and pulse duration.” (i.e. the target nucleic acid is exposed (by the generation of pores) to the environment containing detectable probes (i.e. is exposed to a detectable probe)) (Frenz, paragraph 1128).
Regarding claim 10, Frenz teaches the method can be performed without subjecting the biological sample to enzymatic and/or chemical degradation of the cells (i.e. without contacting the cell with a proteolytic enzyme) (Frenz, paragraph 1005).
Regarding claim 12, Frenz teaches removing the paraffin prior to analysis (i.e. before contacting the sample with the labeled probes (Frenz, paragraph 0221).
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by West et al., US 2019/0262831 A1, published August 29, 2019.
This rejection has been updated as necessitated by the amendments to the claims.
Regarding claim 1, West et al. teach methods for capturing template (i.e. target) nucleic acids in a spatially specific manner (West et al., abstract) comprising applying an electric field to a sample comprising the target nucleic acids while the target nucleic acids specifically bind to a high density array of primers (i.e. detectable probes) (West et al., paragraph 0226 and figure 6). West et al. teach that the nucleic acids are exposed to the array and bind to the array while the electric field is applied (West et al., paragraph 0223-0228).
Regarding claim 2, West et al. teach that the sample is a paraffin-embedded tissue specimen (West et al., paragraphs 0223-0228).
Regarding claims 3-6, West et al. teach suitable samples comprise cell aggregates, cell smears, tissue samples, (West et al., paragraph 0062) and a tissue sample sectioned from an FFPE sample in a thickness of about 4-20 microns (i.e. a slice of whole tissue) West et al., paragraph 0074).
Regarding claim 7, West et al. teach the sample comprises cells and the image map of the tissue with which the probe array is correlated is of sufficient resolution to determine subcellular structures such as the nucleus (i.e. the target polynucleotide is within the nucleus) (West et al., paragraph 0076).
Regarding claim 8, West et al. teach applying an electric field at a sufficient strength and for a sufficient time to expose the target nucleic acids to the probe array (West et al., paragraph 0223-0228).
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barker et al., US 2013/0309688 A1, published November 21, 2013.
This rejection has been updated as necessitated by the amendments to the claims.
Regarding claim 1, Barker et al. teach methods for processing samples for in situ hybridization (Barker et al., paragraph 0002) wherein an electric field is applied to the sample while in contact with detectable nucleic acid probes. Barker et al. teach the electric filed reduces the required reaction time and improves the quality of tissue staining (Barker et al., paragraphs 78-81).
Barker et al. further teach that wash buffers are pulled across a slide by attracting nanoparticles (i.e. removal of a liquid) (Barker et al., paragraph 0089).
Regarding claim 2, Barker et al. teach the sample is a paraffin-embedded tissue sample (Barker et al., paragraph 0002).
Regarding claims 3-6, Barker et al. teach the sample may be a variety of biological samples comprising tissues, histological samples (i.e. whole tissues), thin-layer preparations, a slice of tissue, blood smears, cell preparations, cells, and isolated cells (i.e. cell pellets) (Barker et al., paragraph 0060).
Claims 1 and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pilarski et al., US 2012/0082978 A1, Published April 5, 2012.
This rejection has been updated as necessitated by the amendments to the claims.
Regarding claim 1, Pilarski et al. teach applying an electric field to a sample during hybridization with detectable probes (Pilarski et al., paragraph 0151) (i.e. during nucleic-acid exposure).
Regarding claim 7, Pilarski et al. teach the sample is a population of cells of interest (i.e. comprises one or more cells) (Pilarski et al., paragraph 0026) and that target polynucleotides are within the nucleus of the cells (Pilarski et al., paragraphs 0008 or 0100).
Regarding claim 8, Pilarski et al. teach applying the electric field at a strength and time sufficient to hybridize the detectable probes to the target nucleic acids (i.e. to expose the DNA) (Pilarski et al., paragraph 0151).
Regarding claim 9, Pilarski et al. teach the electric field is applied at a strength of 10 V/cm across channel (712) which is shorter than 75mm in length (i.e. 7.5 cm) (see figure 7). Because field strength=V/m, the total voltage applied across the channel is less than 10V/cm * 7.5 cm (i.e. is less than 75 V) (i.e. the applied potential is less than 500V) (Pilarski et al., paragraph 0151). Furthermore, 10V/cm is equivalent to 1V/mm (i.e. less than 500V/mm).
Claims 1 and 7-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kang et al., “Nanofountain Probe Electroporation (NFP-E) of Single Cells” Nano Letters 2013, 13, pages 2448-2457.
This rejection has been updated as necessitated by the amendments to the claims.
Regarding claim 1, Kang et al. teach applying an electric field to single cells (i.e. a sample comprising target polynucleotides while contacting the sample with a detectable nucleic acid probe (a 30 bp GAPDH-target beacon) (Kang et al., figure 2 and 9e) (i.e. exposing the nucleic acid and hybridization during application of the electric field).
Regarding claim 7, Kang et al. teach the sample comprises one or more cells and the target polynucleotide is in the nucleus (Kang et al., figure 9e).
Regarding claim 8, Kang et al. teach applying the electric field at a strength and time sufficient to expose the target DNA to a detectable nucleic acid probe (Kang et al., figure 9e).
Regarding claim 9, Kang et al. teach applying an electric field at a potential of 30 V across a gap size of 23 nm (i.e. less than 500V) (Kang et al., page 2452, column 2, paragraph 3).
Regarding claim 10, Kang et al. teach electroporating the nucleic acid probe into live cells attached to a solid substrate (i.e. not treated with a proteolytic enzyme).
Regarding claim 11, Kang et al. teaches the sample is rinsed with media without phenol red to avoid autofluorescence (Kang et al., page 2453, column 1, paragraph 1).
Response to arguments
The response asserts that the amendment of claim 1 to recite that “the electric field is also being applied during the step of deparaffinization, antigen retrieval, nucleic-acid exposure, removal of trapped liquid or solvent, and/or coverslip mounting” renders the 102(a)(1) rejections of record moot because “this is not taught in the cited prior art”.
As is addressed in the updated 102(a)(1) rejections above, these broadly claimed limitations are, in fact, present in the cited prior art.
Furthermore, the arguments in the response fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
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 1-4 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Lim et al., US 2018/0120207 A1 (Published May 3, 2018) in view of Fujishima et al., “Novel method for rapid fluorescence in-situ hybridization of ALK rearrangement using non-contact alternating current electric field mixing”, Scientific Reports 7:15116 (Published November 8, 2017).
Regarding claim 1, Lim et al. teaches methods of deparaffinization of tissues comprising applying an electric field to a sample comprising target polynucleotides (Lim et al., paragraph 0015). Lim et al. teach removing paraffin from tissue samples comprising applying an electric field allows for minimization/removal of the necessity for contacting target nucleic acids with aromatic hydrocarbon solvents such as xylene that are known to cause oxidation of DNA and RNA nucleotides that can negatively impact sequencing or hybridization-based detection of the target nucleic acids (Lim et al., paragraph 0015). Lim specifically contemplates that nucleic acid assays such as fluorescence in situ hybridization of DNA or RNA probes to target nucleic acids in deparaffinized tissue could benefit from methods of electrical, rather than purely chemical (i.e. by treatment with xylene) deparaffinization (Lim et al., paragraph 0015).
Lim et al. do not teach contacting the sample with one or more detectable nucleic acid probes which specifically bind to the target polynucleotide while the electric field is being applied.
However, Fujishima et al. teach methods for “rapid fluorescence in-situ hybridization” designed to facilitate hybridization between fluorescent nucleic acid probes and target nucleic acids (Fujishima et al., page 1, paragraph 1). Fujishima et al. teach that the rapid FISH technique produces results in 4.5 hours rather than 20 hours with equivalently accurate results (Fujishima et al., page 1, paragraph 1). The rapid FISH method adapts a method originally developed for rapid immunohistochemistry wherein an electric field is applied to deparaffinized tissue samples while an antibody (or nucleic acid probes) are in contact with the sample (Fujishima et al., page2, 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 modified the method of electric field-mediated paraffin removal from tissue samples and subsequent staining by conventional FISH, taught by Lim et al. with the teachings of Fujishima et al. that applying an electric field during the hybridization process significantly increases the speed with which a clinician may obtain FISH results (Fujishima et al., page 2, paragraph 2). The ordinary artisan would have been motivated to have combined the electric field-assisted deparaffinization step, taught by Lim et al., with the electric field-assisted hybridization step, taught by Fujishima et al. because of the teaching of Fujishima et al. that rapid processing by rapid FISH allows for faster determination of informative genetic signals in cancer samples (Fujishima et al., page 4, paragraph 4) and by the teaching of Lim et al. that fluorescence in-situ hybridization techniques would be expected to benefit from better-quality nucleic acid removal from paraffin (i.e. without or with reduced exposure to DNA damaging chemicals such as xylene) (Lim et al., paragraph 0015).
Regarding claim 2, Lim et al. (paragraph 0015) and Fujishima et al. (page 4, paragraph 7) teach the samples are paraffin-embedded tissues.
Regarding claims 3-4 Lim et al. teach the tissues are embedded in paraffin and may be sectioned (i.e. sliced) prior to mounting on a slide (Lim et al., paragraph 0007-0008).
Regarding claim 7, Fujishima et al. teach the sample comprises one or more cells and the target nucleic acids are within the nuclei of the cells (Fujishima et al., Figure 1).
Regarding claim 8, Fujishima et al. teach the application of the electric field is sufficient to expose the DNA (i.e. the detectable probes can hybridize to the target nucleic acids) (Fujishima et al., Figure 1).
Claims 1, 5-6, 10, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Lim et al. in view of Fujishima et al. as applied to claims 1-4 and 7-8 above, and further in view of Frenz, US 2020/0277664 A1 (Published September 3, 2020).
Regarding claim 1, as described in the preceding 103 rejection, Lim et al. in view of Fujishima et al. teach methods comprising applying an electric field to a sample comprising a target polynucleotide and contacting the sample with detectable nucleic acid probes while the electric field is being applied.
Lim et al. in view of Fujishima et al. teach electric field-assisted methods for paraffin removal comprising minimal contact with mutagenic solvents such as xylene (Lim et al., paragraphs 0015 or 0049) and electric field assisted methods for rapid hybridization of detectable nucleic acid probes to target nucleic acids (Fujishima et al., Figure 1 and page 4, paragraph 7).
Regarding claims 5-6, Lim et al. in view of Fujishima et al. do not teach that a sample may be “cell pellets” or “cell smears”
However, Frenz teaches methods for analyzing the spatial distribution of nucleic acid molecules in a cell (i.e. a sample comprising a target polynucleotide), wherein the introduction of a detectable nucleic acid probe is facilitated by electroporation (i.e. applying an electric field to the sample while contacting the sample with detectable nucleic acid probes) (Frenz, paragraph 1128).
Frenz teaches the sample is a paraffin-embedded tissue specimen, wherein the specimen comprises whole tissue samples, slices of tissue samples, cultured cell pellets, or touch imprints (i.e. cell smears) (Frenz, paragraphs 0209, 0215-0217, and 0221).
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 methods taught by Lim et al. in view of Fujishima et al. comprising electric field-assisted removal of paraffin from tissue samples and hybridization of detectable nucleic acid probes to target nucleic acids in the deparaffinized tissue samples to further apply the techniques disclosed by Lim et al. in view of Fujishima et al. to other frequently used clinical sample types (i.e. cell pellets as in fractionated blood samples (for example, buffy coats or peripheral blood mononuclear cells, etc.) or cell smears (for example, whole blood smears used in, among other applications, parasitology).
Regarding claim 10, Frenz teaches the method can be performed without subjecting the biological sample to enzymatic and/or chemical degradation of the cells (i.e. without contacting the cell with a proteolytic enzyme) (Frenz, paragraph 1005).
Regarding claim 12, Frenz teaches removing the paraffin prior to analysis (i.e. before contacting the sample with the labeled probes (Frenz, paragraph 0221). Alternatively, Lim et al. teach removing substantially all of the paraffin prior to genomic analysis (i.e. hybridizing probes) (Lim et al., paragraph 0049-0051).
Regarding claim 13, Lim et al. teach that removal of paraffin is conventionally performed by dipping the tissue slide in xylene. Lim et al. further teach electric field-based deparaffinization removes most or substantially all of the paraffin, which minimizes or eliminates the use of xylene… which is highly desirable given that xylene is a toxic chemical (Lim et al., paragraph 0049).
Therefore, Lim et al. teach embodiments wherein the use of xylene is “minimized” in the deparaffinization process (i.e. the paraffin is removed by a combination of applying an electric field and rinsing the sample with a deparaffinization solvent) (Lim et al., paragraph 0049). Alternatively, Lim et al. teach other solvents such as isopropyl alcohol are also used to remove paraffin (Lim et al., paragraph 0011).
Response to arguments
The response asserts that the amendment of claim 1 to recite that “the electric field is also being applied during the step of deparaffinization, antigen retrieval, nucleic-acid exposure, removal of trapped liquid or solvent, and/or coverslip mounting” renders the 103 rejections of record moot because “this is not taught in the cited prior art”.
As is addressed in the maintained 103 rejections above, these broadly claimed limitations are, in fact, present in the cited prior art.
Furthermore, the arguments in the response fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,525,759 B2 (herein referred to as ‘759) (issued December 13, 2022) in view of Fujishima et al.
Claim 1 of ‘759 recites a method for preparing a tissue comprising applying an electric field to a tissue sample (i.e. comprising a target polynucleotide). The claims of ‘759 do not recite contacting the sample with detectable nucleic acid probes while the electric field is being applied.
However, Fujishima et al. teach methods for “rapid fluorescence in-situ hybridization” designed to facilitate hybridization between fluorescent nucleic acid probes and target nucleic acids (Fujishima et al., page 1, paragraph 1). Fujishima et al. teach that the rapid FISH technique produces results in 4.5 hours rather than 20 hours with equivalently accurate results (Fujishima et al., page 1, paragraph 1). The rapid FISH method adapts a method originally developed for rapid immunohistochemistry wherein an electric field is applied to deparaffinized tissue samples while an antibody (or nucleic acid probes) are in contact with the sample (Fujishima et al., page2, paragraph 2).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art to have modified the method claimed by ‘759 to further comprise contacting FISH probes with the sample while the electric field is applied, after removal of substantially all of the paraffin. The ordinary artisan would have been motivated to detect nucleic acids in a tissue prepared (i.e. deparaffinized) by the method claimed by ‘759 because of the teaching of Fujishima et al. that that rapid processing (i.e. hybridization) by rapid FISH in deparaffinized clinical samples allows for faster determination of informative genetic signals in cancer samples (Fujishima et al., page 4, paragraph 4).
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 17, and 18 of U.S. Patent No. 10,613,005 B2 (herein referred to as ‘005) in view of Fujishima et al.
Claims 1 and 17 of ‘005 recite a method for deparaffinizing a tissue comprising applying an electric field to the tissue (i.e. a sample comprising a target polynucleotide) (‘005, claim 1) and staining the tissue after removing the paraffin (‘005, claim 17).
The claims of ‘005 do not recite that the stain is a detectable nucleic acid probe or probes or that the electric field is applied to the tissue while the sample is contacted with detectable nucleic acid probes.
However, Fujishima et al. teach methods for “rapid fluorescence in-situ hybridization” designed to facilitate hybridization between fluorescent nucleic acid probes and target nucleic acids (Fujishima et al., page 1, paragraph 1). Fujishima et al. teach that the rapid FISH technique produces results in 4.5 hours rather than 20 hours with equivalently accurate results (Fujishima et al., page 1, paragraph 1). The rapid FISH method adapts a method originally developed for rapid immunohistochemistry wherein an electric field is applied to deparaffinized tissue samples while an antibody (or nucleic acid probes) are in contact with the sample (Fujishima et al., page2, paragraph 2).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art to have modified the method claimed by ‘005 to further comprise contacting FISH probes with the sample while the electric field is applied, after removal of substantially all of the paraffin. The ordinary artisan would have been motivated to detect nucleic acids in a tissue prepared (i.e. deparaffinized) by the method claimed by ‘005 because of the teaching of Fujishima et al. that that rapid processing (i.e. hybridization) by rapid FISH in deparaffinized clinical samples allows for faster determination of informative genetic signals in cancer samples (Fujishima et al., page 4, paragraph 4).
Response to arguments
The response asserts that the amendment of claim 1 to recite that “the electric field is also being applied during the step of deparaffinization, antigen retrieval, nucleic-acid exposure, removal of trapped liquid or solvent, and/or coverslip mounting” renders the double patenting rejections of record moot because “this is not taught in the cited prior art”.
As is addressed in the double patenting rejections of record, these broadly claimed limitations are, in fact, present in the cited prior art.
Furthermore, the arguments in the response fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
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.
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/Z.M.T./Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682