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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/27/2024, 07/10/2024, 10/09/2024 , 04/29/2025, 07/30/2025, 09/25/2025, 07/17/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of Claims
This office action is in response to Applicant's Response to Election / Restriction filed on July 17, 2026.
Claims 1, 5-6, 8-13, 16, 25-27, 29-31, 34, 37, 40-41 are currently pending, with claim 13 withdrawn.
Claims 1, 5-6, 8-12, 16, 25-27, 29-31, 34, 37, 40-41 are under examination.
This is the first action on the merits.
Election/Restrictions
The requirements for species election for "Species of sample"; "Species of removing carrier substrate," set forth in the office action mailed on June 23, 2026 have been withdrawn.
Applicant’s election without traverse of the following species in the reply filed on July 17, 2026 is acknowledged:
Species of sample-carrier constructs workflow: FIG 2A;
Species of carrier substrate: A) The carrier substrate maintains a hydrated interfacial surface (i.e., a plurality of water molecules at the surface forming an interstitial water layer) , the interfacial water is useful at facilitating transfer (FIGS. 3A-3B);
Species of Biomolecule: E) nucleic acid molecule (claim 9, 10) 1;
Species of biomolecule detection: M) Detection of biomolecule relies on generating an amplification product and detecting such amplification product (e.g., STARmap; Proximity Ligation Assay (PLA)) (spec [0135]; [0342]) .
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 13 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Examination on the merits commences on claims 1, 5-6, 8-12, 16, 25-27, 29-31, 34, 37, 40-41.
Priority
The priority date of the instant claims 1, 5-6, 8-12, 16, 25-27, 29-31, 34, 37, 40-41 is October 25, 2021, filling date of the US provisional application NO. 63/271,456.
Claim Objections
Claim 1 is objected to because of the following informalities:
In Claim 1, line 12: "d) e) contacting a biomolecule in said tissue section with a labeled detection agent" should read "d) [[e) ]]contacting a biomolecule in said tissue section with a labeled detection agent."
Claim Interpretation
In evaluating the patentability of the claims presented in this application, claim terms have been given their broadest reasonable interpretation (BRI) consistent with the specification, as understood by one of ordinary skill in the art, as outlined in MPEP§ 2111.
For the purpose of applying prior art, the term "compression modulus," recited in claim 6, is interpreted in light of the specification2 as having the same meaning as "Young's Modulus" (recited in claim 30) ꟷ a measure of material stiffness.
For the purpose of applying prior art, claim 29 recites "thermoplastic elastomer," which is not expressly defined in the application's disclosure.
The commonly understood meaning for the term "thermoplastic elastomer" is a polymer having both thermoplastic (i.e., softens when heated and hardens upon cooling) and elastomeric (i.e., elastic polymer) properties. (See Thermoplastic elastomer - Wikipedia; Archived March 25, 2021 on WaybackMachine).
Claims 6, 25 and 30 recite the term "about," which is defined by the applicant's disclosure in para [0029]:
"As used herein, the term “about” means a range of values including the specified value, which a person of ordinary skill in the art would consider reasonably similar to the specified value. In embodiments, the term “about” means within a standard deviation using measurements generally acceptable in the art. In embodiments, about means a range extending to +/−10% of the specified value. In embodiments, about means the specified value."
Thus, under BRI and in light of the specification, the term "about" is interpreted to encompass ranges of 10% greater than or less than the specified value. For instance, "about 100 kPa" is construed to mean a range from 90-110 kPa.
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 9-12 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 (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 9 and 10, they each depends from claim 1 and recites "the molecule," which lacks clear antecedent basis.
Claim 1 contains two separate recitations of "a biomolecule": one in the preamble and another in part (d). Because these two recitations could refer to different molecules, such as a natural analyte in the tissue (e.g., mRNA), a detection reagent (e.g., a capture probe), or a product of the analyte (e.g., cDNA), it is unclear which molecule is referenced by "the molecule" in claims 9 and 10.
Claims 11-12 are rejected for depending from claim 10 and not remedying the indefiniteness.
Claim Rejections - 35 USC § 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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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, 5, 8-12, 16, 25-27, and 40-41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ramachandran (WO2020176788A1 - Profiling of biological analytes with spatially barcoded oligonucleotide arrays; Published 2020-09-03; cited as Foreign Patent Document in IDS flied on 09/25/2025), as evidenced by
Buckley (Chapter 5 Adhesion, Editor(s): Donald H. Buckley, Tribology Series, Elsevier,Volume 5, 1981, Pages 245-313, ISSN 0167-8922, ISBN 9780444419668,doi.org/10.1016/S0167-8922(08)70678-3.); and
Wikipedia (Hydrogel - Simple English Wikipedia, the free encyclopedia; Archived Feb. 4, 2021 on WaybackMachine).
Ramachandran teaches methods for profiling biological samples with spatially barcoded arrays (Abstract; see also FIGs. 26-27 for examples).
Regarding claim 1, Ramachandran teaches a method of detecting a biomolecule in a tissue section, said method comprising:
a) contacting the tissue section with a first solid substrate, thereby immobilizing the tissue section onto the first solid substrate and generating a sample-carrier construct (p. 45, lines 5-7 “biological sample immobilized on a substrate (e.g., a biological sample prepared using methanol fixation or formalin-fixation and paraffin embedding (FFPE)) is transferred to a spatial array using a hydrogel.”. lines 10-13, “After hydrogel formation, the biological sample is anchored to (e.g., embedded in) the hydrogel wherein separating the hydrogel from the substrate results in the biological sample separating from the substrate along with the hydrogel.”),
wherein the tissue section is bound to the first solid substrate at a first adhesion strength (p. 45, lines 10-13, the biological sample is anchored to the hydrogel);
b) contacting the tissue section of the sample-carrier construct with a second solid substrate to generate an immobilized tissue section (p. 45, lines 13-14, “The biological sample can then be contacted with a spatial array, thereby allowing spatial profiling of the biological sample.” ),
wherein the tissue section is bound to the second solid substrate at a second adhesion strength (p. 45, lines 13-14, the biological sample contacted with a spatial array, a skilled artisan would readily understand the contacting of these two clean surfaces will lead to bonding with an adhesion strength, see Buckley, in Abstract3),
wherein the second adhesion strength is greater than the first adhesion strength (p. 45, lines 14-20, hydrogel is depolymerized after contacting the biological sample with array, therefore it no longer bond to the biological sample and has no adhesion strength);
c) removing the first solid substrate from the immobilized tissue section (p. 45, lines 14-20);
d) contacting a biomolecule in said tissue section with a labeled detection agent (p. 274, lines 23-34, In situ sequencing with labeled nucleotides; p. 275, lines 1-9; p. 333, lines 24-34; p. 98, lines 20-23; p. 132, lines 28-34);
and
e) detecting a light emission from the labeled detection agent, thereby detecting the biomolecule in the tissue section (p. 274, lines 23-34, In situ sequencing with labeled nucleotides; p. 275, lines 1-9; p. 333, lines 24-34; p. 98, lines 20-23; p. 132, lines 28-34).
Regarding claim 5, Ramachandran teaches the first solid substrate comprises water molecules attached to the surface of said first solid substrate (p. 45, lines 5-7, hydrogel. A skilled artisan would readily understand hydrogel retains water throughout its polymer matrix, including its surface, see Wikipedia4).
Regarding claim 8, Ramachandran teaches second solid substrate comprises polyethylenimine (PEI) (p. 302, line 33).
Regarding claims 9-10, Ramachandran teaches a nucleic acid molecule (Fig. 32B; p. 274, lines 23-34, In situ sequencing with labeled nucleotides; p. 275, lines 1-9; p. 333, lines 24-34; p. 98, lines 20-23; p. 132, lines 28-34).
Regarding claim 11, Ramachandran teaches amplifying the nucleic acid molecule to generate amplification products (p. 98, lines 20-23, amplification of the capture probe can increase the number of spatial barcodes used for direct decoding (e.g., in situ sequencing) of the location of the capture probe.).
Regarding claim 12, Ramachandran teaches detecting the amplification products (p. 98, lines 20-23).
Regarding claim 16, Ramachandran teaches digesting the tissue section by contacting the sample-carrier construct with an endopeptidase (p. 317, line 7, adding pepsin to biological sample; see also p. 41, lines 10-12).
Regarding claim 25, Ramachandran teaches thickness of the tissue section is about 1 µm to about 20 µm (p. 38, lines 25, the thickness of a tissue section is 1-10 micrometers).
Regarding claims 26-27, Ramachandran teaches the first solid substrate comprises agarose (p. 45, lines 5-7; p. 209, lines 28-34 - p. 210, line 1).
Regarding claim 40, Ramachandran teaches removing the first solid substrate comprises chemically removing (p. 45, lines 14-20, chemically removing hydrogel using DTT).
Regarding claim 41, Ramachandran teaches a method of detecting a nucleic acid in a tissue section, said method comprising:
a) immobilizing the tissue section onto a hydrogel carrier substrate to generate a sample- carrier construct (p. 45, lines 5-7 “biological sample immobilized on a substrate (e.g., a biological sample prepared using methanol fixation or formalin-fixation and paraffin embedding (FFPE)) is transferred to a spatial array using a hydrogel.”. lines 10-13, “After hydrogel formation, the biological sample is anchored to (e.g., embedded in) the hydrogel wherein separating the hydrogel from the substrate results in the biological sample separating from the substrate along with the hydrogel.”);
b) contacting the tissue section of the sample-carrier construct with a receiving substrate to generate an immobilized tissue section (p. 45, lines 13-14, “The biological sample can then be contacted with a spatial array, thereby allowing spatial profiling of the biological sample.” );
c) removing the hydrogel carrier substrate from the immobilized tissue section (p. 45, lines 14-20);
d) hybridizing a polynucleotide probe to the nucleic acid molecule and amplifying the polynucleotide probe to generate an amplification product (p. 98, lines 20-23, amplification of the capture probe can increase the number of spatial barcodes used for direct decoding (e.g., in situ sequencing) of the location of the capture probe); and
e) hybridizing a primer to the amplification product and incorporating a labeled nucleotide and detecting the labeled nucleotide thereby detecting the biomolecule in the tissue section (p. 333., lines 28-34, “in situ sequencing typically involves incorporation of a labeled nucleotide (e.g., fluorescently labeled mononucleotides or dinucleotides) in a sequential, template-dependent manner or hybridization of a labeled primer (e.g., a labeled random hexamer) to a nucleic acid template such that the identities (i.e., nucleotide sequence) of the incorporated nucleotides or labeled primer extension products can be determined, and consequently, the nucleotide sequence of the corresponding template nucleic acid.”).
Claims 1, 9-10, 25 and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kawamoto (Kawamoto T. Use of a new adhesive film for the preparation of multi-purpose fresh-frozen sections from hard tissues, whole-animals, insects and plants. Arch Histol Cytol. 2003 May;66(2):123-43. doi: 10.1679/aohc.66.123. PMID: 12846553.)
Kawamoto teaches an improved method in fresh-frozen tissue processing using an adhesive film that acts as support during tissue cutting (abstract; Fig. 3; Fig. 5-6, for examples).
Regarding claim 1, Kawamoto teaches a method of detecting a biomolecule in a tissue section, said method comprising:
a) contacting the tissue section with a first solid substrate, thereby immobilizing the tissue section onto the first solid substrate and generating a sample-carrier construct (Fig. 5-6), wherein the tissue section is bound to the first solid substrate at a first adhesion strength (Fig. 5-6);
b) contacting the tissue section of the sample-carrier construct with a second solid substrate to generate an immobilized tissue section (p. 135, right-hand col – p. 136, left-hand col., “Transferring the section from the adhesive film to the glass slide” ),
wherein the tissue section is bound to the second solid substrate at a second adhesion strength (p. 135, right-hand col – p. 136, left-hand col., the tissue section id bound to saline coated glass slide),
wherein the second adhesion strength is greater than the first adhesion strength (p. 135, right-hand col – p. 136, left-hand col., the adhesive is solved in n-hexane, the tissue is left on the glass slide after plastic film removed, a skilled artisan would readily understand that the transfer of tissue onto the glass slide requires the adhesive strength between glass slide and tissue to be grater that the adhesive strength between tissue and the adhesive film );
c) removing the first solid substrate from the immobilized tissue section (p. 135, right-hand col – p. 136);
d) contacting a biomolecule in said tissue section with a labeled detection agent (Fig. 16, Fig. 21, fluorescence labeled detection agent);
and
e) detecting a light emission from the labeled detection agent, thereby detecting the biomolecule in the tissue section (Fig. 16, Fig. 21).
Regarding claims 9-10, Kawamoto teaches nucleic acid molecule (p. 135, right-hand col, para 1, “rat 28S rRNA”).
Regarding claim 25, Kawamoto teaches the tissue section is about 1 µm to about 20 µm (Fig. 17, 5 µm.)
Regarding claim 40, Kawamoto teaches physically removing the first solid substrate (p. 135, right-hand col – p. 136, plastic film is physically removed ).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Ramachandran (WO2020176788A1 - Profiling of biological analytes with spatially barcoded oligonucleotide arrays; Published 2020-09-03; cited as Foreign Patent Document in IDS flied on 09/25/2025), in view of Cambria (Cambria et al. Cell-Laden Agarose-Collagen Composite Hydrogels for Mechanotransduction Studies. Front Bioeng Biotechnol. 2020 Apr 21;8:346. doi: 10.3389/fbioe.2020.00346. PMID: 32373605; PMCID: PMC7186378.)
The teachings of Ramachandran are recited above and applied as for base claim 1.
Regarding claim 6, Ramachandran teaches a first solid substrate being hydrogel, comprising materials including agarose (p. 45, lines 5-7; p. 209, lines 28-34 - p. 210, line 1).
Although Ramachandran does not explicitly teach its hydrogel material comprises a compression modulus greater than 100 kPa, this feature would have been obvious in view of the knowledge in the art.
The compression modulus, also referred to as Young’s modulus or elastic modulus, is a measure of mechanical strength.
Cambria teaches the elastic modulus of agarose hydrogel ranges from ∼1 to a few 1000 kPa, depending on polymer concentration and molecular weight (p. 2, left-hand col, para 3., lines 19-21) . Cambria also teaches various agarose concentrations have been applied in studies, ranging from 1% to above 2% (p. 2, right-hand col., para 2, lines 19-26).
Therefore, a skilled artisan would have found it prima facie obvious to apply an agarose hydrogel material at varied concentration ranges to optimize for its mechanical strength, including a concentration range from 1% to above 2%, which, according to the specification in this application, correspond to compression modulus of about 40 kPa to above 100kPa (p. 143, lines 2-6).
The concentration of an agarose hydrogel is a result-effective variable, and a skilled artisan would have had reason to adjust agarose concentration to obtain a desired mechanical strength for the intended use of tissue embedding and transfer.
Therefore, in the absence of secondary considerations, adjusting the concentration to achieve optimal mechanical strength of a hydrogel would have been an obvious, routine optimization process for a skilled artisan, see MPEP 2143.
Similarly, regarding claim 30, a compression modulus of about 30 kPa would have been obvious because it is close to the modulus values produced by commonly used agarose concentrations and would have been obtained through routine optimization of the agarose hydrogel concentration.
Claims 34 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Ramachandran (WO2020176788A1 - Profiling of biological analytes with spatially barcoded oligonucleotide arrays; Published 2020-09-03; cited as Foreign Patent Document in IDS flied on 09/25/2025), in view of Gao (Gao et al. Q&A: Expansion microscopy. BMC Biol 15, 50 (2017). doi.org/10.1186/s12915-017-0393-3)
The teachings of Ramachandran are recited above and applied as for base claim 1.
Regarding claim 34, Ramachandran teaches generating a sample-carrier construct (p. 45) by embedding a tissue section in hydrogel. Although Ramachandran does not explicitly teach storing the sample carrier construct, it is common knowledge that hydrogel-embedded tissue samples can be stored for later processing and analysis.
For example, Gao teaches that hydrogel-embedded samples can be stored for weeks before further analysis (p. 8, right-hand col., lines 10-15).
Therefore, claim 34 would have been obvious as it represents the KSR principle of predictable use of prior art knowledge according to a known method to yield predictable results. (See MPEP §2143).
Regarding claim 37, Gao teaches storing hydrogel embedded tissue at 4 °C (p. 8, right-hand col., lines 10-15).
Claims 5, 29 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Kawamoto (Kawamoto T. Use of a new adhesive film for the preparation of multi-purpose fresh-frozen sections from hard tissues, whole-animals, insects and plants. Arch Histol Cytol. 2003 May;66(2):123-43. doi: 10.1679/aohc.66.123. PMID: 12846553.), in view of
Ma (Ma et al. Capillary-Force-Assisted Clean-Stamp Transfer of Two-Dimensional Materials. Nano Lett. 2017 Nov 8;17(11):6961-6967. doi: 10.1021/acs.nanolett.7b03449. Epub 2017 Oct 27. PMID: 29058919. ), as evidenced by
Yu (Yu et al. "Thermal bonding of thermoplastic elastomer film to PMMA for microfluidic applications." Surface and Coatings Technology 320 (2017): 437-440.)
The teachings of Kawamoto are recited above and applied as for base claim 1.
Kawamoto teaches using adhesive plastic film for transferring tissue section to a microscope slide for further processing and analysis. Although Kawamoto does not explicitly teach that its plastic film is made of a thermoplastic elastomer material (recited in claim 29) and sample-carrier construct comprises interfacial water (recited in claim 31). These features would have been obvious in view of Ma.
The use of capillary force for transferring thin-layer materials is known in the art.
Ma teaches a simple and clean method of transferring two-dimensional (2D) materials using capillary-force-assisted clean stamp technique that uses a thin layer of evaporative liquid (e.g., water) as an instant glue to increase the adhesion energy between 2D material and polydimethylsiloxane (PDMS) for the pick-up step. After the liquid evaporates, the adhesion energy decreases, and the 2D material can be released. The thin liquid layer is condensed to the PDMS surface from its vapor phase, which ensures low contamination level on the 2D materials (Abstract).
Ma also suggests that its method reduces extra steps, and does not introduce contaminants in the transferring process (p. 6961).
Accordingly, a skilled artisan would have recognized and found it prima facie obvious before the effective filing date of the claimed invention, that Ma’s capillary-force-assisted method of transferring thin-layer material could be applied to Kawamoto’s method for transferring thinly cut tissue sections. This would have resulted in a modified method of transferring tissues sections using a substrate having a PDMS support scaffold (PDMS is a thermoplastic elastomer , see Yu, p. 437.,introduction,“polydimethylsiloxanes (PDMS) film, a type of thermosetting silicone rubber, with plastic substrates.”), wherein a thin layer of water between the tissue section and the PDMS substrate acts as a temporary glue for pick-up. After the water evaporates, the adhesive strength between tissue and PDMS reduces, and the tissue section is released onto a target slide.
The references are related in the problem to be solved: both aim to transfer thin-layer materials to a target surface. Although they disclose different materials being transferred, the underlying principle and key properties are the same ꟷ capillary force from a thin water layer can act as instant glue to pick up thin-layer materials, and the material can later be released due to evaporation.
Therefore, a skilled artisan would have reasonably expected the capillary-force model to be applicable to transferring thin layers of tissue sections. A skilled artisan would have been motivated to make this modification because Ma suggests that its method is simple and clean, applying this modification would have reduced adhesive-related contamination in Kawamoto’s method.
Regarding claim 5, Ma teaches water molecules attached to the surface of a solid substrate (Figure 1).
Prior Art
Below are relevant prior art not used in rejection but pertinent to the claims or disclosure.
Other references also teach using biocompatible hydrogel for material transfer between surfaces:
Zhang (Zhang, Shiming, et al. "Hydrogel‐enabled transfer‐printing of conducting polymer films for soft organic bioelectronics." Advanced Functional Materials 30.6 (2020): 1906016.);
Yi (Yi et al., Wet-Responsive, Reconfigurable, and Biocompatible Hydrogel Adhesive Films for Transfer Printing of Nanomembranes; Adv. Funct. Mater. 2018, 28, 1706498. doi.org/10.1002/adfm.201706498).
Subject Matter Not Taught/Suggested in Prior Art
Claims 1, 5-6, 8-12, 16, 25-27, 29-31, 34, 37, 40-41 are currently rejected in this office action under 35 U.S.C. 102 and/or 35 U.S.C. 103.
While the claims as presently written are not patentable over prior art, they appear to relate to more detailed descriptions in the specification that disclose subject matter not taught by the prior art. For the purpose of compact prosecution, the examiner is highlighting this subject matter not taught by the prior art for applicant's consideration.
See FIG. 3A, as well as the corresponding sections of the specification referenced below:
"[0014] FIGS. 4A-4C presents a diagram of an embodiment described herein using a carrier substrate for tissue section transfer onto a glass slide. In this embodiment, the carrier substrate is an agarose gel and is prepared and placed in a warm water bath (e.g., maintained at a temperature between 42° C. and 67° C.), as shown in FIG. 4A. An FFPE tissue section floats in the water bath, followed by contacting the tissue section with the agarose gel to layer it atop the agarose. The tissue section and agarose gel (collectively referred to as a sample-carrier construct) are removed from the warm water bath and allowed to cool without completely drying out. A portion of the construct is removed, for example using a cutting device, e.g., a hole punch or cutting blade. Multiple portions may be made from a single tissue section. The portions (i.e., cutouts) are then mounted onto a functionalized glass slide by bringing the tissue section in contact with the glass surface. The glass, tissue section, and agarose are then heated to facilitate removal of the agarose gel while retaining the tissue section on the glass surface."
Therefore, the disclosures above teaches collecting a FFPE tissue section that floats in a water bath by contacting the tissue section with the agarose gel to layer it atop the agarose.
No prior art teaches collecting a FFPE tissue section that floats in a water bath using an agarose gel substrate, or any other hydrogel material.
Although the examiner is not suggesting specific claim amendments, incorporating the subject matter not taught by prior art, as noted above, could potentially distinguish the claims from the prior art teachings.
Conclusion
Claim 1 is objected; claims 1, 5-6, 8-12, 16, 25-27, 29-31, 34, 37, 40-41 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIAN NMN YU whose telephone number is (703)756-4694. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at (571) 272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIAN NMN YU/Examiner , Art Unit 1681
1 Claim 13 is withdrawn as being drawn to non-elected species G
2 See specification, pages 51-52:
"As another example, it may be desirable for the hydrogel to have a particular stiffness, e.g., to provide stability in handling the embedded specimen, e.g., a Young's Modulus (also referred to herein as a compression modulus) of about 2-70 kN/m2, for example, about 2 kN/m2, about 4 kN/m2, about 7 kN/m2, about 10 kN/m2, about 15 kN/m2, about 20 kN/m2, about 40 kN/m2, but typically not more than about 70 kN/m2. The ordinarily skilled artisan will be aware that the elasticity of a hydrogel network may be influenced by a variety of factors, including the branching of the polymer, the concentration of hydrogel subunits, and the degree of cross-linking, and will prepare a hydrogel composition that includes a concentration of hydrogel subunits to provide such desired elasticity. "
3 Buckley, Abstract: “When two solid surfaces are brought into contact, adhesion or bonding across the interface can occur. If two solid surfaces are clean and all of the adsorbates are removed, adhesion or bonding of one solid to another always occurs.”
4 Wikipedia, page 1, “Hydrogels are three-dimensional polymeric networks filled with water.”
Prosecution Insights