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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 recites the limitation "the first and second bodies" in line 10. There is insufficient antecedent basis for this limitation in the claim. Claim 11 recites the limitation "the first and the second bodies" in line 12. There is insufficient antecedent basis for this limitation in the claim. The Examiner notes in both cases the proper form is “the first body and the second body” which Applicant uses in claim 11, line 11.
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 and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Duffy et al. (US 7,351,575). Duffy teaches a device for arraying materials. The embodiment of the device most relevant to the instant claims is shown in Figures 8-9 and described in columns 21-23.
Regarding claims 1 and 2 – As shown in Figures 8 and 9, Duffy teaches a device (800) comprising a first body (member 840) including a plurality of first through openings (well orifices 843/wells 845) arranged according to an arrangement pattern; a second body (base plate 110) , having a hydrophilic surface (metal later 130), coupled to the first body (member 840) on the hydrophilic surface (metal layer 130); an intermediate layer (member 140), which extends over the hydrophilic surface (metal layer 130) and is between the first (member 840) and the second (base plate 110) bodies, the intermediate layer (member 140) is made of a hydrophobic material (see column 11, lines 56-62) and has a plurality of second through openings (wells 145), which are arranged according to the arrangement pattern and through which respective regions of the hydrophilic surface (metal layer 130) are exposed, wherein the first and the second bodies are coupled together so that a respective second through opening (wells 145) and a portion of the intermediate layer (well bottom 847 defined by surface 141 – see column 22, lines 1-17 ) surrounding the respective second through openings (wells 145) are exposed through each of the first through openings (orifices 843/wells 845). See also column 21, line 10 – column 23, line 67.
Regarding claims 3 and 4 – Duffy teaches a second body (base plate 110) comprised of silicon with a layer of hydrophilic metal in column 12, lines 28-41 and column 31, line 51 – column 34, line 34.
Regarding claims 5 and 9 – Duffy teaches the use of hydrophobic materials including TEFLON and PMMA in forming the intermediate layer (member 140) in column 11, lines 56-62. The Examiner submits that PMMA meets the viscosity and contact angle limitations recited in the claim.
Regarding claim 8 – As shown in Figures 8 and 9 of Duffy, the second through openings (wells 145) have a polygonal shape having a first diameter, and wherein the first through openings (wells 845) have a polygonal shape having a second diameter, the second diameter being greater than the first diameter. See also column 21, line 60 – column 22, line 17 of Duffy.
Regarding claim 10 – Duffy teaches immobilized biological molecules that form a detection region in the second through openings (845) in column 22, line 40 – column 23, line 25. See also columns 29-36.
Inventorship
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.
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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Conoci et al. (US 2016/0244807) in view of Duffy et al. (US 7,351,575).
Regarding claims 1 and 2 – As shown in Figures 5C and 5D, Conoci teaches a device (chip 1) comprising a first body (structural layer 42) including a plurality of first through openings (2) arranged according to an arrangement pattern; a second body (substrate 35) having a hydrophilic surface (biocompatible layer 40), coupled to the first body (structural layer 42) on the hydrophilic surface (biocompatible layer 40); an intermediate layer (coupling layer 44), which extends over the hydrophilic surface (biocompatible layer 40) and is between the first (structural layer 42) and the second (substrate 35) bodies, the intermediate layer (coupling layer 44) is made of a hydrophobic material (see Paragraph 0058 which teach silicone as the coupling layer 44) and has a plurality of second through openings (openings in layer 44 aligning with bottom chamber 4), which are arranged according to the arrangement pattern wherein the first (structural layer 42) and the second (substrate 35) bodies are coupled together so that a respective second through opening is aligned with each of the first through openings. Conoci does not teach an exposed portion of the intermediate layer surrounding the respective second through opening.
Duffy teaches a device for arraying materials. The embodiment of the device most relevant to the instant claims is shown in Figures 8-9 and described in columns 21-23. As shown in Figures 8 and 9, Duffy teaches a device (800) comprising a first body (member 840) including a plurality of first through openings (well orifices 843/wells 845) arranged according to an arrangement pattern; a second body (base plate 110) , having a hydrophilic surface (metal later 130), coupled to the first body (member 840) on the hydrophilic surface (metal layer 130); an intermediate layer (member 140), which extends over the hydrophilic surface (metal layer 130) and is between the first (member 840) and the second (base plate 110) bodies, the intermediate layer (member 140) is made of a hydrophobic material (see column 11, lines 56-62) and has a plurality of second through openings (wells 145), which are arranged according to the arrangement pattern and through which respective regions of the hydrophilic surface (metal layer 130) are exposed, wherein the first and the second bodies are coupled together so that a respective second through opening (wells 145) and a portion of the intermediate layer (well bottom 847 defined by surface 141 – see column 22, lines 1-17 ) surrounding the respective second through openings (wells 145) are exposed through each of the first through openings (orifices 843/wells 845). See also column 21, line 10 – column 23, line 67. The intermediate layer (member 140) includes a plurality of through openings (wells 145) separated from each other by exposed portions of the intermediate layer to provide a plurality of additional, smaller subwells (wells 145) within the larger wells for holding material. The Examiner submits it would have been obvious to one of ordinary skill of the art at the time of the effective date of the invention to combine the intermediate layer having a plurality of smaller subwells from Duffy with the device of Conoci. One of ordinary skill in the art would provide to provide additional, separate wells for containing materials as taught by Duffy.
Regarding claims 3 and 4 – Conoci discloses a semiconductor material such as silicon for the second body in Paragraph 0053.
Regarding claim 5, 6, and 7 – Conoci teaches the use of hydrophobic materials including silicone paste in forming the intermediate layer (coupling layer 44) in column 11, lines 56-62. The Examiner submits that silicone meets the viscosity and contact angle limitations recited in claim 5.
Regarding claim 8 – Figure 5D of Conoci shows the shape of the openings of the intermediate layer (coupling layer 44) matching the shape of the openings of the first body (structural layer 42).
Regarding claim 9 – Conoci recites the use of PDMS for the first body (structural layer 42) in Paragraphs 0055.
Regarding claim 10 – Conoci teaches receptors (PCR reagents) in the well (2) designed to establish a bond with a binding mate in the well in Paragraphs 0078-0081.
Claims 11, 12, 13, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Duffy et al. (US 7,351,575) in view of Brown et al. (US 2008/0153091). Duffy as described in Paragraphs 8-13 above teaches every element of claims 11, 12, 13, 16 and 17 except for forming the intermediate layer formed by depositing hydrophobic material by screen printing. Duffy recites a method that includes the steps of providing a first body (member 840) including a plurality of first through openings (well 845) arranged according to an arrangement pattern; providing a second body (base plate 110) having a hydrophilic surface (metal layer 130); providing an intermediate layer (member 140) with a plurality of second through openings (wells 145) arranged on the hydrophilic surface (metal layer 130) according to the arrangement pattern and through which respective regions of the hydrophilic surface (metal layer 130) are exposed; and coupling together the first body and the second body by the intermediate layer, and coupling together the first and the second bodies includes aligning each first through opening of the first through openings (wells 845) with a corresponding second through opening of the second through openings (wells 145). See column 9, line 7 – column 10, line 59 of Duffy. Duffy teaches assembling the layers together by positioning them together with registration features in column 10. The Examiner submits this would require pressing the layers. Duffy does not teach forming the intermediate layer with the plurality of second through openings comprising depositing hydrophobic material using a screen-printing technique.
Brown teaches a device for detecting nucleic acids in a sample. The embodiment of the device most relevant to the instant claims is show in Figure 1 and described in Paragraphs 0075-0114-0120. As shown in Figure 1, the device includes a base plate (substrate 20) having bottom plate (23) and a pattern layer (26) of hydrophobic material for forming sample chambers (30). In Paragraph 0078, Brown teaches that the use of screen printing to form the patterned layer allows for up to about 100,000 sample chambers on a 1-inch by 3-inch substrate. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the screen printing step from Brown with the teachings of Duffy. One of ordinary skill in the art at the time would add the screen printing step to Duffy in order to take advantage of the high well density formation of up to 100,00 on a small slide substrate provided by screen printing techniques as taught by Brown.
Regarding claim 12 – As shown in Figures 8 and 9 of Duffy, the second through openings (wells 145) have a polygonal shape having a first diameter, and wherein the first through openings (wells 845) have a polygonal shape having a second diameter, the second diameter being greater than the first diameter. See also column 21, line 60 – column 22, line 17 of Duffy.
Regarding claim 13 – As noted above in Paragraph 19, Duffy teaches assembling the layers together by positioning them together with registration features in column 10. The Examiner submits this would require pressing the layers.
Regarding claim 16 – Duffy teaches the use of hydrophobic materials including PMMA in forming the intermediate layer (member 140) in column 11, lines 56-62. The Examiner submits that PMMA meets the viscosity and contact angle limitations recited in the claim.
Regarding claim 17 – Duffy teaches immobilized biological molecules that form a detection region in the second through openings (845) in column 22, line 40 – column 23, line 25. See also columns 29-36.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Duffy et al. (US 7,351,575) in view of Colombo et al. (US 2015/0044110). Duffy as described in Paragraphs 8-13 above teaches every element of claims 18-20 except for the thermocycler and heating elements. Colombo teaches a microfluidic device with hydrophobic surface modification for forming an array. The embodiments or portions of the device most relevant to the instant claims are shown in Figures 7-9 and described in Paragraphs 0054-0080. As shown in Figures 8 and 9, the device includes a chip (microreactor 40) having a base layer (substrate 1) having a hydrophilic surface (structural layer 2) and an upper layer (surface modification layer 10) comprised of hydrophobic material having openings (island 20) that form sensing region (21). The sensing regions (21) further include receptors formed from immobilized biomolecules which bind analytes of interest. See Figure 8 and Paragraphs 0053-0068. The base layer (1) further includes a plurality of heaters (41) and temperature sensors (42) integrated or fitted onto the substrate. During use, the microreactor is introduced into a thermocycler (45) having a fan (47) for cooling, a detection device (48), and a control unit (46). The thermocycling unit controls the heaters (41) and cooling device to carry out thermal cycles. The Examiner submits it would have been obvious to one of ordinary skill in the art to combine the heater elements, sensor elements, and thermocycler elements from Colombo with the device of Duffy. One of ordinary skill in the art at the time of the effective date of the invention would add the heater elements, sensor elements, and thermocycler elements to Duffy in order to control temperatures in chip as taught by Colombo.
Claims 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Conoci et al. (US 2016/0244807) in view of Duffy et al. (US 7,351,575), and further in view of Brown et al. (US 2008/0153091). Conoci and Duffy as described in Paragraphs 17-24 above teach every element of claims 11-17 except for forming the intermediate layer formed by depositing hydrophobic material by screen printing. Brown teaches a device for detecting nucleic acids in a sample. The embodiment of the device most relevant to the instant claims is show in Figure 1 and described in Paragraphs 0075-0114-0120. As shown in Figure 1, the device includes a base plate (substrate 20) having bottom plate (23) and a pattern layer (26) of hydrophobic material for forming sample chambers (30). In Paragraph 0078, Brown teaches that the use of screen printing to form the patterned layer allows for up to about 100,000 sample chambers on a 1-inch by 3-inch substrate. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the screen printing step from Brown with the combined teachings of Conoci and Duffy. One of ordinary skill in the art at the time of the invention would add the screen printing step to Conoci and Duffy in order to take advantage of the high well density formation of up to 100,00 on a small slide substrate provided by screen printing techniques as taught by Brown.
Regarding claim 12 – Figure 5D of Conoci shows the circular shape of the openings of the intermediate layers coupling layer (44) matching the circular shape of the openings of the first body (structural layer 42).
Regarding claim 13 – As noted above in Paragraph 19, Duffy teaches assembling the layers together by positioning them together with registration features in column 10. The Examiner submits this would require pressing the layers.
Regarding claims 14, 15 and 16 – Conoci teaches the use of hydrophobic materials including silicone paste in forming the intermediate layer (coupling layer 44) in column 11, lines 56-62. The Examiner submits that silicone meets the viscosity and contact angle limitations recited in claim 16.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Conoci et al. (US 2016/0244807), Duffy et al. (US 7,351,575) and Brown et al. (US 6,143,496), and further in view of Colombo et al. (US 2015/0044110). Conoci, Duffy, and Brown as described in Paragraphs 32-35 above teach every element of claims 18-20 except for the thermocycler. With respect to the heater and temperature sensor, Conoci does teach a heater (52) and temperature sensor (54) in Figure 6 and Paragraphs 0069 teaches Colombo teaches a microfluidic device with hydrophobic surface modification for forming an array. The embodiments or portions of the device most relevant to the instant claims are shown in Figures 7-9 and described in Paragraphs 0054-0080. As shown in Figures 8 and 9, the device includes a chip (microreactor 40) having a base layer (substrate 1) having a hydrophilic surface (structural layer 2) and an upper layer (surface modification layer 10) comprised of hydrophobic material having openings (island 20) that form sensing region (21). The sensing regions (21) further include receptors formed from immobilized biomolecules which bind analytes of interest. See Figure 8 and Paragraphs 0053-0068. The base layer (1) further includes a plurality of heaters (41) and temperature sensors (42) integrated or fitted onto the substrate. During use, the microreactor is introduced into a thermocycler (45) having a fan (47) for cooling, a detection device (48), and a control unit (46). The thermocycling unit controls the heaters (41) and cooling device to carry out thermal cycles. The Examiner submits it would have been obvious to one of ordinary skill in the art to combine the heater elements, sensor elements, and thermocycler elements from Colombo with the combined teachings of Conoci, Duffy and Brown. One of ordinary skill in the art at the time of the effective date of the invention would add the thermocycler elements to the combined teachings of Conoci, Duffy and Brown in order to control temperatures in the chip as taught by Colombo.
Conclusion
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/DWAYNE K HANDY/Examiner, Art Unit 1798 September 14, 2025
/JILL A WARDEN/Supervisory Patent Examiner, Art Unit 1798