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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/8/2026 has been entered.
Response to Amendment
The Amendment filed on 1/8/2026 has been entered. Claims 1 and 3-21 remain pending in the application. Applicant’s amendments to the claims have overcome each and every 112(b) rejection previously set forth in the final Office Action mailed 11/21/2025.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-17 and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over United States Application Publication No. 2015/0191772, hereinafter Kunding, in view of United States Application Publication No. 2006/0105453, hereinafter Brenan.
Regarding claim 1, Kunding teaches a gene amplification chip (figure 2A) comprising: a chamber layer (item 16) comprising a first passage (the left most of item 12) and a through-hole array (the middle ones of item 12), the through hole array comprising through holes (figure 2A), that extend vertically through the chamber layer (figure 2A) and are arranged in a horizontal direction (figure 2A); a cover layer (item 32 and the layer of item 38) disposed on one side of the chamber layer (figure 2A), the cover layer comprising a cover channel (item 38) communicating with the first passage and the through holes of the chamber layer (figure 2A), and an inlet (the upper right one of item 36) extending vertically through the cover layer (figure 2A) and communicating with the cover channel (figure 2A), wherein the cover channel, the first passage and the through holes provide different flow paths for different liquids (intended use MPEP § 2114 (II) and is shown in figure 2A); a bottom layer (item 34 and the layer of item 40) disposed on another side of the chamber layer (figure 2A), the bottom layer formed with a bottom channel (item 40) communicating with the first passage and the through holes of the chamber layer (figure 2A); wherein at least one of the cover layer and the bottom layer is formed with an outlet (the upper left and lower right ones of item 36) communicating with any one of the cover channel and the bottom channel (figure 2A), wherein the inlet (the upper right one of item 36) formed in the cover layer is positioned closer to the through holes than to the first passage (figure 2A), the first passage being an opening that extends through the chamber layer (figure 2A), wherein the inlet is located inward of a side edge of the non-through-hole region in the horizontal direction (figure 2A),
Kundling fails to specifically teach a passage width of the first passage is greater than a channel height of the cover layer.
Kundling further teaches that each subarray with differing diameters can be sized to provide different dynamic range of number count of a target polynucleotide (paragraph [0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum passage and channel lengths so that they are the same and the passage width being greater than the channel height which would allow for the required sizes of through holes which would provide the different dynamic range of number count of a target polynucleotide required (paragraph [0035]) (MPEP § 2144.05 (II)).
Kundling fails to teach the through-hole array being spaced apart from the first passage by a non-through-hole region.
Brenanteaches a through hole device with sample wells in which the sample wells are grouped into sub-arrays by controlling the spacing between the wells (Brenan, paragraph [0004]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have spaced the through holes into different groups with non-through holes regions between the groups because it would allow for the arrays to be divided into sub-arrays (Brenan, paragraph [0004]). The examiner notes that as some of the through holes are spaced apart from each other and thereby have non-through hole regions, the one of the through-holes in the grouping of through-holes all the way to the left would be considered the first passage, thereby reading on the instant limitations.
Regarding claim 3, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Kundling and Brenan and the apparatus of modified Kundling is capable of having the first passage and the cover channel are formed such that a sample solution flows from the inlet to the cover channel to be stored in the through holes, and oil having a lower surface tension than the sample solution flows from the inlet to the cover channel, from the cover channel to the first passage, and from the first passage to the bottom channel. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Kundling (see MPEP §2114).
Regarding claim 4, Kundling teaches wherein the first passage has a larger cross-section than a cross-section of a cover channel region connected to the inlet (figure 2A, the cover channel region is defined as having a smaller cross-section than the first passage).
Regarding claim 5, Kundling teaches wherein when the cross-section of the first passage is defined as a value obtained by multiplying the passage width by a passage length of the first passage (paragraph [0035]), and the cross-section of the cover channel region is defined as a value obtained by multiplying the channel height by a channel length (paragraph [0035]).
Kundling fails to specifically teach the passage length and the channel length are a same length in a same direction.
Kundling further teaches that each subarray with differing diameters can be sized to provide different dynamic range of number count of a target polynucleotide (paragraph [0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum passage and channel lengths so that they are the same and the passage width which would allow for the required sizes of through holes which would provide the different dynamic range of number count of a target polynucleotide required (paragraph [0035]) (MPEP § 2144.05 (II)).
Regarding claim 6, Kunding teaches wherein the cover channel has a larger cross-section than a cross-section of the through holes (figure 2A).
Regarding claim 7, Kunding teaches wherein the cross-section of the through holes has a circular shape (paragraph [0164]).
Regarding claim 8, Kunding teaches wherein the chamber layer further comprises a second passage (the right most of item 12) formed on a side opposite the first passage with the through holes formed therebetween (figure 2A).
Regarding claim 9, Kunding teaches wherein the outlet is formed to face the second passage (figure 2A).
Regarding claim 10, Kunding teaches wherein the outlet is formed in the cover layer (the upper left one of item 36).
Regarding claim 11, Kunding teaches wherein the outlet is formed in the bottom layer (lower right one of item 36).
Regarding claim 12, Kunding teaches wherein the chamber layer, the cover layer, and the bottom layer are separately formed and subsequently joined together (paragraph [0167]).
Regarding claim 13, Kundling teaches wherein the chamber layer, the cover layer, and the bottom layer are separately formed and subsequently joined together (figure 5).
However, Kundling discloses the claimed invention except for the chamber layer and the bottom layer are integrally formed. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the chamber layer and the bottom layer integrally formed, since it has been held that forming in one piece an article which has formerly been formed into two pieces and put together involves only routine skill in the art. MPEP §2144.04 (V)(B).
Regarding claim 14, Kunding teaches wherein each of the chamber layer (paragraph [0163]), the cover layer (paragraph [0166]), and the bottom layer (paragraph [0166]) are made of any one of silicon, metal, glass, and polymer.
Regarding claim 15, Kunding teaches wherein the cover layer is made of a transparent material (paragraph [0166]).
Regarding claim 16, Kunding teaches wherein cross sectional dimensions of the cover channel and the first passage are different from each other (figure 2) to flow liquid from the inlet through one of the first passage and the cover channel (intended use MPEP § 2114 (II)).
Regarding claim 17, Kunding teaches an apparatus for gene amplification, the apparatus comprising: a gene amplification chip (figure 2A) comprising a chamber layer (item 16) comprising a first passage (the left most of item 12) and a through-hole array (the middle ones of item 12), the through hole array comprising through holes (figure 2A), that extend vertically through the chamber layer (figure 2A) and are arranged in a horizontal direction (figure 2A); a cover layer (item 32 and the layer of item 38) disposed on one side of the chamber layer (figure 2A), the cover layer comprising a cover channel (item 38) communicating with the first passage and the through holes of the chamber layer (figure 2A), and an inlet (the upper right one of item 36) extending vertically through the cover layer (figure 2A) and communicating with the cover channel (figure 2A), wherein the cover channel, the first passage and the through holes provide different flow paths for different liquids (intended use MPEP § 2114 (II) and as shown in figure 2A), a bottom layer (item 37 and the layer of item 40) disposed on another side of the chamber layer (figure 2A), the bottom layer formed with a bottom channel (item 40) communicating with the first passage and the through holes of the chamber layer (figure 2A), wherein at least one of the cover layer and the bottom layer is formed with an outlet (the upper left and lower right ones of item 36) communicating with any one of the cover channel and the bottom channel (figure 2A); a heat source (paragraph [0130]) configured to heat the gene amplification chip to allow gene amplification to occur in a sample solution (intended use MPEP § 2114 (II)); and a heat source controller (paragraph [0130]) configured to control temperature and time of heating by the heat source (paragraph [0130]); wherein the inlet (the upper right one of item 36) formed in the cover layer is positioned closer to the through holes than to the first passage (figure 2A), the first passage being an opening that extends through the chamber layer (figure 2A), wherein the inlet is located inward of a side edge of the non-through-hole region in the horizontal direction (figure 2A),
Kundling fails to specifically teach a passage width of the first passage is greater than a channel height of the cover layer.
Kundling further teaches that each subarray with differing diameters can be sized to provide different dynamic range of number count of a target polynucleotide (paragraph [0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum passage and channel lengths so that they are the same and the passage width being greater than the channel height which would allow for the required sizes of through holes which would provide the different dynamic range of number count of a target polynucleotide required (paragraph [0035]) (MPEP § 2144.05 (II)).
Kundling fails to teach the through-hole array being spaced apart from the first passage by a non-through-hole region.
Brenanteaches a through hole device with sample wells in which the sample wells are grouped into sub-arrays by controlling the spacing between the wells (Brenan, paragraph [0004]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have spaced the through holes into different groups with non-through holes regions between the groups because it would allow for the arrays to be divided into sub-arrays (Brenan, paragraph [0004]). The examiner notes that as some of the through holes are spaced apart from each other and thereby have non-through hole regions, the one of the through-holes in the grouping of through-holes all the way to the left would be considered the first passage, thereby reading on the instant limitations.
Regarding claim 19, Kundling teaches wherein the heat source comprises a thermoelement (paragraph [0130]).
Regarding claim 20, Kundling teaches an apparatus for bio-particle analysis (figure 6), the apparatus comprising: an apparatus for gene amplification (item 30) in which gene amplification of a sample solution occurs (intended use MPEP § 2114 (II)); a detector (item 52) configured to detect a signal generated in response to the occurrence of gene amplification of the sample solution (intended use MPEP § 2114 (II) and is taught in paragraph [0190]); and a processor configured to analyze bio-particles based on the detected signal (paragraphs [0105], [0066] and [0160]), wherein the apparatus for gene amplification comprises: a gene amplification chip (figure 2A) comprising a chamber layer (item 16) comprising a first passage (the left most of item 12) and a through-hole array (the middle ones of item 12), the through hole array comprising through holes (figure 2A), that extend vertically through the chamber layer (figure 2A) and are arranged in a horizontal direction (figure 2A); a cover layer (item 32 and the layer of item 38) disposed on one side of the chamber layer (figure 2A), the cover layer comprising a cover channel (item 38) communicating with the first passage and the through holes of the chamber layer (figure 2A), and an inlet (the upper right one of item 36) extending vertically through the cover layer (figure 2A) and communicating with the cover channel (figure 2A), wherein the cover channel, the first passage and the through holes provide different flow paths for different liquids (intended use MPEP § 2114 (II) and as shown in figure 2A), a bottom layer (item 37 and the layer of item 40) disposed on another side of the chamber layer (figure 2A), the bottom layer formed with a bottom channel (item 40) communicating with the first passage and the through holes of the chamber layer (figure 2A), wherein at least one of the cover layer and the bottom layer is formed with an outlet (the upper left and lower right ones of item 36) communicating with any one of the cover channel and the bottom channel (figure 2A); a heat source (paragraph [0130]) configured to heat the gene amplification chip to allow gene amplification to occur in a sample solution (intended use MPEP § 2114 (II)); and a heat source controller (paragraph [0130]) configured to control temperature and time of heating by the heat source (paragraph [0130]); wherein the inlet (the upper right one of item 36) formed in the cover layer is positioned closer to the through holes than to the first passage (figure 2A), the first passage being an opening that extends through the chamber layer (figure 2A), wherein the inlet is located inward of a side edge of the non-through-hole region in the horizontal direction (figure 2A),
Kundling fails to specifically teach a passage width of the first passage is greater than a channel height of the cover layer.
Kundling further teaches that each subarray with differing diameters can be sized to provide different dynamic range of number count of a target polynucleotide (paragraph [0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum passage and channel lengths so that they are the same and the passage width being greater than the channel height which would allow for the required sizes of through holes which would provide the different dynamic range of number count of a target polynucleotide required (paragraph [0035]) (MPEP § 2144.05 (II)).
Kundling fails to teach the through-hole array being spaced apart from the first passage by a non-through-hole region.
Brenanteaches a through hole device with sample wells in which the sample wells are grouped into sub-arrays by controlling the spacing between the wells (Brenan, paragraph [0004]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have spaced the through holes into different groups with non-through holes regions between the groups because it would allow for the arrays to be divided into sub-arrays (Brenan, paragraph [0004]). The examiner notes that as some of the through holes are spaced apart from each other and thereby have non-through hole regions, the one of the through-holes in the grouping of through-holes all the way to the left would be considered the first passage, thereby reading on the instant limitations.
Regarding claim 21, Kundling teaches wherein the processor calculates a concentration of the sample solution by measuring a number of through holes in which a fluorescence signal is observed (paragraphs [0105], [0066] and [0160]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kundling and Brenan as applied to claim 17 above, and further in view of United States Application Publication No. 2018/0080064, hereinafter Lee.
Regarding claim 18, Kundling and Brenan teach all limitations of claim 17; however, they fail to teach the heat source comprises: a light source configured to emit light; and a photothermal film attached to an outer surface of the bottom layer and configured to convert light, emitted by the light source, into heat to heat the gene amplification chip.
Lee teaches a device for nucleic acid amplification which has a heat source that comprises: a light source configured to emit light (Lee, paragraph [0108]); and a photothermal film attached to an outer surface of the bottom layer and configured to convert light, emitted by the light source, into heat (Lee, paragraph [0108]) which allows for a low cost and low power consumption thermal cycler (Lee, paragraph [0015]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized a light source and photothermal film because it would allow for a low cost and low power consumption thermal cycler (Lee, paragraph [0015]).
Response to Arguments
Applicant’s arguments, see pages 9-12, filed 1/8/2026, with respect to the rejection(s) of claim(s) 1, 2, 6-12, 14-17 and 19-21 under 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kundling and Brenan.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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