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 .
Detailed Action
This office action is a response to applicant’s communication submitted February 2, 2026, wherein claims 1, 2, 4, 7-9, and 11 are amended, claims 6 and 13 are canceled, and new claims 15-20 are introduced. This application is a continuation in part of PCT/KR2022, filed November 11, 2022, which claims priority to foreign application KR10-2022-054714, filed May 3, 2022.
Claims 1-5, 7-12, and 14-20 are pending in this application.
Claims 1-5, 7-12, and 14-20 as amended are examined on the merits herein.
Withdrawn Rejections
Applicant’s amendment, submitted February 2, 2025, with respect to the rejection of claim 14 under 35 USC 112(b) for including an ambiguous process step in the passive voice, has been fully considered and found to be persuasive to remove the rejection as claim 14 has been amended to clearly and affirmatively describe a step of manufacturing the device. Therefore the rejection is withdrawn.
Applicant’s amendment, submitted February 2, 2026, with respect to the rejection of claims 6 and 13 under 35 USC 112(d) for failing to further limit the base claim, has been fully considered and found to be persuasive to remove the rejection as claims 6 and 13 are canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, submitted February 2, 2026, with respect to the rejection of claims 1-14 under 35 USC 103 for being obvious over Duthie et al. in view of Kohleyer et al., has been fully considered and found to be persuasive to remove the rejection as the cited references do not specifically describe the cross-sectional shape of the channel. Therefore the rejection is withdrawn.
The following rejections of record in the previous action are maintained:
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 5 and 12 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. These claims include a limitation wherein the platinum wires have a preset length and thickness. As all wires necessarily possess some length and thickness, and the actual numerical value of the preset length and thickness is not recited in the claim, it is unclear what distinguishes a preset length and thickness from a non-preset length or thickness, rendering this claim indefinite.
Response to Arguments: Applicant’s arguments, submitted February 2, 2026, with respect to the above grounds of rejection, have been fully considered and not found to be persuasive to remove the rejection. Applicant argues that the entry of new claims 15 and 16, which define the preset length and thickness of the wires, overcomes this rejection. However, defining an indefinite term in a dependent claim does not render an indefinite base claim definite. The recitation of specific lengths and thicknesses in claims 15 and 16 does not serve to define the terms “preset length” and “preset thickness” when they appear in claims 5 and 12. Therefore the rejection is maintained.
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.
Claims 8-12, 16, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Duthie et al. (US pre-grant publication 2010/029915, cited in PTO-1449) in view of Kohlheyer et al. (Reference included with PTO-892)
Independent claim 1 is directed to a portable device for isolating nucleic acid from blood. This device is defined as containing a body in which is disposed a groove accommodated to accommodate blood, a first and second platinum wire at either end of the groove, and a battery whose positive and negative terminal connect to the other ends of said platinum wires. This claim also includes an intended use involving dropping blood into the channel adjacent to one platinum wire, applying an electrical force to the electrodes to cause the nucleic acid from the blood to collect adjacent to the other electrode. However, as written in claim 1, this intended use limitation does not require actually performing said steps, and would be infringed by any device that could be used in said process. Independent claim 8 claims the same method recited in the intended use limitation of claim 1, utilizing the same device recited in said claim.
Duthie et al. discloses a device having a surface configured to adsorb a biological sample and an automated fluid control system configured to contact said sample with one of a plurality of solutions. (p. 1 paragraph 4) Duthie et al. furthermore describes a method of using said device comprising contacting a sample adsorbed to the surface with a solution appropriate to isolating a biological molecule of interest. (p. 1 paragraph 5) In a more specific embodiment the device contains a main channel and cross channel, both of which are reasonably considered to be grooves, both of which have electrophoresis connections at either end. (p. 1 paragraph 7) Such devices are illustrated further in figures 4-7 and paragraphs 59-72 on pp. 7-8. Duthie further describes the device as a portable analyzer and describes it as including an adapter that can be plugged into a battery, as recited in present claim 1. (p. 5 paragraph 44) The device is specifically described as being usable for isolating biomolecules including nucleic acids, viral RNA, and cellular DNA. (p. 1 paragraph 18) Samples from which biomolecules can be isolated include blood samples. (p. 9 paragraph 81) Separation of the components of the sample can be carried out by electrophoresis (i.e. applying an electric field between the electrodes to cause migration of the analyte from one electrode to the other electrode) wherein electrodes are attached to each end of the channel, the electrodes being wires. (p. 7 paragraph 62)
The devices and methods of isolating nucleic acids from blood samples disclosed by Duthie meets all of the limitations of independent claim 8, with the exception that Duthie does not disclose what material the electrode wires are composed of. However, Kohlheyer et al. discloses a microfluidic device for performing separations by electrophoresis wherein the electrodes used to apply the electrical field are made of platinum. (p. 4112 figure 1, also left column third paragraph) It would have been obvious to one of ordinary skill in the art at the time of the invention to use platinum as the material for the electrode wires in the device described by Duthie et al. The fact that Duthie describes electrodes to be used in electrophoresis but does not describe the material they are made of would suggest to one of ordinary skill in the art to look to other disclosures of electrodes for this purpose in order to determine an appropriate material to use. Therefore the disclosure that such electrodes can be made of platinum would have suggested using platinum for this purpose, rendering the claimed device and process obvious.
Regarding claim 9, Duthie et al. discloses that the device contains an appropriate buffer solution which is introduced into the channel to allow for separation of the analyte. (p. 2 paragraph 29, p. 4 paragraph 39) Furthermore the process of electrophoresis described by Duthie (e.g. paragraphs 62-63) would necessarily involve moving the nucleic acid as recited in these claims.
Regarding claim 10, this claim requires that the buffer be physiological saline. According to p. 4 paragraph 36 of Duthie, NaCl (saline) can be a component of a buffer for isolating nucleic acids, and furthermore can be used at any concentration of 0.1-5%, which encompasses physiological saline. (0.9%) Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use physiological saline as a component of the buffer, based on a rationale of a broad range rendering a narrower value within said range obvious.
Regarding claim 11, electrophoresis would necessarily involve applying a voltage to the channel, and Duthie describes detecting the target biomolecules. (p. 5 paragraph 42)
Regarding claim 12, as discussed previously under 35 USC 112, there is no clear definition of what structural feature a “preset” length and thickness comprises. Therefore in their broadest reasonable interpretation, this limitation would necessarily be met by the wires disclosed by Duthie.
Newly introduced claim 18 defines the dimensions of the device body and channel. P. 7 paragraph 64 of Duthie defines the width of the channel as being 2mm in one embodiment and the length being 20mm. (p. 7 paragraph 64) In view of the disclosure of similarly sized channels by Duthie, one of ordinary skill in the art would have found it to be obvious to make a device having a channel with the claimed dimensions. Furthermore, with respect to the dimensions of the device body, one of ordinary skill in the art would have been reasonably able to determine an appropriate dimension for the body, given the requirement that the body be larger than the channel.
Furthermore with respect to claim 18, as well as newly introduced claim 16, which defines the dimensions of the platinum wires, according to MPEP 2144.04(IV)(A), changes in the size or proportion of a prior art item or device do not render said device patentable, unless they would result in a difference in how the device performs. Furthermore inasmuch as the size and shape of the wires depends on the distance between the electrodes and the battery, according to MPEP 2144.04(VI)(C) rearrangement of the parts of a prior art device is a matter of obvious design choice if said rearrangement does not alter the operation of the device. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to determine an appropriate size and dimension for the device body, the channel, and the wires, when constructing an electrophoretic device according to the directions provided by Duthie et al.
Regarding claim 19, which refers to collecting the isolated nucleic acid from a specified position relative to one end of the platinum wire, Duthie et al. discloses the existence of a sample outlet at one end of the channel. (p. 7 paragraph 65, for example) The selection of a particular distance between the end of the wire and the sample outlet is similarly merely an obvious change in the size or arrangement of parts, unless it is shown to alter the operation of the device.
For these reasons the invention taken as a whole is prima facie obvious.
Applicant’s amendment necessitates the following new grounds of rejection:
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.
Claims 1-5, 7, 15, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Duthie et al. (US pre-grant publication 2010/029915, cited in PTO-1449) in view of Kohlheyer et al. (Reference of record in previous action) in view of Bocek et al. (Reference included with PTO-892)
Independent claim 1 is directed to a portable device for isolating nucleic acid from blood. This device is defined as containing a body in which is disposed a groove accommodated to accommodate blood, a first and second platinum wire at either end of the groove, and a battery whose positive and negative terminal connect to the other ends of said platinum wires. This claim also includes an intended use involving dropping blood into the channel adjacent to one platinum wire, applying an electrical force to the electrodes to cause the nucleic acid from the blood to collect adjacent to the other electrode. However, as written in claim 1, this intended use limitation does not require actually performing said steps, and would be infringed by any device that could be used in said process.
Duthie et al. discloses a device having a surface configured to adsorb a biological sample and an automated fluid control system configured to contact said sample with one of a plurality of solutions. (p. 1 paragraph 4) Duthie et al. furthermore describes a method of using said device comprising contacting a sample adsorbed to the surface with a solution appropriate to isolating a biological molecule of interest. (p. 1 paragraph 5) In a more specific embodiment the device contains a main channel and cross channel, both of which are reasonably considered to be grooves, both of which have electrophoresis connections at either end. (p. 1 paragraph 7) Such devices are illustrated further in figures 4-7 and paragraphs 59-72 on pp. 7-8, and include devices having only a single channel as pictured in figures 4 and 5. Duthie further describes the device as a portable analyzer and describes it as including an adapter that can be plugged into a battery, as recited in present claim 1. (p. 5 paragraph 44) The device is specifically described as being usable for isolating biomolecules including nucleic acids, viral RNA, and cellular DNA. (p. 1 paragraph 18) Samples from which biomolecules can be isolated include blood samples. (p. 9 paragraph 81) Separation of the components of the sample can be carried out by electrophoresis (i.e. applying an electric field between the electrodes to cause migration of the analyte from one electrode to the other electrode) wherein electrodes are attached to each end of the channel, the electrodes being wires. (p. 7 paragraph 62)
The devices and methods of isolating nucleic acids from blood samples disclosed by Duthie meet the limitations of independent claims 1 and 8, with the exception that Duthie does not disclose what material the electrode wires are composed of. However, Kohlheyer et al. discloses a microfluidic device for performing separations by electrophoresis wherein the electrodes used to apply the electrical field are made of platinum. (p. 4112 figure 1, also right column third paragraph) It would have been obvious to one of ordinary skill in the art at the time of the invention to use platinum as the material for the electrode wires in the device described by Duthie et al. The fact that Duthie describes electrodes to be used in electrophoresis but does not describe the material they are made of would suggest to one of ordinary skill in the art to look to other disclosures of electrodes for this purpose in order to determine an appropriate material to use. Therefore the disclosure that such electrodes can be made of platinum would have suggested using platinum for this purpose, rendering the claimed device and process obvious.
Additionally, neither Duthie nor Kohleyer describe the cross-sectional shape of the channel, which is defined in presently amended claim 1 as having a uniform polygonal cross section. However, Bocek et al. discloses a method for isotachophoretic separation of charged analytes. (p. 283 summary) This technique is carried out using a device having a groove with a rectangular cross section. (p. 285 last paragraph) While the analytes being separated were not nucleic acids, one of ordinary skill in the art would have seen the disclosure of Bocek et al. as indicating that channels with rectangular cross sections are appropriate for electrophoresis. In view of the fact that Duthie does not specifically define what the cross-sectional shape of the channel is, one of ordinary skill in the art would have to decide what channel geometry to use, and would have regarded a rectangular (polygonal) channel to be one possible embodiment in which the channel can be made.
Regarding claim 2, Duthie et al. discloses that the device contains an appropriate buffer solution which is introduced into the channel to allow for separation of the analyte. (p. 2 paragraph 29, p. 4 paragraph 39) Furthermore the process of electrophoresis described by Duthie (e.g. paragraphs 62-63) would necessarily involve moving the nucleic acid as recited in these claims.
Regarding claim 3, this claim requires that the buffer be physiological saline. According to p. 4 paragraph 36 of Duthie, NaCl (saline) can be a component of a buffer for isolating nucleic acids, and furthermore can be used at any concentration of 0.1-5%, which encompasses physiological saline. (0.9%) Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use physiological saline as a component of the buffer, based on a rationale of a broad range rendering a narrower value within said range obvious.
Regarding claim 4, electrophoresis would necessarily involve applying a voltage to the channel, and Duthie describes detecting the target biomolecules. (p. 5 paragraph 42)
Regarding claim 5, as discussed previously under 35 USC 112, there is no clear definition of what structural feature a “preset” length and thickness comprises. Therefore in their broadest reasonable interpretation, this limitation would necessarily be met by the wires disclosed by Duthie.
Regarding claim 7, Duthie et al. describes the base material as including for example glass and silicone, which are materials which are non-flammable and electrically insulating as recited in these claims. Furthermore, while claims 7 and 14 recite the limitation “implemented using a three-dimensional printer,” this is interpreted as being a product-by-process limitation which imposes no additional structural features on the claimed object, and therefore does not render the claims patentable.
Newly introduced claim 17 defines the dimensions of the device body and channel. P. 7 paragraph 64 of Duthie defines the width of the channel as being 2mm in one embodiment and the length being 20mm. (p. 7 paragraph 64) In view of the disclosure of similarly sized channels by Duthie, one of ordinary skill in the art would have found it to be obvious to make a device having a channel with the claimed dimensions. Furthermore, with respect to the dimensions of the device body, one of ordinary skill in the art would have been reasonably able to determine an appropriate dimension for the body, given the requirement that the body be larger than the channel.
Furthermore with respect to claim 17, as well as newly introduced claim 15, which defines the dimensions of the platinum wires, according to MPEP 2144.04(IV)(A), changes in the size or proportion of a prior art item or device do not render said device patentable, unless they would result in a difference in how the device performs. Furthermore inasmuch as the size and shape of the wires depends on the distance between the electrodes and the battery, according to MPEP 2144.04(VI)(C) rearrangement of the parts of a prior art device is a matter of obvious design choice if said rearrangement does not alter the operation of the device. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to determine an appropriate size and dimension for the device body, the channel, and the wires, when constructing an electrophoretic device according to the directions provided by Duthie et al.
Regarding claim 19, which refers to collecting the isolated nucleic acid from a specified position relative to one end of the platinum wire, Duthie et al. discloses the existence of a sample outlet at one end of the channel. (p. 7 paragraph 65, for example) The selection of a particular distance between the end of the wire and the sample outlet is similarly merely an obvious change in the size or arrangement of parts, unless it is shown to alter the operation of the device.
For these reasons the invention taken as a whole is prima facie obvious.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Duthie et al. in view of Kohleyer et al. as applied to claims 8-12, 16, 18, and 20 above, and further in view of Chan et al. (Reference of record in PTO-1449 submitted 3/4/2025)
The disclosures of Duthie and Chan are discussed above. Duthie in view of Chan does not specifically disclose a process involving an additional step of manufacturing the body of the device through 3D printing. Chan et al. discloses the application of three-dimensional printing to fabricating devices for point-of-care testing. (p. 2714 right column first and second paragraphs) This method allows for rapid prototyping of multiple iterations of a device during its design. (p. 2715 left column last paragraph – 2716 left column first paragraph) Devices that can be fabricated in this manner include fluid handling devices incorporating channels. (pp. 2719-2722, section 3.2) It would have been obvious to one of ordinary skill in the art at the time of the invention to use 3D printing to make the body of the device described by Duthie et al. One of ordinary skill in the art would have seen the disclosure of Duthie et al. as suggesting that this technique is useful for making devices of this type.
Therefore the invention taken as a whole is prima facie obvious.
Conclusion
No claims are allowed in this action. 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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/ANDREA OLSON/ Primary Examiner, Art Unit 1693 3/31/2026
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