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 .
Remarks
This Office Action fully acknowledges Applicant’s remarks filed on July 21st, 2026. Claims 1-18 are pending.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
1) Chip installer for seating the chip as in cl. 11.
2) Heating part configured to be movable as in cl. 11.
3) Cocktail storage unit…into which a cocktail…is introduced as in cl. 11.
4) Eluent storage unit…into which an eluent….is introduced as in cl. 11.
5) Wax storage unit for storing solid wax…as in cls. 1, 11.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
1) A seating tray, platform, or equivalents thereof (see par.[0151] of Applicant’s pre-grant publication US 2023/0400452).
2) A driver connected to the heating element for moving the heater closer or further away and equivalents thereof (see pars.[0167-0170,0181-0183]).
3) A chamber, channel, reservoir, receptacle, or equivalents thereof as seen through pars.[0019,0032,0100].
4) A chamber, channel, reservoir, receptacle, or equivalents thereof as seen through pars.[0019,0032,0100].
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-10 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 outlet" in the recitation to the connection chamber. There is insufficient antecedent basis for this limitation in the claim.
It appears that Applicant intends to recite “an outlet” or “outlets.”
Claim 5 is 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.
The metes and bounds of the sought sample analysis chip, as amended herein, are indefinitely defined.
Initially, it is noted that “the chip” lacks proper antecedent basis in the claims.
Does Applicant intend to provide the sample analysis chip is comprises of a chip of particular confines (i.e. providing definition and discussion to its thickness, upper, and lower portions that are relied upon in this recitation) in which all of the chambers, units, channels, passages reside?
Further, Examiner notes that the recitation “provided in a groove shape…” is indefinitely understood as recitation to a “groove shape” does not provide a structural place of interest for the first/second passage, but merely reads on a shape that is a descriptive element.
Does Applicant intend to recite “provided in a groove” (removing the term “shape” in both instances with respect to the first and second passages) that would clearly set forth a structure of a groove in which the first/second passages reside.
Additionally, as similarly discussed above with the lack of clarity with respect to improper antecedent basis with “the chip,” Applicant should establish and define such a chip in a manner that particularly establishes its dimensions (i.e. thickness, radius, top, and bottom) so as to clearly convey the sought three-dimensional arrangement (see page 17 of Applicant’s remarks and concordant figure 3 of the present application).
Claim 8 is 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.
The metes and bounds of the sought sample analysis chip, as presented in the amendments herein, are indefinitely defined.
Claim 8 provides the further element of a cartridge, however, the cartridge is not structurally/functionally related to the sample analysis chip as in claims 1/7. What is the structural/functional relationship of the recited cartridge to that of the prior confines of the sample analysis chip so as to form the sought operative embodiment?
Further, within the recitation to the further element of the cartridge, there are repeated recitations to a sample storage unit, washing liquid storage unit, cocktail storage unit, and eluent storage unit.
Are these additional, distinct ‘units’ from those already recited within independent claim 1?
Further to this, claim 8 goes on to reference the sample storage unit (and likewise for washing, cocktail, and eluent) that calls into question what unit is being referenced (i.e. one from within the cartridge or one from the base sample analysis chip in claim 1) and how many of these units are provided.
Claims 11-20 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 11, as amended herein, does not set forth clear metes and bounds as to what is sought by the claim.
The preamble of the claim recites “…[a]n apparatus in which a sample analysis chip is installed, the sample analysis chip comprises…” which reads to providing a claim to the sample analysis chip.
However, in the latter portion of the claim there is provided is a process recitation to the analyzer (“wherein the analyzer analyzers…”), followed by discussion of structural elements of the analyzer.
Does Applicant intend to provide a system/combination claim in which the system/combination is made up of a sample analysis chip of its particular structure and analyzer, structured as claimed, and supporting the chip?
Or is the claim, as plainly read by the preamble, merely meant to be positively to the sample analysis chip and the analysis is provided as a process recitation not afforded patentable weight in a device claim, along with a provision to a prospective workpiece in that of the analyzer itself?
Applicant should make clear the type of claim sought and what is being positively required thereby.
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.
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) 1-4, and 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR2020-0064466A (and further see attached Google Patents translation thereof), hereafter KR1, in view of Staimer et al. (US 2005/0037484), hereafter Staimer, Carvalho et al. (US 2002/0106786), hereafter Carvalho, and Corbett (US 2010/0323923).
KR1 discloses a rotary integrated microdevice for gene diagnosis (abstract). With regard to claim 1, KR1 disclose a sample analysis chip comprising a sample storage unit 110, a capture passage 115 communicating with the sample storage unit as claimed and positioned radially outward from the sample storage unit, the capture passage having capture means 118 (i.e. silica beads as in fig. 3 and further related with cl. 6) configured to capture an analysis target. KR1 further discloses a washing liquid storage unit 120 positioned radially inward than the sample storage unit and communicating with the capture passage, a cocktail storage unit 135 positioned radially inward than the sample storage unit and for introducing a cocktail for detection of the analysis target therein (Examiner notes that the positive action of ‘introducing a cocktail…” is drawn to a process step not given patentable weight, wherein the recitation herein is drawn to a capability of the cocktail storage unit to allow introduction of this prospective workpiece in that of a cocktail for detection of the analysis target; KR1 also does utilize gene-amplifying enzymes or indicators for PCR/RT-PCR). KR1 further discloses an eluent storage unit 130 positioned radially inward than the sample storage unit, communicating with the capture passage and for introducing an eluent for separating as claimed (Examiner additionally reasserts the likewise discussion found above with respect to the ‘introducing a cocktail…’) (pars.[0049,0055,0057,0066,0070], figs. 2 and 3, for example).
KR1 further discloses a connection chamber 140 positioned radially outward than the capture passage and cocktail storage unit and communicating with the outlet of the capture passage and the cocktail storage unit. KR1 further discloses a collection chamber 150 positioned radially outward than the connection chamber and communicating with the connection chamber, and into which the eluate comprising the analysis material and the cocktail are introduced (see above discussion wherein the active process is not necessitated in the device claim and wherein it is drawn to a capability thereof that is met by KR1). KR1 further discloses a reaction chamber (i.e. one of 159a-t) positioned radially outward than the collection chamber and communicating with the collection chamber.
With regard to claim 2, KR1 discloses an input channel 156 positioned radially outward than the collection chamber, positioned radially inward than the reaction chamber, communicating with the collection chamber and reaction chamber, and for introducing a mixture of eluate and cocktail as recited therein (see above discussion regarding the recitation reading to the channel’s functionality and without necessitating the active process step), and a connection channel (i.e. one of 158a-158t) connecting the input channel and the reaction chamber.
With regard to claim 3, KR1 discloses a plurality of reaction chambers 159a-t and the plurality of reaction chamber is formed along the circumferential direction of the sample analysis chip and the length of the connection channel is shorter as the distance from the collection chamber 150 increases (see fig. 2 wherein the length of the connection channel is longest at first one 158a that is closest to the collection chamber and shortest at the last one 158t that is furthest away from the collection chamber)
With regard to claim 4, KR1 discloses a disc 1-10A/10B, a first film layer formed on an upper portion of the disk, a second film layer formed on an under portion of the disk, wherein the elements of the analysis chip as claimed (and as modified below with respect to the wax storage unit) are provided in a groove shape in the disk (par.[0047], fig. 1, wherein the processing units 10A/10B are manufactured into a groove shape and adhered to the grooved pattern utilizing a PSA foil (pressure sensitive adhesive foil).
With regard to claim 7, KR1 discloses injection holes for solution injection are formed in each of the sample storage unit, washing liquid storage unit, cocktail storage unit, and eluent storage unit (see cl. 10). With regard to claim 8, as best understood, KR1 discloses further comprising a cartridge having each inlet and each storage unit, the each inlet communicates with each solution storage unit and the each inlet is connected to the each injection holes as claimed (and noting as similarly discussed above that the steps of “injecting” are not necessitated herein nor are they provided patentable weight herein the device claims, and the prior art of KR1 is functionally capable thereof with the commensurate structure provided) (see cls. 15&16).
With regard to claim 9, KR1 discloses an inflow channel 126, a delay channel 128, wherein the inflow channel is disposed between the washing liquid storage unit and the delay chamber to “allow the washing liquid injected…” as claimed, wherein the inflow channel includes a first passageway 126a extending away from the first delay chamber in a first circumferential direction and a second passage 126b (having opposite curvature from 126a; see fig. 2) extending toward the first delay chamber in a second circumferential direction opposite to the first at an end of the first passage. KR1 further discloses the delay channel is disposed between the first delay chamber and the capture passage “to allow…” as recited therein wherein such processes are not necessitated or attributed patentable weight in a device claim and the recitation is drawn to a capability, of which is met by the commensurate structure and disclosure of KR1. KR1 further discloses that the delay channel includes a first delay passage extending radially inward (in-bent portion of 128) at the outlet of the first delay chamber and a second delay passage (out-bent portion of 128) extending radially outward than an end of the first delay passage (pars.[0060-0061,0064], fig. 2, for example).
With regard to claims 1 KR1 does not specifically disclose the capture means within the capture passage is a membrane as claimed (noting, as discussed above, KR1 discloses capture means as in silica beads), and a wax storage unit for storing a solid wax therein positioned radially inward than the reaction chamber and communicating with the reaction chamber.
Staimer discloses optical bio-discs including spiral fluidic circuits for performing assays (abstract). Staimer discloses a capture passage provided with chemically modified membrane(s) so as to capture specific analytes therein while passing the remaining unwanted elements (par.[0263]).
Corbett discloses a thermal cycling device in which to overcome issues of reaction mixture evaporation is to overlie the reaction mixture with oil or wax to act as an evaporation buffer (par.[0161]).
It would have been obvious to one of ordinary skill in the art to modify KR1 to utilize a membrane, and as a glass filter (noting that KR1 already provides for silica beads to the capture means), to form to the capture means such as taught by the analogous art of Staimer to that of bio-discs including fluidic circuits for performing assays in which such a modification represents an obvious alternative form of capture means to likewise provide the desired functionality in capturing the sought analyte while passing the remainder and would have a reasonable expectation of success therein.
Further, it would have been obvious to one of ordinary skill in the art to modify KR1 to utilize a wax storage as claimed such as suggested by the analogous art of Corbett to a thermal cycling device for PCR wherein KR1 similarly contemplates the usage of an oil storage chamber for preventing evaporation of the mixture and Corbett provides that wax and oil are useful alternatives to one another wherein substitution of a wax storage in lieu of the oil storage would have a reasonable expectation of success in KR1 for providing the desired function of evaporation prevention.
With regard to claim 10, KR1 does not specifically disclose that the reaction chamber is thinner than that of other portions of the sample analysis chip.
However, it would have been obvious to one of ordinary skill in the art through routine engineering and design choice to modify the reaction chamber of KR1 to be thinner than the of other portions of the sample analysis chip in order to afford relatively better heat transfer as would be appreciated in KR1 that is concerned with PCR and its thermal cycling processes and such modification would have a reasonable expectation of success in KR1.
Claim(s) 11-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR2020-0064466A (and further see attached Google Patents translation thereof), hereafter KR1, in view of Carvalho, Silverbrook et al. (US 2011/0312841), hereafter Silverbrook, Shigeura et al. (US 2005/0161192), hereafter Shigeura, Corbett, Staimer, and McFall et al. (US 2020/0171503), hereafter McFall.
KR1 has been discussed above as it pertains to various channels, chambers, and units recited as applicable herein and discussed above with respect to KR1 and claim 1 (sample storage unit 110, reaction chamber 159a-t, washing liquid storage unit 120, cocktail storage unit 135, eluent storage unit 130, connection chamber 140, collection chamber 150, wax storage unit 165 (modified below by Corbett). Those remaining channels, chambers, and units are discussed in which KR1 also discloses an apparatus in which a sample analysis chip is installed wherein the sample analysis chip comprises a sample storage unit 110, a pretreatment chamber (“preprocessing unit” as in KR1 and located in a radial direction outward from the sample input chamber), a capture passage 115 with capture means 108 configured for capturing an analysis target material, and providing as an equivalent thereof to a membrane, which is located radially outward than the sample storage unit and the sample introduced into the sample storage unit is pretreated (as likewise discussed above, a step of ‘introduction’ is not actively claimed nor is such a process step attributed patentable weight within this device claim, and such recitation reads on a capability/functionality thereof), a reaction chamber located radially outward than the pretreatment unit and into which the sample pretreated…as claimed (see likewise above discussion). KR1 further discloses the apparatus as claimed, and wherein the recitation “the apparatus analyzes…” is drawn to a process step not afforded patentable weight in a device claim. KR1 discloses the apparatus comprising a chip installer on which the sample analysis chip is seated wherein the genetic diagnostic device rotates (see section 1. Genetic diagnostic chip Example 1, figs, 1&2), and discloses providing an external heat source to apply the heat corresponding to the temperature necessary for each step of the PCR process as heating device as claimed, wherein such heating device is fully capable of being moved closer to or further away by way of given applied forces (pars.[0045,0050-0051,0084,0133], fig. 2). Further, with regard to claim 11, KR1 discloses detecting the target material by fluorescence detection, which provides a sensor in up and down alignment with the reaction chamber(s) (par.[0134). With regard to claim 15, KR1 discloses a plurality of reaction chambers 159a-t formed along a circumferential direction of the sample analysis chip (fig. 2).
With regard to claim 11, KR1 does not specifically disclose a motor included in a chip installer, a membrane configured to capture an analysis target material, and a wax storage unit for storing a solid wax therein positioned radially inward than the reaction chamber and communicating with the reaction chamber.
Carvalho discloses microfluidics devices comprising a rotatable chip with fluidics circuits for performing assays in which the chip is rotated by way of a motor (par.[0069], cl. 34).
It would have been obvious to one of ordinary skill in the art to modify KR1 to utilize a motor rotate the chip such as suggested by the analogous art of Carvalho to rotating microfluidic chips for performing assays in which KR1 likewise desires to rotate the chip to perform fluid operations and assays and application with well-known drive means as a motor provides a suitable and useful on-board mechanism for controllably rotating the chip as desired.
Staimer discloses optical bio-discs including spiral fluidic circuits for performing assays (abstract). Staimer discloses a capture passage provided with chemically modified membrane(s) so as to capture specific analytes therein while passing the remaining unwanted elements (par.[0263]).
It would have been obvious to one of ordinary skill in the art to modify KR1 to utilize a membrane (noting that KR1 similarly provides for silica beads to form a capture means), to form to the capture means such as taught by the analogous art of Staimer to that of bio-discs including fluidic circuits for performing assays in which such a modification represents an obvious alternative form of capture means to likewise provide the desired functionality in capturing the sought analyte while passing the remainder and would have a reasonable expectation of success therein.
Corbett discloses a thermal cycling device in which to overcome issues of reaction mixture evaporation is to overlie the reaction mixture with oil or wax to act as an evaporation buffer (par.[0161]).
Further, it would have been obvious to one of ordinary skill in the art to modify KR1 to utilize a wax storage as claimed such as suggested by the analogous art of Corbett to a thermal cycling device for PCR wherein KR1 similarly contemplates the usage of an oil storage chamber for preventing evaporation of the mixture and Corbett provides that wax and oil are useful alternatives to one another wherein substitution of a wax storage in lieu of the oil storage would have a reasonable expectation of success in KR1 for providing the desired function of evaporation prevention.
With regard to claims 12-16, KR1 does not specifically disclose a wax storage unit with a second heater as claimed, and wherein the heater part includes a Peltier element connected to the first heater, and the heating part is installed on an upper side and a lower side of the reaction chamber, respectively, and the first heater extends along the circumferential direction of the sample analysis chip and the area of the first heater is configured to cover at least all of the plurality of reaction chambers as claimed.
Silverbrook discloses lab-on-a-chip devices for assays such as PCR wherein a plurality of PCR reaction chambers are provided and a plurality of heaters are provided to be elongate and parallel with the longitudinal extent of the PCR reaction chambers, and the heaters are independently controllable (par.[0494], for example).
Shigeura discloses heat transfer for thermal cycling wherein the device includes an upper Thermoelectric module 18 and a lower Thermoelectric module 20 (i.e. Peltier element, as known through synonymous terminology) (pars.[0048-0049], fig. 1, for example).
McFall discloses devices and methods for samples processing and analysis, including PCR, wherein heater pairs on either side of the reaction chamber are movable to and from the reaction chambers so a to particularly affect the various thermal cycling steps in the PCR assay (par.[0007,0011], for example).
It would have been obvious to one of ordinary skill in the art to modify KR1 to provide a heater part as in claims 12-16 such as suggested by analogous art of Silverbrook, Shigeura, and McFall to PCR thermal cycling devices with on-board fluidic sample processing in which providing a movable heater unit provides the benefit of being able to simply and selectively affect the various thermal cycling steps in the PCR process and providing the heater to extend along the circumferential direction with respect to the plurality reaction chambers assures that all of the reaction chambers may be affected by the heater for the desired cycling procedures or other heating/cooling operations.
It would also be likewise appreciated by KR1 through the teachings of Silverbrook/Shigeura/McFall (i.e. movable heaters) and Corbett (wax for preventing evaporation) that akin to that provided by KR1 in the oil chamber that is utilized to provide oil to prevent evaporation, providing the second heater to at least cover the wax chamber is an obvious engineering design choice so as to achieve the desired result of providing the melted wax to the reaction chambers so as to affect the desired evaporation prevention of the reaction mixture therein.
Further, it would have been obvious to one of ordinary skill in the art to modify KR1 to utilize a wax storage as in cl. 12 such as suggested by the analogous art of Corbett to a thermal cycling device for PCR wherein KR1 similarly contemplates the usage of a oil storage chamber for preventing evaporation of the mixture and Corbett provides that wax and oil are useful alternatives to one another wherein substitution of a wax storage in lieu of the oil storage would have a reasonable expectation of success in KR1 for providing the desired function of evaporation prevention.
With regard to claim 17, KR1 does not specifically disclose that a thickness of a portion where the reaction chamber of the sample analysis chip is formed is thinner than that of the other portions.
However, it would have been obvious to one of ordinary skill in the art through routine engineering and design choice to modify the reaction chamber of KR1 to be thinner than the of other portions of the sample analysis chip in order to afford relatively better heat transfer as would be appreciated in KR1 that is concerned with PCR and its thermal cycling processes and such modification would have a reasonable expectation of success in KR1.
With regard to claim 18, KR1 does not specifically disclose an operation processor part configured as claimed.
Shigeura discloses that a computer or other signal processing system may be in communication with the detector in order to provide for further assessment of the detector data (par.[0036]).
It would have been obvious to one of ordinary skill in the art to modify KR1 to include an operation processor part as claimed such as suggested by Shigeura wherein KR1 already provides a detector for detecting fluorescence correlated to the sample and its presence of a target analyte (i.e. “infected with a disease” in as much as provided herein) and providing a processor to receive such data for manipulation and processing thereof represents an obvious modification in order to provide compatible results to be realized in a quick and reliable fashion through connected computing means.
Response to Arguments
Applicant's arguments filed July 21st, 2026 have been fully considered but they are not persuasive.
With regards to the “Claim Interpretation” under 35 USC 112F/6th, Examiner asserts that various recitations, including further added ones through the present amendments, remain construed thereunder as they present generic placeholders with accompanying functionality that is absent sufficient structure(s) recited thereto.
An accompanying corresponding structural indication and equivalents thereof is provided for these elements as seen through Applicant’s disclosure (as viewed through Applicant’s pre-grant publication US 2023/0400452).
With regards to claim 1-10 and 17 rejected under 35 USC 112 b/2nd, Examiner acknowledges Applicant’s remarks and amendments, and notes that the prior antecedent basis issue from claim 1 was not addressed and thus remains as discussed above.
Further, in view of the amendments to claim 8, claim 8 is rejected under 35 USC 112 b/2nd for the reasons discussed above in the body of the action.
With regards to claims 1-10 rejected under 35 USC 103 as unpatentable over KR1 in view of Staimer, Carvalho, Corbett, and Ho, Applicant traverses the rejection.
Applicant asserts that claim 1 has been amended to recite distinguishing of the invention over the applied art.
With regard to claim 1, Examiner asserts that Applicant has failed to structurally distinguish the claimed reaction chamber from that of the cited one in KR1 (i.e. one of 159a-t) positioned radially outward than the collection chamber and communicating with the collection chamber, and Applicant has failed to structurally distinguish the claimed wax storage unit in setting forth any particular structure that obviates or distinguishes from the prior art’s structured wax storage unit.
As above in the body of the action, KR1 is likewise concerned with evaporation and to this end utilizes oil, whereas the analogous art of Corbett similarly recognizes evaporation may be avoided/reduced b overlying with wax as an evaporation buffer, thereby providing a clear and connected obviousness rationale for analogously preventing sample evaporation in providing a chamber storing solid wax as informed by Corbett in lieu of a chamber storing liquid oil as in KR1.
Examiner further asserts that there is no such, explicit exclusionary disclosure in Corbett to utilizing only liquid wax. In fact, wax is conventionally provided in a malleable solid form and Corbett does not speak contrary to this generally understood form of wax.
Lastly, the discussion to neither reference suggesting storing the entire contents of the chamber as solid wax to eliminate any liquid filling or to block leaks from the outset in not persuasive as the argument is not commensurate in scope with the claims, in which the claims do not require this constitution.
Further, and by the above discussion, Applicant asserts that claim 11 is likewise not taught or suggested by the applied prior art. Examiner reasserts those arguments provided above and maintains that the cited prior art teaches such a wax storage unit as claimed.
Lastly, Applicant’s amendment to “rotation of the sample analysis chip causes…” is drawn to a process recitation not afforded patentable weight in a device claim and fails to provide a structural distinction between that of the prior art and the claims.
As such, claims 1-4, 6-10, and 11-18 remain rejected under 35 USC 103 over the cited prior art of record for the reasons discussed above and those provided in the body of the action.
Examiner asserts that in view of the amendments to claim 5, rejection under 35 USC 103 has been obviated.
However, in view of the amendments to claim 5, a new grounds of rejection is provided under 35 USC 112 b/2nd as discussed above in the body of the action.
Allowable Subject Matter
Claims 5 and 6 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record does not teach or fairly suggest, as best understood herein, a first passage connecting the capture passage with the sample storage unit, the first delay chamber, and the second delay chamber is provided in a groove shape extending in a radial direction on an upper portion of the disk, and wherein a second passage connecting the capture passage with the connection chamber is provided in a groove shape extending in a radial direction on a lower portion of the disk.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEIL N TURK/Primary Examiner, Art Unit 1798
