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 .
Response to Arguments
In response to the Applicant’s Remarks on Pages 7-8 stating that support for the amendment can be found in Paragraphs [0042] – [0043] of the Application, it is noted that the currently admitted Specification is marked using pages and line numbers.
Applicant’s arguments, see Pages 7-8, filed 1/12/2026, with respect to the rejection(s) of claims 1-5, 10-11, and 13-15 under U.S.C. 102 have been fully considered and are persuasive. However, claims 1-11 and 13-15 are now rejected under U.S.C. 103 as being unpatentable over Taran (WO2020/016616, cited on the IDS filed 7/29/2022) and further in view of Roe et al. (US20040186394) and Zhou et al. (US 2011/0275058).
On Page 7 of the Remarks, the Applicant asserts that Taran specifically teach aspects of the invention which do not include or contemplate the inclusion of a pointed or tipped element as claimed herein. In response to this argument, the Examiner agrees, however, the rejection of this limitation is made by Taran of in view of Roe et al. (US 2004/018639), where Roe teaches a test strip that incorporates a lancet, see Fig. 1.
On Page 7 of the Remarks, the Applicant further asserts that “Taran does not allow for such an integrate device because its test device is too large.” In response to this argument, the Examiner respectfully disagrees as the device of Taran is meant to be “palm/hand sized,” see Page 9, Lines 13-15, where the inserted cartridge and adaptor can be any size, see Page 10, Lines 27-30. Therefore, the miniaturization of the device of Taran et al. would have been recognized as predictable and within the reach of such an ordinarily skilled artisan to achieve a housing with a height of less than 3cm and a length of 5cm.
On Page 8 of the Remarks, the Applicant states that “any attempt to modify Taran to include [at least one piercing element or cannula with a tip and base end] would require a significant reconstruction and redesigning of Taran while simultaneously changing the principle of operation thereof,” however, the Examiner respectfully disagrees. The sample providing area of Taran is shown to be outside the device, see Fig. 6, where the design of this area is not limited by the invention and can be any commercial test strip, see Page 5, Lines 5-8, and see Page 25 in Taran. Therefore, the modification of the test strip of Taran to include the sample providing area of Roe et al. would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application.
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 16 and 20-21 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 16 states that the invention “comprises at least one of a waveguide and a plurality of mirror surfaces,” however, it is unclear as to whether the invention comprises a waveguide or a plurality of mirror surfaces, or requires both limitations as only the mirrors are used within the claim.
Claim 20 states that the testing device is chosen from a cylindrical shape and a base area with a cubic or rectangular shape, but it is not apparent which elements of the claimed language are to be chosen from the list due to the presence of a semicolon. In the interest of compact prosecution, removal of the semicolon or emphasizing the list of configurations is suggested.
Claim 21 refers to both the cylindrical shape and base area of previous claim 20, but the limitations of claim 20 are presented as a list and are not each positively recited. The Examiner suggests amending the previous claim to clarify that both the cylindrical and rectangular elements are present within the invention.
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.
The limitation of the “flow control means” in Claim 1 is interpreted as a micro-sensor, micro actuators, or a micro pump, see Page 38, Lines 20-28.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-11, 13-15, and 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Taran (WO2020/016616, cited on the IDS filed 7/29/2022) and further in view of Roe et al. (US20040186394) and Zhou et al. (US 2011/0275058).
Regarding claim 1, Taran teaches a testing device comprising a testing assembly for lateral flow assay (lateral flow test strip immunoassay device 100, see Page 1, Fig. 1), the testing assembly comprising:
a liquid sample receiving interface arranged on a support structure (cartridge carrying adaptor) defining a plane (XY), the liquid sample receiving interface being configured to receive a liquid sample (cartridge for accepting sample through holes labeled S arranged on cartridge carrying adaptor, see Fig. 6 and Page 11); and
at least one testing strip fluidly connected to the liquid sample receiving interface (a lateral flow test strip held in a cartridge 602/703, see Figs. 1, 6, and 7, and Pages 11-12), the testing strip comprising:
a capillary wick fluidly connected to the liquid sample receiving interface and including at least one test portion, the test portion comprising at least one reacting material configured for reacting in a predetermined manner to at least one specific analyte (test strip is connected to cartridge and includes test lines where the line is coated in a reagent to provide a visual result in response to exposure to an analyte, see Page 1 and Page 17), wherein the testing device further comprises:
an optical sensor (CMOS imaging sensor, see Page 21), arranged and configured for detecting light reflected from the at least one test portion and for converting the detected light into an electrical signal representing an intensity and/or a color of the detected light (CMOS sensor uses digital filter to determine value of intensity of detected light signals, see Pages 17 and 20), a conversion unit for converting the electrical signal into digital data representing the intensity and/or the color of the detected light (CMOS sensor uses digital filter to calculate intensity value of detected light signals, see Pages 17 and 20); and
a transmitter unit for wirelessly transmitting digital data (NFC interface transmits results of reading, see Page 25, Lines 17-25)
a cover unit attached to the support structure (top section 401 of housing that connects to cartridge carrying adaptor, see Fig. 4 and 6 and Page 11), wherein the testing strip, the optical sensor, the conversion unit, and the transmitter unit are enclosed by the cover unit and the support structure (the test strip, optics, and associated members are enclosed between top section 401, bottom section, and inserted cartridge adaptor 602, see Figs. 4-6 and Pages 10-11).
Taran, however, does not teach that device comprises a liquid sample providing module, the liquid sample providing module comprising at least one piercing element or a cannula having a tip and a base end, wherein the base end is configured to interface with the liquid sample receiving interface.
However, in the analogous art of devices for holding lateral flow test strips, Roe et al. teaches a device (60) that is inserted into an analyte meter, see [0050], comprising a channel (98) wherein a test strip (72) is inserted with a liquid sample providing module (lancet 62) comprising at least one piercing element or a cannula having a tip (blade 80) and a base end (stop edge 82), wherein the base end is configured to interface with the liquid sample receiving interface (the stop edge 82 contacts the end of the test strip 72 to create a sample receiving area, see Fig. 2 and [0049] - [0051]).
While the previous prior art of Taran does not teach a sample providing module with the one piercing element, the stated test reader operates with any rapid lateral flow assays, test strips, dipsticks test or any other tests that are commercially available (see Page 25 in Taran). Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the lateral flow device of Taran to include the lancet as described by Roe et al. for the benefit of acquiring a body fluid without loss, delay or contamination for examination by the device, see [0047] in Roe et al. Further, the modification of the lateral flow device of Taran to include the lancet of Roe et al. would have facilitated the predictable result of supplying a sample directly to a test strip for analysis.
Further, while modified Taran teaches the testing assembly (100), the modified reference does not teach that the testing assembly further comprises:
at least one solution chamber containing a respective buffer solution; and
flow control means configured to control a transfer of the buffer solution to the liquid sample receiving interface or to the at least one testing strip.
However, in the analogous art of microfluidic devices and readers for lateral flow assays, Zhou et al. teaches a lateral flow device comprising at least one solution chamber containing a respective buffer solution (reservoir layer 17 contains a solution used with sample, see [0121]- [0122] and Example 5); and
flow control means configured to control a transfer of the buffer solution to the liquid sample receiving interface or to the at least one testing strip (piston assembly 51 controlled by motor to supply liquid to analysis reservoir, see [0121] –[0122], where the analysis reservoir contains a lateral flow test, see Example 5, [0460] – [0468]).
While Taran does not teach the previously mentioned instant application limitations of the solution chamber and the flow control means, Taran does teach that lateral flow test strip immunoassay device comprises a detector for sensing when the sample has been mixed with a buffer solution, see Page 23, and would therefore need a supply of buffer to the test strip to properly function. Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the invention of Taran to include the fluid dispenser for the lateral flow test strip as exemplified by Zhou et al. for the benefit of providing the system with a full amount of buffer to ensure that there will be a visible response on the test strip that is then detectable by an imager, see [0460] – [0472] in Zhou et al. Further, the modification of the immunoassay device of Taran to include the reservoir and dispenser of Zhou et al. would have facilitated the predictable result of flowing the required fluids to a lateral flow test strip to detect a target analyte.
Regarding claim 2, modified Taran teaches the testing device of claim 1, wherein the transmitter unit is configured for transmitting the digital data via a near-field communication link (NFC, or near-field communication, interface transmits results of reading, see Page 11 and Lines 4-11 and Page 25, Lines 17-25).
Regarding claim 3, modified Taran teaches the testing device of claim 1, comprising at least a first optical element that is arranged and configured for directing light reflected from the at least one test portion to the optical sensor (wide angle lens used to direct the image of the surface of the test strip toward the imaging sensor, see Page 33).
Regarding claim 4, modified Taran teaches the testing device of claim 3, comprising at least one light source that is arranged and configured to illuminate the at least one test portion (UV light source, see Page 4, Lines 18-22 and Page 21, Lines 1-3).
Regarding claim 5, modified Taran teaches the testing device of claim 4, comprising a further second optical element that is arranged and configured for directing illuminating light emitted by the at least one light source to the at least one test portion (UV filter positioned between light source, wide angle lens, and test strip, see Page 35, Lines 15-23).
Regarding claim 6, modified Taran teaches the testing device of claim 1, wherein the optical sensor, the conversion unit, and the transmitter unit are attached to the cover unit (the device is covered by the top surface, where the top surface contains electronics for device operations, see Fig. 4, including the camera, software for conversion, and associated NFC interface for transmission of results, see Pages 34-35).
Regarding claim 7, modified Taran teaches the testing device of claim 1, wherein the flow control means is configured to control a transfer of the buffer solution from the solution chamber to the liquid sample receiving interface (piston assembly 51 controlled by motor to supply liquid to analysis reservoir, see [0121] –[0122], where the analysis reservoir contains a lateral flow test, see Example 5, [0460] – [0468] in Zhou et al.) after the liquid sample has been received via the liquid sample receiving interface.
“Transferring the buffer solution from the solution chamber to the liquid sample receiving interface after the liquid sample has been received via the liquid sample receiving interface” is a limitation with respect to an intended use of the flow control means. An intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458,459 (CCPA 1963). The apparatus of modified Taran is identical to the presently claimed structure and therefore, would have the ability to perform the use recited in the claim since the buffer is released following the sample being deposited into a sample input reservoir (see Example 5 in in Zhou et al.).
Regarding claim 8, modified Taran teaches the testing device of claim 1, wherein the flow control means is configured to control a transfer of the buffer solution from the solution chamber to the at least one testing strip (piston assembly 51 controlled by motor to supply liquid to analysis reservoir, see [0121] –[0122], where the analysis reservoir contains a lateral flow test, see Example 5, [0460] – [0468] in Zhou et al.) after the liquid sample has been transferred from the liquid sample receiving interface to the at least one testing strip.
“Transferring the buffer solution from the solution chamber to the liquid sample receiving interface after the liquid sample has been transferred from the liquid sample receiving interface to the at least one testing strip” is a limitation with respect to an intended use of the flow control means. An intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458,459 (CCPA 1963). The apparatus of modified Taran is identical to the presently claimed structure and therefore, would have the ability to perform the use recited in the claim since the buffer is released following the sample being deposited into a sample input reservoir and is moved down the test strip (see Example 5 in Zhou et al.).
Regarding claim 9, modified Taran teaches the testing device of claim 1, wherein the flow control means comprises microelectromechanical flow control means which are connected to a power management unit for controlling the transfer of the buffer solution (micro-piston assembly 51 controlled by motor to supply liquid to analysis reservoir, see [0022] and [0121] –[0122], where the analysis reservoir contains a lateral flow test, see Example 5, [0460] – [0468] in Zhou et al.).
Regarding claim 10, Taran teaches the testing device of claim 1, wherein the testing device further comprises a cover unit attachable to the support structure (top section 401 of housing that connects to cartridge carrying adaptor, see Fig. 4 and 6 and Page 11).
Regarding claim 11, Taran teaches the testing device claim 10, wherein the testing assembly is non-releasably connected to the cover unit (reader is located within top section 401, see Page 11).
Regarding claim 13, Taran teaches the testing system for testing a liquid sample for the presence of a specific analyte, the testing system comprising a testing device according to claim 1 (device 100); and an external device that is configured for receiving digital data provided by the testing device (portable diagnostic device exchanges data with an application running on a connected device, see Page 26, Lines 15-20).
Regarding claim 14, Taran teaches the testing system of claim 13, further comprising a server that is operatively connected to the external device for transmitting digital data received by the external device to the server (external device is connected to a cloud-based server, see Page 26, Lines 15-20).
Regarding claim 15, Taran teaches the testing system of claim 13, wherein the testing device is configured to provide a raw signal to the external device, said raw signal representing a digital signal that represents an electric sign that in turn represents the optical signal as converted by means of the optical sensor of the testing device (raw data results are transmitted to external storage and the raw data is representative of the optical signal obtained by imaging sensor, see Page 17).
Regarding claim 17, Taran teaches the testing device of claim 1, wherein an antenna of the transmitter unit (407) is integrated into at least one of the cover unit and a printed circuit board (the antenna of the NFC unit is integrated into a printed circuit board 107 and the bottom of the cover unit 401, see Fig. 4 and Page 11, Lines 4-11).
Regarding claim 18, Taran teaches the testing device of claim 1, wherein the transmitter unit draws energy wirelessly from an external device absent an energy source or energy storage unit (NFC antenna has wireless charging function, see Fig. 4 and Page 11, Lines 4-11).
Regarding claim 19, Taran teaches the testing device of claim 1, wherein the piercing element or cannula with tip and base extends outward from an exterior surface of the support structure (lancet extends from stop edge of lancet, analogous to exterior surface of support structure, see [0049] and Fig. 1 in Roe et al.).
Regarding claim 20, modified Taran teaches the testing device of claim 1, wherein the testing device has one of: a cylindrical shape; and a base area with a cubic or rectangular shape (the cartridge carrying device 601 has rectangular shape and the housing 401 has a rounded, oblong shape, see Fig. 4 and Fig. 6).
Regarding claim 21, modified Taran teaches the testing device of claim 20, comprising the cylindrical and cubic shapes of the testing device, see Figs. 4 and 6.
While modified Taran does not explicitly teach that the cylindrical shape has a height of 3cm and a diameter of 5cm and that the cubic shape has a height of 3cm and a length of 5cm, Taran teaches that the size of the cartridge adaptor can be adapted to fit into the housing, see Page 36, Line 24, where the entire testing is palm sized, see Page 9, Lines 13-19.
An ordinally skilled artisan would have recognized that using a smaller housing was a workable option from these teachings because the miniaturization of the testing device to fit within a user’s hand, even if other elements within the housing would have to be slightly rearranged to reduce spacing within the housing of Taran, would have been recognized as predictable and within the reach of such an ordinarily skilled artisan to achieve a housing with a height of less than 3cm and a length of 5cm.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Taran (WO2020/016616, cited on the IDS filed 7/29/2022) in view of Roe et al. (US20040186394) and Zhou et al. (US 2011/0275058), further in view of Tsai et al. (US 20140170757 A1).
Regarding claim 16, modified Taran teaches the testing device of claim 3, but does not teaches that the first optical element comprises at least one of a waveguide and a plurality of mirror surfaces and wherein the plurality of mirror surfaces are inclined toward each other such that light reflected from the at least one test portion is directed to the optical sensor upon reflection on at least one of the plurality of mirror surfaces.
However, in the analogous art of readers for immunochromatographic test strips, Tsai et al. teaches a testing device (500, see Fig. 5) wherein the first optical element (light guide 504) comprises at least one of a waveguide and a plurality of mirror surfaces (mirrors 510 and 512 used to direct light from light source to sensor, see [0050]) and wherein the plurality of mirror surfaces are inclined toward each other such that light reflected from the at least one test portion is directed to the optical sensor upon reflection on at least one of the plurality of mirror surfaces (see Fig. 5).
While the invention of Taran teaches that the device uses a wide angle lens to focus the light to capture an image of the surface of the test strip, it was known before the effective filing date of the instant invention that the light guide of the invention of Tsai et al. was useable to block ambient light so as to capture an image of the test strip, see [0040] in Tsai.
Therefore, a person possessing ordinary skill in the art before the effective filing date of the instant application would have been motivated to modify the wide angle lens component of Taran to instead incorporate the mirrors and associated light guide of Tsai et al. for the benefit of blocking ambient light and directing light from a light source toward a test strip and its reactive area, see [0040]. Modifying a test strip reader to include different optical elements was known and conventional in the art before the effective filing date to achieve the result of portable test strip readers that use reflective detection methods.
The limitation of “at least one of a waveguide and a plurality of mirror surfaces” has been interpreted as a Markush group, including the limitations of a waveguide and a plurality of mirrors, as both elements achieve the same function of directing light within a system.
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.
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/A.N.M./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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