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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 29, 2026 has been entered.
Response to Amendment
The Amendment filed June 29, 2026 has been entered. Claims 1-9 and 11-19 remain pending in the 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 3 and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation “the invasive biofluid”. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 is rejected as depending on rejected claim 3.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-9, 14-16 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz et al. (US 10034625 B1) ("Schwartz") in view of Heikenfeld et al. (US 2018/0353748 A1) ("Heikenfeld")(cited in previous OA pertinent art section).
Regarding claim 1, Schwartz discloses A continuous sensing device for at least one analyte in an invasive biofluid, comprising (Figures 3A, 3B, 3C; column 22, line 65-column 23, line 28; column 4, line 48: "receive measurements continuously");
at least one affinity-based sensor with a plurality of probes with binding that is specific to the at least one analyte (column 1, line 34-40: "sensor comprising aptamer conjugates... configured to obtain one or more measurements related to at least one analyte in... interstitial fluid");
wherein there is at least one diffusion pathway between the at least one affinity-based sensor and the source of the invasive biofluid (FIG. 3, “372” and column 23, line 19-22: "the substrate includes a microneedle array protruding into through the epidermis of the skin to enable the assay component to interact with an analyte in the interstitial fluid of the dermis"); and
Schwartz fails to disclose including at least one sample volume adjacent to the affinity-based sensor, wherein the sample volume is less than one of 10 µL/cm2, 5 µL/cm2, 2 µL/cm2, 1 µL/cm2, 0.5 µL/cm2, or 0.2 µL/cm2.
However, in the same field of endeavor, Heikenfeld teaches including at least one sample volume adjacent to the affinity-based sensor, wherein the sample volume is less than one of 10 µL/cm2, 5 µL/cm2, 2 µL/cm2, 1 µL/cm2, 0.5 µL/cm2, or 0.2 µL/cm2 ([0009], [0088] and Example 2: [0109 – 0110], 2.5 nL in a 10mm2 area is .025 µL/cm2 which is in range).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Schwartz to include a including at least one sample volume adjacent to the affinity-based sensor, wherein the sample volume is less than one of 10 µL/cm2, 5 µL/cm2, 2 µL/cm2, 1 µL/cm2, 0.5 µL/cm2, or 0.2 µL/cm2 as taught by Heikenfeld to reduce the sample size and lag-time ([0110]).
Regarding claim 2, Schwartz as modified discloses The device of claim 1, Schwartz as modified further discloses wherein the affinity-based sensor is ex-vivo (Schwartz FIG. 3A).
Regarding claim 3, Schwartz as modified discloses The device of claim 1, Schwartz as modified further discloses wherein the at least one affinity-based sensor can sense a change in analyte concentration, and wherein the majority of the change in analyte concentration that is sensed by the at least one affinity-based sensor is transported to and from the at least one affinity-based sensor by a diffusion of analyte, and if the analyte concentration in the invasive biofluid decreases the diffusion of analyte is in the direction back towards the source of the invasive biofluid (Schwartz Col. 3 lines 35-38, diffusion implies high concentration to low concentration, backwards diffusion implies decreasing concentration.).
Regarding claim 4, Schwartz as modified discloses The device of claim 1, Schwartz as modified further discloses wherein the at least one affinity-based sensor is an aptamer sensor (Schwartz Col. 12 lines 21-24).
Regarding claim 5, Schwartz as modified discloses The device of claim 4, Schwartz as modified further discloses wherein the at least one affinity-based sensor is an electrochemical aptamer sensor (Schwartz Col. 10 line 44).
Regarding claim 6, Schwartz as modified discloses The device of claim 4, Schwartz as modified further discloses wherein the at least one affinity-based sensor is an optical aptamer sensor (Schwartz Col. 3 lines 31-32).
Regarding claim 7, Schwartz as modified discloses The device of claim 1, Schwartz as modified further discloses wherein the at least one diffusion pathway includes at least one microneedle that provides a pathway for diffusion of the at least one analyte through the dermis (Schwartz Col. 3 lines 19-21).
Regarding claim 8, Schwartz as modified discloses The device of claim 7, Schwartz as modified further discloses wherein the microneedle is hollow (Schwartz FIG. 3, “372” and column 23, line 19-22: "the substrate includes a microneedle array protruding into through the epidermis of the skin to enable the assay component to interact with an analyte in the interstitial fluid of the dermis" Needle implies hollow).
Regarding claim 9, Schwartz as modified discloses The device of claim 1, Schwartz as modified further discloses wherein the at least one affinity-based sensor is outside of the body and outside the stratum-corneum of the skin (Schwartz FIG. 3A).
Regarding claim 14, Schwartz as modified discloses The device of claim 1, Schwartz as modified further discloses wherein the at least one affinity-based sensor is in fluidic communication with a plurality of microneedles, and in further fluidic communication with the dermis, even if at least one, but not all, microneedle is not in fluidic communication with the dermis (Schwartz FIG. 3, “372” and column 23, line 19-22: "the substrate includes a microneedle array protruding into through the epidermis of the skin to enable the assay component to interact with an analyte in the interstitial fluid of the dermis" only one microneedle needs to technically contact the dermis to be in contact).
Regarding claim 15, Schwartz as modified discloses The device of claim 7, Schwartz as modified further discloses wherein the at least one microneedle is a plurality of microneedles, and number of microneedles in the plurality of microneedles is at least one of >3, >10, >20, >50, >100, >200 microneedles (Schwartz FIG. 3b, microneedle array).
Regarding claim 16, Schwartz as modified discloses The device of claim 1, Schwartz as modified further discloses wherein said affinity-based sensor probes have an attached redox couple which generates the signal change (Schwartz Col. 11 lines 49-52).
Regarding claim 18, Schwartz discloses A continuous sensing device for at least one analyte in an invasive biofluid, comprising (Figures 3A, 3B, 3C; column 22, line 65-column 23, line 28; column 4, line 48: "receive measurements continuously"):
at least one affinity-based sensor with a plurality of probes with binding that is specific to the at least one analyte (column 1, line 34-40: "sensor comprising aptamer conjugates... configured to obtain one or more measurements related to at least one analyte in... interstitial fluid");
wherein the at least one affinity-based sensor is in fluidic communication with a plurality of microneedles (FIG. 3, “372” and column 23, line 19-22: "the substrate includes a microneedle array protruding into through the epidermis of the skin to enable the assay component to interact with an analyte in the interstitial fluid of the dermis"), and
in further fluidic communication with a dermis, even if at least one, but not all, microneedle is not in fluidic communication with the dermis (FIG. 3, “372” and column 23, line 19-22: "the substrate includes a microneedle array protruding into through the epidermis of the skin to enable the assay component to interact with an analyte in the interstitial fluid of the dermis" only one microneedle needs to technically contact the dermis to be in contact),
wherein there is at least one diffusion pathway between the at least one affinity-based sensor and the source of the invasive biofluid (FIG. 3, “372” and column 23, line 19-22: "the substrate includes a microneedle array protruding into through the epidermis of the skin to enable the assay component to interact with an analyte in the interstitial fluid of the dermis"); and
Schwartz fails to disclose including at least one sample volume adjacent to the affinity-based sensor, wherein the sample volume is less than one of 10 µL/cm2, 5 µL/cm2, 2 µL/cm2, 1 µL/cm2, 0.5 µL/cm2, or 0.2 µL/cm2.
However, in the same field of endeavor, Heikenfeld teaches including at least one sample volume adjacent to the affinity-based sensor, wherein the sample volume is less than one of 10 µL/cm2, 5 µL/cm2, 2 µL/cm2, 1 µL/cm2, 0.5 µL/cm2, or 0.2 µL/cm2 ([0009], [0088] and Example 2: [0109 – 0110], 2.5 nL in a 10mm2 area is .025 µL/cm2 which is in range).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Schwartz to include a including at least one sample volume adjacent to the affinity-based sensor, wherein the sample volume is less than one of 10 µL/cm2, 5 µL/cm2, 2 µL/cm2, 1 µL/cm2, 0.5 µL/cm2, or 0.2 µL/cm2 as taught by Heikenfeld to reduce the sample size and lag-time ([0110]).
Regarding claim 19, Schwartz as modified discloses The device of claim 18, Schwartz as modified further discloses wherein the plurality of microneedles includes a number of microneedles that is at least one of >3, >10, >20, >50, >100, or >200 microneedles. (Schwartz FIG. 3b, microneedle array).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz in view of Heikenfeld in further view of Liepmann et al. (US 2016/0166185 A1) ("Liepmann").
Regarding claim 11, Schwartz as modified discloses The device of claim 1, Schwartz as modified fails to disclose wherein the at least one analyte has a diffusion coefficient greater than 1.2E-6 cm2/s, and wherein the device has a diffusion lag time that is less than at least one of 250 min, 125 min, 50 min, 25 min, 12.5min, or 5 min.
However, in the same field of endeavor, Liepmann teaches wherein the at least one analyte has a diffusion coefficient greater than 1.2E-6 cm2/s, and wherein the device has a diffusion lag time that is less than at least one of 250 min, 125 min, 50 min, 25 min, 12.5min, or 5 min (Para. [0073] – [0078]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Schwartz as modified to include wherein the at least one analyte has a diffusion coefficient greater than 1.2E-6 cm2/s, and wherein the device has a diffusion lag time that is less than at least one of 250 min, 125 min, 50 min, 25 min, 12.5min, or 5 min as taught by Liepmann in order to have reliable measurements over time (Para. [0109], “The subject blood analyte collection device finds use as a complete and reliable clinical assessment of a total 24 hr blood glucose level for a patient, regardless of their blood glucose variability over time.”).
Regarding claim 12, Schwartz as modified discloses The device of claim 1, Schwartz as modified fails to disclose wherein the at least one analyte has a diffusion coefficient greater than 6E-7 cm2/s, and wherein the device has a diffusion lag time that is less than at least one of 500 min, 250 min, 100 min, 50 min, 25 min, or 10 min.
However, in the same field of endeavor, Liepmann teaches wherein the at least one analyte has a diffusion coefficient greater than 6E-7 cm2/s, and wherein the device has a diffusion lag time that is less than at least one of 500 min, 250 min, 100 min, 50 min, 25 min, or 10 min (Para. [0073] – [0078]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Schwartz as modified to include a including wherein the at least one analyte has a diffusion coefficient greater than 6E-7 cm2/s, and wherein the device has a diffusion lag time that is less than at least one of 500 min, 250 min, 100 min, 50 min, 25 min, or 10 min as taught by Liepmann in order to have reliable measurements over time (Para. [0109], “The subject blood analyte collection device finds use as a complete and reliable clinical assessment of a total 24 hr blood glucose level for a patient, regardless of their blood glucose variability over time.”).
Regarding claim 13, Schwartz as modified discloses The device of claim 1, Schwartz as modified fails to disclose wherein the at least one analyte has a having a molecular weight less than 1000 Da in molecular weight, and wherein the device has a diffusion lag time that is less than at least one of 150 min, 60, 30, 15, 10, 5, 2.5, or 1 min.
However, in the same field of endeavor, Liepmann teaches wherein the at least one analyte has a having a molecular weight less than 1000 Da in molecular weight, and wherein the device has a diffusion lag time that is less than at least one of 150 min, 60, 30, 15, 10, 5, 2.5, or 1 min (Para. [0073] – [0078]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Schwartz as modified to include wherein the at least one analyte has a having a molecular weight less than 1000 Da in molecular weight, and wherein the device has a diffusion lag time that is less than at least one of 150 min, 60, 30, 15, 10, 5, 2.5, or 1 min as taught by Liepmann in order to have reliable measurements over time (Para. [0109], “The subject blood analyte collection device finds use as a complete and reliable clinical assessment of a total 24 hr blood glucose level for a patient, regardless of their blood glucose variability over time.”).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Schwartz in view of Heikenfeld in further view of Bigelow (US 2017/0020422 A1) (“Bigelow”).
Regarding claim 17, Schwartz as modified discloses The device of claim 3 Schwartz as modified fails to disclose wherein the at least one affinity-based sensor is in-dwelling.
However, in the same field of endeavor, Bigelow teaches wherein the at least one affinity-based sensor is in-dwelling (FIG. 1B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Schwartz as modified to include wherein the at least one affinity-based sensor is in-dwelling as taught by Bigelow in order to continuously sense and avoid biofouling (Para. [0013], “Also described herein is a tool that may be used to continuously monitor the concentrations of various drugs or biomarkers (e.g., chemotherapeutic levels) in the blood using catheter or needle bearing at least one aptamer biosensor as described herein. The catheter or needle is specifically designed to permit prolonged monitoring in blood while avoiding biofouling of the sensor through a boundary layer of buffer flowing past the sensor.”).
Response to Arguments
Applicant’s arguments with respect to claims 1-9 and 11-19 have been considered but are moot because the new ground of rejection does not rely solely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH A TOMBERS/ Examiner, Art Unit 3791
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