DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 6, 2025 has been entered.
Response to Amendment
The Examiner acknowledges the Amendments fled May 6, 2025. Claims 1 and 4 have been amended. Claim 7 has been canceled, and new claim 10 has been added. Claims 1-6 and 8-10 remain pending.
Claim Objections
Claim 6 is objected to because of the following informalities: at line 3,
--configured to be-- should be inserted before “perpendicular”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Halac et al. (US 20190120785 A1 – previously cited), hereinafter “Halac”, in view of Zhang (CN 103750819 A – previously cited).
Regarding claim 1, Halac teaches a micro-analyte detection device (Abstract, Figure 13A, wearable assembly 600), comprising: a bottom case (Figure 13B, bottom housing 522), a bottom board of the bottom case is provided with a mounting hole (Figure 13B, aperture 526); a sensor structure (Figure 13C, pre-connected sensor 400), the sensor structure comprises a sensor (Figure 13C, sensor 138) and a sensor base (Figure 4C, substrate 404), and the sensor comprises a signal output end (Figure 4C, proximal end of sensor 138) and a detection end (Figure 4C, distal end of sensor 138), contour shapes of the edge of the sensor base and of the mounting hole match each other (Figure 13B, Paragraph 0249), the edge of the mounting hole and the edge of the sensor base are interlocked (Figure 13B, Paragraph 0249), and the sensor base is installed in the mounting hole (Figure 13B, Paragraph 0249), and a transmitter (Figure 13C, top housing 520, electronics assembly substrate 530), the transmitter comprises a transmitter housing (Figure 13C, top housing 520) and an electronic device disposed in the transmitter housing (Figure 13C, electronics assembly substrate 530, Paragraphs 0250, 0150, 0175), the electronic device is provided with an electrical connection area (Paragraph 0250, “electrical coupling”, Figure 14C, conductive pins 712 and 714), when the transmitter is installed in a working position (Figure 13A-13B), the electrical connection area is electrically connected with the signal output end (Paragraph 0250), wherein the electrical connection area is exposed outside the transmitter housing (Figure 14C), and a position of the electrical connection area corresponds to a position of the signal output end (Figure 14C, proximal end of sensor 138). However, Halac fails to teach wherein a first fastener part is provided at an edge of the mounting hole; a second fastener part is provided at an edge of the sensor base; and the first and second fastener parts are fastened with each other.
Zhang teaches a biosensor device (Abstract, Figure 1) including: a bottom case (Figure 2, fixing seat 1, implant seat 2), wherein a bottom board of the case is provided with a first fastener part (Figure 3, locking teeth 402) at an edge of a mounting hole (Figure 2, holding port 202); and a sensor structure (Figure 3, guide seat 3, sensor mount 901, Paragraph 0015) including a sensor base (Figure 2, guide seat 3), wherein the sensor base includes a second fastener part (Figure 3, locking block 401) at an edge of the sensor base (Figure 3, locking block 401 is shown disposed on outer edge of guide seat 3), wherein the first and second fastener parts are fastened with each other (Paragraph 0066). Zhang also teaches that including such fasteners would help fix the sensor base in position (Paragraph 0066).
It would have been prima facia obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Halac by including a first fastener part provided at an edge of the mounting hole and a second fastener part provided at an edge of the sensor base, wherein the fastener parts are fastened with each other as taught by Zhang in order to help fix the senor base to its position in the mounting hole (Zhang, Paragraph 0066).
Regarding claim 2, Halac as modified by Zhang teaches the sensors shape is a polyline (Halac, Figure 13C, sensor 138).
Regarding claim 3, Halac as modified by Zhang teaches wherein the signal output end (Halac, Figure 4C, proximal end of sensor 138) is a planar structure (Halac, Figure 27, flattened contacts 1000F and 1002F) and is laid on top (Halac, Figure 28) of the sensor base (Halac, Figure 28, substrate 404).
Regarding claim 4, Halac as modified by Zhang teaches wherein a straight line (Halac, Modified Figure 13C, solid line) determined by a longitudinal direction of the signal output end (Halac, Figure 4C, proximal end of sensor 138) and a straight line (Halac, Modified Figure 13C, dashed line) determined by a longitudinal direction of the detection end (Halac, Figure 4C, distal end of sensor 138) intersect (Halac, Modified Figure 13C).
PNG
media_image1.png
222
183
media_image1.png
Greyscale
Modified Figure 13C
Regarding claim 5, Halac as modified by Zhang teaches wherein the straight line (Halac, Modified Figure 13C, solid line) determined by the longitudinal direction of the signal output end (Halac, Figure 4C, proximal end of sensor 138) is perpendicular to the straight line (Halac, Modified Figure 13C, dashed line) determined by the longitudinal direction of the detection end (Halac, Figure 4C, distal end of sensor 138).
Regarding claim 6, Halac as modified by Zhang teaches wherein the straight line (Halac, Modified Figure 13C, dashed line) determined by the longitudinal direction of the detection end (Halac, Figure 4C, distal end of sensor 138) is perpendicular to a skin surface where the detection end punctures (Halac, Paragraph 0249).
Regarding claim 10, wherein a straight line (Halac, Modified Figure 13C, solid line) determined by a longitudinal direction of the signal output end (Halac, Figure 4C, proximal end of sensor 138) and a straight line (Halac, Modified Figure 13C, dashed line) determined by a longitudinal direction of the detection end (Halac, Figure 4C, distal end of sensor 138) are in different planes (Halac, Modified Figure 13C, solid line can be considered to be in a horizontal plane and dashed line can be considered to be in a vertical plane).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Halac in view of Zhang as applied to claim 1 above, and further in view of Deck et al. (CN 108471959 A – previously cited), hereinafter “Deck”.
Regarding claim 8, Halac as modified by Zhang teaches the electrical connection area (Halac, Paragraph 0250, “electrical coupling”, Figure 14C, conductive pins 712 and 714) and the signal output end (Halac, Figure 14C, proximal end of sensor 138) are electrically connected (Halac, Paragraph 0250), but fails to teach that they are electrically connected with a conductive rubber strip disposed between the electrical connection area and the signal output end.
Deck teaches an analyte sensor (Figure 4A, sensor assembly 226) comprising: a sensor (Figure 2C, sensor 110) having a signal output end (Figure 2B, contact portion 128); and a transmitter (Figure 3, electronics unit 188, Paragraph 0043) having an electrical connection area (Figure 3, electrical contacts 220); wherein the signal output end and electrical connection area are electrically connected with a conductive rubber part (Figures 2B-2C and 4B, conductive rubber material 182, Paragraph 0057). Deck also teaches that including such a conductive rubber material can help establish an indirect connection between the two components (Paragraph 0057). The Examiner notes that at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art at the time the invention was made to include wherein the conductive rubber material was in a strip shape. Applicant has not disclosed that the strip shape of the conductive rubber material provides a particular advantage. Furthermore, one of ordinary skill in the art would have expected the devices of the combo and the applicant’s invention to perform equally well with either the conductive rubber material taught by Deck or the claimed conductive rubber material because both would perform the same function of electrically connecting the signal output end and the electrical connection area.
It would have been prima facia obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Halac as modified by Zhang by including a conductive rubber strip disposed between the electrical connection area and the signal output end as taught by Deck in order to help establish an indirect electrical connection between the two components (Deck, Paragraph 0057).
Regarding claim 9, Halac as modified by Zhang teaches the electrical connection area (Halac, Paragraph 0250, “electrical coupling”, Figure 14C, conductive pins 712 and 714) and the signal output end (Halac, Figure 14C, proximal end of sensor 138) are electrically connected (Halac, Paragraph 0250), but fails to teach a sealing member arranged around a position where the signal output end is electrically connected with the electrical connection area.
Deck teaches an analyte sensor (Figure 4A, sensor assembly 226) comprising: a sensor (Figure 2C, sensor 110) having a signal output end (Figure 2B, contact portion 128); and a transmitter (Figure 3, electronics unit 188, Paragraph 0043) having an electrical connection area (Figure 3, electrical contacts 220); wherein the signal output end and electrical connection area are electrically connected with a conductive rubber part (Figures 2B-2C and 4B, conductive rubber material 182, Paragraph 0057) and have a sealing member (Figure 2C, sealing element 176) arranged around the electrical connection between the signal output end and the electrical connection area (Figure 2C). Deck also teaches that including such a sealing element can help protect the electrical connection from external influences such as moisture/sweat (Paragraph 0060).
It would have been prima facia obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Halac as modified by Zhang by including a sealing member arranged around a position where the signal output end is electrically connected with the electrical connection area as taught by Deck in order to help protect the electrical connection from external influences such as moisture/sweat (Deck, Paragraph 0060).
Response to Arguments
Applicant’s arguments, see page 5, filed April 1, 2025, with respect to the rejection of claim 4 under 35 U.S.C. 112 have been fully considered and are persuasive. The rejection of the claim has been withdrawn.
Applicant's arguments, filed April 1, 2025, with respect to the rejection of claims 1-9 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant argues that Halac fails to disclose the feature "wherein the electrical connection area is exposed outside the transmitter housing". The Examiner notes that the conductive pins 712 and 714 of Halac, cited to the electrical connection area, are indeed taught as being exposed outside of the top housing 520, cited to the transmitter housing, as Figure 14C shows the conductive pins protruding from the device. While the pins do not directly protrude from the top housing and instead directly protrude from the bottom housing 522, a portion of the pins are still located outside of the device and thus would be considered to be exposed outside the transmitter housing. Thus, the rejection has been updated to teach the amended limitations moved up from claim 7 and has been maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABEL SEIFU ABEGAZ whose telephone number is (703)756-4502. The examiner can normally be reached 9:00 am - 5:00 pm, M - F.
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 Marmor, can be reached on (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/A.S.A./Examiner, Art Unit 3791
Prosecution Insights