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 .
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.
Notice of Amendment
In response to the amendment(s) filed on 3/2/26, amended claim(s) 1-3 and 5 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
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.
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, 7, and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over GB 2623786 A to Murray-Scott et al. (hereinafter “Murray-Scott”) in view of U.S. Patent Application Publication No. 2021/0228114 to Rebec et al. (hereinafter “Rebec”).
For claim 1, Murray-Scott discloses a monitor for determining analyte concentrations in vivo (Abstract), comprising:
a housing (103) (Figs. 1a-b) configured to (Examiner’s Note: functional language, i.e., capable of) adhere to a patient's skin (page 12, lines 14-17), wherein the housing has a first surface (first surface of 103) configured to (Examiner’s Note: functional language/intended use, i.e., capable of) face towards the patient’s skin upon adhesion (page 12, lines 14-16);
a sensor member (101) (Figs. 1a-b) configured to (Examiner’s Note: functional language, i.e., capable of) extend from the housing into the patient’s skin (as can be seen in Figs. 1a-b).
Murray-Scott does not expressly disclose a pressure sensor spaced apart from the sensor member, positionable between part of the housing and part of the patient’s skin, and configured to extend axially past the first surface of the housing to directly contact the patient’s skin; wherein when pressure is exerted on the housing towards the patient’s skin, the pressure sensor is configured to measure a magnitude of the pressure exerted on the housing.
However, Rebec teaches a pressure sensor (507) (Fig. 5) (para [0143]) spaced apart from the sensor member (150) (Fig. 5) (para [0143]), positionable (Examiner’s Note: construed as meaning able to be positioned, i.e., capable of) between part of the housing and part of the patient’s skin (“…pressure sensor 507 may be included within or coupled to (e.g., positioned on an external face of) such a housing,” para [0143]) (also see “one or more pressure sensors … which sits atop a location where the continuous analyte sensor is inserted into the skin of the user,” para [0042]) (also see Fig. 5), and configured to extend axially past the first surface of the housing to directly contact the patient’s skin (“…pressure sensor 507 may be included within or coupled to (e.g., positioned on an external face of) such a housing,” para [0143]; “…one or more pressure sensors may be mounted on the adhesive patches on the bottom of a body-worn unit (e.g., a bottom of a housing that houses the transmitter board),” para [0176]) (also see [0082], which states that the pressure sensors may structurally be a potentiometric, inductive, capacitive, piezoelectric, strain gauge, or variable reluctance pressure sensor. Those types of pressure sensors having a non-zero dimensionality, therefore if they are mounted or positioned on an external face of the housing, then a skilled artisan would understand them as extending axially past the surface of the housing. The only scenario where this would not be true is if the pressure sensors had a zero-dimensionality to them); wherein when pressure is exerted on the housing towards the patient’s skin, the pressure sensor is configured to measure a magnitude of the pressure exerted on the housing (para [0143]) (also see para [0132]).
It would have been obvious to a skilled artisan to modify Murray-Scott to include a pressure sensor spaced apart from the sensor member, positionable between part of the housing and part of the patient’s skin, and configured to extend axially past the first surface of the housing to directly contact the patient’s skin; wherein when pressure is exerted on the housing towards the patient’s skin, the pressure sensor is configured to measure a magnitude of the pressure exerted on the housing, in view of the teachings of Rebec, for the obvious advantage of making sure that the monitor is securely fastened to the subject.
For claim 2, Murray-Scott, as modified, further discloses wherein the pressure sensor is formed on the first surface of the housing (para [0042], [0143], and/or [0176] of Rebec).
For claim 3, Murray-Scott, as modified, further discloses wherein the pressure sensor is integrally formed on the first surface of the housing (para [0042], [0143], and/or [0176] of Rebec).
For claim 4, Murray-Scott fruther discloses an adhesive layer configured to be positioned between the housing and the patient’s skin, to facilitate adhesion of the monitor to the patient’s skin (page 12, lines 10-16).
For claim 7, Murray-Scott, as modified, further discloses wherein the pressure sensor comprises a deformable portion (para [0082] of Rebec).
For claim 12, Murray-Scott, as modified, further discloses wherein the pressure sensor further comprises at least one electrical trace configured to engage the deformable portion when the pressure exerted on the housing exceeds a predetermined threshold (page 4, line 31 – page 5, line 14) (also see page 17, lines 28-30).
For claim 13, Murray-Scott, as modified, further discloses wherein when the pressure exerted on the housing is below the predetermined threshold, the deformable portion is spaced apart from the at least one electrical trace (page 4, line 31 – page 5, line 14) (also see page 17, lines 28-30).
For claim 14, Murray-Scott, as modified, further discloses at least one further electrical trace configured to engage the deformable portion when the pressure exerted on the housing is below the predetermined threshold (page 6, lines 11-19) (also see page 17, lines 28-30).
For claim 15, Murray-Scott further discloses wherein the monitor is configured to determine a blood glucose level of the patient (Abstract).
Claim(s) 5-6 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Murray-Scott in view of Rebec, and further in view of U.S. Patent Application Publication No. 2005/0080345 to Finburgh et al. (hereinafter “Finburgh”).
For claim 5, Murray-Scott and Rebec do not expressly disclose wherein an opening is formed in the adhesive layer, and wherein the pressure sensor extends from the housing through the opening.
However, Finburgh teaches wherein an opening is formed in the adhesive layer (see Fig. 2a) (para [0126]), and wherein the pressure sensor extends from the housing through the opening (see Fig. 2a) (para [0126]).
It would have been obvious to a skilled artisan to modify Murray-Scott wherein an opening is formed in the adhesive layer, and wherein the pressure sensor extends from the housing through the opening, in view of the teachings of Finburgh, for the obvious advantage of not having the adhesive layer dampen the measured value of the pressure sensor so that a clean pressure measurement may be obtained.
For claim 6, Murray-Scott, as modified, further discloses wherein the adhesive layer has an outer surface that faces away from the housing and that is configured to engage the patient's skin (para [0042], [0143], and [0176] of Rebec).
Murray-Scott and Rebec does not expressly disclose wherein at least part of the pressure sensor is configured to extend axially past the outer surface of the adhesive layer, such that when the adhesive layer contacts the patient’s skin, the pressure sensor is at least partially actuated or otherwise deformed.
However, Finburgh teaches wherein at least part of the pressure sensor is configured to extend axially past the outer surface of the adhesive layer (see Fig. 2a) (para [0126]), such that when the adhesive layer contacts the patient’s skin, the pressure sensor is at least partially actuated or otherwise deformed (see Fig. 2a) (para [0126]).
It would have been obvious to a skilled artisan to modify Murray-Scott wherein at least part of the pressure sensor is configured to extend axially past the outer surface of the adhesive layer, such that when the adhesive layer contacts the patient’s skin, the pressure sensor is at least partially actuated or otherwise deformed, in view of the teachings of Finburgh, for the obvious advantage of not having the adhesive layer dampen the measured value of the pressure sensor so that a clean pressure measurement may be obtained.
For claim 11, Murray-Scott and Rebec do not expressly disclose wherein the pressure sensor further comprises a projection that extends axially from the deformable portion in a direction away from the housing.
However, Finburgh teaches wherein the pressure sensor further comprises a projection that extends axially from the deformable portion in a direction away from the housing (see Fig. 2a) (para [0126]).
It would have been obvious to a skilled artisan to modify Murray-Scott wherein the pressure sensor further comprises a projection that extends axially from the deformable portion in a direction away from the housing, in view of the teachings of Finburgh, for the obvious advantage of not having the adhesive layer dampen the measured value of the pressure sensor so that a clean pressure measurement may be obtained.
Claim(s) 8-10 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Murray-Scott in view of Rebec, and further in view of U.S. Patent Application Publication No. 2025/0213191 to Wood et al. (hereinafter “Wood”) (Examiner’s Note: the cited portion of Wood finding support in U.S. Provisional Application No. 63/616,456 filed 12/29/23).
For claim 8, Murray-Scott and Rebec do not expressly disclose wherein the deformable portion is elastomeric.
However, Wood teaches wherein a deformable portion is elastomeric (“conductive elastomer,” para [0288]).
It would have been obvious to a skilled artisan to modify Murray-Scott wherein the deformable portion is elastomeric, in view of the teachings of Wood, because a conductive elastomeric a suitable material that can lead to the predictable result of measuring pressure.
For claim 9, Murray-Scott and Rebec do not expressly disclose wherein at least the elastomeric portion comprises an electrically conductive material.
However, Wood teaches wherein at least the elastomeric portion comprises an electrically conductive material (“conductive elastomer,” para [0288]).
It would have been obvious to a skilled artisan to modify Murray-Scott wherein at least the elastomeric portion comprises an electrically conductive material, in view of the teachings of Wood, because a conductive elastomeric a suitable material that can lead to the predictable result of measuring pressure.
For claim 10, Murray-Scott, as modified, further discloses wherein the electrically conductive material is only electrically conductive when the pressure exerted on the housing exceeds a predetermined threshold (para [0082] of Rebec).
For claim 16, Murray-Scott and Rebec do not expressly disclose an alarm configured to activate when the blood glucose level of the patient is determined to be below a predetermined blood glucose level.
However, Wood teaches an alarm configured to activate when the blood glucose level of the patient is determined to be below a predetermined blood glucose level (para [0159]).
It would have been obvious to a skilled artisan to modify Murray-Scott to include an alarm configured to activate when the blood glucose level of the patient is determined to be below a predetermined blood glucose level, in view of the teachings of Wood, for the obvious advantage of alerting a healthcare-provider of a hypo-glycemic event (see para [0159] of Wood).
For claim 17, Murray-Scott and Rebec do not expressly disclose wherein activation of the alarm is configured to be blocked when the pressure exerted on the housing exceeds a predetermined threshold.
However, Wood teaches wherein activation of the alarm is configured to be blocked when the pressure exerted on the housing exceeds a predetermined threshold (para [0350]).
It would have been obvious to a skilled artisan to modify Murray-Scott wherein activation of the alarm is configured to be blocked when the pressure exerted on the housing exceeds a predetermined threshold, in view of teachings of Wood, for the obvious advantage of preventing pressure from creating an artifact in the analyte signal so that a more reliable signal may be obtained.
Response to Arguments
Applicant’s arguments have been considered but are moot because the arguments do not address the new grounds of rejection necessitated by Applicant’s amendments presented in the response filed 3/2/26. The only argument that does not appear to be moot are the arguments with respect to claims 10 and 11, but these arguments are conclusory. The examiner would need the logical reasoning laid out that reaches the alleged conclusions, so that it could be addressed. Otherwise, the examiner would just merely submit a conclusory response without being able to address any rationale underpinning.
Conclusion
THIS ACTION IS MADE FINAL. 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 DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791