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 Amendment
In response to amendment filed July 6, 2026, claims 1 and 12-13 are amended. No claims are cancelled and new claim 18 has been added. Claims 1-18 are pending.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 102
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 1-6, 10 and 13-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Schoonmaker (US 20170112532 A1).
With respect to claim 1, Schoonmaker discloses a medical device (see paragraph 0200-0203: device #20), comprising:
a body part that is attachable to a body of a patient (see paragraph 0201: ex vivo disposable housing that is adhered to skin of a patient), the body part having a receiving opening through which a functional element can be reversibly introduced into the body of a patient by an inserting device (see paragraph 0227-0228: housing has a liner which has an opening through which a needle and a sensor can pass during the insertion process; and see paragraph 0220-0223: needle is both inserted and retracted); and
wherein the body part comprises a seal adapted to receive the functional element by the inserting device (see paragraph 0345, 0350: septum is part of housing wherein a needle is inserted through septum; the septum may be made of seal material) and to seal at least a part of the receiving opening after removal of the inserting device from the seal of the body part (see paragraph 0345: septum closes after needle is removed).
With respect to claim 2, all limitations of claim 1 apply in which Schoonmaker further discloses wherein the seal comprises a self- sealing material that is adapted to seal or partially seal an opening in the self-sealing material caused by an inserting device, when or after the inserting device is removed (see paragraph 0345: septum may be made of seal material that is pre-stressed to close up when needle is removed).
With respect to claim 3, all limitations of claim 2 apply in which Schoonmaker further discloses wherein the self-sealing material comprises a foil or a foam or a preformed material (see paragraph 0363,0367: formed septum and mechanical inserted sealing component where septum is preformed).
With respect to claim 4, all limitations of claim 1 apply in which Schoonmaker further discloses wherein the seal comprises a sealing element configured to be introduced into the receiving opening (see paragraph 0345, 0350: septum is part of housing wherein a needle is inserted through septum; the septum may be made of seal material).
With respect to claim 5, all limitations of claim 4 apply in which Schoonmaker further discloses wherein the sealing element comprises a stopper that adapts to the form of the receiving opening (see paragraph 0345, septum can be formed of rigid elastomer to allow rigid hold of wire).
With respect to claim 6, all limitations of claim 1 apply in which Schoonmaker further discloses wherein the seal comprises a movable element that can be moved, by an inserting device, into an open position when the inserting device is inserted through the receiving opening and/or into a closed position when the inserting device is retracted from the receiving opening (see paragraph 0345, 0350: piercing and elastic closure).
With respect to claim 10, all limitations of claim 1 apply in which Schoonmaker further discloses the functional element (see paragraph 0201: sensor sire), wherein the functional element comprises a subcutaneous sensor (see paragraph 0201: sensor), a subcutaneous drug infusion cannula or a combined subcutaneous drug infusion cannula with a subcutaneous sensor.
With respect to claim 13, Schoonmaker discloses a method of using a medical device (see paragraph 0200-0203: device #20; and see paragraph 0011: method of using device), comprising
providing a body part (see paragraph 0201: ex vivo disposable housing that is adhered to skin of a patient) configured to cooperate with an inserting device having a functional element, retracting the inserting device from a receiving opening of the body part of the medical device (see paragraph 0227-0228: housing has a liner which has an opening through which a needle and a sensor can pass during the insertion process; and see paragraph 0220-0223: needle is both inserted and retracted),
wherein the body part is attached to a body of a patient (see paragraph 0201: ex vivo disposable housing that is adhered to skin of a patient), wherein the method further comprises sealing at least part of the receiving opening with a seal of the body part after retracting the inserting device from the receiving opening and away from the seal of the body part (see paragraph 0227-0228: housing has a liner which has an opening through which a needle and a sensor can pass during the insertion process; and see paragraph 0220-0223: needle is inserted).
With respect to claim 14, all limitations of claim 13 apply in which Schoonmaker further discloses, before retracting the inserting device from the receiving opening, inserting the inserting device through the receiving opening and placing a functional element into the body of the patient (see paragraph 0227-0228: housing has a liner which has an opening through which a needle and a sensor can pass during the insertion process; and see paragraph 0220-0223: needle is both inserted and retracted)
With respect to claim 15, all limitations of claim 13 apply in which Schoonmaker further discloses wherein the medical device is the medical device according to claim 1 (see claim 1 above; and see paragraph 0200-0203: device #20).
With respect to claim 16, Schoonmaker further discloses a kit comprising a medical device according to claim 1 (see claim 1 above), a functional element (see paragraph 0201: sensor wire) and an inserting device for inserting the functional element into a body of a patient (see paragraph 0350: needle that is inserted with sensor).
With respect to claim 17, all limitations of claim 16 apply in which Schoonmaker further discloses wherein the inserting device comprises a needle (see paragraph 0350: needle that is inserted).
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Schoonmaker in view of Schuessler (US 20130131799 A1).
With respect to claim 7, all limitations of claim 1 apply in which Schoonmaker does not specifically disclose wherein the seal comprises an absorbent element that is adapted to absorb a fluid and change, upon absorbing the fluid, its form so as to seal at least part of the receiving opening after removal of an inserting device.
Schuessler teaches an absorbent element that is adapted to absorb a fluid and change, upon absorbing the fluid, its form so as to seal at least part of the receiving opening after removal of an inserting device (see paragraph 0016, 0039: hydrogel particles absorb aqueous fluid including body fluid).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schoonmaker with the teachings of Schuessler to have added an absorbent element to a seal because it would have resulted in the predictable result of having compressive forces created by an elastomeric component in the presence of fluid to self-seal a needle puncture (Schuessler: see [0016]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Schoonmaker in view of Schuessler as applied to claim 7 above, and further in view of Bergin (US 20080015481 A1).
With respect to claim 8, all limitations of claim 7 apply in which Schoonmaker and Schuessler do not teach wherein the absorbent material comprises one or more components that support coagulation of blood.
Bergin teaches an absorbent material that comprises one or more components that support the coagulation of blood (see paragraph 0115, 0117-0121: hemostatic bandage may be formed of coagulating materials).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schoonmaker and Schuessler with the teaching of Bergin to add a component that supports the coagulation of blood because it would have resulted in the predictable result of causing coagulation in the puncture area of a needle to achieve hemostasis earlier (Bergin: see [0122]).
Claims 9-11 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Schoonmaker in view of Chiu (US 20180169322 A1).
With respect to claim 9, all limitations of claim 1 apply in which Schoonmaker does not disclose wherein:
the seal comprises an electrically insulating material so that a flow of electrical current through the receiving opening is prevented when the seal seals at least a part of the receiving opening after removal of an inserting device; and/or the seal is made from or comprises an electrically conductive material and the electrically conductive material is conductively connectable to the skin of a patient when the device is attached to a body of a patient.
Chiu teaches a seal (see paragraph 0073: self-sealing septum) comprising an electrically conductive material and the electrically conductive material is conductively connectable to the skin of a patient when the device is attached to a body of a patient (see paragraph 0073-0075: electrically conductive elastomeric interconnect where electrical connection is between device components and when device touches body of patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schoonmaker with the teachings of Chiu to have an electrically conductive seal because it would have resulted in the predictable result of having an electrically connected seal to connect with the various electronic parts of sensor assembly (Chiu: see [0073]-[0075]).
With respect to claim 11, Schoonmaker discloses a device according to claim 1 (see claim 1 above).
Schoonmaker does not specifically disclose an analyte monitoring system comprising a subcutaneous sensor system and an analyte monitor connected or connectable to the subcutaneous sensor system.
Chiu teaches an analyte monitoring system (see paragraph 0039: combined infusing sensing system) comprising a subcutaneous sensor system (see paragraph 0054: body insertable analyte sensor #316) and an analyte monitor connected or connectable to the subcutaneous sensor system (see paragraph 0007, 0039: sensor electronics communicate measurement data to associated infusion device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schoomaker with the teachings of Chiu because it would have resulted in the predictable result of creating a analyte monitoring system that are portable for a user to wear and track analytes (Chiu: see [0003]-[0006]).
With respect to claim 12, all limitations of claim 11 apply in which Chiu further teaches wherein the analyte monitoring system is a continuous analyte monitor (see paragraph 0006, 0085: continuous glucose sensing) and wherein the subcutaneous sensor system further comprises a subcutaneous sensor adapted to sense glucose in a body fluid of a patient when implanted (see paragraph 0006, 0054, 0057: subcutaneous glucose sensor and electrode signals).
With respect to claim 18, Schoonmaker discloses a medical device (see paragraph 0200-0203: device #20), comprising:
a body part that is attachable to a body of a patient (see paragraph 0201: ex vivo disposable housing that is adhered to skin of a patient), the body part having a receiving opening through which a functional element can be reversibly introduced into the body of a patient by an inserting device (see paragraph 0227-0228: housing has a liner which has an opening through which a needle and a sensor can pass during the insertion process; and see paragraph 0220-0223: needle is both inserted and retracted); and
wherein the body part comprises a seal (see paragraph 0345, 0350: septum is part of housing wherein a needle is inserted through septum; the septum may be made of seal material) adapted to seal at least a part of the receiving opening after removal of the inserting device from the seal of the body part (see paragraph 0345: septum closes after needle is removed).
Schoonmaker does not disclose wherein the seal is made from or comprises an electrically conductive material and the electrically conductive material is conductively connectable to the skin of a patient when the device is attached to a body of a patient.
Chiu teaches a seal (see paragraph 0073: self-sealing septum) comprising an electrically conductive material and the electrically conductive material is conductively connectable to the skin of a patient when the device is attached to a body of a patient (see paragraph 0073-0075: electrically conductive elastomeric interconnect where electrical connection is between device components and when device touches body of patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schoonmaker with the teachings of Chiu to have an electrically conductive seal because it would have resulted in the predictable result of having an electrically connected seal to connect with the various electronic parts of sensor assembly (Chiu: see [0073]-[0075]).
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 NIDHI PATEL whose telephone number is (571)272-2379. The examiner can normally be reached Mondays to Fridays 9AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.N.P./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
