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 .
Election/Restrictions
Applicant's election with traverse of claim 1-35 in the reply filed on 7/8/26 is acknowledged. The traversal is on the ground(s) that there would be no serious search burden on the examiner. This is not found persuasive because it is the examiner who determines the search burden. In this case the two different inventions of Group I and Group II are in separate classifications that would not need to be searched together as they do not overlap.
The requirement is still deemed proper and is therefore made FINAL.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 12,064,244. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent discloses the same device with more specifics.
Current Claims
12,064,244
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1
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1 and 26, a cannula by definition is partly hollow.
35
1 and 26, the insertion component inserts the analyte sensor into the body and the insertion body can be an insertion cannula which pierces the skin
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 1-35 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 recites “the longitudinal axis” but there is no antecedent basis for this.
Claim 12 is 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. It is unclear what the receiver is. It could be an electronic receiver or some physical receptacle that is a receiver.
Claim 15 is 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. It is unclear what the module is. It is unclear if it is the electronics unit or something else.
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.
Claim(s) 1-6, 8, 11-14, 16-18, 21-22, 25-28 and 32-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schrul (US20190151564; cited by Applicant) in view of Baker (US20180360493A1; cited by Applicant).
Regarding claim 1, Schrul discloses a medical system (Paragraph [0002], “The invention relates to an injection device for administering a liquid product, in particular a medicine. In particular, the 0invention relates to a mechanism for the injection device with which a needle protection cap placed on a product container can be released or removed from the product container. Moreover, the invention relates to a method for assembling an injection device and/or for preparing an injection device for the administration of a product”), comprising:
a housing (housing #1);
a protective cap removably connected to the housing (Paragraph [0062], “cap 20 is located on the distal end of the receiving housing 1”);
a cannula configured for inserting the analyte sensor into body tissue of a user (Paragraph [0066], “The needle protection cap 17 encompasses the injection needle 11 such that the sterility thereof is ensured in relation to the environment of the needle protection cap 17”. The needle is a cannula), a sterility cap removably connected to the sterile container and sealing off the sterile environment (needle protection cap #17), the sterility cap being spaced from the housing and being inside and attached to the protective cap when the protective cap is connected to the housing; wherein the sterility cap and the protective cap are distinct (Paragraph [0066], “A needle protection cap 17 is releasably attached, e.g. in form fitting and/or frictional manner, to the needle retaining section 14. The needle protection cap 17 can be a so-called rigid needle shield or a soft needle shield. The needle protection cap 17 encompasses the injection needle 11 such that the sterility thereof is ensured in relation to the environment of the needle protection cap 17”);
wherein removing the protective cap from the housing removes the sterility cap from the sterile container and exposes the insertion component for insertion into the body tissue (Paragraph [0013], “The cap (e.g., end cap), which is coupled to one or more engaging elements, can be connected to the needle protection cap via at least one engaging element, such that the removal of the cap from the injection device results in the removal of the needle protection cap from the product container”);
wherein the housing comprises a guiding surface having a length L that cooperates with the protective cap, and wherein the sterility cap has a length l, and L is greater than l (Figs. 6a shows how the guiding portion of the housing extends into the engaging element 22 for the cap to past the end of the needle cap. Figs. 7a-b shows needle protection sleeve #3 extending beyond the needle #11 such that the needle protection cap #17 must pass the needle before being completely removed from the device) and wherein the wherein the guiding cooperates with the protective cap during the removal of the protective cap from the housing to guide the sterility cap axially until the sterility cap clears the insertion component (Paragraph [0013], “The cap (e.g., end cap), which is coupled to one or more engaging elements, can be connected to the needle protection cap via at least one engaging element, such that the removal of the cap from the injection device results in the removal of the needle protection cap from the product container” & Paragraph [0036], “(Paragraph [0013], “The cap (e.g., end cap), which is coupled to one or more engaging elements, can be connected to the needle protection cap via at least one engaging element, such that the removal of the cap from the injection device results in the removal of the needle protection cap from the product container”).
wherein the removal of the protective cap from the housing includes: (i) an unscrewing of the protective cap from the housing via a threaded engagement, (ii) an additional translational movement of the protective cap and housing relative to one another along the longitudinal axis of the housing when the protective cap and housing are pulled apart, and (iii) rotational movements of the sterility cap and the protective cap about the longitudinal axis of the housing (Paragraph [0012], “The cap can be removed from the injection device or the housing with an axial movement or a combined axial-rotational movement of the housing or receiving housing”).
Schrul does not disclose a module comprising: an electronics unit electrically connected to an analyte sensor for detecting an analyte in a body fluid of a user and the cannula containing at least part of the analyte sensor.
However, Baker discloses a module comprising:
an electronics unit electrically connected to an analyte sensor for detecting an analyte in a body fluid of a user (Paragraph [0135], “During use, sensor 132 is disposed under the host's skin and a contact portion of on-skin assembly 102 is electrically connected to transmitter 134”);
an insertion component configured for inserting the analyte sensor into body tissue of the user (Paragraph [0015], “The method includes providing an insertion assembly configured to insert at least a portion of the sensor assembly into the skin of the host”); and
a sterile container containing at least part of the analyte sensor (Paragraph [0131], “Applicator 100 further comprises a sealing element 110 configured to provide a sterile barrier and/or a vapor barrier between an internal environment of housing 104 and an external environment of housing 104”).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Schrul to incorporate the teachings of Baker by adding a module comprising: an electronics unit electrically connected to an analyte sensor for detecting an analyte in a body fluid of a user; an insertion component configured for inserting the analyte sensor into body tissue of the user; and a sterile container containing at least part of the analyte sensor. The advantage of the electronics and sensor is to measure analyte levels in the body. The insertion component is required in order to place the sensor inside the body. A sterile container containing the sensor is necessary in order to prevent contaminants from interfering with the measurement values.
Regarding claim 2, Schrul discloses wherein the guiding surface is circumferential and slides against a complementary circumferential surface of the protective cap when the protective cap is removed from the housing (Paragraph [0012], “The cap can be removed from the injection device or the housing with an axial movement or a combined axial-rotational movement of the housing or receiving housing” & Paragraph [0027], “In preferred embodiments, the cap and the removal element can be engaged, such that a coupling section of the removal element, which is connected to the engaging element via a malleable section that encompasses the circumference of the needle protection cap is moved by the cap when the cap is removed from the receiving housing. As a result, the coupling section can move in relation to the engaging element, and the malleable section can be deformed such that the malleable section constricts the circumference of the needle protection cap, or presses against the circumference of the needle protection cap. As a result, the friction, for example, between the needle protection cap and the malleable section is increased and/or a form fit is produced between the needle protection cap and the malleable section. As a result, the force required for removing the needle protection cap from the cap that is applied to the needle protection cap is not, or not only, transferred from the engaging element to the needle protection cap, but instead, is also transferred via the malleable section”).
Regarding claim 3, Schrul discloses by the rotational movement of the sterility cap, the connection of the sterility cap is untightened and the sterility cap is removable from the sterile container (Paragraph [0012], “The cap can be removed from the injection device or the housing with an axial movement or a combined axial-rotational movement of the housing or receiving housing” & the cap creates the sterile container so rotating the cap will rotate the sterile container).
Regarding claim 4, Baker teaches an indicator seal connected to the protective cap and the housing, wherein the indicator seal is configured to be broken when the protective cap is removed from the housing (Paragraph [0158], “In addition, tamper-evident twist-off collar 530 is disposed at a mating location between housing 504 and removable cap 512. In some embodiments, a first portion 530 a of tamper-evident twist-off collar 530 may be coupled to removable cap 512 and a second portion 530 b of tamper-evident twist-off collar 530 may be coupled to housing 504…In its integral state, tamper-evident twist-off collar 530 may provide a seal (e.g., a sterile barrier and a moisture or water vapor barrier) between housing 504 and removable cap 512. In its separated state, tamper-evident twist-off collar 530 may provide an indication of tampering to a user”).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Schrul to incorporate the teachings of Baker by adding an indicator seal connected to the protective cap and the housing, wherein the indicator seal is configured to be broken when the protective cap is removed from the housing. The advantage of the indicator seal is to ensure the device has not been tampered with.
Regarding claim 5, Baker teaches an adhesive configured for attaching the electronics unit to a skin surface of a user (Paragraph [0008], “In some embodiments the on-skin assembly comprises an adhesive layer configured to adhere the on-skin assembly to the skin of the host”).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Schrul to incorporate the teachings of Baker by adding an adhesive configured for attaching the electronics unit to a skin surface of a user. The advantage of the adhesive is to secure the device to the user to prevent movement when taking a sample and causing harm to the user.
Regarding claim 6, Baker teaches an insertion actuator configured for advancing the insertion component after removal of the protective cap from the housing and for inserting the analyte sensor into the body tissue (Paragraph [0007], “The applicator includes an actuation member configured to, upon activation, cause the insertion assembly to insert at least the portion of the sensor assembly into the skin of the host”).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Schrul to incorporate the teachings of Baker by adding an insertion actuator configured for advancing the insertion component after removal of the protective cap from the housing and for inserting the analyte sensor into the body tissue. The insertion actuator is needed to place the sensor into the body after the protective cap has been removed.
Regarding claim 8, Baker teaches the insertion actuator comprises a return spring configured to retract the insertion component after insertion of the analyte sensor (Paragraph [0133], “As shown in more detail in FIG. 1B, insertion assembly 118 may comprise a needle 140, for example, a C-needle configured to hold at least a portion of a sensor. In some embodiments, insertion assembly 118 may be configured to drive needle 140 utilizing a spring force. In some embodiments, insertion assembly 118 may additionally or alternatively be configured to retract needle 140 after on-skin assembly 102 has been deployed to the skin of the host”).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Schrul to incorporate the teachings of Baker by adding wherein the insertion actuator comprises a return spring configured to retract the insertion component after insertion of the analyte sensor. The purpose of the return spring is to withdraw the needle after insertion to prevent accidental injury after the device is used.
Regarding claim 11, Schrul discloses the rotational movement of the sterility cap allows removal of the sterility cap from the sterile container (Paragraph [0027], “In preferred embodiments, the cap and the removal element can be engaged, such that a coupling section of the removal element, which is connected to the engaging element via a malleable section that encompasses the circumference of the needle protection cap is moved by the cap when the cap is removed from the receiving housing. As a result, the coupling section can move in relation to the engaging element, and the malleable section can be deformed such that the malleable section constricts the circumference of the needle protection cap, or presses against the circumference of the needle protection cap. As a result, the friction, for example, between the needle protection cap and the malleable section is increased and/or a form fit is produced between the needle protection cap and the malleable section. As a result, the force required for removing the needle protection cap from the cap that is applied to the needle protection cap is not, or not only, transferred from the engaging element to the needle protection cap, but instead, is also transferred via the malleable section”).
Regarding claim 12, Baker teaches a receiver (Paragraph [0107], “The system 3100 includes a transcutaneous analyte sensor 3102 and an electronics unit (referred to interchangeably as “sensor electronics” or “transmitter”) 3104 for wirelessly transmitting analyte information to a receiver. The receiver can be located remotely relative to the system 3100” & Paragraph [0108], “In some embodiments, the receiver is mechanically coupled to the electronics unit 3104 to enable the receiver to receive data (e.g., analyte data) from the electronics unit 3104”).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Schrul to incorporate the teachings of Baker by adding a receiver. The receiver is used to receive analyte data from the electronics unit that represents important medical information.
Regarding claim 13, Schrul discloses wherein the protective cap and the sterility cap are made of different materials (Paragraph [0011], “The outer sleeve-like or cap-like component encompasses the inner cap-shaped component, and is permanently connected to the inner cap, for example, such that the outer and inner caps form a unit. The inner component can be made of a harder plastic than the inner component. The outer component can be made of plastic, e.g. of polyethylene, polystyrene, polypropylene, or another suitable plastic. The inner component can be made of synthetic or natural rubber, or another suitable material”).
Regarding claim 14, Baker teaches wherein the housing has a front face configured for contacting skin of the user, wherein the front face has an opening enclosed by a rim, wherein the rim is configured for tightening the skin before insertion of the analyte sensor (Rim of housing #704 touches the skin and would form a tight connection so the device does not move when inserting the needle, “for tightening the skin before insertion of the analyte sensor” is interpreted as intended use).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Schrul to incorporate the teachings of Baker by adding wherein the housing has a front face configured for contacting skin of the user, wherein the front face has an opening enclosed by a rim, wherein the rim is configured for tightening the skin before insertion of the analyte sensor. The advantage of the rim that tightens the skin before insertion of the analyte sensor is to ensure a smooth skin surface in order to have more accurate data and cause less pain to the user.
Regarding claim 16, Schrul discloses wherein the module comprises at least one guiding surface for guiding the sterility cap during removal of the sterility cap (Paragraph [0027], “In preferred embodiments, the cap and the removal element can be engaged, such that a coupling section of the removal element, which is connected to the engaging element via a malleable section that encompasses the circumference of the needle protection cap is moved by the cap when the cap is removed from the receiving housing. As a result, the coupling section can move in relation to the engaging element, and the malleable section can be deformed such that the malleable section constricts the circumference of the needle protection cap, or presses against the circumference of the needle protection cap. As a result, the friction, for example, between the needle protection cap and the malleable section is increased and/or a form fit is produced between the needle protection cap and the malleable section. As a result, the force required for removing the needle protection cap from the cap that is applied to the needle protection cap is not, or not only, transferred from the engaging element to the needle protection cap, but instead, is also transferred via the malleable section”).
Regarding claim 17, Baker teaches wherein the electronics unit comprises at least one of: a measurement device for providing electrochemical measurement values; an amperometric measurement device; a potentiostatic measurement device; a transmitter for transmitting measurement values to at least one external receiver; an integrated data storage device; and an integrated battery (Paragraph [0142], “Transmitter 134 may include hardware, firmware, and/or software that enable measurement of levels of the analyte via a glucose sensor, such as an analyte on-skin assembly 102. For example, transmitter 134 can include a potentiostat, a power source for providing power to on-skin assembly 102, other components useful for signal processing and data storage, and preferably a telemetry module for one- or two-way data communication between transmitter 134 and one or more receivers, repeaters, and/or display devices”).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Schrul to incorporate the teachings of Baker by adding wherein the electronics unit comprises at least one of: a measurement device for providing electrochemical measurement values; an amperometric measurement device; a potentiostatic measurement device; a transmitter for transmitting measurement values to at least one external receiver; an integrated data storage device; and an integrated battery. The electronic unit is advantageous as it allows for sensor data collection.
Regarding claim 18, Baker discloses the electronics unit comprises at least one electronics unit housing, wherein the analyte sensor protrudes into the electronics unit housing and is electrically connected with at least one electronic component within the electronics unit housing (Paragraphs [0109-0110], “During use, a sensing portion of the sensor 3102 can be under the host's skin and a contact portion of the sensor 3102 can be electrically connected to the electronics unit 3104. The electronics unit 3104 can be engaged with a housing (e.g., a base) or directly coupled to an adhesive patch fastened to the skin of the host. The on-skin sensor assembly 3106 may be attached to the host with use of an applicator adapted to provide convenient and secure application. Such an applicator may also be used for attaching the electronics unit 3104 to a base, inserting the sensor 3102 through the host's skin, and/or connecting the sensor 3102 to the electronics unit 3104. Once the electronics unit 3104 is engaged with the base and the sensor 3102 has been inserted into the skin (and is connected to the electronics unit 3104), the sensor assembly can detach from the applicator”).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Schrul to incorporate the teachings of Baker by adding wherein the electronics unit comprises at least one electronics unit housing, wherein the analyte sensor protrudes into the electronics unit housing and is electrically connected with at least one electronic component within the electronics unit housing. The electronics unit housing is advantageous as it provides protection the electronic components. The sensor needs to protrude inside the electronics housing so that they can be electrically coupled.
Regarding claim 21, Baker teaches the electronics unit, cannula and sterile container are parts of a module, further comprising a receptacle in the housing for receiving the module, wherein the receptacle is located in a front face of the housing and is fully or partially surrounded by a frame formed by the housing (Fig. 1B shows transmitter #134 and sensor #132 inside the housing).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Schrul to incorporate the teachings of Baker by adding a receptacle in the housing for receiving the module, wherein the receptacle is located in a front face of the housing and is fully or partially surrounded by a frame formed by the housing. The advantage of a receptacle that is surrounded by a frame formed by the housing is a more mechanically secure system.
Regarding claim 22, Baker teaches wherein the receptacle is covered by the protective cap and the module is accessible when the protective cap is removed from the housing (Fig. 1B shows transmitter #134 and sensor #132 inside the housing covered by removable cap #112. Fig. 9C (although the electronics unit is not shown) shows that the module would be accessible when removable cap #112 is removed).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Schrul to incorporate the teachings of Baker by adding wherein the receptacle is covered by the protective cap and the module is accessible when the protective cap is removed from the housing. The advantage of the receptacle being covered is to protect the module before insertion of the needle.
Regarding claim 25, Baker teaches the analyte sensor is an electrochemical analyte sensor (Paragraph [0139])
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Schrul to incorporate the teachings of Baker by adding wherein the analyte sensor is an electrochemical analyte sensor. An electrochemical analyte sensor is used to collect analyte data from the user.
Regarding claim 26, Baker teaches the insertion component further comprises at least one holder for the insertion cannula (support member #116), wherein the holder, the insertion cannula and the cap form components of the sterile container for the analyte sensor (Paragraph [0131], “Applicator 100 further comprises a sealing element 110 configured to provide a sterile barrier and/or a vapor barrier between an internal environment of housing 104 and an external environment of housing 104. As shown in FIG. 1A, sealing element 110 comprises a removable cap 112 configured to couple with a portion of housing 104”).
Regarding claim 27, Baker teaches the holder comprises a rigid component connected to a proximal end of the insertion cannula (Paragraph [0132], “The applicator 100 further includes a support member 116 configured to inhibit at least lateral movement of insertion assembly 118. In some embodiments, support member 116 may comprise an elastomeric membrane, film, bulk elastomer, foam, or rigid structure. Furthermore, support member 116 can maintain the insertion assembly 118 in position during deleterious movement such as a drop or vibration”).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Schrul to incorporate the teachings of Baker by adding wherein the holder comprises a rigid component connected to a proximal end of the insertion cannula. The advantage of the holder being rigid is a more stable cannula.
Regarding claim 28, Schrul further discloses wherein the sterility cap is connected to the protective cap via one or more guiding elements for transforming a movement of the protective cap into a desired movement of the sterility cap, wherein the sterility cap is unlockable from the holder (Paragraph [0012], “The cap can be removed from the injection device or the housing with an axial movement or a combined axial-rotational movement of the housing or receiving housing” & Paragraph [0027], “In preferred embodiments, the cap and the removal element can be engaged, such that a coupling section of the removal element, which is connected to the engaging element via a malleable section that encompasses the circumference of the needle protection cap is moved by the cap when the cap is removed from the receiving housing. As a result, the coupling section can move in relation to the engaging element, and the malleable section can be deformed such that the malleable section constricts the circumference of the needle protection cap, or presses against the circumference of the needle protection cap. As a result, the friction, for example, between the needle protection cap and the malleable section is increased and/or a form fit is produced between the needle protection cap and the malleable section. As a result, the force required for removing the needle protection cap from the cap that is applied to the needle protection cap is not, or not only, transferred from the engaging element to the needle protection cap, but instead, is also transferred via the malleable section”).
Regarding claims 32 and 33, Schrul further discloses wherein the guiding surface slides against a complementary surface of the protective cap when the protective cap is removed from the housing, wherein the sliding is separate from and in addition to unscrewing of the protective cap from the housing (Paragraph [0012], “The cap can be removed from the injection device or the housing with an axial movement or a combined axial-rotational movement of the housing or receiving housing” & Paragraph [0027], “In preferred embodiments, the cap and the removal element can be engaged, such that a coupling section of the removal element, which is connected to the engaging element via a malleable section that encompasses the circumference of the needle protection cap is moved by the cap when the cap is removed from the receiving housing. As a result, the coupling section can move in relation to the engaging element, and the malleable section can be deformed such that the malleable section constricts the circumference of the needle protection cap, or presses against the circumference of the needle protection cap. As a result, the friction, for example, between the needle protection cap and the malleable section is increased and/or a form fit is produced between the needle protection cap and the malleable section. As a result, the force required for removing the needle protection cap from the cap that is applied to the needle protection cap is not, or not only, transferred from the engaging element to the needle protection cap, but instead, is also transferred via the malleable section”).
Regarding claim 34 and 35, Schrul discloses the cannula is at least partially hollow and the cannula has a sharp tip (Paragraph [0066], “The needle protection cap 17 encompasses the injection needle 11 such that the sterility thereof is ensured in relation to the environment of the needle protection cap 17”. The needle is a cannula).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Schrul and Baker, and further in view of Stafford (US20140031655).
Regarding claim 7, Baker teaches wherein the insertion actuator drives the insertion cannula through the opening during an insertion operation (Paragraph [0007], “The applicator includes an actuation member configured to, upon activation, cause the insertion assembly to insert at least the portion of the sensor assembly into the skin of the host”)
The combination does not disclose wherein the electronics unit has an opening through which the insertion cannula protrudes.
However, Stafford discloses wherein the electronics unit has an opening through which the insertion cannula protrudes (Paragraph [0007], “the introducer is configured for insertion of the sensor through an aperture in the on-body electronics unit prior to insertion through skin and a drive mechanism included in the inserter housing and operatively coupled to the introducer that drives the introducer and retained sensor through the skin”)
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Schul and Baker to incorporate the teachings of Stafford by adding wherein the electronics unit has an opening through which the insertion cannula protrudes. The insertion component needs to protrude inside the electronics unit so that they can be electrically coupled.
Claims 9 are rejected under 35 U.S.C. 103 as being unpatentable over Schrul and Baker further in view of Donnay (WO2011/119896; cited by Applicant).
Regarding claim 9, Schrul does not disclose wherein the protective cap comprises a desiccant
However, Donnay discloses wherein the protective cap comprises a desiccant (Paragraph [00158], “The distal portion of cap 204 may include a recess for retaining a desiccant therein”).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Schrul and Baker to incorporate the teachings of Donnay by adding wherein the protective cap comprises a desiccant. The advantage of the desiccant is to protect the device from moisture.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Schrul and Baker and further in view of Frey (US2019/0231238; cited by Applicant).
Regarding claim 10, Schrul does not disclose a humidity seal received between the protective cap and the housing.
However, Frey discloses a humidity seal received between the protective cap and the housing (Paragraph [0007], “The sensor typically comprises a substrate, such as a flat substrate, onto which an electrically conductive pattern of electrodes, conductive traces and contact pads may be applied. In use, the conductive traces typically are isolated by using one or more electrically insulating materials. The electrically insulating material typically further also acts as a protection against humidity and other detrimental substances and, as an example, may comprise one or more cover layers such as resists”).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Schul and Baker to incorporate the teachings of Frey by adding a humidity seal received between the protective cap and the housing. The benefit of adding a humidity seal is to protect the sensor from moisture that can result in inaccurate data measurements.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Schrul and Baker further in view of Yee (US20100324392; cited by Applicant).
Regarding claim 19, Schrul does not specifically disclose a switching mechanism configured to switch on the electronics unit.
However, Yee discloses a switching mechanism configured to switch on the electronics unit (Paragraph [00140], FIG. 37 illustrates a power supply switch mechanism including an internal switch with a push rod activation of the on-body integrated sensor and sensor housing 122 in accordance with embodiments of the present disclosure. As shown, in one embodiment, push rod 810 may be provided and positioned in the sensor electronics such that when a force is applied in the direction as shown by arrow 830, the push rod 810 is displaced in the same direction and completes the electrical contact between the two contacts 820, 821. In one aspect, the push rod 810 may be provided within a seal 840 such as an O-ring or similar components”).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Schul and Baker to incorporate the teachings of Yee by adding a switching mechanism configured to switch on the electronics unit. The advantage of a switch is to save battery power by only turning on the electronics unit when the device is ready for data collection.
Regarding claim 20, Schrul does not disclose wherein the electronics unit is switched on after the protective cap is removed from the housing.
However, Yee discloses wherein the electronics unit is switched on after the protective cap is removed from the housing (Paragraph [00140], FIG. 37 illustrates a power supply switch mechanism including an internal switch with a push rod activation of the on-body integrated sensor and sensor housing 122 in accordance with embodiments of the present disclosure. As shown, in one embodiment, push rod 810 may be provided and positioned in the sensor electronics such that when a force is applied in the direction as shown by arrow 830, the push rod 810 is displaced in the same direction and completes the electrical contact between the two contacts 820, 821. In one aspect, the push rod 810 may be provided within a seal 840 such as an O-ring or similar components”, Yee shows that an electronics unit can be switched by force applied in a direction. When the protective cap is removed, it causes force in a direction that when combined would switch on the electronics unit the same way).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Schul and Baker to incorporate the teachings of Yee by adding wherein the electronics unit is switched on after the protective cap is removed from the housing. The advantage of a switch is to save battery power by only turning on the electronics unit when the device is ready for data collection.
Claims 15, 23, 24, 29 and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Schrul and Baker further in view of Kamath (US20140121989; cite by Applicant).
Regarding claim 15, Schrul does not disclose the electronics unit is electrically connected to the analyte sensor before the module is received in the housing.
However, Kamath discloses wherein the electronics unit is electrically connected to the analyte sensor before the module is received in the housing (Paragraph [0580], “In some alternative embodiments, the electronics unit is designed for single-use and can optionally be integrally formed with the sensor and/or mounting unit”, if the electronics unit and sensor are integrally formed, they would be connected before place in the housing of the device).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Schul and Baker to incorporate the teachings of Kamath by adding wherein the electronics unit is electrically connected to the analyte sensor before the module is received in the housing. Having the electronics unit and sensor electrically connected before the module is received in the housing allows for faster manufacturing process.
Regarding claim 23, Schrul does not disclose wherein the housing, the module and the protective cap form a pre-assembled single unit.
However, Kamath discloses wherein the housing, the module and the protective cap form a pre-assembled single unit (Paragraph [0580], “In some alternative embodiments, the electronics unit is designed for single-use and can optionally be integrally formed with the sensor and/or mounting unit”).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Schul and Baker to incorporate the teachings of Kamath by adding wherein the housing, the module and the protective cap form a pre-assembled single unit. Having the electronics unit and sensor electrically connected before the module is received in the housing allows for faster manufacturing process.
Regarding claim 24, Kamath teaches the pre-assembled single unit is packaged (Paragraph [0324,0580] ”in this embodiment the sensor system 10 is preferably packaged”)
Regarding claim 29, Schrul does not disclose the electronics unit, the cannula and the sterile container are parts of a factory preassembled module.
However, Kamath discloses the electronics unit, the cannula and the sterile container are parts of a factory preassembled module (Paragraph [0580], “In some alternative embodiments, the electronics unit is designed for single-use and can optionally be integrally formed with the sensor and/or mounting unit”).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Schul and Baker to incorporate the teachings of Kamath by adding the electronics unit, the cannula and the sterile container are parts of a factory preassembled module in order to have the electronics unit and sensor electrically connected before the module is received in the housing allows for faster manufacturing process.
Regarding claims 30 and 31, Schrul does not disclose the electronic module and the analyte sensor are already connected.
However, Kamath discloses the electronic module and the analyte sensor are already connected. (Paragraph [0580], “In some alternative embodiments, the electronics unit is designed for single-use and can optionally be integrally formed with the sensor and/or mounting unit”, if the electronics unit and sensor are integrally formed, they would be connected before place in the housing of the device).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Schul and Baker to incorporate the teachings of Kamath by adding the electronic module and the analyte sensor are already connected. Having the electronics unit and sensor electrically connected before the module is received in the housing allows for faster manufacturing process.
Conclusion
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/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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