CTNF 18/482,482 CTNF 74688 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-fti AIA 1. The present application is being examined under the pre-AIA first to invent provisions. Election/Restriction 2. Applicant's election with traverse of Group I, claims 1-11, in the reply filed on 26 January 2026 is acknowledged. The traversal, see Reply to Restriction Requirement, pp. 1-4, filed on 26 January 2026, was found persuasive. The requirement has been withdrawn. Claim Objections 07-29-01 AIA 3. Claim 1 is objected to because of the following informalities: In lines 17-18, the limitation of “a controller …” is not properly indented, and should be indented the same as “a patch pump …” in order to identify two primary structural elements of the claimed “insulin delivery system” (i.e. “a patch pump” and “a controller”). Examiner has accordingly interpreted the claims to be directed to “[a]n insulin delivery system, comprising: a patch pump …; and a controller …” Appropriate correction is required. 07-30-03-h AIA Claim Interpretation 07-30-03 AIA 4. The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. 07-30-05 5. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. 6. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an input unit” in claim 1, which corresponds to “mechanical and/or electromechanical, button, switch, and the like” (see para. [0040] of the original disclosure, filed 06 October 2023); and “an output unit” in claim 1, which corresponds to “a visual indicator, an audible alert, a vibratory alert, or a combination thereof” (see para. [0040] of the original disclosure, filed 06 October 2023). Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim Rejections - 35 USC § 112 07-30-02 AIA 7. 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. 07-34-01 8. Claims 1-11 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 1 recites the limitation “a controller” in lines 17-18, and also recites “a controller” in line 19. It is not clear whether the controller recited in line 19 refers to the controller recited in lines 17-18 or both recitations refer to different controllers. For further examination, references to “a controller” will be referred to the same controller. Claims 2-11 are rejected due to their dependencies, either directly or indirectly, to base claim 1. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 9. 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. 07-07-fti 10. The following is a quotation of the appropriate paragraphs of pre-AIA 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 – 07-09-fti 07-09 (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States. 07-15-fti 11. Claim s 1-3 and 5-20 are rejected under pre-AIA 35 U.S.C. 102 (b) as being anticipated by Nielsen et al., U.S. Patent Application Publication No. 2006/0264835 A1 (“Nielsen”) . As to Claim 1 , Nielsen teaches the following: An insulin delivery system (“ modular system ”, not labeled) (see “ In the disclosure of the present invention reference is mostly made to the treatment of diabetes by injection or infusion of insulin, however, this is only an exemplary use of the present invention. ” in para. [0003]; and see “ FIG. 27 shows a modular system … ” in para. [0115], and see fig. 27), comprising: a patch pump (“ medical device ”) 900 configured to be worn on a skin surface of a user (see “ In the shown embodiment the base portion comprises a relatively rigid upper portion 11 attached to a more flexible adhesive sheet member 12 having a lower adhesive surface providing the mounting surface per se, the adhesive surface being supplied with a peelable protective sheet. ” in para. [0071], and see fig. 1; and see “ In FIG. 26 is shown a medical device 900 corresponding to the embodiment of FIGS. 1-11, … ” in para. [0114], and see fig. 26), comprising: a housing (“ base portion ”) 10/930 (see “ The needle unit comprises a base portion 10 with a lower mounting surface adapted for application to the skin of a user, and a housing portion 20 in which a hollow infusion needle (not shown) is arranged. ” in para. [0071]); an adhesive patch (“ flexible adhesive sheet member ”) 12 configured to adhere a bottom surface (“ lower mounting surface ”, not labeled) of the housing 10 to the skin surface of the user (see “ In the shown embodiment the base portion comprises a relatively rigid upper portion 11 attached to a more flexible adhesive sheet member 12 having a lower adhesive surface providing the mounting surface per se, the adhesive surface being supplied with a peelable protective sheet. ” in para. [0071]); a reservoir (“ reservoir unit ”) 5/920 configured to store insulin (see “ The reservoir unit 5 comprises a pre-filled reservoir containing a liquid drug formulation (e.g. insulin) and expelling means in the form of an electronically controlled pump for expelling the drug from the reservoir through the needle in a situation of use. ” in para. [0072]); a cannula (“ hollow infusion needle ”) 530 configured to be positioned beneath the skin surface of the user to establish a fluid path between the reservoir 5 and an infusion site (“ infusion site ”, not labeled) of the user when positioned beneath the skin surface (see “ In the above described embodiments, the transcutaneous device has been in the form of a unitary needle device (e.g. an infusion needle as shown or a needle sensor (not shown)), however, the transcutaneous device may also be in the form of a cannula or a sensor in combination with an insertion needle which is withdrawn after insertion thereof. … This type of cannula needle arrangement is well known from so-called infusion sets, such infusion sets typically being used to provide an infusion site in combination with (durable) infusion pumps. ” in para. [0096]), wherein in a first position the cannula 530 is entirely retained within the housing 10 and in a second position the cannula 530 extends outward from the bottom surface of the housing 10 (see “ In a situation of use the assembly is moved downwardly, either manually or by a releasable insertion aid, e.g. a spring loaded member acting through an opening in the housing (not shown) whereby the cannula with the projecting insertion needle is inserted through the skin of a subject. In this position the lower member engages the coupling member 657 to thereby lock the cannula in its extended position, just as the coupling member 667 is released by the release member 622 thereby allowing the upper member to return to its initial position by means of the first spring. ” in para. [0098], and see figs. 23A and 23B); a processor (“ control unit ”) 910 arranged within the housing 10/930 (see fig. 26), wherein the processor 910 is configured to control delivery of insulin and to control insertion of the cannula 530 (see “ In FIG. 26 is shown a medical device 900 corresponding to the embodiment of FIGS. 1-11, however, the reservoir unit has a modular design comprising a "durable" control unit 910 adapted to be mounted on a reservoir unit 920 comprising a reservoir and an expelling assembly controllable by the control unit through contacts 921. ” in para. [0114]); a power supply (“ back-up battery ”, not labeled) arranged within the housing (see “ The control unit may comprise one or more of the following features: a vibrator, a RF transmitter, a RF receiver, a display, a bolus button 918 (as shown) or other user input means, a back-up battery, a memory. ” in para. [0114]); and a transmitter (“ RF transmitter ”, not labeled) configured to be placed in wireless communication with a controller (“ remote controller ”) 940 (see “ The control unit may comprise one or more of the following features: a vibrator, a RF transmitter, a RF receiver, a display, a bolus button 918 (as shown) or other user input means, a back-up battery, a memory. ” in para. [0114]) to receive instructions from the controller 940 for delivering insulin (see “ A remote controller 940 may be used in combination with some of the control units. The control unit may be in the form of a remotely controllable unit 911 which can only be controlled from a remote controller. … A programmable control unit 914 may also be provided, this allowing e.g. a medical practitioner to program the control unit for an individual patient. ” in para. [0115]); and a controller (“ remote controller ”) 940 in bi-directional, wireless communication with the patch pump 900 (see “ The control unit may comprise one or more of the following features: a vibrator, a RF transmitter, a RF receiver, a display, a bolus button 918 (as shown) or other user input means, a back-up battery, a memory. ” in para. [0114]), the controller 940 comprising: an input unit (“ bolus button ”) 918 (see “ The control unit may comprise one or more of the following features: a vibrator, a RF transmitter, a RF receiver, a display, a bolus button 918 (as shown) or other user input means, a back-up battery, a memory. ” in para. [0114]); an output unit (“ display ”, not labeled) (see “ The control unit may comprise one or more of the following features: a vibrator, a RF transmitter, a RF receiver, a display, a bolus button 918 (as shown) or other user input means, a back-up battery, a memory. ” in para. [0114]); and a user interface (“ other user input means ”, not labeled) (see “ The control unit may comprise one or more of the following features: a vibrator, a RF transmitter, a RF receiver, a display, a bolus button 918 (as shown) or other user input means, a back-up battery, a memory. ” in para. [0114]), wherein the controller 940 is configured to receive information associated with operation of the patch pump 900 from the patch pump 900 and to communicate commands to the patch pump 900 for delivery of insulin (see “ A remote controller 940 may be used in combination with some of the control units. The control unit may be in the form of a remotely controllable unit 911 which can only be controlled from a remote controller. A variant 912 thereof may add a bolus button allowing the user to take a bolus of drug without having to use the remote controller. The control unit may be provided as a varity of preprogrammed control units 913, each providing a fixed flow rate as indicated on the unit. Such a unit is intended for use without a remote controller and may include a display 919 as shown. A programmable control unit 914 may also be provided, this allowing e.g. a medical practitioner to program the control unit for an individual patient. ” in para. [0115], and fig. 27), and wherein the controller 940 is configured to transmit an instruction to the patch pump to insert the cannula 530 such that the cannula 530 moves from the first position to the second position (see “ The control and actuation means comprises a pump actuating member in the form of a coil actuator 581 arranged to actuate a piston of the membrane pump, a PCB or flex-print to which are connected a microprocessor 583 for controlling, among other, the pump actuation, contacts 588, 589 cooperating with the contact actuators on the needle unit, signal generating means 585 for generating an audible and/or tactile signal, a display (not shown) and an energy source 586. ” in para. [0089]; see “ In a situation of use, the platform unit is mounted on the skin of a user (e.g. by adhesive means arranged on the mounting surface) and the pump unit is attached and locked to the platform unit by sliding it into engagement therewith substantially in parallel with the mounting surface. During the latter operation the protruding septum and the ramp member is moved into engagement with the needle, thereby breaking the paper barrier cover 122, during which operation fluid communication is established between the second needle portion and the reservoir, just as the needle is pivoted from its initial to its second position, the first pointed needle end thereby penetrating the rubber membrane and the skin of the user. ” in para. [0106]; and see “ After the pump unit has been connected and the needle introduced subcutaneously, the pump can be started. This may happen either automatically as the two units are connected or by separate user-actuatable starting means, e.g. a start button (not shown). ” in para. [0106]). As to Claim 2 , Nielsen teaches the following: an insertion mechanism (“ transcutaneous assembly ”) 650 comprising a needle (“ pointed insertion needle ”) 661 configured to pierce the skin to insert the cannula (“ cannula ”) 651 beneath the skin surface (see “ Thus, FIGS. 23A and 23B show in a schematic representation how a cannula and insertion needle combination can be arranged within a housing 601 of in a given medical device 600 (partly shown), e.g. an infusion device or an infusion set. More specifically, the medical device comprises a transcutaneous assembly 650 comprising a combination of a relatively soft cannula 651 (which e.g. may be of the soft "Teflon.RTM." type) carried by a lower member 653 and a pointed insertion needle 661 (e.g. made from medical grade stainless steel) slidably arranged within the cannula and carried by an upper member 663, both members being mounted to allow axial displacement of the cannula respectively the insertion needle. The cannula comprises a proximal inlet (not shown) allowing it to be or to be arranged in fluid communication with a fluid source. ” in para. [0097], and see figs. 23A and 23B). As to Claim 3 , Nielsen teaches the following: wherein the insertion mechanism 650 is spring-driven (“ first spring ”) 668 (see “ Between the housing of the device and the upper member a first spring 668 is arranged biasing the upper member upwards. Correspondingly, the device also comprises a second spring 658 biasing the lower member upwardly. ” in para. [0097]). As to Claim 5 , Nielsen teaches the following: wherein the controller is configured to transmit an instruction to the patch pump to retract the cannula (see “ When the user intends to remove the delivery device from the skin surface, the user grips the gripping portion of the tab and pulls it in a first direction substantially in parallel with the skin surface, by which action the flexible strip 677 releases the coupling member 657 from the lower member whereby the lower member and thereby the cannula is retracted by means of the second spring. ” in para. [0099]). As to Claim 6 , Nielsen teaches the following: wherein the controller 940 is configured to transmit an instruction to the patch pump 900 to deliver insulin according to a programmed basal profile (see para. [0115]). As to Claim 7 , Nielsen teaches the following: wherein the controller 940 is configured to transmit an instruction to the patch pump 900 to deliver a bolus dosage of insulin (see [0115]). As to Claim 8 , Nielsen teaches the following: a glucose sensor (“ needle sensor ”, not labeled) configured to be positioned subcutaneously in the body of the user to detect glucose, wherein the transmitter of the patch pump 900 is configured to receive signals indicative of glucose levels from the glucose sensor (see “ Further, as the needle of the present invention also may be in the form of a needle sensor, the interior of the medical device may comprise sensor means adapted to cooperate with the needle sensor. ” in para. [0109]). As to Claim 9 , Nielsen teaches the following: wherein the controller 940 is configured to receive the glucose levels from the transmitter of the patch pump 900 (see para. [0010]-[0011]). As to Claim 10 , Nielsen teaches the following: wherein the patch pump 900 further comprises a port (“ outlet means ”, not labeled) in fluid communication with the reservoir (“ reservoir (or pump) unit ”) 150, wherein the port comprises a self-sealing septum (“ reservoir (or pump) unit ”) 155 (see “ The reservoir (or pump) unit 150 comprises a housing in which a reservoir and expelling means are arranged. The reservoir is adapted to contain a liquid drug (e.g. prefilled or adapted to be filled by a user) and comprises an outlet means in the form of a protruding needle penetratable septum 155 adapted to be arranged in fluid communication with the second needle portion. ” in para. [0104]). As to Claim 11 , Nielsen teaches the following: wherein the patch pump 900 further comprises an output unit configured to provide an audible alert (see “ The reservoir unit is preferably provided with signal means and detection means providing the user with an audible alarm signal in case of e.g. occlusion, pump failure or end of content. ” in para. [0073]). As to Claim 12 , Nielsen teaches the following: An on-body patch pump (“ medical device ”) 900 configured to be worn on a body of a user to deliver insulin (see “ In the shown embodiment the base portion comprises a relatively rigid upper portion 11 attached to a more flexible adhesive sheet member 12 having a lower adhesive surface providing the mounting surface per se, the adhesive surface being supplied with a peelable protective sheet. ” in para. [0071], and see fig. 1; and see “ In FIG. 26 is shown a medical device 900 corresponding to the embodiment of FIGS. 1-11, … ” in para. [0114], and see fig. 26), wherein the on-body patch pump 900 comprises: a housing (“ base portion ”) 10/930 (see “ The needle unit comprises a base portion 10 with a lower mounting surface adapted for application to the skin of a user, and a housing portion 20 in which a hollow infusion needle (not shown) is arranged. ” in para. [0071]); an adhesive patch (“ flexible adhesive sheet member ”) 12 configured to adhere a bottom surface (“ lower mounting surface ”, not labeled) of the housing 10 to the body of the user (see “ In the shown embodiment the base portion comprises a relatively rigid upper portion 11 attached to a more flexible adhesive sheet member 12 having a lower adhesive surface providing the mounting surface per se, the adhesive surface being supplied with a peelable protective sheet. ” in para. [0071]); a reservoir (“ reservoir unit ”) 5/920 configured to store insulin (see “ The reservoir unit 5 comprises a pre-filled reservoir containing a liquid drug formulation (e.g. insulin) and expelling means in the form of an electronically controlled pump for expelling the drug from the reservoir through the needle in a situation of use. ” in para. [0072]); a cannula (“ hollow infusion needle ”) 530 configured to be positioned beneath a skin surface of the user to establish a fluid path between the reservoir 5 and an infusion site (“ infusion site ”, not labeled) of the user when the cannula is positioned beneath the skin surface (see “ In the above described embodiments, the transcutaneous device has been in the form of a unitary needle device (e.g. an infusion needle as shown or a needle sensor (not shown)), however, the transcutaneous device may also be in the form of a cannula or a sensor in combination with an insertion needle which is withdrawn after insertion thereof. … This type of cannula needle arrangement is well known from so-called infusion sets, such infusion sets typically being used to provide an infusion site in combination with (durable) infusion pumps. ” in para. [0096]), wherein in a first position the cannula 530 is entirely retained within the housing 10 and in a second position the cannula 530 extends outward from the housing 10 (see “ In a situation of use the assembly is moved downwardly, either manually or by a releasable insertion aid, e.g. a spring loaded member acting through an opening in the housing (not shown) whereby the cannula with the projecting insertion needle is inserted through the skin of a subject. In this position the lower member engages the coupling member 657 to thereby lock the cannula in its extended position, just as the coupling member 667 is released by the release member 622 thereby allowing the upper member to return to its initial position by means of the first spring. ” in para. [0098], and see figs. 23A and 23B); a processor (“ control unit ”) 910 arranged within the housing 10/930 (see fig. 26), wherein the processor 910 is configured to control delivery of insulin and to automatically insert the cannula 530 (see “ In FIG. 26 is shown a medical device 900 corresponding to the embodiment of FIGS. 1-11, however, the reservoir unit has a modular design comprising a "durable" control unit 910 adapted to be mounted on a reservoir unit 920 comprising a reservoir and an expelling assembly controllable by the control unit through contacts 921. ” in para. [0114]); a power supply (“ back-up battery ”, not labeled) arranged within the housing (see “ The control unit may comprise one or more of the following features: a vibrator, a RF transmitter, a RF receiver, a display, a bolus button 918 (as shown) or other user input means, a back-up battery, a memory. ” in para. [0114]); and a transmitter (“ RF transmitter ”, not labeled) configured to wirelessly communicate with a controller (“ remote controller ”) 940 (see “ The control unit may comprise one or more of the following features: a vibrator, a RF transmitter, a RF receiver, a display, a bolus button 918 (as shown) or other user input means, a back-up battery, a memory. ” in para. [0114]) to receive instructions for delivering insulin (see “ A remote controller 940 may be used in combination with some of the control units. The control unit may be in the form of a remotely controllable unit 911 which can only be controlled from a remote controller. … A programmable control unit 914 may also be provided, this allowing e.g. a medical practitioner to program the control unit for an individual patient. ” in para. [0115]) and to receive an instruction to insert the cannula 530 such that the cannula 530 moves from the first position to the second position (see “ The control and actuation means comprises a pump actuating member in the form of a coil actuator 581 arranged to actuate a piston of the membrane pump, a PCB or flex-print to which are connected a microprocessor 583 for controlling, among other, the pump actuation, contacts 588, 589 cooperating with the contact actuators on the needle unit, signal generating means 585 for generating an audible and/or tactile signal, a display (not shown) and an energy source 586. ” in para. [0089]; see “ In a situation of use, the platform unit is mounted on the skin of a user (e.g. by adhesive means arranged on the mounting surface) and the pump unit is attached and locked to the platform unit by sliding it into engagement therewith substantially in parallel with the mounting surface. During the latter operation the protruding septum and the ramp member is moved into engagement with the needle, thereby breaking the paper barrier cover 122, during which operation fluid communication is established between the second needle portion and the reservoir, just as the needle is pivoted from its initial to its second position, the first pointed needle end thereby penetrating the rubber membrane and the skin of the user. ” in para. [0106]; and see “ After the pump unit has been connected and the needle introduced subcutaneously, the pump can be started. This may happen either automatically as the two units are connected or by separate user-actuatable starting means, e.g. a start button (not shown). ” in para. [0106]). As to Claim 13 , Nielsen teaches the following: an insertion mechanism (“ transcutaneous assembly ”) 650 comprising a needle (“ pointed insertion needle ”) 661 configured to pierce the skin to insert the cannula (“ cannula ”) 651 beneath the skin surface (see “ Thus, FIGS. 23A and 23B show in a schematic representation how a cannula and insertion needle combination can be arranged within a housing 601 of in a given medical device 600 (partly shown), e.g. an infusion device or an infusion set. More specifically, the medical device comprises a transcutaneous assembly 650 comprising a combination of a relatively soft cannula 651 (which e.g. may be of the soft "Teflon.RTM." type) carried by a lower member 653 and a pointed insertion needle 661 (e.g. made from medical grade stainless steel) slidably arranged within the cannula and carried by an upper member 663, both members being mounted to allow axial displacement of the cannula respectively the insertion needle. The cannula comprises a proximal inlet (not shown) allowing it to be or to be arranged in fluid communication with a fluid source. ” in para. [0097], and see figs. 23A and 23B). As to Claim 14 , Nielsen teaches the following: wherein the insertion mechanism 650 is spring-driven (“ first spring ”) 668 (see “ Between the housing of the device and the upper member a first spring 668 is arranged biasing the upper member upwards. Correspondingly, the device also comprises a second spring 658 biasing the lower member upwardly. ” in para. [0097]). As to Claim 15 , Nielsen teaches the following: wherein the processor 910 is further configured to control retraction of the cannula 530 based on a signal received from the controller 940 (see “ When the user intends to remove the delivery device from the skin surface, the user grips the gripping portion of the tab and pulls it in a first direction substantially in parallel with the skin surface, by which action the flexible strip 677 releases the coupling member 657 from the lower member whereby the lower member and thereby the cannula is retracted by means of the second spring. ” in para. [0099]). As to Claim 16 , Nielsen teaches the following: wherein the transmitter is configured to receive signals indicative of glucose levels from a glucose sensor (“ needle sensor ”, not labeled) positioned subcutaneously in the body of the user (see “ Further, as the needle of the present invention also may be in the form of a needle sensor, the interior of the medical device may comprise sensor means adapted to cooperate with the needle sensor. ” in para. [0109]). As to Claim 17 , Nielsen teaches the following: wherein the housing 10 further comprises a port (“ outlet means ”, not labeled) in fluid communication with the reservoir (“ reservoir (or pump) unit ”) 150, wherein the port comprises a self-sealing septum (“ reservoir (or pump) unit ”) 155 (see “ The reservoir (or pump) unit 150 comprises a housing in which a reservoir and expelling means are arranged. The reservoir is adapted to contain a liquid drug (e.g. prefilled or adapted to be filled by a user) and comprises an outlet means in the form of a protruding needle penetratable septum 155 adapted to be arranged in fluid communication with the second needle portion. ” in para. [0104]). As to Claim 18 , Nielsen teaches the following: an output unit (“ output means ”, not labeled) configure to provide an audible alert (see “ The reservoir units may further be provided with different input means (e.g. for wireless or non-wireless connection, or manual input), or different output means (e.g. for wireless or non-wireless connection, different display means, or different alarm means). ” in para. [0039]). As to Claim 19 , Nielsen teaches the following: a leakage sensor (“ signal means and detection means ”, not labeled) for detecting leakage of insulin within the housing 10 (see “ The reservoir unit is preferably provided with signal means and detection means providing the user with an audible alarm signal in case of e.g. occlusion, pump failure or end of content. ” in para. [0073]). As to Claim 20 , Nielsen teaches the following: wherein the cannula 530 is configured for delivery of insulin for a period of three to four days (see “ For example, the reservoir unit may be provided with an amount of drug and a delivery pump comprising an energy source allowing the drug to be delivered over e.g. 10 days, … ” in para. [0022]) . Claim Rejections - 35 USC § 103 07-20-fti 12. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made. 07-23-fti The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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. 07-22-fti 13. Claim 4 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nielsen , as applied to claim 1 above, and further in view of Flaherty et al., U.S. Patent No. 6,768,425 B2 (“Flaherty”) . As to Claim 4 , Nielsen teaches the subject matter of claim 1 above. Nielsen does not teach the following: wherein the controller comprises a mobile phone. However, Flaherty teaches the following: a controller (“ remote control device ”) 100 comprises a mobile phone (“ cellular telephone ”, not labeled) (see “ It should be understood that the remote control device 100 may include software and electronic hardware for performing other functions, such that the remote control device 100 is a "multi-function" device. Other functions can include that of a personal digital assistant, such as the Palm Pilot.RTM.. Alternatively, the other functions of the remote control device 100 can include one or more of an electronic game, a barcode reader, a television or VCR remote, or a cellular telephone, for example. ” in col. 6, ll. 31-39). Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Nielsen’s controller (“ remote controller ”) 940 to comprise a mobile phone (“ cellular telephone ”, not labeled), as taught by Flaherty, because of the following technical improvement: Accordingly, there continues to be a need for remote control devices which can be used with medical treatment apparatus, such as disposable infusion pumps, as well as other functions. The additional functions may be related to the therapy or medical treatment apparatus itself, such as a blood glucose measuring function for the diabetic patient controlling an ambulatory insulin pump. The additional functions may be unrelated, such as PDA, cellular telephone, or game functions. Desired remote control devices, therefore, will obviate the need for a user to carry multiple handheld devices. Conclusion 14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm. 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, Jason M Sims can be reached at 571-272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 03/25/2026 Application/Control Number: 18/482,482 Page 2 Art Unit: 3791 Application/Control Number: 18/482,482 Page 3 Art Unit: 3791 Application/Control Number: 18/482,482 Page 4 Art Unit: 3791 Application/Control Number: 18/482,482 Page 5 Art Unit: 3791 Application/Control Number: 18/482,482 Page 6 Art Unit: 3791 Application/Control Number: 18/482,482 Page 7 Art Unit: 3791 Application/Control Number: 18/482,482 Page 8 Art Unit: 3791 Application/Control Number: 18/482,482 Page 9 Art Unit: 3791 Application/Control Number: 18/482,482 Page 10 Art Unit: 3791 Application/Control Number: 18/482,482 Page 11 Art Unit: 3791 Application/Control Number: 18/482,482 Page 12 Art Unit: 3791 Application/Control Number: 18/482,482 Page 13 Art Unit: 3791 Application/Control Number: 18/482,482 Page 14 Art Unit: 3791 Application/Control Number: 18/482,482 Page 15 Art Unit: 3791 Application/Control Number: 18/482,482 Page 16 Art Unit: 3791 Application/Control Number: 18/482,482 Page 17 Art Unit: 3791 Application/Control Number: 18/482,482 Page 18 Art Unit: 3791 Application/Control Number: 18/482,482 Page 19 Art Unit: 3791 Application/Control Number: 18/482,482 Page 20 Art Unit: 3791 Application/Control Number: 18/482,482 Page 21 Art Unit: 3791 Application/Control Number: 18/482,482 Page 22 Art Unit: 3791 Application/Control Number: 18/482,482 Page 23 Art Unit: 3791 Application/Control Number: 18/482,482 Page 24 Art Unit: 3791 Application/Control Number: 18/482,482 Page 25 Art Unit: 3791