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 Species C, Fig. 66, in the reply filed on January 6th 2025 is acknowledged. The traversal is on the ground(s) that there is no search burden and the species have common features. This is not found persuasive because each specie includes mutually exclusive characteristics such as magnets and a metal disk, detents and protruding elements, single mating parts as magnets or adhesives on the housing and sensor, a latch with spring and safety tab, an external layer and a pull tab, a latch for press fit, a flange and a ring, a housing, a latch and protrusion, an adhesive and protruding feature, a flange and protrusion, threaded features, deformable surface, ridges, plural mating parts as magnets or adhesive on the housing and sensor, and a feature and adhesive layer. Each type of coupling is mutually exclusive and distinct. Additionally, the mutually exclusive components of the different species consist of divergent subject matter that would necessitate different fields of search and search strategies, such as searching for magnets or threaded features. Prior art reading on one specie would not necessarily include limitations to the other.
For example, and in response to Applicant’s example, elected Species C includes two magnetic parts 6609 and 6611 which may be secured to the recess 6613 of the injector 6607 and the patch 6601 while Species D includes one recess 6713 and a generic description of magnetic force. The coupling mechanisms employed by Species C and D are mutually exclusive. Further, Applicant’s specification explicitly recites Fig. 66 and 67 to be “another embodiment of the patch and injector” (see [0294] and [0296]).
The requirement is still deemed proper and is therefore made FINAL.
Specification
The disclosure is objected to because of the following informalities:
In paragraph [000270], patch 212 should be corrected to patch 412, and
In paragraph [000277], sensors 436, 450a, and 450b should be corrected to sensors 422, 450a, and 450b.
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “6713” has been used to designate both a recess in injector 6707 and a safety tab or strip in Fig. 67. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 51-52, 63-64, and 69-70 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, 20, and 25 of U.S. Patent No. US 11109800 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the patent includes more limitations than claim 51 of the instant application.
Claim Objections
Claims 51 and 68 are objected to because of the following informalities:
Regarding claim 51, “which reusable patch” should be corrected to “which said reusable patch” for claim language consistency.
Regarding claim 68, “said patch” should be corrected to “said reusable patch” for claim language consistency. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 51-52, 55-57, 61-66, and 69-70 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Flaherty (US 20020040208 A1).
Regarding claim 51, Flaherty discloses a method for measuring a health or physiological parameter from a subject (abstract and [0002]), comprising:
a) providing (i) a reusable patch comprising a first housing having a sensor (reusable assembly 93 comprising a housing 20R and data collection assembly (DCA) sensor assembly 520, [0095]-[0096] and [0098] & Fig. 10; device 10 is described as similar to a “transdermal patch”, [0014]), and
(ii) an injector having a second housing comprising a cannula in fluid communication with a fluid flow path and a reservoir comprising a substance (disposable assembly 94 having a housing 20D comprising exit port tubing lumen 74 (see Fig. 3) terminating in exit port assembly 70, which “exits from the disposable assembly 94 in a direction toward and through the reusable assembly 93”, which is in fluid communication with reservoir 30 comprising a therapeutic and in fluid communication with metering element 48 for dispensing the therapeutic to assembly 70, [0095]-[0096] & Fig. 10), wherein said second housing is coupled to said first housing of said reusable patch, which reusable patch is secured to a body of said subject (housing 20D is attached to housing 20R, which is secured to patient’s skin 210, [0097] & Fig. 4, 6, 10, and 12a; also see [0016], [0047], and [0079]); and
b) using said sensor to (i) measure said health or physiological parameter from said subject (“The DCA [500] sensor assembly 520 includes means of measuring a physiologic parameter. The physiologic parameter can be blood glucose level measured with reflected light or other known technologies, temperature measured with a thermocouple or other known technologies, pressure measured with a transducer or other known technologies, a parameter of blood measured with a needle and vacuum removal assembly, all not shown, or other physiologic parameter that may be valuable in relation to the fluid delivery therapy.”, [0078] & Fig. 10), and (ii) provide one or more outputs corresponding to said health or physiological parameter from said subject (“The information collected by the data collection assembly 500 is transferred to the internal programming of the fluid delivery device 10 and may be additionally transferred to the memory of the remote control device (similar to device 100 of FIG. 1b) via wireless communication described above. The information collected can be made available to the patient or clinician, used to assist in programming of the fluid delivery device 10, used to determine or modify an alarm condition or to activate an alarm transducer, or the information can be used to automatically modify, with or without user confirmation, the future fluid delivery profile.” [0098] & Fig. 10).
Regarding claim 52, Flaherty discloses all the limitations of claim 51. Flaherty further discloses the method wherein said injector comprises said reservoir and said fluid flow path, and wherein said injector is configured to administer a dosage of said substance from said reservoir through said fluid flow path and said cannula to said subject (“The fluid in reservoir 30 may not be under pressure, or may be at a pressure below atmospheric pressure requiring fluid metering element 48 to include a mechanism to pump the fluid from reservoir 30. Such pumping means may be a peristaltic drive as is familiar to those skilled in the art. If the fluid of reservoir 30 is at a pressure above atmospheric, fluid metering means 48 may consist of a fluid metering device without pumping capability as is described above. The fluid metering means 48 is attached to exit port assembly 70. Exit port assembly 70 may… and be connected to a standard transcutaneous infusion set, also not shown.”, [0095] and [0104] & Fig. 10).
Regarding claim 55, Flaherty discloses all the limitations of claim 51. Flaherty further discloses the method wherein said reusable patch comprises a rechargeable battery (“power supply 80… may be rechargeable power sources.”, [0072] & Fig. 10; also see [0069]).
Regarding claims 56-57, Flaherty discloses all the limitations of claim 51. Flaherty further discloses the method wherein said health or physiological parameter comprises a member selected from the group consisting of temperature, blood pressure, and analyte measurement, wherein said analyte is obtained from blood from said subject (“The DCA sensor assembly 520 includes means of measuring a physiologic parameter. The physiologic parameter can be blood glucose level measured with reflected light or other known technologies, temperature measured with a thermocouple or other known technologies, pressure measured with a transducer or other known technologies, a parameter of blood measured with a needle and vacuum removal assembly, all not shown, or other physiologic parameter that may be valuable in relation to the fluid delivery therapy.”, [0078] & Fig. 10).
Regarding claim 61-62, Flaherty discloses all the limitations of claim 51. Flaherty further discloses the method wherein said reusable patch comprises a bandage, and further comprising, depositing said bandage on said body of said subject (fluid delivery device 10 includes a continuous piece of adhesive “that covers the entire device with a boundary significantly larger than the boundary of fluid delivery device 10 to fixedly attach fluid delivery device 10 to the surface of the patient's skin 210”, [0082]; the continuous piece of adhesive is being interpreted as a bandage, as the piece of adhesive covers an area where subcutaneous infusion is to take place, or act as a bandage).
Regarding claim 63, Flaherty discloses all the limitations of claim 51. Flaherty further discloses the method wherein said reusable patch comprises a communication interface (communication element 60, [0096] & Fig. 10; “the data collection assembly may consist of a combination of the communication element 60 of the fluid delivery device 10 and the electronic microcontroller 50.”, [0073]).
Regarding claim 64, Flaherty discloses all the limitations of claim 63. Flaherty further discloses the method wherein said communication interface is configured to transmit data corresponding to said health or physiological parameter to an electronic device in communication with said communication interface (“The data collection assembly 500 may include an integrated sensor, not shown, or a communication element, also not shown. The communication element may be used to communicate with a separate diagnostic device such as a glucometer…. The communication element 60 can communicate with a separate diagnostic device using wireless communication, similar to the communication with the remote control device 100, and the information can be stored in the memory of the electronic microcontroller. The information that is collected by the data collection assembly 500 may be used to feed back to the patient, via the fluid delivery device 10 or remote control device 100, signify an alarm condition, potentially activating a audio or tactile alarm, assist in programming the device with user participation, or automatically modify the programming of the device, potentially alerting the user of the change.”, [0073]-[0074] & Fig. 10; “The information collected by the data collection assembly 500 is transferred to the internal programming of the fluid delivery device 10 and may be additionally transferred to the memory of the remote control device (similar to device 100 of FIG. 1b) via wireless communication described above.”, [0098]).
Regarding claim 65, Flaherty discloses all the limitations of claim 64. Flaherty further discloses the method wherein said electronic device comprises a mobile device (remote control device 100 is a mobile device, [0051] & Fig. 1b and 10).
Regarding claim 66, Flaherty discloses all the limitations of claim 65. Flaherty further discloses the method further comprising, using a computer-implemented mobile application of said mobile device to monitor said health or physiological parameter over a period of time (“The remote control device 100 may include various personal data assistant (PDA) functions such as calendar and date books, address functions, e-mail handling… Alternatively, the remote control device 100 may include the entire electronics and user interface to function as a cellular telephone”, [0055] & Fig. 1b; “The information that is collected by the data collection assembly 500 may be used to feed back to the patient…”, [0074]; ” The information collected by the data collection assembly 500 is transferred… to the memory of the remote control device (similar to device 100 of FIG. 1b) via wireless communication described above. The information collected can be made available to the patient or clinician, used to assist in programming of the fluid delivery device 10, used to determine or modify an alarm condition or to activate an alarm transducer, or the information can be used to automatically modify, with or without user confirmation, the future fluid delivery profile.”, [0098] & Fig. 10).
Regarding claim 69, Flaherty discloses all the limitations of claim 51. Flaherty further discloses the method wherein said one or more outputs comprises an output signal, wherein said output signal comprises one or more members selected from the group consisting of a vibration signal, an audio signal, an electrical signal (“the fluid delivery device may include an alarm transducer 223.”, [0083] & Fig. 6; “The information collected can be made available to the patient or clinician, used to assist in programming of the fluid delivery device 10, used to determine or modify an alarm condition or to activate an alarm transducer, or the information can be used to automatically modify, with or without user confirmation, the future fluid delivery profile.”, [0098] & Fig. 10; see [0109] for disclosure of audio and vibration signal).
Regarding claim 70, Flaherty discloses all the limitations of claim 51. Flaherty further discloses the method further comprising, subsequent to (b), using said injector to administer a dosage of said substance from said reservoir through said fluid flow path and said cannula to said subject (”The information collected can be made available to the patient or clinician, used to assist in programming of the fluid delivery device 10, or the information can be used to automatically modify, with or without user confirmation, the future fluid delivery profile.”, [0098] & Fig. 10; DCA sensor assembly 520 would have to measure the health or physiological parameter and provide an output before the disposable assembly 94 administered a dose from reservoir 30 considering the information collected is used to automatically modify the fluid delivery profile, [0095], and [0104] & Fig. 10).
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) 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty (US 20020040208 A1) as applied to claim 51 above, and further in view of Flaherty ‘439 (US 20020169439 A1).
Regarding claim 53, Flaherty discloses all the limitations of claim 51. Flaherty further discloses the method wherein said injector comprises a second sensor, wherein said second sensor is configured to measure one or more device parameters selected from the group consisting of: an occlusion of said cannula and contact of said cannula into said body of said subject (“Also shown is an occlusion sensor 220 downstream of dispenser 40 and in approximation to exit port tubing lumen 74. Other types of sensors which may be integrated include but are not limited to an occlusion detector, a reservoir volume transducer, a reservoir empty detector, a leak detector, a voltage monitor, a photodetector, a pressure transducer, a fluid contact detector, an impedance monitor or a vibration monitor”, [0071] & Fig. 3).
However, Flaherty fails to explicitly disclose the method wherein said reusable patch comprises a second sensor, wherein said second sensor is configured to measure one or more device parameters selected from the group consisting of:
a dosage of said substance that is administered, a flow rate of dispensing of said substance, a volume of said substance that is administered, an occlusion of said cannula, a duration of contact of said cannula with said body of said subject, and contact of said cannula into said body of said subject.
However, Flaherty ‘439 teaches a method ([0002]) wherein said reusable patch comprises a second sensor (reusable assembly 700 comprises sensor assembly 710, [0068] & Fig. 3), wherein said second sensor is configured to measure one or more device parameters selected from the group consisting of: a flow rate of dispensing of said substance, a volume of said substance that is administered, and an occlusion of said cannula (“The sensor assembly 710 may be an air bubble detector,… a pressure sensor or pressure transducer, or a flow sensor… The sensor assemblies of reusable assembly 700 may include light generators and photosensors to perform measurements, check the clearance of a specific path, or otherwise gather information regarding one or more parameters of the function of the fluid delivery device 10, specifically a parameter related to fluid flow.”, [0068]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the reusable patch of Flaherty with Flaherty ‘439 to include a second sensor since such a modification would provide structure to verify adequate flow in the disposable assembly and check the clearance of the flow path and yield predictable results pertaining to information gathering regarding the function of the fluid delivery device ([0068] of Flaherty ‘459).
Claim(s) 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty (US 20020040208 A1) as applied to claim 51 above, and further in view of Yodfat (US 20140148756 A1).
Regarding claim 54, Flaherty discloses all the limitations of claim 51. Flaherty fails to explicitly disclose the method further comprising providing a charging station configured to couple to said reusable patch.
However, Yodfat teaches a method ([0002]) further comprising providing a charging station configured to couple to said reusable patch (recharging unit 30 configured to couple to and charge reusable part 100, [0126]-[0127] & Fig. 5a).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method of Flaherty with Yodfat to include providing a charging station configured to couple to said reusable patch since such a modification would provide structure to recharge the rechargeable battery 80 of Flaherty (see [0072] of Flaherty) and allow for the continued use of reusable components of a drug delivery system ([0021], [0040], and [0109] of Yodfat).
Claim(s) 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty (US 20020040208 A1) as applied to claim 56 above, and further in view of Perriere (US 20100030111 A1).
Regarding claim 58, Flaherty discloses all the limitations of claim 56. However, Flaherty fails to disclose the method wherein said health or physiological parameter comprises a fat or adipose tissue thickness.
However, Perriere teaches a method ([0001]-[0002] and [0016]) wherein said health or physiological parameter comprises a fat or adipose tissue thickness (“The detector base 6 mainly comprises a detector system 12. Various types of sensors can be used in the detector system 12 depending on the type of intervention: intravenous; intramuscular; or subcutaneous… By way of example, the detector system 12 determines the thickness of the dermis, of the fatty mass….”, [0046]-[0047 & Fig. 1-2).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method of Flaherty with Perriere to include wherein said health or physiological parameter comprises a fat or adipose tissue thickness since such a modification would allow for tissue thickness sensing to determine if the intended site of fluid injection is proper based on the desired application of the medical substance to be injected (see [0001], [0016], and [0046]-[0047] of Perriere).
Claim(s) 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty (US 20020040208 A1) as applied to claim 51 above, and further in view of Ghaffari (US 20100298895 A1).
Regarding claim 59, Flaherty discloses all the limitations of claim 51. Flaherty further discloses the method wherein “[t]he DCA sensor assembly 520 includes means of measuring a physiologic parameter. The physiologic parameter can be blood glucose level measured with reflected light or other known technologies….” ([0078] & Fig. 10).
However, Flaherty fails to explicitly disclose the method wherein said sensor comprises an ultrasound transmitter and an ultrasound receiver, and wherein (b) comprises transmitting an ultrasound signal from said ultrasound transmitter to a location within said body of said subject and
using said ultrasound receiver to receive a signal from said location, and wherein, at least said signal is received by said ultrasound receiver and is used to measure said health or physiological parameter.
However, Ghaffari teaches a method for measuring a health or physiological parameter from a subject (abstract) wherein said sensor comprises an ultrasound transmitter and an ultrasound receiver, and wherein (b) comprises transmitting an ultrasound signal from said ultrasound transmitter to a location within said body of said subject and
using said ultrasound receiver to receive a signal from said location, and wherein, at least said signal is received by said ultrasound receiver and is used to measure said health or physiological parameter (sensing device/sensors 1100 “to detect various parameters of the subject's body including, thermal parameters such as temperature, and infrared; optical parameters; electrochemical and biochemical parameters such as, pH, enzymatic activity, blood components including blood gas and blood glucose, ion concentrations, protein concentrations… Thus, to achieve the detection of the above-mentioned parameters, sensors may include thermistors, thermocouples… ultrasonic including ultrasound emitters and receivers…”, [0119] & Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the sensor of Flaherty with Ghaffari to include an ultrasound transmitter and an ultrasound receiver, and wherein (b) comprises transmitting an ultrasound signal from said ultrasound transmitter to a location within said body of said subject and using said ultrasound receiver to receive a signal from said location, and wherein, at least said signal is received by said ultrasound receiver and is used to measure said health or physiological parameter, since Ghaffari teaches ultrasound emitters and receivers to be art effective sensors for measuring health or physiological parameters such as blood glucose and would yield the same predictable results pertaining to blood glucose measurement (see [0119] of Ghaffari).
Claim(s) 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty (US 20020040208 A1) as applied to claim 51 above, and further in view of Nekouzadeh (US 20190083702 A1).
Regarding claim 60, Flaherty discloses all the limitations of claim 51. Flaherty further discloses the method wherein said reusable patch comprises an opening (reuseable assembly 93 includes an opening in which exit port assembly 70 connects through, [0095] & Fig. 10; “the exit port assembly 70 exits from the disposable assembly 94 in a direction toward and through the reusable assembly 93”). Flaherty also discloses that the “exit port assembly 70… terminates in skin penetrating cannula 72. The skin penetrating cannula 72 can be a rigid member such as a needle, or a flexible cannula. The skin penetrating cannula 72 is inserted through the skin prior to attaching the fluid delivery device to the skin and may be inserted by a needle insertion assistance device, often spring loaded, and known to those skilled in the art. Such a spring loaded mechanism may be integrated into the fluid delivery device 10, not shown.” ([0083]).
However, Flaherty fails to explicitly disclose a method wherein said reusable patch comprises a membrane comprising an opening.
However, Nekouzadeh teaches a drug delivery device 10 with a patch 100 comprising a spring loaded cannula insertion mechanism 12 included in device 10 (see [0022] and [0028] & Fig. 1 of Nekouzadeh). Nekouzadeh further teaches a method (abstract) wherein the delivery device comprises a membrane comprising an opening (opening 31 in the bottom wall 25 comprises a pierceable septum 33 extending across opening 31, [0025] & Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the opening of Flaherty with Nekouzadeh to include a membrane comprising an opening since such a modification would seal the opening prior to use and prevent passage of bacteria into the reusable patch and/or the needle insertion device and would yield predictable results pertaining to sterile needle insertion (see [0025] of Nekouzadeh). As modified, pierceable septum 33 would be included in the opening in reusable assembly 93 of Flaherty.
Claim(s) 67-68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty (US 20020040208 A1) as applied to claim 63 above, and further in view of Yodfat ‘790 (US 20100137790 A1).
Regarding claims 67-68, Flaherty discloses all the limitations of claim 63. However, Flaherty fails to explicitly disclose the method wherein said communication interface is in communication with an additional communication interface of said injector, and wherein said communication interface and said additional communication interface are used to locate said patch or said injector.
However, Yodfat ‘790 teaches a method wherein said communication interface (conductive surface 318 embedded in cradle base 300 of cradle 20, which can be connected and disconnected from the patch unit upon patient’s discretion, [0023] and [0080] & Fig. 12a-12b) is in communication with an additional communication interface of said injector (conductive surfaces 18 and 19 embedded in reusable part 100, [0080] & Fig. 12a-12b),
wherein said communication interface and said additional communication interface are used to locate said patch or said injector (“The three conductive surfaces (18, 19 and 318) together constitute an electronic switch. FIG. 12a illustrates the patch unit (10) and the cradle unit (20) when they are not connected. The switch in this case is in an "OFF" state, thus the CPU assigns the patch unit (10) a "disconnected" status. FIG. 12b illustrates the patch unit (10) connected to the cradle unit (20). In this case electrical contact is established between the conductive surfaces (18, 19) and the conductive surface (318), thus the switch is in an "ON" state, and the CPU assigns the patch unit (10) a "connected" status.”, [0080]; the conductive surfaces are used to determine if the cradle and patch unit are connected or disconnected, or, in other words, to locate the cradle and patch unit with respect to one another).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method of Flaherty with Yodfat ‘790 to include wherein said communication interface is in communication with an additional communication interface of said injector, wherein said communication interface and said additional communication interface are used to locate said patch or said injector, since such a modification would provide means to notify a user of the current position of the device and would “allow the user to safely disconnect and reconnect the patch unit from and to the cradle unit without using the remote control for suspension or resumption of patch operation, “([0024], [0035], [0069] [0072], and [0101] of Yodfat).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783