Prosecution Insights
Last updated: October 04, 2026
Application No. 18/069,858

MEDICAL FLUID INJECTION APPARATUS AND METHOD WITH REUSABLE PATCH

Final Rejection §103
Filed
Dec 21, 2022
Priority
Jul 02, 2020 — provisional 63/047,471 +1 more
Examiner
RADOMSKI, MARTIN ADAM
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Enable Injections Inc.
OA Round
2 (Final)
32%
Grant Probability
At Risk
3-4
OA Rounds
0m
Est. Remaining
88%
With Interview

Examiner Intelligence

Grants only 32% of cases
32%
Career Allowance Rate
10 granted / 31 resolved
-37.7% vs TC avg
Strong +56% interview lift
Without
With
+55.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
51 currently pending
Career history
85
Total Applications
across all art units

Statute-Specific Performance

§103
58.0%
+18.0% vs TC avg
§102
21.9%
-18.1% vs TC avg
§112
18.5%
-21.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 31 resolved cases

Office Action

§103
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Response to Amendment The amendment filed 6/2/2026 has been entered. Claims 51-53, 55-59, and 61-72 are pending in the application. Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 3/5/2026. Claim Rejections - 35 USC § 103 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 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) 51-52, 56-57, 61-66, and 69-71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty (US 20020040208 A1), in view of Nekouzadeh (US 20190083702 A1). Regarding claims 51 and 71, 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” and comprises a flexible cannula 72, 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, [0083], and [0095]-[0096] & Fig. 10), 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”), wherein when said second housing is coupled to said first housing of said reusable patch (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) when said reusable patch is secured to a body of said subject, 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; DCA 500 in use when assembly 93 is attached to skin 210, Fig. 4, 6, 10, and 12a), 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). 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 wherein said reusable patch comprises a membrane comprising an opening, wherein when said second housing is coupled to said first housing of said reusable patch, said opening of said membrane transforms from a closed configuration to an open configuration, wherein said opening is configured for said cannula to advance through, and when said second housing is decoupled from said first housing, said opening of said membrane returns to said closed configuration, and wherein said second housing comprises a protrusion, and wherein said protrusion transforms said opening from said closed configuration to said open configuration when said second housing is coupled to said first housing of said reusable patch. 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), wherein when said second housing is coupled to said first housing of said reusable patch, said opening of said membrane transforms from a closed configuration to an open configuration, wherein said opening is configured for said cannula to advance through (when drug delivery device 10 is attached to patch 100, pierceable septum 33 transforms from a closed configuration, in which insertion mechanism 12 is sealed, to an open configuration, in which trocar 21 and cannula 23 are advanced through, [0022]-[0023], [0025], [0027], [0043] & Fig. 1; trocar 21 is configured to pierce through, or open, septum 33, allowing cannula 23 to advance through, [0027] & Fig. 1), and when said second housing is decoupled from said first housing, said opening of said membrane returns to said closed configuration (when device 10 is decoupled from patch 100, removing insertion mechanism 12, pierceable septum 33 returns to a closed configuration as it is no longer pierced by trocar 21 and cannula 23, [0025] and [0027]), and wherein said second housing comprises a protrusion (delivery device 10 comprising trocar 21, [0025] and [0027] & Fig. 1), and wherein said protrusion transforms said opening from said closed configuration to said open configuration when said second housing is coupled to said first housing of said reusable patch (trocar 21 pierces pierceable membrane 33, transforming membrane 33 from a closed configuration to an open configuration when device 10 is coupled to adhesive 100, [0025] and [0027]-[0028] & 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 and protrusion as above 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 provide means for penetrating the seal and would yield predictable results pertaining to sterile needle insertion and increased patient comfort during subcutaneous entry (see [0025] and [0027]-[0028] of Nekouzadeh). As modified, pierceable septum 33 of Nekouzadeh would be included in the opening of reusable assembly 93 of Flaherty and trocar 21 of Nekouzadeh would be included along with flexible cannula 72 of Flaherty. Septum 33 is provided as the membrane and trocar 21 is provided as the protrusion. Regarding claim 52, Flaherty, as modified, 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 claims 56-57, Flaherty, as modified, 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, as modified, 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, as modified, 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, as modified, 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 an 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, as modified, 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, as modified, 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, as modified, 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, as modified, 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(s) 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty (US 20020040208 A1), in view of Nekouzadeh (US 20190083702 A1), and further in view of Flaherty ‘439 (US 20020169439 A1). Regarding claim 53, Flaherty, as modified, 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, as modified, 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) 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty (US 20020040208 A1), in view of Nekouzadeh (US 20190083702 A1), and further in view of Yodfat (US 20140148756 A1). Regarding claim 55, Flaherty, as modified, 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]). However, Flaherty fails to explicitly disclose wherein the method further comprises 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, as modified, 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, in view of Nekouzadeh (US 20190083702 A1), and further in view of Perriere (US 20100030111 A1). Regarding claim 58, Flaherty, as modified, 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, as modified, 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, in view of Nekouzadeh (US 20190083702 A1), and further in view of Ghaffari (US 20100298895 A1). Regarding claim 59, Flaherty, as modified, 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, as modified, 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) 67-68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty (US 20020040208 A1), in view of Nekouzadeh (US 20190083702 A1), and further in view of Yodfat ‘790 (US 20100137790 A1). Regarding claims 67-68, Flaherty, as modified, 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, as modified, 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). Claim(s) 72 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty (US 20020040208 A1), in view of Nekouzadeh (US 20190083702 A1), and further in view of Watson (US 7129389 B1). Regarding claim 72, Flaherty, as modified, discloses all the limitations of claim 71. However, Flaherty fails to explicitly disclose the method wherein said membrane further comprises an absorbent material, and wherein said absorbent material absorbs bodily fluids from said subject. However, Watson teaches a method (abstract and col 3 lines 6-16) wherein said membrane further comprises an absorbent material, and wherein said absorbent material absorbs bodily fluids from said subject (patch 10 comprising a membrane 12, made of “an elastomeric material, preferably sterile, self-sealing…” and a spacer 14 made of an absorbent material configured to absorb blood and bodily fluids, col 3 lines 17-50 and col 4 lines 14-16 & 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 membrane of Flaherty, as modified, with Watson to include an absorbent material, and wherein said absorbent material absorbs bodily fluids from said subject, since such a modification would provide structure to help prevent a practitioner/user from being exposed to blood-borne pathogens and would yield predictable results pertaining to sterility (col 1 lines 10-30 and col 3 lines 37-49 of Watson). As modified, spacer 14 of Watson would be included with septum 33 of Flaherty as combined with Nekouzadeh. Response to Arguments Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cabiri (US-20130253472-A1), Holt (US-20120010594-A1), Bernstein (US-20110105951-A1), Wall (US-7637891-B2), and Schauderna (US-20170290977-A1). Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT. 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, 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
Read full office action

Prosecution Timeline

Dec 21, 2022
Application Filed
Mar 05, 2026
Non-Final Rejection mailed — §103
Apr 29, 2026
Interview Requested
May 20, 2026
Examiner Interview Summary
Jun 02, 2026
Response Filed
Aug 17, 2026
Final Rejection mailed — §103
Sep 21, 2026
Interview Requested

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Prosecution Projections

3-4
Expected OA Rounds
32%
Grant Probability
88%
With Interview (+55.7%)
3y 7m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 31 resolved cases by this examiner. Grant probability derived from career allowance rate.

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