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 .
Claim Objections
Claim 59 is objected to because of the following informalities: Line 1 reading “a on-body injector” should read --an on-body injector--. Appropriate correction is required.
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.
Claims 30-31, 33-36, 38, 40-44, 46-48, 52-55, 57 and 59 are rejected under 35 U.S.C. 103 as being unpatentable over Inan et al. (USPGPub 2019/0328330) in view of Ono et al. (USPGPub 2007/0225637).
Re Claim 30, Inan teaches a system for detecting an injection site reaction of a subject (Inan ¶ 0041 describing a system designed to detect when IV infiltration occurs and fluid leaks into surrounding tissues), comprising: a patch (220) comprising a sensor (206) (Inan Fig. 2B; ¶ 0045 - further describing sensors being applied to patient using adhesive patches or bandages), wherein said patch (220) is configured to be secured to a body of said subject (Inan ¶ 0045), wherein said sensor (206) is configured to measure one or more health or physiological parameters at or near an injection site during or following an injection at said injection site, when said patch (220) is secured to said body of said subject (Inan ¶ 0042-0043, 0045), a processor (112) in communication with said sensor (206), wherein said processor is configured to determine a presence of said injection site reaction of said subject in response to said injection at or near said injection site based at least in part on said one or more health or physiological parameters measured by said sensor (206) during or following said injection (Inan ¶ 0044-0045, 0073), wherein said injection site reaction comprises one or more of pain, irritation, skin distension, skin color change, tissue color change, or bleeding at or near said injection site, or leakage from said injection site (Inan ¶ 0041 - IV infiltration occurs and fluid leaks).
However, Inan fails to teach a control mechanism configured to reduce a flowrate of said injection in response to said injection site reaction of said subject being determined to be present. Ono teaches a leak detecting apparatus comprising a control mechanism (146) configured to reduce a flowrate of an injection in response to an injection site reaction of a subject being determined to be present (Ono ¶ 0088-0092), the configuration for detecting a leak of a liquid injected into a blood vessel of the subject near a site of needle insertion (Ono ¶ 0004). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included with the system for detecting an injection site reaction of a subject a control mechanism configured to reduce a flowrate of said injection in response to said injection site reaction of said subject being determined to be present as disclosed by Ono, the configuration for detecting a leak of a liquid injected into a blood vessel of the subject near a site of needle insertion (Ono ¶ 0004).
Re Claim 31, Inan in view of Ono teach all of the limitations of Claim 30. Inan further teaches wherein said patch (220) is removably coupled to an injector (Inan ¶ 0043, 0045). Even where it were determined that Inan fails to teach said patch is removably coupled to an injector, Ono teaches an injector (100, 212) and a patch (213) (Ono Fig. 7), said patch (213) removably connected to the injector (100, 212) (Ono ¶ 0072), the patch for holding the injector and sensors until the end of injection (Ono ¶ 0072). Therefore, where it were determined that Inan fails to teach said patch is removably coupled to an injector, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the patch of Inan in view of Ono removably coupled to an injector as disclosed by Ono for holding the injector and sensors until the end of injection (Ono ¶ 0072).
Re Claim 33, Inan in view of Ono teach all of the limitations of Claim 31. Inan fails to teach wherein said injector is an autoinjector. Ono teaches wherein said injector (100, 212) is an autoinjector (Ono Fig. 1; ¶ 0096) for automatically performing an injection (Ono ¶ 0003). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the injector of Inan in view of Ono be an autoinjector as disclosed by Ono for automatically performing an injection (Ono ¶ 0003).
Re Claim 34, Inan in view of Ono teach all of the limitations of Claim 31. Inan fails to teach wherein said injector comprises a reservoir comprising a substance, wherein said reservoir is in fluid communication with a cannula for delivering said substance to said body of said subject. Ono teaches wherein said injector (100, 212) comprises a reservoir (210) comprising a substance (Ono ¶ 0065), wherein said reservoir (210) is in fluid communication with a cannula (211) for delivering said substance to said body of said subject (Ono ¶ 0067-0068). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the injector of Inan in view of Ono comprise a reservoir comprising a substance, wherein said reservoir is in fluid communication with a cannula, as disclosed by Ono, for delivering said substance to said body of said subject (Ono ¶ 0067-0068).
Re Claims 35-36, Inan in view of Ono teach all of the limitations of Claim 31. Inan fails to teach wherein said injector is configured to receive data from said patch; and wherein said data is indicative of said presence of said injection site reaction. Ono teaches wherein said injector (100, 212) is configured to receive data from said patch (213); and wherein said data is indicative of said presence of said injection site reaction (Ono ¶ 0076-0077, 0099), the configuration for preventing an injection into a vessel from leaking under the skin by ending the injection (Ono ¶ 0004, 0073-0089). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the injector of Inan in view of Ono configured to receive data from said patch; and wherein said data is indicative of said presence of said injection site reaction, the configuration as disclosed by Ono for preventing an injection into a vessel from leaking under the skin by ending the injection (Ono ¶ 0004, 0073-0089).
Re Claim 38, Inan in view of Ono teach all of the limitations of Claim 30. Inan further teaches wherein said sensor (206) is configured to measure said one or more health or physiological parameters from a skin surface of said body of said subject (Inan ¶ 0045).
Re Claim 40, Inan in view of Ono teach all of the limitations of Claim 30. Inan teaches wherein said patch (220) further comprises one or more transducers configured to generate an output signal, wherein said output signal is indicative of said presence of said injection site reaction and wherein said output signal is a vibration signal, audio signal, electrical signal, or visual signal, or a combination thereof (Inan ¶ 0070-0075).
Re Claims 41-42, Inan in view of Ono teach all of the limitations of Claim 30. Inan teaches wherein said patch (220) comprises a communication interface for transmitting data corresponding to said one or more health or physiological parameters to an electronic device in communication with said communication interface (Inan ¶ 0062); and wherein said communication interface comprises a wireless communication interface (Inan ¶ 0062).
Re Claims 43-44, Inan in view of Ono teach all of the limitations of Claim 41. Inan teaches wherein said electronic device is a mobile device (Inan ¶ 0044); and wherein said mobile device comprises said processor (Inan ¶ 0062).
Re Claims 46-48, Inan in view of Ono teach all of the limitations of Claim 43. Inan teaches wherein said mobile device further comprises a mobile application (Inan ¶ 0044); wherein said mobile application is configured to collect one or more parameters as input from said subject (Inan ¶ 0044-0045); and wherein said one or more parameters correspond to pain or discomfort of said subject associated with said injection site reaction (Inan ¶ 0042 - swelling of soft tissue and increased skin firmness).
Re Claim 52, Inan in view of Ono teach all of the limitations of Claim 30. Inan teaches wherein said patch (220) further comprises an additional sensor (Inan ¶ 0070-0072).
Re Claim 53, Inan in view of Ono teach all of the limitations of Claim 30. Inan teaches wherein said one or more health or physiological parameters comprise one or more of skin temperature, skin color, skin moisture level, skin pressure, skin impedance, or skin chemistry (Inan ¶ 0045-0046, 0049, 0071-0072).
Re Claim 54, Inan in view of Ono teach all of the limitations of Claim 30. Inan teaches wherein said one or more health or physiological parameters further comprise a body temperature (Inan ¶ 0045-0046, 0049, 0071-0072).
Re Claim 55, Inan in view of Ono teach all of the limitations of Claim 30. Inan teaches wherein said injection site reaction further comprises a rise in skin temperature (Inan ¶ 0045-0046, 0049, 0071-0072).
Re Claim 57, Inan in view of Ono teach all of the limitations of Claim 30. Inan fails to teach wherein said control mechanism is configured to stop or pause said injection at said injection site in response to said injection site reaction being determined to be present. Ono teaches Ono teaches the control mechanism (146) configured to stop or pause said injection at said injection site in response to said injection site reaction being determined to be present (Ono ¶ 0088-0092), the configuration for detecting a leak of a liquid injected into a blood vessel of the subject near a site of needle insertion (Ono ¶ 0004). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the control mechanism of Inan in view of Ono to stop or pause said injection at said injection site in response to said injection site reaction being determined to be present as disclosed by Ono, the configuration for detecting a leak of a liquid injected into a blood vessel of the subject near a site of needle insertion (Ono ¶ 0004).
Re Claim 59, Inan in view of Ono teach all of the limitations of Claim 31. Inan further teaches wherein said injector is an on-body injector (Inan ¶ 0043).
Claims 50-51 are rejected under 35 U.S.C. 103 as being unpatentable over Inan et al. (USPGPub 2019/0328330) in view of Ono et al. (USPGPub 2007/0225637) as applied to Claim 46 above, and further in view of Heldman et al. (USPN 11,367,519).
Re Claim 50, Inan in view of Ono teach all of the limitations of Claim 46. Inan in view of Ono fail to explicitly teach wherein said mobile application is configured to display said presence of said injection site reaction. Heldman teaches systems and methods for drug dosing comprising a mobile application for receiving input from a subject (Heldman Col. 28 Lines 36-50), wherein said mobile application is configured to display said presence of said injection site reaction to notify a user/subject of the reaction needing attention (Heldman Col. 62 Lines 29-38). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the mobile application of Inan in view of Ono to display said presence of said injection site reaction as disclosed by Heldman to notify a user/subject of the reaction needing attention (Heldman Col. 62 Lines 29-38, Col. 76 Line 38 to Col. 77 Line 2, Col. 82 Lines 13-15).
Re Claim 51, Inan in view of Ono teach all of the limitations of Claim 46. Inan in view of Ono fail to explicitly teach wherein said mobile application is configured to notify said subject of said presence of said injection site reaction. Heldman teaches systems and methods for drug dosing comprising a mobile application for receiving input from a subject (Heldman Col. 28 Lines 36-50), wherein said mobile application is configured to notify said subject of said presence of said injection site reaction to notify a user/subject of the reaction needing attention (Heldman Col. 62 Lines 29-38). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the mobile application of Inan in view of Ono to notify said subject of said presence of said injection site reaction as disclosed by Heldman to notify a user/subject of the reaction needing attention (Heldman Col. 62 Lines 29-38, Col. 76 Line 38 to Col. 77 Line 2, Col. 82 Lines 13-15).
Claim 60 is rejected under 35 U.S.C. 103 as being unpatentable over Inan et al. (USPGPub 2019/0328330) in view of Ono et al. (USPGPub 2007/0225637) as applied to Claim 30 above, and further in view of Kersch et al. (USPGPub 2018/0369478).
Re Claim 60, Inan in view of Ono teach all of the limitations of Claim 30. Inan in view of Ono fail to teach wherein said processor is further configured to modulate an injection rate of a subsequent injection on said subject based at least in part on said injection site reaction. Kersch teaches a system for detecting an injection site reaction of a subject (Kersch Abstract) comprising a processor (118) (Kersch Fig. 1) and an injector (100), wherein said processor is configured to modulate an injection rate of a subsequent injection on said subject based at least in part on an injection site reaction (Kersch ¶ 0013, 0040) to enable a practitioner to define customized medicament delivery protocols specific to new experimental and/or newly conceived medicament delivery protocols and/or therapies (Kersch ¶ 0006). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the processor of Inan in view of Ono to modulate an injection rate of a subsequent injection on said subject based at least in part on said injection site reaction as disclosed by Kersch to enable a practitioner to define customized medicament delivery protocols specific to new experimental and/or newly conceived medicament delivery protocols and/or therapies (Kersch ¶ 0006, 0013, 0040).
Response to Arguments
Applicant's arguments filed 02/06/2026 have been fully considered but they are not persuasive. Applicant’s arguments begin at the bottom of Page 5 of the response. There, applicant argues the cited prior art fails to teach or disclose “a processor configured to determine a presence of said injection site reaction of said subject in response to said injection at or near said injection site…, wherein said injection site reaction comprises one or more of pain, irritation, skin distension, skin color change, tissue color change, or bleeding at or near said injection site, or leakage from said injection site, and a control mechanism configured to reduce a flowrate of said injection in response to said injection site reaction.” Secondary reference Ono explicitly teaches stopping an injection upon detection of a site reaction (Ono ¶ 0088-0092). Examiner is interpreting the stopping on an injection as a reduction in flowrate to a rate of zero. It is the position of examiner that applicant’s new dependent Claim 60 better captures what applicant has attempted to convey in independent Claim 30. Examiner would direct applicant to secondary reference Kersch which teaches modulating an injection rate of a subsequent injection on said subject based at least in part on said injection site reaction. Examiner is available for interview at applicant’s leisure.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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/WILLIAM R FREHE/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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