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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/04/2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 08/04/2025. As directed by the amendment: claim 30, and 57 have been amended, claims 45, 49, and 56 have been canceled, and claim 58 has been added. Thus, claims 30 – 36, 38, 40 – 44, 46 – 48, 50 – 55, 57, and 58 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 6 – 11, filed 07/07/2025, with respect to the rejection(s) of claim(s) 30 – 36, 38, 40 – 48, and 50 – 57 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Inan (U.S. 2019/0328330) in view of Ono (U.S. 2007/0225637) (see below).
Further, 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.
Claim Interpretation
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.
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.
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: “a control mechanism” in claim 30, “a communication interface” in claim 41, “said control mechanism” in claim 57, and “said control mechanism” in claim 58.
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 § 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) 30 – 36, 38, 40 – 44, 52 – 55, 57, and 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inan (U.S. 2019/0328330) in view of Ono (U.S. 2007/0225637).
Regarding claim 30 – 36, 57, and 58, Inan teaches a system for detecting an injection site reaction of a subject (a system designed to detect when IV infiltration occurs and fluid leaks into surrounding tissues, as discussed in paragraph [0041]), comprising:
a patch comprising a sensor (sensors such as strain gauges 206 can be applied to the patient using adhesive patches, as discussed in paragraph [0045] and shown in Figure 2A),
wherein said patch is configured to be secured to a body of said subject (sensors can be applied to the patient using adhesive patches, as discussed in paragraph [0045]),
wherein said sensor 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 is secured to said body of said subject (see discussion of continuously examining the local physiological symptoms such as skin temperature, swelling of tissue, increased skin firmness, and bioimpedance in paragraph [0042]);
a processor in communication with said sensor, 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 during or following said injection (see discussion of a processor for processing the signals from wearable sensors to detect the presence of extravascular fluid and provide an indication to a medical professional in paragraph [0073]),
wherein said injection site reaction comprises one or more of pain, irritation, skin distension, skin color change, tissue color change, bleeding, or leakage at or near said injection site (IV infiltration occurs and fluid leaks, as discussed in paragraph [0041]);
Inan further teaches that said patch is coupled to an IV catheter (sensors are attached to an IV catheter, as discussed in paragraph [0045]) and the system can take advantage of wireless communication to send information to a computer with a warning system off-body or an alarm system on the on-body mechanical structure (paragraph [0076]).
However, Inan does not specify a control mechanism configured to adjust said injection in response to said injection site reaction of said subject being determined to be present (claim 30); said patch is coupled to an injector (claim 31); said injector is removeably coupled to said patch (claim 32); said injector is an autoinjector (claim 33); 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 (claim 34); and wherein said injector is configured to receive data from said patch (claim 35); wherein said data is indicative of said presence of said injection site reaction (claim 36); 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 (claim 57); said control mechanism is configured to reduce a flowrate of said injection at said injection site in response to said injection site reaction being determined to be present (claim 58).
Ono teaches a leak detecting apparatus similar to Inan and the current application, further including
a control mechanism configured to adjust said injection in response to said injection site reaction of said subject being determined to be present (injection stopping means 146 controlled by microprocessor 130 to stop driving motor 117 to stop the injection of the liquid when a leak alarm is output, as discussed in paragraph [0092]);
said patch is coupled to an injector (sensor 401 and patch 213 is coupled to injector 100 since injection needle 212 of injector 100 is held by patch 213 and sensor 401 is attached on the surface of patch 213, as discussed in paragraphs [0072] and [0096], and shown in Figure 7);
said injector is removably coupled to said patch (since patch 213 is an adhesive patch, as discussed in paragraphs [0072] and [0096], it can be removed when needed from the injection needle 212 of injector 100);
said injector is an autoinjector (injector 100 as shown in Figure 1 and discussed in paragraph [0096]);
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 (contrast medium in cylinder member 210 of liquid syringe 200 is in fluid communication with needle 212 as shown in Figures 5 and 7 and discussed in paragraph [0065]);
and wherein said injector is configured to receive data from said patch (injector 100 receives data from leak detecting unit 401 via injection control unit 101, as discussed in paragraph [0099]);
wherein said data is indicative of said presence of said injection site reaction (signal representing “occurrence of leak”, as discussed in paragraph [0099]);
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 (injection stopping means 146 controlled by microprocessor 130 to stop driving motor 117 to stop the injection of the liquid when a leak alarm is output, as discussed in paragraph [0092]);
said control mechanism is configured to reduce a flowrate of said injection at said injection site in response to said injection site reaction being determined to be present (injection stopping means 146 controlled by microprocessor 130 to stop driving motor 117 to stop the injection of the liquid when a leak alarm is output, as discussed in paragraph [0092]).
It would have been obvious to one having ordinary skill in the art at the time the application was field to combine the features of Ono with the device of Inan in order to automatically stop the injection of the liquid to automatically prevent the liquid injection from continuing while injection needle exits the blood vessel (Ono, paragraph [0115]).
Regarding claim 38, Inan teaches that said sensor is configured to measure said one or more health or physiological parameters from a skin surface of said body of said subject (see discussion of placing temperature sensor at the wrist in paragraph [0072]).
Regarding claim 40, Inan teaches that said patch 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 (see discussion of LED 512 or audible alarm when the system has detected IV infiltration in paragraph [0062]).
Regarding claim 41, Inan teaches that said patch 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 (Bluetooth or other wireless transmission device to allow communication between the device and a host computer, as discussed in paragraph [0062]).
Regarding claim 42, Inan teaches that said communication interface comprises a wireless communication interface (Bluetooth or wireless transmission device, as discussed in paragraph [0062]).
Regarding claim 43, Inan teaches that said electronic device is a mobile device (laptop or tablet, as discussed in paragraph [0044]).
Regarding claim 44, Inan teaches that said mobile device comprises said processor (the system communicates with a host computer for data processing, as discussed in paragraph [0062]).
Regarding claim 48, Inan teaches that said one or more parameters correspond to pain or discomfort of said subject associated with said injection site reaction (see discussion of swelling of soft tissue and increased skin firmness in paragraph [0042]). Examiner notes that swelling of tissue and increased skin firmness or swelling would correspond to discomfort of the patient associated with the injection site reaction depending on the amounts thereof.
Regarding claim 52, Inan teaches that said patch further comprises an additional sensor (temperature sensors along with strain gauges, as discussed in paragraph [0072]).
Regarding claim 53, Inan teaches that said one or more health or physiological parameters comprise one or more of skin temperature or skin impedance (see discussion monitoring bioimpedance of the skin proximal to the infiltration site in paragraph [0050] and placing temperature sensor at the wrist in paragraph [0072]).
Regarding claim 54, Inan teaches that said one or more health or physiological parameters further comprise a body temperature (see discussion of a skin temperature sensor to provide skin temperature in paragraph [0064]).
Regarding claim 55, Inan teaches that said injection site reaction further comprises a rise in skin temperature (see discussion of temperature fluctuation due to changing ambient temperature or sympathetic arousal in paragraph [0072]).
Claim(s) 46, 47, 49 – 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inan (U.S. 2019/0328330) in view of Ono (U.S. 2007/0225637), and in view of Heldman (U.S. 11,367,519).
Regarding claim 46, Inan and Ono teach claim 43 as seen above.
However, Inan and Ono do not specify that said mobile device further comprises a mobile application (claim 46); said mobile application is configured to collect one or more parameters as input from said subject (claim 47); said mobile application is configured to display said presence of said injection site reaction (claim 50); said mobile application is configured to notify said subject of said presence of said injection site reaction (claim 51).
Heldman teaches a device similar to Inan, Ono, and the current application, further including that:
said mobile device further comprises a mobile application (mobile application, as discussed in Col. 28, lines 36 - 50);
said mobile application is configured to collect one or more parameters as input from said subject (self-reported information, as discussed in Col. 28, lines 36 - 50);
said one or more parameters correspond to pain or discomfort of said subject associated with said injection site reaction (selecting a level on a pain scale, as discussed in Col. 76, lines 55 - 67);
said mobile application is configured to display said presence of said injection site reaction (visual indicator or messages displayed on smartphones can be used to notify the subject, as discussed in Col. 62, lines 29 – 38, and see discussion of notifying the subject of a condition or event requiring attention in Col. 82, lines 13 - 15);
said mobile application is configured to notify said subject of said presence of said injection site reaction (visual indicator or messages displayed on smartphones can be used to notify the subject, as discussed in Col. 62, lines 29 – 38 and discussion of notifying the subject of a condition or event requiring attention in Col. 82, lines 13 - 15).
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Heldman and the combined system of Inan and Ono in order to use self-reporting information in assisting the analysis of the data and alerting the subject of a condition requiring attention (Heldman, Col. 76, line 38 – Col. 77, line 2, Col. 82, lines 13 - 15).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH T BUI whose telephone number is (571)270-1028. The examiner can normally be reached M - F 8 - 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANH T. BUI
Examiner
Art Unit 3783
/Anh Bui/ Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
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