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 Rejections - 35 USC § 102
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.
Claim(s) 1-5 and 7-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pre-Grant Publication 2017/0095638 to Young et al. (Young).
Regarding claim 1, Young teaches a system for controlling injection pressure of an injection device (paragraph 11, e.g. “controlling the injector”) having an inje3ction device (1), a substance reservoir (5), an injection portion (3), a pressure transducer (20) which may be disposed between the reservoir and injection portion to measure injection pressure, and a control device (10) adapted to detect a target subject pressure (paragraph 30, “[t]his difference is compared to the stored criteria”).
Regarding claim 2, Young teaches a syringe (5) with a plunger (5a) and an actuator (6).
Regarding claim 3, Young teaches a needle (3a).
Regarding claim 4, Young teaches a pressure sensor in the form of a strain gauge (paragraph 48).
Regarding claim 5, Young teaches an output readout (paragraph 28, visual display).
Regarding claim 7, Young teaches outputting the target subject pressure (e.g. to compare it against other data, see paragraph 28).
Regarding claim 9, Young teaches comparison between the target subject pressure and the injection pressure (paragraph 30).
Regarding claims 10-11, Young teaches a control mechanism (7a, 7b) adapted to activate at any time including in response to excess pressure. Alternatively, Young teaches that the controller may include an actuator stop (paragraph 29) responsive to excess pressure.
Regarding claim 12, Young teaches that the control mechanism (10) controls the actuator (6, see e.g. paragraph 30).
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) 6, 13-14 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Young in view of US Pre-Grant Publication 2010/0228269 to Garrison et al. (Garrison).
Regarding claim 6, Young teaches the system of claim 1 as discussed above, but does not teach a blood pressure monitor. Garrison teaches another delivery system generally (paragraph 72) and teaches that a control device thereof comprises a blood pressure monitor (paragraph 177). As noted above, Young teaches the detection of harmful conditions. With Garrison in mind, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of this application to use a blood pressure sensor as taught by Garrison to enhance the harmful condition sensing of Young in order to protect the patient.
Regarding claim 13, Young teaches a system and method for controlling injection pressure of an injection device (paragraph 11, e.g. “controlling the injector”) having an inje3ction device (1), a substance reservoir (5), an injection portion (3), a pressure transducer (20) which may be disposed between the reservoir and injection portion to measure injection pressure, and a control device (10) adapted to detect a target subject pressure (paragraph 30, “[t]his difference is compared to the stored criteria”) and controlling the injection based thereon (paragraph 38). Young further teaches injecting a substance from the substance reservoir (paragraph 14) Young does not teach measuring the target pressure with a pressure sensing device connected to a subject. Garrison teaches another delivery system generally (paragraph 72) and teaches that a control device thereof comprises a blood pressure monitor (paragraph 177) for sensing a target subject pressure. As noted above, Young teaches the detection of harmful conditions. With Garrison in mind, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of this application to use a blood pressure sensor as taught by Garrison to enhance the harmful condition sensing of Young in order to protect the patient.
Regarding claim 14, as above with reference to claim 13, it would have been obvious to sense blood pressure in order to prevent harmful conditions. It is generally known in the art that blood pressure measurements include both diastolic and systolic pressures. Since the sensing of systolic pressures is not excluded from the scope of claim 14, the pressure sensing added with respect to claim 13 also includes the scope of a target subject pressure which is diastolic blood pressure.
Regarding claim 16, Young teaches manual adjustment (via 7a, 7b, see paragraph 15) in response to target subject pressure and/or injection pressure (e.g. in response to an alarm as discussed in paragraph 17).
Regarding claim 17, Young teaches alerts (paragraph 29, e.g. a large increase in the rate of change of pressure).
Regarding claim 18, Young teaches that the control device maintains the injection pressure below the target subject pressure by controlling the actuator (paragraphs 17, 30).
Regarding claim 19, Young teaches a control mechanism in the pressure transducer (paragraph 17 re control based on pressure signals and paragraph 30 re controller 10 having stored criteria corresponding to harmful conditions).
Regarding claim 20, Garrison teaches arteriovenous malformation tissues and injection into such (paragraph 125).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Young in view of Garrison as applied to claim 13 above, and further in view of US Pre-Grant Publication 2018/0211562 to Rios et al. (Rios).
Regarding claim 15, the previously applied references render obvious the teachings of claim 13 as discussed above, but do not teach the use of filler or glue. Rios teaches another injection monitoring apparatus generally, and particularly teaches that the injected fluid may be filler or glue for cosmetic procedures (paragraph 117) so as to provide cosmetic or therapeutic benefits to the patient. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use filler or glue as taught by Rios in the injection apparatus of Young in order to provide its known benefits to a patient.
Conclusion
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 19 September 2025