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 5 is objected to because of the following informalities: “the processor is configured to compare to calculated force time product” does not make sense. The examiner suggests changing “to calculated” to “the calculated”. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: “the level” lacks antecedent basis. It is treated as “the lever”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
Claim(s) 2, 3, 8-10, 14 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Despa et al (US 2016/0213856) in view of Rios et al (US 2017/0136185).
Regarding claim 2, Despa discloses a system of measuring injection of a liquid medicine, comprising: a syringe body 140 having proximal and distal ends, a syringe interior, and a syringe flange 155A/B at the proximal end thereof; a stopper member (¶33) disposed in the syringe interior (¶33); a plunger member 150 coupled to the stopper member and configured to be manipulated to insert the stopper member distally in the syringe interior relative to the syringe body (in the normal manner of operating a syringe); a needle 170 coupled to the syringe body at the distal end thereof; a sensor flange 100 (fig 1) removably coupled to the syringe body (fig 2, ¶29), the sensor flange comprising: a sensor 120 to measure an injection characteristic (movement of plunger, ¶31); and a processor 185 to analyze the injection characteristic to determine an occurrence of an injection event (¶38, ¶46 and ¶47).
While Despa substantially discloses the invention as claimed, it does not disclose wherein the sensor is a force sensor and the injection characteristic is a distally directed force applied to a plunger member disposed at least partially in the syringe body.
Rios discloses a syringe attachment in the form of a cap 240 to be attached to the plunger (fig 2B). It includes a force sensor which can be used for feedback for when a measured force falls outside of a desired range (¶9) including warning a caregiver of an inappropriate injection force (¶49). This determination of being outside of a desired range is also determination of an injection event (an acceptable force value injection event vs an incorrect force value injection event).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Despa such that the sensor includes a force sensor and the injection characteristic is a distally directed force applied to a plunger member disposed at least partially in the syringe body as taught by Rios to determine if an applied force is within a desired delivery force range.
Regarding claim 3, wherein the injection event is an injection of a dose of the liquid medicine (Despa claim 11 – device is for liquid medicine).
Regarding claim 8, wherein the sensor flange is configured to be manipulated to insert the stopper member distally in the syringe interior relative to the syringe body (lip 107 of sensor flange is configured to be manipulated as part of injection - ¶34).
Regarding claim 9, the plunger member 145 comprising a proximal end pad to be manipulated simultaneously with the sensor flange to insert the stopper member distally in the syringe interior relative to the syringe body (¶34 – grip device and engage plunger with one hand).
Regarding claim 10, wherein the sensor flange further comprises a load point configured to receive the distally directed force applied to the proximal end pad (see claim 2 regarding use of a force sensor, the element which measures the force is the load point).
Regarding claim 14, while Despa substantially discloses the invention as claimed, it does not disclose wherein the force sensor is configured to measure the distally directed force as a resistance or impedance, and process, store, or transmit the resistance or impedance as a numerical data point.
It requires routine skill in the art to determine how to record the force as it is known sensors generally record in electronic values (which are then translated to realworld values, such as force).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Despa such that the force sensor is configured to measure the distally directed force as a resistance or impedance, and process, store, or transmit the resistance or impedance as a numerical data point as is generally known in the art to measure in electronic values as they are easily stored and transferred.
Regarding claim 18, Despa discloses a system of measuring injection of a liquid medicine, comprising: a syringe body 140 having proximal and distal ends, a syringe interior, and a syringe flange 155A/B at the proximal end thereof; a stopper member (¶33) disposed in the syringe interior (¶33); a plunger member 150 coupled to the stopper member and configured to be manipulated to insert the stopper member distally in the syringe interior relative to the syringe body (in the normal manner of operating a syringe); a needle 170 coupled to the syringe body at the distal end thereof; a sensor flange 100 (fig 1) removably coupled to the syringe body (fig 2, ¶29), the sensor flange comprising: a plurality of sensors 120 (sensors, plural, is used in fig 3, as opposed to singular for every other structure) to measure an injection characteristic (movement of plunger, ¶31); and a processor 185 to analyze the injection characteristic to determine an occurrence of an injection event (¶38, ¶46 and ¶47).
While Despa substantially discloses the invention as claimed, it does not disclose wherein the sensor is a plurality of force sensor and the injection characteristic is a distally directed force applied to a plunger member disposed at least partially in the syringe body.
Rios discloses a syringe attachment in the form of a cap 240 to be attached to the plunger (fig 2B). It includes a force sensor which can be used for feedback for when a measured force falls outside of a desired range (¶9) including warning a caregiver of an inappropriate injection force (¶49). This determination of being outside of a desired range is also determination of an injection event (an acceptable force value injection event vs an incorrect force value injection event).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Despa such that the sensor includes a plurality of force sensor and the injection characteristic is a distally directed force applied to a plunger member disposed at least partially in the syringe body as taught by Rios to determine if an applied force is within a desired delivery force range.
Allowable Subject Matter
Claims 4-7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The examiner did not find a teaching or suggestion for modifying closest art Despa in view of Rios such that the processor is configured to calculate a product of the distally directed force and a time of the injection of the dose of the liquid medicine to derive a calculated force time product, absent impermissible hindsight. The next closest art suggested such a calculation is useful for detecting occlusions, but such is not seen as an obvious, useful feature in a syringe one can see into.
Claims 11-13 and 19-21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The examiner did not find a teaching or suggestion for modifying closest art Despa in view of Rios such that the load point is mechanically coupled to the force sensor by a lever, and wherein the lever pivots about a pivot point to transmit a portion of the distally directed force to the force sensor, absent impermissible hindsight (especially a force sensor with lever that is suitable for the portable sensor flange).
Claims 15-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The examiner did not find a teaching or suggestion for modifying closest art Despa in view of Rios such that the processor is configured to calculate a cumulative force over time. Rios teaches comparing a force to thresholds and generating an alarm based on the comparison. Further modifying the combination to also calculate a cumulative force over time is considered impermissible hindsight.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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, Michael Tsai can be reached at (571)270-5246. 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.
/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783