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 .
This action is in response to Applicant’s after final arguments filed 07/09/2026.
Claims 2, 4, 5, 7, 8, 12, 14, 17, 19, 24, 26, and 32-43 are cancelled.
Claims 25, 27, and 28 are currently amended.
Claims 1, 3, 6, 9, 11, 13, 15, 16, 18, 20-23, 25, and 27-31 are being examined in this Office Action.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gyory (Pub. No. US 20190060565 A1).
Regarding Claim 1, Gyory discloses a therapeutic substance delivery apparatus (Fig. 2) comprising:
a housing (120);
a reservoir (102) disposed at least partially within the housing and configured to hold a therapeutic substance (“liquid drug” – Paragraph [0026]);
a position sensor (106) having at least three discrete states (when 106 is not triggered, when filling, and when emptying, Paragraph [0026]);
a plunger (105), slidable within the reservoir (Figs 2-3);
a plunger-sensor engagement interface (105, 106, 107, Fig. 3) that is coupled to the plunger within the reservoir and extends from within the reservoir to outside of the reservoir (Fig. 2), wherein the plunger and the position sensor are arranged such that the plunger-sensor engagement interface causes the position sensor to change states as the plunger slides within the reservoir (Paragraph [0026]); and
control circuitry (109) configured to identify a new state indication of the apparatus based on (a) a change in state of the position sensor (control module 109 transmitting a warning to a user based on plunger position, “When the flexible reservoir 101 is emptied, continued negative pressure from the pump mechanism 110 causes the plunger 105 to move from position B toward position A, and the button 107 on the switch 106 is activated to transmit a low volume signal to a control module 109. Control module 109 then sends a low-volume warning signal to the user.” – Paragraph [0030]),
wherein:
a first state S1 of the discrete states of the position sensor is a non-triggered state of the position sensor (Fig. 2, before plunger 105 has moved towards end B and triggers sensor 106),
a second state S2 of the discrete states of the position sensor is a triggered state of the position sensor that is indicative of the plunger moving distally within the reservoir (“When the plunger 105 moves from end A to end B for filling, a fluid source is connected to end A. When the plunger 105 passes the side hole 104, fluid fills the chamber 102 and flows through the side hole 104 into the flexible reservoir 101 until the flexible reservoir 101 is filled. At the same time, a sensor 106 is triggered to transmit a volume signal.” – Paragraph [0026]), and
a third state S3 of the discrete states of the position sensor is a triggered state of the position sensor that is indicative of the plunger moving proximally within the reservoir (“When the plunger 105 moves from end B to end A for emptying, the flexible reservoir 101 is emptied first. When the plunger 105 passes the side hole 104, the flexible reservoir 101 is emptied. The sensor 106 is triggered again to transmit another volume signal to indicate low fluid volume in the reservoir.” – Paragraph [0026]).
Regarding Claim 3, Gyory discloses the apparatus according to claim 1, wherein the position sensor has exactly three discrete states, the exactly three discrete states being the first state S1 (Fig. 2, before plunger 105 has moved towards end B and triggers sensor 106), the second state S2 (“When the plunger 105 moves from end A to end B for filling, a fluid source is connected to end A. When the plunger 105 passes the side hole 104, fluid fills the chamber 102 and flows through the side hole 104 into the flexible reservoir 101 until the flexible reservoir 101 is filled. At the same time, a sensor 106 is triggered to transmit a volume signal.” – Paragraph [0026]), and the third state S3 (“When the plunger 105 moves from end B to end A for emptying, the flexible reservoir 101 is emptied first. When the plunger 105 passes the side hole 104, the flexible reservoir 101 is emptied. The sensor 106 is triggered again to transmit another volume signal to indicate low fluid volume in the reservoir.” – Paragraph [0026]).
Regarding Claim 13, Gyory discloses the apparatus according to claim 1, wherein:
(a) the housing is shaped to define a filling port (103) in fluid communication with the reservoir (Fig. 2), and wherein the reservoir is configured to be filled with the therapeutic substance via the filling port (“An exit/entrance 103 of the chamber 102 allows fluid in and out of the chamber 102.” – Paragraph [0026]),
(b) prior to the filling of the reservoir the apparatus is in a sleep state, the plunger is disposed at an initial proximal position within the reservoir, and the position sensor is in the first state S1 (Examiner interprets that a sleep state is where the plunger is closest to end A, and sensor 107 is not yet triggered),
(c) filling the reservoir with the therapeutic substance causes the plunger to slide in a distal direction from the initial proximal position (Fig. 3),
(d) the plunger and the position sensor are arranged such that as the plunger slides in the distal direction, the plunger-sensor engagement interface causes the position sensor to change state from the first state S1 to the second state S2 (“When the plunger 105 moves from end A to end B for filling, a fluid source is connected to end A. When the plunger 105 passes the side hole 104, fluid fills the chamber 102 and flows through the side hole 104 into the flexible reservoir 101 until the flexible reservoir 101 is filled. At the same time, a sensor 106 is triggered to transmit a volume signal.” – Paragraph [0026]), and
(e) the control circuitry is configured to identify that the apparatus is awake and in a filling state in response to the position sensor changing state from the first state S1 to the second state S2(“When the flexible reservoir 101 is filled with fluid, the positive pressure increases and pushes the plunger 105 further back to position B to activate the button 107 on the switch 106 to transmit a high volume signal to the control module 109.” – Paragraph [0031]).
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) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gyory in view of Buck, JR. et al. (Pub. No. US 20100156633 A1, herein Buck, JR.).
Regarding Claim 11, Gyory discloses the apparatus according to claim 1, wherein the apparatus is in a sleep state when packaged for commercial sale (Examiner interprets that a sleep state is where the plunger is closest to end A, and sensor 107 is not yet triggered), and wherein the position sensor is in the first state S1 when the apparatus is in the sleep state (Fig. 2). Examiner notes the limitation “packaged for commercial sale” is intended use and given limited patentable weight for the use of itself as the prior art is capable of being sold commercially.
Gyory does not expressly disclose wherein the control circuitry is configured to (a) identify that the apparatus is in an expired state if a sleep-threshold amount of time has elapsed without the position sensor changing state from the first state Si, and (b) in response thereto, disable the apparatus.
Buck, JR. teaches wherein the control circuitry (28) is configured to (a) identify that the apparatus is in an expired state if a sleep-threshold amount of time has elapsed without the position sensor changing state from the first state S1 (“When the pump 14 has been without power for more than one hour, a review time warning will occur. With this warning, the user is prompted to check and correct if necessary, the current date and time.” – Paragraph [0063], Paragraph [0084]), and (b) in response thereto, disable the apparatus (“the operating error monitored at step 110 may be or include any one or more of the pump errors described hereinabove. If such an error is not detected, the process 100 loop back to the beginning of step 110. If, at step 110, the processor 28 determines that an operating error has been detected, the process 100 advances from step 110 to step 112, where processor 28 is operable to disable, e.g., permanently, operation of the pump 14. Following step 112, the process 100 ends.” - Paragraph [0085], Paragraph [0084]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus disclosed by Gyory wherein the control circuitry is configured to (a) identify that the apparatus is in an expired state if a sleep-threshold amount of time has elapsed without the position sensor changing state from the first state Si, and (b) in response thereto, disable the apparatus as taught by Buck, JR. in order to determine when a pumps lifetime has expired (Buck, JR., Paragraph [0085]).
Allowable Subject Matter
Claims 6, 9, 15, 16, 18, and 20-31 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 prior art of record fails to disclose or make obvious the claimed invention, including the following features:
- Regarding Claim 6, the plunger and the position sensor are arranged such that distal movement of the plunger past the intermediate position to a post-intermediate position within the reservoir causes the plunger-sensor engagement interface to change the state of the position sensor from the second state S2 back to the first state S1. In Gyory, further distal movement, towards end B, of the plunger does not cause a state change back into S1.
- Regarding Claim 15, the plunger and the position sensor are arranged such that upon completion of the reservoir being filled with a threshold volume of the therapeutic substance, the plunger-sensor engagement interface causes the position sensor to change state from the second state S2 back to the first state S1. In Gyory, once the apparatus is filled, the sensor is maintained in S2, and only reverts to S1 upon proximal movement, toward end A, of the plunger.
- Regarding Claim 16, wherein the plunger and the position sensor are arranged such that upon completion of the reservoir being filled with at least a threshold volume of the therapeutic substance, the plunger-sensor engagement interface causes the position sensor to change state from the second state S2 back to the first state S1. In Gyory, once the apparatus is filled, the sensor is maintained in S2, and only reverts to S1 upon proximal movement, toward end A, of the plunger.
- Regarding Claim 20, (a) upon completion of the reservoir being filled with at least a threshold volume of the therapeutic substance, the apparatus is in a filling-complete state, and the position sensor is in the first state S1… (c) the plunger and the position sensor are arranged such that as the plunger slides proximally the plunger-sensor engagement interface causes the position sensor to change state from the first state S1 to the third state S3. In Gyory, once chamber is filled with fluid, the plunger maintains contact with the sensor in a triggered state, and not in a non-triggered state. Sensor 107 does not enter S1 immediately after entering S2.
- Regarding Claim 22, (b) in response to the received input, determine the length of an expected wait-time between the control circuitry initiating the delivery-started state of the apparatus and the plunger-sensor engagement interface causing the position sensor to change state from the first state S1 to the third state S3. In Gyory, the sensor does not go from the first state S1 to the third state S3, instead the sensor is triggered into the second state S2 upon filling of the chamber, then to the third state S3 upon emptying of the chamber.
The combination of the claimed limitations is novel and found to be allowable over the prior art. The cited references taken singly or in combination do not anticipate or make obvious the Applicant’s claimed invention.
Examiner notes that the limitations indicated as containing allowable subject matter above are done so in context of the claims as a whole – e.g. the cited portions of claim 6 are allowable in combination with the rest of the limitations of the claim.
Response to Arguments
Applicant’s arguments filed 07/09/2026 have been fully considered.
In regards to Applicant’s argument:
“The Office Action objected to claim 15, asserting that the limitation of "the state of the apparatus being filling" should instead read "the state of the apparatus being filled." Applicant respectfully submits that this assertion is incorrect. Claim 15 recites the identification of a filling error if the device remains in the "filling" state for too long without the position sensor changing state from the second state S2 back to the first state S1i to indicate that the filling is complete.”
This argument is persuasive and the previous objection is withdrawn.
In regards to Applicant’s argument:
“Claims 25, 27, and 28 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre- AIA ), second paragraph, as being indefinite, with the Office Action asserting that the limitation "a delivery-start-threshold amount of time" is unclear. While not conceding the correctness of this rejection, Applicant has amended claims 25, 27, and 28 to recite that the delivery-start-threshold amount of time is a maximum allowable amount of time between (a) the control circuitry initiating the delivery-started state of the apparatus and (b) the position sensor changing state from the first state Si to the third state S3 (this change of state being indicative that the plunger is moving proximally within the reservoir and thus indicative that the delivery has indeed started).”
This argument is persuasive and the 112(b) rejection for claims 25, 27, and 28 is withdrawn.
In regards to Applicant’s argument:
“Thus, Applicant respectfully submits that Rosskopf does not disclose each and every element recited in claim 1, and therefore could not have anticipated claim 1 under 35 U.S.C. 102. Claims 3, 6, 9, and 11 being dependent from claim 1 and therefore of narrower scope than claim 1, are necessarily not anticipated at least for the reasons provided for why claim 1 is not anticipated.”
This argument is persuasive and the 35 U.S.C. 102 rejection for claim 1 has been withdrawn. However, upon further search and consideration, a new ground of rejection is made in view of Gyory.
In regards to Applicant’s argument:
“Applicant notes that all of the above rejections under 35 U.S.C. 103 rely on Rosskopf as applied by the Office Action to claim 1 or a claim dependent on claim 1. As described hereinabove, Applicant respectfully submits that Rosskopf does not only fail to disclose the three discrete states recited in claim 1, but also fails to suggest these states. The cited secondary references fail to remedy these deficiencies of Rosskopf and were cited for different reasons. As such, Applicant respectfully submits that none of the proposed modifications in the rejections under 35 U.S.C. 103 would have resulted in all of the recited
claim elements.”
This argument is persuasive and the 35 U.S.C. 103 rejection for Claims 13, 15, 16, 18, 20, 22, 23, 25, and 27-31 has been withdrawn. However upon further search and consideration, a new ground of rejection for independent claim 1 is made in view of Gyory.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30am-4:30pm Alt. Fri off.
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, Chelsea Stinson can be reached at 571-270-1744. 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.
/MARK GOLOVAN/Patent Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
