Prosecution Insights
Last updated: October 25, 2026
Application No. 17/812,696

TREATMENT SYSTEM HAVING GENERATOR AND FLUID TRANSFER CARTRIDGE

Final Rejection §103
Filed
Jul 14, 2022
Priority
Jul 19, 2021 — provisional 63/223,518 +3 more
Examiner
PAPE, ALYSSA MORGAN
Art Unit
3794
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Otsuka Medical Devices Co. Ltd.
OA Round
4 (Final)
27%
Grant Probability
At Risk
5-6
OA Rounds
0m
Est. Remaining
64%
With Interview

Examiner Intelligence

Grants only 27% of cases
27%
Career Allowance Rate
7 granted / 26 resolved
-43.1% vs TC avg
Strong +38% interview lift
Without
With
+37.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
35 currently pending
Career history
92
Total Applications
across all art units

Statute-Specific Performance

§101
1.3%
-38.7% vs TC avg
§103
58.7%
+18.7% vs TC avg
§102
23.6%
-16.4% vs TC avg
§112
10.8%
-29.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 26 resolved cases

Office Action

§103
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 . Response to Amendment The amendment filed 06/25/2026 has been entered. Claims 1-17 remain pending in the application. Response to Arguments Applicant's arguments with respect to claims 1-17 have been considered but are not seen as persuasive, see reasoning below. Regarding claim 1, applicant argues that Lee does not disclose a handle therefore, the rationale of a “simple substitution” fails. Examiner disagrees, by definition, a handle is a part of an object that is designed to be held, moved, or touched by the hand. While Lee does not disclose that the operating is gripping or grasping of the housing of the handle, it would be obvious to one skilled in the art, that the body itself acts as the handle. In paragraph [0054] of Lee, it is disclosed how the plunger body functions such that the plunger body is pulled in a proximal direction. Such that if the operate was not gripping or grasping the device somewhere on that housing, there is no opposing force to counteract the force to pull the plunger knob therefore, the operator would just be pulling the entire device towards them. With that being said, when looking at the entire structure shown in Figure 1, the only logical place for an operator to hold the device would be in the central section in between the two openings over 13 & 16, therefore is seen as a handle. While examiner understands applicant was looking for a different type of handle such that it is separate from just the housing, that is why Hopkins was brought in to teach the deficiency. Therefore, the simple substitution of using the housing as a handle is seen as a first element such that the second element is the handle taught by Hopkins. In terms of the argument of the plunger knob being seen as a handle, examiner disagrees, the plunger knob is seen as an actuator, such that the movement of the knob allows for dispensing of the fluid. By adding the curved handle, it would give the user a place to hold onto to produce a counter force when pulling the plunger knob instead of holding the body of the device. Examiner also wants to point out in MPEP 2145 III, it is stated that “The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art”. Therefore, it would have been obvious to one of the ordinary skill in the art to add a handle on the body to grasp instead of the housing itself. Therefore, examiner stands by the rejection for the reasons taught above and in the non-final rejection. In regards to claims 2-16, Examiner sees claim 1 dependents as being unpatentable over Lee in view of Hopkins as taught by the non-final action and the reasonings above. 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 1-4, 9-10, 25-26 & 30 are rejected under 35 U.S.C 103 as being unpatentable over Lee-Sepsick et al. (US 20120116217) herein referred to as Lee, in view of Hopkins et al. (US 20080015515) herein referred to as Hopkins. Regarding Claim 1, Lee discloses A fluid transfer cartridge (Figure 1, 10), comprising: a cartridge shell defining a cartridge cavity between a front face and a rear face (Figure 1, 12a & 12b), wherein the front face includes an opening (Figure 1, 12a); a handle extending from the front face of the cartridge shell over the opening (Figure 1; wherein the central section in between the two openings over 13 & 16 is seen as a handle); and a syringe barrel disposed within the cartridge cavity and visibly exposed through the opening on a first side of the handle (Figure 1, 13). However, Lee does not explicitly disclose wherein the handle curves outward from the front face over the opening to define a space through which fingers of a user can pass to grasp the handle. Hopkins discloses a fluid transfer cartridge (Figure 4; Paragraph [0004]) wherein the handle curves outward from the front face over the opening to define a space through which fingers of a user can pass to grasp the handle (Figure 4, 181). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have substituted the handle taught by Lee to be the handle taught by Hopkins. The motivation being a simple substitution of one known handle, the handle taught by Lee, for another, the handle taught by Hopkins to obtain predictable results of a user being able to grasp a fluid transfer cartridge (MPEP 2143 (B)). Regarding claim 2, Lee in view of Hopkins discloses the fluid transfer cartridge of claim 1. Lee also discloses further comprising a second syringe barrel disposed within the cartridge cavity and visibly exposed through the opening on a second side of the handle (Figure 1, 16). Regarding claim 3, Lee in view of Hopkins discloses the fluid transfer cartridge of claim 1. Lee also discloses wherein the handle extends vertically from an upper end of the opening to a lower end of the opening (Figure 1; wherein the central section in between the two openings over 13 & 16 is seen as a handle). Regarding claim 4, Lee in view of Hopkins discloses the fluid transfer cartridge of claim 1. Lee also discloses wherein the syringe barrel has a syringe axis extending vertically within the cartridge cavity (Figure 1, 13). Regarding claim 9, Lee in view of Hopkins discloses the fluid transfer cartridge of claim 1. Lee also discloses further comprising a syringe holder mounted within the cartridge cavity (Figure 1; wherein syringe holder is seen as the walls holding the syringe 13 is place as well as pressure relief valve 14 which is directly connected), wherein the syringe holder holds the syringe barrel such that rotation of the syringe barrel relative to the cartridge shell is limited (Figure 1; wherein syringe 13 is connected to pressure relief valve in such a way that rotation would be very limited if any). Regarding claim 10, Lee in view of Hopkins discloses the fluid transfer cartridge of claim 1. Lee also discloses wherein the cartridge cavity is defined between the front face (Figure 1, 12a), the rear face (Figure 12b), an upper face (See annotated Figure 1 blow), and a bottom face (See annotated Figure 1 below), and further comprising a syringe piston disposed within the syringe barrel (Paragraph [0054]; wherein syringe plunger which is a piston is not shown in figure 1 but is disposed in container 13), wherein the syringe piston includes a stopper and a shaft extending from the stopper to a shaft end (Paragraph [0054]; wherein fluid seal element acts as a stopper and is at the distal end of the piston shaft), wherein the shaft end is flush with the bottom face when the stopper is at a home position in the syringe barrel (Paragraph [0054]; wherein shaft end will be flush to the proximal side which is seen as the bottom face before pushing the fluid thru), and wherein the shaft end is below the bottom face when the stopper is at an end position in the syringe barrel (Paragraph [0054]; wherein shaft goes all the way thru the container therefore would be below the bottom face when all the fluid is pushed through). PNG media_image1.png 427 697 media_image1.png Greyscale Regarding claim 25, Lee discloses a fluid transfer cartridge shell (Figure 1, 12a & 12b), comprising: a front face having a front face perimeter and a handle extending over an opening (Figure 1, 12a; wherein the central section in between the two openings over 13 & 16 is seen as a handle); and a rear face having a rear face perimeter (Figure 1, 12b), wherein when the front face perimeter is engaged to the rear face perimeter a cartridge cavity is defined between the front face and the rear face such that the cartridge cavity is visibly exposed through the opening on a first side of the handle (Figure 1, 13). However, Lee does not explicitly disclose wherein the handle curves outward from the front face over the opening to define a space through which fingers of a user can pass to grasp the handle. Hopkins discloses a fluid transfer cartridge (Figure 4; Paragraph [0004]) wherein the handle curves outward from the front face over the opening to define a space through which fingers of a user can pass to grasp the handle (Figure 4, 181). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have substituted the handle taught by Lee to be the handle taught by Hopkins. The motivation being a simple substitution of one known handle, the handle taught by Lee, for another, the handle taught by Hopkins to obtain predictable results of a user being able to grasp a fluid transfer cartridge (MPEP 2143 (B)). Regarding claim 26, Lee in view of Hopkins discloses the fluid transfer cartridge of claim 25. Lee also wherein the handle extends vertically from an upper end of the opening to a lower end of the opening (Figure 1; wherein the central section in between the two openings over 13 & 16 is seen as a handle). Regarding claim 30, Lee in view of Hopkins discloses the fluid transfer cartridge shell of claim 25. Lee also discloses wherein the cartridge shell includes a conduit routing plate engaging the front face along an edge (Figure 1, 19), and wherein the conduit routing plate and the front face include respective notches at the edge (Figure 1), the respective notches combining to form a conduit routing port through which a fluid conduit is routed (Figure 1, 21). Claims 5-8, 27 are rejected under 35 U.S.C 103 as being unpatentable over Lee and Hopkins in further view of Ward et al. (WO 2020210142) herein referred to as Ward. Regarding Claim 5, Lee in view of Hopkins discloses the fluid transfer cartridge of claim 1. However, Lee in view of Hopkins does not explicitly disclose a light source within the cartridge cavity, wherein the light source is directed through the syringe barrel. Ward discloses a fluid transfer cartridge (Figure 1) comprising a light source within the cartridge cavity, wherein the light source is directed through the syringe barrel (Figure 12, 332). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid transfer cartridge taught by Lee in view of Hopkins to include a light source as taught by Ward. The motivation being provide a visual indication of the fluid (Ward, Paragraph [0058]). Regarding Claim 6, Lee and Hopkins in further view of Ward discloses the fluid transfer cartridge of claim 5. Ward also discloses wherein the light source is directed through an end face of the syringe barrel (Figure 12, 332). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid transfer cartridge taught by Lee in view of Hopkins to include a light source as taught by Ward. The motivation being provide a visual indication of the fluid (Ward, Paragraph [0058]). Regarding Claim 7, Lee and Hopkins in further view of Ward discloses the fluid transfer cartridge of claim 5. Ward also discloses wherein the light source emits a blue light (Paragraph [0059]; wherein the light source can be changed to multiple colors therefore could emit a blue light). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid transfer cartridge taught by Lee in view of Hopkins to include a light source as taught by Ward. The motivation being providing a light guide that changes colors and/or light patterns to convey the status of the device (Ward, Paragraph [0059]). Regarding Claim 8, Lee and Hopkins in further view of Ward discloses the fluid transfer cartridge of claim 5. Ward also discloses wherein the light source emits a first color of light when the syringe barrel is filled with a first volume of fluid (Paragraph [0059]; wherein light source can emit different colors based on the remaining fluid volume), and wherein the light source emits a second color of light when the syringe barrel is filled with a second volume of fluid (Paragraph [0059]; wherein light source can emit different colors based on the remaining fluid volume.). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid transfer cartridge taught by Lee in view of Hopkins to include a light source as taught by Ward. The motivation being providing a light guide that changes colors and/or light patterns to convey the status of the device (Ward, Paragraph [0059]). Regarding Claim 27, Lee in view of Hopkins discloses the fluid transfer cartridge of claim 25. However, Lee in view of Hopkins does not explicitly disclose a light source within the cartridge cavity, wherein the light source emits a blue light. Ward discloses a fluid transfer cartridge (Figure 1) comprising a light source within the cartridge cavity (Figure 12, 332), wherein the light source emits a blue light (Paragraph [0059]; wherein the light source can be changed to multiple colors therefore could emit a blue light). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid transfer cartridge taught by Lee in view of Hopkins to include a light source as taught by Ward. The motivation being providing a light guide that changes colors and/or light patterns to convey the status of the device (Ward, Paragraph [0059]). Claims 11-13 are rejected under 35 U.S.C 103 as being unpatentable over Lee and Hopkins in further view of Bourne et al. (US 20150297405) herein referred to as Bourne. Regarding Claim 11, Lee in view of Hopkins discloses the fluid transfer cartridge of claim 10. However, Lee in view of Hopkins does not explicitly disclose wherein the shaft includes an external thread, and further comprising a gear mounted on the cartridge shell, wherein the gear includes an internal thread engaging the external thread. Bourne discloses a fluid transfer cartridge (Figure 1) wherein the shaft includes an external thread (Figure 6, 640), and further comprising a gear rotatably mounted on the cartridge shell (Figure 6, 620; such that 620 has to be rotated to be intertwined with the threads), wherein the gear includes an internal thread engaging the external thread to drive the external thread of the shaft in an axial direction when the gear rotated (Paragraph [0039]; Figure 6; wherein external threads of the shaft will move in an axial direction when gear is rotated onto it). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the shaft as taught by Lee to include a gear and threads as taught by Bourne. The motivation being a simple substitution of one type of connection luer connection taught by Lee in view of Hopkins for another, a threaded connection as taught by Bourne to obtain predictable results of connecting the shaft to a syringe barrel (MPEP 2143 (B)). Regarding Claim 12, Lee and Hopkins in further view of Bourne discloses the fluid transfer cartridge of claim 11. Bourne also discloses wherein the external thread and the internal thread have different working depths (Figure 6, 620 & 640). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the shaft as taught by Lee in view of Hopkins to include a gear and threads as taught by Bourne. The motivation being a simple substitution of one type of connection luer connection taught by Lee in view of Hopkins for another, a threaded connection as taught by Bourne to obtain predictable results of connecting the shaft to a syringe barrel (MPEP 2143 (B)). Regarding Claim 13, Lee in view of Hopkins discloses the fluid transfer cartridge of claim 10. However, Lee in view of Hopkins does not explicitly disclose wherein the shaft includes a notch extending longitudinally between the stopper and the shaft end. Bourne discloses a fluid transfer cartridge (Figure 1) wherein the shaft includes a notch extending longitudinally between the stopper and the shaft end (Figure 6, 630). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the shaft as taught by Lee in view of Hopkins to include a notch as taught by Bourne. The motivation being to form a ridge attachment (Bourne, Paragraph [0039]). Claim 14 is rejected under 35 U.S.C 103 as being unpatentable over Lee and Hopkins in further view of Toth et al. (US 10470684) herein referred to as Toth. Regarding Claim 14, Lee in view of Hopkins discloses the fluid transfer cartridge of claim 10. However, Lee in view of Hopkins does not explicitly disclose wherein the syringe piston includes an optical tab disposed on the shaft at the shaft end. Toth discloses a fluid transfer system (Figure 21) wherein an optical tab disposed on the shaft at the shaft end (Figure 15a, 1510). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the syringe piston taught by Lee in view of Hopkins to include the optical tab as taught by Toth. The motivation being to receive from and/or emit energy into the adjacent area (Toth, Column 40, lines 35-37). Claim 15-16 & 28-29 are rejected under 35 U.S.C 103 as being unpatentable over Lee and Hopkins in further view of Leclere (US 20210369940) herein referred to as Leclere. Regarding Claim 15, Lee in view of Hopkins discloses the fluid transfer cartridge of claim 10. However, Lee in view of Hopkins does not explicitly disclose wherein the rear face includes a boss, and further comprising one or more electrical contact pads exposed through the rear face near an upper end of the boss. Leclere discloses fluid transfer cartridge (Figure 1) wherein the rear face includes a boss (Figure 1, 2), and further comprising one or more electrical contact pads exposed through the rear face near an upper end of the boss (Figure 4, 11; wherein the face shown in Figure 4 is seen as the upper end). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the rear face as taught by Lee in view of Hopkins to include electrical contact pads as taught by Leclere. The motivation being able a more robust contact given the removable nature of the cartridge (Leclere, Paragraph [0033]). Regarding Claim 16, Lee and Hopkins in further view of Leclere discloses the fluid transfer cartridge of claim 15. Leclere also discloses wherein the boss includes four or more recesses distributed around a boss perimeter of the boss (See annotated Figure 3A & 5A below). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified boss disclosed by Lee in view of Hopkins in view of Leclere to allow for the recesses taught by Leclere. The motivation being to allow for elements to be put into those recesses (Leclere, Figures 3A & 5A). Regarding Claim 28, Lee in view of Hopkins discloses the fluid transfer cartridge of claim 25. However, Lee in view of Hopkins does not explicitly disclose wherein the rear face includes a boss, and further comprising one or more electrical contact pads exposed through the rear face near an upper end of the boss. Leclere discloses fluid transfer cartridge (Figure 1) wherein the rear face includes a boss (Figure 1, 2), and further comprising one or more electrical contact pads exposed through the rear face near an upper end of the boss (Figure 4, 11; wherein the face shown in Figure 4 is seen as the upper end). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the rear face as taught by Lee in view of Hopkins to include electrical contact pads as taught by Leclere. The motivation being able a more robust contact given the removable nature of the cartridge (Leclere, Paragraph [0033]). Regarding Claim 29, Lee and Hopkins in view of Leclere discloses the fluid transfer cartridge of claim 28. Leclere also discloses wherein the boss includes four or more recesses distributed around a boss perimeter of the boss (See annotated Figure 3A & 5A below). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified boss disclosed by Lee and Hopkins in view of Leclere to allow for the recesses taught by Leclere. The motivation being to allow for elements to be put into those recesses (Leclere, Figures 3A & 5A). PNG media_image2.png 337 340 media_image2.png Greyscale PNG media_image3.png 333 206 media_image3.png Greyscale Conclusion THIS ACTION IS MADE FINAL. 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 ALYSSA M PAPE whose telephone number is (703)756-5947. The examiner can normally be reached M-F 7:30-5:00. 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, Joanne Rodden can be reached at 303-297-4276. 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. ALYSSA M. PAPE Examiner Art Unit 3794 /JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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Prosecution Timeline

Show 2 earlier events
Nov 24, 2025
Response Filed
Mar 25, 2026
Final Rejection mailed — §103
Apr 10, 2026
Response after Non-Final Action
Apr 30, 2026
Request for Continued Examination
May 06, 2026
Response after Non-Final Action
May 26, 2026
Non-Final Rejection mailed — §103
Jun 25, 2026
Response Filed
Sep 14, 2026
Final Rejection mailed — §103 (current)

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Prosecution Projections

5-6
Expected OA Rounds
27%
Grant Probability
64%
With Interview (+37.5%)
3y 8m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 26 resolved cases by this examiner. Grant probability derived from career allowance rate.

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