DETAILED ACTION
Notice of Pre-AIA or AIA Status
This action is in response to the claims set filed 01/03/2023 and Applicant's Response to Election/Restriction of 11/10/2025 following the Requirement for Restriction/Election of 10/02/2025. Claims 1-20 are currently pending with claims 1-11 withdrawn from consideration as being party to a non-elected Group.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 1-11, of Group I, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/10/2025.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: plunger 155 recited in pr. 49. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims.
Therefore, the “at least one occlusion sensor and at least one downstream inline pressure sensor of claim 12, “syringe pump lever” of claims 12-15 and “sides walls” of the swivel door from the limitation “a swivel door that is pivotably attached to the assembly body and that includes side walls” in claim 13 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 13 is objected to because of the following informalities:
Claim 13 line 3 reads “the assembly body” but should likely read “the main assembly body”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 14 recites the limitation “wherein the swivel door has an internal curvature that interlocks with the plunge lever and redirects force applied on the syringe pump lever, such that the plunge lever cannot be depressed when the swivel door is in a closed configuration” which leads to the claim failing the written description requirement. Claim 13, from which claim 14 depends upon, recites of “a lever stopper, and a pull knob stopper”. This would be a different mutually exclusive embodiment based upon the instant specification. The instant disclosure fails to describe using both “a lever stopper, and a pull knob stopper” recited in claim 13 as well as “wherein the swivel door has an internal curvature that interlocks with the lunge lever and redirects force applied on the syringe pump lever such that the plunge lever cannot be depressed when the swivel door is in a closed configuration” recited in claim 14; they are only presented separately. Further, these different embodiments would be provided in the same space, i.e. underneath the plunge lever, based upon figs. 4A-5B and 8A-9.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 12, the limitation “a syringe pump lever in an upright and depressed orientation renders the claim indefinite. the lever presented in the instant specification appears to have a two different orientations, an undepressed or upright position and a depressed position; no orientation which is both upright and depressed is presented. The lever being in an upright and depressed orientation is indefinite as these adjectives conflict with each other.
Claims 13-20 are also rejected under 35 USC § 112(b) due to their respective dependency upon claim 12 rejected above.
Claim 13 recites the limitation "the lever door". There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the plunge lever". There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation “wherein the swivel door has an internal curvature that interlocks with the plunge lever and redirects force applied on the syringe pump lever, such that the plunge lever cannot be depressed when the swivel door is in a closed configuration” which renders the claim indefinite. Claim 13, from which claim 14 depends upon, recites of “a lever stopper, and a pull knob stopper”. It is unclear how both the swivel door having an internal curvature from claim 14 would also be provided in an invention that also has the lever stopper and pull knob stopper of claim 13 given that these appear to be provided as separate and mutually exclusive embodiments in the instant disclosure. The instant disclosure does not describe have it is possible to use both “a lever stopper, and a pull knob stopper” recited in claim 13 as well as “wherein the swivel door has an internal curvature that interlocks with the lunge lever and redirects force applied on the syringe pump lever such that the plunge lever cannot be depressed when the swivel door is in a closed configuration” recited in claim 14 in a single invention. Further, these different embodiments would occupy the same space, i.e. underneath the plunge lever, based upon figs. 4A-5B and 8A-9 which makes it unclear how they can both be provided simultaneously as required by claim 14.
Claims 14 and 15 recite the limitation “the plunge lever” which renders the claim indefinite. Claim 12, from which claim 14 depends upon, previously introduces the “syringe pump lever” which is also recited in claims 14-15. It is unclear based upon the instant disclosure if the plunge lever and the syringe pump are the same or different components.
Claim 15 recites the limitation "the lever stopper". There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the main assembly body". There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the pull knob stopper". There is insufficient antecedent basis for this limitation in the claim.
Claim 16, which depends upon claim 16, recites the limitation "the pull knob lever". There is insufficient antecedent basis for this limitation in the claim. This limitation should likely be “the pull knob stopper” since that is what is discussed in claim 15, from which claim 16 depends upon.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 12 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2003/0233069, herein referenced as Gillespie, in view of US 2019/0351138, herein referenced as Bhandar.
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Figure 1 of Gillespie
Regarding Claim 12, Gillespie discloses a patient-controlled analgesia pump (infusion pump 10 figs. 1-2) comprising:
an actuator (see syringe drive mechanism 20 in figs. 1 and 14-18 which actuates the plunger of the syringe);
a syringe holder (see syringe compartment 34 fig. 2);
a display screen (see display screen 60 of user interface 16 figs. 1-2) ;
a security door assembly (see access door 36 fig. 1), including a receiver (see area of door 36 around lock/key 38 in fig. 1);
a security frame assembly (housing 12 including first member 26 and second member 28 in fig. 1), including a lock assembly (the lock is shown to be provided on the housing 12 in fig. 2 when the door is not present);
a swivel door assembly, including a syringe pump lever (see lever 168 on engagement member 164 in figs. 2 and 15, this being the only structure required for the swivel door assembly by the claim) in an upright and depressed orientation (the lever 168 fig. 15 would have an upright/undepressed orientation and a depressed orientation); and
a plurality of sensors (see plurality of sensors 238 fig. 15 and occlusion sensor 22 fig. 14) including at least one occlusion sensor (22 fig. 14),
wherein the security door assembly interlocks with the security frame assembly (see access door 36 interlocked with housing 12 in fig. 1) and the lock assembly mates with the receiver (see key/lock 38 in fig. 1 which mate with a receiver to lock the access door 36).
However, Gillespie fails to explicitly disclose at least one downstream inline pressure sensor.
Gillespie and Bhandar are analogous art since they both relate to the field of endeavor of medical pumps.
Bhandar teaches of at least one downstream inline pressure sensor (see downstream pressure sensor 174 which is shown to be an inline sensor in fig. 1C). Bhandar further teaches that “pressure sensors (e.g., pressure sensors 174 a, 174 b) may confirm proper IV tube loading” in pr. 77 and that “After the pump reaches steady state, occlusion detection may be based on a change in pressure or delta pressure instead of the High, Medium, or Low threshold settings” in pr. 89, which the downstream pressure sensor would function in.
Therefore, it would have been obvious before the effective filing date of invention to one of ordinary skill in the art to have modified Gillespie with the downstream inline pressure sensor disclosed by Bhandar so as to obtain the benefit of ‘confirming proper IV tube and/or syringe loading as well as monitoring pressure levels for changes in pressure for occlusion detection’ as taught by Bhandar.
Regarding Claim 17, the combination of Gillespie and Bhandar discloses the pump of claim 12, wherein when the security door assembly and security frame assembly interlock and are in a closed configuration (shown in fig. 1), the syringe holder is inaccessible (the syringe compartment 34 is inaccessible when the door 36 is closed as shown in fig. 1).
Regarding Claim 18, the combination of Gillespie and Bhandar discloses the pump of claim 12, wherein when the security door assembly and security frame assembly interlock and are in a closed configuration (shown in fig. 1), the display screen is accessible (see screen 60 of user interface 16 which are accessible in fig. 1).
Regarding Claim 19, the combination of Gillespie and Bhandar discloses the pump of claim 12, wherein when the security door assembly and the security frame assembly interlock and are in a closed configuration (shown in fig. 1), the swivel door assembly is inaccessible (the lever 168 in fig. 15 would be inaccessible when the door 36 is closed since the whole syringe compartment 34 and drive mechanism 20 would be inaccessible).
Regarding Claim 20, the combination of Gillespie and Bhandar discloses the pump of claim 12, wherein when the security door assembly and security frame assembly interlock and are in a closed configuration (shown in fig. 1), the actuator is inaccessible (the drive mechanism 20 is inaccessible when the door 36 is closed as shown in fig. 1).
Allowable Subject Matter
Claims 13-17 would be allowable if rewritten to overcome the claim objection, and/or the rejection(s) under 35 U.S.C. 112(a) and/or 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding Claims 13 and 14, no prior art was found which anticipated or rendered obvious the required limitations of claim 13. Specifically, “wherein the swivel door assembly further comprises a main assembly body to which the lever door pivotably couples, a swivel door that is pivotably attached to the assembly body and that includes side walls, a side wall plate coupled to the main assembly body so as to fully cover the syringe pump lever, a lever stopper, and a pull knob stopper” in context of all intervening limitations. WO2014020633A1 discloses a cover which covers the top of a lever but lacks the other limitations required by the claim. US 2017/0258985 discloses a locking mechanism for the pump’s connection with the plunger head so as to prevent/allow actuation of the coupling mechanism, but fails to recite the particular structure required by the claim.
Regarding Claims 15 and 16, no prior art was found which anticipated or rendered obvious the required limitations of claim 15. Specifically, “wherein the lever stopper is pivotably attached to the main assembly body and interlocks with the syringe pump lever to retain it in an upright orientation, and wherein the pull knob stopper includes a locking pin that mates with the lever stopper at a locking receptacle to selectively lock it when it interlocks with the syringe pump lever”, in context of all intervening limitations. US 2017/0258985 discloses a locking mechanism for the pump’s connection with the plunger head so as to prevent/allow actuation of the coupling mechanism, but fails to recite the particular structure required by the claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 7018361 and US 11724026– US patent grant of prior art cited above
US 2017/0258985 – (also cited in the section above) discloses a syringe infusion pump security system which utilizes a lock to retain a syringe body within the main frame, as well as a separate lock mechanism for the plunger head.
US 12121697 – discloses a syringe pump with a plurality of sensors, the sensors include a downstream force sensor that is used for things such as occlusion detection.
US 11529457 discloses a syringe pump with a lockable housing, a sensor is further provided such that the pump can be programed to only function with the housing is locked/closed.
BR102013022803A2, US 2023/0338648 and 5009641– disclose a syringe pump with a closable cover for the syringe.
US D1021073-S, WO2018036875A1 and US 12214158 – disclose a syringe pump and features related to the plunger head connector and/or items surrounding it.
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/W.L.F./Examiner, Art Unit 3745
/COURTNEY D HEINLE/Supervisory Patent Examiner, Art Unit 3745