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 § 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.
Claims 1, 3-5,7-9, 22 and 24-25 are 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.
Claims 1 and 22 recites “the flow rate of the drug actively controlled only by the actuation of the fluid valve by the digital controller, actuation of the fluid valve by the digital controller occurring only in response to a determination that the piston has travelled the controlled distance”. While the instant application paragraphs [0022], [0031], [0035] provide support for the fluid valve being actuated as a response to a determination that the position has travelled the controlled distance, the instant specification as originally filed does not disclose that the flow rate of the drug is actively controlled only by the actuation of the fluid valve and that the actuation of the fluid valve occurs only in response to a determination that the position has travelled the controlled distance. Flow rate may be partially determined by the flow valve (switch) that changes however, one of ordinary skill in the art would also recognize that flow rate would be determined by the size of the syringe, the speed of the plunger within the syringe moving, the pressure applied to the system etc. Similarly, there is no explicit disclosure that only the distance of the plunger determines when the fluid valve is actuated. Paragraph [0035] as cited by the applicant in the remarks filed 3/20/2026 recites that “the combination of timing and the confirmation that the piston 138 has travelled a controlled distance”, this itself appears to contradict that ‘only’ the distance the piston has travelled actuates the fluid valve, or that ‘only’ the actuation of the fluid valve regulates the flow rate of the drug.
Claims 3-5, 7-9, and 24-25 are rejected due to their dependency on claim 1.
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 1, 3-5, 7-9, 22 and 24-25 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.
Claims 1 and 22 recite “the flow rate of the drug actively controlled only by the actuation of the fluid valve by the digital controller, actuation of the fluid valve by the digital controller occurring only in response to a determination that the piston has travelled the controlled distance”. It is unclear how the flow rate is actively controlled ‘only’ by the actuation of the fluid valve. Flow rate is commonly affected by size of the syringe, the speed/pressure of the piston, and other factors. It is unclear how the flow rate is only being actively controlled by a fluid valve actuation. Furthermore, instant paragraph [0035] appears to teach it’s a combination of “timing and confirmation of the piston 138 has travelled a controlled distance” that allows the flow rate monitor to act as a flow meter. Therefore, it is unclear what the scope of this claim is.
Claims 3-5, 7-9, and 24-25 are rejected due to their dependency on claim 1.
Response to Arguments
Applicant's arguments filed 7/6/2026 have been fully considered but they are not persuasive.
As to the remarks on Pgs. 7-9, the applicant states that that it is obvious to one of ordinary skill in the art that the actuation of the fluid valve is the ‘only’ structure that ‘actively controls’ the flow rate of the drug, therefore the instant specification supports this amendment. However, the examiner does not find this persuasive. The instant specification does not use the terms “actively control”, or “only” in relation to the fluid valve, flow rate or the actuation of the fluid valve. There are many factors that could determine the flow rate of the drug other than the actuation of the fluid valve (as described above); therefore it is unclear if the limitation is supported by the originally filed specification. Therefore the 112 rejections are maintained.
The examiner notes that no prior art based rejections are made due to the clarity issues outlined in the USC 112 rejections above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dorsey (CA 2692057) teaches a enteral feeding system with a fluid valve that is actuated based on the amount of volume that has entered the syringe. Dorsey also teaches that the volume entering the syringe is directly related the movement of the piston within the syringe (See [0027-0028]).
Ogden (US 5611458) teaches a determination of flow rate based on measuring elapsed time between closing the valve at the end of one cycle and the closing of the valve at the end of the next cycle.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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