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 .
Election/Restrictions
Applicant’s election with traverse of Group I in the reply filed on 29 June 2026 is acknowledged. While the election was indicated as “with traverse”, Examiner notes that there were no arguments put forward specifically traversing or pointing out any errors in the requirement. Rather traversal appears to be solely made for the purposes of rejoinder of Claim 24. Examiner notes that method claims will be considered for rejoinder upon the identification of allowable subject matter of the elected invention, however rejoinder is dependent upon the method claims incorporating all of the subject matter of such an allowable device claim.
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(s) 20 is/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.
Regarding Claim 20, Applicant makes reference to a “signal detector” and a “coupling system” to “movably couple the signal detector to an onside surface of the cartridge at one or more locations”. However, this embodiment is recited in a wholly conclusory fashion with no further exposition or disclosure in the instant specification. As such, the instant specification fails to demonstrate that Applicant was in possession of the instantly claimed invention, either actually or constructively, at the time of filing. There is no explanation as to what this particular embodiment is or how it performs, there is no clear exposition of physical structure, or explanation as to what this “system” entails or how it might operate. Furthermore, there is no explanation of what physical structure is particularly meant by a “coupling system” or how such a system might “movably couple”.
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.
Claim(s) 6 and 20 is/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 6, Applicant recites “comprising a drive mechanism”. However, Claim 6 is dependent on Claim 5 which is in turn dependent on Claim 4 which recites “a drive mechanism…” It is therefore unclear if the “a drive mechanism” of Claim 6 is the same or different from the “a drive mechanism” previously introduced in Claim 4.
Regarding Claim 20, Applicant makes reference to a “signal detector” and a “coupling system” to “movably couple the signal detector to an onside surface of the cartridge at one or more locations”. However, this embodiment is recited in a wholly conclusory fashion with no further exposition or disclosure in the instant specification. As such, it is unclear what Applicant means by a “coupling system” and “movably couple”. The phrase “couple” can be a functional term or a structural term and the instant specification fails to define the “system” or how the claimed components might “couple”. As such, the metes and bounds of such a system cannot be ascertained.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-6, 11-14, 19-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2017/0197037 (“Edwards”).
Regarding Claim 1, Edwards discloses a system (10) comprising:
a cartridge (40) including a piston (46) configured to move within a holding chamber (41) of the cartridge and urge medicine toward an interface (59, 23) between the holding chamber and a region external to the cartridge;
a pneumatic drive system (inter alia 37) to actuate movement of the piston within the holding chamber (Par. 100, 103);
a position detector (34) to generate information about a position of the piston within the holding chamber (Par. 118, 155); and
a controller (120) to vent working fluid from the pneumatic drive system at least partially responsive to information about the position of the piston within the holding chamber generated by the position detector (Par. 127, 187 – i.e. “[w]hen the required dose rate is reached, the pneumatic control valve 67 shuts off the pressurized air to the drive cylinder 42 and opens a gas release port 88” and “the sensor 34 is in communication with the processing module 105 and when the require dose rate is reached…”).
Regarding Claim 2, Edwards discloses the controller is configured to: determine an indicated position of the piston within the holding chamber of the cartridge corresponds with a predetermine position; and
generate a command to vent working fluid from the pneumatic drive at least partially responsive to the determination (Par. 127, 187, i.e. the sensor is used to determine the position of the piston with respect to a desired dosage to determine when the movement of the piston indicates that the dose has been delivered whereafter the controller vents the working fluid from the drive in response thereto).
Regarding Claim 3, Edwards discloses the predetermined position is associated with a predetermined amount of medicine (Par. 118, 155).
Regarding Claim 4, Edwards discloses the pneumatic drive system comprises:
a compressor (65), i.e. a source of compressed working fluid which releases the fluid in order to provide the working force to the cylinder, to generate working fluid (Par. 102);
a drive mechanism (49) to apply force to the piston (Par. 103);
a transfer system (71) to provide working fluid to and from the drive mechanism (Par. 121);
a port (88) to permit escape of working fluid from the transfer system; and
a valve (67) to regulate flow of working fluid from the transfer system to the port (Par. 127).
Regarding Claim 5, Edward discloses the valve is configured to exhibit at least two states, the at least two states comprising an open state and a closed state, wherein the open state is associated with permitting flow of working fluid from the transfer system to the port, and wherein the closed state is associated with inhibiting or blocking flow of working fluid from the transfer system to the port (Par. 127, 187).
Regarding Claim 6, Edwards discloses a drive mechanism configured to, at least partially responsive to a command to vent working fluid, change a state of the valve from the open state to the closed state, and from the closed state to the open state (Par. 127, 187).
Regarding Claim 11, Edwards discloses a tank of the compressor (65) is sized to limit an amount of working fluid in the tank to a predetermined maximum amount of working fluid (i.e. the tank holds a maximum mass of working fluid based upon the volume of the tank and the degree to which the tank is compressed).
Regarding Claim 12, Edwards discloses the predetermined maximum amount of working fluid is associated with a predetermined maximum volume displacement of medicine within the holding chamber of the cartridge (i.e. since the volume of medicament to be delivered is based upon the working fluid being released from the compressor the volume of the tank (65) defines a maximum possible volume of medicament that can possibly be delivered by the system).
Regarding Claim 13, Edwards discloses the drive mechanism includes a chamber (43) of the cartridge behind the piston, the chamber to hold working fluid received via the transfer system.
Regarding Claim 14, Edwards discloses an inhibitor (73, 69) to selectively inhibit operation of the pneumatic drive system.
Regarding Claim 19, Edwards discloses the position detector is configured to detect presence of the piston at one or more locations along the extent of the cartridge (Par. 118).
Regarding Claim 21, Edwards discloses that the position detector may comprise an optical signal detector (Par. 118).
Regarding Claim 20, Examiner submits that the instant phrasing in Claim 20, absent any further disclosure, is understood to be sufficiently broad as to encompass the “coupling” of a light signal against the surface of the container/piston, as described by Edwards, the coupling involving the movement of photons on the outer surface which are thereby detected by the sensor arrangement as a detectable light signal.
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) 22 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0197037 (“Edwards”) as applied above, and further in view of WO 2019/006432 (“Brady”).
Regarding Claims 22 and 23, Edwards discloses the invention substantially as claimed except that that the position detector system includes a capacitive signal detector or an inductive signal detector. However, Brady such arrangements are suitable alternatives to linear and optical encoders for determining the piston of a piston/plunger within a chamber (Par. 43, 54). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the sensor of the invention of Edwards to utilize either capacitance or inductance in place of the optical encoder, as disclosed by Brady, thereby only achieving the expected and predicted results associated with simple substitution of known equivalents with the various sensor arrangements being understood by the prior art to be useful and effective for determining piston/plunger position in a known and predictable manner.
Claim(s) 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0197037 (“Edwards”) as applied above, and further in view of
U.S. Publication No. 2011/0196232 (“Kim”) and WO 2016/049542 (“Freidrichs”)
Regarding Claim 14-16, Edwards discloses the invention substantially as claimed except that the system further comprises an inhibitor which is “at least partially responsive to detection of improper venting of then pneumatic drive system” to “inhibit” operation of the system. However, Kim discloses a related pneumatically powered injector system (Fig. 1) which comprises a sensor arrangement which monitors operative temperature and pressure within the compartments of the system to ensure efficacy and safety of the system, the device being provided with an inhibitor (re: “warning light or audio signal” which will be activated to “inhibit”, i.e. warn a user to discontinue use of the system, when the sensor arrangement detects unsafe conditions due to pressure variances, e.g. improper venting which would result in unexpectedly high pressures within the system. It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide an inhibitor in the system of Edwards responsive to unexpected pressure fluctuations such as those pursuant to improper venting, as disclosed by Kim, in order to warn a user about unsafe or non-efficacious operation of the device so that they can discontinue use of the device, wherein the improper venting in modified Edwards will be inclusive to situations where the position of the piston is improper thereby causing the misventing of the system.
Should Applicant argue that the “inhibitor” of Kim does not sufficiently “inhibit” operation of the device itself, rather only acting as a warning/alert to the user to stop operation the following is presented. Freidrichs discloses a medical delivery device which like that of Kim monitors pressure of the system to determine safe and efficacious operation of the system where the sensor arrangement can determine blockages or misoperation of venting systems and issue an output error/alert AND prevent/inhibit further operation of the device (Par. 122). It would have been obvious for one having ordinary skill in the art at the time the invention was made to modify the device of modified Edwards to have the controller prevent further operation of the device, i.e. inhibit operation of the compressor/pump when unsafe pressures are detected included those indicative of misventing of the device, as disclosed by Friedrichs, in order to ensure that the error/alert messages are not ignored/missed by the user and ensure that the device is not continued to be used when malfunctioning.
Claim(s) 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0197037 (“Edwards”) as applied above, and further in view of U.S. Publication No. 2011/0306929 (“Levesque”)
Regarding Claim 7-10, Edwards discloses the compressor comprises a tank (65) and a mechanical button (91) responsive to cause working fluid to be released from the tank into the pneumatic drive system in response to manual operation of the mechanical button. Edwards discloses the invention substantially as claimed except that that release of the fluid is responsive to operation of a piston within the tank. Rather Edwards discloses using a pin-type valve (73) which is activated to release the working fluid into the pneumatic system. However, Levesque discloses a related injector wherein a cartridge reservoir (224) is pressurized by a piston (234) which is fluidically induced to move by pressurizing a chamber (318) by using a compressor comprising a tank (214) which comprises a piston (230) inside the tank, the piston being actuated to force the fluid from the tank into the chamber to thereby convey a specific volume of medicament from the cartridge commensurate in the volume of fluid released from the tank. It would have been obvious for one having ordinary skill in the art at the time the invention was made to replace the compressor of Edwards with a piston and tank arrangement, as disclosed by Edwards, in order to allow the system to be manually pressurized thereby eliminating the need to provide a separate, pre-charged compressed tank.
Allowable Subject Matter
Claim(s) 17 and 18 is/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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 08/25/2026
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