DETAILED ACTION
The amendment filed November 26, 2025 has been entered. Claims 7-20 remain pending.
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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Currently, no claim limitation is being interpreted as invoking 35 U.S.C. 112(f).
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.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2008/0114328 to Doherty et al. (Doherty) in view of US Patent Application Publication 2009/0198208 to Stavsky et al. (Stavsky).
Regarding claim 7, Doherty discloses an electronic medical fluid transfer device (700) configured to transfer medical fluid from a source container (vial; see [0100]) to a destination container (710; see [0100]), the electronic medical fluid transfer device comprising: a computer processor (the computer having a processor which performs the computer program to operate the device; see [0019]); one or more supports (Fig. 7 shows the supports; i.e., the rails that support the modules) configured to receive a fluid transfer module (702) with an intermediate container or pumping region (716 forms an intermediate container and pumping region); an electromechanical driver (plunger manipulator 720 is an electromechanical driver such as a motor which actuates plunger gripper 722 to move plunger 724) configured to contact the intermediate container or pumping region (Fig. 7); a presence sensor (camera; see [0102]) in electronic communication with the computer processor, the presence sensor configured to detect the presence of a portion of the fluid transfer module (the camera detects the position of the needle which is part of the fluid transfer module and is in communication with the computer), wherein the one or more supports are configured to retain the fluid transfer module in place as the volume of liquid is transferred from a source container, into the intermediate container or pumping region, and then into the destination container (the supports hold the transfer module in place during the entire filling operation). Doherty does not disclose a volume sensor in electronic communication with the computer processor, the volume sensor comprising a camera; wherein the electronic medical fluid transfer device is configured to use the volume sensor to control a volume of liquid to be transferred to a destination container. Stavsky teaches a medical transfer device which includes a volume sensor (camera 6) in electronic communication with the computer processor (33), the volume sensor comprising a camera (camera 6 is used to detect the volume of fluid); wherein the electronic medical fluid transfer device is configured to use the volume sensor to control a volume of liquid to be transferred to a destination container ([0148]) to ensure the desired amount of medication is supplied. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a camera for detecting a volume of the fluid as taught by Stavsky in the device of Doherty to verify that the volume of fluid meets the desired volume.
Regarding claim 8, Doherty as modified by Stavsky discloses a combination of the electronic medical fluid transfer device of Claim 7 and the source container (vial; see [0100]).
Regarding claim 9, Doherty as modified by Stavsky discloses a combination of the electronic medical fluid transfer device of Claim 7 and the destination container (710).
Claims 10-20 are rejected under 35 U.S.C. 103 as being unpatentable over Doherty in view of Stavsky as applied to claim 7 above, and further in view of US Patent Application Publication 2011/0004187 to Beiriger (Beiriger).
Regarding claims 10-12, Doherty as modified by Stavsky discloses the electronic medical fluid transfer device of Claim 7 (see above), but does not disclose a gas sensor in the form of an ultrasonic sensor. Beiriger teaches a medical fluid transfer device including a gas sensor (bubble sensor) in the form of an ultrasonic sensor (see [0235]) to detect undesired gas (bubbles) in the fluid transfer system. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included an ultrasonic gas sensor as taught by Beiriger in the system of Doherty as modified by Stavsky to detect undesired gas (bubbles) in the fluid transfer system.
Regarding claim 13, Doherty as modified by Stavsky and Beiriger discloses the electronic medical fluid transfer device of Claim 10, and Beiriger further teaches the computer processor is configured to communicate electronically with the gas sensor (the computer communicates with the gas sensor) and the electromechanical driver (the computer communicates with the driver) to prime the fluid transfer module before use (see [0271]) to remove undesired gas from the system. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the system of Doherty as modified by Stavsky and Beiriger such that the computer processor primes the fluid transfer module prior to use as taught be Beiriger to remove undesired gas from the system.
Regarding claim 14, Doherty as modified by Stavsky and Beiriger discloses the electronic medical fluid transfer device of Claim 13, and Doherty further discloses the computer processor is configured to communicate electronically with the gas sensor (as modified above, the processor communicates with the gas sensor) and the electromechanical drive to purge gas from the fluid transfer module during use (see [0104]; transfer of gas out of transfer device 716).
Regarding claim 15, Doherty as modified by Stavsky and Beiriger discloses the electronic medical fluid transfer device of Claim 10, and the combination further discloses the electronic medical fluid transfer device is configured to use the volume sensor to determine a volume of liquid being transferred to the intermediate container (the volume sensor camera of Stavsky can be positioned to detect the volume of fluid in transfer device 716 of Doherty to ensure the correct volume is being supplied to container 710).
Regarding claim 16, Doherty as modified by Stavsky and Beiriger discloses the electronic medical fluid transfer device of Claim 10, and the combination further discloses the electronic medical fluid transfer device is configured to use the volume sensor to determine a volume of liquid being transferred to the destination container (the volume sensor camera of Stavsky can be positioned to detect the volume of fluid in destination container 710 of Doherty to ensure the correct volume is being supplied to container 710).
Regarding claims 17-18, Doherty as modified by Stavsky and Beiriger discloses the electronic medical fluid transfer device of Claim 10, and Stavsky further teaches the computer processor is configured to store an image from the camera in memory, wherein the image is stored in memory in a file as part of a verification system (see [0138]) to keep records of the medicine dispensed. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further configured the computer of Doherty to save images from the camera in memory as part of a verification system to keep records of the medicine dispensed as taught by Stavsky.
Regarding claim 19, Doherty as modified by Stavsky and Beiriger discloses combination of the electronic medical fluid transfer device of Claim 10 and the fluid transfer module (Doherty: fluid transfer device manipulator 702 have fluid transfer device 716).
Regarding claim 20, Doherty as modified by Stavsky and Beiriger discloses the electronic medical fluid transfer device of Claim 10, but does not disclose the volume sensor is positioned within a housing of the electronic medical fluid transfer device. However, the only options are that the volume sensor is within a housing of the transfer device or outside a housing of the transfer device. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to position the volume sensor within a housing of the transfer device as such a configuration requires only selecting one of a small number of identified and predictable solutions with a reasonable expectation of success. Placing the volume sensor within a housing of the transfer device allows the volume sensor to detect the volume of fluid in the transfer device with minimal obstructions and to move with the transfer device as it moves between its various positions.
Response to Arguments
Applicant's arguments filed November 26, 2025 have been fully considered but they are not persuasive. Applicant’s arguments that the cited documents do not disclose “wherein the one or more supports are configured to retain the fluid transfer module in place as the volume of liquid is transferred from a source container, into the intermediate container or pumping region, and then into the destination container” is not persuasive because, as set forth above, the supports (i.e., rails that support the module) retain the fluid transfer module in place during the entire filling operation (see Fig. 7 of Doherty).
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.
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/NICOLAS A ARNETT/Primary Examiner, Art Unit 3753 February 24, 2026