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
This office action is responsive to the amendment filed on 10/02/2025. As directed by the amendment: claims 1-2, 5, 11-12, 17-20 have been amended, claims 3-4, 6, 10, 13-14, and 16 have been cancelled, and no new claims have been added. Thus, claims 1-2, 5, 7-9, 11-12, 15, and 17-20 are presently pending in this application, with no claims being withdrawn from consideration. Applicant’s amendments to the drawings, specification, and claims have overcome several of the objections, several of the 112(b) rejections, and the 101 rejection of claim 10 as set forth in the Non-Final Office Action mailed on 07/02/2025. Examiner notes the objection to claim 11, the 112(b) rejection of claim 17, and the 101 rejection of claim 9 have been maintained.
Response to Arguments
Applicant’s arguments, see p.13-14 of “Remarks”, filed 10/02/2025, with respect to the 102 rejection of claims 1, 11, and 20 have been fully considered and are persuasive. The 102 rejection of 10/02/2025 has been withdrawn.
Examiner further notes applicant stated on p.12 of “Remarks” that Claim 9 was amended herein to overcome the 101 rejections but this was not reflected in the “Claims” filed on 10/02/2025. Thus, the 101 rejection of claim 9 is maintained.
Drawings
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 “first and second pump modules removably connected to the control unit by way of respective plugin ports on the control unit” in claim 7 and “connecting each infusion device to a control unit by way of respective plugin ports on the control unit” in claim 18 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 Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 9 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 9¸ the phrase “wherein the common delivery conduit is an intravenous tubing connected to a patient” in lines 1-2 positively recites a human organism. Examiner suggests amending to state “wherein the common delivery conduit is an intravenous tubing configured to be connected to a patient.”
Claim Objections
Claims 5, 7, 11-12, 17 and 20 are objected to because of the following informalities:
Regarding claim 5, the phrase “a first level“ in line 6 should read “a first lever” to fix a typo.
Regarding claim 5, the phrase “amotion” in line 8 should read “a motion” to fix a typo.
Regarding claim 5, the phrase “is coordinate” in line 10 should read “is coordinated” for proper grammar,
Regarding claim 7, the phrase “and first and second pump modules removably connected” in line 2 should read “and first and second pump modules are removably connected” for proper grammar.
Regarding claim 11, the phrase “to delivery” in line 4 and line 10 should read “to deliver” for proper grammar.
Regarding claim 11, the phrase “a first compressible channel” in lines 4-5 should read “the first compressible channel” for proper antecedent basis.
Regarding claim 11, the phrase “a second compressible channel” in lines 11-12 should read “the second compressible channel” for proper antecedent basis.
Regarding claim 12, the phrase “wherein each of the first and second pumping segments comprise an upstream occluder, a downstream occluder, and a plunger” in lines 1-3 should read “wherein each group of serially-aligned pumping elements of the first and second pumping segments comprises an upstream occluder, a downstream occluder, and a plunger” for clarity.
Regarding claim 17, the phrase “a first level“ in lines 1-2 should read “a first lever” to fix a typo.
Regarding claim 17, the phrase “amotion” in line 4 should read “a motion” to fix a typo.
Regarding claim 17, the phrase “is coordinate” in line 5 should read “is coordinated” for proper grammar,
Regarding claim 20, the phrase “An patient care unit” in line 1 should read “A patient care unit” for proper grammar,
Regarding claim 20, the phrase “an elongated compressible channel” in lines 8-9 should read “a respective elongated compressible channel” for clarity,
Regarding claim 20, the phrase “the first and second pump modules” in line 12 should read “the first and second infusion pump modules” for proper antecedent basis,
Regarding claim 20, the phrase “the first pump” in line 16 and “the second pump” in line 17 should read “the first infusion pump module” and “the second infusion pump module” for proper antecedent basis,
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.
Claims 1-2, 5, 7-9, 11-12, 15, and 17-20 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 1, the phrase “an infusion device comprising a stand-alone first pump module and a stand-alone second pump module removably separable from the first pump module, the first pump module comprising a first pumping segment operated by a first camshaft and the second pump module comprising a second pumping segment operated by a second camshaft, wherein the first and second pumping segments are configured to operate in parallel with each other” in lines 2-6 fails to comply with the written description requirement and is new matter. Claim 1 fails to comply with the written description requirement for the following reasons:
1. Fig. 7 and para. 0049 discloses “with regards to Fig. 7, infusion device may include a control unit 14 and first and second pump modules 16, 18, 20, 22 removably connected to the control unit 14 by way of respective plugin ports on the control unit” which provides support for pump modules which are removably connected to a control unit but does not provide support for pump modules removably separable from one another. Thus, there is no support in the specification for pump modules that are removably separable from one another.
2. Further, para. 0060 provides support for the “stand-alone” limitation stating “It will also be appreciated that devices such as pumps or patient monitoring devices that provide sufficient programmability and connectivity may be capable of operating as stand-alone devices and may communicate directly with the network without connected through a separate interface unit or control unit 14.” Para. 0049 further states “The first pump module may include the first pumping segment and the second pump module comprising the second pumping segment.” Thus, looking at Fig. 3 depicting the infusion device 12 which is synonymous with the patient care device 12 in Fig. 7 comprising the functional modules, there is not support for the first and second pumping segments as seen in Fig. 3 being stand-alone nor removably separable from one another as the pumping segments 326 of each segment appear integral with the pump housing and each segment is connected by the levers in Fig. 4A in order for operation.
Therefore, this limitation is new matter.
d infusion device being removably separable from the first infusion device” in line 9 fails to comply with the written description requirement and is new matter. Examiner is interpreting the first infusion device and the second infusion device to be synonymous with the first pump module and second pump module. Thus, as discussed above, there is not support for the infusion devices to be removably separable from one another, and further, there is not support for the infusion devices comprising their respective pumping segments to be removably separable from one another.
Regarding claim 20, the phrase “the second infusion pump module being removably separable from the first pump module and the patient care unit” in lines 3-5 fails to comply with the written description requirement and is new matter. As discussed above, there is not support for the infusion devices to be removably separable from one another, and further, there is not support for the infusion devices comprising their respective pumping segments to be removably separable from one another.
Regarding claims 2, 5, 7-9, 12, 15, and 17-19, these claims are rejected due to being dependent upon a rejected base claim.
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 1-20 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 1, the phrase “an infusion device comprising a stand-alone first pump module and a stand-alone second pump module removably separable from the first pump module, the first pump module comprising a first pumping segment operated by a first camshaft and the second pump module comprising a second pumping segment operated by a second camshaft, wherein the first and second pumping segments are configured to operate in parallel with each other” in lines 2-6 renders the claim indefinite because it is unclear. Firstly, the examiner cannot ascertain the scope of a “stand-alone” pump module that is also removably separable from another “stand-alone” pump module as being removably separable indicates a degree of connection which contradicts the term “stand-alone”. Secondly, it is unclear how the first pumping segment is both stand-alone and removably separable from the second pumping segment. Looking at Fig. 3 and para. 0033, the pumping segments 326 of the first and second pumping segments appear integral with the pump housing and each segment is connected by the levers in Fig. 4A in order for operation.
Regarding claim 1, the phrase “a first compressible channel” in line 15 renders the claim indefinite because it is unclear. It is unclear whether this is the same channel as the “respective elongated compressible channel” in line 9 or a different channel. Examiner is interpreting it as one of the respective elongated compressible channels, and examiner suggests applicant amend to state “…configured to compress a respective elongated compressible channel loaded within the respective pumping segments, wherein the respective elongated compressible channel comprises a first compressible channel loaded within the first pumping segment and a second compressible channel loaded in the second pumping segment” in line 9 to tie the first and second channels to the previously recited respective channel.
Regarding claim 1, the phrase “respective deliveries of the first and second fluids are continuous but do not overlap” in lines 20-21 renders the claim indefinite because it is unclear. It is unclear how each respective delivery is continuous yet the deliveries of the first and second fluid do not overlap. Examiner is interpreting this limitation, in light of specification para. 0027-0030, as the fluid delivery is continuous but the respective deliveries of the first and second fluids does not overlap. Examiner suggests amending to state “so that fluid delivery is continuous but respective deliveries of the first and second fluids does not overlap”.
Regarding claim 2, the phrase “wherein delivering a fluid from a respective compressible channel” in lines 4-5 renders the claim indefinite because it is unclear. It is unclear whether this is a different fluid and compressible channel or the same as those mentioned in claim 1. Examiner is interpreting them as the same and suggests amending to state “wherein delivering the fluid from the respective compressible channel”.
Regarding claim 7, the phrase “wherein the infusion device comprises a control unit and first and second pump modules removably connected to the control unit by way of respective plugin ports on the control unit” in lines 1-3 renders the claim indefinite because it is unclear in light of the amendments to claim 1. Firstly, Fig. 7 and para. 0049 discloses “with regards to Fig. 7, infusion device may include a control unit 14 and first and second pump modules 16, 18, 20, 22 removably connected to the control unit 14 by way of respective plugin ports on the control unit”; however, para. 0060 states “It will also be appreciated that devices such as pumps or patient monitoring devices that provide sufficient programmability and connectivity may be capable of operating as stand-alone devices and may communicate directly with the network without connected through a separate interface unit or control unit 14.” Therefore, it is unclear how the pump modules are both stand-alone devices as defined by the spec. and also removably connected to the control unit as claimed. Secondly, it is unclear in light of claim 1 stating the first pump module comprises the first pumping segment and the second pump module comprises the second pumping segment, how said modules and pumping segments are removably connected to the control unit via respective plugin ports. Fig. 3 illustrates the pumping segments 326 as integral with the pump housing and does not illustrate any plugin port structure.
Regarding claim 11, the phrase “the second infusion device being removably separable from the first infusion device” in line 9 renders the claim indefinite because it is unclear. It is unclear how the first infusion device comprising the first pumping segments 326 and the second infusion device comprising the second pumping segments 326 as illustrated in Fig. 3 and 4A are removably separable from one another as discussed above.
Regarding claim 11, the phrases “a first fluid” in line 17 and “a second fluid” in line 18 renders the claim indefinite because they are unclear. It is unclear whether these are different fluids or the aforementioned fluids in claim 11. Examiner is interpreting them as the same.
Regarding claim 11, the phrases “a first compressible channel” in line 17 and “a second compressible channel” in line 18 render the claim indefinite because they are unclear. It is unclear whether these are different channels or the aforementioned channels in claim 11. Examiner is interpreting them as the same.
Regarding claim 11, the phrase “respective deliveries of the first and second fluids are continuous but do not overlap” in lines 22-23 renders the claim indefinite because it is unclear. It is unclear how each respective delivery is continuous yet the deliveries of the first and second fluid do not overlap. Examiner is interpreting this limitation, in light of specification para. 0027-0030, as the fluid delivery is continuous but the respective deliveries of the first and second fluids does not overlap. Examiner suggests amending to state “so that fluid delivery is continuous but respective deliveries of the first and second fluids does not overlap”.
Regarding claim 12, the phrase “wherein delivering a fluid from a respective compressible channel” in line 3 renders the claim indefinite because it is unclear. It is unclear whether this is a different fluid and compressible channel or the same as those mentioned in claim 1. Examiner is interpreting them as the same and suggests amending to state “wherein delivering the fluid from the respective compressible channel”.
Regarding claim 15, the phrase “wherein the infusion device includes…” in lines 1-2 renders the claim indefinite because it is unclear. It is unclear whether this is referring to the first infusion device, the second infusion device, or both. Examiner is interpreting this limitation as a singular infusion device that comprises the first and second pump modules includes a pump housing.
Regarding claim 17, the phrase “a respective lever coordinating a motion of each pumping element of the respective pumping element set based on a motion of the other pumping element of the respective pumping element set” in lines 9-11 renders the claim indefinite because it is unclear. Firstly, it is unclear if “a respective lever” is referencing the first lever, second lever, third lever, or all three levers. Secondly, it is unclear if “each pumping element of the respective pumping element set” and “the other pumping element of the respective pumping element set” are referring to the first group of serially-aligned pumping elements as a whole, a singular element within this first group, the second group of serially-aligned pumping elements as a whole, or a singular element within this second group. Examiner is interpreting this limitation as the first lever coordinates a motion of a first upstream occluder of the first pumping segment based on a motion of a second upstream occluder of the second pumping segment, and so on and so forth for the second lever and the third lever. Examiner suggests applicant amend claim 17 to state:
“wherein the respective upstream occluders, downstream occluders, and plungers comprise a first upstream occluder, a first downstream occluder, and a first plunger of the first pumping segment and a second upstream occluder, a second downstream occluder, and a second plunger of the second pumping segment,
wherein a first lever joins together the upstream occluders, a second lever joins together the downstream occluders, and a third lever joins together the plungers, such that a motion of the upstream occluders is coordinate by the first lever such that a motion of the first upstream occluder is based on a motion of the second upstream occluder, a motion of the downstream occluders is coordinated by the second lever such that a motion of the first downstream occluder is based on a motion of the second upstream occluder, and a motion of the plungers is coordinated by the third lever such that a motion of the first plunger is based on a motion of the second plunger.
Regarding claim 18, the phrase “connecting each infusion device to a control unit by way of respective plugin ports on the control unit” in lines 3-5 renders the claim indefinite because it is unclear in light of the amendments to claim 11. Firstly, Fig. 7 and para. 0049 discloses “with regards to Fig. 7, infusion device may include a control unit 14 and first and second pump modules 16, 18, 20, 22 removably connected to the control unit 14 by way of respective plugin ports on the control unit”; however, para. 0060 states “It will also be appreciated that devices such as pumps or patient monitoring devices that provide sufficient programmability and connectivity may be capable of operating as stand-alone devices and may communicate directly with the network without connected through a separate interface unit or control unit 14.” It is unclear in light of claim 11 stating the first infusion device comprises the first pumping segment and the second infusion device comprises the second pumping segment, how said infusion devices and pumping segments are removably separable from one another and connected to the control unit via respective plugin ports. Fig. 3 illustrates the pumping segments 326 as integral with the pump housing and does not illustrate any plugin port structure.
Claim 18 recites the limitation "the first and second pump modules" in lines 7-8. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this limitation as the first and second infusion devices of claim 11.
Regarding claim 20, the phrase “the second infusion pump module being removably separable from the first pump module and the patient care unit” in lines 3-5 renders the claim indefinite because it is unclear. It is unclear how the first pump module comprising the first pumping segments 326 and the second pump module comprising the second pumping segments 326 as illustrated in Fig. 3 and 4A are removably separable from one another as discussed above.
Regarding claim 20, the phrase “when a respective compressible channel” in line 10 renders the claim indefinite because it is unclear. It is unclear whether this is a different compressible channel or the aforementioned compressible channel. Examiner is interpreting it as the same and suggests amending to state “when the respective compressible channel”.
Claim 20 recites the limitation "the first camshaft and to control the second camshaft" in lines 12-13. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 20, the phrase “respective deliveries of the first and second fluids are continuous but do not overlap” in lines 20-21 renders the claim indefinite because it is unclear. It is unclear how each respective delivery is continuous yet the deliveries of the first and second fluid do not overlap. Examiner is interpreting this limitation, in light of specification para. 0027-0030, as the fluid delivery is continuous but the respective deliveries of the first and second fluids does not overlap. Examiner suggests amending to state “so that fluid delivery is continuous but respective deliveries of the first and second fluids does not overlap”.
Regarding claims 5, 8-9, and 19, these claims are rejected due to their dependency upon a rejected base claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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 KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 4:00 PM EST.
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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