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
Claims 10-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/10/2025.
Response to Amendment
The amendment filed 12/10/2025 has been entered: Claims 10-26 pending in the present application. Claims 10-16 are withdrawn. Claims 17-18 are amended and claims 17-26 are examined on the merits.
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 third and fourth outlets of claims 20-25 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 § 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 22-25 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Case law holds that applicant's specification must be "commensurately enabling [regarding the scope of the claims]" Ex parte Kung, 17 USPQ2d 1545, 1547 (Bd. Pat. App. Inter. 1989) otherwise undue experimentation would be involved in determining how to practice and use applicant's invention. Although the statute itself does not use the phrase "undue experimentation", it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation as stated in Ex parte Forman, 230 USPQ 546, 547 (Bd. Pat. App. Inter. 1986) and in In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Specifically, in In re Wands the Court set forth a non-exhaustive list of factors to be considered in determining whether undue experimentation would be involved in making and/or using the claimed invention. These factors include, but are not limited to:
(a) the breadth of the claims;
(b) the nature of the invention;
(c) the state of the prior art;
(d) the level of one of ordinary skill;
(e) the level of predictability in the art;
(f) the amount of direction provided by the inventor;
(g) the existence of working examples; and
(h) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Claims 22-25 appear to indicate crossover between the outlet pairs (i.e. first and second outlets as the first pair, and third and fourth outlets as the second pair). However, Applicant’s specification describes this function generally (e.g. ¶s 148-152 of Applicant’s specification) and otherwise, only mirrors the claim language. Based on the direction provided by the inventor (Wands Factor F) and the level of one of ordinary skill in the art (Wands Factor E), one of ordinary skill in the art would not be apprised on how Applicant invention is capable of achieving the claimed valve configurations, particularly as the valve assembly is not shown/discussed in detail and is effectively a black box capable of performing the claimed functions. One of ordinary skill in the art would not be able without undue experimentation to remove any vents from the fluid container based on Applicant’s disclosure.
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 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 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Luxon et al. (US 2017/0143880 A1), Kagan et al. (US 2012/0123323 A1), in view of Peret et al. (US 2018/0038501 A1).
Regarding claim 17, Luxon teaches a tubeset assembly (Figs. 1-3; Abstract) comprising:
a tubeset module (valve device 110), the tubeset module comprising:
a housing (container 206) having a body extending between a first outlet formed on a first end of the housing and a second outlet formed on a second end of the housing (Figs. 2A-2B show how the housing has a body that extends between and allows for outlets via connectors 202 and 204);
and a valve defining a first valve configuration in which the first outlet and the second outlet are in fluid communication with one another and a second valve configuration in which fluid communication between the first outlet and the second outlet is blocked (valve 208; ¶ 38 describes open and closed configurations).
Luxon does not explicitly teach a communications interface configured to allow for information to be wirelessly received by the tubeset module, a power source, and a controller configured to transmit, via the communications interface, first instructions and second instructions to the tubeset module;
wherein, in response to receiving the first instructions from the controller, the valve is configured to be actuated to the first valve configuration and wherein, in response to receiving the second instructions from the controller, the valve is configured to be actuated to the second valve configuration.
However, Kagan teaches a tubeset assembly for a wound therapy system, thus being in the same field of endeavor, comprising:
a tubeset module (connector 120, Fig. 1; Abstract; also shown in Fig. 11, connector 420)
a valve configured to selectively permit flow within the tubing when in an open configuration and to selectively block flow when in a closed configuration (¶ 43 describes valves within the tubeset module; also see ¶s 72-73);
a communications interface configured to allow for information to be received by the tubeset module (¶s 43 and 72 describe how the controller operates the valves in the connectors and thus the tubeset module inherently comprises a communications interface);
a power source (an electrical controller must inherently comprise a power source);
a controller configured to transmit, via the communications interface, first instructions and second instructions to the tubeset module;
wherein, in response to receiving the first instructions from the controller, the valve is configured to be actuated to the first valve configuration and wherein, in response to receiving the second instructions from the controller, the valve is configured to be actuated to the second valve configuration (¶s 43 and 72 describe how the controller operates the valves, where the valve configurations are the valve being opened and the valve being closed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Luxon to comprise the controller and power source of Kagan. Doing so would thus comprise the controller configured to transmit instructions to the tubeset module to actuate the valve between first and second valve configurations. Doing so would be advantageous in providing blockage removal means (¶s 35, 52, and 54 of Kagan), and also in generally providing automation.
The combination still does not explicitly teach the communications interface configured to receive communications wirelessly from a controller.
In addressing the same problem as Applicant, the problem being the operation of valves in a tubeset module, Peret teaches a fluid processing module comprising a controller (Fig. 1, element 15), with a valve (element 6) and various sensors (Paragraph 131). Peret also teaches the use of physical wires are wireless communication interchangeably (Paragraph 131).
Thus, Peret shows that using wireless communication devices is an equivalent structure known in the art in that wireless connections are equivalent to wired connections. Therefore, because these two controller communication means were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute the controller connections of Kagan and Locke with the wireless connections of Peret. Doing so would allow for equivalent communication between the controller of Peret and the tubeset module, and would allow for analogous control over the various components therein.
Further, the limitations of the tubeset assembly being “for a wound therapy system” and the tube set module configured “to be operably connected to a fluid canister and fluid tubing of the wound therapy system” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, device of Luxon, Kanan, and Peret has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. it is configured to be used in a wound therapy systems).
Regarding claim 18, Luxon further teaches comprising a first tubing adapter attached to the first outlet of the housing and a second tubing adapter attached to the second outlet of the housing (connectors 202 and 204; ¶ 38).
The limitations of wherein the first tubing adapter and the second tubing adapter are configured “to provide a fluid-tight attachment with fluid tubing of a wound therapy device” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, device of Luxon, Kanan, and Peret has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. it is configured to provide a fluid-tight connection to tubing of a wound therapy device).
Regarding claim 19, Luxon teaches the tubeset module further includes a calibrated leak (valve 210) providing fluid communication between at least one of the housing first end and the housing second end and an ambient atmosphere through an opening extending through the housing body (¶ 38).
Claims 20-26 are rejected under 35 U.S.C. 103 as being unpatentable over Luxon, Kagan, and Peret as applied to claim 17 above, and further in view of Lockwood et al. (US 2005/0004534 A1).
Regarding claims 20-26, the combination of Luxon, Kanan, and Peret does not explicitly teach (claim 20) the tubeset module further includes a third outlet provided on the first end of the housing and a fourth outlet provided on the second end of the housing, (claim 21) wherein in the first valve configuration, the third outlet in the fourth outlet are in fluid communication, (claim 22) wherein in the first valve configuration, fluid communication is blocked between the first outlet and the third outlet, between the first outlet and the fourth outlet, between the second outlet and the third outlet, and between the second outlet and the fourth outlet, (claim 23) wherein in the second valve configuration, fluid communication is provided between the first outlet and the third outlet, (claim 24) wherein the second valve configuration, fluid communication provided between the first outlet and the fourth outlet is blocked, (claim 25) wherein in the second valve configuration fluid communication between the third outlet in the fourth outlet is blocked, and (claim 26) wherein the valve comprises a rotatable valve.
However, Lockwood teaches a tubeset module for a wound dressing (Figs. 1, 5-9 and 25-28; Abstract), thus being in the same field of endeavor, wherein (claim 20) the tubeset module includes a third outlet provided on a first and of the housing and a fourth outlet provided on the second end of the housing (tube 216 comprises a first portion 324 and a second portion 326, comprising a first outlet and a second outlet; tube 218 comprises a first portion 332 and second portion 334, comprises a third outlet and a fourth outlet), (claim 21) wherein in a first valve configuration, the third outlet and fourth outlet are in fluid communication (¶s 127-129 describes when cut out portion 342 aligns to provide fluid communication through tube 218), (claim 22) wherein in the first valve configuration, fluid communication is blocked between the first outlet and the third outlet, between the first outlet and the fourth outlet, between the second outlet and the third outlet, and between the second outlet and the fourth outlet (Fig. 27 and ¶s 56 and 128 describe the valve having an off position which fully blocks all conduits), (claim 23) wherein in the second valve configuration, fluid communication is provided between the first outlet and the third outlet (Figs. 20, 22, and 24 show the use of y-connector 212, which comprises a irrigation portion 248 and a vacuum portion 252; which would connect first and third conduits when the valve is in the open position, where the third conduit and first conduit are most adjacent to where the Y connector can be attached), (claim 24) wherein in the second valve configuration, fluid communication provided between the first outlet and the fourth outlet is blocked (the first outlet and fourth outlet are on different tubes, and thus fluid communication will be blocked in the second valve configuration), and (claim 25) wherein in the second valve configuration fluid communication between the third outlet in the fourth outlet is blocked (where the second valve configuration is when the second tube 218 is closed, the third outlet and fourth outlet would be blocked from one another), and (claim 26) wherein the valve comprises a rotatable valve (¶s 128-131).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Luxon, Kanan, and Peret to comprise the multi-outlet and rotatable valve configuration of Lockwood. Doing so would thus comprise (claim 20) the tubeset module further includes a third outlet provided on the first end of the housing and a fourth outlet provided on the second end of the housing, (claim 21) wherein in the first valve configuration, the third outlet in the fourth outlet are in fluid communication, (claim 22) wherein in the first valve configuration, fluid communication is blocked between the first outlet and the third outlet, between the first outlet and the fourth outlet, between the second outlet and the third outlet, and between the second outlet and the fourth outlet, (claim 23) wherein in the second valve configuration, fluid communication is provided between the first outlet and the third outlet, (claim 24) wherein the second valve configuration, fluid communication provided between the first outlet and the fourth outlet is blocked, (claim 25) wherein in the second valve configuration fluid communication between the third outlet in the fourth outlet is blocked, and (claim 26) wherein the valve comprises a rotatable valve. Doing so would be advantageous in providing a second conduit for additional functions (e.g. irrigation) and also providing valve control over both (¶ 10 of Lockwood).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Adamson (US 3,586,049 A) teaches a valve configuration which provides cross-over between outlets.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALESSANDRO R DEL PRIORE/Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781