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 without traverse of Group I, claims 1-8 and 20 is acknowledged.
Claims 9 and 10-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II and III, respectively, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/06/2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 510 and 508, fig. 5. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
Claim 8 is 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 8, the limitation "the second lumen further includes a third port, and wherein foam is delivered to the cavity through the third port" lacks support in applicant's disclosure. While the third port is disclosed, (see, at least, fig. 5 port 514) said "third port" is not described as capable of delivering foam to the cavity. Rather, the third port (and second lumen in general) is used for foam return from the cavity (see applicant's Specification, paras. 0047, 0082, and 0099).
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Demey et al. (US 10125886 B2).
Regarding claim 1, Demey discloses a foam delivery system comprising: a pressurized container (pressurized container 2) configured to store foam material (col. 3 ll. 27-28); a control valve (valve 3) configured to selectively dispense the foam material from the pressurized container (col. 1 ll. 19-22); and a lumen (dispensing tube 6) configured to direct foam from the pressurized container to an application site within a cavity (col. 2 ll. 2-5, wherein the dispensing tube is capable of directing foam from the pressurized container to a cavity).
Regarding claim 2, in addition to the limitations of claim 1, Demey further discloses a connector (adapter 30 in cooperation with male mounting portion 12) configured to connect the control valve and the lumen such that the lumen is selectively removable from the connector (col. 5 l. 58 to col. 6 l. 5 and fig. 2).
Regarding claim 3, in addition to the limitations of claim 2, Demey further discloses wherein the connector includes a threaded portion (male threaded element 20 and female threaded element 40, col. 6 ll. 6-27).
Regarding claim 4, in addition to the limitations of claim 1, Demey further discloses wherein the lumen comprises one or more ports formed in a side of the lumen (col. 2 ll. 2-5, wherein the distal side of the dispensing tube comprises a port, which is necessary for dispensation).
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.
Claims 5-6, 8, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Demey et al. (US 10125886 B2) in view of Johnson et al. (US 8029498 B2).
Regarding claim 5, in addition to the limitations of claim 4, Demey further discloses the lumen but remains silent to the lumen is a dual lumen. Johnson teaches the lumen is a dual lumen (fig. 4b and col. 8 l. 54 to col. 9 l. 10). It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the lumen to be a dual lumen. In doing so, the device advantageously allows for two separate fluid paths wherein the fluid passing through the paths can be air, gas, antibacterial agents, or foam (Johnson: col. 8 l. 63 to col. 9 l. 7 and col. 5 ll. 60-62)
Regarding claim 6, in addition to the limitations of claim 5, the already modified device further teaches wherein the dual lumen includes a first lumen (Johnson: either first lumen 263 or second lumen 265) and a second lumen (Johnson: either first lumen 263 or second lumen 265), wherein the one or more ports includes a first port and a second port (Johnson: openings 251 and/or distal orifice 243), wherein the first lumen includes the first port, and wherein the second lumen includes a second port (Johnson: col. 9 ll. 11-33).
Regarding claim 8, in addition to the limitations of claim 6, the already modified device further teaches wherein the second lumen further includes a third port (Johnson: openings 251, wherein the second lumen is first lumen 263), and wherein the foam is delivered to the cavity through the third port (Johnson: col. 8 ll. 38-44).
Regarding claim 20, in addition to the limitations of claim 1, the already modified device further teaches wherein the foam delivery system is coupled with an endoscopy system, a laparoscopy system, or a system used in veterinary applications (wherein the lumens and medical foam/fluid can be adapted for use for treating a variety of tissue and organs in conjunction with known methods for medical treatment and procedures, Johnson: col. 30 ll. 24-45).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Demey et al. (US 10125886 B2) in view of Johnson et al. (US 8029498 B2), as applied in claim 6, further in view of Bybordi et al. (US 6979324 B2).
Regarding claim 7, in addition to the limitations of claim 6, the already modified device further discloses wherein the foam is delivered to the cavity through the first port in the first lumen (Johnson: col. 9 ll. 1-10), however, remains silent wherein excess foam is removed from the cavity through the second port in the second lumen. Bybordi teaches wherein excess is removed from the cavity through the second port in the second lumen (drain/suction unit 14, coupled to multi-lumen tubing 2, col. 9 l. 50 to col. 10 l. 9). It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the second lumen to include a means for removing excess foam. The combination of a dual lumen with separate flow paths capable of transporting foam with the vacuum system capable of extracting substance within a cavity achieves the function of removing excess foam within a cavity. In doing so, the devices when combined function predictable and as intended when implemented separate (refer to Johnson: col. 8 l. 53 to col. 9 l. 7, discussing separable flow paths of the dual lumens, and Bybordi, col. 7 ll. 34-51, discussing the function of the drain/suction system in cooperation with a dual lumen for dispensing and removal of substance).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kane et al. (US 20080275409 A1) for a dual lumen system with a vacuum lumen and pressurized delivery lumen and Lao et al. (US 20200086097 A1) for a pressurized foam container with an adjustable lumen.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER STEVEN PARISI whose telephone number is (571)270-5490. The examiner can normally be reached Mon - Fri 8:00 - 5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Angwin can be reached at (571) 270-3735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER S. PARISI/Examiner, Art Unit 3754
/DAVID P ANGWIN/Supervisory Patent Examiner, Art Unit 3754
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