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 .
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 10-20 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 10, the new matter is that “in response to the reduced pressure applied to the outer surface of the sponge via the at least one lumen terminating within the sponge, the sponge is configured to adopt the shape of the delivery member to thereby arrive at a sealed transition between the sponge and the inner wall of the body lumen” since the only mentions that one of the lumens of the multi-lumen tube may be used to apply “a reduced pressure to the outer surface of the sponge”; no mention is made of pressure that can cause the sponge to adopt the shape of the delivery member to thereby arrive at the claimed sealed transition.
While the specification discusses that in response to a reduced pressure applied to the outer surface of the sponge via the drainage tube, the sponge may adopt the shape of the delivery member to thereby arrive at a sealed transition between the sponge and the inner wall of the body lumen (see para [0068]), no discussion is apparent to lead a skilled artisan to conclude that this embodiment has a multi-lumen drainage tube as claimed.
Further, claims 11-20 contain subject matter that was not described in the specification to convey that the inventor possessed an invention with a drainage tube having multiple lumens (as now recited in claim 11) along with the subject matter described in claims 11-20 (e.g., the drainage tube is accommodated within the channel; the drainage tube extends along an entire length of the fluid collecting member; the drainage tube is fixedly connected to the sponge; the drainage tube has a plurality of openings; an overtube encloses the drainage tube; an enteral feeding device is disposed in the drainage tube).
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 10, and all claims depending therefrom, 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 10, the limitation “wherein at least one lumen of the multiple lumens [of the drainage tube] terminates within the sponge and is perforated in the region accommodated within the sponge” is indefinite because the claim lacks antecedent basis for “the region accommodated within the sponge”, and it is unclear whether “at least one lumen of the multiple lumens” could be the previously-recited lumen of the drainage tube which is connectable with a vacuum pump, or whether the at least one lumen that terminates within the sponge should be different from the lumen that is connectable with the vacuum pump.
For the purpose of examination, the limitation will be interpreted to mean “wherein at least one lumen of the multiple lumens terminates within the sponge and is perforated in a region within the sponge”, and the “at least one lumen” could be (but is not required to be) the lumen of the drainage tube connectable with the vacuum pump.
Further regarding claim 10, the limitation “the perforated lumen” is unclear because the claim recites “at least one lumen of the multiple lumens…is perforated”, and the possibility of multiple lumens being perforated” is inconsistent with only one claimed “perforated lumen”.
For the purpose of examination, the limitation will be interpreted to mean “the one or more perforated lumens”.
Further regarding claim 10, the limitation “the inner wall of the body lumen” lacks antecedent basis in the claim for both a body lumen and an inner wall thereof. For the purpose of examination, the limitation will be interpreted to mean “an inner wall of a lumen in the human body”.
Claim Rejections - 35 USC § 102/103
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 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.
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 10-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kleiner (U.S. Pub. 2015/148785, hereinafter "Kleiner"), and/or under 35 U.S.C. 103 as being unpatentable over Kleiner.
Regarding claim 10, Kleiner discloses a vacuum sponge system, comprising:
a sponge 14 (see Fig. 1) having an open-pore structure, an outer surface ("outer face"; see para [0084]), a proximal end 82 (see Fig. 1), and a distal end 78 (see Fig. 1), spaced from the proximal end in an axial direction of the sponge, and a channel that extends from the proximal end of the sponge to the distal end of the sponge; a drainage tube (a tube with concentric suction lumen 30 and drainage lumen 22; see para [0109]) disposed at least partially in the sponge, wherein the drainage tube is in fluid communication with the sponge to provide for exit of a fluid out of the sponge (see para [0091], disclosing that the drainage tube drains fluid drawn through the sponge from the wound);
wherein the drainage tube comprises multiple lumens (i.e., lumens 30 and 22), wherein at least one lumen of the drainage tube is connectable with a vacuum pump (see para [0098], disclosing that the suction lumen 30 can be connected to a vacuum pump); wherein at least one lumen of the multiple lumens terminates within the sponge and is perforated in the region accommodated within the sponge such that a pressure generated by the vacuum pump is applicable to the outer surface of the sponge via the perforated lumen (see para [0087] disclosing that the suction tube has through-openings in the side wall within the sponge);
and wherein one or more of the other lumens of the multiple lumens extend distally from the sponge (see numerous figures, e.g., Figs. 1-4, 14 and 19, showing that the drainage lumen 22 extends distally from the sponge);
and a delivery member 85 (see Fig. 13) having an outer surface and extending in an axial direction of the sponge, and adapted to establish a fluid communication between a region distal from the distal end of the sponge and a region proximal from the proximal end of the sponge when the pressure provided by the pump via the drainage tube is applied in a vicinity of the outer surface of the delivery member and the outer surface of the sponge (see para [0110]; the delivery member 85 includes one or more irrigation channels), wherein the delivery member is disposed within the channel that extends from the proximal end of the sponge to the distal end of the sponge (see Fig. 13).
The limitation "wherein the vacuum sponge system is to be used in gastro-intestinal lumens of human bodies that are a deeper than 10 cm as seen from a body orifice inside a human body" recites the function of the device that does not appear to have any bearing on its structure. The functional limitation is an inherent characteristic of the prior art because the Kleiner device can be situated in the duodenum below the stomach while still accessible at its proximal end from outside the body; see para [0113]). Further, it has been held that a claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Further, Kleiner discloses that in response to the reduced pressure applied to the outer surface of the sponge via the at least one lumen terminating within the sponge, the sponge is configured to adopt the shape of the delivery member to thereby arrive at a sealed transition between the sponge and the inner wall of the body lumen (the delivery member has a tubular shape, and the sponge is configured to adopt a tubular shape as well, to thereby seal the sponge to a tubular endovascular wall; see para [0108]).
It is noted that Kleiner does not explicitly disclose that the lumens 30 and 22 are part of a single, unitary tube. However, to modify the concentric arrangement of the tubes 30 and 22 to be formed out of one single, unitary tube would have been a matter of obviousness to a person of ordinary skill in the art, since it has been held that the use of a one-piece construction (instead of the structure disclosed in Kleiner) was a matter of obvious engineering choice; see In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). Moreover, Applicant has not provided any specific need for combining multiple tubes into a single unitary structure or any specific insight that was contrary to the understandings or expectations of a skilled artisan.
Regarding claim 11, Kleiner discloses the vacuum sponge system of claim 10, wherein the pressure applied to the vicinity of the outer surface of the delivery member and the outer surface of the sponge is reduced compared to atmospheric pressure and comprises a range between 0.01 and 0.99 atm (see para [0136]; suction values applied to the sponge 14 via drainage tube 30 are between 0.007 atm and 0.18 atm).
Regarding claim 12, Kleiner discloses the vacuum sponge system of claim 10, wherein the drainage tube is accommodated within the channel (see Fig. 13).
Regarding claim 13, Kleiner discloses the vacuum sponge system of claim 10, wherein the sponge comprises a fluid collecting member and is disposed along the channel, wherein the channel is parallel to a longitudinal axis of the fluid collecting member (see Fig. 13).
Regarding claim 14, Kleiner discloses the vacuum sponge system of claim 13, wherein the drainage tube extends along an entire length of the fluid collecting member (see Fig. 13).
Regarding claim 15, Kleiner discloses the vacuum sponge system of claim 10, wherein the drainage tube is fixedly connected to the sponge (see para [0087]; the sponge can be provided with a flexible annular end cap that sealingly receives the drainage lumen 30 of the drainage tube, and is affixed to the distal end of the sponge for application of the suction to the sponge via the drainage tube).
Regarding claim 16, Kleiner discloses the vacuum sponge system of claim 10, wherein the drainage tube has a plurality of openings in a portion of the tube to be disposed in the sponge (see Fig. 14).
Regarding claim 17, Kleiner discloses the vacuum sponge system of claim 10, further comprising an overtube 132 (see Figs. 21A-21C) to enclose at least a portion of the sponge, drainage tube, and one or both of a guide member and the delivery member (see para [0121]).
Regarding claim 18, Kleiner discloses the vacuum sponge system of claim 10, wherein the delivery member comprises an enteral feeding device that is extendable distally from the sponge into a stomach or a small intestine of the human body when the sponge is positioned in an esophagus (see para [0115] disclosing that a feeding tube 102 is inserted down the tube 22 and extends beyond the proximal sponge for feeding and/or hydration of the patient; and see para [0138] disclosing that the device may be utilized to assist healing of esophagus).
Regarding claim 19, Kleiner discloses the vacuum sponge system of claim 18, wherein the enteral feeding device is disposed in the drainage tube 30 (see para [0115]).
Regarding claim 20, Kleiner discloses the vacuum sponge system of claim 10, wherein the delivery member comprises an additional tube, to allow gases or stool to exit, and to further allow a large intestine of the human body to be decompressed when the sponge is positioned anally in the large intestine and the pressure is applied to the sponge to effect a collapse of an intestinal lumen onto the sponge (see para [0116]; a feeding tube 102 provided with an inflatable balloon 106 on its proximal end region can include a further longitudinal internal lumen for drainage of bodily fluids and other bodily substances that may pool or accumulate to the distal side of the balloon 106 when the balloon is inflated; the balloon serves to decompress the large intestine).
Response to Arguments
Applicant's arguments filed 06/11/2026 have been considered but they are not fully persuasive. Applicant argued that Kleiner does not disclose the drainage tube comprising multiple lumens wherein at least one of the lumens of the drainage tube is connectable with a vacuum pump.
As noted in the Office action, Kleiner a drainage tube (a tube with concentric suction lumen 30 and drainage lumen 22; see para [0109]) disposed at least partially in the sponge, wherein the drainage tube is in fluid communication with the sponge to provide for exit of a fluid out of the sponge (see para [0091], disclosing that the drainage tube drains fluid drawn through the sponge from the wound). Although it is recognized that Kleiner discloses that elements 22 and 30 are “tubes”, the above-noted discussion of the concentric configuration is functionally and structurally identical to a multi-lumen tubular assembly: two passages are provided within a single tubular structure, where one such passage is connected to the suction source. Further, as noted in the Office action, Kleiner contemplates that the suction tube 30 extends distally out of the sponge; in the concentric arrangement, the lumen 30 would also extend distally out of the sponge.
Applicant’s argument that Kleiner does not disclose that the suction lumen 30 and drainage lumen 22 are unitary (see Remarks, pg. 8) is acknowledged; but the claim does not require a unitary tube, nor does the specification disclose that the lumens should be part of a unitary structure. Even so, a prima facie case of obviousness has been made in this Office action for modifying the prior art to form a unitary or integral structure from tubes 30 and 22.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
09/09/2026
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