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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I: Claims 1-17, drawn to medical device comprises first wall defining first lumen, and plurality of second walls defining second lumen, wherein the first wall and second wall includes a perforation extending longitudinal along first wall or second wall respectively, classified in CPC A61B1/018.
II. Claims 18-20, drawn to a medical device comprise first lumen, second lumen, and an expandable member includes an absorbent member, a balloon, classified in CPC A61B1/00082.
Inventions I and II are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because invention I does not require additional limitation of an expandable member includes an absorbent member, a balloon as recited in group II. The subcombination has separate utility such as using balloon at distal end to expand the viewing area.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired separate status in the art in view of their different classification.
The invention has acquired a separate status in the art due to their recognized divergent subject matter.
The inventions require a different field of searches (e.g., searching in different groups and/or subgroups).
The invention has acquired a separate status in the art due to their unrelated subject matters.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with the Applicant’s representative, Juan S. Gutierrez, on May 28, 2026 a provisional election was made without traverse to prosecute the invention of I, claims 1-17. Affirmation of this election must be made by applicant in replying to this Office action. Claims 18-20 have been withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Jazaeri (US 20190054230) in view of Bourang et al. (US 20240082030).
Regarding claim 1, Al-Jazaeri discloses a medical device (primary catheter 10– figure 2), comprising:
a first wall defining a first lumen (26a defining central lumen 27-see figures 8, 13, paragraphs 0061, 0063), wherein the first lumen is configured to receive a shaft (central lumen 27 is configured to receive shaft 39 of stylet 36-see figures 11, 14, paragraph 0080);
at least one second wall (body 16, outer surface of 26a – figures 4, 8, 11) defining at least one second lumen (defining a corresponding peripheral lumen 25 of peripheral track 25 – see figures 8, 11,13, paragraph 0061), wherein the at least one second lumen is configured to receive an accessory device (peripheral lumen 25 is configured to receive drain 18 (figures 8, 11, 13, paragraph 0065); and
wherein the at least one second wall includes a perforation (longitudinal opening 31a, longitudinal slits 27 or series of openings) extending longitudinally along the at least one second wall (see figures 2, 4, 11, 13, paragraphs 0060, 0063, 0064, 0071).
Al-Jazaeri does not explicitly disclose a first shaft of a medical scope.
Bourang discloses lumen (e.g., central channel 1026) is configured to receive a shaft of a medical scope (shaft 1004 of a catheter 1002 – see include, but are not limited to, figures 10a-10b, paragraph 0137), .
In addition to Al-Jazaeri, Bourang also discloses at least one second lumen (e.g., portion of central channel 1026 for shaft 1032 or guidewire lumen 1034 of second catheter -figures 10a-10B) is configured to receive an accessory device (portion of central channel 1026 or guidewire lumen 1034 is configured to receive guidewire, stent, etc. see figures 10a-10b, paragraph 0138).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Al-Jazaeri with the teaching of a shaft of a medical scope as taught by Bourang in order to yield predictable result for improving medical device delivery systems and methods (paragraph 0009).
Regarding claim 2, Al-Jazaeri in view of Bourang discloses the medical device of claim 1. Al-Jazaeri further discloses wherein the medical device comprises a plurality of second walls defining a plurality of second lumens (26a, 26b, 16 of peripheral tracks 25 defining a plurality of peripheral lumens – see figures 8, 11, 13, paragraphs 0061, 0063).
Regarding claim 3, Al-Jazaeri in view of Bourang discloses the medical device of claim 2. Al-Jazaeri further discloses wherein the plurality of second lumens (peripheral lumens 25) is positioned circumferentially around the first lumen (central lumen 27)– see figures 8, 13).
Regarding claim 4, Al-Jazaeri in view of Bourang discloses the medical device of claim 3. Al-Jazaeri further discloses wherein each of the plurality of second walls include a perforation extending longitudinally along a respective second wall of the plurality of second walls (each of the plurality of walls/surfaces of peripheral lumens include longitudinal slit/opening 17, 31a extending longitudinal along a respective second wall of the peripheral lumens 25– see figures 2, 4, 8, 11, 13, paragraphs 0060, 0063).
Regarding claim 5, Al-Jazaeri in view of Bourang discloses the medical device of claim 4. Al-Jazaeri further discloses wherein the perforation is on an outer surface of the respective second wall (slit/opening is on the outer surface of the respective second wall/surface of peripheral lumen 25– see figures 2, 4, 8, 11, 13, paragraphs 0060, 0063).
Regarding claim 6, Al-Jazaeri in view of Bourang discloses the medical device of claim 5. Al-Jazaeri further discloses wherein the perforation extends from a distalmost end of the respective second wall to a proximalmost end of the respective second wall (longitudinal opening or longitudinal slits extends from a distalmost end to proximalmost end of the respective wall of peripheral lumen see figures 2, 4, 8, 11, 13, paragraphs 0060, 0063. See also Bourang: figure 10b, paragraph 0138, which discloses perforated region 1045 extends from a distalmost end to the proximalmost end of wall of capture tube 1024).
Regarding claim 7, Al-Jazaeri in view of Bourang discloses the medical device of claim 4, wherein the perforation is a second perforation (longitudinal slit 17 or opening 31a of peripheral lumen 25- see figures 2, 8, 11, 13), and wherein the first wall includes a first perforation (opening 31a on surface/wall of central lumen 27 – see figures 8, 11,13, paragraph 0063).
Regarding claim 8, Al-Jazaeri in view of Bourang discloses the medical device of claim 7, wherein the first perforation extends longitudinally along the first wall (longitudinal opening 31a) extends longitudinal along the wall of central lumen 27 –see for example, Al-Jazaeri: figures 8, 11, 13, paragraph 0063).
Regarding claim 9, Al-Jazaeri in view of Bourang discloses the medical device of claim 7. Sharma further discloses wherein the first perforation extends from a distalmost end of the first wall to a proximalmost end of the first wall (longitudinal opening 31a extends from a distalmost end to a proximalmost end of the wall of lumen central lumen 27 – see Al-Jazaeri: figures 8, 11, 13, paragraph 0063).
Regarding claim 10, Al-Jazaeri in view of Bourang discloses the medical device of claim 1, wherein the medical device is a sleeve that is configured to extend from a distal tip of the shaft to a proximal portion of the shaft that remains external to a body lumen (primary catheter is a sleeve/cover that is configured to extend from a distal tip 38 of a shaft to a proximal portion 37 of the shaft that remains external to a body lumen 25, 27 – see include, but are not limited to, Al-Jazaeri: figures 2, 11, 14-15).
Regarding claim 11, Al-Jazaeri in view of Bourang discloses the medical device of claim 1, wherein a tab (e.g., 20a, 31) is formed adjacent to a proximal end of the at least one second wall (e.g., 20a, 31 is formed adjacent to a proximal end of the at least one wall of peripheral track 25– see Al-Jazaeri: figures 8, 11-12, 14, paragraph 0078).
Regarding claim 12, Al-Jazaeri in view of Bourang discloses the medical device of claim 11, wherein a second tab (e.g., 30, 35a, 35b, 38b, 42a, or 42c) is formed adjacent to a proximal end of the first wall (30, 35a, 35b, 38b, 42a, or 42c is formed adjacent to proximal end of the wall of central track 27 – see figures 8, 11-12, 14).
Regarding claim 13, Al-Jazaeri in view of Bourang discloses the medical device of claim 1. Al-Jazaeri further discloses wherein a proximal end of the first wall has a recessed or notched portion (proximal end of wall of central track 27 has an opening 31a or slit portion – see for example, figures 8, 11, 13-14, paragraph 0063).
Regarding claim 14, Al-Jazaeri in view of Bourang discloses the medical device of claim 1, wherein the at least one second lumen has an open proximalmost end and an open distalmost end (at least one of peripheral lumen 25 has an open at each end of the peripheral track 25 – see figures 2, 11, 13, paragraphs 0060, 0063-0064) and wherein the first lumen has an open proximalmost end and an open distalmost end (central lumen 27 has an open at each end – see figures 2, 11, 13, paragraphs 0060, 0063-0064) .
Regarding claim 15, Al-Jazaeri in view of Bourang discloses the medical device of claim 1, wherein a membrane includes the first wall and the at least one second wall (membrane/body 16 or structure 26a includes a first wall/surface of central lumen 27 and the at least one second wall/surface of peripheral track 25 – see Al-Jazaeri: figures 2, 8, 11, 13).
Regarding claim 16, discloses a medical device (10 - figures 2, 11), comprising:
a membrane (membrane/body 16 or structure 26a) defining a central lumen (27) configured to receive a device (shaft 36 or guidewire) and a plurality of outer lumens (peripheral lumens 25) – see figures 2, 8, 11, 13, 14, paragraphs 0061, 0063),
wherein each of the plurality of outer lumens is configured to receive an accessory device (each of the peripheral lumens 25 is configured to receive a drain 18 – see figures 8, 11, 13); and
wherein a perforation (longitudinal opening 31a, longitudinal slits 27) extends longitudinally along a wall (wall/surface of body 16, structure 31a) defining at least one of the plurality of outer lumens (peripheral lumens 25 – see for example, figures 2, 8, 11, 13, paragraphs 0060-0061, 0063).
Al-Jazaeri does not explicitly disclose device/shaft is a medical scope.
Bourang discloses lumen (e.g., central channel 1026) is configured to receive a scope device (scope device of catheter 1002 – see include, but are not limited to, figures 10a-10b, paragraph 0137), .
In addition to Al-Jazaeri, Bourang also discloses a second lumen (e.g., portion of central channel 1026 for shaft 1032 or guidewire lumen 1034 of second catheter -figures 10a-10B) is configured to receive an accessory device (portion of central channel 1026 or guidewire lumen 1034 is configured to receive guidewire, stent, etc. see figures 10a-10b, paragraph 0138); and
a perforation extends longitudinally along second lumen (perforated region 1045 extends along portion of channel 1026 – see figures 10a-10b, paragraph 0138).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Al-Jazaeri with the teaching of a shaft of a scope device as taught by Bourang in order to yield predictable result for improving medical device delivery systems and methods (paragraph 0009).
Regarding claim 17, Al-Jazaeri in view of Bourang discloses the medical device of claim 16, wherein the membrane (16, 26a) includes a plurality of perforations (openings 31a, 12, slits 17 – see figures 2, 11, 13), wherein each perforation of the plurality of perforations extends longitudinally along a respective wall defining each of the plurality of outer lumens (wherein each opening/slit of the plurality of openings 31a/slits 17 extends longitudinally along a respective wall defining each of the plurality of peripheral lumens 25 – see figures 2, 8, 11, 13, paragraphs 0060, 0063).
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.
Claim 1 is alternatively rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bourang et al. (US 20240082030).
Regarding claim 1, Bourang discloses a medical device (catheter system 1000 – figures 10a-10b) comprising:
a first wall defining a first lumen (wall of capture tube 1024 defining channel 1026 – figures 10a-10b), wherein the first lumen (lumen of channel 1026) is configured to receive a shaft (1004) of a medical scope (catheter 1002 – see figures 10a-10b, paragraph 0137);
at least one second wall (wall of capture tube 1024) defining at least one second lumen (lumen of central channel 1026), wherein the at least one second lumen is configured to receive an accessory device (lumen of central channel 1026 is configured to receive accessory second catheter 1032 or stent 1042 – see figures 10a-10b, paragraph 0138); and
wherein the at least one second wall incudes a perforation (perforated region 1045) extending longitudinal along the at least one second wall (perforated region 1045 extending longitudinal along the second wall of capture tube 1024 – see figures 10a-10b, paragraphs 0137-0138).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Loulais (US 9358363) discloses multiple lumen assembly for use in endoscopes or other medical device including a central lumen 170 and a plurality of auxiliary lumens around the central lumen 170, wherein wall of lumen includes perforations/cuts/holes – see figures 4C, 7C, 7D, col. 4, lines 15-25, col. 5, lines 9-36).
Rahimzadeh et al. (US 11259858) discloses endoscopy tube and device for cryotherapy includes multiple lumens with perforations on wall (see figures 4-5, 7, 12).
Fruitt (US 6458076) discloses multi-lumen medical device comprising central lumen surrounded by other lumens – see figure 2).
Elmouelhi et al. (US 12042170) discloses add-on sheath with multiple lumens and perforations 222 on walls (col. 5, lines 1-49, col. 13, lines 1-16).
Smith (US 20030004400) discloses endoscope and endoscopic instrument system having reduced backlash when moving the endoscopic instrument within a working channel of the endoscope.
Crawford et al. (US 20230165447) discloses external sleeve providing additional working channel.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AN SON PHI HUYNH whose telephone number is (571)272-7295. The examiner can normally be reached 9:00 am-6:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANH TUAN T NGUYEN can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AN SON P HUYNH/Primary Examiner, Art Unit 2426
May 29, 2026
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