DETAILED ACTION
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-15, drawn to a tunneling system, classified in A61M 25/0194.
II. Claims 16-20, drawn to a blunt dissection method, classified in A61B 17/320048.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the apparatus can be used to perform a materially different process, such as provide access to the body during a NOTES (Natural Orifice Translumenal Endoscopic Surgery) procedure.
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 a separate status in the art in view of their different classification;
the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
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 Attorney Karen Horowitz on 18 February 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-15. Affirmation of this election must be made by applicant in replying to this Office action. Claims 16-20 are 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 cancelation 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).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Notice of 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 .
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.
Claim Rejections - 35 USC § 102
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.
Claims 1-8, 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raybin et al. (US Patent Publication 2014/0276790).
Claim 1: Rabin’790 discloses a system for tunneling between tissue layers (400; Figures 11a, 11b), said system comprising:
an elongate delivery member (402);
a cutting device (426) deliverable with said elongate delivery member (paragraph [0092]; and
an inflatable device (410a, 410b) positionable on a distal end of said elongate delivery member (Figure 11a, 11b; [paragraph 0095]), wherein said inflatable device is shaped to facilitate insertion into a cut area of tissue cut by said cutting device (paragraph [0095]).
Claim 2: Rabin’790 discloses the elongate delivery member (402) is tubular and defines a delivery lumen therethrough (paragraphs [0075], [0077]).
Claim 3: Rabin’790 discloses cutting device (426) is deliverable through said delivery lumen of said elongate delivery member (paragraph [0092]).
Claim 4: Rabin’790 discloses inflatable device (410a, 410b) is deliverable over the exterior of said elongate delivery member (paragraph [0106]; Figure 13).
Claim 5: Rabin’790 discloses the elongate delivery member (402) is a medical scope (paragraph [0076]), and said delivery lumen is the working channel of said medical scope (paragraph [0075], [0092]).
Claim 6: Rabin’790 discloses the inflatable device (410a, 410b) is deliverable over the exterior of said elongate delivery member (paragraph [0106]; Figure 13).
Claim 7: Rabin’790 discloses the inflatable device (410a, 410b) is axially translatable distally and proximally over the exterior of said elongate delivery member (Figure 13; paragraph [0106]).
Claim 8: Rabin’790 discloses the inflatable device (410a, 410b) is mounted over a sheath (408) and said sheath is axially translatable distally and proximally over said elongate delivery member (paragraph [0106], Figure 13).
Claim 13: Rabin’790 discloses the inflatable device is tapered in a distal direction from an exterior thereof to an exterior of said elongate delivery member (paragraph [0100]; Figure 11b).
Claim 14: Rabin’790 discloses the inflatable device is tapered in a proximal direction from an exterior thereof to an exterior of said elongate delivery member (Figure 11b shows the proximal side of the balloon is tapered).
Claim 15: Rabin’790 discloses the cutting device (426) is a sharp cutting device selected from the group consisting of: a blade, a knife, or an electrosurgical knife (paragraph [0092], [0093]).
Claims 1-9 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated Silvestro (US Patent Publication 2015/0032142).
Claim 1: Silvestro’142 discloses a system (100), said system comprising:
an elongate delivery member (114);
a cutting device (130) deliverable with said elongate delivery member (paragraph [0040], [0047]); and
an inflatable device (112) positionable on a distal end of said elongate delivery member (114; paragraph [0040]), wherein said inflatable device is shaped to facilitate insertion into a cut area of tissue cut by said cutting device (paragraph [0040] discloses the inflatable device can move relative to the delivery member 114 and the cutting device 130; the balloon could therefore move into the cut tissue).
Claim 2: Silvestro’142 discloses the elongate delivery member (114) is tubular and defines a delivery lumen therethrough (paragraphs [0040]).
Claim 3: Silvestro’142 discloses cutting device (130) is deliverable through said delivery lumen of said elongate delivery member (paragraph [0040], [0047]).
Claim 4: Silvestro’142 discloses inflatable device (112) is deliverable over the exterior of said elongate delivery member (inflatable device 112 is mounted to over sheath 102 which is movable relative to 114 – see paragraph [0043] and Figure 1).
Claim 5: Silvestro’142 discloses the elongate delivery member (114) is a medical scope (a scope is a tubular element; 114 is tubular), and said delivery lumen is the working channel of said medical scope (paragraph [0047]).
Claim 6: Silvestro’142 discloses the inflatable device (112) is deliverable over the exterior of said elongate delivery member (inflatable device 112 is mounted to outer sheath 102 which is movable relative to 114 – see paragraph [0043] and Figure 1).
Claim 7: Silvestro’142 discloses the inflatable device (112) is axially translatable distally and proximally over the exterior of said elongate delivery member (114) (Figure 1; paragraph [0040]).
Claim 8: Silvestro’142 discloses the inflatable device (112) is mounted over a sheath (102) and said sheath is axially translatable distally and proximally over said elongate delivery member (paragraph [0040], Figure 1).
Claim 9: Silvestro’142 discloses the inflatable device (112) is movable distally off the exterior of said elongate delivery member (paragraph [0043] discloses the elongate delivery member 114 and sheath 102, which carries balloon 112, are freely translatable relative to each other).
Claim 15: Rabin’790 discloses the cutting device (132) is a sharp cutting device selected from the group consisting of: a blade, a knife, or an electrosurgical knife (paragraph [0040] discloses the tip is sharp, this is considered a blade or knife).
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Rabin’790, as applied to claim 6, further in view of Bleam et al. (US Patent Publication 2004/0073162).
Claim 10, 11, 12: Rabin’790 does not teach an adaptor configured to maintain the inflatable device with respect to said elongate delivery member.
Like Rabin’790, Bleam’162 teaches an inflatable device positioned on the distal end of a delivery member (Rabin’790 teaches inflatable device 410ab positioned on the distal end of the delivery member 402 at paragraph [0081], [0085]; Bleam’162 teaches inflatable device 504 positioned on the distal end of a delivery member 502).
Bleam’162 further teaches providing an adaptor (572, 574) which is configured to maintain the inflatable device with respect to the delivery member (paragraph [0060]). Bleam’162 teaches the adaptor creates a transition region between the catheter body and the balloon (paragraph [0060]).
Further regarding claim 11, Bleam’162 teaches the adaptor has a distal end (574) tapered from a position adjacent a distal end of the inflatable device distally to the exterior of the elongate delivery member (Figure 5, 5a).
Further regarding claim 12, Bleam’162 teaches the adaptor is formed of a compliant material (adaptor 572, 574 is formed on a catheter that is passed through tortuous vasculature of a patient; therefore, the adaptor needs to be compliant/flexible to perform this function).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Rabin’790 such that the balloon is provided with an adaptor, as taught by Bleam’162, in order to secure the balloon relative to the delivery member and to create a transition region between the balloon and delivery member (paragraph [0060]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY BACHMAN whose telephone number is (571)272-6208. The examiner can normally be reached Monday-Friday 9am-5pm and alternating Fridays.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 23 February 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771