DETAILED ACTION
This Office Action is in response to Applicant’s amendment filed 14 May 2026
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 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.
Response to Arguments
Independent claim 1 was amended to recite an adaptor. Similar subject matter was previously recited in dependent claim 10.
Applicant argues that claim 10 was not rejected under Raybin’790 and therefore the amendment to claim 1 should overcome the 102 rejections under Raybin’790. Examiner agrees Raybin’790 does not teach an adaptor and therefore does not teach the limitations of amended claim 1.
Similarly, Applicant argues that claim 10 was not rejected under Silvestro’142 and therefore the amendment to claim 1 should overcome the 102 rejections under Silvestro’142. Examiner agrees Silvestro’142 does not teach an adaptor and therefore does not teach the limitations of amended claim 1.
Claim 10 was rejected under Raybin’790 in view of Bleam’162. Applicant argues the Office Action identifies bands 506 and 508 as the adaptors (page 7 of the 5/14 response) and similar bands 206, 208 are disclosed as rigid in paragraph [0051]. Therefore, Applicant concludes that bands 506, 508 are not compliant as required by amended claim 1 and original claim 12.
The Office Action identified elements 572, 574 as the adaptors – see page 10 of the 2/27/2026 Office Action. Elements 572, 574 are disclosed as being formed from an adhesive at paragraph [0060]. An adhesive is disclosed in paragraph [0054] as Loctite-4014. This is a flowable adhesive which cures. Because the adhesive is flowable when applied, it is considered compliant since it will allow the adaptors (i.e. “adhesive tapers or tapered filets” in paragraph [0060]) to be fitted (i.e. formed) over a variety of delivery members with different outer diameters.
The rejection is updated to address the claim amendments but is otherwise maintained.
Additionally, the amendments to claim 1 raise new matter issues under 35 USC 112(a) in dependent claims 7-10. See below.
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 7-10 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.
Claim 7 recites the inflatable device is axially translatable distally and proximally over the exterior of the elongate delivery member. This is disclosed in paragraph [0007] and paragraph [0050] of the specification, as filed. Paragraph [0050] specifically discloses this translation is performed by attaching the inflatable device to a sheath and translating the sheath. However, claim 1 was amended to recite an adaptor which maintains the position of the inflatable device with respect to the elongate delivery member. The disclosure, as filed, does not disclose the use of an adaptor in combination with translating the inflatable device along the elongate deliver member.
Claim 8 depends from claim 7 and recites the sheath. The disclosure, as filed, does not disclose the use of an adaptor in combination with a sheath translating the inflatable device along the elongate deliver member.
Claim 9 depends from claim 7. Claim 9 recites the inflatable device is movable distally off the exterior of the elongate member. This is shown in Figures 7a, 7b and described in paragraph [0052] of the specification, as filed. However, the specification does not disclose moving the inflatable device distally off the exterior of the elongate member when an adaptor, which is configured to maintain the position of the inflatable device with respect to the elongate delivery member, is present.
Claim 10 depends from claim 1 but recites similar subject matter to claim 9. It is rejected for the same reasons as claim 9: the specification does not disclose moving the inflatable device distally off the exterior of the elongate member when an adaptor, which is configured to maintain the position of the inflatable device with respect to the elongate delivery member, is present.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-6 and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Raybin et al. (US Patent Publication 2014/0276790) in view of Bleam et al. (US Patent Publication 2004/0073162).
Claim 1: Raybin’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]).
Raybin’790 does not teach an adaptor configured to maintain the inflatable device with respect to said elongate delivery member.
Like Raybin’790, Bleam’162 teaches an inflatable device positioned on the distal end of a delivery member (Raybin’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 is formed of a compliant material so the adaptor (572, 574) can be fitted over a variety of elongate delivery members with different outer diameters (The adhesive is disclosed in paragraph [0054] as Loctite-4014. This is a flowable adhesive which cures. Because the adhesive is flowable when applied, it is considered compliant since it will allow the adaptors to be fitted (ie formed) over a variety of delivery members with different outer diameters.)
Claim 2: Raybin’790 discloses the elongate delivery member (402) is tubular and defines a delivery lumen therethrough (paragraphs [0075], [0077]).
Claim 3: Raybin’790 discloses cutting device (426) is deliverable through said delivery lumen of said elongate delivery member (paragraph [0092]).
Claim 4: Raybin’790 discloses inflatable device (410a, 410b) is deliverable over the exterior of said elongate delivery member (the balloon is deliverable into the body while being positioned on the elongate delivery member).
Claim 5: Raybin’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: Raybin’790 discloses the inflatable device (410a, 410b) is deliverable over the exterior of said elongate delivery member (the balloon is deliverable into the body while being positioned on the elongate delivery member).
Claim 11: Bleam’162 teaches the adaptor creates a transition region between the catheter body and the balloon (paragraph [0060]). 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).
Claim 12: In the device of Raybin’790 in view of Bleam’162, the adaptor and inflatable device have an overall configuration which facilitates insertion of the inflatable into cut tissue to further separate the tissue (the balloon and adaptor can be inserted into cut tissue and the balloon can then be inflated)
Claim 13: Raybin’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: Raybin’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: Raybin’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]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771
26 May 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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