33DETAILED 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 § 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.
Claim(s) 1-3, 6, 7, 11, 13 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Margulis (US 20180193197) in view of Loushin (US 20120179187).
With respect to claims 1 and 11, Margulis teaches a system (200, see fig. 4b, 4c, 8 below) for repair of a region within a natural orifice of an ear (see para. 4), comprising: a device (208) for repair of a region within a natural orifice of an ear (see fig. 8 below), comprising: a body (body of 208) that tapers distally to facilitate introduction of a distal end of the device into the ear (see fig. 4b, 4c, 8 below), the body comprising: a second port through which a seal (212) can be introduced into the ear through the device (e.g., at 209, see fig. 4c below, para. 92); the seal for covering the region being sealed (see fig. 8 below), and an introducer (202, 204, 206, 210) for introducing the seal through the device, into the ear via the natural orifice, so that the introducer extends at least into a perforation in the region (see fig. 4c, 8 below); and wherein at least one of said the two or more ports is configured to receive: a surgical device for performing a surgical operation on tissue at the region inside the ear (see fig. 4b below and note that this device is capable of performing this function if one so desires); a fluid delivery device (210 and/or 228, 230, 220) for delivering fluid to the seal when the seal has been introduced into the ear (see para. 88); and the fluid (see para. 88), and wherein at least one of the two or more ports is configured to deliver the fluid to the seal when the seal has been introduced into the ear (see para. 88).
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Margulis does not appear to teach a first port for visibly identifying the region to be sealed and being arranged to maintain visibility of the region during delivery of a seal through a second port, the region being inside the ear; and wherein the device comprises two or more ports, including the first port and the second port.
Loushin, also drawn to ear speculums, teaches a device (e.g., speculum 40a, see fig. 4a below) used to guide a tool to the inner ear (see fig. 5a1) through a second port (main opening of 40a) that also includes a first port (e.g., passage that receives scope 41a) for visibly identifying the region to be sealed and being arranged to maintain visibility of the region the procedure, the region being inside the ear (see para. 49 below) in order to provide a visualization aid to the device without negatively impacting direct visualization, reducing the cross-sectional area of the device available for receiving a tool, or blocking access to the ear canal, during a procedure (see para. 49 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Margulis to include a first port for visibly identifying the region to be sealed and being arranged to maintain visibility of the region during delivery of a seal through a second port, the region being inside the ear; and wherein the device comprises two or more ports, including the first port and the second port, in view of Loushin, in order to provide a visualization aid to the device without negatively impacting direct visualization, reducing the cross-sectional area of the device available for receiving a tool, or blocking access to the ear canal, during a procedure.
As for claim 2, Margulis, as modified by Loushin, further teaches the system of claim 1, the perforation is a perforation of a tympanic membrane of the ear (see para. 76).
As for claim 3, Margulis, as modified by Loushin, further teaches the system of claim 1, wherein the device is a speculum (see fig. 4b, 4c above).
As for claim 6, Margulis, as modified by Loushin, further teaches the system of claim 1 wherein the second port comprises an engagement member (209) for engaging a delivery device (e.g., tube 246), the delivery device being configured to deliver the seal to the region (see fig. 4c above).
As for claim 7, Margulis, as modified by Loushin, further teaches the system of claim 6, wherein the engagement member is configured to engage the delivery device to fix a longitudinal position of the delivery device relative to the second port (see fig. 4c above, para. 92 and note that the engagement member is capable of performing this function).
With respect to claim 13, Margulis teaches a method for repairing a tympanic membrane through a natural orifice of an ear (see para. 4), comprising: inserting, through a device (208) comprising a body that tapers distally to facilitate introduction of a distal end of the device, into the ear (see fig. 4b, 4c and 8 above), the body comprising a second port (see fig. 4c above) that is a port through which a seal (212) can be introduced into the ear through the device (see fig. 8 above), an introducer (see fig. 4b above) into the ear via the natural orifice, so that the introducer extends at least into a perforation in the tympanic membrane (see fig. 8 above); delivering the seal from the introducer to a distal side of the tympanic membrane (see para. 82-83); and attaching the seal to the distal side (see para. 65-67).
Margulis does not teach a first port for visibly identifying a region within an ear via a natural orifice to be sealed and being arranged to maintain visibility of the region during delivery of a seal through a second port, the region being inside the ear.
Loushin, also drawn to ear speculums, teaches a device (e.g., speculum 40a, see fig. 4a above) used to guide a tool to the inner ear (see fig. 5a1) through a second port (main opening of 40a) that also includes a first port (e.g., passage to receive 41a) for visibly identifying the region to be sealed and being arranged to maintain visibility of the region the procedure, the region being inside the ear (see para. 49 above) in order to provide a visualization aid to the device without negatively impacting direct visualization, reducing the cross-sectional area of the device available for receiving a tool, or blocking access to the ear canal, during a procedure (see para. 49 above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Margulis to include a first port for visibly identifying the region to be sealed and being arranged to maintain visibility of the region during delivery of a seal through a second port, the region being inside the ear, in view of Loushin, in order to provide a visualization aid to the device without negatively impacting direct visualization, reducing the cross-sectional area of the device available for receiving a tool, or blocking access to the ear canal, during a procedure.
With respect to claim 29, Margulis teaches a kit (see fig. 13, para. 105) comprising a device (208) comprising a body that tapers distally to facilitate introduction of a distal end of the device into an ear (see fig. 4b, 4c, 8 above), the body comprising a second port (see fig. 4c above), wherein the second port is a port through which a seal (212) can be introduced into the ear through the device (see fig. 8 above); a graft (another of 212, see para. 64, 105); and an introducer (e.g., 202, 204, 206, 210) for introducing the graft through the device (see fig. 13, para. 105, fig. 8 above).
Margulis does not teach a first port for visibly identifying a region within an ear via a natural orifice to be sealed and being arranged to maintain visibility of the region during delivery of a seal through a second port, the region being inside the ear.
Loushin, also drawn to ear speculums, teaches a device (e.g., speculum 40a, see fig. 4a above) used to guide a tool to the inner ear (see fig. 5a1) through a second port (main opening of 40a) that also includes a first port (e.g., to receive 41a) for visibly identifying the region to be sealed and being arranged to maintain visibility of the region the procedure, the region being inside the ear (see para. 49 above) in order to provide a visualization aid to the device without negatively impacting direct visualization, reducing the cross-sectional area of the device available for receiving a tool, or blocking access to the ear canal, during a procedure (see para. 49 above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Margulis to include a first port for visibly identifying the region to be sealed and being arranged to maintain visibility of the region during delivery of a seal through a second port, the region being inside the ear, in view of Loushin, in order to provide a visualization aid to the device without negatively impacting direct visualization, reducing the cross-sectional area of the device available for receiving a tool, or blocking access to the ear canal, during a procedure.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Margulis (US 20180193197) and Loushin (US 20120179187), as applied to claim 6 above, in view of Weitzner (US 20150238180).
As for claim 8, Margulis, as modified by Loushin, teaches a mechanical fastening mechanism (alignment receptacle 209) between the delivery device and engagement member, but does not appear to teach wherein the engagement member comprises a twist lock fixture.
Weitzner, also drawn to guide tubes (delivery devices) used with medical devices, teaches a variety of alternate equivalent mating fastening mechanisms, including twist lock and taper lock mechanisms (see para. 442), in order to provide an interference fit between two mating elements that is well known in the art (see para. 442).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the mating fastening mechanism between the delivery device and engagement member of Margulis, as modified by Loushin, wherein the engagement member comprises a twist lock fixture, in view of Weitzner, as a matter of engineering design choice, in order to provide an interference fit between two mating elements that is well known in the art.
Claim(s) 21, 22 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Margulis (US 20180193197) and Loushin (US 20120179187), as applied to claim 13 above, in view of Bonassar (US 20080003205).
As for claims 21, 22 and 28, Margulis, as modified by Loushin, further teaches wherein the seal is a graft (see para. 63-64), but does not teach wherein the seal is a graft comprising a first body and a second body, the first and second bodies being connected, and wherein delivering the seal from the introducer comprises: advancing the graft so that the first body is positioned distally of the tympanic membrane; withdrawing the introducer to a location proximal of the tympanic membrane; and advancing the graft so that at least part of the tympanic membrane is between the first body and second body; wherein the first body and the second body form a double umbrella shape; and wherein attaching the seal to the tympanic membrane comprises at least one of: delivering fluid to the seal through the device to expand the seal to a formed shape; and warming the seal to a temperature sufficient for the seal to expand to the formed shape.
Bonassar, also drawn to a method for repairing a tympanic membrane (1) through a natural orifice of an ear (see para. 32 below), teaches wherein the seal is a graft comprising a first body and a second body (e.g., first and second ends, see para. 41 below), the first and second bodies being connected (via middle portion), and wherein delivering the seal from the introducer comprises: advancing the graft so that the first body is positioned distally of the tympanic membrane (see para. 41 below); withdrawing the introducer to a location proximal of the tympanic membrane (see fig. 4 below); and advancing the graft so that the second body so at least part of the tympanic membrane is between the first body and the second body (see fig. 4 below, para. 41 below); wherein the first body and the second body form a double umbrella shape (see fig. 2 below, para. 41 below); and wherein attaching the seal to the tympanic membrane comprises at least one of: delivering fluid to the seal through the device to expand the seal to a formed shape; and warming the seal to a temperature sufficient for the seal to expand to the formed shape (see para. 18, 46, 59-61, note properties of hydrogels) in order to provide an alternate equivalent biodegradable repair construct for a tympanic membrane (see para. 2, 36, 38).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Margulis, as modified by Loushin, wherein the seal is a graft comprising a first body and a second body, the first and second bodies being connected, and wherein delivering the seal from the introducer comprises: advancing the graft so that the first body is positioned distally of the tympanic membrane; withdrawing the introducer to a location proximal of the tympanic membrane; and advancing the graft so that at least part of the tympanic membrane is between the first body and second body; wherein the first body and the second body form a double umbrella shape; and wherein attaching the seal to the tympanic membrane comprises at least one of: delivering fluid to the seal through the device to expand the seal to a formed shape; and warming the seal to a temperature sufficient for the seal to expand to the formed shape, in view of Bonassar, in order to provide an alternate equivalent biodegradable repair construct for a tympanic membrane.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Margulis (US 20180193197) and Loushin (US 20120179187), as applied to claim 13 above, in view of Keisuke (DE 4400188A1).
As for claim 27, Margulis, as modified by Loushin, teaches use of an adhesive (250) to attach the seal (patch) to the tympanic membrane (see para. 102) but does not teach, wherein attaching the seal to the tympanic membrane comprises: attaching a suture to the seal; and after the seal has been delivered to the distal side of the tympanic membrane, pulling the suture to bring the seal against the distal side.
Keisuke, also drawn to repair of the tympanic membrane (4), teaches wherein attaching a seal (e.g., 1) to the tympanic membrane comprises: attaching a suture (2) to the seal (see fig. 2-5 below); and after the seal has been delivered to the distal side of the tympanic membrane, pulling the suture to bring the seal against the distal side (see fig. 2-5 below and col. 4 lines 19-56 below) in order to provide an alternate equivalent fastening mechanism to the adhesive taught by Margulis, as modified by Loushin, that will perform the same function of attaching the seal to the tympanic membrane (see col. 4 lines 19-56 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Margulis, as modified by Loushin, wherein attaching the seal to the tympanic membrane comprises: attaching a suture to the seal; and after the seal has been delivered to the distal side of the tympanic membrane, pulling the suture to bring the seal against the distal side, in view of Keisuke, as a matter of engineering design choice, in order to provide an alternate equivalent fastening mechanism to the adhesive taught by Margulis, as modified by Loushin, that will perform the same function of attaching the seal to the tympanic membrane.
Allowable Subject Matter
Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 2/26/2026 have been fully considered but they are not persuasive.
Applicant’s primary argument is that the combination of Margulis and Loushin do not teach a single device body containing first and second ports, specifically, “a first port for visibly identifying the region to be sealed and being arranged to maintain visibility of the region during delivery of a seal through a second port”, as recited in claim 1 lines 6-7. Applicant argues that Loushin does not teach a device with two ports as required by claim 1 because Loushin teaches a “speculum-like device 40a” and a “fiber optic scope 41a” as shown in fig. 4a (see Remarks page 7). For this reason, Applicant contends that Loushin only teaches a single port and that “if a surgical tool is also inserted into 40, it can contact the fiber optic scope, which would then require repositioning” (see Remarks page 8, paragraph 1).
This is not found to be persuasive. As demonstrated in fig. 4a below and also paragraph 49 below, Loushin teaches a second port used to pass devices used for performing a myringotomy or ear tube insertion.
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Loushin also specifically states that 40a includes “a passage or means of passing or attaching a visualization aid such as a fiber optic scope 41 without negatively impacting direct visualization, reducing the cross sectional area of the speculum available for performing a myringotomy or ear tube insertion, or blocking access to the ear canal” (see para. 49 below). This passage or means of passing or attaching a visualization aid is interpreted as the first port. Loushin makes clear that the purpose of the “passage or means of passing or attaching” is to allow the insertion of a visualization tool (scope 41a) without impeding the passage of other tools through the second port (main opening of 40a). In other words, the passage or means of passing or attaching is “a first port for visibly identifying the region to be sealed and being arranged to maintain visibility of the region during delivery of a seal through a second port”. Thus, Loushin teaches a single device with two access ports (one for a visualization scope and one for general insertion of tools). Further, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The passage/first port of Loushin contains enough structure to perform the functional recitation of the first port (i.e., for visibly identifying the region to be sealed and being arranged to maintain visibility of the region during delivery of a seal through a second port.
Applicant does not present any new arguments regarding independent claims 13 and 29.
Applicant further argues that the combination of Margulis and Loushin do not teach that “the second port comprises an engagement member for engaging a delivery device” as recited in claim 6 (see Remarks page 8). Applicant states that Margulis shows “a delivery device (e.g., tube 246) freely extending through the port (209), potentially without contacting the port” referring to figure 3 of Margulis.
This is not found to be persuasive. Claim 6 as written only requires that the second port comprises an engagement member capable of performing the function of engaging a delivery device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Margulis is relied upon for teaching an engagement member (alignment receptacle 209) accommodating (containing within) a delivery device (cylindrical tube 246- see para. 92 below) and is capable of performing the intended function, if one so desires.
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In fact, Margulis describes a sliding accommodation between 209 and 246 (see para. 91 below) for the purpose of alignment of the delivery device with a perforation within an ear. Thus, the limitation “an engagement member for engaging a delivery device”, is taught by Margulis.
Applicant also argues that the combination of Margulis and Loushin does not teach “wherein the engagement member is configured to engage the delivery device to fix a longitudinal position of the delivery device relative to the second port” as required by claim 7. Applicant states that there would be no space in the port (within 212 of Margulis or the large aperture of in 40a of Loushin) to receive the fiber optic scope of Loushin (see Remarks page 9).
This is not found to be persuasive because as stated above, paragraph 49 of Loushin is clear that the passage or means of passing or attaching which receives the fiber optic scope is configured in such a way to do so without negatively impacting direct visualization, reducing the cross sectional area of the speculum available for performing a myringotomy or ear tube insertion, or blocking access to the ear canal. Thus, Loushin teaches a single device with two access ports (one for the visualization fiber optic scope and one for insertion of tools relating to a myringotomy or ear tube insertion). The combination of Margulis and Loushin therefore results in “wherein the engagement member is configured to engage the delivery device to fix a longitudinal position of the delivery device relative to the second port”.
Finally, Applicant argues Margulis and Loushin are silent regarding “to fix a longitudinal position of the delivery device relative to the second port” as required by claim 7 (see Remarks page 10).
This is not found to be persuasive because as stated above, the purpose of the engagement member is for sliding accommodation of the delivery device for alignment of the delivery device with a perforation within an ear (see para. 92 of Margulis). In other words, the engagement member fixes (confines) the longitudinal position (location) of the delivery device within the boundary of the engagement member and prevents relative axial movement out of that boundary. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Margulis teaches an engagement member (alignment receptacle 209) accommodating (containing within) a delivery device (cylindrical tube 246) configured to engage the delivery device to fix (confine) a longitudinal position (location) of the delivery device relative to the second port, and is capable of performing the intended function, if one so desires.
In response to applicant's argument (see Remarks page 10) that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The rejection of claims 1-3, 6-8, 11, 13, 21, 22 and 27-29 is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 20110295073 (fig. 1-5, para. 20), US 20130023914 (fig. 5).
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 Tara Carter whose telephone number is (571) 272-3402. The examiner can normally be reached on M-F 7am-3pm.
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TARA ROSE E CARTER/Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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