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 .
Response to Arguments
Applicant’s arguments filed 12/13/2025 have been fully considered but they are not persuasive. Applicant has amended claim 58 and 81-82 to recite the delivery device comprises a shaft with an angled tip at the distal end of the shaft.
Applicant argues that Harrington’s delivery device is used to advance an anchor through a previously placed straight access needle, and thus would not be able to apss through the access needle if configured with an angled distal tip, and points to figures 5a-b and 6.
This is not persuasive; the shaft of Harrington has a sharp angled tip (see fig. 6 and 7) and the anchor passes through the shaft (see fig. 7).
Allowable Subject Matter
Claims 61, and 68 are 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. The closest prior art is Harrington (Pub. No.: US 2012/0310280) in view of Dillard (Pub. No.: US 2020/0170823) as applied below, however, the combination does not fairly teach or suggest the plurality of migration prevention elements as closer to the proximal end than the distal end of the shaping element, or the at least one migration prevention element comprises a rachet element.
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.
Claims 58, 60, 62-67, 69-78, 80-83 are rejected under 35 U.S.C. 103 as being unpatentable over Harrington (Pub. No.: US 2012/0310280) in view of Dillard (Pub. No.: US 2020/0170823).
Harrington discloses a system for reshaping a nasal tissue of a subject (abstract), comprising:
a delivery device (e.g., fig. 5a) sized and shaped for insertion into a nasal airway of the subject; the delivery device comprising a shaft (e.g., fig. 6, 7), and a guide movable within the shaft (e.g., fig. 7, 8), and an angled tip at a distal end of the shaft (e.g., fig. 6, 7);
and a shaping element 5 comprising:
an elongate body 6 having a relaxed state and a tensioned state (e.g., fig. 1, 2), a proximal end (e.g., end adjacent supporter 10), a distal end (e.g., end adjacent anchor 8), and an intermediate region therebetween (e.g., fig. 2);
an anchor 8 positioned at the distal end of the elongate body configured to secure the shaping element 5 to the nasal tissue (e.g., fig. 1, 2); and
at least one migration prevention element positioned along the intermediate region (not disclosed),
wherein the elongate body 6 is configured to maintain a force on the nasal tissue to alter the shape of the nasal tissue in its tensioned state (e.g., para. 20).
As provided in italicized text above, Harrington lacks at least one migration prevention element positioned along the intermediate region of the elongate body 6. Dillard teaches a system for reshaping nasal tissue of a subject (abstract) including an elongate body (CSM) including at least one migration prevention element (BD) positioned along the intermediate region (e.g., para. 33, fig. 3-4). Dillard teaches these migration prevention elements (BD) provide tension and hold against the soft tissue of the nose to change the shape of the nose (e.g., para. 60). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided the elongate body of Harrington with migration prevention elements as taught by Dillard for the purpose of providing a barbed connection to the soft tissue, preventing migration and allowing for tension along the elongate body to change the shape of the nose. This modification would have occurred using known methods and would have yielded predictable results.
For claim 60, Dillard teaches the system of claim 58, further comprising a plurality of migration prevention elements (e.g., fig. 3, 4).
For claim 62, Dillard teaches the system of claim 60, wherein the plurality of migration prevention elements comprises a plurality of protrusions (e.g., fig. 3, 4).
For claim 63, Harrington and Dillard disclose the system of claim 58, wherein the nasal tissue is nasal septal tissue (Harrington fig. 1, tissue is fully capable of being septal tissue; Dillard para. 12).
For claim 64, Harrington discloses the system of claim 58, wherein the delivery device has a lumen therethrough (e.g., fig. 7).
For claim 65, Harrington and Dillard do not specify the system of claim 58, wherein the shaping element is between about 3 cm and about 30 cm in length, as neither reference specifies the desired length of the implant. However, use of a 3-30 cm length is considered an obvious expedient given the size of the human nose and the filamentous nature of the Harrington and Dillard implants.
For claim 66, Harrington and Dillard discloses the system of claim 58, wherein the shaping element comprises PLPLA (Poly(L-lactide)), DLPLA (Poly(DL-lactide)), LDL-PLA (Poly(DL-lactide-co-L- lactide)), LPLA- HA (Poly(L-lactide) with hydroxylapatite), PGA (Poly(glycolide), PGA-TMC (Poly(glycolide-co-trimethylene carbonate) or polyglyconate), PDO (Poly(dioxanone)), LPLG (Poly(L-lactide-co-glycolide)), DLPLG (Poly(DL-lactide-co-glycolide), or combinations thereof (e.g., Harrington para. 20, Dillard para. 16).
For claim 67, Dillard teaches the system of claim 66, wherein the shaping element comprises PDO (e.g., para. 16).
For claim 69, Dillard teaches the system of claim 58, wherein the at least one migration prevention element is sized and shaped to pass through the nasal tissue in a first direction while being prevented from passing back through the nasal tissue in an opposite direction (barb, e.g., fig. 3,4).
For claim 70, Harrington discloses the system of claim 58, further comprising a needle, wherein the needle is couplable to the shaping element to help direct the shaping element through the nasal tissue (e.g., fig. 6, 7).
For claim 71, Harrington discloses the system of claim 58, wherein the delivery device comprises a curved portion (e.g., fig. 5a).
For claim 72, Harrington discloses the system of claim 58, wherein the delivery device further comprises a handle 26 (e.g., fig. 5a).
For claim 73, Harrington discloses the system of claim 58, wherein the delivery device further comprises an actuator 27 for delivering the shaping element (e.g., fig. 5a).
For claim 74, Harrington discloses the system of claim 58, wherein a tip of the delivery device is atraumatic (e.g., fig. 5b, the sharp edge is part of the implant, with the delivery device end being atraumatic).
For claim 75, Harrington discloses the system of claim 58, wherein the anchor comprises one or more of a T-fastener, and X-shaped fastener, a button, or a barb (e.g., fig. 4e, barb).
For claim 76, Harrington discloses the system of claim 58, wherein the shaping element further comprises a force distributing region 10.
For claim 77, Harrington discloses the system of claim 76, wherein the force distributing region has a width that is greater than the width of the shaping element adjacent to the force distributing region (e.g., fig. 2a).
For claim 78, Harrington discloses the system of claim 58, wherein the shaft of the delivery device comprises one or more ports located on a sidewall thereof (e.g., fig. 6).
For claim 80, Harrington discloses the system of claim 58, wherein the delivery device comprises a sharp tip (e.g., fig. 6-7).
For claim 81, Harrington discloses a system for reshaping a nasal tissue of a subject, comprising: a delivery device sized and shaped for insertion into a nasal airway of the subject (e.g., fig. 5a), the delivery device comprising a shaft, (fig. 6) a guide 25 moveable within the shaft (e.g., fig. 5a, 6, 7), and an angled tip at a distal end of the shaft (e.g., fig. 6, 7); and a shaping element 5 coupled to the guide (e.g., fig. 5a, 7), and comprising: an elongate body 6 having a relaxed state and a tensioned state (e.g., fig. 2), a proximal end (end near element 10), a distal end (end near anchor 8), and an intermediate region therebetween; an anchor 8 positioned at the distal end of the elongate body (e.g., fig. 2); and at least one migration prevention element positioned along the intermediate region (not disclosed), wherein the elongate body is configured to maintain a force on the nasal tissue to alter the shape of the nasal tissue after deployment from the guide (e.g., para. 20).
As provided in italicized text above, Harrington lacks at least one migration prevention element positioned along the intermediate region of the elongate body 6. Dillard teaches a system for reshaping nasal tissue of a subject (abstract) including an elongate body (CSM) including at least one migration prevention element (BD) positioned along the intermediate region (e.g., para. 33, fig. 3-4). Dillard teaches these migration prevention elements (BD) provide tension and hold against the soft tissue of the nose to change the shape of the nose (e.g., para. 60). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided the elongate body of Harrington with migration prevention elements as taught by Dillard for the purpose of providing a barbed connection to the soft tissue, preventing migration and allowing for tension along the elongate body to change the shape of the nose. This modification would have occurred using known methods and would have yielded predictable results.
For claim 82, Harrington discloses the system of claim 81, wherein the elongate member comprises a sharp tip (e.g., para. 30).
For claim 83, Harrington discloses the system of 81, wherein the guide 25 comprises a sharp tip (e.g., fig. 5b).
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.
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/SUBA GANESAN/Primary Examiner, Art Unit 3774