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 6/23/2026, with respect to the amendments overcoming the 35 USC 102a1 and 103 rejection(s) presented in the office action dated 3/23/2026 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, new ground(s) of rejection are made in further view of Allen and Leung (see below), as necessitated by the amendments to the claims.
Claim Objections
Claims 1 and 3-9 are objected to because of the following informalities: “plurality of proximal anchors” should read “plurality of offset proximal anchors” each time it appears in claim 1 (line 7-8) and claims 3-9 for consistency with its first recitation in line 6 of claim 1. Appropriate correction is required.
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, 3-9, and 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenthal et al. (US 2019/0343622) in view of Allen et al. (US 2013/0023724) and Leung et al. (US 8,100,940).
Rosenthal discloses a device comprising: a tension element (3832; fig. 38), the tension element comprising an elongate body having a proximal end (3834) and a distal end (3836); a distal anchor (3840,3842) at the distal end comprising at least a first arm (3840) and a second arm (3842); and a plurality of offset proximal anchors (3835), disposed along a region of the elongate body between the distal anchor and the proximal end (fig. 38). The limitation “for manipulating one or more nasal turbinates” appearing in the preamble is a recitation of intended use, and the prior art must only be capable of carrying out this function in order to meet the limitation. Because the prior art device of Rosenthal meets all of the structural limitations of the claim and is capable of being implanted at least partially within or through a nasal turbinate (noting Rosenthal discloses using device in nasal bones and tissue), it is capable of manipulating one or more nasal turbinates.
Rosenthal does not expressly disclose that the region between the proximal end and the distal end of the tension element, on which the anchors (3835) are disposed, is an undulating region.
Allen discloses another tension element (30) having a plurality of barbs (20) thereon, wherein the region on which the plurality of barbs is disposed is undulating (see fig. 20, 21). According to Allen, the undulations allow utilization of the suture tension to resist rotation of the anchors (20) working against tissue ([0073]), and during initial application of tension this undulating configuration is better able to work in tissue than one in which the suture is in a straight line after anchor deployment ([0074]). Thus, it would have been obvious to one of ordinary skill in the art to have modified the prior art of Rosenthal to construct the region between the proximal and distal ends of the tension element on which the anchors are disposed to be undulating as taught by Allen in order to enhance the effectiveness of the array of proximal anchors.
Rosenthal also fails to expressly disclose that a length of the plurality of proximal anchors decreases along the region of the elongate body from the distal anchor towards the proximal end.
Leung discloses another tension element (122; fig. 11) having a plurality of anchors along its length, wherein a length of the anchors decreases along the elongate body from the distal end (124) towards the proximal end (anchors 129, 127,125). According to Leung, such differing length anchors on a tension element helps to ensure maximum anchoring properties when barb sizes are customized for each tissue layer (col. 25, ll. 57-col. 26, ll. 35). Thus, it would have been obvious to one of ordinary skill in the art to have modified the prior art of Rosenthal to provide the plurality of proximal anchors with lengths that decrease along the region of the elongate body from the distal anchor towards the proximal end as taught by Leung in order to ensure maximum anchoring properties for each tissue layer in which the tension element is anchored.
Regarding claim 3, the plurality of proximal anchors comprises one or more of a barb, hook, spike, leaf, nub, or protrusion (barb 3835; fig. 38).
Regarding claim 4, a distal end of each of the plurality of proximal anchors (3835) is beveled, tapered, sharp, curved, or a combination thereof (e.g., beveled or tapered as understood from cuts used to form anchors; the radially outermost surface of the distal end of each anchor is also curved).
Regarding claim 7, a first set of the plurality of proximal anchors (e.g., proximal-most two proximal anchors in fig. 38) are offset along a longitudinal axis of the elongate body from a second set (e.g., distal-most two proximal anchors) of the plurality of proximal anchors.
Regarding claim 8, the plurality of proximal anchors is symmetrically spaced apart along a length of the elongate body (see even spacing of proximal anchors as understood in view of fig. 38 of Rosenthal).
Regarding claim 9, Leung teaches that the plurality of proximal anchors is asymmetrically spaced apart along a length of the elongate body (see fig. 11, noting smaller distance between bases of 125 and 127, than between bases of 127 and 129). This interpretation is consistent with the instant application’s description, wherein asymmetrically spaced apart is described as adjacent barbs being spaced apart a different distance than other adjacent barbs along the length. It would have been obvious to further modify the prior art of Rosenthal to provide the proximal anchors asymmetrically spaced apart along a length of the elongate body since such an arrangement is known in the art according to Leung and Rosenthal contemplates uneven spacing of anchoring features (see [0089] and [0093]: ribs anchor implant, and ribs can be unevenly spaced), and further discloses that “features of any embodiment may be combined or substituted with features of any other embodiment” (see [0132]).
Regarding claim 11, the device further comprises a needle releasably coupled to the proximal end of the elongate body (see fig. 12, noting needle 1212 inserted into proximal end 1134; see also [0195], wherein device is delivered via a delivery needle such that all portions of the device, including the proximal end of the elongate body, are considered releasably coupled to the needle).
Regarding claims 12-14, the tension element comprises a biodegradable polymer, which may be PDO (poly(dioxanone)) (see [0011]).
Regarding claim 15, because the device of Rosenthal is capable of being placed through, or anchored into, tissue of a middle turbinate, an inferior turbinate, a superior turbinate, or a supreme turbinate, it meets this recitation of intended use.
Regarding claims 5 and 6, Rosenthal in view of Allen and Leung discloses the invention substantially as stated above, noting also that the entire length of the device may be about 20mm ([0196], [0176]), but Rosenthal does not expressly disclose that a first proximal anchor of the plurality of proximal anchors is spaced between about 2.0mm and about 6.0mm from the distal anchor, or spaced about 5.0mm from the distal anchor. However, it would have been obvious to one of ordinary skill in the art to have modified the prior art of Rosenthal to space a first proximal anchor of the plurality of proximal anchors about 5.0mm from the distal anchor since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984, cert. denied, 468 U.S. 830, 225,SPQ 232 (1984). In the instant case, the device of Rosenthal would not operate differently with the claimed dimension since the plurality of proximal anchors of Rosenthal are placed along the length of the elongate member in order to anchor the device into tissue and such dimensioning does not change the function of the first proximal anchor. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the claimed space “may be” within the claimed range, or “may be” the claimed value ([0014]-[0015], [0090] of instant application’s specification).
Claim(s) 1, 3-9, 11-13 and 15 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Krespi et al. (US 2016/0220411) in view of Allen et al. (US 2013/0023724). Krespi discloses a device (e.g., fig. 6) comprising: a tension element, the tension element comprising an elongate body (82; fig. 6) having a proximal end (84) and a distal end (86), and a region therebetween; a distal anchor (distalmost anchor 91) at the distal end comprising at least a first arm (92) and a second arm (92); and a plurality of offset proximal anchors (two barbs 92 of proximal-most 91, and barbs 94, noting all barbs are offset from each other, either longitudinally or circumferentially) disposed along the region, wherein a length (i.e., extension of barb from its connection to at the elongate body to its free tip) of the plurality of proximal anchors decreases along the region of the elongate body from the distal anchor towards the proximal end (e.g., from barbs 92 of proximal-most 91 to barbs 94, length of barbs decreases). The limitation “for manipulating one or more nasal turbinates” appearing in the preamble is a recitation of intended use, and the prior art must only be capable of carrying out this function in order to meet the limitation. Because the prior art device of Krespi meets all of the structural limitations of the claim and is capable of being implanted at least partially within or through a nasal turbinate (noting length of implant may be as small as 10mm: [0061]), it is capable of manipulating one or more nasal turbinates.
Krespi fails to disclose that the region between the proximal and distal ends upon which the plurality of proximal anchors is disposed is undulating.
Allen discloses another tension element (30) having a plurality of barbs (20) thereon, wherein the region on which the plurality of barbs is disposed is undulating (see fig. 20, 21). According to Allen, the undulations allow utilization of the suture tension to resist rotation of the anchors (20) working against tissue ([0073]), and during initial application of tension this undulating configuration is better able to work in tissue than one in which the suture is in a straight line after anchor deployment ([0074]). Thus, it would have been obvious to one of ordinary skill in the art to have modified the prior art of Krespi to construct the region between the proximal and distal ends of the tension element on which the anchors are disposed to be undulating as taught by Allen in order to enhance the effectiveness of the array of proximal anchors.
Regarding claim 3, the plurality of proximal anchors comprises one or more of a barb, hook, spike, leaf, nub, or protrusion (see barbs 92 and 94 in fig. 6).
Regarding claim 4, a distal end of each of the plurality of proximal anchors is beveled, tapered, sharp, curved, or a combination thereof (barbs 92 and 94 considered at least tapered and sharp).
Regarding claim 7, a first set (e.g., barbs 92 of proximal-most 91 in fig. 6) of the plurality of proximal anchors are offset along a longitudinal axis of the elongate body from a second set (94) of the plurality of proximal anchors.
Regarding claim 8, the plurality of proximal anchors is symmetrically spaced apart along a length of the elongate body. In particular, consider a length of the elongate body starting at the proximal-most barb 94 and extending to the distal-most barb 94. Along this length, the plurality of proximal anchors is symmetrically spaced apart.
Regarding claim 9, the plurality of proximal anchors is asymmetrically spaced apart along a length of the elongate body. In particular, consider a length of the elongate body starting at the barbs 92 of the proximal-most 91 extending to and four of the barbs 94. The space between barbs 92 on proximal-most 91 and distal-most 94 is larger than the space between the distal-most 94 and its longitudinally adjacent 94. This interpretation is consistent with the instant application’s description, wherein asymmetrically spaced apart is described as adjacent barbs being spaced a different distance than other adjacent barbs along the length.
Regarding claim 11, the device further comprising a needle releasably coupled to the proximal end of the elongate body (see fig. 16, 17, noting entire device considered releasably coupled to the needle; see also fig. 26).
Regarding claims 12 and 13, the tension element comprises a biodegradable polymer, which may be polyglycolic acid (PGA) (see [0062]).
Regarding claim 15, because the device of Krespi is capable of being placed through, or anchored into, tissue of a middle turbinate, an inferior turbinate, a superior turbinate, or a supreme turbinate, it meets this recitation of intended use.
Regarding claims 5 and 6, Krespi in view of Allen and Leung discloses the invention substantially as stated above, noting also that the functional length (“F” in fig. 6) of the device may be about 20 mm ([0061]), but Krespi does not expressly disclose that a first proximal anchor of the plurality of proximal anchors is spaced between about 2.0mm and about 6.0mm from the distal anchor, or spaced about 5.0mm from the distal anchor. However, it would have been obvious to one of ordinary skill in the art to have modified the prior art of Krespi to space a first proximal anchor of the plurality of proximal anchors about 5.0mm from the distal anchor since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984, cert. denied, 468 U.S. 830, 225,SPQ 232 (1984). In the instant case, the device of Krespi would not operate differently with the claimed dimension since the plurality of proximal anchors of Krespi are placed along the length of the elongate member in order to anchor the device into tissue and such dimensioning does not change the function of the first proximal anchor. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the claimed space “may be” within the claimed range, or “may be” the claimed value ([0014]-[0015], [0090] of instant application’s specification).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenthal in view of Allen and Leung as applied to claim 1 above, and further in view of Kintzing et al. (US 2022/0000609). Rosenthal in view of Allen and Leung discloses the invention substantially as stated above including a distal anchor having first and second arms (3840,3842; fig. 38), but does not expressly disclose that the distal anchor comprises a T-anchor (noting that the arms do not have an approximately 180-degree angle between them).
Kintzing discloses another device used to manipulate nasal tissue, the device comprising a tension element (fig. 7) having an elongate body, a distal anchor (210), and a plurality of proximal anchor (see barbs adjacent 220), wherein the distal anchor comprising a T-anchor (see figs. 7, 21, and par. [0072]). It would have been obvious to one of ordinary skill in the art to have further modified the prior art of Rosenthal to replace the distal anchor illustrated in fig. 7b with a T-anchor as taught by Kintzing, since such a modification can be considered a substitution of one known distal anchor on a device used to manipulate nasal tissue for another, wherein the results of such a modification are predictable (distal anchor secures distal end of tension element relative to tissue) and one skilled in the art would have had a reasonable expectation of success when making such a modification.
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 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 KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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KSH 7/8/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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