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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 04, 2025 has been entered.
Response to Amendment
This Office action is in response to the request for continued examination filed November 04, 2025. Claim 40 is amended. Claims 43-44 are newly added. Claims 28, 30, 36, and 41 are canceled. Claims 27, 29, 31-35, 37-40, and 42-44 are pending and addressed below.
Response to Arguments
Applicant’s arguments, see pages 7-14 of Applicant’s response, filed November 04, 2025, with respect to claims 27, 34, and 41 have been fully considered and are persuasive, particularly with respect to argument (2)(A)(1) regarding claims 27 and 34 in that the prior art of Stallings (U.S. Pat. No. 6776791) teaches away from using a pusher to load the scaffold as modified by Examiner in view of Gabbay (U.S. Pub. No. 2007/0132100), and with respect to argument (2)(C) regarding claim 41 in that the teaching reference of Yaniv (U.S. Pub. No. 2018/0360626) does not explicitly teach deploying the stent specifically in the middle meatus.
The rejection of claims 27, 29, 31-35, 37-40, and 42 has been withdrawn. However, the claims are rejected on a new basis set out below.
Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 27, 29, and 34-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abbate et. al. (U.S. Pub. No. 2010/0043197) hereinafter “Abbate.”
Regarding claim 27, Abbate teaches a method of loading a scaffold, comprising,
a) providing:
1) a first assembly (1800; Fig. 18A) comprising
(i) a loading member (1802; Fig. 18A) that comprises a tapered loading lumen (see Fig. 18B) having a proximal loading lumen end (see Fig. 18B) and a distal loading lumen end (see Fig. 18B), wherein the proximal loading lumen end has a first diameter (see Fig. 18B) and the distal loading lumen end has a second diameter (see Fig. 18B) that is smaller than the first diameter (see Fig. 18B) and
(ii) a delivery sheath (1804; Fig. 18A) having a delivery sheath lumen (see Fig. 18B) that is connected to the loading lumen (see Fig. 18B), and
2) a second assembly (1910, 1914, 1912 in combination; Fig. 19A) comprising
(i) a self-expanding scaffold (1910; Fig. 19A, pp. [0087]), said scaffold (1910) comprising a scaffold wall (e.g., see Fig. 5 showing “self-expanding device” 506) and having a scaffold lumen (see Fig. 5), a proximal scaffold end (see Fig. 5), a distal scaffold end (see Fig. 5), an inner luminal surface (see Fig. 5), and an outer abluminal surface (see Fig. 5),
(ii) an elongate advancement member (1912; Fig. 19A) having a proximal end (see Fig. 19A) and a distal end (see Fig. 19A),
(iii) at least one filament (1914; Fig. 19A) linking an end of the elongate advancement member (1912) to the scaffold (1910), and
(iv) a pusher member (2108; Fig. 21A, it is noted, Abbate teaches the “crimping device” 1800 can be used with one or more pullers or pushers (pp. [0087]) and that any combination of “crimping members” (i.e., pullers or pushers, see pp. [0081]) can be used (pp. [0008]));
b) inserting the second assembly into the proximal loading lumen end (see Fig. 19A) of the loading member (1802, shown as 1902 in Fig. 19A) of said first assembly (1800) so as to create a loaded second assembly (see Fig. 19A, pp. [0087]);
c) advancing said loaded second assembly (Fig. 19A) at least partially through said first assembly (1800) by applying force on said elongate advancement member (1912; pp. [0087]-[0088]), such that the scaffold (1910) is moved through the loading lumen (1802) in a proximal-to-distal direction in said delivery sheath (shown as 1906 in Fig. 19B), and
d) inserting the pusher member (2108) through the proximal loading lumen end of the loading member (2102 in Fig. 21A) to the proximal end of the scaffold (2110 in Fig. 21A) so as to push the scaffold in said delivery sheath (shown as 2106 in Fig. 21B, see Figs. 21A-B, pp. [0090]).
Regarding claim 29, Abbate teaches the invention as discussed above in claim 27. Abbate further teaches the loading member (1800) is in the form of a funnel (see Fig. 18A).
Regarding claim 34, Abbate teaches a method of loading a scaffold, comprising,
a) providing:
1) a first assembly (1800; Fig. 18A) comprising
(i) a loading member (1802; Fig. 18A) that comprises a tapered loading lumen (see Fig. 18B) having a proximal loading lumen end (see Fig. 18B) and a distal loading lumen end (see Fig. 18B), wherein the proximal loading lumen end has a first diameter (see Fig. 18B) and the distal loading lumen end has a second diameter (see Fig. 18B) that is smaller than the first diameter (see Fig. 18B) and
(ii) a delivery sheath (1804; Fig. 18A) having a delivery sheath lumen (see Fig. 18B) that is connected to the loading lumen (see Fig. 18B), and
2) a second assembly (1910, 1914, 1912 in combination; Fig. 19A) comprising
(i) a self-expanding scaffold (1910; Fig. 19A, pp. [0087]), said scaffold (1910) comprising a scaffold wall (e.g., see Fig. 5 showing “self-expanding device” 506) and having a scaffold lumen (see Fig. 5), a proximal scaffold end (see Fig. 5), a distal scaffold end (see Fig. 5), an inner luminal surface (see Fig. 5), and an outer abluminal surface (see Fig. 5), said scaffold (1910) having an as manufactured diameter (the scaffold innately has an as manufactured diameter),
(ii) an elongate advancement member (1912; Fig. 19A) having a proximal end (see Fig. 19A) and a distal end (see Fig. 19A),
(iii) at least one filament (1914; Fig. 19A) linking an end of the elongate advancement member (1912) to the scaffold (1910), and
(iv) a pusher member (2108; Fig. 21A, it is noted, Abbate teaches the “crimping device” 1800 can be used with one or more pullers or pushers (pp. [0087]) and that any combination of “crimping members” (i.e., pullers or pushers, see pp. [0081]) can be used (pp. [0008]));
b) inserting the second assembly (1910, 1912, 1914) into the proximal loading lumen end (see Fig. 19A) of the loading member (1802, shown as 1902 in Fig. 19A) of said first assembly (1800) so as to create a loaded second assembly (see Fig. 19B, pp. [0087]) comprising a crimped scaffold (see Fig. 19B), said crimped scaffold (Fig. 19B) having a reduced diameter as compared to said manufactured diameter (it is evidenced that the crimped scaffold has a reduced diameter compared to the manufactured diameter by nature of the process being used to reduce the scaffold size to fit into a delivery sheath);
c) advancing said loaded second assembly (Fig. 19B) at least partially through said first assembly (1800) by applying force on said elongate advancement member (1912; pp. [0087]-[0088]), such that the crimped scaffold (1910) is moved through the loading lumen in a proximal-to-distal direction in said delivery sheath (shown as 1906 in Fig. 19B); and
d) inserting the pusher member (2108) through the proximal end of the delivery sheath (shown as 2106 in Fig. 21B) and advancing the pusher member (2108) the proximal end of the crimped scaffold (2110 in Fig. 21B) so as to contact the scaffold in said delivery sheath (see Figs. 21A-B, pp. [0090]).
Regarding claim 35, Abbate teaches the invention as discussed above in claim 34. Abbate further teaches the loading member (1800) is in the form of a funnel (see Fig. 18A).
Claim Rejections - 35 USC § 103
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.
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 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.
Claim(s) 31-33, 37-39, and 43-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abbate in view of Inoue (U.S. Pat. No. 6364901).
Regarding claims 31-33 and 37-39, Abbate teaches the invention as discussed above in claim 27 and 34 respectively. Abbate further teaches at least one aperture (108; Fig. 1) in the scaffold wall (1910, see also Figs. 21A-21B showing at least one aperture).
However, Abbate does not explicitly disclose the at least one filament is looped from the elongate advancement member, through the at least one aperture in the scaffold wall, and back to the elongate advancement member,
wherein both ends of the at least one looped filament are attached to the elongate advancement member,
wherein the elongate advancement member comprises a groove and wherein one end of the at least one attached looped filament is positioned in the groove as claimed.
Abbate does teach the “puller” can have any suitable configuration (pp. [0088]) and the apertures (108) can receive a filament therethrough (see Fig. 1, pp. [0036]).
Inoue teaches a configuration of attaching a scaffold (A; Fig. 9) to an elongated advancement member (2; Fig. 9) where at least one filament (4; Fig. 9) is looped from the elongate advancement member (2), through at least one aperture (13; Fig. 9) connected to the scaffold wall (see Fig. 9), and back to the elongate advancement member (2),
wherein both ends of the at least one looped filament (4) are attached to the elongate advancement member (2; one end of the at least one filament 4 connects to the elongate advancement member 2 as seen in Fig. 7 and the other end connects as 4a around element 3 as shown in Fig. 9; Col. 10, lines 35-45), and
wherein the elongate advancement member (2) comprises a groove (1; Fig. 9) and wherein one end of the at least one attached looped filament (4) is positioned in the groove (1; see Fig. 10 further showing the at least one filament 4 positioned in the groove 1).
Inoue is considered to be analogous to the claimed invention because it is in the same field of scaffold loading devices. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the scaffold, filament, and elongate advancement member configuration of Abbate to incorporate the teachings of Inoue by providing a connecting groove in the elongate advancement member and looping the at least one filament between the apertures and the groove. Doing so would be a simple substitution of one known configuration for connecting a scaffold to an elongate advancement member with at least one filament for another to obtain predictable results of providing a method for loading a scaffold with a reasonable expectation of success.
Regarding claim 43, Abbate teaches a method of loading a scaffold, comprising,
a) providing:
1) a first assembly (1800; Fig. 18A) comprising
(i) a loading member (1802; Fig. 18A) that comprises a tapered loading lumen (see Fig. 18B) having a proximal loading lumen end (see Fig. 18B) and a distal loading lumen end (see Fig. 18B), wherein the proximal loading lumen end has a first diameter (see Fig. 18B) and the distal loading lumen end has a second diameter (see Fig. 18B) that is smaller than the first diameter (see Fig. 18B) and
(ii) a delivery sheath (1804; Fig. 18A) having a delivery sheath lumen (see Fig. 18B) that is connected to the loading lumen (see Fig. 18B), and
2) a second assembly (1910, 1914, 1912 in combination; Fig. 19A) comprising
(i) a self-expanding scaffold (1910; Fig. 19A, pp. [0087]), said scaffold (1910) comprising a scaffold wall (e.g., see Fig. 5 showing “self-expanding device” 506) with aperture (108; Fig. 1, see also Figs. 21A-21B showing at least one aperture) and having a scaffold lumen (see Fig. 5), a proximal scaffold end (see Fig. 5), a distal scaffold end (see Fig. 5), an inner luminal surface (see Fig. 5), and an outer abluminal surface (see Fig. 5),
(ii) an elongate pulling member (1912; Fig. 19A) having a proximal end (see Fig. 19A) and a distal end (see Fig. 19A),
(iii) at least one filament (1914; Fig. 19A) linking an end of the elongate advancement member (1912) to the scaffold (1910), and
b) inserting the second assembly into the proximal loading lumen end (see Fig. 19A) of the loading member (1802, shown as 1902 in Fig. 19A) of said first assembly (1800) so as to create a loaded second assembly (see Fig. 19A, pp. [0087]); and
c) advancing said loaded second assembly (Fig. 19A) at least partially through said first assembly (1800) by pulling the elongate advancement member (1912; pp. [0087]-[0088]), such that the scaffold (1910) is moved through the loading lumen (1802) in a proximal-to-distal direction (shown as 1906 in Fig. 19B).
However, Abbate does not explicitly disclose the at least one filament is looped from the elongate pulling member, through the at least one aperture in the scaffold wall, and back to the elongate pulling member as claimed.
Abbate does teach the “puller” can have any suitable configuration (pp. [0088]) and the apertures (108) can receive a filament therethrough (see Fig. 1, pp. [0036]).
Inoue teaches a configuration of attaching a scaffold (A; Fig. 9) to an elongated advancement member (2; Fig. 9) where at least one filament (4; Fig. 9) is looped from the elongate advancement member (2), through at least one aperture (13; Fig. 9) connected to the scaffold wall (see Fig. 9), and back to the elongate advancement member (2) such that first and second ends are secured to the elongate advancement member (2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the scaffold, filament, and elongate pulling member configuration of Abbate to incorporate the teachings of Inoue by looping the at least one filament through the apertures in the scaffold wall, and back to the elongate pulling member such that first and second ends are secured to the pulling member. Doing so would be a simple substitution of one known configuration for connecting a scaffold to an elongate pulling member with at least one filament for another to obtain predictable results of providing a method for loading a scaffold with a reasonable expectation of success.
Regarding claim 44, Abbate teaches the invention as discussed above in claim 43. Abbate further teaches d) severing said at least one filament (1914) so as to disengage the scaffold (1910) from said elongate pulling member (1912, the “storage zone” 1804 is taught as having a blade (pp. [0085]) which is taught as being used to sever the crimping members (pp. [0082])).
However, Abbate does not explicitly disclose removing said at least one filament from the scaffold by pulling on one of the ends of the filament.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have removed the at least one filament by pulling on the ends of the filament since it has been held that "a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. In the instant case, one having ordinary skill in the art would understand that the “crimping member” (handle 1912 and sutures 1914) would need to be removed once severed by the “blade.” To remove the handle and sutures someone could pull either the handle (if the sutures remained attached), pull the middle of the sutures, or pull the end of the sutures. One of ordinary skill in the art would recognize any of the above options could be used to remove the severed crimping member with a reasonable expectation of success.
Claim(s) 40 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abbate in in view of SinusVideos.com (https://www.sinusvideos.com/placement-of-steroid-eluting-stent-after-sinus-surgery-2, Accessed February 19, 2026)(see attached NPL), hereinafter, “Sinus Video.”
Regarding claim 40, Abbate teaches a method of loading a scaffold, comprising,
a) providing:
1) a first assembly (1800; Fig. 18A) comprising
(i) a loading member (1802; Fig. 18A) that comprises a tapered loading lumen (see Fig. 18B) having a proximal loading lumen end (see Fig. 18B) and a distal loading lumen end (see Fig. 18B), wherein the proximal loading lumen end has a first diameter (see Fig. 18B) and the distal loading lumen end has a second diameter (see Fig. 18B) that is smaller than the first diameter (see Fig. 18B) and
(ii) a delivery sheath (1804; Fig. 18A) having a delivery sheath lumen (see Fig. 18B) that is connected to the loading lumen (see Fig. 18B), and
2) a second assembly (1910, 1914, 1912 in combination; Fig. 19A) comprising
(i) a self-expanding scaffold (1910; Fig. 19A, pp. [0087]), said scaffold (1910) comprising a scaffold wall (.g., see Fig. 5 showing “self-expanding device” 506) and having a scaffold lumen (see Fig. 5), a proximal scaffold end (see Fig. 5), a distal scaffold end (see Fig. 5), an inner luminal surface (see Fig. 5), and an outer abluminal surface (see Fig. 5),
(ii) an elongate advancement member (1912; Fig. 19A) having a proximal end (see Fig. 19A) and a distal end (see Fig. 19A),
(iii) at least one filament (1914; Fig. 19A) linking an end of the elongate advancement member (1912) to the scaffold (1910), and
(iv) a pusher member (2108; Fig. 21A, it is noted, Abbate teaches the “crimping device” 1800 can be used with one or more pullers or pushers (pp. [0087]) and that any combination of “crimping members” (i.e., pullers or pushers, see pp. [0081]) can be used (pp. [0008]));
b) inserting the second assembly (1910, 1912, 1914) into the proximal loading lumen end (see Fig. 19A) of the loading member (1802) of said first assembly (1800) so as to create a loaded second assembly (see Fig. 19A, pp. [0087]); and
c) advancing said loaded second assembly (Fig. 19A) at least partially through said first assembly (1800) by applying force on said elongate advancement member (1912; pp. [0087]-[0088]), such that the scaffold (1910) is moved through the loading lumen (1802) in a proximal-to-distal direction in said delivery sheath (shown as 1906 in Fig. 19B);
d) inserting the pusher member (2108) through the proximal loading lumen end of the loading member (2102 in Fig. 21A) to the proximal end of the scaffold (2110 in Fig. 21A);
e) advancing the pusher (2108) to the proximal end of the scaffold (2110) in said delivery sheath (shown as 2106 in Fig. 21B, see Figs. 21A-B, pp. [0090]); and
f) deploying the scaffold (1910) in a sinus space of a patient (pp. [0003]).
However, Abbate does not explicitly disclose the sinus space is the middle meatus.
Sinus Video teaches deploying a scaffold in the middle meatus of a sinus space of a patient (see “Highlights” section of NPL).
Sinus Video is considered to be analogous to the claimed invention because it is in the same field of scaffold delivery into a sinus space. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Abbate to incorporate the teachings of Yaniv by deploying the scaffold to specifically the middle meatus. Doing so would prevent middle turbinate lateralization after an ethmoidectomy as taught by Sinus Video (see “Indications” and “Highlights” section of NPL).
Regarding claim 42, Abbate in view of Sinus Video teaches the invention as discussed above in claim 40. Abbate further teaches said scaffold (1910) is a drug-eluting scaffold (pp. [0003]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL A. ICET whose telephone number is (571)272-0488. The examiner can normally be reached M-F: 8:00-5:00 CT.
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/DANIEL ICET/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771