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 Amendment
In view of the amendment filed on February 23, 2026 claims 1, 6-7, 14 and 19-20 have been amended.
The amendment to claims 6-7 overcome the objection in the Office action issued November 24, 2025. Therefore, the objection to claims 6-7 are hereby withdrawn.
The amendment to claim 1 overcome the rejection under 35 U.S.C. 103 as being unpatentable over Gunderson (US 2006/0030923). Examiner acknowledges Gunderson fails to disclose the new limitation of “a first portion of the sleeve shaft disposed between the outer shaft and the inner shaft, and wherein a second portion of the sleeve shaft extends distally beyond a distal end of the inner shaft.”
Claim 14, lines 6-7 has been amended to read “a polymeric distal end portion that comprises only one or more[[a]] flexible polymers [[and]] extending[[s]] distal to the main tube.” Examiner notes that the limitation “more” is new limitation. Lines 7-8 of claim 14, which is filed May 12, 2023, is reproduced below.
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Referring again to claim 14, applicant’s arguments have been fully considered but they are not persuasive. Applicant argues that incorporate an inner layer of low friction material, an outer layer of low friction material to the entire length of the inner shaft 22 of Gunderson and incorporate stainless steel spiral coil 36 to the shaft 22 fail to provide a polymeric distal end portion that comprises only one or more flexible polymers extending distal to the main tube (see pages 10-11 of the Remarks). Examiner respectfully traverses applicant remarks.
Attention is directed to FIG. 4, which is reproduced and annotated below, of Gunderson and pages 11-12 of the Office action issued November 24, 2025. First paragraph at page 11 of the Office action clearly states “the portion of inner shaft 22 that locate proximal to the stent region 24 is interpreted as a main tube.” The annotated figure below describes examiner’s interpretation of “main tube” and “a polymeric distal end portion…distal to the main tube” as required in claim 14, lines 5-7. The annotated figure below clearly shows a distal end portion extends from the main tube.
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Attention is directed to the full paragraph at the bottom of page 11 and the top of page 12. In this paragraph examiner clearly state that an inner low friction material and an outer low friction are provided to the entire length of the inner shaft 22 of Gunderson (“it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have provided the entire length of the inner shaft 22 of Gunderson with an inner layer of low friction material, an outer layer of low friction material to reduce friction”). Examiner contends that with this modification the distal end portion of inner shaft 22 of Gunderson (see annotated figure above) would include more than one flexible materials. Furthermore, examiner states that the “main tube” is further included stainless steel coil 26 as suggested by Delap to improve stiffness to the inner shaft 22 (“incorporate a middle layer, which includes a stainless steel spiral coil 36, to the proximal section of the stent region 24 to improve flexibility and stiffness of inner shaft 22 as suggested by Delap” (emphasis added)). Examiner did not proposed incorporate the stainless steel coil 26 as suggested by Delap to the distal end portion (stent region 24). Thus, the modification would include a “rigid main tube” because the main tube includes a stainless steel coil 26 and “a polymeric distal end portion that comprises one or more flexible polymers extending distal to the main tube” as required in the claim. Examiner notes that claim 14 is not required to interpreted as the polymeric distal end portion is formed separated from the main tube and the distal end portion is flexible than the main tube (FIGS. 30-31, FIG. 31 is reproduced below, and paragraph [0294] of the publication of the application disclose polymeric distal end portion 1544 is separated or attached to the main tube 1502).
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Applicant further argues that the port 86 in the catheter shown in FIG. 5 of Gunderson are proximal to and spaced axially away from a distal tip of the inner shaft and there is no evidence that the proposed combination would result in ports 86 are located in a polymeric distal end portion at the end of the shaft 22. Examiner respectfully traverses applicant’s remarks. As discussed in sections “a” and “b” above, the stent receiving region 24 of the shaft 22 for mounting stent 30 has been interpreted as the polymeric distal end portion, thus, incorporate ports 86 from the catheter shown in FIG. 5 to the shaft 22 shown in FIG. 4 would result one or more aperture in the polymeric distal end portion.
Applicant further argues that “the portion of the stent receiving 24 of the inner shaft 22 of Gunderson where the ports 86 are shown, is meant to support the stent 30 mounted thereon. If this portion of the shaft were modified to be a polymeric distal end portion that comprises only one or more flexible polymers extending distal to the main tube, there is insufficient evidence that it would function for its intended purpose of supporting the mounted stent” Examiner disagrees with applicant’s remarks. Attention is directed to FIGS. 4-5, the figure shows the inner catheter is designated with reference numeral “22” in paragraph [0024] Gunderson discloses “like reference numerals in the figures shall refer to like features unless otherwise indicated.” Thus, including ports 86 to the stent region 24 of shaft 22 as shown in FIG. 4 would result similar structure to the stent region of the embodiment as shown in FIG. 5.
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 14-18 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 14 recite “a polymeric distal end portion that comprises only one or more flexible polymers extending distal to the main tube” (emphasis added)(lines 6-7). Paragraph [0294] of the publication of the application discloses “An example of a distal tip 1541 of the pusher shaft 1500 is shown in FIG. 31. In some examples, the distal tip 1541 includes a more flexible, polymeric tip or distal end portion 1544 which comprises a flexible polymer. In some examples, the polymeric distal end portion 1544 can comprise the same flexible material as and/or be continuous with the outer polymer layer 1540. Thus, the polymeric distal end portion 1544 of the distal tip 1541 can be reflowed over the distal end 1514 of the main tube 1502 and bonded to the inner liner 1538.” Figure 4, which is reproduced above, and the specification fail to disclose the limitation of “only one or more flexible polymers.”
Claims 15-18 are rejected for the same reason as claim 14 by virtue of dependency on claim 14.
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.
Claim(s) 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson (US 2006/0030923, hereinafter “Gunderson”) in view of Delap (US 2009/0312832, hereinafter “Delap”).
Referring to claim 14, Gunderson discloses a delivery apparatus (FIG. 4, FIG. 4 is reproduced above) comprising:
an outer shaft (sheath 40 with stent region 42 as shown in FIG. 4; paras. [0034]-[0035], [0044] and [0050]) configured to retain a prosthetic implant (stent 30 as shown in FIG. 4) in a delivery configuration;
an inner shaft (inner shaft 22 with stent region 24 as shown in FIG. 4; paras. [0026]) disposed within the outer shaft and configured to interface with an end of the prosthetic implant (flange/hub/protrusion 72 as shown in FIGS. 3 and 4 is used to prevent stent 30 from being inadvertently displaced in the proximal direction (para. [0055])) and move axially relative to the outer shaft 40 (outer shaft 40 and inner shaft 22 are moved with respect to each other when the surgeon deploys the stent 30), the inner shaft comprising:
a the portion of inner shaft 22 that locate proximal to the stent region 24 is interpreted as a main tube);
a sleeve shaft (intermediate shaft or mid-shaft 82 as shown in FIG. 4; para. [0057]) disposed within the outer shaft, a portion of the sleeve shaft disposed between the outer shaft and the inner shaft, the sleeve shaft configured to cover the prosthetic implant (stent 30) in the delivery configuration.
The embodiment as shown in FIG. 4 fails to disclose the inner shaft 22 includes (1) the inner shaft further comprises an outer polymer layer that covers an outer surface of the main tube and is continuous with the polymeric distal end portion and (2) one or more apertures defined therein that extend between an inner surface of inner shaft 22 and an outer surface of the inner shaft.
As to (1) however, in the same field of endeavor, Delap discloses low friction materials may be coated onto or extruded into any of the shaft in the stent delivery system 10 to reduce friction (para. [0049]). Delap discloses the main tube 30 includes a middle layer, which includes a stainless steel spiral coil 36 to provides a desired stiffness to the main tube portion and more flexibility to distal tube portion and wherein the middle layer is located proximal to the stent region (Fig. 2), an inner layer of low friction material and an outer layer of low friction material may be applied to any of the main tube to reduce friction when the shafts are moved relative with each other (para. [0052]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have provided the entire length of the inner shaft 22 of Gunderson with an inner layer of low friction material and an outer layer of low friction material to reduce friction between the guidewire and the inner shaft and between the inner shaft 22 and the mid-shaft 82. Furthermore, it would have been obvious to incorporate a middle layer, which includes a stainless steel spiral coil 36, to the proximal section of the stent region 24 to improve flexibility and stiffness of inner shaft 22 as suggested by Delap. Examiner notes that the modification would include a “rigid main tube” because the main tube includes a stainless steel coil 26 and “a polymeric distal end portion that comprises one or more flexible polymers extending distal to the main tube” as required in the claim..
As to (2), in another embodiment (FIG. 5), Gunderson discloses the inner shaft 22 includes one or more openings (opening 86 as shown in FIG. 5; para. [0060]) defined therein that extend between an inner surface of inner shaft and an outer surface of the inner shaft and that are configured to fluidly couple an inner lumen of the inner shaft with a lumen disposed between the outer surface of the inner shaft 22 and an inner surface of the sleeve shaft 40. Attention is directed to FIG. 5, apparently the advantage of having ports 86 at the stent region is to further provide fluid communication between the guidewire lumen 26 of inner shaft 22 to the inner region of the stent 30 to reduce friction between the inner surface of stent 30 to the outer surface of inner shaft 22. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have provided ports 86 to the stent region of the inner shaft 22 of Gunderson/Delap to provide fluid communication between the guidewire lumen 26 of inner shaft 22 to the inner region of the stent 30.
Referring to claim 15, Gunderson/Delap discloses the delivery apparatus of claim 14, wherein the inner shaft 22 further comprises an outer polymer layer of Delap that covers an outer surface of the main tube and is continuous with the polymeric distal end portion (see item (1) of the rejection of claim 14).
Referring to claim 16, Gunderson/Delap discloses the delivery apparatus of claim 14, wherein the inner shaft 22 further comprises an inner liner covering the inner surface of the polymeric distal end portion and an inner surface of the main tube and wherein the one or more apertures 86 extend through the inner liner (see items (1) and (2) of the rejection of claim 14).
Referring to claim 17, Gunderson/Delap discloses the delivery apparatus of claim 14, wherein the one or more apertures include three apertures spaced apart from one another around a circumference of the polymeric distal end portion (Gunderson: FIG. 5 shows stent region of inner shaft 22 includes four ports 86).
Referring to claim 18, Gunderson/Delap discloses the delivery apparatus of claim 14, wherein the one or more apertures 86 are configured to fluidly couple an inner lumen of the inner shaft 22 with a lumen disposed between an outer surface of the inner shaft 22 and an inner surface of the sleeve shaft 40 (inner shaft 22 as shown in FIG. 4 would have ports 86 to allow fluid from the inner lumen travels to the outer surface of inner shaft 22).
Allowable Subject Matter
Claims 1-13 and 19-20 are allowable.
Kelly (US 2014/0180381, hereinafter “Kelly”) discloses a delivery apparatus (FIGS. 7A-7D, FIG. 7C is reproduced below) comprising:
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an outer shaft 715 (para. [0070]) configured to retain a prosthetic implant (stent 725 para. [0070]) in a delivery configuration; an inner shaft (push shaft 785 with tip 786 as shown in FIGS. 7A-7D; para. [0070]) disposed within the outer shaft 715 and configured to interface with an end of the prosthetic implant 725 (para. [0070])) and move axially relative to the outer shaft 715 (FIGS. 7A-7D); and a sleeve shaft 775 (FIGS. 7A-7D; para. [0070]) disposed within the outer shaft 715, a first portion of the sleeve shaft 775 disposed between the outer shaft 715 and the inner shaft 785, and wherein a second portion of the sleeve shaft 775 extends distally beyond a distal end 786 of the inner shaft 785 configured to cover the prosthetic implant 725 in the delivery configuration (FIGS. 7A-7C).
Kelly fails to disclose the inner shaft 785 includes one or more openings defined therein that extend between an inner surface of inner shaft and an outer surface of the inner shaft and that are configured to fluidly couple an inner lumen of the inner shaft with a lumen disposed between the outer surface of the inner shaft 785 and an inner surface of the sleeve shaft 775.
As to claim 1, there is no art of record alone or in combination that teaches the limitation of the inner shaft includes one or more openings defined therein that extend between an inner surface of inner shaft and an outer surface of the inner shaft and that are configured to fluidly couple an inner lumen of the inner shaft with a lumen disposed between the outer surface of the inner shaft 785 and an inner surface of the sleeve shaft.
As to claim 19, there is no art of record alone or in combination that teaches the limitation of the inner shaft comprising: a rigid, main tube including a distal end portion covered by an outer polymer layer, wherein the main tube comprises a distal section including a plurality of cuts therein, spaced apart from one another along a length of the distal section, and wherein the main tube comprises an intermediate section that is arranged adjacent and proximal to the distal section; a polymeric distal end portion that comprises a flexible polymer, is arranged distal to the main tube, and is continuous with the outer polymer layer; and one or more apertures disposed in the intermediate section of the main tube, wherein the one or more apertures extend between an outer surface of the inner shaft and an inner surface of the inner shaft, through the outer polymer layer and the main tube.
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 TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771
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