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 .
Claim Objections
Claim 37 is objected to because of the following informalities: a period is missing at the end of the claim. Appropriate correction is required.
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) 9-10, 36-45 and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/252702 A1 (hereinafter “Wang”)(U.S. Patent Application No. 17/620,250 is national stage of PCT/CN2019/091935, therefore, U.S. Pub. No. 2022/0362003 is an English translation of WO 2020/252702 A1) in view of Bolduc et al. (US 2005/0070992, hereinafter “Bolduc”) and further in view of Kanji (US 6,916,335, hereinafter “Kanji”).
Referring to claim 9, Wang discloses a vascular stent-graft (FIG. 9; ¶¶ [0043] and [0077]) which includes a tubular body (FIG. 9, which is reproduced and annotated below) having a tubular wall which is comprised of at least a first layer 120 (¶¶ [0031] and [0051]) a proximal anchor section of a cylindrical form (see annotated figure below), preformed with a first diameter and a first length, a distal treatment section (see annotated figure below) a transition section (see annotated figure below) which tapers the tubular body from the anchor segment to the treatment segment, at least one stent (the annotated figure below shows each section has at least one stent) of a first set engaged with the anchor section,
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Referring again to claim 9, Wang discloses the invention substantially as claimed except for disclosing (1) the cover (first layer as claimed in the claim) is in a form of a fabric (examiner notes that the term fabric means that the article is made by knitting or weaving a plurality of filaments together); (2) the distal treatment section has a tapered form; and (3) the stent is configured to bias the anchor section from the first diameter to a second diameter which exceeds the first diameter.
Referring still to claim 9, as to (1), Wang further discloses the covering membrane 120 includes an inner covering membrane 121 and an outer covering membrane 122 and the covering membranes are made from polytetrafluoroethylene (PET), polyesters, polyurethane, silicone, polyethylene or other suitable materials (¶[0083]). However, in same field of endeavor, which is a vascular stent-graft, Kanji discloses cover 7 is formed from polyester filaments and polyethylene filaments that interwoven together to make the cover thin and stronger (col. 11, ln 15-23). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have made one of the covering membrane or both of the covering membranes of Wang by interwoven polyester filaments or polytetrafluoroethylene (PET) filaments or polyurethane filaments or combination of materials listed in paragraph [0083] to make to cover of Wang thin and stronger.
Referring still to claim 9, as to (2), examiner notes that Wang discloses the device is for treating aortic aneurysm and the device is connecting the aorta to a smaller branch vessel (¶ [0005] - ¶ [0006]). However, in same field of endeavor, which is a vascular stent-graft, Bolduc discloses the prosthesis is tapered toward the distal end because the distal end is located at a region with a small diameter (FIG. 11; ¶ [0062]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have made the distal treatment section of the stent-graft of Wang to have a taper profile from along the entire length of the transition section to allow the distal section conforming to the smaller region that branch from the aorta.
Referring again to claim 9, as to (3) Wang discloses the device is for a minimal invasive surgery (Background of the invention section) and the stent is made from shape memory alloys (¶[0079]-¶ [0080]). Thus, one of ordinary skill in the art will appreciate that Wang inherently discloses the device is stored in a collapsed configuration, which has a first diameter, in a catheter to traverse the patient’s vasculature then the device is deployed from the catheter and expanded into an expanded configuration, which has a second diameter that is larger than the first diameter, at a desired location in the vasculature. In alternative, in the same field of endeavor, which is a stent-graft. Bolduc discloses the stents are made from shape memory material so that the device is stored in a collapsed configuration, which has a first diameter, in a catheter to traverse the patient’s vasculature then the device is deployed from the catheter and expanded into an expanded configuration, which has a second diameter that is larger than the first diameter, at a desired location in the vasculature (Figs. 7-11; ¶¶ [0021] and [0033]-[0043]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have made the device of Wang for minimal invasive surgery by making the stents as self-expandable stent so that the device is stored in a collapsed configuration, which has a first diameter, in a catheter to traverse the patient’s vasculature then the device is deployed from the catheter and expanded into an expanded configuration, which has a second diameter that is larger than the first diameter, at a desired location in the vasculature, thereby, reduce recovery time and less pain to the patient.
Referring to claim 10, the modified device of Wang discloses the vascular stent-graft according to claim 9 wherein the first diameter is sized to approximate the aortic diameter at the proximal landing zone (Wang discloses the device is for treating aortic aneurysm, thus, Wang inherently discloses the first diameter is sized to approximate the aortic diameter at the proximal landing zone).
Referring to claim 36, the modified device of Wang discloses the vascular stent-graft according to claim 9 which includes a plurality of stents of a second set engaged with the treatment section, each adapted to maintain the tapered form (the annotated figure above shows the treatment section includes a plurality of stent. Wang as modified by Bolduc would has the condition of each stents adapted to maintain the tapered form of the treatment section).
Referring to claim 37, the modified device of Wang discloses the vascular stent-graft according to claim 36, wherein the tubular wall includes a second layer which covers, coats or encapsulates the first layer (¶ [0083]: “Referring to FIG. 13 again, in a further embodiment, the covering membrane 120 may include an inner covering membrane 121 and an outer covering membrane 122.”).
Referring to claims 38-39, the modified device of Wang discloses the vascular stent-graft according to claim 37, wherein the second layer comprises a liquid-tight material (claim 38) and wherein the liquid-tight material is polyurethane (claim 39). (Wang discloses cover 120 includes an inner covering membrane 121 and an outer covering membrane 122 and the covering membranes are made from polytetrafluoroethylene (PET), polyesters, polyurethane, silicone, high-density polyethylene or other suitable materials (¶[0083]). In the rejection of claim 9, examiner states that only one of the cover membranes is made from interwoven of polyester filaments or polytetrafluoroethylene (PET) filaments or polyurethane filaments or combination of combination of materials listed in paragraph [0083] of Wang. Examiner notes that the covering membrane that is made from a continuous sheet of polyurethane or made from polyurethane filaments is fluid tight. Extrinsic evidence, see paragraph [0063] of Quinn (US 2013/0274857)).
Referring to claims 37-38 and 41, the modified device of Wang discloses the vascular stent-graft according to claim 36, wherein the tubular wall includes a second layer which covers, coats or encapsulates the first layer (claim 37); wherein the second layer comprises a liquid-tight material (claim 38); and wherein the liquid-tight material coats the first layer (claim 41) (Kanji discloses the cover 7 is coated, if necessary, with waterproof material to prevent leakage of blood (col. 11, ln 23-25). 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 a coating as suggested by Kanji to the outer covering membrane of Wang to ensure that there is no leakage to the device of Wang).
Referring to claim 40, the modified device of Wang discloses the vascular stent-graft according to claim 38, wherein the liquid-tight material is provided as a sheet or a tube, which covers and binds to the first layer (In paragraphs [0084]-[0085] Wang discloses covering membranes 121 and 122 can be formed as one piece by thermal bonding. In paragraphs [0085], [0087]-[0090] and FIGS. 14-15 Wang discloses the stent-graft is formed by wrapping a sheet of inner covering membrane on a mandrel, positioning the stents on the inner covering membrane, wrapping a second sheet of outer covering membrane over the stents then thermal bonding the inner covering membrane to the outer covering membrane).
Referring to claim 42, the modified device of Wang discloses the vascular stent-graft according to claim 37, wherein the stents of the first set and the stents of the second set are fixed to the anchor section and the treatment section respectively, interposed between the first layer and the second layer or encapsulated within the second layer (¶ [0083]).
Referring to claim 43, the modified device of Wang discloses the vascular stent-graft according to claim 36, wherein each stent of the first set and the second set is a circumferential self-expanding stent (see rejection of claim 9, item (3) above).
Referring to claim 44, the modified device of Wang discloses the vascular stent-graft according to claim 43, wherein the anchor section has a plurality of stents of the first set engaged therewith (see annotated figure above).
Referring to claim 45, the modified device of Wang discloses the vascular stent-graft according to claim 43, wherein each stent of the second set is engaged with the treatment section sequentially along the second length (see annotated figure above).
Referring to claim 47, the modified device of Wang discloses the vascular stent-graft according to claim 43, wherein each stent of the second set is adapted to maintain the tapered form of the treatment segment. (the annotated figure above shows the treatment section includes a plurality of stent. Wang as modified by Bolduc would has the condition of each stents adapted to maintain the tapered form of the treatment section).
Claim(s) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Bolduc et al. and Kanji as applied to claim 43 above and further in view of Kleiner (US 2010/0262224, hereinafter “Kleiner”).
Referring to claim 46, the modified device of Wang discloses the vascular stent graft according to claim 43 but fails to disclose wherein each stent of the first set is adapted to maintain the second diameter against an elastic recoil force imposed by the aorta on the anchor section. However, in the same field of endeavor, which is a vascular stent-graft, Klein discloses it is well known in the art that a stent must have sufficient radial strength to maintain its size and shape throughout its service life by withstanding the cyclic loading of the vessel caused by the beating heart (¶ [0010]: “a stent must possess adequate radial strength. Radial strength describes the external pressure that a stent is able to withstand without incurring clinically significant damage. Additionally, a stent should be sufficiently rigid to adequately maintain its size and shape throughout its service life despite the various forces that may come to bear on it, including the cyclic loading induced by the beating heart. For example, a radially directed force may tend to cause a stent to recoil inward. Furthermore, the stent should possess sufficient toughness or resistance to fracture from stress arising from crimping, expansion, and cyclic loading.” Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have designed the stents of Wang device to have sufficient radial strength to maintain its size and shape throughout its service life, thereby, maintaining the efficacy and safety of the device.
Claim(s) 11-15 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Bolduc et al. and Kanji as applied to claim 9 above and further in view of Chuter et al. (US 2010/0249899, hereinafter “Chuter”).
Referring to claim 11, the modified device of Wang discloses the vascular stent-graft according to claim 9 but fails to disclose wherein the first diameter (diameter of the anchor section in a collapsed configuration) of the proximal anchor section is in a range 18 mm to 40 mm. However, in the same field of endeavor, which is a vascular stent-graft, Chuter discloses (Fig. 7) proximal end section 12 has a first diameter between 26 mm to 42 mm and a length between 35 mm to 45 mm. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have performed routine experimentation to derive the optimal range for the first diameter of the proximal anchor section since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine experimentation in the art. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). MPEP 2145.05 II(B). (In re Aller, 105 USPQ 233).
Referring to claim 12, the modified device of Wang discloses the vascular stent-graft according to claim 9 wherein the second diameter (diameter of the anchor section in an expanded configuration) exceeds the first diameter between 5% and 20%. ((Wang discloses the device is for a minimal invasive surgery (Background of the invention section) and the stent is made from shape memory alloys (¶[0079]-¶ [0080]). Based on the rejection of claim 9 above, the stent of the device of Wang is made from shape memory material so that it is stored in a collapsed configuration, which has a first diameter, in a catheter to traverse the patient’s vasculature then the device is deployed from the catheter and expanded into an expanded configuration, which has a second diameter that is larger than the first diameter, at a desired location in the vasculature. Thus, making the stents from shape memory material to allow the stent to expand into expanded configuration such that the second diameter of the expanded configuration exceeds the first diameter of the collapsed configuration between 5% and 20% is within the skill of an ordinary skill in the art. Extrinsic evidence, Stockel et al. (US 6,312,454) discloses “The amount of expansion will depend on the degree to which the stent is required to deform elastically for insertion into a lumen and then to expand elastically into contact with the lumen, and optionally to expand it. The nature of the treatment of the stent to give it appropriate elastic properties will be apparent to a person skilled in the art.” (col. 5, ln 35-55)).
Referring to claim 13, the modified device of Wang discloses the vascular stent-graft according to claim 9, wherein the treatment section tapers from a third diameter adjacent the transition section to a fourth diameter at the distal end (see rejection of claim 9 above and the annotated figure above).
Referring to claim 14, the modified device of Wang discloses the vascular stent-graft according to claim 9, wherein the third diameter is in a range 17 mm to 39 mm and wherein the fourth diameter respectively ranges between 15 mm to 38 mm (Stockel discloses the diameter of the distal portion of section 16 can range from 20 to 30 mm (¶ [0056] and Fig. 7). Based on the rejection of claim 9 above, the treatment section has a tapered form along the entire length of the treatment section. Thus, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have performed routing experimentation to derive the optimal range of the third diameter and fourth diameter of the treatment section such that the third diameter is a range 17 mm to 39 mm and the fourth diameter is in a range between 15 mm to 38 mm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine experimentation in the art. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). MPEP 2145.05 II(B). (In re Aller, 105 USPQ 233)).
Referring to claim 15, the modified device of Wang discloses the vascular stent-graft according to claim 9 wherein the first length of the anchor section is in a range 20 mm to 50 mm (in paragraph [0056] and Fig. 7 Stockel discloses the length of the section 12 is 35 mm to 45 mm. Thus, the it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have performed routing experimentation to derive the optimal range of the first length of the anchor section such that the first length is a range 20 mm to 50 mm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine experimentation in the art. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). MPEP 2145.05 II(B). (In re Aller, 105 USPQ 233)).
Referring to claim 17, the modified device of Wang discloses the vascular stent-graft according to claim 9, wherein the second length of the tapered section is in a range 50 to 250 mm (in paragraph [0056] and Fig. 7 Stockel discloses the second length of the section 16 is 45 mm to 55 mm. Thus, the it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have performed routing experimentation to derive the optimal range of the first length of the anchor section to accommodate a longer aneurysm such that the first length is a range 50 mm to 250 mm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine experimentation in the art. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). MPEP 2145.05 II(B). (In re Aller, 105 USPQ 233)).
Conclusion
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771