DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 1/20/2026.
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 .
Status of Claims
Claims 1-20 are pending in the application.
Claims 1-20 are examined on the merits.
Information Disclosure Statement
The new information disclosure statements (IDS) submitted on 12/10/2025 in compliance with the provisions of 37 CFR 1.97. Accordingly, the new information disclosure statement has been considered by the examiner.
Response to Arguments
Applicant’s arguments filed on 01/20/2026 have been fully considered but are moot because the independent claim(s) has/have been amended and the new ground of rejection does not rely on the same combination references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 11/14/2023 in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) has/have been considered by the examiner.
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 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) 1-6, 9-13, and 16-18 is/are rejected under 35 U.S.C 102(a)(1) as being anticipated by Hynes (US PGPUB 20200121439) in view of Hall (US PGPUB 20210106444).
Regarding claim 1, Hynes discloses a stent (a stent 310: ¶0090 and Fig. 8) comprising:
a radially expanding tubular framework (an elongate tubular body (317+315+316): ¶0058, 0090, and Fig. 8; wherein the stent is a radially or self-expanding stent) having a radially outward surface (Fig. 8), a radially inward surface (an inward surface of a lumen formed inside the tubular framework (317+315+316): ¶0058 and 0090), a first end region (a first end region 317: ¶0090 and Fig. 8), a second end region (a second end region 316: ¶0090 and Fig. 8), a medial region positioned between the first end region and the second end region (a medial region 315: ¶0090 and Fig. 8), and a lumen extending from the first end region to the second end region (¶0090); and
a tubular structure positioned over the medial region (a covering layer (20+21) or (320+321): ¶0066, 0090, and Fig. 8); the tubular structure configured to hold the medial region in a first, compressed configuration (the tubular structure (20+21) or (320+321) is made of elastomeric material and is capable of restricting/holding the medial region 315 in a compressed configuration: ¶0066-0069);
wherein one of the first end region or the second end region includes a first flange structure (a flared end portion at/near the first end region 317: ¶0062 and 0074).
Hynes does not disclose the tubular structure has a wall thickness between 0.05 millimeters and 0.25 millimeters.
In the same field of endeavor, stent, Hall discloses an endovascular prothesis 100 comprising a tubular body 110 and a stent 150 (¶0042 and Figs. 1A-2B). Hall further discloses a thickness of a wall 119 of the tubular body 110 is from 0.07 mm to 0.5 mm (¶0042; thus, the taught thickness range overlaps the claimed thickness range).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Hynes in view of Hall by having a wall thickness of the tubular structure between 0.05 millimeters and 0.25 millimeters, motivated by the desires to provide a tubular body of a stent that has good mechanical strength and as it has been held that a prima facie case of obviousness exists when the claimed ranges overlap with ranges disclosed by the prior art. See MPEP § 2144.05 (I). Further, Applicant places no criticality on the thickness claimed, indicating simply that the tubular structure may have a thickness of 0.05 mm, 0.075 mm, 0.25 mm, 0.30 mm, or any other suitable thickness (¶0061).
Regarding claim 2, Hynes further discloses the tubular structure is formed from a bioabsorbable material (¶0066-0067 and 0089-0090).
Regarding claim 3, Hynes further discloses upon bioabsorption of the tubular structure, the medial region of the radially expanding tubular framework radially expands to a second, expanded configuration (¶0058: the stent 310 is a radially or self-expanding stent; Since Hynes discloses that the entire stent radially expands, Hynes implicitly discloses that the medial region of the stent radially expands to a second, expanded configuration. In addition, the stent of Hynes is made of polymeric material such as polyurethane or polypropylene (¶0092) which is the same material as the stent of the instant application (¶0053), the stent of Hynes has the same properties as the claimed stent).
Regarding claim 4, Hynes further discloses the expansion of the medial region of the radially expanding tubular framework is progressive over a period of time due to the bioabsorption of the tubular structure (¶0058, 0076, and see rejection of claim 3 above: Since the tubular structure of Hynes is configured to biodegrade over a given time period and the medial region of the stent of Hynes radially expands, the expansion of the medial region of the radially expanding tubular framework of Hynes is capable of being progressive over a period of time; In addition, the stent of Hynes is made of polymeric material such as polyurethane or polypropylene (¶0092) which is the same material as the stent of the instant application (¶0053), the stent of Hynes has the same properties as the claimed stent).
Regarding claim 5, Hynes further discloses when the medial region is in the second, expanded configuration, the medial region is configured to engage with a tissue surface, thereby exerting a radial force to prevent migration of the stent (¶0059).
Regarding claim 6, Hynes further discloses the medial region of the radially expanding tubular framework includes a first, inner diameter when in the first, compressed configuration and a second, inner diameter when in the second, expanded configuration, wherein the second, inner diameter is greater than the first, inner diameter (the first, compressed configuration of the medial region inherently comprises a first, inner diameter and the second, expanded configuration of the medial region inherently comprises a second, inner diameter; A person having ordinary skill in the art would have understood/recognized the first diameter of the compressed configuration is smaller than the second diameter of the expanded configuration; thus, Hynes discloses the claimed limitation: see rejections of claims 1 and 3 above).
Regarding claim 9, Hynes further discloses the radially expanding tubular framework includes a coating applied over the radially expanding tubular framework (¶0066 and 0078: a coating layer 20/320).
Regarding claim 10, Hynes further discloses the other one of the first end region or the second end region includes a second flange structure (a flared end portion at/near the second end region 316: ¶0062 and 0074).
Regarding claim 11, Hynes discloses a stent (a stent 310: ¶0090 and Fig. 8) comprising:
a radially expanding tubular framework (an elongate tubular body (317+315+316): ¶0058, 0090, and Fig. 8; wherein the stent is a radially or self-expanding stent) having a radially outward surface (Fig. 8), a radially inward surface (an inward surface of a lumen formed inside the tubular framework (317+315+316): ¶0058 and 0090), a first end region (a first end region 317: ¶0090 and Fig. 8), a second end region (a second end region 316: ¶0090 and Fig. 8), a medial region positioned between the first end region and the second end region (a medial region 315: ¶0090 and Fig. 8), and a lumen extending from the first end region to the second end region (¶0090); and
a tubular structure positioned over the medial region (a covering layer (20+21) or (320+321): ¶0066, 0090, and Fig. 8) and formed from a bioabsorbable material (¶0066-0067 and 0089-0090), the tubular structure configured to hold the medial region in a first, compressed configuration (the tubular structure (20+21) or (320+321) is made of elastomeric material and is capable of restricting/holding the medial region 315 in a compressed configuration: ¶0066-0069);
wherein upon bioabsorption of the tubular structure, the medial region of the radially expanding tubular framework radially expands to a second, expanded configuration (¶0058: the stent 310 is a radially or self-expanding stent; Since Hynes discloses that the entire stent radially expands, Hynes implicitly discloses that the medial region of the stent radially expands to a second, expanded configuration. In addition, the stent of Hynes is made of polymeric material such as polyurethane or polypropylene (¶0092) which is the same material as the stent of the instant application (¶0053), the stent of Hynes has the same properties as the claimed stent); and
wherein the radially expanding tubular framework includes a coating applied over the radially expanding tubular framework (¶0066 and 0078: a coating layer 20/320).
Hynes does not disclose the tubular structure has a wall thickness between 0.05 millimeters and 0.25 millimeters.
In the same field of endeavor, stent, Hall discloses an endovascular prothesis 100 comprising a tubular body 110 and a stent 150 (¶0042 and Figs. 1A-2B). Hall further discloses a thickness of a wall 119 of the tubular body 110 is from 0.07 mm to 0.5 mm (¶0042; thus, the taught thickness range overlaps the claimed thickness range).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Hynes in view of Hall by having a wall thickness of the tubular structure between 0.05 millimeters and 0.25 millimeters, motivated by the desires to provide a tubular body of a stent that has good mechanical strength and as it has been held that a prima facie case of obviousness exists when the claimed ranges overlap with ranges disclosed by the prior art. See MPEP § 2144.05 (I). Further, Applicant places no criticality on the thickness claimed, indicating simply that the tubular structure may have a thickness of 0.05 mm, 0.075 mm, 0.25 mm, 0.30 mm, or any other suitable thickness (¶0061).
Regarding claim 12, Hynes further discloses when the medial region is in the second, expanded configuration, the medial region is configured to engage with a tissue surface, thereby exerting a radial force to prevent migration of the stent (¶0059).
Regarding claim 13, Hynes further discloses the medial region of the radially expanding tubular framework includes a first, inner diameter when in the first, compressed configuration and a second, inner diameter when in the second, expanded configuration, wherein the second, inner diameter is greater than the first, inner diameter (the first, compressed configuration of the medial region inherently comprises a first, inner diameter and the second, expanded configuration of the medial region inherently comprises a second, inner diameter; A person having ordinary skill in the art would have understood/recognized the first diameter of the compressed configuration is smaller than the second diameter of the expanded configuration; thus, Hynes discloses the claimed limitation: see rejections of claim 11 above).
Regarding claim 16, Hynes further discloses the first end region includes a first flange structure (a flared end portion at/near the first end region 317: ¶0062 and 0074), and the second end region includes a second flange structure (a flared end portion at/near the second end region 316: ¶0062 and 0074).
Regarding claim 17, Hynes discloses a stent (a stent 310: ¶0090 and Fig. 8) comprising:
a radially expanding tubular framework (an elongate tubular body (317+315+316): ¶0058, 0090, and Fig. 8; wherein the stent is a radially or self-expanding stent) having a first end region (a first end region 317: ¶0090 and Fig. 8), a second end region (a second end region 316: ¶0090 and Fig. 8), a medial region positioned between the first end region and the second end region (a medial region 315: ¶0090 and Fig. 8); and
a tubular structure positioned over the medial region (a covering layer (20+21) or (320+321): ¶0066, 0090, and Fig. 8) and formed from a bioabsorbable material (¶0066-0067 and 0089-0090), the tubular structure configured to hold the medial region in a first, compressed configuration (the tubular structure (20+21) or (320+321) is made of elastomeric material and is capable of restricting/holding the medial region 315 in a compressed configuration: ¶0066-0069);
wherein upon bioabsorption of the tubular structure, the medial region of the radially expanding tubular framework radially expands to a second, expanded configuration (¶0058: the stent 310 is a radially or self-expanding stent; Since Hynes discloses that the entire stent radially expands, Hynes implicitly discloses that the medial region of the stent radially expands to a second, expanded configuration. In addition, the stent of Hynes is made of polymeric material such as polyurethane or polypropylene (¶0092) which is the same material as the stent of the instant application (¶0053), the stent of Hynes has the same properties as the claimed stent);
wherein the expansion of the medial region of the radially expanding tubular framework is progressive over a period of time due to the bioabsorption of the tubular structure (¶0058, 0076, and see rejection of claim 3 above: Since the tubular structure of Hynes is configured to biodegrade over a given time period and the medial region of the stent of Hynes radially expands, the expansion of the medial region of the radially expanding tubular framework of Hynes is capable of being progressive over a period of time; In addition, the stent of Hynes is made of polymeric material such as polyurethane or polypropylene (¶0092) which is the same material as the stent of the instant application (¶0053), the stent of Hynes has the same properties as the claimed stent); and
wherein the medial region of the radially expanding tubular framework includes a first, inner diameter when in the first, compressed configuration and a second, inner diameter when in the second, expanded configuration, wherein the second, inner diameter is greater than the first, inner diameter (the first, compressed configuration of the medial region inherently comprises a first, inner diameter and the second, expanded configuration of the medial region inherently comprises a second, inner diameter; A person having ordinary skill in the art would have understood/recognized the first diameter of the compressed configuration is smaller than the second diameter of the expanded configuration; thus, Hynes discloses the claimed limitation).
Hynes does not disclose the tubular structure has a wall thickness between 0.05 millimeters and 0.25 millimeters.
In the same field of endeavor, stent, Hall discloses an endovascular prothesis 100 comprising a tubular body 110 and a stent 150 (¶0042 and Figs. 1A-2B). Hall further discloses a thickness of a wall 119 of the tubular body 110 is from 0.07 mm to 0.5 mm (¶0042; thus, the taught thickness range overlaps the claimed thickness range).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Hynes in view of Hall by having a wall thickness of the tubular structure between 0.05 millimeters and 0.25 millimeters, motivated by the desires to provide a tubular body of a stent that has good mechanical strength and as it has been held that a prima facie case of obviousness exists when the claimed ranges overlap with ranges disclosed by the prior art. See MPEP § 2144.05 (I). Further, Applicant places no criticality on the thickness claimed, indicating simply that the tubular structure may have a thickness of 0.05 mm, 0.075 mm, 0.25 mm, 0.30 mm, or any other suitable thickness (¶0061).
Regarding claim 18, Hynes further discloses when the medial region is in the second, expanded configuration, the medial region is configured to engage with a tissue surface, thereby exerting a radial force to prevent migration of the stent (¶0059).
Claim(s) 7-8 is/are rejected under 35 U.S.C 103 as being unpatentable over Hynes (US PGPUB 20200121439) in view of Hall (US PGPUB 20210106444), as applied to claim 1 above, and further in view of Hingston (US PGPUB 20180250501).
Regarding claim 7, Hynes/Hall does not disclose the second, inner diameter is 25% greater than the first, inner diameter.
In the same field of endeavor, stent, Hingston discloses a stent 102 configured to move between a first/compressed configuration/diameter and a second/expanded configuration/diameter (¶0020, 0023, and Figs. 1A-B). Hingston further discloses the stent configured to increase up to 50% as the stent moves from the first/compressed configuration/diameter to the second/expanded configuration/diameter (¶0023: the taught range overlaps the claimed range) for the benefit of adapting the stent to tissue conformable (¶0022-0024).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Hynes/Hall in view of Hingston by having the second diameter 25% greater than the first diameter, in order to adapt the stent to tissue conformable, as suggested in ¶0022-0024 of Hingston and as it has been held that scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP § 2144.04 (IV) (A)). Further, Applicant places no criticality on the dimension claimed, indicating simply that the second, inner diameter may be 25% greater than the first, inner diameter (¶0010, 0017, and 0022). Furthermore, one would have been motivated to have the second diameter 25% greater than the first diameter in order to accommodate insertion of the stent through tissue.
Regarding claim 8, Hynes/Hall does not disclose the second, inner diameter is 10% - 25% greater than the first, inner diameter.
Hingston further discloses the stent configured to increase up to 50% as the stent moves from the first/compressed configuration/diameter to the second/expanded configuration/diameter (¶0023: the taught range overlaps the claimed range) for the benefit of adapting the stent to tissue conformable (¶0022-0024).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Hynes/Hall in view of Hingston by having the second diameter 10% - 25% greater than the first diameter, in order to adapt the stent to tissue conformable, as suggested in ¶0022-0024 of Hingston and as it has been held that scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP § 2144.04 (IV) (A)). Further, Applicant places no criticality on the dimension claimed, indicating simply that the second, inner diameter may be 10%-25% greater than the first, inner diameter (¶0011, 0018, and 0023). Furthermore, one would have been motivated to have the second diameter 10%-25% greater than the first diameter in order to accommodate insertion of the stent through tissue.
Claim(s) 14-15 is/are rejected under 35 U.S.C 103 as being unpatentable over Hynes (US PGPUB 20200121439) in view of Hall (US PGPUB 20210106444), as applied to claim 11 above, and further in view of Hingston (US PGPUB 20180250501).
Regarding claim 14, Hynes/Hall does not disclose the second, inner diameter is 25% greater than the first, inner diameter.
In the same field of endeavor, stent, Hingston discloses a stent 102 configured to move between a first/compressed configuration/diameter and a second/expanded configuration/diameter (¶0020, 0023, and Figs. 1A-B). Hingston further discloses the stent configured to increase up to 50% as the stent moves from the first/compressed configuration/diameter to the second/expanded configuration/diameter (¶0023: the taught range overlaps the claimed range) for the benefit of adapting the stent to tissue conformable (¶0022-0024).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Hynes/Hall in view of Hingston by having the second diameter 25% greater than the first diameter, in order to adapt the stent to tissue conformable, as suggested in ¶0022-0024 of Hingston and as it has been held that scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP § 2144.04 (IV) (A)). Further, Applicant places no criticality on the dimension claimed, indicating simply that the second, inner diameter may be 25% greater than the first, inner diameter (¶0010, 0017, and 0022). Furthermore, one would have been motivated to have the second diameter 25% greater than the first diameter in order to accommodate insertion of the stent through tissue.
Regarding claim 15, Hynes/Hall does not disclose the second, inner diameter is 10% - 25% greater than the first, inner diameter.
Hingston further discloses the stent configured to increase up to 50% as the stent moves from the first/compressed configuration/diameter to the second/expanded configuration/diameter (¶0023: the taught range overlaps the claimed range) for the benefit of adapting the stent to tissue conformable (¶0022-0024).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Hynes/Hall in view of Hingston by having the second diameter 10% - 25% greater than the first diameter, in order to adapt the stent to tissue conformable, as suggested in ¶0022-0024 of Hingston and as it has been held that scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP § 2144.04 (IV) (A)). Further, Applicant places no criticality on the dimension claimed, indicating simply that the second, inner diameter may be 10%-25% greater than the first, inner diameter (¶0011, 0018, and 0023). Furthermore, one would have been motivated to have the second diameter 10%-25% greater than the first diameter in order to accommodate insertion of the stent through tissue.
Claim(s) 19-20 is/are rejected under 35 U.S.C 103 as being unpatentable over Hynes (US PGPUB 20200121439) in view of Hall (US PGPUB 20210106444), as applied to claim 17 above, and further in view of Hingston (US PGPUB 20180250501).
Regarding claim 19, Hynes/Hall does not disclose the second, inner diameter is 25% greater than the first, inner diameter.
In the same field of endeavor, stent, Hingston discloses a stent 102 configured to move between a first/compressed configuration/diameter and a second/expanded configuration/diameter (¶0020, 0023, and Figs. 1A-B). Hingston further discloses the stent configured to increase up to 50% as the stent moves from the first/compressed configuration/diameter to the second/expanded configuration/diameter (¶0023: the taught range overlaps the claimed range) for the benefit of adapting the stent to tissue conformable (¶0022-0024).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Hynes/Hall in view of Hingston by having the second diameter 25% greater than the first diameter, in order to adapt the stent to tissue conformable, as suggested in ¶0022-0024 of Hingston and as it has been held that scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP § 2144.04 (IV) (A)). Further, Applicant places no criticality on the dimension claimed, indicating simply that the second, inner diameter may be 25% greater than the first, inner diameter (¶0010, 0017, and 0022). Furthermore, one would have been motivated to have the second diameter 25% greater than the first diameter in order to accommodate insertion of the stent through tissue.
Regarding claim 20, Hynes/Hall does not disclose the second, inner diameter is 10% - 25% greater than the first, inner diameter.
Hingston further discloses the stent configured to increase up to 50% as the stent moves from the first/compressed configuration/diameter to the second/expanded configuration/diameter (¶0023: the taught range overlaps the claimed range) for the benefit of adapting the stent to tissue conformable (¶0022-0024).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Hynes/Hall in view of Hingston by having the second diameter 10% - 25% greater than the first diameter, in order to adapt the stent to tissue conformable, as suggested in ¶0022-0024 of Hingston and as it has been held that scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP § 2144.04 (IV) (A)). Further, Applicant places no criticality on the dimension claimed, indicating simply that the second, inner diameter may be 10%-25% greater than the first, inner diameter (¶0011, 0018, and 0023). Furthermore, one would have been motivated to have the second diameter 10%-25% greater than the first diameter in order to accommodate insertion of the stent through tissue.
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 NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SARAH AL-HASHIMI can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NHU Q. TRAN/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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