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 Arguments
In view of the amendments filed on 7/21/2026, several of the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph rejections, cited in the office action of 4/21/2026, are moot. Claim 1 still lacks antecedent basis for the limitation "the longitudinal axis" in line 11; and therefore, that rejection has been maintained.
Applicant's arguments filed 7/21/2026 have been fully considered, but they are moot in view of the new grounds of rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 9, 10, and their dependent claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 recites the limitation "the longitudinal axis" in line 11. Claims 9 and 10 recite the limitation "the first configuration." There is insufficient antecedent basis for these limitations in the claims. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-4, 8-9, 11-13, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Navia et al. (Patent No.: US 8,685,086 B2; hereinafter “Navia”) in view of Licata et al. (US Pub. No. 2008/0221666 A1; hereinafter “Licata”).
Navia teaches the following regarding claim 1: a medical device configured to expand or fortify a stricture comprising: (1) a central conduit section (central portion of element 52) (e.g., Figs. 1A-1B, 3A-3C); (2) at least two anchoring sections (e.g., upper and lower sections containing elements 60), wherein the anchoring sections are located at each end of the device (e.g., Figs. 1A-1B, 3A-3C) and comprise anchoring hooks (60) with blunt tips (e.g., Figs. 1A-1B, 3A-3C), wherein each anchoring hook is oriented toward the central conduit section when in an undeployed configuration (e.g., Figs. 1A, 3A) and wherein, in a deployed configuration, each anchoring hook: (i) maintains its orientation toward the central conduit section forming an acute angle with the longitudinal axis of the device (e.g., Figs. 1B, 3B), and (ii) exerts a first radial force (force exerted by expanding elements 60) at contact points with a luminal wall of the stricture to secure the device (col. 2, lines 12-35; col. 7, lines 35-53, where the configuration of the device is fully capable of being applied to a stricture); and (3) at least two transitional sections positioned between the conduit section and the at least two anchoring sections (please see annotated Figure A, below), (4) wherein the device can assume at least two configurations: (i) the undeployed configuration (e.g., Figs. 1A, 3A) having a first outer diameter that is substantially constant along the longitudinal axis of the device (e.g., Figs. 1A, 3A; col. 2, lines 1-11), and wherein said first outer diameter allows the structure to be inserted in a stricture (col. 7, lines 35-53; col. 15, lines 53-col. 16, lines 21); and (ii) the deployed configuration (e.g., Figs. 1B, 3B) wherein at least the two anchoring sections of the device have a deployed outer diameter that is larger than the first outer diameter (Figs. 1A-1B, 3A-3C), wherein the deployed outer diameter is large enough to exert a second radial force (force exerted by the expanding main body element 52) against the luminal wall of the stricture (col. 7, lines 35-53; col. 15, lines 53-col. 16, lines 21).
Regarding claims 1, 8, and 12, Navia teaches the limitations of the claimed invention, as described above. While it appears to show the use of an integral/living hinge at each anchoring hook, it does not explicitly recite that each anchoring hook is attached to the device with a living hinge. Licata teaches that it is well known in the art that anchoring structures are connected to the device via a living hinge (Figs. 14A-14D; paras. 0165, 0185, 0215-0218), for the purpose of controlling the expansion of the device and providing the device with the desired flexibility and mechanical characteristics needed to suit the implantation site. Licata further teaches that the living hinge comprises an S-hinge, an eyelet hinge, or a trough hinge (Figs. 14A-14D; paras. 0165, 0185, 0215-0218). It would have been obvious to one having ordinary skill in the art to modify the device of Navia to comprise a living hinge, as taught by Licata, in order to control the expansion of the device and provide the device with the desired flexibility and mechanical characteristics needed to suit the implantation site. Such a modification would be made with a reasonable expectation of success. In addition, it has been held that a simple substitution of one known element for another to obtain predictable results, in the instant case, substituting one type of connector for another, is generally considered to be within the level of ordinary skill in the art.
Please also note that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the structure and dimensions of the Navia device allows it to be fully capable of being used within a stricture.
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Figure A.
Navia teaches the following regarding claim 3: the device of claim 1, wherein each of the conduit section, the at least two transitional sections, and the at least two anchoring sections are configured to form a substantially cylindrical structure (e.g., Figs. 1A-1B, 3A-3C) having an interior lumen (central opening through the device) and a supportive exterior wall (exterior portions).
Navia teaches the following regarding claim 4: the device of claim 1, wherein at least a portion of the supportive wall is configured as a mesh having openings (e.g., Figs. 1A-1B, 3A-3C).
Navia teaches the following regarding claim 9: the device of claim 3, wherein deployment from the first configuration (interpreted as the undeployed configuration) to the deployed configuration increases the minimum interior lumen diameter of the device (e.g., Figs. 1A-1B, 3A-3C; col. 25, lines 13-36).
Navia teaches the following regarding claim 11: the device of claim 1, wherein anchoring hooks comprise attachments (attachment points of elements 60) to the device at different longitudinal points (e.g., Figs. 1A-1B, 3A-3C).
Navia teaches the following regarding claim 12: a medical device for treatment of a stricture, wherein said device can assume at least two configurations, comprising: an undeployed substantially cylindrical configuration (contracted configuration) (e.g., Figs. 1A, 3A) of the device, wherein anchoring hooks (60) with blunt tups are oriented toward a central conduit section of the device (Figs. 1A, 3A), and a deployed configuration (expanded configuration) (e.g., Figs. 1B, 3B-3C) of the device wherein at least two regions (upper and lower regions of elements 60) along the cylindrical length of the device are expanded from an initial cylindrical plane (the plane of the collapsed configuration) (e.g., Figs. 1A, 3A), and wherein the device is expanded enough to exert a radial force (via the expanding main body element 52) against a luminal wall of the stricture (col. 15, lines 53- col. 16, lines 21, where the configuration of Navia is fully capable of being applied to a stricture), and wherein in the deployed configuration the anchoring hooks with blunt tips maintain their orientation toward the central conduit section (e.g., Figs. 1B, 3B-3C) and form an acute angle with a longitudinal axis of the device (Figs. 1B, 3B-3C) thereby exerting additional radial force (via expanding elements 60) to the luminal wall at contact points to secure the device in the stricture (col. 15, lines 53- col. 16, lines 21), and wherein the anchoring hooks with blunt tips are each connected to the device (e.g., Figs. 1A-1B, 3A-3C).
Navia teaches the following regarding claim 13: the device of claim 1 configured to comprise a first, second, third, fourth and fifth longitudinal region (Figure A), wherein: the first and fifth regions are positioned at the device’s ends and comprise anchoring hooks (Figure A) to function as the anchoring sections (Figure A); the third region is positioned in the device’s middle to function as the conduit section (Figure A); andUS2008 18251164 1US. Patent Application No. 16 079,813Response to Restriction Requirement Page 4 of 8the second and fourth regions comprise the transitional sections (Figure A), wherein the second region is positioned between the first and third region (Figure A), and the fourth region is positioned between the third and fifth region (Figure A).
Navia teaches the following regarding claim 21: the device of claim 12 configured to comprise a first, second, third, fourth and fifth longitudinal region, wherein: the first and fifth regions are positioned at the device’s ends (Figure A) and comprise anchoring hooks (Figure A) to function as anchoring sections; the third region is positioned in the device’s middle to function as a conduit section (Figure A); and the second and fourth regions comprise transitional sections, wherein the second region is positioned between the first and third region (Figure A), and the fourth region is positioned between the third and fifth region (Figure A).
Claim 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Navia in view of Licata, further in view of Cooper, Jr. et al. (US Pub. No. 2015/0351904 A1; hereinafter "Cooper").
Navia, as modified by Licata, teaches the limitations of the claimed invention, as described above. However, they do not explicitly recite that the deployment from the first configuration to the deployed configuration decreases the device's length. Cooper teaches that it is well known in the art that the deployment of a valve prosthesis from a first, contracted configuration to a deployed, expanded configuration decreases the device's length (Figs. 11-12, 15A, 23; paras. 0111-0112, 0115-0120), as would be needed to provide the device with the desired dimensions needed to properly fit the implantation site. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the device of Navia and Licata, to comprise materials and designs that will decrease the device's length upon expansion, as taught by Cooper, in order to properly fit the implantation site. Such a modification would be made with a reasonable expectation of success.
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 Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774
