DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 2nd, 2025 has been entered.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 30 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 21. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 21 recites the device further comprising a push rod coupled to the expandable stent. Claim 30 recites the device further comprising push rod configured to force the expandable stent out of the lumen of the flexible catheter, i.e. a push rod coupled to the expandable stent. Claim 30 appears to require the device to include two push rods, which is not disclosed. Therefore, the requirement of the device to include a push rod appears to be a duplicate of the push rod recited in claim 21. The claim will be treated as a duplicate recitation for examination purposes.
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 21-23 and 26-39 are rejected under 35 U.S.C. 103 as being unpatentable over Piskun (U.S. Publication 2011/0224494) in view of Schaer (U.S. Publication 2004/0082859A) and in view of Troutman (U.S. Publication 2017/0296795).
Regarding claims 21, 23, and 26-31:
Piskun discloses a device (for example see Figures 2a-2b) comprising:
(claim 21) a flexible catheter (33) including
(claim 21) a proximal portion
(claim 21) a distal portion
(claim 21) a plurality of flexible elements (12) extending along a length of the flexible catheter
(claim 27) wherein the plurality of flexible elements are capable of being moved from an insertion position to an expanded position to atraumatically engage tissue of a body lumen to render a working space (10) in the body lumen in an asymmetric configuration (see Figures 2a and 2b; paragraphs 22, 54, and 56; claim 3)
(claim 31) wherein the plurality of flexible elements are capable of moving to form a working space (10) within a body lumen
(claim 21) a distal coupler (15) coupled to distal portions of the plurality of flexible elements
(claim 21) an expandable member (5) associated with a distal end of the flexible catheter
(claim 21) wherein the expandable member is configured to transition from a collapsed state within a lumen of the flexible catheter to an expanded state when translated distally out of the lumen of the flexible catheter (paragraphs 20 and 59; the device is configured to translate over element 4, therefore element 4 is capable of translating to move the expandable member in and out of the lumen of the device while the expandable member is in a collapsed configuration)
(claim 23) wherein the expandable member is capable of being moved distally beyond the distal coupler (see Figure 2b)
(claim 24) wherein the expandable member has a fixed position with respect to the distal coupler in the expanded and collapsed configurations, i.e. the expandable member can be held in place with respect to the distal coupler in both the expanded and collapsed configurations (paragraphs 20 and 59)
(claim 26) wherein the expandable member is configured to stabilize the plurality of flexible elements when in the expanded state, i.e. the expandable member helps hold the position of the flexible elements when expanded
(claim 29) wherein in the collapsed state the expandable member is constrained within a lumen of the flexible catheter (paragraph 54)
(claim 21 and 30) a push rod (4) coupled to the expandable stent
(claim 21) wherein the expandable member is configured to transition from the collapsed state to the expanded state via the push rod (the push rod allows fluid into the expandable member causing the member to expand)
(claim 30) wherein the push rod is disposed within the flexible catheter (paragraph 52)
(claim 30) wherein when advanced distally the push rod is configured to force the expandable member out of the lumen of the flexible catheter and into a body lumen (paragraphs 20 and 59; the device is configured to translate over element 4, therefore element 4 is capable of translating to move the expandable member out of the lumen of the device into a body lumen)
(claim 31) a flexible instrument (11; for example see Figures 3 and 12) extending a length of the flexible catheter
(claim 31) wherein the flexible instrument is capable of rotating and moving to an angled position to orient a distal end of the flexible instrument within the working space (paragraphs 55 and 63-65)
Piskun fails to disclose the device wherein the expandable structure is a stent and wherein the stent is formed by a plurality of struts interconnected to form a plurality of geometric shapes and wherein the stent is formed of a shape memory material biased toward the expanded configuration.
Regarding the expandable structure being a stent, Piskun discloses the device comprising an expandable member (5) associated with a distal end of a flexible catheter as discussed above in order to occlude and/or dilate a body lumen (paragraphs 58-59). Schaer teaches a device (for example see Figure 33) comprising a flexible catheter, a plurality of flexible elements (302) extending along a length of the catheter, and an expandable member (260b) associated with a distal end of the flexible catheter, wherein the expandable member is discloses as being either a balloon or wired cage, i.e. a stent (paragraph 164) in order to occlude and/or dilate a body lumen. Because both the device of Piskun and the device of Schaer disclose a device comprising a flexible catheter with an expandable member associated with a distal end of the flexible catheter, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to substitute one expandable member with the other expandable member in order to achieve the predictable results of occluding and/or dilating a body lumen.
Regarding the expandable stent being formed by a plurality of struts interconnected to form a plurality of geometric shapes, Troutman teaches a device comprising an expandable stent (for example see Figures 10A-10C), wherein the expandable stent is formed by a plurality of struts interconnected to form a plurality of geometric shapes (see paragraphs 12, 73, and 74). It would have been ab obvious matter of design choice to one skilled in the art at the time the invention was filed to provide the device of Piskun as modified by Schaer wherein the expandable stent is formed from a plurality of struts interconnected to form a plurality of geometric shapes in view Troutman, since the applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing an expandable stent. In re Dailey and Eilers, 149 USPQ 47 (1966).
Regarding the expandable stent being formed of shape memory material biased toward the expanded configuration, Troutman teaches a device comprising an expandable stent formed from shape memory material, such as Nitinol, that is biased toward the expanded configuration (Troutman teaches an expandable stent that is made from shape memory material that can be collapsed and/or expanded upon shape memory activation and wherein the collapsed configuration gradually expands radially, i.e. is biased to the expanded configuration (see paragraphs 12, 73, 74, and 76). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Piskun as modified by Schaer wherein the expandable stent is formed from a shape memory material biased toward the expanded configuration in view of Troutman, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of it suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claims 32-36:
Piskun discloses a device (for example see Figures 2a-2b) comprising:
(claim 32) a flexible catheter (33) including
(claim 32) a proximal portion
(claim 32) a distal portion
(claim 32) a plurality of flexible elements (12) extending along a length of the flexible catheter
(claim 32) a distal coupler (15) coupled to distal portions of the plurality of flexible elements
(claim 32) an expandable member (5) associated with a distal end of the flexible catheter
(claim 32) wherein the expandable member is configured to transition from a collapsed state within a lumen of the flexible catheter to an expanded state when translated distally out of the lumen of the flexible catheter (paragraphs 20 and 59; the device is configured to translate over element 4, therefore element 4 is capable of translating to move the expandable member in and out of the lumen of the device while the expandable member is in a collapsed configuration)
(claim 34) wherein in the collapsed state the expandable member is constrained within a lumen of the flexible catheter (paragraph 54)
(claim 36) wherein the expandable member is capable of being moved distally beyond the distal coupler (see Figure 2b)
(claim 35) a push rod (4) disposed within the flexible catheter (paragraph 52)
(claim 35) wherein when advanced distally the push rod is configured to force the expandable member out of the lumen of the flexible catheter and into a body lumen (paragraphs 19 and 59)
(claim 31) a flexible instrument (11; for example see Figures 3 and 12) extending a length of the flexible catheter
(claim 31) wherein the flexible instrument is capable of rotating and moving to an angled position to orient a distal end of the flexible instrument within the working space (paragraphs 55 and 63-65)
Piskun fails to disclose the device wherein the expandable structure is a stent, the expandable stent being formed by a plurality of struts interconnected to form a plurality of geometric shapes, and the expandable stent being formed of a shape memory material biased toward the expanded configuration.
Regarding the expandable member being a stent, Piskun discloses the device comprising an expandable member (5) associated with a distal end of a flexible catheter as discussed above in order to occlude and/or dilate a body lumen (paragraphs 58-59). Schaer teaches a device (for example see Figure 33) comprising a flexible catheter, a plurality of flexible elements (302) extending along a length of the catheter, and an expandable member (260b) associated with a distal end of the flexible catheter, wherein the expandable member is discloses as being either a balloon or a wired cage, i.e. a stent (paragraph 164) in order to occlude and/or dilate a body lumen. Because both the device of Piskun and the device of Schaer disclose device comprising flexible catheters with an expandable member associated with a distal end of the flexible catheter, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to substitute one expandable member with the other expandable member in order to achieve the predictable results of occluding and/or dilating a body lumen.
Regarding the expandable stent being formed by a plurality of struts interconnected to form a plurality of geometric shapes, Troutman teaches a device comprising an expandable stent (for example see Figures 10A-10C), wherein the expandable stent is formed by a plurality of struts interconnected to form a plurality of geometric shapes (see paragraphs 12, 73, and 74). It would have been an obvious matter of design choice to one skilled in the art at the time the invention was filed to provide the device of Piskun as modified by Schaer wherein the expandable stent is formed from a plurality of struts interconnected to form a plurality of geometric shapes in view of Troutman, since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing an expandable stent. In re Dailey and Eilers, 149 USPQ 47 (1966).
Regarding the expandable stent being formed of shape memory material biased toward the expanded configuration, Troutman teaches a device comprising an expandable stent formed from shape memory material, such as Nitinol, that is biased toward the expanded configuration (Troutman teaches an expandable stent that is made from shape memory material that can be collapsed and/or expanded upon shape memory activation and wherein the collapsed configuration gradually expands radially, i.e. is biased to the expanded configuration (see paragraphs 12, 73, 74, and 76). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Piskun as modified by Schaer wherein the expandable stent is formed from a shape memory material biased toward the expanded configuration in view of Troutman, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claims 38 and 39:
Piskun discloses a device (for example see Figures 2a-2b) comprising:
(claim 38) a flexible catheter (33) including
(claim 38) a proximal portion
(claim 38) a distal portion
(claim 38) a plurality of flexible elements (12) extending along a length of the flexible catheter
(claim 38) a distal coupler (15) coupled to distal portions of the plurality of flexible elements
(claim 38) an expandable member (5) associated with a distal end of the flexible catheter
(claim 38) wherein the expandable member is configured to transition from a collapsed state within a lumen of the flexible catheter to an expanded state when translated distally out of the lumen of the flexible catheter (paragraphs 20 and 59; the device is configured to translate over element 4, therefore element 4 is capable of translating to move the expandable member in and out of the lumen of the device while the expandable member is in a collapsed configuration)
(claim 38) wherein the expandable member is configured to transition from a collapsed state to an expanded state when in a body lumen (paragraphs 20 and 59)
(claim 39) wherein the expandable member is capable of moving distally beyond the distal coupler (see Figure 2b)
(claim 38) a push rod (4) disposed within the flexible catheter (paragraph 52)
(claim 38) wherein when advanced distally the push rod is configured to force the expandable member out of the lumen of the flexible catheter and into a body lumen (paragraphs 19 and 59)
Piskun fails to disclose the device wherein the expandable structure is a stent and the expandable stent being formed by a plurality of struts interconnected to form a plurality of geometric shapes.
Regarding the expandable structure being a stent, Piskun discloses the device comprising an expandable member (5) associated with a distal end of a flexible catheter as discussed above in order to occlude and/or dilate a body lumen (paragraphs 58-59). Schaer teaches a device (for example see Figure 33) comprising a flexible catheter, a plurality of flexible elements (302) extending along a length of the catheter, and an expandable member (260b) associated with a distal end of the flexible catheter, wherein the expandable member is discloses as being either a balloon or a wired cage, i.e. a stent (paragraph 164) in order to occlude and/or dilate a body lumen. Because both the device of Piskun and the device of Schaer disclose device comprising flexible catheters with an expandable member associated with a distal end of the flexible catheter, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to substitute one expandable member with the other expandable member in order to achieve the predictable results of occluding and/or dilating a body lumen.
Regarding the expandable stent being formed by a plurality of struts interconnected to form a plurality of geometric shapes, Troutman teaches a device comprising an expandable stent (for example see Figures 10A-10C), wherein the expandable stent is formed by a plurality of struts interconnected to form a plurality of geometric shapes (see paragraphs 12, 73, and 74). It would have been an obvious matter of design choice to one skilled in the art at the time the invention was filed to provide the device of Piskun as modified by Schaer wherein the expandable stent is formed from a plurality of struts interconnected to form a plurality of geometric shapes in view of Troutman, since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing an expandable stent. In re Dailey and Eilers, 149 USPQ 47 (1966).
Claims 25 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Piskun (U.S. Publication 2011/0224494) in view of Schaer (U.S. Publication 2004/0082859) further in view of Troutman (U.S. Publication 2017/0296795) further in view of Yamaya (U.S. Patent 7,959,559).
The invention of Piskun as modified by Schaer as further modified by Troutman discloses the invention as claimed except for the expandable stent comprising a central opening to fit over the distal coupler. Yamaya teaches a device (for example see Figures 39-44) comprising a flexible catheter (185) and an expandable member (112A), wherein the expandable member includes a central opening, i.e. is donut shaped, having dimensions configured to cover a distal coupler (121) of the flexible catheter in order to ease deep insertion of the device into a body lumen. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Piskun as modified by Schaer as further modified by Troutman wherein the expandable stent includes a central opening, i.e. is donut shaped, configured to cover the distal coupled of the flexible catheter in view of Yamaya in order to ease deep insertion of the device into a body lumen.
Response to Arguments
Applicant's arguments filed August 1st, 2025 have been fully considered but they are not persuasive. The applicant’s arguments that the reference do not disclose the expandable stent being configured to transition from a collapsed state within the lumen of the flexible catheter to an expanded state when translate distally out of the lumen of the flexible catheter is not persuasive. Piskun discloses body 30 includes a plurality of lumens including a lumen for receiving balloon guide catheter 4 including a distal balloon 5 attached to the distal end of the balloon guide catheter, wherein the balloon in a collapsed state is fully capable of being received within and translated within a lumen of the body such that when translated out of the lumen of the body the balloon is capable of being transitioned to an expanded state meeting the functional limitations of the claim as presented. The claim language only requires that the expandable element be capable of transitioning from a collapsed state and after being translated out of the lumen to expand to an expanded state. There is no requirement that the translation itself causes the transition. Furthermore, the combination of references teach an expandable member, i.e. balloon/stent, made from a shape memory material that is capable of transitioning from a collapsed state to an expanded state when translated out of the lumen.
The applicant’s argument that the Troutman reference is not analogous to the other references is not persuasive. The Piskun reference and the Schaer references are directed to endoscopic instruments, such as Piskun that is an endoscopic device including a balloon catheter, that include expandable members for interacting with a body lumen. The Troutman reference is directed to an endoscopic instrument, such as a ballon catheter, including an expandable member, wherein the expandable member includes a stent (for example see Figures 10A-10C) as discussed above, wherein the stent portion is formed by a plurality of interconnect struts for form a plurality of geometric shapes and wherein the stent portion is formed from a shape memory material, for interacting with a body lumen, such as a chamber of the heart (paragraph 29). One of ordinary skill in the art would look at all endoscopic instruments with expandable members that engage body lumens of a patient for motivation to modify or improve a known device. Therefore, since the references are directed to endoscopic instruments with expandable elements that engage body lumens of a patient the references are analogous.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775
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