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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 10th, 2025 and June 22nd, 2026 has been entered.
Election/Restrictions
Newly submitted claim 52 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The claim is directed to a different embodiment than the originally filed embodiment (for example claim 52 is directed to embodiments shown in Figures 3A, 10A, and 28; the specification does not disclose the cover being used with the originally filed embodiment)
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 52 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.
Claim 50 is rejected under 35 U.S.C. 101 because they are drawn to non-statutory subject matter.
In claim 50 lines 1-2 the applicant positively recites part of a human, i.e. "…in the expanded state the expandable stent engages a wall of a body lumen…”. Thus claim 50 includes a human within its scope and are non-statutory.
A claim directed to or including within its scope a human is not considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution. In re Wakefield, 422 F.2d 897, 164 USPQ 636 (CCPA 1970).
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, 26, 27, 29, 31, 32, 38, 41-47, 50, and 53 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) and in view of Troutman (U.S. Publication 2017/0296795) and in view of Cully (U.S. 2012/0136385).
Regarding claims 21, 26, 27, 29, 31, 41, 46, 47, 50, and 53:
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 41) wherein the working space is an asymmetric chamber
(claim 53) wherein the plurality of flexible elements includes a first and second flexible element that expand to one side of a longitudinal plane containing a longitudinal axis of the flexible catheter to form an asymmetrical work space
(claim 21) a distal coupler (15) coupled to the distal portion 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 via element 4 from elements 19 and 33 which is positioned in lumen 38 (see paragraph 54), therefore element 4 translates within element 19 to move the expandable member in and out of the lumen 38 of the element 33 while the expandable member is in a collapsed configuration)
(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 (see paragraph 54)
(claim 50) wherein in the expanded state the expandable stent is capable of engaging a wall of a body lumen to provide a fixed distal point that stabilizes the plurality of flexible elements
(claim 47) wherein the expandable member is carried on a second catheter (19) disposed within a lumen of the flexible catheter (see paragraph 54)
(claim 21) 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 when translated distally out the via the push rod (the push rod translates the expandable member from the lumen of element 33 and then allows fluid into the expandable member to expand the member)
(claim 46) wherein the push rod is configured to advance the expandable member out of the lumen of the flexible catheter and to retract the expandable stent into the lumen of the flexible catheter
(claim 47) wherein the push rod is disposed within the second catheter (see paragraph 54)
(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 (see paragraphs 55 and 63-65)
Piskun fails to disclose the device wherein the expandable structure is a stent, wherein the stent is formed by a plurality of struts interconnected to form a plurality of geometric shapes, and wherein the stent is formed from 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 disclosed 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 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 paragraph 12, 73, and 74). 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 plurality of struts interconnected to form a plurality of geometric shapes in view of Troutman, since the applicant has not disclosed that such solve any problem or is anything more than one of numerous shapes or configurations a person of ordinary skill in the art would find obvious for the purposes of providing an expandable stent. In re Dailey and Eilers, 149 USPQ 47 (1966).
Regarding the expandable stent being formed of a shape memory material biased toward an expanded configuration, Cully teaches a device (for example see Figures 2A-2B) comprising an expandable member configured to transition from a collapsed configuration to an expanded configuration formed from shape memory material, such as Nitinol, that is biased toward the expanded configuration when released from a constraining mechanism (see paragraph 44). 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 is formed from a shape memory material biased toward the expanded configuration in view of Cully, since it has been held to be within the general skill of a work 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. The device of Piskun as modified by Schaer as further modified by Troutman as further modified by Cully discloses a device wherein the expandable stent is made from a shape memory material that self-expands from a collapsed configuration to an expanded configuration when translated out of the lumen of the flexible catheter, i.e. when the constraining mechanism has been released.
Regarding claims 32 and 42-44:
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 42) wherein the plurality of flexible elements are moveable to form a working space within a body lumen
(claim 43) wherein the plurality of flexible elements are capable of forming the working space when the expandable member is in the expanded state
(claim 44) wherein the plurality of flexible elements are capable of forming the working space when the expandable member is in the collapsed state
(claim 32) a distal coupler (15) coupled to the 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 (see paragraphs 20 and 59)
(claim 42) a flexible instrument (11; for example see Figures 3 and 12) extending a length of the flexible catheter
(claim 42) 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 (see paragraphs 55 and 63-65)
Piskun fails to disclose the device wherein the expandable structure is a stent, wherein the stent is formed by a plurality of struts interconnected to form a plurality of geometric shapes, and wherein the stent is formed from 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 disclosed 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 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 paragraph 12, 73, and 74). 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 plurality of struts interconnected to form a plurality of geometric shapes in view of Troutman, since the applicant has not disclosed that such solve any problem or is anything more than one of numerous shapes or configurations a person of ordinary skill in the art would find obvious for the purposes of providing an expandable stent. In re Dailey and Eilers, 149 USPQ 47 (1966).
Regarding the expandable stent being formed of a shape memory material biased toward an expanded configuration, Cully teaches a device (for example see Figures 2A-2B) comprising an expandable member configured to transition from a collapsed configuration to an expanded configuration formed from shape memory material, such as Nitinol, that is biased toward the expanded configuration when released from a constraining mechanism (see paragraph 44). 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 is formed from a shape memory material biased toward the expanded configuration in view of Cully, since it has been held to be within the general skill of a work 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. The device of Piskun as modified by Schaer as further modified by Troutman as further modified by Cully discloses a device wherein the expandable stent is made from a shape memory material that self-expands from a collapsed configuration to an expanded configuration when translated out of the lumen of the flexible catheter, i.e. when the constraining mechanism has been released.
Regarding claims 38 and 45:
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) wherein the plurality of flexible elements are capable of moving from an insertion position (for example see Figure 2a) to an expanded position (for example see Figure 2b) to form an asymmetric working space within a body lumen
(claim 38) a distal coupler (15) coupled to the distal portion 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 constrained within a lumen of the flexible catheter in a collapsed state
(claim 38) wherein the expandable member is configured to transition from the collapsed state within a lumen of the flexible catheter to an expanded state when translated distally out of the lumen of the flexible catheter (see paragraphs 20 and 59)
(claim 38) wherein the expandable member is configured to engage a wall of a body lumen and stabilize the plurality of flexible elements when in the expanded state
(claim 45) a flexible instrument (11; for example see Figures 3 and 12) extending a length of the flexible catheter
(claim 45) 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 (see paragraphs 55 and 63-65)
Piskun fails to disclose the device wherein the expandable structure is a stent, wherein the stent is formed by a plurality of struts interconnected to form a plurality of geometric shapes, and wherein the stent is formed from 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 disclosed 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 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 paragraph 12, 73, and 74). 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 plurality of struts interconnected to form a plurality of geometric shapes in view of Troutman, since the applicant has not disclosed that such solve any problem or is anything more than one of numerous shapes or configurations a person of ordinary skill in the art would find obvious for the purposes of providing an expandable stent. In re Dailey and Eilers, 149 USPQ 47 (1966).
Regarding the expandable stent being formed of a shape memory material biased toward an expanded configuration, Cully teaches a device (for example see Figures 2A-2B) comprising an expandable member configured to transition from a collapsed configuration to an expanded configuration formed from shape memory material, such as Nitinol, that is biased toward the expanded configuration when released from a constraining mechanism (see paragraph 44). 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 is formed from a shape memory material biased toward the expanded configuration in view of Cully, since it has been held to be within the general skill of a work 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. The device of Piskun as modified by Schaer as further modified by Troutman as further modified by Cully discloses a device wherein the expandable stent is made from a shape memory material that self-expands from a collapsed configuration to an expanded configuration when translated out of the lumen of the flexible catheter, i.e. when the constraining mechanism has been released.
Claim 49 is 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 Cully (U.S. 2012/0136385) further in view of Yamaya (U.S. Patent 7,959,559).
The invention of Piskun as modified by Schaer as further modified by Troutman as further modified by Cully 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 the 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 as further modified by Cully wherein the expandable stent includes a central opening, i.e. is donut shaped, configured to cover the distal coupler 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 June 22nd, 2026 have been fully considered but they are not persuasive. The applicant’s arguments are directed to the new limitations added by the amendment which are discussed above in the new grounds of rejection.
Allowable Subject Matter
Claims 48 and 51 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited references the examiner felt were relevant to the application.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775
Prosecution Insights