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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/26/2026 has been entered.
Response to Arguments
Applicant’s arguments, see pages 6-7, filed 05/26/2026, with respect to the rejection(s) of claim(s) 1 under 35 USC 102(a)(1) in view of Reis have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Knippel/Hansen.
Claim Objections
Claim 1 is objected to because of the following informalities: In line 23 of claim 1, “being arranged pull the pull tab” should be changed to “being arranged to pull the pull tab”. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an engagement feature”, “a first interference feature”, “a first release mechanism” in claim 1, 5, 6, 7, and 10, “a second interference feature” in claim 5 and 6, and “a second release mechanism” in claim 6.
A review of the specification identifies the following structures disclosed as performing the claims functions:
engagement feature – a protrusion (18)
first interference feature – a narrow opening provided inside the handle (26)
first release mechanism – a button (28)
second interference feature – a leaf spring (20)
second release mechanism – a slider (24)
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1 and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Knippel et al. (US 2012/0123528) in view of Hansen et al. (US 2010/0004606).
Regarding claim 1, Knippel et al. discloses a system (10, FIG 1) for deploying an implant ([0028]), the system comprising: a handle (20), a catheter (26) extending from the handle (FIG 1), the catheter being arranged for holding an implant at an implant holding portion (compartment 23, [0028]) at a distal end of the catheter (FIG 1), an implant retaining sheath (24), the implant retaining sheath being arranged so as to surround the implant holding portion so as to retain an implant that is arranged at the implant holding portion (FIG 1, [0028-0031]), a pull tab (22/40, FIG 1-2), the pull tab being connected to the implant retaining sheath ([0030] “The distal sheath 24 is affixed at its proximal end to an outer shaft 22”) so that a proximal pull on the pull tab pulls back the implant retaining sheath so as to release an implant arranged at the implant holding portion ([0030, 0031, 0046]), the pull tab further comprising an engagement feature (51, FIG 2) that is arranged on the pull tab (40 is integrally connected to 22 and moves proximally and distally together. 51 is arranged on element 40 of the pull tab) and that is moved proximally as the pull tab is moved proximally (because 51 is constrained to 40, [0039-0040]), the engagement feature being arranged to engage with a first interference feature (52, FIG 2, [0039-0042]) arranged at a first fixed longitudinal position on the system for deploying the implant (52 is arranged at a longitudinal position of the handle housing in slot 54, FIG 2), wherein an engagement between the engagement feature and the first interference feature provides tactile feedback to a user of the system that the implant retaining sheath has been pulled back a pre-set distance (The user can feel the engagement when 51 abuts with 52 because further proximal retraction is completely prevented, [0039, 0049]), wherein the tactile feedback is complete blocking of further withdrawal of the pull tab ([0054], proximal retraction is completely blocked by the engagement between 51 and 52 until button 50 is pressed to retract the pin [0054]), the system further comprises a first release mechanism (50) for selectively releasing the complete blocking of further withdrawal of the pull tab ([0038-0040 and 0054]), the system further comprising a pull tab withdrawal mechanism (21, IFG 1-2) the pull tab withdrawal mechanism being arranged pull the pull tab proximally so as to release an implant arranged at the implant holding portion ([0046]), the pull tab withdrawal mechanism comprising a thumbwheel FIG 1 shows that 21 is a thumbwheel).
Knippel discloses the thumbwheel causes proximal retraction via a threaded rod mechanism ([0035-0036, 0046-0047]) and therefore is silent regarding the thumbwheel being coupled to a spindle, the spindle being arranged for winding up the pull tab so as to exert a proximal pull on the pull tab.
However, Hansen et al. teaches in the same field of endeavor of systems for deploying an implant (FIG 1 and 3-5) wherein a stent is housed within an implant retaining sheath (14) at the distal end of a catheter ([0051]) and the stent is deployed via proximal retraction of the retaining sheath ([0051, 0054]) and further discloses wherein the mechanism for releasing the stent includes a pull tab (44) and a pull tab withdrawal mechanism comprising a wheel (50) coupled to a spindle (48) arranged for winding up the pull tab ([0056-0058]) to exert proximal pull on the pull tab ([0067]).
Therefore, it would have been obvious to one of ordinary skill in the art to substitute the threaded rod mechanism taught by Knippel with the spindle taught by Hansen, for the purpose of substituting a mechanism commonly known in the art for retracting an outer sheath to expose a stent for deployment at the distal end of the catheter. In the device as modified, at least the proximal end of the pull tab of Knippel is modified to be windable around a spindle to perform the retraction, as is commonly known in the art.
Regarding claim 8, Knippel/Hansen disclose the invention substantially as claimed, as set forth above for claim 1. Knippel further discloses the system further comprising a stent graft implant arranged at the implant holding portion ([0028, 0029, 0031]; although not shown in the figures, it is understood that the device comprises the stent received within the compartment 23 as described).
Regarding claim 9, Knippel/Hansen disclose the invention substantially as claimed, as set forth above for claim 8. Knippel further discloses the implant being a self-expanding implant ([0028]).
Regarding claim 10, Knippel/Hansen disclose the invention substantially as claimed, as set forth above for claim 8. Knippel further discloses the engagement between the engagement feature and the first interference feature corresponds to a partial deployment of the implant ([0049]).
Regarding claim 11, Knippel/Hansen disclose the invention substantially as claimed, as set forth above for claim 1. Knippel further discloses he first release mechanism is operable by a user operable button ([0038-0040] describes the control member 50 as a user operable button).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Knippel et al. (US 2012/0123528) in view of Hansen et al. (US2010004606), further in view of Cully et al. (US 2019/0125517).
Regarding claim 15, Knippel/Hansen disclose the invention substantially as claimed, as set forth above for claim 8.
Knippel is silent regarding the stent graft implant being a TIPS stent graft.
However, Cully teaches in the same filed of endeavor a stent graft implant (10, FIG 1) which is deployable to a form a transjugular intrahepatic portosystemic shunt ([0002, 0007, and 0029]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to select a stent graft configured to form a TIPS stent graft, as taught by Cully ([0029] discloses preferable sizing for a stent graft used for this particular procedure), for the purpose of configuring the device for treatment at a particular site, i.e. between the portal vein and the vena cava.
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Knippel et al. (US 2012/0123528) in view of Hansen et al. (US2010004606), further in view of Wuebbeling et al. (US 2010/0174290).
Regarding claim 16, Knippel/Hansen disclose the invention substantially as claimed, as set forth above for claim 1.
Knippel is silent regarding the handle further comprising a flexible distal tip.
However, Wuebbeling teaches in the same filed of endeavor a handle (1, FIG 2) for retracting a sheath to deploy a stent ([0004, 0037, 0063]) wherein the handle comprises a flexible distal tip (18, FIG 1-2, [0068] discloses the tip “relieves localised compression and bending forces at the catheter proximal end where it is connected to the housing 10”, which is understood to mean that the tip is flexible to provide strain relief).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the handle of Knippel to comprise a flexible distal tip, as taught by Wuebbeling, for the purpose of providing a structure at the distal end of the handle where the handle connects to the catheter sheath such that the user can apply controlled forces to the surgical catheter, and relieves localised compression and bending forces at the catheter shaft proximal end where it is connected to the housing of the handle.
Allowable Subject Matter
Claims 4-7 and 12-14 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
Prosecution Insights