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 .
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: ‘control mechanism’ in claims 1 & 6-10 and ‘force reduction mechanism’ in claims 1, 6-10, & 18-20.
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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 7, 10-14, & 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Argentine (US Pub. No. 2015/0305902 A1).
Regarding claim 1, Argentine discloses a delivery system (Figs. 1-4) for an implant (NOTE: the implant is not positively recited in this limitation since it is part of an intended use clause in the preamble), the delivery system comprising: a handle 101 (Figs. 1-4); an elongate catheter 106 (Figs. 1-4) coupled to the handle 101, the elongate catheter 106 including one or more shafts (106, 104 - Fig. 1A shows the cross-section) and including an implant retention area 107 (Fig. 1) for retaining the implant; a control mechanism 110 (Figs. 1-4) on the handle 101 for longitudinally sliding the one or more shafts 106, 104; and a force reduction mechanism 160 (force reduction discussed in paragraph [0034]; element includes spring assembly 116 - Figs. 1-4) that is selectively actuatable for reducing a force in at least one of the one or more shafts 106, 104 (selectively actuated via actuation button 140 - paragraph [0036]), wherein the force reduction mechanism is adapted to reduce the force upon a longitudinal threshold force being met in the at least one of the one or more shafts 106, 104 (paragraph [0034] - ‘retraction of outer sheath 106 may be initiated by axial rotation of handle 110 due to high frictional forces between outer sheath 106 and prosthesis 102, and, after the frictional forces decrease, retraction of outer sheath 106 may be completed via sliding of handle 110’ - sliding of the handle 110 is selectively actuated by actuation button 140).
Regarding claim 2, Argentine further discloses wherein the control mechanism 110 includes an actuator 140 (Figs. 1-4) for controlling the longitudinal sliding of the one or more shafts.
Regarding claim 3, Argentine further discloses wherein the force reduction mechanism 160 includes an adapter (Figs. 6A-B) engaged with the at least one of the one or more shafts 106, 104, the adapter being selectively engaged with the actuator 140 (Figs. 4-6B), wherein the adapter is capable of disengaging from the actuator 140 to thereby allow relative movement between the actuator 140 and the at least one of the one or more shafts 106, 104.
Regarding claim 4, Argentine further discloses wherein the actuator comprises a knob 113 (paragraph [0036]).
Regarding claim 5, Argentine further discloses a control device 118 for disengaging the adapter 160 from the actuator 140 (paragraph [0036]).
Regarding claim 7, Argentine further discloses wherein the at least one of the one or more shafts is an outer sheath 106 for covering the implant retention area (Figs. 1-4).
Regarding claim 10, the limitation ‘wherein the elongate catheter is for delivering the implant comprising a prosthetic heart valve to a heart valve of a patient’s body’ is merely a further definition of the intended use of the system. The implant is still not positively recited as part of the system, therefore, the prior art does not need to explicitly disclose that the catheter delivers a prosthetic heart valve, rather, the system just needs to be capable of delivering a prosthetic heart valve. Argentine discloses in paragraph [0032] that the delivery system may be used for delivering any type of prosthesis that may utilize a retractable outer sheath. Since a known method of delivering prosthetic heart valves involves a retractable outer sheath, Argentine’s delivery system is capable of delivering a prosthetic heart valve.
Regarding claim 11, Argentine discloses a delivery system (Figs. 1-4) for an implant (NOTE: the implant is not positively recited in this limitation since it is part of an intended use clause in the preamble), the delivery system comprising: an elongate catheter 106 (Figs. 1-4) including an implant retention area 107 (Fig. 1) for retaining the implant, the elongate catheter 106 including one or more shafts (106, 104 - Fig. 1A shows the cross-section); and a control mechanism 110 (Figs. 1-4) for moving the one or more shafts, the control mechanism 110 including an actuator knob having an inner body 160 (Figs. 4-6B) and an outer body 118 (Figs. 4-6B) extending around the inner body 160, the outer body 118 adapted to slip relative to the inner body 160 (Fig. 10 to Fig. 11) to limit a tension force or a compression force in at least one of the one or more shafts 106, 104 transmitted by the actuator knob 110 to the at least one of the one or more shafts 106, 104 (paragraph [0034] - ‘retraction of outer sheath 106 may be initiated by axial rotation of handle 110 due to high frictional forces between outer sheath 106 and prosthesis 102, and, after the frictional forces decrease, retraction of outer sheath 106 may be completed via sliding of handle 110’).
Regarding claim 12, Argentine further discloses wherein the outer body 118 comprises an outer shell (Figs. 4-6B).
Regarding claim 13, Argentine further discloses wherein the inner body 160 is for engaging an adapter 132 (Fig. 4) coupled to a proximal end portion of the at least one of the one or more shafts 106 (Fig. 4).
Regarding claim 14, Argentine further discloses wherein the inner body 160 is for rotating about the adapter 132 and conveying rotational motion of the actuator knob 110 to a longitudinal motion of the adapter 132 (threading engages with the rotating knob 110 and translates the adapter 132 to longitudinally move the catheter 106).
Regarding claim 18, Argentine discloses a delivery system (Figs. 1-4) for implanting a medical device in a body (NOTE: the medical device is not positively recited in this limitation since it is part of an intended use clause in the preamble), the delivery system comprising: a handle 101 (Figs. 1-4); an elongate catheter 106 (Figs. 1-4) coupled to the handle 101, the elongate catheter 106 including an inner shaft 104 and an outer shaft 106, wherein the inner shaft 104 is coupled to the medical device 102 (if the medical device is intended to be claimed as part of the delivery system, a proper positive recitation is required - see note in the preamble regarding the recitation) and wherein the outer shaft 106 has an implant retention area 107 (Fig. 1) along a distal end portion for retaining the medical device 102 in a compressed configuration; an actuator 110 (Figs. 1-4) on the handle 101 for longitudinally sliding the outer shaft 106 relative to the handle via a threaded engagement 132 (Figs. 1-4); and a force reduction mechanism (force reduction discussed in paragraph [0034]; element includes spring assembly 116 - Figs. 1-4) that is selectively actuatable for reducing axial tension or compression in the outer shaft by disengaging the threaded engagement between the actuator and the outer shaft (selectively actuated via actuation button 140 - paragraph [0036]).
Regarding claim 19, Argentine further discloses wherein the force reduction mechanism comprises an adapter 132 (Figs. 1-4) coupled to a proximal end portion of the outer shaft 106 and having a threaded surface sized for engagement with the actuator 110 (Figs. 1-4), wherein the adapter 132 is operable to disengage from the actuator 110 (via actuation button - described in paragraph [0036]).
Regarding claim 20, Argentine further discloses wherein the threaded surface of the adapter 132 is spring biased for engaging the actuator 110 (spring bias from actuation button 140 an spring assembly 116) during movement of the outer shaft 106, and the threaded surface of the adapter 132 is adapted to disengage from the actuator 110 upon a control device adjusting a position of the adapter (paragraph [0036]).
Allowable Subject Matter
Claims 6, 8, 9, & 15-17 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.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to further disclose, teach, or suggest an indicator for indicating a longitudinal force in the at least one of the one or more shafts [claim 6]; wherein the at least one of the one or more shafts is a manifold shaft coupled to one or more sutures for coupling to the implant [claim 8]; an actuator knob on the handle engaged with and for advancing or retracting at least one of the one or more shafts, the actuator knob including a proximal portion and a distal portion; and a releasable coupler configured to engage an elastomeric body to releasably couple the proximal portion of the actuator knob to the distal portion of the actuator knob, the releasable coupler extending between the proximal portion and the distal portion, and wherein the releasable coupler is adapted to disengage from the elastomeric body to allow the proximal portion to disengage from the distal portion upon a longitudinal threshold force being met in the at least one of the one or more shafts engaged with the actuator knob [claim 9]; wherein the inner body or the outer body includes a bearing surface for allowing the inner body to rotate relative to the outer body [claim 15]; and a displacement body for engaging the outer body with the inner body to retain a rotational position of the outer body relative to the inner body, and wherein the displacement body is biased towards an engagement surface of the outer body or the inner body [claim 16].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 July 22, 2026
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