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 .
Election/Restrictions
Applicant’s election of Species 2, FIGS. 8-9, in the reply filed on March 2, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 22-30, which are new claims, are directed to unelected Species (see applicant’s Remarks) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 17, which is dependent on claim 15, recites “the hub” in line 2. Examiner contends that one of ordinary skill in the art will understand that applicant intended to recite “a hub.” 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: “a fastening mechanism” in claim 14, line 5 and claim 15, line 15.
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.
Claim(s) 14-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ness et al. (US 2018/0318077, hereinafter “Ness”).
Referring to claim 14, Ness discloses a delivery system (FIG. 1, ¶ [0036]) configured for a vessel of a patient, comprising:
an interventional device 10 (FIG. 1, ¶ [0036]: “FIG. 1 shows a prosthetic heart valve delivery device 10 assembled to an introducer 100, while FIGS. 2A-B show the general features of delivery device 10. Generally, delivery device 10 includes a catheter assembly 16 for delivering the heart valve to, and deploying the heart valve at, a target location, and an operating handle 20 for controlling the deployment of the valve from the catheter assembly.”), and
an introducer 100 (FIGS. 1 and 3, ¶ [0036]) configured to introduce the interventional device into the vessel of the patient, wherein the introducer comprises a fastening mechanism configured to releasably fasten the introducer to the interventional device to prevent movement of the introducer with respect to the interventional device along a longitudinal axis (z) (FIG. 2A shows hooks 28 on handle for mating with a latching element 132 on introducer 100 (FIG. 3, ¶ [0041]: “Housing 130 may also include a latching element 132 for mating with latching element 28 of handle 20. For example, latching element 132 may be a groove, snap, aperture, or other mechanism configured to couple with latching element 28.”)).
Referring to claim 15, Ness discloses a delivery system (FIG. 1, ¶ [0036]) configured for a vessel of a patient, comprising:
an interventional device 10 (FIG. 1, ¶ [0036]: “FIG. 1 shows a prosthetic heart valve delivery device 10 assembled to an introducer 100, while FIGS. 2A-B show the general features of delivery device 10. Generally, delivery device 10 includes a catheter assembly 16 for delivering the heart valve to, and deploying the heart valve at, a target location, and an operating handle 20 for controlling the deployment of the valve from the catheter assembly.”) comprising a distal end portion, and
an introducer 100 (FIGS. 1 and 3, ¶ [0036]) configured to insert the interventional device into the vessel of the patient, wherein the introducer comprises a tubular sheath 110 extending along a longitudinal axis (z), wherein the sheath surrounds a lumen configured to guide the interventional device 10 into the vessel, wherein the interventional device 10 extends through the lumen of the sheath, wherein said distal end portion forms a dilator 14 (FIG. 1, ¶ [0037]) configured to insert the sheath of the introducer into the vessel (examiner notes that when the introducer 100 is locked to the handle 20 of the interventional device 10, the handle of the interventional device 10 is capable of facilitating the insertion of the sheath into the vessel), and wherein the sheath of the introducer is configured to be expanded from a first state to a second state, wherein an inner diameter (D1) of the sheath in the first state is smaller than an inner diameter (D2) of the sheath in the second state (¶ [0041]: “Preferably, distal sheath 110 is expandable from a first diameter to a larger second diameter. In this and other embodiments described herein, it is preferable that the outer diameter of sheath 110 in the reduced diameter configuration is about 4 mm (12 French), while the inside diameter of the sheath is about 6.67 mm (20 French) in the expanded diameter configuration.”), wherein the introducer comprises a fastening mechanism configured to releasably fasten the introducer to the interventional device to prevent movement of the introducer with respect to the interventional device along the longitudinal axis (z) (FIG. 2A shows hooks 28 on handle 20 for mating with a latching element 132 on introducer 100 (FIG. 3, ¶ [0041]: “Housing 130 may also include a latching element 132 for mating with latching element 28 of handle 20. For example, latching element 132 may be a groove, snap, aperture, or other mechanism configured to couple with latching element 28.”)).
Referring to claim 16, Ness discloses the delivery system according to claim 15, wherein the introducer 100 is pre-mounted on the interventional device 10 such that the interventional device 10 extends through the lumen of the sheath and protrudes out of the lumen with said distal end portion of the interventional device (FIG. 1 shows introducer 100 is attached to handle 20 of the interventional device 10).
Referring to claim 17, Ness discloses the delivery system according to claim 15, wherein the introducer 100 comprises a hub 130 (FIG. 3, ¶ [0041]) connected to a proximal end of the sheath 110, 120, wherein the hub comprises an opening configured to insert the interventional device 10 into the lumen of the sheath (FIG. 1) or to remove the interventional device 10 from the lumen of the sheath of the introducer, and wherein the hub comprises a hemostatic valve configured to seal the opening when the interventional device is removed from the sheath of the introducer (¶ [0041]: “A housing 130 connected to proximal sheath 120 may include additional components including, for example, a flush port 140 and one or more seals or hemostasis valves (not illustrated) to prevent blood from flowing proximally out of introducer 100.”).
Referring to claim 18, Ness discloses the delivery system according to claim 15, wherein in the second state of the sheath (expanded state of the sheath), the distal end portion of the interventional device 10 is allowed to pass through the lumen of the sheath upon removal of the interventional device from the sheath of the introducer 100 (¶ [0046]: “Once the prosthetic heart valve has been implanted, delivery device 10 may be removed from sheath 110A and the patient, at which point the first end 113A of coil 111A may be released, enabling the coil to revert to the reduced diameter configuration and the sheath to be removed from the patient.”).
Referring to claim 19, Ness discloses the delivery system according to claim 15, wherein the interventional device 10 is a delivery catheter configured to deliver an implant (prosthetic heart valve) to an implantation site, wherein the distal end portion of the interventional device comprises a slidable capsule 24 (FIG. 1) configured to carry the implant (¶ [0036]: “Catheter assembly 16 includes an outer shaft 22 extending from operating handle 20 and a distal sheath 24 connected to the distal end of the outer shaft. A compartment 23 defined around an inner shaft 26 in catheter assembly 16 is configured to receive a prosthetic heart valve (not shown), which is held in a collapsed condition when distal sheath 24 covers the compartment.”).
Referring to claim 20, Ness discloses a delivery system (FIG. 1, ¶ [0036]) configured for a vessel of a patient, comprising:
an interventional device 10 comprising a distal end portion (FIG. 1, ¶ [0036]: “FIG. 1 shows a prosthetic heart valve delivery device 10 assembled to an introducer 100, while FIGS. 2A-B show the general features of delivery device 10. Generally, delivery device 10 includes a catheter assembly 16 for delivering the heart valve to, and deploying the heart valve at, a target location, and an operating handle 20 for controlling the deployment of the valve from the catheter assembly.”), and
an introducer 100 (FIGS. 1 and 3, ¶ [0036]) configured to introduce the interventional device 10 into a vessel of the patient, wherein the introducer comprises a tubular sheath extending along a longitudinal axis (z), wherein the sheath is configured to be inserted into the vessel and surrounds a lumen configured to guide the interventional device into the vessel, wherein the interventional device extends through the lumen of the sheath, wherein said distal end portion forms a dilator 14 (FIG. 1, ¶ [0037]) configured to insert the sheath of the introducer into the vessel (examiner notes that when the introducer 100 is locked to the handle 20 of the interventional device 10, the handle of the interventional device 10 is capable of facilitating the insertion of the sheath into the vessel), and wherein the introducer 100 comprises a hub 130 (FIG. 3, ¶ [0041]) connected to a proximal end of the sheath, wherein the hub comprises an opening configured to insert the interventional device 10 into the lumen of the sheath or to remove the interventional device from the lumen of the sheath of the introducer, wherein the hub comprises a hemostatic valve configured to seal the opening when the interventional device is removed from the sheath of the introducer (¶ [0041]: “A housing 130 connected to proximal sheath 120 may include additional components including, for example, a flush port 140 and one or more seals or hemostasis valves (not illustrated) to prevent blood from flowing proximally out of introducer 100.”).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ness et al. in view of KorKuch et al. (US 2021/0236783, hereinafter “KorKuch”).
Referring to claim 21, Ness discloses the delivery system according to claim 15, wherein the fastening mechanism comprises hook mechanism 28 connected to a hub 130, which clamp is configured to clamp the introducer 100 to the interventional device 10 to fasten the introducer to the interventional device (¶ [0040]: “The distal end of handle 20 may include a latching element configured to latch or otherwise lock onto a complementary latching element of introducer 100. Although shown in FIGS. 2A-B as a pair of hooks 28, any other suitable latching mechanism, including snaps, knobs, or similar mechanisms may be used”). Ness fails to disclose the fastening mechanism is a clamp.
Referring again to claim 21, however, in the same field of endeavor, which is a delivery system for delivering an implant, Korkuch discloses a clamp mechanism 250 is used to connect dilator hub 230 of dilator assembly 200 to hub 110 of an expandable sheath assembly 100 (FIGS. 1-2 and 4-7, FIG. 7 is reproduced below).
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Referring still to claim 21, since Ness discloses that other suitable latching mechanism or similar mechanism may be used, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have substitute the hook mechanism of Ness with the clamp mechanism of Korkuch. Furthermore, it has been held that simple substitution of one known element/mechanism for another to obtain predictable results is well known in the art (KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771