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 .
Response to Amendment
In view of the amendment filed on June 18, 2026, claims 15, 17 and 20 have been amended, claim 14 has been canceled and claim 31 has been added. Accordingly, claims 15-31 are pending and claims 15-21 and 31 are under examination. Claims 22-30 are directed to unelected Species (see applicant’s response to election/restriction requirement filed on March 2, 2026) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Response to Arguments
As to prior art rejections, Applicant’s arguments have been fully considered and persuasive. Therefore, all prior art rejections in the most recent Office action are hereby withdrawn.
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 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 Objections
Claim 20 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 17. 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 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) 15-18 and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Polanskyj Stockert et al. (US 5,662,675, hereinafter “Polanskyj”) in view of KorKuch et al. (US 2021/0236783, hereinafter “KorKuch”) and further in view of Ness et al. (US 2018/0318077, hereinafter “Ness”).
Referring to claims 15 and 21, Polanskyj discloses a delivery system 300 (FIGS. 9-11, FIGS. 9-10 are reproduced below) configured for a vessel of a patient, comprising:
an interventional device (inner tubular member 312 and tip 318 as shown in FIGS. 9-10. The inner tubular member 312 for storing components of implant system 100 as shown in FIGS. 3D-4) comprising a distal end portion, and
an introducer 302 (FIGS. 9-11) configured to insert the interventional device 312 into the vessel of the patient, wherein the introducer comprises a tubular sheath 302 extending along a longitudinal axis (z), wherein the sheath surrounds a lumen configured to guide the interventional device 312 into the vessel (FIGS. 3A-3F), wherein the interventional device extends through the lumen of the sheath, wherein said distal end portion forms a dilator (tip 318 as shown in FIGS. 9-11) configured to insert the sheath of the introducer into the vessel
wherein the introducer 302 comprises a fastening mechanism (“A thumbscrew 328 in T-handle 306 may be actuated to engage stabilizer tube 326, thereby locking tubular member 312 in place with respect to sheath 302.” (col. 11, ln. 67 to col. 12, ln. 3)) 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).
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Polanskyj discloses the invention substantially as claimed except for disclosing (1) 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 and (2) wherein the fastening mechanism comprises a clamp connected to a hub, which clamp is configured to clamp the introducer to the interventional device to fasten the introducer to the interventional device.
As to (1), however, in the same field of endeavor, which is an implant delivery system, Ness discloses an expandable introducer sheath 110 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.”). Apparently, the advantage of providing an expandable sheath is to allow the surgeon to insert other interventional device with a diameter larger than the diameter of interventional device 312 to work at the surgical site before deployment of the implant device. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application to have made the tubular sheath 302 as an expandable sheath so that it too would have the same advantage.
As to (2) 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). 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 screw mechanism with the clamp mechanism 250 of Korkuch since it has been held that substitute of one known component/mechanism with another to obtain predictable result 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)).
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Referring to claim 16, the modified system of Polanskyj discloses the delivery system according to claim 15, wherein the introducer 302 is pre-mounted on the interventional device 312 such that the interventional device 312 extends through the lumen of the sheath and protrudes out of the lumen with said distal end portion of the interventional device (FIGS. 9-11).
Referring to claim 17, the modified system of Polanskyj discloses the delivery system according to claim 15, wherein the introducer 302 comprises a hub (T-handle 306 as shown in FIGS. 9-11) connected to a proximal end of the sheath 302 wherein the hub comprises an opening configured to insert the interventional device 312 into the lumen of the sheath (FIGS. 9-11) or to remove the interventional device from the lumen of the sheath of the introducer. Polanskyj fails to disclose wherein the hub comprises a hemostatic valve configured to seal the opening when the interventional device is removed from the sheath of the introducer. However, Korkuch discloses “A hemostatic valve (not shown) may also be included within hub 110, the hemostatic valve being configured to prevent blood from leaking outside of the patient during insertion and/or removal of an intracardiac blood pump or other components.” (para. [0042]). Ness also discloses “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.” (para. [0041]). In view of Korkuch and Ness’ teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have modified the T-handle 306 of Planskyj to include a hemostasis valve to prevent blood from flowing proximally out of the introducer sheath 302.
Referring to claim 18, the modified system of Polanskyj 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 is allowed to pass through the lumen of the sheath upon removal of the interventional device from the sheath of the introducer (Ness: para. [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.” Thus, when the sheath is in an expanded state the tip 318 of the interventional device 312 is capable to pass through the lumen of the sheath in the proximal direction).
Referring to claim 20, the modified system of Polanskyj discloses the delivery system according to claim 15, wherein the introducer comprises a hub (the T-handle 306) connected to a proximal end of the sheath, wherein the hub comprises an opening configured to insert the interventional device 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 (see rejection of claim 17 above).
Allowable Subject Matter
Claims 19 and 31 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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771
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