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 .
This action is in response to the Election/Restriction response filed on 09/02/2025. Claims 1-34 are pending. Claims 1, 19, 23, 25, 31, and 32 are independent.
Election/Restrictions
Applicant's election with traverse of Species A (Figures 1-27) in the reply filed on 09/02/2025 is acknowledged. The traversal is on the ground(s) that the pending claims of the instant application do not present a serious search burden on the Examiner. This is not found persuasive because there is an examination and search burden for these patentably distinct species due to their mutually exclusive characteristics. The species require a different field of search (e.g., searching different groups/subgroups or electronic resources, or employing different search queries); and/or the prior art applicable to one species would not likely be applicable to another species.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 31 is objected to because of the following informalities:
Claim 31, the limitation “translating the platen and deployment rods” should be amended to --translating the platen and a plurality of deployment rods-- to avoid confusion on lack of antecedent basis for “the…deployment rods.”
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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 and 14-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation "the patient" in line 4 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the deployment rod" in line 4 of the claims. Claim 14 recites multiple deployment rods. It is unclear which of the deployment rods that “the deployment rod” is referring to.
Claim 15 recites the limitation "the deployment rod" in line 4 of the claims. Claim 14 recites multiple deployment rods. It is unclear which of the deployment rods that “the deployment rod” is referring to.
Claim 16 recites the limitation "the deployment rod" in line 3 of the claims. Claim 14 recites multiple deployment rods. It is unclear which of the deployment rods that “the deployment rod” is referring to.
Claim 17 recites the limitation "the deployment rod" in line 3 of the claims. Claim 14 recites multiple deployment rods. It is unclear which of the deployment rods that “the deployment rod” is referring to.
The art rejection(s) below is/are made as best understood by the examiner because of the 35 U.S.C. 112 issues stated above.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7, 10, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hauck et al. (US Pub. No.: 2021/0145421) in view of Schaller et al. (US Pub. No.: 2007/0112425)
Regarding claims 1-7, 10, and 18, Hauck discloses [claim 1] a vascular closure assembly (Fig. 1, vascular closure assembly 10), comprising: an actuator assembly (Fig. 1, actuator assembly 12) including: a chassis portion (Fig. 1, chassis portion 14); an elongate housing (Fig. 1, elongate housing 22) with a proximal end (Fig. 3, proximal end 24; para. [0069]) thereof secured to a distal end (Fig. 3, distal end 26) of the chassis portion (Fig. 1, chassis portion 14), a distal end (Fig. 3, distal end 28; para. [0069]) extending away from the chassis portion (Fig. 1, chassis portion 14), a distal section (Fig. 1, distal section 34), and a plurality of anchor deployer lumens (Fig. 4, anchor deployer lumens 42), each anchor deployer lumen (Fig. 4 and para. [0069], anchor deployer lumen 42) extending along the elongate housing (Fig. 1, elongate housing 22) and terminating distally at a distal port (Fig. 3, distal port 44; para. [0069]) disposed in the distal section (Fig. 1, distal section 34) of the elongate housing (Fig. 1, elongate housing 22); and a plurality of anchor deployers (Fig. 4, anchor deployers 52), each anchor deployer (Fig. 4, anchor deployer 52) being slidably disposed within a respective anchor deployer lumen of the elongate housing (Fig. 4, each anchor deployer 52 slidably disposed within a respective anchor deployer lumen 42 of the elongate housing 22; para. [0070]), each anchor deployer (Fig. 4, anchor deployer 52) comprising: a deployment rod (Fig. 29, deployment rod 56) which includes an elongate resilient configuration (Fig. 29, each deployment rod 56 has an elongate resilient configuration; para. [0070]), and an anchor (Fig. 29, anchor 62) which is removably secured to the distal end (Fig. 29, distal end 58) of the deployment rod (Fig. 29, anchor 62 is releasably secured to the distal end 58 of the deployment rod 56; para. [0070]), and which is configured to resist proximal retraction within tissue (Fig. 29, anchor 62 is configured to resist proximal retraction within tissue; para. [0070]); and a filament (Fig. 29, filament 66; para. [0070]) secured to each anchor (Fig. 29, anchor 62). Hauck does not explicitly disclose a pre-shaped distal section that assumes a curved profile while in a relaxed state and a straightened profile while in a constrained state within the respective anchor deployer lumen and that is configured to extend from the respective distal port along a curved path as an extended portion thereof relaxes and assumes the curved profile.
Schaller is in the field of drawing tissue portions toward one another (para. [0003]) and teaches a device (Fig. 21, system 150), comprising a deployment rod (Fig. 22, delivery tube 156) which includes a preshaped distal section (Fig. 23, curved distal end 166; para. [0113]) that assumes a curved profile while in a relaxed state and a straightened profile while in a constrained state within the respective anchor deployer lumen (Fig. 21, Fig. 22, the curved distal ends 166 are preshaped and, when stowed within the guide catheter 154, the distal ends 166 are restrained in a generally linear configuration and move to the precurved configuration when the delivery tubes 156 are deployed from the guide catheter 154; para. [0113]) and that is configured to extend from the respective distal port along a curved path as an extended portion thereof relaxes and assumes the curved profile (Fig. 22, Fig. 23, the curved distal end 166 extends radially outward from a longitudinal axis of the guide catheter 154 when the delivery tube 156 is deployed from the guide catheter 154; para. [0113]).
It would have been obvious to one of ordinary skill in the art before the priority date to modify the device of Hauck to include preshaped delivery tubes as taught by Schaller, the motivation being to facilitate placement of anchors while minimizing complexity of the elongate housing.
Regarding claim 2, modified Hauck discloses the vascular closure assembly of claim 1. Regarding wherein the pre-shaped distal section of each deployment rod is configured to extend distally from the respective distal port until a distal end of the deployment rod is disposed at a tissue penetrating position at a tissue penetrating angle with a distal end of the elongate housing disposed adjacent a tissue layer with a longitudinal axis of the elongate housing being disposed at a tilted deployment angle with respect to the tissue layer, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention for the prior art. If the prior art is capable of performing the intended use, it meets the claim. In this case, the deployment rods of Hauck, as modified by Schaller, are structurally capable of extending distally from the respective distal port until a distal end of the deployment rod is disposed at a tissue penetrating position at a tissue penetrating angle with a distal end of the elongate housing disposed adjacent a tissue layer with a longitudinal axis of the elongate housing being disposed at a tilted deployment angle with respect to the tissue layer.
Regarding claim 3, modified Hauck discloses the vascular closure assembly of claim 2. Regarding wherein the elongate housing and pre-shaped distal section of each of the deployment rods are configured to extend the deployment rods and engage the tissue layer at a tissue penetrating angle with the elongate housing disposed at a deployment angle of about 40 degrees to about 50 degrees with respect to the patient, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention for the prior art. If the prior art is capable of performing the intended use, it meets the claim. In this case, the deployment rods and elongated housing of Hauck, as modified by Schaller, are structurally capable of extending the deployment rods and engaging the tissue layer at a tissue penetrating angle with the elongate housing disposed at a deployment angle of about 40 degrees to about 50 degrees with respect to the patient.
Regarding claim 4, modified Hauck discloses the vascular closure assembly of claim 1. Hauck does not explicitly disclose wherein the pre-shaped distal section of each deployment rod lies in a plane.
Schaller is in the field of drawing tissue portions toward one another (para. [0003]) and teaches a device (Fig. 21, system 150), wherein the pre-shaped distal section (Fig. 23, curved distal end 166) of each deployment rod (Fig. 22, delivery tubes 156) lies in a plane (Fig. 23, the curved distal end 166 of each delivery tube 156 lies in a plane).
It would have been obvious to one of ordinary skill in the art before the priority date to modify the device of Hauck to include preshaped delivery tubes as taught by Schaller, the motivation being to facilitate placement of anchors while minimizing complexity of the elongate housing.
Regarding claim 5, modified Hauck discloses the vascular closure assembly of claim 1, Hauck further disclosing wherein the deployment rods (Fig. 29, deployment rods 56) of the plurality of anchor deployers (Fig. 4, anchor deployers 52) comprise at least two cranial deployment rods (Fig. Fig. 4, Fig. 29, first and second anchor deployers 52 define cranial deployment rods 56), the distal tips (Fig. 29, distal tips 286) of which extend laterally away from the distal section (Fig. 1, distal section 34) of the elongate housing (Fig. 1, elongate housing 22) and each other (Fig. 1, Fig. 12, Fig. 20, Fig. 29, the distal tips 286 of the first and second anchor deployers 52 extend laterally away from the distal section 34 and each other; para. [0070]; para. [0094]-[0095]), and at least two caudal deployment rods (Fig. Fig. 4, Fig. 29, third and fourth anchor deployers 52 define caudal deployment rods 56) that extend away from the distal section (Fig. 1, distal section 34) of the elongate housing (Fig. 1, elongate housing 22) and below the cranial deployment rods (Fig. 1, Fig. 4, Fig. 12, Fig. 20, Fig. 29, third and fourth anchor deployers 52 extend away from the elongate housing 22 and below the defined cranial deployment rods 56; para. [0070]; para. [0094]-[0095]).
Regarding claim 6, modified Hauck discloses the vascular closure assembly of claim 5, Hauck further disclosing wherein the distal sections (Fig. 29, distal tips 286) of the at least two cranial deployment rods (Fig. 4, the defined cranial deployment rods 56) lie in a same plane when in an extended deployed state (Fig. 12, Fig. 20, Fig. 29, the distal tips 286 of the defined cranial deployment rods 56 lie in a same plane when in an extended deployed state; para. [0094]-[0095]). Hauck does not explicitly disclose the pre-shaped distal sections.
Schaller is in the field of drawing tissue portions toward one another (para. [0003]) and teaches a device (Fig. 21, system 150), comprising a pre-shaped distal section (Fig. 23, curved distal end 166) of each deployment rod (Fig. 22, delivery tubes 156).
It would have been obvious to one of ordinary skill in the art before the priority date to modify the device of Hauck to include preshaped delivery tubes as taught by Schaller, the motivation being to facilitate placement of anchors while minimizing complexity of the elongate housing.
Regarding claim 7, modified Hauck discloses the vascular closure assembly of claim 5. Hauck does not explicitly disclose the pre-shaped distal sections of the at least two caudal deployment rods. Regarding wherein the distal sections of the at least two caudal deployment rods lie in respective planes disposed at an angle of about 70 degrees to about 110 degrees to each other, it would have been obvious to one of ordinary skill in the art before the priority date for the distal sections of the at least two caudal deployment rods to lie in respective planes disposed at an angle of about 70 degrees to about 110 degrees to each other, since where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05. The motivation for doing so would have been to facilitate directing of the anchor to a desired tissue location.
Schaller is in the field of drawing tissue portions toward one another (para. [0003]) and teaches a device (Fig. 21, system 150), comprising the pre-shaped distal sections (Fig. 23, curved distal ends 166) of the at least two caudal deployment rods (Fig. 22, delivery tubes 156).
It would have been obvious to one of ordinary skill in the art before the priority date to modify the device of Hauck to include preshaped delivery tubes as taught by Schaller, the motivation being to facilitate placement of anchors while minimizing complexity of the elongate housing.
Regarding claim 10, modified Hauck discloses the vascular closure device of claim 1 Hauck further disclosing wherein the deployment rods (Fig. 29, deployment rod 56) are configured to translate with respect to the elongate housing (Fig. 1, Fig. 29, deployment rods 56 are configured to translated with respect to the elongate housing 22; para. [0070]) but are fixed with respect to rotation about their respective longitudinal axes (Fig. 3, Fig. 29, rods 56 are coupled to anchor deployer actuator 256, and thus are fixed with respect to rotation about their respective longitudinal axes; para. [0092]).
Regarding claim 18, modified Hauck discloses the vascular closure assembly of claim 1. Hauck does not explicitly disclose wherein the pre-shaped distal section of each of the deployment rods includes a smooth continuous curvature.
Schaller is in the field of drawing tissue portions toward one another (para. [0003]) and teaches a device (Fig. 21, system 150), wherein the pre-shaped distal section (Fig. 23, curved distal end 166) of each of the deployment rods (Fig. 22, delivery tubes 156) includes a smooth continuous curvature (Fig. 22, Fig. 23, the curved distal end 166 has a smooth continuous curvature).
It would have been obvious to one of ordinary skill in the art before the priority date to modify the device of Hauck to include preshaped delivery tubes as taught by Schaller, the motivation being to facilitate placement of anchors while minimizing complexity of the elongate housing.
Allowable Subject Matter
Claims 19-30 and 32-34 are allowed.
Claims 8, 9, and 11-13 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.
Claim 31 is objected but would be allowable if rewritten in independent to overcome the claim object stated above.
The following is an examiner’s statement of reasons for allowance on claims 19-22: the prior art fails to teach or render obvious a vascular closure assembly including, inter alia, a plurality of filament retainers disposed proximally of the distal ports of the anchor deployer lumens, each filament retainer being configured to releasably secure a section of a respective filament.
The following is an examiner’s statement of reasons for allowance on claims 23 and 24: the prior art fails to teach or render obvious a vascular closure assembly, comprising, inter alia, a guidewire relief slot which is disposed in the inner lumen through a wall portion thereof, which extends proximally from the distal end of the inner lumen to a proximal end of the guidewire relief slot, and which is configured to accommodate a guidewire extending outwardly from the proximal port of the guidewire lumen of the elongate shaft.
The following is an examiner’s statement of reasons for allowance on claims 25-30: the prior art fails to teach or render obvious a vascular closure assembly, comprising, inter alia, a tensioner which has a first end secured to the chassis, a second end releasably secured to the plunger and which is configured to continuously apply proximally oriented tension to the plunger with respect to the chassis over the retraction length, a platen that is distally translatable with respect to the plunger from a proximal cocked position over a deployment length to a distal position that actuates the trigger latch and releases the plunger allowing proximal translation of the plunger over the retraction length, and a platen latch which is operatively coupled to the chassis with a configuration allowing actuation of the platen latch but preventing distal translation of the platen latch with respect to the chassis, which includes a platen catch that is operatively coupled to the platen releasably securing the platen in the proximal cocked position.
The following is an examiner’s statement of reasons for the allowable subject matter on claim 31: the prior art fails to teach or render obvious a method of actuating an actuator assembly of a vascular closure assembly, comprising, inter alia, translating the platen and deployment rods operatively secured thereto in a distal direction relative to the plunger and chassis under a distal force generated by the released compression spring; actuating a trigger latch which releasably secures the plunger in a distal position with the platen as it translates distally, thereby releasing the plunger from the fixed distal position; translating the plunger, platen and deployment rods secured to the platen in a proximal direction under a proximal force generated by a tensioner which is secured to the chassis and releasably secured to the plunger.
The following is an examiner’s statement of reasons for allowance on claims 32-34: the prior art fails to teach or render obvious a vascular closure assembly, comprising, inter alia, a polymer bushing disposed between the fairlead and the filament lock.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20230310155 A1 Cournane; Stephen et al. discloses a multi-anchor delivery system.
US 6562052 B2 Nobles; Anthony A. et al. discloses a suturing device
US 12508011 B2 Larzon; Thomas et al. discloses a vascular closure device
US 6436088 B1 Frazier; Andrew G. C. et al. discloses a multi-anchor delivery system for closing a tissue opening.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JING RUI OU whose telephone number is (571)270-5036. The examiner can normally be reached M-F 9:00am -5:00pm.
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/JING RUI OU/ Primary Examiner, Art Unit 3771