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
This Office Action is a response to applicant’s arguments and amendment filed 07/17/2026. Claims 1-4, 6, 8-13, 15-16 and 18-20 are amended. Claims 1-20 are currently pending.
The objection of claims 1-2, 6, 8, 10-11 and 13 has been withdrawn due to applicant’s amendment.
The rejection of claims 6 and 12-20 under 35 U.S.C. 112(b) has been withdrawn due to applicant’s amendment; however, see objection of claims 6 and 13 below.
Response to Arguments
Applicant’s arguments, see Remarks, filed 07/17/2026, with respect to the rejection(s) of claim(s) 1-20 under 35 U.S.C. 102(a)(2) as being anticipated by Ness, have been fully considered but are not persuasive. The rejection has been modified, necessitated by applicant’s amendments to the claims.
1) Applicant argues Ness does not disclose turns T1-T3 being individually constructed since each turn is continuous with an adjacent turn (Remarks, pgs. 8-9).
In response to applicant’s first argument, it is respectfully submitted the limitation “individually constructed” is being treated as a product by process limitation as discussed below. The claimed limitation refers to a manufacturing step, and determination of patentability is based on the product itself, as opposed to the process of creating or manufacturing the product. Further, the instant application discloses a plurality of radial members interconnected with each other (figs. 16-17), which is consistent with fig. 4d of Ness, such that Ness is considered to disclose a plurality of elongated, radial members as discussed below.
2) Applicant further argues the turns of the helix in Ness cannot be seen as circumferentially adjacent to the next turn, and are instead longitudinally adjacent (Remarks, pgs. 8-9).
In response to applicant’s second argument, it is respectfully submitted the arguments are narrower than the claim limitation. The term “circumferentially adjacent” refers to structures of or relating to the circumference (see the Merriam-Webster dictionary definition of “circumferentially”), and the claim language does not define any circumference of the device, how the circumference extends, or specify structures extending along the same circumference. The helical coil of Ness is considered to extend in a circumferential direction due to the nature of a coil, such that each turn of the coil is considered to circumferentially extend adjacent to the next turn of the coil as discussed below.
3) Applicant further argues the longitudinal axis of the recess 118A is approximately perpendicular to the longitudinal axis of the Ness sheath, which is distinct from the claims reciting the channel longitudinal axis extending approximately parallel to the sheath longitudinal axis (Remarks, pgs. 8-9).
In response to applicant’s third argument, it is respectfully submitted the arguments are narrower than the claim limitations. The term “longitudinal axis” is not limited to an axis extending along the longest portion of the central channel or the portion oriented similarly to the sheath longitudinal axis. The central channel extends in a longitudinal direction as depicted in annotated fig. 4d below, such that the central channel is considered to have a longitudinal axis along the depicted longitudinal direction. Further, the instant spec. does not describe the longitudinal axis of the central channel extending parallel to the longitudinal axis of the sheath, such that under broadest reasonable interpretation, the longitudinal axis of the central channel can encompass other extension directions besides exactly parallel. Accordingly, the claims remain rejected.
Claim Objections
Claims 6 and 13 are objected to because of the following informalities:
In claim 6, lines 1-2, the phrase “each locking projection” should read “each of the locking projections” or similar language.
In claim 13, lines 18-20, the phrase “an individual tubular structure… the individual tubular structure” should read “an individual tubular structure of the plurality of tubular structures…” or similar language.
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: “coupling member” in claim 14.
Para. [0010] of the published application describes the “coupling member” as a wire, a braided cable, and a polymer suture. “Coupling member” uses the generic placeholder “member” coupled with the term “coupling”, which is functional in that the limitation alternatively recites a member for coupling, and the term “member” is not preceded by a structural modifier since the term “coupling” does not imply any structure.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ness (US 2018/0318077 A1) (all references previously of record).
Regarding claim 1, Ness discloses (see abstract; paras. [0030]-[0096]; figs. 1-8c) an expandable sheath (figs. 1 and 4a-e) for delivering a prosthetic device (para. [0002]) comprising:
a sheath longitudinal axis (longitudinal axis of sheath 110a LA) extending between a proximal region and a distal region of the expandable sheath (para. [0042]); and
a plurality of individually constructed (note the limitation “individually constructed” is treated as a product by process limitation, in which determination of patentability is based on the product itself; since Ness discloses a plurality of elongated radial members, the limitation is considered to be met, see MPEP 2113), elongated radial members (includes three turns T1-T3, para. [0044]; fig. 4d) slidably interconnected to form a tubular structure (slidably interconnected via recesses 118a, forms sheath 110a, para. [0042]; fig. 4a), each of the plurality of radial members including:
a locking arm (portion of 115a including aperture 116a) including a locking projection (117a) extending from an end of the locking arm (fig. 4e); and
a retaining portion (portion of 115a including prongs, fig. 4e) having a central channel (118a) sized and configured to accommodate sliding engagement of a locking arm and locking projection of a circumferentially adjacent radial member (fig. 4d, turns T1-T3 considered to be circumferentially adjacent to each other, as each turn of the coil includes a circumference and the turns of each coil are adjacent to each other), the central channel comprising a channel longitudinal axis (annotated fig. 4d) that extends approximately parallel to the sheath longitudinal axis (annotated fig. 4d depicts the channel longitudinal axis approximately parallel to the sheath longitudinal axis);
wherein the plurality of radial members are circumferentially arranged (figs. 4a-e) such that the locking arm of each of the plurality of radial members slidably engages a corresponding retaining portion of a circumferentially adjacent radial member of the plurality of radial members (fig. 4d); and
wherein the plurality of radial members moves between a non-expanded and expanded state (via use of pull-wire which increases or decreases diameter of coil, see fig. 4d depicting flanges on edge of prongs, para. [0044]), where a circumference of the tubular structure formed by the plurality of radial members in the expanded state is greater than a circumference of the tubular structure in the non-expanded state (when diameter of coil increases or decreases, abstract, para. [0044]).
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Figure 4D of Ness
Regarding claim 2, Ness discloses the expandable sheath of claim 1. Ness further discloses wherein movement of the plurality of radial members between the non-expanded and expanded state causes the locking arms of each of the plurality of elongated radial members to move circumferentially within the central channel of the retaining portion of an adjacent radial member of the plurality of radial members (when diameter of coil increases or decreases, considered to move flange along prongs, para. [0044]; figs. 4d-e).
Regarding claim 3, Ness discloses the expandable sheath of claim 1. Ness further discloses wherein each of the plurality of radial members defines an arcuate shape in cross-section (figs. 4d-e).
Regarding claim 4, Ness discloses the expandable sheath of claim 1. Ness further discloses wherein each of the retaining portions includes an entrance opening (opening of recess 118a) having an engagement member (annotated fig. 4e) sized and configured to retain the locking projection of an adjacent radial member (figs. 4d-e).
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Annotated Figure 4E of Ness
Regarding claim 5, Ness discloses the expandable sheath of claim 4. Ness further discloses wherein the engagement member of each of the retaining portions extends in a direction towards the central channel of the respective retaining portion (depicted in fig. 4e).
Regarding claim 6, Ness discloses the expandable sheath of claim 1. Ness further discloses wherein each locking projection cannot be removed from the corresponding retaining portion of an adjacent radial member of the plurality of radial members without fatally deforming either the corresponding locking arm or the corresponding retaining portion (considered to be prevented from removal once placed within recess 118a corresponding to the shape of the flange, fig. 4e).
Regarding claim 7, Ness discloses the expandable sheath of claim 1. Ness further discloses wherein an expandable inner tubular member (expandable outer layer 112a, para. [0042]; fig. 4a) extends over the plurality of radial members (fig. 4a), wherein an elastic outer member (covering sheath, para. [0045]) extends over the inner tubular member (para. [0045]), and when the inner tubular member is in an expanded configuration, the elastic outer member urges the inner tubular member toward a non-expanded configuration (keeps coil in reduced diameter configuration, para. [0045]).
Regarding claim 8, Ness discloses the expandable sheath of claim 7. Ness further discloses wherein a length of the plurality of radial members corresponds to a length of the inner tubular member (layer 112a covers coil, considered to include a length that corresponds to length of turns of coil, para. [0042]; fig. 4a).
Regarding claim 9, Ness discloses the expandable sheath of claim 7. Ness further discloses wherein the plurality of radial members is coupled to an inner surface of the inner tubular member (may be rigidly fixed at end, para. [0043]).
Regarding claim 10, Ness discloses the expandable sheath of claim 1. Ness further discloses wherein each of the locking arms can slide axially within the channel of an adjacent radial member of the plurality of radial members (considered to be capable of sliding along prongs, figs. 4d-e).
Regarding claim 11, Ness discloses the expandable sheath of claim 1. Ness further discloses wherein each of the retaining portions includes an entrance opening (opening of recess 118a) sized and configured to permit a respective one of the locking arms to be circumferentially introduced through the opening into the respective retaining portion (figs. 4d-e).
Regarding claim 12, Ness discloses the expandable sheath of claim 1. Ness further discloses wherein each of the locking projections defines a U-shape (fig. 4e) in cross-section.
Regarding claim 13, Ness discloses (see abstract; paras. [0030]-[0096]; figs. 1-8c) an expandable sheath (figs. 1 and 4a-e) for delivering a prosthetic device (para. [0002]) comprising a sheath longitudinal axis (longitudinal axis of sheath 110a LA) extending between a proximal region and a distal region of the expandable sheath (para. [0042]) and a plurality of tubular structures (considered to encompass sets of turns T1-T3, fig. 4a), each of the plurality of tubular structures comprising:
a plurality of individually constructed (note the limitation “individually constructed” is treated as a product by process limitation, in which determination of patentability is based on the product itself; since Ness discloses a plurality of elongated radial members, the limitation is considered to be met, see MPEP 2113), elongated radial members (includes three turns T1-T3, para. [0044]; fig. 4d) slidably interconnected (via recesses 118a, para. [0042]; figs. 4a-e), each of the plurality of radial members including:
a locking arm (portion of 115a including aperture 116a) including a locking projection (117a) extending from an end of the locking arm (fig. 4e); and
a retaining portion (portion of 115a including prongs, fig. 4e) having a central channel (118a) sized and configured to accommodate sliding engagement of a locking arm and locking projection of a circumferentially adjacent radial member (fig. 4d, turns T1-T3 considered to be circumferentially adjacent to each other, as each turn of the coil includes a circumference and the turns of each coil are adjacent to each other), the central channel comprising a channel longitudinal axis (annotated fig. 4d) that extends approximately parallel to the sheath longitudinal axis (annotated fig. 4d depicts the channel longitudinal axis approximately parallel to the sheath longitudinal axis);
wherein the plurality of radial members are circumferentially arranged (figs. 4a-e) such that the locking arm of each of the plurality of radial members slidably engages a corresponding retaining portion of a circumferentially adjacent radial member of the plurality of radial members (fig. 4d); and
wherein the plurality of radial members move between a non-expanded and expanded state (via use of pull-wire which increases or decreases diameter of coil, see fig. 4d depicting flanges on edge of prongs, para. [0044]), where a circumference of an individual tubular structure formed by the plurality of radial members in the expanded state is greater than a circumference of the individual tubular structure in the non-expanded state (when diameter of coil increases or decreases, abstract, para. [0044]).
Regarding claim 14, Ness discloses the expandable sheath of claim 13. Ness further discloses wherein each of the plurality of tubular structures is coupled to another of the plurality of tubular structures via a coupling member (pull-wire, para. [0044]) extending longitudinally through each of the plurality of tubular structures (para. [0044]).
Regarding claim 15, Ness discloses the expandable sheath of claim 13. Ness further discloses wherein each of the plurality of radial members defines an arcuate shape in cross-section (figs. 4d-e).
Regarding claim 16, Ness discloses the expandable sheath of claim 13. Ness further discloses wherein each of the locking projections defines a U-shape (fig. 4e) in cross-section.
Regarding claim 17, Ness discloses the expandable sheath of claim 13. Ness further discloses wherein an expandable inner tubular member (expandable outer layer 112a, para. [0042]; fig. 4a) extends over the plurality of tubular structures (fig. 4a), wherein an elastic outer member (covering sheath, para. [0045]) extends over the inner tubular member (para. [0045]), and when the inner tubular member is in an expanded configuration, the elastic outer member urges the inner tubular member toward a non-expanded configuration (keeps coil in reduced diameter configuration, para. [0045]).
Regarding claim 18, Ness discloses the expandable sheath of claim 17. Ness further discloses wherein each of the plurality of tubular structures has a consistent length and spacing along a length of the inner tubular member (depicted in fig. 4a).
Regarding claim 19, Ness discloses the expandable sheath of claim 17. Ness further discloses wherein each of the plurality of tubular structures has a varying length and spacing along a length of the inner tubular member (considered to have varying spacing when first end of coil is wound or unwound, para. [0043]).
Regarding claim 20, Ness discloses the expandable sheath of claim 17. Ness further discloses wherein each of the plurality of tubular structures is coupled to an inner surface of the inner tubular member (may be rigidly fixed at end, para. [0043]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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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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/BRIGID K BYRD/Examiner, Art Unit 3771
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