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 Objections
Claims 1-2, 6, 8, 10-11 and 13 are objected to because of the following informalities:
In claim 1, line 3, the phrase “each of the radial members” should read “each of the plurality of radial members”, to remain consistent in referring to the plurality of members previously introduced.
In claim 1, line 10, the phrase “each of the radial members” should read “each of the plurality of radial members”.
In claim 1, line 11, the phrase “an adjacent radial member” should read “an adjacent radial member of the plurality of radial members”.
In claim 2, line 4, the phrase “an adjacent radial member” should read “an adjacent radial member of the plurality of radial members”.
In claim 6, the phrase “an adjacent radial member” should read “an adjacent radial member of the plurality of radial members”.
In claim 8, the phrase “the radial members” should read “the plurality of radial members”.
In claim 10, the phrase “an adjacent radial member” should read “an adjacent radial member of the plurality of radial members”.
In claim 11, line 3, the phrase “the retaining portion” should read “the respective retaining portion” or similar language.
In claim 13, in the preamble, the phrase “each of the tubular structures” should read “each of the plurality of tubular structures”.
In claim 13, lines 3-4, the phrase “each of the radial members” should read “each of the plurality of radial members”.
In claim 13, line 11, the phrase “each of the radial members” should read “each of the plurality of radial members”.
In claim 13, line 12, the phrase “an adjacent radial member” should read “an adjacent radial member of the plurality of radial members”.
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 § 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 6 and 12-20 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.
Regarding claim 6, the claim recites “the locking projection” in line 1. It is unclear whether the phrase is referring to each of the locking projections previously introduced, at least one locking projection, or a separate locking projection. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to each of the locking projections previously introduced.
Further, the claim recites “the locking arm” in line 3. It is unclear whether the phrase is referring to each of the locking arms previously introduced, at least one locking arm, or a separate locking arm. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to each of the locking arms previously introduced.
Regarding claim 12, the claim recites “wherein each of the locking projections defines a generally U-shape, V-shape, T-shape, or W-shape in cross-section”. The term “generally” is a relative term which renders the claim indefinite. The term “generally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Para. [0084] of the published application describes the locking projection defining a generally U-shape in cross-section, but does not describe what type of geometry is “generally U-shaped”, such that it is unclear what geometries would fall within the definition of a generally U-shape geometry or the other shapes listed. For examination purposes, a U-shape, V-shape, T-shape or W-shape is interpreted as meeting the claimed limitation.
Regarding claim 13, the claim recites “the tubular structure” in lines 14-15. It is unclear whether the phrase is referring to each of the tubular structures previously introduced, at least one tubular structure, or a separate, tubular structure. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to at least one tubular structure previously introduced.
Regarding claim 16, the claim recites “wherein each of the locking projections defines a generally U-shape, V-shape, T-shape, or W-shape in cross-section”. The term “generally” is a relative term which renders the claim indefinite. The term “generally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Para. [0084] of the published application describes the locking projection defining a generally U-shape in cross-section, but does not describe what type of geometry is “generally U-shaped”, such that it is unclear what geometries would fall within the definition of a generally U-shape geometry or the other shapes listed. For examination purposes, a U-shape, V-shape, T-shape or W-shape is interpreted as meeting the claimed limitation.
Claims 14-15 and 17-20 are indefinite due to their dependencies on indefinite base claim 13.
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).
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 plurality of 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 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 an adjacent radial member (fig. 4d);
wherein the plurality of radial members are circumferentially arranged (figs. 4a-e) such that the locking arm of each of the radial members slidably engages a corresponding retaining portion of an adjacent radial member (fig. 4d),
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 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]).
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 (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 define 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 include 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 the locking projection cannot be removed from the corresponding retaining portion of an adjacent radial member without fatally deforming either the 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 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 are 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 (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 include 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 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 generally 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 plurality of tubular structures (considered to encompass sets of turns T1-T3, fig. 4a), each of the tubular structures comprising:
a plurality of 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 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 an adjacent radial member (fig. 4d);
wherein the plurality of radial members are circumferentially arranged (figs. 4a-e) such that the locking arm of each of the radial members slidably engages a corresponding retaining portion of an adjacent radial member (fig. 4d),
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 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]).
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 define 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 generally 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 have 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 have 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 are coupled to an inner surface of the inner tubular member (may be rigidly fixed at end, para. [0043]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2013/0211324 A1 to Voss, disclosing an expandable introducer sheath.
US 8048034 B2 to Eversull, disclosing a sheath.
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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