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/Restriction
Applicant’s election without traverse of Invention I, Species B, corresponding to claims 1-3, 5, 7-10, and 17-20 in the reply filed on 02/04/2026 is acknowledged.
Claims 4, 6 and 11-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/04/2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “44”, in Fig.4, has been used to designate both an atraumatic tip and one or more securement features. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following reference informalities:
Paragraph [0050], “atraumatic tip 44” in lines 2 and 3, uses the same character as the one or more securement features.
Paragraph [0052], “one or more securement features 44” in lines 4, 6, 8 and 10, uses the same character as the atraumatic tip.
Paragraph [0053], “one or more securement features 44” in line 1, uses the same character as the atraumatic tip.
Paragraph [0054], “one or more securement features 44” in line 6, uses the same character as the atraumatic tip.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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: “securement features” in claim 3, line 2.
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. For purposes of examination, “securement features” will be interpreted as bumps or tabs.
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.
Claims 1-3, 5, 7-8 and 17-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Goldberg et al. (US Pub No. 20190307589 A1, herein, Goldberg).
Regarding claim 1, Goldberg discloses an introducer sheath assembly, comprising:
an expandable introducer sheath (100 – Fig.13) including an expandable braid (104 – Fig.4)(Figure 4 is cited to illustrate the introducer sheath in greater detail, including the expandable braid) moveable between a collapsed configuration for delivery (Fig.13, Para [0103]) and an expanded configuration for deployment (Fig.15, Para [0104]), the expandable braid having a first length when in the collapsed configuration and a second, reduced, length when in the expanded configuration (Para [0080], Para [0082]); and
The limitation, “a dilator (300 – Fig.13) adapted to releasably hold the expandable introducer sheath in its collapsed configuration for delivery until the dilator is actuated to release the expandable braid from the dilator, thereby permitting the expandable braid to expand to its expanded configuration” is interpreted to be a functional limitation (the introducer sheath assembly of Goldberg is capable of performing these functions since the assembly comprises all the elements provided above and also a retaining member “the vessel dilator can be advanced distally through the sheath until the retaining member (306 – Fig.11) is removed from over the distal end portion of the sheath.” – Para [0104]).
Examiner note: Goldberg teaches that the delivery apparatus is exemplary only, and can be used in combination with any of the expandable sheath embodiments described therein (Para [0066]), Accordingly, the dilator disclosed in Figs. 11-18 is properly considered in combination with the expandable sheath embodiment shown in Fig.4.
Regarding claim 2, Goldberg discloses the introducer sheath assembly as recited above, further comprising an adhesive band (306 – Fig.11, “adhesive bonds” – Para [0105]) disposed on the dilator (300 – Fig.11), the adhesive band adapted to engage the expandable introducer sheath (100 – Fig.11) until axial movement of the dilator relative to the expandable introducer sheath causes the adhesive band to disengage the expandable introducer sheath (“the vessel dilator can be advanced distally through the sheath until the retaining member is removed from over the distal end portion of the sheath.” – Para [0104]).
Regarding claim 3, Goldberg discloses the introducer sheath assembly as recited above, wherein:
the dilator (300 – Fig.11) further comprises one or more securement features (306 – Fig.11); and
the expandable braid (104 – Fig.4)(“The braided layer an extend along substantially the entire length L of the sheath” – Para [0076]) further comprises one or more securement elements (140 – Fig.11) adapted to releasably engage the one or more securement features (Para [0103]); and
the one or more securement elements are adapted to disengage with the one or more securement features in response to axial movement of the dilator relative to the expandable introducer sheath (“the vessel dilator can be advanced distally through the sheath until the retaining member is removed from over the distal end portion of the sheath.” – Para [0104]).
Regarding claim 5, Goldberg discloses the introducer sheath assembly as recited above, wherein the one or more securement features comprise one or more tabs (Shown at 306 – Fig.11) disposed on an outer surface of the dilator (Fig.11).
Regarding claim 7, Goldberg discloses the introducer sheath assembly as recited above, wherein the expandable braid (104 – Fig.8) comprises a Nitinol braid (“Nitinol” – Para [0076]).
Regarding claim 8, Goldberg discloses the introducer sheath assembly as recited above, wherein the expandable introducer sheath (100 – Fig.4) further comprises a polymeric covering (108 – Fig.4, “outer layer can comprise a polymeric material” – Para [0073]) disposed relative to the expandable braid (104 – Fig.4).
Regarding claim 17, Goldberg discloses a medical device, comprising:
an expandable braid (104 – Fig.4) biased into an expanded configuration for deployment (“as the angle θ increases, the braided layer can foreshorten” – Para [0080], Fig.15) wherein elongating the expandable braid causes the expandable braid to move into an elongated configuration in which the expandable braid is longer and narrower than when in its expanded configuration (“as the angle θ decreases, the braided layer can lengthen” – Para [0080], Fig.13); and
the limitation, “a dilator (300 – Fig.11) adapted to releasably hold the expandable braid in its elongated configuration” is interpreted to be a functional limitation (the introducer sheath assembly of Goldberg is capable of performing these functions since the assembly comprises all the elements provided above, also disclosing “the vessel dilator can be advanced distally through the sheath until the retaining member is removed from over the distal end portion of the sheath.” – Para [0104]).
Regarding claim 18, Goldberg discloses an medical device as recited above, further comprising an adhesive band (306 – Fig.11, “adhesive bonds” – Para [0105]) disposed on the dilator (300 – Fig.11), the limitation, “the adhesive band adapted to engage the expandable braid until axial movement of the dilator relative to the expandable braid causes the adhesive band to disengage the expandable braid” is interpreted to be a functional limitation (the introducer sheath assembly of Goldberg is capable of performing these functions since the assembly comprises all the elements provided above, also disclosing, “the vessel dilator can be advanced distally through the sheath until the retaining member is removed from over the distal end portion of the sheath.” – Para [0104]).
Regarding claim 19, Goldberg discloses a medical device as recited above, wherein:
the dilator (300 – Fig.11) further comprises one or more securement features (306 – Fig.11); and
the expandable braid (104 – Fig.4)(“The braided layer an extend along substantially the entire length L of the sheath” – Para [0076]) further comprises one or more securement elements (140 – Fig.11) adapted to releasably engage the one or more securement features (Para [0103]); and
the one or more securement elements are adapted to disengage with the one or more securement features in response to axial movement of the dilator relative to the expandable braid (“the vessel dilator can be advanced distally through the sheath until the retaining member is removed from over the distal end portion of the sheath.” – Para [0104]).
Regarding claim 20, Goldberg discloses a medical device as recited above, wherein the medical device further comprises a polymeric covering (108 – Fig.4, “outer layer can comprise a polymeric material” – Para [0073]) extending over the expandable braid (104 – Fig.4) extending over the expandable braid (104 – Fig.4).
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 9 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Goldberg in view of Nentwick (US Pub No. 20110245665 A1).
Regarding claim 9, Goldberg discloses the introducer sheath assembly as recited above, comprising a polymeric covering (108 – Fig.4, “outer layer can comprise a polymeric material” – Para [0073]) but Goldberg does not expressly disclose wherein the polymeric covering comprises a spray coated polyurethane or a spray coated silicone.
Nentwick teaches a covering (7 – Fig.2A) comprising a spray coated polyurethane or a spray coated silicone (“can be coated with silicone spray.” – Para [0114]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the polymeric covering as disclosed by Goldberg to comprise a spray coated silicone as taught by Nentwick since spray coated silicone provides additional lubrication before the device is inserted into the body of a patient in order to facilitate better insertion and advancement (Nentwick, Para [0114]).
Claim 10 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Goldberg in view of Ginn et al. (US Pub No. 20190183525 A9, herein, Ginn).
Regarding claim 10, Goldberg discloses the introducer sheath assembly as recited above, but Goldberg does not expressly disclose the assembly further comprising one or more radiopaque markers secured relative to the expandable braid.
Ginn teaches an introducer sheath assembly comprising one or more radiopaque markers (326 – Fig.18A) secured relative to an expandable braid (Fig.18A, Para [0061]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the introducer sheath assembly disclosed by Goldberg to comprise one or more radiopaque markers secured relative to the expandable braid as taught by Ginn since Ginn teaches radiopaque markers provide improved visibility under fluoroscopy or other similar techniques (Ginn, Para [0060]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marissa Taylor whose telephone number is (571)272-3542. The examiner can normally be reached Monday-Thursday 6:30am-3:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARISSA TAYLOR/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783