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/Restrictions
Applicant’s election of Species F, Subspecies vii in the reply filed on April 2, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 2, 11, 13, 18, 22, 24, and 27-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species and Subspecies, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 2, 2026. The Examiner has further withdrawn claim 13 as this is drawn to non-elected Fig. 1C and claim 22, 24, and 27 as this is drawn to non-elected Fig. 2A.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “34” has been used to designate both a rotatable portion and internal surface. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 247, 239, and 200. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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 informalities:
[0056] 3D should be 3H
[0122] “form 246” should be “fork 246”
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: “an axial position of repositioning sheath” should be “an axial position of the repositioning sheath.” 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 36-41 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 36 recites “an introducer hub” in line 4, it is not clear if this is the same or a different introducer hub than is introduced in the preamble.
Claim 39 recites “an introducer hub” in line 3, “a medical device” in line 4, and a repositioning sheath in line 6. It is not clear if these are the same or different components than are introduced in the preamble.
Claim 41 recites “a medical device in line” 10, it is not clear if this is the same or a different device than recited in the claim 29 from which it depends.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Verma (US 2021/0370038 A1).
With regard to claims 1 and 10, Verma teaches a positioning device comprising: a first coupler configured to be removably coupled to a proximal end of an introducer hub (Fig. 3 member 102 connects at threads 302); and a second coupler (Fig. 3 117) configured to be removably coupled to a portion of a repositioning sheath or catheter that is proximal to the first coupler (Fig. 3 sheath 110 extends proximally of the distal end of 117), the first coupler being attached to the second coupler (Figs. 1 and 3, component are attached via at least 110, 108, and 107); wherein the positioning device is configured to maintain an axial position of repositioning sheath or catheter relative to the introducer hub (when components are connection the position is maintained).
Claim(s) 31-34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fischell et al. (US 5,389,090).
With regard to claim 31, Fischell et al. teach a positioning device comprising: a first coupler having a housing (Fig. 1 member 22) and a means for locking the first coupler to an introducer sheath (Fig. 4 22 is locked to 11 via threads, Col. 3 lines 37-39); and a second coupler connected to the first coupler, the second coupler configured to receive a tubular member (Fig. 1 member 21).
With regard to claims 32 and 33, see the alignment tabs/indicia 27 and 28 which confirm when the components are locked (Fig. 1).
With regard to claim 34, as the components rotate, they are pivotably attached.
Claim(s) 36-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bjorkman et al. (US 2004/0254534 A1).
With regard to claim 36, Bjorkman et al. teach a positioning device configured for adjustable positioning of a medical device, repositioning sheath, catheter, or combination thereof, relative to an introducer hub, comprising: a first coupler configured to be removably coupled to a proximal end of an introducer hub (Figs. 12-14 portion including 1184 and extending to 1198); a second coupler configured to slidably receive the medical device, repositioning sheath, catheter, or combination thereof (exemplary Fig. 2, portion not shown in Figs. 12-14, coupler includes at least 8 and 14); and a hinged section configured to allow an adjustable locking portion to rotate around the hinged section relative to the first coupler (Figs. 12-14 hinged section 1198 allows locking portions 1196a/b to rotate relative to the coupler).
With regard to claim 37, insertion is only allowed via the second coupler when the components are connected/locked.
With regard to claim 38 locked in Fig. 12 unlocked in Fig. 13.
With regard to claims 39 and 40, Bjorkman et al. teach a positioning device configured for adjustable positioning of a medical device, repositioning sheath, or both, relative to an introducer hub, comprising: a first coupler configured to be removably coupled to a proximal end of an introducer hub, the first coupler configured to slidably receive a medical device and allow the medical device to enter into the introducer hub Figs. 12-14 portion including 1184 and extending to 1198); a second coupler (exemplary Fig. 2, portion not shown in Figs. 12-14, coupler includes at least 8 and 14) configured to slidably receive a portion of a repositioning sheath and/or catheter device (Fig. 12 receives 1114); and a flexible hinge connecting the first and second couplers (Fig. 1 member 138 connected between the couplers and connecting them in conjunction with additional intervening components), the flexible hinge configured to allow the medical device to be slidably received through the flexible hinge (Figs. 12-14 hinged section 1198, locking portions 1196a/b).
Claim(s) 39 and 41 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Agrawal et al. (US 2018/0256873 A1).
With regard to claim 39, Agrawal et al. teach a positioning device configured for adjustable positioning of a medical device, repositioning sheath, or both, relative to an introducer hub, comprising: a first coupler configured to be removably coupled to a proximal end of an introducer hub, the first coupler configured to slidably receive a medical device and allow the medical device to enter into the introducer hub (Fig. 3 member 16); a second coupler (Fig. 3 member 44) configured to slidably receive a portion of a repositioning sheath and/or catheter device (Fig, 3 member 12); and a flexible hinge connecting the first and second couplers (Fig. 1 member 138 connected between the couplers and connecting them in conjunction with additional intervening components), the flexible hinge configured to allow the medical device to be slidably received through the flexible hinge (Figs. 3 and 4 hinge is portion between portion of 24 which rotates in response to 26 and the portion held by 20, exemplary Fig. 6 at 166).
With regard to claim 41, outer housing portion of 24 held in 20 (exemplary Fig. 6 at 150), joint portion of 24 which rotates (exemplary Fig. 6 148), the device is inserted through the outer housing and space in the joint (Figs. 3 and 4, exemplary Fig. 6 shows definition between the housing and joint portions).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Stevens et al. (US 6,572,580) which has a hinged portion.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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