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 responsive to the preliminary amendment filed on 10/20/2022. As directed by the amendment: no claims have been amended, no claims have been added, claims 1,3, and 23-25 have been canceled. Thus claims 2 and 4-22 are presently pending in this application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on April 4, 2023 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
Figures 1A-2B should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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: Figures 1A-2B are not mention in the Brief Description of the Drawings. All figures, even those which illustrate Prior Art, need to be mentioned in the Brief Description of the Drawings.
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: dilator-receiver mover in claims 2 and 4, lock mechanism in claim 20, and lock device in claim 22.
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. In regards to claims 2 and 4, the dilator-receiver mover is given the broadest reasonable interpretation of “"a position-control device, a translation assembly, a gear assembly” and equivalents thereof (see specification [0031]). In regards to claim 20, the lock mechanism is given the broadest reasonable interpretation of “any suitable lock” or “latch” and equivalents thereof (see specification [0051]). In regards to claim 22, the lock device is given the broadest reasonable interpretation of “snap-fit connector, press-fit connector, any type of locking device, etc.” and equivalents thereof (see specification [0051]).
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(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 7 only includes the limitation “the dilator-receiver mover is configured to operatively connect to the dilator-receiver device”, which is equivalent in scope to the limitation “dilator-receiver mover configured to be operatively connected to the dilator-receiver device” of claim 4, which claim 7 depends from. Therefore, claim 7 does not further limit the subject matter of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(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 2 and 4-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Drontle et al. (US 20130030458), hereinafter Drontle.
Regarding claim 2, Drontle discloses a kit (Fig. 1, catheter assembly 10), comprising: an elongated dilator assembly (Fig. 1, dilator shaft 30 with dilating balloon 36); and an elongated sheath assembly (Fig. 1, advancement apparatus of dilation catheter 10) configured to receive, at least in part, the elongated dilator assembly (Fig. 1-2, catheter 10 is configured to receive shaft 30); and a dilator-receiver device (Fig. 2B, support member 40, which receives shaft 30) configured to be mounted, at least in part, to the elongated sheath assembly (Fig. 2B, support member 40 mounted in handle 12 of catheter 10); and
a dilator-receiver mover (Fig. 2B and [0031], advancer knob 32, which moves shaft 30) configured to be operatively connected to the dilator-receiver device (Fig. 2A-3B and [0034], advancer knob 32 is operably coupled to support member 40), and the dilator-receiver mover also configured to selectively move the dilator-receiver device along a predetermined distance (Fig. 2A-3B and [0033-0034], advancer knob is configured to move support member 40 a predetermined distance, as defined a stop on the slot 42 through which knob 32 travels).
Regarding claim 4, Drontle discloses apparatus for an elongated sheath assembly (Fig. 1, advancement apparatus of dilation catheter 10) configured to receive, at least in part, an elongated dilator assembly (Fig. 1-2, catheter 10 is configured to receive shaft 30 with dilating balloon 36), and the apparatus comprising: a dilator-receiver device (Fig. 2B, support member 40, which receives shaft 30) mounted, at least in part, to the elongated sheath assembly (Fig. 2B, support member 40 mounted in handle 12 of catheter 10); and a dilator-receiver mover (Fig. 2B and [0031], advancer knob 32, which moves shaft 30) configured to be operatively connected to the dilator-receiver device (Fig. 2A-3B and [0034], advancer knob 32 is operably coupled to support member 40), and the dilator-receiver mover also configured to selectively move the dilator-receiver device along a predetermined distance (Fig. 2A-3B and [0033-0034], advancer knob is configured to move support member 40 a predetermined distance, as defined a stop on the slot 42 through which knob 32 travels).
Regarding claim 5, Drontle discloses the apparatus of claim 4, wherein: the dilator-receiver mover is mounted to the elongated sheath assembly (Fig. 2A-3B and [0033], advancer knob 32 is slidably mounted in slot 42 of catheter 10).
Regarding claim 6, Drontle discloses the apparatus of claim 4, wherein: the dilator-receiver device is configured to selectively receive and support, at least in part, the elongated dilator assembly after the elongated sheath assembly, in use, receives, at least in part, the elongated dilator assembly (Fig. 2B, support member 40 receives and supports a portion of shaft 30 after the catheter 10 receives a portion of shaft 30).
Regarding claim 7, Drontle discloses the apparatus of claim 4, wherein: the dilator-receiver mover is configured to operatively connect to the dilator-receiver device (Fig. 2A-3B and [0034], advancer knob 32 is operably coupled to support member 40).
Regarding claim 8, Drontle discloses the apparatus of claim 4, wherein: the dilator-receiver mover is configured to selectively move, at least in part, the dilator- receiver device and the elongated dilator assembly after the elongated dilator assembly is received, at least in part, by the dilator-receiver device (Fig. 2A-3B and [0031-0034], advancer knob 32 is configured to move support member 40 and shaft 30 after the catheter 10 receives a portion of shaft 30).
Regarding claim 9, Drontle discloses the apparatus of claim 4, wherein: the elongated sheath assembly is configured to receive, at least in part, the elongated dilator assembly along, at least in part, a length of the elongated sheath assembly (Fig. 2B, catheter 10 receives a portion of shaft 30 along the length of the catheter 10).
Regarding claim 10, Drontle discloses the apparatus of claim 4, wherein: the elongated sheath assembly defines an exit portal (Fig. 1 and 2A, exit portal at distal end 26 of catheter 10); and the elongated sheath assembly includes: a sheath hub (Annotated Fig. 4, proximal open end of support member 40 defines sheath hub, as it leads/directs a portion of shaft 30 into the extension portion of catheter 10) configured to be received, at least in part, into a hub cavity defined by the elongated sheath assembly (Annotated Fig. 4, sheath hub is received within a hub cavity defined by catheter 10); and the sheath hub also configured to be moveable, at least in part, along the hub cavity (Fig. 2A-3B and Annotated Fig. 4 and [0033-0034], support member 40 is moveable (and shown in its distal most position in Annotated Fig. 4), therefore the sheath hub is moveable within hub cavity); and the sheath hub also configured to abut, at least in part, a dilator hub of the elongated dilator assembly after the dilator hub is positioned to abut, at least in part, the sheath hub (Annotated Fig. 4, sheath hub abuts the dilator hub, defined by helical portion 52 of shaft 30, which is positioned against the sheath hub at its distal end).
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Annotated Fig. 4 of Drontle
Regarding claim 11, Drontle discloses the apparatus of claim 4, wherein: the elongated sheath assembly includes: a first end section (Fig. 4, proximal end section 24) defining an entrance portal leading to a hub cavity (Annotated Fig. 4, proximal end 24 has openings (with ports 22 and 38) which defines an entrance to the hub cavity); and a second end section (Fig. 1 and 2A, distal end section 26) defining an exit portal (Fig. 1 and 2A, exit portal at distal end 26 of catheter 10); and a sheath hub (Annotated Fig. 4, proximal open end of support member 40 defines sheath hub, as it leads/directs a portion of shaft 30 into the extension portion of catheter 10) configured to be received, at least in part, into the entrance portal and the hub cavity of the first end section(Annotated Fig. 4, sheath hub is received through proximal opening and positioned within a hub cavity defined by catheter 10); and the sheath hub also configured to be moveable, at least in part, along the hub cavity after the sheath hub is received, at least in part, in the hub cavity (Fig. 2A-3B and Annotated Fig. 4 and [0033-0034], support member 40 is moveable (and shown in its distal most position in Annotated Fig. 4), therefore the sheath hub is moveable within hub cavity); and the sheath hub also configured to abut, at least in part, a dilator hub of the elongated dilator assembly after the dilator hub is positioned to abut, at least in part, the sheath hub (Annotated Fig. 4, sheath hub abuts the dilator hub, defined by helical portion 52 of shaft 30, which is positioned against the sheath hub at its distal end).
Regarding claim 12, Drontle discloses the apparatus of claim 11, wherein: the dilator-receiver mover is positioned proximate to the sheath hub of the elongated sheath assembly (Fig. 2A-3B and [0034], advancer knob 32 is positioned proximate to and operably coupled to support member 40, and therefore to the sheath hub as well); and the dilator-receiver mover is configured to selectively move, at least in part, the sheath hub and the dilator hub between the first end section and the second end section after the sheath hub, in use, abuts, at least in part, the dilator hub (Fig. 2A-3B and [0031-0034; 0052], advancer knob 32 is configured to move support member 40/sheath hub and the shaft 30/its dilator hub along the length of catheter 10, between the proximal end 24 and distal end 26, wherein the sheath hub and the dilator hub abut).
Regarding claim 13, Drontle discloses the apparatus of claim 12, wherein: the elongated sheath assembly also includes: a sheath-handle assembly (Fig. 1, handle 12 of catheter 10) having a stationary shaft (Fig. 1, 2A-3B and Annotated Fig. 4, stationary shaft portion of handle 12 wherein the internal cavity is reduced to small lumen and slot 42 extends along) defining a shaft lumen (Fig. 2B and 3B, stationary shaft portion defines an internal lumen wherein support member 40 is disposed); and the stationary shaft fixedly extending from the sheath-handle assembly (Figs. 1-3 and Annotated Fig. 4, stationary shaft portion of handle fixedly extends distally from the rest of the handle 12).
Regarding claim 14, Drontle discloses the apparatus of claim 13, wherein: the sheath hub is configured to be movably supported by the sheath-handle assembly (Fig. 2A-3B and Annotated Fig. 4 and [0033-0034], support member 40/sheath hub is moveably supported by the handle 12).
Regarding claim 15, Drontle discloses the apparatus of claim 13, wherein: the dilator-receiver device is configured to selectively receive and support, at least in part, a dilator shaft and the dilator hub of the elongated dilator assembly (Fig. 2B and Annotated Fig. 4, support member 40 receives and supports a portion of shaft 30 and the distal most end of the helical section 52/dilator hub).
Regarding claim 16, Drontle discloses the apparatus of claim 13, wherein: the hub cavity is in fluid communication with the shaft lumen of the stationary shaft (Annotated Fig. 4, hub cavity is in fluid communication with lumen of the stationary shaft portion of handle 12).
Regarding claim 17, Drontle discloses the apparatus of claim 13, wherein: the shaft lumen, of the stationary shaft, is configured to receive a dilator shaft of the elongated dilator assembly (Fig. 2B, 3B and Annotated Fig. 4, lumen of stationary shaft portion is configured to receive the shaft 30).
Regarding claim 18, Drontle discloses the apparatus of claim 4, wherein: the dilator-receiver device includes a moveable shaft (Fig. 2A-3B and [0033-0034], support member 40 is a moveable shaft).
Regarding claim 19, Drontle discloses the apparatus of claim 4, wherein: the dilator-receiver mover is configured to selectively move the dilator-receiver device from a first predetermined distance to a second predetermined distance (Fig. 2A-3B and [0033-0034], the advancer knob is configured to move support member 40 from a first predetermined distance (as seen in positioning of support member 40 in Figs. 2A-B) to a second predetermined distance (as seen in positioning of support member 40 in Figs. 3A-B)) in such a way that the elongated dilator assembly is also moveable from the first predetermined distance to the second predetermined distance (Fig. 2A-3B and [0032-0034], the support member 4 is secured to a portion of shaft 30, therefore the shaft is also moved from a first predetermined distance (as seen in positioning of shaft 30 in Figs. 2A-B) to a second predetermined distance (as seen in positioning of shaft 30 in Figs. 3A-B)).
Claim Rejections - 35 USC § 103
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.
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Drontle (US 20130030458), in view of Matlock et al. (US 20180311472), hereinafter Matlock.
Regarding claim 20, Drontle discloses the apparatus of claim 4.
Drontle fails to disclose wherein: the dilator-receiver mover includes: a gear assembly including: an input gear; and an output gear configured to mesh with the input gear; and wherein: the input gear is moveable along a rotation direction; and the output gear is moveable along a reciprocation path; and the input gear is operatively mounted to a sheath-handle assembly of the elongated sheath assembly; and the output gear is fixedly mounted to the dilator-receiver device. However, Matlock discloses wherein: the dilator-receiver mover includes: a gear assembly (Fig. 22, articulation assembly 340) including: an input gear (Fig. 22, rotary wheel 342 with pinions 344); and an output gear configured to mesh with the input gear (Fig. 33, racks 352 which mesh with pinions 244); and wherein: the input gear is moveable along a rotation direction (Fig. 23B, pinions 344 rotate); and the output gear is moveable along a reciprocation path (Fig. 23B, racks 352 move along linear reciprocation path); and the input gear is operatively mounted to a sheath-handle assembly of the elongated sheath assembly (Fig. 21-22, wheel 342 and pinions 244 are mounted to handle 314/302); and the output gear is fixedly mounted to the dilator-receiver device (Fig 23A-B, racks 352 are mounted translating member 350/shaft 114 (equivalent to support member of Drontle)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Drontle to incorporate the disclosures of Matlock and modify the dilator receiver mover to be a gear assembly including: an input gear; and an output gear configured to mesh with the input gear; and wherein: the input gear is moveable along a rotation direction; and the output gear is moveable along a reciprocation path; and the input gear is operatively mounted to a sheath-handle assembly of the elongated sheath assembly; and the output gear is fixedly mounted to the dilator-receiver device. Doing so would provide a mechanical advantage system with wherein operator only need to rotate a wheel in a clockwise or counter-clockwise direction in order to articulate the device, which also ensures the prevention of unwanted articulation in response to external forces (Matlock, [0095-0097]).
Regarding claim 21, Drontle discloses the apparatus of claim 4.
Drontle fails to disclose a lock mechanism configured to selectively lock the dilator-receiver mover to the elongated sheath assembly; and the lock mechanism also configured to selectively unlock the dilator-receiver mover from the elongated sheath assembly. However, Matlock discloses a lock mechanism (Figs. 24-26, slider assembly 410 has a locking pin 422) configured to selectively lock the dilator-receiver mover to the elongated sheath assembly (Fig. 25-26A and [0103], locking pin 422 locks the slider 442 in its current position relative to elongated body 402); and the lock mechanism also configured to selectively unlock the dilator-receiver mover from the elongated sheath assembly (Fig. 25B-C and [0103-0104], locking pin 422 can be overcome to unlock the slider 442 from its position relative to the elongated body 402).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Drontle to incorporate the disclosures of Matlock and Modify the device to comprise a lock mechanism to selectively lock the dilator-receiver mover to the elongated sheath assembly, and selectively unlock the dilator-receiver mover from the elongated sheath assembly. Doing so would provide the catheter system with a locking slider in order to prevent unwanted movement of the slider maintain the articulated position of the distal components of the device (Matlock, [0098, 0104]).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Drontle (US 20130030458), in view of Stangenes et al. (US 20070270751), hereinafter Stangenes.
Regarding claim 22, Drontle discloses the apparatus of claim 4, the elongated sheath assembly includes: a sheath hub (Annotated Fig. 4, proximal open end of support member 40 defines sheath hub, as it leads/directs a portion of shaft 30 into the extension portion of catheter 10) configured to be received, at least in part, into a hub cavity defined by the elongated sheath assembly (Annotated Fig. 4, sheath hub is received within a hub cavity defined by catheter 10) and wherein: the sheath hub is also configured to abut, at least in part, a dilator hub of the elongated dilator assembly after the dilator hub is positioned to abut, at least in part, the sheath hub (Annotated Fig. 4, sheath hub abuts the dilator hub, defined by helical portion 52 of shaft 30, which is positioned against the sheath hub at its distal end).
Drontle fails to disclose a lock device is installed to the sheath hub and the dilator hub; and the lock device is configured to selectively lock, and unlock, the sheath hub to, and from, the dilator hub. However, Stangenes discloses a lock device is installed to the sheath hub and the dilator hub (Fig. 2-3 and [0059], sheath hub 102 and dilator hub are fitted with corresponding snap lock features); and the lock device is configured to selectively lock, and unlock, the sheath hub to, and from, the dilator hub (Fig. 2-3 and [0059], corresponding snap lock features allow for both coupling of the hubs and then subsequent separation of the hubs).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Drontle to incorporate the disclosures of Stangenes and modify the device to comprise a lock device installed to the sheath hub and the dilator hub, and configured to selectively lock, and unlock, the sheath hub to, and from, the dilator hub. Doing so would allow for temporary coupling of the hubs to provide the components in a locked position relative to each other, while also ensuring said hubs/components may be separated, if necessary, later (Stangenes, [0053,0059]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH D GRASMEDER whose telephone number is (571)272-0258. The examiner can normally be reached M-F 8 am-5 pm EST.
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783