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
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-6, 9-11, 13-14, 16-18, 20-23, drawn to A61B 1/00105.
Group II, claim(s) 44, drawn to A61B 1/00096.
Group III, claim(s) 45, drawn to A61B 1/00105.
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
Species A: First embodiment of an intervention accessory disclosed in FIG. 2A (Claims 16)
Species B: Second embodiment of an intervention accessory disclosed in FIG. 2B (Claims 10-11, 13, 20-21)
Species C: Third embodiment of an intervention accessory disclosed in FIG. 11
If Species B is elected, please also elect one of the following subspecies
Subspecies A: First modification of an under-mounted intervention accessory disclosed in FIG. 9 (Claims 20-21)
Subspecies B: Second modification of an under-mounted intervention accessory disclosed in FIG. 10 (Claim 22)
Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, the following claim(s) are generic: Claim 1 is generic.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I, II, and III lack unity of invention because even though the inventions of these groups require the technical feature of an imaging guidewire, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Stefanchik et al. (US 20040230096 A1, hereinafter Stefanchik) in view of Kortenbach et al. (US 20030036679 A1, hereinafter Kortenbach):
an imaging guidewire (endoscope 100, FIG. 6) comprising:
an elongate shaft (thin wall tube/ sheath 27, FIGS. 2A-2C) extending from a proximal end to a distal end (depicted in FIGS. 4A-4B);
an imaging device (optics/viewing lens 107, FIG. 6) located proximate the distal end of the elongate shaft (FIG. 4A, par. 44 discloses thin wall tube slid over endoscope, i.e. optics can be proximal to the distal end of thin wall tube).
However, Stefanchik does not disclose a lighting element located proximate the distal end of the elongate shaft, wherein the lighting element is arranged in an arcuate configuration to at least partially surround the imaging device.
Kortenbach teaches an analogous endoscope system (apparatus system 610, FIGS. 14-17) having an endoscope (601, FIG. 14) and an intervention accessory (pair of jaws 626, 628, FIG. 17). The endoscope (601) possesses viewing optics (601c, FIG. 14, i.e. imaging device) which are surrounded by a plurality of illuminating optics (601a, 601b, i.e. lighting element) arranged in an arcuate configuration [FIGS. 14-17, 0046].
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the imaging guidewire of Stefanchik with the lighting element(s) of Kortenbach in order to provide optical elements which illuminate the surgical site and aid in delivering a clear image from the surgical site [Kortenbach - 0007].
During a telephone conversation with Stephen M. Komarec on 05/07/2026 a provisional election was made with traverse to prosecute the invention of Group I, claims 1-6, 9-11, 13-14, 16-18, 20-23 . Affirmation of this election must be made by applicant in replying to this Office action. Claim 44 and 45 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
During a telephone conversation with Stephen M. Komarec on 06/08/2026 a provisional election was made without traverse to prosecute the invention of Species B, Subspecies A, claims 1-2, 4, 6, 9-11, 13-14, 20-21, 23. Affirmation of this election must be made by applicant in replying to this Office action. Claims 3, 5, 16-18, 22 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the "working channel into which the imaging guidewire and accessory can simultaneously fit" must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
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 1 and 6 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 1 recites the limitation “intervention accessory configured to slide over” which is drawn to a non-elected embodiment. The examiner is interpreting this to be “configured to slide along” however, appropriate correction is required.
The term “approximately” in claim 6 is a relative term which renders the claim indefinite. The term “approximately” 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. The term does not distinctly define the meets and bounds of the limitation as intended; therefore, the examiner suggests amending the claim to either remove the term or replace it with something more distinct.
Examiner’s Comments
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
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.
Claim(s) 1-2, 4, 6, 9-11, 13-14, 20-21, 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stefanchik et al. (US 20040230096 A1, hereinafter Stefanchik) in view of Kortenbach et al. (US 20030036679 A1, hereinafter Kortenbach).
Regarding Claim 1, Stefanchik discloses
A modular endoscope system (guide system 20, FIG. 1) comprising:
an imaging guidewire (endoscope 100, FIG. 6) comprising:
an elongate shaft (thin wall tube/ sheath 27, FIGS. 2A-2C) extending from a proximal end to a distal end (depicted in FIGS. 4A-4B);
an imaging device (optics/viewing lens 107, FIG. 6) located proximate the distal end of the elongate shaft (FIG. 4A, par. 44 discloses thin wall tube slid over endoscope, i.e. optics can be proximal to the distal end of thin wall tube); and
an intervention accessory (accessory 50, FIG. 2A) configured to slide over the elongate shaft to provide a medical intervention (depicted in FIG. 2C),
wherein the intervention accessory comprises an elongate housing (accessory housing 50, FIG. 2A) having at least one channel (external working channel 52, FIG. 4A) extending at least partially therethrough (depicted in FIG. 4A).
However, Stefanchik does not disclose a lighting element located proximate the distal end of the elongate shaft, wherein the lighting element is arranged in an arcuate configuration to at least partially surround the imaging device.
Kortenbach teaches an analogous endoscope system (apparatus system 610, FIGS. 14-17) having an endoscope (601, FIG. 14) and an intervention accessory (pair of jaws 626, 628, FIG. 17). The endoscope (601) possesses viewing optics (601c, FIG. 14, i.e. imaging device) which are surrounded by a plurality of illuminating optics (601a, 601b, i.e. lighting element) arranged in an arcuate configuration [FIGS. 14-17, 0046].
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the imaging guidewire of Stefanchik with the lighting element(s) of Kortenbach in order to provide optical elements which illuminate the surgical site and aid in delivering a clear image from the surgical site [Kortenbach - 0007].
Additionally, the endoscope of Stefanchik has two undisclosed elements, depicted below in Modified FIG. 6 circled in blue, which are likely unnamed lighting elements and are positioned similarly to the lighting elements of Kortenbach, depicted in FIG. 17, in relation to the respective imaging devices.
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Stefanchik Modified FIG. 6 (US 20040230096 A1)
Regarding Claim 2, Stefanchik, as previously modified by Kortenbach, discloses all of the elements of the current invention disclosed in claim 1, and Stefanchik further discloses
The modular endoscope system of claim 1,
further comprising a cover (end cap 55) located at a distal end of the elongate shaft (depicted in FIG. 3B),
wherein the cover is tapered to push anatomy away from the imaging device and is transparent such that the imaging device can view through the cover (FIG. 3B, par. 56 disclose guide notch of end cap is angled/ tapered for imaging purposes, FIG. 4A discloses end cap allows for imaging, i.e. is transparent).
Regarding Claim 4, Stefanchik, as previously modified by Kortenbach, discloses all of the elements of the current invention disclosed in claim 1, and Kortenbach further teaches
The modular endoscope system of claim 1, wherein the lighting element comprises a plurality of light emitters (illuminating optics 601a, 601b, FIG. 14).
Regarding Claim 6, Stefanchik, as previously modified by Kortenbach, discloses all of the elements of the current invention disclosed in claim 1, and Stefanchik further discloses
The modular endoscope system of claim 1, wherein:
the elongate shaft has an outer profile shape and the imaging device and the lighting element are located within the outer profile shape (FIG. 4A, par. 77 disclose thin wall tube/ sheath is sized for tight fit on endoscope with a clearance of roughly 1 mm);
the outer profile shape is circular and a diameter of the outer profile shape is in a range of approximately 0.8 mm to approximately 3.0 mm (FIGS. 2C, 4A, par. 5 disclose endoscope between 1 mm to 3 mm, i.e. thin wall sheath between 2 mm and 4 mm); and
a combined outer diameter of the imaging guidewire and the intervention accessory does not exceed approximately 5.0 mm (FIG. 4A, par. 5 disclose endoscope between 1 mm to 3 mm, and accessory devices are sized based on diameter of scope being used, i.e. combined outer diameter is generally below 5 mm).
Regarding Claim 9, Stefanchik, as previously modified by Kortenbach, discloses all of the elements of the current invention disclosed in claim 1, and Stefanchik further discloses
The modular endoscope system of claim 1, further comprising a slide feature (guide rail 30, FIG. 2B) extending along at least a portion of the elongate shaft between the proximal end and the distal end (depicted in FIG. 2B).
Regarding Claim 10, Stefanchik, as previously modified by Kortenbach, discloses all of the elements of the current invention disclosed in claim 9, and Stefanchik further discloses
The modular endoscope system of claim 9, wherein the slide feature comprises a slot (guide rail 30, FIG. 2B) configured to receive a mating rail (mating member 40, FIG. 2A),
wherein the slot comprises a radial catch (par. 48 discloses the rail can be sized and shaped to permit the device to slide axially along the length of rail, while preventing the device from disengaging from the rail, i.e. provided with a catch feature).
Regarding Claim 11, Stefanchik, as previously modified by Kortenbach, discloses all of the elements of the current invention disclosed in claim 10, and Stefanchik further discloses
The modular endoscope system of claim 10, wherein the slot is located within an outer profile shape of the elongate shaft (depicted in FIG. 2B).
Regarding Claim 12, Stefanchik, as previously modified by Kortenbach, discloses all of the elements of the current invention disclosed in claim 11, and Stefanchik further discloses
The modular endoscope system of claim 11, wherein the slot has a T- shape (depicted in FIGS. 1, 2C).
Regarding Claim 14, Stefanchik, as previously modified by Kortenbach, discloses all of the elements of the current invention disclosed in claim 9, and Stefanchik further discloses
The modular endoscope system of claim 9, wherein the slide feature comprises a distal stop (par. 48 discloses the rail can be sized and shaped to permit the device to slide axially along the length of rail, while preventing the device from disengaging from the rail, i.e. provided with a stop feature).
Regarding Claim 20, Stefanchik, as previously modified by Kortenbach, discloses all of the elements of the current invention disclosed in claim 1, and Stefanchik further discloses
The modular endoscope system of claim 1, wherein the elongate housing further comprises a laser fiber extending at least partially therethrough (par. 36 discloses accessory is a flexible tubular guide for receiving and guiding medical instruments, par. 78-79 disclose various devices can be provided via accessory such as a tissue ablation system, i.e. laser fiber).
Regarding Claim 21, Stefanchik, as previously modified by Kortenbach, discloses all of the elements of the current invention disclosed in claim 1, and Stefanchik further discloses
The modular endoscope system of claim 1, wherein the elongate housing further comprises an irrigation channel configured to convey a fluid through the elongate housing (par. 36 discloses accessory is a flexible tubular guide for receiving and guiding medical instruments, par. 78-79 disclose various devices can be provided via accessory such as a device adapted for liquid or gas injection, i.e. irrigation, par. 84 discloses example of device being a duct for conveying liquid or gas, i.e. irrigation channel).
Regarding Claim 23, Stefanchik, as previously modified by Kortenbach, discloses all of the elements of the current invention disclosed in claim 1, and Stefanchik further discloses
The modular endoscope system of claim 1, further comprising a duodenoscope (handle 60 + endoscope 100, FIGS. 4A-4B) having a working channel (slot 36 + funnel feature 37, FIG. 4B + par. 60 discloses through bore) into which the imaging guidewire and accessory can simultaneously fit (par. 77-78 disclose endoscope, with rail, and mating member can be simultaneously fit into respective handle parts, i.e. through bore for endoscope, slot for rail and funnel for mating member, allowing for endoscope and guide system to be held together in place during procedure).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABDUL HADI ABBASI whose telephone number is (571)272-4076. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571) 272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABDUL HADI ABBASI/Examiner, Art Unit 3795
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
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