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
The Amendment filed April 28th, 2026 has been entered. Claims 22 and 26 has been amended. Claims 22-26, 28-29, 31-33 are now pending in the application. Some of the previous 35 USC 112 (b) rejections of claim 22 are withdrawn in light of Applicant's amendment.
Response to Arguments
Applicant's arguments filed 04/28/2026 have been fully considered but they are not persuasive.
In response to arguments that Setty et al. (US 20110196204 A1) does not disclose “a proximal end face and a distal end face which face a corresponding end face of adjacent segment” and “a wedge back section” the examiner respectfully disagrees. As detailed below, the examiner has updated the rejection to provide more clarity and better the reject the claims as amended, however, the examiner is maintaining the rejection under 35 U.S.C 102(a)(1) with Setty et al. (US 20110196204 A1) since the amendments do not adequately address all of the 112 issues which leave the claims indefinite until the language is amended to more distinctly limit the intended structure and functions of the invention as claimed. Moreover, any arguments made regarding the invention within the disclosure of the present application will not be considered until the aspects in question are limited by the invention as claimed, such as the intended structure of the wedge back section, which can be interpreted as any section of the segment having a wedge-shape in some way.
Examiner 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”. (See MPEP 2141.02(VI)) 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 § 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.
Claim 22 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. There are several limitations in this claim that are unclear and make it difficult to interpret what is required by the invention as claimed:
The limitation of “for the controlled foldable or angularly adjustable holding of an endoscope head or distal head section” the language used to describe the articulation of a distal end is confusing and indefinite in this limitation, does not particularly point out the intended function and attempts to do it in a roundabout way. The limitation describes controlled foldable holding or angularly adjustable holding which both can be interpreted in several ways whether that be bending, articulation, retraction/ extension, rotation, etc. nonetheless, the room for interpretation leaves ambiguity wherein the examiner suggests amending the limitation to better direct it to the invention as intended.
The limitation of “aligned substantially wedge-shaped with respect to one another” is unclear and indefinite as to what is being structurally limited by this because using a shape to define the alignment of the “end faces” in relation to one another leaves ambiguity as to the intended structural relationships of this aspect.
The limitation of “wherein the through opening in the wedge back section of each segment breaks through the cylinder jacket in a radial direction of the endoscope” is indefinite and difficult to interpret the intended structure of the invention since it is unclear how the openings in each section can break through the cylinder jacket, due to the structural requirements of the cylinder jacket, which is understood as surrounding the segments, as is apparent in the disclosure, which also does not properly convey this aspect. The examiner suggests amending the claim language to more distinctly claim the intended structure.
Claim 26 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. The limitation of “substantially forwardly aligned or stretched position” is unclear and indefinite as to the meets and bounds of the intended structure of the fold-down mechanism, “forwardly aligned” and “stretched” are able to be interpreted in multiple ways, such as the fold-down mechanism being extended or the fold-down mechanism being straightened or part of the fold-down mechanism simply facing the proximal direction, therefore, the claim language should be amended to reflect the intended structure of the invention, for example, the language of “straightened” would more clearly pronounce, what is being interpreted as, the intended structure of the invention. Moreover, amendments made to the claim language sought to alleviate these concerns by providing more language rather than adjusting any older language, however, the limitation of “wherein the endoscope head arranged furthest distally” brings even more confusion since “the endoscope head” refers to the entirety of the segments wherein the fold down mechanism is a component of the endoscope head, as consistent with the disclosure, so what it is unclear what the “endoscope head” is “arranged furthest distally” in relation to and how that alleviates the ambiguity of the limitations “forwardly aligned” and “stretched.”
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.
Claim(s) 22-26, 28-29 and 31-33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Setty et al. (US 20110196204 A1, hereinafter Setty).
Regarding Claim 22, Setty discloses
An endoscope (endotracheal intubation device 100, FIG. 14, par. 69 discloses imaging unit/ camera) including:
an endoscope shaft (channel element 120, FIG. 1) comprising a distal manually actuable fold-down mechanism (curveable channel portion 128, FIG. 1) for the controlled foldable or angularly adjustable holding of an endoscope head or distal head section (distal end 104, FIG. 1) on an endoscope section (rigid channel portion 126, FIG. 1) disposed proximally of the fold-down mechanism (depicted in FIG. 1),
the fold-down mechanism having a number of axially successive substantially cylindrical segments (curveable channel elements 130, FIG. 3) which are actively and angularly adjustable relative to one another via at least one common actuating element (articulating means 160, FIG. 8),
wherein the segments each have:
a proximal end face and a distal end face which face a corresponding end face of adjacent segments in a longitudinal direction of the endoscope (depicted in Modified FIG. 4 below),
wherein the proximal end face and the distal end face of each segment are aligned substantially wedge-shaped with respect to one another (FIG. 4, par. 57 disclose wedge shaped gaps between each channel element, i.e. faces are substantially wedge-shaped, as depicted in Modified FIG. 4 below),
a cylinder jacket (retaining lips 142 + overhang structures 144, FIG. 2) having a wedge back section at a circumferential section of the segment having a maximum axial length (FIGS. 1, 4 depict the sections of the segments with maximum axial length are met with wedge shaped gaps which form wedge-shaped sections at the point, i.e. back section, where the segments meet the retaining lip), and
at least one through opening in a longitudinal direction of the endoscope such that the segments jointly form a working channel (first channel 122, FIG. 1, par. 55 discloses channel elements have openings in longitudinal direction that define first channel),
wherein the through opening in the wedge back section of each segment breaks through the cylinder jacket in a radial direction of the endoscope and is open radially outwards in the wedge back section of each segment (FIGS. 1, 4, par. 60 disclose retaining lips and overhand structure extend outwardly from the first channel, i.e. in a radial direction, as depicted in FIG. 2; FIG. 1 depicts channel being open in the wedge-shaped gap sections),
thereby forming a longitudinal slot (openings + gaps 132, FIGS. 1-4) in the longitudinal direction of the endoscope (FIG. 1, par. 55 disclose sidewalls of segments form openings in the longitudinal directions which in combination with the gaps between segments form a longitudinal slot); and
wherein the wedge back sections of each segment are connected to one another in the longitudinal direction of the endoscope by a flexible or elastic connecting plate (flexible gap cover plate 150, FIG. 3),
which is fixed to an outer side of each segment and covers the respective longitudinal slots (FIG. 3, par. 67 discloses gap cover plate covers at least a portion of the gap or gaps and at least partially shields the first channel),
wherein the connecting plate forms a sliding surface along which medical instruments can be inserted (par. 22 discloses interior wall of first channel that is capable of anchoring tools, par. 24 discloses sensor means mounted within the first channel),
wherein the sliding surface runs continuously in the working channel (depicted in FIG. 6),
wherein the connecting plate also forms hinge sections (retaining bands 154 + hinge portions, FIG. 3),
which are located between adjacent segments (depicted in Modified FIG. 3, circled below),
that are connected to one another for folding down two respective adjacent segments (par. 67 discloses gap cover plate moves, i.e. folds, relative to positions of curveable channel elements).
PNG
media_image1.png
205
259
media_image1.png
Greyscale
PNG
media_image2.png
346
323
media_image2.png
Greyscale
Modified FIG. 3 (US 20110196204 A1) Modified FIG. 4 (US 20110196204 A1)
Regarding Claim 23, Setty discloses
The endoscope according to claim 22, wherein the connecting plate at least partially covers the working channel in the wedge back section (FIG. 3, par. 67 discloses gap cover plate covers at least a portion of the gap or gaps and at least partially shields the first channel).
Regarding Claim 24, Setty discloses
The endoscope according to claim 22, wherein the connecting plate includes tab-shaped holding sections (anchor point 152, FIG. 3) for attachment to the segment and to the distal end section of the endoscope section (par. 67 discloses gap cover plate is capable of being attached to the rigid channel portion, i.e. endoscope section, and the channel elements).
Regarding Claim 25, Setty discloses
The endoscope according to claim 22, wherein the connecting plate is resilient at least at the hinge sections (FIG. 8, par. 67 disclose gap cover plate is able to move between different positions, i.e. return to straight position as depicted in FIG. 8).
Regarding Claim 26, Setty discloses
The endoscope according to claim 25, wherein the hinge sections serve as a return element which is configured to return the fold-down mechanism from a folded- down position to a substantially forwardly aligned or stretched position in which the endoscope head arranged furthest distally is oriented forward in a longitudinal direction of the endoscope (FIG. 8, par. 67 disclose retaining bands allow for movement of gap cover plate which is able to move between different positions, i.e. return to straight position, via the retaining bands, as depicted in FIG. 8; FIG. 3 depicts folded position, FIG. 1 depicts straightened position, therefore, fold-down mechanism capable of actuating return mechanism, i.e. via hinges).
Regarding Claim 28, Setty discloses
The endoscope according to claim 22, wherein the connecting plate is tapered at the hinge sections in a circumferential direction (FIG. 3 depicts gap cover plate being narrowed towards hinge portions, circled below in green).
PNG
media_image1.png
205
259
media_image1.png
Greyscale
FIG. 3 Marked Up (Setty US 20110196204 A1)
Regarding Claim 29, Setty discloses
The endoscope according to claim 22, wherein the connecting plate forms a smooth central section (depicted in FIG. 6),
which is continuous in the longitudinal direction of the endoscope and forms the sliding surface (depicted in FIG. 6),
from which tab-shaped fastening regions (anchor point 152) protrude symmetrically on both sides (depicted in FIG. 6),
which tab-shaped fastening regions serve to fasten the segments and are bent towards each other with respect to the central section (FIG. 3, par. 67 disclose gap cover plate is capable of being attached to the rigid channel portion, i.e. endoscope section, and the channel elements for anchoring, FIG. 3 depicts anchor point being bent towards the rigid channel portion, i.e. the anchor point of the rigid channel portion would inherently bend towards the anchor point of the channel element).
Regarding Claim 31, Setty discloses
The endoscope according to claim 22, wherein the fold-down mechanism is configured to hold the endoscope head at the distal end of an endoscope deflector (conductor 172, FIG. 5-6 depict conductor deflecting sensor means 170, i.e. endoscope imager), which is interposed between the fold-down mechanism and the endoscope shaft (depicted in FIG. 5) and is bendable by way of a separate actuating element (FIG. 6, par. 69 discloses conductor can be isolated from other components and from elements of the external environment, same as articulating means, i.e. conductor which is bendable in FIG. 6, can have a separate actuating element to the rest of the components).
Regarding Claim 32, Setty discloses
The endoscope according to claim 31, wherein when the fold-down mechanism is completely folded down, a bending radius of the fold-down mechanism, is smaller than a bending radius of the endoscope deflector when the endoscope deflector is completely bent down (depicted in FIG. 6).
Regarding Claim 33, Setty discloses
The endoscope according to claim 22, further comprising a channel adjustment mechanism configured to increase or decrease a diameter of the working channel (par. 55 discloses openings in channel elements define first channel, i.e. gaps define part of channel, par. 56 discloses gaps change in size during articulation of the device, i.e. channel changes in size during articulation mechanism, i.e. channel adjustment mechanism),
such that the wedge back section of the segments and the connecting plate are configured to be bendable in an open position, a closed position, a radially inward direction, a radially outward direction, or a combination thereof with respect to the longitudinal direction of the endoscope (par. 56 discloses gaps change in size during articulation of the device, par. 57 discloses gaps have wedge shaped portions between elements, i.e. wedge shaped portions articulate/ change in size with gaps; FIG. 4 and 8 depict that wedge portions are present despite bending operation).
Claim(s) 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schostek et al. (US 20080051802 A1, hereinafter Schostek).
Regarding Claim 22, Schostek discloses
An endoscope (endoscope instrument 8, FIG. 1, par. 69 discloses instrument is endoscope) including:
an endoscope shaft (instrument shaft 5, FIG. 1) comprising a distal manually actuable fold-down mechanism (first structures 3, FIG. 7) for the controlled foldable or angularly adjustable holding of an endoscope head or distal head section (instrument tip 80, FIG. 1) on an endoscope section (distal end 7, FIG. 7) disposed proximally of the fold-down mechanism (depicted in FIG. 7),
the fold-down mechanism having a number of axially successive substantially cylindrical segments (individual tube segments 16, FIG. 7) which are actively and angularly adjustable relative to one another via at least one common actuating element (external bending element 23, FIG. 7),
wherein the segments each have:
a proximal end face and a distal end face which face a corresponding end face of adjacent segments in a longitudinal direction of the endoscope (depicted in Modified FIG. 7 below),
wherein the proximal end face and the distal end face of each segment are aligned substantially wedge-shaped with respect to one another (depicted in Modified FIG. 7 below),
a cylinder jacket (inner tube element 1, FIG. 1) having a wedge back section at a circumferential section of the segment having a maximum axial length (FIGS. 1, 7, par. 76 disclose inner tube will have complimentary structure to segments of first structure), and
at least one through opening in a longitudinal direction of the endoscope such that the segments jointly form a working channel (distal opening 10, FIG. 7, par. 74 disclose endoscopes serves for orientation of a second device, i.e. working surgical instrument, which travels through the channel created by distal opening(s), as depicted in FIG. 19),
wherein the through opening in the wedge back section of each segment breaks through the cylinder jacket in a radial direction of the endoscope and is open radially outwards in the wedge back section of each segment (depicted in FIGS. 7-8),
thereby forming a longitudinal slot in the longitudinal direction of the endoscope (depicted in FIGS. 7-8); and
wherein the wedge back sections of each segment are connected to one another in the longitudinal direction of the endoscope by a flexible or elastic connecting plate (external bending element 23 + bending region 26, FIG. 7),
which is fixed to an outer side of each segment and covers the respective longitudinal slots (depicted in FIG. 7),
wherein the connecting plate forms a sliding surface (bending region 26, FIGS. 7-8) along which medical instruments can be inserted (FIG. 19, par. 74 disclose working instrument travel through channel created by distal opening, i.e. along bending region of bending element),
wherein the sliding surface runs continuously in the working channel (depicted in FIG. 7),
wherein the connecting plate also forms hinge sections (narrowed portion 27, FIG. 8),
which are located between adjacent segments (depicted in FIG. 8),
that are connected to one another for folding down two respective adjacent segments (par. 83 discloses narrowed portion localizes the deformation upon bending of the instrument tip to the bending regions which are positioned between each segment).
PNG
media_image3.png
491
626
media_image3.png
Greyscale
Modified FIG. 7 (US 20080051802 A1)
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ABDUL HADI ABBASI/Examiner, Art Unit 3795
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
Prosecution Insights