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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claim 1 recites, in pertinent part, “wherein the circular electronic display is subtended by a conical volume having an apex at the distal end of the probe and a conical angle of less than 60 degrees”. Regarding the circular electronic display being subtended by a conical volume, paragraph [0086] of the published specification, as originally filed, discloses:
The display 18 may be centered on the axis 22 having a viewable face perpendicular to that axis 22 so that the display 18 is subtended by a right circular cone 133 having its apex at the distal end of the cylindrical probe 28 and its base perpendicular to the axis 22. This subtending cone 133 may have a vertex angle 23 of less than 60 degrees (emphasis added).
As is clear, the specification discloses that the conical volume (133) of the subtended cone has a vertex angle (23) that is less than 60 degrees. It does not disclose that the conical angle is less than 60 degrees for the subtending cone. As is generally known, and as illustrated in Figure 7 of the specification, a vertex angle (23 in Figure 7) of a cone is measured across the apex between opposite sides the cone. A conical angle, however, is the angle between the central axis of the cone and the side of the cone. The vertex angle is twice the conical angle. As the specification discloses that the vertex angle is less than 60 degrees, it follows that the conical angle of the subtending cone must be less than 30 degrees. Thus, the conical angle cannot be less than 60 degrees, as claimed, as it cannot be larger than 30 degrees. Accordingly, the claim fails to comply with the written description requirement.
Independent claim 1 also recites “wherein the circular electronic display has a diameter less than 2.5 inches”. Regarding the diameter of the circular electronic display, paragraph [0086] of the published specification, as originally filed, discloses:
Referring now to FIG. 7, the display 18 may be circular in outline having a diameter of approximately 1.5 inches and less than two inches and desirably less than 2.5 inches.
As claimed, the display could have a diameter than is 1 inch, however, the specification does not disclose a diameter that is less than 1.5 inches. Accordingly, the claim fails to comply with the written description requirement.
Dependent claim 2 recites, “wherein the housing and the circular electronic display are circumscribed by a cone having an apex at the distal end of the probe and a conical angle of less than 60 degrees. Regarding the conical angle of the circumscribing cone, paragraph [0012] of the published specification, as originally filed, discloses:
The display may be circumscribed by a cone having an apex at the distal end of the probe and a conical angle of less than 45 degrees and/or may have a diameter that extends less than three inches from the axis at all angles about the axis.
As is clear, the conical angle is only disclosed as being less than 45 degrees, and not 60 degrees, as claimed. Accordingly, the claim fails to comply with the written description requirement.
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 3 and 8 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.
Regarding claim 3, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation "a conical angle of less than 60 degrees", and the claim also recites "a conical angle of less than 45 degrees", which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Dependent claim 3 recites a circular electronic display having two different conical volumes, each having different a conical angle range. Additionally, independent claim 1 recites that the circular electronic display has a diameter less than 2.5 inches. A probe with a circular electronic display having a diameter of 2.4 inches, for example, would have a different probe length when the conical angle is 50 degrees than when the conical angle is 20 degrees. Accordingly, the claims do not clearly set forth the metes and bounds of the patent protection desired and the claims are rendered indefinite.
Claim 8 recites, in pertinent part, “further including a display”. However, independent claim 1, from which claim 8 depends, recites the otoscope comprising “a circular electronic display”. It is not clear if the otoscope has one circular electronic display or the circular electronic display and another display. Accordingly, the claim is rendered indefinite. For purposes of examination, the display of claim 8 is interpreted as the same display recited in claim 1.
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) 1-4 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang (US 2011/0137118 A1) in view of Lo (US 2018/0333041 A1) in view of Schneider et al. (US 2009/0225159 A1).
Regarding claim 1, Huang discloses an otoscope comprising: a housing (100/200/400; Fig. 2; par. [0038]) adapted for support by a hand of a healthcare professional with the housing in an inspection position adjacent to an outer ear of a patient; an elongate probe element (300; Fig. 6; par. [0039]) having a proximal end supported by the housing so that a distal end (800) of the elongate probe element (300) may extend rigidly from the proximal end to the distal end along a linear axis into an ear canal of the patient (Figs. 5 and 6); an electronic camera (322; Fig. 6; par. [(0039]) supported by the distal end of the elongate probe element (300) for viewing into the ear canal when the distal end of the probe element (300) is positioned in the ear canal of the outer ear; and an electronic display (200; Fig. 6) communicating with the electronic camera (322) and having a display area having an outer periphery displaying an otoscope image taken by the electronic camera and spaced from the distal end of the elongate probe (300) along the linear axis and centered along the linear axis.
Although the image picked up through distal end of the elongate probe of Huang
will be displayed in the shape of a circle, it does not specifically disclose that the electronic display is circular, has a display area defined by an outer circular periphery
and has a diameter of less than 2.5 inches. Lo teaches an analogous otoscope (Figs. 7-
9) wherein the electronic display (26a) is circular (par. [0071]-[0075]) and has a display
area defined by an outer circular periphery (Figs. 7-9). Lo teaches that the circular
display can have a diameter between two inches and three inches (par. [0075]), such
that it can be less than 2.5 inches. Lo also teaches that the electronic display may be
any shape including oval, rectangle, or other polygon (par. [(0075]). Additionally, Schneider teaches an analogous visualization device wherein the opening (98) of the
housing (54) holding the display (46) may be rectangular, circular, or the like, to
complement a shape of the display (par. [0036]; Figs. 4-5), such that if the display is
circular the opening of the housing will be circular as well. It would have been obvious to
one having ordinary skill in the art to have made the display of Huang circular, as taught
by Lo and Schneider, as a simple substitution of one known electronic display shape for
another having the predictable result of displaying the captured image on a screen.
Moreover, matching the shapes of the image and the display screen minimizes unused
space on the display thereby potentially reducing its size. The circular electronic display
of modified Huang also extends outwardly to the circular periphery a substantially same
distance at all angles perpendicular to the linear axis (radius of the circle; Figs. 5 and 8).
Additionally, the circular electronic display is capable of being subtended by a conical
volume having an apex at the distal end of the probe and a conical angle of less than 60
degrees as the conical angle is dependent upon both the diameter of the circular display
and the length of the probe. Applicant has not claimed a length of the probe. Moreover,
as claimed, the display could have a diameter that is 0.5 inch or 2.4 inches and the conical angle could range from 1 to 59 degrees, for example. A probe length would be
different for a circular electronic display having a diameter of 2.4 inches and a conical
angle of 55 degrees than for a circular electronic display having a diameter of 1 inch
and a conical angle of 25 degrees, as both otoscope dimensions, and a variety of
others, read on the claim language
Regarding claim 2, Huang in view of Lo in view of Schneider disclose the
otoscope of claim 1 wherein the housing and the circular electronic display are circumscribed by a cone (Fig. 9) having an apex at the distal end of the probe and a conical angle of less than 60 degrees. The circular electronic display is capable of being contained by a cone having an apex at the distal end of the probe and a conical angle of less than 60 degrees as the conical angle is dependent upon both the diameter of the
housing and circular display and the length of the probe. Applicant has not claimed a length of the probe.
Regarding claim 3, Huang in view of Lo in view of Schneider disclose the
otoscope of claim 2 wherein the housing and the circular electronic display are circumscribed by a cone (Fig. 9) having an apex at the distal end of the probe and a conical angle of less than 45 degrees. The circular electronic display is capable of being contained by a cone having an apex at the distal end of the probe and a conical angle of less than 45 degrees as the conical angle is dependent upon both the diameter of the
housing and circular display and the length of the probe. Applicant has not claimed a length of the probe.
Regarding claim 4, Huang in view of Lo in view of Schneider disclose the
otoscope of claim 1 wherein the circular electronic display extends less than three inches 1.25 inch from the linear axis at all angles about the perpendicular to linear axis
(Lo: par. [0075] - the diameter of between 2-3 inches provides a radius that can be
less than 1.25 inches).
Regarding claim 8, Huang in view of Lo in view of Schneider disclose the
otoscope of claim 1 further including a display (Fig. 2; modified Huang)
indicating a left ear recorded or right ear recorded indicator to the otoscope image (capable of such indication of the right or left ear; Lo: par. [0082] -editing the image by, for example, marking-up).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang in view of Lo in view of Schneider as applied to claim 1 above, and further in view of Hatzilias (US 2016/0051134 A1).
Regarding claim 5, Huang in view of Lo in view of Schneider disclose the
otoscope of claim 1 but does not specifically disclose it further including a processor
executing a stored program for displaying non-image data in a peripheral ring about the
otoscope image. Hatzilias teaches an analogous otoscope (Figs. 1A-1C) comprising a
processor (internal to 100; par. [0033]) executing a stored program for displaying non-
image data in a peripheral ring about the image (Figs. 2 and 8A-8B). Hatzilias teaches
that the non-image data assists the operator in guiding the otoscope during a scan of
the ear canal (par. [0031]-[0035] and [0056]-[0063]). It would have been obvious to one
having ordinary skill in the art to incorporate the stored program in the processor of
Hatzilias into the otoscope of Huang thereby providing non-image data in order to assist
the operator in guiding the otoscope during a scan of the ear canal, as taught by Haitzilias.
Claim(s) 10 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang in view of Lo in view of Schneider as applied to claim 1 above, and further in view of Newman et al. (US 4147163).
Regarding claim 10, Huang in view of Lo in view of Schneider disclose the otoscope of claim 1 wherein the housing (100/200/400) provides a display portion (200/400) holding the circular electronic display (modified 220) and elongate probe (300), and a handle portion (100) extending away from the linear axis to be held by a
healthcare professional (Fig. 1). Although Huang discloses that batteries (121; Fig. 5)
are provided in the handle, it does not specifically disclose how the batteries are
changed and/or charged, and does not specifically disclose wherein the display portion
is mechanically and electrically releasably attachable to the handle portion by means of
a twist lock coupling. Newman teaches an analogous otoscope wherein the viewing
portion (11) is mechanically and electrically releasably attachable to the handle portion
(10) by means of a twist lock coupling (17/16; col. 2, II. 13-20). It would have been
obvious to one having ordinary skill in the art to have releasably coupled the handle of
Huang to the display portion, as taught by Newman, thereby providing a configuration to
replace or charge the batteries and to preserve battery life of the otoscope until the handle and head are electrically coupled.
Regarding claim 13, Huang in view of Lo in view of Schneider in view of Newman
disclose the otoscope of claim 10 wherein the display portion (Newman: 11) includes a
releasable adapter portion (Newman: threads onto 17; col. 2, II. 13-21) releasably receiving the handle portion (Newman: 10).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang in view of Lo in view of Schneider as applied to claim 1 above, and further in view of Walker et al. (US 7354194 B2).
Regarding claim 14, Huang discloses the otoscope of claim 1 but does not specifically disclose it further comprising: a tubular sheath sized to fit within the ear canal and to receive the elongate otoscope probe element therein, wherein the distal end of the tubular sheath is covered by a transparent window and a proximal end providing a connection to the housing. Walker is one of several references which teaches such tubular sheath (20; col. 7, II. 7-18) sheath sized to fit within the ear canal
and to receive an elongate probe element (Fig. 10) therein, the distal end of the tubular sheath providing a transparent window covering (36) allowing imaging therethrough and a proximal end of the tubular sheath providing a connection to the housing (Fig. 10; via 38/52/24; col. 7, II. 7-18). Walker teaches that its sheath stretches when the elongate probe element is inserted into it thereby making the window taught against the probe and reducing any distortions/wrinkling of the window for improved scanning (col. 7, II. 7-18). It would have been obvious to one having ordinary skill in the art to having provided
the replaceable tubular sheath of Walker in the otoscope of Huang in order for increased sanitation without compromising the field of view and images obtained during
a procedure.
Regarding claim 15, Huang in view of Lo in view of Schneider in view of Walker
disclose the otoscope of claim 14 wherein the transparent window covering is an elastic
cot and the connection to the housing stretches the elastic cot over the electronic
camera to provide a transparent covering to the camera allowing imaging therethrough
(Walker: col. 7, II. 7-18).
Claim(s) 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang in view of Lo in view of Schneider as applied to claim 1 above, and further in view of Hendricks (US 2019/0046359 A1).
Regarding claim 17, Huang in view of Lo in view of Schneider disclose the otoscope of claim 1 but does not specifically disclose it further comprising: a tubular
sheath sized to fit within the ear canal and to receive the elongate otoscope probe element therein, wherein the distal end of the tubular sheath provides a tool extending
axially beyond the distal end of the probe element for engaging objects within an ear
within a field of view of the camera. Hendricks teaches an analogous device comprising
a tubular sheath (14; Fig. 1B) sized to fit within an ear canal and to receive an elongate
otoscope probe element therein, wherein a distal end of the tubular sheath provides a
tool (12) extending axially beyond the distal end of the probe element for engaging
objects within an ear within a field of view of the camera (par. [0015]). Hendricks
teaches using the sheath with the otoscope in order to allow an operator to remove ear
wax during a procedure for improved viewing of the ear canal. It would have been
obvious to one having ordinary skill in the art to have provided the tubular sheath and
tool of Hendricks to the otoscope of Huang in order to allow an operator to remove ear wax during a procedure for improved viewing of the ear canal.
Regarding claim 18, Huang in view of Lo in view of Schneider in view of
Hendricks disclose the otoscope of claim 17 wherein the tool element (Hendricks: 12) is
malleable to be formed into a curve with respect to an axis of the tubular sheath and to
retain that curvature (Hendricks: par. [0015]).
Claim(s) 17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang in view of Lo in view of Schneider as applied to claim 1 above, and further in view of Elliott (US 6001059A1).
Regarding claim 17, Huang in view of Lo in view of Schneider disclose the
otoscope of claim 1 but does not specifically disclose it further comprising: a tubular
sheath sized to fit within the ear canal and to receive the elongate otoscope probe
element therein, wherein the distal end of the tubular sheath provides a tool extending
axially beyond the distal end of the probe element for engaging objects within an ear
within a field of view of the camera. Elliot teaches an analogous device comprising a
tubular sheath (12; Fig. 1) sized to fit within an ear canal and to receive an elongate
otoscope probe element therein, wherein a distal end of the tubular sleeve provides a
tool (distal end of 12; col. 2, II. 9- 45) extending axially beyond the distal end of the
probe element for engaging objects within an ear within a field of view of the camera.
Elliot teaches using the sheath with the otoscope in order to allow an operator to
remove ear wax during a procedure for improved viewing of the ear canal. It would have
been obvious to one having ordinary skill in the art to have provided the tubular sheath
and tool of Elliot to the otoscope of Huang in order to allow an operator to remove ear
wax during a procedure for improved viewing of the ear canal.
Regarding claim 19, Huang in view of Lo in view of Schneider in view of Elliott
disclose the otoscope of claim 17 wherein the tool element provides a scoop (Elliot:
flared end of 12) communicating with a channel connectable to a vacuum source (Elliot: col. 2, II. 9-45).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Huang in view of Lo in view of Schneider as applied to claim 1 above, and further in view of Tsai (US 2005/0043588 A1).
Regarding claim 20, Huang in view of Lo in view of Schneider disclose the
otoscope of claim 1 further comprising: a processor (within 100/200) executing a program stored in non-transient medium and communicating with the electronic camera,
and the circular electronic display to provide a dynamic image on the display indicating
the view from the electronic camera. However, Huang does not specifically disclose a
microphone; and a processor executing a program stored in non-transient medium and
communicating with the electronic camera, the microphone, and the electronic display
to operate in a second mode, triggered by a user's voice received by the microphone, to
capture a static image on the display indicating a view from the electronic camera at a
time of the trigger. Tsai teaches an analogous device having a microphone (par. [0045]
- within 150); and a processor executing a program stored in non-transient medium
and communicating with the electronic camera, the microphone, and the electronic
display to operate in a second mode, triggered by a user's voice received by the
microphone, to capture a static image on the display indicating a view from the electronic camera at a time of the trigger (par. [0045]). It would have been obvious to
one having ordinary skill in the art to have provided the microphone and program of Tsai
in the otoscope of Huang in order to allow the operator to capture images of the target
location without moving its hands or the otoscope thereby ensuring image capture of the
desired location.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Huang in view of Lo in view of Schneider as applied to claim 1 above, and further in view of Schultz et al. (US 2011/0009694 A1).
Regarding claim 21, Huang in view of Lo in view of Schneider disclose the otoscope of claim 1 further comprising: multiple LEDs (Schneider: 126; par. [0047]) fixed with respect to the housing (Schneider: Fig. 1). However, it does not specifically disclose optical fibers receiving light from respective LEDs at proximal ends of the optical fibers and extending distally to surround the electronic camera to project light forward from the electronic camera. Schultz teaches an analogous endoscope wherein the light source may be multiple LEDs located at the distal end (par. [0065] and [0072]) or it may may be optical fibers receiving light from multiple LEDs at proximal ends of the optical fibers and extending distally to surround the electronic camera to project light forward from the electronic camera (par. [0065], [0068]-[0069], [0072]-[0073] and [0140]; Fig. 3C). It would have been obvious to one having ordinary skill in the art to provide optical fibers and multiple LEDs to convey light to the target area, as taught by Schultz, as a substitution of one known configuration of illumination for another, having the predictable results of illuminating the target area at a desired brightness, as taught by Schultz.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYNAE E BOLER whose telephone number is (571)270-3620. The examiner can normally be reached Mon - Fri 9:00-5:00.
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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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/RYNAE E BOLER/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
9/16/26
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