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 .
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 rotational mechanism of claims 14 and 18 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 Objections
Claim 1, 3 and 4 are objected to because of the following informalities:
Claim 1, “adjust the orientation of the displayed image when the display is rotated” should be changed to “adjust an orientation of a displayed image when the display unit is rotated”.
Claim 3, “on the housing” should read “on a housing of the attachment assembly”.
Claim 4, “wherein the electrical connectors” should read “wherein electrical connectors”.
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: “an attachment mechanism” in claim 8.
Regarding the attachment mechanism, paragraph [0062] discloses two ball projections. Therefore, the structure determined sufficient to perform the function of connecting the handle to a blade is a pair of ball projections or functional equivalents thereof.
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.
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(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 13, 14 and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 is dependent upon claims 1 and 12 which both cite an automatic image orientation adjustment. However, claim 13 requires user input to change the image orientation. It is unclear how the correction feature and/or image orientation can be both automatic and user required as these two features are mutually exclusive.
Claim 14 requires 360-degree rotation of the display. Claim 14 is dependent upon claim 1 which requires the attachment assembly having radially biased ball projections. It is unclear how the screen would be able to rotate 360 degrees without interference by the structure supporting the ball bearings.
Claim limitation “a rotational mechanism” in claims 14 and 18 has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because no structure is provided in the written description or the figures. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
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, 3 – 6, 8, 9, 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pilbeam et al. (US 2023/0397795 A1) in view of Houser et al. (US 2012/0116388 A1) and in view of Melsky et al. (US 2022/0142708 A1).
Regarding claim 1, Pilbeam discloses a video laryngoscope (100) (Abstract) comprising:
a handle (paragraph [0118] discloses the handle may be part of the control unit ref. 200) configured to facilitate gripping during intubation;
a camera channel (ref. 401) extending along the handle (Fig. 3D);
a blade (ref. 106) configured to slide over and cover the handle (Fig. 1) and the camera channel (Fig. 1), wherein the blade is detachable from the handle after an intubation process (Fig. 1 shows the handle and blade as being separate components, thus detachable);
a camera housing (ref. 410) arranged at a lower end of the handle (Fig. 6), the camera housing including an image sensor (ref. 402) and a light source (ref. 404);
a deflector (ref. 415) positioned between the image sensor and the light source (Figs. 11 – 12B) to minimize light scatter and enhance image quality;
a display unit (ref. 212) removably attached to the handle using a hinge mechanism (paragraph [0136], ref. 214) that allows for adjustable viewing angles;
but is silent regarding an attachment assembly connecting the display unit to the handle, the attachment assembly includes a quick-connect and release mechanism facilitated by radially biased ball projections,
and is also silent wherein the display unit is adapted to automatically adjust the orientation of the displayed image when the display is rotated, facilitating clear viewing in various procedural positions.
Houser teaches a surgical instrument (Abstract) comprising an attachment assembly (Figs. 10A -10B) which includes a quick-connect and release mechanism facilitated by radially biased ball projections (paragraph [0087], ref. 852, Figs. 10A – 10B). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the attachment between the display unit and the handle such that is comprises an attachment assembly connecting the display unit to the handle, the attachment assembly includes a quick-connect and release mechanism facilitated by radially biased ball projections, as taught by Houser, for the purpose of maintaining a connection while still allowing for rotational movement (paragraph [0089]).
Melsky teaches a medical system with endoscopic image orientation (Abstract) comprising controls to automatically process an image and its orientation without user input (paragraph [0098]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the laryngoscope of Pilbeam to include the controls which automatically adjust the orientation of the displayed image when the display is rotted, as taught by Melsky, for the purpose of minimizing required user input and distractions.
Regarding claim 3, Pilbeam in view of Houser and Melsky discloses the video laryngoscope as claimed in claim 1, wherein the display unit includes a user-accessible record button (ref. 206) on the housing (Fig. 4A), enabling clinicians to capture images and videos during use (Pilbeam, paragraph [0139]).
Regarding claim 4, Pilbeam in view of Houser and Melsky discloses the video laryngoscope as claimed in claim 1, wherein a housing of the attachment assembly integrates automatic electrical connectivity with the handle, wherein the electrical connectors within the attachment assembly automatically establish a connection upon aligning and attaching the display unit to the handle (Pilbeam, paragraph [0019]).
Regarding claim 5, Pilbeam in view of Houser and Melsky discloses the video laryngoscope as claimed in claim 1, wherein the display unit includes an output port, enabling connection to external displays for broader visual access during procedures (Pilbeam, paragraph [0016]).
Regarding claim 6, Pilbeam in view of Houser and Melsky discloses the video laryngoscope as claimed in claim 1, wherein the ball projections of the attachment assembly are mechanically biased to extend and retract for securing the display unit in place or releasing it for detachment (Houser, discloses springs for biasing the balls).
Regarding claim 8, Pilbeam in view of Houser and Melsky discloses the video laryngoscope as claimed in claim 1, except wherein the handle includes an attachment mechanism that provides a secure and quickly detachable connection for various blade types. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the laryngoscope of Pilbeam in view of Houser and in view of Melsky to include the same attachment mechanism as taught by Houser such that an attachment mechanism provides a secure and quickly detachable connection for various blade types.
Regarding claim 9, Pilbeam in view of Houser and Melsky discloses the video laryngoscope as claimed in claim 8, wherein the blade is attachable to the handle via the attachment mechanism (as taught by Houser), comprising two radially biased ball projections (Houser, ref. 852) that extend from a center axis of the handle (10) to securely engage with corresponding openings (Houser, Fig. 10A shows an opening or slot) in the blade, the attachment mechanism is adapted to securely hold the blade in place during intubation, and can be pressed to release the blade for detachment after the procedure (Houser, paragraph [0089]).
Regarding claim 11, Pilbeam in view of Houser and Melsky discloses the video laryngoscope as claimed in claim 1, includes a touchscreen interface on the display unit for interactive control over device settings, stored data access, and operational adjustments (Pilbeam, paragraph [0113]).
Regarding claim 12, Pilbeam in view of Houser and Melsky discloses the video laryngoscope as claimed in claim 1, wherein the display unit further comprises an automatic image orientation correction feature configured to adjust the displayed image to a standard upright orientation when the display unit is rotated by approximately 180 degrees, facilitating improved usability during procedures involving patients with elevated body mass index (Pilbeam as modified by Melsky discloses an automatic orientation adjustment of a displayed image).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pilbeam et al. (US 2023/0397795 A1) in view of Houser et al. (US 2012/0116388 A1) and in view of Melsky et al. (US 2022/0142708 A1) and in view of Ouyang et al. (US 2021/0338052 A1).
Regarding claim 7, Pilbeam in view of Houser and Melsky discloses the video laryngoscope as claimed in claim 1, except for further comprising a display cover that wraps around both the display unit and attachment assembly, maintaining sterility throughout the intubation process.
Ouyang teaches an endoscope (Abstract) having a sterile cover (ref. 2002) that wraps around a display and handle of the endoscope (Fig. 20). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the laryngoscope of Pilbeam in view Houser and in view Melsky to include the display cover that wraps around both the display unit and attachment assembly, as taught by Ouyang, for the purpose of maintaining sterility (paragraph [0126]).
Claim(s) 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pilbeam et al. (US 2023/0397795 A1) in view of Houser et al. (US 2012/0116388 A1) and in view of Melsky et al. (US 2022/0142708 A1) and in view of TJELL et al. (US 2024/0074644 A1).
Regarding claim 15, Pilbeam in view of Houser and Melsky discloses the video laryngoscope as claimed in claim 1, except wherein the display unit further comprises password-protected access to stored visual data, requiring a user-defined password to access the stored video files or to connect the video laryngoscope to external computing devices, including personal computers, tablets, and similar devices.
TJELL teaches a medical visualization system (Abstract) comprising password-protected access (paragraph [0032]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the laryngoscope of Pilbeam in view Houser and in view Melsky to include the password-protected access to the laryngoscope, as taught by TJELL, for the purpose of minimizing user mistakes (paragraph [0032]). Note that the password projected access enables the laryngoscope to function in the manner as required by claim 15.
Regarding claim 16, Pilbeam in view of Houser and Melsky and in view of TJELL discloses the video laryngoscope as claimed in claim 15, wherein the display unit includes a default password, wherein the password is configurable by the user to a six-digit combination, thereby enhancing security for patient data protection (TJELL paragraph [0032] discloses a password input which corresponds to a reset password, the reset password being a default password and the password input being user defined).
Claim(s) 17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pilbeam et al. (US 2023/0397795 A1) in view of TJELL et al. (US 2024/0074644 A1).
Regarding claim 17, Pilbeam discloses a video laryngoscope comprising:
a handle with integrated visual transmission capabilities through a camera channel (see remarked Fig. 3D below);
a camera housing (ref. 400) within the camera channel (Fig. 3D) that includes a light source (ref. 404) and an image sensor (ref. 402) separated by a light-absorbing deflector (ref. 415) to reduce glare (paragraph [0186]);
a display unit (ref. 212) that attaches to the handle (Fig. 1B) and is capable of rotating via a hinge (Fig. 4A, ref. 214) to provide optimal viewing angles;
a connection system (ref. 200) between the handle and the display unit that includes a housing with electrical connectors (ref. 112) for instant visual feedback on the display unit (paragraph [0132]); and
but is silent regarding a security feature enabling encryption and password protection for accessing saved images and videos on the video laryngoscope.
TJELL teaches a medical visualization system (Abstract) comprising a security feature enabling encryption (paragraph [0054]) and password protection for accessing systems (paragraph [0032]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the laryngoscope of Pilbeam to include the security feature enabling encryption and password protection to the laryngoscope, as taught by TJELL, for the purpose of minimizing user mistakes (paragraph [0032]).
Regarding claim 19, Pilbeam in view of TJELL discloses the video laryngoscope as claimed in claim 17, wherein the security feature further protects the device's connectivity, preventing unauthorized access or data transfer during or after intubation procedures (the encryption and password protection are fully capable of preventing unauthorized access due to the inherent user limiting capabilities).
Allowable Subject Matter
Claims 2 and 10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 2 and 10 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found to disclose, or suggest a laryngoscope of claim 1 wherein the deflector is detachable and replaceable (claim 2) and wherein the blade is slidable over the camera channel to facilitate attachment and detachment without disrupting the visual transmission of the image sensor (claim 10). Instead, Pilbeam discloses a deflector monolithic with the camera housing and any separation of the blade from the scope would disrupt the electrical connection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
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/TESSA M MATTHEWS/Examiner, Art Unit 3773