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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/26/2025 has been entered.
Status of Claims
New claim 32 recites an integrated monitor. This is directed to the non-elected embodiment of FIG. 4. Therefore claim 32 is withdrawn from consideration.
Applicant’s amendment filed 09/26/2025 has been entered. Claims 1-3, 6-14, and 16-33 are pending, claim 32 is withdrawn from consideration, and claims 1-3, 6-14, 16-31 and 33 are currently under consideration for patentability under 37 CFR 1.104.
Foreign Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copies have been received.
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 latching device (claim 30) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 pressure measuring device (claim 31) 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 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:
A latching device configured to prevent rearward movement of the first operating element that is counter to an actuating direction of the first operating element in claim 30;
A pressure measuring device coupled to the channel, wherein the pressure measuring device is configured to detect an inhalation and exhalation phase of the patient in claim 31.
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.
Claim limitation “a latching device configured to prevent rearward movement of the first operating element that is counter to an actuating direction of the first operating element” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. 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.
Claim limitation “a pressure measuring device coupled to the channel, wherein the pressure measuring device is configured to detect an inhalation and exhalation phase of the patient” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. 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.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3, 5-12, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sadoughi (U.S. 2018/0064895) in view of Grabover et al. (U.S. 2003/0023142) and Matthes (U.S. 2009/0143645).
With respect to claim 1, Sadoughi teaches an intubation aid (100) for inserting a tube (141) into a trachea of a patient, the intubation aid comprising:
a handle (125);
an elongate main part (102) comprising an end that is connected to the handle and a free end (FIG. 1); and
an operating device (135),
wherein the main part is designed to be bent in a first region of the main part when the operating device is actuated (para [0060]), and
wherein the main part further comprises a positioning device (110) which is designed to limit a translational displacement of a tube fitted onto the intubation aid in at least one direction (para [0059]).
However, Sadoughi does not teach the main part is designed to be bent in first and second regions. Sadoughi further does not teach an open channel.
With respect to claim 1, Grabover et al. teaches a visualization device comprising:
a handle (12);
an elongate main part (18,14) comprising an end that is connected to the handle and a free end (FIG. 1), a first region (36), a second region (34) that is separate from the first region and is arranged adjacent to the free end, and a segment (35) between the first and second regions (FIG. 7);
an operating device (16,17),
wherein the main part is designed to be bent in a first region of the main part when the operating device is actuated, wherein the main part is furthermore designed, upon further actuation of the operating device, to be bent in a second region of the main part, which is separate from the first region and is arranged adjacent to the free end of the main part (FIG. 7, para [0023] for example).
With respect to claim 1, Matthes teaches the main part comprises a channel (16) that, at least in part, extends parallel to a longitudinal axis of the main part (FIG. 1 for example) and is suitable for receiving fluid and for conducting the fluid to an end of the channel assigned to the handle (intended use),
wherein the end of the channel assigned to the handle is connectable to a suction unit (suction unit 25 via 40) configured to suction fluid out from the patient via the channel or a gas source configured to deliver a gas to the patient via the channel (para [0029]),
wherein a wall of the main part, viewed in the circumferential direction of the main part, is interrupted such that a gap extends in the longitudinal direction of the main part and connects the channel to an exterior surrounding the main part (FIG.3A-C).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Sadoughi to have two bending regions in the manner taught by Grabover et al. in order to provide a device that is not dependent upon use of passive deflection against tissue in order to properly position the distal end at a desired position (para [0044] of Grabover et al.).
Further, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Sadoughi to have an open channel in the manner taught by Matthes in order to provide a means of releasing a tool located in the channel without the need for withdrawing the scope (para [0030] of Matthes).
With respect to claim 2, Sadoughi teaches the positioning device comprises a holding device (110) which is designed to engage with a segment of the tube in order to secure the latter, at least translationally, relative to the main part (para [0030]).
With respect to claim 6, Sadoughi teaches the main part has a tapering segment arranged adjacent to the free end of the main part (para [0031], see also FIG. 1).
With respect to claim 7, Sadoughi teaches the main part has a tapering segment arranged adjacent to the free end of the main part (para [0031], see also FIG. 1) and the channel extends from the end associated with the handle to the tapering segment of the main part (FIG. 1, para [0031]).
With respect to claim 8, Sadoughi teaches an imaging unit (305), which is designed to record and forward imaging data, is arranged on the free end of the main part (FIG. 3A).
With respect to claim 9, Sadoughi teaches an illumination device (310), which is designed to emit light, is arranged at the free end of the main part (FIG. 3A).
With respect to claim 10, Grabover et al. teaches wherein the first bendable area is arranged at any suitable of length (para [0037]).
With respect to claim 11, Grabover et al. teaches wherein planes in which the main part is capable of being curved in the first region and in the second region are essentially parallel to one another (FIG. 7).
With respect to claim 12, Grabover et al. teaches the first region is capable of being bent from 0 to 30 degrees and/or the second region is capable of being bent from -60 to 40 degrees (para [0038]-[0039]).
With respect to claim 13, Grabover et al. teaches the operating device comprises at least a first operating element (17) and a second operating element (16), wherein the first operating element is designed for deflecting the first region of the main part and the second operating element is designed for deflecting the second region of the main part (para [0042]),
With respect to claim 16, Sadoughi teaches the handle comprises the operating device (FIG. 1).
With respect to claim 17, Sadoughi teaches the holding device is embodied as a locking unit (110) that engages the segment of the tube in a positive fit (para [0059]).
With respect to claim 18, Matthes teaches the end of the channel assigned to the handle is connectable to the gas source, and the gas source is an oxygen source designed to deliver oxygen to the patient via the channel (para [0029]).
With respect to claim 19, Sadoughi teaches the tapering segment is arranged between the free end of the main part and the second bendable region of the main part (FIG. 1).
With respect to claim 20, Sadoughi teaches the imaging unit is an imaging sensor (305).
With respect to claim 21, Sadoughi teaches an illumination device (310), which is designed to emit light onto the region to be recorded by the imaging unit, is arranged at the free end of the main part (FIG. 3A).
With respect to claim 22, Grabover et al. teaches the planes are coinciding (FIG. 7 for example).
With respect to claim 23, Grabover teaches the first bendable area is arranged at a any suitable distance (para [0037]).
With respect to claim 24, Grabover teaches the main part is designed to be bent only in the first region when the operating device is actuated, and the main part is designed to be bent only in the second region upon the further actuation of the operating device (para [0042] for example).
With respect to claim 25, Grabover et al.teaches the main part further comprises a segment (14) between the handle and the first region, the first region is capable being bent in a first direction up to a non-zero angle a relative to the segment between the handle and the first region, the second region is capable of being bent in the first direction up to a non-zero angle B relative to the segment between the first and second regions, and the second region is capable of being bent in a second direction that is opposite to the first direction up to a non-zero angle y (FIG. 7).
With respect to claim 26, Sadoughi teaches the locking device can be any suitable device that secures the ET tube onto the probe (para [0064]). It would be obvious to one of ordinary skill that this would include a cone-based friction fit.
With respect to claim 27, Grabover et al. teaches actuation of the operating device is capable of bending the first region of the main part in a first radial direction up to an angle a relative to the longitudinal axis of the main part but is not capable of bending the first region of the main part in a second radial direction relative to the longitudinal axis of the main part; andthe second radial direction is a direction opposite the first radial direction (FIG. 7).
With respect to claim 28, Grabover et al. teaches actuation of the operation of the operating device is capable of bending the second region of the main part in the first radial direction up to an angle j relative to the longitudinal axis of the main part and is capable of bending the second region of the main part in the second radial direction up to an angle y relative to the longitudinal axis of the main part (FIG. 7).
With respect to claim 29, Grabover et al. teaches actuation of the operating device is capable of bending the first region of the main part up to 30° in the first radial direction relative to the longitudinal axis of the main part; and actuation of the operation of the operating device is capable of bending the second region of the main part up to 45° in the first radial direction relative to the longitudinal axis of the main part and is capable of bending the second region of the main part up to 60° in the second radial direction relative to the longitudinal axis of the main part (FIG. 7).
With respect to claim 30, Grabover et al. teaches a first cable pull (24) that couples the first operating element to the first region of the main part; a second cable pull (25) that couples the second operating element to the second region of the main part; and a latching device (22) configured to prevent rearward movement of the first operating element that is counter to an actuating direction of the first operating element (para [0023] for example).
With respect to claim 33, Matthes et al. teaches the interior of the tube closes off the channel over apportion of the main part (FIG. 3A) and enables fluid to be suctioned from or gas to be delivered to the free end of the main part (intended use).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sadoughi (U.S. 2018/0064895) in view of Grabover et al. (U.S. 2003/0023142) and Matthes (U.S. 2009/0143645) as applied to claim 1 above and further in view of Alonso Babarro (U.S. 2022/0355052).
Sadoughi in view of Karlsson et al. and Matthes teaches an intubation aid as set forth above. However, Sadoughi does not teach the end channel is connectable to a suction unit.
With respect to claim 3, Alonso Babarro teaches wherein the end the channel assigned to the handle is connectable to a suction unit and a virus and bacteria filter suitable for filtering viruses and bacteria from the fluid suctioned out from the patient (para [0221]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Sadoughi to utilize the suction unit of Alonso Babarro in order to allow drainage without exposing the user to any emissions of fluid, dropets, or aerosols (para [0221] of Alonso Babarro).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sadoughi (U.S. 2018/0064895) in view of Grabover et al. (U.S. 2003/0023142) and Matthes (U.S. 2009/0143645) as applied to claim 1 above and further in view of Ouyang et al. (U.S. 2012/0289858).
With respect to claim 14, Sadoughi teaches the intubation aid comprises a communication module designed to communicate with an external unit (para [0050]).
However, Sadoughi does not explicitly teach the communication module is arranged in the handle of the intubation aid.
With respect to claim 14, Ouyang et al. teaches an imaging device with a communication module (3213) arranged in the handle of the device (FIG. 32).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Sadoughi to have the communication module in the handle of the device as taught by Ouyang et al. because there are only a finite number of locations within the endoscope the communication module could be located, and one of ordinary skill in the art could have pursued these known locations with a reasonable expectation of success.
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sadoughi (U.S. 2018/0064895) in view of Grabover et al. (U.S. 2003/0023142) and Matthes (U.S. 2009/0143645) as applied to claim 1 above and further in view of Qiu (U.S. 2009/0044799).
Sadoughi teaches an intubation aid as set forth above. However, Sadoughi does not teach a pressure measuring device.
With respect to claim 31, Qiu teaches a pressure measuring device configured to detect an inhalation and exhalation phase of the patient (para [0041]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Sadoughi to include a pressure measuring device as taught by Qiu in order to distinguish the trachea from the esophagus (para [0041]).
Response to Arguments
Applicant's arguments filed 09/26/2025 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to Karlsson are moot.
Applicant’s arguments that Sadoughi does not provide an enabling disclosure, this is not persuasive. As set forth in MPEP 716.01(c), “[o]bjective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexandra Newton Surgan whose telephone number is (571)270-1618. The examiner can normally be reached Monday-Friday 8am-4pm EST.
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/ALEXANDRA L NEWTON/ Primary Examiner, Art Unit 3799