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 .
Status of Claims
Applicant’s amendment mailed 10/09/2025 has been entered. Claims 1-4, 6-7, and 32 are pending, claims 3, 4, and 7 have been withdrawn from consideration, and claims 1, 2, 6, and 32 are currently under consideration for patentability under 37 CFR 1.104. Previous objections to the drawings are withdrawn in light of Applicant’s amendments. Response to arguments below.
Claim Rejections - 35 USC § 102
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) 1, 2, and 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kucharski et al. (U.S. 2017/0035277).
With respect to claim 1, Kucharski et al. teaches a medical intubating device comprising:
a camera (22),
a hollow tube (28/23) being configured for housing a second device insertable in and removable from the hollow tube, and
a stylet (para [0083]);
wherein the camera is attached to the hollow tube and to the stylet (FIG. 2A,2B);
wherein the camera has a distal end and a proximal end and wherein the hollow tube has an open distal end and a proximal end, and wherein the distal end of the camera is in near proximity with the open distal end of the hollow tube (FIG. 2A); and
wherein the medical intubating device is configured for guiding placement of an endotracheal tube into the airway of a subject, said medical intubating device being insertable into and removable from the endotracheal tube (intended use, see also para [0068] for discussion of diameter).
With respect to claim 2, Kucharski et al. teaches the second device having a distal end and a proximal end (para [0045]), said second device being placed into the hollow tube, and wherein the position of the camera relative to the second medical device is adjustable by sliding the hollow tube along a proximal-distal axis of the second device or by sliding the second device distally to the open distal end of the hollow tube (para [0076], [0088] for example).
With respect to claim 32, this is considered intended use.
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) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kucharski et al. (U.S. 2017/0035277) in view of Molnar (U.S. 2016/0038014).
Kucharski et al. teaches a device as set forth above. However, Kucharski et al. does not teach a bougie.
With respect to claim 6, Molnar teaches a bougie (78) being placed in a hollow tube (118), and wherein the bougie has a proximal end and a distal end, and wherein the distal end of the bougie protrudes distally from the hollow tube (FIG. 8).
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 Kucharski et al. to include a bougie in the manner taught by Molnar in order to guide the visualization device in side of a patient (para [0067] of Molnar). Modifying Kucharski et al. in this way would result in the bougie protruding distally to the distal end of the camera.
Response to Arguments
Applicant's arguments filed 10/09/2025 have been fully considered but they are not persuasive.
On page 6 Applicant argues Kucharski et al. does not disclose or suggest the intubating device, whatsoever. This is not persuasive. The recitation of “a medical intubating device” in the preamble is nominal and does not function to impart any specific structure beyond what is recited in the body of the claim. The camera of Kucharski et al. is capable of being used as a medical intubating device, and therefore meets the plain meaning of the limitation.
On page 6 Applicant argues Kuchyarski et al. discloses an endoscope configured for an arthroscopic knee surgery. This is not persuasive. Paragraph [0027] of Kucharski et al. states, “[t]he described electronic endoscopes are useful for various operative or therapeutic procedures (e.g., arthroscopy, gall stone intervention, gynecologic endoscopy, kidney stone intervention, otolaryngologic endoscopy, and urologic endoscopy).” Therefore Kucharski et al. specifically discloses the endoscope as capable of being used in multiple locations of a body for different types of procedures.
On page 6 Applicant argues Kucharski et al. does not disclose or suggest the stylet attached to a camera. This is not persuasive. To attach is “to fasten, join, or connect something,” (dicrtionary.cambridge.org). The claim does not require the stylet to be permanently fixed to the camera, merely attached. Kucharski et al. specifically teaches a stylet being joined to the camera via the channel connector 9 at least. Therefore Kucharski et al. meets the plain meaning of the claim.
On page 7, Applicant argues Kucharski et al. does not disclose or suggest the intubating device being insertable into and removable from an endotracheal tube. This is not persuasive. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
On page 7, Applicant argues the feature of being insertable into and removable from an endotracheal tube is a structural feature of the claimed medical intubating device being configured (sized) such that the medical intubating device fits into the endotracheal tube. This is not persuasive. As set forth above, Kucharski et al. discloses the device is between 1.5 mm and 2 mm in diameter. Applicant has provided no evidence or arguments that a 1.5 mm device is not capable of performing the intended use of being insertable into and removable from an endotracheal tube.
On page 7, Applicant argues Kucharski et al. comprises a hub and the endoscope is NOT configured for fitting into an endotracheal tube whatsoever. Applicant further argues the endoscope in Kucharski et al. is not insertable into and removable from the endotracheal tube. This is not persuasive at least because Applicant has provided no specific arguments or evidence that the size or shape of the Kucharski et al. device renders it incapable of being inserted into an endotracheal tube.
On page 8 Applicant argues a person of skill cannot use the endoscope of Kucharski et al. to guide the placement of an endotracheal tube. This is not persuasive because, as set forth above, Applicant has provided no specific evidence or arguments that the Kucharski et al. device is incapable of performing the function beyond merely asserting it cannot.
In response to applicant's argument on page 8 that Kucharski et al. is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both Kucharski et al. and the inventors endeavor are in the field of in vivo visible light imaging. Therefore Kucharski et al. is analogous art.
In response to applicant's argument on page 9 that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
On page 9 Applicant argues Kucharski et al. cannot be modified in view of Molnar because the proposed modifications will render Kucharski et al. inoperable for its intended purpose, which is a knee surgery device. This is not persuasive. As set forth above, paragraph [0027] of Kucharski et al. states, “[t]he described electronic endoscopes are useful for various operative or therapeutic procedures (e.g., arthroscopy, gall stone intervention, gynecologic endoscopy, kidney stone intervention, otolaryngologic endoscopy, and urologic endoscopy).” It is clear from this disclosure that the device of Kucharski et al. is not only a “knee surgery device” but rather is a general small-diameter electronic endoscope.
On page 9, Applicant argues the necessary modifications would include removing the coupling hub and the outer cover from the extendable tip, as well as removing the stylet channel. This is not persuasive at least because it is conjecture. Modifying Kucharski et al. in view of Molnar would merely result in adding a bougie to the device of Kucharski et al.
Conclusion
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/ALEXANDRA L NEWTON/Primary Examiner, Art Unit 3799