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 .
DETAILED ACTION
This office action is in response to the filing of the application on 02/04/2023. Since the initial filing, no claims have been amended, added, or canceled, Thus, claim 1-5 are pending in the application.
Claim Objections
Claim 1 is objected to because of the following informalities:
The term “the diameter” lacks antecedent basis; however, this is an objection as the “guide tube” is introduced properly and a tube inherently has a diameter.
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.
At present, no claim limitations are interpreted under 35 USC 112(f).
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 1-5 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 1, the claim recites the limitation “the oral tracheal tube” (ln. 1), “the side” (ln. 2), “the inner wall” (ln. 5), and “the side wall” (ln. 6) and “the end position” (ln. 6). There is insufficient antecedent basis for these limitation in the claim.
Claim 1 further recites the term, “opening for placement of the guide tube or tracheal intubation.” It is unclear what is meant by opening for “tracheal intubation” means as tracheal intubation is a method or medical procedure, not a structural element.
Claim 3 recites the limitation "the depth" (ln. 2). There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "“the middle position” (ln. 3). There is insufficient antecedent basis for this limitation in the claim. It is unclear if claim 5 is requiring a specific middle position. For the purposes of examination, a middle position will be a location between the two end portions.
Claims 2- 5 are rejected as being dependent upon a rejected base claim.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1-2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Kleene (US 2018/0064896) in view of Noyes (US 2022/0184359).
Regarding claim 1, Kleene discloses a device comprising a semicircular tube (Kleene, Fig 2, tube holding device 100 is the semicircular tube; [0054] discloses the cross section of the proximal blade 110 of the tube holding device is generally U-shaped or C-shaped) and a guide tube (Fig 2, flexible tube 107 is the guide tube), the side of the semicircular tube being provided with an opening for placement of the guide tube or tracheal intubation (Fig 6, the side of the tube holding device 100 has two openings 112 which are for placement of the flexible tube 107; See annotated Fig. 6 for convenience below); the diameter of the guide tube is smaller than that of the semicircular tube (Fig 6, the tube holding device 100 must have a larger diameter in order for the flexible tube 107 to fit).
PNG
media_image1.png
496
366
media_image1.png
Greyscale
Kleene does not disclose magnetic portions paired with each other are provided on the inner wall of the semicircular tube as well as on the side wall of the guide tube near the end position.
However, Noyes teaches a similar device including magnetic portions that pair with each other where the magnetic portions are provided on an inner wall of one tube element and a sidewall of another tube element (Noyes, Fig 9, shaft or segment 611; [0169] discloses the shaft or segment 611 has an alternative embodiment 1111 including a curved, open channel 612 or 1112). Noyes also teaches an instrument (Noyes, Fig 9, instrument 600) that is analogous to the semicircular tube via the open channel proving the U-shaped portion (Noyes, Fig 8, 612/1112 provides the open channel). The open channel is made to mount and receive an endoscope (Noyes, Fig 1 and 2, flexible-rigid hybrid endoscope 100) which is analogous to the guide tube of the claimed invention; both the open channel portion and the endoscope have magnetic portions to magnetically pair these parts to one another ([0169] discloses that a magnetic attachment mechanism be used to pair the flexible distal end of the endoscope 140 to the distal end of the instrument 600 with the curved, open channel 612 or 1112).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the semicircular tube and guide tube of Kleene to include magnetic portions paired with each other provided on the inner wall and side wall, as taught by Noyes, as this would have been an obvious substation of one known element for another (substituting the tube retention portion 116 of Kleene to be a magnetic retention as taught by Noyes) and one would expect the modified version to function equally as well. The magnetized portion of the semicircular tube would have a magnet portion on the inner wall and is considered near the middle position (Kleene, Fig 5, tube holding device 100 (acts as the semicircular tube) has a tube retention portion 116 where the flexible tube 107 may be placed in the tube holding device so the surface of the flexible tube makes contact with the inner wall of the tube; [0057] discloses that the tube retention portion is coupled to fit the tip of the flexible tube; See annotated Fig. 5 above for convenience). Use of the magnet portions placed on the inner wall of the tube holding device would allow the magnetic portions of the tube holding device and the side of the flexible tube to be aligned.
PNG
media_image2.png
466
420
media_image2.png
Greyscale
The modified Kleene device includes each structural and functional limitation as claimed such that it would also be for replacing oral tracheal intubation with nasal tracheal intubation.
Regarding claim 2, the modified device of Kleene has the opening extend to two ends of the semicircular tube so that the semicircular tube is U-shaped without external force (Kleene, Fig 6 (see annotated Fig. 6 above) discloses the opening that extended to two ends of a semicircular tube which makes the tube U-shaped without external force; Fig 3 (see annotated Fig 3 below for convenience) shows the cross section of the tube holding device which clearly creates a U shape).
PNG
media_image3.png
228
200
media_image3.png
Greyscale
Regarding claim 5, the modified device of Kleene has the semicircular and flexible tube device as discussed above for claim 1. The modified Kleene device’s magnetic portions (Noyes, Fig 8 and Fig 9, instrument 600 contains an open channel 612 or 1112; [0169] discloses the magnets being located on the surface of the open channel (analogous to the semicircular tube of Kleene)) which are provided on the inner wall of the semicircular tube (Kleene, Fig 5, tube holding device 100 (acts as the semicircular tube) would make contact to the surface of flexible tube 107) near the middle portion (Kleene, Fig 2, tube retention portion 116 is in between the end portions).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kleene in view of Noyes, as applied to claim 1 above, and further in view of Chen (CN 213526988 U).
Regarding claim 3, the modified device of Kleene has the semicircular and flexible tube device as discussed above for claim 1.
The modified device of Kleene does not have the guide tube provided with a scale showing the depth of insertion.
However, Chen teaches a trachea cannula device (Chen, Fig 1 trachea cannula 1) that has a scale line (Chen, Fig 1 shows the scale line 10) that can be used to show the depth of insertion.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified tube device of Kleene to include a scale line as taught by Chen. The scale line can be used to help mark the flexible tube for observation of depth when inserting the tube into the body. Use of the scale line can be used to ensure the tubes are placed into the body at the correct depth.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kleene, Noyes, and Chen, as applied to claim 3 above, and further in view of Trivedi (2022/0218930).
Regarding claim 4, the modified tube device of Kleene has the semicircular and flexible tubes device as discussed in claim 1 above.
The modified tube device of Kleene does not have the guide tube scale is shown as 5-65cm and said guide tube has a length of 65-75cm.
However, Trivedi teaches a similar device that has an elongated tube which includes another insertable tube or stylet with nasal and oral embodiments and include a range of values for the length of the airway management device (Trivedi, Fig 2, airway management device 100). Trivedi further teaches a similar length of 60-70cm for the straightway and an added 13-15cm to the curved portion (Trivedi, Fig 5, curved forward length AB is 14cm and the straight length BC is 65 cm so the total length is 79cm) where the stylet is designed to anatomically align to the base of the tongue and epiglottis and insertion is stopped once the stylet reaches the epiglottis (Trivedi, Fig 4 shows the stylet 112 length that is necessary to reach the glottis; [0058] discloses that the ranges are beneficial for the anatomical curve; [0059] discloses the need to change the sizing with different size ranges in order to accommodate pediatric to obese patients).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Kleene device’s guide tube to have the length of 65-75cm as this appears to be the typical length for such a nasal/oral intubation guide element, as suggested by Trivedi. The modified Kleene device’s guide tube has a length of 65-75cm as taught by Trivedi, and would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the scale of the modified Kleene device to be shown as 5-65cm in light of the length of flexible tube being from 65-75cm as the overall length will be reached for full insertion. Use of the length can allow for the modified device to reach the anatomy necessary and help the user manually keep track of the depth of insertion with a set range to account.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Buchh et al (2024/0157075), Kokotoff et al (2023/0033721), Skirrow et al (2060069806), and Chaudry (20190232007) are all oral or nasal tube devices that has scales.
Kokotoff et al (2023/0033721), Kojima et al (JP 2021029313), Phillips et al (20150157828) are oral or nasal tube devices that have magnetic portions.
Fordinal (20150250967), Zhao (2014/0366887), Kleene (2010/0298644) and Patil et al (5720275) are all oral or nasal tube devices that have a semicircular and/or U-shaped shape.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMIE H. BISHOP whose telephone number is (571)270-1093. The examiner can normally be reached Mon-Thurs: 7:15am-4:15pm; Friday: 7:15-3:15pm.
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, Timothy Stanis can be reached at (571) 272-5139. 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.
/JAMIE H. BISHOP/Examiner, Art Unit 3785
/COLIN W STUART/Primary Examiner, Art Unit 3785
Prosecution Insights