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 .
Response to Amendment
The Amendment filed 05 May 2026 has been entered. Claims 1-4, 8-9, 12-16 and 18-34 are pending in the application with claims 5-7, 10-11 and 17 canceled. Claims 1-4, 8-9, 12, 15 and 18-19 are currently amended with claims 21-34 newly added. Applicant’s amendment to the Claims have overcome some, but not every, objection and 35 U.S.C. 112 rejection previously set forth in the Non-Final Office Action mailed 05 Feb 2026. The remaining issues are restated below.
The prior nonstatutory double patenting rejection is updated based on the amendment to the claims both in the instant application and in the reference application.
It is noted for applicant’s consideration that the initial claim objection in the Non-Final Office action was not specifically requesting applicant to use the language “the/said one or more internal projections”. The citation of the language “the/said” was intended to note that certain claim limitations referred to “the projections” while other claim limitations instead used the alternate terminology “said projections”. The claim objection was aimed at requesting both inclusion of the language “one or more” (which applicant has complied with) and consistency in selecting either the term “the” or the term “said”. Applicant can leave the claim language in its present form of “the/said” but is also welcome to only use one of those two terms.
It is noted that while new claim 21 is a literal combination of prior claims 1 and 11 the claim fails to take into consideration the 35 U.S.C. 112(b) rejection of prior claim 11. Note on Pg. 4 of the Non-Final Office Action that based upon the antecedent basis issues identified in claim 11, which are also present in new claim 21, the claim could only be reasonably read as dependent on claim 10 instead of directly on claim 1. As discussed below, portions of the correction required to new claim 21 are found in claim 28 (which generally corresponds to former claim 10).
Claim Objections
Claim(s) 1-4, 8-9, 12-16, 18-19, 24-25 and 29 is/are objected to because of the following informalities:
Claim 1, Ln. 1 recites “An endotracheal comprising” which should read “An endotracheal tube comprising”
Claim 1, Ln. 6 recites “the\said” which should read “the/said” with the slash direction reversed
Claim 1, Ln. 9 recites “the maximum height” which should read “a maximum height” as it is a first introduction
Claim 24, Ln. 1 recites “on or more” which should read “one or more”
Claim 25, Ln. 3 recites “the maximum height” which should read “a maximum height” as it is a first introduction
Claim 29, Ln. 1 recites “the ET tube” which should read “the endotracheal tube” for consistency with claim 21
Appropriate correction is required.
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(s) 16 and 21-34 is/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 pre-AIA the applicant regards as the invention.
Claim 16 recites the limitation “the endotracheal tube body” in Ln. 1-2. There is insufficient antecedent basis for the limitations in the claim. Claim 1 has been amended to delete reference to a body of the endotracheal tube. Applicant should clarify whether the limitation refers to the hollow tube of claim 1 or whether a body needs to be specifically introduced.
Claim 21 recites the limitations “the main tube body” in Ln. 7 and “the device” in Ln. 8. There is insufficient antecedent basis for the limitations in the claim. It appears the claim is intending to refer to the main body portion recited in former claim 10, which now corresponds to claim 28. The “device” only appears to refer to the claimed endotracheal tube. Thus, for the purposes of examination the claim will be read as requiring the limitations of claim 28 which introduce the main body portion and establish the main body portion as a separate component from the distal tip portion. Applicant should make this full amendment to the claim, drawing upon the limitations of claim 28. Note that the language “the device” in claim 29 should also be addressed.
Claim 28 recites the limitation “the endotracheal tube body” in Ln. 1. There is insufficient antecedent basis for the limitations in the claim. Applicant should clarify whether the limitation refers to the hollow tube of claim 21 or whether a body needs to be specifically introduced.
Claim 31 recites the limitation “the endotracheal tube body” in Ln. 1. There is insufficient antecedent basis for the limitations in the claim. Applicant should clarify whether the limitation refers to the hollow tube of claim 21 or whether a body needs to be specifically introduced.
Claim Interpretation - 35 USC § 112(f)
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: “control mechanism” in claims 19 and 34.
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.
The corresponding structure for the “control mechanism” is best understood from the specification as at least: actuator 107 (¶0105; Fig. 1).
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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-4, 8-9, 12-16, 18, 21-24 and 26-33 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16 and 25 of copending Application No. 18/200,741 in view of Agdanowski (U.S. Patent 4488548). Reference claim 25 includes all limitations of instant claim 1 with the exception of the specificity that the [one or more] internal projections are tapered in at least one direction. Similarly, reference claim 16 includes all limitations of instant claim 21 with the exception of the specificity that the [one or more] internal projections are tapered in at least one direction. Note is made the reference claim 16 lacks antecedent basis for its term “main tube body” and thus must be reasonably read as dependent on reference claim 15 with its recitation of a “main body portion” which would appear to correspond to the intended “main tube” claiming of reference claim 16.
Agdanowski teaches an endotracheal tube (Figs. 1-2 #14; Col. 2, Ln. 65-68) comprising one or more internal projections (Figs. 2-3 #58; Col. 3, Ln. 62 – Col. 4, Ln. 10), said one or more internal projections projecting radially inwardly (Figs. 2-3 #58 radially inward from #36) from an internal wall surface (Figs. 2-3 #36) of a distal tip portion of the endotracheal tube (Fig. 2 #58 at distal tip portion of the tube), wherein the one or more internal projections are tapered in at least one direction (Fig. 2 – longitudinal tapering at opposite ends or Fig. 3 rounded upper tip; Col. 6, Ln. 40-47 – inclined to serve as ramp). Agdanowski teaches a tapering of the internal projections as providing the benefit of supplying a ramp to guide an inner catheter into proper position (Col. 6, Ln. 40-47).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in reference claim 16 or 25 the [one or more] internal projections are tapered in at least one direction in order to provide the benefit of supplying a ramp to guide an inner catheter into proper position in view of Agdanowski.
A further mapping of dependent claims is as follows:
Instant claim 2 vs. limitations in reference claim 1
Instant claims 3-4 vs. Agdanowski (Fig. 2)
Instant claim 8 as obvious in view of Agdanowski (Fig. 2)
Instant claim 9 vs. limitations in reference claim 1
Instant claims 12-14 as obvious in view of Agdanowski (Fig. 2). Note also the obviousness versus instant claims 12-14 rendered by the helically wound, meshed or braided reinforcement structure recited in reference claim 1.
Instant claim 15 vs. Agdanowski (Fig. 2)
Instant claim 16 vs. limitations in reference claim 1
Instant claim 18 vs. limitations in reference claim 18
Instant claim 22 vs. limitations in reference claim 1
Instant claims 23-24 vs. Agdanowski (Fig. 2)
Instant claim 26 as obvious in view of Agdanowski (Fig. 2)
Instant claim 27 vs. limitations in reference claim 1
Instant claim 28 vs. reference claim 16
Instant claims 29-31 as obvious in view of Agdanowski (Fig. 2). Note also the obviousness versus instant claims 12-14 rendered by the helically wound, meshed or braided reinforcement structure recited in reference claim 1.
Instant claim 32 vs. Agdanowski (Fig. 2)
Instant claim 33 vs. limitations in reference claim 1
This is a provisional nonstatutory double patenting rejection.
Claim(s) 19-20 and 34 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16 and 25 of copending Application No. 18/200,741 in view of Agdanowski (U.S. Patent 4488548) and further in view of Poormand (U.S. Pub. 2020/0297957). Reference claims 16 and 25 are silent as to particular structures of the stylet.
Poormand teaches an intubation kit (Figs. 9-11) including a stylet (Figs. 1a-1b; ¶¶0045, 0063-0065) having a pivotable tip located at a distal end of the body (Poormand – Figs. 2a-2b; ¶0046) and a connector (Poormand – Fig. 9; ¶0063). Poormand teaches these structures as common for stylets used in the respiratory art to assist a clinician during patient intubation (¶¶0006-0007, 0063-0065).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in either reference claim 16 or 25 the stylet having a pivotable tip and a connector as those are commonly found structures in stylets used in the respiratory art to assist a clinician during patient intubation in view of Poormand.
Claim(s) 1-4, 8, 12-15, 21-24, 26 and 28-32 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 71 and 76 of copending Application No. 19/107,473 in view of Agdanowski (U.S. Patent 4488548). Reference claim 71 includes all limitations of instant claim 1 with the exception of the specificity that the [one or more] internal projections are tapered in at least one direction. Similarly, reference claim 76 includes all limitations of instant claim 21 with the exception of the specificity that the [one or more] internal projections are tapered in at least one direction (the use of two different materials obviously indicates different buckling properties).
Agdanowski teaches an endotracheal tube (Figs. 1-2 #14; Col. 2, Ln. 65-68) comprising one or more internal projections (Figs. 2-3 #58; Col. 3, Ln. 62 – Col. 4, Ln. 10), said one or more internal projections projecting radially inwardly (Figs. 2-3 #58 radially inward from #36) from an internal wall surface (Figs. 2-3 #36) of a distal tip portion of the endotracheal tube (Fig. 2 #58 at distal tip portion of the tube), wherein the one or more internal projections are tapered in at least one direction (Fig. 2 – longitudinal tapering at opposite ends or Fig. 3 rounded upper tip; Col. 6, Ln. 40-47 – inclined to serve as ramp). Agdanowski teaches a tapering of the internal projections as providing the benefit of supplying a ramp to guide an inner catheter into proper position (Col. 6, Ln. 40-47).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in reference claim 71 or 76 the [one or more] internal projections are tapered in at least one direction in order to provide the benefit of supplying a ramp to guide an inner catheter into proper position in view of Agdanowski.
A further mapping of dependent claims is as follows:
Instant claims 2-4 vs. Agdanowski (Fig. 2)
Instant claim 8 as obvious in view of Agdanowski (Fig. 2)
Instant claims 12-14 as obvious in view of Agdanowski (Fig. 2). Note also the obviousness versus instant claims 12-14 rendered by the helically wound, meshed or braided reinforcement structure recited in reference claim 1.
Instant claim 15 vs. Agdanowski (Fig. 2)
Instant claims 22-24 vs. Agdanowski (Fig. 2)
Instant claim 26 as obvious in view of Agdanowski (Fig. 2)
Instant claim 28 vs. reference claim 76
Instant claims 29-31 as obvious in view of Agdanowski (Fig. 2). Note also the obviousness versus instant claims 12-14 rendered by the helically wound, meshed or braided reinforcement structure recited in reference claim 1.
Instant claim 32 vs. Agdanowski (Fig. 2)
This is a provisional nonstatutory double patenting rejection.
Claim(s) 18-20 and 34 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 71 and 76 of copending Application No. 18/200,741 in view of Agdanowski (U.S. Patent 4488548) and further in view of Poormand (U.S. Pub. 2020/0297957). Reference claims 71 and 76 are silent as to a stylet.
Poormand teaches an intubation kit (Figs. 9-11) including a stylet (Figs. 1a-1b; ¶¶0045, 0063-0065) for guiding an endotracheal tube (Figs. 9-11 #101; ¶0063-0065) during intubation. Poormand teaches a stylet as providing the benefit of assisting a clinician during patient intubation (¶¶0006-0007, 0063-0065).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in reference claim 11 a stylet for guiding the endotracheal tube during intubation in order to provide the benefit of assisting a clinician during patient intubation in view of Poormand.
Allowable Subject Matter
Claims 1-4, 8-9, 12-16 and 18-20 are allowed over the prior art. The claims are subject to the above nonstatutory double patenting rejection.
Claim(s) 21-34 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Some of the claims are additionally subject to the above nonstatutory double patenting rejection.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1, the claim is allowed for having been amended to include the limitations of former claim 7, which was indicated as allowable subject matter in the preceding Office action.
Regarding claim 21, note is made that the claim was written with the intent to capture the allowable subject matter of former claim 11 (Pg. 7-8 of Applicant’s Remarks). It is however found that applicant failed to address the 35 U.S.C. 112(b) rejection of prior claim 11. As such the claim is rejected under 35 U.S.C. 112(b) and the claim is still interpreted as requiring the limitations of former claim 10, now found in claim 28. The instant claim is thus interpreted as introduce the main body portion and establish the main body portion as a separate component from the distal tip portion. With, and only with, that combination of limitations the instant claim is found allowable over the prior art in the same manner discussed of former claim 11 in the preceding Office action.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
Prosecution Insights