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
This office action is in response to the amendment filed 12/15/2025. As directed by the amendment, claims 1-7, 9-11 and 13-20 have been amended. Claims 1-20 are pending in the instant application.
Applicant has amended the drawings to address the objections thereto, which are hereby withdrawn.
Applicant has amended the claims to address minor informalities; the previous objections to the claims are withdrawn.
Applicant has amended the claims such that a human organism is no longer positively recited; the rejections under 35 USC 101 are withdrawn.
The amendment of claim 13 does not fully address the rejection thereof under 35 USC 112(a)/first paragraph, because claim 13 still depends from claim 10, and the specification as originally filed does not depict/support the ratchet mechanisms of Figs. 28A-B and 43 in combination with the “grommet” embodiment of claim 10 [they are depicted in combination with the pivotally-interconnected embodiment of claim 4]. The rejection under 35 USC 112(a)/first paragraph is updated below.
Applicant has amended claims 1-3, 5, 6, 11 (in part), 17 and 18 to address the previous rejections thereof under 35 USC 112(b)/second paragraph. However, indefinite issues still remain with regards to claims 10, 14 and 15; the rejections under 35 USC 112(b)/second paragraph are updated below, where any rejection not maintained/ updated below has been withdrawn.
Applicant has amended claims 19 and 20 to be properly further limiting; the rejections under 35 USC 112(d)/fourth paragraph are withdrawn.
Response to Arguments
Applicant's arguments filed 12/15/2025 (hereinafter “Remarks”) have been fully considered but they are not persuasive.
On pages 12-13 of Remarks, Applicant argues that the instant use of “grommet” to describe a c-shape device rather than a ring/loop is not indefinite, asserting that the instant two-piece configuration is similar to “a strain relief bushing.”
The Examiner respectfully notes that the definition supplied by Applicant on the bottom of page 12 of Remarks reinforces that a grommet “is a ring,” whereas the claimed “one or more semi-cylindrically or c-shaped grommets” only form a ring when two are used together, e.g. instant Fig. 32B, yet the scope of claim 10 (“one or more”) encompasses just one “semi-cylindrically or c-shaped grommet.” The two-piece devices described on page 13 of Remarks are acknowledged by Applicant as being “strain relief bushings.” A bushing is not the same as a grommet, because a grommet is ring-shaped, whereas a bushing can be c-shaped or two separate pieces, see the attached definitions of grommets versus bushings. Applicant’s amendment to the specification introduces new matter, and it does not resolve the indefinite issue with regards to claim 10, because it is still unclear whether the claimed “grommet” reads on a single c-shaped element/is not required to form a ring, or whether formation of a ring shape (a la instant Fig. 32B) is required. The Examiner notes that instant para [0114] recites: “grommet 1205…formed by a pair of elongate c-shaped cylindrical grommet halves or sections 1221”, such that the body of the specification describes the carriage member or collar comprising either one “grommet” or two “semi-cylindrically or c-shaped grommet halves or sections,” but not “one or more semi-cylindrically or c-shaped grommets” as currently claimed.
On page 14 of Remarks, Applicant states that claim 15 was amended to depend on claim 2 and to recite a locking mechanism in addition to the release mechanism, asserting that “the structure to which each apparatus corresponds has been clarified and requests that the rejections of claims 14 and 15 under 35 USC 112(f)…and 35 USC 112(b)…be withdrawn.”
First, the Examiner respectfully notes that the interpretation under 35 USC 112(f) is not a rejection. Second, Applicant did not indicate what structure(s) is/are intended to correspond to the claimed “mechanisms,” such that the rejections under 35 USC 112(b)/second paragraph with regards to claims 14 and 15 have not been addressed. As such, claims 14 and 15 continue to be interpreted under 35 USC 112(f)/sixth paragraph, and the rejections under 35 USC 112(b)/second paragraph with regards to claims 14 and 15 are updated below.
Applicant argues on page 16 of Remarks that “Kanowitz…is not a proper reference…inasmuch as it falls within the exceptions set forth in both 35 USC 102(b)(2)(A)…102(b)(2)(C)….the Examiner cannot establish a prima facie case of obviousness based upon an exempt reference (Kanowitz).”
The Examiner respectfully notes that the applied Kanowitz reference has a publication date of 09/29/2016. The priority date of the instant application is 03/09/2020, almost 3.5 years later. Therefore, the applied Kanowitz reference is available as a prior art reference under 102(a)(1), and the relevant exemptions under 35 USC 102(b)(1) (not 35 USC 102(b)(2) as contested by Applicant) do not apply, because the disclosure of the applied Kanowitz reference was more than a year before the effective filing date of the claimed invention. Therefore, the applied Kanowitz reference is not an exempt reference, and the rejections in view of the applied Kanowitz reference are maintained/ updated below.
Pages 16-17 of Remarks contain no further substantive arguments regarding the dependent claims; therefore, the previous art rejections are maintained/updated below.
Specification
The amendment filed 12/15/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the specification as originally filed contains no mention of the term grommet “describe[ing] or defin[ing] a device similar in configuration to a surgical or electrical grommet” (no surgical or electrical grommet was originally disclosed, and what is the scope of “similar”?) and the amendment, as best understood, attempts to redefine the disclosed “grommet” as a two piece strain relief bushing, but the functionality of a strain relief bushing was not present in the specification as originally filed.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claims 11 and 17 are objected to because of the following informalities:
Regarding claim 11, line 2 should read either “each semi-cylindrically or c-shaped grommet” or “each
Regarding claim 17, in light of the other amendments to consistently recite alternative language, it appears that lines 3 and 7 should read “the support member or frame” (two instances)
Appropriate correction is required.
Claim Interpretation
Regarding claim 1, an airway device that is flexible will be considered “adapted to conform to a patient’s trachea after it is installed” as a result that flows from its flexibility, since the specification as originally filed includes no additional information regarding any particular structural and/or material requirements regarding this functionality.
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 securing device” in claim 1, “a release mechanism” in claim 14, “a locking mechanism” and “a release mechanism” in claim 15, “a lateral position adjustment mechanism” in claim 16, and “an attachment apparatus” in claim 17.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 13 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Regarding claim 13, the specification as originally filed discloses an adjustable ratchet mechanism comprising ratchet teeth 1137 (Figs. 28A-B; para [0111]) or ratchet teeth 1685 (Fig. 43; para [0124]). However, neither of these ratchet mechanisms are associated with the “grommet” embodiment, see discussion of claim 10 below, from which claim 13 depends. Therefore, the specification as originally filed lacks written description for the combination of features/embodiments recited in claim 13. Applicant could address this rejection by amending claim 13 to depend from claim 2 or 4.
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 10-14 and 17 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 10 (and its dependent claims 11-14), the term “grommet” is not used according to its typical definition of a ring- or loop-shaped item, because a ring/loop is not a semi-cylindrical/c-shape, it is a closed shape. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). Moreover, while instant Figs. 30-32C depict “semi-cylindrically or c-shaped grommet sections 1221,1221’” that are halves of a ring-shaped item and not permanently connected, e.g. they are not connected by a hinge, claim 10 only recites “one or more…grommets” (emphasis added) such that claim 10 is not understood to be restricted to this embodiment, rendering unclear whether the claimed carriage member/collar must be a closed ring-shape or whether it can be a c-shape, i.e. by virtue of comprising just one semi-cylindrically or c-shaped “grommet.” For purposes of compact prosecution, both interpretations will be applied in the art rejections below.
The claim limitation “a release mechanism” in claims 14 and 15 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. Claims 14 and 15 recite two different “release mechanisms;” however, it is unclear in the specification to what structures the “release mechanisms” in claims 14 and 15 correspond, because instant Figs. 28A-29B and 43-45B are understood to be the inventive release mechanisms, i.e. a button/lever that allows the distance between cylindrical members of a hinged carriage member/collar to be adjusted while the carriage member/collar is positioned within/enclosed by the securing device/tower structure, and a button/lever that pushes the flanged side of a spring-biased, hinged carriage member/collar away from the inner flanges on one side of the securing device/tower structure to allow the carriage member/collar to be moved within the securing device/tower structure, respectively, but claims 14 and 15 depend from claim 10, which refers to the “grommet” embodiment of Figs. 30-32C, which is not disclosed as having similar release mechanisms. At best, the “grommet” embodiment has clasps 1252,1252’ and a latch 1125 (Fig. 31A), although latch 1125 itself does not “selectively position the carriage member within the clamping member,” such that it is unclear if these elements in Fig. 31A are intended to constitute the claimed release mechanisms, or if the dependency is incorrect and claims 14-15 were intended to depend from claim 2 (and thus be directed to the embodiments of Figs. 28A-29B and 43-45B). Therefore, the claims are indefinite and are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For purpose of examination, clasps/latches will be considered to read on the claims, since they are mechanisms associated with the grommet embodiment and claims 14-15 depend from claim 10, which refers to the grommet embodiment.
To address this rejection, Applicant may:
(a) Amend the claims so that the claim limitations 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 claims, 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 17 recites the limitation "the securing apparatus" in the last line thereof. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the claim will be considered to read “the securing device”.
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.
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(s) 1-3, 10, 11, 13 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kanowitz (US 2016/0279367 A1; hereinafter “Kanowitz”) in view of Van der Vegt et al. (EP 3,572,111 A1; hereinafter “Van der Vegt”).
Regarding claim 1, Kanowitz discloses an airway stabilization system (airway stabilization system 1) (Fig. 1) for securing an airway device (e.g. airway device 100) adapted to maintain an airway in a patient, the patient having a head, a face, a chin, a chest, a mouth, an oral cavity, vocal cords or larynx, a thoracic area, a trachea having a length and forming an airway in the patient, and a carina defining a point at which the trachea separates into a left and a right bronchial tube (Figs. 9-10; where nothing would preclude the use of the airway device in animals), the airway stabilization system comprising:
an airway device (airway device 100) (Figs. 1 and 3) having a flexible elongate body (flexible member or body portion 102) (Fig. 3; para [0052]) having a longitudinal axis (along axis 37) (Figs. 1 and 3), the flexible body being adapted to conform to the patient’s trachea after it is installed in a preselected position in the patient (by virtue of being flexible, see para [0052]), the flexible body including a continuous sidewall having outer and inner surfaces extending between a proximal (patient-end) (proximal end portion 104) and a distal (machine-end) (distal end portion 106) portion thereof, thereby forming a hollow conduit or airway (Fig. 3; paras [0019] and [0052]);
a support member or frame (face plate 12) securable to the patient (Figs. 1-2 and 9-10; para [0047]);
a securing device or tower structure (restraining device or tower 30) secured to the support member or frame and extending outwardly therefrom along the longitudinal axis of the airway device in a direction that is configured to be away from the patient’s face (Figs. 1-2 and 9-10; para [0048]); and
a carriage member or collar (collar 120) adjustably positioned in the support member or tower structure and adapted to receive the airway device in securing engagement therewith (Figs. 1 and 3-5; paras [0048-49]), the carriage member or collar being adapted to secure the airway device and to cooperate with the securing device or tower structure to maintain the airway device in the preselected position in the patient and to prevent movement thereof as a result of multidirectional forces being applied to the airway device (paras [0048-51], [0057] and [0060]).
Kanowitz is silent regarding the securing device or tower structure being adjustably secured to the frame or support member. However, Van der Vegt demonstrates that it was well known in the airway stabilization art before the effective filing date of the claimed invention for a securing device/tower structure (retainer 5) (Figs. 1-2) to be adjustably secured to the frame or support member (support member 3) (paras [0025-26] and [0041]; see also para [0006]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Kanowitz to include wherein the securing device or tower structure is adjustably secured to the frame or support member as taught by Van der Vegt, in order to provide the predictable result of a known means for securing the airway device/endotracheal tube at a plurality of locations relative to the support for access and/or patient comfort (Van der Vegt paras [0006] and [0042]).
Regarding claim 2, Kanowitz in view of Van der Vegt teaches the airway stabilization system of claim 1 wherein Kanowitz further discloses wherein the securing device or tower structure (30) includes a pair of oppositely disposed pivotally interconnected c-shaped collars or clamshells (collars 32, 34) (Fig. 2; para [0048]), each c-shaped collar or clamshell having a first end (top end in Fig. 2) and a second end (bottom end in Fig 2) and a body portion extending therebetween (Fig. 2), the body portion having an inner surface (inner surface 68) and an outer surface (outer surface 66), the inner surface of at least one of the c-shaped collars or clamshells including a plurality of uniformly spaced-apart annular flanges (flanges 72) positioned axially along the inner surface of the body portion and extending inwardly therefrom (Fig. 2; para [0049], and also see para [0054]), and a plurality of structural recesses (structural recesses 74) positioned axially along the inner surface of the body portion intermediate an adjacent two of the plurality of uniformly spaced-apart annular flanges of the at least one of the pair of oppositely disposed pivotally interconnected c-shaped collars or clamshells (Fig. 2; para [0049]).
Regarding claim 3, Kanowitz in view of Van der Vegt teaches the airway stabilization system of claim 2 wherein Kanowitz further discloses wherein the inner surfaces of each of the pair of oppositely disposed pivotally interconnected c-shaped collars or clamshells includes a plurality of uniformly spaced-apart annular flanges (flanges 72) positioned axially along the inner surface of the body portion and extending inwardly therefrom Fig. 2; para [0049], and also see para [0054]), and a plurality of structural recesses (structural recesses 74) positioned axially along the inner surface of the body portion intermediate an adjacent two of the plurality of uniformly spaced-apart annular flanges of each of the pair of oppositely disposed pivotally interconnected c-shaped collars or clamshells (Fig. 2; para [0049]).
Regarding claim 10, Kanowitz in view of Van der Vegt teaches the airway stabilization system of claim 3 wherein Kanowitz further discloses wherein the carriage member or collar comprises one c-shaped “grommet” (collar 120) (Fig. 4), being positioned within and operatively connected to the c-shaped collars or clamshells of the securing device or tower structure and configured to extend outwardly from the patient’s face coaxially with the longitudinal axis of the airway device (Figs. 1, 5 and 10; para [0051]).
Regarding claim 11, Kanowitz in view of Van der Vegt teaches the airway stabilization system of claim 10 wherein Kanowitz further discloses wherein the/each c-shaped “grommet” has first and second ends (top and bottom ends in Fig. 4) and a body portion having an inner surface (inner surface of 120 in Kanowitz Fig. 4) and an outer surface (outer surface of 120 in Kanowitz Fig. 4) extending therebetween (Kanowitz Fig. 4), the outer surface of the “grommet” including at least one annular flange (annular flanges or ribs 122) extending radially outwardly from the outer surface and adapted to operatively interact with one of the plurality of structural recesses formed intermediate the uniformly spaced-apart annular flanges positioned axially along the inner surface of at least one of the clamshells (Kanowitz Figs. 1-2; paras [0049] and [0054]).
Regarding claim 13, Kanowitz in view of Van der Vegt teaches the airway stabilization system of claim 10 but modified Kanowitz is silent regarding wherein the carriage or collar includes an adjustable ratchet mechanism adapted to releasably clamp airway devices of different flexible body sizes. However, Van der Vegt further teaches that it was known in the airway stabilization art before the effective filing date of the claimed invention for a securing device or tower structure (retainer 5) (Figs. 1, 7 and 9) to include an adjustable ratchet mechanism (comprising teeth 55) adapted to releasably clamp airway devices of different flexible body sizes (paras [0051-54]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Kanowitz to include wherein the securing device or tower structure includes an adjustable ratchet mechanism adapted to releasably clamp airway devices of different flexible body sizes as taught by Van der Vegt, in order to provide the predictable result of utilizing a known mechanism to allow the system to accommodate different diameter lines (Van der Vegt para [0054]).
Regarding claim 15, Kanowitz in view of Van der Vegt teaches the airway stabilization system of claim 10 wherein Kanowitz further discloses, as best understood, further including a locking mechanism (interlocking feature 42 comprising the latches/locking members labeled 43 in Fig. 2) adapted to releasably lock the pivotally interconnected c-shaped collars or clamshells together circumferentially around the carriage member or collar in stabilizing and supporting engagement therewith (Fig. 2 in view of para [0048], where the latches/locking members labeled 43 in Fig. 2 are understood to releasably lock into the openings/locking members labeled 45 in Fig. 2 to provide the claimed functionality) and a release mechanism (comprising quick-release actuator or button 43) adapted to selectively position the carriage member or collar within the securing device or tower structure (Fig. 2; para [0048], where the collars 32 and 34 can be opened/released and the carriage member selectively positioned therein).
Regarding claim 16, Kanowitz in view of Van der Vegt teaches the airway stabilization system of claim 1 wherein Van der Vegt further educates modified Kanowitz to include wherein the airway stabilization system includes a lateral position adjustment mechanism (comprising connector 31 and rails 21) adapted to laterally adjust the position of the securing device or tower structure on the support member or frame (Van der Vegt Figs. 1-2; para [0041]), in order to provide the adjustability discussed above regarding claim 1.
Regarding claim 17, Kanowitz in view of Van der Vegt teaches the airway stabilization system of claim 16 wherein Kanowitz further discloses wherein the support member or frame (12) comprises a body (comprising sections 14 and 16) having a symmetrical configuration adapted to conform to the patient’s face (Kanowitz Fig. 2, where the body is symmetrical and curved to conform as claimed), the frame including an upper or outer surface configured to face away from the patient (facing up in Fig. 2; see Figs. 9-10) and a lower or bottom surface facing toward the patient (facing down in Fig. 2; see Figs. 9-10), the upper and lower surfaces being interconnected by a pair of oppositely disposed, spaced apart side portions of the body (opposing vertical edges connecting the front/upper and rear/lower surfaces of the frame) and wherein the frame further comprises first and second oppositely disposed end portions (left and right portions of the frame in Fig. 2), each of the first and second oppositely disposed end portions including at least one aperture or slot (aperture or slot 19) formed therein and adapted to receive an attachment apparatus or strap (strap 13) configured to secure the securing [device] to the patient’s head (Fig. 9; para [0047]).
Regarding claim 18, Kanowitz in view of Van der Vegt teaches the airway stabilization system of claim 17 wherein Kanowitz further discloses wherein the support member or frame includes a cheek pad or layer of cushioning material (cushioning layer 15) secured to the lower or bottom surface of the frame at each of the first and second oppositely disposed end portions (Figs. 1-2; para [0048]), but modified Kanowitz is silent regarding wherein the cheek pads/cushioning layers are releasably secured to the lower surfaces; however, Van der Vegt further teaches that it was known in the airway stabilization art before the effective filing date of the claimed invention for cheek pads/cushioning layers (pads 13) (Figs. 1-2) to be releasably secured to the lower/rear surfaces (facing away from the viewer in Van der Vegt Fig. 1) (pads 13, removably attached to the main member, Van der Vegt para [0036]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Kanowitz to further include wherein the cheek pads/cushioning layers are releasably secured to the lower surfaces as further taught by Van der Vegt, in order to provide the predictable result of pads that can be changed out/replaced when soiled.
Regarding claim 19, Kanowitz in view of Van der Vegt teaches the airway stabilization system of claim 18 wherein Kanowitz further discloses wherein the cheek pad or layer of cushioning material is a waterproof material (rubber, para [0048]).
Claim(s) 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kanowitz in view of Van der Vegt as applied to claim 2 above, and further in view of Wells (US 5,862,801; hereinafter “Wells”).
Regarding claim 4, Kanowitz in view of Van der Vegt teaches the airway stabilization system of claim 2 wherein Kanowitz further discloses wherein the carriage member or collar (120) includes an elongate c-shaped cylindrical member (Fig. 4), positioned within and operatively connected to the c-shaped collars or clamshells and extending outwardly from the patient’s face coaxially with the longitudinal axis of the airway device (Figs. 1, 4 and 10), but modified Kanowitz is silent regarding a pair of pivotally interconnected elongate c-shaped cylindrical members, each cylindrical member being positioned within and operatively connected to a respective one of the c-shaped collars or clamshells. However, Wells teaches that it was known in the airway stabilization art before the effective filing date of the claimed invention for a member that surrounds an endotracheal tube to either be a single c-shaped cylindrical member similar to that of Kanowitz Fig. 4 (see Wells Fig. 4) or to comprise a pair of pivotally interconnected elongate c-shaped cylindrical members (portions 14, 16) (Wells Figs. 2-3), such that it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Kanowitz to include a pair of pivotally interconnected elongate c-shaped cylindrical members as taught by Wells, each cylindrical member being positioned within and operatively connected to a respective one of the c-shaped collars or clamshells given Kanowitz Figs. 1-2 in view of Wells Figs. 2-3, in order to provide the predictable result of a known (hinged) collar arrangement for suitably connecting the collar of Kanowitz to the airway device/endotracheal tube thereof, e.g. one where there is no need to snap the device onto the tube (Wells col. 3, lines 3-7).
Regarding claim 5, Kanowitz in view of Van der Vegt and Wells teaches the airway stabilization system of claim 4 wherein modified Kanowitz teaches wherein each of the elongate c-shaped cylindrical members includes first and second ends (top and bottom ends of Kanowitz Fig. 4, when modified to have a hinge opposite channel 123 as taught by Wells Fig. 3 as discussed above regarding claim 4) and a body portion having an inner surface (inner surface of 120 in Kanowitz Fig. 4) and an outer surface (outer surface of 120 in Kanowitz Fig. 4) extending therebetween (Kanowitz Fig. 4), the outer surface of at least one of the pair of elongate c-shaped cylindrical members including at least one annular flange (annular flanges or ribs 122) extending radially outwardly from the outer surface and being adapted to operatively interact with one of the plurality of structural recesses formed intermediate the substantially uniformly spaced-apart annular flanges positioned axially along the inner surface of the at least one of the c-shaped collars or clamshells (Kanowitz Figs. 1-2; paras [0049] and [0054]).
Regarding claim 6, Kanowitz in view of Van der Vegt and Wells airway stabilization system of claim 5 wherein modified Kanowitz teaches wherein the outer surface of the at least one of the pair of elongate c-shaped cylindrical members (Kanowitz Fig. 4, when modified to have a hinge opposite channel 123 as taught by Wells Fig. 3 as discussed above regarding claim 4) includes at least one annular flange (annular flanges or ribs 122) extending radially outwardly from the outer surface thereof and adapted to operatively and releasably interact with one of the plurality of structural recesses formed intermediate the substantially uniformly spaced-apart annular flanges positioned axially along the inner surface of the at least one of the c-shaped collars or clamshells, thereby providing for vertical adjustment of the airway device in the patient’s trachea (Kanowitz Figs. 1-2; paras [0049], [0054] and [0057-60]; where collars 32, 34 can be opened, the collar 120 moved up or down, and the collars 32, 34 closed again to provide the claimed operable and releasable interaction/vertical adjustment).
Regarding claims 7-8, Kanowitz in view of Van der Vegt and Wells airway stabilization system of claim 5 but modified Kanowitz is silent regarding wherein the inner surface of at least one of the pair of elongate c-shaped cylindrical members is coated with an adhesive material, particularly a pressure sensitive adhesive (PSA) adapted to adhesively engage the outer surface of the airway device. However, Wells further teaches that it was known in the airway stabilization art before the effective filing date of the claimed invention to include wherein the inner surface (inner surface 24) of at least one of the pair of cylindrical members (portions 14, 16) is coated with an adhesive material (pressure sensitive adhesive 22), particularly a pressure sensitive adhesive (PSA) adapted to adhesively engage the outer surface of the airway device (Fig. 3; col. 3, lines 42-45). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Kanowitz to include wherein the inner surface of at least one of the pair of cylindrical members is coated with an adhesive material, particularly a pressure sensitive adhesive (PSA) adapted to adhesively engage the outer surface of the airway device as further taught by Wells, in order to utilize well known means to provide the predictable result of ensuring that the collar is held in position on the airway device/endotracheal tube (Wells col. 3, lines 42-45).
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kanowitz in view of Van der Vegt and Wells as applied to claim 7 above, and further in view of Russo (US 2009/0211573 A1; hereinafter “Russo”).
Regarding claim 9, Kanowitz in view of Van der Vegt and Wells airway stabilization system of claim 7 wherein modified Kanowitz teaches wherein the adhesive material is a bonding agent adapted to be applied or injected into an interface intermediate the outer surface of the airway device and the inner surface of the at least one of the pair of elongate c-shaped cylindrical members (adhesive applied between the outer surface of the airway device/endotracheal tube and the inner surface of the modified collar of Kanowitz as taught by Wells, as discussed above regarding claim 7), but modified Kanowitz is silent regarding wherein the bonding agent is a permanent bonding agent. However, it has been held to be within the general skill of one in the art to select a known material on the basis of its suitability for the intended use, see MPEP 2144.07, and Russo demonstrates that it was well known in the airway stabilization art before the effective filing date of the claimed invention to utilize a permanent bonding agent (adhesive 44) (Figs. 3-4; adhesive 44 that can permanently…adhere to an endotracheal tube 45, para [0030]) to attach a collar (comprising strip 22) to the outer surface of an airway device (endotracheal tube 45). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Kanowitz to include wherein the bonding agent is a permanent bonding agent as taught by Russo, in order to utilize a known material to provide the predictable result of securely adhering the collar to the airway device/endotracheal tube, to prevent relative movement therebetween.
Claim(s) 10 (alternatively), 11, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kanowitz in view of Van der Vegt as applied to claim 3 above, and further in view of Kang (US 2008/0092901 A1; hereinafter “Kang”).
Regarding claim 10, Kanowitz in view of Van der Vegt teaches the airway stabilization system of claim 3 wherein Kanowitz further discloses wherein the carriage member or collar comprises one grommet (collar 120’, which is ring-shaped and thus comprehends a grommet), being positioned within and operatively connected to the c-shaped collars or clamshells of the tower structure and extending outwardly from the patient’s face coaxially with the longitudinal axis of the airway device (Figs. 1, 5 and 10; para [0051]), but Kanowitz is silent regarding more semi-cylindrically or c-shaped “grommets.” However, it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art, see MPEP 2144.04.V.C., and Kang teaches that it was known in the airway stabilization art before the effective filing date of the claimed invention for a collar (comprising body 1) (Figs. 16, 41 and 42) for encircling an airway device (tubular 1002) (para [0004]) to comprise, as best understood, more semi-cylindrically or c-shaped “grommets” (body sections 1a&b) (Fig. 16), such that it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Kanowitz to include more semi-cylindrically or c-shaped “grommets” as taught by Kang, each of the “grommets” being positioned within and operatively connected to a respective one of the c-shaped collars or clamshells of the tower structure and extending outwardly from the patient’s face coaxially with the longitudinal axis of the airway device as taught by Kanowitz Figs. 1-2 and 5 in view of Kang Fig. 16 teaching collar 120’ being formed in two halves as discussed above, in order to utilize a known collar arrangement (two attachable halves) for suitably connecting the collar of Kanowitz to the airway device/endotracheal tube thereof, e.g. one where there is no need to slide the collar along the length airway device/endotracheal tube in order to position the collar as desired.
Regarding claim 11, Kanowitz in view of Van der Vegt and Kang teaches the airway stabilization system of claim 10 wherein modified Kanowitz teaches wherein each c-shaped “grommet” has first and second ends (top and bottom ends in Kanowitz Fig. 5, when the collar 120’ is formed as two detachable halves as taught by Kang Fig. 16 as discussed above) and a body portion having an inner surface (inner surface of 120’ in Kanowitz Fig. 5) and an outer surface (outer surface of 120’ in Kanowitz Fig. 5) extending therebetween (Kanowitz Fig. 5), the outer surface of the “grommet” including at least one annular flange (annular flanges or ribs 122’) and at least one structural recess (structural recesses 124’) extending radially outwardly from the outer surface and adapted to operatively interact with one of the plurality of structural recesses formed intermediate the uniformly spaced-apart annular flanges positioned axially along the inner surface of at least one of the clamshells (Kanowitz Figs. 1-2; paras [0049] and [0054]).
Regarding claim 13, Kanowitz in view of Van der Vegt and Kang teaches the airway stabilization system of claim 10 but modified Kanowitz is silent regarding wherein the securing device or tower structure includes an adjustable ratchet mechanism adapted to releasably clamp airway devices of different flexible body sizes. However, Van der Vegt further teaches that it was known in the airway stabilization art before the effective filing date of the claimed invention for a securing device or tower structure (retainer 5) (Figs. 1, 7 and 9) to include an adjustable ratchet mechanism (comprising teeth 55) adapted to releasably clamp airway devices of different flexible body sizes (paras [0051-54]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Kanowitz to include wherein the securing device or tower structure includes an adjustable ratchet mechanism adapted to releasably clamp airway devices of different flexible body sizes as taught by Van der Vegt, in order to provide the predictable result of utilizing a known mechanism to allow the system to accommodate different diameter lines (Van der Vegt para [0054]).
Regarding claim 14, Kanowitz in view of Van der Vegt and Kang teaches the airway stabilization system of claim 10 wherein, as best understood, Kang further educates modified Kanowitz to include wherein the carriage member includes a release mechanism (latch elements 17, 17b) (Kang Fig. 16, paras [0128-131]) adapted to permit selective adjustment of the position of an airway device with respect to a patient’s vocal cords (the two halves of the modified collar of Kanowitz as taught by Kang can be separated and the position of the airway device/endotracheal tube moved up or down relative to Kang Fig. 16).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kanowitz in view of Van der Vegt and Kang as applied to claim 10 above, and further in view of Wells.
Regarding claim 12, Kanowitz in view of Van der Vegt and Kang teaches the airway stabilization system of claim 10 but modified Kanowitz is silent regarding wherein the inner surface of at least one of the grommets is coated with an adhesive material. However, Wells further teaches that it was known in the airway stabilization art before the effective filing date of the claimed invention to include wherein the inner surface (inner surface 24) of a two-portion collar for surrounding an airway device/endotracheal tube (comprising portions 14, 16) is coated with an adhesive material (pressure sensitive adhesive 22) (Fig. 3; col. 3, lines 42-45). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Kanowitz to include wherein the inner surface of at least one of the grommets is coated with an adhesive material as further taught by Wells, in order to utilize well known means to provide the predictable result of ensuring that the collar is held in position on the airway device/endotracheal tube (Wells col. 3, lines 42-45).
Claim(s) 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kanowitz in view of Van der Vegt as applied to claim 18 above, and further in view of de Oliveira et al. (US 2019/0381267 A1; hereinafter “de Oliveira”).
Regarding claim 19, Kanowitz in view of Van der Vegt teaches the airway stabilization system of claim 18 but modified Kanowitz is silent regarding wherein the cheek pad or layer of cushioning material is a hydrocolloid absorbent, or a silicone gel pad. However, it has been held to be within the general skill of one in the art to select a known material on the basis of its suitability for the intended use, see MPEP 2144.07, and de Oliveira teaches that it was known in the airway stabilization art before the effective filing date of the claimed invention for the cheek pad or layer of cushioning material (base article 110) (Fig. 7) to be a hydrocolloid absorbent, or a silicone gel pad (skin-contact adhesives…silicone…hydrocolloid, para [0153], see also para [0161]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for the cheek pad/cushioning material of Kanowitz to be a hydrocolloid absorbent, or a silicone gel pad as taught by de Oliveira, in order to utilize materials well known to be skin friendly and/or good for adhering to the skin so as to provide additional attachment of the system of modified Kanowitz to the face of the user (de Oliveira paras [0109] and [0160]).
Regarding claim 20, Kanowitz in view of Van der Vegt and de Oliveira teaches the airway stabilization system of claim 19 wherein de Oliveira further educates modified Kanowitz to include wherein each cheek pad or layer of cushioning material includes a skin contact adhesive layer having a perforated pattern (de Oliveira paras [0153] and [0160-161] in view of para [0163]: “methods for achieving a high relative rate of moisture vapor transmission…perforating the adhesive, para [0163]) whereby moisture is wicked to each cheek pad or layer of cushioning material, in order to provide the predictable result of a cushioned, breathable cheek pad that provides additional attachment of the system of modified Kanowitz to the face of the user (de Oliveira paras [0109] and [0160]).
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.
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/KATHRYN E DITMER/ Primary Examiner, Art Unit 3785