DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
The present Office action is responsive to the application as filed on 06-28-2024. As directed, claims 1-20 are currently pending examination.
Specification
The disclosure is objected to because of the following informalities:
At paragraph 43, beginning at line 8, the “closure element” is defined by reference numeral “904” which has previously been used to designate the “ventilator holding element” whereas the “closure element” was previously designated as reference numeral “906”. Throughout lines 8-10, the instances where the “closure element” is designated “904” should be amended to designate reference numeral “906” for clarity.
Appropriate correction is required.
Claim Objections
Claims 2-3, 6-8, 10, and 16-20 are objected to because of the following informalities:
At claim 2, line 1, a comma should be added following “claim 1” for consistency.
At claim 2, line 3, the phrase “configured to be” should be added before “positioned” to more clearly avoid claiming the huma organism.
At claim 3, line 1, a comma should be added after “claim 2” for consistency.
At claim 6, line 1, a comma should be added after “claim 1” for consistency.
At claim 7, line 1, a comma should be added following “claim 6” for consistency.
At claim 8, line 1, a comma should be added following “claim 1” for consistency.
At claim 10, line 1, a comma should be added following “claim 1” for consistency.
At claim 16, line 13, “the” should be added before “neck strap” for clarity.
At claim 17, line 1, “a ventilator circuit to a tracheostomy tube” should be replaced with “the ventilator circuit to the tracheostomy tube” as the limitations were previously introduced in claim 16, line 1 and thus have antecedent basis.
At claim 18, line 1, “a ventilator circuit to a tracheostomy tube” should be replaced with “the ventilator circuit to the tracheostomy tube” as the limitations were previously introduced in claim 16, line 1 and thus have antecedent basis.
At claim 19, line 1, “a ventilator circuit to a tracheostomy tube” should be replaced with “the ventilator circuit to the tracheostomy tube” as the limitations were previously introduced in claim 16, line 1 and thus have antecedent basis.
At claim 20, line 1, “a ventilator circuit to a tracheostomy tube” should be replaced with “the ventilator circuit to the tracheostomy tube” as the limitations were previously introduced in claim 16, line 1 and thus have antecedent basis.
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.
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/the “ventilator holding element” in claims 1, 5-6, 8-9, 12, 16, and 18-19 which is interpreted relative to the instant specification at paragraphs 37, 43, and Figures. 6C-8 and 9A-10 to include a securing element with an opening therethrough in the form of a sling, and functional equivalents thereof.
A/the “closure element” in claims 1, 4, 6-9, 12, 15-16, and 19-20 which is interpreted relative to the instant specification at paragraphs 38-39 and 43 and Figures 6A-7 and 9A-10 to be hook and loop fasteners, snap(s), buckle(s), a cam mechanism, and/or tab(s), and functional equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9, 14, and 16-20 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 9, the claim recites “a first tab and a second tab positioned on the ventilator holding element” which renders the claim indefinite. Claim 8, from which claim 9 depends, recites “at least one tab positioned on the ventilator holding element”, but because claim 9 is not presently written to further limit this “at least one” tab of claim 8, it is unclear whether the claimed “first tab” and “second tab” of claim 9 are included in the “at least one tab” of claim 8, or if they are additional tabs.
For the purposes of examination, the first and second tab of claim 9 will be interpreted as included in the at least one tab of claim 8. In order to overcome the rejection, Applicant may amend claim 9 such that “the at least one tab includes a first tab and a second tab” to clarify the claim.
Regarding claim 14, the claim recites “at least one fastener positioned on a proximal side of the first segment” and “at least one fastener positioned on a proximal side of the second segment” which renders the claim indefinite. Claim 13, from which claim 14 depends, recites “at least one fastener positioned on a proximal side of the neck strap”, but because claim 14 is not presently written to further limit this “at least one fastener” in claim 13, it is unclear whether the recited fasteners in claim 14 are included in the at least one fastener of claim 13, or if they are in additional to the at least one fastener of claim 13.
For the purposes of examination, the fasteners of claim 14 will be interpreted as included in the at least one fastener of claim 13. To overcome the rejection, Applicant may amend claim 14 to specify that “the at least one fastener positioned on the proximal ide of the neck strap further comprises:”.
Regarding claim 16, line 6 recites “a ventilator circuit”, line 9 recites “a portion of a ventilator circuit”, and line 11 recites “a tracheostomy tube” which each render the claim indefinite. This is because line 1 of the same claim already introduces each of the claimed features, thus it is unclear if multiple of the same feature are introduced, or if the body of claim 16 refers to the same elements in line 1 of the claim.
For the purposes of examination, the claim will be interpreted such that one of each element is positively recited in the claim. Applicant may overcome the rejection by amending line 6 to read “the ventilator circuit, line 9 to read “a portion of the ventilator circuit”, and line 11 to read “the tracheostomy tube”.
Claims 17-20 are rejected by virtue of their dependence on claim 16.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dillworth (US 2013/0213405).
Regarding claim 1, Dillworth discloses a ventilator anti-disconnect system (system including collar 12, toes 20, and patch 70) (paragraph 59, lines 1-4; paragraph 60, lines 1-3; paragraph 64, lines 1-5; Figs. 6A-9) comprising:
a neck strap (20) (paragraph 64, lines 1-5; paragraph 65, lines 1-9; Fig. 7);
a ventilator holding element (70) having an opening (82) therein configured to accept a portion of a ventilator circuit (22) therethrough (paragraph 60, lines 1-3; paragraph 64, lines 1-5; paragraph 65, lines 1-9; Figs. 6A-7); and
a closure element (Velcro portions on ends 72/74 and their mated portions on 20) configured to releasably connect the ventilator holding element (80) to the neck strap (20) (paragraph 63, lines 1-4; paragraph 64, lines 1-5; paragraph 65, lines 1-9; paragraph 67, lines 3-8; Figs. 7-9).
Regarding claim 2, Dillworth discloses the ventilator anti-disconnect system of claim 1, as discussed above.
Dillworth further discloses wherein a proximal side of the neck strap (20) includes at least one fastener for engaging a tracheostomy collar (12) positioned on a neck of a patient (paragraph 44, lines 1-7; paragraph 67, lines 5-8; Figs. 7-9, note the analogous collar 12 as seen in Fig. 1 and duplicated in Figs. 7-9, where paragraph 67 indicates that tie 20 can be removed from the collar at point 106, and the fastener is portions of the Velcro attachment).
Regarding claim 3, Dillworth discloses the ventilator anti-disconnect system of claim 2, as discussed above.
Dillworth further discloses wherein the at least one fastener comprises at least one hook of a hook and loop fastener system and at least one loop of the hook and loop fastener system (paragraph 44, lines 1-7; paragraph 67, lines 5-8; Figs. 7-9).
Regarding claim 4, Dillworth discloses the ventilator anti-disconnect system of claim 1, as discussed above.
Dillworth further discloses two closure elements (Velcro portions on ends 72/74 and their mated portions on 20) (paragraph 59, lines 3-4; paragraph 64, lines 1-5; paragraph 65, lines 1-9; Figs. 7-9).
Regarding claim 5, Dillworth discloses the ventilator anti-disconnect system of claim 1, as discussed above.
Dillworth further discloses wherein an end of the ventilator holding element (70) is affixed to an end of the neck strap (20) (paragraph 64, lines 1-5; paragraph 65, lines 1-9; Figs. 7-9; note that 70 is affixed to 20 via Velcro closure elements on ends 72/74 of 70 when in the fastened position).
Regarding claim 6, Dillworth discloses the ventilator anti-disconnect system of claim 1, as discussed above.
Dillworth further discloses wherein:
the neck strap (20) comprises a first segment affixed to a first end of the ventilator holding element (70) and a second segment affixed to a second end of the ventilator holding element (70) (paragraph 64, lines 1-5; paragraph 65, lines 1-9; Figs. 7-9; note that 80 is affixed to 20 via Velcro closure elements on ends 72/74 of 70 when in the fastened position); and
at least a portion of the closure element (Velcro portions on ends 72/74 and their mated portions on 20) is connected to the second segment of the neck strap (20) (paragraph 64, lines 1-4; paragraph 65, lines 1-9; Figs. 7-9; note that Velcro closure elements on ends 72/74 of 70 are in connection with respective ties 20 as seen in Fig. 8).
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Regarding claim 7, Dillworth discloses the ventilator anti-disconnect system of claim 6, as discussed above.
Dillworth further discloses wherein the closure element (Velcro portions on ends 72/74 and their mated portions on 20) comprises a tab having at least one hook of a hook and loop fastener system and at least one loop of the hook and loop fastener system on a surface thereof (paragraph 64, lines 1-4; paragraph 65, lines 1-9; paragraph 67, lines 6-9; Figs. 7-9).
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Regarding claim 8, Dillworth discloses the ventilator anti-disconnect system of claim 1, as discussed above.
Dillworth further discloses wherein the closure element (Velcro portions on ends 72/74 and their mated portions on 20) comprises:
at least one tab positioned on the ventilator holding element (70) (paragraph 64, lines 1-4; paragraph 65, lines 1-9; paragraph 67, lines 6-9; Figs. 7-9); and
at least one connector positioned on the neck strap (20) and configured to releasably engage the at least one tab (paragraph 64, lines 1-4; paragraph 65, lines 1-9; paragraph 67, lines 6-9; Figs. 7-9).
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Regarding claim 9, Dillworth discloses the ventilator anti-disconnect system of claim 8, as discussed above.
Dillworth further discloses wherein the closure element (Velcro portions on ends 72/74 and their mated portions on 20 further comprises:
a first tab and a second tab positioned on the ventilator holding element (70) (paragraph 64, lines 1-4; paragraph 65, lines 1-9; paragraph 67, lines 6-9; Figs. 7-9, note left and right tb elements in the annotated Figs. 7-8 below);
a first connector positioned at a first end of the neck strap (20) and configured to releasably engage the first tab (paragraph 64, lines 1-4; paragraph 65, lines 1-9; paragraph 67, lines 6-9; Figs. 7-9); and
a second connector positioned at a second end of the neck strap (20) and configured to releasably engage the second tab (paragraph 64, lines 1-4; paragraph 65, lines 1-9; paragraph 67, lines 6-9; Figs. 7-9).
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Regarding claim 10, Dillworth discloses the ventilator anti-disconnect system of claim 8, as discussed above.
Dillworth further discloses a first flange connector positioned at a first end of the neck strap (see annotated Fig. 7 below); and
a second flange connector positioned at a second end of the neck strap (see annotated Fig. 7 below);
wherein each of the first flange connector and the second flange connector are configured to engage a tracheostomy flange (see annotated Fig. 7 below).
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Regarding claim 11, Dillworth discloses the ventilator anti-disconnect system of claim 1, as discussed above.
Dillworth further discloses wherein the ventilator holding element (70) is a sling (paragraph 59, lines 1-4; paragraph 62, lines 1-6; Fig. 6A, note that 70 holds the ventilator circuit portions, and can therefore be regarded as a sling, and also includes strap 92 which is shown in Fig. 7 to engage 22 as a sling).
Regarding claim 12, Dillworth discloses a ventilator anti-disconnect system (system including collar 12, toes 20, and patch 70) (paragraph 59, lines 1-4; paragraph 60, lines 1-3; paragraph 64, lines 1-5; Figs. 6A-9) comprising:
a neck strap (20) having a first segment and a second segment, said neck strap (20) configured to be positioned around a neck of a patient (paragraph 64, lines 1-5; paragraph 65, lines 1-9; Figs. 7-8, see left and right segments of ties 20);
a ventilator holding element (70) having an opening (82) therein configured to accept a portion of a ventilator circuit (22) therethrough (paragraph 60, lines 1-3; paragraph 64, lines 1-5; paragraph 65, lines 1-9; Figs. 6A-7), a first end of the ventilator holding element (70) connected to the first segment of the neck strap (20), and a second end of the ventilator holding element (70) connected to the second segment of the neck strap (20) (paragraph 64, lines 1-5; paragraph 65, lines 1-9; Figs. 7-9; note that 80 is affixed to 20 via Velcro closure elements on ends 72/74 of 70 when in the fastened position); and
a closure element (Velcro portions on ends 72/74 and their mated portions on 20) connected to the second segment of the neck strap (20) (paragraph 64, lines 1-4; paragraph 65, lines 1-9; Figs. 7-9; note that Velcro closure elements on ends 72/74 of 70 are in connection with respective ties 20 as seen in Fig. 8) configured to releasably engage the first segment of the neck strap (20) (paragraph 63, lines 1-4; paragraph 64, lines 1-5; paragraph 65, lines 1-9; paragraph 67, lines 3-8; Figs. 7-9).
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Regarding claim 13, Dillworth discloses the ventilator anti-disconnect system of claim 12, as discussed above.
Dillworth further discloses at least one fastener on a proximal side of the neck strap (20) configured to releasably engage a tracheostomy collar (12) positioned on a neck of a patient (paragraph 44, lines 1-7; paragraph 67, lines 5-8; Figs. 7-9, note the analogous collar 12 as seen in Fig. 1 and duplicated in Figs. 7-9, where paragraph 67 indicates that tie 20 can be removed from the collar at point 106, and the fastener is portions of the Velcro attachment).
Regarding claim 14, Dillworth discloses the ventilator anti-disconnect system of claim 13, as discussed above.
Dillworth further discloses:
at least one fastener on a proximal side of the first segment of the neck strap (20) (paragraph 44, lines 1-7; paragraph 67, lines 5-8; Figs. 7-9, note the analogous collar 12 as seen in Fig. 1 and duplicated in Figs. 7-9, where paragraph 67 indicates that tie 20 can be removed from the collar at point 106, and the fastener is portions of the Velcro attachment); and
at least one fastener on a proximal side of the second segment of the neck strap (20) (paragraph 44, lines 1-7; paragraph 67, lines 5-8; Figs. 7-9, note the analogous collar 12 as seen in Fig. 1 and duplicated in Figs. 7-9, where paragraph 67 indicates that tie 20 can be removed from the collar at point 106, and the fastener is portions of the Velcro attachment).
Regarding claim 15, Dillworth discloses the ventilator anti-disconnect system of claim 12, as discussed above.
Dillworth further discloses wherein the closure element (Velcro portions on ends 72/74 and their mated portions on 20) comprises a tab having at least one hook of a hook and loop fastener system and at least one loop of the hook and loop fastener system on a surface thereof (paragraph 64, lines 1-4; paragraph 65, lines 1-9; paragraph 67, lines 6-9; Figs. 7-9).
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Regarding claim 16, Dillworth discloses a method of securing a ventilator circuit (22) to a tracheostomy tube (14) (paragraph 67, lines 1-9; Figs. 7-9; claim 20), comprising steps of:
positioning a ventilator anti-disconnect system (system including patch 70, ties 20, and collar 12) around a neck of a patient (paragraph 59, lines 1-4; paragraph 64, lines 1-4; paragraph 65, lines 1-9; Figs. 7-9), wherein the ventilator anti-disconnect system (system including patch 70, ties 20, and collar 12) comprises:
a neck strap (20) (paragraph 64, lines 1-4; paragraph 65, lines 1-9; Figs. 7-9),
a ventilator holding element (70) having an opening (82) therein for accepting a portion of a ventilator circuit (22) therethrough (paragraph 59, lines 1-4; paragraph 60, lines 1-3; paragraph 62, lines 1-6; Fig. 7), and
at least one closure element (Velcro portions on ends 72/74 and their mated portions on 20) associated with the ventilator holding element (70) configured to releasably engage the neck strap (20) (paragraph 63, lines 1-4; paragraph 64, lines 1-5; paragraph 65, lines 1-9; paragraph 67, lines 3-8; Figs. 7-9);
inserting a portion of a ventilator circuit (22) through the opening (82) in the ventilator holding element (70) (paragraph 62, lines 1-5; Fig. 7; claim 20);
connecting the ventilator circuit (22) to a tracheostomy tube (14) (paragraph 64, lines 1-4; Figs. 7-9; claim 20); and
engaging the ventilator holding element (70) to neck strap (20) with the at least one closure element (Velcro portions on ends 72/74 and their mated portions on 20) (paragraph 64, lines 1-4; paragraph 65, lines 1-9; Figs. 7-9; claim 20).
Regarding claim 17, Dillworth discloses the method of securing a ventilator to a tracheostomy tube of claim 16, as discussed above.
Dillworth further discloses wherein a proximal side of the neck strap (20) includes at least one fastener for engaging a tracheostomy collar (12) positioned on a neck of a patient (paragraph 44, lines 1-7; paragraph 67, lines 5-8; Figs. 7-9, note the analogous collar 12 as seen in Fig. 1 and duplicated in Figs. 7-9, where paragraph 67 indicates that tie 20 can be removed from the collar at point 106, and the fastener is portions of the Velcro attachment).
Regarding claim 18, Dillworth discloses the method of securing a ventilator to a tracheostomy tube of claim 16, as discussed above.
Dillworth further discloses wherein an end of the ventilator holding element (70) is affixed to an end of the neck strap (20) (paragraph 64, lines 1-5; paragraph 65, lines 1-9; Figs. 7-9; note that 70 is affixed to 20 via Velcro closure elements on ends 72/74 of 70 when in the fastened position).
Regarding claim 19, Dillworth discloses the method of securing a ventilator to a tracheostomy tube of claim 18, as discussed above.
Dillworth further discloses wherein:
the neck strap (20) comprises a first segment affixed to a first end of the ventilator holding element (70) and a second segment affixed to a second end of the ventilator holding element (70) (paragraph 64, lines 1-5; paragraph 65, lines 1-9; Figs. 7-9; note that 80 is affixed to 20 via Velcro closure elements on ends 72/74 of 70 when in the fastened position); and
at least a portion of the at least one closure element (Velcro portions on ends 72/74 and their mated portions on 20) is connected to the second segment of the neck strap (20) (paragraph 64, lines 1-4; paragraph 65, lines 1-9; Figs. 7-9; note that Velcro closure elements on ends 72/74 of 70 are in connection with respective ties 20 as seen in Fig. 8).
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Regarding claim 20, Dillworth discloses the method of securing a ventilator to a tracheostomy tube of claim 19, as discussed above.
Dillworth further discloses wherein the at least one closure element (Velcro portions on ends 72/74 and their mated portions on 20) comprises a tab having at least one hook of a hook and loop fastener system and at least one loop of the hook and loop fastener system on a surface thereof (paragraph 64, lines 1-4; paragraph 65, lines 1-9; paragraph 67, lines 6-9; Figs. 7-9).
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kesler-Carter (US 2022/0387742) is cited for the anti-disconnect system shown throughout Figures 1-2A.
Ballenger (US 2010/0262093) is cited for its sling for holding a ventilator circuit portion and a tracheostomy tube as shown in Figure 1.
Peichel (US 2009/0145439) is cited for its tracheostomy collar as seen in Figure 1.
Leckie (US 2009/0014010) is cited for its tracheostomy collar as seen in Figure 8.
Steeves (US 2005/0188993) is cited for its tracheostomy attachment as seen in Figures 1-3.
Kron (US 2004/0060565) is cited for its tracheostomy attachment as seen in Figures 3-4.
Ancona (US 6,612,309) is cited for its tracheostomy attachment as seen in Figures 1-5.
Briggs, III (US 5,839,437) is cited for its tracheostomy attachment as seen in Figure 3.
Wapner (US 4,331,144) is cited for its tracheostomy attachment as seen in Figures 1-2.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAIGE BUGG whose telephone number is (571)272-8053. The examiner can normally be reached Monday-Friday 9-5.
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, 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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/PAIGE KATHLEEN BUGG/Primary Examiner, Art Unit 3785
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