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 amendments filed 1/5/2026 have been entered. Accordingly, claims 1, 3, 6-7, 9, 11-12, 14, and 17-26 are pending in the current application.
Response to Arguments
Applicant's arguments filed 1/5/2026 have been fully considered but they are not persuasive. The Examiner notes that while the same primary prior art reference is being applied, a new interpretation of the reference is now being relied upon to better reflect the newly amended claims. Regarding the new limitation of “curved tubular channel bending at an angle of 180 degrees or more”, the Examiner notes a new secondary reference is now being relied upon to address this particular new limitation.
Applicant argues on page 3 of the remarks that McKown does not teach or suggest a longitudinal recess formed in a tubular wall that extends continuously between a first and second open channel end to define a longitudinal slot having a width less than a maximum internal diameter of the curved channel, to therefore permit lateral press-in insertion of a tube into the curved channel, further stating that McKown instead relies on open grooves without enclosing the cannula tubes within the channels. The Examiner respectfully disagrees, noting that Paragraph 0067 of McKown clearly states the depth of the groove 54 is at least half the diameter of the cannula supply tube 11, 12, to therefore sufficiently retain a cannula tube 11, 12, therein. Therefore, the Examiner maintains that the curved tubular channel/groove 54 clearly permits the press-in insertion of a nasal cannula tube, the secure said tube within the retainers.
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.
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 1 and 26, and thus their dependent claims, are 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. Claims 1 and 26 recite the limitation of “a longitudinal recess formed in the tubular wall of the curved tubular channel”, however there is no description of a “recess” in either Applicant’s specification and/or drawings.
Claims 1, 12 and 26, and thus their dependent claims, 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 claims 1 and 26, both claims recite the limitation(s) of “a longitudinal recess formed in the tubular wall of the curved tubular channel”, and “the longitudinal recess extending continuously from the first open channel end to the second open channel end and defining a longitudinal slot that is open to the curved tubular channel” however there is no description of a “recess” in either Applicant’s specification and/or drawings. Furthermore, it is unclear how the “recess” is different from the tubular channel and/or the tubular slot in which it defines. Applicant’s Figures show the tube securement members as having curved tubular walls forming a curved tubular channel. Therefore, for the purpose of examination, the Examiner has taken this limitation to mean the curved tubular walls form a curved tubular channel, and the “recess” is intended to mean the same structural component as the channel and the slot.
Regarding claim 12, claim 12 is currently dependent upon claim 2, however claim 2 has since been canceled per the amendments filed 1/5/2026. It is unclear what claim 12 is meant to depend upon. For the purpose of examination, the Examiner will interpret claim 12 as being dependent upon claim 1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3, 6-7, 9, 11, 14, 17-23 and 25-26 rejected under 35 U.S.C. 103 as being unpatentable over McKown (US 2004/0025884 A1) in view of Roberts (US 2017/0065785 A1).
Regarding claim 1, McKown teaches a headgear assembly for securing a nasal cannula to a subject (nasal cannula apparatus comprising a headgear assembly 2, Abstract and Figure 3), the headgear assembly comprising: a headband having a first end and a second end (headgear 2 comprises a crown headband portion 25 comprising a first and second end 26, 27, Paragraph 0075 and Figure 3); and a first tube securement member coupled to the headband proximate to the fist end (the headgear 2 comprises two cannula retainers 20 coupled to the first and second ends 26, 27 of the headband 25, Paragraph 0078 and Figure 3), a second tube securement member coupled to the headband proximate the second end (the headgear 2 comprises two cannula retainers 20 coupled to the first and second ends 26, 27 of the headband 25, Paragraph 0078 and Figure 3), wherein each of the first tube securement member and the second tube securement member comprise a unitary body comprising a tubular wall (the cannula retainers 20 are unitary bodies and may take the shape of an arced retainer 50 comprising an arched structure (wall) as shown in Figure 8 and described in Paragraph 0066) defining a curved tubular channel extending from a first open channel to a second open channel end (the arced retainers 50 form a curved groove 54 with a first and second end, Figure 8 and Paragraph 0066), the curved tubular channel having a generally circular transverse cross-section and a longitudinal centerline that defines a generally C-shaped bend between the first open channel end and the second open channel end (the arced retainer 50 forms a C-shaped curved groove 54 between its first and second ends such that groove has a generally circular transverse cross-section and a centerline that bends between the first and second open ended channels, Figures 7-8 and Paragraph 0066), a longitudinal recess formed in the tubular wall of the curved tubular channel, the longitudinal recess extending continuously from the first open channel end to the second open channel end and defining a longitudinal slot that is open to the curved tubular channel (The Examiner notes the 112b rejection presented above regarding the recess vs. the channel; and for the purpose of examination, the Examiner has taken this limitation to mean the curved tubular walls form a curved tubular channel, and the “recess” is intended to mean the same structural component as the channel; Therefore, as McKown’s arched retainers 50 comprise a curved longitudinal groove 54 extending continuously from a first end to a second end, the Examiner considers this limitation to be met), the longitudinal slot having a width less than a maximum internal diameter of the tubular channel (the curved tubular groove 54 formed in the arced retainer 50 is at least half the diameter of the cannula supply tub 11, 12 to therefore sufficiently retain the cannula tube in place, Paragraph 0067) wherein the curved tubular channel is preformed to define and maintain the generally C-shaped bend between the first and second open channel end (C-shaped groove 54 is preformed to maintain the nasal cannula tube in place, Paragraph 0067 and Figures 7-8) and wherein the longitudinal slot and the tubular wall cooperate to permit a tube to be pressed laterally into the curved tubular channel through the longitudinal slot and to resist lateral removal of the tube from the curved tubular channel during use (the curved tubular groove 54 formed by the walls of the arched retainer 50 is at least half the diameter of the cannula supply tub 11, 12 to therefore sufficiently retain the cannula tube, therefore resisting lateral removal of the tube while the in use, Paragraph 0067 and Figure 8).
However, Although McKown teaches an arced nasal cannula tube retainer comprising a curved, C-shaped tubular channel (grooved arced retainers 50 comprising tubular groove formed therewithin, Paragraphs 0066-0067 and Figures 7-8), further teaching the radius of curvature of the groove 54 may vary between 1 inch to 10 inches (Paragraph 0066) McKown doesn’t explicitly the curved tubular channel bending through an angle greater than or equal to 180 degrees.
However, Roberts teaches a headgear assembly configured to secure a nasal cannula tube in place while the device is being used (Abstract and Figure 1) comprising a generally C-shaped curved tubular channel securing the nasal cannula tube (holding piece 402 comprises a C-shaped seam (shown as stitching) bending at an angle greater than or equal to 180 degrees to therefore hold nasal cannula tubing in place, Paragraph 0034 and Figure 4)).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify McKown’s headgear assembly by having the curved tubular channel groove 54 bend at an angle of 180 degrees or greater, as taught by Roberts, as having the arced retaining structures bend at a larger angle may further enhance the securement of the nasal tubing with the retainer, as a sharper angle bend may prevent the tubing from slipping.
Regarding claim 3, McKown further teaches wherein the headgear assembly is configured such that, when worn by the subject, portion of the tube connected to the nasal cannula is routed away from the subject’s ears so that no portion of the tube contacts the subject's ears (the retainers 50 are affixed to the headgear 5 such that neither the supply tubes 11 and 12 or the fasteners 50 rub on the patient’s ears or face, Paragraph 0024 and Figures 2-3).
Regarding claim 6, McKown further teaches wherein the longitudinal slot is defined by a first edge extending along a first plane (see proximal 55 portion extending along a first plane, Figure 8) and said second edge (distal 53, Figure 8) extends along a second plane that is spaced from said first plane (see distal 53 portion extending along a second plane that is spaced from the proximal 55 portion, Figure 8).
Regarding claim 7, McKown further teaches wherein a second edge defining the longitudinal slot is inset from said first edge defining the longitudinal slot (see spatial arrangement of the distal 53 portion with respect to the proximal portion 55, Figure 8).
Regarding claim 9, McKown further teaches wherein the tubular wall applies a compressive force to the tube received in the curved tubular channel to retain the tube by frictional engagement (the groove 54 of the arced retainer 50 is sized such that it receives and holds a standard nasal cannula tubing 11, 12, Paragraph 0066-0067).
Regarding claim 11, McKown further teaches wherein the first and second tube securement members secure the tube at locations spaced from the nasal cannula such that the headgear assembly does not contact the nasal cannula during use (retainers 50 secures the tubing 11,12 without contacting the cannula 18 during use, Figure 2).
Regarding claim 14, McKown further teaches further comprising the nasal cannula and said tube connected to the nasal cannula (nasal cannula 18 and supply tubes 11, 12, Figure 2).
Regarding claim 17, McKown further teaches wherein the longitudinal recess formed in the tubular wall extends along only one circumferential side of the curved tubular channel (the curved groove 54 formed in tubular walls of each arced retainer 50 does not extend fully around a circle, therefore extends along one circumferential side of the curved tubular channel, Figures 7-8).
Regarding claim 18, McKown further teaches wherein the headband defines a support path over an upper portion of the subject's head such that, when the headgear assembly is worn, the first and second tube securement members are positioned anterior to the subject's ears (headgear assembly 2 comprises a crown headband portion 25 worn on an upper portion of the subject’s head, the length of the headband material is adjustable, therefore allowing the retainers 50 to be placed anywhere along the length of the headband material, therefore the arced retainers 50 are fully capable of being positioned anterior to the subject’s ears, Paragraph 0060 and Figures 1-3).
Regarding claim 19, McKown further teaches wherein the headband is configured to extend over a top portion of the subject's head and to position the first and second tube securement members, when worn, above a level of the subject's cheek and below a level of the subject's eyebrow (headgear assembly 2 comprises a crown headband portion 25 worn on an upper portion of the subject’s head, the length of the headband material is adjustable, therefore allowing the retainers 50 to be placed anywhere along the length of the headband such that the arced retainers 50 are fully capable of being positioned above a level of the subject’s cheeks and below a level of the subject’s eyebrow, Figures 1-3).
Regarding claim 20, McKown further teaches wherein the first and second tube securement members are coupled to the headband at locations that position each tube securement member, when worn, between a respective ear and a respective eye of the subject (headgear assembly 2 comprises a crown headband portion 25 worn on an upper portion of the subject’s head, head, the length of the headband material is adjustable, therefore allowing the retainers 50 to be placed anywhere along the length of the headband, therefore the arced retainers 50 are fully capable of being positioned between a respective ear and eye of the subject, Paragraph 0060 and Figures 1-3).
Regarding claim 21, McKown further teaches wherein the headband and the tube securement members cooperate to laterally offset the tube securement members forward of the subject's ears when worn (the length of the headband material is adjustable, therefore allowing the retainers 50 to be placed anywhere along the length of the headband, therefore the retainers are fully capable of being forward with respective to the user’s ears when worn, Paragraph 0060 and Figures 1-3).
Regarding claim 22, McKown further teaches wherein the first tube securement member and the second tube securement member are discrete components that are separate from one another and independently coupled to the headband (the arced retainers 50 are separate and discrete components independently affixed to the material 81 of the headband 25, Paragraph 0066 and Figures 1-3).
Regarding claim 23, McKown further teaches wherein the longitudinal slot of each tube securement member faces away from skin of the subject when the headgear assembly is worn (the groove 54 of each arced retainer 50 is positioned away from the skin the subject when assembly is worn, Figures 1-3).
Regarding claim 25, McKown further teaches wherein the longitudinal slot of each tube securement member faces toward an interior of the generally C-shaped bend of the curved tubular channel (the curved groove 54 faces towards an interior of the C-shaped bend of the curved channel, Figures 7-8).
Regarding claim 26, McKown teaches a method of securing a nasal cannula to a subject using a headgear assembly (nasal cannula apparatus comprising a headgear assembly 2, Abstract and Figures 1-3; headband assembly 2 comprises two arced cannula retainers 50 configured to secure nasal cannula tubes 11, 12, Paragraph 0067 and Figures 7-8), the method comprising: providing a headband having a first end and a second end (headgear 2 comprises a crown headband portion 25 comprising a first and second end 26, 27, Paragraph 0075 and Figure 3); providing a first tube securement member coupled to the headband proximate the first end (the headgear 2 comprises two cannula retainers 20 coupled to the first and second ends 26, 27 of the headband 25, Paragraph 0078 and Figure 3) and a second tube securement member coupled to the headband proximate the second end (the headgear 2 comprises two cannula retainers 20 coupled to the first and second ends 26, 27 of the headband 25, Paragraph 0078 and Figure 3), each of the first and second tube securement members comprising: a unitary body having a tubular wall (the cannula retainers 20 are unitary bodies and may take the shape of an arced retainer 50 comprising an arched structure (wall) as shown in Figure 8 and described in Paragraph 0066) that defines a curved tubular channel extending from a first open channel end to a second open channel end (the arced retainers 50 form a curved groove 54 with a first and second end, Figure 8 and Paragraph 0066), the curved tubular channel having a generally circular transverse cross-section and a longitudinal centerline that defines a generally C-shaped bend between the first open channel end and the second open channel end (the arced retainer 50 forms a C-shaped curved groove 54 between its first and second ends such that groove has a generally circular transverse cross-section and a centerline that bends between the first and second open ended channels, Figures 7-8 and Paragraph 0066), and a longitudinal recess formed in the tubular wall and extending continuously from the first open channel end to the second open channel end to define a longitudinal slot that is open to the curved tubular channel (The Examiner notes the 112b rejection presented above regarding the recess vs. the channel; and for the purpose of examination, the Examiner has taken this limitation to mean the curved tubular walls form a curved tubular channel, and the “recess” is intended to mean the same structural component as the channel; Therefore, as McKown’s arched retainers 50 comprise a curved longitudinal groove 54 extending continuously from a first end to a second end, the Examiner considers this limitation to be met), the longitudinal slot having a width less than a maximum internal diameter of the curved tubular channel (the curved tubular groove 54 formed in the arced retainer 50 is at least half the diameter of the cannula supply tub 11, 12 to therefore sufficiently retain the cannula tube in place, Paragraph 0067), the curved tubular channel being preformed to define and maintain the generally C-shaped bend (C-shaped groove 54 is preformed to maintain the nasal cannula tube in place, Paragraph 0067 and Figures 7-8); positioning the headband on the subject's head (see Figure 1); laterally pressing a tube connected to the nasal cannula through the longitudinal slot and into the curved tubular channel of the first tube securement member (the groove 54 of the arced retainer 50 is sized such that it receives and holds a standard nasal cannula tubing 11, 12, Paragraph 0066-0067).; and laterally pressing a tube connected to the nasal cannula through the longitudinal slot and into the curved tubular channel of the second tube securement member (the groove 54 of the arced retainer 50 is sized such that it receives and holds a standard nasal cannula tubing 11, 12, Paragraph 0066-0067), wherein the longitudinal slot and the tubular wall cooperate to resist lateral removal of the tube from the curved tubular channel during use (the curved tubular groove 54 formed by the walls of the arched retainer 50 is at least half the diameter of the cannula supply tub 11, 12 to therefore sufficiently retain the cannula tube, therefore resisting lateral removal of the tube while the in use, Paragraph 0067 and Figure 8).
However, Although McKown teaches an arced nasal cannula tube retainer comprising a curved, C-shaped tubular channel (grooved arced retainers 50 comprising tubular groove formed therewithin, Paragraphs 0066-0067 and Figures 7-8), further teaching the radius of curvature of the groove 54 may vary between 1 inch to 10 inches (Paragraph 0066) McKown doesn’t explicitly the curved tubular channel bending through an angle greater than or equal to 180 degrees.
However, Roberts teaches a headgear assembly configured to secure a nasal cannula tube in place while the device is being used (Abstract and Figure 1) comprising a generally C-shaped curved tubular channel securing the nasal cannula tube (holding piece 402 comprises a C-shaped seam (shown as stitching) bending at an angle greater than or equal to 180 degrees to therefore hold nasal cannula tubing in place, Paragraph 0034 and Figure 4)).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify McKown’s headgear assembly by having the curved tubular channel groove 54 bend at an angle of 180 degrees or greater, as taught by Roberts, as having the arced retaining structures bend at a larger angle may further enhance the securement of the nasal tubing with the retainer, as a sharper angle bend may prevent the tubing from slipping.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over McKown (US 2004/0025884 A1) in view of Roberts (US 2017/0065785 A1) and in further view of Kessy (US 2012/0285471 A1).
Regarding claim 12, McKown in view of Roberts teach the headgear assembly of Claim 2 (the Examiner notes the 112b rejection presented above), and although McKown further teaches the securement member (retainer 50, Figures 7-8) comprising an engagement member with the headband (Figure 3), McKown is silent wherein each of the first and second tube securement members further comprises an engagement member comprising a slot configured to receive a portion of the headband and allow the headband secure to itself.
However, Kessy teaches a headgear assembly comprising a headband (element “a”, Figure 1 and Abstract) and a nasal cannula tube securement member (element “c”, Figure 1), wherein the tube securement member further comprises an engagement member comprising a slot configured to allow a portion of the headband to pass through and secure to itself (element “b” comprises a slot through which the headband “a” may pass through and secure to itself, Figure 1 and Paragraph 0009).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify McKown’s headgear assembly such that the tube securement member included a slot through which the headband may pass through, as taught by Kessy, as this configuration between the retainer and the headband would allow for the user to adjust the length of the headband as desired by either loosening and/or tightening the headband using the slotted configuration.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over McKown (US 2004/0025884 A1) in view of Roberts (US 2017/0065785 A1) and in further view of Pal (WO 2006/113913 A2).
Regarding claim 24, McKown in view of Roberts teach the headgear assembly of claim 1, and although both McKown and Roberts teach curved tubular channels with a generally circular configuration(s), they don’t explicitly state wherein the curved tubular channel has a generally omega-shaped configuration.
However, Pal teaches a device comprising a receiving cavity intended to secure a medical cannula tube (Abstract) wherein the cavity comprises a curved tubular channel with an omega-shaped configuration (the receiving cavity 159 may have the shape of a groove, arch, curved, omega-shape, and the like, Page 56 lines 17-24 and Figure 9B).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify McKown’s headgear assembly such that the curved groove 54 of each arced retainer 50 has an omega-shaped configuration, as the tabs of the omega configuration may assist the user in removing the cannula tubes as needed.
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 SARAH B LEDERER whose telephone number is 571-272-7274. The examiner can normally be reached on Monday - Friday, 7:30 AM - 4:30 PM.
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, Brandy Lee can be reached on (571)-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA).
/SARAH B LEDERER/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785