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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/22/2026 has been entered.
Response to Arguments
Applicant's arguments (AA) filed on 02/22/2026 have been fully considered but they are not persuasive.
Applicant asserts that Ehrlich fails to teach “a cannula tube support member configured to allow a cannula tube to have movement in the vertical and horizontal directions, relative to the cannula tube support member”, making the following arguments:
The cited section of Ehrlich is void of any teaching or suggest of the catheter holder being elastic or configured to allow the catheter tube to move slightly from the head but not dislodge the pulmonary artery catheter entirely.
With the respect to the catheter holder, Ehrlich explicitly teaches the function of the catheter holder is to hold one or more catheter tubes. Moreover, Applicant argues that given the plain meaning of hold (defined in AA as “to keep in one’s grasp, to keep from moving and/or to keep from departing”) Ehrlich explicitly teaches, contrary to Examiner assertion, that the catheter does not allow a cannula tube to have movement in the vertical and horizontal directions, relative to the holder.
Examiners statement that the amount of slack of the cannula tube between the holder and the insertion site would determine if the cannula tube would pull away, is not relevant to the explicit claim language which requires the cannula tube support member to be configured to allow a cannula tube to move in the vertical and horizontal directions, relative to the cannula tube support member. Moreover, applicant further argues that the Examiners statement confirms and validates Applicant’s assertion that Ehrlich teaches the following: that the catheter holder does not allow a cannula tube to have movement in the horizontal and vertical directions.
Regarding argument (i): Upon further consideration, Examiner agrees with Applicant that the cited section of Ehrlich ([0026]), although teaching that the catheter assembly 100b as a whole can be elastic, it not sufficient to suggest that the catheter holder (106a) itself is elastic. Nevertheless, Examiner asserts that the claim does not require the cannula tube support member to be elastic, only that the cannula tube support member be “configured to allow a cannula tube to have movement in the vertical and horizontal directions, relative to said cannula tube support member, when the user moves their head sideways without having the cannula tube pull away from the insertion site”. Examiner asserts that Ehrlich paragraph [0034] and FIG. 3C show/describe a cannula tube member (106b which comprises a first strap 310a, a slit, and second strap 310b) that would allow the cannula tube to move in the vertical and horizontal directions, relative to the cannula tube support member. Examiner further asserts that the cited section of Ehrlich ([0026]) is still relevant as it highlights that, like Applicant’s instant invention (Applicant’s specification, [0015]), the function of Ehrlich’s assembly is to provide a holder that allows a catheter tube to move without dislodging.
Regarding point (ii), Examiner agrees with Applicant that the function of the catheter holder described in Ehrlich (106a) is to hold one or more catheter tubes. This being said, Examiner disagrees with Applicant’s characterization of the word “hold”. Examiner asserts that the act of holding does not preclude movement. In the case of Ehrlich, the catheter holder “holds” the catheter by constraining its movement, not fully eliminating it. Additionally, applying Applicants characterization of the word “hold” (defined in AA as “to keep in one’s grasp, to keep from moving and/or to keep from departing”) would conflict with Applicant’s stated desire, i.e., provide a wearable cannula tube holder for securing the cannula tubes while allowing some movement of the cannula tubes (Applicant’s specification [0015]). That is, using the definition of “hold” provided in AA, would make it impossible for Applicant’s cannula holder to have the stated function of both keeping the cannula tube from moving and allowing for movement of the cannula tube.
Regarding point (iii), Examiner respectfully disagrees. Examiner asserts that the amount of slack in the tube is relevant to the explicit claim language, as the amount of slack would directly influence movement of the cannula tube relative to the cannula tube support member in the vertical direction. Regarding Applicant’s assertion that such a statement further confirms that Ehrlich teaches that the catheter holder does not allow a cannula to have movement in the horizontal and vertical directions, Examiner respectfully disagrees and directs Applicant to the above paragraph (paragraph 5 (Regarding point (ii)).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 limitations are:
In re claim 1, 8 and 9: “first attachment mechanism”
In re claim 1, 8 and 9: “second attachment mechanism”
In re claim 1, and 6 : “cannula tube support member”
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they 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 these limitations 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 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 limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1, 4, 5, 6, 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Ehrlich (US 2016/0015938) in view of Freestone et al. (US 2021/0170134).
In re claim 1, Ehrlich discloses a wearable cannula tube holder (FIG. 1B: 100b) comprising:
a head strap (FIG. 3A-3C: 300) having
a first end (340),
a center portion (area in between first and second end indicated by 322/324) and
a second end (342);
a cannula tube support member (106a; shown in greater detail in FIG. 3C) configured to allow a cannula tube (114a) to have movement in the vertical and horizontal directions, relative to the cannula tube support member, when the user moves their head sideways without having the cannula tube pull away from an insertion site (FIG. 3C; [0026, 0034]);
a first attachment mechanism (302a) attached to said head strap and located at said first end of said end strap (FIG. 3A); and
a second attachment mechanism (302b) attached to said head strap and located at said second end of said head strap (FIG. 3B);
said head strap being configured to form a closed loop when said first attachment mechanism engages said second attachment mechanism (FIG. 1B; strap forms closed loop around patient’s head)
Ehrlich does not disclose
said head strap including a plurality of seams to create a plurality of quilted portions located in said first end of said head strap, a plurality of quilted portions located in said center portion of said head strap, and a plurality of quilted portions located in said second end of said head strap such that all of said head strap is constructed of quilted portions;
said plurality of quilted portions being configured to provide air flow under said head strap when said head strap is engaged with a user.
Freestone discloses an analogous head strap comprised of quilted portions (FIG. 27-28: 4910).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the entire head strap of Ehrlich to include quilted portions, as taught by Freestone. One would have been motivated to make this modification because adding quilted portions provides extra padding improving the comfortability of the headgear (Free stone, [0397]). Accordingly, such a modification would yield “said head strap including a plurality of seams to create a plurality of quilted portions located in said first end of said head strap, a plurality of quilted portions located in said center portion of said head strap, and a plurality of quilted portions located in said second end of said head strap such that all of said head strap is constructed of quilted portions”.
Regarding the limitation “said plurality of quilted portions being configured to provide airflow under said head strap when said strap is engaged with a user”, it is apparent that the modification of Ehrlich with Freestone described above would yield “said plurality of quilted portions being configured to provide airflow under said head strap when said head strap is engaged with a user” because the quilted portions (i.e., raised squares illustrated in Freestone) create pockets of space for air to move through. Moreover, Examiner notes that the limitation “configured to provide airflow under said head strap when said head strap is engaged with a user” comprises functional language and is given patentable weight only in how it materially alters or adds structure to the apparatus of the claims. See MPEP 2114. The prior art need only be able to perform the function in order to anticipate the claimed invention. It is clear that the system of the proposed combination could be operated in the claimed manner if desired.
In re claim 4, Ehrlich discloses wherein said head strap is constructed of a medical grade material ([0035]: “silicon”).
In re claim 5, Ehrlich discloses wherein said head strap is constructed of a medical grade fabric ([0035]: “felt”).
In re claim 6, Ehrlich discloses wherein said cannula tube support member is an open loop of material (FIG. 3C; open loop is created by straps 310a and 310b) having an opening (space between headstrap and loop created by 310a and 310b) for the cannula tube [0034] .
In re claim 8, Ehrlich discloses wherein said first attachment mechanism and said second attachment mechanism are a hooks and latches attachment system ([0034]: “hook-and-loop fasteners”).
In re claim 9, Ehrlich discloses, wherein said first attachment mechanism and said second attachment mechanism are a snap attachment system ([0034]: “a button and eye”).
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Ehrlich (US 2016/001593) in view of Freestone et al. (US 2021/0170134) in view of Yezerski (US 10,912,910).
In re claim 2, the proposed combination does not yield wherein said quilted portions include a foam-like material.
Yezerski discloses a patient protection apparatus configured to be worn on the patient’s head (abstract). Yezerski further discloses the protection apparatus having a quilted portion (FIG. 2: 60; col. 9, lines 17-20: “pocket”) that includes a foam pad (90; col. 10, lines 24-30).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the quilted portions of the proposed combination to include a foam-like material, as taught by Yezerski. One would have been motivated to make this modification because adding foam would provide additional comfort to the patient (Yezerski: col. 9, lines 14-17).
In re claim 3, the proposed combination does not disclose, wherein each quilted portion includes a closable opening configured to enable adding thereto or removal therefrom of said foam-like material.
Yezerski further discloses the quilted portion having a closeable opening (68) which facilitates easy removal and replacement of the foam pad (col. 9, lines 40-43).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify each quilted portion of the proposed combination to include a closeable opening, as taught by Yezerski. One would have been motivated to make this modification to find a balance between the comfort provided by many quilted sections and the utility of being able to easily remove/replace the foam pads.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Payne, Jr. (US 6,938,620) discloses a tube support device (Fig. 2) that includes a tube holder (28, 29) made out of an elastic material (col. 5, lines 6-18). The tube holder is configured such that it allows the tube to move forward and backward without sliding out of the tube holder (col. 5, lines 19-24).
Garrow (US 4,665,566) discloses a headband with fasteners for attaching a medical tube (abstract).
Schwartz et al. (US 2023/0082919) discloses a cannula fixation device (abstract).
D’Aloiso et al. (US 2017/0157364) discloses a cannula stabilization device with two tubing holders (abstract).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
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, David Hamaoui can be reached at (571)-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796