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 .
Election/Restrictions
Applicant’s election without traverse of Species A (Figures 5-8) in the reply filed on 2/9/2026 is acknowledged.
Claims 19-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/9/2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the d-ring of a surgical stretcher (claim 9) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 8-10 and 14-16 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.
Claim 8 recites “wherein the respective anchor point is a portion of a siderail of a surgical stretcher”. It is unclear if applicant is not positively claiming the surgical stretcher, or if it is meant to be intended use. Since claim 7 recites the straps are “wherein each of the distal portions of the two or more securement straps comprise a hook-and-loop portion configured to removably secure the distal portions to respective anchor points in a hook-and-loop securement”, claim 8 has been interpreted as intended use. The same issue applies to claim 9.
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). The term “tacky surface” in claim 14 is used by the specification to mean “a surface having adequate adhesion such that the mentum strap 110 may remain on the mentum of the patient, such that the tacky surface does not leave an adhesive residue as the mentum strap 110 is removed,” [0090] while the accepted meaning is “somewhat sticky to the touch” (see definition at Merriam Webster or dictionary.com. The specification and claim 15 further state that the tacky surface may comprise an adhesive coating. This is unclear, however, since the specification does not provide any specific examples of what kinds of adhesive coatings are suitable/not suitable. Is the claim intended to encompass all adhesive coatings, or are there only specific coatings that would be covered by the claim? Paragraph [0091] goes on to read “In embodiments, the elastomeric material may include medical grade silicone, heat cured rubber (HSR) elastomer, high temperature vulcanizing silicone rubber, and/or liquid silicone rubber (LSR) elastomer, to name a few”. It is unclear if the more specific use of the term “tacky surface” only applies to when the surface is one of these specific materials or to also the adhesive coating. The same issue applies to claims 10 and 16. For purposes of examination, the phrase “tacky surface” has been given its plain and ordinary meaning.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 2-4 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 2 recites “wherein an airway passage of the patient is unobstructed in the extended state” which positively recites the human body.
Claim 3 recites “wherein a tilt angle is defined as the difference between the extended angle and the resting angle, and the tilt angle in the extended state is in the range of 10 to 30 degrees” which positively recites the human body (tilt angle).
Claim 4 recites “wherein the tilt angle is set by adjustment of a respective length of the two or more securement straps” which positively recites the human body (tile angle).
It is suggested applicant use “configured to” or similar language to overcome the rejection.
Claim Rejections - 35 USC § 102
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 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 1-4 and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ahlf (US 2022/0265950 A1).
Regarding claim 1, Ahlf discloses a mentum securement device (mandible harness designed to hold the patient in a “jaw-thrust” position, Abstract; Fig. 2) comprising: a mentum strap (110, Fig. 1; mandible cradle 110, para [0016]) defined by opposing distal portions (see opposing left and right portions of 110, Fig. 1-2), a superior end and an opposing inferior end (see opposing upper and lower ends of 110, Fig. 1-2), and a first surface configured to be positioned on and in facing relation to a mentum of a patient undergoing anesthesia (see inner surface of 110 positioned on and facing towards the mentum of the patient, Fig. 1 and 3; 110 contoured to meet the upper and lower inferior borders of a patient’s mandible, para [0016]; a wearable apparatus designed to assist an anesthesia provider in maintaining a patent airway, Abstract); and, two or more securement straps each having a proximal portion attached to a respective opposing distal portion of the mentum strap (see proximal portions of straps 114 connected to respective left and right portions of 110, Fig. 2; straps 114, para [0017]) and a distal portion configured for securement to an anchor point (see distal portions of straps 114 extending to be coupled to anchors, Fig. 2-3; straps at the back of the cradle extending to reach a standard operating-table frame structure, para [0017]), wherein the mentum strap and the two or more securement straps are configured to position the mentum of the patient to an extended state, wherein in the extended state the mentum of the patient is at an extended angle relative to a neck of the patient, wherein in a resting state the mentum of the patient is at a resting angle relative to a neck of the patient, wherein the extended angle is greater than the resting angle (110 holds the patient’s head in a jaw-thrust position with the strap at the back of the cradle extending to reach a standard operating-table frame structure to which is it tethered, para [0017]; jaw thrust position is achieved by adjusting straps 114, para [0018]).
Regarding claim 2, Ahlf discloses the mentum securement device of claim 1, wherein an airway passage of the patient is unobstructed in the extended state (maintaining a patent airway… hold the patient in a “jaw thrust” position, Abstract).
Regarding claim 3, Ahlf discloses wherein the device is capable of use such that a tilt angle is defined as the difference between the extended angle and the resting angle, and the tilt angle in the extended state is in the range of 10 to 30 (via adjustment of the length and attachment location of the straps 114; Figures 1-3; [0017]-[0018]).
Regarding claim 4, Ahlf discloses wherein the device is capable of use such that the tilt angle is set by adjustment of a respective length of the two or more securement straps (114; Figures 1-3; [0017]-[0018]).
Regarding claim 11, Ahlf discloses wherein the two or more securement straps are configured to fail upon application of a predetermined tension force (an elastic band portion of the strap is designed to absorb the movement of the patient’s body during a surgical procedure, para [0017]; Ahlf’s elastic band portion of the straps are considered capable of “configured to fail upon application of a predetermined tension force” since all elastic bands have a predetermined tension where they reach their limit of stretching and will fail).
Regarding claim 12, Ahlf discloses the mentum securement device of claim 1, wherein the mentum strap is comprised of an elastomeric material (cradle may be constructed of… castable-elastomeric materials, para [0007]).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Frank (US 2005/0217681 A1).
Regarding claim 1, Frank discloses a mentum securement device (Abstract, Figure 26) comprising: a mentum strap (752) defined by opposing distal portions (see opposing left and right portions of 752, Figure 26), a superior end and an opposing inferior end (see opposing upper and lower ends of 752, Figure 26), and a first surface configured to be positioned on and in facing relation to a mentum of a patient undergoing anesthesia (see inner surface of 752 positioned on and facing towards the mentum of the patient, Figure 26); and, two or more securement straps (754) each having a proximal portion attached to a respective opposing distal portion of the mentum strap (Figures 25-26) and a distal portion configured for securement to an anchor point (Figures 25-26), wherein the mentum strap and the two or more securement straps are configured to position the mentum of the patient to an extended state, wherein in the extended state the mentum of the patient is at an extended angle relative to a neck of the patient, wherein in a resting state the mentum of the patient is at a resting angle relative to a neck of the patient, wherein the extended angle is greater than the resting angle (Figure 26 via adjustment of straps 754).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ahlf (US 2022/0265950 A1) in view of Bashaw (US 4,297,994).
Regarding claim 5, Ahlf discloses that as applied above wherein each of the two or more securement straps comprising a buckle configuration to adjust the respective lengths of the two or more securement straps (buckle mechanism 120, Figures 2-3; [0017]) but does not disclose the straps comprising a webbing. Bashaw teaches a chin strap (24) that comprises webbing (Col. 5, lines 9-20). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the straps of Ahlf comprised of webbing as taught by Bashaw for providing a durable material for positioning the chin and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Ahlf (US 2022/0265950 A1) in view of Bashaw (US 4,297,994) in view of Frank (US 2005/0217681 A1).
Regarding claim 6, Ahlf and Bashaw teach that as applied above. Ahlf discloses the two or more securement straps are configured for adjustment of the respective lengths of the two or more securement straps ([0017]-[0018]). Ahlf and Bashaw do not disclose the two or more securement straps further comprise a hook-and-loop portion at the distal portion configured for adjustment by interlocking the hook-and- loop portion at one or more positions along lengths of the two or more securement straps. Frank teaches a medical device for overcoming airway obstruction wherein securement straps (16) further comprise a hook-and-loop portion (16a) at the distal portion configured for adjustment by interlocking the hook-and- loop portion at one or more positions along lengths of the two or more securement straps (Figure 2; [0067]). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Ahlf and Bashaw having a hook-and-loop portion at the distal portion configured for adjustment by interlocking the hook-and-loop portion at one or more positions along lengths of the two or more securement straps as taught by Frank as being a well known alternative to buckles and for providing greater ease of usability and adjustability.
Claims 13, 16, and 18 rejected under 35 U.S.C. 103 as being unpatentable over Ahlf (US 2022/0265950 A1) in view of Aarestad et al (US 2008/0163875 A1).
Regarding claim 13, Ahlf discloses that as applied above but does not specify wherein the elastomeric material comprises a material selected from the group consisting of: medical grade silicone, heat cured rubber (HSR) elastomer, high temperature vulcanizing silicone rubber, and liquid silicone rubber (LSR) elastomer. Aarestad teaches a device for creating an obstruction free upper airway wherein the elastomeric material of the vessel (105) comprises a material selected from the group consisting of: medical grade silicone, heat cured rubber (HSR) elastomer, high temperature vulcanizing silicone rubber, and liquid silicone rubber (LSR) elastomer ([0041]). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Ahlf wherein the elastomeric material is selected from the group consisting of: medical grade silicone, heat cured rubber (HSR) elastomer, high temperature vulcanizing silicone rubber, and liquid silicone rubber (LSR) elastomer as taught by Aarestad for providing sealed engagement with the user and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 16, Ahlf teaches the mentum securement device of claim 1, wherein the mentum strap is comprised of an elastomeric material (elastomeric mandible harness, Abstract), but Ahlf does not specifically teach the mandible harness being made of a tacky elastomeric material. However, in similar art, Aarestad teaches a device for creating an obstruction free upper airway comprising a vessel worn against the chin (see 105 against the chin, Fig. 1A, para [0036]), the vessel being able to form a seal using an adhesive or an elastomeric seal using elastomeric materials (para [0041] Aarestad discloses the same elastomeric materials disclosed by applicant and thus is considered to be tacky given that silicone and rubber are known to be tacky). Accordingly, it would have it would have been obvious to a person having ordinary skill in the art to ensure the elastomeric material of Ahlf is tacky like the elastomeric materials used by Aarestad to form a seal, in order to ensure the mandible cradle does not slip and cause the airway of the patient to close due to the improved seal provided by the tackiness.
Regarding claim 18, Ahlf teaches the mentum securement device of claim 1, but does not disclose wherein the mentum strap comprises one or more pleats. Aarestad teaches a device for creating an obstruction free upper airway comprising a vessel worn against the chin (see 105 against the chin, Fig. 1A, para [0036]), the vessel attached to pleats to allow for natural head motion (see bellows as pleated, Fig. 1A; para [0042]). Accordingly, it would have been obvious to apply the pleated bellows structure of Aarestad on the lower portion of the mentum strap of Ahlf, in order to enable the chin pad to apply pressure to a greater area of the chin while still allowing for natural head motion during neck flexion, increasing patient comfort.
Claims 7-9, 14-15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Frank (US 2005/0217681 A1).
Regarding claim 7, Frank discloses in the embodiment of Figure 26 as applied above that the two or more securement straps are configured for adjustment of the respective lengths of the two or more securement straps ([0095]). Frank do not disclose in the current embodiment wherein each of the distal portions of the two or more securement straps comprise a hook-and-loop portion configured to removably secure the distal portions to respective anchor points in a hook-and-loop securement. Frank teaches in an alternative embodiment wherein each of the distal portions of the two or more securement straps comprise a hook-and-loop portion (16a) configured to removably secure the distal portions to respective anchor points in a hook-and-loop securement (Figure 2; [0067]). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the current embodiment of Frank wherein each of the distal portions of the two or more securement straps comprise a hook-and-loop portion configured to removably secure the distal portions to respective anchor points in a hook-and-loop securement as taught by the alternative embodiment of Frank as being a suitable alternative form of attachment and for providing greater ease of usability and adjustability of the straps.
Regarding claim 8, Frank further discloses wherein the device is capable of use where a respective anchor point is a portion of a siderail of a surgical stretcher (Figure 26).
Regarding claim 9, Frank further discloses wherein the device is capable of use wherein the respective anchor point is a tie- down d-ring of a surgical stretcher (Figure 26).
Regarding claims 14-15, Frank discloses that as applied above but does not disclose in the current embodiment of Figure 26 wherein at least a portion of the first surface comprises a tacky surface configured to be removably adhered to the mentum of the patient. Frank teaches in an alternative embodiment wherein at least a portion of the first surface comprises a tacky surface configured to be removably adhered to the mentum of the patient (606, Figure 7; [0073]) and further teaches wherein the first surface comprises an adhesive coating (606, Figure 7; [0073]). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the current embodiment of Frank having the tacky surface comprising an adhesive coating as taught by the alternative embodiment of Frank so that the strap bonds with the patient and remains in position during use.
Regarding claim 17, Frank discloses that as applied above and appears to show perforations in the mentum strap (Figure 26 where straps 754 attach to 752) although not explicitly disclosed. Frank teaches in an alternative embodiment the mentum strap (602) has a plurality of perforations (602a, Figure 14d; [0085]). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the current embodiment of Frank having a plurality of perforations as taught by the alternative embodiment of Frank for attaching the securement straps to the mentum strap.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Frank (US 2005/0217681 A1) in view of Dimmitt et al (US 10,342,693 B1).
Regarding claim 10, Frank discloses that as applied above and discloses wherein each of the distal portions of the securement straps comprise hook-an-loop fasteners to removably secure the distal portions to respective anchor points (16a, Figure 2; [0067]). Frank does not disclose a tacky first surface. Dimmitt et al teaches a pair of straps having adhesive (26) for adjustable retention as an alternative to Velcro (Col. 2, lines 35-37; claim 7). Accordingly, it would have been obvious to a person having ordinary skill in the art to apply the tacky, adhesive surface of Dimmitt on the straps of Frank, as taught as being a suitable alternative to Velcro in order to further increase the strength of the attachment of the straps without reducing the ability of the straps to be adjustable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kari Rodriquez whose telephone number is 571-270-1909. The examiner can normally be reached Monday-Friday 6-3 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at (571) 270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARI K RODRIQUEZ/Primary Patent Examiner, Art Unit 3786