DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on 12/8/2025. As directed by the amendment: claim(s) 9, 11, 13-15, and 19 have been amended. Thus, claims 1-19 are presently pending in this application.
Examiner notes that applicant’s claims filed 12/8/2025 indicate claims 11 and 19 as “previously presented” however, examination of the claims reveals that both claims have been amended.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Israel on 9/10/2021. It is noted, however, that applicant has not filed a certified copy of the IL 286271 application as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement(s) have been considered by the examiner.
Response to Arguments
Applicant's arguments filed 12/8/2025 have been fully considered but they are not persuasive.
Regarding applicant’s argument regarding priority on page 5:
Applicant is correct regarding the one-year-after-filing date falls on a Sat., so the applicant had until the next Mon. (one year and two days) to file the application, accordingly the claim for priority can be based on the noted international application IL 286271.
However, as applicant also noted, an access code to the internation application had not been provided and thus the office has not yet received a copy of certified copy of the international application. Applicant's remarks indicate that a petition for acceptance of a late indication of the access code is being prepared for filing.
Regarding applicant’s argument regarding the preceding 101 rejection on page 5-6:
Applicant's present amendment resolves the preceding office actions stated 101 rejection of claims 14-15.
Regarding applicant’s argument regarding the preceding 112b rejection on page 6:
Applicant's present amendment resolves the preceding office actions stated 112b rejection of claims 9, 11, and 13.
Regarding applicant’s argument regarding the preceding 112d rejection on page 6-7:
The rejection to claim 2 under 112(d) is withdrawn.
Regarding applicant’s argument regarding the independent claims on page 8-9:
Applicant argues that the prior art relied upon in the preceding office action does not teach the following limitations of the present independent claim 1:
"an open frame configured to be mounted on a patient's neck, said frame is encircling the patient's neck "
Applicant particularly argues that a person of ordinary skill in the art would interpret the claim term "encircling" to mean that "the frame extends substantially around the circumference of the neck, forming a continuous or near-continuous structural loop around the neck, which allows the frame to be closed around the neck by a fastening element".
First, by applicant's own interpretation of the claim term encircling, D'Aloiso's frame extends substantially around the circumference of a patient's neck so as to form a near-continuous structural loop around the neck, see examiner's annotation of D'Aloiso's fig 1+2+7.
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Second, examiner notes that applicant's interpretation of the claim term encircling is impermissibly narrow and incorporates limitations from applicant's disclosure which are not included in the broadest reasonable interpretation of the term "encircling". Examiner notes that the broadest reasonable interpretation of the claim term " encircle" to a person of ordinary skill in the art, not inconsistent with the disclosure, may be best provided by Cambridge's English dictionary: "to surround or form a circle around something". As demonstrated in examiner's annotation of D'Aloiso's fig 1+2+7 above and the prior art rejection of the preceding and present office action.
"at least one fastening element for closing the open frame onto the patient's neck and adjusting it to the neck's dimensions"
Applicant particularly argues that the frame of D'Aloiso is not "configured to be mounted on a patient's neck and to encircle the patient's neck or a fastening element for closing the open frame onto the patient's neck and adjusting it to the neck dimensions.
The claimed fastening element of D'Aloiso, adjustable base garment attachment 75 and attachment plates 28, permit members 80 to secure to platform 20 and garment 70, and therein closing the claimed frame in the manner by which all of its elements are secured together and are disposed on a patient's neck by the manner that platform 20's helmet 60 rests on a patient's head atop the patient's neck. Further the office action was clear in that fastening elements are considered functionally capable of adjusting to the neck's dimensions in the manner by which adjustable base garment attachment 75 can be positioned at various locations on base garment 70 to fit to a patient's specific anatomy, see paragraph 50+52 of D'Aloiso, such that attachment 75 may be be positioned relatively superiorly or inferiorly on garment 70 to distance or approximate platform 20 and its helmet 60 relative to garment 70. Such anatomy such as a patient's neck length dimension determines the distance which an appropriately disposed helmet should be positioned relative to garment 70 to adequately position the invention on a patient.
Examiner notes for applicant that amendments to the claims which better define the specific dimensions (i.e. length, width, circumference, diameter, etc.) and the manner by which the fastening element's adjustment changes certain dimensions of the frame (i.e. reducing/enlarging an inner circumference/diameter of the frame such that an inner surface of the frame directly contacts/supports the patient's neck) may distinguish such amended claims from the prior art rejection of record and may arrive at potentially allowable subject matter. Depending on the language of such proposed amendments, examiner may require further search and consideration to determine whether such amendments constitute allowable subject matter or not.
"at least one opening at the cannula entry point for allowing approach to at least one neck artery and/or vein"
Applicant particularly argues D'Aloiso does not disclose at least one opening at the cannula entry point and instead discloses tubing holders positioned on the opposite ends of bearing platform 20 configure to secure and route tubing 9 from cannula 7, along track 50.
However, examiner's preceding office action was clear that fig 1b illustrates the opening between members 80, platform 20, and garment 70 which permits cannula 7 to be inserted at the cannula entry point, cannulation site 3. For the sake of illustrating for applicant the interpretation provided in preceding office action, examiner provides the following annotation of D'Aloiso's fig 1b which highlights this opening between members 80, platform 20, and garment 70 where the cannula 7 enters the patient.
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Accordingly, examiner's rejection of the claims in view of the prior art of record applied in the preceding office action stands.
Applicant argues that the prior art relied upon in the preceding office action does not teach the following limitations of the present independent claim 19:
Applicant argues that claim 19 recites the frame structure and fastening element as described in claim 1, and for their aforementioned reasons, should constitute allowable subject matter.
Examiner's arguments above regarding that same subject matter details the reasoning why examiner's interpretation of the prior art forming the basis of the rejection stands.
Applicant argues that the prior art relied upon in the preceding office action does not teach the following limitations of the present independent claim 19:
"the frame comprises one or more frame segments"
However, applicant does not explicitly detail why they consider D'Aloiso silent in this regard. Examiner notes that the preceding office action was clear in that the claimed frame is formed of garment 70, helmet 60, support members 80, and bearing platform 20, and thus garment 70, helmet 60, members 80, and platform 20 are segments/portions/parts/elements/components/structures belonging to the frame and thus anticipate the limitations of the claim.
"an opening sized to allow surgical approach to a neck artery or vein at the cannula entry point"
However, applicant does not explicitly detail why they consider D'Aloiso silent in this regard. Examiner's preceding office action was clear that fig 1b illustrates the opening between members 80, platform 20, and garment 70 which permits cannula 7 to be inserted at the cannula entry point, cannulation site 3. For the sake of illustrating for applicant the interpretation provided in preceding office action, examiner provided the annotation of D'Aloiso's fig 1b above which highlights this opening for the surgical insertion of a cannula 7 and cannulation site 3.
Accordingly, examiner's rejection of the claims in view of the prior art of record applied in the preceding office action stands.
Regarding applicant’s argument regarding claim 9 on page 9-10:
Applicant argues that in “clear contrast” to the prior art, the present invention "achieves fixation through an openneck frame and adjustable fastening, providing a simpler, self-contained mechanism for cannula stabilization" and for that reason, as well as those reasons detailed in applicants arguments regarding claim 1, the invention of claim 9 is patentable.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant argues that the prior art relied upon in the preceding office action does not teach the following limitations of the presently amended claims:
"said niche having two holes at the right and left sides of the niche that allow the cannula to be secured to the frame by securing elements"
Applicant particularly argues that the prior art of Nilson's tracks 74 76 cannot be considered be considered holes, as they were so interpreted in the preceding office action, and applicant alleges that because Nilson's tracks 74 76 are not formed on a curved section of a frame a person of ordinary skill in the art would not be motivated nor taught to modify D'Aloiso with the teachings of Nilson.
Examiner notes that broadest reasonable interpretation of the claim term " holes" to a person of ordinary skill in the art, not inconsistent with the disclosure, may be best provided by Cambridge's English dictionary: "an empty space in an object, usually with an opening to the object's surface, or an opening that goes completely through an object". Accordingly, as the preceding and present office action's prior art rejection of record consider the claimed hole of Nilson to be tracks 74 76 together with their respective open ends 90 94, the empty space bound within tracks 74 76 and their respective open ends can be considered holes.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a throughhole) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Examiner further notes that preceding office action was clear in that the limitations of claim 8 are not disclosed/taught by Nilson, and instead are disclosed by D'Aloiso, including the niche being formed on a curved section of the frame. Nilson is instead relied upon for the holes and securing elements which aid in securing a tube within a niche. Thus in the combination made in the prior art rejection of claim 9, disposes Nilson's holes on the curved section disclosed by D'Aloiso to securing D'Aloiso's tubing in its niche. Disposing a hole on varied surface topography, including planar and curvilinear surfaces, is within the ordinary and routine skill of a person of ordinary skill in the art, and is at the very least demonstrated by Nilson, in that it is capable of forming a curved shape in that its tracks 74 76 are cylindrical in nature, and is further demonstrated by D'Aloiso in that it's niche -which is a type of hole- is formed from and on an arcuate surface.
Examiner notes that a person of ordinary skill in the art in possession of D'Aloiso would look to Nilson because Nilson's teachings address a problem applicant is trying to solve of a manner of securing a tube to an apparatus where the tube is disposed in a channel of the apparatus. Further, as examiner noted in the preceding office action and examiner's rejection as necessitated by the amendment below, a person of ordinary skill in the art would be motivated to combine these pieces of prior art in order to advantageously arrive at invention with improved means for securing its tubing in place.
Accordingly, examiner's rejection of the claims in view of the prior art of record applied in the preceding and present office action stands.
Regarding applicant’s argument regarding dependent claims on page 9:
Applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims are allowable.
However, as examiner discusses above, the rejection of the independent claims stands, and for at least that reason and the interpretation of the prior art provided in the preceding office action, the dependent claims are rejected.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-8, 10-19 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by US 20170157364 A1, henceforth written as D'Aloiso.
Regarding claim 1, D’Aloiso discloses:
A cannula fixation device comprising at least:
(cannula stabilization device 10; fig 1b)
a. an open frame configured to be mounted on a patient's neck, said frame is encircling the patient's neck
(claimed open frame comprises at least garment 70, helmet 60, support members 80, and bearing platform 20; fig 1b illustrates the manner by which the claimed frame surround, therein encircle, patient 1's neck)
and having at least one opening at the cannula entry point for allowing approach to at least one neck artery and/or vein;
(fig 1b illustrates the opening (not enumerated) between members 80, platform 20, and garment 70 which allows for a cannula 7 to be inserted into a vein/artery, see paragraph 27)
b. at least one cannula holder configured to allow securing of a cannula to said frame; and
(paragraph 30; tubing holder 30 and tubing track 50 secures tubing 9, where tubing 9 and cannula 7 are considered the claimed cannula; fig 2)
c. at least one fastening element for closing the open frame
(adjustable base garment attachment 75 and attachment plates 28 secure members 80 to platform 20 and garment 70, therein closing the claimed frame in the manner by which all of its elements are secured together; fig 7+8)
onto the patient's neck
(helmet 60 and platform 20 are disposed on a patient's head, which is disposed on their neck, therein the claimed frame is closed on the patient's neck as it's helmet 60 is supported by the neck)
and adjusting it to the neck's dimensions;
claim language of “adjusting it to” implies a functional language and the prior art must at least be capable of performing the recited function of adjusting the frame to the dimensions of the patient's neck.
(paragraph 50+52; adjustable base garment attachment 75 can be positioned at various locations on base garment 70 to fit to a patient's specific anatomy; accordingly, as a patient's neck height determines the distance which helmet 60, and therein platform 20, is away from garment 70, the attachment 75 is functionally capable of adjusting for a patient's neck dimensions by being disposed relatively superiorly or inferiorly on garment 70 to adjust a height by which the member 80, mated to attachment 75, is disposed for setting an adequate height for helmet 60 via the connection to platform 20)
wherein said cannula fixation device is configured to secure at least one cannula inserted into the neck artery and/or vein of said patient and preserve the cannula position within the artery and/or vein in any body positioning, while said patient is lying down, standing, or sitting.
claim language of “configured to” implies a functional language and the prior art must at least be capable of performing the recited function of securing a cannula in a neck and stabilizing its position in the vasculature while a patient is lying down, standing or sitting.
(paragraph 27; device 10 is functionally capable of securing and stabilizing a cannula in the vasculature of the patient during the claimed stationary activity as it is disclosed as being functionally capable of limiting head and neck movements of a patient such they can ambulate without dislodging cannula 7 from the cannulation site 3, ambulating is an activity which imposes greater dynamics on the cannula-vein interaction and risk of dislocation as opposed to stationary activity; fig 1; paragraph 60, a prototype of the disclosed invention is demonstrated as minimizing cannula movement to an acceptable level when a patient moves from laying down to sitting, and sitting to standing)
Regarding claim 2, D’Aloiso discloses:
A cannula fixation device according to claim 1, wherein said frame is made of a rigid or semi-rigid material.
(paragraph 36; platform 20 is made of plastic which can be considered either rigid or semi-rigid)
Regarding claim 3, D’Aloiso discloses:
A cannula fixation device according to claim1, wherein said frame is composed of two or more frame sections sequentially connected to each other.
(fig 1b+6 illustrates the garment 70 has right and left torso sections (not enumerated) conjoined sequentially by a set of straps (not enumerated) )
Regarding claim 4, D’Aloiso discloses:
A cannula fixation device according to claim 3 further comprising connectors for connecting said frame sections.
(fig 1b+6, illustrate the straps (not enumerated) which connect the right and left torso sections (not enumerated) of garment 70)
Regarding claim 5, D’Aloiso discloses:
A cannula fixation device according to claim1, wherein said frame comprises a left opening and a right opening so as to enable simultaneous approach to the left and right neck arteries and veins.
(fig 1b illustrates the left and right opening between members 80, platform 20, and garment 70, as divided by patient 1 such that the invention enables a simultaneous left and right neck cannulation)
Regarding claim 6, D’Aloiso discloses:
A cannula fixation device according to claim1, further comprising an inner soft layer attached to said frame and covers said frame either fully or partially.
(paragraph 31; aperture 38 features a foam lining which cushions, therein is soft, tubing from mechanical abrasion, therein formed on an inner surface and covers part of the claimed frame; fig 2)
Regarding claim 7, D’Aloiso discloses:
A cannula fixation device according to claim1, wherein said at least one cannula holder is a part of said frame or an independent connecting element attached thereto.
(paragraph 30; fig 2 demonstrates that tubing holder 30 is connected to platform 20 via hinge 36)
Regarding claim 8, D’Aloiso discloses:
A cannula fixation device according to claim1, wherein said at least one cannula holder is a curved section of said frame creating a niche.
(fig 2b illustrates the manner by which tubing track 50 is a curved section of platform 20, and forms a niche between its arcuate shaped brackets 54)
Regarding claim 10, D’Aloiso discloses:
A cannula fixation device according to claim1, wherein said at least one cannula holder is a selected from the group consisting of: clips, straps, -- at least two subsequent mechanical projections, clasp, --
Examiner provides that the broadest reasonable interpretations of the above cannula holder Markush group embodiments as they are understood by a person of ordinary skill in the art, not inconsistent with the speciation:
Clip: "a usually small piece of metal or plastic that holds things together or keeps things in place" - Encyclopedia Britannica
Strap: "a narrow and usually flat piece of a material that is used for fastening, holding together, or wrapping something" - Encyclopedia Britannica
Clasp: "a device for holding together objects or parts of something" - Encyclopedia Britannica
(in light of examiner's aforementioned interpretation of the above claim terms, tubing holder 30 can be considered a clip, strap, and clasp by the manner in which it holds the tubing 9 in its aperture 38; further the protrusions (not enumerated) of arm 34 forming the gap which forms aperture 38, as well as the protrusions (not enumerated) of holder base 32 forming the gap which complementarily form aperture 38 constitute subsequent mechanical projections which mate in a closed form to hold tubing 9 in aperture 38; similarly brackets 54 of track 50 likewise constitute subsequent mechanical projections by the nature by which they are disposed relative to surface 52)
Regarding claim 11, D’Aloiso discloses:
A cannula fixation device according to claim1, wherein said frame further comprises at least two projections configured to hold an ascending portion of the cannula and fixate it to the frame.
(the projections (not enumerated) which protrude from base 32, with aperture 38 therebetween, to mate with holder arm 34 constitute the claimed at least two projections; projections of base 32 are configured to hold a portion of the claimed cannula in that the surfaces of the projections (not enumerated) mate with arm 34 to hold the claimed cannula in place and fix it the claimed frame, see paragraph 30-32)
Regarding claim 12, D’Aloiso discloses:
A cannula fixation device according to claim1, wherein said frame is composed of different heights at different areas around the neck.
(fig 1 illustrates the different heights which elements of the claimed frame are disposed at relative to a patient's neck)
Regarding claim 13, D’Aloiso discloses:
A cannula fixation device according to claim1, wherein said at least one fastening device is selected from the group consisting of: a strap comprising a hook-and-loop fastener, elastic modular strap, clips, straps, adhesive tape, and clasp.
(Paragraph 52; attachment 75 secures to garment 70 via hook and loop closure, and further a hook and loop closure can be considered clip, strap, and clasp by the nature of its individual hooks and engage individual loops to secure one element to another)
Regarding claim 14, D’Aloiso discloses:
A cannula fixation device according to claim1, configured to secure said at least one cannula inserted into said vein or artery of said patient during one of the following: extracorporeal blood processing, cardio-vascular therapeutic or diagnostic procedure, hemodialysis, plasmapheresis, transvenous cardiac pacing, invasive hemodynamic monitoring, and heart-lung machine.
Examiner notes the claim language relied upon for examination of “configured to” and “device may be used when” implies a functional language and the prior art must at least be capable of performing the recited function being operable while a patient is intubated.
(fig 1 illustrates that the invention in use does not block or impede access to a patient's nose, mouth, or trachea therein the invention is functionally capable of being used while a nasotracheal, orotracheal, or intratracheal procedure is performed on a patient undergoing the claimed procedures; examiner further notes that the D'Aloiso in paragraph 3-6+13 discloses its invention being used to support Extracorporeal membrane oxygenation an invasive therapeutic procedure broadly involving the extracorporeal processing/purifying of blood and monitoring of hemodynamics)
Regarding claim 15, D’Aloiso discloses:
A cannula fixation device according to claim1, configured to secure said at least one cannula inserted into said vein or artery of said patient when said patient is positioned in a prone position.
Examiner notes the claim language relied upon for examination of “configured to” implies a functional language and the prior art must at least be capable of performing the recited function while a patient is in a prone position.
(paragraph 27; device 10 is functionally capable of securing and stabilizing a cannula in the vasculature of the patient during the claimed stationary activity as it is disclosed as being functionally capable of limiting head and neck movements of a patient such they can ambulate without dislodging cannula 7 from the cannulation site 3, ambulating is an activity which imposes greater dynamics on the cannula-vein interaction and risk of dislocation as opposed to stationary activity; fig 1; paragraph 60, further a prototype of the disclosed invention is demonstrated as minimizing cannula movement to an acceptable level when a patient moves from laying down to sitting, and sitting to standing)
Regarding claim 16, D’Aloiso discloses:
A cannula fixation device according to claim1, wherein said secured cannula is further connected to a tube, and said tube is functionally connected to the frame by said cannula holders.
(fig 1+6 demonstrates the manner which the tubing 9, connected to cannula 7, is secured to the claimed frame by the claimed cannula holders)
Regarding claim 17, D’Aloiso discloses:
A cannula fixation device according to claim 16, wherein said tube is supported by a rigid assembly mounted on the portion of the tube that is attached to the frame so as to prevent kink/collapse of said tube.
(Paragraph 31; arms 34 and base 32, constituting the rigid assembly, secure the tubing in aperture 38 "without pinching or kinking the tubing")
Regarding claim 18, D’Aloiso discloses:
A cannula fixation device according to claim 17, wherein said rigid assembly is either one of the following: -- u shapes --
(fig 2, illustrates the u-shapes formed of base 32 and arms 34)
Regarding claim 19, D’Aloiso discloses:
A cannula fixation device for securing at least one cannula inserted into the neck artery and/or vein of a patient and preserve the cannula position within the artery and/or vein in any body positioning, said cannula fixation device comprising at least:
(cannula stabilization device 10 secures tubing 9 and cannula 7, together considered the claimed cannula; fig 1b)
a. an open frame comprising one or more frame segments
(claimed open frame comprises at least garment 70, helmet 60, support members 80, and bearing platform 20; fig 1b illustrates the manner by which the claimed frame surround patient 1's neck)
and configured to be mounted on a patient's neck,
(helmet 60 and platform 20 are disposed on a patient's head, which is disposed on their neck, therein the claimed frame is closed on the patient's neck as it's helmet 60 is supported by the neck)
said frame having at least one opening in dimensions allowing to approach at least one neck artery and/or vein at the entry point for performing a medical procedure;
(fig 1b illustrates the opening (not enumerated) between members 80, platform 20, and garment 70 which allows for a cannula 7 to be inserted into a vein/artery, see paragraph 27)
b. at least one cannula holder configured to allow securing and/or fixating of a cannula inserted into the patient's body to said frame; and
(paragraph 30; tubing holder 30 and tubing track 50 secures tubing 9; fig 2)
c. at least one fastening element for closing the open frame
(adjustable base garment attachment 75 and attachment plates 28 secure members 80 to platform 20 and garment 70, therein closing the claimed frame in the manner by which all of its elements are secured together; fig 7+8)
onto the patient's neck to encircle the neck
(fig 1b illustrates the manner by which the claimed frame surrounds, therein encircles, patient 1's neck)
and adjusting it to the neck's dimensions.
claim language of “adjusting it to” implies a functional language and the prior art must at least be capable of performing the recited function of adjusting the frame to the dimensions of the patient's neck.
(paragraph 50+52; adjustable base garment attachment 75 can be positioned at various locations on base garment 70 to fit to a patient's specific anatomy; accordingly, as a patient's neck height determines the distance which helmet 60, and therein platform 20, is away from garment 70, the attachment 75 is functionally capable of adjusting for a patient's neck dimensions by being disposed relatively superiorly or inferiorly on garment 70 to adjust a height by which the member 80, mated to attachment 75, is disposed for setting an adequate height for helmet 60 via the connection to platform 20)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over D'Aloiso, as applied to claim 8 above, in view of US 20130165863 A1, henceforth written as Nilson.
Regarding Claim 9,
D'Aloiso discloses all of the elements of the current invention which the present claim is dependent upon, as described above, however, D'Aloiso is silent regarding:
A cannula fixation device according to claim 8, said niche having two holes at the right and left sides that allow the cannula to be secured to the frame by securing elements.
However, Nilson teaches a securement device for medical tubing:
wherein said niche is having two holes at the right and left sides of the niche that allows to secure the [tubing] to the frame.
(Paragraph 49-51; tracks 74 76 with their respective open ends 90 94, therein together the claimed holes, are disposed to the right and left of channel 16c, therein a niche, and the claimed holes can receive rails 78 80 of strap 18 to secure tubing 12; fig 2-6)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate Nilson's teachings of disposing holes adjacent a niche for securing a medical tubing strap to the claimed niche of D'Aloiso, by disposing Nilson's claimed holes in D'Aloiso's tubing brackets 54 such that the Nilson's strap 18 travels therebetween to secure D'Aloiso's tubing 9 against its track 50 and thus secures D’Aloiso’s cannula 7 at an end of D’Aloiso’s tubing 9 to the claimed frame, as such a modification involving combining equivalents known for the same purpose of securing tubing in a channel would only involve routine skill in the art, see MPEP 2144.06(I), and such a modification would advantageously arrive at an invention with further means for securing tubing to an ambulatory patient therein reducing risks associated with loose tubing such as kinking, pinching, or getting snagged such that the cannula/tubing is forcefully removed from a patient.
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 FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FORREST B DIPERT/Examiner, Art Unit 3783 /MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783