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
Examiner acknowledges the reply filed on 02/02/2026 in which claims 1-4 and 6-20 have been amended, claim 5 has been canceled, and claim 21 is newly added. Currently, claims 1-4 and 6-21 are pending for examination in this application.
Response to Arguments
Applicant has resolved the objections to the claims.
Applicant has resolved the 35 U.S.C. § 101 and 112(b) rejections to the claims. However, additional rejections under 35 U.S.C. § 101 have been indicated.
Applicant’s arguments, see Remarks pg. 11-15, filed 02/02/2026, with respect to the rejection(s) of claim(s) independent claims 1 and 11 under 35 U.S.C. § 103 in view of the Nashed and Gee references have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ritz et al. (US 20200129718 A1) and Gee (GB 2336547 A).
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 11-21 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 11 recites "wherein the subject-specific facial adapter emulates specific geometric contours of a subject’s face". This limitation should be amended to functionally recite " wherein the subject-specific facial adapter is configured to emulate specific geometric contours of a subject’s face ".
Claim 20 recite "wherein the subject-specific facial adapter emulates specific geometric contours of a subject’s face". This limitation should be amended to functionally recite " wherein the subject-specific facial adapter is configured to emulate specific geometric contours of a subject’s face ".
Claims 12-19 and 21 are rejected based on their dependency on a rejected claim.
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, 3, 9, and 10 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Ritz et al. (US 20200129718 A1).
Regarding claim 1, Ritz discloses a mask (Resuscitation and Ventilation Mask; title; figure 4-6) comprising:
a body ([0065] mask 40; figure 4-6) comprising:
a first connector ([0063] connection 43 for a medical gas; figure 4-6) couplable with a positive pressure respiratory device ([0069] Mask 40 is attached to a conventional T piece 76, and then to a source of medical gas via flexible pipe 75; figure 6); and
a second connector couplable with tubing from a suction generator ([0063] suction connection 42. In its original form, connection 43 is connected to a suitable medical gas supply, and connection 42 to suction; figure 4-6); and
an interface ([0065] converter insert 50; figure 4-6) configured to be removably secured to the body (40) via negative pressure generated by the suction generator ([0013] the mask body is formed from a mask shell, the mask shell having a central opening surrounded by a peripheral recess adapted to receive suction, to thereby operatively affix the first mask shell to a user to facilitate the supply of a medical gas to a user, and an conversion insert, said insert on one side providing said engagement seal, and on the other providing a mating surface to engage the peripheral recess. [0062] FIG. 4 shows an implementation in which a mask which is adapted to be adhered by suction, for example as shown in the applicant's co-pending WO2016119006, can be modified by an insert to function according to the present invention [0065] FIGS. 4 and 5 shows a converter insert 50 adapted to be inserted into mask 40 to convert it into a mask according to the present invention. Insert 50 has an upper projection 51 with a shape adapted to mate with the interior surface of annular groove 41. Upper projection 51 further blocks the connection between suction connections and the groove 41, so that this is not a path for the loss of pressure from the medical gas delivery), wherein the interface is configured to be in contact with a subject's face (see figure 6), and wherein the interface comprises a flexible material conformable to the subject's face ([0066] The lower, engagement surface 52 is part-toroidal in form, and is made from a similar grade of silicone rubber to the first implementation. Thus, a similar seal and engagement can be produced to the first implementation, using a composite device. [0067] In an alternative implementation, the toroidal form could be provided using a silicone gel with an toroidal tube; figure 4-6).
Regarding claim 3, Ritz discloses the mask of claim 1, wherein the flexible material comprises one or more of silicone ([0066] The lower, engagement surface 52 is part-toroidal in form, and is made from a similar grade of silicone rubber to the first implementation) and open cell foam.
Regarding claim 9, Ritz discloses the mask of claim 1, wherein the body (40) comprises a facial adapter (circumferential toroidal portion; see figure 4-6 and Examiner Annotations 1 below) and a housing (cup/bowl portion; see figure 4-6 and Examiner Annotations 1 below).
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Examiner Annotations 1
Regarding claim 10, Ritz discloses the mask of claim 1, wherein generating negative pressure via the suction generator isolates an interior of the mask from an exterior of the mask ([0013] the mask body is formed from a mask shell, the mask shell having a central opening surrounded by a peripheral recess adapted to receive suction, to thereby operatively affix the first mask shell to a user to facilitate the supply of a medical gas to a user. [0065] a converter insert 50 adapted to be inserted into mask 40 to convert it into a mask according to the present invention. Insert 50 has an upper projection 51 with a shape adapted to mate with the interior surface of annular groove 41. Upper projection 51 further blocks the connection between suction connections and the groove 41, so that this is not a path for the loss of pressure from the medical gas delivery; figure 5-6).
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.
Claim(s) 2 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ritz et al. (US 20200129718 A1) as applied to claim 1 above, and further in view of Derringer et al. (US 20110209701 A1).
Regarding claim 2, Ritz discloses the mask of claim 1, but is silent as to wherein the flexible material comprises a porous medium or a viscoelastic solid with one or more holes.
However, Derringer teaches a nose pad cushion for attachment to a mask [0012] wherein [0048] FIG. 1 show's a nose cushioning pad 45. An inner layer is formed of a fibrous, foam or other porous absorbent material such as a soft gauze material 60 sandwiched between layers of a soft silicone material. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the lower engagement surface of Ritz to comprise an inner layer of foam or other porous absorbent material, as taught by Derringer in order to improve the comfortability of the cushion.
Regarding claim 8, Ritz discloses the mask of claim 1, but is silent as to wherein the interface comprises grooves on an exterior edge of the mask.
However, Derringer teaches a nose pad cushion for attachment to a mask [0012] wherein the cushion interface comprises grooves on an exterior edge of the mask interface ([0012] The cushion can include an outer surface including pores, micro grooves, pits, or other textured surface means for holding a liquid, paste, powder, gel, salve, or other form of a medical product impregnated thereon between the user's skin and the cushion surface).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the insert of Ritz to implement grooves on an exterior edge of the mask in order to provide a textured surface for holding a liquid, paste, powder, gel, salve, or other form of a medical product impregnated thereon between the user's skin and the cushion surface, as taught by Derringer [0012].
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ritz et al. (US 20200129718 A1) as applied to claim 1 above, and further in view of Eves et al. (US 20180272095 A1).
Regarding claim 4, Ritz discloses the mask of claim 1, but is silent as to wherein the body comprises a rigid material.
However, Eves teaches a mask shell 6005 manufactured from polycarbonate, see [0299]. Applicant’s specifications [0038], teaches polycarbonate is a rigid material.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the body of Ritz to be made from polycarbonate, in order to provide a suitable material for a body for a mask as taught by Eves [0299].
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ritz et al. (US 20200129718 A1) as applied to claim 1 above, and further in view of Gee (GB 2336547 A)
Regarding claim 6, Ritz discloses the mask of claim 1, wherein:
the body comprises a first internal passageway fluidly coupled to the second connector ([0063] an annular groove 41, connected to suction connection 42; figure 4-5); but is silent as to the interface comprises a second internal passageway configured to be fluidly coupled to the first internal passageway of the body when the body and the interface are removably secured such that negative pressure flowing between the first and second internal passageways removably secures the body to the interface.
However, Gee teaches a mask (figure 1-3) including a body comprising a first internal passageway (label E indicates the void between the internal and external skins, C and D; figure 1; pg. 1 line 25) fluidically coupled to a suction outlet (suction outlet B; figure 1) and an interface comprising a second internal passageway configured to be fluidly coupled to the first internal passageway of the body (label F indicates the flexible soft rubber padding. This is continuous around the perimeter of both the internal and external skins, labelled C and D. It is positioned so there is no occlusion of the suction void, label E; figure 1; pg. 1 line 27-29).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the converter insert of Ritz to implement an internal passageway continuous with the first internal passageway of the body such that there is no occlusion of the suction, as taught by Gee in order to adhere the mask to the contours of the face and create an air tight seal via suction during the simultaneous delivery of ventilation therapy from the mechanical ventilator (see Gee pg. 1 line 4-6). As modified, the interface and body create an airtight seal to fix the mask and the interface adheres to the user’s face via the suction applied by the suction connection 42.
Regarding claim 7, modified Ritz teaches the mask of claim 6, wherein the interface comprises a sealing feature ([0065] upper projection 51; figure 5) configured to isolate, when the interface is contacting the subject's face and the body and the interface are removably secured (see figure 5-6), an interior of the body (45) from:
an exterior environment of the mask ([0065] Insert 50 has an upper projection 51 with a shape adapted to mate with the interior surface of annular groove 41. Upper projection 51 further blocks the connection between suction connections and the groove 41, so that this is not a path for the loss of pressure from the medical gas delivery; figure 5); and
the first and second internal passageways of the body (see figure 5 and [0065]) and the interface (as modified above, the second internal passageway is provided through the center of the padding/insert. See Gee figure 1 void at center of padding F is isolated from interior of mask during use) respectively.
Claim(s) 11, 13, 15-17, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gee (GB 2336547 A) and Ritz et al. (US 20200129718 A1).
Regarding claim 11, Gee discloses a mask (Face Mask for Mechanically Ventilated Patient; title; figure 1-3) comprising:
a non-subject-specific housing (labels C and D indicate the internal and external skins of the mask respectively; figure 1; pg. 1 line 24) comprising connector couplable with a positive pressure respiratory device (label A indicates the ventilation inlet; figure 1; pg. 1 line 18. simultaneous delivery of ventilation therapy from the mechanical ventilator; pg. 1 line 5);
a non-subject specific interface (label F indicates the flexible soft rubber padding; figure 1; pg. 1 line 27), wherein the non-subject specific interface is configured to be in contact with the subject’s face (F; figure 1-3), and wherein the non-subject specific interface comprises a flexible material conformable to the subject’s face (label F indicates the flexible soft rubber padding; figure 1; pg. 1 line 27).
Gee is silent as to the mask comprising: a subject-specific facial adapter configured to be coupled to the non-subject specific housing and a non-subject specific interface, wherein the subject specific facial adapter emulates specific geometric contours of a subject’s face.
However, Ritz teaches a mask (mask 40; figure 4-6) comprising: a subject-specific facial adapter (circumferential toroidal portion; see figure 4-6 and Examiner Annotations 1 above) configured to be coupled to a housing (cup/bowl portion; see figure 4-6 and Examiner Annotations 1 below) and an interface ([0065] converter insert 50; figure 4-6), wherein the subject specific facial adapter emulates specific geometric contours of a subject’s face ([0058] The diameter of the mask will vary depending upon the age of the user. For a neonate, it typically will vary from 20 to 38 mm; for a full term infant, 50 mm. The circular shape means that there is no preferred orientation for the mask as it is place onto the user. [0059] The toroidal shape has been found to be very effective and to provide a better seal on an infant whose face is more or less round).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the face mask of Gee to implement a circumferential toroidal facial adapter between the housing and the interface of the mask, in order to better adapt to a user’s face that is rounder, such as an infant, as taught by Ritz [0059].
Regarding claim 13, modified Gee teaches the mask of claim 11, but is silent as to wherein the flexible material comprises one or more of silicone and open cell foam.
However, Ritz teaches the interface comprises a flexible material comprising silicone ([0066] The lower, engagement surface 52 is part-toroidal in form, and is made from a similar grade of silicone rubber to the first implementation).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the flexible soft rubber padding of Gee to comprise a silicone rubber in order to provide a material for engaging a user’s face, as taught by Ritz [0066].
Regarding claim 15, modified Gee teaches the mask of claim 11, wherein:
the non-subject-specific housing further comprises:
a second connector couplable with tubing from a suction generator (label B indicates the suction outlet; figure 1-3; pg. 1 line 20. The suction is generated from the suction units already available at the hospital bed sides. The face mask is designed to accommodate the dimensions of the standard forms of suction and ventilation available; figure 1-3; pg. 1 line 7 and 10-11), and
a first internal passage fluidly coupled to the second connector (label E indicates the void between the internal and external skins, C and D. This void is continuous with the suction outlet, label B; figure 1; pg. 1 line 25-26);
but is silent as to the subject-specific facial adapter comprises a second internal passageway configured to be fluidly coupled to the first internal passageway of the non-subject-specific housing when the non-subject-specific housing and the subject-specific facial adapter are mechanically coupled together; and
However, Ritz teaches an internal passageway ([0063] an annular groove 41, connected to suction connection 42; figure 4-5) configured in the subject-specific facial adapter (circumferential toroidal portion; see figure 4-6 and Examiner Annotations 1 above).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the subject specific facial adapter to implement an annular groove connected the suction outlet as taught by Ritz in order to allow the suction to applied through the facial adapter and to the interface as seen in Ritz figure 5.
Modified Gee teaches the non-subject-specific interface (F; figure 1-3) comprises a third internal passageway (see reference numeral 13 at label F; figure 1) configured to be fluidly coupled to the second internal passageway of the subject-specific facial adapter when the subject-specific facial adapter and the non-subject-specific interface are mechanically coupled together (as modified above, the void E extends through facial adapter and to flexible soft rubber padding, see Gee pg. 1 line 27-29, to enable suction through the entire mask).
Regarding claim 16, modified Gee teaches the mask of claim 15, wherein the first (Gee: labels C and D indicate the internal and external skins of the mask respectively; figure 1), second (Ritz: walls on both sides of annular groove 41; figure 5) and third (Gee: passageway through both walls of padding F at reference numeral 13; figure 1) internal passageways are double-walled.
Regarding claim 17, modified Gee teaches the mask of claim 15, wherein the non-subject specific interface (padding F; figure 1) comprises a sealing feature (flexible soft rubber exterior of padding F; see figure 1) configured to isolate, when the non-subject-specific interface is contacting the subject’s face and the mask components are mechanically coupled together, an interior of the mask from (interior of mask continuous with ventilation inlet A; figure 1):
an exterior environment of the mask (The face mask works on the principle of the mask adhering to the contours of the face and creating an air tight seal via suction during the simultaneous delivery of ventilation therapy from the mechanical ventilator; pg. 1 line 4-6. Examiner notes the exterior of padding forms an airtight seal with the user’s face and isolates the interior of the mask from the external environment of the mask); and
an internal passageway formed from the first, second and third internal passageways (The face mask works on the principle of the mask adhering to the contours of the face and creating an air tight seal via suction during the simultaneous delivery of ventilation therapy from the mechanical ventilator; pg. 1 line 4-6. Examiner notes that as modified, the exterior of padding forms an airtight seal with the user’s face and isolates the interior of the mask from the continuous internal passageway formed between the internal and external skins of the mask C and D, the walls on both sides of annular groove 41 formed in the facial adapter (see Ritz figure 5), and the walls of padding F at reference numeral 13).
Regarding claim 19, modified Gee teaches the mask of claim 11, wherein generating negative pressure via the suction generator isolates an interior of the mask from an exterior of the mask (The face mask works on the principle of the mask adhering to the contours of the face and creating an air tight seal via suction during the simultaneous delivery of ventilation therapy from the mechanical ventilator. The suction is generated from the suction units already available at the hospital bed sides; pg. 1 line 4-7. Examiner notes the exterior of padding forms an airtight seal with the user’s face and isolates the interior of the mask from the external environment of the mask).
Regarding claim 20, Gee discloses a mask (Face Mask for Mechanically Ventilated Patient; title; figure 1-3) comprising:
a non-subject-specific housing (labels C and D indicate the internal and external skins of the mask respectively; figure 1; pg. 1 line 24) comprising:
a first connector couplable with a positive pressure respiratory device (label A indicates the ventilation inlet; figure 1; pg. 1 line 18. simultaneous delivery of ventilation therapy from the mechanical ventilator; pg. 1 line 5); and
a second connector couplable with tubing from a suction generator (label B indicates the suction outlet; figure 1-3; pg. 1 line 20. The suction is generated from the suction units already available at the hospital bed sides. The face mask is designed to accommodate the dimensions of the standard forms of suction and ventilation available; figure 1-3; pg. 1 line 7 and 10-11);
a non-subject specific interface (label F indicates the flexible soft rubber padding; figure 1; pg. 1 line 27) configured to be in contact with the subject’s face (F; figure 1-3), wherein the non-subject specific interface comprises a flexible material conformable to the subject’s face (label F indicates the flexible soft rubber padding; figure 1; pg. 1 line 27) to create a seal using negative pressure generated by the suction generator (The face mask works on the principle of the mask adhering to the contours of the face and creating an air tight seal via suction during the simultaneous delivery of ventilation therapy from the mechanical ventilator. The suction is generated from the suction units already available at the hospital bed sides; pg. 1 line 4-7).
Gee is silent as to the mask comprising: a subject-specific facial adapter coupled to the non-subject-specific housing and a non-subject specific interface, wherein the subject-specific facial adapter emulates specific geometric contours of a subject’s face.
However, Ritz teaches a mask (mask 40; figure 4-6) comprising: a subject-specific facial adapter (circumferential toroidal portion; see figure 4-6 and Examiner Annotations 1 above) coupled to a housing (cup/bowl portion; see figure 4-6 and Examiner Annotations 1 below) and an interface ([0065] converter insert 50; figure 4-6), wherein the subject-specific facial adapter emulates specific geometric contours of a subject’s face ([0058] The diameter of the mask will vary depending upon the age of the user. For a neonate, it typically will vary from 20 to 38 mm; for a full term infant, 50 mm. The circular shape means that there is no preferred orientation for the mask as it is place onto the user. [0059] The toroidal shape has been found to be very effective and to provide a better seal on an infant whose face is more or less round).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the face mask of Gee to implement a circumferential toroidal facial adapter between the housing and the interface of the mask, in order to better adapt to a user’s face that is rounder, such as an infant, as taught by Ritz [0059].
Claim(s) 12 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gee (GB 2336547 A) and Ritz et al. (US 20200129718 A1) as applied to claim 11 above, and further in view of Derringer et al. (US 20110209701 A1).
Regarding claim 12, modified Gee teaches the mask of claim 11, but is silent as to wherein the flexible material comprises a porous medium or a viscoelastic solid with one or more holes.
However, Derringer teaches a nose pad cushion for attachment to a mask [0012] wherein [0048] FIG. 1 show's a nose cushioning pad 45. An inner layer is formed of a fibrous, foam or other porous absorbent material such as a soft gauze material 60 sandwiched between layers of a soft silicone material. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the flexible soft rubber padding of Gee to comprise an inner layer of foam or other porous absorbent material, as taught by Derringer in order to improve the comfortability of the cushion.
Regarding claim 18, modified Gee teaches the mask of claim 11, but is silent as to wherein the non-subject-specific interface comprises grooves on an exterior edge of the mask.
However, Derringer teaches a nose pad cushion for attachment to a mask [0012] wherein the cushion interface comprises grooves on an exterior edge of the mask interface ([0012] The cushion can include an outer surface including pores, micro grooves, pits, or other textured surface means for holding a liquid, paste, powder, gel, salve, or other form of a medical product impregnated thereon between the user's skin and the cushion surface).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the flexible soft rubber padding of Gee to implement grooves on an exterior edge of the mask in order to provide a textured surface for holding a liquid, paste, powder, gel, salve, or other form of a medical product impregnated thereon between the user's skin and the cushion surface, as taught by Derringer [0012].
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gee (GB 2336547 A) and Ritz et al. (US 20200129718 A1) as applied to claim 11 above, and further in view of Eves et al. (US 20180272095 A1).
Regarding claim 14, modified Gee teaches the mask of claim 11, but is silent as to wherein the non-subject-specific housing comprises a rigid material.
However, Eves teaches a mask shell 6005 manufactured from polycarbonate, see [0299]. Applicant’s specifications [0038], teaches polycarbonate is a rigid material.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the internal and external skins of the mask of Gee to be made from polycarbonate, in order to provide a suitable material for a body for a mask as taught by Eves [0299].
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gee (GB 2336547 A) and Ritz et al. (US 20200129718 A1) as applied to claim 11 above, and further in view of Karp et al. (US 20210113789 A1).
Regarding claim 21, modified Gee teaches the mask of claim 11, but is silent as to wherein the subject-specific facial adapter comprises a 3D-printed material.
Ritz teaches [0056] The mask is preferably moulded from a material such as silicone rubber.
Additionally, Karp teaches a mask (figure 1-2). Karp teaches [0024] Components of the gas sequestration devices of the present invention can be constructed from any suitable material, including but not limited to metals and polymers, such as stainless steel, titanium, aluminum, polyether ether ketone (PEEK), polyethylenes, polyvinyls, polyurethanes, polyamides, polycarbonates, silicones, and the like. In some embodiments, certain components or portions of certain components can be constructed from a transparent or translucent material. Transparent or translucent materials can permit unobstructed visual inspection of the device and patient during use. The components and systems can be made using any suitable method known in the art. The method of making may vary depending on the materials used. For example, devices substantially comprising a metal may be milled from a larger block of metal or may be cast from molten metal. Likewise, components substantially comprising a plastic or polymer may be milled from a larger block, cast, or injection molded. In some embodiments, the devices may be made using 3D printing or other additive manufacturing techniques commonly used in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the facial adapter of modified Gee to be made of a 3D-printed silicone material as it is a commonly used manufacturing technique as taught by Karp [0024].
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 Mautin I Ashimiu whose telephone number is (571)272-0760. The examiner can normally be reached Monday - Friday, 7:30 a.m. - 4:30 p.m. ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.I.A./Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785