DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed on 12/19/2025 has been entered. Claims 1-2, 4, 9, 12, 22, 26-27, 32-34, 39, 43, 47, 49-50, 62, and 67-69 are pending in the application. Claims 3, 5-8, 10-11, 13-21, 23-25, 28-31, 35-38, 40-42, 44-46, 48, 51-61, and 63-66 are cancelled. Claims 67-69 are new. The amendments to the claims and specification overcome each and every objection previously set forth in the Non-Final Office Action mailed on 8/29/2025.
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 4, 9, 12, 22, 26-27, 32-34, 39, 43, 47, 49-50, and 67-69 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 4 recites the limitation “an interface outlet at an opposite end of the patient interface”. However, claim 4 does not recite a first or initial end, so it is unclear what must be considered the “opposite” end of the patient interface. For examination purposes, the Examiner interprets “an opposite end of the patient interface” as “an end of the patient interface opposite of the interface inlet”.
Claims 9, 12, 22, 26-27, 32-34, 39, 43, 47, 49-50, and 67-69 are rejected by virtue of their dependency on rejected claim 4.
Claim 32 recites the limitation “a support structure at a first end”. It is unclear whether the “first end” is intended to be the same end recited in line 3 of claim 4. For examination purposes, the Examiner interprets “a support structure at a first end” as “a support structure at the end of the patient interface opposite of the interface inlet”.
Claims 33-34 and 39 are rejected by virtue of their dependency on rejected claim 32.
Claim 39 recites the limitation “the first end connectable to the housing inlet”. It is unclear whether this “first end” is intended to mean the first end of the tube or the first end previously recited in claim 32 (which would be further unclear – see the 112b rejection of claim 32 above). For examination purposes, the Examiner interprets “the first end connectable to the housing inlet” as “the first end of the tube connectable to the housing inlet”.
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 1-2, 4, 9, 12, 22, 26-27, 32-34, 39, 43, 49-50, 62, and 68-69 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van Der Linden et al. (US 2005/0119607 A1, hereinafter referred to as “Van Der Linden ‘607”).
Regarding claim 1, Van Der Linden ‘607 discloses a patient interface for protecting a surgical cavity (see Figs. 1-2, par. [0004], [0020]-[0021]) the patient interface comprising:
one or more enclosing layers (heparin coating on porous body 3) defining at least in part a gas flow path (gas flow path through device of Figs. 1-2) capable of directing gases to the surgical cavity (see Figs. 1-2, par. [0021], [0031]), the gas flow path (gas flow path through device of Figs. 1-2) having a first end (proximal end nearest gas source 2) and a second end (distal end nearest porous body 3) opposite the first end (proximal end nearest gas source 2) (see Figs. 1-2, par. [0021]-[0022], [0026]-[0027]);
an interface inlet (inlet at connection to gas source 2) positioned at the first end (proximal end nearest gas source 2) (see Figs. 1-2, par. [0021], [0027]);
an interface outlet (outlet at porous body 3) positioned at the second end (distal end nearest porous body 3) (see Figs. 1-2, par. [0021]); and
one or more deformable elements (stiffening member 18) positioned between the first end (proximal end nearest gas source 2) and the second end (distal end nearest porous body 3) (see Figs. 1-2, par. [0027]), the one or more deformable elements (stiffening member 18) configured to allow the patient interface to be bent into a bent shape and to retain the bent shape (see Figs. 1-2, par. [0027]).
Regarding claim 2, Van Der Linden ‘607 discloses a patient interface for protecting a surgical cavity (see Figs. 1-2, par. [0004], [0020]-[0021]) the patient interface comprising:
an inlet (inlet at connection to gas source 2) fluidly connectable with a gas source (gas source 2) (see Figs. 1-2, par. [0021], [0027]); and
an outlet (outlet at porous body 3) (see Figs. 1-2, par. [0021]),
wherein the patient interface is configured to be bent into a bent shape corresponding to the surgical cavity and to retain the bent shape (see Figs. 1-2, par. [0027]), and
wherein the patient interface is configured to deliver a conditioned flow of gas to the surgical cavity (see par. [0023]-[0025]), the conditioned flow of gas:
having a reduced velocity relative to a velocity of a flow of gas at the inlet (inlet at connection to gas source 2) (see par. [0025]),
having a diffuse flow (see par. [0025]),
being heated (see par. [0023]-[0024]),
being substantially laminar or non-turbulent (see par. [0025]), or
any combination of (i) to (iv) (see par. [0023]-[0025]).
Regarding claim 4, Van Der Linden ‘607 discloses a patient interface for protecting a surgical cavity (see Figs. 1-2, par. [0004], [0020]-[0021]) the patient interface comprising:
an interface inlet (inlet at proximal end of first conduit portion 1’) configured to connect to a gases supply tube (second conduit portion 1”) (see Figs. 1-2, par. [0021], [0027]);
an interface outlet (outlet at porous body 3) at an opposite end (distal end nearest porous body 3) of the patient interface, the interface outlet (outlet at porous body 3) configured to deliver diffused gases to the surgical cavity (see Figs. 1-2, par. [0021], [0025]); and
one or more enclosing layers (heparin coating on porous body 3) at least partly defining a gas flow path (gas flow path through device of Figs. 1-2) between the interface inlet (inlet at proximal end of first conduit portion 1’) and the interface outlet (outlet at porous body 3) (see Figs. 1-2, par. [0021]-[0022], [0026]-[0027], [0031]), the gas flow path (gas flow path through device of Figs. 1-2) including a formable section (section having stiffening member 18) between the interface inlet (inlet at proximal end of first conduit portion 1’) and the interface outlet (outlet at porous body 3) (see Figs. 1-2, par. [0027]); and
at least one deformable element (stiffening member 18) positioned within the formable section (section having stiffening member 18) (see Figs. 1-2, par. [0027]), the at least one deformable element (stiffening member 18) forming at least one bending direction for the formable section (section having stiffening member 18) (see Figs. 1-2, par. [0027]).
Regarding claim 9, Van Der Linden ‘607 discloses the patient interface of claim 4, further comprising a gas permeable substrate (porous body 3) enclosed by the one or more enclosing layers (heparin coating on porous body 3) (see par. [0031]).
Regarding claim 12, Van Der Linden ‘607 discloses the patient interface of claim 9, wherein the gas permeable substrate (porous body 3) comprises an open cell foam (see par. [0025]).
Regarding claim 22, Van Der Linden ‘607 discloses the patient interface of claim 4, wherein gases exiting the interface outlet (outlet at porous body 3) are substantially laminar and/or non-turbulent (see par. [0025]).
Regarding claim 26, Van Der Linden ‘607 discloses the patient interface of claim 4, wherein the one or more enclosing layers (heparin coating on porous body 3) each comprise a membrane (see par. [0031]).
Regarding claim 27, Van Der Linden ‘607 discloses the patient interface of claim 4, wherein the one or more enclosing layers (heparin coating on porous body 3) are each formed of a breathable material that allows passage of water molecules through the breathable material (see par. [0031]).
Regarding claim 32, Van Der Linden ‘607 discloses the patient interface of claim 9, further comprising a support structure (attachment member 15) at a first end (see Fig. 2), the support structure (attachment member 15) defining a housing inlet (inlet of channel 16 at first conduit portion 1’) and a housing outlet (outlet of channel 16 at porous body 3), the housing outlet (outlet of channel 16 at porous body 3) being in fluid communication with the interface inlet (inlet at proximal end of first conduit portion 1’) (see Figs. 1-2, par. [0026]-[0027], [0029]).
Regarding claim 33, Van Der Linden ‘607 discloses the patient interface of claim 32, wherein the at least one deformable element (stiffening member 18) attaches to the support structure (attachment member 15) (see Fig. 2, par. [0026]-[0027]).
Regarding claim 34, Van Der Linden ‘607 discloses the patient interface of claim 32, wherein the support structure (attachment member 15) abuts the gas permeable substrate (porous body 3) (see Fig. 2, par. [0030]).
Regarding claim 39, Van Der Linden ‘607 discloses the patient interface of claim 32, further comprising a tube (first conduit portion 1’) having a first end (distal end of first conduit portion 1’ at attachment member 15) and a second end (proximal end of first conduit portion 1’), the first end (distal end of first conduit portion 1’ at attachment member 15) connectable to the housing inlet (inlet of channel 16 at first conduit portion 1’) of the support structure (attachment member 15) (see Figs. 1-2, par. [0026]-[0027], [0029]).
Regarding claim 43, Van Der Linden ‘607 discloses the patient interface of claim 4, further comprising a front surface (proximal surface of attachment member 15 at first conduit portion 1’) and a rear surface (distal surface of attachment member 15 at porous body 3), wherein the rear surface (distal surface of attachment member 15 at porous body 3) comprises an adhesive (see Figs. 1-2, par. [0026]-[0027], [0029]).
Regarding claim 49, Van Der Linden ‘607 discloses the patient interface of claim 43, wherein the one or more enclosing layers (heparin coating on porous body 3) includes a cut-out on the rear surface (distal surface of attachment member 15 at porous body 3) adjacent the interface outlet (outlet at porous body 3) (see par. [0025]-[0026], [0031], gas flows from attachment member and through porous body 3 and its heparin coating into the surgical cavity such that at least one cut-out is present in each of the attachment member 15, porous body 3, and heparin coating).
Regarding claim 50, Van Der Linden ‘607 discloses the patient interface of claim 9, wherein at least a portion of a side region of the gas permeable substrate (porous body 3) is unobstructed (see Fig. 2, par. [0026], [0030], porous body 3 is only obstructed where it attaches to attachment member 15).
Regarding claim 62, Van Der Linden ‘607 discloses a method of protecting a patient from a loss of moisture and/or loss of heat and/or from an infection at a surgical site during surgery (see Figs. 1-2, par. [0004], [0020]-[0021], [0024]) the method comprising:
positioning an interface (see Figs. 1-2) on a surface adjacent the surgical site (see Fig. 1, par. [0020]), the interface comprising:
one or more enclosing layers (heparin coating on porous body 3) defining at least in part a gas flow path (gas flow path through device of Figs. 1-2) capable of directing gases to the surgical site (see Figs. 1-2, par. [0021], [0031]), the gas flow path (gas flow path through device of Figs. 1-2) having a first end (proximal end nearest gas source 2) and a second end (distal end nearest porous body 3) opposite the first end (proximal end nearest gas source 2) (see Figs. 1-2, par. [0021]-[0022], [0026]-[0027]);
an inlet (inlet at connection to gas source 2) positioned at the first end (proximal end nearest gas source 2) (see Figs. 1-2, par. [0021], [0027]);
an outlet (outlet at porous body 3) positioned at the second end (distal end nearest porous body 3) (see Figs. 1-2, par. [0021]); and
bending the interface (see Figs. 1-2) into a bent shape that conforms to the surface, wherein the interface (see Figs. 1-2) retains the bent shape (see Figs. 1-2, par. [0027]).
Regarding claim 68, Van Der Linden ‘607 discloses the patient interface of claim 4, wherein the formable section (section having stiffening member 18) is located in a head of the patient interface (see Figs. 1-2, the stiffening member 18 extends to attachment member 15 and porous body 3 such that it can be considered in a distal head/end of the patient interface).
Regarding claim 69, Van Der Linden ‘607 discloses the patient interface of claim 4, wherein a direction of the gas flow path (gas flow path through device of Figs. 1-2) is determined by the at least one bending direction (see Figs. 1-2, par. [0027], stiffening member 18 determines the bending direction of first conduit portion and thus the direction of the gas flow path).
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 47 is rejected under 35 U.S.C. 103 as being unpatentable over Van Der Linden et al. (US 2005/0119607 A1, hereinafter referred to as “Van Der Linden ‘607”), as applied to claim 4 above, in view of Blacklock (US 2021/0369986 A1).
Regarding claim 47, Van Der Linden ‘607 discloses the patient interface of claim 4. However, Van Der Linden ‘607 fails to state a removal tab.
Blacklock teaches a patient interface (see Figs. 1-5) comprising a removal tab (see par. [0032], adhesive surfaces on the patient interface can be covered with a release paper before use).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the patient interface of Van Der Linden ‘607 to include a removal tab, as taught by Blacklock, in order to accommodate adhesives which can removably adhere the patient interface to the surgical site during use and thus can be covered with the removal tab prior to use (see Blacklock par. [0032]).
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over Van Der Linden et al. (US 2005/0119607 A1, hereinafter referred to as “Van Der Linden ‘607”), as applied to claim 9 above, in view of Van Der Linden (US 2013/0226074 A1, hereinafter referred to as “Van Der Linden ‘074”).
Regarding claim 67, Van Der Linden ‘607 discloses the patient interface of claim 9. However, Van Der Linden ‘607 fails to state wherein the at least one deformable element is located within the gas permeable substrate.
Van Der Linden ‘074 teaches a patient interface (see Figs. 1-2) wherein the at least one deformable element (stiffening member 14) is located within the gas permeable substrate (body 5) (see Figs. 1-2, par. [0035], [0050]-[0052]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the patient interface of Van Der Linden ‘607 such that the at least one deformable element extends into the gas permeable substrate, as taught by Van Der Linden ‘074, in order to allow the gas permeable substrate to better conform to the shape of the particular surgical site (see Van Der Linden ‘074 par. [0050]-[0051]).
Response to Arguments
Applicant’s arguments with respect to claims 1-2, 4, 62, and their dependent claims have been considered but are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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