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 .
Status of the Claims
Claims filed 12/16/2025 has been entered. Claims 34-44 are pending and under consideration.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 34-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-11 and 13 of U.S. Patent No. 12171643 (‘643).
As to claims 34-44, claims 1-4, 6-11 and 13 of ‘643 teach or suggest the claimed invention, as follows (with claim dependencies shown in paratheses, e.g., 3/2/1 as claim 3 incorporating claims 1 and 2)
Clm
34
35
36
37
38
39
‘643
1
2
3
4
6
10
Clm
40
41
42
43
44
‘643
7
8
9
11
13
The differences between present claims and the claims of ‘643 claims do not identically recite each element of current claims (e.g., using substantially similar but not identical terms; different elements are in different claims; and/or different combinations of elements).
However, the ‘643 claims teach or suggest each element of the current claims, as listed above, such that the present claims would have been obvious over the ‘902 claims to one of ordinary skill in the art at the time of the present invention.
Specification
The amendment filed 12/16/2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The incorporation by reference of the international patent application PCT/EP2018/079329 and of UK provisional application No. 1718014.2 is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 12/13/2024 see MPEP 1893.03(b). Therefore the specification amendment of 12/16/2024 to include the incorporation by reference is new matter, per MPEP 608.01(p).
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 34-44 are rejected under 35 U.S.C. 103 as being unpatentable over Allen et al (US 20150141941 A1) in view of Locke et al (US 20140163490 A1) and Greer (US 20080167631 A1).
Regarding claim 34, Allen substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
A method of treating a wound, the method comprising:
positioning a wound dressing apparatus (figure b1 and [0191 and 0197] positioning wound treatment system b100 over wound) over the wound, the wound dressing apparatus comprising:
a wound dressing (figure b1, b3a-c [0191 and 0197] wound dressing b110 further illustrated in figures b3a-c b2100) comprising a first layer (figure b3a, backing layer b2140) comprising an aperture (figure b3a, orifice b2145), and a second layer (figure b3a, absorbent layer b2110) comprising a recess (figure b3a-c, through hole b2146 extending entire thickness of the absorbent layer b2110) extending vertically through an entire thickness of the second layer, the second layer positioned beneath the first layer and the recess positioned beneath the aperture (figure b3aj-c, the absorbent layer b2110 positioned beneath the backing layer b2140 and the through hole b2146 beneath the orifice b2145); and
a fluidic connector (figure b3a-c and [0191 and 0197], suction port b2150 further illustrated in figures 1-16, fluidic connector 500) comprising an orifice (figures b3-ac, orifice of the suction port b2150 aligned with the orifice b2145 ) aligned with the aperture in the first layer and a three-dimensional filter (figures b3a-c, filter element b2130 inherently includes a thickness, which is considered a three-dimensional structure) positioned at the orifice in the fluidic connector and extending through the aperture in the first layer; and
applying negative pressure to the wound dressing through the fluidic connector ([0047]), wherein when under negative pressure, the three-dimensional filter extends from an upper end to a lower end of the recess in the second layer, wherein the three-dimensional filter prevents wound exudate from exiting the wound dressing through the aperture of the first layer during the application of negative pressure.
Allen does not teach the tree-dimensional filter extending through the aperture in the first layer; and
wherein when under negative pressure, the three-dimensional filter extends from an upper end of the recess in the second layer, wherein the three-dimensional filter prevents wound exudate from exiting the wound dressing through the aperture of the first layer during the application of negative pressure.
In the same field of endeavor, namely a medical wound care systems, Locke teaches the tree-dimensional filter (figure 2 and [0037], a filter 133 extending toward a recess of a retention ouch 116. Accordingly, the proposed combination includes a filter positioned above the first layer, as taught by Allen, and reaching the recess of the second layer through the aperture as taught by Locke) extending through the aperture in the first layer; and
wherein when under negative pressure, the three-dimensional filter extends from an upper end in the second layer (figure 2, the filter element 133 at least extends from an upper end), wherein the three-dimensional filter prevents wound exudate from exiting the wound dressing through the aperture of the first layer during the application of negative pressure ([0074] filter 133 prevent excess fluid reaching the reduced-pressure conduit 158).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Allen to incorporate the teachings of Locke and provides the filter as claimed for the purpose of preventing the dressing from clogging as taught by Locke ([0036]). Furthermore, one of skill in the art motivated to do so as Allen teaches that the absorbent layer contains a gel-forming material that expands when absorbing liquid ([0132]). Thus, the filter extending through the aperture in the first layer toward the recess of the second layer would prevent the saturated second layer from blocking the recess and aperture, thereby maintaining an air path from the port through the first and second layers to the underlying transmission layer.
The combination does not expressly teach the three-dimensional filter extend to a lower end of the recess.
In the same field of endeavor, namely a subatmospheric pressure dressing, Greer teaches the three-dimensional filter extend from an upper end to a lower end of the recess (figure 2, porous screen 14 extend from upper end to a lower end of a recess of a base 12).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Allen, as modified by Locke, to incorporate the teachings of Greer for the purpose of promoting flow of wound exudate from the wound through the filter to the port as taught by Greer ([0027]). Furthermore, The modification is beneficial as Allen teaches that the absorbent layer contains a gel-forming material that expands when absorbing liquid ([0132]). Furthermore, one of skill in the art motivated to do so as Allen teaches that the absorbent layer contains a gel-forming material that expands when absorbing liquid ([0132]). Thus, filter extending through the recess of the second layer would prevent the saturated second layer from blocking the recess and aperture, thereby maintaining an air path from the port through the first and second layers to the underlying transmission layer.
Regarding claim 35, Allen, as modified by Locke and Greer, teaches the method of claim 34.
The combination further teaches wherein the first layer comprises a cover layer (Allen; figure b3a, b2140 covers the wound and components of the dressing underneath).
Regarding claim 36, Allen, as modified by Locke and Greer, teaches the method of claim 34.
The combination further teaches wherein the second layer comprises an absorbent layer (Allen; figure b3a and [0201] absorbent layer b2110).
Regarding claim 37, Allen, as modified by Locke and Greer, teaches the method of claim 34.
The combination further teaches wherein the fluidic connector comprises a sealing surface (Allen; figure b3a and [0204] surface of suction b2150 sealed to the top of the backing layer b2140 over an orifice b2145) surrounding the orifice that seals the fluidic connector to the wound dressing.
Regarding claim 38, Allen, as modified by Locke and Greer, teaches the method of claim 34.
The combination further teaches wherein the filter is at least partially cylindrically shaped or cuboid-shaped (Allen; figures 5c and b3a, the filter b2130 is at least partially cylindrically shaped).
Regarding claim 39, Allen, as modified by Locke and Greer, teaches the method of claim 34.
The combination further teaches wherein the wound dressing further comprises a wound contact layer (Allen; figure b3a, wound contact layer b2102).
Regarding claim 40, Allen, as modified by Locke and Greer, teaches the method of claim 34.
The combination further teaches wherein the three-dimensional filter comprises a filter layer (Allen; filter element comprises acrylic co-polymer membrane [0140-0141])
Regarding claim 41, Allen, as modified by Locke and Greer, teaches the method of claim 40.
The combination further teaches wherein the filter layer is oleophobic ([0140] filter element comprises oleophobic filter membrane).
Regarding claim 42, Allen, as modified by Locke and Greer, teaches the method of claim 40.
The combination further teaches wherein the three-dimensional filter further comprises a spacer core (Allen; [0140-0141] support layer of the filter element), wherein the spacer core is at least partially enclosed by the filter layer (Allen; acrylic co-polymer membrane at least partially formed on the support layer [0140-0141]).
Regarding claim 43, Allen, as modified by Locke and Greer, teaches the method of claim 34.
The combination further teaches wherein the wound dressing further comprises a transmission layer (Allen; figure 3b and [0200] transmission layer b2105).
Regarding claim 44, Allen, as modified by Locke and Greer, teaches the method of claim 34.
The combination further teaches wherein the fluidic connector (Allen; figure 5c [0191 and 0197], 500) comprises a top layer and a lower layer (Allen; figure 5c, top and bottom layer 510 and 540), wherein the top layer and the lower layer are sealed to form the fluidic connector (Allen; [0156] 510 and 540 are sealed), wherein the lower layer comprises a first side facing the top layer and an opposite second side (Allen; figure 5c and [0155], the bottom side of 540 configured to facing the backing layer and opposite upper side facing spacer layer 520).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kieswetter et al (US 20190151156 A1)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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/SETH HAN/Examiner, Art Unit 3781
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