DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 03/16/2026.
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 Claims
Claim(s) 20-39 is/are pending in the application.
Claim(s) 23 and 30-33 is/are withdrawn from further consideration
Claim(s) 20-22, 24-29, and 34-39 are examined on the merits.
Response to Arguments
Applicant’s arguments/remarks filed on 03/13/2026 have been fully considered.
Applicant argues that the air filter of Albert cannot be used with the connector of Horn because there is no indication that it would have been desirable to position the air filter of Albert in the connector of Horn. The argument is not found persuasive. The air filter 2416 of Albert is positioned in the connector 2410 in a negative pressure wound therapy system (¶0182 and Fig. 24A); thus, the air filter 2415 of Albert is capable of being used with a connector in a negative pressure wound therapy system. In addition, a person having ordinary skill in the art would have understood that an air filter is configured to prevent bacteria and other microorganisms in the atmosphere from entering the wound space. Thus, the air filter of Albert is capable of being used with the connector of Horn in order to prevent bacteria and other microorganisms in the atmosphere from entering the wound space.
Applicant argues that Larsen does not teach a filter housing and none of references teaches a connector comprising a filter housing. The arguments are not found persuasive. Larsen discloses/suggests to house the filter 12 in a housing 13 (a drive unit 13: Fig. 1). The drive unit 13 of Larsen has a shape of a housing and can be functioned as a housing; therefore, Larsen discloses a filter housing. In addition, while Horn in view of Albert discloses the filter is positioned in the connector, one of ordinary skill in the art would have been able to carry out such a modification (e.g., incorporating a filter housing for the filter) to achieve the predictable result of protecting the filter from external environment. Thus, Horn in view of Albert and Larsen discloses the air filter within the air filter housing and the air filter housing is positioned in the connector.
With respect to the claim objection(s), applicant’s amendment(s) to the claim(s) has/have overcome the objection(s).
With respect to the claim interpretation(s) under 35 U.S.C. § 112(f), applicant’s amendment(s) to the claim(s) has/have overcome claim interpretation(s) under 35 U.S.C. § 112(f).
With respect to the claim rejection(s) under 35 U.S.C. § 112(b), applicant’s amendment(s) to the claim(s) has/have overcome the claim rejection(s).
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 20-22, 24-29, 34-36, and 39 is/are rejected under 35 U.S.C 103 as being unpatentable over Horn (US PGPUB 20120184931) in view of Albert (US PGPUB 20140330224) and Larsen (US PGPUB 20090030383).
Regarding claim 20, Horn discloses a connector device (20: ¶0027 and Figs. 1-2) for a negative pressure wound therapy system (Abstract), said connector device (20) comprising:
a wound side connector (a wound side connector 18: Fig. 1);
a connector housing (a housing of 20: Figs. 1-2) configured to couple to the wound side connector (18), the connector housing comprising:
an air inlet opening (a port that is connected to flow channel 28 for supplying air: ¶0027, Fig. 1, and see annotated Fig. 5 below),
wherein:
the connector device further comprises a fluid outlet (a flow channel 26: ¶0027 and see annotated Fig. 5 below), said fluid outlet adapted to be fluidly coupled to a negative pressure source (26 is adapted to be connected to a vacuum-generating device 12: ¶0027 and Fig. 1),
the wound side connector (18) is configured to couple to a fluid removing conduit (a conduit 22: ¶0027 and Fig. 1) and an air supplying conduit (a conduit 24: ¶0027 and Fig. 1),
such that when said connector device is engaged with said wound side connector (Fig. 1),
said fluid removing conduit (22) is fluidly connected to said fluid outlet (22 is fluidly connected to the fluid outlet 26: ¶0027 and Fig. 1) and,
said air supplying conduit (24) is fluidly connected to said air feeding port (24 is fluidly connected to said air feeding port: ¶0027, Fig. 1, and see annotated Fig. 5 below).
Horn does not disclose the connector housing comprising an air filter.
In an analogous art for being directed to solve the same problem, providing/using air filter while supplying air in order to prevent bacteria and other microorganisms in the atmosphere from entering the wound space, Albert discloses a negative pressure wound treatment system 2401 comprising a port 2405 situated under a drape 2403 pierceable by a piercing fluidic connector 2410 (¶0182). Albert further discloses the connector 2410 comprising an air filter 2416 (¶0182 and Fig. 24A).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the connector housing of Horn in view of Albert by incorporating an air filter, motivated by the desires to prevent bacteria and other microorganisms in the atmosphere from entering the wound space, as suggested in ¶0182 of Albert.
Horn/Albert does not disclose the air filter is within an air filter housing and the air inlet opening is in fluid communication with the air filter housing.
In the same field of endeavor, negative pressure wound therapy system, Larsen discloses a suction system for removal of fluids from a surface (Abstract and Fig. 1) comprising a filter 12 at air inlet opening 10 (¶0103-0104 and Fig. 1). Larsen further discloses/suggests to house the filter 12 in an air filter housing (a drive unit 13 having the shape/function of a housing: Fig. 1). Larsen also discloses the air inlet opening 10 is in fluid communication with the air filter housing 13 (a pump head 4 is connected to the drive unit 13 and air will pass through the air drive unit 13 to the filter 12 and further through the air inlet opening 10: ¶0102-0104 and Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the connector device of Horn in view of Larsen by incorporating an air filter housing to house the air filter and having the air inlet opening is in fluid communication with the air filter housing, as suggested in ¶0102-0104 and Fig. 1 of Larsen. One of ordinary skill in the art would have been able to carry out such a modification to achieve the predictable result of protecting the air filter from external environment.
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Regarding claim 21, Horn further discloses said air inlet opening (see annotated Fig. 5 above) is arranged at a radial distance from said fluid outlet (see annotated Fig. 5 above).
Regarding claim 22, Horn further discloses said connector device comprises an opposing connector housing coupling side of said connector device (see annotated Fig. 5 above) that is adapted to couple to the wound side connector (the opposing connector housing coupling side is adapted to couple to the wound side connector 18: ¶0027-0028 and see annotated Fig. 5 above) so that, when the opposing connector housing coupling side is engaged with the wound side connector (Figs. 1-2 and see annotated Fig. 5 above), at least a portion of the wound side connector extends past the opposing connector housing coupling side of the connector housing in a direction toward the connector housing device side of the connector housing (at least a portion of the opposing connector extends past the opposing connector housing coupling side of the connector housing in a direction toward the connector housing device side of the connector housing in order to positively couple 18 and 20 together: ¶0028, Figs. 1-2, and see annotated Fig. 5 above).
Regarding claim 24, Horn further discloses wherein a fluid conduit (a second suction section 16: ¶0027 and Fig. 1) is connected to said fluid outlet (26: Fig. 1).
Regarding claim 25, Horn/Albert/Larsen does not disclose the air filter that provides an air leakage of between 0.5 ml/min to 70 ml/min at a pressure of 120 mmHg.
However, since the taught air filter and the claimed air filter are patentably indistinct in terms of structure, the taught air filter is considered/expected to be capable of providing an air leakage of between 0.5 ml/min to 70 ml/min at a pressure of 120 mmHg. See MPEP §§ 2112.01 (I), 2114 (I)-(II), and 2115. Further, one having ordinary skill in the art would be motivated to tailor the air leak rate between 0.5 ml/min to 70 ml/min at a pressure of 120 mmHg for the purposes of preventing improper sealing of the drape over the wound site, and/or physical damage to the system.
Regarding claim 26, Horn further discloses said connector device is adapted to form a snap-on, threaded, luer-lock, or bayonet engagement, with said wound side connector (the connector device is adapted to form a snap-on engagement with said wound side connector 18: ¶0028 and Figs. 5-6).
Regarding claim 27, Horn/Albert does not disclose the air filter housing and the fluid outlet extend parallel to each other.
Larsen also discloses/suggests the air filter housing (13) and the fluid outlet (5) extend parallel to each other (Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the connector device of Horn in view of Larsen by arranging the air filter housing and the fluid outlet such that they extend parallel to each other, as suggested in Fig. 1 of Larsen. One of ordinary skill in the art would have been able to carry out such a modification to achieve the predictable result of maintaining a well-defined negative pressure over a wound surface and avoid clotting. Examiner further notes that there was no evidence of the criticality of the arrangement of the air filter housing and the fluid outlet within the specification.
Regarding claim 28, Horn/Albert does not disclose the air filter housing has, in cross section, in planes perpendicular to an axis of extension of the air filter housing, a rectangular outer profile.
Larsen further discloses/suggests to house the filter 12 in the air filter housing and the air filter housing has a rectangular outer profile (the drive unit 13 has the shape/function of a housing and has a rectangular outer profile: Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the connector device of Horn in view of Larsen by incorporating an air filter housing that has a rectangular outer profile to house the air filter, as suggested in ¶0102-0104 and Fig. 1 of Larsen and as it has been held that a mere change in shape of an element is generally recognized as being within the level of ordinary skill in art when the change in shape is not significant to the function of the combination (See MPEP § 2144.04 (IV) (B)). One of ordinary skill in the art would have been able to carry out such a modification to achieve the predictable result of protecting the air filter from external environment. Examiner further notes that there was no evidence of the criticality of the shape of the air filter housing within the specification.
Regarding claim 29, Horn further discloses the air inlet opening is a first inlet opening (see annotated Fig. 5 above) and the connector housing comprises at least one additional air inlet opening (“at least flow channels that lead away from the wound cover and are guided through both connector parts”: ¶0007).
Regarding claims 34-35, Horn/Albert/Larsen discloses all the limitations as discussed above for claim 20.
Since the connector device of Horn/Albert/Larsen meets the structural limitations of the claimed connector device, it will inherently perform the method steps as claimed (See MPEP § 2112.02 (I)). Thus, Horn/Albert/Larsen further discloses a method of connecting the connector device, said wound fluid side assembly comprising the fluid removing conduit and the air supplying conduit, a portion of each one of said flexible fluid removing conduit and said air supplying conduit being connected to said wound side connector; and applying suction to a suction interface via said fluid outlet and said fluid removing conduit (a suction interface is at/near a wound space 4: Fig. 1).
Regarding claim 36, Horn/Albert/Larsen discloses the connector device as in claim 20 (see rejection of claim 20 above).
Horn further discloses a negative pressure wound therapy system, comprising:
negative pressure source (a vacuum-generating device 12: ¶0027 and Fig. 1),
a wound cover member (a wound cover 6: ¶0027 and Fig. 1) having a suction interface (at/near a wound space 4: ¶0027 and Fig. 1),
the connector device (20: see rejection of claim 20 above):
the fluid removing conduit (a conduit 22: ¶0027 and Fig. 1),
the air supplying conduit (a conduit 24: ¶0027 and Fig. 1), and
wherein the wound side connector (a first connector part 18: ¶0027 and Fig. 1) connected to the fluid removing conduit and the air supplying conduit (Fig. 1), and
wherein:
the fluid outlet (26) is connected to the negative pressure source (Fig. 1),
the connector device having a connector housing coupling that is adapted to be connected to the wound side connector (Fig. 1 and annotated Fig. 5 above) in order to:
- fluidly connect the fluid removing conduit to the fluid outlet (Fig. 1 and see annotated Fig. 5 above), and
- fluidly connect the air supplying conduit to the air inlet opening to allow air ambient to be supplied at a controlled air leakage rate to the air supplying conduit through the air filter (¶0027, Fig. 1, and see annotated Fig. 5 above).
Regarding claim 39, Horn/Albert/Larsen does not disclose the air filter that provides an air leakage of between 0.5 ml/min to 70 ml/min at a pressure of 120 mmHg.
However, since the taught air filter and the claimed air filter are patentably indistinct in terms of structure, the taught air filter is considered/expected to be capable of providing an air leakage of between 0.5 ml/min to 70 ml/min at a pressure of 120 mmHg. See MPEP §§ 2112.01 (I), 2114 (I)-(II), and 2115. Further, one having ordinary skill in the art would be motivated to tailor the air leak rate between 0.5 ml/min to 70 ml/min at a pressure of 120 mmHg for the purposes of preventing improper sealing of the drape over the wound site, and/or physical damage to the system.
Claim(s) 37-38 is/are rejected under 35 U.S.C 103 as being unpatentable over Horn (US PGPUB 20120184931) in view of Albert (US PGPUB 20140330224) and Larsen (US PGPUB 20090030383), as applied to claim 36 above, and further in view of Jaeb (US PGPUB 20090227969).
Regarding claim 37, Horn further discloses the negative pressure source comprising a pump (Fig. 1).
Horn/Albert/Larsen does not disclose the air leakage rate through the air filter is selected to be in the range of 1 to 5 ml/min.
However, since the taught air filter and the claimed air filter are patentably indistinct in terms of structure, the taught air filter is considered/expected to be capable of providing an air leakage in the range of 1 to 5 ml/min. See MPEP §§ 2112.01 (I), 2114 (I)-(II), and 2115. Further, one having ordinary skill in the art would be motivated to tailor the air leak rate in the range of 1 to 5 ml/min for the purposes of preventing improper sealing of a drape over the wound site, and/or physical damage to the system.
Horn/Albert/Larsen does not disclose the pump is arranged to have a suction capacity of up to 1 L/min and the negative pressure source comprising battery.
In the same field of endeavor, negative pressure treatment system, Jaeb discloses a reduced pressure treatment system includes a reduced pressure source (a pump) and a reduced pressure dressing (Abstract and Fig. 1). Jaeb further discloses the pump has a suction capacity of up to 1 L/min (5 – 1000 mL/min or 0.005 – 1 L/min: ¶0126; thus, the taught range suction capacity overlaps the claimed range suction capacity) for the benefit of creating enough reduced pressure to be therapeutic for wound therapy (¶0126). Jaeb also discloses a battery is utilized to provide electric power to the pump (¶0131).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the system of Horn in view of Jaeb by selecting the suction capacity as claimed and using a battery for the pump, in order to create enough reduced pressure to be therapeutic for wound therapy and provide electric power for the pump as needed, as suggested in ¶0126 and 0131 of Jaeb and as it has been held that a prima facie case of obviousness exists when the claimed ranges overlap with ranges disclosed by the prior art. See MPEP § 2144.05 (I).
Regarding claim 38, Horn further discloses the negative pressure source comprising a pump (Fig. 1).
Horn/Albert/Larsen does not disclose the air leakage rate through the air filter is selected to be in the range of 10 to 30 ml/min.
However, since the taught air filter and the claimed air filter are patentably indistinct in terms of structure, the taught air filter is considered/expected to be capable of providing an air leakage in the range of 10 to 30 ml/min. See MPEP §§ 2112.01 (I), 2114 (I)-(II), and 2115. Further, one having ordinary skill in the art would be motivated to tailor the air leak rate in the range of 10 to 30 ml/min for the purposes of preventing improper sealing of a drape over the wound site, and/or physical damage to the system.
Horn/Albert/Larsen does not disclose the pump is arranged to have a suction capacity of 1 - 5 L/min and the negative pressure source comprising battery.
Jaeb further discloses the pump has a suction capacity of 1 L/min (¶0126; thus, the taught range suction capacity overlaps the claimed range suction capacity) for the benefit of creating enough reduced pressure to be therapeutic for wound therapy (¶0126). Jaeb also discloses a battery is utilized to provide electric power to the pump (¶0131).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the system of Horn in view of Jaeb by selecting the suction capacity as claimed and using a battery for the pump, in order to create enough reduced pressure to be therapeutic for wound therapy and provide electric power for the pump as needed, as suggested in ¶0126 and 0131 of Jaeb and as it has been held that a prima facie case of obviousness exists when the claimed ranges overlap with ranges disclosed by the prior art. See MPEP § 2144.05 (I).
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 NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SARAH AL-HASHIMI can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NHU Q. TRAN/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781
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