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 Claims
Claims 1-20 are pending and examined on the merits.
Information Disclosure Statement
The two information disclosure statements (IDS’s) submitted on 09/25/2024 and 02/09/2026 were filed before the mailing date of the First Office Action on the Merits. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Buan (U.S. Pre Grant Pub. No. 2021/0236701 A1).
Regarding claim 1, Buan teaches: A chemical pump assembly useful for negative pressure therapy (see at least Abstract; see also Fig. 1 and at least para. [0012]) comprising:
a chemical pump housing (16 in Fig. 1 and para. [0012]) having an inner chamber (22 in Fig. 3 and para. [0012]);
a reactor (see chemical pump assembly 12 in para. [0015]) located within the inner chamber (see para. [0015]) being configured to react with a selected gas found in air so as to consume the selected gas when exposed to air in the inner chamber (see at least para. [0015]);
an opening (40 in para. [0016] and Fig. 3) provided in the chemical pump housing (see at least para. [0016]) that is in fluid communication with the inner chamber (see at least para. [0016]); and
a cover (see thin film 62 in para. [0020] and Fig. 3) disposed over at least a portion of the chemical pump housing (see at least Fig. 3 showing film 62 disposed over upper housing 18 of chemical pump housing 16; see also para. [0012]) for sealing the opening to prevent ingress of air through the opening into the inner chamber after activation of the reactor (see at least para. [0020]), the cover including:
a cover body (see at least Fig. 3 showing the thin film 62 having a body) having an underside surface facing the chemical pump housing (as shown in Fig. 3, the underside of the film 62 faces the upper housing 18 of chemical pump housing 16), the underside surface having an adhesive thereon for affixing the underside surface to the chemical pump housing (para. [0021] teaches that a release layer 66 covers an adhesive on the bottom surface of the thin film 62), and
a removable liner disposed over the adhesive on the underside surface (see release layer 66 in para. [0021]), the removable liner including a pull tab extending laterally away from the chemical pump housing (see second pull tab 46 at least in para. [0021]; Figs. 1-3 show the second pull tab 46 as extending laterally away from the chemical pump housing 16).
Regarding claim 2, Buan teaches the invention as discussed above in claim 1. Additionally, Buan teaches wherein the cover body is a thin and/or metallized film (see at least para. [0020-0021]).
Regarding claim 3, Buan teaches the invention as discussed above in claim 1. Additionally, Buan teaches wherein the removable liner includes a first section and a second section (with reference to Fig. 4, para. [0021] teaches a slit 68 is provided in the release layer 66 so that a second section of the release layer 66 is removed exposing the adhesive prior to affixing the thin film 62 to the top surface of the upper housing 18, while the portion of the release layer 66 beneath the flap 64 can remain; the portion of the release layer 66 beneath the flap 64 is considered the first section), the first and second sections independently removable from the cover body relative to one another (see para. [0021]), and wherein the pull tab is formed integrally with the first section (when the second pull tab 46 is pulled, the second pull tab 46 disconnects the release layer 66 from the flap 64 and the adhesive disposed on the bottom surface of the flap 64 is exposed; see para. [0021] and Fig. 4).
Regarding claim 4, Buan teaches the invention as discussed above in claim 3. Additionally, Buan teaches wherein the first and second sections define a slit line (see slit 68 in Fig. 4 and para. [0021]) extending laterally across the cover body at a location where the first and second sections meet one another (see at least Fig. 4 and para. [0021]).
Regarding claim 5, Buan teaches the invention as discussed above in claim 4. Additionally, Buan teaches wherein the pull tab is disposed at the location of the slit line (as shown in Fig. 2, pull tab 46 is disposed at the location of the slit 68 beneath flap 64; see also Fig. 4).
Regarding claim 6, Buan teaches the invention as discussed above in claim 5. Additionally, Buan teaches wherein the pull tab includes a distal end, a proximal end, a first side and a second side (see at least Fig. 4 showing a proximal and distal end and a first and second side), and wherein the second side (the second side is considered to be a bottom of pull tab 46) is colinear with the slit line (as shown in Fig. 4, and as broadly recited, the bottom side of pull tab 46 is considered to be colinear with slit 68) so that removal of the removable liner from the cover body occurs in result of a removable force applied in a direction parallel to the slit line (as taught in para. [0021], and as broadly recited, when release layer 66 is removed from thin film 62, a force will necessarily apply in a direction parallel to the slit 68 when the release layer 66 is removed in a direction parallel to the slit 68).
Regarding claim 7, Buan teaches the invention as discussed above in claim 4. Additionally, Buan teaches wherein the first section is disposed over a corresponding first portion of the cover body (see at least Figs. 3-4 showing a slit 68 provided in the release layer 66 so that the release layer has a first portion covering the first section 64 of the thin film 62) and the second section is disposed over a corresponding second portion of the cover body (see at least Figs. 3-4 showing a slit 68 provided in the release layer 66 so that the release layer has a second portion covering the second section of the thin film 62, which is adjacent numeral 66 in Fig. 4), the first portion of the cover body positioned to be over and encompassing of the opening provided in the chemical pump housing (see at least Figs. 1-3).
Regarding claim 8, Buan teaches the invention as discussed above in claim 1. Additionally, Buan teaches wherein the pull tab is a second pull tab (para. [0021] teaches that the second pull tab 46 is connected to a release layer 66 provided on a bottom surface of the thin film 62) with the chemical pump assembly including:
a first pull tab which extends from the inner chamber to ambient atmosphere through the opening (para. [0019] teaches that the first pull tab 44 is pulled away from the chemical pump housing 16 through opening 40); and
a removable layer connected to the first pull tab which shields the reactor from air in the inner chamber until the removable layer is removed (para. [0018] teaches that the first pull tab 44 can be pulled to remove the first pull tab 44 from the opening 40. When the first pull tab 44 is pulled through the opening 40, the removable layer 50 is removed from the packet 48 and, if desired, from the inner chamber 22 through the opening 40, exposing the chemical pump 36 to ambient atmosphere).
Regarding claim 9, Buan teaches the invention as discussed above in claim 8. Additionally, Buan teaches further including a packet in which the reactor is placed (para. [0018], with reference to Figs. 3-4, teaches a packet 48 including a removable layer 50 covers the chemical pump 36 so as to prevent the chemical pump 36 from being exposed to ambient atmosphere or air within the inner chamber 22 until after removal of the removable layer 50 from the packet 48), and adhesive is provided on the removable layer on a side facing the packet, with exception of a small section at and end of the removable layer opposite from the opening (para. [0019] teaches the removable layer 50 is coated on an upper side, per the orientation shown in FIG. 3, with an adhesive, with the exception of a small section 52 at and end of the removable layer 50 opposite from the opening 40. The upper side of the removable layer being the side facing the packet 48).
Regarding claim 10, Buan teaches the invention as discussed above in claim 1. Additionally, Buan teaches wherein the cover body moves into the opening toward the inner chamber to provide an indication that the inner chamber is under negative pressure when the cover body is covering the opening and the inner chamber is under negative pressure (see at least para. [0021]).
Regarding claim 11, Buan teaches the invention as discussed above in claim 1. Additionally, Buan teaches wherein the chemical pump assembly is connectable to a dressing defining an enclosed volume so that the inner chamber is in fluid communication with the enclosed volume (see at least para. [0011 and 0024]).
Regarding claim 12, Buan teaches: A method for operating a pump assembly of a negative pressure system (see at least para. [0024]), the method comprising:
providing a fluid connection between a chemical pump housing (16 in Fig. 1 and para. [0012]) and a dressing placed over a tissue site (see at least para. [0011 and 0024]), the chemical pump housing having an inner chamber (22 in Fig. 3 and para. [0012]) and an opening fluidly connected to the inner chamber (40 in para. [0016] and Fig. 3);
activating a reactor (see chemical pump assembly 12 in para. [0015]; see also para. [0003]) located within the inner chamber of the chemical pump housing (see para. [0015]) to enable the reactor to react with a selected gas found in air so as to consume the selected gas when exposed to air in the inner chamber (see at least para. [0015]); and
after activating the reactor, covering the opening with a cover (see thin film 62 in para. [0020] and Fig. 3) disposed over at least a portion of the chemical pump housing (see at least Fig. 3 showing film 62 disposed over upper housing 18 of chemical pump housing 16; see also para. [0012]) for sealing the opening to prevent ingress of air through the opening into the inner chamber (see at least para. [0020]), wherein covering the opening includes removing a removable liner disposed over an adhesive on an underside surface of a cover body (see release layer 66 in para. [0021]) by pulling a pull tab of the removable liner that extends laterally away for the chemical pump housing in a lateral direction across the cover body (see second pull tab 46 at least in para. [0021]; Figs. 1-3 show the second pull tab 46 as extending laterally away from the chemical pump housing 16).
Regarding claim 13, Buan teaches the method as discussed above in claim 12. Additionally, Buan teaches wherein covering the opening further includes affixing the underside surface of the cover body to the chemical pump housing (para. [0021] teaches affixing the thin film 62 to the top surface of the upper housing 18, via the underside surface of the thin film 62) after removing the removable liner by pushing the underside surface at which the removable liner was removed toward the chemical pump housing (para. [0021] teaches a release layer 66 provided on a bottom surface of the thin film 62, the release layer 66 covers an adhesive on the bottom surface of the thin film 62).
Regarding claim 14, Buan teaches the method as discussed above in claim 12. Additionally, Buan teaches wherein the pull tab is a second pull tab (para. [0021] teaches that the second pull tab 46 is connected to a release layer 66 provided on a bottom surface of the thin film 62) and activating the reactor includes:
pulling a first pull tab, which extends from the inner chamber of the chemical pump housing to ambient through the opening in the chemical pump housing (para. [0019] teaches that the first pull tab 44 is pulled away from the chemical pump housing 16 through opening 40), to remove a removable layer to expose the reactor located within the inner chamber to air (para. [0018] teaches that the first pull tab 44 can be pulled to remove the first pull tab 44 from the opening 40. When the first pull tab 44 is pulled through the opening 40, the removable layer 50 is removed from the packet 48 and, if desired, from the inner chamber 22 through the opening 40, exposing the chemical pump 36 to ambient atmosphere).
Regarding claim 15, Buan teaches the method as discussed above in claim 12. Additionally, Buan teaches wherein the cover is a thin or metallized film (see at least para. [0020-0021]) having a show surface facing away from the chemical pump housing (Fig. 2 illustrates a show surface of thin film 62 facing away from the chemical pump housing 16) and the underside surface facing toward the chemical pump housing (see para. [0021] and Fig. 2 teaching affixing the thin film 62 to the top surface of the upper housing 18, via the underside surface of thin film 62).
Regarding claim 16, Buan teaches the method as discussed above in claim 12. Additionally, Buan teaches wherein the removable liner includes a first section having the pull tab integrally formed therewith and a second section (with reference to Fig. 4, para. [0021] teaches a slit 68 is provided in the release layer 66 so that a second section of the release layer 66 is removed exposing the adhesive prior to affixing the thin film 62 to the top surface of the upper housing 18, while the portion of the release layer 66 beneath the flap 64 can remain; the portion of the release layer 66 beneath the flap 64 is considered the first section; when the second pull tab 46 is pulled, the second pull tab 46 disconnects the release layer 66 from the flap 64 and the adhesive disposed on the bottom surface of the flap 64 is exposed; see para. [0021] and Fig. 4), the first and second sections independently removable relative to one another (see para. [0021]).
Regarding claim 17, Buan teaches the method as discussed above in claim 16. Additionally, Buan teaches wherein the second section is removed from the underside surface of a corresponding portion thereof that is affixed to the chemical pump housing at a location offset relative to the opening (with reference to Fig. 4, para. [0021] teaches a slit 68 is provided in the release layer 66 so that a second section of the release layer 66 is removed exposing the adhesive prior to affixing the thin film 62 to the top surface of the upper housing 18, while the portion of the release layer 66 beneath the flap 64 can remain; wherein the first, left portion of the thin film 62 is positioned over the opening 40, leaving the second section offset relative to said opening).
Regarding claim 18, Buan teaches: A cover for a chemical pump assembly useful for negative pressure therapy (para. [0020] teaches the chemical pump assembly 12 further includes a cover, an example of which being a thin film 62 described below, for sealing the opening 40 to prevent ingress of air through the opening 40 into the inner chamber 22 after the removable layer 50 has been removed) comprising:
a cover body (see at least Fig. 3 showing thin film 62 having a body) having an underside surface that faces an associated chemical pump housing (16 in Fig. 1 and para. [0012]; as shown in Fig. 3, the underside of the film 62 faces the upper housing 18 of chemical pump housing 16), the underside surface having an adhesive thereon for affixing the underside surface to the associated chemical pump housing (para. [0021] teaches that a release layer 66 covers an adhesive on the bottom surface of the thin film 62), and
a removable liner disposed over the adhesive on the underside surface (see release layer 66 in para. [0021]), the removable liner including a pull tab extending laterally away from the chemical pump housing (see second pull tab 46 at least in para. [0021]; Figs. 1-3 show the second pull tab 46 as extending laterally away from the chemical pump housing 16).
Regarding claim 19, Buan teaches the invention as discussed above in claim 18. Additionally, Buan teaches wherein the removable liner is a thin film that includes a first section and a second section (with reference to Fig. 4, para. [0021] teaches a slit 68 is provided in the release layer 66 so that a second section of the release layer 66 is removed exposing the adhesive prior to affixing the thin film 62 to the top surface of the upper housing 18, while the portion of the release layer 66 beneath the flap 64 can remain; the portion of the release layer 66 beneath the flap 64 is considered the first section), the first and second sections independently removable from the cover body relative to one another (see para. [0021]), and wherein the pull tab is formed integrally with the first section (when the second pull tab 46 is pulled, the second pull tab 46 disconnects the release layer 66 from the flap 64 and the adhesive disposed on the bottom surface of the flap 64 is exposed; see para. [0021] and Fig. 4).
Regarding claim 20, Buan teaches the invention as discussed above in claim 19. Additionally, Buan teaches wherein the first and second sections define a slit line (see slit 68 in Fig. 4 and para. [0021]) extending laterally across the cover body at a location where the first and second sections meet one another (see at least Fig. 4 and para. [0021]).
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.
Claim 1 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 11,083,833 B1, and claim 12 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 11,083,833 B1. Although the claims at issue are not identical, they are not patentably distinct from each other because one of ordinary skill in the art would have reasonably recognized that the claims in the present application are taught by the claims of the granted patent. For example, claim 1 of the present application is taught by claim 3 of the granted patent:
Regarding claim 1 of the present application, U.S. Patent No. 11,083,833 B1 teaches: A chemical pump assembly useful for negative pressure therapy (see claim 1) comprising:
a chemical pump housing having an inner chamber (see claim 1);
a reactor located within the inner chamber being configured to react with a selected gas found in air so as to consume the selected gas when exposed to air in the inner chamber (see claim 1);
an opening provided in the chemical pump housing (see claim 1); and
a cover (see claim 2) for sealing the opening to prevent ingress of air through the opening into the inner chamber after activation of the reactor (see claim 2), the cover including:
a cover body having an underside surface facing the chemical pump housing, the underside surface having an adhesive thereon for affixing the underside surface to the chemical pump housing (see claim 3), and
a removable liner disposed over the adhesive on the underside surface, the removable liner including a pull tab extending laterally away from the chemical pump housing (see claim 3).
While claim 1 of the present application includes the limitations that “the opening is in fluid communication with the inner chamber” and “the cover is disposed over at least a portion of the chemical pump housing”, which are not found in the granted claims of U.S. Patent No. 11,083,833 B1, those differences are not enough to patentably distinguish claim 1 of the present application from claim 3 of the granted patent at least because the opening of the patented claim is inherently in fluid communication with the inner chamber, and because the cover of the patented claim is inherently disposed over at least a portion of the chemical pump housing. Since claim 2 of the granted patent discloses that sealing the opening prevents ingress of air through the opening into the inner chamber, the opening has to be in fluid communication with the inner chamber and the cover, which seals the opening, which is disposed over at least a portion of the chemical pump housing.
Similarly, claim 12 of the present application is taught by claim 12 of the granted patent:
Regarding claim 12 of the present application, U.S. Patent No. 11,083,833 B1 teaches: A method for operating a pump assembly of a negative pressure system (see claim 10), the method comprising:
providing a fluid connection between a chemical pump housing and a dressing placed over a tissue site (see claim 10), the chemical pump housing having an inner chamber (see claim 10);
activating a reactor located within the inner chamber of the chemical pump housing to enable the reactor to react with a selected gas found in air so as to consume the selected gas when exposed to air in the inner chamber (see claim 10); and
after activating the reactor, covering the opening with a cover disposed over at least a portion of the chemical pump housing for sealing the opening (see claims 10-11) to prevent ingress of air through the opening into the inner chamber (see claim 10), wherein covering the opening includes removing a removable liner disposed over an adhesive on an underside surface of a cover body (see claim 11) by pulling a pull tab of the removable liner (see claim 10) that extends laterally away for the chemical pump housing in a lateral direction across the cover body (see claim 3).
While claim 12 of the present application includes the limitations that “the opening is in fluid communication with the inner chamber”, and that the “pull tab of the removable liner…extends laterally away for the chemical pump housing in a lateral direction across the cover body”, which are not found in the granted claims of U.S. Patent No. 11,083,833 B1, those differences are not enough to patentably distinguish claim 12 of the present application from claim 12 of the granted patent at least because the opening of the patented claim is inherently in fluid communication with the inner chamber, and because the pull tab of the removable liner extends laterally away for the chemical pump housing in a lateral direction across the cover body. Since claim 10 of the granted patent discloses that sealing the opening prevents ingress of air through the opening into the inner chamber, the opening has to be in fluid communication with the inner chamber. Additionally, since claim 10 of the granted patent discloses that the first pull tab extends from the inner chamber of the chemical pump housing to ambient through the opening in the chemical pump housing, the first pull tab necessarily extends at least partially laterally away from the inner chamber of the chemical pump housing in a lateral direction.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Donda (U.S. Pre Grant Pub. No. 2018/0318165 A1) – Tissue Treatment Device and Method
Buan ‘479 (U.S. Pre Grant Pub. No. 2020/0069479 A1) - Dressing
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 5PM ET.
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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
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