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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/05/2025 has been entered.
Status of Claims
Claims 1-20 are pending and examined on the merits.
Claims 1, 3, 4, 16, and 17 are currently amended.
Response to Amendment
Applicant’s amendments filed 12/05/2025 have been fully considered.
Claim Objections:
Applicant amended the independent claim to remove the limitations for a process within an apparatus claim. Accordingly, the objection of claim 1 is withdrawn.
Claim Rejections under 35 USC 101:
Applicant amended the independent claim to overcome the 35 USC 101 claim rejection. Accordingly, the rejections of claims 1-20 under 35 USC 101 are withdrawn.
Response to Arguments
Applicant provided amendments to the independent claim which necessitates a new ground of rejection. Accordingly, Applicant’s arguments filed 05/07/2025 have been considered but they are moot. Specifically, Putzer (U.S. Pre Grant Pub. No. 2003/0114804 A1) is introduced as a new secondary reference in the present rejection for disclosing and rendering obvious some of the limitations presented via the current amendment. Shadduck (U.S. Pre Grant Pub. No. 2018/0303515 A1), Baker (U.S. Pre Grant Pub. No. 2008/0154183 A1), and Baker (U.S. Pre Grant Pub. No. 2008/0154183 A1) are reintroduced as a primary and secondary references in the present rejection for disclosing and rendering obvious some of the limitations presented in the current amendment.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-2, 5-6, 8-12, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Shadduck (U.S. Pre Grant Pub. No. 2018/0303515 A1) in view of Putzer (U.S. Pre Grant Pub. No. 2003/0114804 A1).
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Regarding claim 1, Shadduck, with reference to Image 1 above, teaches: A medicinal applicator system (see Image 1) for the application (see at least Abstract), extraction (Id.), and whirlpool of medicinal mediums to and from targeted tissues (as will be further described below, with reference to Figs. 17-22 the medicinal applicator system comprises spiral elements 665 on applicator tip 610; while para. [0083] the spiral elements 665 are described as capable of being actuated and does not describe a whirlpool effect; due to the shape of the spiral elements 665, a whirlpool will necessarily occur at the medicinal applicator system), comprising:
an applicator tip (see Image 1) having a first end (Id.) opposite a distal end (Id.) thereof;
an axial passage (as shown in Image 1, the axial passage is the interior of the medical applicator system) defined by an interior surface of a sidewall (Id.), said axial passage communicating through said applicator tip from a connecting aperture (Id.) at said first end (a first end exists at negative pressure source 140, the fluid source 145, and/or the electrical source 150) to an outlet aperture at said distal end (see Image 1);
said first end of said applicator tip configured to form a sealed engagement of said axial passage with a passage communicating negative air pressure therethrough (as shown in Image 1, the first end is fluidly connected to the negative air pressure source via the axial passage; see also para. [0051]);
at least one fluid passage (see Image 1) to at least one fluid opening positioned within said axial passage adjacent said distal end (see Image 1; see also ports 148 in Fig. 7A);
said fluid passage for a sealed engagement to a pressurized fluid stream (see at least para. [0052]; as shown in Fig. 7A, fluid passage 188 is connected with a negative pressure source which would cause a pressurized fluid stream);
said captured fluid flow subsequent to communication thereof with said targeted tissues is evacuable through said axial passage to a fluid outlet (a user is fully capable of removing contact between the applicator tip and a patient to evacuate the captured fluid flow through the axial passage; see also para. [0064]).
However, Shadduck fails to explicitly teach that a gap is defined by a surrounding portion of the interior surface, said gap extending within opposing sides of said interior surface between said outlet aperture on one side thereof and said fluid opening on an opposite side thereof, that the fluid opening is positioned within the axial passage to direct a portion of the pressurized fluid stream toward the gap, or that a captured fluid flow is formed in said gap for communication to said targeted tissues, as required by the claim.
Putzer teaches an analogous suction head in the same field of endeavor of medical devices (see Abstract) comprising a gap (as at numeral 19 in Fig. 1) defined by a surrounding portion of an interior surface (as shown in Fig. 1, gap 19 is surrounded by an interior surface of suction nozzle 22), said gap extending within opposing sides of said interior surface (see Fig. 1) between an outlet aperture on one side thereof and a fluid opening on an opposite side thereof (as shown in Fig. 1, gap 19 extends from an outlet aperture marked by numeral 27 to a fluid opening adjacent suction tube 18).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Shadduck to incorporate the teachings of Putzer by including the claimed gap at least in order to achieve a permanent and reliable air-tight connection with the negative pressure source, as taught by Putzer (see para. [0011]).
Additionally, in the device of Shadduck in view of Putzer, a captured fluid flow is formed in said gap for communication to said targeted tissues at least because the gap is in communication with (see at least Abstract of Putzer).
Regarding claim 2, Shadduck in view of Putzer teaches the invention as described above in claim 1. Additionally, Shadduck teaches: a plurality of said fluid openings directing a plurality of said portions from said pressurized fluid stream, into said gap (see plurality of flow channels 146 in Fig. 9 and para. [0052]).
Regarding claims 5 and 6, Shadduck in view of Putzer teaches the invention as described above in claims 1 and 2, respectively. Additionally, Shadduck teaches said fluid openings each configured to project a respective said portion of said pressurized fluid stream at an acute angle relative to an axis of said axial passage (see fluid flow arrow in Image 1).
Regarding claim 8, Shadduck in view of Putzer teaches the invention as described above in claim 1. Additionally, Shadduck teaches: wherein said fluid passage runs through a rib extending from said interior surface of said sidewall (as shown in Image 1, the fluid passage runs through a rib).
Regarding claim 9, Shadduck in view of Putzer teaches the invention as described above in claim 1. Additionally, Shadduck teaches:
an elongated applicator body (see Fig. 1) with an upper portion, a lower portion, a front end, and a rear end (at least inherent);
a medicinal fluid container supported by said applicator body (see fluid source 148 in Fig. 1 and para. [0053]), said medicinal fluid container communicating said pressurized fluid stream to said fluid passage (see para. [0053]);
said fluid outlet comprising a waste fluid container (see chamber 215 in Fig. 9) supported by said applicator body (chamber 215 is considered supported by the applicator body since it is located within the applicator body; see Fig. 9);
said first end of said applicator tip engaged with said passage communicating negative air pressure therethrough (see at least Image 1) which is positioned at a front end of said applicator body (front end is considered to be the location of the first end of the applicator tip);
a source of said negative pressure being engaged with said applicator body (see Image 1);
said source of negative pressure being in flow communication with said waste fluid container whereby a supply of negative pressure is delivered from said source of negative pressure to said waste fluid container (para. [0051] teaches that the negative pressure source 140 communicates with aspiration channel 142; para. [0067] teaches that aspiration channel 142 is in fluid communication with collection chamber 215);
said outlet aperture in said applicator tip being in flow communication with said waste fluid container for delivery of waste fluid and debris from said targeted tissues to said waste fluid container (see at least Fig. 9);
said application, extraction, and whirlpool of medicinal mediums to and from targeted tissues operate to and from said targeted tissues by the manipulation of said negative pressure air flow in said applicator tip (para. [0064], for example, teaches the negative pressure source 140 provides suction through the central opening 144; therefore, manipulation of the negative pressure air flow causes the application, extraction, and whirlpool of medicinal mediums; additionally, whirlpool of medicinal mediums is caused due to the shape of the spiral elements 665); and
an on and off pulsation of said negative pressure being communicated to said targeted tissues by manual oscillation of said distal end of said applicator tip by said user of said applicator tip (as shown in at least Figs. 7A-B, the distal end of the applicator tip is manually oscillated by a user to be directly adjacent a user’s skin, as shown in Fig. 7B, and to be detached from a user’s skin, as shown in Fig. 7A).
Regarding claim 10, Shadduck in view of Putzer teaches the invention as described above in claim 9. Additionally, Shadduck teaches:
said waste fluid container includes a separator for dividing incoming gas from said negative air pressure from incoming waste fluid and debris captured from said fluid flow within said gap (see for example filter 225 in Fig. 9 and para. [0067]);
said separator routing said waste fluid and debris into said waste fluid container for disposal (see para. [0067] and Fig. 9); and
said separator routing said incoming gas exhaust to said external source of negative pressure (see upward pointing arrow between numerals 175 in Fig. 9; see also para. [0067]).
Regarding claims 11-12, Shadduck in view of Putzer teaches the invention as described above in claims 1 and 9, respectively. Additionally, Shadduck teaches said distal end of said applicator tip has a tissue contact surface formed of soft permeable material (see at least para. [0050]; since the skin contact surface 122 comprises ports 148 and opening 144, it is permeable).
Regarding claims 16-17, Shadduck in view of Putzer teaches the invention as described above in claims 1 and 9, respectively. Additionally, Shadduck teaches wherein said at least one fluid passage running to at least one fluid opening positioned within said axial passage adjacent said distal end (see Image 1) is comprised of and elongated fluid feed tube running external to said applicator tip (as can be seen in at least Image 1, the fluid passage is an elongated fluid feed tube that is located at the periphery of the applicator tip; therefore, the fluid feed tube is external the applicator tip), said fluid feed tube being connected to a fitting (as shown in Fig. 11A, aspiration port 420 communicates with annular channel 450 which is considered to be a fitting) extending from an exterior surface of said sidewall of said applicator tip (as shown in Fig. 11A, annular channel 450 is at an exterior portion of the sidewall) which delivers said portion of said pressurized fluid stream through said sidewall (pressurized fluid is delivered through the fluid passage which is located in the sidewall) and into said gap (see Fig. 11A).
Regarding claims 18-19, Shadduck in view of Putzer teaches the invention as described above in claims 1 and 9, respectively. Additionally, Shadduck teaches wherein a shape of said outlet aperture is a an outlet shape, from a group of outlet shapes including, rectangular, polygonal, rectangular, square, circular, and elliptical (see at least Fig. 2).
Claims 3-4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Shadduck (U.S. Pre Grant Pub. No. 2018/0303515 A1) in view of Putzer (U.S. Pre Grant Pub. No. 2003/0114804 A1), as applied above to claim 1, and further in view of Baker (U.S. Pre Grant Pub. No. 2008/0154183 A1).
Regarding claims 3-4, Shadduck in view of Putzer teaches the invention as described above in claims 1-2, respectively. However, neither Shadduck nor Putzer explicitly teach a transparent portion of said sidewall surrounding said gap whereby said turbulent fluid flow formed by said captured fluid flow within said gap is viewable therethrough, as required by the claims.
Baker teaches an analogous irrigating and aspiration system (see Abstract) comprising a body 4, an irrigant reservoir 54, and an aspirant reservoir 56 that can be transparent or translucent (see at least para. [0073 and 0086]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Shadduck in view of Putzer to incorporate the teachings of Baker by making a transparent portion of said sidewall surrounding said gap such that turbulent fluid flow formed by said captured fluid flow within said gap is viewable therethrough at least in order to allow a user to identify when to replace the irrigation fluid as well as to check the cleanliness and/or operation of the device, as taught by Baker (see para. [0086]).
Regarding claim 7, Shadduck in view of Putzer, and further in view of Baker teaches the invention as described above in claim 4. Additionally, Shadduck teaches: said fluid openings each configured to project a respective said portion of said pressurized fluid stream at an acute angle relative to an axis of said axial passage (see fluid flow arrow in Image 1).
Claims 13-15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Shadduck (U.S. Pre Grant Pub. No. 2018/0303515 A1) in view of Putzer (U.S. Pre Grant Pub. No. 2003/0114804 A1), as applied above to claim 1, and further in view of Locke (U.S. Pre Grant Pub. No. 2020/0289806 A1).
Regarding claim 13, Shadduck in view of Putzer teaches the invention as described above in claim 9. Additionally, Shadduck teaches a variable speed device for adjusting said strength of negative pressure (para. [0067] teaches that the controller 155 can intermittently turn off the negative pressure source 140; therefore, the strength of the negative pressure source is adjustable from at least the off position to an on position). However, Shadduck in view of Putzer fails to explicitly teach a negative pressure gauge, as required by the claim.
Locke teaches an analogous apparatus for treating a tissue site comprising an oxygen source and a negative-pressure source (see at least Abstract). Locke further teaches that the source of negative pressure is external to is external to the applicator body (as shown in at least Fig. 2, the negative pressure source 118 is external to the wound dressing 104) and includes a negative pressure gauge (see pressure sensor 110 in Fig. 1 and para. [0021]) for indicating a strength of the output of negative pressure (see at least para. [0032]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Shadduck in view of Putzer to incorporate the teachings of Locke by including a negative pressure gauge in the form of a pressure sensor at least because Locke teaches that sensors are generally known in the art as any apparatus operable to detect or measure a physical phenomenon or property (see para. [0032]).
Regarding claim 14, Shadduck in view of Putzer teaches the invention as described above in claim 9. However, Shadduck in view of Putzer fails to explicitly teach that the applicator is adapted to receive regulated oxygen flow, as required by the claim.
Locke teaches wherein:
the dressing is adapted to receive regulated oxygen flow in communication with the outlet aperture (para. [0049] teaches that oxygen may be delivered continuously from oxygen source 102); and
said regulated oxygen being applied and extracted to and from said targeted tissues by manipulation of the negative pressure air flow (as shown in Figs. 2 and 4-5, the system in Locke is a closed system; therefore, the application of negative pressure will necessarily cause the application and extraction of oxygen to and from the wound site).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Shadduck in view of Putzer to incorporate the teachings of Locke by adapting the applicator of Shadduck in view of Putzer to receive regulated oxygen flow in communication with the outlet aperture in said applicator tip at least because Locke teaches that the application of concentrated oxygen at a tissue site can be highly beneficial for new tissue growth and/or healing (see para. [0003] of Locke). Additionally, one of ordinary skill in the art would have reasonably recognized that when the device of Shadduck in view of Putzer is in the configuration of Fig. 7A (as shown in Shadduck), oxygen will flow into the space between the applicator tip and the wound, and when the device of Shadduck in view of Putzer is in the configuration of Fig. 7B (as shown in Shadduck), oxygen will be prevented from flowing into the space between the applicator tip and the wound.
Regarding claim 15, Shadduck in view of Putzer teaches the invention as described above in claim 9. However, Shadduck in view of Putzer fails to explicitly teach a shut-off and metering valve, as required by the claim.
Locke teaches a shut-off and metering valve (see valve 120 in para. [0025]) that operatively engages with the negative air pressure in the wound dressing 104 (see para. [0025]). Locke further teaches that said shut-off metering valve employable to manipulate a flow of negative pressure in the dressing (see at least para. [0025]) whereby it is employable to apply and extract said fluid flow in said gap to and from said targeted tissues and to pulsate negative pressure on and off said targeted tissues (para. [0025] teaches that the valve 120 may be actuated to optimize fluid removal by having settings for high, medium, and low opening pressure).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Shadduck in view of Putzer to incorporate the teachings of Locke by operatively engaging the negative air pressure with a shut-off and metering valve that manipulates a flow of negative pressure to apply and extract the fluid flow in the gap to and from the targeted tissues at least because inclusion of such a valve is well known in the prior art, as evidenced by its disclosure in Locke (see at least para. [0025]). Additionally, one of ordinary skill in the art would have recognized that the valve can be used to pulsate negative pressure on and off said targeted tissues by simply moving the valve between the first position, which may be a closed position preventing flow through the valve, and the second position, which may be an open position permitting flow through the valve (see para. [0025] of Locke).
Regarding claim 20, Shadduck in view of Putzer teaches the invention as described above in claim 9. Additionally, Shadduck teaches a method employing the medicinal applicator system of claim 9 to apply, extract, and whirlpool medicinal liquid mediums to and from targeted tissues and for pulsation of negative pressure on and off targeted tissue through the manipulation of negative pressure air flow (see at least Claim 13), comprising the steps of:
(a) providing said medicinal applicator system assembled with said applicator tip in communication with at least one pressurized fluid stream having at least one medicinal medium (see at least Fig. 1 and para. [0052]; para. [0063] teaches that the fluid source 145 contains an infusion fluid);
(b) regulating said pressurized fluid supply having said at least one medicinal medium suitable for contact upon said targeted tissue (para. [0064] teaches that controller 155 allows fluid to flow from the fluid source 145 through ports 148; therefore, the supply of pressurized fluid is regulated);
(c) positioning said applicator tip adjacent to said targeted tissues to form a decreased negative pressure air flow relation within said distal end of said applicator tip (as shown in Fig. 7A, when the applicator tip is positioned adjacent but not directly in contact with a target tissue site, a decreased negative pressure air flow will be formed within the distal end of the applicator tip due to the applicator tip not forming a closed system with the target tissue site);
(d) applying said pressurized fluid supply having said at least one medicinal medium to said targeted tissue by gravity feed, external tank feed, pump feed or a combination of each (para. [0064] teaches that fluid flow can be provided by a positive pressure pump);
(e) positioning said distal end of said applicator tip closer to said targeted tissues to form an increased negative pressure air flow relation within said applicator tip (as shown in Fig. 7B, when the applicator tip is positioned directly in contact with a target tissue site, an increased negative pressure air flow will be formed within the distal end of the applicator tip due to the applicator tip forming a closed system with the target tissue site);
(f) manipulating the position of said distal end of said applicator tip adjacent to said targeted tissues to form decreased negative pressure air flow relation within said applicator tip or increased negative pressure air flow relation within said applicator tip (at least inherent; when the distal end of the applicator tip is manipulated while in direct contact with the target tissue site, the negative pressure air flow will necessarily increase and/or decrease due to forming or not forming of a closed system with the target tissue site).
Conclusion
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