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 .
Election/Restrictions
Applicant’s election without traverse of Group 3, Claims 29-37 in the reply filed on 01/25/2026 is acknowledged. Claims 14-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim.
Status of Claims
Claims 14-37 are pending in the application.
Claims 29-37 are examined on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 10/2/2023 in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) has/have been considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “sealing element(s)” of the applicator must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 32-33 and 37 is/are objected to because of the following informalities:
Claim 32, “the micronozzles have a diameter in the range of 40 and 60 microns” should read -- the micronozzles have a diameter in [[a range of 40 and 60 microns --.
Claim 33, “the micro-jets emanating from the nozzles of the applicator” should read -- the micro-jets emanating from the [[micronozzles of the applicator --.
Claim 37, “the occlusion tubes may be elastic tubes” should read -- the [[occlusion tubes]] vacuum occlusion tube and the occlusion infusion tube may be elastic tubes --.
Appropriate correction is required.
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.
Claim 29-37 is/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 29 recites the limitation “said applicator installed in a receiving channel of the operating handle and held in place by the friction forces of an applicator sealing elements” which is indefinite. There is insufficient antecedent basis for “friction force” in the claim. It is also unclear if the claimed “applicator” same or different the “disposable transparent applicator” introduced earlier in the claim. In addition, it is unclear what structure of the sealing elements. The specification does not provide any structures or definitions of the “sealing elements” and the drawings also do not show the “sealing elements”. The limitation has been examined below as if it read -- said applicator installed in a receiving channel of the operating handle and held in place by [[force of [[a sealing [[element of the applicator --.
Claim(s) 30-37 is/are rejected as being dependent from claim 29 and therefor including all the limitation thereof.
Claim 29 recites the limitation “a plurality of micronozzles … configured to supply pressurized therapeutic fluid micro-jets delivered via said hollow body” which is indefinite. It is also unclear if the claimed “pressurized therapeutic fluid” same or different the “fluid” introduced earlier in the claim. The limitation has been examined below as if it read -- a plurality of micronozzles … configured to supply [[pressurized therapeutic]] the fluid in a form of high-pressure micro-jets delivered via said hollow body --.
Claim(s) 30-37 is/are rejected as being dependent from claim 29 and therefor including all the limitation thereof.
Claim 29 recites the limitation “… to aspirate the contaminated fluid containing therefrom” which is indefinite. There is insufficient antecedent basis for “contaminated fluid” in the claim. The limitation has been examined below as if it read -- to aspirate [[
Claim(s) 30-37 is/are rejected as being dependent from claim 29 and therefor including all the limitation thereof.
Claim 31 recites the limitation “the rotation speed of each of the peristaltic pumps is variable to control the speed and volume of aspiration” which is indefinite. There is insufficient antecedent basis for “rotation speed” in the claim. The limitation has been examined below as if it read -- [[a rotation speed of each of the peristaltic pumps is variable to control [[
Claim 34 recites the limitation “the application of vacuum and pressurized fluid by the negative pressure applicator to the wound surface is carried out by moving the operating handle along the wound surface by changing the speed and the direction of movement” which is indefinite. There is insufficient antecedent basis for “application of vacuum and fluid” and “speed and direction of movement” in the claim. In addition, it is also unclear if the claimed “pressurized fluid” same or different the “fluid” introduced in claim 29 and if the claimed “negative pressure applicator” same or different the “disposable transparent applicator” introduced in claim 29. The limitation has been examined below as if it read -- [[an application of vacuum and [[disposable transparent [[
Claim 36 recites the limitation “the applicator may be of cylindrical shape with a diameter of contact sport of 5 mm” which is indefinite. The phrase “may be” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The claim(s) has/have been examined below as if the limitations following the phrase are not part of the claimed invention (i.e. not required).
Claim 37 recites the limitation “the vacuum occlusion tube and the occlusion infusion tube may be elastic tubes” which is indefinite. The phrase “may be” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The claim(s) has/have been examined below as if the limitations following the phrase are not part of the claimed invention (i.e. not required).
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) 29, 30-34, and 36 is/are rejected under 35 U.S.C 103 as being unpatentable over Wiest (US PAT 5098387) in view of Tremaine (US PAT 6156004) and Tavger (US PGPUB 20140378889).
Regarding claim 29, Wiest discloses a system for wound treatment through a mobile negative pressure wound therapy (Abstract and Fig. 1), the system comprising:
a control unit (a control unit 1: Col. 3, lines 12-27 and Fig. 1) comprising two peristaltic pumps (peristaltic pumps 13 and 14: Col. 3, lines 12-27 and Fig. 1), said control unit configured to regulate operation of the pumps and wherein one of the peristaltic pumps is configured for creating high fluid pressure for supplying a fluid to a wound surface and the other pump is configured to apply negative pressure on the wound (Abstract, Col. 1, lines 51-60; Col. 2, lines 19-32; and Fig. 1: delivery pump and suction pump);
an elongated operating handle (a medical instrument 5: Col. 3, lines 11-25; Figs. 1 and 3) configured to be in fluid communication with the peristaltic pumps (Fig. 1), wherein the handle comprising a central aspiration channel (a suction tube 35: Col. 3, lines 58-68 and Fig. 3) and a side infusion channel (an irrigation tube 34: Col. 3, lines 58-68 and Fig. 3) defining two ports through which a vacuum occlusion tube (aspiration line 11: Col. 3, lines 58-68; Figs. 1 and 3) and an occlusion infusion tube (irrigation line 7: Col. 3, lines 58-68; Figs. 1 and 3) connect said handle with said peristaltic pumps of the control unit (Figs. 1 and 3).
Wiest does not disclose a disposable transparent applicator configured to be in fluid communication with said two ports, said applicator installed in a receiving channel of the operating handle and held in place by the friction forces of an applicator sealing elements and due to difference of negative pressures in the aspiration channel, wherein the applicator comprises: a cylindrical hollow body formed by an inner part and an outer part glued at their ends, said inner part defining an axial cylindrical channel with a conical surface at a distal end thereof forming an inner conical part of the applicator hermetically contacting a part of the wound surface; and a plurality of micronozzles disposed around wide portion of the conical surface which contacts the wound surface and configured to supply pressurized therapeutic fluid micro-jets delivered via said hollow body in fluid communication with the infusion channel to remove contaminations from the wound and peri-wound skin, wherein the axial channel of the cylindrical hollow body is disposed in direct communication with the central aspiration channel of the handle to apply negative pressure on the wound causing the treated area to be deformed and retracted into said conical part, thereby obtaining the therapeutic level of negative pressure above the wound and to aspirate the contaminated fluid containing therefrom.
In the same field of endeavor, suction/irrigation handpiece/applicator, Tremaine discloses an apparatus for irrigating a local irrigation site includes a disposable transparent applicator (a suction/irrigation tip 12 that is removably connected to a suction/irrigation handpiece 10 and the tip 12 is transparent and discarded after using: Abstract; Col. 2, line 60 – Col. 3, line 5; Col. 3, lines 25-26; Col. 5, line 37; and Fig. 1) for the benefits of providing a suction and irrigation apparatus having a reduced risk of clogging with aspirated biological debris and providing a suction and irrigation tip moldable to shape of a local irrigation site (Col. 2, lines 34-40). Tremaine further discloses the tip 12 configured to be in fluid communication with a suction port 26 and an irrigation port 28 (Col. 3, lines 10-25 and Fig. 1, the tip 12 installed in a receiving channel of the handpiece 10 (a handpiece fitting 30: Col. 3, lines 59-61; and Fig. 1) and held in place by friction force of a sealing element of the applicator (by a friction fit by a clip 56: Col. 3, lines 58-67 and Fig. 4). In addition, Tremaine discloses the applicator 12 comprises: a cylindrical hollow body formed by an inner part and an outer part glued at their ends (a cylindrical hollow shield 46 formed by an inner part and an outer part mounted at a distal end 32 of the tip 12: Col. 3, lines 25-37; and Fig. 3), said inner part defining an axial cylindrical channel with a conical surface at a distal end thereof forming an inner conical part of the applicator hermetically contacting a part of the wound surface (Figs. 2-3); and a plurality of nozzles disposed around wide portion of the conical surface which contacts the wound surface (a plurality of holes 78: Col. 4, lines 30-57 and Fig. 3) and configured to supply fluid delivered via said hollow body in fluid communication with the infusion channel to remove contaminations from the wound and peri-wound skin (Col. 4, lines 30-57 and Fig. 3), wherein the axial channel of the cylindrical hollow body is disposed in direct communication with the central aspiration channel of the handle to apply negative pressure on the wound (Fig. 1) causing the treated area to be deformed and retracted into said conical part, thereby obtaining the therapeutic level of negative pressure above the wound and to aspirate contaminated fluid containing therefrom (with the structure and material formed of the applicator 12, the applicator 12 is capable of causing the treated area to be deformed and retracted into said conical part, thereby obtaining the therapeutic level of negative pressure above the wound and to aspirate the contaminated fluid containing therefrom).
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 system of Wiest in view of Tremaine by incorporating a disposable transparent applicator as claimed and incorporating a receiving channel on the operating handle, in order to provide a suction and irrigation apparatus having a reduced risk of clogging with aspirated biological debris and provide a suction and irrigation tip moldable to shape of a local irrigation site, as suggested in Col. 2, lines 34-40 of Tremaine.
Tremaine further discloses/suggests that the sizes of nozzles/holes 78 are selected to provide a specialized spray pattern for the irrigation fluid and to regulate the force with which the irrigation fluid is emitted from the applicator 12 (Col. 4, lines 42-46). Wiest/Tremaine does not disclose the plurality of nozzles are micronozzles.
In an analogous art for being directed to solve the same problem, system for delivering solution into pores of human skin, Tavger discloses a system/method for delivering liquid into the pores of recipient human skin (Abstract and ¶0063). Tavger further discloses the system comprising a handpiece with a tip with micronozzles (one or more nozzles that are smaller than pore size and the pores are hair follicles, sebaceous glands and/or sweat glands: ¶0011, 0015, and 0063) for the benefits of delivering material through a larger number of pores on the treated skin surface and ensuring outlet of the micronozzles coincide with inlets of the pores (¶0011).
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 Wiest in view of Tavger by replacing nozzles with micronozzles, in order to deliver material through a larger number of pores on a wound surface and ensuring outlet of the micronozzles coincide with inlets of the pores, as suggested in ¶0011 of Tavger. Thus, the plurality of micronozzles of Wiest/Tremaine/Tavger is capable of supplying the fluid in form of high-pressure micro-jets delivered via said hollow body in fluid communication with the infusion channel to remove contaminations from the wound and peri-wound skin.
Regarding claim 30, Wiest further disclose one of the peristaltic pumps comprises of an infusion pump configured to draw the fluid from a reservoir and create pressurized fluid for wound treatment (the delivery pump 13 is configured to draw fluid from a reservoir 8: Col. 3, lines 12-27 and Fig. 1; and wherein the pump 13 is a peristaltic pump; thus, the pump 13 is structurally and functionally equivalent to the claimed infusion pump).
Regarding claim 31, Wiest further disclose a rotation speed of each of the peristaltic pumps is variable to control speed and volume of aspiration (Col. 1, lines 50-60 and Col. 3, lines 40-51).
Regarding claim 32, Wiest/Tremaine does not disclose the micronozzles have a diameter in a range of 40 and 60 microns.
Tavger further discloses the micronozzles having a diameter no greater than 50 microns (¶0011 and 0015; the taught diameter range overlaps the claimed diameter range) for the benefits of delivering material through a larger number of pores on the treated skin surface and ensuring outlet of the micronozzles coincide with inlets of the pores (¶0011). Tavger also discloses having an outer diameter of a tip 23 of the handpiece 15 of 5 mm with a nozzle diameter of 50 microns provides best medical effect for treatment performed by moving the handpiece 15 over the skin surface (¶0070).
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 Weist in view of Tavger by having a diameter of micronozzles as claimed, in order to deliver material through a larger number of pores on a wound surface and ensuring outlet of the micronozzles coincide with inlets of the pores, as suggested in ¶0011 and 0070 of Tavger and as it has been held that scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP § 2144.04 (IV) (A)).
Regarding claim 33, Wiest/Tremaine does not disclose an axis of the micronozzles creates an angle of 90 degrees with respect to a surface forming the inner conical part of the applicator such that the micro-jets emanating from the micronozzles of the applicator are perpendicular to the surface of the wound.
Tavger further discloses an axis of the micronozzles creates an angle of 90 degrees with respect to a surface forming the inner conical part of the applicator such that the micro-jets emanating from the micronozzles of the applicator are perpendicular to the surface of the wound (nozzles 27 are positioned in a distal part of a tip 23 and are perpendicular to its inside surface: ¶0067-0069 and Fig. 2) for the benefit of assisting in delivering medical solution into a wound surface under pressure (¶0067 and 0070).
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 Wiest in view of Tavger by having the micronozzles with an angle of 90 degrees with respect to a surface forming the inner conical part of the applicator, in order to assist in delivering medical solution into a wound surface under pressure, as suggested in ¶0067 and 0070 of Tavger.
Regarding claim 34, an application of vacuum and fluid by the disposable transparent applicator to the wound surface of Wiest/Tremaine/Tavger is carried out by moving the operating handle along the wound surface by changing a speed and a direction of movement (the operating handle of Wiest/Tremaine/Tavger is capable of moving to change a speed and direction of movement: see rejection of claim 29 above).
Regarding claim 36, Wiest does not disclose the applicator may be of cylindrical shape with a diameter of contact sport of 5 mm.
Tremaine discloses the applicator 12 may be of cylindrical shape (the shield 46 has cylindrical shape: see rejection of claim 29 above) and further discloses the shield 46 is shaped during use to conform to the shape and contour of the irrigation site (Col. 4, lines 10-15).
Tavger further discloses having an outer diameter of a tip 23 of the handpiece 15 of 5 mm with a nozzle diameter of 50 microns provides best medical effect for treatment performed by moving the handpiece 15 over the skin surface (¶0070).
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 Wiest in view of Tremaine and Tavger by having a diameter of the cylindrical shape of 5 mm, motivated by the desires to conform to the shape and contour of the wound site, as suggested in Col. 4, lines 10-15 of Tremaine, ¶0070 of Tavger, and as it has been held that scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP § 2144.04 (IV) (A)).
Claim(s) 35 is/are rejected under 35 U.S.C 103 as being unpatentable over Wiest (US PAT 5098387) in view of Tremaine (US PAT 6156004) and Tavger (US PGPUB 20140378889), as applied to claim 29 above, and further in view of Urie (US PGPUB 20010031943).
Regarding claim 35, Wiest further discloses delivering irrigation fluid in the system (Col. 1, lines 12-27), but Wiest/Tremaine/Tavger does not disclose the fluid comprises one or more therapeutic fluids.
In the same field of endeavor, negative pressure wound system, Urie discloses an apparatus for the treatment of tissue comprises a wound dressing 10 (Abstract and Fig. 1). Urie further discloses delivering therapeutic fluids to a wound site can be beneficial in wound healing and for irrigation purposes (¶0024).
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 Wiest in view of Urie by using therapeutic fluid as the irrigation fluid, in order to assist in wound healing and for irrigation purposes, as suggested in ¶0024 of Urie.
Claim(s) 37 is/are rejected under 35 U.S.C 103 as being unpatentable over Wiest (US PAT 5098387) in view of Tremaine (US PAT 6156004) and Tavger (US PGPUB 20140378889), as applied to claim 29 above, and further in view of Wudyka (US PGPUB 20110196321).
Regarding claim 37, Wiest further discloses the vacuum occlusion tube (aspiration line 11: Col. 3, lines 58-68; Figs. 1 and 3) and the occlusion infusion tube (irrigation line 7: Col. 3, lines 58-68; Figs. 1 and 3), but Wiest/Tremaine/Tavger does not disclose the vacuum occlusion tube and the occlusion infusion tube may be elastic tubes.
In the same field of endeavor, negative wound therapy systems, Wudyka discloses an apparatus 10 comprising a wound dressing 12 (¶0025 and Fig. 1) and a vacuum source 40 (¶0031). Wudyka further discloses the apparatus comprising conduit 36 made of elastomeric or polymeric materials (¶0032).
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 Wiest in view of Wudyka by selecting elastomeric/polymeric material for the tubes, motivated by the desires to provide flexible tubes for assisting in moving applicator around the wound, as suggested in ¶0032 of Wudyka and as it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07).
Conclusion
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
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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