DETAILED ACTION
This action is responsive to the preliminary amendment filed 10/27/22.
Claims 11-30 are rejected.
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.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 11-12, 14-15, 20-22, 24-25 and 30 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Shadduck (US 6162232).
Regarding claim 11, Shadduck teaches a skin treatment system (Abstract, “An instrument and technique for the removal of dermal layers in a controlled manner utilizing (i) a high-pressure gas delivery source, (ii) a source for delivery of a cooling fluid and a crystalline abrasive”) comprising: a handpiece (Figs. 2a-b, hand-held body 8) comprising a tip located along a distal end of the handpiece (Figs. 2a-b, skin interface surface 15), the tip being configured to contact skin tissue (Figs. 2a-b and col. 6, lines 25-28, “a skin interface surface indicated at 15 with an opening portion 22 that extends to interior chamber portion 24 to interface with a treatment area TA of a patient's skin”), wherein the handpiece includes at least one fluid delivery passage (Fig. 3a, cooling fluid tubing 43); a fluid system comprising a fluid container, the fluid container configured to contain a treatment fluid, wherein at least a volume of the treatment fluid contained in the fluid container is transferred to or near the working end of the handpiece (Figs. 2a-b, media reservoir or source 40; col. 6, lines 44-48, “A 2nd delivery means comprising a media reservoir or source indicated at 40 is provided to introduce a cooling fluid CF carrying crystal abrasives CA into interior chamber 24 to intermix with the high-pressure gas streams 36A and 36B.”) via the at least one fluid delivery passage during use (Fig. 3a, showing the cooling fluid reservoir 40 attached to the interior chamber 24 through cooling fluid tubing 43); and a thermal conditioning assembly configured to heat and cool the treatment fluid (Fig. 4, thermal energy system 70; col. 9, line 62 – col. 10, line 8, “As indicated in FIG. 4, the system 5 may optionally have a thermal energy system 70 for altering the temperature of fluid CF to any temperature below the patient's body temperature […]. Any type of a thermal energy system 70 that is known in the art may be used to remove heat from (or apply heat to) the fluid CF”).
Regarding claim 21, Shadduck teaches a skin treatment system (Abstract, “An instrument and technique for the removal of dermal layers in a controlled manner utilizing (i) a high-pressure gas delivery source, (ii) a source for delivery of a cooling fluid and a crystalline abrasive”) comprising: a handpiece (Figs. 2a-b, hand-held body 8) comprising a distal end configured to contact skin tissue (Figs. 2a-b, skin interface surface 15; col. 6, lines 25-28, “a skin interface surface indicated at 15 with an opening portion 22 that extends to interior chamber portion 24 to interface with a treatment area TA of a patient's skin”); a fluid system in fluid communication with the handpiece (Figs. 2a-b, media reservoir or source 40), wherein the fluid system comprises a fluid container (Figs. 2a-b, media reservoir or source 40) for containing a treatment fluid (Col. 6, lines 44-48, ‘cooling fluid CF’), wherein at least a volume of the treatment fluid contained in the fluid container is configured to be transferred to or near the distal end of the handpiece during use (Col. 6, lines 44-48, “A 2nd delivery means comprising a media reservoir or source indicated at 40 is provided to introduce a cooling fluid CF carrying crystal abrasives CA into interior chamber 24 to intermix with the high-pressure gas streams 36A and 36B.”); and a thermal conditioning assembly configured to heat and cool the treatment fluid (Fig. 4, thermal energy system 70; col. 9, line 62 – col. 10, line 8, “As indicated in FIG. 4, the system 5 may optionally have a thermal energy system 70 for altering the temperature of fluid CF to any temperature below the patient's body temperature […]. Any type of a thermal energy system 70 that is known in the art may be used to remove heat from (or apply heat to) the fluid CF”).
Regarding claims 12 and 22, Shadduck, further teaches wherein the thermal conditioning assembly is configured to at least partially heat or cool the treatment fluid before said treatment fluid is transferred to or near the working end of the handpiece (Fig. 4, showing the thermal energy system connected to coolant fluid reservoir 40 implying that the thermal conditioning occurs prior to the delivery of the fluid to the handpiece).
Regarding claims 14 and 24, Shadduck further teaches wherein the thermal conditioning assembly is incorporated into the fluid system (Fig. 4, showing the thermal energy system connected to coolant fluid reservoir 40, which is part of the ‘fluid system’).
Regarding claims 15 and 25, Shadduck further teaches wherein the fluid container comprises a vial or a cartridge (Col. 6, lines 44-48 discloses a ‘media reservoir or source 40’, a ‘reservoir’ can be considered a ‘vial’ under the broadest reasonable interpretation of the term).
Regarding claims 20 and 30, Shadduck further teaches wherein the handpiece comprises at least one vacuum passage, wherein the vacuum passage is configured to be placed in fluid communication with a vacuum source (Figs. 2a-b, flexible tube 58 connected to vacuum source 80), the at least one vacuum passage being configured to transfer spent treatment fluid away from the tip (Col. 10, lines 28-35, “The negative (-) pressurization means or vacuum source 80 is provided which communicates with interior chamber 24 in body 8A for evacuating skin debris and spent fluid CF plus agent CA from the treatment site TA. As can be seen in FIGS. 3A-3B and 9A-9B, flexible tube 58 extends from interior chamber 24 to a collection reservoir 60.”).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 13, 16-17, 23 and 26-27 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shadduck in view of Ignon et al. (US 20110082415, “Ignon”).
Regarding claims 13 and 23, Shadduck fails to teach wherein the thermal conditioning assembly is incorporated into the handpiece.
Ignon teaches an analogous skin treatment system (Abstract, “According to some embodiments, a microdermabrasion device for treating skin comprises a handpiece assembly having a distal end and a proximal end. ”) comprising: a handpiece (Fig. 1, handpiece assembly 100) comprising a tip located along a distal end of the handpiece (Fig. 1, tip 160), the tip being configured to contact skin tissue (Abstract, “The microdermabrasion device additionally comprises a tip configured to be positioned along the distal end of the handpiece assembly, wherein the tip is adapted to contact skin surface.”), wherein the handpiece includes at least one fluid delivery passage (Fig. 4a and par. 165, “With continued reference to FIG. 4A, the adjustable distal portion 130 can include a delivery channel 140 or other conduit that places the intermediate region 142 in fluid communication with the tip 160.”); a fluid system comprising a fluid container (Fig. 2a, cartridge 200), the fluid container configured to contain a treatment fluid, wherein at least a volume of the treatment fluid contained in the fluid container is transferred to or near the working end of the handpiece (Par. 151, “In some embodiments, serums, salicylic acid, other anti-acne acids and materials, microcapsules, capsules, other time-release products and substances, other fluids and/or other materials contained within the cartridge 200 can be drawn toward the tip 160 using one or more suction sources (e.g., the vacuum source configured to remove waste materials from the tip 160). ”) via the at least one fluid delivery passage during use (Fig. 4f and par. 183, “In alternative embodiments, as discussed in greater detail herein, the delivery channel 140' can be configured to convey water, saline, other dilutants or dissolvents and/or other fluids from the cartridge 200' to the tip 160'.”); a thermal conditioning assembly configured to heat the treatment fluid (Par. 31, “In some arrangements, the device further includes a heating element configured to selectively heat a fluid being conveyed through the delivery conduit, another interior passage or conduit of the handpiece assembly, the tip, an inlet line and/or the like.”); and wherein the thermal conditioning assembly is incorporated into the handpiece (Par. 31, “a heating element configured to selectively heat a fluid being conveyed through the delivery conduit, another interior passage or conduit of the handpiece assembly”).
Ignon further teaches that the fluid container is a removable cartridge receivable by the handpiece (Par. 13, “In some embodiments, the handpiece assembly comprises a recess configured to removably receive a cartridge”).
Therefore, in view of Ignon, it would have been obvious to POSITA at the time that the invention was made to provide the media reservoir of Shadduck as a removable cartridge mountable on the handpiece and to incorporate the thermal conditioning assembly of Shadduck into the handpiece, in order to reduce the form factor of the system and to make it more compact, as taught by Ignon.
Regarding claims 16 and 26, Shadduck, as modified, further teaches wherein the handpiece is configured to receive the fluid container (Shadduck has previously been modified in view of Ignon to comprise a mountable cartridge style reservoir; see Ignon, fig. 3a, cartridge 200; par. 13, “In some embodiments, the handpiece assembly comprises a recess configured to removably receive a cartridge”).
Regarding claims 17 and 27, Shadduck, as modified, further teaches wherein the handpiece comprises a receiving area configured to receive the fluid container (Shadduck has previously been modified in view of Ignon to comprise a mountable cartridge style reservoir; see Ignon, fig. 3a, cartridge 200 received in recess 111; par. 13, “In some embodiments, the handpiece assembly comprises a recess configured to removably receive a cartridge”).
Claims 18-19 and 28-29 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shadduck in view of Ignon et al. (US 20070156124, “Ignon 2”).
Regarding claims 18 and 28, Shadduck fails to teach wherein the fluid system comprises a manifold, the manifold configured to receive the fluid container.
Ignon 2 teaches an analogous skin treatment system (Abstract, “An apparatus for treating skin has a console with a user input device and a handpiece assembly.”) comprising: a handpiece (Fig. 2a, handpiece assembly 18) comprising a tip located along a distal end of the handpiece (Fig. 2a, tip 34), the tip being configured to contact skin tissue (Par. 76, “The distal end 102 of the tip 34 may be angled with respect to the handpiece assembly 18 to increase the contact area with the patient's skin”), wherein the handpiece includes at least one fluid delivery passage (Fig. 3, input lumen 92; par. 79, “The fluid then flows through the main body 30 and ultimately to the tip 34. As shown in FIG. 3, the main body 30 comprises a plurality of lumens 90, 92 in a fluid communication with the tip 34. Fluid from the input line 52 can flow through the input lumen 92 to the tip 34.”); a fluid system comprising a fluid container, the fluid container configured to contain a treatment fluid (Fig. 1, containers 26; par. 119, “Referring again to FIG. 1, the console 12 includes a manifold system 24 that holds containers 26 containing treatment fluids”), wherein at least a volume of the treatment fluid contained in the fluid container is transferred to or near the working end of the handpiece via the at least one fluid delivery passage during use (Par. 79, “The fluid then flows through the main body 30 and ultimately to the tip 34. As shown in FIG. 3, the main body 30 comprises a plurality of lumens 90, 92 in a fluid communication with the tip 34. Fluid from the input line 52 can flow through the input lumen 92 to the tip 34.”); and wherein the fluid system comprises a manifold, the manifold configured to receive the fluid container (Fig. 1, manifold system 24 receiving containers 26; par. 24, “The illustrated containers 26 of FIG. 1 are preferably releasably coupled to the manifold system 24. The manifold system 24 can deliver treatment material from the containers 26 to the line 20 as mentioned above.”).
Ignon 2 further teaches that the manifold system can be used to selectively deliver either sequentially or simultaneously multiple treatment materials to the skin of the user (Par. 72, “In certain embodiments, the console 12 has a user input device 32 for selecting a treatment material to be passed through the line 20 to the handpiece assembly 18. During some skin treatment procedures, treatment materials from multiple containers 26 are sequentially or simultaneously applied to the patient's skin during a "wet" mode of operation.”).
Therefore, in view of Ignon 2, it would have been obvious to POSITA at the time that the invention was made to modify Shadduck by providing a manifold system, in order to allow the operator to sequentially or simultaneously deliver multiple treatment fluids to the skin of the user, as taught by Ignon 2.
Regarding claims 19 and 29, Shadduck, as modified, further teaches wherein the fluid container comprises at least two bottles, the manifold configured to receive the at least two bottles (Shadduck has previously been modified in view of Ignon 2 to comprises a manifold system; see Ignon 2, par. 16, “In some embodiments, a manifold system comprises a body portion configured to receive releasably at least two bottles.”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM JOSEPH AVIGAN whose telephone number is (571)270-3953. The examiner can normally be reached Monday-Friday 9am-5pm.
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ADAM JOSEPH. AVIGAN
Examiner
Art Unit 3739
/ADAM J AVIGAN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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