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 .
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(s) 1, and dependents, 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.
Regarding Claim 1, Applicant recites “surrounding at least one tube and terminating in a distal exit port defined by a circumferential edge… to define a localized environmental jet spray isolation chamber extending from said base to a distal exit port…” [emphasis added] However, these limitations create confusion as to whether these two “a distal exit port”(s) are the same or different. Both structures appear to be defining the same structure identified in the specification (see item 140). As such, it is unclear how many “distal exit ports” are necessary to meet the claim.
Regarding Claim 3, Applicant recites “terminating in a circumferential edge defining said distal exit port”. However, since Claim 1, on which Claim 3 is dependent, already requires “a circumferential edge” which defines the “distal exit port” this creates confusion as to whether the “a circumferential edge” of Claim 3 is the same or different from this previous edge.
Claim Rejections - 35 USC § 103
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) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2008/0319453 (“Tavger”).
Regarding Claim 1, Tavger discloses a dermal treatment handpiece (100) which comprises:
An elongate body (102) having proximal (104) and distal (106);
A jet spray delivery head (112; Fig. 7) formed at the distal end of the body, said delivery head being connected to a source of a liquid suspension of a therapeutic agent (see generally 110 – Par. 68) and to a source of a pressurized gas (see generally 108 – Par. 68) for a selectable combined supply of the liquid suspension and of the pressurized gas, to said jet spray delivery head;
wherein said jet spray delivery head comprises:
a base (see Fig. 7 – where 102 and 150 adjoin one another) formed at said distal end of said body;
a nozzle (150) extending from into said isolation chamber from said base, said nozzle being connected to a combined inflow of the liquid suspension and the pressurized gas (see Fig. 7); and
at least one tube (154) mounted within said nozzle for receiving the combined inflow, comprising a delivery tip for emitting, along a delivery axis in response to receiving the combined inflow, a high pressure, high velocity jet spray of microdroplets (Fig. 7 – Par. 1, 73), said spray including an emergent portion adjacent to the jet spray delivery head (see Fig. 7, re: the arrows).
Tavger discloses the invention substantially as claimed except that that the device includes a “cylindrical wall” extending axially away from the base, the cylindrical wall circumferentially surrounding the at least one tube and terminating in a distal exit port defined by a circumferential edge which extends past said at least one delivery tip so as to surround said emergent portion of said spray so as to define a localized environmental jet spray isolation chamber extending from said base to a distal exit port, wherein the diameter of said distal exit port is less than the widest diameter of said elongated body.
However, in alternative embodiments (200) Tavger discloses that the delivery device nozzle may include a cylindrical wall (204) extending away from the base, the cylindrical wall circumferentially surrounding the nozzle/tube and terminating in a distal exit port (232) defined by a circumferential edge which extends past the delivery tip so as to surround the emergent portion of the spray (see Fig. 10 – 224) so as to define a localized environmental jet spray isolation chamber (220) extending from the base to a distal exit port (232), wherein the diameter of the distal exit port is less than the widest diameter of the elongate body (see Fig. 10).
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It would have been obvious for one having ordinary skill in the art at the time the invention was made to include a cylindrical (note that Applicant appears to be using “cylindrical” in a broader sense than its strict geometric definition to cover circumferential structures having tapering shapes – see Fig. 3; Par. 11) wall extending away from the base to circumferentially surround the tube to thereby create a localized environmental jet spray isolation chamber with a distal exit port which is smaller in diameter than the widest portion of the elongate body, as disclosed with respect to the second embodiment of Tavger, said chamber being described as useful to permit the selectively application of vacuum/suction (218) to draw liquid, gas, and abraded tissue particles or debris from the tissue surface (Par. 79-80) permitting separation and disposal of waste materials incident to the procedure.
Regarding Claim 2, Tavger is silent as to any effect that the isolation chamber might have with respect to “reduce the influence of deleterious, localized air currents on the jet spray, thereby increasing the efficacy of the jet spray as it exits the isolation chamber through the distal exit port, into the environment”. However, inasmuch as the invention of Tavger constitutes the admitted prior art which is recognized by Applicant as being “highly susceptible to local atmospheric disturbances, particularly localized air currents…” (see Par. 42 of the instant PGPUB). Examiner submits that the physical structure of the isolation chamber of modified Tavger would be understood to construct a device which is “operative to reduce the influence of deleterious, localized air currents… thereby increasing the efficacy of the jet spray…” (particularly dependent upon the distance the device of modified Tavger is held from the target skin tissue as well as the incident air currents provided in any particular operating environment) irrespective of whether Tavger recognizes such a utility (as opposed to the utility of preventing backsplash and overspray). It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention).
Regarding Claim 3, Tavger, as modified (see Fig. 10) discloses the isolation chamber comprises a frustoconical cylindrical wall extending axially away from said base, the wall being tapered at its distal end and terminating in a circumferential edge defining said distal exit port.
Regarding Claims 4 and 5, Tavger discloses said at least one tube comprises a single tube for providing a single jet spray (see Fig. 4) along a delivery axis or three tubes for providing a combined jet spray along a delivery axis (see Fig. 7).
Claim(s) 1-2, 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2008/0319453 (“Tavger”) in view of U.S. Publication No. 2005/0124946 (“Landau”)
Regarding Claim 1, Tavger discloses a dermal treatment handpiece (100) which comprises:
An elongated body (102) having proximal (104) and distal (106) ends;
a jet spray delivery head (112, Fig. 7) formed at said distal end of said body, said delivery head being connected to a source of a liquid suspension of a therapeutic agent (at 110) and to a source of a pressurized gas (at 108) for a selectable combined supply of the liquid suspension and of the pressurized gas, to said jet spray delivery head;
wherein said jet spray delivery head comprises: a base formed at said distal end of said body (see Fig. 7, generally at 102 to which 150 is affixed);
a nozzle (150) extending from said base, said nozzle being connected to a combined inflow of the liquid suspension and the pressurized gas (see Fig. 7); and
at least one tube (154) mounted within said nozzle for receiving the combined inflow, the at least one tube comprising a delivery tip for emitting, along a delivery axist in response to receiving the combined inflow, a high pressure, high velocity jet spray of microdroplets, said spray including an emergent portion adjacent to the spray delivery head (Fig. 7 – Par. 1, 73).
Tavger discloses the invention substantially as claimed except that that the device includes a “cylindrical wall” extending axially away from the base, the cylindrical wall circumferentially surrounding the at least one tube and terminating in a distal exit port defined by a circumferential edge which extends past said at least one delivery tip so as to surround said emergent portion of said spray so as to define a localized environmental jet spray isolation chamber extending from said base to a distal exit port, wherein the diameter of said distal exit port is less than the widest diameter of said elongated body.
However, Landau discloses a related dermal treatment, spray device (Fig. 1 – Abstract) comprising a handpiece (22) for receipt of a liquid solution and a nozzle/tube arrangement (70) extending from a base (42) of the device in order to convey a pressurized, liquid spray to the skin. Landau discloses that the device may include a localized environmental jet spray isolation chamber (48) constructed as a “cylindrical wall” (68) (note Applicant appears to be using “cylindrical” in a very broad sense to define a three dimensional shape which circumferentially extends about the nozzle) extending axially away from the base, the cylindrical wall circumferentially surrounding the nozzle and terminating in a distal exit port defined by a circumferential edge which extends past said at least one delivery tip so as to surround said emergent portion of said spray so as to define a localized environmental jet spray isolation chamber extending from said base to a distal exit port (see Fig. 2 – Par. 43), wherein the diameter of said distal exit port is less than the widest diameter of said elongated body (see Fig. 1).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the device of Tavger with a localized environmental jet spray isolation chamber extending from the base to a distal exit port and containing the nozzle/tube arrangement, as disclosed by Landau, in order to assist in containing the jet spray preventing backsplash and overspray.
In the instant case the relationship between the diameter of the discharge exit port of the isolation chamber and the diameter of the widest part of the elongate body is a product of not only the isolation chamber dimensions, but also a product of the elongate body, wherein adjusts to either could result in the instantly claimed relationship. Here, Landau illustrates that the elongate body (22) may be enlarged to thereby create the claimed relationship (See Fig. 1). It would have been obvious for one having ordinary skill in the art at the time the invention was made to increase the diameter of the elongate body of Tavger, as disclosed by Landau, as an obvious design choice owing to mere user, ergonomic preference, whereby users with larger hands may find gripping a larger tool to be more comfortable. It has been held that mere changes in size and proportion that effect only expected and predictable results are obvious and require only routine and customary skill in the art, see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955), and In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). Again, the relative dimensions between the isolation chamber and the elongate body may be altered by changes to one component or the other whereby there is no specific importance, as per the instant specification, as to the relationship between the two dimensions that confers any particular benefit. Examiner submits that the function of the isolation chamber (as disclosed) is a product of the absolute dimensions of the isolation chamber and NOT any correlation between the width of the isolation chamber and the maximum width of the elongate body.
Regarding Claim 2, in the instant case Tavger fails to explicitly recite that the “jet spray has a formulation integrity prone to the influence of deleterious, localized air currents” with the isolation chamber limiting affects by isolating the emergent portion of the spray. However, inasmuch as the invention of Tavger constitutes the admitted prior art which is recognized by Applicant as being “highly susceptible to local atmospheric disturbances, particularly localized air currents…” (see Par. 42 of the instant PGPUB). Examiner submits that the physical structure of the isolation chamber of modified Tavger (see 68 of Landau for the basic structure and location of the chamber) would be understood to, when combined with Tavger, construct a device which is “operative to reduce the influence of deleterious, localized air currents… thereby increasing the efficacy of the jet spray…” (particularly dependent upon the distance the device of modified Tavger is held from the target skin tissue) irrespective of whether Tavger or Landau recognize such a utility (as opposed to the utility of preventing backsplash and overspray). It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention).
Regarding Claims 4 and 5, Tavger discloses said at least one tube comprises a single tube for providing a single jet spray (see Fig. 4) along a delivery axis or three tubes for providing a combined jet spray along a delivery axis (see Fig. 7).
Response to Arguments
Applicant's arguments filed with respect to the claims have been fully considered but they are not persuasive.
Applicant argues (Pg. 6) that “differences in the shape, size, and intended use of the two structures demonstrates that the claimed device is not a logical development from the cited device, and is non-obvious over the combined cited references.” However, this is not persuasive. Both Tavger and Landau (generally analogous to the invention of Rucisnki) are related to spray devices for spraying a fluid spay to the skin. Landua discloses that an isolation chamber/shield is useful in preventing overspray from splashing over the operating environment and user and therefore construction of such an isolation chamber in the invention of Tavger would be understood to be of particular utility for accomplishing the same goal. Here, the breadth of the claim is not sufficient to elucidate any supposed shape, size, and intended use distinctions between the instantly claimed shield and that of Landau and modification of Tavger to include a shield of the type of Landau for the same purposes of isolating fluid spray to prevent overspray would be of particular utility and any unrecognized functions (i.e. protecting the jet spray from air currents) would flow naturally from the inclusion of such a shield regardless of whether or not the ordinary user would have appreciated them at the time of modification of Tavger. As noted above, the relative dimensions between the shield and the elongate body are not merely a product of the shape and function of the isolation chamber itself, but can also be incidentally arrived upon through modifications to the elongate body for purposes such as ergonomics (i.e. a larger diameter elongate body might be preferred by some users, particularly those with larger hands, in order to allow for a more comfortable, preferred grip).
Applicant argues (Pg. 6) “Rucinski’s back-splash protective shield is hemispherical and does not surround anything being delivered from the device’s exit ports”. However, this is not persuasive. Examiner submits that the shape of Landau’s shield is frustoconical (see Fig. 2) and therefore “cylindrical” in the same broad sense as Applicant’s shield. It also clearly surrounds the discharge nozzle whereby such a surround is necessary for it to impart its stated goal of isolating the fluid spray to prevent spray back to the environment and user. As claimed (see Clm. 1, 2, 4, and 5) there is no distinction made between the absolute diameters of the two isolation chambers/shields (i.e. the prior art of Landau or the instantly claimed invention) – rather the correlation is only made with the diameter of the elongate body whereby the diameter of the elongate body is understood to be wholly immaterial to effects of the isolation chamber and it would have been obvious to alter the diameter of the body independent from the diameter of the chamber without having ANY effect on the function of the isolation chamber. The fact that the purpose of the Landua (and Rucsinki) shields is to protect the user and not necessarily to protect the integrity of the stream is immaterial inasmuch as the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 01/15/2026