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 .
In view of the appeal brief filed on 2/10/2025, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
Response to Arguments
Applicant’s arguments with respect to claims 1 and 28 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Previously, claims 1 and 28 were rejected under 35 U.S.C. 103 as being unpatentable over Curtis in view of Goulko and Anderson. Now, claims 1 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Lind in view of Melman. The arguments with regards to the absorbent material were seen as persuasive.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4, and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Lind, US 20130012932, herein referred to as “Lind”, in view of Melman et al., US 20220354567, herein referred to as “Melman”.
Regarding claim 1, Lind discloses a tip for application of cryogenic matter onto a skin tag (Figures 12-13), comprising: a conduit (Figure 13: passages 98 and 99) configured to receive therein cryogenic matter ([0072]); an absorbent application element (Figure 13: regions 76 and 78): configured to absorb and contain cryogenic matter from the conduit ([0072]); and having an exposed face configured to apply the cryogenic matter directly onto the skin tag (Figure 13: regions 76 and 78 and [0072]: “enters regions 76 and 78 that open to one another such that the absorbent material deployed in each region 76 and 78 contact each other when the tweezer arms 72 and 74 are in a closed deployment”); and a material (Figure 13: 72o and 74o) in contact with at least a portion of the absorbent application element (Figures 13: regions 76 and 78); configured to conduct cold from the absorbent application element (Figure 13: because 72o and 74o are in contact with regions 76 and 87, the must conduct cold from regions 76 and 78); and comprising a lip extending circumferentially outward at least partially around a perimeter of the exposed face (Figure 13: there is a lip around regions 76 and 78). Lind does not explicitly disclose a tip wherein the material in contact with at least a portion of the application element is thermally conductive, or comprising a layer of insulating material disposed exterior to portions of the thermally conductive material.
However, Melman teaches a tip (Figures 3A-B) wherein the material in contact with at least a portion of the absorbent application element (Figure 3A: in combination, location-wise the absorbent application element of Lind is in the position of surface 303) is thermally conductive (Figure 3A: conductive cavity 302 and [0039]: “the electrode can be formed of a conductive metallic material” wherein any metallic material is thermally conductive); and comprising a layer of insulating material disposed exterior to portions of the thermally conductive material (Figures 3A-B: rim 304 is exterior to conductive cavity 302 and [0038]: “the rim 304 can be electrically insulated, thermally insulated or both”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the tip disclosed by Lind so the material in contact with at least a portion of the application element is thermally conductive and so that it comprises a layer of insulating material disposed exterior to portions of the thermally conductive material as taught by Melman to increase the strength of the thermal therapy on the target tissue (Melman [0021]).
Regarding claim 2, Lind in view of Melman discloses the tip of claim 1, and Melman further discloses a tip wherein the thermally conductive material comprises a casing disposed around an entire perimeter of the absorbent application element (Figures 3A-B: in combination, location-wise the absorbent application element of Embodiment A of Lind is in the position of surface 303; thus, the conductive cavity 302 is disposed around an entire perimeter of surface 303).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the tip disclosed by Embodiment A of Lind so that the thermally conductive material comprises a casing disposed around an entire perimeter of the absorbent application element as taught by Melman to increase the strength of the thermal therapy on the target tissue (Melman [0021]).
Regarding claim 4, Lind in view of Melman discloses the tip of claim 1, and Lind further discloses a tip wherein the lip extends circumferentially outward around at least a portion of a bottom half of the absorbent application element, said bottom half defined as the half that is closer to skin collateral to the lesion when the conduit is arranged perpendicular to the skin (Figure 13: tips 72t and 74t).
Regarding claim 28, Lind discloses a tip for application of cryogenic matter onto a skin tag (Figures 12-13), comprising: a conduit (Figure 13: passages 98 and 99) configured to receive therein cryogenic matter ([0072]); an absorbent application element (Figure 13: regions 76 and 78): configured to absorb and contain cryogenic matter from the conduit ([0072]); and having an exposed face configured to apply the cryogenic matter directly onto the skin tag (Figure 13: regions 76 and 78 and [0072]: “enters regions 76 and 78 that open to one another such that the absorbent material deployed in each region 76 and 78 contact each other when the tweezer arms 72 and 74 are in a closed deployment”); a material (Figure 13: 72o and 74o) in contact with at least a portion of the absorbent application element (Figures 13: regions 76 and 78); configured to conduct cold from the absorbent application element (Figure 13: because 72o and 74o are in contact with regions 76 and 87, the must conduct cold from regions 76 and 78); and comprising a lip extending circumferentially outward around at least a portion of the absorbent application element (Figure 13: there is a lip around regions 76 and 78). Lind does not explicitly disclose a tip wherein the material in contact with at least a portion of the application element is thermally conductive, or comprising a layer of insulating material disposed exterior to portions of the thermally conductive material, the insulating material configured to protect skin collateral to the skin tag from being damaged by the cryogenic matter.
However, Melman teaches a tip (Figures 3A-B) wherein the material in contact with at least a portion of the absorbent application element (Figure 3A: in combination, location-wise the absorbent application element of Lind is in the position of surface 303) is thermally conductive (Figure 3A: conductive cavity 302 and [0039]: “the electrode can be formed of a conductive metallic material” wherein any metallic material is thermally conductive); and comprising a layer of insulating material disposed exterior to portions of the thermally conductive material (Figures 3A-B: rim 304 is exterior to conductive cavity 302 and [0038]: “the rim 304 can be electrically insulated, thermally insulated or both”), the insulating material configured to protect skin collateral to the skin tag from being damaged by the cryogenic matter (Figures 3A-B: rim 304 inherently protects collateral skin tissue because it is insulating; in practice, the skin tag would fill the dome 301, and be treated, while the collateral skin would be in contact with insulated rim 304 and would thus be protected from damage).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the tip disclosed by Lind so the material in contact with at least a portion of the application element is thermally conductive and so that it comprises a layer of insulating material disposed exterior to portions of the thermally conductive material as taught by Melman to increase the strength of the thermal therapy on the target tissue (Melman [0021]).
Regarding claim 29, Lind in view of Melman discloses the tip of claim 28, and Lind further discloses a tip wherein the lip extends circumferentially outward around at least a portion of a perimeter of the absorbent application element (Figure 13: there is a lip around regions 76 and 78).
Regarding claim 30, Lind in view of Melman discloses the tip of claim 28, and Lind further discloses a tip wherein the lip extends circumferentially outward around at least a portion of a bottom half of the absorbent application element, said bottom half defined as the half that is closer to the skin collateral to the skin tag when the conduit is arranged perpendicular to the skin (Figure 13: tips 72t and 74t).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Lind in view of Melman, further in view of Cluzeau et al., US 20040102768, herein referred to as “Cluzeau”.
Regarding claim 3, Lind in view of Melman discloses the tip of claim 2, but does not explicitly disclose a tip wherein the lip extends around less than an entire perimeter of the casing.
However, Cluzeau teaches a tip (Figure 1: apparatus 1) wherein the lip (Figure 1: housing 11) extends around less than an entire perimeter of the casing (Figure 1: housing 11 extends around about half of opening 8).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the tip disclosed by Lind so that the lip extends around less than an entire perimeter of the casing as taught by Cluzeau for monitoring the temperature of the zone of use in order to avoid certain temperatures (Cluzeau [0033]).
Claims 5 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Lind in view of Melman, further in view of Levy et al., US 20110040361, herein referred to as “Levy”.
Regarding claims 5 and 34, Lind in view of Melman discloses the tips of claims 1 and 28, respectively, but does not explicitly disclose a device wherein the thermally conductive material includes stainless steel.
However, Levy teaches a device (Figure 2) wherein the thermally conductive material includes stainless steel (Figure 2: cladding 4 and [0033]: “The front end 3 of the tube 1 is tipped with a cladding 4 made with a material such as stainless steel”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the tip disclosed by Lind so that the thermally conductive material includes stainless steel as taught by Levy so that is has efficient heat conductivity while also being easy to clean to reduce germ transmission (Levy [0033]).
Claims 6 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Lind in view of Melman, further in view of Anderson et al., US 20140303696, herein referred to as “Anderson”.
Regarding claims 6 and 35, Lind in view of Melman and Anderson discloses the tips of claims 1 and 28, respectively, but does not explicitly disclose a tip wherein the insulating material includes plastic.
However, Anderson teaches a device (Figure 1) wherein the insulating material includes plastic (Figure 1: optional handle 130 and [0032]: “An optional handle 130, which can be formed of an insulating material such as plastic, can be affixed to the cooling arrangement 120 to facilitate handling and positioning of the apparatus 100.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the tip disclosed by Lind so that insulating material includes plastic as taught by Anderson to ensure insulation, while facilitates handling and positioning of the apparatus (Anderson [0032]).
Claims 7 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Lind in view of Melman, further in view of Shadduck et al., US 20080132826, herein referred to as “Shadduck”.
Regarding claims 7 and 36, Lind in view of Melman and Anderson discloses the tips of claims 1 and 28, respectively, with Lind disclosing the absorbent application element (Figure 13: regions 76 and 78), but does not explicitly disclose a tip wherein the absorbent application element comprises open cell foam.
However, Shadduck teaches a tip (Figure 14) wherein the absorbent application element comprises open cell foam (Figure 14: resistive element 420 and [0067]: “In one embodiment, the resistive element 420 comprises a flow permeable structure such as a syntactic material or open-cell material (FIG. 14)… The open-cell material also can be an open cell foam that is metal plated, a sintered material, a plated entangled filament material, or any ordered or disordered structure commonly known in the art.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the tip disclosed by Lind so that the absorbent application element comprises open cell foam as taught by Shadduck so that the element will have very high surface areas for conducting heat (Shadduck [0067]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nora W Rhodes whose telephone number is (571)272-8126. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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/NORA W RHODES/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794