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 .
Response to Amendment
The amendment filed August 14th, 2026 has been entered. Applicant’s amendments to the claims have overcome the 112(b) rejections previously set forth in the Non-Final Rejection mailed May 14th, 2026.
Response to Arguments
. Applicant’s arguments with respect to claim(s) 16 & 20 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.
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 32 is 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 32 recites the limitation “the plurality of layers” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 16-19 & 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Hoey et al. (U.S. Pub. No. 20150025515, previously cited), herein referred to as “Hoey” in view of Butenkemper et al. (U.S. Pub. No. 20230082650, earliest effective filing date), herein referred to as “Butenkemper”.
Regarding claim 16, Hoey discloses a vapor generator for use in a medical device (Abstract: An induction coil vapor generator is provided that may include any of a number of features … The generator can be disposed in a medical device to treat tissue with vapor), the vapor generator including:
a latticed body (microtubes 108, Fig. 1; wherein when viewed perpendicular to the microtubes’ longitudinal axis, the lumens create a 2D lattice) in fluid communication with a source of fluid (fluid source 118) and defining a plurality of fluid pathways along which fluid from the source of fluid travels ([0039]: a plurality of metallic microtubes 108 disposed within the inner assembly. The microtubes can be coupled to a fluid source 118); and
a coil (coiled magnet wire 102) disposed about the latticed body, wherein the coil includes windings that are wound about the longitudinal axis of the latticed body ([0049]: The coiled magnet wire 102 can be wound along a length D5 of the outer assembly, ranging from the full length of the outer assembly to only the length of the microtubes 108 (microtube length illustrated by D4); see Fig. 1 where this is along the axis of the microtubes 108), wherein the coil is configured to receive a current so as to heat the fluid traveling along the plurality of fluid pathways, thereby generating a vapor ([0041]: The coiled magnet wire can comprise any electrically insulated wire, such as insulated copper, silver, gold or aluminum wire used in electromagnets (magnet wire or Litz wire), and can be coupled to a RF generator that produces a current in the coiled magnet wire to generate an inductive field. This inductive field can then be used to heat the inner assembly and/or microtubes to convert fluid in the microtubes into a heated condensable vapor).
But Hoey fails to disclose wherein the latticed body includes a plurality of struts defining a plurality of openings, wherein at least a first set of the plurality of struts have first longitudinal axes that extend at least partially along a longitudinal axis of the latticed body, wherein the first longitudinal axes extend along a longest dimension of respective struts of the first set of the plurality of struts, and wherein at least a second set of the plurality of struts have second longitudinal axes that extend in a direction that is perpendicular to the longitudinal axis of the latticed body, wherein the second longitudinal axes extend along a longest dimension of respective struts of the second set of the plurality of struts.
However, Butenkemper discloses wherein the latticed body (mesh heating element 204) includes a plurality of struts (filaments 204a-c) defining a plurality of openings (openings between filaments 204a-c), wherein at least a first set of the plurality of struts have first longitudinal axes that extend at least partially along a longitudinal axis of the latticed body ([0138]: The plurality of first filaments 204a are arranged in a first direction of the interwoven mesh heating element 204, which first direction is aligned with the direction of the applied varying magnetic field provided by the induction coil), wherein the first longitudinal axes extend along a longest dimension of respective struts of the first set of the plurality of struts ([0108]: The plurality of first filaments 204a are arranged in a first direction of the interwoven mesh heating element 204, which first direction is aligned with the direction of the applied varying magnetic field provided by the induction coil; see Fig. 5), and wherein at least a second set of the plurality of struts have second longitudinal axes that extend in a direction that is perpendicular to the longitudinal axis of the latticed body ([0138]: The plurality of second filaments 204b are arranged in a second direction of the interwoven mesh heating element 204. The second direction is substantially orthogonal to the first direction; see Fig. 5), wherein the second longitudinal axes extend along a longest dimension of respective struts of the second set of the plurality of struts ([0138]: The plurality of second filaments 204b are arranged in a second direction of the interwoven mesh heating element 204. The second direction is substantially orthogonal to the first direction; see Fig. 5).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the latticed body of Hoey to be the latticed body of Butenkemper for the purpose of the arrangement helping to convey or draw liquid aerosol-forming substrate into the heating element, which in turn helps to wet the heating element and a dense mesh pattern helps to convey liquid aerosol-forming substrate within the mesh (Butenkemper: [0032], [0038]).
Regarding claim 17, Hoey in view of Butenkemper discloses wherein the plurality of fluid pathways define routes of fluid travel along (a) a path approximately parallel to a longitudinal axis of the latticed body and (b) a path transverse to the longitudinal axis of the latticed body (Butenkemper: [0138]: The plurality of first filaments 204a are arranged in a first direction of the interwoven mesh heating element 204, which first direction is aligned with the direction of the applied varying magnetic field provided by the induction coil … The plurality of second filaments 204b are arranged in a second direction of the interwoven mesh heating element 204. The second direction is substantially orthogonal to the first direction; wherein filaments woven in this way provide apertures that define fluid paths approximately parallel to the longitudinal axis of the latticed body (since fluid is supposed to flow along the longitudinal axis/direction) and approximately transverse to the longitudinal axis (since fluid will fill the volume of the mesh so it will fill out radially)).
Regarding claim 18, Hoey discloses a needle (needle 532, Fig. 5) of the medical device but fails to disclose wherein at least a portion of the latticed body is disposed within a needle of the medical device.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention for at least a portion of the latticed body is disposed within a needle of the medical device since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04(VI)(C).
Regarding claim 19, Hoey discloses wherein the latticed body has an approximately cylindrical shape ([0043]: The microtubes 108 can be encased in inner assembly 106, with O-ring supported pressure-fit caps 110a and 110b sealing both ends of the inner assembly; wherein this describes a generally cylindrical shape if the caps are O-rings).
Regarding claim 31, Hoey in view of Butenkemper wherein all of the plurality of layers and all of the struts are integrally formed with one another (Butenkemper: [0138]: The plurality of first filaments 204a are arranged in a first direction of the interwoven mesh heating element 204, which first direction is aligned with the direction of the applied varying magnetic field provided by the induction coil … The plurality of second filaments 204b are arranged in a second direction of the interwoven mesh heating element 204. The second direction is substantially orthogonal to the first direction; wherein a woven structure is seen as being an integrally formed structure such that the filaments are integrally formed with one another).
Regarding claim 32, Hoey in view of Butenkemper discloses wherein the first longitudinal axes are parallel to the longitudinal axis of the latticed body (Butenkemper: [0138]: The plurality of first filaments 204a are arranged in a first direction of the interwoven mesh heating element 204, which first direction is aligned with the direction of the applied varying magnetic field provided by the induction coil).
Claims 20-24 & 30 are rejected under 35 U.S.C. 103 as being unpatentable over Hoey in view of Takahashi et al. (U.S. Pat. No. 6008482), herein referred to as “Takahashi”.
Regarding claim 20, Hoey discloses a vapor generator for use in a medical device (Abstract: An induction coil vapor generator is provided that may include any of a number of features … The generator can be disposed in a medical device to treat tissue with vapor), the vapor generator including:
a latticed body (microtubes 108, Fig. 1; wherein when viewed perpendicular to the microtubes’ longitudinal axis, the lumens create a 2D lattice) in fluid communication with a source of fluid (fluid source 118), along which fluid from the source of fluid travels ([0039]: a plurality of metallic microtubes 108 disposed within the inner assembly. The microtubes can be coupled to a fluid source 118), wherein the plurality of fluid pathways define routes of fluid travel along (a) a path approximately parallel to a longitudinal axis of the latticed body ([0039]: a plurality of metallic microtubes 108 disposed within the inner assembly. The microtubes can be coupled to a fluid source 118); and
a coil (coiled magnet wire 102) disposed about the latticed body, wherein the coil is configured to receive a current so as to heat the fluid traveling along the plurality of fluid pathways, thereby generating a vapor (magnet wire or Litz wire), and can be coupled to a RF generator that produces a current in the coiled magnet wire to generate an inductive field. This inductive field can then be used to heat the inner assembly and/or microtubes to convert fluid in the microtubes into a heated condensable vapor).
But Hoey fails to disclose wherein the latticed body includes a plurality of layers each having a plurality of openings, wherein adjacent layers of the plurality of layers are connected to one another by struts that are integrally formed with both of the adjacent layers, wherein the plurality of openings of the plurality of layers define a plurality of fluid pathways along which fluid from the source of fluid travels, wherein the plurality of fluid pathways define routes of fluid travel along (a) a path approximately parallel to a longitudinal axis of the latticed body and (b) a path transverse to the longitudinal axis of the latticed body.
However, Takahashi discloses wherein the latticed body (porous heating element 18) includes a plurality of layers (layers of fine wire elements 20, Fig. 2) each having a plurality of openings (pores 19), wherein adjacent layers of the plurality of layers are connected to one another by struts that are integrally formed with both of the adjacent layers (Col. 7, lines 60-64: An example of the open-celled porous metallic material includes a sponge-like metallic material of a kind tradenamed "CELMET" available from Sumitomo Electric Industries, Ltd. of Japan; Col. 8, lines 8-15: Where the CELMET material is employed, and considering that the CELMET material currently available is being produced in the form of a web of, for example, 90 cm in maximum width and about 1 cm in thickness, the heating element 18 employed in the practice of the present invention is prepared by laminating a plurality of CELMET discs one above the other, the number of which may vary depending upon the desired length of the heating element 18; where the struts along the circular surfaces connect each disc), wherein the plurality of openings of the plurality of layers define a plurality of fluid pathways along which fluid from the source of fluid travels (Col. 8, lines 59-60: the heating element 18 within the water-filled heating chamber 16 have its pores 19 filled up by the water), wherein the plurality of fluid pathways define routes of fluid travel along (a) a path approximately parallel to a longitudinal axis of the latticed body and (b) a path transverse to the longitudinal axis of the latticed body (see Col. 7, lines 60-64 & Col. 8, lines 8-15; wherein in a porous/sponge structure, this is seen as having a plurality of fluid pathways in all directions which would include approximately parallel to a longitudinal axis of the latticed body and transverse to the longitudinal axis of the latticed body). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the latticed body of Hoey to latticed body of Takahashi for the purpose of steam can be produced at a relatively high steam producing speed with a substantially entire amount of the dissipated heat utilized at a high efficiency for the production of steam (Takahashi: Col. 9, lines 3-6).
Regarding claim 21, Hoey in view of Takahashi discloses wherein the plurality of layers are arranged in a repeating pattern (Takahashi: Col. 8, lines 8-15: Where the CELMET material is employed, and considering that the CELMET material currently available is being produced in the form of a web of, for example, 90 cm in maximum width and about 1 cm in thickness, the heating element 18 employed in the practice of the present invention is prepared by laminating a plurality of CELMET discs one above the other, the number of which may vary depending upon the desired length of the heating element 18).
Regarding claim 22, Hoey in view of Takahashi discloses wherein the plurality of openings of each of the plurality of layers have a same shape (Takahashi: Col. 8, lines 8-15: Where the CELMET material is employed, and considering that the CELMET material currently available is being produced in the form of a web of, for example, 90 cm in maximum width and about 1 cm in thickness, the heating element 18 employed in the practice of the present invention is prepared by laminating a plurality of CELMET discs one above the other, the number of which may vary depending upon the desired length of the heating element 18), and wherein the plurality of openings of a first layer of the plurality of layers are rotated with respect to the plurality of openings of a second, adjacent layer of the plurality of layers (wherein in a stacked configuration of discs, this is seen as adjacent layers would be rotationally offset from one another).
Regarding claim 23, Hoey in view of Takahashi fail to explicitly disclose wherein each of the plurality of openings has a clover shape, a rounded X shape, a fish-eyed shape, a diamond shape, a triangle shape, or a fan shape. It would have been an obvious matter of design choice to make the different portions of each of the plurality of openings has a clover shape, a rounded X shape, a fish-eyed shape, a diamond shape, a triangle shape, or a fan shape, of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 24, Hoey in view of Takahashi discloses wherein all of the plurality of layers are identical (Takahashi: Col. 8, lines 8-15: Where the CELMET material is employed, and considering that the CELMET material currently available is being produced in the form of a web of, for example, 90 cm in maximum width and about 1 cm in thickness, the heating element 18 employed in the practice of the present invention is prepared by laminating a plurality of CELMET discs one above the other, the number of which may vary depending upon the desired length of the heating element 18).
Regarding claim 30, Hoey in view of Takahashi discloses wherein the struts connecting adjacent layers of the plurality of layers have longitudinal axes that extend at least partially along the longitudinal axis of the latticed body (Takahashi: Col. 8, lines 8-15: Where the CELMET material is employed, and considering that the CELMET material currently available is being produced in the form of a web of, for example, 90 cm in maximum width and about 1 cm in thickness, the heating element 18 employed in the practice of the present invention is prepared by laminating a plurality of CELMET discs one above the other, the number of which may vary depending upon the desired length of the heating element 18; wherein “at least partially” does not specify an exact length such that portions of fine wire elements 20 connecting each of the discs are seen as comprising longitudinal axes and therefore meeting the limitation), wherein the longitudinal axis extends through all layers of the plurality of layers (Col. 8, lines 8-15: Where the CELMET material is employed, and considering that the CELMET material currently available is being produced in the form of a web of, for example, 90 cm in maximum width and about 1 cm in thickness, the heating element 18 employed in the practice of the present invention is prepared by laminating a plurality of CELMET discs one above the other, the number of which may vary depending upon the desired length of the heating element 18; wherein the longitudinal axis of the latticed body has all of the discs aligned along that axis).
Allowable Subject Matter
The following is an examiner’s statement of reasons for allowance:
The current prior art of record, neither alone nor in combination, fail to disclose " a heating core including a first coil and a second coil, wherein the second coil is disposed radially inward of the first coil, wherein the first coil and the second coil are concentric" in combination with the other claim limitations.
Hastings (US 20180360523, previously cited) discloses a vapor generator for use in a medical device (Abstract: A vapor delivery needle is provided that may include any of a number of features; [0013]: A prostate treatment device is provided, comprising an introducer shaft sized and configured for transurethral access into a patient, a handle coupled to the introducer shaft, a vapor generator), the vapor generator including: a heating core (vapor generator 112, Fig. 7) including a first coil (inner vapor coil 136) and a second coil (inner vapor coil 136, wherein the numbering of the coils is seen as arbitrary), wherein a first lumen of the first coil and a second lumen of the second coil are in fluid communication with a source of fluid ([0066]: The inner vapor coil can be connected to a supply of sterile water through a plastic tube that extends from the inner coil to a fluid source; wherein the numbering of the coils is seen as arbitrary), and wherein the first lumen and the second lumen define at least one fluid pathway along which fluid from the source of fluid travels ([0066]: Sterile water can be introduced into the inner vapor coil; wherein the numbering of the coils is seen as arbitrary); and a third coil (RF coil 138) disposed about the heating core ([0066]: an outer RF coil 138 of conductive wire that surrounds the inner vapor coil), wherein the third coil is configured to receive a current so as to heat the fluid traveling along the at least one fluid pathway, thereby generating a vapor ([0066]: RF current applied by a RF generator 139 to leads 140 of the outer RF coil can inductively heat the inner vapor coil and generates a steam or vapor). But Hastings fails to disclose “wherein the second coil is disposed radially inward of the first coil, wherein the first coil and the second coil are concentric”.
Keller (US 6610083, previously cited) discloses a first coil (lumen 58; Col. 13, lines 13-14: outer lumens 58, 60, 62 disposed around an inner lumen 64 in a helical pattern) and a second coil (lumen 60; Col. 13, lines 13-14: outer lumens 58, 60, 62 disposed around an inner lumen 64 in a helical pattern), wherein the second coil is disposed radially inward of the first coil (Col. 13, lines 13-14: outer lumens 58, 60, 62 disposed around an inner lumen 64 in a helical pattern, see Fig. 1 where each coil is disposed within the other such that one coil is disposed radially inward of the other and "radially inward" is being interpreted broadly such that it could include being disposed radially inward for any length). But Keller fails to disclose “wherein the second coil is disposed radially inward of the first coil, wherein the first coil and the second coil are concentric”.
Claims 1-2, 10-12, 15 & 27-28 are allowed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
