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 .
Information Disclosure Statement
The information disclosure statement (IDS) dated 02/03/2026 and 02/12/2026 have been received and considered.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, provisional Application Nos. 62/019,225, 62/035,588 and 62/085,772, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Provisional application 62/086,208 provides support to claims 1, 6-8, 12,14, 19, 20 for a priority date of 12/02/2014.
Claims 2-5, 9-11, 13, 15-18 have support in provisional application 62/164,710 for a priority date of 05/21/2015.
Response to Amendment
The amendment filed 01/09/2026 has been entered. Claims 1-20 remain pending in the application, with claim 21 newly added.
Response to Arguments
Applicant's arguments filed 01/09/2026 have been fully considered.
The argument on page 7 that Batista’s heating element in the embodiment of figs. 4A-B not producing uniform heat has been considered but is moot, since the scope of the claims has changed and the rejection has been updated.
The argument that Neumann differs from Batista has been considered, but is not persuasive. It appears that applicant's argument suggests that Neumann is non-analogous art. It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Neumann is performing the same function as Batista, i.e., vaporizing an active substance (Neumann [0009]).
The remaining arguments are moot because the update scope of the amended claims has resulted in a new grounds of rejection than that applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Interpretation
The term “low enough electrical conductance” in claim 1 is a relative term. While “low enough” is not defined by the claim, the specification does provide a guidance on what is considered “low enough” electrical conductance by providing the range of resistance of the carrier material on pages 33 (beginning on line 30) to page 34. The original specification page 34 first para. gives an example that the resistivity is higher than 1 µΩ∙m at 20°C.
Claim 3 limitation “a thermal conductivity high enough to allow the carrier material to disperse heat” is similar to claim 1 in that the claim does not define what is “high enough”; however, the specification provides information on selecting materials with the correct thermal conductivity. The original specification states that the thermal conductivity should be at least 0.1 W/mK and gives further examples on page 33, first full para.
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 (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.
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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claims 1, 3, 5-7, 9-11, 14, 17, and 20 are rejected under 35 U.S.C. 103 as unpatentable over Batista et al (US 2017/0164657), hereafter Batista, in view of Das et al (US 5573692), hereafter Das, and further in view of McCullough et al. (US 2016/0354561 A1), hereafter McCullough, and Neumann et al. (US 2003/0049025), hereafter Neumann.
Regarding Claim 1, Batista discloses a dose unit for use with an inhaler device (figs. 4A-B, [0104] lines 1-2, aerosol forming cartridge 420), said dose unit including at least one bioactive agent releasable by vaporization (fig. 4B, aerosol forming substrate 424 [0105] lines 7-10 in an example is tobacco to be vaporized), said dose unit comprising: a pallet (fig. 4B, aerosol-forming substrate 424 [0105]) comprising a solid carrier material (in the embodiment of fig. 4B, 424 is a solid block of tobacco [0105]), said at least one bioactive agent being in and/or on said carrier material (the exemplary substrate in embodiment of fig. 4B is a block of tobacco cast leaf which contains the volatile compounds to be vaporized [0105] lines 7-10); an air permeable electrically resistive heating element in thermal contact with a largest surface area of said pallet (fig. 4B, first and second heaters 426, 427 are shown as having mesh heating elements 436 and contacting the largest surface area sides of the substrate [0105]); wherein the heat applied by said electrically resistive heating element is evenly distributed over and conducted to the surface of the dose unit (fig. 4B, the mesh heating elements 436 are evenly distributed across the substrate and conduct heat to the pallet through contact [0104-0105]).
The embodiment of figs. 4A-B is silent on the heating element being a single piece, and the electrically resistive heating element is configured to provide electrical continuity along said single piece (fig. 4B, the two heating elements 436 are shown as a mesh structure, but it is not clear if each is a single piece), and silent on the carrier material (424) being stable and inert at a vaporization temperature.
Batista teaches several alternative variations of the example substrate in figs. 4A-B meant to be vaporized [0033], one of which is a porous carrier onto which a liquid substrate is absorbed ([0028]).
Batista also teaches several variations on the form factor of the electrically resistive heating element, such as that shown in the embodiment of fig. 2B (heating element 236 [0088]), which is a single piece and provides electrical continuity along said single piece ([0088]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to simply substitute Batista’s solid tobacco block carrier, to instead use the porous carrier material onto which a liquid is absorbed for vaporization, which is stable and inert at a vaporization temperature, as Batista teaches that this is a known alternative to the substrate described in the fig. 4A-B embodiment, that would function equally well to vaporize a bioactive substance.
It additionally would have been obvious to one of ordinary skill in the art to simply substitute each of the mesh heating elements of the embodiment of figs. 4A-B for a single piece heating element in the embodiment of fig. 2B, as Batista demonstrates that this is an obvious alternative heating element which is equally able to retain a pallet for vaporization in a cavity for vaporization, as well as to provide the heat needed to vaporize the substance contained in the pallet (Batista [00106]).
However, Batista remains silent on said carrier material having a low enough electrical conductance so as to avoid current passing therethrough instead of through said electrically resistive heating element (instead, Batista has an electrically insulative foil 437 which is part of the heating element in fig. 4B); as well as being silent on the carrier of the figure 4B embodiments being stable and inert at a vaporization temperature of said at least one bioactive agent.
Das teaches the use of a ceramic substrate for a heater for use in a smoking device (col. 1 lines 23-26) which has a low enough electrical conductance so as to avoid current passing therethrough (fig. 1, electrically insulating substrate 20, col. 8 line 22) in order to vaporize a tobacco flavor medium (col. 8 lines 21-27). This ceramic substrate, preferably alumina, is also stable and inert at a vaporization temperature of at least one bioactive agent in order to avoid oxidation at the correct temperature over repeated heating pulses (col. 4 lines 31-33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use alumina as the material for Batista’s substrate, which has a low enough electrical conductance so as to avoid current passing therethrough, as taught by Das, in order to heat the agent to be vaporized without carrying current through the agent; and that the substrate should be stable and inert at a vaporization temperature of the bioactive agent, as taught by Das, to avoid oxidation of the substrate at the temperatures required to vaporize the agent.
The now modified Batista remains silent on wherein the dose unit is a single dose unit used in a single inhalation session by the inhaler device (neither Batista nor Das discusses dosing).
McCullough teaches a drug delivery cartridge for an inhalation vaporization device (abstract) which uses dosing cartridges that are either single dose or multi-dose ([0101] and [0115]). (Examiner’s note: it is understood that a single dose unit is used in a single inhalation session by the inhaler device, since the definition of “dose” is “the measured quantity of a therapeutic agent to be taken at one time” (Merriam-Webster)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make Batista’s dose unit a single dose unit as taught by McCullough, as a person of ordinary skill in the art would have been able to choose from the two known alternative dose unit options in the art, single or multi-dose. A single dose unit used in a single inhalation session by the inhaler device would have been an obvious-to-try design choice, as the only alternative is a multi-dose unit.
In the event that it is not obvious that the heat applied by Batista’s heating element as modified is able to be evenly distributed over the dose unit, Neumann teaches a resistive heating element (fig. 2a, heating element 2 [0098] is a resistance heater [0016]) which heats evenly and uniformly ([0021]) in order to prevent uneven release of the active compound that needs to be vaporized ([0009]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design Baptista’s heating element to ensure evenly distributed heating to the substrate in order to ensure an even release of the active compounds to be vaporized, as taught by Neumann ([0009]).
Regarding Claim 3, the modified Batista discloses a dose unit of claim 1, wherein said carrier material has a thermal conductivity high enough to allow the carrier material to disperse heat throughout said pallet (in the modified Batista, the substrate material is a ceramic, preferably alumina, as modified by Das col. 4 lines 31-35, which transfers heat from the heater to the substance to be vaporized, Das col. 8 lines 21-28).
Regarding Claim 5, the modified Batista discloses a dose unit of claim 1, but does not explicitly disclose wherein said pallet is sufficiently air permeable to allow a flow of at least 0.5 liter of gas per minute under a pulling vacuum of at least 1-5 kPa through said pallet.
However, Batista does disclose that the overall smoking device should have an appropriate resistance to draw, which is the pressure required to force air at a rate of 17.5 ml/sec (or about 1 L/min) through the smoking device ([0046]). Batista expresses this pressure in mmWG (mm water gauge) and preferably this resistance to draw pressure (i.e., the pressure needed to pull the required air flow through the device would create a pulling vacuum) should be most preferably between 95-105 mmWG (converts to 0.93 to 1.03 kPa). Since the cartridge (fig. 4A, 420) containing the pallet/aerosol forming substrate (424) is included in the overall device, it must have at least the above resistance to draw and would not be greater than the disclosed range, since that would increase the pressure of the resistance to draw. Thus, Batista discloses that the preferred air flow through the overall device (and thus the air permeable pallet) is 1 L/min at a pulling vacuum of 0.93-1.03 kPa through the device.
In the event that it is not clear that Batista anticipates the air permeability of the pallet/aerosol forming substrate to be at least 0.5 liter of gas per minute under a pulling vacuum of at least 1-5 kPa by having a resistance to draw pressure of 0.93-1.03 kPa to draw 1 L/min, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the air permeability from at least 0.5 liters of gas per minute at a vacuum pressure of at least 1-5 kPa to be 1 L/min at a resistance to draw pressure of 1-1.03 kPa as taught by Batista, as the applicant appears to have placed no criticality on the claimed range (see page 29, first full para.; the claimed range of the pulling vacuum is described as the pulling force exerted by the lungs upon inhale) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding Claim 6, the modified Batista discloses a dose unit of claim 1, wherein said electrically resistive heating element directly contacts at least one surface of said pallet (Batista’s mesh heating element is shown as directly contacting the substrate 424 in fig. 4B; [0105]; the modified heating element as single piece would be assembled in the same manner as fig. 4).
Regarding Claim 7, the modified Batista discloses a dose unit of claim 1, wherein said electrically resistive heating element comprises a mesh which extends across at least two opposite surfaces of said pallet (Batista fig. 4B, as modified with the heating element 236 of fig. 2B, is arranged in a mesh structure; the heating elements 236 replace the heating elements 436 in fig. 4A-B, which are shown to directly contact both the top and bottom surfaces of the substrate 424; examiner notes that “mesh” has been interpreted to be a material made of a network of wire or thread).
Regarding Claim 9, the modified Batista discloses a dose unit of claim 1, wherein said carrier material has a combustion temperature, a decomposition temperature or a melting temperature higher than the vaporization temperature of the bioactive agent (Das col. 4 lines 30-35, the alumina substrate does not oxidize at operating temperatures from repeated pulsings; the operating temperature is sufficient to vaporize the substance [0031], [0035] lines 1-2).
Regarding Claim 10, the modified Batista discloses a dose unit of claim 1, but is silent on wherein said carrier material is unreactive with the bioactive agent when in contact with the bioactive agent at a temperature range that falls within the range spanning from a storage temperature to a combustion and decomposition temperature of the bioactive agent. While Das discloses that the carrier material/substrate does not oxidize at the temperatures needed to vaporize the agent over multiple cycles (col. 4 lines 30-33), the disclosure does not discuss whether the carrier material is unreactive with the bioactive agent at the claimed temperature range.
However, Das’s substrate is the same material disclosed by applicant (Das col. 4 lines 30-31, ceramic such as alumina; applicant discloses the carrier material to also include alumina, page 24 lines 9-13, and pages 30-31). Thus, one of ordinary skill in the art would expect that the alumina substrate in the modified Batista would be unreactive with the bioactive agent at a temperature range that falls within the range spanning from a storage temperature to a combustion and decomposition temperature, since the alumina substrate is used to repeatedly vaporize an agent, similar to the applicant’s device.
Regarding Claim 11, the modified Batista discloses a dose unit of claim 1, but is silent on wherein said carrier material is unreactive with the bioactive agent when in contact with the bioactive agent at a temperature range spanning from a storage temperature to a temperature being 50°C higher than a vaporization temperature of the bioactive agent. While Das discloses that the carrier material/substrate does not oxidize at the temperatures needed to vaporize the agent over multiple cycles (col. 4 lines 30-33), the disclosure does not discuss whether the carrier material is unreactive with the bioactive agent at the claimed temperature range.
However, Das’s substrate is the same material disclosed by applicant (Das col. 4 lines 30-31, ceramic such as alumina; applicant discloses the carrier material to also include alumina, page 24 lines 9-13, and pages 30-31). Thus, one of ordinary skill in the art would expect that the alumina substrate in the modified Batista would be unreactive with the bioactive agent at a temperature range that falls within the range spanning from a storage temperature to 50°C higher than a vaporization temperature of the bioactive agent, since the alumina substrate is used to repeatedly vaporize an agent similarly to the applicant’s device.
Regarding Claim 14, the modified Batista discloses a dose unit of claim 1, but does not explicitly disclose wherein a thickness of said dose unit is between 0.1 mm to 2mm.
However, Batista does disclose that the cartridge assembly (fig. 4A [0104] line 2; this assembly is equivalent to the dose unit in applicant’s fig. 1A-B) has a height between 2mm-10mm ([0016]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to dimension the height (or thickness) of the modified Batista’s cartridge assembly to have a thickness of 2mm, as the applicant appears to have placed no criticality on the claimed range (page 58, first para.) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding Claim 17, the modified Batista discloses a dose unit of claim 1, wherein said carrier material is formed from one or more substances including: ceramic composite (Das, the substrate 20 is a ceramic, col. 4 lines 30-31), alumina (col. 4 line 31).
Regarding Claim 20, the modified Batista discloses a dose unit of claim 1, wherein said electrically resistive heating element (Batista fig. 4A-B as modified has heating elements 436 replaced with fig. 2B heating element 236) comprises an electrode contact-receiving region on either side of a region extending across said pallet (Batista fig. 2B, the heating element 236 has electrode contacts 238 on either side of the pallet extending across the short side of the pallet [0088]).
Claims 2 and 3 are rejected under 35 U.S.C. 103 as unpatentable over Batista, Das, McCullough, and Neumann, as evidenced by MatWeb Material Property Data (data sourced from ASM Engineered materials Reference Book, Second Edition, 1994; accessed at https://www.matweb.com/search/DataSheet.aspx?MatGUID=1bf6c5b8daed427693211c5f985b90a2&ckck=1 on 03/11/2025), hereafter MatWeb.
Regarding Claim 2, the modified Batista discloses a dose unit of claim 1, but does not explicitly disclose wherein said carrier material has an electric resistivity of at least 10 µΩ-m.
The material of the carrier for the electrically insulated substrate of Batista, when modified with Das as described in claim 1, is a ceramic preferably being alumina (Das col. 4 lines 30-35). Matweb demonstrates that the electrical resistivity of alumina was a known material property, and is 1014 Ω-cm at 25°C, which is greater than 10 µΩ-m.
Regarding Claim 4, the modified Batista discloses a dose unit of claim 3, but does not explicitly disclose wherein said thermal conductivity is of at least 0.1 W/mK.
The material of the carrier for the electrically insulated substrate of Batista, when modified with Das as described in claim 1, is a ceramic preferably being alumina (Das col. 4 lines 30-35). Matweb demonstrates that the thermal conductivity of alumina is a known material property, and is 17.0 W/m-K, which is greater than 0.1 W/mK.
Claim 8 is rejected under 35 U.S.C. 103 as unpatentable over Batista, Das, McCullough, and Neumann, further in view of Steinberg (US 2014/0373857), hereafter Steinberg.
Regarding Claim 8, the modified Batista discloses a dose unit of claim 7, wherein said electrically resistive heating element (as modified, Batista fig. 2B, heating elements 236 are replacing heating elements 436 in fig. 4A-B) with two ends (fig. 4B, each heater has an end) and having a hollow in which said pallet is positioned (there are 2 heating elements positioned, one on either side of the pallet/aerosol forming substrate 424 with the pallet positioned in the hollow or space between the two heating elements) such that an electrical current flows across both of the at least two opposite surfaces when a voltage is applied between the two ends (two panels 426, 427 each have electrical contacts 438 on each of two ends [0106] line 4, which are replaced in the modification with the electrical contacts 238; current is applied to the heaters [0108])).
However, the modified Batista is silent on the heating elements comprising a U-shape.
Steinberg teaches a smoking device which uses a U-shaped heating element surrounding vaporizable material (fig. 1, heating element 26 surrounds a bowl area 38 where smoking material is placed [0034]). The U-shape heating element is a good electrical resistance match for high-energy storage batteries which tend to have high single cell voltages ([0031]), which allows for an extended battery life compared to other heating devices ([0004]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of Batista’s heating element from two separate panels to be a long U-shaped heating element surrounding the vaporizing pallet, as taught by Steinberg, for the benefit of having a matching electrical resistance for a high-energy storage battery, which has a longer life compared to other devices (Steinberg [0031]).
Claims 12-13 and 16 are rejected under 35 U.S.C. 103 as unpatentable over Batista, Das, McCullough, and Neumann, further in view of Raether et al (US 2014/0373859), hereafter Raether.
Regarding Claim 12, the modified Batista discloses a dose unit of claim 1, but is silent on wherein said pallet comprises packed particles (in the modified device, Batista’s porous carrier material, which has been modified with Das to be an alumina; however, neither disclosure discusses the manufacturing method of these structures).
Raether teaches a non-combustible porous ceramic matrix for use in a smoking article (abstract, fig. 2, composite heat source 6 [0104]), where the composite heat source comprises a porous non-combustible ceramic matrix and a particulate combustible fuel embedded within the matrix [0012], and the aerosol generating substrate releases volatile compounds upon heating ([0086]). Raether teaches that a porous non-combustible ceramic matrix can be manufactured using die compaction ([0074] lines 1-4) using a suitable particulate size of ceramic ([0075]).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to manufacture the modified Batista’s porous carrier material by using the die compaction method taught by Raether to press the alumina (as modified by Das) into the required shape for Batista’s aerosol forming substrate (fig. 4B 424). Raether’s manufacturing method of die pressing was a known method in the art for packing particles into a porous non-combustible ceramic matrix.
Regarding Claim 13, the modified Batista discloses a dose unit of claim 12, but is silent on wherein said particles have a diameter larger than 10 microns.
However, Raether teaches that the composite heat source, which is comprised of particulate combustible fuel embedded in a porous non-combustible ceramic matrix ([0012]), where the fuel particle size is between 1-200µm ([0066]) and the non-combustible porous ceramic matrix is formed from particulate matter having a median D50 size at least 5 times smaller than the particulate combustible fuel ([0065]). This would put the range of the ceramic matrix particulate size between 0.2-40 µm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the size of the pressed alumina particles of the modified Batista’s substrate from 0.2-40 µm as taught by Raether to have a diameter from 10-40 microns (i.e., larger than 10 microns) since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
In the instant case, the particle size of Raether (while not specifically disclosed, the particle size is large enough to permit an airflow through the particles in pores of 10 microns) would still allow air to flow between the particles. Further, applicant places no criticality on the range claimed, indicating simply that the dimensions of the particles are larger than the holes in the air-permeable retaining mesh of the heating element (specification page 32, last para.).
Regarding Claim 16, the modified Batista discloses a dose unit of claim 1, but is silent on wherein said pallet is formed by pressing particles in a mold so as to unify the particles into an air-permeable matrix (in the modified device, Batista’s porous carrier material has been modified with Das to be alumina; however, neither disclosure discusses the manufacturing method of these structures).
Raether teaches a non-combustible porous ceramic matrix for use in a smoking article (abstract, fig. 2, composite heat source 6 [0104]), where the composite heat source comprises a porous non-combustible ceramic matrix and a particulate combustible fuel embedded within the matrix [0012], and the aerosol generating substrate releases volatile compounds upon heating ([0086]). Raether teaches that a porous non-combustible ceramic matrix can be manufactured using die compaction ([0074] lines 1-4) using a suitable particulate size of ceramic ([0075]). Die compaction is a method of pressing particles in a mold so as to unify particles, and in Raether’s device, to become an air-permeable matrix.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to manufacture the modified Batista’s porous carrier material by using the die compaction method taught by Raether to press the alumina (as modified by Das) into the required shape for Batista’s aerosol forming substrate (fig. 4B 424). Raether’s manufacturing method of die pressing was a known method in the art for packing particles into a porous non-combustible ceramic matrix. Examiner’s note: the claimed phrase “pressing particles in a mold” is being treated as a product by process limitation; that is, a pallet is made by pressing particles in a mold to form the pallet shape. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 103 rejection may be made and the burden is shifted to the application to shown an unobvious difference. See MPEP 2113. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior art was made by a different process. In re Thorpe, 777F.2d 695, 698,227 USPQ 964,966 (Fed. Cir. 1985). Thus, even though Raether uses a die pressing process to form an air-permeable matrix, it appears that the end product in the combination would be the same or similar as that claimed, since Applicant’s pallet and Raether’s matrix are both air-permeable ceramics. Applicant is reminded that Claim 16 is not directed to a method of manufacturing.
Claim 15 is rejected under 35 U.S.C. 103 as unpatentable over Batista, Das, McCullough, and Neumann, further in view of Hajaligol (US 5530225), hereafter Hajaligol.
Regarding Claim 15, the modified Batista discloses a dose unit of claim 1, but is silent on wherein a weight of said pallet is between 1 mg to 100 mg.
Hajaligol teaches a heater for an electrical smoking device (title) which includes the goal of minimizing the weight of the mass of the device overall by adjusting the thickness of a heater blade and substrate (fig. 3, heater blade 120 and insulating ceramic substrate 121 col. 11 lines 16-17; reducing the mass of the device col. 12 lines 12-20). A lighter weight unit decreases the amount of energy required to heat the heater, which in turn can reduce the size and weight of the battery needed to power the device (col. 12 lines 16-20).
It has been held that where the general conditions of the claims are disclosed in the prior art, finding the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05.II.A). Optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over prior art (MPEP 2144.05). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the weight of the modified Batista’s pallet to be between 1-100mg as needed for the appropriate weight of the overall device.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as unpatentable over Batista, Das, McCullough, and Neumann, further in view of Whittle et al. (US 2005/0063686), hereafter Whittle.
Regarding Claim 18, the modified Batista discloses a dose unit of claim 1, but is silent on whether the device can vaporize a substance other than tobacco ([0026]).
Whittle teaches a vaporization device with a similar concept to Batista (fig. 3B, [0063] and [0066], a substance to be vaporized, 4, is applied to a ceramic resistor 1 to transfer heat generated via connectors 3) wherein said at least one bioactive agent includes a bioactive agent selected from the group consisting of Δ9-tetrahydrocannabinol (THC), cannabidiol (CBD), tetrahydrocannabivarin (THCV) ([0034]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the bioactive agents taught by Whittle in the vaporization device of Batista, since both devices have a similar operation (heat applied to a substrate containing an active substance, which is able to control the heat delivered to vaporize the substance; see Batista [0043] and Whittle [0015]).
Regarding Claim 19, the modified Batista discloses a dose unit of claim 1, wherein the bioactive agent is provided in and/or on said carrier material (in the modified Batista, the embodiment fig. 4B, substrate 424 is modified to be a porous carrier material [0028], which is taught by Das to be an alumina substrate). However, the modified Batista does not explicitly disclose that the bioactive agent is provided at a pre-determined amount.
Whittle teaches that, depending on the substance to be delivered, it might be desirable to control the dosage to be vaporized (Whittle [0013]). Whittle teaches applying a specific amount of cannabis extract to the resistive element that is to be vaporized by the user ([0034]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the bioactive agent in and/or on the modified Batista’s carrier material at a pre-determined amount in order to control the dose delivered to the user, as taught by Whittle.
Regarding Claim 21, the modified Batista discloses a dose unit of claim 1, but is silent on whether the device can vaporize a substance other than tobacco ([0026]).
Whittle teaches a vaporization device with a similar concept to Batista (fig. 3B, [0063] and [0066], a substance to be vaporized, 4, is applied to a ceramic resistor 1 to transfer heat generated via connectors 3) wherein said at least one bioactive agent comprises Δ9-tetrahydrocannabinol (THC) ([0034]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the bioactive agents taught by Whittle in the vaporization device of Batista, since both devices have a similar operation (heat applied to a substrate containing an active substance, which is able to control the heat delivered to vaporize the substance; see Batista [0043] and Whittle [0015]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA K. TOICH whose telephone number is (703)756-1450. The examiner can normally be reached M-Th 7:30 am - 4:30 pm, every other F 7:30-3:30 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy S. Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARA K TOICH/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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