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 Arguments
Applicant's arguments filed 08/27/2025 with respect to the previous rejection of claim 1 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant has argued that Mansfield does not disclose a sterilizing unit adapted to hold one or more of an inert gas and a sterilizing gas in its internal volume; however, as discussed in the prior Office Action, Mansfield discloses “an inert gas” or a gas “which aids in reducing the viability of certain bacteria, fungi and yeast in certain applications” (para. 34, cited in the prior Office Action) which is introduced in the sterilizing unit (para. 34-35, cited in the prior Office Action).
A secondary reference, Sinha, was provided to address the limitation of one or more screens disposed in the gas inlet through which the one or more of the inert gas and the sterilizing gas must pass before entering into the internal volume. Applicant has argued that Sinha’s purpose of providing the one or more screens is “in direct contrast to the screens of the present invention”. This argument is not found persuasive, because it has been held that “The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant.” (MPEP 2144). In this case, although the motivation may different than Applicant’s motivation, the Examiner maintains that the prior art does provide a motivation to modify the unit disclosed by Mansfield with one or more screens as claimed, namely, to improve uniformity of sterilization by providing turbulent gas flow that enhances uniformity of temperature and pressure conditions (see pp. 3-5 of the prior Office Action). As to the argument pertaining to the Glazer reference, this reference was not relied upon for teaching the screen limitation, and therefore the argument is not persuasive.
Applicant’s claim amendments have necessitated a new grounds of rejection, presented below.
The newly submitted drawings dated 08/27/2025 have overcome the prior drawings objection.
Claim Objections
Claims 11, 18, and 43-44 are objected to because of the following informalities:
Please change “sterilizer unit” in each of claims 11, 18, and 43-44 to “sterilization unit” for consistency with claim 1
Appropriate correction is required.
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 43 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 43 recites “The sterilizer unit of claim 1, further comprising a vaporizer unit comprising a heater, a sterilizing fluid injector and a sterilizing gas outlet in fluid communication with the sterilizer unit” and this limitation is unclear, as the vaporizer unit is a subcomponent of the sterilizer unit (understood to mean the sterilization unit as defined in claim 1), but also claimed to be “in fluid communication with the sterilizer unit”, i.e., the language would appear to state that the vaporizer is in fluid communication with itself. It is recommended to amend the claim to recite that the vaporizer is in fluid communication with another subcomponent of the sterilization unit, such as the body.
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 1, 9, 11, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Mansfield et al. (US Patent Application Publication 2021/0299287) (already of record) in view of Sinha et al. (US Patent Application Publication 2012/0173203) (already of record).
Regarding claim 1, Mansfield et al. discloses a sterilization unit for sterilizing a product (Abstract, para. 2-5), comprising:
a body (called vessel) (102) having an internal volume for receiving the product to be sterilized (para. 31), and comprising at least one opening through which the product can be introduced and/or withdrawn from the internal volume (para. 31); a gas inlet in fluid communication with the internal volume for introducing one or more of an inert gas and a sterilizing gas into the internal volume during sterilization (para. 34-35), wherein the at least one opening is adapted to be sealed for pressurization of the internal volume (para. 9, 18, 31); and
a pressure release valve (called exit gas flow valve) (para. 43, 51);
wherein the body is capable of being pressurized to a pressure of, for example, 300 PSI (para. 57) (falls within the claim range; 300 PSI is equivalent to about 20 atm).
Mansfield et al. is silent as to one or more screens disposed in the gas inlet through which the one or more of the inert gas and the sterilizing gas must pass before entering into the internal volume.
However, Mansfield et al. discloses wherein the body is a cylindrical vessel (para. 31) (Fig. 1, sheet 1 of 7) and that the product treated therein comprises a plurality of one or more materials (para. 54) which are subjected to desired temperature and pressure condition for treatment based on the gas admitted into the internal volume via the gas inlet (para. 12, 31, 51-53).
Furthermore, Sinha et al. discloses a cylindrical container having an internal volume for receiving products to be treated (para. 20) (Fig. 1, sheet 1 of 13), comprising a plurality of gas inlets in fluid communication with the internal volume to deliver a gas thereto (para. 20), wherein the container is configured to maintain a desired temperature and high pressure therein to impart a treatment to the products (para. 3, 21). Sinha et al. further discloses wherein each inlet of the plurality of gas inlets has a screen disposed therein (para. 33) (Fig. 7, sheet 7 of 13), through which the gas must pass before entering the internal volume (para. 33). Sinha et al. discloses that providing the screens in this manner produces a high turbulence intensity pattern in gas flow delivered to the internal volume which advantageously maximizes the number of products in the internal volume that receive a desired gas flow property for treatment (Abstract, para. 33-34).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the unit disclosed by Mansfield et al. such that one or more screens are disposed in the gas inlet through which the one or more of the inert gas and the sterilizing gas must pass before entering into the internal volume, as Sinha et al. discloses providing such a screen in each inlet of a plurality of gas inlets for a treatment vessel in order to provide a turbulent airflow that enhances uniformity of treatment within the vessel, and the skilled artisan would have been motivated to enhance uniformity of temperature and pressure conditions within the internal volume to ensure that materials therein are subjected to sterilization conditions uniformly.
Regarding claim 9, Mansfield et al. discloses a heater disposed at or adjacent to the gas inlet to heat the one or more of the inert gas and the sterilizing gas (para. 16, 56).
Regarding claim 11, Mansfield et al. in view of Sinha et al. teaches the screen disposed in the gas inlet, as set forth above.
Mansfield et al. is silent as to a plurality of gas inlets radially spaced around the body, wherein the screen is disposed radially around the body, covering the gas inlets.
However, Sinha et al. discloses a plurality of gas inlets each having a screen, as discussed in the rejection of claim 1, above. Specifically, Sinha et al. discloses a plurality of gas inlets radially spaced around the body (para. 20) (Fig. 1, sheet 1 of 13), each having a screen covering the inlet (Fig. 7, sheet 7 of 13) (thus each screen is disposed radially around the body), wherein this particular configuration advantageously enhances turbulence patterns as discussed in the rejection of claim 1, above (see also para. 20, 33-34).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to further modify the sterilizer unit disclosed by Mansfield et al. to comprise a plurality of gas inlets radially spaced around the body, wherein the screen is disposed radially around the body, covering the gas inlets, based on the teachings of Sinha et al., in order to provide turbulence patterns known to enhance uniformity of temperature and pressure conditions within the internal volume to ensure that materials therein are subjected to sterilization conditions uniformly.
Regarding claim 18, Mansfield et al. discloses wherein the product is cannabis (para. 8, 31) and that the unit is a cylindrical vessel having a length of 24 inches and a diameter of 12.75 inches (para. 31) (thus, the prior art vessel would be fully capable of containing and sterilizing about 10 lbs to about 25 lbs of cannabis or hemp in a single batch, as Applicant’s own specification states that cylindrical bodies having a diameter of “about 4 inches to about 12 inches” and length of “about 10 inches to about 24 inches” can accommodate about 10 lbs to about 25 lbs of product, see para. 67-70 of the specification as-filed).
Even if it should be found that the vessel disclosed by Mansfield et al. is not adapted to sterilize about 10 lbs to about 25 lbs of cannabis or hemp in a single batch, it is well-established that changes in size of a prior art package constitute a prima facie obvious modification to those skilled in the art (MPEP 2144.04), and it would have been well within the purview of the skilled artisan to adjust the size of the vessel disclosed by Mansfield et al. to accommodate about 10-25 lbs of cannabis or hemp in order to scale-up treatment of products to enhance the efficiency of the device.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Mansfield et al. (US Patent Application Publication 2021/0299287) (already of record) in view of Sinha et al. (US Patent Application Publication 2012/0173203) (already of record), as applied to claim 1, above, and in further view of Glazer et al. (US Patent Application Publication 2014/0234165) (already of record).
Regarding claim 8, Mansfield et al. discloses the gas inlet for introducing one or more of an inert gas and a sterilizing gas into the internal volume, and the pressure release valve, as set forth in the rejection of claim 1, above. Specifically, Mansfield et al. discloses introducing CO2 as a sterilizing gas (para. 34) wherein the gas is thereafter released by the release valve into an ambient environment (para. 43).
Mansfield et al. is silent as to a sensor disposed to be adapted to measure a concentration of sterilizing gas form the release valve.
Glazer et al. discloses a system comprising a tank (12) in which a product is sterilized (para. 56) (Fig. 2, sheet 2 of 28) by means of a sterilizing gas injected into the tank (para. 58, 65). The tank comprises a vent (43) configured to exhaust gas from the tank (para. 79), and a sensor (44) disposed to be adapted to measure a concentration of the sterilizing gas from the vent (para. 79), the sensor configured to determine if sterilizing gas levels are too high for release into ambient air (para. 79).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the system taught by Mansfield et al. to comprise a to a sensor disposed to be adapted to measure a concentration of sterilizing gas form the release valve, as Glazer et al. discloses that it was known in the art to provide such a sensor to determine if sterilizing gas levels are too high for release into ambient, and the skilled artisan would have been motivated to determine a concentration of sterilizing gas released into ambient, e.g., to determine if the ambient environment is suitable for human workers.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Hebb et al. (US Patent Application Publication 2024/0023567) in view of Kowatsch et al. (US Patent 5,733,503) and Lho et al. (US Patent Application Publication 2014/0241953).
Regarding claim 43, Hebb et al. discloses a sterilization unit for sterilizing a product (Abstract, para. 12), comprising:
a body (105) (para. 188) having an internal volume for receiving the product to be sterilized (para. 213-215), and comprising at least one opening through which product can be introduced and/or withdrawn from the internal volume (para. 215); a gas inlet in fluid communication with the internal volume for introducing one or more of an inert gas and a sterilizing gas into the internal volume during sterilization (e.g., the gas can be nitrogen or helium which are inert gases or vaporized hydrogen peroxide which is a sterilizing gas) (para. 12, 189), wherein the at least one opening is adapted to be sealed for pressurization of the internal volume (para. 215); and
a pressure release valve (para. 189),
wherein the body is capable of being pressurized to 140 bar (falls within the claim range; 140 bar is equivalent to about 138 atm) (para. 215; see also para. 188).
Hebb et al. is silent as to the unit comprising one or more screens disposed in the gas inlet through which the one or more of the inert gas and the sterilizing gas must pass before entering into the internal volume; and a vaporizer unit comprising a heater, a sterilizing fluid injector and a sterilizing gas outlet in fluid communication with the sterilizer unit.
As to the limitation of the one or more screens, Kowatsch et al. discloses a sterilization unit for sterilizing a product (Abstract) comprising an opening for delivering vaporized hydrogen peroxide to the product for sterilization thereof (col. 10 lines 11-49) (Figs. 5-9, sheets 4-8 of 11), wherein the opening is provided with a screen (160) having a mesh size of 105 microns through which the gas must pass before reaching the product (col. 9 lines 48-67). The screen limits the amount of liquid form vaporized hydrogen peroxide that reaches the product in preference to vapor phase hydrogen peroxide for sterilization (col. 2 lines 35-39).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the gas inlet disclosed by Hebb et al. to comprise one or more screens disposed therein through which the sterilizing gas must pass before entering the internal volume, as Kowatsch et al. discloses that it was known in the art to provide such a screen to limit the amount of liquid hydrogen peroxide that reaches a product to be sterilized in preference to vaporized hydrogen peroxide for sterilization purposes, and the skilled artisan would have been motivated to ensure the delivery of vaporized hydrogen peroxide to the internal volume as is preferred in the art for sterilization.
As to the limitation of the vaporizer unit comprising a heater, a sterilizing fluid injector and a sterilizing gas outlet in fluid communication with the sterilizer unit, Hebb et al. discloses wherein the gas may be vaporized hydrogen peroxide as discussed above; however, Hebb et al. is silent as to the specific structural configuration for generating vaporized hydrogen peroxide.
However, Lho et al. discloses a sterilization unit (Abstract) comprising a body (110) wherein a product to be sterilized is provided (para. 34) and a vaporizer unit for generating vaporized hydrogen peroxide to be used for sterilization in the body (para. 38) (Figs. 1-2, sheets 1-2 of 4), the vaporizer unit comprising a heater (141a) (para. 38), a sterilizing fluid injector (141d) (para. 38), and a sterilizing gas outlet (142) in fluid communication with the sterilizer unit (para. 38, 44).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the device disclosed by Hebb et al. to comprise a vaporizer unit comprising a heater, a sterilizing fluid injector and a sterilizing gas outlet in fluid communication with the sterilizer unit, as Lho et al. discloses that it was known in the art to provide such a configuration for generating vaporized hydrogen peroxide for a sterilization application, and the skilled artisan would have been motivated to use a known configuration recognized in the art to be suitable for generating vaporized hydrogen peroxide.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Hebb et al. (US Patent Application Publication 2024/0023567) in view of Kowatsch et al. (US Patent 5,733,503).
Regarding claim 44, Hebb et al. discloses a sterilization unit for sterilizing a product (Abstract, para. 12), comprising:
a body (105) (para. 188) having an internal volume for receiving the product to be sterilized (para. 213-215), and comprising at least one opening through which product can be introduced and/or withdrawn from the internal volume (para. 215); a gas inlet in fluid communication with the internal volume for introducing one or more of an inert gas and a sterilizing gas into the internal volume during sterilization (e.g., the gas can be nitrogen or helium which are inert gases or vaporized hydrogen peroxide which is a sterilizing gas) (para. 12, 189), wherein the at least one opening is adapted to be sealed for pressurization of the internal volume (para. 215); and
a pressure release valve (para. 189),
wherein the body is capable of being pressurized to 140 bar (falls within the claim range; 140 bar is equivalent to about 138 atm) (para. 215; see also para. 188).
Hebb et al. is silent as to the unit comprising one or more screens disposed in the gas inlet through which the one or more of the inert gas and the sterilizing gas must pass before entering into the internal volume wherein the one or more screens have a mesh size of about 0.2 µm to about 1000 µm.
As to the limitation of the one or more screens, Kowatsch et al. discloses a sterilization unit for sterilizing a product (Abstract) comprising an opening for delivering vaporized hydrogen peroxide to the product for sterilization thereof (col. 10 lines 11-49) (Figs. 5-9, sheets 4-8 of 11), wherein the opening is provided with a screen (160) having a mesh size of 105 microns through which the gas must pass before reaching the product (col. 9 lines 48-67). The screen limits the amount of liquid form vaporized hydrogen peroxide that reaches the product in preference to vapor phase hydrogen peroxide for sterilization (col. 2 lines 35-39).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the gas inlet disclosed by Hebb et al. to comprise one or more screens having a mesh size of 105 microns (falls within the claim range) disposed therein through which the sterilizing gas must pass before entering the internal volume, as Kowatsch et al. discloses that it was known in the art to provide such a screen to limit the amount of liquid hydrogen peroxide that reaches a product to be sterilized in preference to vaporized hydrogen peroxide for sterilization purposes, and the skilled artisan would have been motivated to ensure the delivery of vaporized hydrogen peroxide to the internal volume as is preferred in the art for sterilization.
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 HOLLY KIPOUROS whose telephone number is (571)272-0658. The examiner can normally be reached M-F 8.30-5PM.
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799