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 .
Election/Restrictions
Applicant’s election without traverse of Group I including claims 1-8 in the reply filed on 7/24/26 is acknowledged. Claims 9-20 have been cancelled and claims 21-32 are directed towards the invention of Group I.
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.
Claims 27-28 and 32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 27 recites the limitation “reducing the pressure within the at least one pressure vessel during the predetermined dwell time to cause a portion of the heated fluid to evaporate within the at least one pressure vessel” (emphasis added) however claim 21 which claim 27 depends from recites “maintaining, for a predetermined dwell time, the heated fluid within the at least one pressure vessel in a liquid state by maintaining the pressure within the at least one pressure vessel at a level sufficient to prevent boiling of the heated fluid” (emphasis added). It cannot be determined how the liquid is simultaneously controlled to remain in the liquid state as required by claim 21 while also being evaporated as required by claim 27, because a fluid cannot be controlled to both not evaporate and evaporate at the same time during the same dwell time. Claim 21 essentially excludes the vaporization of the fluid during the dwell time while claim 27 seeks to positively recite a vaporization of the fluid during that same dwell time, and therefore the scope of what is required by claim 27 cannot be determined and the claim is indefinite.
Claim 28 is rejected for depending on claim 27.
Claim 32 is rejected similarly for reciting “intermittently reducing a pressure within the at least one pressure vessel during the predetermined dwell time to cause respective portions of the heated fluid to evaporate within the at least one pressure vessel at different intervals during the predetermined dwell time” (emphasis added) while depending from claim 29 which recites “supplying the heated fluid from the heated fluid source to at least one pressure vessel of the bioreactor system while maintaining the heated fluid in a liquid state; circulating the heated fluid through the at least one pressure vessel for a predetermined dwell time”. It cannot be determined how the liquid is simultaneously controlled to remain in the liquid state as required by claim 29 while also being evaporated as required by claim 32, because a fluid cannot be controlled to both not evaporate and evaporate at the same time during the same dwell time. Claim 29 essentially excludes the vaporization of the fluid during the dwell time while claim 32 seeks to positively recite a vaporization of the fluid during that same dwell time, and therefore the scope of what is required by claim 32 cannot be determined and the claim is indefinite.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 6, 8, 21, 25, and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (CN 103239739 A).
Regarding claim 1, Wang (CN 103239739 A) teaches –
A method for sterilizing process equipment configured to produce comestible cell-based food products (par. 2 discloses the method is directed towards a sterilizing a bioreactor and the step of producing comestible cell-based food is not positively claimed and therefore is not considered part of the method as claimed), the method comprising:
pressurizing at least one pressure vessel of a bioreactor system (par. 14 step c discloses a pressurizing step including the pressurization of the jacket, the jacket being the pressure vessel) at a pressure above an atmospheric pressure (par. 14 step C discloses .3 MPa or ~3 atmospheres which is above atmospheric pressure);
circulating heated fluid in the bioreactor system, the heated fluid having a temperature above an atmospheric boiling point of the heated fluid (par. 14 step B discloses circulating hot water at 140 degrees C, which is above the ambient boiling point of water);
maintaining, in the at least one pressure vessel of the bioreactor system, the pressure above the atmospheric pressure and the temperature above the atmospheric boiling point for a predetermined dwell time (par. 14, the circulating step occurs for some time and the maintaining of the above conditions in the jacket); and
removing the heated fluid from the at least one pressure vessel (the superheated water is continuously circulated and therefore continuously removed from the jacket by line 8 at the valve shown in fig. 1, par. 9 also discloses the presence and use of a water outlet of the jacket).
Regarding claim 2, Wang further teaches pressurizing the at least one pressure vessel of the bioreactor system between 2 bar and 4 bar; and circulating the heated fluid in the bioreactor system with the temperature between 110 degrees Celsius and 180 degrees Celsius (par. 14 discloses both .3 Mpa which is 3 bar and 140 degrees centigrade, both of these values anticipated the claimed values).
Regarding claim 6, Wang further teaches maintaining the temperature of the heated fluid in the at least one pressure vessel during the predetermined dwell time by injecting additional heated fluid into the bioreactor system from a heated fluid source integrated with the bioreactor system (pars. 12-14 the water from the source 2 is injected into the tank 4 for heating by heating means 5 and then added to the jacket during the heating period, these components being integrated as a system).
Regarding claim 8, Wang further teaches circulating the heated fluid in the bioreactor system from a superheated water storage tank integrated with the bioreactor system (par. 14 tank 4 holds water).
Regarding claim 21, Wang teaches –
A method for sterilizing process equipment of a bioreactor system (par. 2 discloses the method is directed towards a sterilizing a bioreactor), the method comprising:
pressurizing at least one pressure vessel of the bioreactor system at a pressure above an atmospheric pressure (par. 14 step c discloses a pressurizing step including the pressurization of the jacket, the jacket being the pressure vessel);
circulating heated fluid in the bioreactor system, the heated fluid having a temperature above an atmospheric boiling point of the heated fluid (par. 14 step B discloses circulating hot water at 140 degrees C, which is above the ambient boiling point of water); and
maintaining, for a predetermined dwell time, the heated fluid within the at least one pressure vessel in a liquid state by maintaining the pressure within the at least one pressure vessel (par. 14, the circulating step occurs for some time and the maintaining of the above conditions in the jacket) at a level sufficient to prevent boiling of the heated fluid (the abstract and pars. 3-4 specifically disclose that the device has the advantage over other implementations because steam is not used and superheated water is used, par. 14 teaches the conditions under which this state is maintained).
Regarding claim 25, Wang further teaches maintaining the temperature of the heated fluid during the predetermined dwell time by introducing additional heated fluid into the bioreactor system (par. 14 discloses opening the water inlet valve 2, which introduces more water into the system, during the circulation).
Regarding claim 29, Wang teaches –
A method for sterilizing process equipment of a bioreactor system (par. 2 discloses the method is directed towards a sterilizing a bioreactor), the method comprising:
heating fluid in a heated fluid source integrated with the bioreactor system to a temperature above an atmospheric boiling point of the fluid (par. 14 step B discloses circulating hot water at 140 degrees C, which is above the ambient boiling point of water; the heating taking place in the tank 4);
supplying the heated fluid from the heated fluid source to at least one pressure vessel of the bioreactor system while maintaining the heated fluid in a liquid state (par. 14 discloses the supply of the superheated water to the jacket);
circulating the heated fluid through the at least one pressure vessel for a predetermined dwell time (par. 14); and
during the predetermined dwell time, introducing additional heated fluid from the heated fluid source into the bioreactor system to maintain the temperature of the heated fluid above the atmospheric boiling point (par. 14 discloses opening the water inlet valve 2, which introduces more water into the system, during the circulation, the water being maintained above 100 degrees C).
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (CN 103239739 A).
Regarding claim 4, Wang is set forth above with regards to claim 1 but appears to be silent with regards to the adjusting of alkalinity of the heated fluid to a pH of greater than 7.
However, this modification would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, because the modification of the pH of a water or fluid stream is merely one of routine optimization. See MPEP 2145.05(II). One would have been motivated to find an optimal or workable range of the alkalinity of the water to avoid corrosion of or damage to the jacket during treatment.
Regarding claim 22, Wang is set forth above with regards to claim 21 but appears to be silent with regards to the particular flow rate of the heated fluid.
However, this modification would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, because the modification of the flow rate of a water or fluid stream is merely one of routine optimization. See MPEP 2145.05(II). One would have been motivated to find an optimal or workable range of flow rate to best control the heat transfer characteristics of the system to better control the temperature and sterilization.
Regarding claim 23, Wang is set forth above with regards to claim 21 but appears to be silent with regards to the particular flow regime of the heated fluid.
However, this modification would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, because the modification of the flow regime by control of the flow rate of a water or fluid stream is merely one of routine optimization. See MPEP 2145.05(II). One would have been motivated to find an optimal or workable range of flow rate to best control the heat transfer characteristics of the system to better control the temperature and sterilization.
Allowable Subject Matter
Claims 3, 5, 7, 24, 26, and 30-31 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 27-28 and 32 are would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 3, the prior art, alone or in combination, fails to teach or fairly suggest each and every limitation of the claim. The prior art considered to be the closest prior art is Wang (CN 103239739).
Wang teaches the sterilization system of claim 1 but is silent with regards to a mineral buffer. There would be no reason to modify Wang to include a mineral buffer without hindsight reasoning from Applicant’s disclosure, and therefore the claim is allowable over the prior art.
Regarding claims 5, 26-28, and 31-32, the prior art, alone or in combination, fails to teach or fairly suggest each and every limitation of the claims. The prior art considered to be the closest prior art is Wang (CN 103239739).
Wang teaches the maintenance of the water in the liquid state (abstract) and specifically teaches the advantages of the method are derived from the omission of steam from the process (abstract, pars. 2-4). Therefore, an ordinary artisan would not be motivated to modify Wang without impermissible hindsight from Applicant’s disclosure to arrive at the invention of claims 5, 26-28, and 21-32 which all require the evaporation of the fluid, which in the case of Wang would involve producing and using steam which the reference teaches away from. Therefore, the claims are allowable over the prior art.
Regarding claims 7, 24, and 30, the prior art, alone or in combination, fails to teach or fairly suggest each and every limitation of the claims. The prior art considered to be the closest prior art is Wang (CN 103239739) in view of Pashley (CA 3083377 A1).
Wang teaches the sterilization of process equipment using liquid water as set forth above but is silent with regards to compressed air being used to pressurize the vessel.
Pashley teaches supplying compressed fluid to a reactor system (Fig. 9. p. 135 discloses a compressed CO2 application) to heat the fluid (p. 135, 74 disclose the application of heated gas under pressure to the vessel), however the system is open and the gas does not treat a jacket for sterilizing a bioreactor it instead treats the fluid itself. There would be no motivation to combine Wang and Pashley such that the compressed gas of Pashley is applied to the fluid of Wang to specifically maintain the pressure at or above a particular level as claimed to arrive at the claimed invention. Therefore claims 7, 24, and 30 are allowable over the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDAN A HENSEL whose telephone number is (571)272-6615. The examiner can normally be reached Mon-Thu 8:30 - 7pm;.
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, Maris Kessel can be reached at (571) 270-7698. 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.
/BRENDAN A HENSEL/Examiner, Art Unit 1758
Prosecution Insights