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 .
Claim Rejections - 35 USC § 112(b)
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 12–14 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 12 recites:
12. A fermenter or bioreactor system comprising:
a. a disposable reaction container contained within a fermenter or bioreactor reactor vessel, the reactor vessel comprising at least one heat transfer system;
b. the disposable reaction container being connected to a coalescer comprising an internal tortuous fluidic pathway through which exhaust gas is configured to be emitted from the disposable reaction container;
c. the coalescer being connected to an exhaust line configured for leading the exhaust gas from the coalescer to an exhaust filter;
d. the exhaust line being connected to a heated air source that is configured to introduce heated external air directly into the exhaust line to produce a mixed exhaust gas having a temperature above that of the exhaust gas, wherein the heated air source is configured to introduce the heated air into the exhaust gas after it exits the coalescer and before it enters the exhaust filter;
e. a sterile filter positioned between the heated air source and the exhaust line, wherein a first fluidic pathway is positioned between sterile filter and the heated air source, and a second fluidic pathway is positioned between the sterile filter and the exhaust line, and,
f. the exhaust line being positioned between the second fluidic pathway and the exhaust filter, the exhaust filter being configured such that the mixed exhaust gas exits the system through the exhaust filter, wherein the heated air source is not directly connected to the exhaust filter. Emphasis added.
Claim 12 is indefinite because it is unclear whether the “exhaust filter” is a positively or non-positively recited structural element of the claimed system. This is because the “exhaust filter” is initially introduced in limitation c.) as a non-positively recited element as the claim says that the coalescer is configured for leading exhaust gas from the coalescer to an exhaust filter. But the body of the claim appears to indicate that the exhaust filter is a positively recited element as the claim describes, for instance in limitation f.), the exhaust line being positioned between the second fluidic pathway and the exhaust filter.
To overcome this rejection, claim 12 could be amended to read:
12. A fermenter or bioreactor system comprising:
a. a disposable reaction container contained within a fermenter or bioreactor reactor vessel, the reactor vessel comprising at least one heat transfer system;
b. the disposable reaction container being connected to a coalescer comprising an internal tortuous fluidic pathway through which exhaust gas is configured to be emitted from the disposable reaction container;
c. the coalescer being connected to an exhaust line and an exhaust filter, wherein the exhaust line is configured for leading the exhaust gas from the coalescer to [[an]] the exhaust filter;
d. the exhaust line being connected to a heated air source that is configured to introduce heated external air directly into the exhaust line to produce a mixed exhaust gas having a temperature above that of the exhaust gas, wherein the heated air source is configured to introduce the heated air into the exhaust gas after it exits the coalescer and before it enters the exhaust filter;
e. a sterile filter positioned between the heated air source and the exhaust line, wherein a first fluidic pathway is positioned between sterile filter and the heated air source, and a second fluidic pathway is positioned between the sterile filter and the exhaust line, and,
f. the exhaust line being positioned between the second fluidic pathway and the exhaust filter, the exhaust filter being configured such that the mixed exhaust gas exits the system through the exhaust filter, wherein the heated air source is not directly connected to the exhaust filter.
Claims 13 and 14 are indefinite because they depend from claim 12.
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.
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 12–14 are rejected under 35 U.S.C. 103 as being unpatentable over Staheli et al., US 2011/0207218 A1 in view of DiMinno, Jr. US 3,834,126 and in further view of Ward et al., US 2018/0238317 A1.
Regarding claim 12, Staheli teaches a system 10 comprising a container 12 as part of a bioreactor or fermenter. See Staheli Fig. 1, [0024], [0027]. The system 10 reads on the “fermenter or bioreactor system.”
The system 10 comprises a disposable container 12 (the “disposable reaction container”) disposed within a support housing 14 (the “fermenter or bioreactor vessel”). See Staheli Fig. 1, [0027]. The support housing 14 comprises has heating elements mounted on or within the housing (“at least one heat transfer system”). Id. at [0027].
The container 12 is connected to a condenser system 16 (the “coalescer”) for removing moisture from humid exhaust gas from the container 12. See Staheli Fig. 1, [0045]. The condenser system 16 comprises an internal fluid channel 136 forming a torturous path (the “internal tortuous fluidic pathway through which exhaust gas is emitted from the disposable reaction chamber”). Id. at Fig. 7, [0050]
The condenser system 16 is connected two exhaust line 214A, 214B (line 214A reads on the “exhaust line”) leading the exhaust gas from the condenser system 16 to a filter 298 (the filter 298 connected to line 214A reads on the “exhaust filter”). See Staheli Fig. 10, [0076], [0085].
The exhaust gas line 214A is connected to the filter 298, and the filter 298 is configured such that gases that pass through the filter 298 exit the system through the filter 298. See Staheli [0076].
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Staheli differs from claim 12 because it is silent as to the exhaust lines 214A, 214B (214A is the “exhaust line”) being connected to a heated air source that introduces that introduces heated external air directly into the exhaust line 214A to produce a mixed exhaust gas having a temperature above that of the exhaust gas, wherein the heated air is introduced into the exhaust gas after it exits the coalescer and before it enters the filter 298 (the “exhaust filter”), as claimed.
But the filters 298 are used to remove remaining moisture from the gas that exists the condenser system 16. See Staheli [0076]. Also, the filters 298 are provided with a heating mechanism to help evaporate moisture that condenses within the filters 298 to prevent clogging. Id. at [0086].
With this in mind, DiMinno teaches a water separator for removing water vapor from air. The water separator comprises an inlet duct 30 that supplies humid air to a coalescer 32 comprising a fibrous mat (similar to a filter), which is used to remove moisture from the air. Id. at Fig., col. 2, ll. 30–40. During operation, the fibrous mat can become clogged with ice, and warm air is periodically supplied to the fibrous mat to unclog it. Id. at col. 2, l. 65–col. 3, l. 5. The warm air is supplied through a tube that is connected to the inlet duct 30. Id. at Fig., col. 2, l. 65–col. 3, l. 5. Therefore, the warm air is introduced to the fibrous mat as a mixed gas comprising the air moving through the inlet duct 30 and the warm air. Id.
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It would have been obvious for filters 298 to be heated using the warm air mechanism of DiMinno because this would merely represent the simple substitution of one known element for another to yield predictable results. See MPEP 2143, subsection I, B. In other words, the filters 298 of Staheli require some mechanism for heating them to drive off water to prevent clogging, while DiMinno teaches a warm air mechanism to heat up a fibrous mat so that it is not clogged. Therefore, using the heating mechanism of DiMinno with Staheli would have been obvious because it would involve using a known heating mechanism to perform the required function of Staheli to increase the temperature of the filters 298 to prevent water from clogging them.
With this modification, each exhaust line 214A, 214B of Staheli would comprise a tube supplying warm air into the exhaust line, in the same way as the tube supplying warm air introduces the heated air into the inlet duct 30 of DiMinno. The source of warm air of DiMinno reads on the “heated air source.” It introduces external heated air having a temperature above that of the exhaust gas directly into the exhaust line 214A of Staheli (the “exhaust line”) to produce a mixed exhaust gas having a temperature above the exhaust, as claimed, because DiMinno illustrates the source of warm air being directed into the incoming airstream directed to the coalescer 32. The source of warm air is configured to introduce the heated air into the exhaust gas after the exhaust gas exits the condenser 216 and before it enters each filter 298, as claimed, because each tube supplying warm air into the exhaust line 214A, 214B is located downstream of the condenser 216. The heated mixed gas stream would passes through the filter 298 of Staheli, as claimed, because the heated mixed gas is intended to heat the filter 298.
Staheli as modified differs from claim 12 because it is silent as to a sterile filter positioned between the source of warm air and the exhaust line 214A, with a first fluidic pathway positioned between the sterile filter and the source of warm air and a second fluidic pathway positioned between the sterile filter and each exhaust line 214A, with the exhaust line 214A being positioned between the second fluidic pathway and the exhaust filter 298.
But the system 10 of Staheli is a bioreactor. See Staheli [0005].
With this in mind, Ward teaches a system comprising a bioreactor 2, comprising a filtration system 1 that is connected to the bioreactor 2. See Ward Fig. 6A, [0062]. Compressed air is supplied to the filtration system 1 through line 21. Id. at Fig. 6A, [0068]. A sterilizing filter 22 is provided between the source of compressed air and the filtration system 1. Id. The sterilizing filter 22 is beneficial because it prevents contaminants from entering the system.
It would have been obvious to provide a sterilizing filter between the source of warm air of DiMinno and the exhaust line 214A of Staheli to prevent contaminants from entering the system 10.
With this modification, the pathway between the source of warm air and sterile filter reads on the “first fluidic pathway…positioned between the sterile filter and the heated air source.” The pathway between the sterile filter and the exhaust line 214A reads on the “second fluidic pathway…positioned between the sterile filter and the exhaust line.” The source of warm air is not directly connected to the exhaust filter 298, as claimed, because the sterile filter separates the source of warm air from the exhaust filter 298.
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Regarding claim 13, Staheli as modified teaches the limitations of claim 12, as explained above.
Staheli as modified differs from claim 13 because it is silent as to the humidity of the “mixed exhaust gas” (i.e., the exhaust gas downstream of the condenser system 16 of Staheli with the warm air from DiMinno).
But Staheli teaches that it is desirable for the gas entering the filter 298 to be dry so that moisture does not evaporate on it. See Staheli [0086]. Therefore, it would have been obvious for the warm air of DiMinno to be dryer than the exhaust gas downstream of the condenser system 16 to ensure that water does not condense on the filter 298. With this modification, the relative humidity of the mixed exhaust gas would be less than that of the exhaust gas, as claimed.
Regarding claim 14, Staheli teaches heat can be transferred directly to the container 12. See Staheli [0027]. Staheli also teaches that the support housing 14 can be jacked with at least one fluid channels that enables fluid to be pumped through the channels to heat or cool the support housing 14. See Staheli [0027]. This reads on “c) heat transfer is accomplished by…direct contact, and/or the heat transfer fluid is gas and/or liquid.” Note that while claim 14 requires limitations a) to i), the claim only requires that one of these limitations is satisfied, as it is written with the “and/or” clause between limitations i) and i).
Response to Arguments
35 U.S.C. 112(a) Rejections
The Examiner withdraws the previous 35 U.S.C. 112(a) rejections in light of the amendments.
35 U.S.C. 112(b) Rejections
The Examiner withdraws the previous 35 U.S.C. 112(b) rejections in light of the amendments.
35 U.S.C. 103 Rejections
The Applicant argues that it is unreasonable to allege that the modification of Staheli by DiMinno is not a rearrangement of the system of DiMinno. See Applicant Rem. filed August 5, 2026 (“Applicant Rem.”) 8. Rather, it is argued DiMinno introduces warm air before a coalescer whereas the filter in Staheli is positioned downstream of the coalescer 16. Id.
The Examiner respectfully disagrees. The coalescer 36 of DiMinno has a similar structure and performs the same function as the exhaust filter 298 of Staheli. Specifically, the coalescer 36 of DiMinno is made of matted fibers and is to remove water from an airstream. See DiMinno Fig. 1, col. 2, ll. 36–40. Likewise, the exhaust filter 298 comprises a filter material and is sued to remove moisture from gas. See Staheli [0076]. The source of warm air in DiMinno is positioned upstream of the coalescer 36 to warm the fibrous material to perform functions such as melting ice. Also, Staheli comprises a heater (with an unspecified structure) that is applied to the filter 298 to warm the filter 298 to help evaporate moisture that may condense within the filter. See Staheli [0086]. Therefore, positioning the source of warm air of DiMinno upstream of the filter 298 of Staheli is a reasonable modification—because the source of warm air is upstream of the fibrous coalescer 36 with the source of warm air of DiMinno being used for the same purpose as the filter heater of Staheli.
The Applicant also argues that the rejection fails to explain why a person of ordinary skill in the art would have selected the particular heating mechanism of DiMinno for incorporation into Staheli. See Applicant Rem. 9. The Applicant asserts that DiMinno does not remove water from gas but prevents or removes ice crystals from the fibrous coalescer 36. Id. It is asserted that the only “why” provided in the rejection is that Staheli and DiMinno could be combined, but asserts that this is not a sufficient reason why the combination would have been made. Id.
The Examiner respectfully disagrees. The simple substitution of one known element for another to obtain predictable results is a rationale that may support a conclusion of obviousness. See MPEP 2143. Here, Staheli requires some heating mechanism to heat the moisture-removing filter 298 to help evaporate moisture. DiMinno teaches a heating mechanism for a fibrous coalescer 36 that uses a source of warm air to heat the coalescer 36. Therefore, it would have been obvious to use the source of warm air of DiMinno to heat the filter 298 of Staheli because this would simply represent substituting one known element for another to yield predictable results because Staheli requires some mechanism to heat the filter 298 to drive off moisture while the source of warm air of DiMinno is used to heat a fibrous coalescer 36 to perform functions such as melting ice.
With respect to the Applicant’s argument that DiMinno does not remove water from gas but instead prevents or removes ice crystals from the fibrous coalescer 36 is irrelevant. The heater of Staheli is used to evaporate moisture that may condense within the filter 298. See Staheli [0086]. The source of warm air of DiMinno would be able to perform this function because it is used to raise the temperature of the fibrous coalescer 36 to melt ice.
With respect to the Applicant’s argument that Staheli already provides a solution to the problem of heating the filter 298 by using an electrical heating approach—Staheli is not limited to using an electrical heater for the filter 298. Instead, an electrical heater is cited as one example that can be used to heat the filter 298. See Staheli [0086].
With respect to the Applicant’s argument that a person of ordinary skill in the art would not have looked to DiMinno on the basis that DiMinno is in the field of aircraft air conditioning systems—this argument is unpersuasive because DiMinno is in the same field of endeavor as instant application, at least because DiMinno is classified in the field of gas separation (U.S. Class 55—Gas Separation) while instant application is also classified in gas separation (U.S. Class 96—Gas Separation: Apparatus). DiMinno is also analogous art because it is reasonably pertinent to the problem faced by the inventor of heating a filter material to remove or prevent moisture from accumulating.
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 T. BENNETT MCKENZIE whose telephone number is (571)270-5327. The examiner can normally be reached Mon-Thurs 7:30AM-6:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dieterle can be reached at 571-270-7872. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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T. BENNETT MCKENZIE
Primary Examiner
Art Unit 1776
/T. BENNETT MCKENZIE/Primary Examiner, Art Unit 1776
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