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(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 12–15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed 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 emitted from the disposable reaction container;
c. the coalescer being connected to an exhaust line leading the exhaust gas from the coalescer to an exhaust filter;
d. the exhaust line being connected to a heated air source that introduces heated external air directly into the exhaust line to produce a mixed exhaust gas having a temperature above that of the exhaust gas, wherein heated air is introduced into the exhaust gas after it exits the coalescer and before it enters the exhaust filter; and,
e. the exhaust line being connected to the exhaust filter which is configured such that the mixed exhaust gas exits the system through the exhaust filter, wherein the exhaust filter is not itself heated by heated external air. Underlining from Applicant; Emphasis added.
The Applicant has not pointed out where the new limitation of “wherein the exhaust filter is not itself heated by heated external air” is supported, nor does there appear to be written description of this limitation in the application as filed. See MPEP 2163.04, subsection I. Note that the specification is silent as to the exhaust filter itself not being heated by heated external air. Also, the disclosure appears to describe the exhaust filters being heated by heated external air that is introduced into the exhaust gas after it exits the coalescer and before it enters the exhaust filter. See Spec. [0031].
Claims 13–15 lack written description because they depend from claim 12.
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 12–15 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 emitted from the disposable reaction container;
c. the coalescer being connected to an exhaust line leading the exhaust gas from the coalescer to an exhaust filter;
d. the exhaust line being connected to a heated air source that introduces heated external air directly into the exhaust line to produce a mixed exhaust gas having a temperature above that of the exhaust gas, wherein heated air is introduced into the exhaust gas after it exits the coalescer and before it enters the exhaust filter; and,
e. the exhaust line being connected to the exhaust filter which is configured such that the mixed exhaust gas exits the system through the exhaust filter, wherein the exhaust filter is not itself heated by heated external air. Emphasis added.
Claim 12 is indefinite because it is a single claim which claims both an apparatus and the method steps of using the apparatus. Specifically, claim 12 is an apparatus claim because it is to a system. But the claim recites method steps of using the apparatus in the italicized limitations. For instance, the last limitation of—“the exhaust filter is not itself heated by external air”—describes a method step of using the apparatus, as it positively states that the exhaust filter is not heated by heated external air. Claim 12 is indefinite, therefore, because it is unclear whether infringement would occur when a system is created that allows the method steps to be performed (e.g., the system is capable of the exhaust filter itself not being heated by external air), or whether infringement requires that the method steps are actually performed (e.g., the exhaust filter is actually not heated by external air). See MPEP 2173.05(p), subsection II (a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite).
Claim 12 is further indefinite because it is unclear whether the “heated air” in limitation (d) refers to the “heated external air” initially introduced in limitation (d). The claim is also indefinite because it is unclear whether the recitation of “heated external air” in limitation (e) refers to the “heated external air” in limitation (d).
To overcome these 35 U.S.C. 112(b) rejections, claim 12 could be amended to read (note that these amendments would not necessarily overcome the 35 U.S.C. 112(a) issues above):
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 external air
e. the exhaust line being connected to the exhaust filter which is configured such that the mixed exhaust gas exits the system through the exhaust filter, wherein the exhaust filter is configured such that it is not itself heated by the heated external air. Underlining added.
Claims 13–15 are indefinite because they depend from claim 12.
Also, claim 14 recites:
14. The system of claim 13 wherein:
a) the system comprises a jacketed tank head integral with the reactor vessel;
b) the disposable reaction container comprises internal first and second zones, the first internal zone comprising a reaction mixture and the second internal zone comprising a headspace into which humid gas migrates from the first zone; the first zone is maintained at a first temperature; the second zone at a second temperature lower than the first temperature; and, fluid migrating from the headspace coalesces within the internal tortuous fluidic pathway of the coalescer;
c) heat transfer is accomplished by radiative, convective, conductive or direct contact, and/or heat transfer fluid that is gas and/or liquid;
d) the system comprises a jacketed tank head;
e) wherein the coalescer comprises upper and lower surfaces and the internal tortuous fluidic pathway is contiguous with the either of both of said upper and/or lower surfaces, the coalescer is comprised of at least two pieces of flexible material fused together to form a chamber comprising the internal tortuous fluidic pathway, the internal tortuous fluidic pathway is defined by fused sections of the at least two pieces of flexible material, and/or the internal tortuous fluidic pathway is defined by a third material contained within the chamber;
f) the system comprises at least one anti-foam device positioned between the disposable reaction container and the coalescer;
g) the heat transfer system comprises at least one baffle comprising a first sub-assembly consisting essentially of a first material adjoined to a second material to form a first distribution channel, a second sub-assembly consisting essentially of a first material adjoined to a second material to form a second distribution channel, optionally a closure bar that adjoins the first sub-assembly and the second sub-assembly to one another, and, a relief channel between the first sub-assembly and the second sub-assembly, wherein the closure bar, when present, sets the width of the relief channel, and the distribution channels and the relief channel do not communicate unless a leak forms within a distribution channel, optionally wherein at least one such baffle is associated with the first zone and a separate such baffle is associated with the second zone;
h) the system comprises multiple coalescers;
i) the coalescer comprises a tortuous fluid pathway comprising a flexible, semi-rigid, or rigid tubular form; and/or,
j) the system comprises an exhaust pump. Emphasis added.
Claim 14 is indefinite because it is a single claim which claims both an apparatus (the “system”) and method steps for using the apparatus (in the italicized limitations). See MPEP 2173.05(p), subsection II.
Claim 14 is also indefinite because it is unclear whether the “heat transfer” in limitation (c) is intended to be performed by the “heat transfer system” of claim 12.
To overcome this rejection, claim 14 could be amended to read:
14. The system of claim 13 wherein:
a) the system comprises a jacketed tank head integral with the reactor vessel;
b) the disposable reaction container comprises internal first and second zones, the first internal zone comprising a reaction mixture and the second internal zone comprising a headspace into which humid gas is configured to migrate configured to be maintained at a first temperature; the second zone is configured to be maintained at a second temperature lower than the first temperature; and, the disposable reaction container is configured such that fluid migrating from the headspace coalesces within the internal tortuous fluidic pathway of the coalescer;
c) the at least one heat transfer system is configured such that heat transfer is accomplished by radiative, convective, conductive or direct contact, and/or heat transfer fluid that is gas and/or liquid;
d) the system comprises a jacketed tank head;
e) wherein the coalescer comprises upper and lower surfaces and the internal tortuous fluidic pathway is contiguous with the either of both of said upper and/or lower surfaces, the coalescer is comprised of at least two pieces of flexible material fused together to form a chamber comprising the internal tortuous fluidic pathway, the internal tortuous fluidic pathway is defined by fused sections of the at least two pieces of flexible material, and/or the internal tortuous fluidic pathway is defined by a third material contained within the chamber;
f) the system comprises at least one anti-foam device positioned between the disposable reaction container and the coalescer;
g) the heat transfer system comprises at least one baffle comprising a first sub-assembly consisting essentially of a first material adjoined to a second material to form a first distribution channel, a second sub-assembly consisting essentially of a first material adjoined to a second material to form a second distribution channel, optionally a closure bar that adjoins the first sub-assembly and the second sub-assembly to one another, and, a relief channel between the first sub-assembly and the second sub-assembly, wherein the closure bar, when present, sets the width of the relief channel, and the distribution channels and the relief channel do not communicate unless a leak forms within a distribution channel, optionally wherein at least one such baffle is associated with the first zone and a separate such baffle is associated with the second zone;
h) the system comprises multiple coalescers;
i) the coalescer comprises a tortuous fluid pathway comprising a flexible, semi-rigid, or rigid tubular form; and/or,
j) the system comprises an exhaust pump. Underlining added.
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.
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 would read on the “heated air source.” It would introduce 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, as claimed, because DiMinno illustrates the source of warm air being directed into the incoming airstream directed to the coalescer 32. The mixed gas stream would pass through the filter 298 of Staheli, as claimed.
With respect to the limitation of—“wherein the exhaust filter is not itself heated by external air”—this is a functional limitation because it describes what the apparatus does, rather than its structure. The manner of operating a device does not differentiate an apparatus claim from the prior art. See MPEP 2114, subsection IV. Instead, an apparatus claim covers what a device is, not what a device does. Id. The structure of Staheli in view of DiMinno is the same as the system of claim 1, as explained above. Therefore, the limitation of—“wherein the exhaust filter is not itself heated by external air”—does not differentiate claim 12 from the prior art.
Regarding claim 13, Staheli in view of DiMinno teaches the limitations of claim 12, as explained above.
The prior art combination 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 j), the claim only requires that one of these limitations is satisfied, as it is written with the “and/or” clause between limitations i) and j).
Claim 15 is 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 15, Staheli in view of DiMinno teaches the limitations of claim 12, as explained above.
The combination of Staheli in view of DiMinno differs from claim 15 because it is silent as to a sterile filter between the source of warm air of DiMinno and the exhaust line 214A of Staheli. 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.
Response to Arguments
Claim Objections
The Examiner withdraws the previous objection to claim 14.
35 U.S.C. 112(b) Rejections
The Examiner withdraws the previous 35 U.S.C. 112(b) rejection of claim 14. Note, however, that the claim remains rejected as indefinite for the reasons stated above.
35 U.S.C. 103 Rejections
The Applicant argues that claim 12 is patentable of Staheli in view of DiMinno, asserting that the claimed system does not heat the filter, whereas the prior art combination heats the filter 298. See Applicant Rem. filed November 18, 2025 (“Applicant Rem.”) 5–6.
The Examiner respectfully disagrees with the Applicant’s analysis. The limitation of—“wherein the exhaust filter is not itself heated by heated external air”—describes the function of the system rather than its structure. The manner of operating a device does not differentiate an apparatus claim from the prior art. See MPEP 2114, subsection II. Instead, an apparatus claim covers what a device is and not what a device does. Id. Here, the combination of Staheli in view of DiMinno teaches a system with the same structure as in claim 12. Therefore, the limitation—“wherein the exhaust filter is not itself heated by heated external air”—fails to patentably distinguish over the prior art because it describes the manner of operating the device rather than its structure.
The Applicant also argues that modifying the prior art to use the warm air heating mechanism of DiMinno as the heating mechanism for each filter 298 of Staheli is not simple substitution, asserting that the warm air heating mechanism of DiMinno does not have the same function as the filter heating mechanism of Staheli. See Applicant Rem. 6–8. Specifically, it is argued that the disclosure of DiMinno only relates to a water separator that is heated by the warm air, while asserting that the system of DiMinno does not include any component that would be understood as similar to the filter 298 of Staheli or the exhaust line leading to it. Id. Instead, it is argued that the water separator is analogous to the condenser 110 of Staheli. It is further argued that the modification in the rejection would have required removal of one component of the system of DiMinno to reposition it to a non-corresponding position in the system of Staheli. Id.
The Examiner respectfully disagrees. The filters 298 of Staheli are similar to the water separator of DiMinno because the filters 298 are used to remove moisture from gas supplied to the filters 298 through lines 214A, 214B. See Staheli [0076]. The filters are also provided with a mechanism to help evaporate moisture that condenses within the filters to prevent clogging. Id. at [0086]. Staheli is not limited as to the particular structure of the heating mechanism for the filters 298. Id. DiMinno teaches a water separator comprising a coalescer 32 made of a fibrous mat (which in the art is similar to a filter), that is used to remove water supplied to it through inlet duct 30. See DiMinno Fig., col. 2, ll. 30–40. The inlet duct 30 has tube attached to it that is configured to periodically provides warm air to the gas supplied to the coalescer 32, so that the coalescer 32 is heated to prevent ice from clogging it. Id. at col. 2, l. 65–col. 3, l. 5.
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Therefore, the warm air heating mechanism of DiMinno performs the same function as the filter heater of Staheli, of heating a filter-like mechanism for removing water from gas to prevent clogging. Staheli is not limited to the type of heating mechanism used to warm the filters 298. Therefore, it would have been obvious to use the heating mechanism of DiMinno as the mechanism to heat each filter 298 of Staheli because this would merely represent the simple substitution of one known heating mechanism for another to yield the predictable result of warming each filter 298 to prevent water from clogging it.
The Applicant further argues that it would not have been obvious to modify Staheli to use the heating mechanism of DiMinno, asserting that Staheli already provides a potential solution to the residual moisture problem, by suggesting in paragraph [0086] that an electric heating element could be used to heat each filter 298. See Applicant Rem. 10. As such, the Applicant asserts that there would have been no motivation to consider modifying Staheli to include the warm air heating mechanism of DiMinno. Id.
The Examiner respectfully disagrees. The motivation for using the warm air heating mechanism of DiMinno to heat each filter 298 in Staheli is that this is merely swapping one known heating mechanism for another to achieve the predictable result of providing heat to each filter 298 to prevent clogging, and therefore represents the combination of familiar elements according to known methods that does no more than yield predictable results. See MPEP 2143, subsection I, B. The fact that Staheli suggests that an electric heating element can be used does not change the analysis because Staheli provides the electric heating element as an example of a type of heating mechanism that can be used. See Staheli [0086] (“For example, electrical heating elements can be applied to the outside surface of filters 298”).
Conclusion
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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T. BENNETT MCKENZIE
Primary Examiner
Art Unit 1776
/T. BENNETT MCKENZIE/Primary Examiner, Art Unit 1776