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 .
Remarks
This Office Action fully acknowledges Applicant’s remarks filed on June 16th, 2026. Claims 1-20 are pending.
Election/Restrictions
Applicant's election with traverse of Group II, claims 5-14 and 17-20 in the reply filed on June 16th, 2026 is acknowledged. The traversal is on the ground(s) that unity of inventions exists between Groups I-II.
This is not found persuasive because, as previously discussed, the common technical feature across both Groups I and II does not make a contribution over the prior art and thus Groups I and II lack unity.
Applicant’s further citation to MPEP 803 is not pertinent here as this is a national stage entry application that is governed by unity of invention practice found in MPEP 1893.03(d) and 37 CFR 1.499.
Examiner further notes within MPEP 1893.03(d) –
“Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a) ), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.”
The requirement is still deemed proper and is therefore made FINAL.
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 5-14 and 17-20 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.
Claims 5-11 are drawn to a “use claim” wherein the metes and bounds as to the active process(es) sought to obtain the particular application of “culturing microorganisms…using the device of claim 1” are indefinitely defined.
The recitation of claim 5 is a “use claim” as it sets forth the use of the device of claim 1 to culture microorganisms, and, as discussed above, is absent the particular, active process steps thereto.
What are active steps applied to the device of claim 1 so as to culture microorganisms therewith. This can initially be seen with the general “in the culture device of claim 1” in which Applicant may intend to provide an inlet/input port to the fermenter if that is the intended place so as to have the culturing “in” the device of claim 1. Subsequent to that, what are the active step(s) that afford such culturing of microorganism (i.e. nutrient feed supply, inoculum supply, temperature adjustments, pressure sensing/adjustments, detected amount of cells cultured, harvesting of cells, etc…)?
Examiner notes that dependent claims 6-11 provide recitations that read to some degree to active steps involved in carrying out culturing of microorganisms, but it remains that these claims depend from claim 5, and in which claims 6-11 have further issues of clarity that will be discussed later.
Likewise to the above discussion as in claim 5, Claims 12-14, 17-18, 19, and 20 are likewise drawn to “use claims” in which the metes and bounds to the active method step(s) provided for achieving the recited culturing of the polyhydroxyalkanoate-producing microorganism.
Furthermore to the above, and such as in claim 19, for example, it is noted that claim 19 remains an indefinite “use claim” wherein its reference to claim 9 does not suffice in providing clear metes and bounds to culturing polyhydroxyalkanoate-producing microorganism with the device of claim 1.
Claim 9 has dependency back to claim 7 and to claim 6, wherein claim 6 provides steps of 1) “measuring the liquid surface height…” and 2) “adjusting a culture condition…”
However, these steps alone do not suffice in providing definitive and clear active steps that afford culturing polyhydroxyalkanoate-producing microorganism with the device of claim 1.
Namely, the claims are without initial provisions to culturing in the first place (i.e. supply of particular nutrient and cells, temperature control, oxygen control, etc…) so as to provide base, initial active steps that beget or allow for a liquid surface height and foam layer height form and thus be able to be measured (as in step a), and to inform “culture conditions” to then be adjusted as in step b.
This is likewise seen in claim 11.
Further, as to claims 6-11, 13-16, and 18, the recitations are indefinitely understood and indefinitely defined in their metes and bound as they pertain to setting forth active steps for culturing for the desired functionality recited therein.
As discussed above with respect to claim 9, it is seen that claim 6 sets forth two active steps a and b, however, such steps are indefinitely understood and provided for in the context of the culturing methodology.
The claims are without initial provisions to culturing in the first place (i.e. supply of particular nutrient and cells, temperature control, oxygen control, etc…) so as to provide base, initial active steps that beget or allow for a liquid surface height and foam layer height to form in the first place and thus be able to be measured (as in step a), and to inform “culture conditions” to then be adjusted as in step b.
The claims do not set forth active steps that function to afford such supply of liquid (whether this be the “culture solution” or a combination of flows as in the nutrient, cells, oxygen, etc…), and acting up such liquid solution in a manner that affords a fill level to be determined (i.e. fed to the fermenter through an inlet coincident with the operatively connected liquid level sensor) and such that the feed liquid/solution affords formation of a foam whose height may then be measured by the concordant sensor(s).
It is also noted that claim 1, which is codified in the preamble as a “culture device”, merely provides a fermenter with the functionality for containing a liquid, and a group of sensors for that level detection and pressure detection, which does not speak to provision for actively culturing microorganisms.
This can be similarly seen in claims 7-10 in which there is no particular basis for any of the cited “culture conditions.”
For example, the claims are without positive provision to a carbon source in the first place, let alone the ability to tune or adjust said source for particular application thereof.
This is likewise seen with respect to “culture solution stirring power” wherein the claims are absent any particular provision of an element and/or step that affords mixing (i.e. agitator, mixing blades, mixing) let alone to altering the base mixing operation by way of a particular power thereof. Lastly, “bubbling condition” is without any preceding support to physical infrastructure and/or active step(s) that afford “bubbling” let alone to altering particulars thereof in that of “bubbling conditions.”
This is likewise seen with respect to claim 11, wherein the claims are absent any provision of an element or step that affords any sort of “gas holdup” let alone the ability to adjust such “gas holdup” by controlling a “gas holdup ratio…”
It is further noted that “bubbling condition”(and as in cl. 10) is indeterminate in its metes and bounds to the active step being applied as the recitation itself is vague and the specification does not remedy this with particular discussion and definition thereto. Examiner notes discussion of “bubbling condition” in pars.[0039,0040,0044], for example.
Par.[0044] is most notable, but it is not understood what various conditions are found by way of “0.2 vvm to 2 vvm” and the other preferential ranges.
Vvm is interpreted as volume of air supplied per minute divided by the volume in the bioreactor.
The claims are absent provision to active assessment of the volume nor a provision of an air source and its activation so as to inform an active step of any of these values to the “bubbling condition.”
Claims 5-14 and 17-20 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.
The metes and bounds of claims 5-14 and 17-20 are indefinitely provided in the context of the incorporation of claim 1, in which the device of claim 1 is provided by way of a use-statement therewith.
To this end, the following issues of clarity are noted with respect to the device of claim 1 as recited therein.
The recitation “…the at least two pressure sensors each being the pressure sensor” is indefinitely understood and presents a redundant/circular discussion.
To this end, does Applicant intend to initially recite “A pressure sensor device for detecting…” so as to subsequently define that the pressure sensor device comprises at least two sensors as claimed?
Further, the metes and bounds of the arrangement sought of the at least two pressure sensors within the confines of the culture device are indefinitely defined herein.
The claim recites “….installed below the gas-liquid interface…” however such a gas-liquid interface is drawn to a prospective element, in which the claims do not positively necessitate any such gas or liquid, nor an interface thereof, and are instead drawn to a fermenter configured to contain a liquid, wherein such a liquid may undergo actions/reactions so as to form foam.
By this, does Applicant intend to provide that the at least two pressure sensors are physically installed at particular portions of the fermenter itself?
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5, as best understood herein, is/are rejected under 35 U.S.C. 103 as being unpatentable over Larsen (US 2011/0244543) in view of Kulczyk (USPN 10,876,878) and Wittler (USPN 4,997,660).
With regard to claim 5, Larsen discloses culturing microorganisms with a culture solution (pars.[0002,0007-0011,0044,0053-0056,0070], for example) with a culture device as in claim 1. To this end, Larsen discloses a pressure sensor for detecting a liquid surface height from the bottom of the fermenter to a gas-liquid interface, the culture device having at least two pressure sensors (at least two pressure sensors placed at different zones of the fermenter and such different zones at least constituting an upper pressure sensor and a lower pressure sensor; par.[0093]) installed at the gas-liquid interface, the at least two pressure sensors each being the pressure sensor, the at least two pressure sensors detecting the liquid surface height in accordance with a difference in pressure between the upper pressure sensor and the lower pressure sensor (Examiners notes that a liquid, nor a foam, nor a gas-liquid interface are positively necessitated elements of the culture device and are drawn to prospective workpieces not afforded patentable weight).
With regard to claim 5, Larsen does not specifically disclose a liquid surface sensor for detecting a foam layer height from a bottom of the fermenter to a top of a foam layer (Examiner notes that a ‘foam layer’ is not positively necessitated element of the device and this is drawn to a prospective workpiece).
With regard to claim 5, Larsen does not specifically disclose the at least two pressure sensors being functionally capable of detecting the liquid surface height in accordance with a difference in pressure between the upper pressure sensor and the lower pressure sensor.
Kulcyk discloses a liquid level monitoring system (abstract). Kulcyk discloses an upper pressure sensor 5 and a lower pressure sensor 4 in which a differential measurement between the two is used to calculate the liquid level height, and Kulcyk discloses that vertically separated pressure transducers permits compensation for changes in liquid density (lines 4-25, col . 5, for example).
Wittler discloses a method and apparatus for controlling form in a vinegar fermentation process (abstract). Wittler discloses a foam sensor 25 to detect the height of the accumulated foam in the fermenter and to energize the motor 16 through the control device 26 in accordance with the detected foam height so as to automatically reduce foam build up that may interfere with the fermentation process (lines 43-67, col. 2; lines 14-67, col. 8).
It would have been obvious to one of ordinary skill in the art to modify Larsen to utilize at least two pressure sensors being functionally capable of detecting the liquid surface height in accordance with a difference in pressure between the upper pressure sensor and the lower pressure sensor such as taught by the analogous art of Kulcyk to monitoring liquid levels in a tank so as to provide a differential pressure monitoring arrangement to the fermenter in Larsen that is more accurate and less sensitive to liquid-density variations.
Further, it would have been obvious to one of ordinary skill in the art to modify Larsen to provide a liquid surface sensor for detecting a foam height from a bottom of the fermenter to a top of a foam layer such as suggested by the analogous subject matter of Wittler to a fermenter so as to provide the aerated fermentation system of Larsen with an automated mechanism in that of a liquid surface sensor for the foam height to a motor and controller for reducing and avoiding excessive foam that can interfere with the fermentation process.
Claim(s) 12 and 13, as best understood herein, is/are rejected under 35 U.S.C. 103 as being unpatentable over Larsen in view of Kulczyk, Wittler, and Kawata et al. (US 2011/0104767), hereafter Kawata.
Larsen’s disclosure is imported from above as in the rejection of claim 5.
This is likewise seen for Kulczyk and Wittler.
With regard to claim 12, Larsen does not specifically disclose a liquid surface sensor for detecting a foam layer height from a bottom of the fermenter to a top of a foam layer (Examiner notes that a ‘foam layer’ is not positively necessitated element of the device and this is drawn to a prospective workpiece).
With regard to claim 12, Larsen does not specifically disclose the at least two pressure sensors being functionally capable of detecting the liquid surface height in accordance with a difference in pressure between the upper pressure sensor and the lower pressure sensor.
With regard to claim 12, Larsen does not specifically disclose culturing polyhydroxyalkanoate.
With regard to claim 13, Larsen does not specifically disclose that the culture solution comprises a surface-active carbon source.
Kawata discloses a method for producing polyhydroxyalkanoates (PHAs) in a fermenter, and in which PHAs are a type of biodegradable plastic produced by a wide variety of bacteria (abstract; pars.[0003,0054], for example). Kawata further discloses the culture solution comprises a surface-active carbon source as in glycerol (and equivocal to Applicant’s disclosed lipids, polyhydric alcohols) (pars.[0010,0013], for example).
It would have been obvious to one of ordinary skill in the art to modify Larsen to utilize at least two pressure sensors being functionally capable of detecting the liquid surface height in accordance with a difference in pressure between the upper pressure sensor and the lower pressure sensor such as taught by the analogous art of Kulcyk to monitoring liquid levels in a tank so as to provide a differential pressure monitoring arrangement to the fermenter in Larsen that is more accurate and less sensitive to liquid-density variations.
Further, it would have been obvious to one of ordinary skill in the art to modify Larsen to provide a liquid surface sensor for detecting a foam height from a bottom of the fermenter to a top of a foam layer such as suggested by the analogous subject matter of Wittler to a fermenter so as to provide the aerated fermentation system of Larsen with an automated mechanism in that of a liquid surface sensor for the foam height to a motor and controller for reducing and avoiding excessive foam that can interfere with the fermentation process.
Lastly, it would have been obvious to one of ordinary skill in the art to modify Larsen to culture PHA-producing microorganisms and utilizing a culture solution comprising a surface-active carbon source as in glycerol such as taught by the analogous art of Kawata to microorganism production, and in which Larsen discloses that its fermenter is appropriate for methanotrophic bacteria and similar processes and is adaptable to different microbial fermentation processes by adjusting nutrient and gas feeds (par.[0002,0044,0055], for example) in which PHA is a commercial microbial fermentation application pertinent for production to the large field of biodegradable plastics, and to make with a likewise fermenter as in Larsen that sets forth adaptability to different microbial fermentation processes and would have a reasonable expectation of success therein.
Allowable Subject Matter
Claims 6-11, 14, and 17-20 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: The prior art of record does not teach or fairly suggest, as best understood herein, the particular steps to the methods of claims 6-11, 14, and 17-20.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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, Charles Capozzi can be reached at 571-270-3638. 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.
/NEIL N TURK/Primary Examiner, Art Unit 1798