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 .
Notes
All the objections and rejections in the previous Office Action not reiterated herein have been withdrawn.
Specification
The disclosure is objected to because of the following informalities: The amended specification filed on March 7, 2026 has not been entered because it does not conform to 37 CFR 1.125(b) and (c) because: the substitute specification does not show all deleted subject matter. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a fluid handling system” in claim 86; “an electronic processing system” in claim 86; and “a bioreaction control system” in claim 87.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 86-99 and 106-111 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.
It is unclear if the “optical interrogation region” recited in line 16 is referring to the optical interrogation region recited earlier in the claim (in line 14-15) or is an additional optical interrogation region. Claims 87-99 and 106-111 are included in this rejection by virtue of their dependency upon a rejected base claim.
Claim 86 recites the limitation "an optical interrogation region disposed within the common flow chamber" in line 16. However, the common flow chamber is not positively recited in the claim and thus unclear if the optical interrogation region is a required element of the claimed system.
Claim 87 recites the limitation "a bioreaction control system configured to respond to the one or more of physical characteristics or biochemical characteristics of the at least one target media constituent by one or more of monitoring or controlling the bioreactor." However, the bioreactor is not positively recited in the claim and thus the metes and bounds of the claim is unclear.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 86-87, 89-90, 94-95, 99, 106-107 and 109-111 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wagner et al (already of record, US 2018/0024041; hereinafter “Wagner”).
It is noted that the invention contains a bioreactor, active media and a common flow chamber. However, the bioreactor, active media and the common flow chamber are not positively recited in the instant claims.
Regarding claim 86, Wagner discloses a system for monitoring a bioreactor comprising: a fluid handling system configured to extract active media from the bioreactor and produce an analysis media stream, the active media containing at least one target media constituent from the bioreactor (flow-control device of Wagner is structurally the same as the instant fluid handling system and thus considered to be fully capable of perform the recited function “to extract active media from the bioreactor and produce an analysis media stream”; see [0011]); a reference media source comprising one of (i) a fresh media source configured to supply fresh media to the bioreactor or (ii) a filter stage of the fluid handling system configured to remove the at least one target media constituent from the active media to produce reference media (media source (222); [0139]); a fluid combiner configured to introduce the analysis media stream and the reference media into a common flow chamber in laminar flow such that a laminar interface is established between the analysis media and the reference media (FIGS. 13-14: flow cell channel of Wagner is structurally the same as the instant fluid combiner and thus considered to be fully capable “to introduce the analysis media stream and the reference media into a common flow chamber in laminar flow such that a laminar interface is established between the analysis media and the reference media”; see [0139]); an optical characteristics measurement subsystem comprising at least one optical source and at least one detector disposed relative to the common flow chamber and configured to measure differential optical characteristics of the analysis media and the reference media within the flow chamber (system of Wagner includes light sources and detectors adapted to measure spectral wavelength of one or more analytes; see Abstract; FIG. 4; [0013], [0025], [0049]-[0050], [0079], [0093], [0135], [0138],[0140]-[0147]); and an electronic processing system configured to calculate, based on the measured differential optical characteristics, one or more of physical characteristics or biochemical characteristics of the at least one target media constituent (optical detection system adapted to determine fluid characteristics based a measurement from the optical characteristics measurement subsystem; see Abstract; FIG. 4; [0013], [0025], [0049]-[0050], [0079], [0181], [0141]-[0147]). Regarding the limitation “the common flow chamber being configured such that fluid flow within the chamber induces varying spatial displacement of the laminar interface relative to an optical interrogation region as a function of flow dynamics within the chamber; to supply fresh media to the bioreactor” the common flow chamber is not positively recited as an element of the claimed system. Furthermore, it is noted that the recitations of functional language "e.g., to extract active media from the bioreactor and produce an analysis media stream; and, to introduce the analysis media stream and the reference media into a common flow chamber in laminar flow such that a laminar interface is established between the analysis media and the reference media" are drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed system and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 87, Wagner further discloses a bioreaction control system configured to respond to the one or more of physical characteristics or biochemical characteristics of the at least one target media constituent by one or more of monitoring or controlling the bioreactor (system includes a controller adapted to generate a motion control signal for driving a motion control device in response to the optical measurement; [0030]. [0079]). Furthermore, Applicant is reminded that the bioreactor is not element of the claimed system.
Regarding claim 89, the fluid combiner of Wagner is structurally the same as the instant fluid combiner and thus considered to be capable of performing the recited function “combine the analysis media and the reference media in a laminar flow that maintains a distinct boundary between the analysis media and the reference media within the optical interrogation region.” Also see FIGS. 13-14; [0139]-[0140]). Furthermore, it is noted that apparatus claims cover what a device is, not what a device does. Therefore, the recitation of functional language “e.g., combine the analysis media and the reference media in a laminar flow that maintains a distinct boundary between the analysis media and the reference media within the optical interrogation region” fails to define additional structural elements to the system. Because the prior art discloses the structural elements of claim 89, the claim is anticipated by the prior art. See § MPEP 2114.
Regarding claim 90, Wagner discloses wherein relative pressures of the analysis
media and the reference media at the distinct boundary moves the distinct boundary orthogonal to a direction of the laminar flow at a media-dependent frequency within the optical interrogation region (system of Wanger includes pressure generator generating varying pressure differential between the analysis media and the reference media; see FIGS. 13-14; [0139]).
Regarding claim 94, Wagner further discloses wherein where the optical characteristics
measurement subsystem measures a difference in scattered light at one or more wavelengths
between the analysis media and the reference media ([0088], [0103], [0141]-[0147]).
Regarding claim 95, Wagner further discloses wherein the electronic processing system further determines a source of the scattered light selected from a list of scattered light sources consisting of: aggregates of molecules; aggregates of proteins, viral particles, cells, cell aggregates, extracellular vesicles including exosomes; microcarriers with or without attached cells; and cell debris (DNA, RNA, proteins, fluid surrounding cells or tissue, droplets; [0041]-[0048], [0088], [0103]).
Regarding claim 99, the electronic processing system of Wagner is structurally the same as the instant system and thus considered to be capable of performing the recited function “to measure a state of the cells based on the optical characteristics of the cells.” Furthermore, it is noted that the analysis media stream is material worked on and not an element of the claimed system. It is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2115. Furthermore, it is noted that apparatus claims cover what a device is, not what a device does. Further, the limitation “to measure a state of the cells based on the optical characteristics of the cells” is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114).
Regarding claim 106, the fluid system of Wagner is structurally the same as the instant fluid system and thus considered to be capable of performing the recited function “to modulate relative pressures of the analysis media and the reference media at a predetermined frequency.” Further, the system of Wanger includes pressure generator generating varying pressure differential between the analysis media and the reference media; see FIGS. 13-14; [0139]). Furthermore, it is noted that apparatus claims cover what a device is, not what a device does. Therefore, the recitation of functional language “e.g., modulates relative pressures of the analysis media and the reference media at a predetermined frequency” fails to define additional structural elements to the system. Because the prior art discloses the structural elements of claim 89, the claim is anticipated by the prior art. See § MPEP 2114.
Regarding claim 107, Wagner discloses wherein the optical characteristics measurement subsystem measures optical characteristics of the analysis media and the reference media at the predetermined frequency (optical detection system adapted to measure optical characteristics of the analysis media and the reference media at a predetermined frequency; FIGS. 13-14; [0049], [0093], [0135], [0138],[0139]-[0147]).
Regarding claim 109, Wagner discloses wherein the optical characteristics measurement subsystem measures the optical characteristics aligned with the vortex shedding frequency (optical detection system adapted to measure optical characteristics of the analysis media and the reference media at a predetermined frequency; FIGS. 13-14; [0049], [0093], [0135], [0138],[0139]-[0147]).
Regarding claim 110, Wagner further discloses wherein the analysis media stream includes one or more target proteins produced from cells in the bioreactor (see [0041]-[0048], [0088], [0103]).
Regarding claim 111, Wagner further discloses wherein the electronic processing system calculates a level of the one or more target proteins (optical detection system adapted to measure optical characteristics of proteins within the analysis media including; [0049], [0093], [0135], [0138],[0139]-[0147]).
Therefore, Wagner meets and anticipates the limitations set forth in claim(s) 86-87, 89-90, 94-95, 99, 106-107 and 109-111.
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 91, 93, 96-98 and 108 are rejected under 35 U.S.C. 103 as being unpatentable over Wagner as applied to claims 86 and 89 above.
Regarding claim 91, Wagner further discloses wherein the flow chamber includes an obstruction in the laminar flow that sets up a vortex modulation prior to the laminar flow entering the optical interrogation region (posts, notches, or other flow modifying structures to induce desired or varying levels of turbulent flow within the channel; [0025]). Wagner does not explicitly disclose the obstruction disposed in the flow chamber before the optical interrogation region. However, Wagner does disclose “[t]he location of the fluidic boundary within the channel may be controlled or changed in order to change or enhance the interaction between fluids, (e.g. different locations in the channel may provide different levels of interaction due to such structures or design elements within the channel.” See [0025]. In view of Wagner, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the location of the obstruction of the system of Wagner with the claimed location to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have made said modification because Wagner discloses that the location of the fluidic boundary and thus the obstruction along the flow chamber can be controlled or changed in order to change or enhance the interaction between fluids (see Wagner at [0025]). Furthermore, the limitation “to set up a vortex modulation prior to the laminar flow entering the optical interrogation region” is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114).
Regarding claim 93, Wagner discloses the system according to claim 86 as set forth above. Wagner does not explicitly disclose wherein the optical characteristics measurement subsystem uses an optical phase differential technique to measure a difference in refractive index between the analysis media and the reference media at one or more wavelengths. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the optical characteristics measurement subsystem of Wagner with optical characteristics measurement subsystem that uses optical phase differential technique to measure a difference in refractive index between the analysis media and the reference media at one or more wavelengths, because said modification would have been the substitution of one known optical characteristics measurement means for another for the predictable result of characteristics of fluids within a flow channel.
Regarding claim 96, Wagner does not explicitly disclose a bioreactor, wherein the
bioreactor is a continuous perfusion mode bioreactor configured to process the fresh media continuously added to the bioreactor at a first rate. However, Wagner does disclose wherein fluids in the system includes fluids such as fluids from pharmacological production processes ([0043]) or fluids containing cells ([0041]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed a bioreactor reactor including a continuous perfusion mode bioreactor with the system of Wagner to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have made said modification for the purpose of providing the sources of fluids such as fluids from pharmacological production processes or fluids containing cells to the flow chamber as suggested by Wagner ([0041], [0043]). Furthermore, the limitation “to process the fresh media continuously added to the bioreactor at a first rate” is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114).
Regarding claim 97, the electronic processing system of Wagner is structurally the same as the instant system and thus considered to be capable of performing the recited function “to measure cell nutrient concentration.” Also see [0041]-[0048], [0088], [0103]) of Wagner which discusses the measurement of cellular nutrients and uptake of nutrients and /or production of metabolites. Furthermore, it is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed system and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 98, the electronic processing system of Wagner is structurally the same as the instant system and thus considered to be capable of performing the recited function “to measure cell metabolite concentration.” Also see [0041]-[0048], [0088], [0103]) of Wagner which discusses the measurement of cellular nutrients and uptake of nutrients and /or production of metabolites. Furthermore, it is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed system and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 108, the obstruction of Wagner is structurally the same as the instant obstruction and thus considered to be capable of performing the recited function “sets up a vortex modulation prior to the laminar flow entering the optical interrogation region, wherein the vortex modulation establishes a vortex shedding frequency based on a pressure of one or more of the analysis media or the reference media and at least one condition thereof”).
Claim 92 is rejected under 35 U.S.C. 103 as being unpatentable over Wagner as applied to claim 86 above, and further in view of Ping et al (already of record, WO 2017127916-A1).
Regarding claim 92, Wagner discloses the system according to claim 86 as set forth above. Wagner further discloses wherein the wherein the optical characteristics measurement subsystem measures optical absorption for a polarization of light at one or more wavelengths ([0013], [0015], [0017], [0049]), but does not explicitly disclose wherein the optical characteristics measurement subsystem measures optical absorption for at least two polarizations of light at one or more wavelengths.
Ping discloses a system comprising a flow channel (see, e.g., FIG. 25A; [00123]) and optical characteristics measurement subsystem measures optical absorption for at least two polarizations of light at one or more wavelengths of particles with the flow channel ([0121] and [00123]). In view of Ping, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the optical characteristics measurement subsystem of Wagner with the optical characteristics measurement subsystem of Ping to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have made said modification for the purpose of enhancing detection accuracy as disclosed by Ping ([0121] and [00123]).
Allowable Subject Matter
Claim 88 is 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 86-99 and 106-111 have been considered but are moot in view of the new ground of rejection.
With respect to the Applicant’s arguments regarding the interpretation of claim elements “a fluid handling system” recited in claim 86, “an optical characteristics measurement subsystem” recited in claim 86, and “an electronic processing system” in claim 86, in view of the Applicant’s amendment, the limitation “an optical characteristics measurement subsystem” is no longer interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the limitations “a fluid handling system” recited in claim 86 and “an electronic processing system” in claim 86, are still interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitations still meet the three-prong test set forth above.
In response to the Applicant’s argument that Wagner fails to disclose the functions performed by the claimed fluid combiner (see Remarks at pate 15), Applicant’s argument is noted but is not persuasive. It is first noted that apparatus claims cover what a device is, not what a device does. Therefore, the recitation of functional language “e.g., combine the analysis media and the reference media in a laminar flow that maintains a distinct boundary between the analysis media and the reference media within the optical interrogation region” fails to define additional structural elements to the system. Because Wagner discloses all of the structural limitations of the claimed Wagner, the claim is anticipated by the prior art. See § MPEP 2114. Further, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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 LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799
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