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 .
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: There is insufficient antecedent basis for the limitation “an electrical connector” in the claim.
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.
Claim Rejections - 35 USC § 112
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 1-15 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.
Independent claim 1 recites the limitation "the coupler configured to receive an electrical connector" in lines 8-9. However, said limitation fails to comply with written description requirement. The instant specification, as originally filed, discloses coupling means to enable the probe to be connected to other components (see paragraph [0043]). However, the specification is silent as to what constitutes other components, and a coupling means that receives a component. The specification does describe the other components to include an electrical connector. As such, said limitation constituted new matter.
Claims 2-15 are included in this rejection.
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 1-15 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 1 recites the limitation "a bioreactor" in line 1, and “a bioreactor” in line 2. It is unclear how many bioreactors are required by the claim.
Claims 2-15 are included in this rejection.
Claim 1 recites the limitation "the bioreactor" in line 16. It is unclear which bioreactor the limitation is referring to.
The term “substantially” in claim 2 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 6 recites the limitation "the core" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "biomass sensing probe once the biomass measurement has been taken" in lines 3-3. However, it is unclear if the probe disposal required in claim 15 is related to the disposal recited earlier in claim 14.
Appropriate correction is required.
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.
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.
Claims 1-8 and 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Selman et al. (already of record, US 8,988,082; hereinafter “Selman”) in view of Forney (already of record, US 2004/0122280).
Regarding claim 1, Selman discloses a system for obtaining a biomass measurement from a medium contained within a bioreactor, the system comprisinga bioreactor having a wall enclosing an interior, the wall comprising a port FIGS. 1-2: bioreactor (1) having at least one port 3; col. 3, ll. 48-61; col. 4, ll. 3-6); anda biomass sensing probe comprising an elongate body formed of a plastic material, and at least one electrode provided on a first region of the body (FIG.4: monitoring device 10 having an elongate housing with an electrode end comprising at least one electrode; col. 3, line 62 to col. 4, line 17; col. 5, ll. 40-41; Abstract); the port comprising a channel having a longitudinal axis (FIG. 2: port 3), and the port is configured to receive the probe and form a watertight seal with the probe, when the probe is located in an operative position within the port (biomass sensing probe is push fitted within the port of the bioreactor, and thus considered to be watertight seal; col. 1, ll. 55-67; col. 4, ll. 39-47), wherein in the operative position the first region of the body is exposed to the interior of the bioreactor (electrode end of the biomass sensing probe is exposed to the biomass medium within the bioreactor; col. 4, ll. 3-17).
Selman does not explicitly disclose wherein the profile of the channel is tapered and the biomass sensing probe body has a tapered profile, and wherein the watertight seal being attained through the tapering profile of the biomass sensing body and the interior of the port. Forney discloses a sensing probe comprising an optical element (FIG. 1: optical probe 30) and a port comprising a channel adapted to receive the optical element (FIG. 1: tube 20 having an interior channel; [0021]). Forney discloses wherein the optical element and channel are matably tapered so that a fluid-tight seal is formed between the tube and the optical element ([0021]). In view of Forney, it would have been prima facie obvious to one of ordinary skill in the art to have modified the complementary profile of the biomass sensing probe and channel of the system of Selman to the have the tapering profile as disclosed by Forney 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 said modification would have been the simple substitution of one known sealing means (i.e., complementary shapes forming water-tight seal) with another for the predictable result of forming a water-tight seal between two components. Further, one of ordinary skill in the art would have made said modification since it has been held that a mere change in shape of an element is generally recognized as being within the level of ordinary skill in art when the change in shape is not significant to the function of the combination (MPEP 2144.04 IV.B.). Selman discloses a coupler located in the elongated body, and the coupler is located external to the port for receiving the electrical connector(FIG. 4: socket/pin connector 44; col. 5, ll. 27-29). Selman does not explicitly disclose wherein the coupler is located at one end of the elongate body. 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 rearranged the coupler of Selman such that the coupler is an end of the elongated body, since it has been held that a mere rearrangement of element without modification of the operation of the device involves only routine skill in the art (see MPEP § 2144.04 VI. C.). One would have been motivated to rearrange the coupler of Selman such that the coupler is an end of the elongated body in order to achieve ease of access to the coupler during connection to electrical components.
Furthermore, it is noted that the recitation of functional language "to receive an electrical connector" 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). The prior art discloses all of the structural features of the claimed coupler and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 2, modified Selman discloses wherein the longitudinal axis of the channel is substantially perpendicular to the wall of the bioreactor (Selman, FIGS. 1 and 2: port 3).
Regarding claim 3, modified Selman discloses wherein the channel is circular in cross-section (elongated tube port (3) having a shape that correspond to the shape of the monitoring device 10 having a circular shape; Selman, col. 3, ll. 57-61; col. 4, ll. 38-45).
Regarding claim 4, modified Selman discloses wherein the biomass sensing probe comprises conducting means connected to the at least one electrode (electrical connector 19 connected to the electrode end at a first end and electrical connector pin 31 at a second end; Selman, col. 2, ll. 27-33; col. 4, ll. 52-56).
Regarding claim 5, modified Selman discloses wherein the biomass sensing probe body is modular and comprises a plurality of probe body components (monitoring device 10 includes a first component (12) and a second component (12); Selman, FIG. 4; col. 3, ll. 62-36; col. 4, ll. 32-52).
Regarding claim 6, modified Selman discloses wherein the core is hollow in its interior (Selman, FIG. 4: monitoring device includes a tip (14), core (31,33) and a shell (17)).
Regarding claim 7, modified Selman discloses wherein the portion of the probe which is exposed to the interior of the bioreactor when the probe is in the operative position is formed of gamma sterilisable materials (at least a portion of the monitoring device is formed of gamma sterilizable material; Selman, col. 2, ll. 25-26 and 47-51; col. 5, ll. 6-14).
Regarding claim 8, modified Selman does not explicitly disclose wherein the portion of the probe which is exposed to the interior of the bioreactor when the probe is in the operative position is formed of materials having a melting point of less than 100°C. However, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to have substituted the material of the biomass sensing probe of Selman with a material having a melting point of less than about 100°C, because such modification would have been the simple substitution of one known material for another with reasonable expectation of success. Further, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07).
Regarding claim 10, modified Selman discloses wherein the at least one electrode comprises 2 to 6 electrodes (Selman, FIG. 4: electrode end 14 includes 4 electrodes (21a,21b)).
Regarding claim 11, modified Selman further discloses wherein the system further comprises biomass signal processing means (signal processing electronics; Selman at col. 6, ll. 22-28).
Regarding claim 12, modified Selman discloses wherein the biomass sensing probe and/ or the bioreactor are configured for single use (Selman at col. 2, ll. 25-26; col. 3, ll. 54-57).
Regarding claim 13, modified Selman discloses a method of obtaining a biomass measurement comprising: providing the system of claim 1 (see claim 1 above); inserting the biomass sensing probe into the port in the operative position (col. 4, ll. 3-6); obtaining the biomass measurement (col. 4, ll. 9-12); and disposing of the probe (probe connected to the bioreactor is disposed; col. 2, ll. 25-26 and 56-59; col. 3, ll. 54-57; col. 4, ll. 32-35).
Regarding claim 14, modified Selman further discloses a process of securing the biomass sensing probe in the operative position in the port (col. 4, ll. 38-47).
Regarding claim 15, modified Selman further discloses the process of disposing of the bioreactor and/or the biomass sensing probe once the biomass measurement has been taken (probe connected to the bioreactor is disposed; col. 2, ll. 25-26 and 56-59; col. 3, ll. 54-57; col. 4, ll. 32-35).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Selman in view of Forney as applied to claim 1 above, and further in view of Taniguchi et al (JP 2010-073984; with English machine translation) (hereinafter “Taniguchi”).
Regarding claim 9, modified Selman discloses the system according to claim 1. Modified Selman does not explicitly disclose wherein the port comprises over-insertion prevention means. Taniguchi discloses a housing (FIG. 1) and over-insertion prevention means (stopper 19) coupled to a probe (FIG. 1; [0024] of the English machine translation document). In view of Taniguchi, 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 the stopper of Taniguchi with the probe of modified Selman in order to prevent over-insertion of the probe into the bioreactor as disclosed by Taniguchi ([0024]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kuennecke (DE 10-2016-120699) discloses a bioreactor and a probe coupled to the bioreactor.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 5712721374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799
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