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 Objections
Regarding the previous claim objection, the objection is withdrawn in light of the amendment.
Claim Interpretation
Regarding claim 25, the claim interpretation is withdrawn in light of the amendments.
Claim Rejections - 35 USC § 112
The previous claim rejections under 35 U.S.C. § 112(a) and 35 U.S.C. § 112(b) are withdrawn in light of the amendments.
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 6-8, 10-16, and 25-27 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.
Regarding claim 25, it is possible that Applicant intends to have meant the support for the amended feature of claim 25 is in the instant specification, paragraph [0136]: “the foot portion 41 may also be provided in a detachably secured manner, as shown in Fig. 36 by way of example”. However, based upon the amended claim language that is currently recited and the support cited in the Applicant Remarks (instant specification, paragraphs [0030]-[0039] and [0174]), the claim interpretation that the examiner is using for the sake of compact prosecution is as follows: “a window assembly [… forming] a structure separate from and attachable to the holder body of the sensor receptacle”. This claim language is interpreted to show that the window assembly is separate from and is attachable to the holder body of the sensor receptacle. However, this interpretation is not found in the instant specification, even at paragraphs [0030]-[0039] and [0174]. Contrarily, paragraphs [0174]-[0175] of the instant specification appears to show that the invention’s components are secured to one another, for instance, by a GTMS compression glass seal and/or by laser welding.. In view of this, the amended limitation is considered to be new matter
Regarding the dependent claims 6-8, 10-16, and 26-27, these claims are rejected for the same reason as the base claim upon which they depend.
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 6-8, 10-16, and 25-27 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.
Regarding claim 25, the claim recites the following two limitations in the same claim:
“a window assembly comprising a transparent element surrounded by an annular or cylindrical metallic main body to form a structure separate from and attachable to the holder body of the sensor receptacle”, and,
“wherein the main body of the window assembly is hermetically sealed to the end of the holder body by welding”.
It is unclear how a window assembly is currently separate from and attachable (not necessarily “attached”) to the holder body of the sensor receptacle as well as how the same window assembly is currently hermetically sealed to the holder body by welding at the same time. Because this is an apparatus claim, the product-by-process limitations implied in “attachable” should not be read upon in the claim; however, “welding” implies structure. Therefore, the components recited in the claim are being interpreted as being welded together, regardless of any process that shows that they were formerly separate and attachable to one another (but not “attached”).
Regarding the dependent claims 6-8, 10-16, and 26-27, these claims are rejected for the same reason as the base claim upon which they depend.
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.
Claims 6, 8, 10-16, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Krause (US 4,803,365) (previously cited) in view of Koerperick (US 20150330903) (previously cited), Abel (US 2019/0339196) (previously cited), and Terentiev (US 2013/0171723) (previously cited).
Regarding claim 25, Krause discloses a sensor receptacle (abstract “optical probe mounting device”) extending in a feedthrough (col. 3, lines 65-68 and Figs. 3-4 element 32 “optical well” is a feedthrough extending into the interior of the biological reactor) for supporting at least one sensor (abstract “optical probe”) for a bioreactor (abstract “biological reactor vessel”), comprising:
a window assembly (Fig. 2, element 42 “quartz optical well window”) comprising a transparent element (Fig. 2, element 42 “quartz optical well window”) surrounded by an annular or cylindrical metallic main body (Fig. 2, element 34 “cylindrically shaped tube” and col. 4, lines 50-55); and
a holder body (Fig. 2, element 32 “optical well”) with a sensor receiving area (Fig. 2, element 34 “cylindrically shaped tube”) inside the holder body (Fig. 2, element 32 “optical well”) and an end (Fig. 2, element 32 “optical well” left side of the well) for accepting placement of the window assembly (Fig. 2, element 42 “quartz optical well window”), and wherein the transparent element (Fig. 2, element 42 “quartz optical well window”) is transmissive to electromagnetic radiation (claim 1 “passage of ultraviolet light”).
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Krause, Fig. 2
Krause does not disclose:
a window assembly [… forming] a structure separate from and attachable to the holder body of the sensor receptacle.
Regarding feature 1, Koerperick discloses a window assembly (paragraph [0037]; Fig. 5, element 290 “first surface in optical communication … whereby an optical path length is formed”) forming a structure separate from the holder body of the sensor receptacle (paragraphs [0028] and [0030] “optical probe integral to the disposable flange 100 houses the optical waveguides 130 and 140”).
In the analogous art of a container with a sensor adapter, it would have been obvious to one skilled in the art before the effective filing date to modify Krause with the window assembly separate from the sensor receptacle of Koerperick in order to allow for frequent measurement and monitoring of bioreactors for the purpose of controlling the environment of the bioreactor for cell culture using sensors and systems to monitor nutrients and other constituents in an automated fashion and control the levels thereof (Koerperick, paragraph [0007]). The specific orientation of a separate window assembly would be useful for near-infrared electromagnetic radiation in optical measurements (Koerperick, paragraph [0030]).
Regarding the phrase “a window assembly [… forming] a structure separate from and attachable to the holder body of the sensor receptacle” the limitation is a product-by-process limitation, due to the later limitation of “the window assembly is hermetically sealed to the end of the holder body by welding”. Because the two components are already welded together in the claim, the interpretation as being “separate from and attachable to” is a process limitation in the assembly of the sensor receptacle. Therefore, the limitation is a product-by-process limitation. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” MPEP § 2113.
If it is deemed that the claim limitation is to be interpreted as limiting, making parts separable or removable would be obvious. MPEP § 2144.04(V)(C). It would have been obvious to one skilled in the art before the effective filing date to modify the two parts of the invention that were not previously welded together to be separate from but attachable to each other (via welding) in order to assemble components from different sources (such as those from different locations and suppliers); then, with the thermally welded seal of Terentiev (paragraph [0035] “thermal welding … preferably hermetic”) as described below, these components can be sealed together with another sealing method in the state of the art that is liquid-impervious and hermetic (Terentiev, paragraph [0035]). It is to be noted that before they are welded, they must be separate.
Krause does not disclose:
wherein the transparent element is hermetically sealed in the main body; and wherein the main body of the window assembly is hermetically sealed to the end of the holder body by welding.
Regarding feature 2, Abel discloses that the transparent element is hermetically sealed (paragraph [0025] “gas tight window”) in the main body (paragraph [0025] “by mounting said window within said thermal shielding region and on said first housing member”).
In the analogous art of housing for light sensors in cell culture vessels, it would have been obvious to one skilled in the art before the effective filing date to modify the liquid-tight window of Krause with the hermetic equivalent gas-tight window of Abel in order to prevent gases from the bioreactor that include water vapor from entering the optical sensor well and impairing the function of the light sensor (Abel, paragraph [0025]). Avoidance or minimization of condensation would allow for more accurate measurements of the bioreactor medium.
Regarding feature 2, if it is deemed that modified Krause does not disclose that the main body of the window assembly is hermetically sealed to the end of the holder body by welding, Terentiev discloses hermetically fused seals, in the context of sensor ports to bioreactors (paragraph [0035] “thermal welding … preferably hermetic”).
In the analogous art of hermetically welded sensor ports to bioreactors, it would have been obvious to one skilled in the art before the effective filing date to substitute the hermetic seal of modified Krause with the thermally welded seal of Terentiev as another sealing method in the state of the art that is liquid-impervious and hermetic (Terentiev, paragraph [0035]).
Regarding claim 6, Krause discloses wherein the holder body (Fig. 2, element 32 “optical well”) has a cylindrically symmetrical shape (Fig. 2, element 34 “cylindrically shaped tube”) and the sensor receiving area is sealed by the window (col. 4, lines 65-68).
Modified Krause teaches the hermetic seal, rather than an O-ring.
Regarding claim 8, Krause discloses wherein the transparent element comprises a material selected from the group consisting of quartz glass (claim 1 and col. 4, lines 50-55). Furthermore, Krause discloses the use of alternative types of glasses other than quartz glasses (col. 5, lines 20-30).
Regarding the limitations “glass” and “borosilicate glass”, the limitation is already fulfilled as it is phrased in the alternative.
Regarding claim 10, Krause discloses the window (Fig. 2, element 42 “quartz optical well window”).
Krause does not disclose wherein the window is laser welded to the holder body.
Terentiev discloses wherein the bag is laser welded to the holder body (paragraph [0035]).
In the analogous art of sensor receptacles, it would have been obvious to one skilled in the art before the effective filing date to modify the method in which the window was attached to the holder body of Krause with the laser welding of Terentiev in order to provide a hermetic and liquid impervious seal (Terentiev, paragraph [0035]).
Additionally, regarding the claim, the limitation is a product-by-process limitation. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” MPEP § 2113.
Regarding claim 11, Krause discloses wherein the transparent element has a shape selected from the group consisting of plate-like with plane-parallel main surfaces (Fig. 2-4).
Regarding the remainder of the limitation, “wherein the transparent element has a shape selected from the group consisting of … plano-convex, plano-concave, biconvex, biconcave, convexo-concave, and concavo-convex”, the remainder of the limitation is claimed in the alternative.
In addition, the claim limitation is obvious, as the configuration of the claimed shape is a matter of choice, absent persuasive evidence that the particular configuration is significant. MPEP § 2144.04(IV)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the shape of the transparent element in order to have different lenses to focus light on the sensor to be received in the sensor receptacle.
Regarding claim 12, Krause discloses wherein the transparent element further forms part of an imaging system associated with the window (col. 2, line 65 to col. 3, line 10 “fluorescence measuring optical probe”).
Regarding claim 13, Krause discloses wherein the holder body (Fig. 2, element 32 “optical well”) has a radially extending lateral shoulder (Figs. 2-3, element 44, “optical well flange”) abutting on an upper flange of the feedthrough (Figs. 3-4, element 22 “flange portion” or col. 4, lines 58-64), the lateral shoulder being positioned a first axial distance away from the transparent element (Figs. 2-3, element 42 “quartz optical well window”) so that the first axial distance defines a second axial distance between the transparent element and an inner surface of the bioreactor (Fig. 3, element 12 “wall of a biological reactor vessel”).
Regarding claim 14, Krause discloses wherein the holder body (Fig. 2, element 32 “optical well”) has a flange (Figs. 2-3, element 44, “optical well flange”) that extends radially outwardly and defines a contact surface for a seal in an axial direction (Figs. 2-4, element 48 “O-ring”).
Modified Krause teaches a seal, rather than an O-ring.
Regarding claim 15, Krause discloses further comprising a covering cap (Fig. 2, element 58 “Safety cap”) having a contact surface for a seal (Fig. 2, element 64 “O-ring”).
Krause does not disclose the covering cap forming part of a sensor.
However, it would have been obvious to one skilled in the art before the effective filing date to modify the shape of the body portion of the sensor of Fig. 3 of Krause in order to form a cap having a contact surface for a seal similarly to Fig. 2 of Krause. This contact surface seal of Fig. 2 of Krause would be able to further seal the sensor of Fig. 3 of Krause to the sensor receptacle, preventing external environmental conditions (e.g., dust or other environmental contamination) from entering the sensor receptacle while the sensor is inside it, and also would better form a stable seal to prevent the sensor from being jostled in place which may influence measurements.
Additionally, regarding this limitation, changing the shape and rearrangement of parts would have been obvious to one of ordinary skill in the art as an obvious matter of design choice and would not have modified the operation of the device. MPEP § 2144.04(VI)(C). Placing a sealing O-ring contact surface around a cap that forms part of a sensor would be a matter of obvious design choice in comparison to the Krause patent.
Regarding claim 16, Krause discloses wherein the sensor receptacle is autoclavable (col. 4, lines 50-60).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Krause (US 4,803,365) (previously cited) in view of Koerperick (US 20150330903) (previously cited), Abel (US 2019/0339196) (previously cited), and Terentiev (US 2013/0171723) (previously cited) as applied to claim 25, as evidenced by Huang (“UV-to-IR highly transparent ultrathin diamond nanofilms with intriguing performances: Anti-fogging, self-cleaning and self-lubricating”) (previously cited).
Regarding claim 7, Krause discloses wherein the transparent element (Fig. 2, element 42 “quartz optical well window”) exhibits a transmittance (claim 1 “without undue attenuation”) in a spectral range of wavelengths between 250 and 2000 nm (claim 1 “ultraviolet light”).
Krause does not specifically disclose wherein the transparent element exhibits a transmittance of greater than 80 % in a spectral range of wavelengths between 250 and 2000 nm.
However, evidentiary reference Huang shows that quartz glass has the implicit property of having a transmittance of greater than 80% in a spectral range of wavelengths between 250 and 2000 nm (Fig. 3 “Bare quartz”).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Krause (US 4,803,365) (previously cited) in view of Koerperick (US 20150330903) (previously cited), Abel (US 2019/0339196) (previously cited), and Terentiev (US 2013/0171723) (previously cited) as applied to claim 8, further in view of Naugler (US 5709724) (previously cited).
Regarding claim 26, Krause discloses wherein the transparent element (Fig. 2, element 42 “quartz optical well window”) is secured to the metallic main body (Fig. 2, element 34 “cylindrically shaped tube” and col. 4, lines 50-55; col. 5, lines 15-29) by a seal (col. 5, lines 15-29).
Notably, Krause discloses that other seals may be used (col. 5, lines 15-29).
Krause does not disclose:
is hermetically sealed
by a glass-to-metal seal (GTMS) compression glass seal formed by heating together the transparent element with the main body until the transparent element has exceeded its glass transition temperature, and thereafter cooling the main body and transparent element to room temperature
Regarding feature 1, modified Krause teaches this feature (see feature 2 disclosed by Abel of the rejection to parent claim 25).
Regarding feature 2, Naugler discloses a glass-to-metal seal (GTMS) compression glass seal (background section, col. 1, lines 40-60) formed by heating together the transparent element with a main body (col. 1, lines 25-31) until the transparent element has exceeded its glass transition temperature, and thereafter cooling the main body and transparent element to room temperature (col. 1, lines 43-59).
In the analogous art of glass seals, it would have been obvious to one skilled in the art before the effective filing date to modify the glass seal of modified Krause with the compression glass seal of Naugler in order to provide a method of providing an airtight and insulating environment (Naugler, col. 1, lines 10-25).
Regarding the limitation “formed by heating together the transparent element with the main body until the transparent element has exceeded its glass transition temperature, and thereafter cooling the main body and transparent element to room temperature” the transparent element is glass. As cited above (Naugler, col. 1, lines 43-59), a compression glass seal would be expected from the Naugler process.
Additionally, regarding the claim, the limitation is a product-by-process limitation. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” MPEP § 2113.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Krause (US 4,803,365) (previously cited) in view of Koerperick (US 20150330903) (previously cited), Abel (US 2019/0339196) (previously cited), and Terentiev (US 2013/0171723) (previously cited), as applied to claim 25, further in view of Naugler (US 5709724) (previously cited) and Paterek (US 20120034403) (previously cited).
Regarding claim 27, Krause discloses a seal (col. 5, lines 15-29).
Krause does not disclose wherein a hermetic seal comprises a leak rate of less than 1*10-3 mbar·1/sec at room temperature when exposed to He on one side and to a pressure difference of 1 bar.
Naugler discloses wherein a hermetic seal comprises a leak rate of less than 1*10-6 cc/sec of helium according to Military Standard 883, method 1014.9 (col. 8, lines 35-45).
In the analogous art of glass seals, it would have been obvious to one skilled in the art before the effective filing date to modify the glass seal of modified Krause with the compression glass seal of Naugler in order to provide a method of providing an airtight and insulating environment (Naugler, col. 1, lines 10-25).
If it is deemed that Naugler’s hermetic seal does not disclose the limitation, it would have been obvious, given Naugler’s hermetic seal and its testing standards, to have achieved a leak rate of less than 1*10-3 mbar·l/sec at room temperature when exposed to He on one side and to a pressure difference of 1 bar, as this is the quantifiable and technical definition of a standard hermetic seal. Nevertheless, Paterek discloses a hermetic seal with this claimed property at 1 × 10-9 mba·l/sec (paragraph [0045]). In the analogous art of a hermetically sealed sight glass, it would have been obvious to one skilled in the art before the effective filing date to modify the seal of modified Krause with the exact technical definition of a hermetically sealed glass to metal seal as in Paterek (Paterek, paragraph [0057]) in order to do liquid level monitoring, light monitoring, and color monitoring (Paterek, paragraph [0051]).
Additional Prior Art References
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure.
ATEQ Leak testing (“How to determine and define leak rate specifications”) (previously cited).
Response to Arguments
Applicant’s arguments filed 09/17/2025 have been fully considered but they are not persuasive.
Regarding Applicant remarks about claim 25, a new 35 U.S.C. § 112(a) rejection and a new 35 U.S.C. § 112(b) rejection have both been placed on the record due to the amendment. The amended limitations have not been shown to have specification support at the cited locations within the instant specification, and the amended limitation is confusing due to the fact that the claim limitation states that the components are both separate from (but are still “attachable to”) each other, but are also welded (and are therefore attached) with each other at the same time. This claim language has been interpreted as a manner of manufacturing the invention. It is to be noted that no clear arguments are presented against the combination of references but merely an argument that the prior art does not teach the amended limitations. In addition, Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
The amendment with regards to the prior art has been treated on its merits.
Conclusion
THIS ACTION IS MADE FINAL. 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 NATHAN G ESPERON whose telephone number is 571-272-9807, and whose fax number is 571-273-8464. The examiner can normally be reached 9 am - 6 pm Monday through Thursday, and 9 am - 6 pm every other Friday.
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/N.G.E./Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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