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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 03/17/2026 has been entered.
Election/Restrictions
Regarding new claim 28, the claim is to be examined with the currently non-withdrawn claims, as restriction under MPEP § 821.03 using election by original presentation (via two-way distinctness) was not warranted.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 25 and 28 are objected to because of the following informalities:
Regarding claim 25, in the last line of the claim, the phrase “wherein the main body” should be “wherein the metallic main body”. The amendment above would prevent confusion over the materials used in the phrase compared to the limitation of “an annular or cylindrical metallic main body” in the third-to-last and second-to-last lines in the claim.
Regarding claim 28, in line 5, the phrase “a window assembly separate from the holder body” should be “the window assembly separate from the holder body”.
Regarding claim 28, in line 8, the phrase “the main body” should be “the metallic main body”, for similar reasons as stated above for claim 25, just for claim 28 instead.
Regarding claim 28, in line 9, the phrase “the main body” should be “the metallic main body”, for similar reasons as stated above for claim 25, just for claim 28 instead.
Regarding claim 28, in line 14, the phrase “the main body” should be “the metallic main body”, for similar reasons as stated above for claim 25, just for claim 28 instead.
Regarding claim 28, in line 15, the phrase “the main body” should be “the metallic main body”, for similar reasons as stated above for claim 25, just for claim 28 instead.
Regarding claim 28, in lines 15-16, the phrase “and transparent element” should be “and the transparent element”.
Appropriate correction is required.
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 6-8, 10-16, and 25-28 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, paragraphs [0030], [0034]-[0035], [00121], [00173]-[00177], and [00195] 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. However, claim 25 contains the phrases “an end for accepting placement of a window assembly” and “wherein the window assembly is separate from the holder body”. In view of this, as the components are not separated from each other, the amended limitation is still considered to be new matter.
Regarding claim 27, the Examiner noticed that the following phrase was used:
1*10-3 mbar·*l/sec
However, the only written description about this matter (instant specification, paragraph [00137]) supports the use of first arithmetic multiplication (the asterisk sign in the magnitude or numbers portion), then exclusively, dot multiplication (the dot sign in the units or letters portion) in the context of the phrase above, as written below:
1*10-3 mbar·l/sec
This second phrase could be verbally described as (“one times ten to the negative third power millibars dot liters per second”) and has written description.
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.
Regarding new independent claim 28, paragraphs [0030], [0034]-[0035], [00121], [00173]-[00177], and [00195] 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. However, claim 28 contains the phrases “an end for accepting placement of a window assembly” and “a window assembly separate from the holder body”. In view of this, as the components are not separated from each other, the amended limitation is considered to be new matter.
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 25-28 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 6, the claim recites the limitation “the window” in line 3. There is insufficient antecedent basis for this limitation in the claim. One possible way to overcome this rejection would be to use the limitation “the window assembly”.
Regarding claim 10, the claim recites the following limitation:
wherein the window assembly is laser welded to the holder body
However, in parent claim 25, the claim recites the following limitations:
an end for accepting placement of a window assembly
wherein the window assembly is separate from the holder body
It is unclear how a window assembly is separate from the holder body of the sensor receptacle as well as how the same window assembly is currently hermetically sealed to the holder body by laser welding at the same time. Additionally, the product-by-process limitations due to laser welding implies structure. Therefore, the components recited in claim 10 are being interpreted as being laser welded together, regardless of any structure that shows that they were previously separated.
Regarding claim 25, the claim recites the following limitations:
an end for accepting placement of a window assembly
wherein the window assembly is separate from the holder body
Contrarily, claim 25 also recites these limitations:
wherein the perimeter [of the transparent element] is hermetically sealed to the inner surface [of the metallic main body]
and wherein the [metallic] main body is hermetically sealed to the end of the holder body
It is unclear how a window assembly is separate from the holder body of the sensor receptacle as well as how the same window assembly is currently hermetically sealed to the holder body at the same time. Therefore, the components recited in claim 25 are being interpreted as being hermetically sealed together, regardless of any structure that shows that they were previously separated.
Regarding claim 27, the claim recites the limitation “the hermetic seal” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim, due to the two different hermetic seals in parent claim 25.
Regarding claim 27, the Examiner noticed that the following phrase was used:
1*10-3 mbar·*l/sec
The part of the above phrase only regarding the units should be rewritten to exclude the superscripted duplication of multiplication signs – i.e. the two different forms of superscripted multiplication (both exponentiated dot multiplication and arithmetic multiplication •*).
Only dot multiplication is necessary, and it should not be superscripted; superscript denotes exponentiation instead of multiplication. In some contexts, duplication of multiplication signs juxtaposed to each other also denotes exponentiation. The claim language does not mathematically accurately describe the invention, and in some contexts describes exponentiation, so the term is both indefinite and inaccurate. Accordingly in the context of the phrase above, a different phrase could be used as written below:
1*10-3 mbar·l/sec
This second phrase could be verbally described as (“one times ten to the negative third power millibars dot liters per second”) and is definite.
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.
Regarding new independent claim 28, the claim recites the following limitation:
an end for accepting placement of a window assembly
a window assembly separate from the holder body
However, also in claim 28, the claim recites the following limitations:
wherein the main body is hermetically sealed to the end of the holder body
wherein the transparent element is hermetically sealed to the metallic main body by a glass-to-metal seal (GTMS) compression glass seal
It is unclear how a window assembly is separate from the holder body of the sensor receptacle as well as how the same window assembly is currently hermetically sealed to the holder body by a glass-to-metal seal (GTMS) compression glass seal at the same time. Therefore, the components recited in claim 28 are being interpreted as being hermetically sealed together, regardless of any structure that shows that they were previously separated.
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 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 a window assembly (Fig. 2, element 42 “quartz optical well window”),
wherein the window assembly comprises (1) a transparent element (Fig. 2, element 42 “quartz optical well window”) having a perimeter (Fig. 2) and transmissive to electromagnetic radiation (claim 1 “passage of ultraviolet light”), and (2) an annular or cylindrical metallic main body (Fig. 2, element 34 “cylindrically shaped tube”; and col. 3, lines 50-55, and col. 4, lines 1-5) having an inner surface (Fig. 2, element 34 “cylindrically shaped tube” has an inner surface; and col. 3, lines 50-55, and col. 4, lines 1-5).
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Krause, Fig. 2
Krause does not disclose:
wherein the window assembly is separate from the holder body
wherein the perimeter is hermetically sealed to the inner surface, and wherein the main body is hermetically sealed to the end of the holder body
Regarding feature 1, Koerperick discloses wherein the window assembly (paragraph [0037]; Fig. 5, element 290 “first surface in optical communication … whereby an optical path length is formed”) is separate from the holder body (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 holder body 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 “wherein the window assembly is separate from the holder body” the limitation is a product-by-process limitation, due to the later limitation of “wherein the perimeter is hermetically sealed to the inner surface, and wherein the main body is hermetically sealed to the end of the holder body”. Because the two components are already hermetically sealed together in the claim, the interpretation of “the window assembly [being] separate from the holder body” 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 hermetically sealed together to be separate to each other in order to assemble components from different sources (such as those from different locations and suppliers); then, with the seal of Terentiev (paragraph [0035] “thermal welding … preferably hermetic”) as described below, these components can be sealed together with a sealing method in the state of the art that is liquid-impervious and hermetic (Terentiev, paragraph [0035]).
Regarding feature 2, Abel discloses: wherein the perimeter [of the window assembly] is hermetically sealed (paragraph [0025] “gas tight window”) to the inner surface (paragraph [0025] “by mounting said window within said thermal shielding region and on said first housing member”), and wherein the main body is hermetically sealed to the end of the holder body (paragraph [0034] “gasket” and “seal”).
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, 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 (see rejection to claim 25, above as well as modified Krause in view of Koerperick, Abel, and Terentiev).
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).
Additionally, regarding the limitation “glass, quartz glass, and borosilicate glass”, 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 remaining limitations “glass” and “borosilicate glass”, the limitation is already fulfilled as it is phrased in the alternative.
Regarding claim 10, Krause discloses the window assembly (Fig. 2, element 42 “quartz optical well window”).
Krause does not disclose wherein the window assembly 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 assembly 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 assembly (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 (see rejection to claim 25, above as well as modified Krause in view of Koerperick, Abel, and Terentiev).
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 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, Naugler discloses hermetically sealing (abstract) by [way of] 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/or 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·l/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]).
Claim 28 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), Terentiev (US 2013/0171723) (previously cited), and Naugler (US 5709724) (previously cited).
Regarding claim 28, 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 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 a window assembly (Fig. 2, element 42 “quartz optical well window”); and
wherein the window assembly (Fig. 2, element 42 “quartz optical well window”) comprises a transparent element (Fig. 2, element 42 “quartz optical well window”) transmissive to electromagnetic radiation (claim 1 “passage of ultraviolet light”) and an annular or cylindrical metallic main body (Fig. 2, element 34 “cylindrically shaped tube”; and col. 3, lines 50-55, and col. 4, lines 1-5), wherein the transparent element has a perimeter (Fig. 2), wherein the main body has an inner surface (Fig. 2, element 34 “cylindrically shaped tube” has an inner surface; and col. 3, lines 50-55, and col. 4, lines 1-5), wherein the transparent element comprises a material selected from the group consisting of quartz glass (claim 1 and col. 4, lines 50-55); and, 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).
Krause does not disclose:
a window assembly separate from the holder body
wherein the perimeter is hermetically sealed to the inner surface, wherein the main body is hermetically sealed to the end of the holder body
and wherein the transparent element is hermetically sealed to the metallic main body 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, Koerperick discloses wherein the window assembly (paragraph [0037]; Fig. 5, element 290 “first surface in optical communication … whereby an optical path length is formed”) is separate from the holder body (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 holder body 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 “wherein the window assembly is separate from the holder body” the limitation is a product-by-process limitation, due to the later limitation of “wherein the perimeter is hermetically sealed to the inner surface, and wherein the main body is hermetically sealed to the end of the holder body”. Because the two components are already hermetically sealed together in the claim, the interpretation of “the window assembly [being] separate from the holder body” 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 hermetically sealed together to be separate to each other in order to assemble components from different sources (such as those from different locations and suppliers); then, with the seal of Terentiev (paragraph [0035] “thermal welding … preferably hermetic”) as described below, these components can be sealed together with a sealing method in the state of the art that is liquid-impervious and hermetic (Terentiev, paragraph [0035]).
Regarding feature 2, Abel discloses: wherein the perimeter [of the window assembly] is hermetically sealed (paragraph [0025] “gas tight window”) to the inner surface (paragraph [0025] “by mounting said window within said thermal shielding region and on said first housing member”), and wherein the main body is hermetically sealed to the end of the holder body (paragraph [0034] “gasket” and “seal”).
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, 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 feature 3, Naugler discloses hermetically sealing (abstract) by [way of] 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.
Additionally, regarding the limitation “glass, quartz glass, and borosilicate glass”, 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 remaining limitations “glass” and “borosilicate glass”, the limitation is already fulfilled as it is phrased in the alternative.
Response to Arguments
Applicant’s arguments filed 03/17/2026 have been fully considered but they are not persuasive.
Regarding Applicant arguments, pg. 6 of 12, regarding claim 28, the new independent claim has been added to the currently examined claim set. No election by original presentation was found to be applicable to the new independent claim 28.
Regarding Applicant arguments, pg. 6 of 12, regarding claim 25, although there may be a holder body and a window assembly, these two components are not separate from each other as they are hermetically sealed together. Please see the 112 rejections above for new matter and indefiniteness for the independent claims 25 and 28, as well as dependent claims.
Regarding Applicant arguments, pg. 7 of 12, regarding the claim interpretation about separate and attachable components, the parts of the specification allegedly describing separate components are paragraphs [00121], [00173]-[00174], [00177], and [00195] as stated in these Applicant arguments. These paragraphs are duplicated below:
[00121] The window 11 comprises a main body 10 which comprises steel or is made of steel and holds the transparent element 12, as will be described in more detail below with reference to FIGS. 25 through 32.
[00173] The window 11 shown in FIG. 25 comprises an annular or cylindrical body 10 made of steel, which encloses the transparent element 12 laterally while exerting thereon a compressive force which ensures a permanently hermetic connection between the transparent element 12 and the main body 10, which is sufficiently pressure-resistant and heat-resistant for the purposes of the present invention.
[00174] The transparent element of the window is secured to the main body 10 by the GTMS compression glass seal, and the main body is secured to the holder body 13 of the sensor receptacle.
[00177] Once fused, the assembly of transparent element 12 and main body 10 is then cooled to room temperature, thereby forming a respective window 11 that includes a substantially sheet-like transparent element 12.
[00195] The main body 10 of the window 11 is preferably connected directly to the holder body 13 in a hermetically sealed manner, by welding, in particular by laser welding, so that the holder body 13 is hermetically sealed at its lower end against the interior of the container 3.
In rebuttal:
Paragraph [00121] describes a steel body and a transparent structure, but nothing is said of them being separate.
Paragraph [00173] describes a permanent hermetic connection between the steel body and the transparent element, showing that the seal is a permanent part of the structure of the invention.
Paragraph [00174] describes securing the transparent element to the main body, and securing the main body to the holder body. This is achieved in part by a glass-to-metal-seal compression glass seal. If the parts were to be separate at some point, it would be during the manufacturing of the invention, not as the final invention being produced as a product. Therefore, the term “separate” in the claims is not fulfilled by this paragraph under 35 U.S.C. § 112(a), as the claims refer to a product and not a method of making a product. No written description exists for the invention as a final, claimed product having separate parts.
Paragraph [00177] describes another process or method step of manufacturing the invention, not the final product as currently claimed. Additionally, the term “fused” implies a structural connection, not separate parts.
Paragraph [00195] describes another process or method step of manufacturing the invention, not the final product as currently claimed. Additionally, the term “welding” implies a structural connection, not separate parts.
Regarding Applicant arguments, pg. 7 of 12, the term “welding” as described with these paragraphs is determined to be “a well-known method of attachment to those of skill in the art” [italics added].
Regarding Applicant arguments, pg. 7 of 12, regarding the hermetic seal being part of the structure, this part of the structure of the invention has been rejected under 35 U.S.C. § 103.
Regarding Applicant arguments, pgs. 7-8 of 12, the rejections under 35 U.S.C. §§ 112(a) and 112(b) have been maintained, see above arguments and rejections.
Regarding Applicant arguments, pg. 9 of 12, arguments are related to a product-by-process limitation where the product is manufactured from separate parts initially and then assembled together. However, the claimed invention is not a method of manufacturing, but is instead drawn to a product. The arguments – that the components of the window assembly and the sensor receptacle are separate – are not relevant as these two components are literally sealed together in the invention. The connection between these components, however, contains structural material as a laser weld in dependent claim 10. However, this laser weld has been rejected under 35 U.S.C. § 103 accordingly.
Regarding Applicant arguments, pg. 9 of 12, Krause discloses a number of claim limitations.
Regarding the following limitations:
a window assembly [… forming] a structure separate from and attachable to the holder body of the sensor receptacle.
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.
These limitations were met by secondary references in a rejection under 35 U.S.C. § 103. The condition “separate from” is not only not present in the originally filed application, resulting in a 35 U.S.C. § 112(a) written description rejection, but also it is rejected under 35 U.S.C. § 112(b) for indefiniteness, as the window assembly is sealed by “welding” but is yet “separate from and attachable to” the holder body of the sensor receptacle. The Applicant has added product-by-process limitations to the structure of the device. The device does not have separate and yet attachable components because these components have already been welded together. One is a method of manufacturing, while the other is the final product. Regardless, Koerperick discloses optical windows forming a structure that is separate from the retaining body, but also attached to the retaining body. In detail, although the optical windows are attached to the Koerperick’s flange, they form a distinctly separate feature from this flange. The term “separate” in this case is to be interpreted broadly, given the previous indefiniteness issue. To summarize, the window assembly is claimed to be “separate” from “the holder body”, yet is connected to it through its “hermetically sealed” connection to the “welded” “main body”. The components are not separate in one sense of the term – they are connected. However, the components are separate in a different sense of the term – they are different components. The claim limitation results in an indefiniteness rejection.
Regarding Applicant remarks, on pg. 11 of 12, 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”). Although welding is not mentioned in Abel, the housing is attached to the chamber through a gasket. However, such forms of integration of parts are unnecessary to disclose from Abel as they are present in Terentiev. Terentiev discloses hermetically sealed welding (paragraph [0035] “thermal welding … preferably hermetic”). Lastly, in response to Applicant’s arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
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/N.G.E./Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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