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 .
Response to Amendment
In the applicant’s reply of 27 May 2026, the abstract, specification, and claims were amended. Based on these amendments, the abstract and specification objections included in the previous office action are withdrawn. Additionally, some of the claim objections and § 112(b) rejections are withdrawn. The remainder are repeated below, modified as needed. The limitation “positioning device” in claim 13 is no longer being interpreted under § 112(f) because the limitation was deleted from the claim.
Response to Arguments
Applicant’s arguments filed on 27 May 2026 have been fully considered, but they are not persuasive.
Applicant argues that Zhang discloses connecting the mutually facing end face portions by performing a surface activation treatment and pressing the end face portions against one another with a compression force, and that Zhang does not disclose that the mutually facing end face portions are placed in contact with one another within an overmolding mold. This argument is not persuasive. 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); MPEP 2145(IV). The overmolding mold, the overmolding cavity, and the filling of the overmolding cavity with flowable silicone are disclosed by Gagne (Fig. 3; [0031]-[0032]). Zhang is relied upon for the teaching that the end face portions to be connected can be abutted, and Zhang discloses that the coincidental bond is a circumferential seal wherein the bonded ends 112 and 202 are abutted ([0047]). Zhang further discloses that the fastening device surrounding the exterior seam may be an overmolded polymer ([0053], [0092]), so Zhang is not limited to the silicone tape identified by applicant.
Applicant argues that element 100 of Figure 3 of Zhang is not a mold. The rejection does not rely upon Figure 3 of Zhang or upon element 100 of Zhang. The rejection cites Figures 1A-1B and [0047] of Zhang for abutting end face portions and [0053] of Zhang for overmolding at the seam. This argument is therefore not responsive to the rejection as set forth.
Applicant argues that connectors or adapters are employed in Gagne, Zhang, and Wegener to join the tube sections, whereas in the claimed invention the tube sections are joined to one another without a connector or adapter. This argument is not persuasive for two reasons.
First, claim 10 does not recite that the silicone tube sections are connected without a connector or adapter. Claim 10 recites the transitional phrase “comprising” and is therefore open to the presence of additional elements. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See MPEP 2111.01 and 2145(VI).
Second, the argument is not supported by the references. The connector 20 of Gagne has ends 22, 24, 26 that are received within the tubing segments 12, 14, 16, such that a frictional interface is formed where each tubing segment joins with the respective end of the connector 20 ([0024]). In the coupler embodiment of Fig. 2B, the connector 20 is therefore positioned radially inward of the tubing segments, and the end face portions of the tubing segments face one another and nearly abut one another. Abutting the end face portions as taught by Zhang does not require the removal or modification of the connector 20. Further, Zhang discloses that the fluid path is substantially free of an external physical connector, a thermal weld connection, or combination thereof ([0054], [0107]).
Applicant argues that nowhere in Wegener is it disclosed that the tubing sections to be sterilized are made of silicone. Wegener is not relied upon for silicone tubing. Gagne discloses that the tubing segments 12, 14, 16 may be formed from silicone ([0013], [0024]). This argument attacks Wegener individually. See MPEP 2145(IV). Note further that Zhang discloses that the first polymeric material and the second polymeric material of the profiles may be a silicone elastomer ([0033]), and that the profiles are in the form of tubes having a hollow bore ([0034], [0037]).
Applicant argues that Wegener sterilizes the coupler 32 and the connectors 22a, 22b rather than the end face portions of the tubing, and that Wegener therefore provides no indication to irradiate the end face portions of the silicone tube sections to be connected with a UV sterilization wavelength. This argument is not persuasive. Wegener is relied upon for the teaching that irradiating the surfaces that are to be joined with UV-C light provides a sterile connection. Wegener discloses that the light source is used to irradiate the connectors and the coupler to sterilize them as they are connected ([0036]), and that UV-C light is known to kill or inactivate microorganisms ([0035]). Applying this known technique to the end face portions of the silicone tube sections of Gagne, which are the surfaces that are joined in Gagne, is the application of a known technique to a known method ready for improvement to yield predictable results. See MPEP 2143(I)(D). The need for a sterile connection is present in Gagne, which relates to connectors “used by pharmaceutical and biological applications or other hygienic process industries” ([0002]).
Applicant argues that Wegener discloses a different joining method that is not applicable to the overmolding method of claim 10, and that the ordinarily skilled person would not have been motivated to combine Wegener with Gagne. The rejection does not propose to substitute the Luer connection of Wegener for the overmolded connection of Gagne. The rejection proposes to sterilize the surfaces that are joined in Gagne, using the UV-C irradiation taught by Wegener, while retaining the overmolding of Gagne. It is not necessary that the references be physically combinable, and the test for obviousness is what the combined teachings would have suggested to one of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); MPEP 2145(III).
Applicant argues that Andersson discloses a method for producing a cured silicone compound possessing a solid form rather than a method for connecting two silicone tube sections. Andersson is relied upon only for its teaching that 365 and 395 nm are preferred wavelengths for curing liquid silicone rubber ([0075]). This argument attacks Andersson individually. See MPEP 2145(IV).
Applicant argues that a combination of Gagne with Andersson, or with both Wegener and Andersson, would not have provided the ordinarily skilled person with any hint to employ two distinct UV wavelengths, and that only with improper hindsight could one of ordinary skill in the art arrive at the claimed combination. This argument is not persuasive. Wegener teaches that UV-C light in the range of 250-280 nm is preferred because it is known to kill or inactivate microorganisms ([0035]), and Andersson teaches that 365 and 395 nm are preferred wavelengths for curing liquid silicone rubber ([0075]). Selecting the wavelength that each reference identifies as preferred for the function it performs does not require any knowledge drawn from applicant's disclosure, and the recited difference between the two wavelengths is the consequence of that selection. Any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971); MPEP 2145(X)(A).
Specification
The amendment filed on 27 May 2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
At Pg. 4, Ln. 36 to Pg. 5, Ln. 1 of the substitute specification filed on 27 May 2026 (“the specification”), the recitation of “a UV curing silicone material tube with two silicone tube sections, which are connected to each other at their end faces by overmolding, for supplying media in a pharmaceutical media transfer method”.
The specification as originally filed recites at Pg. 4, Ln. 10-11 that the use of a UV curing silicone material according to claim 7 has turned out to be particularly suitable for the connection method. Original claim 7 recites a use of a liquid, UV curing silicone material as overmolding material in a method according to one of claims 1 to 3. In the specification, the phrase “according to claim 7” has instead been replaced with subject matter drawn from original claim 6, which recites a use of a connected silicone tube with two silicone tube sections, which are connected to each other at their end faces by overmolding, for supplying media in a pharmaceutical media transfer method. This same subject matter is separately recited at Pg. 4, Ln. 30-35 of the specification.
The resulting recitation describes a tube composed of a UV curing silicone material. The original disclosure does not describe a tube composed of a UV curing silicone material. The silicone tube sections 1, 2 are described as being made from a material which predominantly consists of silicone (see Pg. 5, Ln. 30-35), and the UV curing silicone material is described as the flowable silicone 15 which is used as the overmolding material (see Pg. 7, Ln. 33-35).
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claims 10, 16, 19, and 20 are objected to because of the following informalities:
In claim 10, “such that the end face portions facing each other and abut each other” should be replaced with “such that the end face portions face each other and abut each other”.
In claim 10, “curing the flowable silicone by UV light irradiation by UV light irradiation with a UV curing wavelength” should be replaced with “curing the flowable silicone by UV light irradiation with a UV curing wavelength”.
In claim 16, “a mobile configuration for the laboratory use” should be replaced with “a mobile configuration for laboratory use”.
In claim 19, “comprising the step of applying” should be replaced with “comprising the steps of applying”.
In claim 20, “the UV curing of the silicone material in cured state” should be replaced with “the UV curing silicone material in a cured state” for consistency with claim 19.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 13-21 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 13 recites the limitations “the UV sterilization wavelength”, “the flowable silicone”, and “the UV curing wavelength”. There is insufficient antecedent basis for these limitations in the claim.
Claim 13 does not introduce a UV sterilization wavelength, flowable silicone, or a UV curing wavelength, and claim 13 does not consistently rely on claim 10 for antecedent basis. Claim 13 recites “end face portions of the silicone tube sections to be connected” and “an overmolding mold” as newly introduced features, even though claim 10 recites both features, but claim 13 then recites “the UV sterilization wavelength” and “the UV curing wavelength” as though these features had already been introduced. Claim 13 also recites “the flowable silicone” before reciting “a feeding device for flowable silicone” later in the same claim. Because claim 13 treats some features recited in claim 10 as newly introduced and other features recited in claim 10 as previously introduced, it is unclear whether the features preceded by definite articles are the features recited in claim 10 or additional features.
For purposes of examination, claim 13 is being interpreted as reciting “a UV sterilization wavelength”, “flowable silicone”, and “a UV curing wavelength” instead.
Applicant may overcome this rejection by amending claim 13 to introduce each of these features within claim 13, or by amending claim 13 to rely on claim 10 consistently for those features recited in both claims.
Claims 14-18 and 21 are rejected based on their dependency from claim 13. Note that claims 14 and 15 repeat the limitations “the UV sterilization wavelength”, “the flowable silicone”, and/or “the UV curing wavelength”.
Claim 17 recites the limitations “the silicone supply tube” and “the silicone discharge tube”. There is insufficient antecedent basis for these limitations in the claim. Claim 17 depends from claim 13, and neither claim 13 nor claim 10 recites a silicone supply tube or a silicone discharge tube. A silicone supply tube and a silicone discharge tube are recited only in claim 11, from which claim 17 does not depend.
Claim 17 further recites “presetting data for the silicone supply tube and the silicone discharge tube sections to be connected” and a reading unit “matched to the silicone supply tube and the silicone discharge tube sections to be connected respectively”. It is unclear what relationship, if any, exists between the tube sections recited in claim 17 and the silicone tube sections to be connected that are recited in claim 13. Claim 13 recites an apparatus for connecting two silicone tube sections, and it is unclear whether claim 17 is reciting presetting data for those same two silicone tube sections or for additional tube sections. It is also unclear what relationship, if any, exists between the tube sections of claim 17 and the silicone supply tube and the silicone discharge tube.
For purposes of examination, claim 17 is being interpreted as introducing a silicone supply tube and a silicone discharge tube. The tube sections of claim 17 are being interpreted as being the same as those of claim 13, and these tube sections are being interpreted as being sections of the silicone supply tube and the silicone discharge tube of claim 17. This interpretation is consistent with the specification, which describes the silicone tube section 1 as part of the silicone supply tube 6 and the silicone tube section 2 as part of the silicone discharge tube 7, and which describes the silicone supply tube section and the silicone discharge tube section as representing the two silicone tube sections 1, 2 to be connected. See Pg. 6, Ln. 8-11 and Ln. 31-34. Note that each of claims 18 and 21 recites “the presetting data of the tubes for the tube sections to be connected”. Accordingly, amendments to claim 17 may necessitate corresponding amendments to claims 18 and 21.
Claims 18 and 21 are rejected based on their dependency from claim 17.
Claim 19 recites “applying a first UV wavelength to cure the silicone material and applying a second UV wavelength to sterilize the silicone material, wherein the first UV wavelength is different from the second UV wavelength”. Claim 19 depends from claim 10, which recites sterilizing end face portions of the silicone tube sections to be connected by UV light irradiation with a UV sterilization wavelength, curing the flowable silicone by UV light irradiation with a UV curing wavelength, and that the UV curing wavelength differs from the UV sterilization wavelength.
It is unclear what relationship, if any, exists between the first UV wavelength of claim 19 and the UV curing wavelength of claim 10, and between the second UV wavelength of claim 19 and the UV sterilization wavelength of claim 10. It is likewise unclear whether the step of applying a first UV wavelength to cure the silicone material is the step of curing the flowable silicone recited in claim 10 or an additional step. Because claim 10 requires two UV wavelengths that differ from each other and claim 19 requires two UV wavelengths that differ from each other, claim 19 may be read as requiring as few as two UV wavelengths or as many as four.
For purposes of examination, the first UV wavelength of claim 19 is being interpreted as the UV curing wavelength of claim 10, the second UV wavelength of claim 19 is being interpreted as the UV sterilization wavelength of claim 10, and claim 19 is being interpreted as additionally requiring that the silicone material be sterilized by the UV sterilization wavelength.
Claim 20 is rejected based on its dependency from claim 19.
Claim Interpretation
Claim 13 recites “a UV source for sterilizing end face portions of the silicone tube sections to be connected ... and for curing of the flowable silicone”. Under the broadest reasonable interpretation, this limitation encompasses both a single UV source that performs the sterilizing and the curing and two or more UV sources that together perform the sterilizing and the curing. The specification describes both arrangements, stating that two different UV sources can be used for the cross-linking irradiation and the sterilization irradiation, respectively, and that it is alternatively possible to work with a collective UV source for which the respective irradiation wavelengths are set by corresponding filters. See Pg. 8, Ln. 21-25. This interpretation is consistent with claim 14, which recites a first UV source and a second UV source, and with claim 15, which recites a UV source whose wavelengths are settable by corresponding filters.
Claim 13 further recites “wherein the silicone tube sections are positioned so as to be connected to one another at the end face portions thereof”. The silicone tube sections are the material worked upon by the claimed apparatus and are not recited as components of the apparatus. The material or article worked upon by an apparatus does not limit an apparatus claim. See MPEP 2115. Accordingly, this limitation is being treated as requiring only that the apparatus be capable of positioning silicone tube sections such that the tube sections can be connected to one another at their end face portions. See also MPEP 2114(II).
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.
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 10-14 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0200038 (“Gagne”) (cited in an IDS) in view of US 2021/0199226 (“Zhang”) (cited in an IDS), US 2017/0252550 (“Wegener”), and US 2013/0093124 (“Andersson”).
Regarding claim 10, Gagne discloses a method for connecting two silicone tube sections ([0013]), comprising:
positioning the end face portions of the silicone tube sections to be connected to face each other in an overmolding mold (Fig. 3; [0031]-[0032]);
overmolding the end face portions in the overmolding mold by filling an overmolding cavity of the overmolding mold with flowable silicone ([0032]); and
curing the flowable silicone by UV light irradiation with a UV curing wavelength ([0032]).
Gagne does not disclose that the end face portions of the silicone tube sections abut one another. However, the end face portions nearly abut one another in the embodiment of Fig. 2B. Additionally, Zhang discloses abutting tube ends (Figs. 1A-B, [0047]) and overmolding at the seam ([0053]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have abutted the end face portions of Gagne if desired since Zhang discloses that such an arrangement is suitable in an overmolded tube connection.
Gagne does not disclose sterilizing end face portions of the silicone tube sections to be connected by UV light irradiation with a UV sterilization wavelength or that the UV curing wavelength differs from the UV sterilization wavelength.
Wegener discloses a device and method for connecting two medical fluid flow systems, each having a respective connector, by using an ultraviolet (UV) light source to irradiate the connectors ([0009]-[0010], Figs. 5A-D), thereby providing a sterile connection ([0036]). The UV light source preferably provides UV-C light (e.g., in the range of 250-280 nm), which is known to kill or inactivate microorganisms ([0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have sterilized the end face portions of Gagne, as taught by Wegener, to ensure a sterile connection. Note that Gagne relates to connectors “used by pharmaceutical and biological applications or other hygienic process industries” ([0002]).
With respect to the UV sterilization wavelength being different from the UV curing wavelength, Gagne uses liquid silicone rubber for the overmolding ([0032]), and liquid silicone rubber is cured using a different wavelength range than the range disclosed by Wegener for sterilization. Specifically, while Gagne does not disclose any particular wavelength for the UV curing, Andersson teaches that 365 and 395 nm are preferred wavelengths for curing liquid silicone rubber ([0075]). As noted above, Wegener teaches that it is preferred to use UV-C light (e.g., in the range of 250-280 nm) to kill or inactivate microorganisms ([0035]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the preferred wavelengths identified by Wegener and Andersson for the sterilization of the tube ends and the curing of the liquid silicone rubber, respectively.
Regarding claim 11, see the rejection of claim 10. Modified Gagne discloses a pharmaceutical media transfer method for supplying a pharmaceutical medium from a source reservoir to a target reservoir ([0002]-[0004] of Gagne), comprising:
providing the pharmaceutical medium in the source reservoir ([0002]-[0004] of Gagne) including a silicone supply tube being in media communication with the source reservoir (the tubing segment 12 of Gagne can serve as an inlet; [0024]-[0025]);
providing the target reservoir ([0002]-[0004] of Gagne) including a silicone discharge tube being in media communication with the target reservoir (the tubing segment 14 or 16 of Gagne can serve as an outlet; [0024]-[0025]);
displacing the pharmaceutical medium in a silicone supply tube section of the silicone supply tube ([0002]-[0004] of Gagne);
cutting the silicone supply tube section of the silicone supply tube for creating a sterile end face portion of the silicone supply tube section; cutting a silicone discharge tube section of the silicone discharge tube for creating a sterile end face portion of the silicone discharge tube section ([0042] of Zhang discloses that the tubes being joined can be cut. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have cut the tubing segments of Gagne as needed to achieve the desired length. This would represent a combination of prior art elements according to known methods to yield predictable results. See MPEP 2143(I)(A).);
connecting the silicone supply tube section with the silicone discharge tube section with the method according to claim 10, wherein the silicone supply tube section on the one hand and the silicone discharge tube section on the other hand represent the two silicone tube sections to be connected by the method (see the rejection of claim 10); and
transferring the pharmaceutical medium from the source reservoir to the target reservoir via the connected tube sections ([0002]-[0004] of Gagne).
Regarding claim 12, modified Gagne does not explicitly disclose that the cutting of the silicone supply tube section and/or the silicone discharge tube section is performed at a cutting temperature that is less than 80° C. However, Zhang discloses that “Any method of cutting is envisioned” ([0042]). In addition, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 13, see the rejections of claims 10 and 11. With respect to the recited UV source, and with respect to the recitation “wherein the silicone tube sections are positioned so as to be connected to one another at the end face portions thereof”, see the Claim Interpretation section above.
Regarding claim 14, modified Gagne discloses that the UV source comprises a first UV source for sterilizing the end face portions of the silicone tube sections to be connected by a UV light irradiation with the UV sterilization wavelength (the UV light bulb 62 of Wegener; [0035]; Fig. 1) and a second UV source for curing the flowable silicone by UV light irradiation with the UV curing wavelength (the UV light source 48 of Gagne; [0031]-[0032]; Fig. 3).
Regarding claim 19, see the rejection of claim 10, as well as the corresponding rejection under 35 U.S.C. 112(b). Modified Gagne discloses a method of using a liquid, UV curing silicone material as overmolding material in the method according to claim 10 ([0028] and [0032] of Gagne), comprising the step of applying a first UV wavelength to cure the silicone material ([0032] of Gagne; [0075] of Andersson).
Modified Gagne does not explicitly disclose applying a second UV wavelength to sterilize the silicone material.
Wegener discloses that the light source is used to irradiate the connectors and the coupler to sterilize them as they are connected ([0036]), and that the connectors and the coupler are irradiated for a period of time prior to being joined so that a sufficient dosage of UV-C light is delivered to sterilize the inner and outer surfaces of the coupler and the exterior surfaces of the connector valves ([0044]). The coupler 32 of Wegener is the component that is interposed between the two connectors and whose fluid flow path is placed in communication with the fluid flow paths of the connectors once the connection is made ([0045]). Wegener therefore sterilizes not only the tube-side components but also the material that is interposed between them and that forms part of the completed fluid path.
Zhang discloses that a fastening device surrounding at least a portion of the exterior seam of the coincidental bond may be a clamp, a polymer tape, an overmolded polymer, a glue, or a combination thereof ([0053], [0091]-[0092]). Zhang further discloses that the material applied over the seam is itself surface treated with the surface activation treatment described for the bonding and sterilizing of each of the two profiles, and that the surface activation treatment provides a method of bonding and sterilizing polymeric materials while maintaining a sterilized connection ([0054]-[0055]). Note that the surface activation treatment of Zhang is a corona treatment, a plasma treatment, or an ion treatment ([0051]). Zhang is relied upon for the teaching that the additional material which is applied to and forms part of the connection is itself sterilized, and Wegener is relied upon for the use of UV light irradiation as the sterilization means.
In modified Gagne, the flowable silicone is the material that is interposed between the sterilized end face portions and that forms part of the completed connection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the UV sterilization wavelength that is already applied to the end face portions to the silicone material as well, in order to maintain the sterility of the connection, as taught by Wegener and Zhang. Wegener discloses that UV-C light is known to kill or inactivate microorganisms ([0035]), so the sterilization acts upon the microorganisms rather than upon the substrate and would be expected to be effective on the silicone overmolding material as it is on the silicone tube sections. Further, Gagne discloses that the mold 40 should be transparent to UV radiation and stable during the curing process, and that the mold 40 may be made from quartz glass ([0031]), so the UV sterilization irradiation can be applied to the silicone material within the mold. This would represent the application of a known technique to a known method ready for improvement to yield predictable results. See MPEP 2143(I)(D).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Gagne in view of Zhang, Wegener, and Andersson, as applied to claim 13 above, and further in view of US 2013/0026682 (“Rist”).
Regarding claim 15, modified Gagne does not disclose that the UV source is configured such that the respective irradiation wavelengths for sterilizing the end face portions of the silicone tube sections to be connected and for curing the flowable silicone are settable by corresponding filters.
Rist discloses an irradiation unit for curing polymers with a selectable UV light source that enables the ideal wavelength to be chosen for the polymer being cured ([0144]-[0147]). The UV light source can be a UV lamp with wavelength-selective filters ([0136]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the irradiation unit of Rist in place of the separate UV light sources of Wegener and Gagne since Rist teaches that a single UV light source can still enable the use of different wavelengths, as desired for sterilization and curing. This would represent a simple substitution of one known element for another (one UV source configuration for another) to obtain predictable results. See MPEP 2143(I)(B).
Claims 16-18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Gagne in view of Zhang, Wegener, and Andersson, as applied to claim 13 above, and further in view of US 2023/0203419 (“Strange”).
Regarding claim 16, modified Gagne does not explicitly disclose a mobile configuration for laboratory use, clinical use, use in a clean room environment or use in a pre-series environment, wherein the apparatus is configured to be mobile and has a plurality of castors, which are mounted on a frame of the apparatus, and wherein the apparatus has a traction drive.
Strange discloses a robotic device 2 to manipulate a fluid connection between a first consumable 13 and a second consumable 13 to create an aseptic connection that enables a controlled transfer of fluid or cell material between the first consumable 13 and the second consumable 13 ([0129]). The robotic device 2 can comprise a wheel-mounted base unit 2a, which can house a motor and other control and communication componentry that are together configured to enable the robotic device 2 to move within or around a floor 17 of a bioprocessing system 1 ([0123]). The motor that enables the robotic device 2 to move within or around the floor 17 is a traction drive.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the apparatus of modified Gagne with wheels and a motor to enable the apparatus to connect different components of a system as needed. Note [0002]-[0004] of Gagne, which disclose that various reactants, solutions, and washes are often pumped or otherwise transported to various subsystems using conduits and associated valves and that there may be a large numbers of conduits.
Regarding claims 17 and 18, modified Gagne does not disclose the features of these claims. See also the rejection of claim 17 under 35 U.S.C. 112(b) above and the interpretation of claim 17 set forth therein.
Strange discloses a robotic device 2 to manipulate a fluid connection between a first consumable 13 and a second consumable 13 to create an aseptic connection that enables a controlled transfer of fluid or cell material between the first consumable 13 and the second consumable 13 ([0129]). Tubes 150 can have identification marks 150-1, such as QR codes, to provide data about the tubes 150, such as their location, orientation, materials, size, and/or other properties ([0142]). For example, the identification mark 150-1 can indicate: a unique reagent ID, a tube size and material (which can affect welding and pumping parameters), a distance between the identification mark 150-1 and the corresponding container 13, and/or the orientation of the tube (such as to indicate which direction leads towards the container 13) ([0142]). One advantage of providing the identification marks 150-1 is that the identification marks 150-1 can be used to indicate to a processing and control unit 38 what settings should be used for welding and pumping ([0142]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have placed QR codes on the tubes of modified Gagne so that connection of the tubes could proceed based on factors such as tube size and material, as taught by Strange. This would drive selection of the cutting blade and overmolding mold. Specifically, the overmolding mold would need to be sized appropriately for the tube size, and the cutting blade would depend on the tube size and/or material.
Regarding claim 21, see the rejection of claims 17 and 18. The QR codes disclosed by Strange ([0142]) are two-dimensional codes, and a reading unit that reads a QR code is a two-dimensional code reader.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Gagne in view of Zhang, Wegener, and Andersson, as applied to claim 19 above, as evidenced by US 5,952,397 (“Fujiki”).
Regarding claim 20, modified Gagne does not explicitly disclose that the UV curing of the silicone material in cured state has a hardness in the range of Shore A40 to Shore A60. However, this property is expected to be present. See MPEP 2112. Additionally, Fujiki discloses that, when a photocurable liquid silicone rubber composition is exposed to UV light, it forms a product having a Shore A hardness of 20-60 (Col. 1, Ln. 66 to Col. 2, Ln. 5).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to John DeRusso whose telephone number is (571)270-1287. The examiner can normally be reached Monday-Friday, 10:00 AM-6:00 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sam Zhao, can be reached at (571) 270-5343. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/John J DeRusso/Primary Examiner, Art Unit 1744
Prosecution Insights