DETAILED ACTION
The present application and its arguments have been reviewed and currently claims 1, 8-13, 17-20, and 23-24 are rejected, claims 2-4 are withdrawn, and claims 5-7, 14-16, and 21-22 are cancelled.
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 Arguments
Applicant's arguments filed 2/20/2026 have been fully considered but they are not persuasive.
In response to applicants arguments on page 8 that Wegener in view of Takemoto, and Inman does not disclose the newly added limitation, the examiner respectfully disagrees as the combination would not comprise a bonding material, primer, chemical treatment and would not comprise an external physical connector or thermal weld as the combination would disclose a device comprising two tube ends connected to each other using a surface activation treatment as opposed to conventional methods taught by both Wegner and Inman (ex., thermal weld or adhesives) based on the teachings of Takemoto (ex., see pages 3-6 of the Office Action on 11/20/2025, where the combination of Wegener in view of Inman and Takemoto would not disclose a device comprising a bonding material, thermal weld, or external connector).
In response to applicant's arguments on page 10 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). In this case, Wegener discloses sterilized medical tubes are known to be connected at the ends (see fig. 1), Inman explicitly discloses that silicone materials for medical tubes provide the benefit that the tubes will not degrade with any medical substances (3:51-56), and Takemoto explicitly discloses that using the conventional methods (ex., Wegner method or Inman method) on tubing provides drawbacks and using surface activation treatment allows silicone tubes (4:27-31) to be connected without using conventional methods (9:37-41).
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 8-13, 17-20, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Wegner et al. (U.S. PGPub No. 2014/0077488) in view of Takemoto (U.S. Patent No. 10,500,794) and Inman et al. (U.S. Patent No. 8,424,923).
In regards to claim 1, Wegner discloses:
A multi-lumen article (see fig. 2) comprising at least two profiles (see near 12) comprising at least two lumen (14a and 14b),
wherein the at least two profiles comprise a first profile (axial end face of 14a, fig. 4) and a second profile (axial end face of 14b, fig. 4; ex., see near 12 where both profits are abutting),
the first profile comprising a first end (ex., see fig. 9, where the tubes comprises ends fused together thermal fusion),
a first terminus at the first end having a first end surface (see fig. 4, where both pipes comprise end surfaces), and a first lumen (15a, fig. 9),
wherein the first lumen provides a fluid flow in a first path (see fig. 1, where 14a goes one path direction); and
the second profile comprising a second end (see the end of 14b in fig. 4),
a second terminus at the second end having a second end surface (see end of pipe 14b in fig. 4), and a second lumen (15b, fig. 9),
wherein the second lumen provides a fluid flow in a distinct path different than the first path (similarly, see fig. 1, where both fluid paths are distinct in direction),
wherein the first profile and the second profile comprises a thermoplastic (see 0045),
wherein the first end surface and the second end surface are abutted and coincidently bonded without a bonding material, a primer, a chemical treatment, or a combination thereof at an interface at the first end surface and the second end surface to form a sterile coincident bond (see fig. 4-9, where there is no bonding material therebetween),
the bond having cohesive strength between the first end surface and the second end surface (it is inherent that once the end faces are bonded that a cohesive strength remains between both end faces of the pipes),
wherein a first inner diameter of the first lumen (see 15a in fig. 9) and a second inner diameter of the second lumen (see 15b in fig. 9) are substantially the same to provide a continuous volume fluid flow from the first profile to the second profile (ex., see fig. 9, where there are diameters that are equal as these are constant diameter tubes),
wherein the fluid flow has a path that is substantially free of an external physical connector (ex., there is no suggestion of this as shown in fig. 2), and
wherein the profiles and the coincident bond are non-cytotoxic, non-hemolytic, non-pyrogenic, animal-derived component-free, non-mutagenic, non-bacteriostatic, non-fungistatic, or any combination thereof (as best understood, thermoplastics and thermosetting materials do not have properties that would prohibit the growth of bacteria/fungus/etc. or that would break down red blood cells or cause harm to cells),
but does not disclose:
wherein the first profile and the second profile comprise a thermoset silicone elastomer material.
In regards to using Silicone Elastomer (ex., silicone rubber), Inman discloses a similar device such that:
wherein “silicone is therefore used in this application such that the tubes 14 and manifold 12 will not significantly degrade, react with, leach or otherwise significantly absorb any medicinal substances as the medicinal substances pass through the tubes 14 and manifold 12” (3:51-56),
wherein in order to join the tubes and t-shaped connector, as adhesive is used (5:66-67 and 6:1-3),
Both Wegener and Inman does not disclose that thermoset silicone material can be joined to another thermoset silicone material without a bonding material therebetween (ex., adhesives are used in-between).
It would have been obvious to one of ordinary skill in the art before the effective filling date to modify both the first and second profile of Wegener to comprise a thermoset silicone material (ex., silicone rubber) because Inman discloses that tubes are known to comprises silicone materials (3:51-67 and 4:1-17) to provide the benefit that Silicone Rubber will not significantly degrade, react with, leach or otherwise significantly absorb any medicinal substances as the medicinal substances pass through the tubes and connector (3:51-56; ex., pharmaceutical companies) and it has been held that a selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). See MPEP 2144.07.
In regards to bonding Thermoset Silicone, Takemoto discloses two silicone resin tubes (10 and 11, fig. 1; see 4:27-31, where the tubes are the same material and made of silicone resin) bonded together without an adhesive or thermal fusion (ex., butt fusion welding) such that they are coincidently bonded via the use of surface activation treatment such as ultraviolet irradiation treatment or plasma treatment (5:5-13; see fig. 3, where an ultraviolet treatment is used; see fig. 4, where a plasma treatment is used; see fig. 5 where all that is required is fold portion 11 over),
wherein the surface activation treatment eliminates the drawbacks of joining tubes by conventional methods, such as adhesives or thermal fusion (ex., butt fusion welding), which can create defects such as stiffness and contraction at the joining portions of the tubes (9:37-41; 1:46-51, where drawbacks of thermal fusion are disclosed; 1:52-64, where other drawbacks of adhesives are disclosed),
wherein thermal fusion of joining portion is hardened, which may, in turn, impair the flexibility of the resulting tube assembly (1:46-51),
wherein “the degree of freedom for selecting a material(s) for the first tube and the second tube is large, and in addition, thermal fusion of the first tube and the second tube or use of an adhesive is not required. This can eliminate development of a defect such as stiffness and contraction at the joining portions of the tubes.” (3:28-33)
It would have been obvious to one of ordinary skill in the art before the effective filling date to use a surface activation treatment on the ends of the first and second tube of Wegener in view of Inman to provide a large degree of material selection and eliminate the need of butt-fusion/adhesives which can cause defects such as stiffness/contraction at the joining parts of tubes because Wegener discloses that it is known to use fusion to bond thermoplastic tubes together, Inman discloses that adhesives are used to connect silicone tubes to each other (5:66-67 and 6:1-3), and Takemoto discloses that surface activation treatment eliminates the drawbacks of joining tubes by conventional methods, such as adhesives or thermal fusion, which can create defects such as stiffness and contraction at the joining portions of the tubes (9:37-41; 1:46-51, where drawbacks of thermal fusion are disclosed; 1:52-64, where other drawbacks of adhesives are disclosed) and allows for a larger material selection of the tubes (3:28-33).
In regards to claim 8, Wegener further discloses:
The multi-lumen article in accordance with claim 1, wherein the first profile comprises a tube.
In regards to claim 9, Wegener in view of Inman and Takemoto further discloses:
The multi-lumen article in accordance with claim 1, wherein the coincident bond withstands a seal integrity pressure test of at least 1 psi air pressure for about 30 minutes under dry and wet conditions (it appears there is nothing structural that would prevent such functional limitation).
In regards to claim 10, Wegener in view of Inman and Takemoto further discloses:
The multi-lumen article in accordance with claim 1, wherein the coincident bond is provided via surface activation treatment (see the rejection of claim 1 above where Takemoto uses a surface activation treatment).
It is noted that “wherein the coincident bond is provided via surface activation treatment” is a product-by-process limitation. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). It is the patentability of the product that is to be determined and not recited process steps irrespective of whether or not only process steps are set forth.
In regards to claim 11, Wegener in view of Inman and Takemoto further discloses:
The multi-lumen article in accordance with claim 10, wherein the surface activation treatment comprises processing input energy to a surface of the first profile, the second profile, or combination thereof with wave irradiation, particle irradiation, or combination thereof (see the rejection of claim 1 above where Takemoto uses a surface activation treatment).
It is noted that “wherein the surface activation treatment” is a product-by-process limitation. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). It is the patentability of the product that is to be determined and not recited process steps irrespective of whether or not only process steps are set forth.
In regards to claim 12, Wegener in view of Inman and Takemoto further discloses:
The multi-lumen article in accordance with claim 10, wherein the surface activation treatment provides a sterile connection of a treated surface of the at least one profile (it is inherent that providing a surface activation treatment would provide a sterile connection as Wegner explicitly discloses a sterile connection).
It is noted that “wherein the surface activation treatment” is a product-by-process limitation. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). It is the patentability of the product that is to be determined and not recited process steps irrespective of whether or not only process steps are set forth.
In regards to claim 13, Wegener discloses:
A method of providing a multi-lumen article (see fig. 2 hereinafter) comprising:
providing at least a first profile (see near 14a) comprising a first end (see near 12 on the left side), a first terminus at the first end having a first end surface (axial end face of 14a), and a first lumen (15a);
providing at least a second profile (see near 14b) comprising a second end (see near 12 on the right side), a second terminus at the second end having a second end surface (axial end face of 14b), and a second lumen (15b),
contacting the second end surface of the second profile directly abutted to the first end surface of the first profile to coincidently bond without a bonding material, a primer, a chemical treatment, or combination thereof the first end surface to the second end surface at an interface of the first end surface and the second end surface and provide a fluid path (ex., compare from fig. 4 to fig. 9, where fig. 9 shows both bonded),
wherein the first lumen has fluid flow in a first path (ex., see 14a in fig. 1) and the second lumen has a fluid flow in a distinct path different than the first path (ex., see 14b in fig. 1) and
wherein the bond has cohesive strength between the first end surface and the second end surface (see fig. 2),
wherein a first inner diameter of the first lumen (see 15a in fig. 9) and a second inner diameter of the second lumen (see 15b in fig. 9) are substantially the same to provide a continuous volume fluid flow from the first profile to the second profile (ex., see fig. 9, where there are diameters that are equal as these are constant diameter tubes),
wherein the fluid path is substantially free of an external physical connector (ex., there is no suggestion of this as shown in fig. 2), and
wherein the profiles and the coincident bond are non-cytotoxic, non-hemolytic, non-pyrogenic, animal-derived component-free, non-mutagenic, non-bacteriostatic, non-fungistatic, or any combination thereof (as best understood, thermoplastics and thermosetting materials do not have properties that would prohibit the growth of bacteria/fungus/etc. or that would break down red blood cells or cause harm to cells),
but does not disclose:
wherein the first profile and the second profile comprise a thermoset silicone elastomer material;
providing a surface activation treatment;
treating at least the first end surface, the second end surface, or combination thereof with the surface activation treatment,
wherein the surface activation treatment provides a sterile connection of the treated surface of at least the first profile, the second profile, or combination thereof.
In regards to using Silicone Elastomer (ex., silicone rubber), Inman discloses a similar device such that:
wherein “silicone is therefore used in this application such that the tubes 14 and manifold 12 will not significantly degrade, react with, leach or otherwise significantly absorb any medicinal substances as the medicinal substances pass through the tubes 14 and manifold 12” (3:51-56),
wherein in order to join the tubes and t-shaped connector, as adhesive is used (5:66-67 and 6:1-3),
Both Wegener and Inman does not disclose that thermoset silicone material can be joined to another thermoset silicone material without a bonding material therebetween (ex., adhesives are used in-between).
It would have been obvious to one of ordinary skill in the art before the effective filling date to modify both the first and second profile of Wegener to comprise a thermoset silicone material (ex., silicone rubber) because Inman discloses that tubes are known to comprises silicone materials (3:51-67 and 4:1-17) to provide the benefit that Silicone Rubber will not significantly degrade, react with, leach or otherwise significantly absorb any medicinal substances as the medicinal substances pass through the tubes and connector (3:51-56; ex., pharmaceutical companies) and it has been held that a selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). See MPEP 2144.07.
In regards to bonding Thermoset Silicone, Takemoto discloses two silicone resin tubes (10 and 11, fig. 1; see 4:27-31, where the tubes are the same material and made of silicone resin) bonded together without an adhesive or thermal fusion (ex., butt fusion welding) such that they are coincidently bonded via the use of surface activation treatment such as ultraviolet irradiation treatment or plasma treatment (5:5-13; see fig. 3, where an ultraviolet treatment is used; see fig. 4, where a plasma treatment is used; see fig. 5 where all that is required is fold portion 11 over),
wherein the surface activation treatment eliminates the drawbacks of joining tubes by conventional methods, such as adhesives or thermal fusion (ex., butt fusion welding), which can create defects such as stiffness and contraction at the joining portions of the tubes (9:37-41; 1:46-51, where drawbacks of thermal fusion are disclosed; 1:52-64, where other drawbacks of adhesives are disclosed),
wherein thermal fusion of joining portion is hardened, which may, in turn, impair the flexibility of the resulting tube assembly (1:46-51),
wherein “the degree of freedom for selecting a material(s) for the first tube and the second tube is large, and in addition, thermal fusion of the first tube and the second tube or use of an adhesive is not required. This can eliminate development of a defect such as stiffness and contraction at the joining portions of the tubes.” (3:28-33)
It would have been obvious to one of ordinary skill in the art before the effective filling date to use a surface activation treatment on the ends of the first and second tube of Wegener in view of Inman to provide a large degree of material selection and eliminate the need of butt-fusion/adhesives which can cause defects such as stiffness/contraction at the joining parts of tubes because Wegener discloses that it is known to use fusion to bond thermoplastic tubes together, Inman discloses that adhesives are used to connect silicone tubes to each other (5:66-67 and 6:1-3), and Takemoto discloses that surface activation treatment eliminates the drawbacks of joining tubes by conventional methods, such as adhesives or thermal fusion, which can create defects such as stiffness and contraction at the joining portions of the tubes (9:37-41; 1:46-51, where drawbacks of thermal fusion are disclosed; 1:52-64, where other drawbacks of adhesives are disclosed) and allows for a larger material selection of the tubes (3:28-33).
In regards to claim 17, Wegner further discloses:
The method of providing the multi-lumen article in accordance with claim 13, wherein the first profile comprises a tube (see fig. 2).
In regards to claim 18, Wegner in view of Inman and Takemoto further discloses:
The method of providing the multi-lumen article in accordance with claim 13, wherein the coincident bond withstands a seal integrity pressure test of at least 1 psi air pressure for about 30 minutes under dry and wet conditions.
In regards to claim 19, Wegner in view of Inman and Takemoto further discloses:
The method of providing the multi-lumen article in accordance with claim 13, wherein the surface activation treatment comprises processing input energy to a surface of the first profile, the second profile, or combination thereof with wave irradiation, particle irradiation, or combination thereof.
In regards to claim 20, Wegner in view of Inman and Takemoto further discloses:
The method of providing the multi-lumen article in accordance with claim 13, wherein the surface activation treatment provides a sterile connection of a treated surface of the first profile and the second profile.
In regards to claim 23, Wegner in view of Inman and Takemoto further discloses:
The multi-lumen article in accordance with claim 1, wherein the first end surface has a first wall thickness and the second end surface has a second wall thickness, wherein the first wall thickness and the second wall thickness are substantially the same (it is inherent that not using thermal fusion both ends of Wegner would result in the ends be the same).
In regards to claim 24, Wegner in view of Inman and Takemoto further discloses:
The method of providing the multi-lumen article in accordance with claim 13, wherein the first end surface has a first wall thickness and the second end surface has a second wall thickness, wherein the first wall thickness and the second wall thickness are substantially the same (it is inherent that not using thermal fusion both ends of Wegner would result in the ends be the same).
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 ALEXANDER TYLER RUFRANO whose telephone number is (571)272-6223. The examiner can normally be reached Mon - Fri 8:30AM to 4:30PM.
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/A.T.R./Examiner, Art Unit 3679
/Matthew Troutman/Supervisory Patent Examiner, Art Unit 3679
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