Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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.
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 99-100, 104-108, 110-119, and 121-124 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 99, line 9 recites “an effective amount of a first hydrosilylation catalyst”. The scope of the claim is confusing given that it is not clear what is meant by “effective” amount or what would be considered an “effective” amount of the catalyst.
Claim 99, line 18 recites “an effective amount of a second hydrosilylation catalyst”. The scope of the claim is confusing given that it is not clear what is meant by “effective” amount or what would be considered an “effective” amount of the catalyst.
Claim 99, line 19 recites “a substantial amount of the first cross-linkable polymer”. The scope of the claim is confusing given that it is not clear what is meant by “substantial” amount or what amounts would be considered “substantial”.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 99-100, 104-108, 110-112, 114, 116-119, 121-122, and 124 are rejected under 35 U.S.C. 103 as being unpatentable over Nadeau et al. (US 2017/0191586) in view of Yeakle et al. (US 2020/0157345) and Adler et al. (US 2008/0315148) as evidenced by Jansen (Comparing Thermoplastic Elastomers and Thermoset Rubber) .
Regarding claims 99-100, 104, 106-108, 110-112, 114, 116-117, and 124, Nadeau et al. disclose a composite tube (see paragraph 0002) comprising inner layer (i.e. first layer) that includes a silicone polymer and outer layer that includes a thermoplastic polymer (see paragraph 0017). The inner layer includes any reasonable silicone polymer including hydride-containing polydimethylsiloxane and vinyl-containing polydimethylsiloxane as well as platinum catalyst (see paragraphs 0018-0019). The outer layer (i.e. second layer) includes ethylene propylene diene elastomer (EPDM) as well as crosslink promoter and siloxane catalyst (see paragraphs 0030 and 0032).
Nadeau et al. do not disclose first layer or second layer as presently claimed.
Yeakle et al. disclose curable silicone composition for tubing (see paragraphs 0001 and 0016). The composition comprises linear polysiloxane (i.e. first cross-linkable polymer), crosslinker (i.e. first crosslinker), and hydrosilylation catalyst (i.e. first hydrosilylation catalyst) (see paragraph 0004). The linear polysiloxane includes polysiloxane having at least two alkenyl groups (see paragraphs 0008-0010) where alkenyl group necessarily contains carbon-carbon double bond. The crosslinker is a polysiloxane containing at least two silicone-bonded hydrogen atoms (see paragraph 0012). The hydrosilylation catalyst includes platinum catalyst (see paragraph 0012). The composition comprises 80-98 wt.% component A which comprises 30-80 wt.% linear polysiloxane (see paragraph 0013) and therefore, it is calculated that the composition comprises 24-78.4 wt.% linear polysiloxane (0.3*80 – 0.8*98). The composition comprises about 7 wt.% crosslinker (see Table 1). The catalyst is present in a catalytic quantity (i.e. effective amount) (see paragraph 0012). The composition has excellent light transmittance in the UVC wavelength range while retaining mechanical properties (see paragraph 0024).
In light of the motivation for using curable silicone composition disclosed by Yeakle et al. as described above, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to use the curable silicone composition as the inner layer of Nadeau et al. in order to produce composite tube that has excellent light transmittance in the UVC wavelength range as well as good mechanical properties.
Nadeau et al. in view of Yeakle et al. do not disclose second layer as presently claimed.
Adler et al. discloses rubber compound (see paragraph 0001) comprising 100 phr rubber (i.e. second cross-linkable polymer), crosslinking agent (i.e. second crosslinking agent), and hydrosilylation catalyst (i.e. second hydrosilylation catalyst) (see paragraphs 0014-0016). The rubber includes EPDM a well as butadiene rubber, isoprene rubber, and polyisobutylene having two terminal vinyl groups, i.e. rubber having a first terminal group and second terminal group that is vinyl (C2 alkenyl) group (see paragraphs 0021-0022) which necessarily contain at least two carbon-carbon double bonds. The crosslinker includes siloxane crosslinking agent comprising at least two SiH groups (see paragraphs 0024-0025). The hydrosilylation catalyst includes platinum catalyst (see paragraph 0031). The crosslinker is present in an amount of about 3-5% (4/124 – 6/128) (see Table 1A, first three examples). Given that the cross-linkable polymer of Adler et al. is a rubber as described above, the rubber compound does not include a polysiloxane cross-linkable polymer. The rubber compound has improved mechanical properties including an increase in elongation at break, the tensile strength and/or the tear propagation resistance (see paragraph 0013).
In light of the motivation for using rubber compound disclosed by Adler et al. as described above, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to use the rubber compound of Adler et al. as the outer layer of Nadeau et al. in view of Yeakle et al. in order to produce composite tube with improved mechanical properties including an increase in elongation at break, the tensile strength and/or the tear propagation resistance.
Regarding claim 105, it is well known as evidenced by Jansen that polybutadiene rubber, butyl rubber, and isoprene rubber are thermosetting (see page 37).
Regarding claims 118-119, Nadeau et al. discloses the inner layer (i.e. first layer) has a thickness of 0.022 inches or 0.56 mm while the outer layer (i.e. second layer) has a thickness of 0.019 inches or 0.48 mm (see paragraph 0098).
Regarding claim 121, Nadeau et al. disclose each layer is cured or crosslinked to form the composite tube (see paragraphs 0020, 0047, 0057).
Regarding claim 122, Nadeau et al. disclose the inner layer (i.e. first layer) defines the central lumen (see paragraph 0006).
Claims 113 and 115 are rejected under 35 U.S.C. 103 as being unpatentable over Nadeau et al. (US 2017/0191586) in view of Yeakle et al. (US 2020/0157345) and Adler et al. (US 2008/0315148) as applied to claim 99 above and further in view of Kropp et al. (US 2002/0142174).
Regarding claims 113 and 115, Nadeau et al. in view of Yeakle et al. and Adler et al. disclose article as set forth above, however, there is no disclosure that the first-crosslinker and the second cross-linker are the same and of formula III as claimed.
Adler et al. disclose second cross-linker of the following formula:
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81
276
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where R1 is C1-C10 hydrocarbon group including alkyl group, R2 is oxygen, and a=b=0-20 (see paragraphs 0024-0025 and 0028) and therefore is identical to that of claimed Formula III.
Yeakle et al. disclose that the first cross-linker is a polysiloxane containing at least two silicon-bonded hydrogen atoms and contain units including R2SiO2/2 and HR2SiO1/2 (see paragraph 0012) but do not explicitly disclose that the first cross-linker is of formula III as claimed.
Kropp et al. disclose heat-curable silicone composition comprising reactive silicone having at least two unsaturated functional groups, silicone crosslinker having at least two reactive silicon hydride functional groups, and a catalyst including platinum catalyst (see paragraphs 0015-0018 and 0062). The silicone crosslinker is of the formula:
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114
315
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where R7 and R9 are H, R8 and R10 are C1-C20 alkyl group, x=10-10,000, and y=1-20 (see paragraphs 0040 and 0046-0047) and therefore is identical to that of claimed Formula III as well as the second cross-linker of Adler et al. The silicone crosslinker is present in amount of about 1% to about 10% to achieve desired amount of crosslinking (see paragraph 0047).
In light of the motivation for using about 1% to about 10% silicone crosslinker disclosed by Kropp et al. as described above, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to use the silicone crosslinker as the first cross-linker in Nadeau et al. in view of Yeakle et al. and Adler et al. in order to produce composite tube with desired amount of crosslinking. The 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 also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).”
Claim is 123 rejected under 35 U.S.C. 103 as being unpatentable over Nadeau et al. (US 2017/0191586) in view of Yeakle et al. (US 2020/0157345) and Adler et al. (US 2008/0315148) as applied to claim 121 above and further in view of Patterson et al. (US 2007/0005003).
Regarding claim 123, Nadeau et al. in view of Yeakle et al. and Adler et al. disclose article as set forth above, however, while Nadler et al. disclose composite tube (see paragraph 0002) including as a medical device (see paragraph 0061) made from inner layer and outer layer (see paragraph 0017), there is no disclosure of dual-chambered tube as claimed.
Patterson et al. disclose a multi-lumen catheter including a dual lumen catheter (see Abstract, paragraph 0042, Fig 1). It is disclosed that these catheters are made of materials including silicon (see paragraph 0044). Multi-lumen catheters are known to be used for the purpose of creating two or more separate fluid pathways (see paragraph 0005).
In light of the disclosure of Patterson et al., it would have been obvious to one of ordinary skill in the art to use the layers of Nadeau et al. in view of Yeakle et al. and Adler et al. to form a specific composite tube, namely, a dual lumen catheter and thereby arrive at the claimed invention.
Response to Arguments
Applicant’s arguments filed 10/23/2025 have been fully considered and are persuasive. Therefore, the rejections of record have been withdrawn. However, upon further consideration, new grounds of rejection are set forth above and therefore, the action is non-final.
Conclusion
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/CALLIE E SHOSHO/Supervisory Patent Examiner, Art Unit 1787