DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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.
Claim 14 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.
The term “low-volatility polydimethylsiloxanes” in claim 14 is a relative term which renders the claim indefinite. The term “low-volatility polydimethylsiloxanes” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claim 14 is indefinite because it is not clear what volatility the polydimethylsiloxanes have to have in order to be considered “low-volatility”.
The term “low-temperature fluids” in claim 14 is a relative term which renders the claim indefinite. The term “low-temperature fluids” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claim 14 is indefinite because it is not clear what properties a fluid has to have in order to be considered a “low-temperature” fluid.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 6, 9, 11, 14-17, 22-25, 27, 28, 31 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al (U.S. Patent Publication No. 2011/0060313).
In the case of claims 1 and 33, Liu teaches a medical device such as a catheter made of a polymer substrate which had been infused with an impregnation fluid in the form of a surface modifying agent (Abstract, Page 2 Paragraph 0021 and Page 6 Claim 13).
As for claims 2 and 3, as was discussed previously, the device of Liu was a catheter and therefore the substrate was biocompatible and Liu further teaches that the polymer substrates comprised silicones (Page 5 Paragraph 0061).
As for claims 6, 9 and 14, Liu teaches that the impregnation fluid/modifying agent comprised silicone oils having polar/hydroxyl groups making the impregnation fluid hydrophilic (Page 4 Bottom of Paragraph 0038 and Paragraphs 0039-0055).
As for claim 11, Liu teaches having used a silicone oil with a viscosity of 15-20 centistokes (cSt) (Page 6 Paragraph 0064), which was within the claimed range.
As for claims 15-17, Liu teaches that substantially all of the free silicon oil was removed from the substrate surface and therefore not producing an immobilized liquid layer on the surface of the substrate by chemically removing the silicone oil from the surface of the substrate after impregnation by washing the substrate with hexane (Page 6 Paragraph 0064).
As for claims 22-25, as was discussed previously, Liu teaches having infused/impregnated the polymer substrate with silicone oil. Furthermore, according to Page 31 Paragraph 0136 of the specification of the present application as originally filed, when a polymer substrate is impregnated/infused with silicone oil the adhesion and/or adsorption of fibrinogen and serum albumin proteins is reduced and the adhesion and/or adsorption of the proteins of claim 25 is increased.
As for claims 27 and 28, the treated polymer substrate of Liu was a catheter tubing 21 for insertion into a patient (Page 5 Paragraphs 0057 and 0058) and therefore had an outward facing surface which interfaced with tissue and an inward facing surface which interfaced with a biological fluid.
In the case of claim 31, as was discussed previously in the rejection of claims 1, 3, 9 and 15, Liu teach infusing a polymeric substrate/tubing of a catheter comprised of silicone with silicone oil followed by removing any excess silicone oil from the surface of the substrate. Liu teaches that the infusing was conducted by immersing the substrate for a period of time in a fluid comprising the modifier/silicone oil (Page 3 Paragraph 0028).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al as applied to claim 3 above, and further in view of Davies et al (U.S. Patent # 10,857,329).
The teachings of Liu as it applies to claim 3 have been discussed previously and are incorporated herein.
In the case of claim 4, though Liu teaches that the polymeric substrate of the catheter comprised polymeric elastomers (Page 4 Paragraph 0035) including silicones (Page 5 Paragraph 0061) Liu does not specifically teach that the polymeric substrate comprised polydimethylsiloxane.
Davies teaches a catheter (Abstract) comprising a lumen comprised of a biocompatible stretchable polymer comprised of either silicone elastomers or polydimethylsiloxane (Column 7 Lines 33-54).
Based on the teachings of Davies, at the time the present invention was effectively filed it would have been obvious to one of ordinary skill in the art to have formed the polymeric substrate of Liu from polydimethylsiloxane because this was a known silicone material in the art for forming catheters.
Claims 5, 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al as applied to claim 1 above, and further in view of Hunter (U.S. Patent Publication No. 2004/0030301).
The teachings of Liu as it applies to claim 1 have been discussed previously and are incorporated herein.
In the case of claims 5, 7 and 8, though Liu teaches that the medical device comprised a polymeric substrate, Liu does not teach any of the specific polymer of claim 5. Furthermore, Liu does not teach that the polymeric substrate comprised an organogel including anthracene, anthraquinone or a steroid-based molecule. However as was discussed previously, the medical device of Liu was a catheter and Liu teaches that the polymeric substrate comprised a blend of polymers (Page 5 Paragraph 0059).
Hunter teaches a catheter comprising a hydrophilic surface coat (Abstract) comprised of anthraquinone and polyvinylpyrrolidone (Page 1 Paragraphs 0006 and 0015) wherein the body of the catheter was comprised of silicone (Page 1 Paragraph 0016).
Based on the teachings of Hunter, at the time the present invention was effectively filed it would have been obvious to one of ordinary skill in the art to have formed the polymeric substrate of Liu from polyvinylpyrrolidone and anthraquinone in order to provide the catheter with a hydrophilic surface coating.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al.
The teachings of Liu as it applies to claim 9 have been discussed previously and are incorporated herein.
In the case of claim 19, as was discussed previously, Liu teaches shaving impregnated/infused a polymeric substrate with silicone oil. Liu does not teach that the silicone oil was infused into the substrate at an amount of 50% to 99.99% of the maximum absorption capacity of the polymeric substrate. However, 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). See MPEP section 2144.05.II.A.
Furthermore, Liu teaches that the degree of impregnation was a relevant process parameter affecting the surface properties of the polymer substrate (Pages 3-4 Paragraph 0034) and that silicone oil affected the contact angle of the polymer substrate (Page 6 Paragraphs 0064-0066).
At the time the present invention was effectively filed it would have been obvious to one of ordinary skill in the art to have determined optimal absorption amounts of the silicone oil into the polymeric substrate of Liu through routine experimentation because the amount/degree of impregnation affected the contact angle of the polymeric substrate.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Spallek (U.S. Patent # 6,117,48) teaches a method for coating a catheter component with silicone oil and Smith, III (U.S. Patent # 5,639,810) teaches a method for infusing elastomer materials used in forming medical devices with silicone oil.
Conclusion
Claims 1 through 9, 11, 14 through 17, 19, 22 through 25, 27, 28, 31 and 33 have been rejected. No claims were allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P WIECZOREK whose telephone number is (571)270-5341. The examiner can normally be reached Monday - Friday, 6:00 AM - 3:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Cleveland can be reached at (571)272-1418. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P WIECZOREK/Primary Examiner, Art Unit 1712