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 .
Status of the Claims
By amendment filed June 23, 2026 claims 1, 14, 31 and 33 have been amended, claim 60 is new and claim 16 has been cancelled. Claims 1 through 9, 11, 14, 15, 17, 19, 22 through 25, 27, 28, 31, 33 and 60 are currently pending.
Response to Arguments
Applicant's arguments filed June 23, 2026 have been considered but they are not fully persuasive. Applicant’s arguments against claims 1 and 31 have overcome the prior art rejections. However, previously cited reference Spallek (U.S. Patent # 6,117,480) taught that it was known in the art to remove excess silicone oil from the surface of a medical device mechanically by passing the device through a foil after infusion/impregnation.
Applicant’s arguments against claim 33 are not persuasive because claim 33 is a product-process-claim and applicant has not provided any objective evidence or argument that mechanically removing excess impregnation fluid from the surface of a polymeric substrate would have produced a medical device structurally different from the medical device taught by Liu. "[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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983). See MPEP section 2113.
New claim 60 is not persuasive over the prior art of record because Liu teaches an embodiment wherein the silicone oil had a viscosity of 150-20 cSt (Page 6 Paragraph 0064), which was within the claimed range.
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.
Claim 33 is 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 claim 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). Liu further teaches that excess impregnation fluid in the form of silicone oil was removed from the surface of the polymeric substrate post-infusion (Page 6 Paragraph 0064).
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 1-3, 6, 9, 11, 14-15, 17, 19, 22-25, 27-28, 31, 33 and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al in view of Spallek et al (U.S. Patent # 6,117,480).
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). Liu further teaches that the modifying agent comprised silicone oil and was removed after infusion/impregnation (Page 6 Paragraph 0064).
Though Liu teaches having removed post-infusion excess impregnation fluid from the surface of the substrate Liu does not teach that the removal was conducted mechanically.
Spallek teaches a method for coating/impregnating a medical cannula with silicone oil wherein after impregnation the excess silicone oil was removed from the cannula mechanically by passing the impregnated cannula through a foil (Abstract and Column 4 Lines 36-46). Spallek teaches by mechanically removing excess silicone oil by passing the cannula through the foil an invisible thin and continuous layer of silicone oil was obtained as well as removing any potentially adhering particles (Column 4 Lines 47-60).
Based on the teachings of Spallek, at the time the present invention was effectively filed it would have been obvious to one of ordinary skill in the art to have mechanically removed the excess impregnation fluid/silicone oil from the surface of the substrate of Liu by passing the infused substrate through a foil in order to substantially remove all the silicone oil from the surface leaving only an invisible layer and removing any potentially adhering particles from the substrate surface.
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 claims 11 and 60, 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 and 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 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 in view of Spallek through routine experimentation because the amount/degree of impregnation affected the contact angle of the polymeric substrate.
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 in view of Spallek teach infusing a polymeric substrate/tubing of a catheter comprised of silicone with silicone oil followed by mechanically 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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al in view of Spallek 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 in view of Spallek as they apply 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 in view of Spallek 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 in view of Spallek 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 in view of Spallek as they apply 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 in view of Spallek from polyvinylpyrrolidone and anthraquinone in order to provide the catheter with a hydrophilic surface coating.
Conclusion
Claims 1 through 9, 11, 14, 15, 17, 19, 22 through 25, 27, 28, 31, 33 and 60 have been rejected. No claims were allowed.
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 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
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