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 § 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.
Claims 1-2 and 5-11 are rejected under 35 U.S.C. 103 as being unpatentable over Madsen et al (20140249489) in view of Webb (3522070).
Madsen teaches sterilized ready to use catheter.
Madsen, paragraph 18 of the PGPUB, teaches a sterilized set comprising a medical device provided with a hydrophilic coating and an aqueous liquid for wetting the hydrophilic coating.
Madsen, paragraph 22 of the PGPUB, teaches said liquid comprising a solution of a hydrophilic polymer.
Madsen, paragraph 23 of the PGPUB, teaches hydrophilic polymers can be water soluble polysaccharides or derivatives thereof such as carboxymethylcellulose (CMC).
Madsen, paragraph 36 of the PGPUB, teaches a set has been sterilized using radiation while in contact with said liquid comprising a solution of a hydrophilic polymer.
Madsen, paragraph 71 of the PGPUB, teaches a preferred embodiment pharmaceutically active compounds such as antioxidants.
Madsen, paragraph 69 of the PGPUB, teaches the wetting liquid of the invention may also, if desired, comprise plasticizers for the hydrophilic coating such as diethylene glycol.
Madsen, paragraph 31 of the PGPUB, teaches CMC is suitably used in an amount from 0.005 to 3.0%.
Although Madsen teaches a wetting liquid comprising 0.005 to 3.0% CMC, diethylene glycol and an antioxidant, Madsen does not teach the amount of diethylene glycol and antioxidant present in the wetting liquid.
Webb teaches an improvement in aqueous dispersion compositions for coating comprising water, emulsifying agent and organic-soluble, water-insoluble cellulosic polymer
Webb, col. 2, teaches the composition comprises 25-80% by weight of water.
Webb, col. 8, teaches sodium carboxymethyl cellulose present, in amounts of 0.05 to 1% by weight of the total composition, also can be added.
Webb, col. 8, teaches the compositions of this invention are useful in coating metal, wood, paper, fabric, plastic, fiber, etc.
Webb, col. 7, teaches antioxidants can be included in the composition such gallic acid.
Webb, cols. 7-8, teaches antioxidants can be included in the composition such gallic acid.
Antioxidants range from about .025 to 2% based on the weight of the cellulose derivative.
Webb, col. 8, teaches sodium carboxymethyl cellulose present, in amounts of 0.05 to 1% of the total composition, also can be added.
Therefore, antioxidants would be present in the composition in the amount of .0000125-.02 wt%.
Webb teaches the composition comprises optionally and preferably up to 30%, and preferably 8 to 12% of plasticizer.
Webb teaches surprisingly, the films made from compositions of the present modifications of the invention are considerably better in abrasion resistance than solvent-base films. Such improved abrasion resistance is of high importance for lacquers for automobiles, floors and many other uses. The compositions of this invention are also unique in that they yield clear films with a minimum of plasticizer coalescing agent and other costly solvent-type additives.
It 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 for the antioxidant as taught by Madsen to be gallic acid in the amount of .0000125-.02 wt% as taught by Webb and a plasticizer as taught by Madsen to be in the amount of 8 to 12% as taught by Webb as this composition is unique in that they yield clear films with a minimum of plasticizer coalescing agent and other costly solvent-type additives.
Diethylene glycol as taught by the references reads on a solution enhancer as claimed in claim 1.
Regarding claim 2, Webb, col. 8, teaches sodium carboxymethyl cellulose present, in amounts of 0.05 to 1% of the total composition, also can be added.
It 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 that CMC as taught by Madsen can be substituted out for sodium CMC as these are interchangeable compounds.
Regarding claim 5, Madsen, paragraph 35 of the PGPUB, teaches saline or another non-toxic osmolality increasing agent is preferably present in the physiological range.
Regarding claim 6, Webb, col. 2, teaches the composition comprises 25-80% by weight of water.
Regarding claims 7-8, Webb, cols. 7-8, teaches antioxidants can be included in the composition such gallic acid.
Antioxidants range from about .025 to 2% based on the weight of the cellulose derivative.
Therefore, antioxidants would be present in the composition in the amount of .0000125-.02 wt%.
Regarding claims 9-10, Madsen, paragraph 70 of the PGPUB, teaches buffers for pH or antibodies, e.g. monoclonal antibodies for specific proteins, may also be enclosed in the wetting liquid of the invention.
It 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 that a buffer solution has a neutral pH such as 7 to ensure the solution as a whole remains non-reactive.
Regarding claim 11, Madsen, paragraph 69 of the PGPUB, teaches the wetting liquid of the invention may also, if desired, comprise plasticizers for the hydrophilic coating such as diethylene glycol.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Madsen et al (20140249489) in view of Webb (3522070) as applied to claim 1 and further in view of Song (20050037048).
Although the references teach gallic acid to be an antioxidant, the references do not teach propyl gallate to be an antioxidant.
Song teaches a medical device containing an antioxidant.
Song, paragraphs 23-24 of the PGPUB, teaches one or more antioxidants are provided in the medical devices.
Antioxidants include gallic acid and alkyl gallates (propyl, octyl, dodecyl).
It 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 that propyl gallate as taught by Song can be used in place of gallic acid as taught by the references above as both gallic acid and propyl gallate are known antioxidants used in a medical devices.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Madsen et al (20140249489) in view of Webb (3522070) as applied to claim 1 and further in view of Madsen (WO2006037321) and further in view of Song (20050037048).
Madsen, paragraph 31 of the PGPUB, teaches CMC is suitably used in an amount from 0.005 to 3.0%.
The references teach gallic acid in the amount of .0000125-.02 wt%.
It 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 that CMC as taught by Madsen can be substituted out for sodium CMC as these are interchangeable compounds.
Webb teaches the composition comprises optionally and preferably up to 30%, plasticizer.
Although Madsen teaches plasticizers for the hydrophilic coating such as diethylene glycol, Madsen does not teach the plasticizer to be propylene glycol.
Madsen ‘321 teaches a medical device having a wetted hydrophilic coating.
Madsen ‘321 teaches the hydrophilic plasticizers for use in the coating compositions of the invention are selected from propylene glycol and dipropylene glycol.
It 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 that propylene glycol as taught by Madsen ‘321 can be used as a plasticizer as taught by the references above as Madsen ‘321 teaches either propylene glycol or dipropylene glycol are appropriate plasticizers for hydrophilic coatings.
Although the references teach gallic acid to be an antioxidant, the references do not teach propyl gallate to be an antioxidant.
Song teaches a medical device containing an antioxidant.
Song, paragraphs 23-24 of the PGPUB, teaches one or more antioxidants are provided in the medical devices.
Antioxidants include gallic acid and alkyl gallates (propyl, octyl, dodecyl).
It 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 that propyl gallate as taught by Song can be used in place of gallic acid as taught by the references above as both gallic acid and propyl gallate are known antioxidants used in a medical devices.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Madsen et al (20140249489) in view of Webb (3522070) as applied to claim 1 further in view of Bi et al (CN101314730, English translation).
Although the references teach stirring the mixture, the references do not teach ultrasonically agitating the mixture.
Bi, page 2, teaches by using the preparation method of the invention, the antioxidant can be quickly dissolved and dispersed in the biodiesel to form an antioxidant prefabricated liquid with good stability as long as the ultrasonic strengthening treatment is carried out at room temperature for 1-15 minutes.
The prefabricated liquid prepared by the method of the present invention has good stability. Ultrasound has the obvious effect of enhancing the rapid penetration and mutual dissolution of solid-liquid two-phase substances, and maintains the apparent temperature of the mixture at room temperature or near room temperature, which is conducive to maintaining the stability of the antioxidant prefabricated liquid.
It 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 to ultrasonically mix as taught by Bi the mixture as taught by the references above as the step of ultrasonically mixing has the obvious effect of enhancing the rapid penetration and mutual dissolution of solid-liquid two-phase substances, and maintains the apparent temperature of the mixture at room temperature or near room temperature, which is conducive to maintaining the stability of the antioxidant prefabricated liquid.
Response to Arguments
Applicant's arguments filed have been fully considered but they are not persuasive.
Applicant argues the compositions and films of Webb are meant to dry and harden. In contrast, claim 1 specifically recites that the composition is liquid. Accordingly, Webb fails the “field of endeavor” test.
It is unclear why a person of ordinary skill in the art looking to develop, e.g., liquid compositions for preventing or retarding degradation of a functional coating on a medical device, would look to compositions with, e.g., “improved abrasion resistance [] for lacquers for automobiles, floors and many other uses.” Webb, col. 8, Ins 30-42 (emphasis added). These are different problems. Accordingly, Webb fails the “reasonably pertinent” test.
Examiner respectfully traverses.
Webb, col. 1, teaches a unique basic coating dispersion, which can be formulated into a wide variety of finished compositions having a wide range of properties with a minimum of expensive additives.
Therefore, Webb demonstrates a teaching that the dispersion can be used in broadly any type of finished product such as the finished product of Madsen.
Further, Webb demonstrates that the amount of gallic acid as an antioxidant and the amount of a plasticizer taught in the references results is beneficial properties such as minimizing the plasticizer coalescing agent and other additives.
Webb is only used as teaching reference in order to teach the amount of gallic acid as an antioxidant and the amount of a plasticizer. It is noted that the "test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference... Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art", In re Keller, 642 F.2d 413,208 USPQ 871,881 (CCPA 1981) and that "combining the teachings of references does not involve an ability to combine their specific structures", In re Nievelt, 482 F.2d 965, 179 USP 224, 226 (CCPA).
It is also noted that there is no requirement in 35 U.S.C. 103, the MPEP or KSR International Co. v. Teleflex Inc. that a secondary reference must implicitly or explicitly acknowledge, appreciate or address the need for the solutions offered by a primary reference. Applicant's argument would improperly restrict the meaning of “obvious” under 35 U.S.C. 103.
It is noted that while Webb does not disclose all the features of the present claimed invention, Webb is used as teaching reference, namely to teach the amount of gallic acid as an antioxidant and the amount of a plasticizer, in order to minimize the plasticizer coalescing agent and other additives, and therefore, it is not necessary for this secondary reference to contain all the features of the presently claimed invention, In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973), In re Keller 624 F.2d 413, 208 USPQ 871, 881 (CCPA 1981). Rather this reference teaches a certain concept, and in combination with the primary reference, discloses the presently claimed invention.
Further, it is unclear to examiner if the coating, after the medical device has been irradiated while in contact with the composition, is present in liquid or solid form.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US20160250381 teaches crosslinked polymers.
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 STEFANIE J COHEN whose telephone number is (571)270-5836. The examiner can normally be reached 10am- 6pm M-F.
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, Coris Fung can be reached at (571) 270-5713. 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.
/STEFANIE J COHEN/Examiner, Art Unit 1732 11/6/25