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 § 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(s) 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al. (US 2001/0027299 A1).
With regard to claim 33, Yang discloses A coated medical device (Fig. 2) comprising: a substrate (24); and a lubricious coating (13/15), the lubricious coating comprising a hydrogel layer (13); and long polymer chains (15, [0029]), wherein the long polymer chains are disposed at least partially within the lubricious coating ([0029]).
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.
Claim(s) 1, 3, 6-9, 11-13, 17, 21-22, 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 2001/0027299 A1) in view of Kizhakkedathu et al. (US 2013/0303981 A1).
With regard to claim 1 and 3, Yang discloses A coated medical device (fig. 2) comprising: a substrate (24); and a lubricious coating (13/15), the lubricious coating comprising an outer protective layer (15), the outer protective layer comprising long polymer chains ([0029], hydrogel coating is generally chain-structured, non-crosslinked polymers), and wherein the lubricious coating is disposed on the substrate (as seen in Fig. 2). Yang discloses the claimed invention except for the specific average chain length of greater than 100kDa or between 100 and 300 kDa. However, it would be prima facie obvious for one of ordinary skill in the art to optimize the length of the polymer chain as doing so would not alter the overall function of the device.
However, Yang does not explicitly disclose that the chains include a bonded end and a mobile free end.
Kizhakkedathu teaches a substrate (Fig. 1a, element 10) with a lubricious coating comprising long polymer chains (12) wherein the long polymer chains include a bonded end and a mobile free end (see Fig. 1a, showing the bonded end on the substrate and the chain extending radially away creating a mobile free end).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the polymer chains of Yang with the mobile free end as taught by Kizhakkedathu for the purpose of allowing the coating to respond to stimuli and allowing it to return to its original shape afterwards ([0052]).
With regard to claim 6, Yang discloses the long polymer chains except for the specific material.
Kizhakkedathu teaches comprising at least one selected from the group consisting of a comb structure, a bottle brush structure (Fig. 1a), a star structure, a hyperbranched structure, a mucin structure, and a dendritic structure.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the polymer chains of Yang with the mobile free end as taught by Kizhakkedathu for the purpose of allowing the coating to respond to stimuli and allowing it to return to its original shape afterwards ([0052]).
With regard to claim 7, Yang discloses wherein the long polymer chains are uncross-linked ([0029]).
With regard to claim 8, Yang discloses the lubricious coating further comprising an underlying hydrogel layer (13, [0029], [0038]).
With regard to claim 9, Yang discloses the hydrogel layer comprising one or more of polyvinylpyrrolidone (PVP), a photo-reactive PVP, polyacrylamide (PA) ([0021], claim 2), and a photo- reactive PA.
With regard to claim 11, Yang discloses the hydrogel layer comprising: a first sublayer (13); and a second sublayer (15).
With regard to claim 12, Yang discloses wherein the second sublayer is crosslinked to a greater extent than the first sublayer (first sublayer is the hydrogel coating which is non-crosslinked polymers, [0029], the second layer can be made of cross-linked polymers [0032], thus making it more cross linked than the first sublayer).
With regard to claim 13, Yang discloses the lubricious coating further comprising a base coat (13).
With regard to claim 17, Yang discloses the claimed invention except for the specific material of the polymer chains.
Kizhakkedathu teaches the long polymer chains comprising at least one selected from the group consisting of a polyvinylpyrrolidone, a polyvinylalcohol, a polyacrylamide, a polyethyleneglycol ([0063]), a polysulfobetaine, a phosphoryl choline capped polymer, and a poloxamer.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the polymer chains of Yang with the specific material as taught by Kizhakkedathu because the substitution of one well-known material for another is within the skill of one of ordinary skill in the art and does not alter the overall function of the device ([0063]).
With regard to claim 21, Yang discloses the long polymer chains comprising a non-ionic backbone chain ([0038]).
With regard to claim 22, Yang discloses wherein the long polymer chains are grafted onto an underlying surface or at least partially embedded within and crosslinked into an underlying layer ([0029], [0032], [0038]).
With regard to claim 25, Yang discloses the outer protective layer (15).
However Yang does not disclose non-covalently bonded.
Kizhakkedathu teaches further comprising non-covalently bonded long polymer chains, wherein the non-covalently bonded long polymer chains are configured to elute from the lubricious coating ([0112]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the polymer chains of Yang with the specific material as taught by Kizhakkedathu because the substitution of one well-known material for another is within the skill of one of ordinary skill in the art and does not alter the overall function of the device ([0112]) and further for providing ending capabilities ([0112]).
With regard to claim 26, Yang discloses the claimed invention except for the covalently bonded end and a mobile free end.
Kizhakkedathu teaches wherein the long polymer chains include a covalently bonded end ([0112]) and a mobile free end (see Fig. 1a, element 12).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the polymer chains of Yang with the mobile free end and covalently bonded end as taught by Kizhakkedathu for the purpose of allowing the coating to respond to stimuli and allowing it to return to its original shape afterwards ([0052]).
With regard to claim 33, Yang discloses A coated medical device (Fig. 2) comprising: a substrate (24); and a lubricious coating (13/15), the lubricious coating comprising a hydrogel layer (13); and long polymer chains (15, [0029]), wherein the long polymer chains are disposed at least partially within the lubricious coating ([0029]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 2001/0027299 A1) in view of Kizhakkedathu et al. (US 2013/0303981 A1) in further view of Shelley et al. (US 2009/0088711 A1).
With regard to claim 10, Yang/Kizhakkedathu teach the claimed invention except for a coefficient of friction.
Shelley teaches a multi layer coated medical device that teaches the layers having different coefficient of frictions (abstract, claim 2). Further it would be prima facie obvious to optimize the coefficient of friction as doing so would not alter the overall function of the device.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yang/Kizhakkedathu with the different coefficients of friction as taught by Shelley for the purpose of forming a catheter tube that is able to be inserted into the body (abstract, claim 2).
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 2001/0027299 A1) in view of Kizhakkedathu et al. (US 2013/0303981 A1) in further view of Li et al. (US 2013/0158518 A1).
With regard to claim 18, Yang/Kizhakkedathu teach the claimed invention except for polyzwitterion.
Li teaches a coated medical device using a hydrophilic polymeric material similar to the device material of Yang ([0190]). Li further teaches the long polymer chains comprising a polyzwitterion ([0190], [0196], [0198, [0207]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yang/Kizhakkedathu with the polyzwitterion as taught by Li for the purpose of creating a non-fouling material for the medical device ([0196]).
With regard to claim 19, Yang/Kizhakkedathu teach the claimed invention except for polyzwitterion.
Li teaches the long polymer chains comprising a zwitterionic subunit, wherein the zwitterionic subunit disposed on an exterior portion of the long polymer chains ([0190], [0196], [0198], [0207]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yang/Kizhakkedathu with the polyzwitterion as taught by Li for the purpose of creating a non-fouling material for the medical device ([0196]).
With regard to claim 20, Yang/Kizhakkedathu teach the claimed invention except for polyzwitterion.
Li teaches the long polymer chains comprising a zwitterionic subunit, wherein the zwitterionic subunit is disposed on an end of the long polymer chains. ([0190], [0196], [0198], [0207]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yang/Kizhakkedathu with the polyzwitterion as taught by Li for the purpose of creating a non-fouling material for the medical device ([0196]).
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 2001/0027299 A1) in view of Dapron et al. (US 2003/0032013 A1).
With regard to claim 33, Yang discloses A coated medical device (Fig. 2) comprising: a substrate (24); and a lubricious coating (13/15), the lubricious coating comprising a hydrogel layer (13); and long polymer chains (15, [0029]), wherein the long polymer chains are disposed at least partially within the lubricious coating ([0029]).
However, Yang does not disclose the length of the polymer chains.
Dapron teaches a polymer coating ([0052]) and further teaching the polymer chains are between 100 to 300kDA ([0038]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yang with the polymer chain length as taught by Dapron for the purpose of optimizing the chain length for coating ([0038], [0052]).
Response to Arguments
Applicant's arguments filed 7/7/26 have been fully considered but they are not persuasive. Applicant states that it would not be obvious to optimize the prior art of Yang to teach the polymer chain length. Applicant states that support for the rejection is needed for routine optimization and Yang does not mention a chain length and therefore would not be obvious to modify. Applicant also specifically mentions that the long chains provide specific benefits not discussed in Yang. It is believed that the specific long polymer change range can be optimized as the claims are device claims and Yang teaches the structure of the device. Thus while Yang does not disclose a specific chain length, the polymer chain structure is taught by Yang and would inherently have a certain length that can be optimized. Further it is suggested that the specific benefits of the claimed range that Applicant mentions in the response be added to the claims to further provide significance to the claimed range. While this would be a functional limitation it would still be considered to have some weight in the claims to provide support for the claimed range.
Alternatively, several other pieces of prior art mention chain lengths for polymer coatings that may read on the claims.
Dapron et al. (US 2003/0032013 A1)
[0052] discuses a polymer coating and [0038] discloses a polymer length
Baumhof et al. (US 2013/0259879 A 1)
[00170]-[0173]
Landolina et al. (US 2018/0185543 A1)
[0029], [0043]
It is suggested the long polymer chains be further described or the specific medical device being used in order to overcome the current rejection.
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.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783
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