DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/16/2025 has been entered.
Previous Rejections
Applicant’s arguments, filed 10/16/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Response to Arguments
Applicant’s arguments with respect to claim 12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103 - Obviousness
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) 12-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Havenstrite et al (US 2017/0360994), in view of Elton et al (USP 5,290,585 A), further in view of Beck et al (US 2009/0280182 A1) and further in view of Aizenberg et al (US 2008/0095977 A1).
Havenstrite taught medical devices (e.g., endoscope, at ¶ [0010] and at claim 9; drug depot at ¶ 0116 and at claim 2), coated thereon, by covalent attachment, with a hydrogel layer. The hydrogel layer included a first species comprising polyethylene glycol (PEG) and a second species comprising polyacrylamide (PAM) [abstract]. Substrates were disclosed [0107, 0183, 0209, 0211, 0297-0298]. An outer hydrogel network comprised of interpenetrating polymer networks formed in either simultaneous or sequential polymerization steps. For example, upon forming the initial outer hydrogel layer, the layer can be swollen in a monomer solution along with a crosslinker and initiator. Upon exposure to UV light, a second interpenetrating network will form. The double network confers additional mechanical strength and durability, while maintaining high water content and high biocompatibility [0112].
Havenstrite differs from the claimed invention in that Havenstrite was not specific that the hydrogel materials were self-lubricating; that the double interpenetrating network comprising a first and second network had interconnections between the two networks; that the hydrogel materials covalently bound a layer of methacrylate bound to a substrate, as recited in claim 12.
Elton taught lubricious hydrogel coatings on medical devices introduced into the body [abstract and title]. The coatings were hydrophilic, extremely lubricious and retained lubricity (e.g., reads on self-lubricating), wherein the coatings exhibited a significantly reduced coefficient of friction [abstract; col 2, lines 27-31]. As per Elton, it has long been known that hydrophilic coatings with low friction (coefficient of friction of 0.3 or less) are useful for a variety of medical devices. When low friction surfaces are used, the devices, upon introduction into the body, slide easily with arteries, veins, cannula and other body orifices and passageways [col 1, lines 9-15].
Beck taught interpenetrating network hydrogels incorporated into implants and devices [abstract]. Devices comprised a first cross-linked (e.g., a covalently cross-linked) polymer network and a second polymer network that was cross-linked and/or polymerized in the presence of the first polymer network. The first polymer network was PEG. The second polymer network was a hydrophilic and/or ionizable polymer network, e.g., a cross-linked polyacrylamide (PAAm) network [0064-0065].
FIG. 1 of Beck illustrates an example of an interpenetrating hydrogel comprising a first cross-linked polymer network fully interpenetrated by a second cross-linked polymer network [0030]. The two polymer networks are irreversibly entwined with each other by the formation of covalent bonds. In certain variations of hydrogels, two polymer networks may interact in addition to being entangled, e.g., hydrogen bonding may be present between groups on two different polymer networks (e.g., reads on interconnections between the two networks), wherein bonding increased the mechanical strength and physical properties of the hydrogel [0066, 0068].
Aizenberg taught an apparatus, as a drug-release system, comprising an anchoring layer, which acted as an adhesive layer configured to attach a substrate. In one embodiment, an anchoring layer of poly (glycidylmethacrylate) (PGMA) was covalently bonded to both the substrate and a polyacrylamide hydrogel layer [¶s 0038 and 0054; claim 18].
Since Havenstrite taught hydrogel-coated medical devices for entry into the body (e.g., endoscope), it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Havenstrite, self-lubricating hydrogel materials, as taught by Elton. The ordinarily skilled artisan would have been motivated to easily slide the medical device within the arteries, veins, cannula and other body orifices and passageways, as taught by Elton [Elton, at col 1, lines 9-15; col 2, lines 27-31; and, at the abstract].
Since Havenstrite taught hydrogel coated medical devices comprising a double interpenetrating network, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Havenstrite, interconnections between the first and second networks, as taught by Beck. The ordinarily skilled artisan would have been motivated to increase the mechanical strength and physical properties of the hydrogel, as taught by Beck [Fig. 1, abstract, 0030, 0064-0066, 0068].
Since Havenstrite taught drug depots, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Havenstrite, an anchoring layer of poly (glycidylmethacrylate) (PGMA), covalently bonded to both the substrate and a polyacrylamide hydrogel layer, as taught by Aizenberg. The ordinarily skilled artisan would have been motivated to provide a drug-release system, as taught by Aizenberg [¶s 0038 and 0054; claim 18].
Havenstrite, in view of Elton, Beck and Aizenberg, reads on claims 12-13, 18 and 20.
Claims 14-15 are rendered prima facie obvious because Havenstrite taught that the coatings can be formed on a surface of a medical device, or in an aqueous solution (e.g., before being applied upon the device; e.g., reads on free-standing without a base material) [0032, 0188].
Claims 16-17 are rendered prima facie obvious because Havenstrite taught active agents, including antimicrobial agents (e.g., reads on antifouling product) [0110-0111].
The instant claim 20 recites a friction coefficient of 1 or lower.
Elton taught a coefficient of 0.02 at Examples 12 and 14. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
Claim(s) 19 is are rejected under 35 U.S.C. 103 as being unpatentable over Havenstrite et al (US 2017/0360994), in view of Elton et al (USP 5,290,585 A) further in view of Beck et al (US 2009/0280182 A1), further in view of Aizenberg et al (US 2008/0095977 A1).and further in view of Choudhury et al (US 2019/0060530 A1).
The 35 U.S.C. 103 rejection over Havenstrite, in view of Elton, Beck and Aizenberg, was previously discussed.
Additionally, Havenstrite taught the hydrogel comprising a hydrophilic layer [claim 1] comprising a first and second species, each of the 1st or 2nd species comprising PAM and/or alginate [claims 82-83], whereby the 1st and 2nd species formed cross-links to react [claim 87], and covalently bond to the outer surface of the device [claim 89]. Furthermore, Havenstrite taught the water content of the hydrogel layer at between about 80 % to 98 % [claim 33].
Although Havenstrite taught hydrogels comprising crosslinked PAM and alginate, Havenstrite was not specific the amount of the combined acrylamide and alginate, as recited in claim 19.
Choudhury taught hydrogels [claim 1] comprising crosslinked polyacrylamide and alginate [claim 8], wherein the ratio of the water/polymer was 86% to 14 %, adjustable to a ratio of 75 % to 25 % [claim 2; ¶ 0035]. The ratio provided a highly stretchy, elastic and bendable tough gel, able to withstand a high level of torsion deformation [0012-0014].
Since Havenstrite taught hydrogels comprising crosslinked PAM and alginate, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Havenstrite, amounts thereof (PAM and alginate), as taught by Choudhury. The ordinarily skilled artisan would have been motivated to provide a highly stretchy, elastic and bendable tough gel, able to withstand a high level of torsion deformation, as taught by Choudhury [Choudhury at ¶s 0012-0014 and 0035; and, at claims 1 and 8].
It would have been prima facie obvious to the ordinarily skilled artisan to include within Havenstrite, the polymers at a water/polymer ratio of 86% to 14 %, adjustable as desired, because at this ratio, the hydrogel is highly stretchy, elastic, bendable, and is able to withstand a high level of torsion deformation, as taught by Choudhury.
The instant claim 19 recites 75-90 % water and 10-25 % combined acrylamide and alginate.
Havenstrite taught 80-98 % water. Choudhury taught a water/polymer ratio of 86% to 14 %, adjustable as desired. A prima facie case of obviousness exists because of overlap, as discussed above.
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612
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