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
Claims 21-24 and 26-36 are pending, presented for examination, and rejected as set forth in greater detail below.
Claim Interpretation
Applicants claims are directed to methods of contacting a medical device having a functionalized surface with a further liquid composition combining a carboxymethylcellulose compound and any of specific generic categories of gallic acid compound, and radiation sterilizing the device/composition combination, as well as defining the coating friction the compositions are to possess. Dependent claims narrow the scope of the gallic acid compound to, most specifically, propyl gallate, in defined concentration ranges. Additional dependent claims specify that the carboxymethylcellulose is sodium carboxymethylcellulose, again present in the composition in defined concentrations. Additional components, “solution enhancers” such as glycerol in defined concentrations, an “aqueous base” such as saline in a preferred embodiment, “stabilizers,” and “buffer solutions” to provide a composition pH within a defined range are recited by additional dependent claims. A particular sterilizing dose of radiation is described by dependent claim 15. A catheter having particular structural elements is ultimately recited as the medical device to be used in the method recited, while also specifying that the functional coating is hydrophilic. Claim 23 indicates that the coating composition of Claim 21 which is to be placed on a medical device with a functional coating is one which “consists essentially of” defined concentrations of propyl gallate, CMC, propylene glycol, an aqueous base solution, a stabilizer, and/or a buffer solution having a pH of 3-6.5. As the application fails to indicate what basic and novel characteristics of the invention any potentially additional components of the coating composition are not to interfere with, this claim will be interpreted as encompassing a composition “comprising” the recited elements. See In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (the transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention), see also PPG Industries v. Guardian Industries, 156 F.3d 1351, 1355, 48 USPQ2d at 1355 (Fed. Cir. 1998) (absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising”: “PPG could have defined the scope of the phrase ‘consisting essentially of’ for purposes of its patent by making clear in its specification what it regarded as constituting a material change in the basic and novel characteristics of the invention.”. Claim 24 indicates that the coating composition of Claim 21 which is to be placed on a medical device with a functional coating is one which “consists of” defined concentrations of propyl gallate, CMC, propylene glycol, an aqueous base solution, a stabilizer, and/or a buffer solution having a pH of 3-6.5. As no limits are placed on the components present in any of the aqueous base solution, stabilizer, or buffer solution, any components the art describes as compatible with each of an aqueous base solution, stabilizer, or buffer solution will be considered permissible as a component of Claim 24. Claims 26-30 specify that the device is to “maintain(s) a coefficient of friction…” under certain conditions of use. Claims 31-33 recite various ratios of antioxidant to CMC, or antioxidant to enhancer to CMC, or enhancer to antioxidant the compositions are to possess. Claims 34 and 35 add PVP in defined concentrations. Claim 36 specifies that the antioxidant is to be dissolved into solution via ultrasonic agitation.
Response to Amendment
Applicants amendments to Claims 21 and 26-30 have addressed the 35 U.S.C. 112(b) issues raised by the Examiner in the previous office action. These rejections are therefore WITHDRAWN.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 21, 22, and 26-35 are rejected under 35 U.S.C. 103 as being unpatentable over Madsen (WO2006/117372), in view of Huang (U.S. 8,147,769), Nhuyen (Huynh Nguyen, et al, Sterilization of Allograft Bone: Is 25 kGy the Gold Standard for Gamma Irradiation?, 8 Cell Tissue Bank. 81 (2007)), and Utas (U.S. 8,747,882).
Madsen describes coating medical devices such as the catheters with a hydrophilic coating. (Pg.1). Madsen indicates that these hydrophilic coatings can have some disadvantages if unprotected, and describes that it was known in the art to apply to these hydrophilic coated catheter surfaces a composition combining a solvent and polysaccharide, as well as additional agents beneficial in such coatings, to preserve the slipperiness provided by the underlying hydrophilic coat on the catheter. (Pg.2). Water retention and the slipperiness which results can be further preserved, even during the process of radiation sterilization of such medical devices, by including polymers such as the carboxymethylcellulose of the instant claims. (Pg.3-4). Madsen indicates that the slippery hydrophilic coatings of catheters may be preserved through the process of radiation sterilization by contacting a catheter having a hydrophilic coating with an aqueous solution of hydrophilic polymer. (Pg.4). Madsen specifically describes a process whereby a medical device has been provided with a hydrophilic coating, said medical devices is immersed in an aqueous liquid containing a hydrophilic polymer, language which addresses the “liquid” limitation of the CMC/solution enhancer limitations, and the combination is then sterilized by exposure to an appropriate amount of radiation. (Pg.4, 6, 8). Each of the polyvinylpyrrolidone in concentrations of about 6% of newly added Claims 34 and 35, as well as the carboxymethylcellulose of the instant claims, as well as suitable salts thereof, are described as suitable hydrophilic polymers for use in the liquid applied to the catheter, preferably in a concentration of between 0.005-3%, a range overlapping and therefore rendering obvious the CMC concentrations of the instant claims. (Pg.9-10, see also In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”)). Madsen indicates that an embodiment of the invention involves enclosing the catheter and solution within a package which is then sterilized, describing the packaging disclosed in Nøsted (WO98/19729) as particularly useful. (Pg.11). Saline is a particularly recited form of the aqueous solution to be used as the liquid solvent, with plasticizers such as the glycerol applicants claim as a “solution enhancer” and a pH buffer. (Pg.13). While the particular concentrations of aqueous base solution or stabilizer recited by the claims are not recited by Madsen, Madsen does indicate each of the solvent and plasticizer contribute desirable properties to the compositions into which they are incorporated for the purposes of the methods described. A person of ordinary skill in the art would reasonably have expected that the amounts of each, are result-effective variables that achieve the results each of the components referred to provide. As such, it would have been routine to optimize the amounts of these components within the total composition suggested by Madsen. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where 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.). Madsen indicates that it is desirable and an object of the invention to create medical device coatings that not only possess low coefficients of friction upon manufacture, sterilization, and storage, but to preserve the lubricity and low coefficients of friction to optimize the utility of the medical devices so lubricated. (pg.3-5, 9-11). While not recited in the same units or terminology as Claims 21 or 26-30, these teachings of Madsen establish that maintenance of a suitably low coefficient of friction is not only a desirable goal achievable by the employ of any of a variety of techniques known to the skilled artisan, but that the establishment and maintenance of such low coefficients of friction are result-effective variables suitable for optimization by the skilled artisans employ of little more than routine experimentation. This renders the limitations of Claims 21 or 26-30 obvious as a result of the knowledge possessed by the skilled artisan. See Aller, supra.
The entirety of the disclosure of Madsen therefore suggests to the skilled artisan that hydrophilic coatings of catheters can be further protected and improved by coating catheters with a hydrophilic coating, then exposing those coated catheters to an aqueous solution containing, among others, PVP, CMC, glycerol, and saline, then sterilizing the combination by exposure to sufficient radiation to achieve sterilization. The specific combination of features claimed is disclosed within the broad disclosure of the reference, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any motivation to select this specific combination of process steps, anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to have selected various combinations of various disclosed steps from within a prior art disclosure, to arrive at methods “yielding no more than one would expect from such an arrangement.”
Despite describing methods of sterilizing catheters by coating catheters with a hydrophilic coating, then exposing those coated catheters to an aqueous solution containing, among others, PVP, CMC, glycerol, and saline, then sterilizing the combination by exposure to sufficient radiation to achieve sterilization, nothing of Madsen describes incorporating gallic acid or its ester derivatives into the aqueous catheter sterilizing solution, nor is sodium CMC specifically described as the form of CMC to be used, nor are particular intensities of radiation described.
This is addressed by the teachings of Huang, which indicates that incorporating between 0.001-10% by weight of a “free radical scavenger or antioxidant” into polymeric components to be coated onto underlying substrates can serve to protect underlying coatings from chemical degradation occasioned by radiation sterilization procedures. (Col.5, L.44-52; Col.6, L.26-45, see Petersen, supra). The propyl gallate addressing the limitations of instant claims 1, 2, and 6 is recited as a particularly preferred free radical scavenger or antioxidant. (Col.7, L.49-57).
It would have been prima facie obvious to have included between 0.001-10% propyl gallate in the aqueous catheter protecting solution of Madsen because Huang indicates that the incorporation of agents such as propyl gallate in these concentrations serves to protect underlying medical device coatings from chemical degradation known to result from radiation sterilization. See In re Sernaker, 702 F.2d 989, 994-95 (Fed. Cir. 1983) (“The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination.”). Again, while the particular ratios of antioxidant to CMC, or antioxidant to solution enhancer to CMC, or the antioxidant to solution enhancer recited by newly added Claims 31-33 are not specified, given the result-effective variables each of these components represent, the claimed ratios of each can only be said to represent the routine optimization of such concentrations according to the ordinary skill an artisan possesses. See Aller, supra.
Neither of Madsen nor Huang describe the particular radiation dosage to sterilize the medical devices described.
This is cured by the teachings of Nhuyen, which establish that the 25 kGy dose of gamma radiation recited by instant Claim 15 has been recommended for terminal sterilization of medical products. (Pg.81). The use of a 25 kGy dose of radiation to sterilize the catheters of the instant claims, following the teaching of Madsen concerning the use of radiation to sterilize the medical devices they describe, therefore appears to be little more than the predictable use of prior art elements according to their established functions, and obvious thereby. KSR, supra.
None of Madsen, Huang, and Nhuyen, however, teach that the coating composition should be buffered to a point within the range of 3.0-6.5.
This is cured by the teachings of Utas, which indicates that buffering a hydrophilic coating of a medical device such as a urinary catheter to a point in the range of 4-8, preferably below 7.0, increase the antimicrobial activity of the coating and reduces the likelihood of bacterial infection, a range overlapping and therefore rendering obvious that of the present claims. (Abs., passim)
It would have been prima facie obvious for a skilled artisan at the time of the instant application to have buffered the coating of the hydrophilic coated catheter described by Madsen to a point above 4 and below 7 because Utas indicates such a modification of a hydrophilic urinary catheter coating would have the beneficial effect of reducing the likelihood of a bacterial infection. See In re Sernaker, supra.
Claims 21-24 and 26-35 are rejected under 35 U.S.C. 103 as being unpatentable over Madsen, Huang, Nhuyen, and Utas as applied to Claims 21, 22, and 26-35 above, and further in view of Orlowski (WO2014/177221).
Madsen, Huang, Nhuyen, and Utas, discussed in greater detail above, suggest methods of treating catheters by coating catheters with a hydrophilic coating, then exposing those coated catheters to an aqueous solution containing, among others, PVP, CMC, glycerol, saline, and propyl gallate, then sterilizing the combination by exposure to sufficient radiation to achieve sterilization, more specifically a 25 kGy dose of gamma radiation.
Neither of Madsen, Huang, Nhuyen, or Utas describe employing propylene glycol as a component of the coating composition.
This is cured by the teachings of Orlowski, which indicates that the propylene glycol of Claims 21-24 was at the time the instant application was filed known to be useful as a plasticizer of polymeric catheter coating compositions containing carboxymethylcellulose. Pg.21, L.30 – Pg. 23, L.16).
It would have been prima facie obvious for a skilled artisan at the time the instant application was filed to have used propylene glycol, or in the case of Claim 22 a combination of propylene glycol and glycerol, as the plasticizers in the CMC/propyl gallate catheter coating solutions suggested by the teachings of Madsen, Huang, Nhuyen, and Utas. This is because the art available at the time the present application was filed recognized that each of glycerol and propylene glycol were plasticizers known to be useful in CMC containing aqueous polymeric solutions for coating catheters. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985), In re Fout, 675 F.2d 297 (CCPA 1982), see also In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). As nothing of the Madsen, Huang, Nhuyen, Utas, or Orlowski references require the use of anything other than a hydrophilic polymer such as PVP and carboxymethylcellulose, a solvent such as water, and optionally includes any, or none, of either plasticizers such as glycerol or propylene glycol, or pH buffers, nothing outside the metes and bounds of the combination of propyl gallate, CMC, propylene glycol, an aqueous base solution, and a stabilizer and/or a buffer solution having a pH of 3-6.5 is taught by the art.
Claims 21-24 and 26-36 are rejected under 35 U.S.C. 103 as being unpatentable over Madsen, Huang, Nhuyen, Utas, and Orlowski as applied to Claims 21-24 and 26-35 above, and further in view of Kwok (Philip Chi Lip Kwok & Hak-Kim Chan, Nanotechnology Versus Other Techniques in Improving Drug Dissolution, 20 Curr. Pharma. Design 474 (2014)).
Madsen, Huang, Nhuyen, Utas, and Orlowski discussed in greater detail above, suggest methods of treating catheters by coating catheters with a hydrophilic coating, then exposing those coated catheters to an aqueous solution containing, among others, PVP, CMC, glycerol or propylene glycol, saline, and propyl gallate, then sterilizing the combination by exposure to sufficient radiation to achieve sterilization, more specifically a 25 kGy dose of gamma radiation.
None of Madsen, Huang, Nhuyen, Utas, and Orlowski describe employing ultrasonication to dissolve the propyl gallate into the solution to be used as the coating composition.
This is cured by the teachings of Kwok, which establishes that ultrasonication was at the time known to be a method used to enhance dissolution rates of solutes in solvents. (pg.478). Because ultrasonication as recited by Claim 36 is a technique known to increase dissolution rates of solutes in solution, it would have been prima facie obvious to have used sonication as a means of dissolving propyl gallate, or indeed any of the solid components of the compositions recited by the Claims, into the coating material suggested by the art.
Response to Arguments
Applicants arguments filed 15 September 2025 have been fully considered.
Applicants sole argument is that the examiner has failed to address the claim limitation concerning the coating friction of the sterilized medical device, specifically that the coefficient of friction is 4-8. Applicants argument on this point ignore the fact that the Examiner has established that the art of record recognizes the coefficient of friction of sterilized medical devices such as catheters are result-effective variables suitable for optimization through routine experimentation. “The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Here, as set forth previously and again above, Madsen indicates that it is not only desirable, but a specific object of their invention to provide medical device coatings that not only possess low coefficients of friction upon manufacture, sterilization, and storage, but to preserve the lubricity and low coefficients of friction to optimize the utility of the medical devices so lubricated. (Madsen Pg.3-5, 9-11). This establishes that maintenance of a suitably low coefficient of friction is not only a desirable goal achievable by the employ of any of a variety of techniques known to the skilled artisan, but that the establishment and maintenance of such low coefficients of friction are result-effective variables suitable for optimization by the skilled artisans employ of little more than routine experimentation. Applicants offer no evidence tending to establish that the specific low coefficient of friction recited by the claims provides any form of unexpected benefit to compositions possessing such specific low coefficients of friction. As a result, the obviousness of choosing a particular low coefficient of friction the medical devices subjected to the methods of the instant claims remains unrebutted.
Conclusion
No Claims are allowable.
THIS ACTION IS MADE FINAL. 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 SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614