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 .
Priority
The instant application filed 06/16/2022, is a 371 filing of PCT/US2020/065403, filed 12/16/2020, which claims domestic benefit to US provisional application 62/951,740, filed 12/20/2019.
Status of Claims/Application
The remarks and amendment of 05/30/2025 are acknowledged. Claims 1, 13, and 15 are amended and claims 21-28 are canceled. Claims 1-20 are currently pending and are examined on the merits herein.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/18/2022 and 11/08/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Objections/Rejections
Claim 13 was objected to for informalities. Applicant’s amendment to claim 13 has overcome the objection and the objection is withdrawn.
Claims 13 and 14 were rejected under 35 USC 112(b) for being indefinite. Applicant’s amendment to claim 13 has overcome the rejection and the rejection is withdrawn.
Claims 1-20 were rejected under 35 USC 103. Applicant’s amendments to claims 1 and 15 have overcome the rejections and the rejections are withdrawn.
The following grounds of rejection are new as necessitated by amendment:
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 (i.e., changing from AIA to pre-AIA ) 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 1-6 and 10-18 are rejected under 35 U.S.C. 103 as being unpatentable over EP 3,421,071 A1 (Hedegard, A., et al, 02 JAN 2019, on record), hereinafter EP’071 in view of US 6,605,751 B1 (Gibbins, B.L., et al, 12 AUG 2003, IDS dated 07/18/2022), hereinafter US’751.
EP’071 teaches a sterilized medical device assembly comprising a medical device having a hydrophilic surface on at least a part thereof, such as a hydrophilic urinary catheter, and a package forming a closed compartment accommodating the medical device (abstract; claim 1). The medical device is arranged in an activated state in the package, with the hydrophilic surface being wetted with a wetting fluid (abstract; claim 1). The wetting liquid is freely arranged in the closed compartment of the package, and in direct contact with the hydrophilic surface of the medical device (abstract; claim 1). Figure 1 depicts a hydrophilic catheter of the invention, wherein at least a part of the elongate shaft 12 forms an insertable length to be inserted through a body opening of the user, such as the urethra in case of a urinary catheter. At least the insertable length is preferably, in the context of a hydrophilic catheter, provided with a hydrophilic surface, such as a hydrophilic surface coating which provides a low-friction surface when wetted with a wetting fluid (¶ [0061]). The wetting liquid is preferably an aqueous liquid, comprising at least 75% of weight of water (¶ [0045]). The wetting liquid may also comprise one or more additives, such as an anti-bacterial agent, a pharmaceutical active substance, or the like (¶ [0045]). One or several osmolality increasing agent(s), such as sodium chloride, may also be provided (¶ [0046]). The osmolality increasing agent(s) may be provided in the wetting liquid (¶ [0046]). Most preferably, the osmolality-increasing compound(s) is selected from a group that includes sodium chloride and calcium chloride(¶ [0048]). When sodium chloride is used as an osmolality increasing agent, it is preferred to use 2-4% of weight of the sodium chloride in the wetting liquid (¶ [0049]). A high concentration of osmolality-increasing compound(s) improves the properties of the resulting wetted hydrophilic layer in respect of e.g. stability during wetting, and thereby stability during use, friction, and in particular a lowered extraction force, and water retention (¶ [0046]).
Thus EP’071 discloses a medical product comprising a package having a cavity containing: a medical device at least partially made from a hydrophilic polymer; a hydration medium including a liquid for hydrating the hydrophilic polymer, wherein the hydration medium is free flowing within the package and in contact with the hydrophilic polymer as recited in claim 1.
The teachings of EP’071 differ from that of the instant invention in that EP’071 does not teach a silver antimicrobial within the hydrophilic polymer nor a stabilization agent that explicitly interacts with one or more components of the silver antimicrobial as recited in claims 1 and 15.
US’751 teaches methods and compositions for making a silver-containing antimicrobial hydrophilic material. More particularly, the invention comprises methods and compositions for stabilized silver antimicrobial devices. The matrix may be formed into any desired shape for its desired uses (abstract). For example, the matrices of the invention can be used for adding antimicrobial characteristics to body contact medical devices such as catheter coatings (col. 19, lines 28-33). The ionic form (of silver) is unstable and may react to light to form insoluble elemental silver (col. 16, lines 34-36). This form has minimal antimicrobial activity and moreover is a black precipitate that strongly discolors the matrix when it is formed (col. 16, lines 36-38). Therefore, it is desirable to stabilize the silver in hydrated polymers by providing an excess of chloride ions in the matrix to favor association rather than disassociation (col. 16, lines 41-44). In a preferred embodiment, a stabilizing solution comprises a solution of electron acceptors such as a copper chloride or ferric chloride solution, for addition to a silver-containing matrix mixture to aid in the prevention of the reaction of ionic silver (col. 16, lines 64-67). The methods of preparing this matrix include adding silver nitrate (i.e., a silver salt) to the matrix mixing batch (col. 17, lines 27-29). After formation of the finely dispersed silver complex, dissolve either copper chloride or ferric chloride (col. 17, lines 31-34). Alternatively, molar equivalents of calcium chloride or other soluble chloride salt may be substituted for the ferric or copper chloride (col. 17, lines 34-37).
It would have been obvious to combine the products of EP’071 and US’751 before the effective filing date of the claimed invention by using the silver-containing antimicrobial hydrophilic material of US’751 as the hydrophilic material in the medical device of EP’071 to yield the instantly claimed invention. One of ordinary skill in the art would have been motivated to incorporate the silver-containing hydrophilic material of US’751 into the medical device of EP’071 due to the desirable antibacterial properties of the silver-containing hydrophilic material. This conclusion flows naturally from the teachings of both EP’071 and US’751. Specifically, EP’071 teaches a medical device, such as a urinary catheter, having a hydrophilic surface while US’751 teaches a hydrophilic matrix that is incorporated into body contact medical devices such as catheter coatings as a means of introducing antimicrobial characteristics. One of ordinary skill in the art would have had a reasonable expectation of success since both EP’071 and US’751 teach body contact medical devices, like catheters, comprising hydrophilic coatings.
It would have been further obvious to incorporate the calcium chloride stabilizing solution of US’751 into the product of EP’071 to yield the instantly claimed invention. One of ordinary skill in the art would have been motivated to include the calcium chloride stabilizing solution of US’751 in the combined hydrophilic matrix of EP’071 and US’751 for the benefit of preventing the reaction of ionic silver which leads to reduced antimicrobial activity and discoloration as taught by US’751. One of ordinary skill in the art would have a reasonable expectation of success because US’751 teaches the incorporation of a calcium chloride stabilizing solution into a silver-containing antimicrobial hydrophilic material that can be used for a catheter coating while EP’071 teaches a medical device, specifically a catheter, having a hydrophilic surface.
As such, the combined product of EP’071 and US’751 will comprise a silver antimicrobial and a stabilization agent within the hydrophilic polymer of the medical device. The stabilization agent, specifically calcium chloride, interacts with one or more components of the silver antimicrobial to reduce discoloration as taught by US’751. Regarding the discoloration of the hydration medium specifically, the prevention of black precipitate and discoloration in the hydrophilic matrix will necessarily prevent discoloration of the hydration medium. As such, the combined product of EP’071 and US’751 further reads on claims 1 and 3.
Regarding claims 2 and 13, it would have been obvious to include calcium chloride in the hydration medium of the combined product of EP’071 and US’751. As discussed above, EP’071 teaches the inclusion of an osmolality-increasing compound such as calcium chloride in the wetting liquid while US’751 teaches the inclusion of a stabilization agent such as calcium chloride in the hydrophilic polymer. One of ordinary skill in the art would have been motivated to include calcium chloride in the hydration medium of the combined product of EP’071 and US’751 since calcium chloride will improve stability during wetting as taught by EP’071 and improve stability of the silver-containing hydrophilic matrix which is in direct contact with the hydration medium. Furthermore, it would have been prima facie obvious for one of ordinary skill in the art to use 2-4% of calcium chloride in the hydration medium since 2-4% is a known and effective amount of an osmolality-increasing agent for use with a hydrophilic catheter as taught by EP’071. It is further noted that while EP’071 teaches calcium chloride to improve stability as an osmolality-increasing agent, US’751 teaches it to improve stability by binding to silver to reduce discoloration as discussed above. Since a compound cannot be separated from its properties, calcium chloride may serve either purpose in the context of the invention. See MPEP § 2112.01.
Regarding claims 4 and 5, it would have been obvious that the combined product of EP’071 and US’751 would comprise a urinary catheter with a hydrophilic polymer coating since the medical device of EP’071 is a urinary catheter with a hydrophilic surface (abstract; claim 8; Fig. 1).
Regarding claims 6 and 18, it would have been obvious to use a silver salt such as silver nitrate as the source of silver in the combined product of EP’071 and US’751 as taught by US’751.
Regarding claims 10-12, as discussed above, the combined product of EP’071 and US’751 comprises a stabilization agent such as calcium chloride. As such, the stabilization agent (i.e., calcium chloride) comprises a salt that includes an anion and a cation which will bind with any other anions and cations present in the solution since the ability of an anion and a cation to form an ionic bond is an inherent property.
Regarding claim 14, it would have been obvious to include other additives in the hydration medium of the combined product of EP’071 and US’751 since EP’071 teaches that anti-bacterial agents or pharmaceutical active substances may be incorporated into the wetting liquid. One of ordinary skill in the art would have been motivated to include other additives in the wetting liquid in order to introduce compounds with desirable antibacterial or pharmaceutical activity as taught by EP’071.
The combined product of EP’071 and US’751 reads on the limitations of claim 15 as addressed above in the rejections of claims 1, 4, and 5. Regarding the catheter tube and lubricous coating disposed on the catheter tube, the urinary catheter comprises an elongated shaft (i.e., a tube) wherein at least a part of the elongated shaft is insertable into the urethra and comprises the hydrophilic surface coating as taught by EP’071. The limitations of claims 16-18 have been addressed above in the rejections of claims 2-3 and 6, respectively.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over EP 3,421,071 A1 (Hedegard, A., et al, 02 JAN 2019, on record), hereinafter EP’071 in view of US 6,605,751 B1 (Gibbins, B.L., et al, 12 AUG 2003, IDS dated 07/18/2022), hereinafter US’751 as applied to claims 1-6 and 10-18 above, and further in view of WO 2014/138885 A1 (Nadworny, P., L., et al, 18 SEP 2014, on record), hereinafter WO’885.
The combined teachings of EP’071 and US’751 are discussed above.
The combined teachings of EP’071 and US’751 differ from that of the instantly claimed invention in that EP’071 and US’751 do not teach wherein the silver antimicrobial comprises silver and iodine.
WO’885 teaches articles of manufacture that include at least one silver iodate for imparting antimicrobial properties, particularly as it relates to the manufacture, use, and properties of medical devices, including by not limited to catheters (abstract). Some embodiments of the invention include one or more silver iodate compounds as an active agent, imparting an antimicrobial property or properties on or in a polymer (¶ [0016]). The active agent includes a family of silver (I) periodate compounds (¶[0017]). These compounds include silver (I) iodate; pentasilver hexaoxoiodate; silver orthoperiodate; silver periodate (VII); silver iodate (VII) and more (¶[0017]). Any polymer may be employed in the invention, but the use of hydrophilic polymers is preferred (¶ [0057]).
It would have been obvious to modify the product from the combined teachings of EP’071 and US’751 with the silver compounds of WO’885 before the effective filing date of the claimed invention to incorporate the silver iodate, silver periodate, or pentasilver hexaoxoiodate of WO’885 in the combined product of EP’071 and US’751. It would have been prima facie obvious for one of ordinary skill in the art to use silver iodate, silver periodate, or pentasilver hexaoxoiodate because they are known and effective compounds that impart antimicrobial properties on a hydrophilic polymer as taught by WO’885. One of ordinary skill in the art would have a reasonable expectation of success because WO’885 teaches that silver iodate, silver periodate, or pentasilver hexaoxoiodate can be used to impart antimicrobial properties on a hydrophilic polymer that can further be used in catheters in the same manner as the silver-containing, hydrophilic catheter of EP’071 and US’751.
Response to Arguments
1. Applicant’s arguments with respect to the rejection of claims 1-20 under 35 USC 103 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.
Conclusion
No claims are 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 SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 7:30-5 (Flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616