DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to communications filed April 14, 2026.
Status of Claims
1. Claims 1-12 and 23-30 are pending and currently under consideration for patentability.
Claims 13-18 and 22 are canceled and clams 24-30 are newly presented via April 14, 2026 amendment.
Response to Amendments
2. Applicant has amended the claims to remove the relative term “about;” accordingly, the previously applied 35 U.S.C. 112(b) rejections are overcome and withdrawn herein.
Response to Arguments
3. Applicant’s arguments with respect to claim(s) 1-18 and 22-23 have been considered but are moot because the new ground of rejection does not rely on the same combination of applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Darouiche (US PGPUB 2007/0093894), which was previously introduced in the pertinent prior art not relied upon section of the most recent Office action, is now being utilized as a secondary reference for teaching and rendering obvious the newly presented limitations.
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.
4. Claim(s) 1-12 and 23-30 are rejected under 35 U.S.C. 103 as being unpatentable over Nielsen et al. (US PGPUB 2015/0065998) in view of Darouiche (US PGPUB 2007/0093894).
5. With regard to claim 1, Nielsen discloses a medical product (abstract; [0003-0006]; Figs. 1a, 1b, 2a, 2b) comprising: a package (packing means, 3) containing a medical device (catheter elements, 1 and 2; [0031]), wherein the medical device (1 and 2) has a hydrophilic portion (abstract; [0034-0043]); and a hydration medium (liquid wetting medium; within compartment, 5) comprising water ([0017]; [0048]) and a sulfanilamide (silver sulfadiazine; [0144]; Example 13; [0313-0318]); and wherein the hydration medium (within 5) contacts the hydrophilic portion of the medical device ([0066]; [0068]).
However, Nielsen is silent in regard to the sulfanilamide not being in salt form.
Within the same field of endeavor, of incorporation of antimicrobial combinations onto device to reduce infection (abstract), Darouiche discloses a medical product ([0036]; [0042]) comprising a hydration medium comprising water ([0064]; [0073]) and a sulfanilamide, wherein the sulfanilamide is not in salt form ([0027-0029]; [0078-0079]; claim 14).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the hydration medium disclosed by Nielsen to include a sulfanilamide that is not in salt form, similar to that disclosed by Darouiche, in order to utilize alternative bacteriostatic antibiotics known to successfully inhibit the growth of microorganisms without damage to the host, as suggested by Darouiche in paragraph [0029], with a reasonable expectation of success.
6. With regard to claim 23, Nielsen discloses a method of making a medical product (abstract; [0003-0006]; Figs. 1a, 1b, 2a, 2b), comprising: placing a medical device (1, 2) within a package (3; “arrangement of the catheter element(s) in the first compartment of the packing means”; [0149]), wherein the medical device (1 and 2) has a hydrophilic portion (abstract; [0034-0043]); and placing a hydration medium (liquid wetting medium; within compartment, 5) into the package (“arrangement of the liquid swelling means in the second compartment of the packing means”; [0149]; [0151-0157]), wherein the hydration medium comprises water ([0017]; [0048]) and a sulfanilamide (silver sulfadiazine; [0144]; Example 13; [0313-0318]), wherein the hydration medium (within 5) is in contact with the hydrophilic portion of the medical device ([0066]; [0068]); and sealing the package (3; [0223-0224]).
However, Nielsen is silent in regard to the sulfanilamide not being in salt form.
Within the same field of endeavor, of incorporation of antimicrobial combinations onto device to reduce infection (abstract), Darouiche discloses a medical product ([0036]; [0042]) comprising a hydration medium comprising water ([0064]; [0073]) and a sulfanilamide, wherein the sulfanilamide is not in salt form ([0027-0029]; [0078-0079]; claim 14).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the hydration medium disclosed by Nielsen to include a sulfanilamide that is not in salt form, similar to that disclosed by Darouiche, in order to utilize alternative bacteriostatic antibiotics known to successfully inhibit the growth of microorganisms without damage to the host, as suggested by Darouiche in paragraph [0029], with a reasonable expectation of success.
7. With regard to claims 2, 9, 24 and 25, while Nielsen fails to explicitly disclose, within the same embodiment (Example 13), that the hydration medium further comprises a glycerol in an amount between about 0.99 wt% to about 9.9 wt%, glycerol is a well-known component useful as a plasticizer and vehicle solvent for catheters, and Nielsen provides explicit suggestion for utilizing glycerol as a component within the hydration medium as an osmolality increasing agent ([0089]; [0162]); wherein the content of osmolality increasing agent within the hydration medium is typically in the range of 0-1000 mM ([0090]); and an embodiment is disclosed wherein the content of osmolality increasing agent within the hydration medium is 0.7 wt% ([0285]). Additionally, Darouiche discloses the use of glycerol in the hydration medium for increasing the efficacy of the adherence of the antimicrobial combination to the medical device ([0054]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the hydration medium disclosed by Nielsen in view of Darouiche to further comprise a glycerol, similar to that suggested by Nielsen in alternate embodiments, in order to improve the comfort during use of the medical device, as suggested by Nielsen in paragraph [0089], and increase the efficacy of the adherence of the antimicrobial combination to the medical device, as suggested by Darouiche in paragraph [0054].
Further, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the content of the glycerol within the hydration medium disclosed by Nielsen in view of Darouiche to be in an amount between about 0.99 wt% to about 9.9 wt%, since it has been held 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In the instant case, one having ordinary skill in the art would recognize that the inclusion of glycerol within the hydration medium will enhance comfort during use of the medical device (Nielsen [0089]) and increase the efficacy of the adherence of the antimicrobial combination to the medical device (Darouiche [0054]); and through routine experimentation, a desired range of glycerol content can be readily determined with a reasonable expectation of success.
8. With regard to claims 3-7 and 26-27, Nielsen, as modified by Darouiche above, discloses the sulfanilamide not in salt form, Nielsen further discloses that the hydration medium (liquid wetting medium; within compartment, 5) comprises sulfadiazine (silver sulfadiazine; [0144]), a sulfanilamide compound, in an amount of 0.03 wt% (0.3 g/L; Example 13; [0313-0318]; [0053]); and Darouiche further discloses that the sulfanilamide is one or more of: sulfapyridine, sulfamethoxydiazene, sulfathiazole, sulfacetamide, sulfadiazine, sulfadoxine, sulfamethizole, sulfacarbamide, sulfamethazine, sulfamethoxypyridazine, sulfamethoxazole, sulfafurazole, sulfaguanidine, sulfaisodimidine, sulfamethoxine, and sulfamoxole ([0029]; [0078]).
9. With regard to claim 8, while Nielsen discloses that the hydration medium (liquid wetting medium; within compartment, 5) comprises sulfadiazine (silver sulfadiazine; [0144]), a sulfanilamide compound, in an amount of 0.03 wt% (0.3 g/L; Example 13; [0313-0318]; [0053]), Nielsen fails to explicitly disclose that the hydration medium comprises sulfanilamide in an amount between about 0.05 wt% to about 0.1 wt%.
Nonetheless, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the content of the sulfanilamide within the hydration medium disclosed by Nielsen to be in an amount between about 0.05 wt% to about 0.1 wt%, since it has been held 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In the instant case, one having ordinary skill in the art would recognize that the inclusion of sulfanilamide within the hydration medium will enhance antibacterial effect during use of the medical device (Nielsen [0313]) and through routine experimentation, a desired range of sulfanilamide content can be readily determined with a reasonable expectation of success. Additionally, Nielsen’s disclosure of sulfanilamide compound, in an amount of 0.03 wt% (0.3 g/L; Example 13; [0313-0318]; [0053]) can be reasonably considered “about 0.05 wt%,” as presently claimed.
10. With regard to claims 10-11 and 28-29, Nielsen discloses that the medical device (1, 2) is a catheter including a shaft (1; Figs. 1a, 1b, 2a, 2b; [0023]; [0031]); wherein the hydration medium contacts the shaft ([0066]; [0068]).
11. With regard to claims 12 and 30, Nielsen discloses that the hydrophilic portion of the medical device (1, 2) comprises a hydrophilic coating ([0034-0043]).
Conclusion
12. 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.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J MENSH/ Primary Examiner, Art Unit 3781
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