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 Status
Claims 1,5-8, and 10 are under current examination to the extent of the elected species wherein diethylenetriaminepentaacetic acid (DTPA) is the specific formula 1 compound; Ag and Zn as the ions; solution form; the composition does NOT contain fibers.
Applicants' arguments and amendments filed on 10/27/2025 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Objections
Claim 6 objected to because of the following informalities: It is believed that Applicants meant to recite Ag2Zn(DTPA) and not DTPADPTA. Appropriate correction is required.
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.
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, 5-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over William John Simpson (CA2478137A1-English translation attached) in view of Garza-Cervantes (Synergistic Antimicrobial Effects of Silver/Transition-Metal Combinatorial Treatments) and Manzhi et al. (CN103392738A-English translation attached).
The instant claims are being examined to the elected species of: diethylenetriaminepentaacetic acid (DTPA) as the specific formula 1 compound; Ag and Zn as the ions; solution form.
Simpson teaches metal ion chelate complexes which comprises one or more metals including Ag combined with Zn, see claims 1 and 11. The cheating agent is DTPA (diethylenetriaminepentaacetic) see claim 4. The composition can be in aqueous liquid form (liquid), see claims 9-10 and pages 4-5, 12 and entire document. The formulation can comprise excipients and other antibacterial agents that are not metal (thus forms a composition) such as cephalosporin, see page 16, 33 and pages 14, 30 and 31.
Simpson teaches that the metal for the complex can comprise Fe, Co, Ni, Cu, Zn, Cr, Al, Cd, Ag, Se and mixtures thereof, but does not expressly teach a combination of Zn and Ag specifically together.
Garza-Cervantes et al. teach that silver combined with transition metals including Zn have synergistic antimicrobial activity, see abstract.
Manzhi et al. teach silver zinc complexes with complexing agents (chelator) provides for antimicrobial activity. The silver is present from 0.01-1 parts with zinc from 0.02-5 parts encompassing weight ratios of 1:1.
It would have been prima facie obvious to provide Ag and Zn as the metal ions with the DTPA of Simpson.
One of ordinary skill in the art would have been motivated to so because Manzhi et al. teach that Ag-Zn with a complexing agent that is a chelator provides for antimicrobial activity and Garza-Cervantes teaches that silver provides synergism with zinc. There would have been a reasonable expectation of success as Simpson teaches that the metal ions can be mixtures thereof complexed with chelating agents such as DTPA.
Regarding claim 14, even though product by process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product by process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In the instant case, the product is obvious over the product of Simpson in view of Garza-Cervantes and Manzhi and thus is unpatentable. The weight ratio of Garza-Cervantes of the silver to zinc is suggested to be from 1:1.
Claims 1, 5-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Back et al. (United States Patent 6303039) in view of Garza-Cervantes (Synergistic Antimicrobial Effects of Silver/Transition-Metal Combinatorial Treatments).
The instant claims are being examined to the elected species of: diethylenetriaminepentaacetic acid (DTPA) as the specific formula 1 compound; Ag and Zn as the ions; solution form.
Back et al. teaches metal ion chelate complexes which comprises at least two metals combined with at least one chelating agent, see claims 1. The cheating agent is DTPA (diethylenetriaminepentaacetic) see claim 8 and column 4, lines 32-38. The composition can be in aqueous solution form as it dissolves in water (liquid), see claim 1. The formulation can comprise excipients including surfactants (thus forming a composition), see column 3, lines 44-46, column 5, lines 10-14, and entire document.
Beck et al. teach that the metal for the complex can comprise at least two of Ag, Cu, Ni, Sn and Zn, but does not expressly teach a combination of Zn and Ag specifically together.
Garza-Cervantes et al. teach that silver combined with transition metals including Zn have synergistic antimicrobial activity, see abstract and entire document.
It would have been prima facie obvious to provide Ag combined with Zn as the at least two metal ions with the DTPA of Beck et al.
One of ordinary skill in the art would have been motivated to so because Garza-Cervantes teaches that silver provides synergism with transition metals which include zinc. There would have been a reasonable expectation of success as Beck teaches that the metal ions can be at least two metals with chelating agents such as DTPA.
Regarding claim 14, even though product by process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product by process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In the instant case, the product is obvious over the product of Beck in view of Garza-Cervantes and thus is unpatentable. The weight ratio of the silver to zinc is suggested to be from 13:1 of silver to zinc, reading on about 10:1 see example 18 of Beck.
Response to Remarks
Applicants argue that Example 1 in Simpson discloses copper-EDTA complexes which does not include mixed metals. Applicants argue that no where in Simpson is there an investigation of DTPA which would motivated a person having ordinary skill to utilize DTPA over EDTA since the examples utilize EDTA to arrive at better levels of antimicrobial activity and enhanced loading capabilities. Applicants argue that DTPA is not exemplified with mixed metals in Simpson.
Examiner respectfully submits that Applicants appear to be arguing that DTPA is not exemplified since there is no investigation involving the DTPA (i.e. examples), however a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005). While Simpson exemplifies EDTA, the chelating agents can include DTPA in the alternative to EDTA.
Applicants argue that Garza-Cervantes does not form a completes with DTPA. Garza-Cervantes is focused on overcoming the drawbacks associated with transition metal toxicity but does not teach the use of silver/transition metal complexed with DTPA. Applicants argue that Manzhi dos not teach complexes of DTPA with mixed metals.
In response, Examiner respectfully submit that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Here, a complex of DTPA with metal ions is already taught by Simpson. Simpson does not expressly teach a AgZn combination. However, as taught in Garza Cervantes, silver with Zn imparts synergistic antimicrobial activity. Thus, it would have been obvious to utilize the Ag and Zn metal ions of Simpson with the DPTA already disclosed in Simpson to achieve synergism in antimicrobial activity. With regards to Manzhi, it is noted that Simpson already teaches metal ions complexing with DPTA. Manzhi teaches that silver with complexing agents provide antimicrobial activity and suggests the amounts that silver and zinc can be present.
With regard to Beck, Applicants argue that Beck does not teach or suggest that DPTA is mixed with the metal compounds claimed but simply discloses a mixture of metal ions and chelating agents with no investigation into whether compounds might be formed, the chemical make up or mode of action of these compounds. Applicants argue that Beck is focused on industrial application and not health.
Applicants’ arguments are unpersuasive because Beck expressly teaches metal ion chelate complex which includes DTPA combined with metals, see clam 8 and column 4, lines 32-38. Applicants appear to be arguing that DTPA is not exemplified since there is no investigation involving the DTPA (i.e. examples), however a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005). With regards to Beck teaching industrial application, it is note d that claim 1 does not require any specific utility. The instant claims are not limited to the health care field.
Applicants argue that the amended claims show surprisingly unexpected results since the claimed composition has a dual mechanism of action when placed in a biofilm setting. Applicants point to examples at page 43, line 25 to show improved antimicrobial activity compared to EDTA based analogues. Table 1 shows the claimed compounds have efficacy against S. aureus and P aeruginosa that is 16 fold or 4 fold versus EDTA.
Examiner respectfully submits that regarding Applicants’ discovery of the mechanism of action, the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). The example at paragraph [0214] shows that when comparing values of Ag3Cu (DTPA) and Ag2Cu(EDTA) there is a significant increase in potency for DTPA than EDTA complex. AgZn DTPA and AgCu DTPA both show potent antimicrobial activity against bacterial strains of S. Aureus and P aeruginosa. The example comparing EDTA to DTPA utilizes Ag2Cu (EDTA)versus Ag3Cu (DTPA). Furthermore, the amounts used for the example is 16mg/ml DTPA. The examples further show (paragraph 0126) that Tris and urea increase the MIC of both DTPA complexes. Combinations with DTPA and antimicrobials increase the potency of the complexes. Paragraph [0218] shows that a MIC of 0.256% of DTPA complexes eradicates S. aureus, however the instant claims do not require any amount of the complexes. Furthermore, improved antimicrobial activity is taught by Garza-Cervantes because silver and zinc complex together are taught to provide synergistic antimicrobial activity. Thus, the combination of silver and zinc would be expected to have improved antimicrobial activity. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). In the instant case, the complexes of claim 1 are not commensurate with the amounts exemplified.
Conclusion
Currently, no claims are allowed and all claims are rejected.
Applicant’s arguments/remarks are considered unpersuasive. 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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619