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 Application
The amendment and remarks of 2 June 2026 are entered.
The election requirement remains in effect.
Claim 16 has been canceled. Claims 1-15 and 17-20 are pending. Claim 20 is withdrawn without traverse. Claims 1-15 and 17-19 are being examined on the merits.
Applicants’ petition to make special based upon age has been accepted as of 16 October 2025.
The rejection of claim 16 under 35 U.S.C. 112(b) is withdrawn in light of the cancellation of said claim in the amendment of 2 June 2026.
The rejection of claims 1-15 and 17-19 under 35 U.S.C. 103 as being unpatentable over ‘053 and Steiner is maintained, with the Examiner’s response found below.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-15 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Salamone and Salamone (US 8,829,053 B2, published 9 September 2014, here after referred to as ‘053) and Steiner et al. (Bioengineering 8:63, published 11 May 2021, hereafter referred to as Steiner).
The ‘053 patent discloses an antimicrobial formulation for wound care (see e.g. Abstract). The ‘053 patent discloses a formulation having a polymeric biguanide of at least 0.05% by weight, a chelating agent of at least 0.01-1% by weight, and a vicinal diol at a weight ratio to the biguanide of 1:0.05 to 1:500 (see e.g. claim 1). The biguanide can be PHMB (see e.g. claims 5 and 18). The vicinal diol includes glycerol 1-(2-ethylhexyl) ether and 1,2-dihydroxyoctane (see e.g. claim 18). The chelating agent include EDTA (see e.g. claim 14).
The difference between ‘053 and the claimed invention is that ‘053 does not disclose inclusion of hydrolyzed collagen.
The Steiner art discloses usage of collagen in wound healing applications (see e.g. Abstract). Steiner discloses hydrolyzed collagen as useful for wound healing applications (see e.g. Section 6.3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to combine the composition of ‘053 containing antimicrobial formulations for wound healing containing a biguanide, a vicinal diol, and a chelating agent with the hydrolyzed collagen wound healing agent of Steiner. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). As both ‘053 and Steiner disclose that their formulations are useful for wound healing it follows that they can be combined into a third formulation also to be used for wound healing. There would have been a reasonable expectation of success because of the common goal of wound healing. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claim 2, the ‘053 patent shows that various combinations of biguanides, vicinal diols, and chelating agents results in more than a 2-log reduction of planktonic bacteria (see e.g. Figures 3-5, claim 1).
With respect to claim 3, the ‘053 patent sets for elements that lead to around 1% weight % and allowing for the hydrolyzed collagen to make up the remaining 10-99.9 wt-%.
With respect to claims 4-8, as set forth above ‘053 discloses overlapping biguanides including PHMB, and being present in at least 0.05 wt-%. ‘053 also discloses 10-350 ppm of the bis(biguanide) (see e.g. claim 6).
With respect to claims 9-11, as set forth above ‘053 discloses vicinal diols being glycerol 1-(2-ethylhexyl) ether and/or 1,2-dihydroxyoctane at 0.01-1 wt-% (see e.g. claims 1, 3, and 18).
With respect to claims 13 and 14, as set forth above ‘053 discloses overlapping chelating agents including EDTA.
With respect to claim 15, as set forth above ‘053 already allows for the biguanide, vicinal diol, and chelating agent within the ranges as claimed, which allows for the hydrolyzed collagen to fall within the range of remaining wt-%.
With respect to claim 17, ‘053 suggests that the formulation can include growth factors (see e.g. Col.15 lines 1-16).
With respect to claim 18, ‘053 suggests inclusion of glycolipids, glycoproteins, immunological response modifiers, and saccharides (see e.g. Col.15 lines 1-16).
With respect to claim 19, ‘053 discloses various overlapping forms including liquids, creams, foams, lotions, and aerosols (see e.g. Col.15 lines 37-40).
Response to Arguments:
The Applicants argue that the Office asserts ‘053 provides a composition of at least 0.05 wt% polymeric biguanide, a chelating agent of 0.01-1 wt%, and a vicinal diol at a ratio of 1:0.05-1:500 with respect to the polymeric biguanide, which must provide a four-log kill of organisms in a biofilm, not simple planktonic organisms, within ten minutes.
The Examiner agrees that ‘053 offers the polymeric biguanide, chelating agent, and vicinal diol in the amounts as claimed. However, nowhere in the rejection is a discussion made of a four-log kill of organisms in a biofilm not including simple planktonic organisms. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a four-log kill of organisms in a biofilm) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The Applicants argue that Steiner does not remedy the deficiencies of ‘053.
The Examiner disagrees, and notes that there are no particular arguments supporting why Steiner does not provide a collagen formulation for wound healing to allow for combination with ‘053.
The Applicants cite MPEP 2142.02(II). The Applicant argue that the Office has not taken into account the underlying interaction of biguanides with hydrolyzed collagen and potential for deactivation of the biguanide from complexation with hydrolyzed collagen to lose biocidal synergy. The Applicants argue the references alone or in combination do not lead to the claimed composition.
The Examiner disagrees. MPEP 2142.02(II) does not guide one to import limitations from the specification into the claims. The claims are interpreted in light of the specification, but nothing in the claims as presented discuss anything regarding the above log kill requirement as argued, nor that biguanides and hydrolyzed collagen may interact to reduce biocidal synergy. In this case, if the Applicant is attempting to argue that there are secondary considerations such as unexpected results, no evidence is provided that the alleged biocidal synergy was unexpected. A search of the specification does not provide any evidence that the combination was alleged to be synergistic or offer unexpected results. Even allowing for the allegations to constitute unexpected results, those are not found persuasive as discussed below.
The Applicants point towards the specification in [0060] and [0096] regarding charge-charge interactions between anionic hydrophilic polymers and biguanides, and anti-biofilm activity as in Example 2. Again, the Applicants are arguing features that are not claimed. Even considering the potential for charge-charge interactions and reducing in biofilm efficiency, there is no direct evidence provided to lead one of ordinary skill in the art to expect that the combination of the ‘053 and Steiner art would not be effective, especially since the claims in general do not require any particular activity.
The Applicants argue it would have been counterintuitive to combine a negatively charged hydrolyzed collagen and the composition of ‘053 when the hydrolyzed collagen is present at a high level and would disable the cationic biguanide of ‘053.
Again, in general the Applicants are arguing features which are not claimed. Only claim 3 makes any reference to the level of hydrolyzed collagen, and there is no evidence provided to support the argument that the presence of hydrolyzed collagen inactivates the composition. Even allowing for this, there are no claims that require any sort of activity of the composition outside of claim 2.
The Applicants argue Tables 2, 3, and 4 demonstrate loss of antimicrobial activity when hydrolyzed collagen is present as compared to the ‘053 formulation. The Applicants argue the HC+AM solution surprisingly eliminated planktonic MRSA at 30 minutes.
The Examiner has considered Table 2-4 and not found them persuasive to overcome the rejection of record. Regarding Table 2, there is no evidence provided in the specification or the arguments that the reduction in MRSA in a HC+AM solution at 30 minutes was unexpected, especially since the log reduction of 6.117 was exactly the same as found for the AM solution alone. Tables 3 and 4 might show that the HC+AM combination is less effective than AM alone for P. aeruginosa and C. albicans, but this does not indicate that the combination generally is less effective across all bacterial species. Again, the claims themselves do not require any such kill level within 30 minutes, and claim 2 at best requires the 2-log reduction within 24 hrs. This would be present across all species as tested for the HC+AM solution with log reduction of 6.136, 6.008, and 6.101, respectively for MRSA, P. aeruginosa, and C. albicans.
The Applicants argue it was further surprising that efficacy increased over time, discussing Tables 2-4.
The Examiner argues that no evidence is provided to support the assertion that the efficacy increase over time was surprising. Even considering the data in Tables 2-4 to establish practical significance required for unexpected results, there is no evidence that that results were statistically significant.
The Applicants argue again that an expectation would be that the combination would deactivate the biguanide. The Applicants argue the Examples show this was not the case. The Applicants argue the Office must consider comparative data in the specification to reach a conclusion of obviousness.
The Examiner disagrees for the reasons above, and further that nothing in the claims requires that the biguanide be active. The Examiner has considered the data from the specification and not found it persuasive to establish a conclusion of non-obviousness.
The Applicants summarize the arguments.
The Examiner has considered the Applicants’ arguments and not found them persuasive. The rejection is maintained.
Conclusion
No claims are allowed.
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.
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/Z.J.M/Patent Examiner, Art Unit 1658 /SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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