DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Oath/Declaration
Declaration filed under 37 C.F.R. 1.132 on 10/16/25 has been fully considered but is not found persuasive to overcome the obviousness conclusion of this case. See Response to Arguments section for details.
Maintained Claim Objections
Claim 70 remains objected to because of the following informalities: claim 70 recites “…and further wherein when the microsheet is applied to a wound the water-soluble sacrificial polymer layer dissolves…”. The Examiner suggests adding a comma after the when clause; specifically, adding a comma after “wound”.
Examiner’s note: the comma that was added in the claim set filed on 10/16/25 is not after the when clause and therefore does not obviate the above objection.
Appropriate correction is required.
Maintained Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Applicant Claims
2. Determining the scope and contents of the prior art.
3. Ascertaining the differences between the prior art and the claims at issue, and 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 70, 75, 79, 80, 83, 107, 108, 111, 119, and 163-166 remain rejected under 35 U.S.C. 103(a) as being unpatentable over Abbott et al. (Pub. No.: US 2011/0189287; Pub. Date: Aug, 4, 2011), Myers et al. (Pub. No.: US 2007/0122455; Pub. Date: May 31, 2007), and Rogosnitzky (US 2011/0104246; published: 5/5/11).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Regarding claims 70, 75, 111, 119, and 163-166, Abbott discloses a wound dressing medical article comprising a polymer multilayer of sequential and repeat application of layers comprising at least one wound active agent having a thickness of from about 1 nm to 500nm, wherein the at least one wound active agent includes antimicrobial silver in the form of silver nanoparticles or ionic silver incorporated into the polymer multilayer [0056], [0057], [0075] and [0076], wherein the polymer multilayer includes repeat polymer multilayers formed by the alternating addition of anionic and cationic polyelectrolytes [0076] including wherein the layers comprises PEG or polyacrylic acid ([0217], [0279], and [0212]), wherein the release rate of the antimicrobial silver is in an amount about 0.1 to 0.5 ug/cm2 a day [0053], with a load of between 0.01and 500 ug/cm2 [0052] and [0056] which means that release rate can be over at least 2 or over 30 days, wherein the nanoscale polymer with active agent deposited on a support, wherein said support comprises an active agent such as antimicrobial silver [0052] that is water soluble [0044],is from about 1 micrometer to 10 mm thick [0046], and comprises polyvinyl alcohol [0044], wherein the microsheet has a compliance from 3kPa to 5GPA [0042] and the support layer has the Young’s modulus of 1-600kPa and preferably about 10-100kPa for mechanical properties equivalent to biological tissue [0227], the limitation of a the Young’s modulus overlapping the range of 0.1 to 10GPa is met, wherein the wound active agents are incorporated into the polyelectrolyte layer for delivery to a wound such as silver anti-infective agents in an amount to kill 99.99% of a bacteria (abstract and [0048]), the killing of bacteria once the composition is applied to a wound would inhibit a biofilm in a wound.
The polymeric support of Abbott that is water soluble and made up of polyvinyl alcohol with antimicrobial silver active agents is equivalent to the instantly claimed water soluble sacrificial layer.
Regarding claim 79, Abbott discloses wherein the positively charged polyelectrolyte is selected from poly(L-lysine), poly(ethylene imine), and poly(allylamine hydrochloride) [0019].
Regarding claim 80, Abbott discloses wherein the negatively charged polyelectrolyte polyglutamic acid [0019].
Regarding claim 83, Abbott discloses wherein the active agent is dispersed in the polymer multilayer [0043].
Regarding claims 97, 107, and 108, Abbott discloses wherein the alternating cationic and anionic polyelectrolytes are sequentially and repeatedly layered [0019] wherein specific embodiments include at least 4 alternating layers with wound active agent [0128] and [0129]; wherein the cationic polymer includes poly acrylic acid [0131]; wherein the definition of wound active agent includes anti-infective agents such as ionic silver or silver nanoparticles [0075]. Each set of repeating agents are structurally the same as a wound active nanoscale polymer layer and a second polymer layer adjacent to said wound active nanoscale polymer layer, accordingly the limitations are met.
With regards to the new claim 70 limitation “wherein when the microsheet is applied to a wound the water-soluble sacrificial polymer layer dissolves within 30 seconds to one hour to provide a burst release of said second wound active agent”, the MPEP states the following (MPEP §2112(I)):
I. SOMETHING WHICH IS OLD DOES NOT BECOME PATENTABLE UPON THE DISCOVERY OF A NEW PROPERTY
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“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Therefore, in view of MPEP §2112, claiming a new use/function/property for such known composition (e.g., burst release), which is inherently present in the prior art, does not necessarily make the claim patentable.
Furthermore, with regards to the abovementioned “burst release” limitations of instant claim 70, the prior art teaches the same composition as claimed and therefore, the composition's properties are necessarily present; the Examiner directs attention to MPEP 2112.01(II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present”.
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Abbott does not disclose the limitation wherein the sacrificial polymer layer has a thickness variation of less than 20% of the average thickness when measured in the cross section.
However, in the same field of endeavor of water-soluble thin films made out of polyvinyl alcohol [0063] for use on the surface of the skin or a wound [0154], Myers discloses wherein the films are uniform ([0007], [0102], [0136]). A uniform film includes a uniform thickness of a film with no desired variation in the thickness throughout the film. This meets the limitation of less than the sacrificial polymer layer has a thickness variation of less than 20% of the average thickness when measured in the cross section.
Abbott does not disclose the limitation wherein the second wound active agent is gallium ion or gallium alloy.
However, in the same field of endeavor as wound healing medical articles such as topically applied wound treatments (e.g., bandages) to promote healing (Abstract), Rogosnitzky discloses wherein the composition includes gallium nitrate (i.e., a gallium ion salt) (Abstract and [0020]). Rogosnitzky teaches that it was found that liquid gallium nitrate solutions applied directly to bleeding open wounds are very effective at the immediate treatment of the wounds and the promotion of the early stages of hemostasis ([0017]). With regards to the amount, Rogosnitzky teaches that an aqueous form of gallium nitrate, which may be quite compatible for topical use, may be prepared by directly dissolving the Ga(NO3)3 salts in water at a concentrations higher than the 1% typically used for intravenous injection purposes ([0033]). Furthermore, teaches that in a preferred embodiment, still higher concentrations, often between about 2% and 20% weight/volume of gallium nitrate/water, occasionally as high as 42%, and preferably in the 5% to 15% range may be adequate as a basis for a variety of different topical treatments for fresh wounds ([0033]).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of invention to combine the teachings of Abbott to include multiple wound active agents in a nanoscale polymer matrix comprising a wound dressing medical article comprising a polymer multilayer of sequential and repeat application of layers the alternating addition of anionic and cationic polyelectrolytes [0076], wherein the positively charged polyelectrolyte is selected from poly(L-lysine), poly(ethylene imine), and poly(allylamine hydrochloride) [0019] and the negatively charged polyelectrolyte is polyglutamic acid [0080]; wherein specific embodiments include at least 4 alternating layers with multiple wound active agents ([0056], [0128], and [0129]); wherein the cationic polymer includes poly acrylic acid [0131]; wherein the definition of wound active agent includes anti-infective agents such as ionic silver or silver nanoparticles [0075] or alternatively wherein the nanoscale polymer with active agent deposited on a support, wherein said support is from about 1 micrometer to 10 mm thick [0046] and wherein said support comprises a polymeric support [0052] comprising soluble polyvinyl alcohol [0044] as a matter of design choice, as instantly claimed, with a reasonable expectation of success, at the time of the instant invention. Said design choice amounting to combining the prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would be motivated to do so and have a reasonable expectation of success because Abbott had already disclosed each of these alternatives for a multilayered wound care article. It would have only required routine experimentation to modify the disclosure of Abbot to meet each of the claimed limitation of the nanoscale multilayer polymer wound care medical article.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to combine the teachings of Abbott et al. and Myers et al. for the water soluble polyvinyl alcohol film layer to be uniform as disclosed by Myers in the wound dressing medical article comprising a polymer multilayer of sequential and repeat application of layers comprising at least one wound active agent, wherein the wound active agent is an antimicrobial incorporated into the polymer multilayer [0056], [0057], [0075] and [0076] as disclosed by Abbott as a matter of combining prior art elements according to known methods to yield predictable results as instantly claimed with a reasonable expectation of success, at the time of the instant invention. One of ordinary skill in the art would be motivated to have a uniform thickness in order to have a uniform dissolution rate, uniform contact to a surface, a homogenous presence of a drug or agent that might be present in the support, and a uniform stability/strength throughout the substrate layer. One who would have practiced the invention would have had a reasonable expectation of success because Abbott had already disclosed wound dressing medical article comprising a support layer comprising dissolvable polyvinyl alcohol, while Myers provided guidance with respect to the water-soluble polyvinyl alcohol layer being uniform. It would have only required routine extermination to modify the method of Abbott for a uniform thickness of the support layer as required by the instant claims.
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to combine two compositions, each of which is taught by the prior art to be useful for the same purpose (silver of Abbott ([0110]) and gallium nitrate of Rogosnitzky ([0062]) for the purpose of providing antibacterial activity in a wound treatment), in order to form a third composition to be used for the very same purpose (See MPEP 2144.06-I).
The amount of gallium nitrate is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of gallium nitrate, an antibacterial agent, in order to best achieve the desired results as such would provide advantageous biological effect. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. 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, 105 USPQ 233 (CCPA 1955). In the instant case, Rogosnitzky teaches that an aqueous form of gallium nitrate, which may be quite compatible for topical use, may be prepared by directly dissolving the Ga(NO3)3 salts in water at a concentrations higher than the 1% typically used for intravenous injection purposes ([0033]). Furthermore, teaches that in a preferred embodiment, still higher concentrations, often between about 2% and 20% weight/volume of gallium nitrate/water, occasionally as high as 42%, and preferably in the 5% to 15% range may be adequate as a basis for a variety of different topical treatments for fresh wounds ([0033]). The Examiner considers it prima facie obvious to optimize the amounts of any biologically active agent to achieve their known biological effect, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the amounts of gallium nitrate would impact the efficacy in the treatment of wounds and therefore be an optimizable variable.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious at the time the invention was made.
Response to Arguments
Applicants’ arguments have been fully considered, but are not found persuasive.
Applicants argue that Abbott does not teach or suggest a burst release of gallium (i.e., the second wound active agent as defined in the claim) (Remarks: p. 5).
This is not found persuasive. In response, and as indicated in the above rejection, “the prior art teaches the same composition as claimed and therefore, the composition's properties are necessarily present; the Examiner directs attention to MPEP 2112.01(II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present”. In other words, the Examiner acknowledges that the prior art is silent with regards to the claimed “burst release”, but that such is inherent since the composition taught in the prior art is structurally the same. Therefore, the burden shifts to the Applicants (see MPEP 2112.01 (V)).
Applicants argue that Rogosnitzky fails to teach or suggest that gallium nitrate can be incorporated into a water-soluble layer in the article as claimed (Remarks: p. 5).
This is not found persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Since the instant rejection is an obviousness-type rejection, none of the references (i.e., Abbott and Rogosnitzky) has to teach each and every claim limitation. It is the combination of the prior art references that renders the instant claims prima facie obvious and applicants did not provide any evidence that one of skill in the art would not have been motivated or would not have reasonably expected to be successful in arriving at the claimed invention as set forth in the rejection above. In the instant case, Abbott teaches the general structure of the claimed microsheet, including the location wound active agents. Rogosnitzky is relied upon for its teaching that gallium nitrate is also used as a wound active agent for the same purpose as those agents (e.g., silver) taught in the structure of Abbott.
Applicants argue that there is no evidence in any of the combined references that a combination of silver in a PEM layer and gallium in water soluble polymer layer would be effective in treating or preventing infection in wound (Remarks: p. 5). Applicants direct attention to the Declaration filed on 10/16/25, which established that gallium and silver have a synergistic effect when provided in the articles as claimed (Remarks: ¶ bridging p. 5-6).
This is not found persuasive. This is not found persuasive. In response to Applicants’ argument of unexpected results, the Examiner responds with the following statements:
(a) It is not clear from the test data provided in the specification that there is a synergistic effect. Specifically, the data provided in the specification and declaration do not indicate the concentration of the Ag or Ga. Synergy is often dependent on the concentration of each ingredient and the data in, for example, Figure 1 of the Declaration, does not shoe the concentration. The Figure shows that both Ag and Ga alone have an effect on the biofilm growth. It is unclear from the bar graph that the effect of the combination of Ag and Ga is in fact a synergistic effect and not merely an additive effect. Statistical analysis is suggested to provide that evidence.
(b) Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof (See MPEP § 716.02(c)-II). In the instant case, there is expectation of producing desirable inhibition of biofilm by incorporating two active agents known with such activity: Abbott teaches silver’s activity and Rogosnitzky teaches gallium’s activity.
(c) 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 (see MPEP § 716.02(d)). In the instant case, it is unclear what the concentration of silver and gallium is used in the comparable data and therefore it is unclear if the data supports the open-ended concentration in the instant claims. It is noted, that there is only one test data with unknown concentration.
Conclusion
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 GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/GENEVIEVE S ALLEY/ Primary Examiner, Art Unit 1617