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 .
DETAILED ACTION
Status of claims
The amendment filed on April 26, 2026 is acknowledged. Claims 4, 7, and 11-12 have been canceled. Claims 1-3, 5-6, 8-10 and 13-20 are currently under examination in the instant office action.
Applicants' arguments, filed on April 26, 2026, have been fully considered but they are not deemed to be persuasive or moot in view of a new ground of rejection which are necessitated by the amendments (newly added limitations in claims 1 and 3 that change the scope of the claims). Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. Responses are limited to Applicants' arguments relevant to either reiterated or newly applied rejections.
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 of this title, 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.
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.
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 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.
Claims 1-3, 5-6, 8-10 and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 10111959 in view of WO 2020/161086.
As to claims 1-2, 5, and 8, US 10111959 teaches an antimicrobial composition comprising at least one alkenyl- and/or alkynyl-substituted polysiloxane (corresponding to claimed Component (B)), at least one polysiloxane comprising silicon-bonded hydrogen atoms (corresponding to claimed Component (A)), and at least one hydrosilylation catalyst, which further comprises at least one silver salt (silver containing antimicrobial agent) and at least one hydrophilic component (excipient/hydrophilic additive compound) (abstract, col 2, lines 52-64, col 17, lines 19-22, and claim 1). US 10111959 further teaches the term “polysiloxane” shall be understood to pertain to all types of polysiloxanes such as polydiorganosiloxanes (col 6, lines 23-26) and the term “alkenyl- and/or alkynyl-substituted polysiloxane” is to be understood as comprising polydiorganosiloxanes substituted with groups comprising unsaturated carbon-carbon bonds, i.e. both carbon-carbon double bonds and/or carbon-carbon triple bonds as terminal groups (col 6, lines 1-20). Thus, the at least one alkenyl- and/or alkynyl-substituted polysiloxane is Component (B) as claimed and the at least one polysiloxane comprising silicon-bonded hydrogen atoms is Component (A) as claimed. US 10111959 discloses that the presence of silver-containing compounds, such as silver salts and/or silver ions, and (optionally silver release-enhancing) hydrophilic components in the compositions, as well as in the gels and dressings, confer antimicrobial properties not only to the products per se, but also imply that the silver salts/ions can exert antimicrobial effects in surrounding areas (col 3, lines 34-43).
US 10111959 discloses methods for preparing the antimicrobial gels comprising: the steps of mixing at least one alkenyl- and/or alkynyl-substituted polysiloxane, at least one catalyst, and silica particles, followed by subsequently adding silver salt paste to the mixture, forming a component A, wherein the silver paste may comprise a polymer network such as PEG and a polysiloxane-polyether copolymer and a suitable silver salt such as silver sulfate; a component B may be formed through mixing at least one alkenyl- and/or alkynyl-substituted polysiloxane (polydiorganosiloxanes having one or more terminal groups comprising carbon-carbon multiple bond), at least one crosslinker (CL) comprising silicon-bonded hydrogen atoms, and at least one chain extender (CE) comprising silicon-bonded hydrogen atoms; thereafter, a silver-release enhancing hydrophilic component is mixed with the mixture, optionally after heating and/or melting the silver-release enhancing hydrophilic component; finally, component A and component B are mixed together prior to coating of a suitable medical substrate, and the preparation is finalized through curing the mix into an antimicrobial gel (FIG. 1, col 14, line 53- col 15, line 5, col 5, line 57-col 6, line 34, and Table 1 and 2). US 10111959 further discloses antimicrobial gels are produced from said antimicrobial composition through crosslinking the at least one alkenyl- and/or alkynyl-substituted polysiloxane and the at least one polysiloxane comprising silicon-bonded hydrogen atoms (col 2, lines 52-64). Thus, it implicitly discloses that the silver paste comprising at least one silver salt and a polymer network (excipient) in a discontinuous phase and the polysiloxane network formed by component A and component B in a continuous phase.
Also, US 10111959 discloses formulations comprising sugar alcohols such as sorbitol and mannitol, polyethylene glycol (PEG), and polypropylene as excipients (Table 5 and, col 7, lines 6-30, and col 21, lines 23-26). US 10111959 further disclose a formulation comprising an example comprising PEG 3000 (3000 g/mol), PEG 6000 (6000 g/mol) or PEG 8000 (8000 g/mol) as an excipient (Table 5). As to claim 3 as amended, US 10111959 discloses that either PEG or polypropylene glycol can be selected as a hydrophilic component, which enhances silver release for antimicrobial gel composition (col 7, lines 6-30 and claim 3).
As to claims 9-10, 16-17, and 19, US 10111959 discloses the silver salt concentration may range from approximately 1% to 30%, and preferably from approximately 2% to 20% (col 9, lines 32-34) and the (silver release-enhancing) hydrophilic component (excipient) is preferably present in a concentration that ranges from approximately 3% to 40% (w/w), and more preferably from 4% to 30% (lines col 9, 57-61). US 10111959 specifically discloses formulations comprising PEG, mannitol and sorbitol as an excipient wherein the weight percent of the excipient is greater than the weight percentage of the silver containing compound such as silver sulfate based on the total weight of the composition (see Table 5, 3N1, 9N4, and 9N8), meeting the limitation of the instant claim 9. Also, the Table 5 discloses formulations comprising an excipient such as PEG at a concentration of 10 wt% based on the total weight of the composition (3N1 and 3N6), which falls within the range of claims 10 and 17. In an example of 3N1 in Table 5, the weight percent of the excipient such as PEG 3000 and Velvesil plus is 2 times greater than the weight percent of the silver-containing antimicrobial agent, which reads on the instant claims 16 and 19.
As to claim 13-14, US 10111959 teaches that antimicrobial dressings can be prepared through mixing at least one alkenyl- and/or alkynyl-substituted polydiorganosiloxane and at least one hydrosilylation catalyst to form a component A and subsequently, at least one alkenyl- and/or alkynyl-substituted polydiorganosiloxane is mixed with a polysiloxane comprising silicon-bonded hydrogen atoms to form a component B, followed by continuous mixing of components A and B by joining two streams comprising component A and component B, respectively (col 17, lines 9-19. US 10111959 further teaches that antimicrobial gels are formed through crosslinking the at least one alkenyl- and/or alkynyl-substituted polysiloxane and the at least one polysiloxane comprising silicon-bonded hydrogen atoms (col 2, line 52-col 3, line 12).
As to claim 15, US 10111959 discloses that the antimicrobial gel may further comprise one or more excipients selected from siloxane-containing copolymers, siloxane polymer networks (organopolysiloxane), and silica particles (filler) (col 9, lines 19-22). US 10111959 further discloses that in order to further improve the antimicrobial and overall properties of the antimicrobial composition, the compositions may comprise at least one siloxane-containing copolymer selected from the group comprising at least one siloxane polymer network and at least one siloxane polyether (SPE) wherein the siloxane polymer network is selected from the poly-ether-siloxane copolymer networks, cyclopentasiloxane-alkyl cetearyl dimethicone copolymer networks (Velvesil 125), and vinyldimethyl/trimethylsiloxysilicate stearyl dimethicone crosspolymer (column 7, line 55-col 8, line 12). US 10111959 specifically disclose a formulation comprising Component A comprising vinyl terminated PDMS (Vin 1000), silica (filler) and catalyst (silicone A), Component B comprising Vin 1000, CL and CE, silver sulfate, velvesil plus (organopolysiloxane) and PEG 8000, wherein the formulation is prepared by the following steps: 1) adding a silicone component A (3.75 g), in accordance with example 1, in a jar with PEG 8000 (3 g). 2) heating at 80° C. until the PEG is molten; the phases are subsequently mixed in a Speedmixer until an emulsion is formed (a timeframe of approximately 2 min); 3) preparing a paste of silver sulfate (3 g) and Velvesil plus (1.5 g) by mixing the silver powder and the Velvesil in a jar, and blending with the Speedmixer; 4) adding the silver paste to component A and mix 5) adding inhibitor (0.015 g) to silicone B and mix; and 6) add silicone component B (3.75 g) (Table 1-2 and Example 1-2).
As to claim 20, US 10111959 discloses that the antimicrobial gel is to be applied in order to create a wound dressing comprising the antimicrobial gel may be any surface that will generate the desired properties, wherein the substrate include an adhesive (i.e., adhesive gel) (col 11, lines 40-50 and claim 16).
While US 10111959 teaches and suggests the use of PEG such as PEG 3000 as excipietn/hydrophilic component (see col 7, lines 6-13), it does not disclose a specific embodiment comprising PEG with an average molecular weight of 300-2000 g/mol or 300-1000 g/mol recited in claims 1 and 18 as amended.
However, it was known in the art that a polyethylene glycol (PEG) is used as hydrophilic polymer for a therapeutic composition comprising antimicrobial agent such as silver and it may have an average molecular weight of about 100 g/mol to about 40,000 g/mol, preferably about 200 to about 1,000 g/mole, and selected from a group comprising PEG-100, PEG-200, PEG-400, PEG-600, PEG-1000, PEG-3000, PEG-4000, PEG-10000, PEG-35000, or a mixture thereof as evidenced by WO 2020/161086 ([0008], [0074] and [0086]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use polyether such as PEG and poly(propylene glycol) having claimed MW for the composition of US 10111959 because PEGs having a wide range of average MW can be used as hydrophilic polymer for the antimicrobial composition as evidenced by WO 2020/161086. Also, US 10111959 already discloses the use of PEG-3000 as hydrophilic polymer. For example, it would have been prima facie obvious to one of ordinary skill in the art to use PEG-2000 or PEG-1000 instead of PEG-3000 since they are taught to be suitable hydrophilic polymers for the antimicrobial composition. One of ordinary skill in the art would have been able to carry out such a substitution on the reasonable expectation that they would have similar properties as hydrophilic polymer in the absence of evidence to the contrary. As to claim 3 as amended, it would have been obvious to select poly(propylene glycol) in place of PEG because both can be interchangeably used as suitable hydrophilic component for the antimicrobial composition as evidenced by US 10111959.
As to the newly added limitation, “the composition does not exhibit an observable change in color after exposure to air having a relative humidity of 50% at 20°C for 24 hours” in claim 1 and “the excipients inhibits the silver-containing antimicrobial agent from forming element silver or silver oxide in the presence of air having a relative humidity of 50% at 20°C” recited in claim 6, they are intended results of the composition. However, the prior art references in combination teach and suggest the same composition comprising the same components as claimed, including the same silver-containing antimicrobial agent such as silver sulfate and the same excipient such as polyether such as PEG and poly(propylene glycol). Thus, the same polyether excipient necessarily inhibits the same silver-containing antimicrobial agent from forming element silver or silver oxide in the presence of air having a relative humidity of 50% at 20°C and thus the composition necessarily does not exhibit an observable change in color after exposure to air having a relative humidity of 50% at 20°C for 24 hours as claimed. It is noted that products of identical chemical composition cannot have mutually exclusive properties and 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 re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). When the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Alternately, the 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. See 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).
Response to Applicant’s arguments
Applicant argues that Löwenhielm does not teach a polyether having an average molecular weight of 300-2,000 g/mol and Dagger does not teach or suggest a therapeutic composition that does not exhibit an observable change in color after exposure to air having a relative humidity of 50% at 20°C for 24 hours, thus Dagger does not cure the deficiencies of Löwenhielm. Applicant further argued that as the art cited by the Examiner fails to teach all of the limitations required by claim 1 as amended, it is patentable. Applicant also stated that it is a well-established legal principle that to establish a case of prima facie obviousness of the claimed invention, all of the claim limitations must be taught or suggested by the prior art. See In re Royka, 490 F.2d 981 (CCPA 1974).
In response to the argument based on In re Royak, subsequent Supreme Court precedent in KSR rejected a rigid application of such requirements and the Supreme Court noted that the analysis under 35 USC 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that "[a] person of ordinary skill is... a person of ordinary creativity, not an automaton." Id. at 1742.KSR. Also, MPEP 2143.03 states that "[A]ll words in a claim must be considered in judging the patentability of that claim against the prior art", but does not require that all of the claim limitations must be taught or suggested by the prior art. 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).
In this case, US 10111959 already discloses the use of polyether such as PEG-3000 and poly(propylene glycol) as hydrophilic polymer for an antimicrobial composition comprising the same components (A) and (B) and a silver containing antimicrobial agent as claimed. It was known in the art that PEGs having a wide range of average MW including PEG-200, PEG-1000, and PEG-3000 can be used as hydrophilic polymer for the antimicrobial composition as evidenced by WO 2020/161086. Thus, it would have been prima facie obvious to one of ordinary skill in the art to use PEG-2000 or PEG-1000 instead of PEG-3000 since they are taught to be suitable hydrophilic polymers for the antimicrobial composition. One of ordinary skill in the art would have been able to carry out such a substitution on the reasonable expectation that they would have similar properties as hydrophilic polymer in the absence of evidence to the contrary. Applicant did not provide any evidence showing the criticality of the MW of PEG.
As to the limitation “the composition does not exhibit an observable change in color after exposure to air having a relative humidity of 50% at 20°C for 24 hours”, it is an inherent property of the claimed composition. Since the prior art references in combination teach and suggest the same composition comprising the same components as claimed, including the same silver-containing antimicrobial agent such as silver sulfate and the same PEG, the same PEG excipient necessarily inhibits the same silver-containing antimicrobial agent from forming element silver or silver oxide in the present of air having a relative humidity of 50% at 20°C for 24 hours and thus the composition necessarily does not exhibit an observable change in color after exposure to air having a relative humidity of 50% at 20°C for 24 hours as claimed. It is noted that products of identical chemical composition cannot have mutually exclusive properties and 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 re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). There is no evidence that the composition of the prior art does not have the claimed property (no observable change in color after exposure to air having a relative humidity of 50% at 20°C for 24 hours). Applicants are advised that In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) states: "Where, as here, the claimed and prior art product is identical or substantially identical, or is produced by an identical or substantially identical process, the PTO can require an applicant to prove that the prior art product does not necessarily or inherently possess the characteristics of his claimed product ........ Whether the rejection is based on 'inherency' under 35 USC 102, on 'prima facie obviousness' under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products [footnote omitted]."
For the foregoing reasons, Applicant's arguments have not been found to be persuasive.
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 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 date of this final action.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
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