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
Claims 1-20 are pending and under examination in the instant office action.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-10, 13-17, and 19-20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by US 10111959 (cited in the IDS filed on 7/12/2024).
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.
As to claim 3, US 10111959 disclose formulations comprising sugar alcohols such as sorbitol and mannitol and polyethylene glycol (PEG) as excipients (Table 5 and, col 7, lines 6-30, and col 21, lines 23-26).
As to claim 4, US 10111959 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). The excipient (PEG) has average molecular weights more than 300 g/mol, meeting the instant claim 4.
As to claim 6 and 7, they further recite intended results of the composition. However, the prior art teaches 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 PEG. Thus, the same excipient necessarily inhibits the same silver-containing antimicrobial agent from element silver or silver oxide in the present of air having a relative humidity of 50% at 20°C hours and 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).
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).
As such, the instant claims are anticipated by US 10111959.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 10111959 in view of WO 2020/161086.
US 10111959 as applied supra is herein applied for the same teachings in their entirety.
While US 10111959 teaches and suggests the use of PEG such as PEG 3000 as hydrophilic components (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 11-12 and 18.
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 PEG 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.
Conclusion
No claims are allowed.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611