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 .
Applicant’s arguments, filed 02/20/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 Status
Claims 1-9 are pending.
Claims 8 and 9 are withdrawn.
Claim Rejections - 35 USC § 112(b) or pre-AIA 2nd ¶
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites “wherein the viscosity of the first agent is 20,000 mPas or less,” and it is unclear if the viscosity of claim 5 is intended to be modified by the newly amended “wherein the viscosity is measured by a falling-ball viscometer under 25 deg C” of claim 1, or if the viscosity of claim 5 was measured by some other technique, as “the viscosity” of claim 1 implies the measurement technique applies only to the silicone of component (c). For purposes of examination, the claim is interpreted as a viscosity as measured at any temperature with any technique, were the limitation is broadly recited.
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 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al (Nat. Mater., 2016, vol 15, pp. 911-920), in view of SpecialChem (XIAMETER PMX-1184 Silicone Fluid, 2018), Akthakul et al (WO 2017083398 A1), and Hidefumi et al (WO 2019124419 A1), as evidenced by SciFinder (Andisil VS 165K substance detail, retrieved 2025), Chem Buyers Guide (Product List: 189, retrieved 2025), AB (Andisil XL, retrieved 2025), and UnivarSolutions (XIAMETER PMX-1184 Silicone Fluid, retrieved 2025).
Yu et al teach an elastic second skin composition (i.e., artificial skin), comprising a step 1 composition comprising VS 165K (vinyl terminated polydimethylsiloxane, viscosity 165K mPas), VS 10K (vinyl terminated polydimethylsiloxane, viscosity 10K mPas), XL-11, PMX-1184 (dimethicone and trisiloxane, i.e., a silicone), etc., and a step 2 composition comprising a platinum catalyst (pg. 917 materials, supplementary table 1. As evidenced by UnivarSolutions, PMX-1184 comprises a mixture of decamethyltetrasiloxane and octamethyltrisiloxane (synonyms). As evidenced by SciFinder, VS 165K comprises at least two carbon-carbon double bonds. As evidenced by Chem Buyers Guide, XL-11 is a methylhydroxysiloxane-dimethylsiloxane copolymer. As evidenced by AB, XL-11 is trimethylsiloxy terminated. The film was crosslinked when exposed to the platinum catalyst (pg. 919 1st col 2nd para).
Yu et al does not disclose the specific viscosity of PMX-1184 (i.e., the silicone).
SpecialChem (XIAMETER PMX-1184 Silicone Fluid, 2018) discloses viscosities ranging from 1.45-1.75 mPas at 25 deg C for PMX-1184 were known (see viscosity).
Akthakul et al teach compositions that can form a prosthetic skin comprising polymer A, polymer B, and polymer C (¶ 95). Polymer A is an organopolysiloxane comprising at least two carbon double bonds or at least one carbon triple bond, polymer B is an organopolysiloxane having at least two Si-H units, and polymer C is one or more organopolysiloxanes having a viscosity of about 0.7 to about 10,000 cSt at about 25 deg C, such as vinyl dimethicone, etc. (¶ 95, claims 11, 15, 38, 39). The first part of the composition can have a viscosity of less than about 30,000 cP at about 25 deg C (claim 70). The amount of low viscosity organopolymer is critical and can be adjusted to achieve desired set-to-touch time and tack-free time, and increasing the molar ratio of low viscosity component reduced set-to-touch time (¶ 129). In certain embodiments, the composition comprises one or more additives, including pigments, dyes, etc., (¶¶ 122, 123, 169, claim 57).
Hidefumi et al teach solvent curable organopolysiloxane compositions comprising organopolysiloxanes that may be dispersed in a liquid organopolysiloxane of low viscosity (for example a chain organopolysiloxane with low viscosity of around 0.5 to 10 mPas at 25 deg C) (pg. 8 last ¶). If the viscosity of organopolysiloxanes exceeds 1000 mPas at 25 C, the curing time will be long (abs, see ¶ bridging pp. 6-7).
Regarding polymer A of claim 1, VS 165K comprises at least two carbon-carbon double bonds, as evidenced above.
Regarding polymer B of claim 1, where XL-11 is a silicon hydride containing polysiloxane with random pendant silicon-hydride functionality, it would be expected that the polysiloxane would have at least two Si-H units in the molecule. Further, as evidenced by the instant specification, XL-11 is used in the working embodiments as polymer B, and polymer B is disclosed as having at least two Si-H units.
Regarding the viscosity of the silicone of claim 1, it would have been obvious, when formulating the artificial skin composition of Yu et al, to adjust the viscosity of PMX-1184 within the claimed range, where the viscosity of PMX-1184 can vary from 1.45-1.75 mPas at 25 deg C. Further, the skilled artisan would have had motivation to lower the viscosity where Akthakul et al teaches the amount of low viscosity organopolymer can be adjusted to achieve desired set-to-touch time and tack-free time, and increasing the molar ratio of the low viscosity component reduced set-to-touch time. Likewise, where Hidefumi et al appears to suggest that increased dynamic viscosity of low viscosity silicones in curable organopolysiloxane compositions results in increased cure times, the skilled artisan would reasonably expect that lower viscosity silicone would result in faster cure times. From these teachings, the skilled artisan would reasonably expect that decreasing the viscosity of the silicone would result in faster cure times, and would be motivated to decrease cure times in order to achieve faster artificial skin formation upon application.
Regarding falling-ball viscometer limitation of claim 1, while the claim recites a viscosity as measured by falling-ball viscometer at 25 deg C, the dynamic viscosity of the silicone appears to be inherent to the component itself, rather than the technique used to measure the viscosity. While the instant specification measured their tested PMX-1184 as having a viscosity of 1.6 mPas, falling within the ranges known from SpecialChem (1.45-1.75 mPas at 25 deg C ), it would be reasonably expected that the viscosity as measured by falling-ball viscometer under the same temperature conditions and densities, that the resulting viscosities would overlap the instantly claimed range.
Purely arguendo, even if there were slight deviations in the measured dynamic viscosity between measurement techniques, the general motivation provided by the prior art is that lower viscosity silicones would be expected to shorten cure time, and therefore, it would have been well within the relative skills of the skilled artisan to select from other silicone oils with low viscosities, including those 1.5 mPas or less at 25 deg C as taught Akthakul et al, in order to achieve desired cure times and resulting formulation properties, for the same reasons discussed above. 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. See MPEP 2144.05(II)(A).
Regarding claim 2, PMX-1184 comprises a mixture decamethyltetrasiloxane (4 silicon atoms) and octamethyltrisiloxane (3 silicon atoms).
Purely arguendo, if somehow PMX-1184 cannot have a viscosity within the claimed range as measured by falling-ball viscometer at 25 deg C, it would have been obvious to select from other low viscosity silicones falling within the claimed range for the same reasons discussed above. Where vinyl dimethicone is a polydimethylsiloxane that comprises repeating monomer units that comprise silicon atoms that vary in number with increasing or decreasing chain length, it would have been obvious for the skilled artisan to select from any suitable chain length for dimethicone polymers, such as having 3 to 5 silicon atoms, as the chain length and number of silicon atoms are not limited by Akthakul et al. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). such as vinyl dimethicone, as a taught by Akthakul et al.
Regarding polymer A of claim 3, VS 165K comprises at least two carbon-carbon double bonds, as evidenced above.
Regarding claim 4, XL-11 is a trimethylsiloxy terminated methylhydroxysiloxane-dimethylsiloxane copolymer, as evidenced above.
Regarding claim 5, it would have been obvious to formulate the first step of Yu et al with known viscosities suitable for artificial skin compositions, such as less than about 30,000 cSt (i.e., less than about 30,000 mPas) at about 25 deg C, as taught by Akthakul et al and for the same reasons discussed above.
Purely arguendo, if the viscosity was intended to be measured using a falling-ball viscometer under 25 deg C, the examiner notes that the claim is directed to a composition rather than a method, and where a viscosity of 30,000 cSt (i.e., less than about 30,000 mPas) at 25 deg C is made obvious above, it would be reasonably expected that the viscosity would overlap the instantly claimed range as measured using a falling-ball viscometer under 25 deg C. Further, it would have been well within the relative skills of the skilled artisan to routinely optimize the viscosity of the first component in order to achieve desired properties such as spreadability, film thickness, etc., depending on the desired use. 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. See MPEP 2144.05(II)(A).
Regarding claim 6, it would have been obvious to formulate the first step with a pigment or dye, where pigments and dyes were known to be included in artificial skin compositions, as taught by Akthakul et al, for the same reasons discussed above.
Regarding claim 7, the step 2 formulation appears to be free of a pigment, a dye, and a filler, as instantly claimed.
Response to Arguments
First, Applicants assert Yu does not teach PMX 1184 with a dynamic viscosity of 1.5 mPas or less at 25 deg C, measured by falling-ball viscometer. Applicants assert SpecialChem does not remedy Yu’s deficiencies as the reference teaches a range of 1.45-1.75 mPas at 25 deg C, without any link to artificial skin, crosslinking rate, or to Yu’s system. Applicants assert listing a property in isolation does not constitute a teaching or suggestion to modify Yu’s formulation. Applicants assert SpecialChem uses PMC-1184 at 1.6 mPas in comparative Example 1 of Table 1. Second, Applicants assert Hidefumi does not remedy the deficiencies of Yu and SpecialChem. Applicants assert Hidefumi does not teach or suggest that setting the viscosity of the silicone component blended into the first agent to 1.5 mPas or less would significantly reduce crosslinking time. Applicants point to Hidefumi fig. 2, and asserts the low viscosity range of Hidefumi is in the order of up to 1,000 mPas. Applicants assert Hidefumi fig. 2 merely shows relative cure time trends within its own much higher viscosity scale and formulation context and provides no guidance that reducing silicone viscosity to 1.5 mPas or less would yield the unexpectedly rapid cure times. Third, Applicants assert Akthakul does not remedy the deficiencies of Yu, SpecialChem, and Hidefumi, as it was cited solely for the disclosure of the viscosity or composition of the first agent. Fourth, Applicants assert the present application provides unexpected results of a composition comprising a silicone having a viscosity of 1.5 mPas or less at 25 deg C. Applicants assert table 1 shows silicones with a viscosity of 1.5 mPas or less consistently achieve cross-linking times of 15-25 seconds, whereas those with higher viscosity oils or non-silicone oils require 37-65 seconds. Applicants assert the cited references provide no teaching or expectation that such a selection would yield the substantial and practically significant reduction in crosslinking time.
First, respectfully, this argument is not persuasive. While the examiner agrees that Yu et al does not appear to specifically teach falling-ball viscometer at 25 deg C, the reference does teach PMX-1184, a low viscosity silicone. It was known from SpecialChem that the dynamic viscosity of PMX-1184 can vary between 1.45 and 1.75 mPas at 25 deg C. As such, it would have been obvious for the skilled artisan to select from any of the known viscosities of PMX-1184, such as those overlapping the instantly claimed range. Motivation for selecting from the lower viscosity silicone is provided by Akthakul et al and Hidefumi et al for the same reasons discussed above, where it would be expected that the lower viscosities would result in faster cure times. Regarding the falling-ball viscometer at 25 deg C, the viscosities appear to overlap the instantly claimed range for the same reasons discussed above. Purely arguendo, even if there were slight deviations in the measured dynamic viscosity between measurement techniques, the general motivation provided by the prior art is that lower viscosity silicones would be expected to shorten cure time, and therefore, it would have been well within the relative skills of the skilled artisan to select from other silicone oils with low viscosities, including those 1.5 mPas or less at 25 deg C as taught Akthakul et al, as measured by any method, in order to achieve desired cure times and resulting formulation properties, for the same reasons discussed above. 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. See MPEP 2144.05(II)(A).
Second, respectfully, this argument is not persuasive. The examiner notes that Applicants refer to fig. 2 of Hidefumi et al, however there does not appear to be any figures in the Hidefumi et al reference, and it is not clear to the examiner what teachings Applicants are referring to. While Hidefumi et al teach viscosities ranging from 1-1,000 mPas at 25 deg C, the reference teaches that at viscosities above 1,000 mPas, the curing time will be long, which appears to suggest that higher viscosities result in longer curing times. Accordingly, the skilled artisan would have motivation to select from lower viscosities, in order to shorten cure times, as discussed above. Further, Akthakul et al is cited above and teaches the amount of low viscosity silicone is critical, where increased low viscosity silicone decreases cure time and set-to-touch time. Accordingly, from Hidefumi et al and Akthakul et al, the skilled artisan learns that viscosity plays a significant role in cure times, with lower viscosities resulting in faster curing times and set-to-touch times. From this, the skilled artisan would have motivation to select from lower viscosity silicones in order to achieve desired cure times, where the general expectation would be that lower viscosity silicones provide faster curing.
Third, respectfully, this argument is not persuasive. In view of Applicants amendments, Akthakul et al is also cited above for providing additional motivation for selecting a low viscosity silicone falling within the claimed range, for the same reasons discussed above.
Fourth, respectfully, this argument is not persuasive. Applicants assert table 1 shows unexpected results in crosslinking time when using a silicone with a viscosity of 1.5 mPas or less, however, the results appear to merely show a near linear trend, where the data appears to show that as viscosity decreases, crosslinking time increases, and vice versa. From the data, there does not appear to be a threshold value for viscosity upon which crosslinking time is unexpectedly improved. As discussed above, the skilled artisan would reasonably expect that a lower viscosity would increase cure time, and thus, increase crosslinking time. Allegations of unexpected results require greater than expected results as evidence of nonobviousness. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent. See MPEP 716.02(a). Here, the general expectation provided by the prior art of lower viscosity resulting in faster cure times, aligns with the data presented by Applicants, and therefore, does not appear to be greater than expected results to support nonobviousness.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al (Nat. Mater., 2016, vol 15, pp. 911-920), in view of SpecialChem (XIAMETER PMX-1184 Silicone Fluid, 2018), Akthakul et al (WO 2017083398 A1), Hidefumi et al (WO 2019124419 A1), and Al-Moameri et al (Chem Eng Sci., 2017, 161, pp. 14-23, hereinafter “Al-Moameri”).
The references are discussed above, additional motivation for adjusting the viscosity of the silicone is provided by Al-Moameri.
Al-Moameri teaches increases in viscosity in thermoset reactions leads to reduced frequencies of reacting moiety collisions with respective reduced reaction rates (abs). Viscosity is a key parameter that impacts rate of diffusion, where the rate of diffusion increases as the viscosity decreases (pg 16 col 1 3rd ¶). Increased viscosity leads to decreased diffusion rate (pg 16 2nd col 6th ¶). Initial reaction rates are fast due to low viscosity (pg 21 2nd col last ¶).
Regarding claim 1, additional motivation to adjust the viscosity of the silicone component is provided by Al-Moameri, where the reference teaches that a decreased viscosity results in increased diffusion rate and faster reaction rates, and an increased viscosity reduces the frequencies of reacting moiety collisions and reduced reaction rates, it would have been obvious to for the skilled artisan to adjust down the viscosity of the silicone to within the claimed ranges, in order to achieve faster reaction rates, and thus, faster cure times. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding falling-ball viscometer limitation of claim 1, while the claim recites a viscosity as measured by falling-ball viscometer at 25 deg C, the dynamic viscosity of the silicone appears to be inherent to the component itself, rather than the technique used to measure the viscosity. While the instant specification measured their tested PMX-1184 as having a viscosity of 1.6 mPas, falling within the ranges known from SpecialChem (1.45-1.75 mPas at 25 deg C ), it would be reasonably expected that the viscosity as measured by falling-ball viscometer under the same temperature conditions and densities, that the resulting viscosities would overlap the instantly claimed range.
Purely arguendo, even if there were slight deviations in the measured dynamic viscosity between measurement techniques, the general motivation provided by the prior art is that lower viscosity silicones would be expected to shorten cure time, and therefore, it would have been well within the relative skills of the skilled artisan to select from other silicone oils with low viscosities, including those 1.5 mPas or less at 25 deg C as taught Akthakul et al, in order to achieve desired cure times and resulting formulation properties, for the same reasons discussed above. 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. See MPEP 2144.05(II)(A).
Regarding the additional limitations of claims 1-7, the claims are rejected for the same reasons discussed above as applied to each and every claimed limitation.
Conclusion
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 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 JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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