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 .
Response to Amendment
Applicants’ response filed 6/16/2026 did not include any claim amendments. Applicants’ arguments addressed below are not persuasive in overcoming the 35 USC 103 rejections over D’Souza and separately over Wu from the office action mailed 3/16/2026; therefore, these rejections are maintained below.
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.
Claims 33-40 are rejected under 35 U.S.C. 103 as being unpatentable over D’Souza et al., US Patent Application Publication No. 2011/0313363 (hereinafter referred to as D’Souza).
Regarding claims 33, 36 and 39-40, D’Souza discloses a method of lubricating an interface between a first component having a surface in frictional engagement with a surface of a second component, including a syringe assembly or syringe pump wherein the first component is a syringe barrel having an interior surface and the second component is a syringe plunger formed by an elastomeric material that is coated with a lubricous coating and forms a tight seal with the barrel of the syringe (as recited in claims 33 and 39) (see Abstract and see Figures).
D'Souza further discloses a lubricous coating comprising a first, curable organopolysiloxane having at least two alkenyl groups (reads on “second silicone being an organopolysiloxane that is copolymerizable with the first silicone” as recited in claim 33); and a second, moisture-curable organopolysiloxane having at least two polar groups (reads on “a first silicone being a hydrolysable siloxane capable of crosslinking reaction upon exposure to moisture at ambient temperature” as recited in claim 33), the second organopolysiloxane being different from the first organopolysiloxane (Para. [0055]-[0077]) wherein the lubricous coating provide a breakloose force of 15N or less (as recited in claim 36) (see Table 10), and can have a thickness of up to 2 microns (as recited in claim 40) (Para. [0081]).
Regarding claims 34-35 and 37-38, D’Souza discloses a force required to maintain steady slide of one surface over another after breakout or breakloose is referred to as the "sustaining force.” Two main factors contribute to static friction and thus to the breakout or breakloose force. The term "stick" as used herein denotes the tendency of two surfaces in stationary contact to develop a degree of adherence to each other. The term "inertia" is conventionally defined as the indisposition to motion which must be overcome to set a mass in motion. Inertia is that component of the breakout force which does not involve adherence. All of these forces are lowered by the lubricous coating taught by D’Souza (Para. [0011] and See Figures and Tables). Also, it is the position of the examiner that as D’Souza discloses all the lubricant composition components of instant claim 33 and the syringe assembly recited in instant claim 33 that claims 34-35 and 37-38 are read upon by D’Souza.
Claim Rejections - 35 USC § 103
Claims 33-40 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al., US Patent Application Publication No. 2008/0071228 (hereinafter referred to as Wu).
Regarding claims 33, 36 and 39-40, Wu discloses a method of lubricating an interface between a first component having a surface in frictional engagement with a surface of a second component, including a syringe assembly or syringe pump wherein the first component is a syringe barrel having an interior surface and the second component is a syringe plunger formed by an elastomeric material that is coated with a lubricous coating and forms a tight seal with the barrel of the syringe (as recited in claims 33 and 39) (see Abstract and see Figures).
Wu further discloses a lubricous coating comprising a first, curable organopolysiloxane having at least two alkenyl groups (reads on “second silicone being an organopolysiloxane that is copolymerizable with the first silicone” as recited in claim 33); and a second, moisture-curable organopolysiloxane having at least two polar groups (reads on “a first silicone being a hydrolysable siloxane capable of crosslinking reaction upon exposure to moisture at ambient temperature” as recited in claim 33), the second organopolysiloxane being different from the first organopolysiloxane (Para. [0063]-[0082]) wherein the lubricous coating provide a breakloose force of 15N or less (as recited in claim 36) (see Tables), and can have a thickness of 1 to 2 microns (as recited in claim 40) (Para. [0086]).
Regarding claims 34-35 and 37-38, Wu discloses a force required to maintain steady slide of one surface over another after breakout or breakloose is referred to as the "sustaining force.” Two main factors contribute to static friction and thus to the breakout or breakloose force. The term "stick" as used herein denotes the tendency of two surfaces in stationary contact to develop a degree of adherence to each other. The term "inertia" is conventionally defined as the indisposition to motion which must be overcome to set a mass in motion. Inertia is that component of the breakout force which does not involve adherence. All of these forces are lowered by the lubricous coating taught by Wu (Para. [0011] and See Figures and Tables). Also, it is the position of the examiner that as Wu discloses all the lubricant composition components of instant claim 33 and the syringe assembly recited in instant claim 33 that claims 34-35 and 37-38 are read upon by Wu.
Response to Arguments
Applicants’ arguments filed 6/16/2026 regarding claims 33-40 have been fully considered and are not persuasive.
Applicants argue that D’Souza does not render the instant claims obvious because D’Souza fails to teach a lubricous coating composition having two synergistically interacting components which include a specific co-reactive pair, and D'Souza provides no motivation to select these specific types of silicones and combine them to achieve a copolymerized network. This argument is not persuasive. Applicants have not defined either of the silicone compounds by structure in the claims. Based on the instant specification the silicone compounds of D’Souza fall within the scope of the two silicone compounds as defined by the claims and would therefore read on the claims. Furthermore, in paragraph 0076 D’Souza discloses the composition further comprises a catalytic amount of a catalyst for promoting crosslinking of crosslinkable groups of the organopolysiloxane(s) which further shows that the silicone compounds are more than just “mixed” and reads on the claims as instantly recited.
The same rationale for the Wu reference reading on the instant claims is applicable. Wu explicitly discloses silicone compounds defined in the instant specification as falling within the scope of silicone compounds of the instant claims.
Finally, applicants argue that the instant application demonstrates synergy between the two silicone compounds that is not taught by the prior art references of record, and as such overcomes the obviousness rejections set forth. This argument is not persuasive. In order to demonstrate synergistic results applicants must fulfill two criterions: 1) applicants must compare their formulations against the closest prior art, and 2) the claims must be commensurate in scope with the data provided.
Regarding the first criteria – applicants have not compared their formulations against the closest prior art, nor shown that the comparative examples from the instant specification adequately represent the closest prior art.
Regarding the second criteria – the claims are not commensurate in scope with the data provided. For example, the example formulations from the instant specification require very specific silicone compounds present in very narrow concentration ranges within the composition. For these reasons applicants have not fulfilled this criteria in the unexpected results analysis.
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 VISHAL V VASISTH whose telephone number is (571)270-3716. The examiner can normally be reached M-F 9:00-4:30 and 7:00-10:00p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Prem Singh can be reached at 5712726381. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VISHAL V VASISTH/Primary Examiner, Art Unit 1771
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