DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Notice of Response
In response to the remarks filed on 7/28/2025, claims 1-20 are acknowledged and remain pending. The following new and reiterated grounds of rejection are set forth:
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Haines et al. (US Patent No. 8,323,166 B2) (cited by Applicant), further in view of Felts (US Patent No. 6,112,695) (cited by Applicant).
Regarding claim 1, Haines et al. discloses a syringe comprising a barrel and a plunger (see col. 4, lines 57-63), the barrel having an inner surface and the plunger having a side surface engaging the barrel inner surface, wherein the inner surface of the barrel comprises a lubricity coating,
the lubricity coating having the following atomic ratios, measured by X-ray photoelectron spectroscopy (XPS): SiwOxCy, where w is 1, x is from about 0.5 to about 2.4, and y is from about 0.6 to about 3 (see col. 7, line 62-col. 8, line 36);
the lubricity coating having an average thickness, measured by transmission electron microscopy (TEM), between 10 and 1000 nm (see col. 9, lines 39-49);
wherein the lubricity coating is made by plasma enhanced chemical vapor deposition (PECVD) (see col. 4, lines 51-53); and
wherein the lubricity coating is effective to reduce the plunger sliding force, breakout force, or both at least 45 percent relative to an uncoated syringe barrel (see col. 5, lines 44-60, col. 9, lines 15-19, and col. 11, lines 15-27).
Haines et al. is silent with respect to the gases present during the PECVD process and therefore does not specifically teach (a) providing a gas comprising an organosilicon precursor in the vicinity of the substrate surface, and (b) generating a plasma in the gas, thus forming the lubricity coating by plasma enhanced chemical vapor deposition (PECVD), wherein the plasma is generated by an inner electrode positioned within the barrel and an outer electrode positioned outside the barrel. Felts teaches (a) providing a gas comprising an organosilicon precursor in the vicinity of the substrate surface (see col. 5, lines 36-52, col. 6, lines 40-54, and col. 10, lines 12-15), and (b) generating a plasma in the gas, thus forming the lubricity coating by plasma enhanced chemical vapor deposition (PECVD) (see col. 4, lines 13-15), wherein the plasma is generated by an inner electrode (40) positioned within the barrel (12) and an outer electrode (86) positioned outside the barrel (see Figure 1 and col. 7, lines 16-48 and col. 10, lines 1-11
It would have been obvious to one of ordinary skill in the art at the time of invention to modify the syringe/lubricity coating of Haines et al. to include (a) providing a gas comprising an organosilicon precursor in the vicinity of the substrate surface, and (b) generating a plasma in the gas, thus forming the lubricity coating by plasma enhanced chemical vapor deposition (PECVD), wherein the plasma is generated by an inner electrode positioned within the barrel and an outer electrode positioned outside the barrel, as disclosed in Felts, so as to cause the organosilicon precursor to be highly activated throughout the interior of the barrel, thus enhancing the uniformity of the coating deposited on the interior surface of the barrel (see Felts: col. 10, lines 41-49).
Regarding claim 2, Haines et al. discloses the barrel is made from borosilicate glass (see col. 5, line 2).
Regarding claim 3, Haines et al. discloses the barrel is made from a thermoplastic material (see col. 5, lines 5-11).
Regarding claim 4, Haines et al. discloses the thermoplastic material is selected from a group consisting of a polycarbonate, an olefin polymer, a cyclic olefin copolymer, and a polyester (see col. 5, lines 5-11).
Regarding claim 5, Haines et al. discloses the inner surface of the barrel further comprises a barrier coating of SiOx, in which x is from about 1.5 to about 2.9 (see col. 7, lines 55-61 and col. 10, lines 3-17).
Regarding claim 6, Haines et al. discloses the barrier coating is positioned between the lubricity coating and the inner surface of the syringe barrel (see col. 7, lines 55-61 and col. 10, lines 3-17).
Regarding claim 7, Felts teaches the gas comprises O2 in a volume-volume ratio to the organosilicon precursor of from 0.01:1 to 0.5:1 (see col. 9, lines 61-67).
Regarding claim 8, Felts teaches the gas comprises a noble gas (see col. 5, lines 7-14).
Regarding claim 9, Felts teaches the noble gas is argon (see col. 5, lines 7-14).
Regarding claim 10, Felts teaches the gas comprises organosilicon precursor, noble gas and O2 (see col. 10, lines 12-15). It would have been obvious to one of ordinary skill in the art at the time of invention for the gas of Felts et al. to include 1 to 6 standard volumes of the organosilicon precursor, from 1 to 100 standard volumes of a noble gas, and from 0.1 to 2 standard volumes of O2, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 11, Felts teaches the organosilicon precursor is a cyclic organosilicon precursor (see col. 5, lines 36-52, col. 6, lines 40-54, and col. 10, lines 12-15).
Regarding claim 12, Felts teaches the organosilicon precursor is octamethylcyclotetrasiloxane (OMCTS) (see 5, lines 36-52).
Regarding claim 13, Felts teaches the plasma is generated by electrodes at RF frequency (see col. 7, lines 28-44).
Regarding claim 14, Felts teaches the ratio of electrode power to plasma volume is less than 10 W/ml (see col. 10, lines 1-11).
Regarding claim 15, Felts teaches the ratio of electrode power to plasma volume is from 0.1 W/ml to 6 W/ml (see col. 10, lines 1-11).
Regarding claim 16, Haines et al. teaches the syringe barrel has a void volume of 1 to 10 mL (see Figure 3).
Regarding claim 17, Haines et al. teaches the syringe barrel has a void volume of 1 to 3mL (see Figure 3).
Regarding claim 18, Haines et al. teaches the lubricity coating is cured after being formed by plasma enhanced chemical vapor deposition (PECVD) (see col. 4, lines 51-55, col. 8, lines 63-67, and col. 9, lines 15-19).
Regarding claim 19, Felts teaches the gas comprises O2 in a volume-volume ratio to the organosilicon precursor of from 0.01:1 to 0.5:1 (see col. 9, lines 61-67) and the ratio of electrode power to plasma volume is less than 10 W/ml (see col. 10, lines 1-11).
Regarding claim 20, Haines et al. discloses a pharmaceutical formulation in the lumen (see col. 6, line 63-col. 7, line 14).
Response to Arguments
Applicant's arguments filed 7/28/2025 have been fully considered but they are not persuasive.
In response to Applicant’s argument that Haines provides no disclosure of how to apply a lubricious coating by any of the methods described by Haines, the Examiner respectfully disagrees and notes that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
In response to Applicant’s argument that a person of ordinary skill in the art would not understand Haines as teaching a coating of SiwOxCy, where w is 1, x is from about 0.5 to about 2.4, and y is from about 0.6 to about 3, made by PECVD, the Examiner respectfully disagrees and notes the cited portions of Haines appear to describe a coating that meets the claimed ratio range of Si, O, and C and that the coating can by applied by plasma assisted chemical vapor deposition. Applicant has not explained how the cited portions are allegedly different than what is described by the claims. This argument amounts to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
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). Specifically, in response to Applicant’s argument that Haines does not teach a person of ordinary skill in the art how to apply the lubricity coating to the inside of a syringe barrel by a PECVD process, the Examiner notes that a) Haines is merely relied upon to generically teach a PECVD process (see col. 4, lines 51-53) and is not relied on for any specifics as to how, and b) Felts is relied upon to teach the specifics as to how the lubricity coating is applied to the inside of a syringe barrel by a PECVD process. The combined teachings of Haines and Felts teach applying a lubricity coating of SiwOxCy, where w is 1, x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3. In particular, Haines teaches the specifics of the coating itself having the claimed ratio range of Si, O, and C, and Felts teaches the specifics of how the coating is applied using PECVD.
In response to Applicant’s arguments regarding claim 7 and 19, the Examiner disagrees with Applicant’s characterization of Felts. Felts describes a first process gas and a second process gas, and the second process gas includes a first gas component and a second gas component. The first gas component is typically an oxidizing gas such as oxygen (see col. 5, line 54-58 and col. 10, lines 12-15), and the second gas component is an organosilicon (see col. 5, lines 38-45 and col. 10, lines 12-15), and the ratio of flow rates of the second gas component to the first gas component is between 1:1 and 1:100 (see col. 9, lines 65-67). Thus, this ratio has nothing to do with the first process gas, as Applicant argues.
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 DEVIN B HENSON whose telephone number is (571)270-5340. The examiner can normally be reached M-F 7 AM ET - 5 PM ET.
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/DEVIN B HENSON/ Primary Examiner, Art Unit 3791