DETAILED ACTION
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 amendment filed on April 8, 2025 was received. Claim1 was amended. Claims 13-23 were canceled. Claims 24-31 were added.
The text of those sections of Title 35. U.S.C. code not included in this action can be found in the prior Office Action Issued December 4, 2024.
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.
Claims 1, 4, 6-12, 24, 28 and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Wills (US20190015561) in view of Hama (US20050155553).
Regarding claim 1, Wills teaches a method of coating the interior surface of vessels by plasma enhanced chemical vapor deposition (PECVD) (paragraphs 0002, 0013 and 0027). Wills teaches to draw a partial vacuum in the lumen (internal volume) of the vessels using a vacuum supply (evacuating an internal volume of each of the plurality of vessels using vacuum supply) (paragraphs 0023-0024, 0163-0165 and 0227). Wills teaches to introduce one or more source gases into each of the vessels (paragraphs 0165, 0227), Wills teaches to generate pulsed RF plasma within the vessels using the source gases (paragraphs 0165, 0176, 0207, 0219 and 0227). Wills teaches to deposit a coating comprising at least one barrier coating in each of the vessels using the plasma (paragraphs 0023-0024, 0163-0165 and 0227).
Wills does not explicitly teach to place the vessels in openings in a metal RF electrode, evacuating using a single vacuum line via an exhaust manifold, introducing gases using a single source line via a gas inlet manifold, and the RF signal is applied to the metal RF electrode. However, Hama teaches a mass production apparatus for coating the internal surfaces of containers by plasma CVD (PECVD) (paragraphs 0001 and 0005). Hama teaches to place the plurality of vessels in openings of the film forming chamber 6 which is formed by an external RF electrode 3 (paragraphs 0050 and, 0096 figure 2). The electrode 3 is reasonably expected to be metal as it is conventional to use metal material as electrode and Hama further teaches the RF supply rod equipment is metal (paragraph 0062). Hama teaches to evacuating the vessels using a single vacuum line 13 via an exhaust manifold 4b (paragraphs 0079 and 0094, figure 2) Hama teaches to introduce gases using a single source line 11 via a gas inlet manifold 10 (paragraphs 0075 and 0095, figure 2). Hama teaches RF signal is applied to the metal RF electrode (paragraph 0062). Hama teaches the chamber has multiple rows of housing spaces (paragraph 0017), for example of two, three or four (pargraph 0014) (coating plurality of vessels simultaneously). Hama teaches the increase the number of the vessels in each chamber increase the productivity (paragraph 0017). Therefore, it would have been within the skill of the ordinary artisan to adjust and optimize the number of vessels in the chamber in the process to yield the desired productivity. Discovery of optimum value of result effective variable in known process is ordinarily within skill of art. In re Boesch, CCPA 1980, 617 F. 2d 272, 205 USPQ215. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the mass production PECVD apparatus as suggested by Hama in the method of Wills because Hama teaches mass production apparatus is able to mass produce coating of the interior surfaces of the containers (paragraphs 0004-0005); and such particular system is able to achieve miniaturize the apparatus and raise the mass production efficiency.
Regarding claim 4, Wills teaches the duty cycle is 50%, which is inside of the claimed range (paragraphs 0213, 0214 and 0219).
Regarding claim 6, Hama teaches to deliver the gases into the vessels with the internal electrodes 9a-d (paragraph 0021, 0047 and 0056), which appears to have a “probe” shape. However, it is well settled that the configuration of the claimed gas inlet probe was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant (MPEP 2144.04 IV). And separation of parts has no patentable significance unless a new and unexpected result is provided (MPEP 2144.04 V). It would be obvious to one of ordinary skill in the art before the effective filing date to use a non-probe device, such as a nozzle to provide the gases to each nozzle in light of teaching of Hama.
Regarding claim 7, Hama teaches to deliver the gases into the vessels with the internal electrodes 9a-d (gas inlet probe) (paragraph 0021, 0047 and 0056).
Regarding claim 8, Wills teaches the coating comprises a tie coating between the wall of the container and the barrier coating (paragraphs 0075-0076, see figures 1-2).
Regarding claim 9, Wills teaches the tie coating comprises SiOxCy, in which x is between 0.5 and 2.4 and y is between 0.6 and 3 (paragraph 0078).
Regarding claim 10, Wills teaches wherein the coating further comprises a pH coating or layer, the pH coating or layer having an interior surface facing the lumen and an outer surface facing the barrier coating or layer (paragraphs 0097-0099, figures 1-2).
Regarding claim 11, Wills teaches the pH protective coating or layer comprises SiOxCy wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3.
Regarding claim 12, Wills teaches the vessel wall is thermoplastics (paragraph 0064).
Regarding claim 24, Wills teaches the vessel wall is polyethylene terephthalate, polyethylene naphthalate or cyclic olefin copolymer etc, which are cyclic block copolymer resin (paragraph 0064).
Regarding claim 28, Hama teaches the electrode comprises a plurality of wall portions, each of which surrounds a wall of one of the plurality of vessels and each of the wall portions is integral with the rest of the electrode (see figure 2).
Regarding claim 30, Wills teaches the vessels are syringe barrels, vials or blood collection tubes (paragraphs 008-0050, and 0017).
Regarding claim 31, Hama teaches the precursor gas flows through a insulating member 4a (the partition) immediately before entering the vessel (paragraphs 0052 and 0050, see figure 2). Hama teaches the partition being permeable to precursor gas as there is an opening (figure 2), and the insulating member is around to form insulating state between the cover 4b, the conducting internal electrode and the external electrode (paragraph 0052) and shaped in a way to prevent the coating forming the outside of the vessel (see figure 2). Thus, Hama teaches the partition prevent the plasma from igniting outside of the vessel to form the coating film on the outside surface.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Wills (US20190015561) in view of Hama (US20050155553) as applied to claims 1, 4, 6-12, 24, 28 and 30-31 above, and further in view of Felts (US20140295053).
Regarding claim 2, Wills in view of Hama teaches all the limitations of this claim, except the claimed pulse high power. Felts teaches a method for forming a barrier coating on the interior surface of a vessels by PECVD (abstract, 0013 and 0016). Felts teaches plasma is generated with electrodes supplied with an electric power of from 8 to 500 W for a barrier layer SiOx coating (paragraph 0271), which overlaps with the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exist. In re Wertheim, 541 F.2d 257, 191USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler,116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). See MPEP 2144.05. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the power level to generate plasma as suggested by Felts in the method of Wills in view of Hama because Felts teaches such power level is suitable for forming a barrier layer SiOx coating (paragraph 0271), which is the same as Wills.
Regarding claim 3, Wills teaches the pulsed RF signal has a pulse low power level of 0w (paragraphs 0213, 0219).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Wills (US20190015561) in view of Hama (US20050155553) as applied to claims 1, 4, 6-12, 24, 28 and 30-31 above, and further in view of Behle (US20040142184).
Regarding claim 5, Wills in view of Hama teaches all limitations of this claim, except the pulse train frequency. However, Behle teaches a method of PECVD a barrier layer (abstract, paragraph 0025), and discloses when the pulse frequency is low, it is possible to introduce high levels of energy during a pulse; when the pulse frequency is high, it is possible to produce particularly pure layers (paragraph 0034). Therefore, it would have been within the skill of the ordinary artisan to adjust and optimize the pulse frequency in the process to yield the desired energy level during a pulse and the desired purity for the deposited layer. Discovery of optimum value of result effective variable in known process is ordinarily within skill of art. In re Boesch, CCPA 1980, 617 F. 2d 272, 205 USPQ215.
Claims 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Wills (US20190015561) in view of Hama (US20050155553) as applied to claims 1, 4, 6-12, 24 and 28, 30-31 above, and further in view of Weikart (US20140154399).
Regarding claims 25-27, Wills in view of Hama teaches all limitations of these claim, except the will comprises a winder opening with camera for viewing the plasma. Hama teaches the electrode comprises a plurality of wall portions, each of which surrounds a wall of one of the plurality of vessels (see figure 2). However, Weikart teaches a method oof plasma modifying a syringe barrel (abstract). Weikart teaches an optical detector 350, such as a camera, is provided to show whether the plasma in a container includes streamer of ono-uniform plasma versus a completely fill of exposed portion s of container with uniform plasma (paragraph 0614). Since a “window” would required to be provided for the placement of the camera and each of the vessels are being monitored, the combination of Wills, Hama and Weikart teaches the plurality of wall portions comprises a window opening through which the plasma can be viewed, one or more cameras configured to capture images of the plasma though the plurality of windows, and interrogating images captured by the one or more camera to determine whether the plasma within each of the plurality of vessels has one or more properties (uniformity) within a predefined acceptable range. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the camaras to monitor the plasma as suggested by Weikart in the method of Wills in view of Hama because Weikart teaches such mechanism can measure the plasma characteristics in the vessels during the process, such as plasma uniformity (pargraph 0614).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Wills (US20190015561) in view of Hama (US20050155553) as applied to claims 1, 4, 6-12, 24 and 28, 30-31 above, and further in view of Shimada (US20150292089).
Regarding claim 29, Wills in view of Hama teaches all limitations of this claim, except orientation of the vessels. However, Shimada teaches a container coating device to preform plasma CVD inside of the container (abstract and 0021), and discloses an opening of each of the plurality of vessels is oriented downward in the opening of the RF electrode, and wherein each of the gas inlet manifold and the exhaust manifold are position below the metal RF electrode (see figures 1 and 2, paragraphs 0028 and 0030). In is well settled that duplication or parts or rearrangement of parts has no patentable significance unless a new and unexpected result is provided (MPEP 2144.04 VI). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply such arrangement as suggested by Shimada in the method of Wills and Hama, because Shimada teaches such the downward arrangement is also applicable to the plasma CVD device similar to the Wills in view of Hama (with upward arrangement) ones (see figures 1-2).
Response to Arguments
Applicant's arguments filed on April 8, 2025 have been fully considered but they are not persuasive.
Applicant’s principal arguments are:
Hama teaches as the number increase, other aspect of the method/system become increasingly complex, thus Hama teaches away from having twelve vessels in the chamber as claimed.
Claim 6 limitation is not disclosed by the prior art.
In response to Applicant’s arguments, please consider the following comments:
Hama teaches the complexity issue is solved by the special arrangement of the vessels in the chamber, not by avoiding to increase the number of vessels (pargraph 0017). In addition, it is well settled that nonpreferred and alternative embodiments constitute prior art and disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments (see MPEP 2123 II). Thus, Hama teaching of two, three and four vessels as examples does not teach away from the claimed feature.
As discussed above, Hama teaches to deliver the gases into the vessels with the internal electrodes 9a-d (paragraph 0021, 0047 and 0056), which appears to have a “probe” shape. However, it is well settled that the configuration of the claimed gas inlet probe was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant (MPEP 2144.04 IV). And separation of parts has no patentable significance unless a new and unexpected result is provided (MPEP 2144.04 V). It would be obvious to one of ordinary skill in the art before the effective filing date to use a non-probe device, such as a nozzle to provide the gases to each nozzle in light of teaching of Hama. Applicant has not submit the persuasive evidence that the particular configuration of the claimed container was significant.
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.
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/N.V.L/Examiner, Art Unit 1717
/Dah-Wei D. Yuan/Supervisory Patent Examiner, Art Unit 1717
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