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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 7/29/26;12/19/24 are in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDSs are being considered by the Examiner.
Allowable Subject Matter
Claim 2 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 31 and 54 are allowed.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1, 3-6, 8-9, 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Abrams et al. (WO 2020/118275) (“Abrams”) in view of Iwano et al. (US 9,867,946) (“Iwano”).
Abrams discloses: A process for forming a plurality of continuous channels in or through a film residing on at least a part of a circumferential outer surface of a gasket, the gasket comprising a main body and an internal cavity, the internal cavity being defined by an inner surface of the gasket and comprising an open end, the process comprising:(a) inserting one end of a mandrel into the open end of the internal cavity;(b) positioning the mandrel and the gasket relative to a laser; and(c) applying a laser beam emitted from the laser to a plurality of locations on a surface of the film while rotating the mandrel and the gasket along a longitudinal axis of the mandrel to form the plurality of continuous channels. (see Abrams claim 1)
The channels in Abrams are described as being continuous rather than non-continuous. Iwano, in the analogous art, teaches that the laser cutting of the channels is not particularly limited to continuous channels. Iwano teaches cutting non-continuous channels (Figs.3,4) and one or more parallel channels (Fig.5), C3L20-28. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the laser cutting of the continuous channels of Abrams to include non-continuous channels as taught by Iwano to vary sliding resistance (Iwano C3L16-19).
Combining emodiments in Iwano, each non-continuous channel is approximately parallel to the other non-continuous channels, each non-continuous channel of the plurality of non-continuous channels extends partially around the circumferential outer surface of the gasket in a manner of design choice based on the options available by Iwano’s teaching.
Abrams further comprising: monitoring a plurality of the selected locations from the plurality of locations at which the laser beam was applied using a laser micrometer and adjusting the laser beam based on the monitoring. [0058-0059]
a thickness of the film residing on the at least a part of the circumferential outer surface portion of the gasket is about 10- 30 microns, about 15-35 microns, about 20-50 microns, or about 20 microns. (see Abrams claim 2)
the film is configured to slide along a tube of a syringe and is chemically stable. (see Abrams claim 3, Fig.2)
the gasket comprises an elastic material, and wherein the film is capable of preventing migration of components from the elastic material of the gasket. (see Abrams claim 4)
the gasket comprises an elastic material, and wherein the gasket is secured to the mandrel by press-fit assembly. (see Abrams claim 5)
a diameter of at least a part of the mandrel that is inserted into the internal cavity of the gasket is greater than an inner diameter of the internal cavity before insertion of the mandrel. (see Abrams claim 6)
each non-continuous channel of the plurality of non-continuous channels comprises axially opposed first and second side walls and a floor. (see Abrams claim 8)
each non-continuous channel of the plurality of non-continuous channels comprises an axial width between the side walls selected from 1-100 microns, 5-50 microns, 10-30 microns, and 15-25 microns. (see Abrams claim 10)
each non-continuous channel of the plurality of non-continuous channels comprises a radial depth selected from 0-100 microns, 5-50 microns, 10-30 microns, and 15-25 microns. (see Abrams claim 10)
each non- continuous channel of the plurality of non-continuous channels comprises a laser-cut depth selected from 20-80 microns, 30-60 microns, 40-50 microns, 50-60 microns, 40-45 microns, 45- 50 microns, 50-55 microns and 55-60 microns. (see Abrams claim 11)
one or more of the plurality of non-continuous channels extend through the film into the circumferential outer surface of the gasket. (see Abrams claim 12)
the plurality of non-continuous channels each comprises a radial depth greater than a thickness of the film on the surface of the gasket. (see Abrams claims 2 and 10)
the plurality of non-continuous channels comprise comprises a first circumferentially extending lip located adjacent to a first side wall of the channel and extending radially above the film. (see Abrams claim 13)
the plurality of non- continuous channels further comprise comprises a second circumferentially extending lip located adjacent to a second side wall and extending radially above the film. (see Abrams claim 14)
the first lip comprises a first peak height selected from 10-100 microns, 15-60 microns, 20-50 microns, or 30-40 microns, and wherein the second lip comprises a second peak height selected from 10-100 microns, 15-60 microns, 20-50 microns, or 30-40 microns. (see Abrams claim 15)
the first lip of each non-continuous channel of the plurality of non-continuous channels comprises a first peak width selected from 200-1,000 micron, 275-550 microns, 300-400 microns, or 450-500 microns, and wherein a second lip of each non-continuous channel of the plurality of non- continuous channels comprises a second peak width selected from 200-1,000 micron, 275-550 microns, 300-400 microns, or 450-500 microns. (see Abrams claim 16)
(all reference to the claims in Abrams continues to include the combination with Iwano)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783
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