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 .
Status of Claims
Claims 1-15 are pending in the application.
Claims 1-15 are examined on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 08/30/2023 and 02/17/2025 in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) has/have been considered by the examiner.
Claim Rejections - 35 USC § 112
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(s) 12 is/are 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 12 recites the limitation “the lubricant comprises a silicone oil” which is indefinite. There is not sufficient antecedent basis for “lubricant” in the claim. The limitation “…” has been examined below as if it read – [[a lubricant comprises a silicone oil --.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claim(s) 1-2, 5, 9-10, 13, and 15 is/are rejected under 35 U.S.C 102(a)(1) as being anticipated by Masahiro (JP 2009061343).
Regarding claim 1, Masahiro discloses a medical device (a syringe 1: Fig. 1) comprising a container defined by walls (Fig. 1) and having a first end having an opening (Fig. 1), wherein the opening is sealed by a rubber component (a gasket 11 comprises a fluororubber molded body and a rubber-like elastic molded body: ¶6 of pg. 5 and Fig. 2),
wherein the rubber component is formed from a self-lubricating rubber (lubricant is applied to the gasket: ¶5 of pg. 1) formed from a rubber composition comprising a halogenated isobutylene-isoprene co-polymer (butyl rubber: ¶4 of pg. 5; a person having ordinary skill in the art would have understood/recognized that butyl rubber is a halogenated isobutylene-isoprene co-polymer) and at least one of (1) clay minerals or silica and (2) a liquid polyisoprene and butadiene homopolymer (clay or silica: ¶3 of pg. 5).
Regarding claim 2, Masahiro further discloses the medical device selected from the group consisting of a syringe assembly, drug cartridge, needleless injector, liquid dispensing device, liquid metering device, sample collection tube or plate assembly, catheter, and vial (a syringe assembly: Fig. 1).
Regarding claim 5, Masahiro further discloses the halogenated isobutylene- isoprene co-polymer comprises a chloro-isobutylene-isoprene co-polymer (¶4 of pg. 5).
Regarding claim 9, Masahiro further discloses the walls comprise glass, stainless steel, or a polymeric material (glass or polypropylene: ¶2 and 6 of pg. 3; and Fig. 1).
Regarding claim 10, Masahiro further discloses the polymeric material comprises polypropylene and/or a cyclic polyolefin (polypropylene: ¶6 of pg. 3).
Regarding claim 13, Masahiro implicitly discloses the halogenated isobutylene- isoprene co-polymer is non-staining (the same material inherently and necessarily exhibits the same property; thus, the halogenated isobutylene-isoprene co-polymer of Masahiro is non-staining).
Regarding claim 15, Masahiro further discloses at least a portion of the rubber component is laminated by a polymer comprising ethylene tetrafluoroethylene (ETFE) and/or polytetrafluoroethylene (PTFE) (¶2 of pg. 7).
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 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.
Claim(s) 1, 3-4, and 11 is/are rejected under 35 U.S.C 103 as being unpatentable over Lum (US PGPUB 20110224610) in view of Masahiro (JP 2009061343).
Regarding claim 1, Lum discloses a medical device (a medical device 800: ¶0306 and Figs. 77-85) comprising a container defined by walls (a syringe barrel 810 and a sidewall 814: ¶0306 and Figs. 77-85) and having a first end having an opening (at/near a distal wall 812: ¶0306 and Fig. 80), wherein the opening is sealed by a rubber component (a stopper 860 is formed from an elastomeric material: ¶0307 and Fig. 81).
Lum implicitly discloses the rubber component is formed form a self-lubricating rubber (the stopper 860 is able to slide against the walls within the syringe barrel from a pre-use position to a post-use position: ¶0306 and Figs. 82-84).
Lum discloses the rubber component 860 is formed from an elastomeric material (¶0307 and Fig. 81), but does not disclose and compositions of the rubber component.
In the same field of endeavor, medical device, Masahiro discloses a medical device (a syringe 1: Fig. 1) comprising a container defined by walls (Fig. 1) and having a first end having an opening (Fig. 1), wherein the opening is sealed by a rubber component (a gasket 11 comprises a fluororubber molded body and a rubber-like elastic molded body: ¶6 of pg. 5 and Fig. 2). Masahiro further discloses the rubber component formed from a rubber composition comprising a halogenated isobutylene-isoprene co-polymer (butyl rubber: ¶4 of pg. 5; a person having ordinary skill in the art would have understood/recognized that butyl rubber is a halogenated isobutylene-isoprene co-polymer) and at least one of (1) clay minerals or silica and (2) a liquid polyisoprene and butadiene homopolymer (clay or silica: ¶3 of pg. 5) for the benefits of improving sealing performance, retaining high slidability, and preventing pharmaceutical from adhering to the gasket/stopper (¶5-6 of pg. 2).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the medical device of Lum in view of Masahiro by selecting a halogenated isobutylene-isoprene co-polymer and silica as rubber composition, in order to improve sealing performance, retain high slidability, and prevent pharmaceutical from adhering to the stopper, as suggested in ¶5-6 of pg. 2 of Masahiro and as it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07).
Regarding claim 3, Lum further discloses the rubber component comprises a pierceable septum (a pierceable septum 872: ¶0308 and Fig. 81).
Regarding claim 4, Lum further discloses the medical device comprises a drug delivery system for injecting a medicament (¶0306), wherein the container comprises a syringe barrel configured to receive the medicament (¶0306), wherein the rubber component comprises a stopper configured to slide against the walls within the syringe barrel from a pre-use position to a post-use position (the stopper 860: ¶0306 and Figs. 82-84).
Regarding claim 11, Lum further implicitly discloses the stopper and/or the walls are substantially free of a lubricant (the stopper 860 is able to slide against the walls within the syringe barrel from a pre-use position to a post-use position without a lubricant: ¶0306 and Figs. 82-84).
Claim(s) 6 is/are rejected under 35 U.S.C 103 as being unpatentable over Masahiro (JP 2009061343) in view of Yoshida (US PGPUB 20170014431).
Regarding claim 6, Masahiro does not disclose the clay minerals comprise calcined magnesium silicate clay or aluminum silicate clay.
In the same field of endeavor, syringe, Yoshida discloses a syringe 1 comprising an outer cylinder 21, a gasket 22, a plunger 24, and a seal cap 23 (¶0020 and Fig. 2). Yoshida further discloses the gasket 22 formed by vulcanized chlorinated butyl rubber and calcined clay or kaolinite or aluminum silicate clay (¶0028). Yoshida also discloses the kaolinite is added as an inorganic filler or an inorganic reinforcing agent (¶0017-0018).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the clay of Masahiro in view of Yoshida by selecting calcined clay or kaolinite or aluminum silicate clay as an inorganic reinforcing agent or an inorganic filler, in order to assist in vulcanization reaction of the gasket/stopper. as suggested in ¶0027-0028 of Yoshida and as it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07).
Claim(s) 7 is/are rejected under 35 U.S.C 103 as being unpatentable over Masahiro (JP 2009061343) in view of Kuraray (Kuraray Liquid Rubber. (2021, April). https://www.elastomer.kuraray.com/wp-content/uploads/2021/04/Kuraray-Elastomer-Product-Brochures-Kuraray-Liquid-Rubber.pdf ).
Regarding claim 7, Masahiro does not disclose the liquid polyisoprene and butadiene homopolymer has a weight average molecular weight of from 20,000 to 50,000 g/mol.
In the same field of endeavor, liquid rubber for rubber applications, Kuraray discloses a liquid polyisoprene homopolymer (LIR-30 or LIR-50) has an average MW from 28000 to 54000 g/mol and a liquid butadiene homopolymer (LBR-305) has an average MW of 26000 g/mol (the taught MW range overlaps the claimed MW range: pg. 6-7) for the benefits of reducing processing time while maintaining rubber compounds’ physical properties (pg. 2).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the medical device of Masahiro in view of Kuraray by having average MWs of liquid polyisoprene and butadiene homopolymer as claimed, in order to reduce processing time and maintain rubber compounds’ physical properties, as suggested in pg. 2 of Kuraray and as it has been held that a prima facie case of obviousness exists when the claimed ranges overlap with ranges disclosed by the prior art. See MPEP § 2144.05 (I).
Claim(s) 8 is/are rejected under 35 U.S.C 103 as being unpatentable over Masahiro (JP 2009061343) in view of Yoshida (US PGPUB 20170014431) and Gruendken (US PGPUB 20180334521).
Regarding claim 8, Masahiro does not disclose the rubber composition comprises: from 50 to 100 phr of the halogenated isobutylene-isoprene co-polymer; from 30 to 60 phr of the clay minerals or silica; and from 3 to 30 phr of the liquid polyisoprene and butadiene homopolymer.
Yoshida further discloses/suggests the rubber composition of the gasket contains 50 to 110 parts by weight of the calcined clay for 100 parts by weight of the chlorinated butyl rubber (the taught phr ranges overlap the claimed phr ranges: ¶0029) for the benefit of stably preserving injection solution for a long time without deformation of a gasket (¶0009).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the medical device of Masahiro in view of Yoshida by selecting the claimed phr ranges for halogenated isobutylene-isoprene co-polymer and the clay minerals or silica, in order to stably preserve injection solution for a long time without deformation of a gasket, as suggested in ¶0009 of Yoshida and as it has been held that a prima facie case of obviousness exists when the claimed ranges overlap with ranges disclosed by the prior art. See MPEP § 2144.05 (I).
In an analogous art for being directed to solve the same problem, thermoplastic elastomer composition used in medical fields, Gruendken discloses a vulcanizable composition comprising a mixture of specific block copolymer thermoplastic elastomer, a polyolefin, a rubber softener, a crosslinking agent and a liquid diene rubber crosslinking co-agent (¶0002). Gruendken further discloses the liquid diene rubber containing a copolymer of only isoprene and butadiene (¶0113-0114). Gruendken further suggests the liquid diene rubber has an amount of from 1 to 50 parts by weight (the taught phr range overlaps the claimed phr range: ¶0028) for the benefit of providing dynamically vulcanized thermoplastic elastomer composition that is flexible, has excellent elastomeric properties and is moldable (¶0002).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the medical device of Masahiro/Yoshida in view of Gruendken by selecting the claimed phr range for the liquid polyisoprene and butadiene homopolymer, in order to provide dynamically vulcanized thermoplastic elastomer composition that is flexible, has excellent elastomeric properties and is moldable, as suggested in ¶0002 of Gruendken and as it has been held that a prima facie case of obviousness exists when the claimed ranges overlap with ranges disclosed by the prior art. See MPEP § 2144.05 (I).
Claim(s) 12 is/are rejected under 35 U.S.C 103 as being unpatentable over Masahiro (JP 2009061343) in view of Sudo (US PGPUB 20170014431).
Regarding claim 12, Masahiro further discloses a lubricant to improve slidability between the gasket and the syringe barrel (¶5 of pg. 1), but does not disclose the lubricant comprises a silicone oil.
In the same field of endeavor, syringe, Sudo discloses a sealing stopper or piston for a syringe and a prefilled syringe using the same, provided with a backstop function (Abstract and Figs. 1A-C). Sudo further discloses a lubricant comprising silicone oils is applied on an inner wall of a barrel of the syringe (¶0032).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the medical device of Masahiro in view of Sudo by using silicone oil as the lubricant, in order to improve slidability between the gasket and the syringe barrel, as suggested in ¶0032 of Sudo and ¶5 of pg. 1 of Masahiro.
Claim(s) 14 is/are rejected under 35 U.S.C 103 as being unpatentable over Masahiro (JP 2009061343) in view of Kutsovsky (US PGPUB 20220332016).
Regarding claim 14, Masahiro further discloses the rubber composition is cured to form the self-lubricating rubber by peroxide vulcanization (last paragraph of pg. 4 and ¶2-3 of pg. 6), but does not disclose the rubber composition is cured to form the self-lubricating rubber by sulfur vulcanization.
In an analogous art for being directed to solve the same problem, using vulcanizing agents to crosslink rubbers, Kutsovsky discloses methods of preparing composites from solid elastomer(s) and wet filler(s), as well as products, including composites, vulcanizates, and articles therefrom (Abstract). Kutsovsky further discloses sulfur and peroxides are interchangeable vulcanizing agents in order to crosslink rubbers (¶0308).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the medical device of Masahiro in view of Kutsovsky by substituting peroxide with sulfur for the vulcanization method to cure the rubber composition, in order to crosslink the rubbers, as suggested in ¶0308 of Kutsovsky and as it has been held that the substitution of a known material/element for another exchangeable material/element supports a prima facie obviousness determination (See MPEP § 2143 (I) (B)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SARAH AL-HASHIMI can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NHU Q. TRAN/Examiner, Art Unit 3781
/JACQUELINE F STEPHENS/Primary Examiner, Art Unit 3781