DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 04/22/2026.
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.
Response to Arguments
Applicant’s arguments filed on 04/22/2026 have been considered but are moot because the new ground of rejection does not rely on the same combination references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
With respect to the claim rejection(s) under 35 U.S.C. § 112(b), Applicant's amendments introduced new claim rejection(s).
Claim Interpretation
In claims 1 and 7-8, the limitation “liquid polyisoprene and butadiene homopolymer” has been interpreted below as a liquid polyisoprene and butadiene (in view of ¶0122 and Table 1 of Applicant’s published application: a liquid polyisoprene and butadiene homopolymer includes polyisoprene liquid rubber and butadiene liquid rubber).
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. The limitation of claim 12 contradicts the limitation of claim 11. According to claim 11, the stopper and/or the walls are free of lubricant. It is unclear whether the stopper and/or the walls require(s) the lubricant. Thus, claim 12 cannot be evaluated/examined due to the 112(b) issued explained above.
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) 1-5, 9-11, 13, and 15 is/are rejected under 35 U.S.C 103 as being unpatentable over Lum (US PGPUB 20110224610) in view of Masahiro (JP 2009061343) and Maeda (US PGPUB 20170296757).
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) 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 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).
Lum/Masahiro does not disclose the rubber composition comprising a liquid polyisoprene and butadiene; however, Masahiro discloses/suggests the rubber composition comprising one or more additives (¶3 of pg. 5).
In the same field of endeavor, rubber composition for medical device, Maeda discloses a nozzle cap formed from a rubber composition (Abstract). Maeda further discloses the rubber composition comprising additives or reactive plasticizers and the reactive plasticizers are liquid rubbers such as liquid polyisoprene (LIR-30) and liquid butadiene (LBR-305) (¶0063) for the benefit of improving needle stick resistance (¶0061).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the medical device of Lum in view of Maeda, in order to improve needle stick resistance, as suggested in ¶0061 of Maeda 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). In addition, a person having ordinary skill in the art would have understood/recognized that using liquid rubbers such as liquid polyisoprene (LIR-30) and liquid butadiene (LBR-305) as reactive plasticizers enhance flexibility of the rubber composition or the medical device.
Regarding claim 2, Lum 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 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 5, Lum in view of Masahiro further discloses the halogenated isobutylene- isoprene co-polymer comprises a chloro-isobutylene-isoprene co-polymer (¶4 of pg. 5 of Masahiro and see the rejection of claim 1 above).
Regarding claims 9 and 10, Lum/ Maeda does not disclose the walls comprise glass, stainless steel, or a polymeric material; and the polymeric material comprises polypropylene and/or a cyclic polyolefin.
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) and the polymeric material comprises polypropylene and/or a cyclic polyolefin (polypropylene: ¶6 of pg. 3).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the medical device of Lum in view Masahiro by selecting polypropylene as a material of the walls, motivated by the desires to a medical grade material that is cost-effective and lightweight, as suggested in ¶6 of pg. 3 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 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).
Regarding claim 13, Lum in view of 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: see rejection of claim 1 above).
Regarding claim 15, Lum in view of 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 of Masahiro and see rejection of claim 1 above).
Claim(s) 6 is/are rejected under 35 U.S.C 103 as being unpatentable over Lum (US PGPUB 20110224610) in view of Masahiro (JP 2009061343) and Maeda (US PGPUB 20170296757), as applied to claim 1 above, and further in view of Yoshida (US PGPUB 20170014431).
Regarding claim 6, Lum does not disclose the rubber composition further comprising clay minerals comprising calcined magnesium silicate clay or aluminum silicate clay.
Maeda further discloses the rubber composition comprising clay (¶0093 and 0100) and Masahiro further discloses the rubber composition further comprising clay minerals (¶3 of pg. 5), but still does not disclose the clay minerals comprising 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 further modified the rubber composition of Lum in view of Masahiro/Maeda and 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 Lum (US PGPUB 20110224610) in view of Masahiro (JP 2009061343) and Maeda (US PGPUB 20170296757), as applied to claim 1 above, and further in view of Sahni (US PGPUB 20250059403).
Regarding claim 7, Lum/Masahiro/Maeda does not disclose the liquid polyisoprene and butadiene has a weight average molecular weight of from 20,000 to 50,000 g/mol.
In the same field of endeavor, rubber compositions, Sahni discloses rubber-based, pressure-sensitive adhesive compositions for medical use (¶0033) comprising liquid rubbers such as liquid isoprene rubber homopolymers and liquid butadiene rubber homopolymers (¶0022). Sahni further discloses average molecular weight of the liquid rubber is from 300 Daltons to 100000 Daltons (¶0021: which is equivalent to 300 – 100000 g/mol; thus, the taught MW range overlaps the claimed MW range) for the benefits of providing useful attributes for the rubber-based compositions such as high cohesive integrity and high adhesion (Abstract and ¶0033).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the medical device of Lum in view of Sahni by having average MWs of liquid polyisoprene and butadiene homopolymer as claimed, in order to provide useful attributes for the rubber-based compositions such as high cohesive integrity and high adhesion, as suggested in Abstract and ¶0033 of Sahni 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 Lum (US PGPUB 20110224610) in view of Masahiro (JP 2009061343) and Maeda (US PGPUB 20170296757), as applied to claim 1 above, and further in view of Yoshida (US PGPUB 20170014431). .
Regarding claim 8, Lum/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.
Maeda further discloses the reactive plasticizer of the rubber composition contains no greater than 20 parts by mass or parts by weight of the total rubber composition (the taught phr ranges overlap the claimed phr ranges: ¶0063) for the benefit of improving needle stick resistance (¶0061).
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 further modified the medical device of Lum in view of Maeda and Yoshida by selecting the claimed phr ranges for halogenated isobutylene-isoprene co-polymer, the clay minerals or silica, and the liquid polyisoprene and butadiene, in order to improve needle stick resistance and stably preserve injection solution for a long time without deformation of a gasket, as suggested in ¶0061 of Maeda and ¶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).
Claim(s) 14 is/are rejected under 35 U.S.C 103 as being unpatentable over Lum (US PGPUB 20110224610) in view of Masahiro (JP 2009061343) and Maeda (US PGPUB 20170296757), as applied to claim 1 above, and further in view of Kutsovsky (US PGPUB 20220332016).
Regarding claim 14, Lum/Maeda does not disclose the rubber composition is cured to form the self-lubricating rubber by sulfur vulcanization.
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 further modified the medical device of Lum 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
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.
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
/JESSICA ARBLE/Primary Examiner, Art Unit 3781
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