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 .
Election/Restrictions
Applicant's election with traverse of Group 1, Claims 1-9, and 26-29 in the reply filed on 06/22/2026 is acknowledged. The traversal is on the ground(s) that there would be no serious search and/or examination burden if Group I and Group II (Claims 23-25) were examined together because it would be reasonably expected that the search for one of Group I or Group II would necessarily produce results applicable to the other group since the two groups include an elastomeric material. However, this is not found persuasive because Group I and Group II do not relate to a single general inventive concept, but rather, are drawn to two materially different products, an elastomeric material and a medical device, respectively, which requires additional search and consideration. Moreover, the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries).
Accordingly, the requirement is still deemed proper and is therefore made FINAL.
Claims 23-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on 06/22/2026.
Claim Analysis
Summary of Claim 1:
An elastomeric material for forming a stopper for a syringe comprising
a rubber composition and a phase-separating composition,
wherein the phase- separating composition migrates within the rubber composition to form a drug-absorption resistant barrier layer.
Claim Objections
Claim 9 is objected to because of the following informalities:
Claim 9 recites “optionally above 0 and to about 1 phr, optionally between about 1 phr to about 6 phr” which is grammatically incorrect. Applicant is advised to rephrase to “optionally above 0 and to about 1 phr, or optionally between about 1 phr to about 6 phr” (emphasis added).
Appropriate correction is required.
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 29 is 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 pre-AIA the applicant regards as the invention.
Claim 29 recites the limitations "the drug-absorption resistant barrier layer" in Line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear what “the drug-absorption resistant barrier layer” is referring to, whether it is referring to the phase-separating composition of Claim 26, from which Claim 29 depends, or something else/additional.
Accordingly, the scope of this claim is deemed indefinite.
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, 3-5, 7-8, 26, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Mori et al. (JPH10152590A; hereafter as “Mori”).
Regarding Claims 1 and 26, Mori teaches an elastomer composition that can be used as a stopper and syringe gaskets [Claim 1; ¶ 0038], corresponding to the elastomeric material for forming a stopper for a syringe of Claim 1 and elastomeric material of Claim 26, comprising:
a mixture of polyurethane and polymer polyols [Claim 1; ¶ 0013, 0019, 0033, 0041]; wherein the polyurethane forms a polyurethane sea-island type phase separation structure [Claim 1; ¶ 0013, 0019, 0033], corresponding to the phase-separating composition of Claims 1 and 26.
However, Mori does not mention the claimed rubber composition with sufficient specificity to constitute anticipation within the meaning of 35 U.S.C. 102.
Nevertheless, Mori teaches employing polymer polyols including, among other things, polybutadiene polyols [Claim 1; ¶ 0013, 0019, 0033, 0041], wherein the polybutadiene polyol corresponds to the claimed rubber composition of Claim 1. According to Mori, one or more polymer polyols can be used and the polymer polyol contributes to good moldability in elastomer compositions [¶ 0013, 0021].
Given the above teachings, it would have been obvious to one of ordinary skill in the art to select the claimed rubber composition, i.e., polybutadiene polyols, from the those listed in Mori, with a reasonable expectation of successfully using the same for producing the syringe stopper and obtaining desired moldability.
Moreover, Mori does not explicitly teach the phase-separating composition migrates within the rubber composition to form the drug-absorption resistant barrier layer as required by the claims of the present application. According to ¶ 0036 of the instant Specification, the step of mixing rubber and the phase-separating composition results in the phase-separating composition migrating in the rubber composition to form a barrier. Since Mori teaches the same step of mixing the rubber composition and phase-separation composition, Mori’s mixture would also be expected to result in the claimed migration of the phase-separating composition within the rubber composition to form a barrier layer that functions as a drug-absorption resistant barrier layer as required by the claims.
As to Claims 3-5, and 8: Mori teaches polybutadiene polyols [¶ 0019], which corresponds to the synthetic rubber of Claim 3 and also reads on the polybutadiene of Claim 4. The polyurethane (phase-separating composition) taught by Mori is known to have a surface energy of 38 mJ/m2 1. The polybutadiene (rubber composition) taught by Mori has a surface energy of 48 mJ/m2 2, and thus, meets the limitation “wherein the phase-separating composition has a lower surface energy than the rubber composition” of Claim 5. The polyurethane used in the phase-separating composition of Mori is also known to have melting temperature of 65-121 °C3, which is encompassed by the melting point of from about -80 °C to about 180 °C of Claim 8.
Regarding Claims 7 and 28, Mori further teaches polyolefin polyols [¶ 0013, 0019], corresponding to the olefin of Claims 7 and 28.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Mori et al. (JPH10152590A; hereafter as “Mori”) as applied to claims 1, 3-5, 7-8, 26, and 28 above, and further in view of Sudo et al. (US 6,090,081; hereafter as “Sudo”).
Mori teaches the syringe stopper, rubber composition, phase-separating composition, and drug-absorption resistant barrier layer of Claim 1 as set forth above and incorporated herein by reference.
However, Mori does not explicitly teach the natural rubber of Claim 2.
Nevertheless, Sudo teaches a sealing stopper for a syringe, wherein medicament being enclosed or sealed by the sealing stopper for the syringe having a rubber body laminated with a film that prevents the rubber body from elution of rubber components and contamination of a medicament in contact with the rubber stopper [Claims 1, 4; Column 4, Lines 22-29]. Sudo further teaches the rubber body may comprise natural rubber [Column 8 Lines 4-9], thereby corresponding to the natural rubber of Claim 2.
Sudo offers the motivation that rubbers, such as natural rubber, have excellent sanitary and gaseous permeability resistance as to enable stable long-term storage of a liquid medicament [Column 8, Lines 4-16].
Mori and Sudo are considered to be analogous art as the claimed invention, as all are in the same field of syringe stoppers.
Thus, it would have been obvious to one of ordinary skill in the art to add the claimed natural rubber taught by Sudo to the rubber composition in the elastomeric material of the stopper of Mori with a reasonable expectation of successfully obtaining improved syringe stopper properties.
Claims 6, 9, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Mori et al. (JPH10152590A; hereafter as “Mori”) as applied to claims 1, 3-5, 7-8, 26, and 28 above, and further in view of Kimura et al. (WO 2007/119687A1; English translation incorporated herein; hereafter as “Kimura”).
Mori teaches the syringe stopper, rubber composition, phase-separating composition, and drug-absorption resistant barrier layer of Claims 1 and 26 as set forth above and incorporated herein by reference.
However, Mori does not explicitly teach the specific phase-separating compositions of Claims 6 and 27, i.e., paraffin wax, polyethylene wax, and silicone, and its particular amount as required by Claim 9.
Nevertheless, Kimura teaches a medical rubber stopper with excellent sealing and gas barrier properties and low elution into the liquid contents [¶ 0019], comprising:
for example, 0.5 parts by weight of paraffin wax, polyethylene wax, and silicone oil [¶ 0029, 0120, 0121], thereby reading on the paraffin wax, polyethylene wax, and silicone of Claims 6 and 27 and also,
is encompassed by above 0 to about 20 phr of the phase-separating composition of Claim 9.
Kimura offers the motivation that lubricants may be used to improve sliding properties [¶ 0120].
Thus, it would have been obvious to one of ordinary skill in the art to add the claimed amount of paraffin wax, polyethylene wax, and silicone oil (phase-separating composition) of Kimura to the elastomer composition of Mori with a reasonable expectation of successfully using the same for medical stoppers and obtaining enhanced sliding properties.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rodriguez et al. (WO 2011/080543 A1) teaches syringe assemblies having coated surfaces exhibiting low gas/liquid permeability [Abstract], comprising polytetrafluoroethylene-coated butyl rubber stopper [¶ 0034-0035; Fig. 12-13].
Oshita et al. (US 2018/0030195A1) teaches a pharmaceutical rubber stopper [¶ 0170], a syringe [¶ 0170], block copolymer [Claim 1], butyl rubber [Claim 1; ¶ 0165], paraffin wax [¶ 0223] and polyethylene wax [¶ 0223].
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/DORIS LING/Examiner, Art Unit 1764
/HANNAH J PAK/Primary Examiner, Art Unit 1764
1 Polyurethane has a surface energy of 38 mJ/m2 [Hild, “Surface Energy of Plastics”, Tristar, Table 1]
2 Polybutadiene has a surface energy of 43-48 mJ/m2 [“Surface Energy Data for Polybutadiene rubber, CAS #9003-17-2”, Diversified Enterprise, Table 1].
3 Polyurethane has a melting temperature in the range of 65-121 °C [Golofit, “Polyurethane Melting Temperature (And Decomposition Facts)”, Presto Flooring Company, ¶ 1].
Prosecution Insights