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 .
This communication is responsive to the claim set filed 11/29/2023. Claims 1-9 are pending and under consideration.
Claims 1-9 are rejected for the reasons set forth below.
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.
Claim Interpretation
The preambles of the instant claims 1-9 recite “medical rubber product,” “medical” describes the intended use rather than the structure of the rubber product. In other words, the limitation of "medical” is not positively recited structures of claims 1-9 and they do not receive patentable weight (see MPEP 2111.02(II)). However, the limitation is mapped to prior art for the purpose of compact prosecution.
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 4 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the halogenated isobutylene-isoprene rubber is at least one type of rubber selected from the group consisting of chlorinated isobutylene-isoprene rubbers, brominated isobutylene-isoprene rubbers, and brominated isobutylene-para-methylstyrene copolymer rubbers. However, isobutylene-para-methylstyrene copolymer is not an isobutylene-isoprene polymer. Therefore, the scope of Claim 4 is indefinite.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 and 7-9 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Muraki (US6,822,015 ).
Regarding Claims 1-2, Muraki teaches a rubber article for a medical treatment wherein the rubber article is formed from a rubber composition (ab.). Muraki teaches the rubber article is sterilized by gamma rays (col.15-16 between Table 1 and Table 2).
The Office realizes that all of the claimed effects or physical properties are not positively stated by Muraki. However, Muraki teaches all of the claimed ingredients made by a substantially similar process. The original specification does not identify a feature that results in the claimed effect or physical property outside of the presence of the claimed components. Therefore, the claimed effects and physical properties, i.e. the Ss and P values would naturally arise and be achieved by a composition with all the claimed ingredients. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP § 2112.01. If it is the applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant’s position; and (2) it would be the Office’s position that the application contains inadequate disclosure that there is no teaching as to how to obtain the claimed properties with only the claimed ingredients.
Regarding Claim 3, attention is drawn to Examples 1 and 4 wherein the rubber compositions comprising halogenated isobutylene-isoprene rubber and a triazine derivative as crosslinking agent.
Regarding Claim 4, the rubber of Examples 1 and 4 is chlorinated isobutylene-isoprene rubber.
Regarding Claim 5, the rubber compositions of Examples 1 and 4 contain polyethylene.
Regarding Claim 7, the rubber compositions of Example 1 and Example 4 have, respectively, polyethylene in the amount of 15 and 10 parts per 100 parts of the chlorinated isobutylene-isoprene rubber, falling within the claimed 3 to 30 parts per 100 parts of the base polymer.
Regarding Claim 8, the rubber compositions of Example 1 and Example 4 have, respectively, have a JIS A hardness of 42 and 43, falling within the claimed 30 to 70 degrees. Muraki is silent on compression set, as discussed in Claims 1-2 above, the compression set is inherently present.
Regarding Claim 9, Muraki discloses that the rubber articles is used for a rubber stopper (ab.).
Claims 1-6 and 8-9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by MAEDA (US2017/0296757).
Regarding Claims 1-2 and 8, Maeda teaches a nozzle cap for a refilled syringe made from a rubber composition (claim 1). Therefore, a medical rubber product formed from an elastic material. Maeda further teaches the refilled syringe is sterilized by radiation such as a gamma ray ([0006]). The same reasoning stated at para. 7, the claimed Ss, P, JIS-A hardness and the compression set are inherently present because Maeda teaches a substantially identical product to that of the instant claim 1.
Regarding Claims 3-4, the Example 1 composition comprising chlorinated isobutylene-isoprene rubber (CIIR) and a triazine crosslinking agent.
Regarding Claims 5-6, the Example 1 composition comprising LDPE HIGHWAX 220P from Mitsui Chemicals. According to the product information provided by Mitsui Chemicals, HIGHWAX 220P has a degree of crystallinity 70% (evidence will be provided upon request).
Regarding Claim 9, Maeda teaches a nozzle cap for a refilled syringe (claim 1).
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.
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.
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Muraki, as applied to Claim 1 at para. 7, and in further view of Karuppiah et al. (Acta Biomaterialia 4 (2008) 1401-1410).
The disclosure of Muraki on the instant Claim 1 is incorporated herein by reference.
Muraki teaches the rubber composition comprising an isobutylene copolymer, as a predominant component, is selected from the group including chlorinated isobutylene-isoprene copolymer and brominated isobutylene-isoprene (claim 1), triazine derived crosslinking agent (6:30-43), and ultrahigh molecular weight polyethylene (4:63-66).
The difference between Muraki and the instant Claim 6 is that Muraki is silent on the degree of crystallinity.
However, Karuppiah discloses that medical-grade ultra-high molecular weight polyethylene of 55.1% of crystallinity has good surface roughness, elastic modulus, hardness (Table 1), friction coefficient, wear resistance and scratch resistance (Table 2). In view of such benefits, one ordinary skilled artisan, before the effective filing date of the instant application, would have been motivated to use ultra-high molecular weight polyethylene having 55.1% of crystallinity for the rubber composition of Muraki because the rubber composition of Muraki is used for making medical rubber stopper (claim 1).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over MAEDA (US2017 /0296757), as applied to Claim 5 at para. 8.
The disclosure of Maeda on the instant Claim 5 is incorporated herein by reference.
The Example 1 composition contains LDPE in the amount of 2 parts by 70 parts of CIIR by mass, i. e., 2.9 parts per 100 parts of CIIR by mass. 2.9 parts per 100 parts of CIIR by mass is close to the claimed 3 parts per 100 parts by mass of the (a) base polymer. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. (See MPEP 2144.05 (I) (citing Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5 and 7-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-13 of U.S. Patent No.12,577,377 B2 (‘377).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 12 of ‘377 claims a medical rubber product molded from a rubber composition comprising a base polymer consisting essentially of a halogenated isobutylene-isoprene rubber, polyethylene and a triazine derivative as a crosslinking agent. Although Claim 12 of ‘377 is silent on the claimed Ss, P, JIS-A hardness and compression set values, as discussed at para. 5 above, the claimed effects or physical properties are necessarily present because Claim 12 of ‘377 claims a substantially identical medical rubber product to that of the instant Claim 1. Thus, Claim 12 of ‘377 reads on the limitations of the instant Claims 1-3, 5, 8-9.
Claim 13 of ‘377 claims the limitations of the instant Claims 4 and 7.
Claims 1-5 and 7-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9-10 of copending Application No. 18/085,606 (‘606) dated 05/12/2026.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 of ‘606 claims a medical rubber part made from an elastomer wherein the elastomer is a cured product of a rubber composition consisting essentially of a base polymer, polyethylene, triazine derivative as a crosslinking agent, and wherein the base polymer contains halogenated isobutylene-isoprene rubber. Claim 1 of ‘606 further claims the halogenated isobutylene-isoprene rubber is at least one rubber selected from the group consisting of chlorinated isobutylene-isoprene rubber, brominated isobutylene-isoprene rubber, and brominated isobutylene-para-methylstyrene copolymer rubber. Although Claim 1 of ‘606 is silent on the claimed Ss, P, JIS-A hardness and compression set values, as discussed at para. 5 above, the claimed effects or physical properties are necessarily present. Therefore, Claim 1 of ‘606 reads on the limitations of the instant Claims 1-5 and 8.
Claim 9 of ‘606 claims the limitation of the instant Claim 7. Claim 10 of ‘606 claims the limitation of the instant claim 9.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HUIHONG QIAO whose telephone number is (571)272-8315. The examiner can normally be reached 9AM - 5PM.
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/HUIHONG QIAO/ Examiner, Art Unit 1763
/JOSEPH S DEL SOLE/ Supervisory Patent Examiner, Art Unit 1763
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