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 .
Claims 1-2 are currently amended.
Claims 3-4 are cancelled.
Claims 1-2 are being examined in this application.
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.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Yamashita (JP 2020081835 A) in view of Funatsu et al. (US 20170087255 A1, herein, Funatsu).
Regarding claim 1, Yamashita discloses a syringe sealing body in a pre-filled (prefilled syringe 1 – Fig.1) having a surface portion in contact with a hydrogen peroxide solution in the syringe (“portion where the syringe and the hydrogen peroxide solution are in direct contact is a resin”, see para [0013]), wherein:
the syringe sealing body (cap 40 and gasket 60 – Fig.1) is capable of suppressing generation of foreign solid matter derived from the surface portion of the syringe sealing body caused by contacting the hydrogen peroxide solution at 60°C for a period of at least 1 month.
Yamashita does not appear to expressly disclose a material of the surface portion in contact with the hydrogen peroxide solution is selected from the group consisting of fluoro rubber, fluororesin, silicone rubber, and a styrenic elastomer.
However, Yamashita does disclose that “the syringe…may be composed of a plurality of materials.” (see para [0015]).
Funatsu teaches a material of the surface portion in contact with the hydrogen peroxide solution is selected from the group consisting of fluoro rubber, fluororesin, silicone rubber, and a styrenic elastomer (“as materials for forming the seal member 53, it is preferable to use natural rubber, synthetic rubber such as isoprene rubber, butadiene rubber, fluororubber, and silicone rubber; and thermoplastic elastomers such as olefin-based elastomers and styrene-based elastomers”, see para [0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the portion in contact with the hydrogen peroxide solution disclosed by Yamashita so that the material is selected from the group consisting of fluoro rubber, fluororesin, silicone rubber, and a styrenic elastomer in order to “to seal “a front end portion of the outer cylinder 12, and the intravascular blood replacing liquid 1 filled inside the outer cylinder” (Funatsu, para [0036]).
Examiner interprets the syringe sealing body to be capable of “suppressing generation of foreign solid matter derived from the surface portion of the syringe sealing body caused by contacting the hydrogen peroxide solution at 60°C for a period of at least 1 month” since the combination of Yamashita and Funatsu has the same structure as the claimed invention.
Furthermore, examiner interprets the limitation “capable of suppressing generation of foreign solid matter…” to be intended use. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. See MPEP 2114.II.
Regarding claim 2, Yamashita in view of Funatsu discloses the syringe sealing body (Yamashita, Fig.1) according to claim 1, wherein the syringe sealing body comprises a gasket and a cap (Yamashita, cap 40 and gasket 60 – Fig.1).
Response to Arguments
Applicant's arguments filed 08/31/2026 have been fully considered but they are not persuasive.
In regards to Applicants argument:
“Replacement Sheet 2 of the drawings is enclosed herewith in which the "sealing portion 45" referenced in paragraph [0019] has been inserted into Fig. 1B. Withdrawal of the grounds of objection is respectfully requested.”
This argument is persuasive and the objection has been withdrawn.
In regards to Applicants argument:
“Claim 1 has been amended to remove "the syringe"…Claim 3 has been canceled herewith without prejudice or disclaimer. Withdrawal of the rejection under 35 U.S.C. § 112(d) or 35 U.S.C. § 112 (pre-AIA ), fourth paragraph, is respectfully requested.”
This argument is persuasive and the 35 U.S.C. § 112(b) and 112(d) rejections has been withdrawn.
In regards to Applicants argument:
“Further, because neither Yamashita nor Funatsu teach suppressing generation of foreign matter caused by hydrogen peroxide, one skilled in the art would not have had a reasonable expectation of successfully nor predictably obtaining a syringe sealing body having the capability of suppressing generation of foreign solid matter derived from the surface portion of the syringe sealing body caused by contacting the hydrogen peroxide solution at 60"C for a period of at least 1 month as recited in amended Claim 1.”
This is not persuasive because the combination Yamashita in view Funatsu teaches the claimed structure of the instant application. The combination of Yamashita in view of Funatsu teaches the structure of the claimed invention and it is the opinion of the examiner that, as such, any purported advantages that result from the claimed structure would also flow naturally from the prior art combination.
Therefore, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Hence, the 35 U.S.C. § 103 rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 TAGWA M ABU-DAYEH whose telephone number is (571)270-0389. The examiner can normally be reached 8am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached at (571)270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.A./Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
