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 .
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 (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.
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.
Claim(s) 1-11, 13-15, and 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5785682 A (Grabenkort).
Regarding Claim 1, Grabenkort teaches a device (10) (Figs. 1-2), comprising:
a first end (at (18));
a second end (at (20)) opposite the first end (Fig. 2); and
a chamber (24) extending between the first end and the second end, the first end being configured to be engageable with a reservoir (36) (as seen in Fig. 6) to accept a fluid (D) from the reservoir and into the chamber, and the second end being configured to release a fluid from the chamber to a delivery location (at T, Fig. 8).
Regarding Claim 2, Grabenkort further teaches the device comprises a body (16) (Fig. 2), the body including the first end (at (18)) and the second end (at (20)) and at least partially defining the chamber (24) (Fig. 2).
Regarding Claim 3, Grabenkort further teaches the first end (at (18)) includes an engagement assembly (at 30) configured to be engageable with the reservoir (36) (Fig. 6).
Regarding Claim 4, Grabenkort further teaches the first end (at (18)) includes a recessed portion (interior surface (17) being recessed) that is sized and configured to contain the engagement assembly (at 30) therein (Fig. 2).
Regarding Claim 5, Grabenkort further teaches the engagement assembly (30) includes:
a stopper (26); and
a retaining cap (30), the retaining cap retaining the stopper within the recessed portion (17) when the device is assembled (Fig. 6).
Regarding Claim 6, Grabenkort further teaches the stopper (26) is composed of a self-sealing material (Col. 4: ll. 45-48 describing an elastomeric material being sealingly positioned).
Regarding Claim 7, Grabenkort further teaches the retaining cap (30) includes an aperture (the interior of (30)), the aperture exposing at least a portion of the stopper (stopper (26) being exposed to the interior of (30), as seen in Fig. 2).
Regarding Claim 8, Grabenkort further the first end (at (18)) includes a flange (18), the flange at least partially defining the recessed portion (Fig. 2 showing recessed portion (17) extending into (12)).
Regarding Claim 9, Grabenkort further teaches at least one delivery aperture (the interior of tubing T, as seen in Fig. 6) at the second end (at (20)).
Regarding Claim 10, Grabenkort further the second end (at (20)) at least partially defines the at least one delivery aperture (the interior of tubing T, as seen in Fig. 6) (Fig. 8).
Regarding Claim 11, Grabenkort further teaches a cap (22), at least a portion of the cap being engaged with the second end (at (20)) when the device is assembled (Fig. 2).
Regarding Claim 13, Grabenkort further teaches a device (10) (Figs. 1-8) for reconstituting a lyophilized material (Col. 7: ll. 56-62), the device comprising:
a body (16) including a first end (at (18)), a second end (at (20)) opposite the first end, and a chamber (24) extending between the first end and the second end (Fig. 2), the first end having a first opening (the opening at (18)) and the second end having a second opening (20), each of the first opening and the second opening being in fluid communication with the chamber (Fig. 2);
an engagement assembly (at 30) coupled to the first end and being in fluid communication with the first opening; and
at least one delivery aperture (inside T, Fig. 8) at the second end and being in fluid communication with the second opening (Fig. 8).
Regarding Claim 14, Grabenkort further teaches a cap (22) (Fig. 2), at least a portion of the cap being engageable with the second end (at (20)) (Fig. 2).
Regarding Claim 15, Grabenkort further the second opening (20) (Fig. 2) of the second end (at (20)) of the body (16) defines the at least one delivery aperture (the interior of T, Fig. 8).
Regarding Claim 17, Grabenkort further teaches a method of reconstituting a powdered material (Col. 7: ll. 56-62), the method comprising:
engaging a reservoir (36) (Fig. 6) with an engagement assembly (at (30)) of a delivery device (10), the delivery device defining a first end (at (18)) having the engagement assembly and a first opening (inside (18)), a second end (at (20)) having at least one delivery aperture (inside T, Fig. 8), and a chamber (24) extending between the first end and the second end, the chamber containing the powdered material (M) (Col. 5: ll. 30-34); and
delivering a fluid (D) from the reservoir through the engagement assembly and into the chamber to reconstitute the powdered material (Col. 4: ll. 30-36, Col. 7: ll. 31-37).
Regarding Claim 18, Grabenkort further teaches delivering the reconstituted (Col. 4: ll. 30-36) powdered material (M) to a delivery location (at T, Fig. 8) through the at least one delivery aperture (the interior of T).
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 (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.
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) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grabenkort in view of US 20160089216 A1 (Muller).
Regarding Claim 12, Grabenkort fails to teach the body is composed of a resiliently deformable material.
Muller teaches a syringe [0001] (10) (Fig. 1) wherein the body (16) is composed of a resiliently deformable material [0042], allowing for fine dosing [0025].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the body of Grabenkort with the deformable material taught by Muller to provide a fine dosage quickly, with visual and sensorial control [Muller 0025].
Claim(s) 16, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grabenkort in view of US 5779668 A (Grabenkort), hereinafter Grabenkort ‘668.
Regarding Claim 16, Grabenkort further teaches the first end (at (18)) defines a recessed portion (interior surface (17) being recessed), the engagement assembly (at 30) being entirely within (as seen in Fig. 2) the recessed portion when the device is assembled, the engagement assembly including:
a stopper (26); and
a retaining cap (30), the retaining cap defining an aperture that exposes at least a portion of the stopper therethrough (Fig. 2).
Grabenkort fails to teach the stopper being between the first opening and the retaining cap when the device is assembled.
Grabenkort ‘668 teaches a mixing syringe system (110) (Col. 1: ll.11-15) (Fig. 14) comprising a stopper (134) which is between the first opening (inside (110B)) and the retaining cap (150A) when the device is assembled (Fig. 14).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stopper of Grabenkort to be between the first opening and the retaining cap as taught by Grabenkort ‘668 to improve sterility (Grabenkort ‘668, Col. 11: ll. 34-39).
Regarding Claim 19, Grabenkort further teaches the engagement assembly (at (30)) includes:
a stopper (26); and
a retaining cap (30), the retaining cap defining an aperture that exposes at least a portion of the stopper therethrough (Fig. 2).
Grabenkort fails to teach the stopper being between the first opening and the retaining cap when the delivery device is assembled.
Grabenkort ‘668 teaches a mixing syringe system (110) (Col. 1: ll.11-15) (Fig. 14) comprising a stopper (134) which is between the first opening (inside (110B)) and the retaining cap (150A) when the device is assembled (Fig. 14).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stopper of Grabenkort to be between the first opening and the retaining cap as taught by Grabenkort ‘668 to improve sterility (Grabenkort ‘668, Col. 11: ll. 34-39).
Regarding Claim 20, Grabenkort further the reservoir (26) is a hypodermic syringe (14) having a needle (46) (Fig. 4), the step of engaging the reservoir with the engagement assembly (at 30) including inserting at least a portion of the needle through the aperture (interior of 30) of the retaining cap (30), through the stopper (26), and into the chamber (24) of the delivery device (10) (as seen in Fig. 6).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 10201692 B2 and US 8096971 B2 disclose syringe system comprising a first end, second end, the first end engageable with a reservoir and chamber.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANS KALIHER whose telephone number is (303)297-4453. The examiner can normally be reached Monday-Friday 08:00-05:00 MT.
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/HANS KALIHER/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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