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 § 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 10 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.
Regarding claim 10, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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, 3, 7, 8, 110, 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jo et al (KR 2016-0006635 A). Machine translation provided herewith.
Regarding claim 1, Jo discloses a stopper for a syringe (page 18) comprising a body having a proximal tail for attachment to a plunger rod 120 of the syringe and a distal head (page 18), and a plurality of protrusions 141 extending from an outer surface of the head (page 18), the protrusions are arranged in at least one circle on the outer surface of the head of the stopper and an angular distance between two adjacent protrusions in the circle is less than the angular distance occupied by the protrusions (page 18: protrusions abut each other and therefore the space between each protrusion is less than the space occupied by the protrusion).
Regarding claim 3, Jo discloses that the protrusions are arranged in an outer circle around an outer perimeter of the outer surface of the head of the stopper (page 18) and further in at least one additional concentric circle within the outer circle (fig. 18), and an angular distance between two adjacent protrusions in each circle is less than the angular distance occupied by one of the protrusion (page 18: as noted above, the protrusions abut each other and therefore the distance between them is less than the distance occupied by them).
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Regarding claim 7, Jo discloses that the protrusions are arranged in an outer circle around an outer perimeter of the outer surface of the head of the stopper (see figure from page 18 annotated above), and a protrusion in the center of the circle.
Regarding claim 8, Jo discloses that the outer surface of the head of the stopper is flat (page 18).
Regarding claim 10, Jo discloses that the head of the stopper is conical (page 18) and has a circle of protrusions that are triangular in shape (page 18). The remainder of the claim after “preferably” is interpreted to be not positively recited.
Regarding claim 15, Jo discloses a syringe (page 18) comprising a syringe body defining a chamber (page 18), a plunger rod 120 in the chamber, and a stopper according to claim 1 (page 18; see claim 1 above).
Claim(s) 11, 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kern et al (US 9,238,543).
Regarding claim 11, Kern discloses a stopper for a syringe comprising a body 24 having a proximal tail adapted for attachment to a plunger rod of the syringe – note “adapted for attachment” is interpreted to be an intended use limitation wherein the plunger rod is not positively recited. The proximal end of the body of Kern is capable of being connected to a syringe plunger. Kern discloses that the body has a distal head (fig. 2), a plurality of annular ribs 30 around a circumference of an outer sidewall of the body and a plurality of grooves 23 between the ribs (fig. 2), wherein the ribs are spaced from one another by the grooves (fig. 2), and a plurality of protrusions 28 extending outwardly from eh outer side wall of the body in a radial direction from within the grooves (fig. 2).
Regarding claim 12, Kern shows six protrusions spaced equally around the body and therefore the protrusions are spaced within the claimed range, i.e. roughly 60 degrees separated.
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) 2, 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jo in view of Ma et al (CN 202933324 U). Machine translation provided herewith.
Claim 2 differs from Jo in calling for a cavity adapted to receive and engage at least a portion of the plunger rod of the syringe is defined within the body of the stopper and an opening to the cavity is provided in the tail of the stopper, and protrusions are provided on the tail of the stopper and are arranged in at least one circle on the outer surface of the tail of the stopper extending from an annular ring on the outer surface of the tail of the stopper defined between an outer perimeter of the end face and an outer perimeter of the cavity. Ma teaches a stopper for a syringe including a cavity for receiving a portion of the plunger rod of the syringe and an opening to the cavity being provided in the tail of the stopper (fig. 1). 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 stopper of Jo to include a cavity to receive the plunger rod as taught by Ma to provide a two part piston plunger as is well known in the art and which allows the plunger rod and the stopper to be formed from different materials and separately sterilized as needed.
Ma further teaches that protrusions are provided on the tail of the stopper and arranged in a circle on the outer surface of the tail between an outer perimeter of the rear end face and the perimeter of the cavity (fig. 1). 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 outer surface of the tail of Jo to include protrusions as taught by Ma to provide a surface that prevents sticking.
Regarding claim 6, Jo disclose that the protrusion are located in a single circle (page 18). Since the protrusions are abutting each other, the minimum number of protrusions is necessarily defined by the claimed definition.
Claim(s) 4, 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jo.
Claim 4 differs from Jo in calling for the protrusions to be substantially cylindrical. Applicant has not provided criticality to the shape of the protrusions. The specification page 3, para. 0010 discloses that the protrusions may have any shape. Jo also shows the protrusions having a variety of shapes in various drawings. Therefore, a person of ordinary skill in the art would expect the protrusions of Jo to perform equally well having any shape. Therefore, it would have been a matter of obvious design choice to modify the shape of the protrusions of Jo to be substantially cylindrical.
Jo discloses that the protrusions are adjacent to each other and therefore the number of protrusions necessarily falls within the claimed definition.
Regarding claim 5, Jo discloses the concentric circle of protrusions within the first circle as discussed with regard to claim 3 above (page 18). Since the protrusions abut each other, the number of protrusions necessarily fall within the claimed definition.
Allowable Subject Matter
Claims 9, 13, 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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