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 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 “two distinct parts” in line 3. This limitation is unclear as the cap comprises more than “two distinct parts” (i.e. grooves, lugs, openings, breakable portions etc.) For purposes of examination it is interpreted that the “two distinct parts” refer to a two part skirt (16, 17) of the cap.
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.
Claim(s) 1-3, 5-6, 8-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frezza (US Patent Pub. 20090149817) in view of McConnell et al. (US Patent 7628772 hereinafter “McConnell”).
Regarding Claim 1, Frezza teaches (Figs 1, 3 and 6) a pre-filled syringe (Fig 1) comprising:
- a tubular body (1) extending along a longitudinal axis, having two open ends (2 and where 10 points to) and containing a fluid to be administered to a patient (See [0011]),
- a plunger, (6) one of the ends of which forms a piston, (4) mounted for sliding in the tubular body (1), the plunger (6) passing through the opening of one of the ends (2) of the tubular body (1),
- a connection tip (9) comprising a tubular part (10) communicating with the opening of another of the ends of the tubular body to create a passage for the fluid that is to be administered;
-a fluid tight stopper (Fig 3, 13) comprising a breakable zone (Fig 3, 14) connected to the free end of the tubular part (10) of the tip,
- a cap (Fig 6, 15) comprising:
a fixing or coupling portion (20) for fixing or coupling to the stopper (13),
a portion forming a skirt (17) in dissociable form or molded as one with the fixing or coupling portion (20), and which extends as far as the tubular body (See [0061] "The skirt 17 extends as far as the body 1 of the syringe"); and
- means for fixing at least part of the cap to the tubular body or the connecting tip (cap must have some means to attach as shown in Fig 3; see [0059] teaching the cap is fitted on the tip), configured to allow a twisting of at least part of the cap (15) about its longitudinal axis to cause the breakable zone (13) to rupture thereby allowing the cap with the stopper (13) to be physically separated from the tip (See [0058] teaching how twisting of the cap allows for the breakable zone of 13 to rupture).
Frezza does not specify the means comprising at least one snap-fastening lug and at least one snap-fastening opening or groove collaborating in snap-fastening with the snap-fastening lug and being configured to allow a twisting of at least part of the cap about its longitudinal axis.
McConnell teaches (Fig 3) a means comprising at least one snap-fastening lug (13) and at least one snap-fastening opening (14) or groove (15) collaborating in snap-fastening with the snap-fastening lug and being configured to allow a twisting of at least part of the cap (Col 5 lines 14-44 teaches how the lug 13 is inserted into groove 15 and twisted to fit into opening 14; therefore the examiner interprets that this mechanism is configured to allow twisting of the cap).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the means for fixing of Frezza with a means comprising at least one snap-fastening lug and at least one snap-fastening opening or groove collaborating in snap-fastening with the snap-fastening lug and being configured to allow a twisting of at least part of the cap about its longitudinal axis as taught by McConnell. One of ordinary skill in the art would have been motivated to do so in order to provide a releasable coupler that still allows for rotation of the cap, while also allowing for the cap to be effectively locked to the base (McConnell Col 5 lines 14-44).
Regarding Claim 2, the combination of Frezza and McConnell teaches the pre-filled syringe as claimed in claim 1, wherein
- the connection tip comprises an exterior part (Frezza 11), at an exterior periphery of the tubular part, comprising the at least one outwardly projecting snap-fastening lug (McConnell 13) ;and
- the skirt comprises the at least one open-ended snap fastening opening (McConnell 14) or groove (McConnell 15) collaborating in snap-fastening with the at least one lug (McConnell Col 5 lines 40-41).
Regarding Claim 3, the combination of Frezza and McConnell teaches all elements of claim 1 as described above. The combination does not specify the pre-filled syringe wherein -the skirt comprises an interior part comprising at least one inwardly projecting lug; and-the connection tip comprises an exterior part, at an exterior periphery of the tubular part, the at least one open-ended snap-fastening opening or groove collaborating in snap-fastening with the at least one lug.
McConnell teaches a projecting lug (13) on the exterior part of the connection tip and an opening ended snap fastening (14) mechanism on the skirt. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the syringe such that-the skirt comprises an interior part comprising at least one inwardly projecting lug; and-the connection tip comprises an exterior part, at an exterior periphery of the tubular part, the at least one open-ended snap-fastening opening or groove collaborating in snap-fastening with the at least one lug (switching the lugs and openings of McConnell). One of ordinary skill in the art would have been motivated to do so as this would be a simple rearrangement of parts that would result in the same locking function between the skirt and the base of the syringe (MPEP 2144.04 (VI) (C) In reJapikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)). Additionally, one of ordinary skill in the art would recognize that switching the location of the lugs and openings of McConnell would be a simple reversal of parts (MPEP 2144.04 (VI)(A) In reGazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955)).
Regarding Claim 5, the combination of Frezza and McConnell teaches all elements of claim 2 as described above. The combination further teaches the pre-filled syringe wherein the cap is produced as a single one-piece component (this is a product by process limitation) comprising:
- the at least one snap-fastening groove or opening (McConnell 14, 15, 17) delimited by at least two zones (McConnell 14, 15), a first (McConnell 14) in which the snap-fastening of the lug occurs (McConnell Col 6 lines 10-12) and at least a second (McConnell 17) in continuity of the first, and in which the lug becomes lodged when the cap is twisted (McConnell Col 5 lines 2-4); and
- at least one disengagement open-ended opening or groove (McConnell 15) in the continuation of the second zone (McConnell 17), the disengagement open-ended opening or groove being configured to allow physical separation of the cap with the stopper (McConnell Col 6 lines 63-66).
Regarding Claim 6, the combination of Frezza and McConnell teaches the pre-filled syringe as claimed in claim 5, wherein the at least one snap-fastening groove or opening comprises comprising a single second zone allowing the cap to be twisted in just one direction of rotation (See McConnell Col 5 line 63 – Col 6 line 4 teaching how the cap must be ‘reverse-rotated’ to be disengaged; this is interpreted as only a ‘one direction rotation’ (the user cannot rotate in both directions for the disengagement)).
Regarding Claim 8, the combination of Frezza and McConnell teaches all elements of claim 2 as descried above. The combination further teaches the pre-filled syringe wherein the exterior part of the tip (Frezza 9, McConnell 11) or the skirt comprises comprising two diametrically opposite snap-fastening lugs (McConnell 13; see Fig 5 showing two diametrically opposite lugs) and the skirt (Frezza 17, McConnell 12) or the tip respectively comprises comprising two diametrically opposite snap-fastening grooves (McConnell 15) or open-ended openings (McConnell 14) each collaborating with one of the two snap-fastening lugs (See McConnell Fig 3 and Fig 5).
Regarding Claim 9, the combination of Frezza and McConnell teaches all elements of claim 1 as described above. Frezza further teaches the pre-filled syringe wherein the tubular body (1), the connection tip (9) with the stopper (13) and the snap-fastening lug(s) (McConnell 13) being are molded as one as a single one-piece component (this is a product by process limitation, as all structural elements are taught by Frezza and McConnell, it is interpreted that the combination meets all elements of this limitation; furthermore Frezza [0057] teaches a one-piece molding).
Regarding Claim 10, the combination of Frezza and McConnell teaches all elements of claim 9 as described above. Frezza further teaches the pre-filled syringe wherein the one- piece component is produced in a synthetic material and obtained by molding (See [0057]).
Regarding Claim 11, the combination of Frezza and McConnell teaches all elements of claim 1 as described above. Frezza further teaches the pre-filled syringe wherein the cap (15) comprises at least one open-ended orifice (Fig 6; 25) intended for the passage of a sterilizing fluid (See [0069] “The cap additionally comprises an orifice 25 intended for the passage of the sterilization fluid.”).
Regarding Claim 12, the combination of Frezza and McConnell teaches all elements of claim 1 as described above. Frezza further teaches the pre-filled syringe wherein the cap (15) comprises an upper end wall (16) from which the coupling portion (20) projects in the form of a tube and is coupled to the stopper (13) through complementing shapes (See Fig 6 and [0064]).
Regarding Claim 13, the combination of Frezza and McConnell teaches all elements of claim 12 as described above. Frezza further teaches the stopper (13) and/or the tubular coupling portion (20) having complementing polygonal cross sections (See [0064] “the obturator 13 and the hollow stub 20 have matching polygonal shapes 22, 23, for example hexagonal shapes.”).
Regarding Claim 14, the combination of Frezza and McConnell teaches all elements of claim 1 as described above. Frezza further teaches the pre-filled syringe wherein the connection tip (9) is in the form of a cone of a Luer or Luer lock (see [0059).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frezza (US Patent Pub. 20090149817) in view of McConnell (US Patent 7628772) as applied to claim 2 above, and further in view of Jansen et al. (US Patent 6196998 hereinafter “Jansen”).
Regarding Claim 4, the combination of Frezza and McConnell teaches all elements of claim 2 as described above. The combination does not specify the pre-filled syringe wherein the cap comprises: - two distinct parts one of them being in dissociable form or molded as one with the fixing or coupling portion and the other extending as far as the tubular body and incorporating the at least one opening or groove, and- at least one twist-breakable bridging piece, connecting the two parts some distance from one another so that the twisting of the part in dissociable form or molded as one with the fixing or coupling portion does not cause the other part, which is kept snap-fastened, to turn but causes simultaneous rupturing of the breakable zone and of the at least one bridging piece, the rupturing of the latter providing a user with a visual indication that an action has been performed correctly.
Jansen teaches (Figs 5 and 7) a syringe cap (26) comprising two distinct parts (88, 90), one of them being in dissociable form or molded as one with the fixing or coupling portion and the other extending as far as the tubular body (this is a product by process limitation), - at least one twist-breakable bridging piece (86), connecting the two parts (88, 90) some distance from one another so that the twisting of the part in dissociable form or molded as one with the fixing or coupling portion does not cause the other part, which is kept snap-fastened, to turn but causes simultaneous rupturing of the breakable zone and of the at least one bridging piece, the rupturing of the latter providing a user with a visual indication that an action has been performed correctly (See Col 6 lines 43 – 64).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cap of Frezza such that the cap comprises two distinct parts one of them being in dissociable form or molded as one with the fixing or coupling portion and the other extending as far as the tubular body and incorporating the at least one opening or groove, and at least one twist-breakable bridging piece, connecting the two parts some distance from one another so that the twisting of the part in dissociable form or molded as one with the fixing or coupling portion does not cause the other part, which is kept snap-fastened, to turn but causes simultaneous rupturing of the breakable zone and of the at least one bridging piece, the rupturing of the latter providing a user with a visual indication that an action has been performed correctly as taught by Jansen. One of ordinary skill in the art would have been motivated to do so in order to provide evidence of any tampering or misuse of the syringe (Jansen Col 6 line 43-48).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frezza (US Patent Pub. 20090149817) in view of McConnell (US Patent 7628772) as applied to claim 5 above, and further in view of Okihara et al. (US Patent Pub. 20150011936 hereinafter “Okihara”).
Regarding Claim 7, the combination of Frezza and McConnell teaches all elements of claim 5 as described above. The combination does not specify the at least one snap-fastening groove or opening comprises comprising a narrowing between the two zones, which narrowing is configured so that when the cap is twisted, an action of the lug entering the narrowing generates an audible click that indicates to a user that the action has been performed correctly.
Okihara teaches (Fig 2) a cap (5) with a snap fastening groove that comprises a narrowing (see groove 82, the groove narrows).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the groove/opening of the snap fastening system of the modified Frezza such that at least one snap-fastening groove or opening comprises comprising a narrowing between the two zones as taught by Okihara. One of ordinary skill in the art would recognize this modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
The combination does not specify an action of the lug entering the narrowing generates an audible click that indicates to a user that the action has been performed correctly.
McConnell teaches (Col 9 line 50 – Col 10 line 3) that snap fit engagements may provide tactical and audible feedback such as a click to notify the user of secure engagement.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the snap fastening engagement of the modified Frezza such that an action of the lug entering the narrowing generates an audible click that indicates to a user that the action has been performed correctly as taught by McConnell. One of ordinary skill in the art would have been motivated to do so in order to ensure the user is notified of a secure engagement (McConnell Col 9 lines 61-66).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/QUYNH-NHU H. VU/Primary Examiner, Art Unit 3783