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 .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the "gasket comprises a second surface facing the first surface" must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
In the figures, the second surface appears to face away from the first surface.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1, 3, 4, 6, 15 and all claims depending therefrom are 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 claims 1 and 15, the limitation of "the first surface comprising a first recessed portion" is unclear because it is not known how a first surface could comprise a recessed portion which, itself, would result in the first surface not having a flat surface shape. The recessed portion would appear to comprise another surface that interrupts the first surface.
Claim 3 recites " he second recessed portion comprises an opening portion having a same width as or a narrower width than a width of an opening of the first recessed portion", but no opening of the first recessed portion has been claimed.
Claim 4 recites a second surface "comprises a protruding portion"; but this portion appears to be different than the second surface, not a part thereof (i.e., if the portion protrudes from the second surface then it is a different surface).
Claim 6 recites "the second surface comprises a second recessed portion"; but this portion appears to be different than the second surface, not a part thereof (i.e., if the portion is recessed from the second surface then it is a different surface).
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.
Claims 1, 2, 4, 5, 7, 9 and 11-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McCaffrey et al (U.S. Pub. 2018/0200444 A1, hereinafter "McCaffrey").
Regarding claim 1, McCaffrey discloses a tubular body kit comprising:
a tubular body 202 (see Fig. 5) including a storage chamber partitioned by a gasket 504 (see Fig. 6), the storage chamber being configured to store a liquid (see para [0029] referring to drug 218 that can be liquid); and
the gasket movable in a tube axial direction in the tubular body (see para [0050], disclosing that the plunger can be moved axially with respect to the tubular body), the gasket including a first surface 516 (see Fig. 5) facing the storage chamber, wherein the first surface has a flat surface shape or a curved surface shape (the surface is flat), the first surface comprising a first recessed portion 514 (see Fig. 5).
Regarding claim 2, McCaffrey discloses the tubular body kit according to claim 1, wherein the gasket comprises a second surface 518 facing the first surface (see Fig. 5 and 35 U.S.C. 112 rejection, above), and the second surface comprises a second recessed portion (defined by height 528 and/or 530) at a position facing the first recessed portion.
Regarding claims 4 and 5, McCaffrey discloses the tubular body kit according to claim 1, wherein the gasket comprises a second surface (see annotated Fig. 5, below) facing the first surface, and the second surface comprises a protruding portion (having height 530 and/or 528; see Fig. 5). As per claim 5, the protruding portion is shown to surround a region of the second surface facing the first recessed portion, and protrudes from the second surface in the tube axial direction (see annotated Fig. 5).
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McCaffrey, Annotated Fig. 5
Regarding claim 7, McCaffrey discloses the tubular body kit according to claim 2, further comprising: a guide member 506 (see Fig. 5) comprising a through hole configured to guide a needle piercing through the gasket, wherein the second surface comprises a second recessed portion is configured to engage with the guide member.
Regarding claim 9, McCaffrey discloses the tubular body kit according to claim 4, further comprising a guide member 506 (see Fig. 5) comprising a through hole 520 (see Fig. 5) configured to guide a needle 510 (see Fig. 5) to pierce piercing the gasket, wherein the protruding portion engages with the guide member (see Fig. 5).
Regarding claim 11, McCaffrey discloses that the first recessed portion is provided at a central region of the first surface (see Fig. 5).
Regarding claim 12, McCaffrey discloses the tubular body kit according to claim 1, wherein the tubular body is a syringe tube (see Fig. 5; a syringe has been interpreted to mean a device consisting of a plunger fitting tightly within a cylindrical barrel to inject or withdraw fluids), and the gasket is detachably attachable to a plunger (such as 506) movable in the syringe tube (additionally, it is noted that this feature does not appear to impart a structural limitation to the gasket itself; the gasket 504 could be attached to a plunger even if element 506 were considered to be a guide and not a plunger).
Regarding claim 13, McCaffrey discloses the tubular body kit according to claim 1, where in the tubular body is a tubular container comprising a closed end (end 208 closed by a crimp 212; see Fig. 5) and an open end (opposite the closed end; see Fig. 5)
Regarding claim 14, McCaffrey discloses the tubular body kit according to claim 13, further comprising: a stopper 508 configured to close the open end (see Fig. 5), wherein the gasket is detachably attachable to the stopper (this feature does not appear to impart a structural limitation to the gasket itself; the stopper 508 could be attached to the gasket 504 by a pressure fit, for example).
Regarding claim 15, McCaffrey discloses a gasket comprising:
a first surface 516 (see Fig. 5) having a flat surface shape or a curved surface shape (the surface is flat), the first surface comprising a first recessed portion 514 (see Fig. 5), the first surface configured to partition a liquid storage chamber in a tubular body (see 35 U.S.C. 112(b) rejection, above; the gasket partitions the liquid storage chamber); and
a second surface facing the first surface (a second surface 518 facing the first surface (see Fig. 5 and 35 U.S.C. 112 rejection, above),
wherein the gasket is movable in a tube axial direction in the tubular body configured to store liquid (see para [0029] referring to drug 218 that can be liquid; and see para [0050], disclosing that the plunger can be moved axially with respect to the tubular body).
Claims 1-6, 11-13 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ogawa et al (U.S. Pat. 9,039,664 B2, hereinafter "Ogawa").
Regarding claim 1, Ogawa discloses a tubular body kit comprising:
a tubular body 6 (see Fig. 1) including a storage chamber partitioned by a gasket 1 (see Fig. 1), the storage chamber being configured to store a liquid (see col. 3, line 63 referring to a "drug containing portion 7"); and
the gasket movable in a tube axial direction in the tubular body (see col. 4, lines 27-30, disclosing that the gasket can be moved axially with respect to the tubular body), the gasket including a first surface facing the storage chamber (where protective film 3 is located), wherein the first surface has a flat surface shape or a curved surface shape (the surface is flat), the first surface comprising a first recessed portion 4 (see Fig. 1) or 9 (see Fig. 4).
Regarding claim 2, Ogawa discloses the tubular body kit according to claim 1, wherein the gasket comprises a second surface (see Annotation "A" of Fig. 4, below) facing the first surface, and the second surface comprises a second recessed portion (see annotated Fig. 4, below) at a position facing the first recessed portion.
Regarding claim 3, Ogawa discloses the tubular body kit according to claim 2, comprising a second recessed portion (see Annotation "A" of Fig. 4, below), wherein the second recessed portion comprises an opening portion having a same width as or a narrower width than a width of an opening of the first recessed portion.
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Ogawa, Annotation "A" of Fig. 4
Regarding claims 4 and 5, Ogawa discloses the tubular body kit according to claim 1, wherein the gasket comprises a second surface facing the first surface, and the second surface comprises a protruding portion (see Ogawa, Annotation "B" of Fig. 4, below). Further, as per claim 5 specifically, the protruding portion is shown to surround (annularly) a region of the second surface facing the first recessed portion, and protrudes from the second surface in the tube axial direction.
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Ogawa, Annotation "B" of Fig. 4
Alternatively, regarding claims 4-6, Ogawa discloses the tubular body kit according to claim 1, wherein the gasket comprises a second surface facing the first surface, and the second surface comprises a protruding portion (see Ogawa, Annotation "C" of Fig. 4, below). Further, as per claim 5 specifically, the protruding portion is shown to surround (annularly) a region of the second surface facing the first recessed portion, and protrudes from the second surface in the tube axial direction, and as per claim 6, the second surface comprises a second recessed portion at a position facing the first recessed portion, and the protruding portion surrounds the second recessed portion, and protrudes from the second surface in the tube axial direction.
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Ogawa, Annotation "C" of Fig. 4
Regarding claim 11, Ogawa discloses the tubular body kit according to claim 1, wherein the first recessed portion is provided at a central region of the first surface (see Fig. 3 showing central recess 4).
Regarding claim 12, Ogawa discloses the tubular body kit according to claim 1, wherein the tubular body is a syringe tube (see Abstract), and the gasket is detachably attachable to a plunger movable in the syringe tube (using threads 5, which are provided on the back side thereof for attaching a plunger; see col. 4, lines 3-6).
Regarding claim 13, Ogawa discloses the tubular body kit according to claim 1, wherein the tubular body is a tubular container comprising a closed end and an open end (see Fig. 1 showing closed end at bottom of the tubular container and open end at the top of the tubular container).
Regarding claim 15, Ogawa discloses a gasket comprising:
a first surface having a flat surface shape or a curved surface shape (the surface is flat), the first surface comprising a first recessed portion 4 (see Fig. 1) or 9 (see Fig. 4), the first surface configured to partition a liquid storage chamber in a tubular body (see 35 U.S.C. 112(b) rejection, above; the gasket 1 partitions the liquid storage chamber); and
a second surface facing the first surface (see Ogawa, Annotation "B" or "C" of Fig. 4, above),
wherein the gasket is movable in a tube axial direction in the tubular body configured to store liquid (see col. 4, lines 27-30, disclosing that the gasket can be moved axially with respect to the tubular body).
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.
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over McCaffrey in view of Lockhart (U.S. Pat. 2,568,346, hereinafter "Lockhart").
Regarding claims 8 and 10, it is noted that McCaffrey does not appear to disclose that each of at least a part of an inner side surface of the second recessed portion (extending along distance 530; see Fig. 5) and at least a part of the guide member 506 comprises a respective one of screw grooves configured to engage with each other. McCaffrey is silent as to how the guide member 506 is engaged to the inner side surface of the second recessed portion.
Lockhart discloses a tubular body part of a syringe, comprising a gasket and a tubular insert for the gasket used to guide a needle, the insert being engaged with the gasket by threaded screw portions (e.g., 23; see Fig. 4).
A skilled artisan would have found it obvious at the time of the invention to modify each of at least a part of an inner side surface of the second recessed portion and at least a part of the guide member 506 comprises a respective one of screw grooves configured to engage with each other, with a reasonable expectation of success based on the teaching in Lockhart of engaging a needle guide with a gasket using threaded screw portions. The screw groove configuration would permit relatively simple engagement and disengagement of the guide member from the rest of the gasket, without destroying either component, while still maintaining the desired firm fit between the guide member and the gasket.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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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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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 02/18/2026