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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-15, 19 and 20 in the reply filed on 11/24/2025 is acknowledged.
Claim Rejections - 35 USC § 102
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, 2, 4-6, 12, 13 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dietl (US 2019/0009034).
Regarding claim 1, Dietl discloses a syringe, comprising: a barrel 2 defining a bore comprising an internal surface (fig 1), wherein the internal surface is free of a lubricating material (¶8 – stopper and barrel made of different material to provide greater lubricity; glass is not used because it requires “external lubricant”; also ¶33 which discusses static friction, thus direct contact, between barrel and plunger tip); a syringe plunger slidingly disposable within the bore, the syringe plunger comprising: a handle portion 5; and a plunger tip 4 (figs 2-6) disposed at a distal end of the handle portion, the plunger tip comprising: a central portion 50/51 in axial alignment with the handle portion (¶34); a circumferential hinge (see annotated figure below) circumferentially coupled to the central portion (fig 2); and a wiper portion circumferentially coupled to the circumferential hinge, the wiper portion comprising: a first circumferential seal (see annotated figure below); and a second circumferential seal disposed distally of the first circumferential seal (see annotated figure below), wherein the first and second circumferential seals are free of a lubricating material (¶8 – same reasoning of why no external lubricant is applied), and wherein the first and second circumferential seals slidingly engage with the internal surface of the bore (fig 6).
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Regarding claim 2, wherein a minimum thickness of the circumferential hinge is thinner than a thickness of the central portion and the wiper portion (thinner than wall between 50/51 and thinner than portion of wiper which includes second circumferential seal 49 (upper/distal bump in fig 5).
Regarding claim 4, wherein the first circumferential seal comprises a convex shape (see first seal in fig 4, which is left region indicated by 49).
Regarding claim 5, wherein the second circumferential seal comprises a convex shape (see second seal in fig 4, which is right region indicated by 49).
Regarding claim 6, further comprising a circumferential recess disposed between the first circumferential seal and the second circumferential seal (see region between two regions indicated by 49 in fig 4).
Regarding claim 12, wherein the handle portion comprises a disk 22 configured to axially align the plunger tip with a longitudinal axis of the barrel (fig 1).
Regarding claim 13, wherein the handle portion comprises a plurality of longitudinal ribs configured to axially align the plunger tip with the longitudinal axis of the barrel (fig 1).
Regarding claim 15, wherein the barrel comprises one or more of polycarbonate, polypropylene, polystyrene, polypropylene, cyclo-olefin polymer, cyclo- olefin copolymer, amorphous nylon or glass (¶8).
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dietl (US 2019/0009034).
Regarding claim 3, while Dietl substantially discloses the invention as claimed, it does not disclose wherein the minimum thickness of the circumferential hinge ranges from 0.2 millimeter to 0.8 millimeter.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to determine an appropriate minimum thickness of the circumferential hinge, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955). In the instant application, both Applicant’s and Dietl use the hinge as the biasing means to ensure proper sealing.
Claim(s) 10, 11 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dietl (US 2019/0009034) in view of Manera et al (US 2004/0010238).
Regarding claim 10, while Dietl substantially discloses the invention as claimed, it does not disclose wherein the syringe plunger comprises a unibody construct.
Manera discloses a plunger comprising a unibody construct (fig 3A), which makes it easier and economical to manufacture (¶44).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Dietl such that the syringe plunger comprises a unibody construct as taught by Manera to make manufacture easier and more economical.
Regarding claim 11, wherein the syringe plunger comprises one or more of high density polyethylene, polypropylene, nylon, low density polyethylene, or polyoxy methylene.
Manera discloses the plunger is made of high-density polyethylene (¶44) as, when paired with a polypropylene barrel, easier sliding is achieved and the does not require as close molding tolerances that other combinations may requires.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Dietl such that the syringe plunger comprises high-density polyethylene and the barrel of polypropylene as taught by Manera to achieve easier and so that the manufacture of the components does not require as close molding tolerances
Regarding claim 14, while Dietl substantially discloses the invention as claimed, it does not disclose the barrel comprises a detent extending radially inward from the internal surface, and wherein the detent is configured to retain the plunger tip within the bore.
Manera discloses protrusions/detents 34/36 extending radially inward from the internal surface (fig 4B) and wherein the detent is configured to retain the plunger tip within the bore (¶45).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Dietl such that the barrel comprises a detent extending radially inward from the internal surface, and wherein the detent is configured to retain the plunger tip within the bore as taught by Manera to indicate to the user the end of range of the plunger.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dietl (US 2019/0009034) in view Lawson (US 2009/0099525).
Regarding claim 19, Dietl discloses a syringe plunger, comprising: a handle portion 5; and a plunger tip 4 (figs 2-6) disposed at a distal end of the handle portion (fig 1), the plunger tip comprising: a central portion 50/51 in axial alignment with the handle portion; a circumferential hinge circumferentially coupled to the central portion (see annotated figure above); and a wiper portion circumferentially coupled to the circumferential hinge, the wiper portion comprising: a proximal circumferential seal (see annotated figure above); and a distal circumferential seal disposed distally of the first circumferential seal (see annotated figure above).
While Dietl substantially discloses the invention as claimed, it does not explicitly disclose wherein the proximal and distal circumferential seals are free of mold flashing.
Lawson discloses mold flashing may interfere with sealing (¶20).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Dietl such that the proximal and distal circumferential seals are free of mold flashing as taught by Lawson to prevent interference with the circumferential seals’ sealing ability.
Allowable Subject Matter
Claims 7, 8 and 20 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.
The examiner did not find a teaching or suggestion for modifying the circumferential hinge to be biased in either the distal or proximal directions as the plunger is displaced within the bore as such would appear to decrease the sealing ability of Dietl (due to stretching at least one of the circumferential seals), which is against the teachings of Dietl.
Claim 9 is 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.
The examiner did not find a teaching or suggestion for modifying the circumferential hinge to be biased proximally when the plunger is inserted into the bore wherein the first and second circumferential seals contact the internal surface. Such would render Dietl unsuitable for its intended purpose as the hinge needs to be biased distally (as it extends distally) as per fig 5 to function.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783