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 Group I and Species A in reply filed on June 23th, 2026 is acknowledged. Applicant canceled claims 15-17 from Group II and incorporated subject matter of claims 15-17 into Group I.
Therefore claims 23-26 and 28 (as indicated by Applicant) are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claims 2, 12 and 13 is/are objected to due to the following informalities:
In claim 2, line 1, should be amended to remove “wherein the barrel end defines a barrel orifice” since claim 1 already recites “a barrel orifice defined by the barrel end”.
In claim 2, line 2, the term “securedly” should be corrected to “securely” for grammatical correctness.
In claim 12, line 3, “the interior wall” should be corrected to “an interior wall” since this term was not previously introduced.
In claim 13, line 2, a comma and the term “and” should be inserted after the term “end” for grammatical correctness.
In claim 13, line 3, “the needle engagement surface” should be corrected to “the syringe needle end engagement surface” for claim language consistency.
In claim 13, line 4, “the user engagement” should be corrected to “the user engagement surface” for claim language consistency.
Appropriate correction is required.
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, 5-8 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sharon et al. (US 20080082044 A1).
Regarding claim 1, Sharon discloses A syringe device (syringe assembly 2 in Fig. 1), comprising:
a barrel (plunger unit 30 which is engaged with dispensing unit 10 to form a two-compartment syringe assembly [0075]; it is interpreted that body 50 of plunger unit 30 and body 12 of dispensing unit 10 is the barrel of syringe device 2), having an interior (inner side wall of body 12 [0083] is interpreted as interior surface; see interior surface in annotated Fig. 2 below) and an exterior surface (see exterior surface of body 12 in annotated Fig. 2), the interior surface at least partially defining an interior cavity (compartment of body 12 [0083] is interpreted as interior cavity; see interior cavity in annotated Fig. 2 below) for holding a therapeutic composition (dispensing unit 10 is filled with a medicament [0074]);
a barrel end (bottom end of body 50 in [0078] is interpreted as barrel end; see barrel end in annotated Fig. 2), wherein a flange (flange 51 in Fig. 1) is positioned at or near the barrel end (flange 51 is located near bottom end of body 50 in annotated Fig. 2) and threading structures (body 50 is provided with mating screw threads near its bottom end [0078]) are positioned about a barrel orifice (bottom end opening 50b is interpreted as barrel orifice in Fig. 2) defined by the barrel end (bottom opening 50b is located near bottom end of body 50 in annotated Fig. 2);
a barrel cap (closure element 38 in Fig. 1) configured to attach to the barrel end (threaded closure element 38 for sealing the bottom-end opening 50b of the plunger unit 30 [0078]), the barrel cap comprising an exterior surface (see exterior surface in annotated Fig. 2 below), an interior surface (see inner sidewall in annotated Fig. 2 below) comprising threading (screw threads 40 along inner sidewall [0078]; see also annotated Fig. 2) for removably engaging the threading structures (body 50 is provided with mating screw threads near its bottom end so that the closure member 38 is screwed onto body 50 [0078]), and a secondary seal (o-rings 42 in Fig. 2) configured for placement between the interior surface of the barrel cap and the barrel end (part of the inner surface of closure element 38 adjacent the central aperture is provided with a plurality of inner sealing ribs, or a plurality of grooves 43 for receiving o-rings 42 [0079]); and
a needle end (nipple 20 in Fig. 2; nipple 20 is adapted and configured for attaching an appropriate dispensing device, e.g. a hypodermic needle [0073]).
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Annotated Fig. 2 of Sharon
Regarding claim 2, Sharon disclosed all limitations of claim 1. Sharon further discloses wherein the barrel end defines a barrel orifice (bottom end opening 50b is interpreted as barrel orifice in Fig. 2; bottom opening 50b is located near bottom end of body 50 in annotated Fig. 2 above), the barrel orifice defining an opening (orifice 50b is interpreted to make an opening to access the interior cavity) to the interior cavity and the flange configured to securedly receive the barrel cap (closure element 38 has a central aperture along its longitudinal axis so that plunger 44 is received through the central aperture of closure element 38 which can be moved up and down the plunger shaft 41 until it abuts against a protruding flange 51 [0079]; closure element 38 is interpreted to be securely received by flange 51 due to abutting against flange 51).
Regarding claim 3, Sharon disclosed all limitations of claim 2. Sharon further discloses the flange extends outward asymmetrically about the barrel orifice (flange 51 has asymmetric shape which is defined by flat cutout; see annotated Fig. 1 below).
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Annotated Fig. 1 of Sharon
Regarding claim 5, Sharon disclosed all limitations of claim 2. Sharon further discloses wherein the barrel cap is removably engaged to the barrel end (it is interpreted the closure element 38 is removably secured barrel end opening 50b since it is screwed on via screw threads 40).
Regarding claim 6, Sharon disclosed all limitations of claim 3. Sharon further discloses wherein the barrel cap removably engages the flange (it is interpreted the closure element 38 removably engages flange 51 since closure element 38 is screwed on barrel end opening 38 until closure element 38 abuts against flange 51)
Regarding claim 7, Sharon disclosed all limitations of claim 5. Sharon further discloses wherein engagement of the threading of the barrel cap with the threading structures secures the barrel cap to the barrel end by twist application (body 50 is provided with mating screw threads near its bottom end so that the closure member 38 can be screwed onto body 50 [0078]; it is interpreted that the action of screwing closure member 38 onto body 50 requires twist application)
Regarding claim 8, Sharon disclosed all limitations of claim 7. Sharon further discloses wherein the threading structures about the barrel orifice are located above the flange (mating screw threads of body 50 is interpreted to be located above the face of the flange closest to the bottom opening 50b in Fig. 1 since closure element 38 abuts against the face of the flange closest to the bottom opening 50b).
Regarding claim 12, Sharon disclosed all limitations of claim 1. Sharon further discloses a needle cap (screw cap 19 in Fig. 2) for sealing the needle end (screw cap 19 covers the nipple 20 in Fig. 2), comprising:
a syringe needle end engagement surface (see needle end engagement surface annotated Fig. 2 above) defining tip threaded structures for engaging needle end threading structures at the interior wall of the needle end (dispensing unit 10 is provided with a screw thread for sealing attachment of a removable screw cap 19 [0073]; it is interpreted the screw thread of unit 10 is located on the needle end engagement surface for attachment of screw cap 19).
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over the embodiment of Sharon et al. (US 20080082044 A1) in Fig. 1 and further in view of the embodiment of Sharon in Fig. 10B.
Regarding claim 4, Sharon disclosed all limitations of claim 2 in the embodiment of Fig. 1. However, Sharon failed to explicitly disclose wherein the flange extends outward symmetrically about the barrel orifice.
However, Sharon teaches in another embodiment in Fig. 10B, a radial flange 249 in syringe assembly 200. Sharon further teaches in the embodiment of Fig. 10B the radial flange 249 prevent excess movement of bung 248 [0111]. One of ordinary skill in the art recognizes that the radial flange 249 of Fig. 10B performs same function as the flange 51 of Fig. 1 since flange 51 is interpreted to prevent excess movement of closure element 38 after abutting against flange 51 as set forth in [0079].
Therefore, it would have been to one of ordinary skill in the art, prior to effective filing date of the invention to modify the flange of the embodiment of Sharon in Fig. 1 to extend outward symmetrically since it has been held that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929). See MPEP 2144.05.II.A. In the instant case, the flange of syringe assembly 2 would not operate differently if it extends outward symmetrically. Further, Applicant places no criticality on symmetric extension of the flange in claim 4.
Claim(s) 9, 10 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharon et al. (US 20080082044 A1) and further in view of Silverman et al. (US 20200146280 A1).
Regarding claim 9, Sharon disclosed all limitations of claim 8. However, Sharon failed to explicitly disclose comprising therapeutic mammalian cells within the interior cavity, wherein the therapeutic mammalian cells are a component of the therapeutic composition.
However, Silverman teaches the medical device is the barrel or lumen of a syringe, and a composition is sealed within the barrel [0037].
Silverman further teaches cells for use with the composition and device include mammalian cells, therapeutic cells, for example therapeutic human cells [0022]. One of ordinary skill in the art teaches the medication of Sharon is to be configured to be composed of therapeutic mammalian cells as taught by Silverman.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the syringe device of Sharon to include therapeutic mammalian cells within the interior cavity, wherein the therapeutic mammalian cells are a component of the therapeutic composition as taught by Silverman since such a modification enables the device of Sharon to maintain the viability of therapeutic mammalian cells at low temperature [Silverman, 0009].
Regarding claim 10, Sharon as modified by Silverman disclosed all limitations of claim 9. Sharon further discloses wherein the secondary seal is selected from an induction seal or a gasket (o-ring 42 in Fig. 2 is interpreted as gasket in light of the Specification).
Regarding claim 13, Sharon disclosed all limitations of claim 12. Sharon further discloses an elastomeric stopper (opening 16 is sealed with a membrane with cap 19 [0074]) for engaging a needle tip orifice (opening 16 in Fig. 1) defined at the needle end (opening 16 is located on nipple 20 in Fig. 1).
a user engagement surface (see user engagement surface in annotated Fig. 2 above), but failed to explicitly disclose wherein the needle engagement surface is spaced inwardly from the user engagement.
However, Silverman teaches a needle cap 500 in Fig. 1A wherein outer surface 510 is spaced inwardly from the user engagement surface (surface of cap 500 is interpreted as user engagement surface of Silverman in Fig. 1A). One of ordinary skill in the art teaches the syringe of Sharon to be configured to have tip 245 and needle cap 500 of Silverman, to have needle engagement surface spaced inwardly as taught by Silverman.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the syringe device of Sharon to include the needle engagement surface is spaced inwardly from the user engagement as taught by Silverman to provide tight securement of the needle cap.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
US 20140228802 A1 (Mackey) related to a syringe device with barrel cap.
US 20240226444 A1 (Halvorsen) related to a syringe device with barrel cap.
US 20170216531 A1 (Garza) related to a cryo-syringe device with a barrel cap and a needle cap.
US 20230270935 A1 (Lyness) related to a medicament container with cap that is converted into a syringe.
US 20220370719 A1 (Ricci) related to a syringe device with a tip cap.
WO 2021133599 A1 (Ryan) related to a disinfecting syringe tip with cap.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHMOOD FAROOQ whose telephone number is (571)272-7276. The examiner can normally be reached Monday-Friday: 7:30-5:00p EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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