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 .
Status of Claims
As directed by the amendment filed on 24 February 2026: claim(s) 1, 13, and 16 have been amended, claim(s) 21 have been cancelled, claim(s) 21 have been added. Thus, claims 1-3 and 5-20 are presently pending.
Response to Arguments
Applicant's arguments filed 24 February 2026 have been fully considered but they are not persuasive.
Regarding the argument that "the barrier coating 170 is disposed on the proximal rib as illustrated in annotated FIGS. 8 and 9 of Cully" on pg. 8, FIGS. 8 and 9 of Cully shows two exemplary embodiments and is not exclusively limiting (“non-limiting figures” [0013]). Cully teaches that the coating 170 may be modified “to assist in the prevention of oxygen into the syringe” ([0090]).
Cully discloses the amended claims as discussed below.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5, 7-10, 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cully et al. (US 20210146054 A1).
Regarding Claim 1, Cully discloses a syringe ("syringe 10" [0029]; FIG. 1a) comprising:
a barrel ("barrel 15" [0029]) comprising an interior surface ("barrel 15 has a hydrophilic interior surface" [0029]);
a plunger ("plunger rod 85" [0032]) comprising:
an elongate handle portion defining a proximal end and a distal end ("plunger rod 85 has opposed distal and proximal ends 90 and 95" [0032]; FIG. 1b); and
a plunger tip ("stopper 100" [0032]) coupled to the distal end of the elongate handle portion ("attached at the distal end 90" [0032]; FIG. 1a),
the plunger tip 100 comprising a first material ("stopper 100 may be formed of an elastomeric body 125" [0034]) and including an annular wall and a top portion coupled to the annular wall ("stopper 100 may include one or more circumferentially extending annular ribs" [0032]; FIG. 8); and
a coating ("low friction barrier film" [0035] & "barrier coating 170" [0085]; FIG. 8) disposed on at least a portion of an external surface of the plunger tip ("surrounding the elastomeric body 125" [0035 & "surrounding a portion of the stopper 100" [0085]), the coating comprising a second material ([0035]-[0040] & [0087]-[0089]),
wherein at least one material property of the first material differs from at least one material property of the second material ("elastomeric body 125 can include any elastomer suitable for the application, most notably rubbers constructed from butyl, bromobutyl, chlorobutyl, silicone, nitrile, styrene butadiene, polychloroprene, ethylene propylene diene, fluorelastomers, or combinations or blends of any of the foregoing" [0034] & "barrier film may include one or more fluoropolymer films such as, but not limited to, polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE) films" [0035])
and wherein a coefficient of friction between the second material and the interior surface is lower than a coefficient of friction between the first material and the interior surface ("oxygen barrier material minimizes friction between the stopper and the interior surface of the barrel … coefficient of friction of the barrier coating 170 may be less than the coefficient of friction of the stopper material thereby allowing the stopper 100 to move smoothly in the barrel 15" [0085]),
wherein the annual wall comprises a proximal ridge, a medial ridge, and a distal ridge ("two or more ribs 120" [0032]; FIG. 5), and
wherein the coating is disposed on the medial ridge and the distal ridge (“barrier coating 170 may also cover the distal surface of stopper 100 (e.g, the entirety of the stopper 100)” [0086]).
Cully fails to specify the coating is absent from the proximal ridge. However, Cully teaches that the locations of the coating may be modified to suitably “assist in the prevention of oxygen into the syringe” ([0090]; “barrier coating 170 may not be provided on the distal fluid-contacting surface of stopper 100” [0086]) “without significantly impacting the slide force” ([0085]) “or contaminating fluids within the fluid chamber” ([0085]). Furthermore, the court as held that the rearrangement of parts is an obvious matter of design choice when such rearrangement would not have modified the operation of the device. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). In this case, the rearrangement of the coating would not have changed the operation of the syringe (i.e. the plunger & stopper still slides with a lower coefficient of friction due to the presence of the coating). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Cully such that the coating is disposed on the medial ridge and the distal ridge and absent from the proximal ridge to suitably “assist in the prevention of oxygen into the syringe” ([0090]; “barrier coating 170 may not be provided on the distal fluid-contacting surface of stopper 100” [0086]) “without significantly impacting the slide force … or contaminating fluids within the fluid chamber” ([0085]).
Regarding Claim 2, Cully discloses the second material comprises polyethylene, perfluoropolyether (PFPE), or perfluoropolyalkylether (PFAE) ("polyethylene" [0038]-[0040]).
Regarding Claim 3, Cully discloses the second material comprises linear low-density polyethylene (LLDPE), high-density polyethylene (HDPE), expanded polytetrafluoroethylene (ePTFE), polytetrafluoroethylene (PTFE), or composites thereof ("expanded polytetrafluoroethylene (ePTFE)" [0038]-[0040]).
Regarding Claim 4, Cully discloses a coefficient of friction between the second material and the interior surface is lower than a coefficient of friction between the first material and the interior surface ("coefficient of friction of the barrier coating 170 may be less than the coefficient of friction of the stopper material" [0085]).
Regarding Claim 5, Cully discloses the coating isolates the first material from a substance loaded in the reservoir by preventing physical contact between the first material and the substance ("the film, e.g., the ePTFE film or densified ePTFE film, surrounds the elastomeric body 125 in its entirety" [0053]).
Regarding Claim 7, Cully discloses the coating is absent from the external surface of a portion of the annular wall ("film partially surrounds the elastomeric body 125" [0053]).
Regarding Claim 8, Cully discloses the syringe is free of liquid silicone lubricants ("syringe 10 includes a barrel 15 that is free or substantially free of silicone" [0029] & [0055]).
Regarding Claim 9, Cully discloses the coating has a thickness from about 0.1 pm to about 50 pm ("Barrier films can be made with thicknesses ranging from 0.5 micron to 20 microns" [0053]).
Regarding Claim 10, Cully discloses the coating is adhered to at least a portion of an external surface of the plunger tip ("barrier coating 170 may include a laminate that is adhered or bonded to the stopper 100" [0088]).
Regarding Claim 13, Cully discloses a syringe component (FIG. 1a) comprising:
a plunger tip ("stopper 100" [0032]) comprising a first material ("stopper 100 may be formed of an elastomeric body 125" [0034]), and including an annular wall and a top portion coupled to the annular wall ("stopper 100 may include one or more circumferentially extending annular ribs" [0032]; FIG. 8);
wherein the annual wall comprises a proximal ridge, a medial ridge, and a distal ridge ("two or more ribs 120" [0032]; FIG. 5); and
a coating ("low friction barrier film" [0035] & "barrier coating 170" [0085]; FIG. 8) disposed on at least a portion of an external surface of the plunger tip ("surrounding the elastomeric body 125" [0035 & "surrounding a portion of the stopper 100" [0085]), the coating comprising a second material,
wherein at least one material property of the first material differs from at least one material property of the second material ("elastomeric body 125 can include any elastomer suitable for the application, most notably rubbers constructed from butyl, bromobutyl, chlorobutyl, silicone, nitrile, styrene butadiene, polychloroprene, ethylene propylene diene, fluorelastomers, or combinations or blends of any of the foregoing" [0034] & "barrier film may include one or more fluoropolymer films such as, but not limited to, polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE) films" [0035])
wherein the coating is disposed on the medial ridge and the distal ridge (“barrier coating 170 may also cover the distal surface of stopper 100 (e.g, the entirety of the stopper 100)” [0086]).
Cully fails to specify the coating is absent from the proximal ridge. However, Cully teaches that the locations of the coating may be modified to suitably “assist in the prevention of oxygen into the syringe” ([0090]; “barrier coating 170 may not be provided on the distal fluid-contacting surface of stopper 100” [0086]) “without significantly impacting the slide force” ([0085]) “or contaminating fluids within the fluid chamber” ([0085]). Furthermore, the court as held that the rearrangement of parts is an obvious matter of design choice when such rearrangement would not have modified the operation of the device. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). In this case, the rearrangement of the coating would not have changed the operation of the syringe (i.e. the plunger & stopper still slides with a lower coefficient of friction due to the presence of the coating). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Cully such that the coating is disposed on the medial ridge and the distal ridge and absent from the proximal ridge to suitably “assist in the prevention of oxygen into the syringe” ([0090]; “barrier coating 170 may not be provided on the distal fluid-contacting surface of stopper 100” [0086]) “without significantly impacting the slide force … or contaminating fluids within the fluid chamber” ([0085]).
Regarding Claim 14, Cully discloses a coefficient of friction between the second material and an interior surface of a syringe is lower than a coefficient of friction between the first material and the interior surface of the syringe ("coefficient of friction of the barrier coating 170 may be less than the coefficient of friction of the stopper material" [0085]).
Regarding Claim 15, Cully discloses the coating is configured to isolate the first material in the plunger tip from a substance loaded in a reservoir defined by an interior surface of a syringe by preventing physical contact between the first material and the substance ("the film, e.g., the ePTFE film or densified ePTFE film, surrounds the elastomeric body 125 in its entirety" [0053]).
Claim(s) 6 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cully et al. in view of Butts et al. (US 20170209648 A1).
Regarding Claim 6, Cully discloses the plunger tip comprises silicone ("elastomeric body 125 can include any elastomer suitable for the application, most notably … silicone" [0034]) but fails to expressly disclose the substance comprises polyvinyl alcohol (PVA) or gelatin foam. However, Butts teaches coverings for syringe plunger tips (see Abstract) wherein the substance comprises polyvinyl alcohol (PVA) or gelatin foam (“substance containing polyvinyl alcohol (PVA) within the syringe barrel” [0016]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Cully to incorporate the teachings of Butts to enhance the compatibility of the plunger tip with the substance contained within the syringe barrel ([0016]-[0018]).
Regarding Claim 6, Cully fails to expressly disclose the plunger tip and coating comprise a geometric coupling feature. However, Butts teaches coverings for syringe plunger tips (see Abstract) wherein the plunger tip and coating comprise a geometric coupling feature (“Ridges or detents 348 may protrude from the inner surface 344 for engaging features of the plunger tip 330 and for holding the covering 340 in position on the plunger tip 330 via, for example, a friction fit” [0032]; FIG. 3B). Therefore, it would have been obvious to modify the device of Cully according to Butts to ensure the attachment of the coating to the plunger tip ([0032]-[0034]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cully et al. in view of Nakamura et al. (US 20160243305 A1).
Regarding Claim 11, Cully discloses the plunger tip ("stopper 100" [0032]) but fails to expressly disclose the coating is covalently bonded to the portion of the external surface of the plunger tip. However, Nakamura teaches “a gasket body and a soft coating provided on a portion that comes into contact with the inner surface of the outer cylinder” (see Abstract) wherein the coating is covalently bonded to the portion of the external surface (“in order to improve strength of the coating layer itself and adhesive strength to the gasket body … establish a strong bond such as a covalent bond for the gasket body” [0062]). Therefore, it would have been obvious to modify the device of Cully according to Nakamura to obtain a coating that has “excellent smooth and flexible properties” ([0061]-[0062]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 5-6, 12-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 9 of U.S. Patent No. US 10653845 B2 in view of Cully et al. (US 20210146054 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of U.S. Patent No. US 10653845 B2 in view of Cully discloses at least all features of instant independent claims 1 and 13.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781