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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/06/2026 has been entered.
Status of Claims
This action is in response to Applicant’s amendment filed on 3/06/2025.
Claim 1 was previously canceled.
Claim 3 is canceled.
Claims 2, and 4-10 remain pending in the application.
Applicant’s amendments to the Claims have overcome each and 112(b) rejection previously set forth in the Final Office Action mailed 01/29/2025.
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.
Claims 2, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Limaye et al. (U.S. Patent Pub. 20130267904), hereinafter Limaye, in further view of Sanpietro et al. (U.S. Patent No. 5562626), hereinafter Sanpietro, in further view of Lum et al. (U.S. Patent Pub. 20100217206), hereinafter Lum, and further in view of Baldwin et al. (U.S. Patent No. 3941128), hereinafter Baldwin.
Regarding claim 2, Limaye discloses an injection system (syringe 100; see FIG. 1; the Examiner notes that all reference characters cited below refer to FIGS. 1-5 unless otherwise stated), comprising:
a molded body member (barrel 106; “providing a molded cylindrical barrel”, [0005) having a circumferentially continuous proximally facing retention ledge (“a tapered notch 128 on an outer surface of the barrel 106”, [0023]) at a distal end thereof (see FIG. 5); and
a needle hub assembly (needle hub 104) coupled to the retention ledge at the distal end of the molded body member (“When the tapered notch 128 is displaced adjacent to the recessed surface 122, the tapered notch 128 unbiases into the recessed surface 122 to fasten the needle hub 104 to the barrel 106. That is, the recessed surface 122 and the tapered notch 128 implement a latching mechanism to fix the needle hub 104 to the barrel 106.”, [0023]), the needle hub assembly comprising
a needle hub coupled to the retention ledge (see FIG. 5), and
a needle (needle 102) coupled to the needle hub (see FIG. 4), and
wherein the retention ledge is disposed completely within the needle hub (see FIG. 5). However, Limaye does not expressly state wherein the needle hub has a pair of latches disposed at a proximal end thereof and configured to interfere with the retention ledge to couple the needle hub to the retention ledge of the molded body member.
Sanpietro teaches a safety syringe having a sheath that automatically extends over the needle (Abstract) wherein the needle hub (needle hub assembly 16) has a pair of latches (locking tabs 68 of collar 66) disposed at a proximal end thereof (see FIGS. 1-2) and configured to interfere with the retention ledge (“tapered neck region 14 adapted to receive a conventional needle hub assembly 16”, Col 2 Lines 44-45) to couple the needle hub to the retention ledge of the molded body member (see FIG. 1).
It would have been obvious to one having ordinary skill in the art at the effective filing date to modify the needle hub of Limaye to include a pair of latches disposed at a proximal end thereof and configured to interfere with the retention ledge to couple the needle hub to the retention ledge of the molded body member. Doing so would allow for the prevention of movement and advancement of the syringe barrel and sheath, as taught by Sanpietro (see Col 4 Lines 33-48]).
However, Limaye in view of Sanpietro does not expressly state wherein the needle hub defines a pair of openings in a sidewall of the needle hub, and wherein each latch of the pair of latches is disposed in an opening of the pair of openings.
Lum teaches syringes having a snap-fit mechanism for attaching a needle hub to a syringe barrel (Abstract) wherein the needle hub (needle hub 120/124 with collar 130) defines a pair of openings in a sidewall of the needle hub (gap 138), and
wherein each latch of the pair of latches (arms 140) is disposed in an opening of the pair of openings (see FIG. 5).
It would have been obvious to one having ordinary skill in the art at the effective filing date to modify the needle hub of Limaye in view of Sanpietro to include a pair of openings in a sidewall of the needle hub, and wherein each latch of the pair of latches is disposed in an opening of the pair of openings. Doing so permits a snap-fit relationship between the needle hub and the barrel, without relative rotation, as taught by Lum (see [0043]).
However, Limaye in view of Sanpietro in view of Lum does not expressly state comprising a gasket disposed between the distal end of the molded body member and an inner surface of the needle hub, wherein the gasket is configured to prevent contaminants from moving from an exterior of the needle hub into an interior of the molded body member.
Baldwin teaches a fluid dispensing arrangement for injecting liquid parenteral drugs or other liquids (Abstract) further comprising a gasket (a suitable ring seal 33) disposed between the distal end of the molded body member (lip flange 27 of barrel 21) and an inner surface of the needle hub (hub flange 43f; see FIG. 3), wherein the gasket is configured to prevent contaminants from moving from an exterior of the needle hub into an interior of the molded body member (the Examiner notes a rubber O ring with a liquid tight seal (see Col 4 Lines 38-46) would prevent the travel of fluid and therefor the contaminants in said fluid).
It would have been obvious to one having ordinary skill in the art at the effective filing date to modify the device of Limaye in view of Sanpietro in view of Lum to include a gasket disposed between the distal end of the molded body member and an inner surface of the needle hub wherein the gasket is configured to prevent contaminants from moving from an exterior of the needle hub into an interior of the molded body member. Doing so would allow for creation of a liquid tight seal connection between the barrel and the needle hub, as taught by Baldwin (see Col 4 Lines 38-46).
Regarding claim 9, Limaye in view of Sanpietro in view of Lum in view of Baldwin teaches the claimed invention as discussed above concerning the rejection of claim 2, and Sanpietro further teaches wherein the pair of latches are configured to deflect circumferentially outward to allow the pair of latches to pass over the circumferentially continuous proximally facing retention ledge (see outward deflection of tabs 66 in FIG. 1; “locking tabs 68 are hinged to the expansion collar 66 and are capable of flaring outwardly away from the expansion collar 66 when biased away from the needle hub assembly 16.”, Col 4 Lines 1-4).
Regarding claim 10, Limaye in view of Sanpietro in view of Lum in view of Baldwin teaches the claimed invention as discussed above concerning the rejection of claim 2, and Lum further teaches wherein the pair of latches (arms 140) are each flexible radially (See FIG. 5).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Limaye et al. ( U.S. Patent Pub. 20130267904), hereinafter Limaye, in further view of Sanpietro et al. (U.S. Patent No. 5562626), hereinafter Sanpietro, in further view of Lum et al. (U.S. Patent Pub. 20100217206), hereinafter Lum, further in view of Baldwin et al. (U.S. Patent No. 3941128), hereinafter Baldwin, and further in view of Gupta et al. (U.S. Patent Pub. 20150045731), hereinafter Gupta.
Regarding claim 4, Limaye in view of Sanpietro in view of Lum in view of Baldwin teaches the claimed invention as discussed above concerning the rejection of claim 2, however, Limaye in view of Sanpietro in view of Lum in view of Baldwin does not expressly state wherein the body member is molded from Cyclic Olefin Copolymer or Cyclic Olefin Polymer.
Gupta teaches syringe distal connectors that facilitate mounting of a luer assembly to pre-formed resilient syringe barrel (see [0007]) wherein the body member is molded from Cyclic Olefin Copolymer or Cyclic Olefin Polymer (“the term "glass" should be understood to include other similarly non-reactive materials suitable for use in a pharmaceutical grade application that would normally require glass (e.g., Type I borosilicate glass), including but not limited to certain non-reactive polymers such as cyclic olefin copolymers (COC) and cyclic olefin polymers (COP)”, [0024]; pre-formed resilient syringe barrel, such as, for example, a straight, glass barrel [0007]).
It would have been obvious to one having ordinary skill in the art at the effective filing date to modify the body member of Limaye in view of Sanpietro in view of Lum in view of Baldwin to be molded from Cyclic Olefin Copolymer or Cyclic Olefin Polymer. Doing so would make the device more suitable for use in a pharmaceutical grade application and not readily susceptible to leaching or gas migration under ambient temperature and pressure, as taught by Gupta (see [0024-0025]).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Limaye et al.( U.S. Patent Pub. 20130267904), hereinafter Limaye, and further in view of Diaz et al. (U.S. Patent Pub. 20190374716), hereinafter Diaz
Regarding claim 5, Limaye discloses an injection system (syringe 100; see FIG. 1; the Examiner notes that all reference characters cited below refer to FIGS. 1-5 unless otherwise stated), comprising:
a molded body member (barrel 106; “providing a molded cylindrical barrel”, [0005) having a needle coupling member (“a tapered notch 128 on an outer surface of the barrel 106”, [0023]) at a distal end thereof (see FIG. 5); and
a needle hub assembly (needle hub 104 ) coupled to the needle coupling member at the distal end of the molded body member (“When the tapered notch 128 is displaced adjacent to the recessed surface 122, the tapered notch 128 unbiases into the recessed surface 122 to fasten the needle hub 104 to the barrel 106. That is, the recessed surface 122 and the tapered notch 128 implement a latching mechanism to fix the needle hub 104 to the barrel 106.”, [0023]), the needle hub assembly comprising
a needle hub coupled to the needle coupling member (see FIG. 5), and
a needle (needle 102) coupled to the needle hub (see FIG. 4), and
wherein the needle hub has a retaining ring (flange 116) disposed inside of a proximal end thereof (see FIGS. 4-5),
wherein an interior surface of the retaining ring is configured to couple the needle hub to an exterior surface of the needle coupling member of the molded body member (“recessed surface 122 and the tapered notch 128 implement a latching mechanism to fix the needle hub 104 to the barrel 106.”, [0023]), and
wherein the retaining ring is disposed completely within the needle hub (see FIG. 5), and
wherein the needle hub defines a side opening in a sidewall thereof (recessed surface 122),
wherein the retaining ring is disposed in the side opening (see FIG. 5). However, Limaye does not expressly state wherein the side opening defines a path through the needle hub from an interior of the needle hub and an exterior of the needle hub.
Diaz teaches wherein the side opening defines a path through the needle hub from an interior of the needle hub and an exterior of the needle hub (see openings 985 and 980).
It would have been obvious to one having ordinary skill in the art at the effective filing date to modify the device of Limaye and Diaz to include side opening defining a path through the needle hub from an interior of the needle hub and an exterior of the needle hub. Doing so allows for the first liquid in the distal chamber to be able to exit the injections system, as taught by Diaz (see [0113]).
Regarding claim 6, Limaye in view of Diaz teaches the claimed invention as discussed above concerning the rejection of claim 5, however, Limaye in view of Diaz does not expressly state wherein the retaining ring comprises a plurality of teeth configured to flex to allow passage of the needle coupling member in a distal direction and to dig into the needle coupling member to prevent movement in a proximal direction.
Sanpietro teaches a safety syringe having a sheath that automatically extends over the needle (Abstract) wherein the retaining ring (collar 66) comprises a plurality of teeth (locking tabs 68) configured to flex to allow passage of the needle coupling member in a distal direction and to dig into the needle coupling member to prevent movement in a proximal direction (Col 3 Lines 59-67 – Col 4, Lines 1-4).
It would have been obvious to one having ordinary skill in the art at the effective filing date to modify the retaining ring of Limaye in view of Diaz to include a plurality of flexible teeth. Doing so would allow for the prevention of movement and advancement of the syringe barrel and sheath, as taught by Sanpietro (see Col 4 Lines 33-48]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Limaye et al.( U.S. Patent Pub. 20130267904), hereinafter Limaye, further in view of Diaz et al. (U.S. Patent Pub. 20190374716), hereinafter Diaz, and further in view of Baldwin et al. (U.S. Patent No. 3941128), hereinafter Baldwin.
Regarding claim 7, Limaye in view of Diaz teaches the claimed invention as discussed above concerning the rejection of claim 5, however, Limaye in view of Diaz does not expressly state comprising a gasket disposed between the distal end of the molded body member and an inner surface of the needle hub.
Baldwin teaches a fluid dispensing arrangement for injecting liquid parenteral drugs or other liquids (Abstract) further comprising a gasket (a suitable ring seal 33) disposed between the distal end of the molded body member (lip flange 27 of barrel 21) and an inner surface of the needle hub (hub flange 43f; see FIG. 3).
It would have been obvious to one having ordinary skill in the art at the effective filing date to modify the device of Limaye in view of Diazto include a gasket disposed between the distal end of the molded body member and an inner surface of the needle hub. Doing so would allow for creation of a liquid tight seal connection between the barrel and the needle hub, as taught by Baldwin (see Col 4 Lines 38-46]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Limaye et al. ( U.S. Patent Pub. 20130267904), hereinafter Limaye, in further view of Diaz et al. (U.S. Patent Pub. 20190374716), hereinafter Diaz, in further in view of Gupta et al. (U.S. Patent Pub. 20150045731), hereinafter Gupta.
Regarding claim 8, Limaye discloses the claimed invention as discussed above concerning the rejection of claim 5, however, Limaye in view of Diaz does not expressly state wherein the body member is molded from Cyclic Olefin Copolymer or Cyclic Olefin Polymer.
Gupta teaches syringe distal connectors that facilitate mounting of a luer assembly to pre-formed resilient syringe barrel (see [0007]) wherein the body member is molded from Cyclic Olefin Copolymer or Cyclic Olefin Polymer (“the term "glass" should be understood to include other similarly non-reactive materials suitable for use in a pharmaceutical grade application that would normally require glass (e.g., Type I borosilicate glass), including but not limited to certain non-reactive polymers such as cyclic olefin copolymers (COC) and cyclic olefin polymers (COP)”, [0024]; pre-formed resilient syringe barrel, such as, for example, a straight, glass barrel [0007]).
It would have been obvious to one having ordinary skill in the art at the effective filing date to modify the body member of Limaye in view of Diaz to be molded from Cyclic Olefin Copolymer or Cyclic Olefin Polymer. Doing so would make the device more suitable for use in a pharmaceutical grade application and not readily susceptible to leaching or gas migration under ambient temperature and pressure, as taught by Gupta (see [0024-0025]).
Response to Arguments
Applicant’s arguments, see Remarks filed 3/06/2026, with respect to the rejection(s) of claim(s) 2-9 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Limaye (U.S. Patent Pub. 20130267904), in further view of Sanpietro (U.S. Patent No. 5562626), in further view of Lum (U.S. Patent Pub. 20100217206), and further in view of Baldwin (U.S. Patent No. 3941128).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (571) 272-5452. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
04/04/2025
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783