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 .
Acknowledgments
In the reply, filed on March 6, 2026, Applicant amended claims 26 and 43.
Applicant cancelled claims 44-46.
Applicant added new claims 47-53.
In the non-final rejection of December 10, 2025, Examiner objected to claim 43. Applicant amended claim 43. Objection is withdrawn.
Currently, claims 26-30, 33-43, and 47-53 are under examination.
Claim Objections
Claims 43 and 48 are objected to because of the following informalities:
In regards to claim 43, line 13, “a plunger rod” should be changed to “the plunger rod”.
In regards to claim 48, line 1, “width” should be changed to “a width”.
In regards to claim 48, line 2, “width” should be changed to “the width”.
Appropriate correction is required.
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.
Claims 43 and 49-53 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kalitzki et al (US 2014/187779).
In regards to claim 43, Kalitzki et al teaches a packaging assembly (Figures 1a-1c) comprising:
a syringe having a barrel, a flange, and a plunger rod (Figure 1a)
a backstop configured to be coupled with the syringe adjacent to the flange (Figure 1a)
a packaging configured to receive an entire length of the syringe coupled with the backstop (Figures 1b-1c), the packaging comprising:
a first set of support walls and a second set of support walls configured to receive and support the barrel of the syringe (Figures 1b-1c)
a raised wall section comprising opposing side walls configured to receive and support a plunger rod of the syringe, and a wall extending generally perpendicular to the opposing side walls and configured to receive an end of the plunger rod to prevent and/or restrict movement of the plunger rod within the packaging (Figures 1b-1c)
In regards to claim 49, Kalitzki et al teaches wherein the syringe is a pre-filled syringe (Title) containing a medicament (medicinal products).
In regards to claim 50, Kalitzki et al teaches wherein the medicament comprises a VEGF antagonist (aflibercept).
In regards to claim 51, Kalitzki et al teaches wherein the VEGF antagonist comprises a non-antibody VEGF antagonist (aflibercept).
In regards to claim 52, Kalitzki et al teaches wherein the VEGF antagonist comprises a VEGF-Trap (aflibercept).
In regards to claim 53, Kalitzki et al teaches wherein the VEGF-Trap comprises an aflibercept (aflibercept).
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 26-30, 33-36, 38-42, and 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over Sigg et al (US 2014/0012227), and further in view of Lee (US 4,664,128).
In regards to claim 26, Sigg et al teaches an injection device (Figures 1-5) comprising:
a syringe (1) having a barrel (2) having a proximal open end and a distal end, a flange (28), and a plunger rod (26) having a lock ring (32) (paragraph [0060]: rod shoulder 32 is substantially disc, or ring, shaped)
a backstop (6) configured to be coupled with the syringe adjacent to the flange, the backstop having an opening configured to permit the plunger rod to extend through the backstop (Figure 2) and a collar portion defining an inner surface extending around at least a portion of the barrel of the syringe when the backstop is coupled with the syringe (Figure 2)
wherein the opening of the backstop is configured to permit movement of the plunger rod in a proximal direction until the lock ring abuts or engages a surface (34) defining the opening (paragraph [0060]: The shoulders 32, 34 are configured to cooperate to substantially prevent movement of the rod 26 away from the outlet end 14 when the backstop shoulder 34 and rod shoulder 32 are in contact. The backstop shoulder 34 extends from outside the bore radius to a radius less than the rod shoulder radius so that the rod shoulder 32 cannot pass the backstop shoulder 34 by moving along the first axis A)
Sigg et al is silent about wherein the inner surface includes a plurality of protrusions extending away from the inner surface, and wherein, upon coupling the syringe with the backstop, the plurality of protrusions are configured to engage the barrel to create a space between the barrel and the inner surface and to permit or promote airflow through the space. Lee teaches an injection device (Figures 3-5 and 7) wherein an inner surface includes a plurality of protrusions (25) extending away from the inner surface, and wherein, upon coupling a syringe (12/18/13) with a backstop (21), the plurality of protrusions are configured to engage a barrel (12) to create a space between the barrel and the inner surface and to permit or promote airflow through the space (Figure 7). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the inner surface, of the device of Sigg et al, to include a plurality of protrusions, as taught by Lee, as such will compress the barrel wall, thereby providing for tighter frictional engagement between the backstop and the external wall of the barrel (column 5, lines 24-27).
In regards to claim 27, in the modified device of Sigg et al and Lee, Sigg et al is silent about wherein the plurality of protrusions include at least two protrusions. Lee teaches wherein the plurality of protrusions include at least two protrusions (25). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of protrusions, of the modified device of Sigg et al and Lee, to include at least two protrusions, as taught by Lee, as such will compress the barrel wall, thereby providing for tighter frictional engagement between the backstop and the external wall of the barrel (column 5, lines 24-27).
In regards to claim 28, in the modified device of Sigg et al and Lee, Sigg et al is silent about wherein the plurality of protrusions include at least three protrusions. Lee teaches wherein the plurality of protrusions include at least three protrusions (25). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of protrusions, of the modified device of Sigg et al and Lee, to include at least three protrusions, as taught by Lee, as such will compress the barrel wall, thereby providing for tighter frictional engagement between the backstop and the external wall of the barrel (column 5, lines 24-27).
In regards to claim 29, in the modified device of Sigg et al and Lee, Sigg et al is silent about wherein the plurality of protrusions include at least four protrusions. Lee teaches wherein the plurality of protrusions include at least four protrusions (25). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of protrusions, of the modified device of Sigg et al and Lee, to include at least four protrusions, as taught by Lee, as such will compress the barrel wall, thereby providing for tighter frictional engagement between the backstop and the external wall of the barrel (column 5, lines 24-27).
In regards to claim 30, in the modified device of Sigg et al and Lee, Sigg et al is silent about wherein the plurality of protrusions include at least five protrusions. Lee teaches wherein the plurality of protrusions include at least five protrusions (25). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of protrusions, of the modified device of Sigg et al and Lee, to include at least five protrusions, as taught by Lee, as such will compress the barrel wall, thereby providing for tighter frictional engagement between the backstop and the external wall of the barrel (column 5, lines 24-27).
In regards to claim 33, in the modified device of Sigg et al and Lee, Sigg et al teaches wherein the collar portion is configured to engage the syringe in a snap-fit relationship (Figure 2).
In regards to claim 34, in the modified device of Sigg et al and Lee, Sigg et al teaches wherein the barrel defines an axis (Figures 1-2); however, Sigg et al is silent about the plurality of protrusions are ribs extending generally parallel with the axis. Lee teaches wherein the barrel defines an axis and the plurality of protrusions are ribs (25) extending generally parallel with the axis (Figure 7). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of protrusions, of the modified device of Sigg et al and Lee, to be ribs, as taught by Lee, as such will compress the barrel wall, thereby providing for tighter frictional engagement between the backstop and the external wall of the barrel (column 5, lines 24-27).
In regards to claim 35, in the modified device of Sigg et al and Lee, Sigg et al teaches wherein the backstop further includes a cavity configured to receive at least a portion of the flange of the syringe in the cavity, and wherein the cavity is defined by opposing surfaces (Figure 2).
In regards to claim 36, in the modified device of Sigg et al and Lee, Sigg et al teaches wherein the opposing surfaces include an upper opposing surface and a lower opposing surface (Figure 2).
In regards to claim 38, in the modified device of Sigg et al and Lee, Sigg et al teaches wherein the syringe is a pre-filled syringe (1) containing a medicament (20).
In regards to claim 39, in the modified device of Sigg et al and Lee, Sigg et al teaches wherein the medicament comprises a VEGF antagonist (paragraph [0043]).
In regards to claim 40, in the modified device of Sigg et al and Lee, Sigg et al teaches wherein the VEGF antagonist comprises a non-antibody VEGF antagonist (paragraph [0043]).
In regards to claim 41, in the modified device of Sigg et al and Lee, Sigg et al teaches wherein the VEGF antagonist comprises a VEGF-Trap (paragraph [0032]).
In regards to claim 42, in the modified device of Sigg et al and Lee, Sigg et al teaches wherein the VEGF-Trap comprises an aflibercept (paragraph [0032]).
In regards to claim 47, in the modified device of Sigg et al and Lee, Sigg et al teaches wherein a diameter of the lock ring is larger than a diameter of the plunger rod (Figure 2).
In regards to claim 48, in the modified device of Sigg et al and Lee, Sigg et al teaches wherein a diameter or width of the opening of the backstop is greater than the diameter of the plunger rod (Figure 2), and wherein the diameter or width of the opening of the backstop is smaller than the diameter of the lock ring (Figure 2)(paragraph [0060]).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Sigg et al and Lee, as applied to claim 36 above, and further in view of Blomquist (US 2012/0041388) and Dugand et al (US 2013/0053788).
In regards to claim 37, in the modified device of Sigg et al and Lee, Sigg et al does not teach wherein the upper opposing surface includes at least one protrusion extending into the cavity, and wherein the lower opposing surface includes at least one protrusion extending into the cavity. Blomquist teaches an injection device (Figures 1-8) wherein an upper opposing surface includes at least one protrusion (120) extending into a cavity (118) (Figure 6A). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the upper opposing surface, of the modified device of Sigg et al and Lee, to include at least one protrusion extending into the cavity, as such will ensure a snug fit of the syringe (paragraph [0045]). Further, Dugand et al teaches an injection device (Figures 1A-2B, with the extender member 42 of Figure 3 instead of the extender member 42 of Figures 1A-2B) wherein a lower opposing surface includes at least one protrusion (48’) extending into a cavity (Figure 3). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the lower opposing surface, of the modified device of Sigg et al, Lee, and Blomquist, to include at least one protrusion extending into the cavity, as taught by Dugand et al, as such will allow for snap-fastening the backstop to the flange (paragraph [0023]) with improved appearance by not projecting beyond the proximal surface of the wall of the backstop (paragraph [0056]).
Response to Arguments
Applicant’s arguments with respect to claims 26-30, 33-43, and 47-53 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In regards to claim 26, Applicant argued: The Office cites Sigg as allegedly disclosing "a backstop (backstop 6) further includ[ing] a cavity (cavity of sandwich portion 30 which receives flange 28) configured to receive at least a portion of a flange (28) of a syringe (syringe 1) in the cavity, and wherein the cavity is defined by opposing surfaces." Office Action at 5-6. Even assuming the Office's characterizations of Sigg are correct, which Applicant does not concede, Sigg fails to remedy the deficiencies of Lee and Ruddocks. That is, Sigg also fails to disclose or suggest the above-quoted features of amended claim 26. Indeed, the Office Action does not suggest otherwise (Remarks, page 11). Examiner disagrees. In the new grounds of rejection under Sigg et al and Lee, Sigg et al teaches a syringe (1) having a barrel (2) having a proximal open end and a distal end, a flange (28), and a plunger rod (26) having a lock ring (32) (paragraph [0060]: rod shoulder 32 is substantially disc, or ring, shaped), a backstop (6) configured to be coupled with the syringe adjacent to the flange, the backstop having an opening configured to permit the plunger rod to extend through the backstop (Figure 2) and a collar portion defining an inner surface extending around at least a portion of the barrel of the syringe when the backstop is coupled with the syringe (Figure 2), wherein the opening of the backstop is configured to permit movement of the plunger rod in a proximal direction until the lock ring abuts or engages a surface (34) defining the opening (paragraph [0060]: The shoulders 32, 34 are configured to cooperate to substantially prevent movement of the rod 26 away from the outlet end 14 when the backstop shoulder 34 and rod shoulder 32 are in contact. The backstop shoulder 34 extends from outside the bore radius to a radius less than the rod shoulder radius so that the rod shoulder 32 cannot pass the backstop shoulder 34 by moving along the first axis A).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEFALI D PATEL whose telephone number is (571)270-3645. The examiner can normally be reached Monday-Friday 8:30am-4:30pm 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 C 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
Prosecution Insights