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 II (Claims 1-3, 6-8, 10, and 12-14) in the reply filed on 24 June 2026 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) 1-3 and 7-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2017/0354789 (“Bendek”).
Regarding Claim 1, Bendek discloses an injection device (1) comprising:
a medicament container (11) including a needle (13);
a needle shield (15); and
a cap (5) comprising a needle shield remover (9), the needle shield remover comprising at least one flexible elongate member (9a), the elongate member being provided with a gripping member (9f) configured to engage a needle shield (see Fig. 4b), and
wherein the injection device is configured such that when the medicament container is in the device (see Fig. 4b) the gripping member is positioned proximal to the needle shield (see Fig. 4b – Par. 65, re: “The medicament delivery member shield grippers 9f extend beyond the distal edge of the medicament delivery member shield”, wherein Bendek references the “distal” direction to refer to the “proximal” direction in the instant application).
Regarding Claim 2, Bendek discloses the needle shield remover comprises a pair of flexible elongate members (e.g. 9a, 9b);
each elongate member being provided with a gripping member (9f) configured to engage a needle shield (see Fig. 4b).
Regarding Claim 3, Bendek discloses the pair of elongate members form an opposing pair (see Fig. 4b).
Regarding Claim 7, Bendek discloses the needle shield remover is formed from a metal (Par. 17).
Regarding Claim 8, Bendek discloses the gripping member comprises a portion that is bent inwardly (see Fig. 4b; see also Fig. 2).
Claim(s) 1-3, 6, 10, and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2009/040603 (“Abry”)
Regarding Claim 1, Abry discloses an injection device (1) comprising:
a medicament container (50) including a needle (see Fig. 28 – not labeled);
a needle shield (2); and
a cap (8) comprising a needle shield remover (33), the needle shield remover comprising at least one flexible elongate member (see Fig. 27 – not labled, see the interior arms which engage the shield), the elongate member being provided with a gripping member (see the proximal end of the elongate member) configured to engage a needle shield (see Fig. 26-28 in series), and
wherein the injection device is configured such that when the medicament container is in the device the gripping member is positioned proximal to the needle shield (see Fig. 26).
Regarding Claim 2, Abry discloses the needle shield remover comprises a pair of flexible elongate members (see Fig. 26);
each elongate member being provided with a gripping member configured to engage a needle shield (see Figs. 26-28).
Regarding Claim 3, Abry discloses the pair of elongate members form an opposing pair (see Fig. 26).
Regarding Claim 6, Abry discloses the elongate member (37) is provided with a second gripping member in a distal part of the member configured to engage with a cap (see at 36).
Regarding Claim 10, Abry discloses the cap comprises an end wall (see the distal end) and an outer wall (26) that extends proximally from the end wall;
the end wall including an aperture (see where 37 is received) to allow the needle shield remover to be inserted into the cap (i.e. the needle shield remover is inserted through the aperture such that 37 is retained within the aperture).
Regarding Claim 12, Abry discloses the cap further comprises a portion (36, 37, 38) to insert into the aperture to prevent distal movement of the needle shield remover.
Regarding Claim 13, Abry discloses the cap is provided with a corresponding aperture to receive the second gripping member (see Fig. 26).
Claim(s) 1-3, 6, 10, 13, 14, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2012/0191047 (“Raday”).
Regarding Claim 1, Raday discloses an injection device (1000) comprising:
a medicament container (1041) including a needle (1044);
a needle shield (1048); and
a cap (1038, 1040) comprising a needle shield remover (1040), the needle shield remover comprising at least one flexible elongate member (1110), the elongate member being provided with a gripping member (1118) configured to engage a needle shield (see Fig. 5B), and
wherein the injection device is configured such that when the medicament container is in the device the gripping member is positioned proximal to the needle shield (see Fig. 5B).
Regarding Claim 2, Raday discloses the needle shield remover comprises a pair of flexible elongate members (see Fig. 3B);
each elongate member being provided with a gripping member configured to engage a needle shield (see Fig. 3B).
Regarding Claim 3, Raday discloses the pair of elongate members form an opposing pair (see Fig. 3B).
Regarding Claim 6, Raday disclose the elongate member is provided with a second gripping member (1138, 1132) in a distal part of the member configured to engage with a cap (Par. 68).
Regarding Claim 10, Raday discloses the cap comprises an end wall (see Fig. 1) and an outer wall (1039) that extends proximally from the end wall (see Fig. 1);
the end wall including an aperture (1220, 1222) to allow the needle shield remover to be inserted into the cap (Par. 68).
Regarding Claim 13, Raday discloses the cap is provided with a corresponding aperture (1222) to receive the second gripping member (Par. 68).
Regarding Claim 14, Raday discloses the cap further comprises an inner wall (121) that extends proximally from the end wall (see Fig. 2C);
the flexible elongate member being disposed along an outer surface of the inner wall (see Fig. 2C).
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.
Claim(s) 10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0354789 (“Bendek”) as applied above, and further in view of WO 2018/197559 (“Plevnik”).
Regarding Claim 10 and 12, Bendek discloses the cap comprises an end wall (i.e. the distal end; generally 7d) and an outer wall (7c) which extend proximally from the end wall. Bendek discloses the invention substantially as claimed except that that the end wall comprises an “aperture to allow the needle shield remover to be inserted into the cap”. However, Plevnik discloses a similar cap and shield gripper (Fig. 3A) wherein the device comprises a cap (40) with an end wall (46) and an outer wall (48) which extend proximally therefrom, the end wall including an aperture (see Fig. 3B) to allow the needle shield remover (56) to be inserted into the cap during assembly, the cap further comprising a portion (54) to insert into the aperture to prevent distal movement of the needle shield remover once assembled (see Fig. 4). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the device of Bendek to comprise a removable insert portion exposing an aperture through which the shield gripper may be inserted during assembly, as disclosed by Plevnik, to make it easier to assemble the device (Pg. 3 – Plevnik).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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.
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.
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 08/20/2026
Prosecution Insights