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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 36-37 recites the limitation "the seal" in line 1, it is not clear if the seal is the first or the second seal or both seals. There is insufficient antecedent basis for this limitation in the claim. For examining purposes “the seal” is interpreted as “the second seal”.
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) 18-21, 23-32 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowe et al. (WO 2017009640) hereinafter Cowe in view of Karlsson et al. (WO 2014/076225) hereinafter Karlsson.
Claim 18, Cowe teaches medicament delivery device sub-assembly comprising:
an injection needle assembly (Figure 17A-2), a cartridge (1002) and a seal (1157),
the injection needle assembly (1011) having opposite distal and proximal ends, the injection needle assembly comprising:
a retainer member (1014) configured to be connectable to the cartridge;
a hub (1156) configured to be coaxially displaceable within the retainer member and provided with an injection needle (1154/1110) having proximal and distal pointed ends;
a cap member (1160) interactively connected to both the hub and to the retainer member; and
Cowe fails to teach a sealing member arranged between said cap member and said retainer member for preventing contamination of said injection needle before use, wherein the seal seals a gap between the injection needle assembly and the cartridge. Karlsson teaches an elastic sealing member (56) arranged between a cap member (12) and said retainer member (18) for preventing contamination of said injection needle before use, wherein the seal seals a gap between the injection needle assembly and the cartridge (Refer to page 9, lines 1-5), the sealing member is ring shaped (See Figure 2).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to include a seal in the device of Cowe between the cap and retainer member of Cowe as taught by Karlsson to protect the medication from contamination, (See page 6 lines 20-25, Karlsson).
Claim 19, Cowe teaches the seal (1157) is ring-shaped (see Figure 17a).
Claim 20, Cowe teaches the seal (1157) comprises a central passage (see Fig 17a).
Claim 21, Cowe teaches the seal is made of an elastic material (page 6, lines 1-2).
Claim 23, Cowe teaches wherein the seal is an O-ring (see page 31, lines 15-20).
Regarding Claim 24, modified Cowe fails to explicitly teach wherein the seal is a pad. However, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to substitute any art-recognized o-ring seal for a pad seal, as the specification expressly teaches that multiple forms of seals may be used in various positions without affecting the function of the device (see page 13, lines 13-20 of the current specification). The selection of a specific seal from among known, functionally equivalent alternatives (such as O-rings, pads, or extensions) would have been a routine design choice, motivated by considerations such as material availability, cost, manufacturability, or user preference.
Claim 25, Cowe teaches a transversal extending wall (1017) of the injection needle assembly, wherein the transversal extending wall is between the cartridge and the injection needle (See Figure 17A).
Claim 26, Cowe teaches the seal (1157) is a distally extending extension of a transversal extending wall of the injection needle assembly, wherein the transversal extending wall is between the cartridge and the injection needle (see Figure 17a).
Claim 27, Cowe teaches the seal (1157) is in the gap between the injection needle assembly and one or more of a cylindrical portion of the cartridge, a shoulder of the cartridge, a neck of the cartridge, a head of the cartridge, a membrane of the cartridge and a crimp of the cartridge (see Figure 17a).
Claim 28, Cowe teaches the seal is in the gap between the cartridge and one or more of a transversal extending wall of the injection needle assembly and a distal tubular part of the injection needle assembly (see Figure 17a).
Claim 29, modified Cowe teaches wherein said sealing member comprises an elastic member (see page 8, lines 29-30 of Karlsson).
Claim 30, modified Cowe teaches said sealing member is generally ring-shaped, (see Figure 2 of Karlsson).
Claim 31, modified Cowe teaches the seal (1157) seals a gap between the retainer member (1014) of the injection needle assembly and the cartridge (1002).
Claim 32, modified Cowe teaches a medicament delivery device comprising a medicament delivery device sub-assembly according to claim 18 (see Figure 17A-17B).
Claim 34, modified Cowe teaches a method of assembly of a medicament delivery device sub- assembly, the method comprising the steps of:
providing an injection needle assembly as described in claim 18; providing a cartridge (1002);
and assembling the cartridge and the injection needle assembly together with a seal in a sterile environment, so that the seal isolates a sterile volume between the cartridge and the injection needle assembly (see Figure 17a).
Claim(s) 35-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karlsson et al. (WO 2014/076225) hereinafter Karlsson in view of Cowe et al. (WO 2017009640) hereinafter Cowe.
Claim 35, Karlsson teaches a sub-assembly for use in a medicament delivery device, where the sub-assembly comprises:
a retainer (18);
a hub (32) comprising a double ended injection needle (38), where the hub is operatively engaged with the retainer such that the hub moves axially relative to the retainer and the cartridge when a cap (12) enclosing the injection needle is removed from the retainer; and
a second seal (56) arranged between the cap and the retainer (18) that prevents contamination of the injection needle before use when the cap is attached to the retainer.
Karlsson fails to explicitly teach a cartridge containing medicament that is engaged with an inside portion of the retainer, and a first seal operatively engaged with both the inside portion of the retainer and with an outside portion of the cartridge.
Cowe teaches a cartridge (1002) containing medicament (lines 11-22, page 30) connected to a needle hub (1155/1156, Figs 17a-b) and a needle (110/1154) and a first seal (1028/1157) operatively engaged with both the inside portion of the retainer and with an outside portion of the cartridge.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to include a cartridge in the proximal end of the retainer and a seal in the device of Karlsson as taught by Cowe, to deliver a medicament with the device and the seal to protect the medication from spilling and maintain it sterile before use.
Claim 36, modified Karlsson teaches the seal (56) is ring-shaped, comprises a central passage and is made of an elastic material (see page 8, lines 29-30)
Claim 37, modified Karlsson teaches the seal (56) is in the gap between the cartridge and one or more of a transversal extending wall of the retainer and a distal tubular part of the retainer (See Figure 2), and wherein the sealing member comprises an elastic member and is generally ring-shaped (refer to page 8, lines 29-30).
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowe et al. (WO 2017009640) hereinafter Cowe in view of Karlsson et al. (WO 2014/076225) hereinafter Karlsson, as applied to claim 18, and further in view of Giambattista et al. (US 2011/0125106) hereinafter Giambttista.
Regarding Claim 33, modified Cowe fails to explicitly teach the medicament delivery device is an autoinjector. Giambatista teaches a medicament delivery device subassembly, for an auto injector (See Figs 2-4, Refer to paragraph [0029]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the needle assembly of modified Cowe in an autoinjector as taught by Giambatista, to deliver a medicament with the device while maintaining the medicament sealed.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowe et al. (WO 2017009640) hereinafter Cowe in view of Karlsson et al. (WO 2014/076225) hereinafter Karlsson, as applied to claim 18, and further in view of SAKAI ET AL. (JP 05277187 A) hereinafter Sakai.
Regarding Claim 22, modified Cowe fails to explicitly teach the seal is made of a thermoplastic elastomer. Sakai teaches a thermoplastic O-ring (5 “The O-ring 5 is formed of a lubricating rubber composed of a thermoplastic fluororesin as a first essential component, a fluororubber as a second essential component, and a low molecular weight fluoropolymer as a third essential component”) for use in a medicament delivery device.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use a thermoplastic elastomer as the material of the O-ring seal of modified Cowe, as taught by Sakai to form a seal in the needle assembly.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDELMIRA BOSQUES whose telephone number is (571)270-5614. The examiner can normally be reached 9:00am-5:00pm M-F.
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, Edelmira Bosques can be reached at 571-270-5614 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.
EDELMIRA BOSQUES
Supervisory Patent Examiner
Art Unit 3762
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772
Prosecution Insights