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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1/9/25;11/21/25 are in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDSs are being considered by the Examiner.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 12, 17, 25-31, 33-38 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by McCawley et al. (12,714,793) (“McCawley”). McCawley discloses:
(claims 1,29,37) a housing 8; a container 73 disposed within the housing and configured to contain medicament; a plunger 50 slidably disposed within the container; a plunger rod configured to push the plunger through the container to dispense the medicament when the container contains medicament C4L55-C5L13; and a gas canister 40 configured to travel with the plunger rod and containing a compressed gas, wherein the gas canister is configured to release the compressed gas to drive the plunger rod to dispense the medicament out of a distal end of the container C12L12-C13L2.
Claims 29-31: C12L12-C13L2
Claim 37: needle 78
Claim 12: a button is configured to activate an element 60 configured to pierce the gas canister, wherein the gas canister is configured to release the compressed gas upon being pierced. C4L55-C6L9, C12L12-28
Claims 17,33: a needle 78 attached to a distal end of the container, Fig.7a
Claim 25: needle guard 79,86
Claims 26,34: vent hole 8d, Fig.4b
Claims 27,35: the gas canister 40 is attached to the plunger rod C4L57-61,C5L54-C6L10, Fig.7a,b
Claims 28,36: the gas canister is disposed within the plunger rod C4L57-61,C5L54-C6L10, Fig.7a,b
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 2-11, 19-24, 39-42 are rejected under 35 U.S.C. 103 as being unpatentable over McCawley.
McCawley discloses the device and method as substantially claimed but does not directly disclose the size of the medicament container (claims 2-6), the viscosity of the medicament delivered (claims 7-11), the gauge of the needle used (claims 19-21, 39-40), the length of the needle used (claims 22-24), the shape of needle (claim 41). The ranges within these limitations are obvious over McCawley because McCawley does teach delivery of viscous agents via a needle (C5L1-13). The specific limits are obvious design considerations that fail to distinguish over McCawley. C8L39-50
Claims 13-16, 18, 32 are rejected under 35 U.S.C. 103 as being unpatentable over McCawley in view of McCawley et al. (US 2025/0144298)(“McCawley ‘298”).
McCawley discloses the invention as substantially claimed, see above, but does not directly disclose an interlock configured to prevent the element from piercing the gas canister while the interlock is in a locked position. ‘298 McCawley, in the analogous art, teaches a safety feature to prevent unwanted firing. ‘298 McCawley teaches an interlock that flexes radially in and out of a housing cutout when the interlock is in the locked and unlocked positions, respectively [0035-0036][0088-0089][0079]. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add the interlock as taught by ‘298 McCawley to the other McCawley device for safety to a user and to prevent misfiring of the device.
With respect to claim 18, the interlock is configured to move to an unlocked position when the needle is attached to the medicament delivery device, see Figs. 9a-c of ‘298 McCawley.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 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 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.
/DEANNA K HALL/Primary Examiner, Art Unit 3783
Prosecution Insights