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 .
Status of Claims
The claims filed 07/03/2024 have been entered. Claims 1-5 are pending in the application.
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 1-5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the operation" in 7. There is insufficient antecedent basis for this limitation in the claim. For the sake of examination, the limitation will be in interpreted as “an operation”.
Claims 2-5 are rejected as depending from a rejected claim.
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)(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 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Destefano (US 2018/0021508).
Regarding Claim 1, Destefano discloses a drug injection device (10, Fig 1A) comprising: a base (2252, Fig 14A) having an opening (2252E, Fig 14A); a housing (12, Fig 1A) disposed above the base (See Figs 1A-1C); a patch (2270, Fig 14A) mounted on the base to cover the opening (Para 0125); and a needle assembly mounted on the housing and including a needle (2214, Fig 14A) and a cannula (2260, Fig 14A); wherein an end of the cannula is inserted into the patch to position the cannula and is supported on patch, before an operation of the needle assembly (See Fig 14B wherein the cannula is supported on the patch 2270 before the operation of withdrawing occurs. The claim language does not specify what operation of the needle assembly the cannula must be inserted into the patch before).
Regarding Claim 2, Destefano discloses a center portion of the patch is configured to cover the opening, and an edge portion of the patch is configured to be fixed on the base (Para 0125; See Fig 14A).
Regarding Claim 3, Destefano discloses an attachment portion (“adhesive patch”) disposed below the base (Para 0147), and wherein the end of the cannula is to be inside of the opening and above the attachment portion (See Fig 14A).
Regarding Claim 4, Destefano discloses the needle assembly further comprises: a first holder (2212, Fig 14A) supporting the needle; a second holder (flange portion comprising septum 2280, Fig 16B) disposed on one side of the first holder and supporting the cannula (See Fig 14A); and an elastic member (2218, Fig 14B) connected to the first holder, wherein, when the elastic member is expanded, the first holder and the second holder are moved to an extended position (See Fig 14B), and the cannula and the needle are moved through the attachment portion (Para 0125).
Regarding Claim 5, Destefano discloses the elastic member (2218, Fig 14C) is contracted, only the first holder and the needle are returned to an original position, and the second holder is supported by the patch (Para 0126, See Fig 14C).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 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.
/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights