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 .
Response to Amendment
This office action is responsive to the preliminary amendment filed on 05/20/2022. As directed by the amendment: claims 1, 3, 4, and 6 – 15 have been amended. Thus, claims 1 – 15 are presently pending in this application.
Claim Objections
Claim 1 is objected to because of the following informalities:
“protuding” in claim 1 line 8 should read “protruding”
Appropriate correction is required.
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.
Claim(s) 1 – 15 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 “wherein said first position is proximal to said injection end and said second position is distal from said injection end” as seen lines 20 - 21. However, it is unclear where precisely is “the injection end” and what position would be “proximal to” or “distal from” the injection end as claimed. Applicant is advised to amend the claims to clearly define the injection end, the first position and the second position in order to overcome this rejection.
All remaining claims are rejected as they depend from rejected independent claim 1.
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.
Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kalina (U.S. 2019/0105077).
Regarding claim 1, Kalina teaches a drug injection device (apparatus 200, Figures 2A and 21B), comprising:
a needle holder (component 238, Figures 2H and annotated Figure 21B below) defining a drug delivery direction (drug delivery direction extends from the device 200 toward the eye 100 as shown in Figure 21B), wherein said drug delivery direction extends towards an injection end (the distal most tip of abutting segment as shown in the annotated Figure 21B below);
an ejector (see annotated Figure 21B below) comprising
a fixing segment (stop member 233, Figures 2A, and 21B, and annotated Figure 21B below) fixed to said needle holder and arranged along said drug delivery direction as discussed in paragraph [0109] and shown in Figures 2H, 21B, and annotated Figure 21B below;
and an abutting segment (insertion tube 356, Figures 2A, 21B, and the annotated Figure 21B below), extending towards the injection end and protrudes beyond the needle holder as discussed in paragraph [0100] and shown in Figures 2B, 2H, and 21B;
a needle member (component 231 and tip 208, Figures 2A, 3A, and 21B), movably arranged relative to said needle holder as shown in Figures 2A, 2H, and 21B and discussed in paragraph [0107], said needle member comprising:
a needle hub (component 231, Figures 2B and the annotated Figure 21B below), and a needle shaft (tip 208, Figure 2B) attached to said needle hub,
and said needle shaft being coaxially arranged with said ejector such that said abutting segment is inserted into said needle shaft (tip 208 always surround at least a portion of insertion tube 356 as discussed in paragraph [0104] and shown in Figures 2A, 21B and the annotated Figure 21B below);
and an actuation assembly (retraction member 232, Figures 2B, 21B, and the annotated Figure 21B below) connected to said needle holder and said needle hub, wherein said actuation assembly is configured to drive said needle member to move between a first position (position of needle member 208 as shown in Figure 21B and the annotated Figure 21B below) and a second position relative to said needle holder (position of needle member 208 as shown in Figure 2A),
and wherein said first position is proximal to said injection end (needle member 208 is retracted and proximal of the distal most tip of insertion tube 356 as shown in Figure 21B and the annotated Figure 21B below) and said second position is distal from said injection end (needle member 208 is extended over the distal tip of insertion tube 356 as shown in Figure 2A).
PNG
media_image1.png
826
520
media_image1.png
Greyscale
Regarding claim 2, Kalina teaches that said needle holder further comprises a concave space, and said fixing segment is located in said concave space (see fixing segment 233 and concave space in Figure 2H and annotated Figure 2H below).
PNG
media_image2.png
850
836
media_image2.png
Greyscale
Allowable Subject Matter
Claims 3 – 15 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior arts discovered during examination are: Sutkin (U.S. 2014/0257241), Kahook (U.S. 2020/0129334), Kalina (U.S. 2019/0105077), and Ianchulev (U.S. 2021/0361484).
Regarding claim 3, prior arts do not teach wherein said needle holder further comprises a rib section disposed in said concave space and is arranged parallel to said drug delivery direction; and a fixation post located in said concave space with said drug delivery direction perpendicularly passing through said fixation post wherein said ejector further comprises a collar, located at an end of said fixing segment away from said abutting segment, and wherein said fixing segment is placed at the top edge of said rib section with said fixation post passing through said collar.
Regarding claim 4, prior arts do not teach that wherein said needle holder further comprises a guide rod located on said drug delivery direction and extending towards said injection end, and wherein said abutting segment passes through said guide rod along an axial direction of said guide rod and protrudes beyond said guide rod.
Claims 5 – 15 are objected to be allowable due to their dependency on claim 4.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH T BUI whose telephone number is (571)270-1028. The examiner can normally be reached M - F 8 - 5.
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, Chelsea Stinson can be reached at (571) 270-1744. 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.
ANH T. BUI
Examiner
Art Unit 3783
/Anh Bui/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783