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
The amendment filed on 11/25/2025 has been entered. Claims 1-7 and 9-14 are pending in the application. Claim 8 is cancelled. The amendments to the claims overcome each and every objection, 112(a) rejection, and 112(b) rejection previously set forth in the Non-Final Office Action mailed on 9/23/2025.
Claim Objections
Claim 14 is objected to because of the following informalities:
-Claim 14, lines 7-8: please correct “the auxiliary portion” to “the auxiliary engaging portion”
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.
Claims 7 and 11 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 7 recites the limitation "the at least one engaging arm" in line 3. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the Examiner interprets “the at least one engaging arm engaged” in claim 7 as “and wherein at least one engaging arm of the stopper is engaged”.
Claim 11 recites the limitation “the guide post” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the Examiner interprets “the guide post” as “a guide post of the needle holder”.
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 1-7 and 9-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang (US 2019/0175819 A1).
Regarding claim 1, Yang discloses a needle mechanism module for a drug infusion device (see Figs. 1-10), comprising:
an infusion needle (U-shape needle), provided with a front end (short end 51) and a rear end (long end 52) (see Figs. 7-8, par. [0045] and [0049]);
a needle holder (needle seat 2), provided with at least an auxiliary engaging part (cavity 24) (see Fig. 8a, par. [0046] and [0051]-[0052]), wherein the infusion needle (U-shape needle) is arranged on the needle holder (needle seat 2), when the needle holder (needle seat 2) is at a working position (see Fig. 8c), the rear end (long end 52) is inserted into a skin (see par. [0049]), and the front end (short end 51) is connected to a drug storage unit of the drug infusion device (see Figs. 7-8, par. [0049]);
an auxiliary engaging portion (hook 31), arranged within the drug infusion device, engaged with the auxiliary engaging part (cavity 24) to limit the needle holder (needle seat 2) at the working position (see Figs. 8a and 8c, par. [0046] and [0051]-[0052]); and
a stopper (needle seat cover 7), arranged on a housing of the drug infusion device (see Fig. 10b), when the needle holder (needle seat 2) is at a non-working position (see Figs. 8b and 10b, par. [0051] and [0054]), the stopper (needle seat cover 7) limits a position of the needle holder (needle seat 2) (see Fig. 10b, par. [0051] and [0054]), wherein in a thickness direction, a thickness of a forward end of the stopper (needle seat cover 7) is smaller than a thickness of a backward end of the stopper (needle seat cover 7), the forward end of the stopper (needle seat cover 7) is closer to a forward direction of the stopper (needle seat cover 7) which is a direction of sliding toward the needle holder (needle seat 2) to realize engagement with the needle holder (needle seat 2), the backward end of the stopper (needle seat cover 7) is closer to a backward direction of the stopper (needle seat cover 7) which is a direction of leaving the needle holder (needle seat 2) and releasing the engagement with the needle holder (needle seat 2), and the thickness direction is perpendicular to the forward direction and the backward direction (see annotated Fig. 10a below, the total thickness of the forward end is discontinuous and thus is smaller than the continuous total thickness of the backward end).
PNG
media_image1.png
417
527
media_image1.png
Greyscale
Regarding claim 2, Yang discloses the needle mechanism module for the drug infusion device of claim 1, wherein the needle holder (needle seat 2) includes a guide post (multi-cavity column 22) which moves along a guide cavity (cavity 110) that is provided in the housing of the drug infusion device (see Figs. 4-5, par. [0045]).
Regarding claim 3, Yang discloses the needle mechanism module for the drug infusion device of claim 2, wherein the auxiliary engaging part (cavity 24) is arranged on the guide post (multi-cavity column 22) (see Figs. 5 and 8a, par. [0046]) or under a top of the needle holder (needle seat 2) (see Fig. 8a), and the auxiliary engaging part (cavity 24) comprises a hole or a slot (see Fig. 5, par. [0046]).
Regarding claim 4, Yang discloses the needle mechanism module for the drug infusion device of claim 1, wherein a slider (side edges of needle seat cover 7 with vertical grips, see Fig. 10) is provided on the stopper (needle seat cover 7) while the housing is provided with a sliding groove (needle seat container 11), the slider (side edges of needle seat cover 7 with vertical grips, see Fig. 10) is arranged in the sliding groove (needle seat container 11), and the slider (side edges of needle seat cover 7 with vertical grips, see Fig. 10) slides along the sliding groove (needle seat container 11) to make the stopper (needle seat cover 7) engage or release the needle holder (needle seat 2) (see Figs. 7-10, par. [0054]).
Regarding claim 5, Yang discloses the needle mechanism module for the drug infusion device of claim 4, wherein at least one engaging arm (latch 71) is provided on the stopper (needle seat cover 7) (see Fig. 10, par. [0054]).
Regarding claim 6, Yang discloses the needle mechanism module for the drug infusion device of claim 5, further comprising a first engaging portion (portion of latch 71 which engages slot 222), wherein the first engaging portion (portion of latch 71 which engages slot 222) is provided on the at least one engaging arm (latch 71) to engage with the needle holder (needle seat 2) and limit the position of the needle holder (needle seat 2) (see Fig. 10, par. [0054]).
Regarding claim 7, Yang discloses the needle mechanism module for the drug infusion device of claim 2, wherein a side surface of a guide post (multi-cavity column 22) of the needle holder (needle seat 2) is provided with convexes or concaves (surfaces of slot 222), the at least one engaging arm (latch 71) engaged with the convexes or concaves (surfaces of slot 222) to limit the position of the needle holder (needle seat 2) (see Figs. 8a and 10, par. [0051] and [0054]).
Regarding claim 9, Yang discloses the needle mechanism module for the drug infusion device of claim 1, wherein the stopper (needle seat cover 7) is provided with an unlock rod (button 3) (see Fig. 10b, par. [0052] and [0054]).
Regarding claim 10, Yang discloses the needle mechanism module for the drug infusion device of claim 9, further comprising an unlock hole (slot 221), wherein an opening of the unlock hole (slot 221) is provided on a top of the needle holder (needle seat 2) (see Fig. 8a), wherein the unlock rod (button 3) is configured to release the engagement of the auxiliary engaging part (cavity 24) and the auxiliary engaging portion (hook 31) through the unlock hole (slot 221) (see Fig. 8a, par. [0052]).
Regarding claim 11, Yang discloses the needle mechanism module for the drug infusion device of claim 10, wherein the opening of the unlock hole (slot 221) is provided on the top of the needle holder (needle seat 2) (see Fig. 8a), and longitudinal directions of the unlock hole (slot 221) and the guide post (multi-cavity column 22) are parallel to each other (see Fig. 8a).
Regarding claim 12, Yang discloses the needle mechanism module for the drug infusion device of claim 3, wherein a mode to release and reset the needle holder (needle seat 2) comprises a pop-up mode (see Fig. 7, par. [0052], the needle seat 2 is popped up by spring 42) or a pushing mode (see Fig. 7, par. [0052], the needle seat 2 is pushed up by spring 42).
Regarding claim 13, Yang discloses the needle mechanism module for the drug infusion device of claim 12, further comprising a spring (spring 42) arranged in the guide cavity (cavity 110) (see Figs. 4-5 and 7, par. [0045]-[0046]), which is compressed by the needle holder (needle seat 2) when the needle holder (needle seat 2) is in the working position (see Figs. 7a-b, par. [0051]-[0052]).
Regarding claim 14, Yang discloses the needle mechanism module for the drug infusion device of claim 9, further comprising a locking lever (button 3) (see Fig. 5, par. [0046]), wherein the auxiliary engaging part (cavity 24) is a hole or a slot (see Fig. 5, par. [0046]), a first end of the locking lever is movably arranged inside the auxiliary engaging part (cavity 24) while a second end of the locking lever is engaged with the auxiliary engaging portion (hook 31) (see Fig. 5, par. [0046]), a fulcrum of the locking lever (button 3) is arranged between the first end and the second end of the locking lever (button 3) (see Fig. 5), and the second end is pushed by an unlock rod (latch 71) of the stopper (needle seat cover 7) to move a distance to release engagement of the auxiliary portion (hook 31) and the locking lever (button 3) and release the needle holder (needle seat 2) (see Fig. 5, par. [0046]).
Response to Arguments
Applicant's arguments filed 11/25/2025 have been fully considered but they are not persuasive. Applicant argues that Yang fails to teach the limitations “wherein in a thickness direction, a thickness of a forward end of the stopper is smaller than a thickness of a backward end of the stopper, the forward end of the stopper is closer to a forward direction of the stopper which is a direction of sliding toward the needle holder to realize engagement with the needle holder, the backward end of the stopper is closer to a backward direction of the stopper which is a direction of leaving the needle holder and releasing the engagement with the needle holder, and the thickness direction is perpendicular to the forward direction and the backward direction” as recited in amended claim 1. However, the Examiner respectfully disagrees. In the rejection of claim 1 above, the Examiner has included an annotation of Fig. 10a of Yang, which appears to show each of the above amended limitations. The total thickness of the forward end is discontinuous and thus is smaller than the continuous total thickness of the backward end as shown in Fig. 10a of Yang. Therefore, Yang still appears to anticipate claim 1 as currently recited.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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.
/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783