Prosecution Insights
Last updated: August 06, 2026
Application No. 18/604,309

INSERTION DEVICE FOR A BIOSENSOR

Non-Final OA §102§112
Filed
Mar 13, 2024
Priority
Mar 15, 2023 — provisional 63/490,314
Examiner
TU, AURELIE H
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
BIONIME Corporation
OA Round
1 (Non-Final)
56%
Grant Probability
Moderate
1-2
OA Rounds
1y 3m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 56% of resolved cases
56%
Career Allowance Rate
132 granted / 234 resolved
-13.6% vs TC avg
Strong +60% interview lift
Without
With
+60.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
50 currently pending
Career history
300
Total Applications
across all art units

Statute-Specific Performance

§101
20.7%
-19.3% vs TC avg
§103
33.0%
-7.0% vs TC avg
§102
14.7%
-25.3% vs TC avg
§112
28.7%
-11.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 234 resolved cases

Office Action

§102 §112
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 . Election/Restrictions Applicant's election with traverse of claims 1-19 in the reply filed on 22 May 2026 is acknowledged. The traversal is on the ground(s) that both Invention I and II require an elastic member and that there is no search burden on the Examiner. This is not found persuasive because as previously mentioned in the Restriction Election Requirement mailed on 27 March 2026, Invention II does not require “a first elastic member having one of ends that is positioned relative to said main body unit, and another one of said ends that resiliently abuts against said implant seat” (emphasis added). In addition to this, Invention II does not require “wherein said implant seat is displaced downwardly by releasing a resilient force of said first elastic member” (emphasis added). Thus, although Inventions I and II are directed to related products, the inventions as claimed have a materially different design. The Examiner also disagrees that there is no search burden as the product of Invention I may be used for sensing neural activity, as classified in A61B2018/00839, and the product of Invention II may be used for glucose monitoring, as classified in A61B5/14532. The requirement is still deemed proper and is therefore made FINAL. Claim Objections Claims 2 and 7 are objected to because of the following informalities: “said guiding pin” in lines 5-6 and 7 (recited twice) of claim 2 should read as “said at least one guiding pin” “said guiding pins” in line 9 of claim 7 should read as “said at least one guiding pins” 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 1 and 3-6 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. Claims 2 and 7-19 are further rejected due to their dependency to claim 1. The term “resiliently” in claim 1 is a relative term which renders the claim indefinite. The term “resiliently” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what it means to “resiliently abut” as an object could abut an object with force or without force. Furthermore, the disclosure does not provide a clear definitely for “resiliently.” Clarification is requested. The term “stably” in claim 1 is a relative term which renders the claim indefinite. The term “stably” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what it means for something to “stably move” as an object is either moving or not moving. Clarification is requested. Claim 3 recites the limitation “two guiding pins” in line 7. It is unclear if this limitation is referring to “at least one guiding pin” as mentioned in claim 2. Clarification is requested. “Ones of said guiding pins” is also recited in lines 8-9. It is unclear if this is referring to “two guiding pins” or “at least one guiding pin.” Clarification is requested. Claim 4 recites the limitation “said guiding pins” in line 3. It is unclear if this limitation is referring to “two guiding pins” in claim 3 or “at least one guiding pin” in claim 2. Clarification is requested. Claim 5 recites “by abovementioned structural dispositions with respect to each other” in line 7. It is unclear what this is referring to. Clarification is requested. Claim 6 recites “by abovementioned structural dispositions with respect to each other” in lines 5-6. It is unclear what this is referring to. Clarification is requested. 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, 2, 9, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang et al. ‘960 (US Pub No. 2021/0030960). Regarding claim 1, Huang et al. ‘960 teaches an implant device for a biosensor (Title, Abstract), comprising: a housing unit (Figs. 1-4 upper casing 10 and [0045]) that has an accommodating space (accommodating space 14 and [0045]); an implant module (insertion module 30 and [0046]) that is disposed in said accommodating space of said housing unit ([0046]); said implant module including: a main body unit (main body assembly 300 and [0047]) linked to said housing unit, said main body unit defining a displacement space (displacement space 301 and [0047]); a guiding set connected to said main body unit and located in said displacement space (main body 31 and [0068]); an implant seat detachably limited to said main body unit and guided by said guiding set to be displaced in said displacement space (insertion seat 33 and [0048]); a first elastic member having one of ends that is positioned relative to said main body unit, and another one of said ends that resiliently abuts against said implant seat (first elastic member 34 and [0051]); a needle withdrawal seat detachably limited to said implant seat and guided by said guiding set (retraction seat 35 and [0052]); a second elastic member resiliently abutting between said implant seat and said needle withdrawal seat (second elastic member 37 and [0053]); and a needle implant member (insertion needle 36 and [0052]); a bottom seat that is detachably limited to said main body unit (base 50 and [0054]); and a sensor component that is detachably limited to said bottom seat (sensor assembly 70 and [0055]); wherein said implant seat is displaced downwardly by releasing a resilient force of said first elastic member until a limiting relationship with said main body unit is released to thereby perform an automatic needle implantation ([0056], [0059]); when the needle implantation is completed, the limiting relationship of said implant seat and said main body unit is released, and a limiting relationship of said implant seat and said needle withdrawal seat is released, so said needle withdrawal seat finishes an automatic needle withdrawal by releasing a resilient force of said second elastic member, and said implant seat and said needle withdrawal seat are guided by said guiding set to stably move ([0059]). Regarding claim 2, Huang et al. ‘960 teaches wherein said main body unit (main body assembly 300) of said implant module has a main body member (lower portion 303 and [0047]) and a main body cover (upper portion 302 and [0047]) detachably linked to said main body member ([0047]-[0048]), said guiding set (main body 31) has at least one guiding pin (pair of engaging structures 315 and [0047]) connected between said main body member and said main body cover, said implant seat has at least one first guiding hole (casing engaging structures 124 and [0047]) provided for said guiding pin to slidably extend therethrough, and said needle withdrawal seat has at least one second guiding hole provided for said guiding pin to slidably extend therethrough (Because there is a pair of engaging structures 315 and a pair of casing engaging structures 124, one of ordinary skill would understand that there are two body engaging structures and two casing engaging structures.). Regarding claim 9, Huang et al. ‘960 teaches wherein said first elastic member and said second elastic member of said implant module may be pre-compressed springs ([0051], [0053]). Regarding claim 11, Huang et al. ‘960 teaches wherein said housing unit further includes a bottom cover (Fig. 1 lower casing 20 and [0065]) and a peel-off element connected to said bottom seat and said bottom cover ([0054]), said bottom cover being used to detachably couple (Fig. 2 base hook structures 54 and [0075]) to an opening of said accommodating space of said housing member and including a bottom plate portion (Fig. 1 base seat 51 and [0054]), said bottom seat including a main housing body (511), an adhesive pad fixed to said main housing body (adhesive pad 52 and [0054]), and a release layer detachably attached to said adhesive pad (Figs. 24, 25 release layer 55 and [0075]), said peel-off element being connected to said bottom plate portion and said release layer, said release layer being peeled-off from said adhesive pad when said bottom cover is removed from said opening of said accommodating space (Figs. 25, 26 and [0081]). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURELIE H TU whose telephone number is (571)272-8465. The examiner can normally be reached [M-F] 7:30-3:30. 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, Alexander Valvis can be reached at (571) 272-4233. 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. /AURELIE H TU/ Primary Examiner, Art Unit 3791
Read full office action

Prosecution Timeline

Mar 13, 2024
Application Filed
Aug 23, 2024
Response after Non-Final Action
Jul 21, 2026
Non-Final Rejection mailed — §102, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
56%
Grant Probability
99%
With Interview (+60.2%)
3y 8m (~1y 3m remaining)
Median Time to Grant
Low
PTA Risk
Based on 234 resolved cases by this examiner. Grant probability derived from career allowance rate.

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