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 . 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 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.
Response to Amendment
This Office Action is responsive to the amendment filed 12/02/2025 (“Amendment”). Claims 1, 3-6, 8, 13, 14, 16, 17, 20, 161, and 162 are currently under consideration. The Office acknowledges the amendments to claims 1, 4, 12, 14, and 16-19, as well as the cancellation of claims 2 and 15 and the addition of new claims 161 and 162. Claims 7, 9-12, 18, and 19 remain withdrawn.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 162 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Specifically, the patentability of a product does not depend on its method of production, so the product-by-process element is not given patentable weight. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
Claims 1, 3-6, 8, 13, 14, 16, 17, 20, 161, and 162 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2019/0223767 (“Muller”) in view of US Patent Application Publication 2024/0315608 (“Choi”).
Regarding claim 1, Muller teaches [a] medical device system comprising: a housing configured to be worn on skin of a host and including a distal surface for facing towards the skin and a proximal surface facing opposite the distal surface (Fig. 1, base element 1, ¶ 0054), the housing including an opening for a needle (Figs. 4B, 6, 8, etc., cannula 3) to be retracted proximally through from the skin (¶ 0072); an analyte sensor (Fig. 4B, sensor 6) having a first portion coupled to the housing (coupled to base element 1 as described in ¶¶s 0064 and 0065) and a second portion configured to extend distally from the housing and be guided by the needle into the skin of the host (Figs. 10, 12, etc., ¶ 0072) …; and a stopper body (Figs. 2B, 4B, etc., cam 5a) configured to impede the … analyte sensor … from retracting proximally through the opening upon the needle retracting proximally through the opening and based on stiction between the analyte sensor and the needle produced based on the sterilization process (¶¶s 0072 and 0080, overcoming an adhesion or rubbing between the sensor and the cannula).
Muller does not appear to explicitly teach a portion of the analyte sensor forming a bend positioned between the first portion and the second portion, the second portion being positioned within a channel of the needle during a sterilization process applied to at least the second portion of the analyte sensor and the needle (but, note that the product-by-process element is not given patentable weight, as the patentability of a product does not depend on its method of production, but is based on the product itself). Muller does not appear to explicitly teach the stopper configured to impede the portion of the analyte sensor that forms the bend from retracting proximally (but only because it does not appear to explicitly teach a bend).
Choi teaches, in a CGM device that uses an applicator for sensor insertion (Abstract, ¶¶s 0010, 0011, etc.), the sensor having a bend positioned between first and second portions (Fig. 4, at connection part 112), the second portion being positioned within a channel of the needle (Figs. 7 and 8 – also see ¶¶s 0047, 0050, 0052, etc.), including during a sterilization process since the process can be performed at any time. Choi teaches a stopper body configured to impede the portion of the analyte sensor that forms the bend from retracting proximally (Figs. 6-8, a portion of housing 120, as well as retention protrusion 136, preventing vertical travel of this portion).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a bend between portions of the sensor of Muller, as in Choi, for the purpose of enabling the different portions to lie in different planes, thereby housing the sensor electronics flatly against the body (Choi: ¶¶s 0044-0046, etc.). It would have been obvious to use a stopper body like that of Choi, and as already taught by Muller, to prevent vertical travel of the skin-inserted portion of the sensor when the cannula is retraced, at the bend as in Choi, for the purpose of maintaining sensor insertion (Muller: ¶ 0072, overcoming an adhesion or rubbing between the sensor and the cannula; Choi: ¶¶s 0051 and 0052, maintaining depth of insertion), as the simple substitution of one known stopper body for another with predictable results (retaining the sensor while another element is retracted), and for the purpose of easier manufacture (e.g. integral with the housing in one molding operation, no slot needed for a cam, etc.).
Regarding claim 3, Muller-Choi teaches all the features with respect to claim 1, as outlined above. Muller-Choi further teaches wherein the second portion is straight and is axially aligned with the opening (Muller: Figs. 4B, 6, 8, etc.).
Regarding claim 4, Muller-Choi teaches all the features with respect to claim 1, as outlined above. Muller-Choi further teaches wherein the stopper body is configured to contact the analyte sensor to impede the analyte sensor from retracting proximally upon the needle retracting proximally through the opening (Muller: ¶¶s 0064, 0072, 0080; Choi: Figs. 6-8, a portion of housing 120, as well as retention protrusion 136, preventing vertical travel).
Regarding claim 5, Muller-Choi teaches all the features with respect to claim 1, as outlined above. Muller-Choi further teaches wherein the stopper body is positioned proximate the opening (Muller: Figs. 11 and 12; Choi: Figs. 6-8).
Regarding claim 6, Muller-Choi teaches all the features with respect to claim 1, as outlined above. Muller-Choi further teaches wherein the stopper body comprises a tab extending into the opening (Muller: Figs. 4B, 11, 12; Choi: Figs. 6-8, the portion of housing 120 beyond retention protrusion 136).
Regarding claim 8, Muller-Choi teaches all the features with respect to claim 1, as outlined above. Muller-Choi further teaches wherein the stopper body is integral with the housing (Choi: ¶¶s 0023, 0050, Figs. 6-8, a portion of housing 120, as well as retention protrusion 136).
Regarding claim 13, Muller-Choi teaches all the features with respect to claim 1, as outlined above. Muller-Choi further teaches wherein the stopper body is positioned proximal of the analyte sensor (Muller: ¶ 0064, Figs. 11 and 12; Choi: Figs. 6-8, the portion of housing 120).
Regarding claims 14, 16, and 17, Muller-Choi teaches all the features with respect to claim 1, as outlined above. Muller-Choi further teaches the needle (Muller: ¶ 0061, Figs. 2B, 4B, 6, 8, etc., cannula 3), a needle hub positioned at a proximal portion of the needle, and wherein the stopper body is positioned between the needle hub and the analyte sensor (Muller: Fig. 4B, cannula upper part 4, with the cam 5a being positioned between cannula upper part 4 and sensor 6; Choi: Figs. 6-8, the portion of housing 120 being located between the sensor and the proximal portion of the needle), wherein the needle is positioned within the opening of the housing and extends parallel with the second portion of the analyte sensor (Muller: Figs. 4B, 11, 12).
Regarding claim 20, Muller-Choi teaches all the features with respect to claim 1, as outlined above. Muller-Choi further teaches wherein the analyte sensor comprises a transcutaneous analyte sensor (Muller: Abstract).
Regarding claim 161, Muller-Choi teaches all the features with respect to claim 1, as outlined above. Muller-Choi further teaches wherein the distal surface of the housing is coupled to a patch for being worn on the skin of the host (Choi: Fig. 1, ¶ 0069, adhesive portion 230. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a patch for the purpose of facilitating adhesion/attachment to the skin, as described), and the first portion of the analyte sensor is coupled to a portion of the housing that is integral with the distal surface of the housing (Choi: Figs. 4 and 5, the arranged that results from the different portions of the sensor lying in different planes).
Regarding claim 162, Muller-Choi teaches all the features with respect to claim 1, as outlined above. Muller-Choi further teaches wherein the sterilization process is an ethylene oxide sterilization process (this element does not further limit the structure, which is taught by Muller-Choi as above).
Response to Arguments
Applicant’s arguments filed 12/02/2025 have been fully considered. In response to the arguments and amendments regarding the rejections under 35 USC 102, they are persuasive. However, a new grounds of rejection has been made under 35 USC in further view of Choi, and all claims remain rejected in light of the prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday-Friday, 7am-3pm PT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson, can be reached at telephone number (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791