DETAILED ACTION
Applicant’s arguments, filed 05/04/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Applicant has amended their claims, filed 05/04/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicant has canceled claims 5-6, 11-24, 30-38, 40, 42-45, 48, 50-52, 54-62, 64-70, and 75-85. Claims 1-4, 7-10, 25-29, 39, 41, 46-47, 49, 53, 63, and 71-74 are pending and hereby under examination.
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 .
Claim Objections
Claim 71 is objected to because of the following informalities:
Claim 71, lines 3-4, “on-skin wearable medical device” should read “first on-skin wearable medical device”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“Engagement portion” first recited in claim 8;
“Retainer portion” first recited in claim 25;
“Device couplers” first recited in claim 26; and
“Ejection portion” first recited in claim 39.
The identified structure for the corresponding claim limitations are as follows:
“Engagement portion” is identified as “The engagement portion may comprises a plurality of wearable retention and/or alignment elements 534a, 534b … The engagement portion may have other configurations in examples. Wearable retention elements 534a, 534b may comprise, e.g., arms, deflection element, tabs, detents, snaps or any other features capable of a retaining function” (Paragraph 0131).
“Retainer portion” is identified as “the retainer portion 1044 may include one or more device couplers 1046 that may couple the on-skin wearable medical device to the adaptor body 1020” (Paragraph 0248) and ”The device couplers 1046 may have a variety of forms in examples. Referring to FIG. 29B, the device couplers 1046 may include protrusions … or a recess, or one or more of a protrusion or recess … may comprise an adhesive or may have another form” (Paragraph 0249).
“Device couplers” is identified as ”The device couplers 1046 may have a variety of forms in examples. Referring to FIG. 29B, the device couplers 1046 may include protrusions … or a recess, or one or more of a protrusion or recess … may comprise an adhesive or may have another form” (Paragraph 0249).
“Ejection portion” is identified as “The ejection portion may comprise one or more openings in a surface of the adaptor body” (Paragraph 0010) and “The openings 1162 may be configured to allow an ejection assembly of the applicator to pass through, to contact the on-skin wearable device and cause it to eject from the adaptor body 1140. The ejection assembly, for example, may comprise one or more protrusions configured to pass through the openings 1162” (Paragraph 0310).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-4, 7-10, 25-29, 39, 41, 46-47, 49, 53, 63, and 71-74 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.
Regarding claims 1, 7, 46, and 71, it is unclear how the wearable housing of the first on-skin wearable medical device is smaller than a wearable housing of the second on-skin wearable medical device if the component of the applicator of the first on-skin wearable medical device retains the second on-skin wearable medical device. How would the second on-skin wearable medical device fit within or be retained by a component of the applicator of a smaller on-skin wearable medical device? It appears that Applicant intends to claim that an applicator comprises an adaptor body that interfaces between the applicator and a first on-skin wearable medical device. The applicator is configured to hold the second on-skin wearable medical device without the adaptor body, and the applicator is configured to hold a first on-skin wearable medical device with the adaptor body. Examiner takes this interpretation based on Figs. 27-28 and corresponding paragraphs 0216-229. However, Applicant should clarify the relationship between the first and the second on-skin wearable medical devices. Claims 2-4, 8-10, 25-29, 39, 41, 47, 49, 53, 63, and 72-74 are also rejected due to their dependence on claims 1, 46, and 71.
Regarding claim 2, it is unclear what the relationship is between the first configuration and the second configuration. It appears Applicant intends to claim that the adaptor body is configured to interface between at least the portion of the first on-skin wearable medical device and a portion of the applicator having a first configuration, and the portion of the applicator configured to engage the second on-skin wearable medical device having a second configuration. That is, the adaptor body is required to engage the first on-skin wearable medical device, but the adaptor body is not required to engage the second on-skin wearable medical device. For examination purposes, that is how the claim will be interpreted. However, Applicant should clarify the relationship between the two configurations and the two on-skin wearable medical devices.
Regarding claim 2, it is unclear if “a portion of the applicator” is the same as the “component of the applicator” as first recited in claim 1. It appears they are directed towards the same structure as the component of the applicator is configured to retain a second on-skin wearable medical device, and the portion of the applicator is configured to engage the second on-skin wearable medical device. However, Applicant should clarify the difference, if any. For examination purposes, the portion and the component of the applicator will be interpreted as the same structure.
Regarding claim 26, it is unclear if the device couplers are a part of the first on-skin wearable medical device or the adaptor body. For examination purposes, it will be interpreted such that the device couplers are a part of the first on-skin wearable medical device or the adaptor body. However, Applicant should clarify the relationship between the device couplers, the first on-skin wearable medical device, and the adaptor body. Claims 27-29 are also rejected due to their dependence on claim 26.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 8-10, 25-29, 39, 41, 46-47, 49, 53, 63, and 71-74 are rejected under 35 U.S.C. 103 as being unpatentable over Gray (US 20210338161) and Donnay (US 11266335).
Regarding claims 1, 8-10, 25-29, 39, and 41, Donnay discloses an apparatus comprising: an adaptor body (Col 22, lines 24-56, specifically "For example, in certain embodiments a given inserter can be configured to install a first device and a second device at different times … For example, an inserter may be modifiable to be used with more than one medical device, to include more than one type of medical device, e.g., by attaching an adapter and/or removing detaching a portion of an inserter”), and
wherein a component of the applicator is configured to retain a second on-skin wearable medical device (Fig. 22, inserter 200 with on body housing retained in carriage 230).
Donnay fails to explicitly disclose wherein the adaptor body is configured to interface between at least a portion of a first on-skin wearable medical device and the component of an applicator of the first on-skin wearable medical device and wherein a wearable housing of the first on-skin wearable medical device is smaller than a wearable housing of the second on-skin wearable medical device.
Gray and Donnay are in the same field of wearable medical devices. Gray teaches an applicator of an on-skin sensor assembly wherein an adaptor body (Fig. 82A-D, holder 8224) is configured to interface between at least a portion of a first on-skin wearable medical device (Fig. 82A-D, holder 8224 attached to on-skin sensor assembly 360) and a component of an applicator of the first on-skin wearable medical device (Paragraph 0421, “Holder 8224 is configured to guide on-skin sensor assembly 360 while coupled to needle carrier assembly 8208 during insertion, e.g., at least during translation from a proximal position to a distal insertion position”; Figs. 82A-D, wherein holder 8224 has needle holder 8208 with wearable retention elements 8272a/b extending through holder 8224; Examiner interprets the component of an applicator as the wearable retention elements). Examiner interprets the sensor assembly of Gray retained in the adaptor body as smaller than the on body housing retained in the inserter without an adapter as disclosed by Donnay. Donnay discloses the inserter for applying a sensor to the body and discloses, in some embodiments, that an adapter may be added to apply different medical devices, such as with an adapter or by removing parts of the inserter. Examiner interprets that by adding an adapter, the sensor would be small; by not having an adapter, the sensor would be larger; and by removing parts of the insertion assembly, the sensor would be even larger.
Regarding the limitations of claims 8-10, 25-29, 39, and 41, Donnay fails to disclose the limitations of these claims.
Gray further teaches:
wherein the adaptor body is configured to adapt at least the portion of the first on-skin wearable medical device to fit an engagement portion of the applicator (Paragraph 0351, “Needle carrier assembly 7108 comprises a plurality of wearable retention and/or alignment elements 7372a, 7372b configured to extend through holder 7124”; Paragraph 0418, “In some embodiments, wearable retention elements 8272a, 8272b may extend around rather than through holder 8224”, wherein the engagement portion is the wearable retention elements, as interpreted above);
wherein the adaptor body includes a retention area / cavity / retainer portion for receiving at least the portion of the first on-skin wearable medical device (see Fig. 82C below; Per the claim interpretation above, a “retainer portion” is interpreted to include being a cavity or recess);
one or more device couplers for coupling the first on-skin wearable medical device to the adaptor body (Paragraph 0421, “Holder 8224 is configured to guide on-skin sensor assembly 360 while coupled to needle carrier assembly 8208 during insertion”; Figs. 82A-D, wherein holder 8224 has needle holder 8208 with wearable retention elements 8272a/b extending through holder 8224; Examiner interprets “device couplers” to be the protrusions defined by the wearable retention elements 8272a/b. The wearable retention elements 8272a/b extend through or around the holder to couple the holder 8224 to the applicator 8200/needle carrier assembly 8208 system), wherein the one or more device couplers comprise an adhesive (Paragraph 0198, “In some embodiments, the respective retention elements may comprise snap fits, friction fits, interference features, elastomeric grips and/or adhesives configured to couple on-skin sensor assembly 160 with needle carrier assembly 508”), wherein the one or more device couplers comprise one or more of a protrusion or a recess configured to engage at least the portion of the first on-skin wearable medical device (Figs. 82A-D, wherein the retention elements 8272a/b protrude from the needle carrier assembly 8208; Examiner interprets the retention elements of the needle carrier assembly as “engaging” with the needle carrier assembly and allow the needle carrier assembly to engage with the sensor assembly 360), and wherein the one or more device couplers are configured to deflect (Paragraph 0010, “the applicator further includes an activation element configured to deflect the retention element”; Paragraph 0418, “Wearable retention elements 8272a, 8272b may comprise, e.g., arms, deflection element, tabs, detents, snaps or any other features capable of a retaining function”);
wherein the adaptor body includes an ejection portion configured to allow at least the portion of the first on-skin wearable medical device to eject from the adaptor body (Fig. 82D, wherein the retention elements 8272a/b that pass through holder 8224 releases sensor assembly 360 from needle carrier assembly; Paragraph 0421, “on-skin sensor assembly 360 may be stripped or released from holder 8224 and/or needle carrier assembly 8208 once on-skin sensor assembly 360 is disposed on the skin of the host”; Examiner interprets the ejection portion, as described above, as the holes in the holder to allow for the retention elements 8272a/b to pass through); and
wherein the first on-skin wearable medical device includes a transcutaneous analyte sensor (Figs. 3A-B, sensor assembly 360 with sensor 338; Paragraph 0007, “The present systems and methods relate to systems and methods for measuring an analyte in a host, and for applying a transcutaneous analyte measurement system to a host”), and the adaptor body is configured to be positioned within a housing of the applicator (Figs 82A-D, holder 8224 within applicator 8200).
While Donnay discloses that an adapter may be used, Gray discloses the specifics of such an adapter, wherein an applicator with a holder for interfacing between the applicator and sensor assembly, as described above. This modifiable adapter system disclosed by Donnay is useful such that the inserter can be reused (Col 22, line 35) and medical devices of different sizes can be used, and Gray teaches the details of such a device with the adaptor body (Figs. 82A-D, holder 8224). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the insertion assembly of Donnay to incorporate the teachings of the holder interfacing between an applicator and a smaller sensor assembly as taught by Gray to have a reuseable device usable with medical devices of different sizes.
Regarding claims 2-4 and 7, Donnay as modified by Gray further discloses wherein the adaptor body is configured to interface between at least the portion of the first on-skin wearable medical device having a first configuration and a portion of the applicator configured to engage a second configuration of at least a portion of the second on-skin wearable medical device that is different than the first configuration (Examiner notes that the sensor assembly system as disclosed by Gray is the first configuration of the wearable housing of the first on-skin sensor assembly, and the /on-body system as disclosed by Donnay is the second configuration of the wearable housing of the second on-skin sensor assembly)
As Gray explicitly discloses using the holder 8224 for use with the sensor assembly 360 (see Figs. 82A-D of Gray, Examiner interprets this configuration as using the adaptor body and the sensor assembly 360 is small), this configuration is different in shape and size than the inserter 200/on-body system 122 as disclosed by Donnay (see Fig. 22 of Donnay, Examiner interprets this configuration to as not using the adaptor body and the on-body system is larger than the sensor assembly 360; Examiner interprets the on-body system 122 as being larger in shape/size which would necessarily mean larger in diameter and/or height than the sensor assembly 360).
Regarding claims 46, 53, and 63, Donnay discloses a system comprising: an applicator (Fig. 22, insertion device 200) and an adaptor body (Col 22, lines 24-56, specifically "For example, in certain embodiments a given inserter can be configured to install a first device and a second device at different times … For example, an inserter may be modifiable to be used with more than one medical device, to include more than one type of medical device, e.g., by attaching an adapter and/or removing detaching a portion of an inserter”), and
wherein a component of the applicator is configured to retain a second on-skin wearable medical device (Fig. 22, inserter 200 with on body housing retained in carriage 230).
Donnay fails to explicitly disclose wherein the adaptor body is configured to interface between at least a portion of a first on-skin wearable medical device and the component of an applicator of the first on-skin wearable medical device and wherein a wearable housing of the first on-skin wearable medical device is smaller than a wearable housing of the second on-skin wearable medical device.
Gray and Donnay are in the same field of wearable medical devices. Gray teaches an applicator of an on-skin sensor assembly wherein an adaptor body (Fig. 82A-D, holder 8224) is configured to interface between at least a portion of a first on-skin wearable medical device (Fig. 82A-D, holder 8224 attached to on-skin sensor assembly 360) and a component of an applicator of the first on-skin wearable medical device (Paragraph 0421, “Holder 8224 is configured to guide on-skin sensor assembly 360 while coupled to needle carrier assembly 8208 during insertion, e.g., at least during translation from a proximal position to a distal insertion position”; Figs. 82A-D, wherein holder 8224 has needle holder 8208 with wearable retention elements 8272a/b extending through holder 8224; Examiner interprets the component of an applicator as the wearable retention elements). Examiner interprets the sensor assembly of Gray retained in the adaptor body as smaller than the on body housing retained in the inserter without an adapter as disclosed by Donnay. Donnay discloses the inserter for applying a sensor to the body and discloses, in some embodiments, that an adapter may be added to apply different medical devices, such as with an adapter or by removing parts of the inserter. Examiner interprets that by adding an adapter, the sensor would be small; by not having an adapter, the sensor would be larger; and by removing parts of the insertion assembly, the sensor would be even larger.
Regarding the limitations of claims 53 and 63, Donnay fails to disclose the limitations of these claims.
Gray further teaches:
wherein the adaptor body includes a retention area for receiving at least the portion of the first on-skin wearable medical device (see Fig. 82C below; Per the claim interpretation above, a “retainer portion” is interpreted to include being a cavity or recess);
wherein the adaptor body includes an ejection portion configured to allow at least the portion of the first on-skin wearable medical device to eject from the adaptor body (Fig. 82D, wherein the retention elements 8272a/b that pass through holder 8224 releases sensor assembly 360 from needle carrier assembly; Paragraph 0421, “on-skin sensor assembly 360 may be stripped or released from holder 8224 and/or needle carrier assembly 8208 once on-skin sensor assembly 360 is disposed on the skin of the host”; Examiner interprets the ejection portion, as described above, as the holes in the holder to allow for the retention elements 8272a/b to pass through); and the applicator includes an ejection actuator configured to eject the first on-skin wearable medical device from the adaptor body (Paragraph 0421, on-skin sensor assembly 360 may be stripped or released from holder 8224 and/or needle carrier assembly 8208 once on-skin sensor assembly 360 is disposed on the skin of the host; Paragraph 0357, “In some embodiments, a spring (not shown) may be configured to exert a force against a portion of needle carrier assembly 7108, for example in a distal direction, sufficient to prevent needle carrier assembly 7108 from inertially triggered detaching from holder 7124 during insertion”).
While Donnay discloses that an adapter may be used, Gray discloses the specifics of such an adapter, wherein an applicator with a holder for interfacing between the applicator and sensor assembly, as described above. This modifiable adapter system disclosed by Donnay is useful such that the inserter can be reused (Col 22, line 35) and medical devices of different sizes can be used, and Gray teaches the details of such a device with the adaptor body (Figs. 82A-D, holder 8224). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the insertion assembly of Donnay to incorporate the teachings of the holder interfacing between an applicator and a smaller sensor assembly as taught by Gray to have a reuseable device usable with medical devices of different sizes.
Regarding claim 47, Donnay as modified further discloses wherein the applicator includes an engagement portion configured to engage the adaptor body (Fig. 81, in another embodiment, retention members, such as ribs 2520 and pinch spring arms 2522 located on carriage 2516 to prevent on body housing 122 from falling out of inserter 2500).
Regarding claim 49, Donnay as modified by Gray further discloses wherein engagement portion is configured to engage the second on-skin wearable medical device (Fig. 81, ribs 2520/pinch spring arms 2522 coupled to on body housing 122) having a different configuration than the first on-skin wearable medical device (Examiner interprets the inserter 2500 system shown in Fig. 81 of Donnay as a different configuration than the applicator 8200 system with holder 8224 shown in Figs. 82A-D of Gray).
Regarding claim 71, Donnay a method comprising: an adaptor body (Col 22, lines 24-56, specifically "For example, in certain embodiments a given inserter can be configured to install a first device and a second device at different times … For example, an inserter may be modifiable to be used with more than one medical device, to include more than one type of medical device, e.g., by attaching an adapter and/or removing detaching a portion of an inserter”), and
wherein a component of the applicator is configured to retain a second on-skin wearable medical device (Fig. 22, inserter 200 with on body housing retained in carriage 230).
Donnay fails to explicitly disclose utilizing an applicator to apply a first on-skin wearable medical device to a skin of a host, an adaptor body interfacing between at least a portion of the on-skin wearable medical device and a component of an applicator of the first on-skin wearable medical device, and wherein a wearable housing of the first on-skin wearable medical device is smaller than a wearable housing of the second on-skin wearable medical device.
Gray and Donnay are in the same field of wearable medical devices. Gray teaches an applicator of an on-skin sensor assembly wherein an adaptor body (Fig. 82A-D, holder 8224) is configured to interface between at least a portion of a first on-skin wearable medical device (Fig. 82A-D, holder 8224 attached to on-skin sensor assembly 360) and a component of an applicator of the first on-skin wearable medical device (Paragraph 0421, “Holder 8224 is configured to guide on-skin sensor assembly 360 while coupled to needle carrier assembly 8208 during insertion, e.g., at least during translation from a proximal position to a distal insertion position”; Figs. 82A-D, wherein holder 8224 has needle holder 8208 with wearable retention elements 8272a/b extending through holder 8224; Examiner interprets the component of an applicator as the wearable retention elements). Examiner interprets the sensor assembly of Gray retained in the adaptor body as smaller than the on body housing retained in the inserter without an adapter as disclosed by Donnay. Donnay discloses the inserter for applying a sensor to the body and discloses, in some embodiments, that an adapter may be added to apply different medical devices, such as with an adapter or by removing parts of the inserter. Examiner interprets that by adding an adapter, the sensor would be small; by not having an adapter, the sensor would be larger; and by removing parts of the insertion assembly, the sensor would be even larger.
Regarding the limitations of claims 72-73, Donnay fails to disclose the limitations of these claims.
Gray further teaches:
wherein the adaptor body adapts at least the portion of the first on-skin wearable medical device to fit an engagement portion of the applicator (Figs. 82A-D, wherein the holder 8224 comprises openings for the needle carrier assembly 8208 retention elements 8272a/b to fit thereto to couple with the sensor assembly 360); and
wherein the adaptor body adapts at least the portion of the first on-skin wearable medical device to fit an engagement portion of the applicator (Figs. 82A-D, wherein the holder 8224 comprises openings for the needle carrier assembly 8208 retention elements 8272a/b to fit thereto to couple with the sensor assembly 360).
While Donnay discloses that an adapter may be used, Gray discloses the specifics of such an adapter, wherein an applicator with a holder for interfacing between the applicator and sensor assembly, as described above. This modifiable adapter system disclosed by Donnay is useful such that the inserter can be reused (Col 22, line 35) and medical devices of different sizes can be used, and Gray teaches the details of such a device with the adaptor body (Figs. 82A-D, holder 8224). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the insertion assembly of Donnay to incorporate the teachings of the holder interfacing between an applicator and a smaller sensor assembly as taught by Gray to have a reuseable device usable with medical devices of different sizes.
Regarding claim 74, Donnay as modified by Gray further discloses wherein engagement portion is configured to engage the second on-skin wearable medical device (Fig. 81, ribs 2520/pinch spring arms 2522 coupled to on body housing 122) having a different configuration than the first on-skin wearable medical device (Examiner interprets the inserter 2500 system shown in Fig. 81 of Donnay as a different configuration than the applicator 8200 system with holder 8224 shown in Figs. 82A-D of Gray).
Response to Arguments
Applicant has not amended or argued against the 112(f) interpretation, see page 7, filed 05/04/2026; thus, the limitations identified above continue to be interpreted as described above.
Applicant’s arguments, see pages 7-8, filed 05/04/2026, with respect to the rejection of claims 1-10, 25-29, 39, 41, 46-47, 49, 53, 63, and 71-74 under 35 U.S.C. §102(a)(1) and §103 have been fully considered and are persuasive. Applicant has amended the claims to recite the adaptor body is configured to interface between a first on-skin wearable medical device and a component of an applicator, and the component of the applicator retains a second on-skin wearable medical device when the adaptor body is not present. Examiner agrees that Gray does not teach these limitations. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Donnay and Gray, as described above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rao (US 20220167919) teaches wherein an analyte applicator can be reused to apply more than one analyte sensor (Paragraph 0010).
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 NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm 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, Jason Sims can be reached at (571)272-7540. 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.
/NOAH M HEALY/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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