DETAILED ACTION
Claims 1-10, 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 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 § 102
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 1-3, 5, 8-10, 25-29, 39, 41, 46-47, 53, 63, and 71-73 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gray (US 20210338161).
Regarding claim 1, Gray teaches an apparatus comprising:
an adaptor body (Figs. 6A-7F, holder 524) configured to interface between at least a portion of an on-skin wearable medical device (Figs. 6A-7F, on-skin sensor assembly 160) and an applicator of the on-skin wearable medical device (Figs. 6A-7F, applicator 500; Fig. 6F, protrusion 654 of housing 502 of applicator 500 immobilizes holder 524; Paragraph 0198, “on-skin sensor assembly 160 including a plurality of attachment points 662a-662f configured to mate with respective retention elements on needle carrier assembly 508 and/or holder 524”).
Regarding claim 2, Gray further teaches wherein the adaptor body is configured to interface between at least the portion of the 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 an on-skin wearable medical device that is different than the first configuration (Paragraph 0206, “on-skin sensor assembly 160 including a plurality of attachment points 662a-662f configured to mate with respective retention elements on needle carrier assembly 508 and/or holder 524”, Examiner notes that the retention elements of needle carrier assembly is the portion of the applicator configured to engage with a second configuration of the on-skin sensor assembly, while the retention elements of the holder engages a first configuration of the on-skin sensor assembly).
Regarding claim 3, Gray further teaches wherein the second configuration differs from the first configuration in one or more of a shape or a size (Paragraph 0206, “on-skin sensor assembly 160 including a plurality of attachment points 662a-662f configured to mate with respective retention elements on needle carrier assembly 508 and/or holder 524”, Examiner notes that the holder and needle carrier assembly would require different shapes to mate with the on-skin sensor assembly).
Regarding claim 5, Gray further teaches wherein the on-skin wearable medical device having at least the portion with the first configuration is the same on-skin wearable medical device that has at least the portion with the second configuration (Paragraph 0206, “on-skin sensor assembly 160 including a plurality of attachment points 662a-662f configured to mate with respective retention elements on needle carrier assembly 508 and/or holder 524”, Examiner notes that the retention elements of needle carrier assembly is the portion of the applicator configured to engage with a second configuration of the on-skin sensor assembly, while the retention elements of the holder engages a first configuration of the on-skin sensor assembly).
Regarding claim 8, Gray further teaches wherein the adaptor body is configured to adapt at least the portion of the 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”).
Regarding claim 9, Gray further teaches wherein the adaptor body includes a retention area for receiving at least the portion of the on-skin wearable medical device (Fig. 6H, on-skin sensor assembly 160 within holder 524).
Regarding claim 10, Gray further teaches wherein the adaptor body includes a cavity for receiving at least the portion of the on-skin wearable medical device (Fig. 6H, on-skin sensor assembly 160 within holder 524).
Regarding claim 25, Gray further teaches wherein the adaptor body includes a retainer portion for retaining at least the portion of the on-skin wearable medical device to the adaptor body (Paragraph 0206, “on-skin sensor assembly 160 including a plurality of attachment points 662a-662f configured to mate with respective retention elements on needle carrier assembly 508 and/or holder 524”).
Regarding claim 26, Gray further teaches one or more device couplers for coupling the on-skin wearable medical device to the adaptor body (Paragraph 0206, “on-skin sensor assembly 160 including a plurality of attachment points 662a-662f configured to mate with respective retention elements on needle carrier assembly 508 and/or holder 524”; Paragraph 0198, “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 and/or holder 524”).
Regarding claim 27, Gray further teaches 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 and/or holder 524”).
Regarding claim 28, Gray further teaches 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 on-skin wearable medical device (Fig. 6H, retention elements 672a/b of holder 524 with protrusion holding sensor 160).
Regarding claim 29, Gray further teaches 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 0196, “FIG. 6E illustrates a retention element 642 of holder 524 … In some embodiments, retention element 642 is a deflectable arm, or any other type of protrusion or snap.”).
Regarding claim 39, Gray further teaches wherein the adaptor body includes an ejection portion configured to allow at least the portion of the on-skin wearable medical device to eject from the adaptor body (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 0343, “Applicator 7100 may further include a holder 7124 releasably coupled to needle carrier assembly 7108 and configured to guide needle carrier assembly 7108 and on-skin sensor assembly 360 while coupled to needle carrier assembly 7108, e.g., at least during translation from a proximal position to a distal insertion position. As will be described in more detail below, on-skin sensor assembly 360 may be stripped or released from holder 7124 and/or needle carrier assembly 7108 once on-skin sensor assembly 360 is disposed on skin 130 of the host.”).
Regarding claim 41, Gray further teaches wherein the on-skin wearable medical device includes a transcutaneous analyte sensor (Paragraph 0002, “More particularly, systems and methods are provided 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, needle carrier assembly 8208 within applicator 8200).
Regarding claim 46, Gray teaches a system comprising:
an applicator of an on-skin wearable medical device (Figs. 82A-D, applicator 8200); and
an adaptor body configured to interface between at least a portion of the on-skin wearable medical device and the applicator of the on-skin wearable medical device (Figs. 6A-7F, applicator 500; Fig. 6F, protrusion 654 of housing 502 of applicator 500 immobilizes holder 524; Paragraph 0198, “on-skin sensor assembly 160 including a plurality of attachment points 662a-662f configured to mate with respective retention elements on needle carrier assembly 508 and/or holder 524”).
Regarding claim 47, Gray further teaches wherein the applicator includes an engagement portion configured to engage the adaptor body (Fig. 6F, protrusion 654 of housing 502 of applicator 500 immobilizes holder 524”).
Regarding claim 53, Gray further teaches wherein the adaptor body includes a retention area for receiving at least the portion of the on-skin wearable medical device (Fig. 6H, on-skin sensor assembly 160 within holder 524).
Regarding claim 63, Gray further teaches:
the adaptor body includes an ejection portion configured to allow at least the portion of the on-skin wearable medical device to eject from the adaptor body (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 0343, “Applicator 7100 may further include a holder 7124 releasably coupled to needle carrier assembly 7108 and configured to guide needle carrier assembly 7108 and on-skin sensor assembly 360 while coupled to needle carrier assembly 7108, e.g., at least during translation from a proximal position to a distal insertion position. As will be described in more detail below, on-skin sensor assembly 360 may be stripped or released from holder 7124 and/or needle carrier assembly 7108 once on-skin sensor assembly 360 is disposed on skin 130 of the host.”) and
the applicator includes an ejection actuator configured to eject the on-skin wearable medical device from the adaptor body (Paragraph 0422, wherein the applicator contains an insertion assembly to translate holder, needle carrier assembly, and on-skin sensor assembly which then may decouple from holder and on-skin sensor assembly).
Regarding claim 71, Gray teaches a method comprising:
utilizing an applicator (Figs. 6A-7F, Applicator 500 and on-skin sensor assembly 160) to apply an on-skin wearable medical device to a skin of a host (Paragraph 0002, “More particularly, systems and methods are provided for applying a transcutaneous analyte measurement system to a host”), an adaptor body interfacing between at least a portion of the on-skin wearable medical device and the applicator (Figs. 6A-7F, applicator 500; Fig. 6F, protrusion 654 of housing 502 of applicator 500 immobilizes holder 524; Paragraph 0198, “on-skin sensor assembly 160 including a plurality of attachment points 662a-662f configured to mate with respective retention elements on needle carrier assembly 508 and/or holder 524”).
Regarding claim 72, Gray further teaches wherein the on-skin wearable medical device comprises a coupling mismatch with the applicator (Figs. 6A-7F, applicator 500; Fig. 6F, protrusion 654 of housing 502 of applicator 500 immobilizes holder 524; Paragraph 0198, “on-skin sensor assembly 160 including a plurality of attachment points 662a-662f configured to mate with respective retention elements on needle carrier assembly 508 and/or holder 524”; Examiner notes that the attachment points may mate with the retention elements of only holder 524; thus, the applicator and medical device cannot couple).
Regarding claim 73, Gray further teaches wherein the adaptor body adapts at least the portion of the 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”).
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 4, 6-7, 49, and 74 are rejected under 35 U.S.C. 103 as being unpatentable over Gray as applied to claims 1-2, 47, and 71 above, and further in view of Donnay (US 11266335).
Regarding claims 4 and 6-7, Gray discloses wherein the on-skin wearable medical device has a first configuration; however, Gray is silent as to a larger, second on-skin wearable medical device.
However, Donnay teaches an apparatus for insertion of a medical device in the skin of a subject wherein an insertion assembly is provided to install a medical device to the subject. The insertion assembly contains an insert or adapter to insert various medical devices, or combinations of such devices, into the subject (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”). Examiner notes that Donnay discusses that the inserter can be configured to many different devices, including combinations of such devices, which Examiner interprets to mean devices of different sizes.
Donnay discusses this is useful so that the inserter can be reused (Col 22, line 35). 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 Gray to incorporate the teachings of Donnay to have a reuseable device.
Regarding claims 49 and 74, Gray discloses a first on-skin wearable medical device (Figs. 2-3 and 6A-7F sensor assembly 160/260/360) and the applicator having an engagement portion (Paragraph 0351, “Needle carrier assembly 7108 comprises a plurality of wearable retention and/or alignment elements 7372a, 7372b configured to extend through holder 7124”); however, Gray is silent as to the engagement portion configured to engage a second on-skin wearable medical device having a different configuration than the first on-skin wearable medical device.
However, Donnay teaches an apparatus for insertion of a medical device in the skin of a subject wherein an insertion assembly is provided to install a medical device to the subject. The insertion assembly contains an insert or adapter to insert various medical devices, or combinations of such devices, into the subject (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”). Examiner notes that Donnay discusses multiple types of medical devices being used, thus reading on the limitation of a different configuration than the first on-skin wearable medical device.
Donnay discusses this is useful so that the inserter can be reused (Col 22, line 35). 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 Gray to incorporate the teachings of Donnay to have a reuseable device.
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).
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.
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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.
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/NOAH M HEALY/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791