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 .
Drawings
The drawings are objected to. Figs. 1-5d and 7a-14c do not contain black and white drawings utilizing black ink, see 37 C.F.R. 1.84(a)(1). Figs. 6a-6d contain photographs; however, photographs are not the only practicable medium to show the depicted elements, see 37 C.F.R. 1.84(b)(1).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 limitations are: engagement members in claim 1; gripping members in claim 5; force applicator in claim 7 (the spring is optional); automatic cannula retraction mechanism in claims 10 and 11 (the spring is optional in claim 7); sensor module activation member in claim 13.
Prong 1: “member”, “section”, “applicator”, and “mechanism” are generic placeholders. See MPEP 2181 §I, subsection A, ¶1.
Prong 2: the transition word “to” is used, followed by functional language.
“one or more engagement members to configured to engage one or more corresponding abutment surfaces”;
“gripping members configured to secure the sensor module”;
“the force applicator configured to apply a second axial force” (note that the spring is optional, which necessitated the claim interpretation);
“automatic cannula retraction mechanism” (note no transition word);
“the sensor module activation member to activate”;
Prong 3: there is not sufficient structure to modify the generic placeholders.
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.
The examiner interprets the engagement members, engagement surfaces, hooks and/or other protrusions 103a of the collar 103 (see specification ¶[0061] and Fig. 5b) to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof for the one or more engagement members.
The examiner interprets the grip jaws or holding arms 701 (see specification ¶[0063] and Figs. 7a-7c) to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof for the gripping members.
The examiner interprets the spring (see specification ¶[0021] and ¶[0065]) to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof for the force applicator.
The examiner interprets the spring (see specification ¶[0021] and ¶[0065]) to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof for the automatic cannula retraction mechanism.
The examiner interprets the switch-ON post 901 and activation area 902 (see specification ¶[0078]-[0079]; Figs. 9a-9d) to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof for the automatic cannula retraction mechanism.
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 Objections
Claims 1, 15, and 19 are objected to because of the following informalities:
in claim 1, line 7: “to configured to” should be “configured to”;
in claim 15, line 2: “material” should be inserted after “deformable”;
in claim 19, line 1: “The kit” should be “A kit”; and
in claim 19, line 7: “to user using” should be “to the user using”.
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 1-20 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 1 recites the limitation “the skin” in line 1. There is insufficient antecedent basis for this limitation in the claim. Amending the recitation to “skin” would overcome the present rejection. The claim is being read as such for the purposes of examination.
Claim 1 recites “thereby prevent relative movement of the collar and the body”; however, it is not clear what specifically is preventing the relevant movement. Is it the engagement members, the abutment surfaces, a combination of the two, or something else? This inconsistency renders claim 1 indefinite. Appropriate clarification is required.
Claims 2-19 are rejected by virtue of their dependence from claim 1.
Regarding claim 3, the phrase "optionally" in line 7 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purposes of examination, the limitations following “optionally” are interpreted as not being part of the claimed invention.
Claim 4 is rejected by virtue of its dependence from claim 3.
Regarding claim 6, the phrase "optionally" in line 4 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purposes of examination, the limitations following “optionally” are interpreted as not being part of the claimed invention.
Regarding claim 7, the phrase "optionally" in line 4 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purposes of examination, the limitations following “optionally” are interpreted as not being part of the claimed invention.
Claims 8 and 11 are rejected by virtue of their dependence from claim 7.
Regarding claim 9, the phrase "optionally" in line 4 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purposes of examination, the limitations following “optionally” are interpreted as not being part of the claimed invention.
Claim 10 is rejected by virtue of its dependence from claim 9.
Regarding claim 16, the phrase "optionally" in line 7 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purposes of examination, the limitations following “optionally” are interpreted as not being part of the claimed invention.
Claim 17 is rejected by virtue of its dependence from claim 16.
Claim 19 recites the limitation “the skin” in line 1. There is insufficient antecedent basis for this limitation in the claim. Amending the recitation to “skin” would overcome the present rejection. The claim is being read as such for the purposes of examination.
Claim 19 recites “a sensor module” in line 4, but it is not clear if this recitation is the same as, related to, or different from the recitation “a sensor module” in claim 1, line 1 (the sensor modules appears to be included in the inserted device via the carriage, see line 4). The indefinite article “a” suggests that the recitations are different, but the similar phraseology and context of the claim suggest that they are the same. If the recitations are the same, the present recitation should be “the sensor module”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claim 19 recites “the inserter device configured to, during use, move the sensor module into contact with the user to thereby secure the sensor module to user using said non-biocompatible adhesive” in lines 6-7. While the specification has support for such a recitation (see specification ¶[0033]-[0034]), it appears as if the non-biocompatible adhesive never contacts the user due to the usage of a non-biocompatible adhesive. It appears as if the non-biocompatible adhesive is only used to attach the sensor module to the epidermal support patch. The confusion between what appears to be happening and what appears to be claimed (i.e., “move the sensor module into contact with the user to thereby secure the sensor module to user using said non-biocompatible adhesive”) renders claim 19 indefinite. Appropriate clarification is required.
Claim 20 is rejected by virtue of its dependence from claim 19.
Claim 20 recites “a user” in line 2, but it is not clear if this recitation is the same as, related to, or different from the recitation “a user” in claim 19, line 1. The indefinite article “a” suggests that the recitations are different, but the similar phraseology and context of the claim suggest that they are the same. If the recitations are the same, the present recitation should be “the user”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
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.
The succeeding art rejections to the claims under 35 U.S.C. § 102 and 103 below are made with the claims as best understood and interpreted in light of the preceding rejections under 35 U.S.C. § 112 above.
Claims 1-3, 5-12, 14, and 16-17 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Rao et al. (US Patent Application Publication 2022/0202367 – cited by Applicant), hereinafter Rao.
Regarding Claim 1, Rao teaches an analyte measurement device including a shell with electronics enclosed therewithin (see abstract; Figs. 1 and 3A-3F). Rao teaches an inserter device for securing a sensor module (¶[0156] the sensor control device 20102; Figs. 4D-4G) to the skin of a user (see abstract; Figs. 1 and 3A-3F),
the inserter device configured, during use, to drive a pointed end of the sensor module at least partially into the skin of the user (see generally ¶[0146]-[0154], the insertion of the sensor into the skin of the user, see also ¶[0215] and ¶[0240]-[0245] the sharp module 2550 includes the sharp shaft 2554 and the sharp distal tip 2556 for guiding and inserting the sensor tail 2408 into the skin; Figs. 3A-3F, 17E, 39A-39F),
the inserter device comprising:
a body (¶[0156] the housing 20702; Figs. 4D-4G) housing a carriage (¶[0156] the sensor carrier 20710; Figs. 4D-4G) for receiving the sensor module therein before use (¶[0156] the sensor control device 20102; Figs. 4D-4G);
a collar radially surrounding the carriage (¶[0156] the sheath 20704; Figs. 4D-4G) and movable relative to the body in an axial direction from a first position (¶[0368] the first position is before sufficient force is applied to move the sheath 318; Fig. 39A) to a second position (¶[0369]-[0370] the sensor is inserted into the skin of the user via movement of the sheath 318; Figs. 39A-39B),
the collar comprising one or more engagement members (¶[0162] and ¶[0182] the detent snap 1402; Figs. 7C-7E and 8A-8B) to configured to engage one or more corresponding abutment surfaces on an inner surface of the body in the first position (¶[0161] the locking ribs 1340; Figs. 7C-7E) and thereby prevent relative movement of the collar and the body (¶[0162] the detent snaps 1402 of the sheath 704 are locked into place in the locked grooves 1332 of the locking rib 1340; Figs. 7C-7E);
wherein the one or more engagement members and/or abutment surfaces are configured such that an axial force applied to the body causes the one or more engagement members and abutment surfaces to disengage from one another, thereby facilitating movement of the collar from the first position to the second position (¶[0162]-[0164] the force applied to the proximal end of the housing 702 shift the detent snaps 1402 into the unlocked grooves 1334¸ then shift the detent snaps 1402 past the firing detents 1344 as the sheath 704 moves into the second position, in which the sensor is implanted, the second position achieved once the detent snaps 1402 engage the lockout grooves 1336, so that reuse of the device is prevented; Figs. 7C-7E).
Regarding Claim 2, Rao teaches the device of claim 1 as stated above. Rao further teaches the collar is configured to move in the axial direction relative to the body upon the application of the axial force that causes the one or more engagement members and the one or more abutment surfaces to disengage from one another (¶[0162]-[0164] the force applied to the proximal end of the housing 702 shift the detent snaps 1402 past the abutment surfaces 1332, 1334, 1344, 1338 disengages them, before engagement with the lockout recess 1336; Figs. 7C-7E).
Regarding Claim 3, Rao teaches the device of claim 1 as stated above. Rao further teaches wherein at least one of (i) the one or more engagement members; and (ii) the one or more abutment surfaces; comprises a deformable section, wherein the axial force deforms the deformable section such that the one or more engagement members and the one or more abutment surfaces disengage from one another; and optionally wherein the one or more engagement members comprise the deformable section; and wherein the one or more abutment members are configured such that the axial force causes the one or more abutment members to deform the deformable sections radially inwards (¶[0162]-[0164] the detent snaps 1402 bend inward as the sheath 704 is moved towards the proximal end of the housing 702; Figs. 7C-7E and 8C).
Regarding Claim 5, Rao teaches the device of claim 1 as stated above. Rao further teaches wherein the carriage comprises a plurality of gripping members configured to secure the sensor module within the carriage, the gripping members configured to release the sensor module upon movement of the collar to the second position (¶[0203] the sensor carrier 20710 includes retention arms 20710B, each with the sensor retention feature 20710E, which can allow release of the sensor control device 20102 upon delivery; Figs. 9D-9E).
Regarding Claim 6, Rao teaches the device of claim 5 as stated above. Rao further teaches the collar comprises a plurality of jaw posts (¶[0197] and ¶[0203] the ribs 20704U; Figs. 8O and 9D-9E), the jaw posts each configured to engage a respective one of the gripping members in the first position and exert a radially inward force on the gripping members; and optionally wherein the jaw posts are configured such that movement of the collar to the second position causes the jaw posts to disengage the respective gripping members (¶[0197] and ¶[0203] the retention arms 20710B comprise the lock interfaces 20710F, which engage ribs 20704U such that the retention arms 20710B are prevented from flexing outward before the second position, such as during a shock event; Figs. 8O and 9D-9E).
Regarding Claim 7, Rao teaches the device of claim 1 as stated above. Rao further teaches the inserter device comprises a force applicator, the force applicator configured to apply a second axial force from the body to the collar; and optionally wherein the force applicator is a spring (¶[0016]-[0017], ¶[0294], and ¶[0369]-[0370] the spring 1118 that biases the sharp carrier upward in the housing, it would also be pushing up against the ; Figs. 24B and 39A-39E).
Regarding Claim 8, Rao teaches the device of claim 7 as stated above. Rao further teaches the force applicator biases the collar to the first position (¶[0016]-[0017], ¶[0294], and ¶[0369]-[0370] the spring 1118 that biases the sharp carrier upward in the housing, which would also be pushing up against the sheath; Figs. 24B and 39A-39E).
Regarding Claim 9, Rao teaches the device of claim 1 as stated above. Rao further teaches the carriage comprises a protrusion configured, during use, to guide the at least one pointed end of the sensor module to pierce the skin of the user when the collar is in the second position; and optionally wherein the protrusion is a cannula (¶[0215] and ¶[0240]-[0245] the sharp module 2550 includes the sharp shaft 2554 and the sharp distal tip 2556 for guiding and inserting the sensor tail 2408 into the skin; Figs. 3A-3F, 17E, 39A-39F).
Regarding Claim 10, Rao teaches the device of claim 9 as stated above. Rao further teaches comprising an automatic cannula retraction mechanism (¶[0016]-[0017], ¶[0294], and ¶[0369]-[0370] the spring 1118 that biases the sharp carrier upward in the housing; Figs. 24B and 39A-39E).
Regarding Claim 11, Rao teaches the device of claim 7 as stated above. Rao further teaches comprising an automatic cannula retraction mechanism; and wherein the force applicator is the automatic cannula retraction mechanism (¶[0016]-[0017], ¶[0294], and ¶[0369]-[0370] the spring 1118 that biases the sharp carrier upward in the housing; Figs. 24B and 39A-39E).
Regarding Claim 12, Rao teaches the device of claim 1 as stated above. Rao further teaches a cap removably connected to the body, the cap configured to enclose a cavity of the body, the cavity for housing the sensor module (¶[0156], ¶[0171], and ¶[0174]-[0175] the cap 20708 which is threadedly removable from the housing 20702, and has a cavity for the sensor carrier 20710; Figs.4D-4G, 7M-7Q, and 7S-7X).
Regarding Claim 14, Rao teaches the device of claim 12 as stated above. Rao further teaches a seal ring removably positioned between the body and the cap, the seal ring configured to prevent a disconnection of the cap and the body (¶[0156] and ¶[0170] the gasket 20701 that seals the housing and the cap; Figs. 4D-4G).
Regarding Claim 16, Rao teaches the device of claim 12 as stated above. Rao further teaches a first end of the cap comprises a first flange, the first end of the cap being axially proximate to the body; the body comprises a second flange; and the inserter device comprises a gasket positioned between the first flange and the second flange; and optionally wherein the first flange comprises an engagement surface configured to engage with the gasket (¶[0170] and ¶[0174] the gasket retention ring 20702E and the plurality of retention pockets 20702F of the housing 20702 and the gasket sealing surface 20708G of the cap 20708; Figs. 4d-4G and 7N).
Regarding Claim 17, Rao teaches the device of claim 16 as stated above. Rao further teaches inserter device comprises a second cavity between the body and the first flange, the second cavity configured to receive the gasket (see Fig. 4G,the cavity formed between the gasket sealing surface 20708G of the cap 20708 and the housing 20702 with the gasket 20701 therewithin).
Claim Rejections - 35 USC § 103
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 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.
The succeeding art rejections to the claims under 35 U.S.C. § 103 below are made with the claims as best understood and interpreted in light of the preceding rejections under 35 U.S.C. § 112 above.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Rao as applied to claim 14 above.
Regarding Claim 15, Rao teaches the device of claim 14 as stated above. Rao teaches a seal ring removably positioned between the body and the cap, the seal ring configured to prevent a disconnection of the cap and the body (¶[0156] and ¶[0170] the gasket 20701 that seals the housing and the cap; Figs. 4D-4G), but not specifically what type of material that gasket comprises.
Rao further teaches that the seal ring 5028 of the sensor cap 5018 may comprise an elastomeric O-ring (see ¶[0266] and ¶[0334]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the gasket material (i.e., elastomeric O-ring) of the sensor cap seal ring for the gasket because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the gasket requires an implementation and the elastomeric O-ring is one such implementation.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Rao as applied to claim 3 above, and in view of Baker et al. (US Patent Application Publication 2018/0360358), hereinafter Baker.
Regarding Claim 4, Rao teaches the device of claim 3 as stated above. Rao is silent regarding the deformable sections are elastically deformable.
Baker teaches applicators for applying on-skin sensor assemblies (see abstract and Fig. 1), in which various components of the system may comprise elastomeric materials (see ¶[0181] and ¶[0196] the main portion 1460/3408 (i.e., the body) may comprise an elastomeric material; Figs. 14 and 34A).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the elastomeric material of the sensor body with the sensor body/cap of Rao because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) Rao requires a deformable material and Baker teaches one such material; and/or (3) the elastomeric material may help to absorb at least a portion of energy if the applicator is dropped (see Baker ¶[0181] and ¶[0196]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Rao as applied to claim 14 above, and in view of Konya (US Patent Application Publication 2020/0297257 – EP document cited by Applicant), hereinafter Konya.
Regarding Claim 13, Rao teaches the device of claim 12 as stated above. Rao is silent regarding the cap comprises a sensor module activation member, wherein the cap is configured such that the process of removing the cap from the body causes the sensor module activation member to activate the sensor module housed within the body.
Konya teaches a medical system with a housing and sterile cap for inserting an analytical sensor into body tissue of a user (see abstract and Fig. 1), in which the cap comprises a sensor module activation member, wherein the cap is configured such that the process of removing the cap from the body causes the sensor module activation member to activate the sensor module housed within the body (¶[0056] and ¶[0156] the switching mechanism, such as the mechanical switch connected to the cap, configured to switch on the electronics unit when removed, so as to help provide a simple operating procedure which can be managed even by elderly people and children).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the switching mechanism of Konya to turn on the sensor when the cap of Rao is removed because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the automatic switch on when the protective cap is removed can help provide a simple operating procedure which can be managed even by elderly people and children (see Konya ¶[0156]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Rao as applied to claim 12 above, and in view of Robinson et al. (US Patent Application Publication 2022/0087579 – cited by Applicant), hereinafter Robinson.
Regarding Claim 18, Rao teaches the device of claim 16 as stated above. Rao does not specifically teach the cap further comprises one or more apertures for insertion of a gas into the cavity.
Robinson teaches a sensor applicator with an electronics housing and a cap, with a sensor control device sealed therewithin (see abstract and Figs. 1-2G) in which the cap further comprises one or more apertures for insertion of a gas into the cavity (¶[0401]-[0404] the sensor control device 2602 may be subjected to gaseous chemical sterilization via vents 2908 defined in the applicator cap 210; Figs. 29A-30).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the sterilization of Robinson with the applicator of Rao because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the sterilization would prepare the device for use with the user; and/or (3) the sterilization modality would sterilize the components without interacting with the enzymes, chemistry, or biologics of the tail (i.e., the sensor) (see Robinson ¶[0403]).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rao as applied to claim 1 above, and in view of Taub (US Patent 7,951,080 – cited by Applicant), hereinafter Taub.
Regarding Claim 19, Rao teaches the device of claim 16 as stated above. Rao further teaches the kit of parts for securing a sensor module to the skin of a user (see generally Figs. 1-4C and 39A-39F), the kit of parts comprising:
an inserter device according to preceding claim 1 (see above claim 1 mapping); and
a sensor module (¶[0156] the sensor control device 20102; Figs. 4D-4G), the sensor module having an adhesive patch on a surface thereof for securing the sensor module to the user; the inserter device configured to, during use, move the sensor module into contact with the user to thereby secure the sensor module to user using said adhesive patch (¶[0141], ¶[0261], ¶[0267], and ¶[0326] the patch 105 that is utilized to secure the sensor to the user’s skin for a period of time; Figs. 1, 4D-4G, and 39A-39F).
Rao does not specifically teach utilizing a non-biocompatible adhesive.
Taub teaches devices and methods for maintaining a medical device on a user’s body (see abstract), in which the medical device may be secured to the user’s skin via an intermediary patch, such that the user’s skin is in contact with a non-irritating adhesive (i.e., biocompatible) of the patch only, and the irritating adhesive (i.e., non-biocompatible) that secures the medical device to the patch is not in contact with the user’s skin (see col. 9 ln. 4-25).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the intermediary patch modality of Taub with securing the applicator of Rao because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the intermediary patch modality protects the user’s skin from an irritating adhesive utilized on the sensing portion.
Regarding Claim 20, Rao teaches the kit of claim 19 as stated above. The modified Rao further teaches an epidermal support patch having a biocompatible adhesive on a surface thereof for securing the patch to the skin of a user; and wherein securing the sensor module to the user comprises affixing the patch to the user and moving the sensor module into contact with the patch, to thereby secure the sensor module to the patch using said non-biocompatible adhesive (see Rao ¶[0141], ¶[0261], ¶[0267], and ¶[0326] the patch 105 that is utilized to secure the sensor to the user’s skin for a period of time, Figs. 1, 4D-4G, and 39A-39F; see Taub col. 9 ln. 4-25, the medical device may be secured to the user’s skin via an intermediary patch, such that the user’s skin is in contact with a non-irritating adhesive (i.e., biocompatible) of the patch only, and the irritating adhesive (i.e., non-biocompatible) that secures the medical device to the patch is not in contact with the user’s skin).
Conclusion
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/J.D.M./ Examiner, Art Unit 3791
/JENNIFER ROBERTSON/ Supervisory Patent Examiner, Art Unit 3791
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