DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
2. According to the Preliminary Amendment, filed 16 October 2024, the status of the claims is as follows:
Claims 1 and 14 are currently amended;
Claims 2-4, 6-13, and 15-18 are as originally filed; and
Claim 5 is cancelled.
Claim Interpretation
3. 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.
4. 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:
(i) “a tissue piercing element” in claim 1; and
(ii) “a mounting unit” in claim 1.
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
5. 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.
6. The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
7. Claims 1-4 and 6-13 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Say et al, U.S. Patent No. 6,175,752 B1 (“Say”).
As to Claim 1, Say teaches the following:
A sensor device for measuring an analyte concentration (“The present invention is, in general, directed to devices and methods for the in vivo monitoring of an analyte, such as glucose or lactate.”, see col. 1, ll. 5-7), the sensor device comprising:
a sensor unit (“implantable sensor”) 42 comprising an in vivo portion (labeled generally as “distal end”) 67 having a tissue piercing element (“barb”) 125 and a sensor body (elongate, “narrow width 53” portion between “electrodes 58 and 60” and the wide “width 55” portion in fig. 2) 53 (“Although the substrate 50 in at least some embodiments has uniform dimensions along the entire length of the sensor 42, in other embodiments, the substrate 50 has a distal end 67 and a proximal end 65 with different widths 53, 55, respectively, as illustrated in FIG. 2. In these embodiments, the distal end 67 of the substrate 50 may have a relatively narrow width 53. For sensors 42 which are implantable into the subcutaneous tissue or another portion of a patient's body, the narrow width 53 of the distal end 67 of the substrate 50 may facilitate the implantation of the sensor 42. Often, the narrower the width of the sensor 42, the less pain the patient will feel during implantation of the sensor and afterwards.”, see col. 8, ll. 51-63; “The sensor 42 may include optional features to facilitate insertion of an implantable sensor 42, as shown in FIG. 12. For example, the sensor 42 may be pointed at the tip 123 to ease insertion. In addition, the sensor 42 may include a barb 125 which assists in anchoring the sensor 42 within the tissue of the patient during operation of the sensor 42.”, see col. 8, ll. 42-47; and see figs. 2 and 12),
the sensor body 53 comprises comprising at least one electrode (“at least one working electrode”) 58 and a membrane (“sensing layer”) 64 covering at least a portion of the at least one electrode 58 (“A sensing layer 64 (see FIGS. 3A and 3B) is often formed proximate to or on at least one of the working electrodes 58 to facilitate the electrochemical detection of the analyte and the determination of its level in the sample fluid, particularly if the analyte can not be electrolyzed at a desired rate and/or with a desired specificity on a bare electrode.”, see col. 7, ll. 40-45),
wherein a largest dimension of a cross section (“cross-sectional width”) 124 transverse to a longitudinal axis of the tissue piercing element 125 is greater than a largest dimension of a cross section (not labeled, see cross section width of “sensor 42” in fig. 13B) transverse to a longitudinal axis of the senor body 53 (best illustrated by fig. 13B, where the “cross-sectional width 124” is wider than the cross sectional width of “sensor 42”; and also see “The insertion devices 120 of FIGS. 13B and 13C are U- or V-shaped implements that support the sensor 42 to limit the amount that the sensor 42 may bend or bow during insertion. The cross-sectional width 124 of the insertion devices 120 illustrated in FIGS. 13B and 13C is typically 1 mm or less, preferably 700 .mu.m or less, more preferably 500 .mu.m or less, and most preferably 300 .mu.m or less.” in col. 27, l. 63, to col. 28, l. 3); and
a mounting unit (“sensor control unit”) 44 configured to support the sensor device 42 on an exterior surface of a host' s skin (“The sensor 42 is coupled to the sensor control unit 44 which is typically attached to the skin of a patient.”, see col. 6, ll. 59-61).
As to Claim 2, Say teaches the following:
wherein the mounting unit 44 comprises a guiding portion (“carrier”) 204 configured to guide insertion of the in vivo portion 67 of the sensor unit 42 through the host's skin and to support a column strength of the sensor unit 42 such that the in vivo portion 67 is capable of being inserted through the host's skin without substantial buckling (see col. 28, ll. 51-60; and see col. 28, ll. 29-33); and wherein the guiding portion 204 is configured to remain ex vivo during insertion of the in vivo portion 67 of the sensor unit 42 (see col. 28, ll. 44-65; and see fig. 26).
As to Claim 3, Say teaches the following:
wherein the tissue piercing element 125, with the support of the guiding portion 204, is capable of withstanding an axial load greater than about 1 Newton without substantial buckling (see col. 28, ll. 29-33; and matter of intended use of the “barb 125” and “carrier 204”, which are capable of performing the function based on their structures).
As to Claim 4, Say teaches the following:
wherein the tissue piercing element 125 is configured to protect the membrane from damage during insertion of the in vivo portion of the sensor unit (matter of intended use of the “barb 125”, which is capable of performing the function based on its structure).
As to Claim 6, Say teaches the following:
wherein the at least one electrode comprises a working electrode 58 and a reference electrode 62 (see col. 7, ll. 30-35).
As to Claims 7 and 8, Say teaches the following:
wherein the sensor body 53 further comprises a support member configured to protect the membrane from damage during insertion of the sensor unit, wherein the at least one electrode 58 is a support member (see fig. 2).
As to Claim 9, Say teaches the following:
wherein the support member, with the support of a guiding member (“carrier”) 204 of the mounting unit 44, is capable of withstanding an axial load greater than about 1 Newton without substantial buckling (see col. 28, ll. 29-33; and matter of intended use of the “width 53” and “carrier 204”, which are capable of performing the function based on their structures).
As to Claims 10 and 11, Say teaches the following:
wherein the support member (“conductive traces”) 52 is configured to support at least a portion of the at least one electrode 58 (see fig. 2), and wherein the support member 52 is configured to substantially surround the at least one electrode (see fig. 2).
As to Claims 12 and 13, Say teaches the following:
wherein the mounting unit 44 comprises a sensor electronics unit operatively and detachably connected to the sensor body 53, and wherein the sensor electronics unit is configured to be located over a sensor insertion site (see col. 36, ll. 18-45; and see figs. 14-17).
8. Claims 14-18 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Stafford, U.S. Patent Application Publication No. 2008/0119707 A1 (“Stafford”).
As to Claim 14, Stafford teaches the following:
A sensor array (“analyte monitoring system”) 10 for measuring an analyte concentration (see “FIG. 1 shows a top view of an exemplary embodiment of a combined fluid delivery and analyte monitoring system 10 constricted according to some aspects of the present invention, while FIG. 2 shows an elevational end view of system 10 mounted on the skin of patient P.” in para. [0018], and see figs. 1 and 2), the sensor array 10 comprising:
a laminate (“flexible patch”) 12 comprising an adhesive layer (“adhesive”, not labeled) configured for adhering the laminate to a host’s skin (see “Flexible patch 12 may be provided with an adhesive on a bottom surface to secure patch 12 to the skin of the patient during use.” in para. [0018]); and
a plurality of sensor devices (“transcutaneous analyte sensors”) each attached to the laminate and each configured for insertion through the skin at a different insertion site (see “Flexible patch 12 may be provided with one or more sensor sites 34 for receiving transcutaneous analyte sensors. Multiple sensors can be used simultaneously to provide redundant analyte readings.” in para. [0023]),
wherein each sensor device comprises a sensor unit and a mounting unit (“one or more sensor sites”) 34 configured to support the sensor device on an exterior surface of the host’s skin,
the sensor unit (“sensor”) 42 comprising an in vivo portion having a tissue piercing element (“sharp edge”) and a sensor body (“flexible substrate”) 50, the sensor body 50 comprising at least one electrode (“at least one working electrode”) 58 and a membrane (not labeled) covering at least a portion of the at least one electrode (see “Transcutaneous analyte sensors can be inserted into the user's skin using an automatic introducer or inserter device, such as those described in U.S. patent application Ser. No. 10/703,214, published Jul. 8, 2004 under publication number 20040133164, incorporated herein by reference in its entirety.” in para. [0024]; and see U.S. Patent Application Publication No. 2004/0133164 A1, para. [0056], [0058]).
As to Claim 15, Stafford teaches the following:
wherein the laminate comprises sensor electronics (“controller and transmitter module”) 16 operatively connected to the sensor devices (see para. [0018] and [0024]).
As to Claim 16, Stafford teaches the following:
wherein the plurality of sensor devices are configured to provide parallel measurements of analyte concentration (see para. [0023]).
As to Claim 17, Stafford teaches the following:
wherein the plurality of sensor devices comprises a first sensor device and a second sensor device (see para. [0023]),
wherein the first sensor device is configured to measure analyte concentration at a first range of analyte concentrations and the second sensor device is configured to measure analyte concentration at a second range of analyte concentrations, wherein the first range is different from the second range (see para. [0023]).
As to Claim 18, Stafford teaches the following:
wherein the plurality of sensor devices comprises a first sensor device and a second sensor device (see para. [0023]),
wherein the first sensor device comprises a first sensor body configured to reside in a host tissue at a first depth (see para. [0023]),
wherein the second sensor device comprises a second sensor body configured to reside in the host tissue at a second depth, and wherein the first depth is different from the second depth (see para. [0023]).
Conclusion
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M 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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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 01/26/2026