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 04 May 2026, the status of the claims is as follows:
Claims 1 and 14 are currently amended;
Claims 2-4, 6-13, 15, and 16-18 are as originally filed;
Claim 19 is new; and
Claims 5 and 16 are cancelled.
Response to Arguments
3. Applicant’s arguments, see Remarks, pp. 6-7, filed 04 May 2026, with respect to the rejection of claims 1-4 and 6-13 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”), have been fully considered in view of the Amendment, filed 04 May 2026, and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is discussed below.
4. Applicant’s arguments, see Remarks, pp. 6-7, filed 04 May 2026, with respect to the rejection of claims 14-18 under pre-AIA 35 U.S.C. 102(e) as being anticipated by Stafford et al, U.S. Patent Application Publication No. 2008/0119707 A1 (“Stafford ‘707”), have been fully considered in view of the Amendment, filed 04 May 2026, and are persuasive. Therefore, the rejection has been withdrawn.
Claim Interpretation
5. 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.
6. 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 § 103
7. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
8. This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
9. Claims 1-4 and 6-13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stafford, U.S. Patent Application Publication No. 2007/0078322 A1 (“Stafford ‘322”), in view of Say et al., U.S. Patent No. 6,175,752 B2 (“Say”).
As to Claim 1, Stafford ‘322 teaches the following:
A sensor device for measuring an analyte concentration (see “In one embodiment, there is provided a method and apparatus for providing an integrated sensor introducer mechanism and transmitter unit for use in continuous or semi-continuous monitoring systems such as glucose monitoring systems which includes a disposable sensor introducer provided within the integrated sensor/transmitter assembly and which is retained within the assembly during the time period of the sensor in active mode.” in para. [0006]), the sensor device comprising:
a sensor unit (“sensor”) 503 comprising an in vivo portion (“portion”) 701 having a tissue piercing element (“introducer portion”) 502 and a sensor body (body, not labeled, of “sensor 503”) (see “More specifically, it can be seem from FIGS. 7A-7B that when the downward pressure is applied upon the substantially dome shaped inserter introducer trigger mechanism 104, the upper conical portion of the inserter introducer trigger mechanism 104 takes a substantially inverted conical shape, and with the same force, driving the portion 701 of the sensor 503 (FIG. 5A) through the patient's skin.” in para. [0028]),
the sensor body comprising at least one electrode (“at least one working electrode”) 58 … (see “That is, in the case of analyte sensors, the working, reference, and counter electrodes (in certain embodiments an electrode may function as both reference and counter electrodes) are each coupled to a respective one of the contact points 504, and in turn, each of which are in electrical communication with the respective contacts on the transmitter unit 101.” in para. [0029]; and see “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.” in para. [0034]),
the tissue piercing element 502 comprising a distal tip (“insertion unit may include a sharp portion”, not labeled) configured for piercing tissue (see “In a further embodiment, the insertion unit may include a sharp portion, the sharp portion configured to couple to a portion of the sensor, the sharp portion further configured to pierce through a skin of the patient to position at least the portion of the sensor in the patient, where the at least the portion of the sensor may be configured to be in fluid contact with a biological fluid of a patient. In one embodiment, the biological fluid includes one of interstitial fluid or blood.” in para. [0046]) and the sensor unit 503 being configured for direct press insertion through a host’s skin without the use of a separate applicator (see “Further, as shown in the Figures, an analyte sensor 503 is provided in cooperation with the introducer portion 502 such that in one embodiment, when the trigger portion 501 is activated by the patient, for example, by the application of downward pressure on the outer surface of the trigger portion (the outer surface of the "dome shaped" area), the introducer portion 502 is in turn configured to be driven in a substantially complimentary direction to the direction of the applied pressure, and further, displacing at least a portion of the sensor 503 with the introducer portion 502.” in para. [0028]); and
a mounting unit (“transmitter mount base portion”) 103 configured to support the sensor device 503 on an exterior surface of a host' s skin (see “The transmitter mount base portion 103 is configured to be placed on the skin of a patient, and as will be discussed in further detail, and includes a sensor introducer and the sensor pre-assembled therein.” in para. [0021]), the mounting unit 103 comprising an adhesive layer (“adhesive patch”) 201 disposed on a bottom surface (see bottom surface, not labeled, of “transmitter mount base portion 103” in fig. 2) (see “Referring to FIG. 2, there is shown an adhesive patch 201 that is configured to receive the transmitter unit base portion 103 on its upper surface, while the lower surface is provided with an adhesive material, and where the lower surface is configured to be securely attached to the skin of the patient, thus effectively providing a firm and secure mounting of the integrated sensor introducer and transmitter assembly 100.” in para. [0025]) and an upper surface (“sensor introducer trigger mechanism”) 104 adapted to receive a pressure from a user for insertion of the in vivo portion 701 (see “Further, as shown in the Figures, an analyte sensor 503 is provided in cooperation with the introducer portion 502 such that in one embodiment, when the trigger portion 501 is activated by the patient, for example, by the application of downward pressure on the outer surface of the trigger portion (the outer surface of the "dome shaped" area), the introducer portion 502 is in turn configured to be driven in a substantially complimentary direction to the direction of the applied pressure, and further, displacing at least a portion of the sensor 503 with the introducer portion 502. In other words, the introducer portion 502 is configured in one embodiment to transcutaneously place a portion of the sensor 503 so that the portion of the sensor is in fluid contact with the biological fluid (for example, interstitial fluid) of the patient.” in para. [0028]).
Stafford ‘322 does not teach the following:
the sensor body comprising at least one electrode and a membrane covering at least a portion of the at least one electrode.
However, Say teaches the following:
a sensor body (“substrate”) 50 comprising at least one electrode (“working electrode”) 58 (see figs. 3A and 3B) and a membrane (“sensing layer”) 64 covering at least a portion of the at least one electrode (see “The sensing layer 64 may be formed as a solid composition of the desired components (e.g., an electron transfer agent and/or a catalyst). These components are preferably non-leachable from the sensor 42 and more preferably are immobilized on the sensor 42. For example, the components may be immobilized on a working electrode 58. Alternatively, the components of the sensing layer 64 may be immobilized within or between one or more membranes or films disposed over the working electrode 58 or the components may be immobilized in a polymeric or sol-gel matrix. Examples of immobilized sensing layers are described in U.S. Pat. Nos. 5,262,035, 5,264,104, 5,264,105, 5,320,725, 5,593,852, and 5,665,222, U.S. patent application Ser. No. 08/540,789, and PCT Patent Application No. US98/02403 entitled "Soybean Peroxidase Electrochemical Sensor", filed on Feb. 11, 1998, incorporated herein by reference.” in col. 16, ll. 6-22).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Stafford ‘322’s sensor body (body, not labeled, of “sensor 503”) to be Say’s sensor body (“substrate”) 50 comprising at least one electrode (“working electrode”) 58 and a membrane (“sensing layer”) 64 covering at least a portion of the at least one electrode, in order to provide the following technical advantage of using a “sensing layer” covering at least one electrode:
Some analytes, such as oxygen, can be directly electrooxidized or electroreduced on the working electrode 58. Other analytes, such as glucose and lactate, require the presence of at least one electron transfer agent and/or at least one catalyst to facilitate the electrooxidation or electroreduction of the analyte. Catalysts may also be used for those analyte, such as oxygen, that can be directly electrooxidized or electroreduced on the working electrode 58. For these analytes, each working electrode 58 has a sensing layer 64 formed proximate to or on a working surface of the working electrode 58. Typically, the sensing layer 64 is formed near or on only a small portion of the working electrode 58, often near a tip of the sensor 42. This limits the amount of material needed to form the sensor 42 and places the sensing layer 64 in the best position for contact with the analyte-containing fluid (e.g., a body fluid, sample fluid, or carrier fluid).
As to Claim 2, Stafford ‘322 teaches the following:
wherein the mounting unit 103 comprises a guiding portion (body portion, not labeled, of “introducer portion 502”) configured to guide insertion of the in vivo portion 701 of the sensor unit 503 through the host's skin and to support a column strength of the sensor unit 503 such that the in vivo portion 701 is capable of being inserted through the host's skin without substantial buckling (see “Furthermore, as can be seen from FIG. 6, the substantially dome shaped inserter introducer trigger mechanism 104 is configured to be collapsible when the patient applies downward pressure to drive the introducer portion 502 through the patient's skin. Further, when the downward pressure is removed from the dome shaped inserter introducer trigger mechanism 104, the outer inserter introducer trigger mechanism 104 is configured to return to substantially the original shape, and concurrent therewith, removing the introducer portion 502 from the insertion site of the patient, while leaving behind the subcutaneous portion of the sensor in fluid contact with the patient's biological fluid.” in para. [0033]); and wherein the guiding portion 502 is configured to remain ex vivo during insertion of the in vivo portion 701 of the sensor unit 503 (see “Referring to FIGS. 9A-9B, it can be seen that after the sensor 503 is placed transcutaneously through the patient's skin at the intended location and in fluid contact with the patient's biological fluid, the introducer portion 502 is retained substantially completely within the dome shaped sensor introducer trigger mechanism 104 provided within the integrated sensor introducer and transmitter assembly 100.” in para. [0037]).
As to Claim 3, Stafford ‘322 teaches the following:
wherein the tissue piercing element 502, with the support of the guiding portion (body portion, not labeled, of “introducer portion 502”), is capable of withstanding an axial load greater than about 1 Newton without substantial buckling (see para. [0033]; and matter of intended use of the “introducer portion 502”, which is capable of performing the function based on their structures).
As to Claim 4, Stafford ‘322 teaches the following:
wherein the tissue piercing element 502 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 “introducer portion 502””, which is capable of performing the function based on its structure).
As to Claim 6, Stafford ‘322 teaches the following:
wherein the at least one electrode comprises a working electrode (“working electrode”, not labeled) and a reference electrode (“reference electrode”, not labeled) (see “As shown, the one or more contact points 504 of the sensor 503 (which in one embodiment may correspond to a respective one of the working electrode, a counter electrode, and a reference electrode, for example), are configured to couple to a respective contacts on the transmitter unit 101 (FIGS. 3A-3B) such that the sensor 503, which is in fluid contact with the patient's biological fluids, is in electrical communication with the transmitter unit 101.” in para. [0032]).
As to Claims 7 and 8, Stafford ‘322 teaches the following:
wherein the sensor body (body, not labeled, of “sensor 503”) further comprises a support member (“one or more contact points”) 504 configured to protect the membrane from damage during insertion of the sensor unit 503, wherein the at least one electrode is a support member (see figs. 9A and 9B).
As to Claim 9, Stafford ‘322 teaches the following:
wherein the support member (“one or more contact points”) 504, with the support of a guiding member (body portion, not labeled, of “introducer portion 502”) of the mounting unit 103, is capable of withstanding an axial load greater than about 1 Newton without substantial buckling (see para. [0033]; and matter of intended use of the “introducer portion 502”, which is capable of performing the function based on their structures).
As to Claims 10 and 11, Stafford ‘322 teaches the following:
wherein the support member (“one or more contact points”) 504 is configured to support at least a portion of the at least one electrode, and wherein the support member is configured to substantially surround the at least one electrode (see “As shown, the one or more contact points 504 of the sensor 503 (which in one embodiment may correspond to a respective one of the working electrode, a counter electrode, and a reference electrode, for example), are configured to couple to a respective contacts on the transmitter unit 101 (FIGS. 3A-3B) such that the sensor 503, which is in fluid contact with the patient's biological fluids, is in electrical communication with the transmitter unit 101.” in para. [0032]).
As to Claims 12 and 13, Stafford ‘322 teaches the following:
wherein the mounting unit 103 comprises a sensor electronics unit (“transmitter unit”) 102 operatively and detachably connected to the sensor body (body, not labeled, of “sensor 503”) (see “In a further embodiment, the transmitter unit 102 may includes a wireless communication unit for wireless transmission of the signal, where the wireless communication unit may include one or more of a radio frequency (RF) communication unit, a Bluetooth communication unit, an infrared communication unit, an 801.11x communication unit, or a Zigbee communication unit. Similarly, the receiver unit may be configured to support one more or of the above-referenced wireless communication protocols to communicate with the transmitter unit.” in para. [0042]), and wherein the sensor electronics unit 102 is configured to be located over a sensor insertion site (see fig. 2).
Allowable Subject Matter
10. Claims 14, 15, and 17-19 are allowed.
11. The following is a statement of reasons for the indication of allowable subject matter:
As to Claims 14, 15, and 17-19, neither Stafford ‘322, Say, Stafford ‘707, nor the prior art of record teaches the sensor array of base claim 14, including the following, in combination with all other limitations of the base claim:
a plurality of sensor devices each attached to the laminate and each configured for insertion through the skin at a different insertion site, wherein each sensor device comprises a sensor unit, the sensor unit comprising an in vivo portion having a tissue piercing element and a sensor body, the sensor body comprising at least one electrode and a membrane covering at least a portion of the at least one electrode, wherein each sensor device is configured for direct press insertion through the host's skin without the use of a separate applicator, and wherein the plurality of sensor devices comprises (i) at least one first sensor device configured to generate a glucose sensor signal indicative of glucose concentration, (ii) at least one second sensor device configured to generate a lactic-acid sensor signal indicative of lactic acid concentration, and (iii) at least one third sensor device configured to generate a ketone sensor signal indicative of ketone concentration, the first, second, and third sensor devices being different sensor devices.
Conclusion
12. 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.
13. 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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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 06/30/2026
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