DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 16 and 24 are objected to because of the following informalities: Claim 16 requires a period at the end of the claim. Claim 24 recites “ ; ” at the end of the sentence, but instead should recite a period. 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 14-30 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.
The term “substantially” in claim 14 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what the term “substantially” imposes on the drive direction, e.g., %20, +/- 2, etc. For examination purposes, the limitation can be interpreted to be broad or narrow.
Claim 16 recites “wherein the introducer comprises an insulative between” in lines 1-2, but is indefinite. What is the insulative referring to, a layer, a coating, etc.? For examination purposes, any insulative component is interpreted to teach the limitation. Further clarification required.
Claim limitation “first and second electrical contacts” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. It is unclear what the structural component that the electrical contacts are correlated to. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims not listed are rejected by virtue of claim dependency.
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 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 –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 14, 16-20, 23, and 25-30 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Brister et al. (US 20090076360), hereinafter Brister.
Regarding claim 1, Brister teaches an assembly for applying an on-body patch device to a skin surface of a user, the assembly comprising: an insertion device (see figs. 1, 6, 8A, 22B-C), comprising:
a housing (see fig. 6, applicator body 18);
an introducer (Id. guide tube 66); and
a bias spring (see para. [0251,0260], “Although the embodiments described herein suggest manual insertion and/or retraction of the various components, automation of one or more of the stages can also be employed. For example, spring-loaded mechanisms that can be triggered to automatically insert and/or retract the sensor, needle, or other cooperative applicator components can be implemented” thereby indicating that a bias spring to aid in retracting and inserting);
the on-body patch device, comprising:
an in vivo analyte sensor (see figs. 3 and 22B, sensor 32,432); and
sensor electronics comprising a first electrical contact biased towards a second electrical contact (see para. [0470], “wherein a cannula layer is provided, the system is configured such that the electrical contacts are held apart by the cannula layer, such that removal of the cannula layer activates the electrical connection of the sensor and electrical contacts”; see figs. 7A-D and 10A-B and para. [0167-169], “ the sensor 32 extends through the contacts 28 wherein the sensor is electrically and mechanically secure by the relaxation of elastomer around the sensor” and “, a conductive, stiff plastic forms the contacts, which are shaped to comply upon application of pressure (for example, a leaf-spring shape).” Which indicates that the electrical contacts are biased towards adjacent contacts via several methods),
wherein the introducer separates the first electrical contact and the second electrical contact when the introducer and the on-body patch device are in a pre-deployment position (see fig. 7A and 22B, before deployment of the sensor the contacts are separated by the introducer),
wherein, in response to a force applied on the housing, the introducer and the on- body patch device are configured to be driven in a direction substantially perpendicular to the skin surface from the pre-deployment position to an insertion position (see fig. 1),
wherein the bias spring is configured to retract the introducer from the insertion position to a retracted position (see para. [0251,0260], spring aids in retracting and inserting), and
wherein the first electrical contact and the second electrical contact are configured to contact each other when the introducer is retracted, and to establish an electrical connection and activate the on-body patch device (see para. [0150,0155,0167-169,0470], the electrical circuit with the electrical contacts and the sensor is achieved upon retraction of the introducer, leaving only the patch and sensor; see para. [0468], “During sensor insertion/deployment, the sensor is configured to be received by and slide through the cannula layer 460, after which the cannula layer is removed and a seal is formed around the electrical contacts. In some embodiments, some or the entire sensor is pre-inserted through the cannula layer. Alternatively, an applicator can be provided to cooperate with the cannula layer to enable sensor insertion there through”).
Regarding claim 16, Brister teaches wherein the introducer comprises an insulative between the first electrical contact and the second electrical contact when the introducer and the on body patch device are in the pre-deployment position (see para. [0468], “one exemplary material suitable for use with the cannula layer is tetrafluoroethylene” which indicates there is an insulative layer between the first and second electrical contact before deployment).
Regarding claim 17, Brister teaches wherein the separation of the first electrical contact and the second electrical contact by the introducer comprises a break in a circuitry of the sensor electronics (see para. [0470, “removal of the cannula layer activates the electrical connection” ).
Regarding claim 18, Brister teaches wherein the sensor electronics further comprises a battery, and wherein the break in the circuitry of the sensor electronics comprises a break between the battery and a remaining circuitry of the sensor electronics (see para. [0321,0325], disposable region comprises the battery and the sensor system is reusable).
Regarding claim 19 Brister teaches wherein contact between the first electrical contact and the second electrical contact, when the introducer is retracted, comprises a completion in the break in the circuitry of the sensor electronics (see para. [0470], “the system is configured such that the electrical contacts are held apart by the cannula layer, such that removal of the cannula layer activates” indicating that, when apart, the device is deactivated).
Regarding claim 20, Brister teaches wherein the first electrical contact and the second electrical contact are spring-loaded towards each other (see para. [0168-169], “ a conductive, stiff plastic forms the contacts, which are shaped to comply upon application of pressure (for example, a leaf-spring shape)” and “a wiping action can be incorporated into the design to remove contaminants from the surfaces during connection”).
Regarding claim 23, Brister teaches wherein the bias spring is configured to retract the introducer from the insertion position to the retracted position in a direction opposite to the direction in which the introducer and the on-body patch device are driven from the pre-deployment position to the insertion position (see para. [0251,0260], “ automated insertion and/or retraction of the sensor/needle, for example, using spring-loaded components”).
Regarding claim 25, Brister teaches wherein the introducer is entirely retained with the housing of the insertion device when the introducer is in the retracted position (see figs. 1, 6 and 8G).
Regarding claim 26, Brister teaches wherein the insertion device is configured to be removed from the skin surface, while the on-body patch device is retained on the skin surface, after the bias spring retracts the introducer to the retracted position (see fig. 8G).
Regarding claim 27, Brister teaches wherein the insertion device further comprises an end cap configured to be rotatably coupled to the housing of the insertion device (see para. [0261], “a continuous torque, when the applicator components are configured to rotatingly engage one another, can replace the continuous force.” Which indicates that instead of pushing the end cap for insertion/retraction, the end cap can be twisted to provide the same action).
Regarding claim 28, Brister teaches wherein the on-body patch device further comprises an adhesive layer disposed on a bottom surface of the on-body patch device, wherein the adhesive layer disposed on a bottom surface of the on-body patch device to the skin surface of the user (see para. [0159], “an adhesive pad, preferably disposed on the mounting unit's back surface ”).
Regarding claim 29, Brister teaches wherein the in vivo analyte sensor comprises: a proximal portion configured to be positioned above the skin surface and in electrical communication with the sensor electronics; and a distal portion configured to be transcutaneously positioned under the skin surface in fluid contact with interstitial fluid, and to detect an analyte level in the interstitial fluid (see para. [0171], “ the sensor 32 includes a distal portion 42, also referred to as the in vivo portion, adapted to extend out of the mounting unit for insertion under the host's skin, and a proximal portion 40, also referred to as an ex vivo portion, adapted to remain above the host's skin after sensor insertion and to operably connect to the electronics unit”).
Regarding claim 30, Brister teaches wherein the introducer is configured to position the distal portion of the in vivo analyte sensor under the skin surface in fluid contact with the interstitial fluid when the introducer and the on-body patch device are driven to the insertion position (see para. [0148,0171], “ A transcutaneous analyte sensor system is provided that includes an applicator for inserting the transdermal analyte sensor under a host's skin” ).
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 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.
Claim 15 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Brister, as applied to claim 14, further in view of Straessler et al. (US 20100234830), hereinafter Straessler.
Regarding claim 15, Brister fails to teach wherein the introducer comprises a non-conducting needle.
Straessler teaches a patch-type medical device that monitors analyte of a user (see abstract, para. [0062] and figs. 1a-b). The device comprising a needle made out of plastics (see para. [0074]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Brister, such that the assembly comprises a non-conducting needle, as taught by Straessler, because Brister requires a needle, but fails to provide details. Straessler teaches a needle made out of plastic can aid with measuring analytes.
Claims 21-22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Brister, as applied to claim 14, further in view of Shaw et al. (US 20090306601), hereinafter Shaw.
Regarding claims 21-22, Brister fails to teach wherein the introducer comprises a plastic material or a glass material.
Shaw teaches a medical device comprising a needle for insertion in a subject (see abstract and fig. 1). The device further comprises a housing, actuators, caps, covers, that are formed from plastic, metal, ceramic, or the like (see para. [0066]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Brister, such that the introducer of the needle comprises plastic material or glass material, as taught by Shaw, as it would merely be substituting of one known element (glass or plastic) for another (undisclosed material of Brister) to obtain predictable results.
Claim 24 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Brister, as applied to claim 14, further in view of Peyser et al. (US 20070249922), hereinafter Peyser.
Regarding claim 24, Shaw fails to teach wherein the on-body patch device is configured to be disposed entirely within the insertion device when the introducer and the on-body patch device are in the pre-deployment position.
Peyser teaches a medical device configured to be inserted in a patient for analyte monitoring (see abstract). The device comprising a patch device for attachment with the user and an insertion device, wherein the patch device is disposed entirely within the insertion device (see figs. 19A-D and 20A-22D, insertion device 1803 and patch type sensor 1804).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have changed the shape of the patch device, such that it was disposed entirely within the insertion device, as it would not have modified the operation of the device and is an obvious matter of design choice (see MPEP 2144.04 IV. B)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Micinski teaches a sensor-dispensing instrument 390, the button 392 is pressed causing an electrical connection (not shown) between the button 392 and the motor 400 (FIG. 30B) to be made, and therefore causing the motor 400 to be activated. (US 20070241126 A1)
Funderburk teaches using a spring to retract and insert a sensor for analyte detection. (US 20040133164 A1)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN NATHAN ORTEGA whose telephone number is (571)270-7801. The examiner can normally be reached M-F 7:10 am - 5:00 pm.
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791