DETAILED ACTION
Claims 1-20 are pending and hereby under examination.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “22” has been used to designate both “adhesive material” in paragraph 0055 and “first o-ring” in paragraph 0063 and as depicted in Fig. 2. 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. 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 Objections
Claim 19 is objected to because of the following informalities:
Regarding claim 19, line 5, “and” should be removed.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“seal structure” first recited in claim 1.
The identified structure for the corresponding claim limitation is as follows:
“seal structure” is identified as “the seal structure includes first and second O-rings” (Paragraph 0012).
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
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-10 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Antonio (US 20210378560 – cited by Applicant) and Bond (US 20230167902).
Regarding claims 1-4, Antonio discloses a sensor device comprising:
a housing configured to be secured to a patient (paragraph 0073, “The adhesive patch 120 is coupled to the bottom housing portion 124 and affixes the bottom housing portion 124, and thus, the glucose sensor 114, to an anatomy, such as the skin of the user”);
a seal structure located within the housing (Fig. 3, sealing members 116a/b; Paragraph 0068, “The sealing members 116a, 116b comprise O-rings”); and
a sensor probe having at least one substrate supported by the housing (Fig. 3, glucose sensor 114; Paragraph 0002, thin film sensors), the substrate having a first length portion and a second length portion, the first length portion being external to the housing and configured to be inserted into the patient when the housing is secured to the patient (Paragraph 0066, “Generally, a distal end 114a of the glucose sensor 114 is cannulated and positionable in subcutaneous tissue of the user by an insertion needle of the sensor inserter 104 to measure the glucose oxidase enzyme”), the second length portion being in or on the housing and having a section that extends through the seal structure (Fig. 3, base 156 of glucose sensor 114; Fig. 5, wherein base 156 extends through sealing members 116a/b);
wherein the section of the second length portion of the at least one substrate that extends through the seal structure has at least one side edge (Fig. 3, base 156 having side edges).
Antonio fails to explicitly disclose wherein at least one edge, or two edges, has a tortuous edge pattern that enhances a seal effect of the seal structure at the section of the second length portion of the at least one substrate, and wherein the edge pattern comprises a wave pattern having a plurality of peaks and valleys.
However, Bond teaches a gasket for sealing two mated surface, wherein at least one sealing layer overlays onto a serrated region 110 containing a plurality of serrations 118 on either face (Figs. 4A-E, wherein the serrations have peaks and valleys), which is useful to provide an effective seal when the sealing layer is pressed into the serrations (Paragraph 0088). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the base edge of the glucose sensor in Antonio to include the serrated edge of Bond to provide an effective seal of the sealing layer.
Regarding claim 5, Antonio as modified further discloses wherein the seal structure comprises first and second O-rings, and the section of the second length portion of the sensor substrate extends between the first and the second O-rings (Figs. 3 and 5, wherein base 156 sits between sealing elements 116a/b; Paragraph 0068, “The sealing members 116a, 116b comprise O-rings”).
Regarding claim 6, Antonio as modified further discloses wherein the housing comprises a base and a cover (Fig. 3, top housing portion 122 and bottom housing portion 124), and wherein the sensor device comprises a stacked arrangement including the first O-ring arranged on the base (Fig. 3, sealing member 116b on bottom housing portion 124), the section of the second length portion of the sensor substrate arranged on the first O-ring (Fig. 3, glucose sensor 114 with base 156 arranged between sealing members 116a/b), the second O-ring arranged on the section of the second length portion of the sensor substrate, and the cover arranged on the second O-ring (Fig. 3, sealing member 116a on base 156 and under top housing portion 112).
Regarding claim 7, Antonio as modified further discloses wherein the housing includes a base and a cover, wherein the base has a first annular cavity in which the first O-ring resides, and the cover has a second annular cavity in which the second O-ring resides (Fig. 5, diamond shaped cavity 136 for sealing members 116a/b).
Regarding claim 8, Antonio as modified further discloses wherein at least one of the first and second annular cavities has a cross-section shape that tapers from a narrower dimension toward a depth of the cavity, to a wider dimension toward an open side of the cavity to enhance compression of the O-ring residing therein, when the base and the cover are coupled together (Fig. 5, diamond shaped cavity 136 narrow at the top and bottom and widening towards the base 156).
Regarding claim 9, Antonio as modified further discloses wherein each of the first and second annular cavities has a cross-section shape that tapers from a narrower dimension toward a depth of the cavity, to a wider dimension toward an open side of the cavity to enhance compression of the O-rings, when the base and the cover are coupled together (Fig. 5, diamond shaped cavity 136 narrow at the top and bottom and widening towards the base 156).
Regarding claim 10, Antonio as modified further discloses wherein the at least one substrate of the sensor probe comprises a first substrate having one or more electrical conductors or electrical components (Fig. 3, printed circuit board assembly 118 with PCB 164, magnet sensor 119, controller 162, and spring contacts in contact with glucose sensor 114; Paragraphs 0069-0070).
Regarding claims 17-18, Antonio discloses a method of making a sensor device, the method comprising:
providing a housing configured to be secured to a patient (paragraph 0073, “The adhesive patch 120 is coupled to the bottom housing portion 124 and affixes the bottom housing portion 124, and thus, the glucose sensor 114, to an anatomy, such as the skin of the user”);
arranging a seal structure located within the housing (Fig. 3, sealing members 116a/b; Paragraph 0068, “The sealing members 116a, 116b comprise O-rings”); and
supporting a sensor probe having at least one substrate supported by the housing (Fig. 3, glucose sensor 114; Paragraph 0002, thin film sensors), the substrate having a first length portion and a second length portion, the first length portion being external to the housing and configured to be inserted into the patient when the housing is secured to the patient (Paragraph 0066, “Generally, a distal end 114a of the glucose sensor 114 is cannulated and positionable in subcutaneous tissue of the user by an insertion needle of the sensor inserter 104 to measure the glucose oxidase enzyme”), the second length portion being in or on the housing and having a section that extends through the seal structure (Fig. 3, base 156 of glucose sensor 114; Fig. 5, wherein base 156 extends through sealing members 116a/b);
wherein the section of the second length portion of the at least one substrate that extends through the seal structure has at least one side edge (Fig. 3, base 156 having side edges).
Antonio fails to explicitly disclose wherein at least one edge has a tortuous edge pattern that enhances a seal effect of the seal structure at the section of the second length portion of the at least one substrate, and wherein the edge pattern comprises a wave pattern having a plurality of peaks and valleys.
However, Bond teaches a gasket for sealing two mated surface, wherein at least one sealing layer overlays onto a serrated region 110 containing a plurality of serrations 118 on either face (Figs. 4A-E, wherein the serrations have peaks and valleys), which is useful to provide an effective seal when the sealing layer is pressed into the serrations (Paragraph 0088). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the base edge of the glucose sensor in Antonio to include the serrated edge of Bond to provide an effective seal of the sealing layer.
Regarding claim 19, Antonio as modified further discloses wherein arranging a seal structure within the housing comprises:
arranging a first O-ring on a base of the housing, the first O-ring having a central opening (Fig. 3, sealing member 116b on bottom housing portion 124);
arranging a portion of the at least one substrate to extend through the opening in the first O-ring (Fig. 3, glucose sensor 114 with base 156 arranged between sealing members 116a/b);
arranging the second O-ring on the first O-ring, with a central opening of the second O-ring in alignment with the central opening first O-ring (Fig. 5, sealing members 116a/b arranged on each other and aligned with central opening); and
extending a section of a second portion of the at least one substrate between the first O-ring and the second O-ring (Fig. 5, glucose sensor with distal end 114a within sealing member 116b and base 156 between sealing members 116a/b).
Regarding claim 20, Antonio as modified further discloses wherein:
the housing includes a base and a cover configured to couple together;
arranging a first O-ring comprises locating the first O-ring in a first annular cavity in the base;
arranging the second O-ring comprises locating the second O-ring in a second annular cavity in the cover (Fig. 5, sealing members 116a/b within diamond shaped cavity 136);
at least one of the first and second annular cavities has a cross-section shape that tapers from a narrower dimension toward a depth of the cavity, to a wider dimension toward an open side of the cavity to enhance compression of the O-ring residing therein, when the base and the cover are coupled together (Fig. 5, diamond shaped cavity 136 tapered from narrow ends spaced away from base 156 and widens toward base 156).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Antonio and Bond as applied to claim 10 above, and further in view of Antonio (US 20170290533 – cited by Applicant), hereinafter “Antonio 2017”, and Hsu (US 20160045158).
Regarding claims 11 and 13, Antonio as modified discloses the sensor probe as described above. Antonio as modified fails to disclose wherein the probe contains a second substrate and wherein the second substrate has a coating of a drug or treatment substance on one side.
However, Antonio 2017 teaches an insertion device with a sensor and sealing members (Fig. 4), wherein the probe contains a second substrate (Figs. 69A-B, first sensor 6940 and second sensor 6944; Figs. 79, first sensor 7940 and second sensor 7944). A particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been motivated in applying this known technique of having two sensors of Antonio 2017 to the known device of Antonio as modified that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Antonio and Bond to incorporate the teachings of Antonio 2017 and the results of having two sensors would have been predictable to one of ordinary skill in the art.
Hsu teaches a device for monitoring a subject wherein a surface of the transdermal sensor is coated with a therapeutic agent (Paragraph 0019) on the contact surface (Paragraph 0025, which Examiner interprets that only one side is coated) which is useful for passive/active transdermal drug delivery (Paragraph 0019). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Antonio, Bond, and Antonio 2017 to incorporate the therapeutic agent coating of Hsu for passive/active transdermal drug delivery.
Regarding claim 12, Antonio as modified fails to explicitly disclose wherein the second substrate has a mark or other indicia that identifies the one side provided with the coating of the drug or treatment substance.
However, Antonio 2017 teaches an insertion device wherein visual markings are applied on the insertion device (Figs. 47A-B, markings 4716/4718). A particular known technique of applying a visual marking to convey a message was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been motivated to apply this known technique of using a marking to convey a message of Antonio 2017 to the known device of Antonio, Bond, and Hsu that was ready for improvement and the results of indicating a drug-coated side of a substrate would have been predictable to one of ordinary skill in the art.
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Antonio (US 20210378560 – cited by Applicant), Bond (US 20230167902), and Van Antwerp (US 7468033 – cited by Applicant).
Regarding claims 14-16, Antonio discloses an electronics substrate comprising:
a body of a sensor having one or more electrically conductive members or electrical components supported thereon (Fig. 3, glucose sensor 114; Fig. 3, printed circuit board assembly 118 with PCB 164, magnet sensor 119, controller 162, and spring contacts in contact with glucose sensor 114; Paragraphs 0069-0070), the body having a length portion having a section configured to extend through a seal structure (Fig. 5, base 156 of sensor 114 passing through seal members 116a/b);
Regarding the claim limitations of claims 14-16, while Antonio discloses a thin film sensor (Paragraph 0002), Antonio fails to explicitly disclose a body of electrically insulating material. Antonio also fails to disclose a section of the length portion of the sensor having at least one side edge having an undulating edge pattern, and the undulating edge pattern comprises a wave pattern having a plurality of peaks and valleys.
However, Van Antwerp discloses an insulating layer on the sensor apparatus which is used to protect a portion of the sensor (Col 10, lines 50-62). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the thin film sensor of Antonio to include an electrically insulating layer of Van Antwerp to protect a portion of the sensor.
Bond teaches a gasket for sealing two mated surface, wherein at least one sealing layer overlays onto a serrated region 110 containing a plurality of serrations 118 on either face (Figs. 4A-E, wherein the serrations have peaks and valleys), which is useful to provide an effective seal when the sealing layer is pressed into the serrations (Paragraph 0088). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the base edge of the glucose sensor in Antonio and Van Antwerp to include the serrated edge of Bond to provide an effective seal of the sealing layer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791