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 .
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. Such claim limitation(s) is/are: “means for withdrawing and removing” in claims 5-6.
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 structural support(s) can at least be found in Fig. 4 (e.g. element N including elements 400 and S2) and paragraphs [0123-0124] of the PGPUB.
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 2 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). In regard to claim 2, the claim recites “the sensor probe is inserted into the body”. The phrase should be read as “the sensor probe is configured to be inserted into the body” to avoid improperly defining the apparatus in relation to a living being.
Claim Rejections - 35 USC § 102
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.
Claims 1-4 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pace et al. (USPGPUB 2013/0150691 – applicant cited). In regard to claim 1, Pace discloses a sensor applicator assembly for a glucose monitoring system (Figs. 1-51 and associated descriptions), comprising: a sensor module configured to measure a blood glucose level (elements 310, 312, 222, 2102, 2104, 2300, 2502, and/or 4100, Figs. 3, 10, 11F, 21, 23-24, and 41 and associated descriptions) and including a sensor probe (elements 1102, 2202, and/ or 2802, Figs. 10-11, 23, and 28 and associated descriptions) and a sensor housing surrounding a portion of the sensor probe to support the sensor probe (elements 310, 222, 2102, and/ or 2502, Figs. 3, 10, 11, 21, and 25 and associated descriptions); and an applicator in which the sensor module is fixedly coupled (elements 216 and/ or 314, Figs. 10-11 and associated descriptions), and configured to eject the sensor module through one open side thereof to attach the sensor module to a body of an object (lower opening of elements 216 and/or 314, Figs. 10-11 and associated descriptions), wherein a needle is detachably coupled to the sensor housing and penetrates the sensor housing in a first direction (element 1030 and associated penetration direction, Figs. 10-11 and associated descriptions), a needle head is disposed on a top end portion of the needle (elements 2106 and/or 2104, Figs. 21 and associated descriptions), a guide protrusion protrudes from a bottom end portion of the needle head in the first direction (one or more arms of element 2106 and/or element 2104, Figs. 21 and associated descriptions), the guide protrusion is positioned adjacent to the needle in a second direction different from the first direction (left or right direction(s) of element 2106 and/or element 2104 different than the top-down needle direction, Figs. 21 and associated descriptions), the sensor housing has a needle penetrating hole (the hole for receiving the needle, Figs. 21 and associated descriptions) and a guide hole defined in a position adjacent to the needle penetrating hole in the second direction (the guide holes for receiving the arms and/ or element 2104, Figs. 21 and associated descriptions), and wherein the needle is inserted into the needle penetrating hole and the guide protrusion is inserted into the guide hole (Figs. 21 and associated descriptions).
In regard to claim 2, Pace discloses one end portion of the sensor probe protrudes from a lower surface of the sensor housing (Figs. 10-11 and 21 and associated descriptions), and wherein the needle surrounding the one end portion of the sensor probe is inserted into the body together with the sensor probe in response to the sensor module being ejected (Figs. 10-11 and 21 and associated descriptions).
In regard to claim 3, Pace discloses the guide hole extends from the needle penetrating hole in the second direction (Figs. 21 and associated descriptions).
In regard to claim 4, Pace discloses the guide hole and the needle penetrating hole are connected to each other (Figs. 21 and associated descriptions).
In regard to claim 9, Pace discloses the guide protrusion is positioned in an outer side of the needle in the second direction, and the guide hole is positioned in an outer side of the needle penetrating hole in the second direction (Figs. 21 and associated descriptions).
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.
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Pace as applied to claims 1-4 and 9 above, and further in view of Halac et al. (USPGPUB 2017/0188912). In regard to claims 5-7, Pace discloses all the claimed limitations except the applicator includes: a main container having a press button mounted on a portion of the main container; a plunger body coupled to a first position within the main container, wherein the plunger body is decoupled from the first position and moves to a second position in response to the press button being manipulated, wherein the sensor module is coupled to one end of the plunger body such that the plunger body moves together with the sensor module from the first position to the second position; an elastic plunger spring for applying elastic force to the plunger body so that the plunger body moves from the first position to the second position; and a needle withdrawing means for withdrawing and removing the needle from the body by moving the needle after the needle is inserted into the body; wherein the needle withdrawing means includes: a needle withdrawing body engaged with the plunger body to move from the first position to the second position along with the plunger body, and coupled with the needle head disposed on the top end portion of the needle; and a needle withdrawing elastic spring for applying elastic force to the needle withdrawing body in a direction in which the needle withdrawing body moves toward the first position, wherein, when a movement of the plunger body to the second position is completed, the needle withdrawing body is disengaged from the plunger body and is moved by the elastic force of the needle withdrawing elastic spring; and wherein the main container includes an external container, on which the press button is mounted, and an internal container coupled to an interior of the external container to guide the plunger body along a path.
Halac teaches a sensor applicator assembly for a glucose monitoring system (Figs. 75-91 and associated descriptions) comprises a main container (elements 192q, 150q and/or 152q, Figs. 86-89 and associated descriptions) having a press button mounted on a portion of the main container (button, [0620]); a plunger body coupled to a first position within the main container (element 162q, Figs. 86-89 and associated descriptions), wherein the plunger body is decoupled from the first position and moves to a second position in response to the press button being manipulated (Figs. 86-87 and associated descriptions; [0620]), wherein the sensor module is coupled to one end of the plunger body such that the plunger body moves together with the sensor module from the first position to the second position (element 134q, Figs. 86-87 and associated descriptions; [0620]); an elastic plunger spring for applying elastic force to the plunger body so that the plunger body moves from the first position to the second position (element 402q, Figs. 86-87 and associated descriptions); and a needle withdrawing means for withdrawing and removing the needle from the body by moving the needle after the needle is inserted into the body (elements 160q and 234q, Figs. 86-87 and associated descriptions; [0620]); wherein the needle withdrawing means includes: a needle withdrawing body engaged with the plunger body to move from the first position to the second position along with the plunger body (element 160q, Figs. 86-87 and associated descriptions,) and coupled with a needle head disposed on the top end portion of the needle (the rod shape structure disposed on a top of the needle 156, (Figs. 86-89 and associated descriptions); and a needle withdrawing elastic spring for applying elastic force to the needle withdrawing body in a direction in which the needle withdrawing body moves toward the first position (element 234q, Figs. 86-87 and associated descriptions), wherein, when a movement of the plunger body to the second position is completed, the needle withdrawing body is disengaged from the plunger body and is moved by the elastic force of the needle withdrawing elastic spring (Figs. 87-88 and associated descriptions); and wherein the main container includes an external container (element 392q, Figs. 86-89 and associated descriptions), on which the press button is mounted ([0620]), and an internal container coupled to an interior of the external container to guide the plunger body along a path (element 150q and/or 152q, Figs. 86-89 and associated descriptions).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute at least a part of the applicator assembly (Pace) to the configuration of the applicator assembly and associated elements/ function as taught by Halac to yield predictable results, since both systems are glucose sensor applicator assemblies and one of ordinary skill in the art would have recognized that the configuration of the applicator assembly as taught by Halac is an alternative equivalent applicator assembly for disposing a glucose sensor on a body and retrieving a needle after positioning the sensor (see Halac). The rationale would have been the simple substitution of one known, equivalent element for another to obtain predictable results (obvious to substitute elements, devices, etc.), KSR, 550, U.S. at 417.
Allowable Subject Matter
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record does not teach or suggest “a needle head coupling portion is disposed on a bottom end portion of the needle withdrawing body and is coupled to the needle head disposed on the top end portion of the needle, and a needle support block is disposed on the needle withdrawing body to support the needle so that the needle does not move with respect to the needle withdrawing body”, in combination with the other claimed elements/ steps.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHU CHUAN LIU whose telephone number is (571)270-5507. The examiner can normally be reached M-Th (6am-6pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791
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