DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The action is in response to the application filed on 02/04/2025. Claims 1-25 are pending and examined below.
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.
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 4, 5, 12, 16, 17, 18, 19, 21, 25, and claims dependent thereof 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.
Regarding claims 4, 5, 12, 16, 17, 18, 19, 21, 25, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 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.
Claim(s) 1-2, 6-8, 14-22 is/are rejected under 35 U.S.C. 102(a)(1) as being rejected by US 20170188910 A1 (hereinafter referred to as “Halac”).
Regarding claim 1, Halac, a transcutaneous sensor, teaches an anchoring assembly for attaching a sensor assembly (134) to a sensor base (126, 128; as shown in Figures 3-4), the sensor assembly comprising:
an analyte sensing device (138; Figures 1-4); and
a sensor module (192; Figures 1-4);
wherein the sensor base comprises a first surface comprising a first area adapted to receive the sensor module and an opposite second surface, the second surface comprising an adhesive (paragraph [0272]; as shown in Figures 4-5);
wherein the sensor module comprises a sensor module baseplate comprising an outer surface adapted to be placed on the first surface and an opposite inner surface and a sensor module edge delimiting the outer and the inner surface (312; paragraph [0470]; Figures 33-39);
wherein the sensor module further comprises a sensor module housing mounted on the inner surface of the sensor module baseplate (192; paragraph [0470]; as shown in Figures 33-39);
wherein said sensor module is adapted to be coupled to the first surface of the sensor base by first means (202; 206; paragraphs [0331]-[0334]; Figures 15-16);
wherein the first means comprises first attaching means being a part of the sensor assembly and adapted to attach to second attaching means being a part of the sensor base (paragraph [0328]; Figure 16); and
wherein the first means further comprises guiding means for guiding the sensor module to the first area (182, 206; Figures 4, 15, 16. 33-39).
Regarding claim 2, Halac teaches wherein the guiding means comprises a pater-mater arrangement the pater part is a part of the sensor assembly and the mater part is a part of the sensor base or the pater part is a part of the sensor base and the mater part is a part of the sensor assembly (as shown in Figures 15-16).
Regarding claim 6, Halac teaches wherein the guiding means is an integrated part of the first and the second attachment means, and/or
wherein the first attaching means comprises the outer surface and the second attaching means comprises a double sided adhesive pad one side of the pad adapted to adhere to the first surface of the sensor module and the opposite side of the pad adapted to adhere to the outer surface, and/or
wherein the second attaching means comprises flexible latch arms with latch fingers and placed on the sensor module and adapted for snap-fit engagement with the first attaching means being a part of the sensor assembly, or
wherein the second attaching means comprises flexible latch arms with latch fingers adapted for snap-fit engagement with the first attaching means comprising the sensor module baseplate, or
wherein the second attaching means comprises flexible latch arms with latch fingers adapted for snap-fit engagement with the first means comprising corrugations placed at the outside of the sensor module housing (as shown in Figures 4, 15, 16).
Regarding claim 7, Halac teaches An inserter assembly for inserting an analytic sensoring device (138) such as a continuous glucose monitoring sensor into a subcutaneous tissue of a body, said inserter assembly comprising an insertion device (132) comprising a cover (152) with a first end and an opposite second end (Figures 61-64) and a sensor carrier (162) placed inside the cover comprising insertion means (156) such as an insertion needle, said sensor carrier is moved from a first position (Fig. 61) to a second position (Figure 63) by activating a first energy storing unit (402) activated by an deployment device (396,404) placed in the insertion device, the inserter assembly further comprising a sensor assembly (134) comprising the continuous glucose monitoring sensor (138) adapted to be inserted and placed into the tissue when the sensor carrier is in the second position (paragraph [0287]); a sensor base (128) placed at the second end of the cover (Figs. 61-64) comprising a first surface comprising a first area adapted to receive a sensor module and an opposite second surface (Figures 4-6, 61-64), the second surface comprising an adhesive (126) adapted to adhere to a surface (paragraph [0275]) wherein the sensor assembly comprises the sensor module (192) connected to the continuous glucose monitoring sensor (138), said sensor module comprises a sensor module baseplate (312) comprising an outer surface adapted to be placed at the first surface and an opposite inner surface and a sensor module edge delimiting the outer and the inner surfaces (Figs. 34-39); the sensor module further comprises a sensor module housing (192) mounted at the inner surface of the sensor module baseplate (Figs. 34-39), said sensor module is adapted to be moved together with the continuous glucose monitoring sensor by a piston (150), and in the second position of the sensor carrier the sensor module is by first means adapted to be attached to the first surface of the sensor base (Fig. 63) and the continuous glucose monitoring sensor is placed in the subcutaneous tissue when the sensor carrier reaches its second position (paragraph [0236]; Fig. 63) wherein, said first means comprises first attaching means (202) being a part of the sensor assembly and adapted to attach to second attaching means (206) being a part of the sensor base (paragraph [0328]; Fig. 16) and that the first means further comprises guiding means (182,206) for guiding the sensor module to the first area (Figs. 4, 15, 16).
Regarding claim 8, Halac teaches wherein the guiding means comprises a pater-mater arrangement the pater part is a part of the sensor assembly and the mater part is a part of the sensor base or the pater part is a part of the sensor base and the mater part is a part of the sensor assembly (as shown in Figures 4, 15, 16).
Regarding claim 14, Halac teaches wherein the guiding means is an integrated part of the first and the second attachment means, and/or
wherein first attaching means comprises the outer surface and the second attaching means comprises a double sided adhesive pad one side of the pad adapted to adhere to the first surface of the sensor module and the opposite side of the pad adapted to adhere to the outer surface, or
wherein the second attaching means comprises flexible latch arms with latch fingers and placed at the sensor module and adapted for snap-fit engagement with the first attaching means being a part of the sensor assembly, or
wherein the second attaching means comprises flexible latch arms with latch fingers adapted for snap-fit engagement with the first attaching means comprising the sensor module baseplate, or
wherein the second attaching means comprises flexible latch arms with latch fingers adapted for snap-fit engagement with the first means comprising corrugations placed at the outside of the sensor module housing, and/or
wherein the sensor base is adapted to cover a passage encircled by the second end of the cover, whereby the sensor carrier and the sensor assembly is enclosed in a cavity formed by the cover and the sensor base, and that the inserter assembly comprises means adapted to attach the sensor base to the insertion device (Figures 4, 15, 16, 33-39).
Regarding claims 15, Halac teaches wherein the inserter assembly further comprises a second energy storing unit, said second energy storing unit is activated by activating means when the sensor carrier reaches its second position, by said activating the sensor carrier is adapted to be moved to a third position different from the second position, and in a direction towards the first end of the cover (paragraphs [0572]-[0579]; Figures 61-64).
Regarding claim 16, Halac teaches wherein the first energy storing unit comprises at least a first spring adapted to bring the sensor carrier from the first position to the second position and the second energy storing unit comprises a second spring adapted to transport the sensor carrier to the third position, and a longitudinal central axis of the first spring is coinciding with a longitudinal central axis of the second spring, and optionally
(i) wherein the first spring is a coil spring placed inside the piston and surrounding the sensor carrier, said spring is compressed, when the sensor carrier is in the first position, and with a first free end placed nearest the second end of the cover is pressing towards an inside surface of the piston, and the second opposite placed free end of the spring is pressed towards a part of the inserter assembly placed opposite the inside surface of the piston, or
(ii) wherein the second spring is a coil spring and placed inside the sensor carrier in a cavity, said first free end of the second spring abuts against an internal base part of the piston and an opposite placed second free end of the second spring abuts against an internal upper surface of the sensor carrier (paragraphs [0572]-[0579]; Figures 61-64).
Regarding claim 17, Halac teaches wherein an inner housing encircles the piston, and a base lock is placed around the inner housing and being slidable in the longitudinal direction of the assembly, said inner housing comprises releasable locking means adapted to lock the sensor base to the insertion device when the sensor carrier is in the first position, said locking means is adapted to be released by the base lock when the sensor carrier is in the second position thereby releasing the sensor base from the insertion device, and optionally wherein the base lock comprises a sleeve surrounding a portion of the inner housing and further comprising flexible arms the longitudinal axes thereof being parallel with a longitudinal axis of the inserter assembly (paragraphs [0348]-[0349]; Figure 18).
Regarding claim 18, Halac teaches wherein the sensor module comprises electrical connectors for connecting to an electrical circuitry and for transmitting the signals received from the continuous glucose monitoring sensor to a transmitter, and optionally wherein the transmitter comprises an electrical circuitry for transmitting signals received from the sensor assembly to a remote unit and the transmitter further comprises a power supply such as batteries (paragraphs [0456]-[0496]; Figures 4, 33-38).
Regarding claim 19, Halac teaches wherein the first surface of the sensor base comprising the first area adapted to receive the sensor module further comprises a second area separated from the first area comprising a through-going bore in said sensor base, said through-going bore is adapted to receive a part of the continuous glucose monitoring sensor and to secure an upper part of the continuous glucose monitoring sensor to the sensor base, and optionally wherein the second area further is adapted to fasten an upper part of the continuous glucose monitoring senor to the sensor base while a lower part of the continuous glucose monitoring sensor comprising a pin-formed elongated body is injected through the bore and is placed in the subcutaneous tissue when the sensor carrier reaches its second position (as shown in Figures 4, 15, 16, 33).
Regarding claim 20, Halac teaches wherein the injection means comprises an insertion needle, which in sectional view is C-formed comprising a lateral opening delimited by sidewalls and a sharp tip and that the lateral opening of the C-form comprises a sharp region at both limiting sidewalls, and/or wherein the piston comprises a lower piston-surface part adapted to abut against a top-surface of the sensor module, said piston surface and the injection needle are moved synchronous from the first position to the second position, said the injection needle and the lower piston surface part are placed in a distance from each other (as shown in Figures 42-43, 61-63).
Regarding claim 21, Halac teaches wherein the sensor carrier comprises a needle hub attaching the insertion needle; the needle hub is configured to be moved by the piston from the first to the second position, and optionally wherein the sensor carrier comprises a hollow part in which the needle hub is placed and that the second energy storing unit is placed in a circular cavity arranged between the outside of the needle hub and the inside of the hollow part when the sensor carrier is in the first position and the second position (as shown in Figures 42-43, 61-63).
Regarding claim 22, Halac teaches wherein the first means comprises flexible elongated retention arms comprising retention means such as taps or beards adapted to be locked into recesses (as shown in Figures 4, 15, 16, 33).
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 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.
Claim(s) 3, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halac as applied to claim 1 above, and further in view of EP 3771409 A1 (hereinafter referred to as “Huang”).
Regarding claims 3 and 9, Halac does not explicitly teach wherein the guiding means comprises at least one projecting converging part being a part of either the sensor base or the sensor assembly; said projecting converging part is adapted to fit into a projecting-receiving-opening being a part of either the sensor base or the sensor assembly and the part opposite where the projecting converging part(s) is/are placed,
or wherein the guiding means comprises at least two projecting converging parts a first projecting converging part and a second projecting converging part said both projecting converging parts are placed at the first surface of the sensor module and that sensor assembly comprises the same amount of projecting-receiving-openings as the number of projecting converging parts said each projecting converging part fits into such an opening,
or wherein the guiding means comprises one projecting converging part being a part of the sensor module base plate, said sensor module edge of the sensor module base plate is converging towards the first surface of the sensor module; and that the guiding means further comprises a substantially annular wall possibly separated into segments and placed on the first surface said projecting converging part is adapted to snap fit into the annular wall.
However, Huang teaches wherein the guiding means comprises at least one projecting converging part being a part of either the sensor base or the sensor assembly; said projecting converging part is adapted to fit into a projecting-receiving-opening being a part of either the sensor base or the sensor assembly and the part opposite where the projecting converging part(s) is/are placed,
or wherein the guiding means comprises at least two projecting converging parts a first projecting converging part and a second projecting converging part said both projecting converging parts are placed at the first surface of the sensor module and that sensor assembly comprises the same amount of projecting-receiving-openings as the number of projecting converging parts said each projecting converging part fits into such an opening,
or wherein the guiding means comprises one projecting converging part being a part of the sensor module base plate, said sensor module edge of the sensor module base plate is converging towards the first surface of the sensor module; and that the guiding means further comprises a substantially annular wall possibly separated into segments and placed on the first surface said projecting converging part is adapted to snap fit into the annular wall (paragraph [0073]; as shown in Figure 49). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Halac, for the guiding means to have a projection, as taught by Huang, because doing so helps to secure the sensor in the preferred position.
Conclusion
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/ABID A MUSTANSIR/ Examiner, Art Unit 3791
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