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 Objections
Claims 4 are objected to because of the following informalities:
Claim 4 recites “wherein device for delivering medicament” in line 1-2. This was likely intended to read “wherein the device for delivering medicament”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
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.
Claims 1 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.
As to claim 1, the examiner recommends removing the wording of “for delivering the medicament to the user” after the first instance. Certain recitations make it unclear if this is merely referring to the device introduced in line 2, or if it is referring to a new function. For example, “the needle cartridge assembly configured to move from (1) a telescoping position above the device for delivering medicament…” makes it sound as if the needle cartridge assembly being in the telescoping position is for delivering medicament, which appears to be contrary to how the system works. The examiner notes that multiple dependent claims recite similar wording.
Claim 1 recites the limitation "the detachable activation" in the final 2 lines of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites “the device for delivering”, which is inconsistent with other claims that recite “the device for delivering medicament” and is therefore unclear (however, see rejection of claim 1 above).
Claim 11 recites “the device for delivering”, which is inconsistent with other claims that recite “the device for delivering medicament” and is therefore unclear (however, see rejection of claim 1 above).
Claim 11 recites the limitation "the detachable activation" in the final 2 lines of the claim. There is insufficient antecedent basis for this limitation in the claim.
As to claim 30, the examiner recommends removing the wording of “for delivering the medicament to the user” after the first instance. Certain recitations make it unclear if this is merely referring to the device introduced in line 2, or if it is referring to a new function. For example, “the needle cartridge assembly configured to move from (1) a telescoping position above the device for delivering medicament…” makes it sound as if the needle cartridge assembly being in the telescoping position is for delivering medicament, which appears to be contrary to how the system works. The examiner notes that multiple dependent claims recite similar wording.
Claim 30 recites the limitation "the detachable activation" in the final 2 lines of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 34 recites “a baseplate having a floor and wall that extend from the floor”, which is grammatically incorrect and unclear if the claim is trying to say there are multiple walls that extend from the floor or a single wall that extends from the floor.
Claim 34 recites the limitation "the first and second spaced walls of the needle cartridge assembly" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 34 was perhaps intended to depend from claim 33 which gives proper antecedent basis.
Claim 35 recites “the device for delivering”, which is inconsistent with other claims that recite “the device for delivering medicament” and is therefore unclear (however, see rejection of claim 30 above).
As to claim 40, the examiner recommends removing the wording of “for delivering the medicament to the user” after the first instance. Certain recitations make it unclear if this is merely referring to the device introduced in line 2, or if it is referring to a new function. For example, “the needle cartridge assembly configured to move from (1) a telescoping position above the device for delivering medicament…” makes it sound as if the needle cartridge assembly being in the telescoping position is for delivering medicament, which appears to be contrary to how the system works. The examiner notes that multiple dependent claims recite similar wording.
Claim 40 recites the limitation "the detachable activation" in the final 2 lines of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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)(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 12, 30-34, 40-44 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamen et al. (US 2007/0228071, hereafter “Kamen”).
An infusion system (10; see Figs. 63A-64D, 66A-67F, 93A-93C) comprising:
a device (disposable part Y) for delivering medicament to a user, the device configured to be mounted to the user (para 0226, 0459);
an infusion needle (cannula 5010) for delivering the medicament to the user (Fig. 86A, para 0447, 0448);
a needle cartridge assembly (5040) for supporting the infusion needle, the needle cartridge assembly configured to move from (1) a telescoping position above the device for delivering medicament, wherein the infusion needle is in a retracted position within the device for delivering medicament (see inserter 5100 which installs assembly 5040 into base of patch infusion device and into tissue, FIGS. 89, para [0455]: "5040 to an automatic inserter. For example, the releases shown in FIGS. 86A-86B as 5052 may receive pins of an automatic insertion device. Referring to both FIGS. 89A and 89B a representative embodiment of an automatic inserter 5100 is shown. As shown in the front view of FIG. 89A, the inserter 5100 includes pins 5130 which travel in pin slots 5140 within an inserting cartridge recess 5120. In practice, the infusion and sensor assembly (not shown, shown in FIGS. 86A and 86B as 5040) is pressed into the cartridge recess 5120 ... The inserter 5100 is then either held against the skin or aligned with a cannula housing and sensor housing on a base (not shown) and fired by pressing a trigger 5110. Upon firing, the pins 5130 travel in their slots 5140, thereby forcing the infusion device and sensor (both not shown) into a patient": note during insertion there is a point where the needle is within the base and the remainder of the cartridge is above the base, e.g. FIGS. 93B) to (2) an advanced position within the device, wherein the infusion needle is in a deployed position inserted into a subcutaneous tissue of the user's skin (para[0455]: ''The inserter 5100 is then either held against the skin or aligned with a cannula housing and sensor housing on a base (not shown) and fired by pressing a trigger 5110. Upon firing, the pins 5130 travel in their slots 5140, thereby forcing the infusion device and sensor (both not shown) into a patient"; see FIGS. 93B-93C, para [0459]: "Although FIGS. 93A-93C show a cannula 5010, the infusion and sensor assembly shown in FIG. 86B can be inserted using the locking feature 5210 and method shown and described in FIGS. 93A-93C"; e.g. see FIG._93C); and
a detachable activation mechanism (5100) for (a) moving the needle cartridge assembly from the telescoping position to the advanced position and for (b) releasing the device for delivering medicament upon activation of the detachable activation by the user (Fig. 89, para [0455], [0448])).
Regarding claim 2, Kamen teaches the infusion system of claim 1 further comprising a CGM sensor for measuring glucose level in a user ("The sensor base 5023 is the section of the analyte sensor that is not inserted into the patient. In one embodiment, the base 5023 contains electronic contacts for the electrochemical analysis of blood glucose. A probe 5025 protrudes from the base 5023 of the analyte sensor 5020.", para [0447]) that is supported by and configured to move along with the cartridge assembly from the telescoping position, wherein the CGM sensor is in the retracted position within the device for delivering medicament ("The inserter 5100 is then either held against the skin or aligned with a cannula housing and sensor housing on a base (not shown) and fired by pressing a trigger 5110. Upon firing, the pins 5130 travel in their slots 5140, thereby forcing the infusion device and sensor (both not shown) into a patient", para [0455]: note during insertion there is a point where the sensor needle is within the base and the remainder of the cartridge is above the base, e.g. FIGS. 93B) to the advanced position, wherein the infusion needle is in a deployed position inserted into a subcutaneous tissue of the user's skin (para[0455]: ''The inserter 5100 is then either held against the skin or aligned with a cannula housing and sensor housing on a base (not shown) and fired by pressing a trigger 5110. Upon firing, the pins 5130 travel in their slots 5140, thereby forcing the infusion device and sensor (both not shown) into a patient"; see FIGS. 938-93C, para [0459]: "Although FIGS. 93A-93C show a cannula 5010, the infusion and sensor assembly shown in FIG. 868 can be inserted using the locking feature 5210 and method shown and described in FIGS. 93A-93C"; e.g. see FIG. 93C).
Regarding claim 3, Kamen teaches the infusion system of claim 2 wherein the CGM sensor and infusion needle are integrated (integrated sensor and needle, Fig. 86A-86B).
Regarding claim 4, Kamen teaches the infusion system of claim 1 wherein device for delivering medicament includes a housing having an opening to receive the needle cartridge assembly (opening 5030 of device Y, Figs. 93A-93C).
Regarding claim 5, Kamen teaches the infusion system of claim 1 the needle cartridge assembly includes first and second spaced walls defining a gap (see gap between wall of 5060 and wall holding 5023, Figs. 86A-86B).
Regarding claim 6, Kamen teaches the infusion system of claim 5 wherein the device for delivering medicament includes a baseplate having a floor and wall that extend from the floor, wherein the first and second spaced walls of the needle cartridge assembly are configured to receive the wall of the baseplate in the advanced position of the needle cartridge assembly (cutaway of baseplate Y (Figs. 93) shows a floor and walls wherein the needle cartridge assembly is introduced, reasonably assuming analogous negative receiving space for entirety of 5040).
Regarding claim 12, Kamen teaches the infusion system of claim 1 wherein the medicament is insulin ("The device delivers insulin", para [0237]).
Regarding claim 30, Kamen teaches an infusion system (Abstract) comprising:
a device for delivering medicament to a user, the device configured to be mounted on the user (base portion of patch pump device, para (0226): "Embodiments of the device include a portable or non-portable device for fluid delivery. Some embodiments of the device include a base portion that is disposable and a top portion that is non-disposable. The device includes embodiments where an infusion device is inserted through the base portion and directly into a patient. These device embodiments are patch pump devices. The patch pump may be adhered to the patient using an adhesive, a strap, or other suitable arrangement"; e.g. see base Y, FIGS. 93, para[0459]);
an analyte sensor for measuring an analyte in the user ("The sensor base 5023 is the section of the analyte sensor that is not inserted into the patient. In one embodiment, the base 5023 contains electronic contacts for the electrochemical analysis of blood glucose. A probe 5025 protrudes from the base 5023 of the analyte sensor 5020.", para (0447]) and an infusion needle for delivering the medicament to the user (cannula 5010, FIGS. 86, para[0447]-(0448]: "the infusion device 5010 is a cannula that is introduced into the patient using an introducing needle 5240 ... the introduction needle 5240 is removed and the septum 5060 is sealed to a fluid source, which, in some embodiments of the device described herein, is the fluid line"; see para[0455],[0459]: "the infusion and sensor assembly shown in FIG. 868 can be inserted" describing assembly of FIG. 86 goes into base of FIGS. 93);
·a needle cartridge assembly for supporting the analyte sensor and/or the infusion needle, the needle cartridge assembly configured to move from (1) a telescoping position above the device for delivering medicament, wherein the analyte sensor and/or infusion needle are/is in a retracted position within the device for delivering medicament (see inserter 5100 which installs assembly 5040 into base of patch infusion device and into tissue, FIGS. 89, para[0455]: "5040 to an automatic inserter. For example, the releases shown in FIGS. 86A-86B as 5052 may receive pins of an automatic insertion device. Referring to both FIGS. 89A and 898 a representative embodiment of an automatic inserter 5100 is shown. As shown in the front view of FIG. 89A, the inserter 5100 includes pins 5130 which travel in pin slots 5140 within an inserting cartridge recess 5120. In practice, the infusion and sensor assembly (not shown, shown in FIGS. 86A and 868 as 5040) is pressed into the cartridge recess 51·20 ... The inserter 5100 is then either held against the skin or aligned with a cannula housing and sensor housing on a base (not shown) and fired by pressing a trigger 5110. Upon firing, the pins 5130 travel in their slots 5140, thereby forcing the infusion device and sensor (both not shown) into a patient": note during insertion there is a point where the needle is within the base and the remainder of the cartridge is above the base, e.g. FIGS. 938) to (2) an advanced position within the device, wherein the infusion needle and/or analyte sensor are/is in a deployed position inserted into a subcutaneous tissue of the user's skin (para[0455]: "The inserter 5100 is then either held against the skin or aligned with a cannula housing and sensor housing on a base (not shown) and fired by pressing a trigger 5110. Upon firing, the pins 5130 travel in their slots 5140, thereby forcing the infusion device and sensor (both not shown) into a patient"; see FIGS. 93B-93C, para[0459]: "Although FIGS. 93A-93C show a cannula 5010, the infusion and sensor assembly shown in FIG. 868 can be inserted using the locking feature 521 0 and method shown and described in FIGS. 93A-93C"; e.g. see FIG. 93C); and
a detachable activation mechanism for (a) moving the needle cartridge assembly from the telescoping position to the advanced position and for (b) releasing the device for delivering medicament upon activation of the detachable activation by the user (para[0455]: "The inserter 5100 is then either held against the skin or aligned with a cannula housing and sensor housing on a base (not shown) and fired by pressing a trigger 511 0. Upon firing, the pins 5130 travel in their slots 5140, thereby forcing the infusion device and sensor (both not shown) into a patient"; see FIGS. 93B-93C, para[0459]: "Although FIGS. 93A-93C show a cannula 5010, the infusion and sensor assembly shown in FIG. 868 can be inserted using the locking feature 5210 and method shown and described in FIGS. 93A-93C"; e.g. see FIG. 93C).
Regarding claim 31, Kamen teaches the infusion system of claim 30 wherein the analyte sensor and infusion needle are integrated (integrated sensor and needle, Fig. 86A-86B).
Regarding claim 32, Kamen teaches the infusion system of claim 30 wherein the device for delivering medicament includes a housing having an opening to receive the needle cartridge assembly (opening 5030 of device Y, Figs. 93).
Regarding claim 33, Kamen teaches the infusion system of claim 30 the needle cartridge assembly includes first and second spaced walls defining a gap (see gap between wall of 5060 and wall holding 5023, Figs. 86A-86B).
Regarding claim 34, Kamen teaches the infusion system of claim 30 wherein the device for delivering medicament includes a baseplate having a floor and wall that extend from the floor, wherein the first and second spaced walls of the needle cartridge assembly are configured to receive the wall of the baseplate in the advanced position of the needle cartridge assembly (cutaway of baseplate Y (Figs. 93) shows a floor and walls wherein the needle cartridge assembly is introduced, reasonably assuming analogous negative space for 5040, FIG. 86).
Regarding claim 40, Kamen teaches the infusion system of claim 30 wherein the medicament is insulin ("The device delivers insulin", para (0237]) and the analyte sensor is a CGM sensor for measuring glucose level in the user (''The sensor base 5023 is the section of the analyte sensor that is not inserted into the patient. In one embodiment, the base 5023 contains electronic contacts for the electrochemical analysis of blood glucose. A probe 5025 protrudes from the base 5023 of the analyte sensor 5020.", para (0447]).
Regarding claim 41, Kamen teaches an infusion system (Abstract) comprising:
a device for delivering medicament to a user, the device configured to be mounted the user (base portion of patch pump device, para[0226]: "Embodiments of the device include a portable or non-portable device for fluid delivery. Some embodiments of the device include a base portion that is disposable and a top portion that is non-disposable. The device includes embodiments where an infusion device is inserted through the base portion and directly into a patient. These device embodiments are patch pump devices. The patch pump may be adhered to the patient using an adhesive, a strap, or other suitable arrangement"; e.g. see base Y, FIGS. 93, para[0459));
a needle for infusing medicament into the user or introducing an infusion catheter to infuse the medicament into the user (cannula 5010, FIGS. 86, para[0447]-[0448]: "the infusion device 5010 is a cannula that is introduced into the patient using an introducing needle 5240 ... the introduction needle 5240 is removed and the septum 5060 is sealed to a fluid source, which, in some embodiments of the device described herein, is the fluid line"; see para[0455],[0459]: "the infusion and sensor assembly shown in FIG. 86B can be inserted" describing assembly of FIG. 86 goes into base of FIGS. 93);
a needle cartridge assembly for supporting the needle, the needle cartridge assembly configured to move from (1) a telescoping position above the device for delivering the medicament, wherein the needle is in a retracted position within the device for delivering the medicament (see inserter 5100 which installs assembly 5040 into base of patch infusion device and into tissue, FIGS. 89, para[0455]: "5040 to an automatic inserter. For example, the releases shown in FIGS. 86A-86B as 5052 may receive pins of an automatic insertion device. Referring to both FIGS. 89A and 89B a representative embodiment of an automatic inserter 5100 is shown. As shown in the front view of FIG. 89A, the inserter 5100 includes pins 5130 which travel in pin slots 5140 within an inserting cartridge recess 5120. In practice, the infusion and sensor assembly (not shown, shown in FIGS. 86A and 86B as 5040) is pressed into the cartridge recess 5120 ... The inserter 5100 is then either held against the skin or aligned with a cannula housing and sensor housing on a base (not shown) and fired by pressing a trigger 5110. Upon firing, the pins 5130 travel in their slots 5140, thereby forcing the infusion device and sensor (both not shown) into a patient": note during insertion there is a point where the needle is within the base and the remainder of the cartridge is above the base, e.g. FIGS. 93B) to (2) an advanced position within the device, wherein the needle is in a deployed position inserted into tissue of the user's skin (para[0455]: "The inserter 5100 is then either held against the skin or aligned with a cannula housing and sensor housing on a base (not shown) and fired by pressing a trigger 5110. Upon firing, the pins 5130 travel in their slots 5140, thereby forcing the infusion device and sensor (both not shown) into a patient"; see FIGS. 93B-93C, para[0459]: "Although FIGS. 93A-93C show a cannula 5010, the infusion and sensor assembly shown in FIG. 86B can be inserted using the locking feature 5210 and method shown and described in FIGS. 93A-93C"; e.g. see FIG. 93C ); and
a detachable activation mechanism for (a) moving the needle cartridge assembly from the telescoping position to the advanced position and for (b) releasing the device for delivering medicament upon activation of the detachable activation by the user (para[0455]: "The inserter 5100 is then either held against the skin or aligned with a cannula housing and sensor housing on a base (not shown) and fired by pressing a trigger 5110. Upon firing, the pins 5130 travel in their slots 5140, thereby forcing the infusion device and sensor (both not shown) into a patient"; see FIGS. 93B-93C, para [0459]: "Although FIGS. 93A-93C show a cannula 5010, the infusion and sensor assembly shown in FIG. 86B can be inserted using the locking feature 5210 and method shown and described in FIGS. 93A-93C"; e.g. see FIG. 93C).
Regarding claim 42, Kamen teaches the infusion system of claim 41 further comprising an analyte sensor for measuring an analyte in a user ("The sensor base 5023 is the section of the analyte sensor that is not inserted into the patient. In one embodiment, the base 5023 contains electronic contacts for the electrochemical analysis of blood glucose. A probe 5025 protrudes from the base 5023 of the analyte sensor 5020.", para [0447]) that is supported by and configured to move along with the cartridge assembly from the telescoping position, wherein the analyte sensor is in the retracted position within the device for delivering medicament (''The inserter 5100 is then either held against the skin or aligned with a cannula housing and sensor housing on a base (not shown) and fired by pressing a trigger 5110. Upon firing, the pins 5130 travel in their slots 5140, thereby forcing the infusion device and sensor (both not shown) into a patient", para [0455]: note during insertion there is a point where the sensor needle is within the base and the remainder of the cartridge is above the base, e.g. FIGS. 93B) to the advanced position, wherein the needle is in a deployed position inserted into the tissue of the user (para[0455): "The inserter 5100 is then either held against the skin or aligned with a cannula housing and sensor housing on a base (not shown) and fired by pressing a trigger 5110. Upon firing, the pins 5130 travel in their slots 5140, thereby forcing the infusion device and sensor (both not shown) into a patient"; see FIGS. 93B-93C, para[0459]: "Although FIGS. 93A-93C show a cannula 5010, the infusion and sensor assembly shown in FIG. 86B can be inserted using the locking feature 5210 and method shown and described in FIGS. 93A-93C"; e.g. see FIG. 93C).
Regarding claim 43, Kamen teaches the infusion system of claim 41 wherein the analyte sensor and needle are integrated (integrated sensor and needle, Fig. 86A-86B).
Regarding claim 44, Kamen teaches the infusion system of claim 41 wherein the medicament is insulin ("The device delivers insulin", para [0237]) and the analy1e sensor is a CGM sensor for measuring glucose level in the user ("The sensor base 5023 is the section of the analyte sensor that is not inserted into the patient. In one embodiment, the base 5023 contains electronic contacts for the electrochemical analysis of blood glucose. A probe 5025 protrudes from the base 5023 of the analy1e sensor 5020.", para [0447]).
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 of this title, 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.
Claim(s) 7, 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamen.
Regarding claim 7, Kamen teaches the infusion system of claim 6 wherein the device for delivering further includes a top housing for covering the baseplate (para[0226]), but fails to describe the top housing including a wall that extends around the needle cartridge assembly, thereby functioning as barrier to prevent leakage into other parts of the device.
Kamen discloses a top housing but does not disclose the details in the instant embodiment. In further embodiments, Kamen discloses a top housing including a wall that extends around the needle cartridge assembly, thereby functioning as barrier to prevent leakage into other parts of the device FIGS. 64C-D). It would have been obvious to one skilled in the art before the effective filing date of the instant invention to incorporate any top housing design, such as the one disclosed In the alternate embodiment, so as to provide a secure covering for the device.
Regarding claim 35, Kamen teaches the infusion system of claim 34 wherein the device for delivering further includes a top housing for covering the baseplate (para[0226]), but fails to describe the top housing including a wall that extends around the needle cartridge assembly, thereby functioning as barrier to prevent leakage into other parts of the device.
Kamen discloses a top housing but does not disclose the details in the instant embodiment. In further embodiments, Kamen discloses a top housing including a wall that extends around the needle cartridge assembly, thereby functioning as barrier to prevent leakage into other parts of the device FIGS. 64C-D). It would have been obvious to one skilled in the art to incorporate any top housing design, such as the one disclosed in the alternate embodiment, so as to provide a secure covering for the device.
Claim(s) 8-11 and 36-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamen in view of Gray et al. (US 2018/0368771, hereafter “Gray”).
As to claim 8, Kamen teaches the infusion system of claim 1 but does not further teach wherein the detachable activation mechanism includes first and second release arms that are configured to move from a first position wherein the device is secured within the detachable activation mechanism and a second position where the device is released from the detachable activation mechanism upon activation by the user.
Gray teaches an infusion system (Abstract) with an inserter that applies both the infusion device and the sensor and cannula (para[0446]: "The infusion cannula and analyte sensor may be inserted transcutaneously by the same applicator device") and wherein the detachable activation mechanism ("Applicator 500 may further compose a drive assembly 510 configured to drive the insertion element of needle carrier assembly 508 in a distal direction to a distal insertion position and in a proximal direction from the distal insertion position to a proximal retraction position.", para [0187], Gray states that 160 can be used with 500, para (0446]) includes first and second release arms (672a and 672b, Fig. 6H) that are configured to move from a first position wherein the device is secured within the detachable activation mechanism and a second position where the device is released from the detachable activation mechanism upon activation by the user ("FIG. 6H illustrates retention elements 672a, 672b of holder 528 configured to releasably couple on-skin sensor assembly 160 to holder 528.", para [0200]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use an insertion device similar to Gray to insert the device into the patient while also allowing for the needle to be inserted and then retracted (see above-cited portions of Gray).
Regarding claim 9, Kamen and Gray teach the infusion system of claim 8, Gray further teaches wherein the first and second arms each Include a flange for engaging the device for delivering medicament to the user, thereby securing the device within the detachable activation mechanism (flanges 678a and 678b, Fig. 6H). It would have been further obvious to one skilled in the art to use the insertion device of Gray to allow delivery of the needle as well as the delivery device at the same time.
Regarding claim 10, Kamen and Gray teach the infusion system of claim 8, Gray describes wherein the detachable activation mechanism includes a spring for biasing the first and second arms outwardly (system of Kamen modified above to include include insertion mechanism of Gray; see spring 512, FIG. 5, para[0195]-[0196], [0200] of Gray: note during retraction, spring retracts 508 which causes outward rotation of the bottom of the arms).
Regarding claim 11, Kamen and Gray teach the infusion system of claim 9, Gray further teaches wherein the device for delivering includes a groove (662a) for (a) receiving the flanges when the first and second arms are in the first position, thereby securing the device for delivering medicament within the detachable activation mechanism and for (b) releasing of the flanges when the first and second arms are in the second position, thereby releasing the device from the detachable activation (see para 0198, Fig. 6H). It would have been further obvious to one skilled in the art to incorporate grooves in the delivery device to ensure it is secured in the insertion device prior to delivery to the patient (see para 0198, Fig. 6H of Gray).
Regarding claim 36, Kamen teaches the infusion system of claim 30 but does not further teach wherein the detachable activation mechanism includes first and second release arms that are configured to move from a first position wherein the device is secured within the detachable activation mechanism and a second position where the device is released from the detachable activation mechanism upon activation by the user.
Gray teaches an infusion system (Abstract) with an inserter that applies both the infusion device and the sensor and cannula (para[0446]: "The infusion cannula and analyte sensor may be inserted transcutaneously by the same applicator device") and the detachable activation mechanism ("Applicator 500 may further compose a drive assembly 510 configured to drive the insertion element of needle carrier assembly 508 in a distal direction to a distal insertion position and in a proximal direction from the distal insertion position to a proximal retraction position.", para [0187], Gray states that 160 can be used with 500, para [0446]) includes first and second release arms (672a and 672b, Fig. 6H) that are configured to move from a first position wherein the device is secured within the detachable activation mechanism and a second position where the device is released from the detachable activation mechanism upon activation by the user ("FIG. 6H illustrates retention elements 672a, 672b of holder 528 configured to releasably couple on-skin sensor assembly 160 to holder 528.", para [0200]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use an insertion device similar to Gray to insert the device into the patient while also allowing for the needle to be inserted and then retracted (see above-cited portions of Gray).
Regarding claim 37, Kamen and Gray teach the infusion system of claim 37, Gray further teaches wherein the first and second arms each include a flange for engaging the device for delivering medicament to the user, thereby securing the device within the detachable activation mechanism (flanges 678a and 678b, Fig. 6H). It would have been further obvious to one skilled in the art, when modifying Kamen, to use the insertion device wherein the first and second arms each include a flange for engaging the device for delivering medicament to the user, thereby securing the device within the detachable activation mechanism as described by Gray to allow delivery of the needle as well as the delivery device at the same time.
Regarding claim 38, Kamen and Gray teach the infusion system of claim 36, Gray describes wherein the detachable activation mechanism includes a spring for biasing the first and second arms outwardly (spring 512, FIG. 5, para[0195]-[0196], [0200]: note during retraction, spring retracts 508 which causes outward rotation of the bottom of the arms)
Regarding claim 39, Kamen and Gray teach the infusion system of claim 37, Dex Com further teaches wherein the device for delivering includes a groove (661a) for (a) receiving the flanges when the first and second arms are in the first position, thereby securing the device for delivering medicament within the detachable activation mechanism and for (b) releasing of the flanges when the first and second arms are in the second position, thereby releasing the device from the detachable activation (grooves 662a, Fig. 6H): It would have been further obvious to one skilled in the art to incorporate grooves in the delivery device to ensure it is secured in the insertion device prior to delivery to the patient (see para 0198, Fig. 6H of Gray).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11 and 30-44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18772140 (reference application). Although the claims at issue are not identical, the examiner notes that each element in the instant claims can be found within the claims of the reference application. For example all the limitations of instant claim 1 can be found within claims 1-2 of the reference application. The only difference is that claim 2 of the reference application also gives an analyte sensor as an alternative/addition to the infusion needle. This addition of an analyte sensor however is mentioned in the instant application in claim 30. It appears that for each of the instant claims, there is at least one corresponding claim of the reference patent that teaches/makes obvious all the limitations of the instant claims.
Claims 1-11 and 30-44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18772138. Although the claims at issue are not identical, the examiner notes that each element in the instant claims can be found within the claims of the reference application. For example, all the limitations of instant claim 1 can be found within claim 4 of the reference application. It appears that for each of the instant claims, there is at least one corresponding claim of the reference patent that teaches/makes obvious all the limitations of the instant claims.
The above are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/James D Ponton/Primary Examiner, Art Unit 3783
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