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 17 are objected to because of the following informalities:
Claim 17, lines 2-3 recite “wherein housing”. This should likely read “wherein the housing”.
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: “a detachable activation mechanism for causing the cartridge assembly to move from (1) the telescoping position to (2) the advanced position in the device” in claims 1 (also in claims 13 and 22 which recite similar wording).
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 § 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 1-28 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” and/or “for delivering” 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, “(1) a telescoping position above the device, wherein the first and second introducer needles are in a retracted position within the device for delivering medicament…” makes it sound as if 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 2 recites the limitation " the detachable activation" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the baseplate" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the baseplate" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation " the detachable activation" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites “…CGM sensor. 10.” It is not clear why “10.” is included.
As to claim 13, the examiner recommends removing the wording of “for delivering the medicament” and/or “for delivering” 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, “a detachable activation mechanism for deploying the device for delivering…” is ambiguous as to whether it is merely referring to the device as previously mentioned or if “for delivering” is referring to the deploying specifically. The examiner notes that multiple dependent claims recite similar wording.
Claim 13 recites the limitation " the cartridge assembly" in line 9-10. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation " the telescoping position" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation " the advanced position" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 introduces “a cartridge assembly”, “a telescoping position”, and “an advanced position”, which are unclear because claim 13 already refers to similar limitations. Claim 15 also refers to “the cartridge assembly”.
Claim 17 depends from itself. It will be assumed that claim 17 is intended to depend from claim 13.
Claim 18 recites the limitation "the first and second introducer needs" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It is assumed that “needs” was intended to say “needles”
As to claim 20, the examiner recommends removing the wording of “for delivering the medicament” and/or “for delivering” 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, “(1) a telescoping position above the device, wherein the first and second introducer needles are in a retracted position within the device for delivering medicament” makes it sound as if 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 26 recites the limitation "the first and second introducer needs" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It is assumed that “needs” was intended to say “needles”
Dependent claims inherit the deficiencies of the claims from which they depend.
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, 11-17, 19-25, 27 and 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamen et al. (US 2007/0228071 A1, hereafter “Kamen”).
As to claim 1, Kamen describes an infusion system (Abstract) comprising:
a device for delivering medicament to a user, the device for delivering configured to be mounted to the user (patch pump device with base portion, 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"), the device including a first introducer needle (introducing needle 5240, FIG. 86B, para[0448]) for introducing an infusion catheter into the user for infusing the medicament (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]: "held against the skin or aligned with a cannula housing and sensor housing on a base" describing this goes into previously described base of infusion device) and a second introducer needle for introducing an analyte sensor into the user for sensing an analyte in the user (5072 for 5025, FIGS. 86, para[0448],[0445]: "an
introduction needle 5072 which aids in skin puncture for insertion of the sensor probe 5025"; para[0447]-[0448]: "cannula or needle 5010 and an analyte sensor ... probe 2025");
a cartridge assembly (infusion and sensor assembly 5040, FIGS. 86, para[0447]), configured to move from (1) a telescoping position above the device, wherein the first and second introducer needles are in a retracted position within the device for delivering medicament and (2) an advanced position within the device, wherein the first and second introducer needles are in a deployed position inserted into tissue of the user (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 first position is during firing and second position is upon completion of firing); and
a detachable activation mechanism for causing the cartridge assembly to move from (1) the telescoping position to (2) the advanced position in the device (automatic inserter 5100, FIGS. 89, para [0455],[0448]).
As per claim 2, Kamen describes the infusion system of claim 1 wherein the detachable activation mechanism is configured to release the device for delivering medicament upon activation of the detachable activation by the user (para[0453]: "The inserter 5012 will thus release the infusion device 5010 and sensor 5023 and then, the inserter 5012 can either be removed from the inserter device 5013 and the inserter device 5013 refilled, or, the inserter device 5013 and inserter 5012 can be discarded"; see para[0454]-[0455] disclosing automatic insertion device is extension of this device).
As per ciaim 3, Kamen describes the infusion system of claim 1 further comprising a hub removably engaging the cartridge assembly, the hub supporting the first and second introducer needles (5120 via 5130, FIG. 89A, para[0455]: "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, causing pins 5130 to be inserted into the holes in the infusion and sensor assembly (shown as 5052 in FIGS. 86A and 86B).").
As per claim 4, Kamen describes the infusion system of claim 1 wherein the device for delivering medicament includes a baseplate (base, e.g. see portion of Y against skin 5220, FIGS. 93, para[0226],[0459]: "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 nondisposable. 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").
As per claim 5, Kamen describes the infusion system of claim 1 wherein the device for delivering medicament includes a housing configured to be mounted on the baseplate (see portion of Y with 5030 shown mounted to baseplate (portion of Y against skin), FIGS. 93, para[0459],[0226]), wherein housing has an opening and channel to receive the cartridge assembly (see portion 5030 receiving cannula 5010 or 5040, FIGS. 93, para[0459],[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").
As per claim 6, Kamen describes the infusion system of claim 5 wherein the cartridge assembly includes a housing with a ledge to function as a stop, thereby preventing the cartridge assembly from extending beyond the baseplate (see bottom of cartridge portion 5070, FIGS. 86 interacting with stop 5160, FIG. 89A, para [0455]: "Inserter foot 5160 limits the downward travel of the infusion and sensor assembly").
As per claim 11, Kamen describes the infusion system of claim 1 wherein the medicament is insulin and the analyte sensor is a CGM sensor (para [0232],[0216],[0487],[0505]: describing glucose, continuous operation and continuous data)
As per claim 12, Kamen describes the infusion system of claim 1 wherein the device for delivering includes the infusion catheter and/or the analyte sensor (para [0232]; see 5010/5025, FIGS. 86, para [0447]-[0448]: "cannula or needle 5010 and an analyte sensor ... probe 2025").
As per claim 13, Kamen describes an infusion system (Abstract) comprising:
a device for delivering medicament to a user, the device for delivering configured to be mounted to the user (patch pump device with base portion, 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"), the device including a first introducer needle (introducing needle 5240, FIG. 868, para [0448]) for introducing an infusion catheter into the user for infusing the medicament (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]: "held against the skin or aligned with a cannula housing and sensor housing on a base" describing this goes into previously described base of infusion device) and a second introducer needle for introducing an analyte sensor into the user for sensing an analyte in the user (5072 for 5025, FIGS. 86, para [0448],[0445]: " an introduction needle 5072 which aids in skin puncture for insertion of the sensor probe 5025"; para[0447]-[0448]: "cannula or needle 5010 and an analyte sensor ... probe 2025"); and
a detachable activation mechanism for deploying the device for delivering on the user and for detaching from the device subsequent to deployment (see inserter 5100 para [0453]: "The inserter 5012 will thus release the infusion device 5010 and sensor 5023 and then, the inserter 5012 can either be removed from the inserter device 5013 and the inserter device 5013 refilled, or, the inserter device 5013 and inserter 5012 can be discarded"; see para[0454]-[0455] disclosing automatic insertion device is extension of this device), wherein the detachable activation mechanism is configured to cause the cartridge assembly to move from (1) the telescoping position to (2) the advanced position in the device (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-868 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 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 first position is during firing and second position is upon completion of firing).
As per claim 14, Kamen describes the infusion system of claim 13, further comprising a cartridge assembly supporting the first and second introducer needles (infusion and sensor assembly 5040, FIGS. 86, para[0447]), the cartridge assembly configured to move from (1) a telescoping position above the device, wherein the first and second introducer needles are in a retracted position within the device for delivering medicament and (2) an advanced position within the device, wherein the first and second introducer needles are in a deployed position inserted into tissue of the user (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-868 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 868 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 first position is during firing and second position is upon completion of firing).
As per claim 15, Kamen describes the infusion system of claim 14 further comprising a hub removably engaging the cartridge assembly, the hub supporting the first and second introducer needles (5120 via 5130, FIG. 89A, para[0455]: "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 5120, causing pins 5130 to be inserted into the holes in the infusion and sensor assembly (shown as 5052 in FIGS. 86A and 868).").
As per claim 16, Kamen describes the infusion system of claim 13 wherein the device for delivering medicament includes a baseplate (base, e.g. see portion of Y against skin 5220, FIGS. 93, para[0226],[0459]: "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 nondisposable. 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").
As per claim 17, Kamen describes the infusion system of claim 13 wherein the device for delivering medicament includes a housing configured to be mounted on the baseplate (see portion of Y with 5030 shown mounted to baseplate (portion of Y against skin), FIGS. 93, para[0459],[02261), wherein housing has an opening and channel to receive the cartridge assembly (see portion 5030 receiving cannula 5010 or 5040, FIGS. 93, para[0459],[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").
As per claim 19, Kamen describes the infusion system of claim ·13 wherein the analyte sensor is a CGM sensor and the medicament is insulin (para[0232],[0216],[0487],[0505]: describing glucose, continuous operation and continuous data).
As per claim 20, Kamen describes the infusion system of claim 13 wherein the device for delivering includes the infusion catheter and/or the analyte sensor (para[0232]; see 5010/5025, FIGS. 86, para[0447]-[0448]: "cannula or needle 5010 and an analyte sensor ... probe 2025").
As per claim 21, Kamen describes an infusion system (Abstract) comprising:
a device for delivering medicament to a user, the device for delivering configured to be mounted to the user (patch pump device with base portion, 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"), the device including a first introducer needle (introducing needle 5240, FIG. 868, para [04481] for introducing an infusion catheter into the user for infusing the medicament (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]: "held against the skin or aligned with a cannula housing and sensor housing on a base" describing this goes into previously described base of infusion device) and a second introducer needle for introducing an analyte sensor into the user for sensing an analyte in the user (5072 for 5025, FIGS. 86, para[0448],[0445]: "an introduction needle 5072 which aids in skin puncture for insertion of the sensor probe 5025"; para[0447]-[0448]: "cannula or needle 5010 and an analyte sensor ... probe 2025"); and
a cartridge assembly supporting the first and second introducer needles (infusion and sensor assembly 5040, FIGS. 86, para [0447]), the cartridge assembly configured to move from (1) a telescoping position above the device, wherein the first and second introducer needles are in a retracted position within the device for delivering medicament and (2) an advanced position in the device, wherein the first and second introducer needles are in a deployed position inserted into tissue of the user (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-868 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 first position is during firing and second position is upon completion of firing).
As per claim 22, Kamen describes the infusion system of claim 21 further comprising a detachable activation mechanism for deploying the device for delivering on the user and for detaching from the device subsequent to deployment (para[0453]: "The inserter 5012 will thus release the infusion device 5010 and sensor 5023 and then, the inserter 5012 can either be removed from the inserter device 5013 and the inserter device 5013 refilled, or, the inserter device 5013 and inserter 5012 can be discarded"; see para[0454]-[0455] disclosing automatic insertion device is extension of this device), wherein the detachable activation mechanism is configured to cause the cartridge assembly to move from (1) the telescoping position to (2) the advanced position in the device (automatic inserter 5100, FIGS. 89, para [0455],[04481).
As per claim 23, Kamen describes the infusion system of claim 21 further comprising a hub removably engaging the cartridge assembly, the hub supporting the first and second introducer needles (5120 via 5130, FIG. 89A, para[0455]: "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 5120, causing pins 5130 to be inserted into the holes in the infusion and sensor assembly (shown as 5052 in FIGS. 86A and 868).").
As per claim 24, Kamen describes the infusion system of claim 21 wherein the device for delivering medicament includes a baseplate (base, e.g. see portion of Y against skin 5220, FIGS. 93, para[0226],[0459]: "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 nondisposable. 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").
As per claim 25, Kamen describes the infusion system of claim 24 wherein the device for delivering medicament includes a housing configured to be mounted on the baseplate (see portion of Y with 5030 shown mounted to baseplate (portion of Y against skin), FIGS. 93, para[0459],[0226]), wherein housing has an opening and channel to receive the cartridge assembly (see portion 5030 receiving cannula 5010 or 5040, FIGS. 93, para[0459],[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").
As per claim 27, Kamen describes the infusion system of claim 21 wherein the analyte sensor is a CGM sensor and the medicament is insulin (para[0232],[0216],[0487],[0505]: describing glucose, continuous operation and continuous data).
As per claim 28, Kamen describes the infusion system of claim 21 wherein the device for delivering includes the infusion catheter and/or the analyte sensor (para [0232]; see 5010/5025, FIGS. 86, para[0447]-[0448]: "cannula or needle 5010 and an analyte sensor ... probe 2025").
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) 7-10 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 7, Kamen discloses the infusion system of claim 1 as described above, but is silent to 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 8, Kamen and Gray make obvious the infusion system of claim 7, and 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 needles as well as the delivery device at the same time.
Regarding claim 9, 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 10, 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).
Claim(s) 18 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamen in view of Ethelfeld et al. (US 2009/0048563 A1 A1, hereafter “Ethelfeld”).
As to claim 18, Kamen describes the infusion system of claim 13, but fails to describe wherein the first and second introducer needs are U-shaped.
Ethelfeld describes U-shaped needles (1510, FIG. 21A).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a differently shaped needle, including U-shaped. One would have been motivated to do so as Ethelfeld discloses that “This allows the soft catheter with needle to be placed horizontally before vertical insertion, as a guide 1530 bends the catheter and needle during the insertion. U-shaped spring steel structures are generally known, e.g. from tape measures 1550. An advantage of this concept is the low height of a device housing needed to keep the needle and soft catheter within the device, without removing the needle fully when it after insertion is pulled proximally through the septum 1521. A further advantage is very little space occupied by the needle after insertion” (para 0102). Additionally, the instant application describes that “Introducer needle 1810 is also preferably U-shaped, but it may be any shape as known to those skilled in the art” (instant disclosure, para [0073]). Therefore the instant disclosure is silent to any particular advantage of making the first and second introducer needles be U-shaped, and changes in shape have generally been held to be within the level of ordinary skill in the art (see MPEP 2144.04 IV. B)
As to claim 26, Kamen describes the infusion system of claim 21, but fails to describe wherein the first and second introducer needs are U-shaped.
Ethelfeld describes U-shaped needles (1510, FIG. 21A).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a differently shaped needle, including U-shaped. One would have been motivated to do so as Ethelfeld discloses that “This allows the soft catheter with needle to be placed horizontally before vertical insertion, as a guide 1530 bends the catheter and needle during the insertion. U-shaped spring steel structures are generally known, e.g. from tape measures 1550. An advantage of this concept is the low height of a device housing needed to keep the needle and soft catheter within the device, without removing the needle fully when it after insertion is pulled proximally through the septum 1521. A further advantage is very little space occupied by the needle after insertion” (para 0102). Additionally, the instant application describes that “Introducer needle 1810 is also preferably U-shaped, but it may be any shape as known to those skilled in the art” (instant disclosure, para [0073]). Therefore the instant disclosure is silent to any particular advantage of making the first and second introducer needles be U-shaped, and changes in shape have generally been held to be within the level of ordinary skill in the art (see MPEP 2144.04 IV. B)
Conclusion
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/James D Ponton/Primary Examiner, Art Unit 3783
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