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 3, 9, and 12 are objected to because of the following informalities:
As to claim 3, the wording of “wherein the analyte sensor and infusion needle are integrated” should be amended to “wherein the analyte sensor and the infusion needle are integrated” in order to clarify that the wording refers to the infusion needle that was previously introduced.
As to claim 9, “for measuring glucose level” in line 2 should likely read “for measuring a glucose level”.
As to claim 12, the wording of “wherein the analyte sensor and needle are integrated” should be amended to “wherein the analyte sensor and the needle are integrated” to clarify that the wording refers to the infusion needle that was previously introduced.
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 device for delivering medicament to a user” in claim 1, 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” in claim 4.
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 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 1-13 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 4 recites the limitation "the detachable activation" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the analyte sensor" in line 1. There is insufficient antecedent basis for this limitation in the claim.
As to claim 10, 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 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) 1-4 and 9-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamen et al. (US 2007/0228071, hereafter “Kamen”).
As to claim 1, Kamen discloses 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 on the user (para 0226, 0459);
an infusion needle (cannula 5010) for delivering the medicament to the user (Fig. 86A, para 0447, 0448); and
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).
As to claim 2, Kamen discloses the infusion system of claim 1 further comprising an analyte sensor (5023+5025) 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]) 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 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 further comprising 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 9, Kamen teaches the infusion system of claim 1 wherein the analyte sensor is a CGM sensor for measuring glucose level in the user (para [0232], [0237], [0402], [0404], [0447]) and the medicament is insulin (para [0232], [0235], [0237]).
Regarding claim 10, Kamen discloses an infusion system (abstract) comprising:
a device (disposable part Y) 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]);
a needle (5010; or, alternatively, 5240) for infusing medicament into the user or introducing an infusion catheter to infuse the medicament into the user (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 medicament, wherein the 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 needle is in a deployed position inserted into a 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).
Regarding claim 11, Kamen discloses the infusion system of claim 10 further comprising 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]) 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 12, Kamen teaches the infusion system of claim 10 wherein the analyte sensor and needle are integrated (integrated sensor and needle, Fig. 86A-86B).
Regarding claim 13, Kamen teaches the infusion system of claim 10 wherein the medicament is insulin (para [0232], [0235], [0237]).
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) 5-8 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 5, Kamen teaches the infusion system of claim 4 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 6, Kamen and Gray teach the infusion system of claim 5, 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 7, Kamen and Gray teach the infusion system of claim 6, 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 8, Kamen and Gray teach the infusion system of claim 6, 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).
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 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3 of copending Application No. 18724048 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the similar subject matter of an infusion system comprising: a device for delivering medicament to a user, the device configured to be mounted on the user; an infusion needle for delivering the medicament to the user; and a needle cartridge assembly 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 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. The difference between the instant claim 1 and claim 1 of the reference application is that instant claim 1 is broader in that it does not require 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. Additionally, the limitations of instant claims 2-3 are found within (sometimes in a broader manner) claims 1-3 of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 30, 31, and 36-39 of copending Application No. 18724048 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the similar subject matter of an infusion system comprising: a device for delivering medicament to a user, the device configured to be mounted on the user; an infusion needle for delivering the medicament to the user; and a needle cartridge assembly 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 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. The differences between the instant claim 1 and claim 30 of the reference application are that instant claim 1 is broader in that it does not require a detachable activation mechanism and an analyte sensor as required in claim 30 of the reference application. In addition, the limitations of instant claims 2-8 can be found through claims 30, 31, and 36-39 of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 3 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 41-44 of copending Application No. 18724048 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the similar subject matter of an infusion system comprising: a device for delivering medicament to a user, the device configured to be mounted on the user; an infusion needle for delivering the medicament to the user; and a needle cartridge assembly 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 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. The differences between the instant claim 1 and claim 41 of the copending application are that instant claim 1 is broader in that it does not require a detachable activation mechanism as required in claim 41 of the copending application. In addition, the limitations of instant claims 2, 3 and 9 can be found throughout claims 41-44 of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 10-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of copending Application No. 18724048 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the similar subject matter of an infusion system comprising: a device for delivering medicament to a user, the device configured to be mounted on the user; an infusion needle for delivering the medicament to the user; and a needle cartridge assembly 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 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. The difference between the instant claim 10 and claim 1 of the reference application is that instant claim 10 is broader in that it does not require 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. Additionally, instant claim 10 gives the option that the needle is a needle for infusing medicament into the user or introducing an infusion catheter to infuse the medicament into the user (emphasis added). However, given that the bolded portion is an option, it is not required. Additionally, the limitations of instant claims 11-13 are found within (sometimes in a broader manner) than claims 2-4 of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 10-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 41-44 of copending Application No. 18724048 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same subject matter of an infusion system comprising: a device for delivering medicament to a user, the device configured to be mounted on the user; a needle for infusing medicament into the user or introducing an infusion catheter to infuse the medicament into the user; 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 medicament, wherein the needle is in a retracted position within the device for delivering medicament to (2) an advanced position within the device, wherein the needle is in a deployed position inserted into a tissue of the user’s skin. The difference between the instant claim 10 and claim 41 of the reference application is that instant claim 10 is broader in that it does not require 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. Additionally, the limitations of instant claims 11-13 are found within claims 41-44 of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18772140 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same subject matter of an infusion system comprising: a device for delivering medicament to a user, the device configured to be mounted on the user; an infusion needle for delivering the medicament to the user; and a needle cartridge assembly 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 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. The difference between instant claim 1 and claim 2 of the reference application is that instant claim 1 is broader in that it does not require a detachable activation mechanism and that it does not give an option for an analyte sensor for measuring an analyte in a user and/or an infusion needle for delivering the medicament to the user.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of copending Application No. 18772140 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same subject matter of an infusion system comprising: a device for delivering medicament to a user, the device configured to be mounted on the user; an infusion needle for delivering the medicament to the user; and a needle cartridge assembly 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 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. The difference between instant claim 1 and claim 10 of the reference application is that instant claim 1 is broader in that it does not require a detachable activation mechanism for deploying the device on the user and detaching from the device subsequent to deployment, wherein the detachable activation mechanism is configured to move the needle from (1) a retracted position within the device for delivering medicament wherein the needle is retracted within the device for delivering medicament to (2) an advanced position, wherein the needle is in a deployed position inserted into a tissue of the user. Additionally, the instant claim 1 does not give the option for a needle for delivering the medicament to the user or introducing a catheter for infusing medicament to the user.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 10 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of copending Application No. 18772140 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same subject matter of an infusion system comprising: a device for delivering medicament to a user, the device configured to be mounted on the user; a needle for infusing medicament into the user or introducing an infusion catheter to infuse the medicament into the user; 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 medicament, wherein the needle is in a retracted position within the device for delivering medicament to (2) an advanced position within the device, wherein the needle is in a deployed position inserted into a tissue of the user’s skin. The instant claim 10 is broader in that it does not require a detachable activation mechanism for deploying the device on the user and detaching from the device subsequent to deployment, wherein the detachable activation mechanism is configured to move the needle from (1) a retracted position within the device for delivering medicament wherein the needle is retracted within the device for delivering medicament to (2) an advanced position, wherein the needle is in a deployed position inserted into a tissue of the user.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 4, 5, 6, 7, and 8 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1, 8, 9, 10, and 11, respectively, of copending Application No. 18724048 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Conclusion
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/James D Ponton/Primary Examiner, Art Unit 3783
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