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 .
Status of Claims
This office action is responsive to the amendment filed 19 April 2024.
Claims 1-15 are cancelled.
Claims 16-30 are presently pending in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 30 is 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.
Claim 30 recites the limitation "the first end portion" and “the second end portion” in lines 6 and 7 of the claim respectively. There is insufficient antecedent basis for these limitations in the claim. For the purposes of examination, Examiner interprets “the first end portion” and “the second end portion” to mean –the first end—and –the second end—respectively.
Claim 30 also recites the limitation “the inlet portion” in line 7 of the claim. There is insufficient antecedent basis for these limitations in the claim. For the purposes of examination, Examiner interprets “the inlet portion” to mean –the inlet--.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claims 16-21, 24-27, and 29 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Savage (US Patent Publication No. 20160199576 A1).
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Regarding claim 16, Savage teaches an infusion subassembly (Savage: Fig. 1, wearable system 100), comprising:
a pump (Fig. 1, pump unit 140); and
a user wearable garment (Fig. 1, wearable garment 110), including a protruding support portion (Fig. 1, pump unit support portion 114) supporting the pump (140) to the user wearable garment (Fig. 1, unit 140 is supported in portion 114) and a container supporting portion (Fig. 2B, reservoir support portion 130), the container supporting portion (130) being configured to support a medicament container (Fluid reservoir; para. 0194) to the user wearable garment (para. 0194), wherein the container supporting portion (130) comprises an end surface (Fig. 2B above, end surface A), the end surface (A) comprising an end portion (Fig. 2B above, end portion B) and an opening (in order for the inlet conduit 134 to fluidly connect to a fluid reservoir, there must be an opening present at portion B above for the conduit to connect to; para. 0195),
wherein the pump (140) is connectable to the end portion (para. 0195) of the end surface (A), and wherein the pump (140) is configured to force medicament from the medicament container (para. 0194) to be dispensed through the opening of the end surface (unit 140 delivers fluid from a fluid reservoir to the delivery site; para. 0190).
Regarding claim 17, Savage teaches the infusion subassembly above, wherein the pump (140) is connectable to the end portion (B) of the container supporting portion (130) by an elongated tube (Fig. 2B, conduit 134) between the pump (140) and the end portion (B; para. 0195).
Regarding claim 18, Savage teaches the infusion subassembly above, wherein the protruding support portion (114) and the container supporting portion (130) are integrally formed with the user wearable garment (Fig. 2A and 2B, portion 114 and 130 are shown to be integral with garment 110).
Regarding claim 19, Savage teaches the infusion subassembly above, further comprising a control unit (Fig. 4, system 400) connected to the pump (140), wherein the control unit (400) comprises control circuitry (Fig. 4, controller 410) configured to transmit a control signal to the pump (controller sends signal to pump mechanism 330; para. 0208), the control signal (para. 0208) representing instructions which, when executed by the pump (140), cause activation of the pump (para. 0208) to force transfer of medicament from the medicament container (para. 0194) out through the opening (para. 0195) of the end surface (A; para. 1095 and 0208).
Regarding claim 20, Savage teaches the infusion subassembly above, wherein the control unit (400) is embedded in the user wearable garment (system 400 is part of pump unit 140, which is embedded in garment 110; para. 0208).
Regarding claim 21, Savage teaches the infusion subassembly above, wherein the pump (140) is a peristaltic pump (peristaltic pump; 0065).
Regarding claim 24, Savage teaches the infusion subassembly above, wherein the user wearable garment (100) comprises a base portion (Fig. 1, front side 112 and back section 116), and two arm portions (Fig. 1, straps 113a and b), wherein each arm portion (113a and b) extends from the base portion (Fig. 1, straps 113a and b extend from front side 112).
Regarding claim 25, Savage teaches the infusion subassembly above, wherein the base portion (112 and 116) and the arm portions (113a and b) are integrally formed with each other (Fig. 1, straps 113a and b are integral with front side 112).
Regarding claim 26, Savage teaches the infusion subassembly above, wherein the two arm portions (113a and b) are, together with the base portion (112 and 116), configured to form a closed loop (Fig. 1, together, straps 113a and b and front and back sides 112 and 116 form a closed loop).
Regarding claim 27, Savage teaches an infusion assembly, comprising
the infusion subassembly above,
a medicament container (Fluid reservoir; para. 0194) supported by the container supporting portion (130) and connected to the pump (para. 0190),
a needle insertor arrangement (Fig. 2A, delivery site 210, intravenous delivery via catheter and needle; para. 0105 and 0120) comprising an inlet (Fig. 2A above, inlet C), and
an elongated tube (Fig. 2A, fluid supply line 215) extending between a first end (Fig. 2B above, connection of conduit 134 to end portion B above; para. 0195) and a second end (Fig. 2A above, connection from line 215 to inlet C), wherein the first end (134 to B) is attached to the end portion (B) of the container supporting portion (130), and the second end (215 to C) is attached to the inlet (C) of the needle insertor arrangement (210).
Regarding claim 29, Savage teaches an infusion assembly, wherein the needle insertor arrangement (210) comprises an injection site abutment surface (delivery site 210 is abuts patient skin; para. 0196) configured to be arranged in abutment with a medicament recipient subject to medicament treatment (para. 0196).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Savage in view of LaBove et al. (US Patent No. 4087864 A), hereinafter LaBove.
Regarding claim 22, Savage teaches the infusion subassembly above, wherein the container supporting portion (130) is an elongated container supporting portion (Fig. 2B, portion 130 is shown to be an elongate rectangular portion), and wherein the opening is a first opening (para. 0195), and the end portion (B) is a first end.
Savage does not expressly disclose the elongated container supporting portion further comprising a second opening at a second end, the elongated container supporting portion extending between the first end and the second end, wherein the medicament container is insertable to the elongated container supporting portion from the second opening.
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LaBove teaches an elongated container supporting portion (LaBove: Fig. 1, medication pocket 14 is shown to be an elongate rectangle) comprising a first opening (Fig. 1, opening formed on lower strap 52; col 3, ln 4-15) at a first end (Fig. 1, end of pocket 14 towards strap 52) and a second opening (Fig. 1 above, opening A) at a second end (Fig. 1 above, end of pocket 14 towards opening A), the elongated container supporting portion (14) extending between the first end (towards 52) and the second end (towards A), wherein a medicament container (Fig. 1, pouch 16) is insertable to the elongated container supporting portion (14) from the second opening (Fig. 1, pouch 16 is inserted through opening A; col 3, ln 4-15).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the subassembly of Savage such that the elongated container supporting portion further comprising a second opening at a second end, the elongated container supporting portion extending between the first end and the second end, wherein the medicament container is insertable to the elongated container supporting portion from the second opening as taught by LaBove in order to allow the medication container to be furnished to the patient and allow for easy affixing of the medicament container (col 2, ln 19-33 and col 2, ln 63 – col 3, ln 3).
Regarding claim 23, Savage in view of LaBove disclose the subassembly above.
Savage does not expressly disclose the elongated container supporting portion extending, during use of the infusion subassembly, between the first end and the second end in an at least partially vertical direction relative to ground.
LaBove teaches an elongated container supporting portion (LaBove: 14) extending, during use of an infusion subassembly (Fig. 1, vest V), between the first end (towards 52) and the second end (towards A) in an at least partially vertical direction relative to ground (Fig. 1, pocket 14 is arranged vertically).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the subassembly of Savage such that the elongated container supporting portion extending, during use of the infusion subassembly, between the first end and the second end in an at least partially vertical direction relative to ground as taught by LaBove in order to allow the solution within the medication container to hang in the direction of gravity (col 2, ln 63 – col 3, ln 3).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Savage in view of Py (US Patent Publication No. 20200261182 A1).
Regarding claim 28, Savage teaches an infusion assembly.
Savage does not expressly disclose an aspiration needle is attached to the first end of the elongated tube, the aspiration needle being penetrated through a lid of the medicament container.
Py teaches an aspiration needle (Py: Fig. 6, piercing member 108) is attached to a first end of an elongated tube (Fig. 6, member 108 is attached to conduit 106 end), the aspiration needle (108) being penetrated through a lid of a medicament container (Fig. 6, member 108 pierces elastic septum 110 of container 24; para. 0089).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the infusion assembly of Savage such that an aspiration needle is attached to the first end of the elongated tube, the aspiration needle being penetrated through a lid of the medicament container as taught by Py in order to ensure sterile transfer of medicament (Py: para. 0089).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Savage in view of Hooven et al. (US Patent No. 10449293 B2), hereinafter Hooven.
Regarding claim 30, Savage discloses a method of controlling medicament delivery to a medicament recipient (systems and methods; para. 0102) using the infusion assembly above,
wherein the method (para. 0102) comprises the steps of:
positioning an injection site abutment surface (delivery site 210 is abuts patient skin; para. 0196) of the needle insertor arrangement (210) in abutment with a skin surface of a medicament recipient subject to medicament treatment (para. 0196),
attaching the first end (134 to B) of the elongated tube (215) to the medicament container (16),
attaching the second end (215 to C) of the elongated tube (215) to the inlet (C) of the needle insertor arrangement (210); and
controlling the pump (140) to transfer medicament from the medicament container (para. 0194) to the transferring medicament to the penetration needle (medicament infused via needle from container to delivery site; para. 0120) via the inlet portion (C) of the needle insertor arrangement (210; para. 0120 and 0190).
When the prior art device is the same as a device described in the specification for carrying out or being made by the claimed method, it can be assumed the device will obviously perform or be made by the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). MPEP 2112.02
Savage does not expressly disclose controlling the needle insertor arrangement to force a penetration needle of the needle insertor arrangement to protrude from the injection site abutment surface.
Hooven teaches controlling a needle insertor arrangement (Fig. 1, injection device 10) to force a penetration needle (Fig. 1, needle 12) of the needle insertor arrangement (10) to protrude from an injection site abutment surface (Fig. 1, skin contacting surface 18).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Savage such that it included controlling the needle insertor arrangement to force a penetration needle of the needle insertor arrangement to protrude from the injection site abutment surface as taught by Hooven in order to allow for a wearable injection device with a retractable needle (col 3, ln 51-62).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEI GONZALEZ whose telephone number is (703)756-5908. The examiner can normally be reached 7:30am - 4:00pm (CT).
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/LEI GONZALEZ/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
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