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 1, 7 and 8 are objected to because of the following informalities:
Claim 1 recites the limitation “the group” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation “the group” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation “the reservoir volume” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
7a and 7b recited in paragraph 0046.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 8 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.
Regarding claim 8, the recitation “a venting opening” renders the claim indefinite because the claim is unclear if “a venting opening” is positively claimed as a part of the claimed invention. For examination purposes, examiner construes that “a venting opening” is positively claimed as a part of the claimed invention.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 recites the limitation which is already recited in claim 1, lines 7-8. While claim 5 does recite the term “interoperate”, the term doesn’t really provide any structural limitations that would further limit the structure of the invention claimed in claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 13 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seeley et al. (US 2015/0119804 A1).
Regarding claim 13, Seeley teaches a body-wearable medical device 100 (figure 8) comprising a disposable container fastener 145 configured for detachably fastening a disposable container 200 to the body-wearable medical device 100, wherein the body-wearable medical device is an insulin pump, a continuous glucose monitor or a handheld diabetes management device (paragraph 0002, lines 1-6).
Regarding claim 14, Seeley teaches wherein the disposable container fastener 145 comprises a mechanical, non-adhesive disposable container fastener 145.
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 1-3, 5, 6 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Seeley et al. (US 2015/0119804 A1) in view of Sutcliffe et al. (US 2010/0054847 A1).
Regarding claim 1, Seeley teaches a medical system 200 (figure 8), comprising:
a body-wearable medical device 100 selected from the group consisting of an insulin pump, a continuous glucose monitor, and a handheld diabetes management device (paragraph 0002, lines 1-6);
a disposable container 200 (element 200 could be disposed away if needed) having a reservoir 230 configured for storing a foodstuff or a drug (paragraph 0031, “fluid”), the disposable container 200 having an opening 247 (although specification does not discuss element 247, examiner construes element 247 as a refilling port as claimed in claim 6 of the prior art or any opening that allows refilling element 230 or an opening in element 235 that allows fluidic communication with element 230) that provides access to the reservoir 230 and;
a fastener 245 (paragraph 0041, lines 11-13) configured to detachably fasten the disposable container to the body-wearable medical device.
Seeley is silent regarding a tamper evident closure that seals the opening.
However, Sutcliffe teaches a design of a dispenser a tamper evident closure that seals the opening (paragraph 0094, lines 1-5) for the purpose of indicating that the opening has been accessed (paragraph 0094, lines 1-5).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, modify the refilling port of Seeley to incorporate a tamper evident closure that seals the opening as taught by Sutcliffe for the purpose of indicating that the opening has been accessed (paragraph 0094, lines 1-5).
Regarding claim 2, Seeley teaches wherein the fastener 245 (paragraph 0041, lines 11-13) comprises a mechanical, non-adhesive medical device fastener.
Regarding claim 3, Seeley teaches wherein the fastener 245 comprises a medical device bracket (see “B” in figure 8 below) configured for at least partially embracing the body-wearable medical device 100 and/or for at least partially embracing the disposable container 200.
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Regarding claim 5, Seeley discloses wherein the fastener 245 is configured to interoperate to detachably (paragraph 0041, lines 11-13) fasten the disposable container 200 to the body-wearable medical device 100.
Regarding claim 6, Seeley discloses wherein the fastener comprises a hook-and-loop fastener, a hook-and-eye fastener, a latch fastener 245 or clip fastener 245.
Regarding claim 9, Seeley teaches a disposable container 200 (element 200 could be disposed away if needed), comprising:
a reservoir 230 configured for storing a foodstuff or a drug (paragraph 0031, “fluid”),
an opening 247 (although specification does not discuss element 247, examiner construes element 247 as a refilling port as claimed in claim 6 of the prior art or any opening that allows refilling element 230 or an opening in element 235 that allows fluidic communication with element 230) that provides access to the reservoir 230 and;
a body-wearable medical device fastener 245 (paragraph 0041, lines 11-13) configured for detachably fastening the disposable container to the body-wearable medical device, a body-wearable medical device 100 is an insulin pump, a continuous glucose monitor, and a handheld diabetes management device (paragraph 0002, lines 1-6).
Seeley is silent regarding a tamper evident closure that seals the opening.
However, Sutcliffe teaches a design of a dispenser a tamper evident closure that seals the opening (paragraph 0094, lines 1-5) for the purpose of indicating that the opening has been accessed (paragraph 0094, lines 1-5).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, modify the refilling port of Seeley to incorporate a tamper evident closure that seals the opening as taught by Sutcliffe for the purpose of indicating that the opening has been accessed (paragraph 0094, lines 1-5).
Regarding claim 10, Seeley teaches wherein the body-wearable medical device fastener 245 (paragraph 0041, lines 11-13) comprises a non-adhesive medical device fastener.
Regarding claim 11, Seeley teaches wherein the body-wearable medical device fastener 245 comprises a medical device bracket (see “B” in figure 8 above) configured for at least partially embracing the body-wearable medical device 100.
Claims 4 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Seeley et al. (US 2015/0119804 A1) in view of Sutcliffe et al. (US 2010/0054847 A1) and further in view of Kamen et al. (US 2009/0275896 A1).
Regarding claim 4, Seeley/Sutcliffe (hereinafter referred as “modified Seeley”) discloses the claimed invention substantially as claimed, as set forth above in claim 1. Seeley further discloses wherein the disposable container 200 comprises an edge (edge of element 200), which when the disposable container 200 is fastened to the body-wearable medical device 100, contacts the body-wearable medical device 100.
While Seeley shows in figures 1 and 2 where edges of the disposable container contacts entire edge of the body-wearable medical device, one can construe that the edge of element 200 will contact corresponding edge/surface of element 100. Seeley further discloses that shape could be customized to accommodate to a particular patient’s needs/desires (paragraph 0004, lines 9-11) however, modified Seeley is silent regarding an edge being a circumferential edge and circumferentially contacts the body-wearable medical device.
However, Kamen teaches a design of a system (figure 3) wherein the disposable container 114 comprises a circumferential edge (edge of element 114 is circumferential) and circumferentially contacts the body-wearable medical device 102 (see figure 2 where edge of element 114 circumferentially contacts the body-wearable medical device) for the purpose of using a well-known shape of the disposable container and the body-wearable device (figure 3).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the shape of modified Seeley to incorporate an edge being a circumferential edge and circumferentially contacts the body-wearable medical device as taught by Kamen for the purpose of using a well-known shape of the disposable container and the body-wearable device (figure 3).
Regarding claim 12, modified Seeley discloses the claimed invention substantially as claimed, as set forth above in claim 9. Seeley further discloses wherein the disposable container 200 comprises an edge (edge of element 200), which when the disposable container 200 is fastened to the body-wearable medical device 100, contacts the body-wearable medical device 100.
While Seeley shows in figures 1 and 2 where edges of the disposable container contacts entire edge of the body-wearable medical device, one can construe that the edge of element 200 will contact corresponding edge/surface of element 100. Seeley further discloses that shape could be customized to accommodate to a particular patient’s needs/desires (paragraph 0004, lines 9-11) however, modified Seeley is silent regarding an edge being a circumferential edge and circumferentially contacts the body-wearable medical device.
However, Kamen teaches a design of a system (figure 3) wherein the disposable container 114 comprises a circumferential edge (edge of element 114 is circumferential) and circumferentially contacts the body-wearable medical device 102 (see figure 2 where edge of element 114 circumferentially contacts the body-wearable medical device) for the purpose of using a well-known shape of the disposable container and the body-wearable device (figure 3).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the shape of modified Seeley to incorporate an edge being a circumferential edge and circumferentially contacts the body-wearable medical device as taught by Kamen for the purpose of using a well-known shape of the disposable container and the body-wearable device (figure 3).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Seeley et al. (US 2015/0119804 A1) in view of Sutcliffe et al. (US 2010/0054847 A1) and further in view of Haerten et al. (US 4,077,405).
Regarding claim 7, modified Seeley discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Seeley is silent regarding wherein the reservoir has a volume selected from the group consisting of up to 20 cm3, up to 15 cm3, and equal to 13 cm3.
However, Haerten teaches a design of an implantable drug delivery device (figure 1) wherein the reservoir has a volume selected from the group consisting of up to 20 cm3 (column 3, lines 10-16), up to 15 cm3 (column 3, lines 10-16), and equal to 13 cm3 for the purpose of using the small amount of volume enough to cover the specific number of days (column 3, lines 10-16) and to be carried by the patient (column 4, lines 43-49).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the volume of the reservoir of modified Seeley to incorporate wherein the reservoir has a volume selected from the group consisting of up to 20 cm3, up to 15 cm3, and equal to 13 cm3 as taught by Haerten for the purpose of using the small amount of volume enough to cover the specific number of days (column 3, lines 10-16) and to be carried by the patient (column 4, lines 43-49).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Seeley et al. (US 2015/0119804 A1) in view of Sutcliffe et al. (US 2010/0054847 A1) and further in view of Davis et al. (US 2004/0267182 A1).
Regarding claim 8, modified Seeley discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Seeley is silent regarding wherein the disposable container comprises a rip-open venting closure sealing a venting opening of the reservoir volume.
However, Davis teaches a design of a dispenser 120 (figure 4) wherein the disposable container 120 comprises a rip-open venting closure 134 sealing a venting opening 135 of the reservoir volume for the purpose of relieving inner pressure and letting the fluid flow out of disposable container (paragraph 0018, lines 1-4).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the disposable container of modified Seeley to incorporate wherein the disposable container comprises a rip-open venting closure sealing a venting opening of the reservoir volume as taught by Davis for the purpose of relieving inner pressure and letting the fluid flow out of disposable container (paragraph 0018, lines 1-4).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783