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 .
Information Disclosure Statement
The information disclosure statement filed 11/6/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. No copy of the document listed as foreign reference number 44 of the IDS was filed in this application or any of the parent application. Foreign reference number 44 of the IDS has not been considered.
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.
No claim limitations are interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1 and 15 are objected to because of the following informalities:
in claim 1, line 4: “a” should be inserted before “transfer cartridge”;
in claim 15, line 2: “the” should be inserted before “removal”.
Appropriate correction is required.
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.
Claims 2, 4, 8-10, and 12-20 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.
Claim 2 recites “the blood sampling transfer device” in line 2, but it is not clear if this recitation is the same as, related to, or different from “a transfer device” of claim 1, line 3. If they are the same, “the blood sampling transfer device” in claim 2 should be “the transfer device”. If they are different, their relationship should be made clear. Also, if they are different, there is insufficient antecedent basis for this recitation in claim 2.
Claim 4 recites “a substantially impermeable and sterile enclosure” in lines 2-3, which contains the relatively term “substantially” that renders the claim indefinite. The term “substantially impermeable and sterile” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear how impermeable and how sterile an enclosure should be so as to be substantially impermeable and sterile. The specification only uses the expression once but provides no metrics so that one could determine if an enclosure is substantially impermeable and sterile.
Claim 8 recites “a fluid sample” in line 3. Also, claim 10 recites “the fluid sample” in line 4. It is not clear if these recitations are the same as, related to, or different from “a biological fluid” of claim 1, line 1. The relationship among these recitations should be made clear.
Claims 9-10 are rejected by virtue of their dependence from claim 8.
Claim 12 recites “the fluid sample” in line 2, but it is not clear if this recitation is the same as, related to, or different from “a biological fluid” of claim 1, line 1. The relationship between these two recitations should be made clear. Also, if they are different, there is insufficient antecedent basis for this limitation in claim 12.
Claim 13 recites “a fluid sample” in line 2, but it is not clear if this recitation is the same as, related to, or different from “a biological fluid” of claim 1, line 1 and/or “the fluid sample” in claim 12, line 2. The relationships among these recitations should be made clear.
Claim 14 recites “the lancet device” in lines 4-5. Also, claim 20 recites “the lancet device” in line 4. It is not clear if these recitations are the same as, related to, or different from “a lancing device” of claim 14, line 4. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear. Also, if they are different, there is insufficient antecedent basis for the recitation in claim 14.
Claims 15-20 are rejected by virtue of their dependence from claim 14.
Claim 19 recites “the transfer device” in line 1 in which there is insufficient antecedent basis for this limitation in the claim. Also, it is not clear what relationship this recitation has with the other features of the claimed method. Clarification is required.
Claim 19 recites “the blood sample” in line 2, but it is not clear if this recitation is the same as, related to, or different from “a sample” of claim 14, line 5. If they are the same, “the blood sample” in claim 19 should be “the sample”. If they are different, the relationship between these two recitations should be made clear. Also, if they are different, there is insufficient antecedent basis for this limitation in claim 19.
Claim 19 recites “the exit portion” in line 3, but it is not clear if this recitation is the same as, related to, or different from “an exit port” of claim 19, line 2. If they are the same, “the exit portion” in claim 19 should be “the exit port”. If they are different, the relationship between these two recitations should be made clear. Also, if they are different, there is insufficient antecedent basis for “the exit portion” in claim 19.
Claim 20 recites “applying the lancing tape the skin surface” in line 3, which is so grammatically awkward that its meaning is not clear.
Claim 20 recites “a blood sample” in line 4, but it is not clear if this recitation is the same as, related to, or different from “a sample” of claim 14, line 5. If they are the same, “a blood sample” in claim 20 should be “the sample”. If they are different, the relationship between these two recitations should be made clear.
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, 7-8, and 14-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 12 of U.S. Patent No. 10,925,530 (the reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 12 of the reference patent includes all the features of claims 1 and 7-8 of the present application.
Claim 7 or 12 of the reference patent would have made the method steps of claims 14-15 of the present application obvious since the capabilities of the components recited in claim 7 or 12 suggest the method steps of claims 14-15 of the present application.
Claims 1-5 and 7-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 10 of U.S. Patent No. 10,925,530 (the reference patent), in view of one of U.S. Patent No. 6,869,405 (Marsden) or U.S. Patent No. 6,264,619 (Ferguson).
Claim 7 of the reference patent includes all the features of claim 1 of the present application except “a package having a compartment sized and adapted to receive the lancet device and the transfer device therein”. Marsden or Ferguson teaches the use of a blister package as a type of packaging member and a sealing cover secured over the blister package so as to protect the devices contained therein and prevent contamination before use (FIGS. 1 and 11 of Marsden; FIG. 1 and col. 3, lines 5-8 of Ferguson). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a blister package with a sealing cover, as suggested by Marsden or Ferguson, so as to protect the device and prevent contamination before use.
Claim 7 of the reference patent (as modified) includes all the features of claim 1, 3, 4, 7, and 8 of the present application.
With respect to claim 2 of the present application, Ferguson shows that different components are received in different compartments (see FIG. 1 of Ferguson; col. 3, lines 5-8 of Ferguson). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use different compartments for the lancet device and the transfer device since it prevents impact between the two components during storage and shipping. Claim 7 of the reference patent (as modified) includes all the features of claim 2 of the present application.
Claim 7 of the reference patent (as modified) includes all the features of claim 5 of the present application with the cover being the tamper-indicating member.
Claim 10 of the reference patent (as modified) includes all the features of claim 9 of the present application.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 10,925,530 (the reference patent), in view of one of U.S. Patent No. 6,869,405 (Marsden) or U.S. Patent No. 6,264,619 (Ferguson), and further in view of U.S. Patent No. 4,577,630 (Nitzsche).
The combination includes a lancet. Nitzsche teaches a lancet that is activated by contact pressure (abstract and cols. 7-8 of Nitzsche). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the contact activated lancet of Nitzsche as the lancet since (1) it controls the puncture of the lancet to the skin and/or (2) it is a simple substitution of one known element for another to obtain predictable results.
Claim 7 of the reference patent (as modified) had all the features of claim 6 of the present application.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 10,925,530 (the reference patent), in view of one of U.S. Patent No. 6,869,405 (Marsden) or U.S. Patent No. 6,264,619 (Ferguson), and further in view of U.S. Patent No. 3,640,267 (Hurtig).
Hurtig teaches that the arrangement of a dispensing bulb can include tabs 24 and 26 (col. 3, lines 10-20 of Hurtig) to control flow and a conventional fluid coupling to draw a collection sample out for analysis (col. 4, lines, 45-50 of Hurtig). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the tabs 24 and 26 and the conventional fluid coupling of Hurtig so as to better control the flow of the fluid from the body and into an analysis device.
Claim 10 of the reference patent (as modified) includes all the features of claim 10 of the present application with the tabs being the valve.
Claims 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 11 of U.S. Patent No. 10,925,530 (the reference patent), in view of one of U.S. Patent No. 6,869,405 (Marsden) or U.S. Patent No. 6,264,619 (Ferguson), and further in view of U.S. Patent No. 5,419,913 (Podell).
The combination includes an adhesive lancing tape. Podell teaches that hydrogel adhesive with polyurethane is one form of adhesive (abstract of Podell) and that removable plastic peel strips 35 protect the adhesive from contamination (col. 5, lines 15-25 of Podell). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the hydrogel adhesive of Podell as the adhesive since (1) a type of adhesive is required and Podell teaches one such adhesive and/or (2) it is a simple substitution of one known element for another to obtain predictable results. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the removable plastic peel strip of Podell so as to protect the adhesive from contamination.
Claim 7 of the reference patent (as modified) had all the features of claims 11-12 of the present application.
Claim 11 of the reference patent (as modified) had all the features of claim 13 of the present application.
Claims 1, 3, 7-8, and 14-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 13-14, and 16 of U.S. Patent No. 12,082,931 (the reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 13 of the reference patent includes all the features of claims 1 and 7-8 of the present application.
Claim 14 of the reference patent includes all the features of claim 3 of the present application.
Claim 8 of the reference patent would have made the method steps of claim 14 of the present application obvious since the capabilities of the components recited in claim 8 suggest the method steps of claim 14 of the present application.
Claim 16 of the reference patent would have made the method steps of claim 15 of the present application obvious since the capabilities of the components recited in claim 16 suggest the method steps of claim 15 of the present application.
Claims 1- 4 and 7-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 and 10-11 of U.S. Patent No. 12,082,931 (the reference patent), in view of one of U.S. Patent No. 6,869,405 (Marsden) or U.S. Patent No. 6,264,619 (Ferguson).
Claim 8 of the reference patent includes all the features of claim 1 of the present application except “a package having a compartment sized and adapted to receive the lancet device and the transfer device therein”. Marsden or Ferguson teaches the use of a blister package as a type of packaging member and a sealing cover secured over the blister package so as to protect the devices contained therein and prevent contamination before use (FIGS. 1 and 11 of Marsden; FIG. 1 and col. 3, lines 5-8 of Ferguson). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a blister package with a sealing cover, as suggested by Marsden or Ferguson, so as to protect the device and prevent contamination before use.
Claim 8 of the reference patent (as modified) includes all the features of claims 1, 3, 4, and 7 of the present application.
With respect to claim 2 of the present application, Ferguson shows that different components are received in different compartments (see FIG. 1 of Ferguson; col. 3, lines 5-8 of Ferguson). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use different compartments for the lancet device and the transfer device since it prevents impact between the two components during storage and shipping. Claim 8 of the reference patent (as modified) includes all the features of claim 2 of the present application.
Claim 8 or 10 of the reference patent (as modified) includes all the features of claim 8 of the present application.
Claim 11 of the reference patent (as modified) includes all the features of claim 9 of the present application.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 12,082,931 (the reference patent), in view of one of U.S. Patent No. 6,869,405 (Marsden) or U.S. Patent No. 6,264,619 (Ferguson), and further in view of U.S. Patent No. 4,577,630 (Nitzsche).
The combination includes a lancet. Nitzsche teaches a lancet that is activated by contact pressure (abstract and cols. 7-8 of Nitzsche). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the contact activated lancet of Nitzsche as the lancet since (1) it controls the puncture of the lancet to the skin and/or (2) it is a simple substitution of one known element for another to obtain predictable results.
Claim 8 of the reference patent (as modified) had all the features of claim 6 of the present application.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 12,082,931 (the reference patent), in view of one of U.S. Patent No. 6,869,405 (Marsden) or U.S. Patent No. 6,264,619 (Ferguson), and further in view of U.S. Patent No. 3,640,267 (Hurtig).
Hurtig teaches that the arrangement of the dispensing bulb can include tabs 24 and 26 (col. 3, lines 10-20 of Hurtig) to control flow and a conventional fluid coupling to draw a collection sample out for analysis (col. 4, lines, 45-50 of Hurtig). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the tabs 24 and 26 and conventional fluid coupling of Hurtig so as to better control the flow of the fluid from the body and into an analysis device.
Claim 11 of the reference patent (as modified) includes all the features of claim 10 of the present application with the tabs being the valve.
Claims 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 and 12 of U.S. Patent No. 12,082,931 (the reference patent), in view of one of U.S. Patent No. 6,869,405 (Marsden) or U.S. Patent No. 6,264,619 (Ferguson), and further in view of U.S. Patent No. 5,419,913 (Podell).
The combination includes an adhesive lancing tape. Podell teaches that hydrogel adhesive with polyurethane is one form of adhesive (abstract of Podell) and that removable plastic peel strips 35 protect the adhesive from contamination (col. 5, lines 15-25 of Podell). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the hydrogel adhesive of Podell as the adhesive since (1) a type of adhesive is required and Podell teaches one such adhesive and/or (2) it is a simple substitution of one known element for another to obtain predictable results. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the removable plastic peel strip of Podell so as to protect the adhesive from contamination.
Claim 8 of the reference patent (as modified) had all the features of claims 11-12 of the present application.
Claim 12 of the reference patent (as modified) had all the features of claim 13 of the present application.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. 12,082,931 (the reference patent), and further in view of U.S. Patent No. 4,577,630 (Nitzsche).
Claim 13 of the reference patent includes a lancet. Nitzsche teaches a lancet that is activated by contact pressure (abstract and cols. 7-8 of Nitzsche). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the contact activated lancet of Nitzsche as the lancet since (1) it controls the puncture of the lancet to the skin and/or (2) it is a simple substitution of one known element for another to obtain predictable results.
Claim 13 of the reference patent (as modified) had all the features of claim 6 of the present application.
Claims 11-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. 12,082,931 (the reference patent), in view of U.S. Patent No. 5,419,913 (Podell).
Claim 13 of the reference patent includes an adhesive lancing tape. Podell teaches that hydrogel adhesive with polyurethane is one form of adhesive (abstract of Podell) and that removable plastic peel strips 35 protect the adhesive from contamination (col. 5, lines 15-25 of Podell). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the hydrogel adhesive of Podell as the adhesive since (1) a type of adhesive is required and Podell teaches one such adhesive and/or (2) it is a simple substitution of one known element for another to obtain predictable results. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the removable plastic peel strip of Podell so as to protect the adhesive from contamination.
Claim 13 of the reference patent (as modified) had all the features of claims 11-12 of the present application.
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 1-5, 7, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,163,442 (Ono), in view of one of U.S. Patent No. 6,869,405 (Marsden) or U.S. Patent No. 6,264,619 (Ferguson).
Ono teaches a blood sampling transfer device (FIGS. 10-13 of Ono), comprising: an adhesive lancing tape (the patch 7 and the adhesive 9 in FIG. 13 of Ono) having a target (the target indicated in the below annotated FIG. 12 of Ono (FIG. 1 of the Office Action)), and a flow channel (the channel through the patch 7 and adhesive 9 – col. 5, lines 38-47 of Ono) in fluid communication with a portion of the target (during the penetration with the lance 12 of Ono); and a transfer cartridge (the tube 1 in FIG. 13 of Ono) removably connected to the lancing tape. Ono teaches an alternative embodiment of the tube 1 in FIGS. 14-16. To the extent that the tube 1 of FIGS. 14-16 may be different from the tube 1 of FIGS. 10-13, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the tube 1 in FIG. 14-16 as the tube 1 in FIGS. 10-13 since (1) it is a simple substitution of one known element for another to obtain predictable results, and/or (2) it would incorporate reagent chambers so as to indicate the amount of blood sugar, etc. (col. 3, lines 43-47 of Ono) and/or (3) the necessary tests can be completely performed within the collector and/or (4) it would collect larger amounts of blood (col. 1, lines 38-44 of Ono).
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FIG. 1: Annotated FIGS. 12 and 13 of Ono.
Marsden or Ferguson teaches the use of blister packaging (FIGS. 1 and 11 of Marsden and its description; FIG. 1 of Ferguson and its description), which is known to protect the devices contained therein and prevent contamination before use. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the packaging of Marsden or Ferguson with the device of Ono so as to protect the device and prevent contamination before use.
With respect to claim 1, the combination teaches or suggests a kit for sampling a biological fluid comprising:
a lancet device (the lance 12 of Ono);
a transfer device, the transfer device including a lancing tape (the patch 7, the adhesive 9, and the sheet 10 in FIGS. 12-13 of Ono) having a flow channel (the channel through the patch 7 and adhesive 9 – col. 5, lines 38-47 of Ono) and transfer cartridge (the tube 1 of Ono as modified) removably connected to the lancing tape; and
a package having a compartment sized and adapted to receive the lancet device and the transfer device therein (the packaging - FIGS. 1 and 11 of Marsden and its description; FIG. 1 of Ferguson and its description).
With respect to claim 2, Ferguson shows that different components are received in different compartments (see FIG. 1 of Ferguson; col. 3, lines 5-8 of Ferguson). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use different compartments for the lancet device and the transfer device since it prevents impact between the two components during storage and shipping. Thus, the combination teaches or suggests that the package comprises a first compartment adapted to receive the blood sampling transfer device (the first compartment suggested by FIG. 1 of Ferguson) and a second compartment sized and adapted to receive the lancet device (the second compartment suggested by FIG. 1 of Ferguson).
With respect to claim 3, the combination teaches or suggests that the package comprises a blister package (the blister packaging of the combination- FIGS. 1 and 11 of Marsden and its description; FIG. 1 of Ferguson and its description)
With respect to claim 4, the combination teaches or suggests that the package comprises a sealing cover secured over an opening in the compartment, wherein the sealing cover provides a substantially impermeable and sterile enclosure (the cover of Ferguson or Marsden; FIG. 1 and col. 3, lines 5-8 of Ferguson; FIG. 1 of Marsden).
With respect to claim 5, the combination teaches or suggests that the package includes a tamper-indicating member (the cover of Ferguson or Marsden; FIG. 1 and col. 3, lines 5-8 of Ferguson; FIG. 1 of Marsden).
With respect to claim 7, the combination teaches or suggests that the lancing tape (the patch 7, the adhesive 9, and the sheet 10 in FIGS. 12-13 of Ono) of the transfer device comprises a target (the target indicated in the above annotated FIG. 12 of Ono (FIG. 1 of the Office Action)) and the flow channel (the channel through the patch 7 and adhesive 9 – col. 5, lines 38-47 of Ono) is in fluid communication with a portion of the target (during the penetration with the lance 12 of Ono).
With respect to claim 11, the combination teaches or suggests that the lancing tape (the patch 7, the adhesive 9, and the sheet 10 in FIGS. 12-13 of Ono) includes a superior surface and an inferior surface, wherein the inferior surface includes an adhesive layer (the adhesive 9 and the patch 7 in FIG. 13 of Ono) and a peel-off layer (the sheet 10 of Ono) protecting the adhesive layer.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,163,442 (Ono), in view of one of U.S. Patent No. 6,869,405 (Marsden) or U.S. Patent No. 6,264,619 (Ferguson), and further in view of U.S. Patent No. 4,577,630 (Nitzsche).
The combination teaches or suggests a lancet device (the lance 12 of Ono). Nitzsche teaches a lancet that is activated by contact pressure (abstract and cols. 7-8 of Nitzsche). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the contact activated lancet of Nitzsche as the lancet of Ono since (1) it controls the punction of the lancet to the skin and/or (2) it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 6 the combination teaches or suggests that the lancet device comprises a contact activated lancet (the contact activated lancet of Nitzsche ).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,163,442 (Ono), in view of one of U.S. Patent No. 6,869,405 (Marsden) or U.S. Patent No. 6,264,619 (Ferguson), and further in view of U.S. Patent No. 5,419,913 (Podell).
The combination teaches or suggests an adhesive (the adhesive 9 of Ono). Podell teaches that hydrogel adhesive with polyurethane is one form of adhesive (abstract of Podell). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the hydrogel adhesive of Podell as the adhesive of Ono since (1) a type of adhesive is required and Podell teaches one such adhesive and/or (2) it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 12, the combination teaches or suggests that the adhesive layer comprises a seal-sealing or self-healing polymer (the hydrogel adhesive of Podell as the adhesive 9 of Ono) that prevents leaks of the fluid sample.
With respect to claim 13, the combination teaches or suggests that the lancing tape (the patch 7, the adhesive 9, and the sheet 10 in FIGS. 12-13 of Ono) includes an upper portion having a compressible blister configured for receiving a fluid sample (the middle bump of the patch 7 seen in FIGS. 12-13 of Ono).
Claims 14-15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,163,442 (Ono).
Ono teaches a blood sampling transfer device (FIGS. 10-13 of Ono), comprising: an adhesive lancing tape (the patch 7 and the adhesive 9 in FIG. 13 of Ono) having a target (the target indicated in the above annotated FIG. 12 of Ono (FIG. 1 of the Office Action)), and a flow channel (the channel through the patch 7 and adhesive 9 – col. 5, lines 38-47 of Ono) in fluid communication with a portion of the target (during the penetration with the lance 12 of Ono); and a transfer cartridge (the tube 1 in FIG. 13 of Ono) removably connected to the lancing tape. Ono teaches an alternative embodiment of the tube 1 in FIGS. 14-16. To the extent that the tube 1 of FIGS. 14-16 may be different from the tube 1 of FIGS. 10-13, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the tube 1 in FIG. 14-16 as the tube 1 in FIGS. 10-13 since (1) it is a simple substitution of one known element for another to obtain predictable results, and/or (2) it would incorporate reagent chambers so as to indicate the amount of blood sugar, etc. (col. 3, lines 43-47 of Ono) and/or (3) the necessary tests can be completely performed within the collector and/or (4) it would collect larger amounts of blood (col. 1, lines 38-44 of Ono).
With respect to claim 14, the combination teaches or suggests a method for using a blood sampling device comprising:
applying a lancing tape (applying the patch 7, the adhesive 9, and the sheet 10 in FIGS. 12-13 of Ono) having a transfer cartridge (the tube 1 of Ono as modified) connected thereto onto a selected sampling site, wherein the lancing tape includes a target (the target indicated in the above annotated FIG. 12 of Ono (FIG. 1 of the Office Action));
placing a tip of a lancing device onto the target and applying a force to activate the lancet device and obtain a sample from the sampling site (using the lance 12 of Ono; FIG. 9 of Ono);
allowing the sample to flow from a lancing tape flow channel associated with the target into a transfer cartridge flow channel (the flow from the channel through the patch 7 and adhesive 9 (col. 5, lines 38-47 of Ono) into the channel 25 or another one of the channels to the right of the reagent chamber 18 of the tube 1 of FIG. 14 of Ono) ; and
upon filling of the cartridge, removing the transfer cartridge from the lancing tape (removing the tube 1 of Ono as modified; FIG. 13 of Ono).
With respect to claim 15, the combination teaches or suggests that the lancing tape (the patch 7, the adhesive 9, and the sheet 10 in FIGS. 12-13 of Ono) and the transfer cartridge (the tube 1 of Ono as modified) are connected by a frangible portion (the frangible portion in the above annotated FIG. 12 of Ono (FIG. 1 of the Office Action) and wherein removal of the transfer cartridge from the lancing tape causes the transfer cartridge flow channel to be sealed from an external environment (the use of the sealing wall in the above annotated FIG. 12 of Ono (FIG. 1 of the Office Action)).
With respect to claim 20, the combination teaches or suggests that the lancing tape includes an adhesive surface (the adhesive 9 and the patch 7 in FIG. 13 of Ono) covered by a peel layer and the selected sampling site comprises a skin surface, and wherein the method further comprises removing the peel layer (the sheet 10 of Ono), applying the lancing tape the skin surface (see FIG. 9 of Ono; col 5, lines 11-40 of Ono), and activating the lancet device to pierce the skin surface through the target to obtain a blood sample (col 5, lines 11-40 of Ono).
Claims 1-5, 7, and 113 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,163,442 (Ono), in view of U.S. Patent No. 5,422,018 (Saunders), and further in view of U.S. Patent No. 6,869,405 (Marsden) or U.S. Patent No. 6,264,619 (Ferguson).
Ono teaches a blood sampling transfer device (FIGS. 10-13 of Ono), comprising a tube 1 (FIGS. 10-13 of Ono). Ono teaches an alternative embodiment of the extreme end of the tube 1 in FIGS. 20-21. To the extent that the extreme end of the tube 1 of FIGS. 20-21 may be different from the extreme end of the tube 1 of FIGS. 10-13, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the extreme end of the tube 1 in FIG. 20-21 as the extreme end of the tube 1 in FIGS. 10-13 since (1) it is a simple substitution of one known element for another to obtain predictable results, and/or (2) it provides the ability to connect to larger collection containers or tubes (col. 6, lines 29-35 of Ono).
Ono teaches that the tube 1 may include a coupling 34 so as to be connected to a large tube for blood collection (FIGS. 20-21; col. 6, lines 29-35 of Ono). It is well known in the art to use tubes and centrifuges to analyze blood (col. 1-6 of Saunders disclosing the use of a tube and centrifuge for obtaining a fraction of interest in blood)1. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the tube and centrifuge of Saunders since Ono teaches the connection of a tube and the use of centrifuges will permit the analysis of various fractions of interest in blood.
Marsden or Ferguson teaches the use of blister packaging (FIGS. 1 and 11 of Marsden and its description; FIG. 1 of Ferguson and its description), which is known to protect the devices contained therein and prevent contamination before use. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the packaging of Marsden or Ferguson with the device of Ono so as to protect the device and prevent contamination before use.
With respect to claim 1, the combination teaches or suggests a kit for sampling a biological fluid comprising:
a lancet device (the lance 12 of Ono);
a transfer device, the transfer device including a lancing tape (the patch 7, the adhesive 9, and the sheet 10 in FIGS. 12-13 of Ono) having a flow channel (the channel through the patch 7 and adhesive 9 – col. 5, lines 38-47 of Ono) and transfer cartridge (the tube 1 and the tube of Saunders or Nielsen) removably connected to the lancing tape; and
a package having a compartment sized and adapted to receive the lancet device and the transfer device therein (the packaging - FIGS. 1 and 11 of Marsden and its description; FIG. 1 of Ferguson and its description).
With respect to claim 2, Ferguson shows that different components are received in different compartments (see FIG. 1 of Ferguson; col. 3, lines 5-8 of Ferguson). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use different compartments for the lancet device and the transfer device since it prevents impact between the two components during storage and shipping. Thus, the combination teaches or suggests that the package comprises a first compartment adapted to receive the blood sampling transfer device (the first compartment suggested by FIG. 1 of Ferguson) and a second compartment sized and adapted to receive the lancet device (the second compartment suggested by FIG. 1 of Ferguson).
With respect to claim 3, the combination teaches or suggests that the package comprises a blister package (the blister packaging of the combination- FIGS. 1 and 11 of Marsden and its description; FIG. 1 of Ferguson and its description)
With respect to claim 4, the combination teaches or suggests that the package comprises a sealing cover secured over an opening in the compartment, wherein the sealing cover provides a substantially impermeable and sterile enclosure (the cover of Ferguson or Marsden; FIG. 1 and col. 3, lines 5-8 of Ferguson; FIG. 1 of Marsden).
With respect to claim 5, the combination teaches or suggests that the package includes a tamper-indicating member (the cover of Ferguson or Marsden; FIG. 1 and col. 3, lines 5-8 of Ferguson; FIG. 1 of Marsden).
With respect to claim 7, the combination teaches or suggests that the lancing tape of the transfer device comprises a target (the target indicated in the above annotated FIG. 12 of Ono (FIG. 1 of the Office Action); col. 5, lines 14-47 of Ono) and the flow channel (the channel through the patch 7 and adhesive 9 – col. 5, lines 38-47 of Ono) is in fluid communication with a portion of the target (during the penetration with the lance 12 of Ono).
With respect to claim 11, the combination teaches or suggests that the lancing tape (the patch 7, the adhesive 9, and the sheet 10 in FIGS. 12-13 of Ono) includes a superior surface and an inferior surface, wherein the inferior surface includes an adhesive layer (the adhesive 9 and the patch 7 in FIG. 13 of Ono) and a peel-off layer (the sheet 10 of Ono) protecting the adhesive layer.
With respect to claim 12, the combination teaches or suggests that the adhesive layer comprises a seal-sealing or self-healing polymer (the adhesive 9 and the latex or the thin “SARAN” plastic material of the patch 7 of Ono) that prevents leaks of the fluid sample.
With respect to claim 13, the combination teaches or suggests that the lancing tape (the patch 7, the adhesive 9, and the sheet 10 in FIGS. 12-13 of Ono) includes an upper portion having a compressible blister configured for receiving a fluid sample (the middle bump of the patch 7 seen in FIGS. 12-13 of Ono).
Claims 14-15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,163,442 (Ono), in view of U.S. Patent No. 5,422,018 (Saunders).
Ono teaches a blood sampling transfer device (FIGS. 10-13 of Ono), comprising a tube 1 (FIGS. 10-13 of Ono). Ono teaches an alternative embodiment of the extreme end of the tube 1 in FIGS. 20-21. To the extent that the extreme end of the tube 1 of FIGS. 20-21 may be different from the extreme end of the tube 1 of FIGS. 10-13, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the extreme end of the tube 1 in FIG. 20-21 as the extreme end of the tube 1 in FIGS. 10-13 since (1) it is a simple substitution of one known element for another to obtain predictable results, and/or (2) it provides the ability to connect to larger collection containers or tubes (col. 6, lines 29-35 of Ono).
Ono teaches that the tube 1 may include a coupling 34 so as to be connected to a large tube for blood collection (FIGS. 20-21; col. 6, lines 29-35 of Ono). It is well known in the art to use tubes and centrifuges to analyze blood (col. 1-6 of Saunders disclosing the use of a tube and centrifuge for obtaining a fraction of interest in blood)2. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the tube and centrifuge of Saunders since Ono teaches the connection of a tube and the use of centrifuges will permit the analysis of various fractions of interest in blood.
With respect to claim 14, the combination teaches or suggests a method for using a blood sampling device comprising:
applying a lancing tape (applying the patch 7, the adhesive 9, and the sheet 10 in FIGS. 12-13 of Ono) having a transfer cartridge (the tube 1 and the tube of Saunders) connected thereto onto a selected sampling site, wherein the lancing tape includes a target (the target indicated in the above annotated FIG. 12 of Ono (FIG. 1 of the Office Action));
placing a tip of a lancing device onto the target and applying a force to activate the lancet device and obtain a sample from the sampling site (using the lance 12 of Ono; FIG. 9 of Ono);
allowing the sample to flow from a lancing tape flow channel associated with the target into a transfer cartridge flow channel (the flow from the channel through the patch 7 and adhesive 9 (col. 5, lines 38-47 of Ono) into the channel 25 or another one of the channels that lead to any of the chambers to the right of the reagent chamber 18 of the tube 1 of FIG. 14 of Ono or to any of the chambers of the tube of Saunders); and
upon filling of the cartridge, removing the transfer cartridge from the lancing tape (removing the tube 1 of Ono as modified; FIG. 13 of Ono).
With respect to claim 15, the combination teaches or suggests that the lancing tape (the patch 7, the adhesive 9, and the sheet 10 in FIGS. 12-13 of Ono) and the transfer cartridge (the tube 1 and the tube of Saunders) are connected by a frangible portion (the frangible portion in the above annotated FIG. 12 of Ono (FIG. 1 of the Office Action) and wherein removal of the transfer cartridge from the lancing tape causes the transfer cartridge flow channel to be sealed from an external environment (the use of the sealing wall in the above annotated FIG. 12 of Ono (FIG. 1 of the Office Action)).
With respect to claim 20, the combination teaches or suggests that the lancing tape includes an adhesive surface (the adhesive 9 and the patch 7 in FIG. 13 of Ono) covered by a peel layer and the selected sampling site comprises a skin surface, and wherein the method further comprises removing the peel layer (the sheet 10 of Ono), applying the lancing tape the skin surface (see FIG. 9 of Ono; col 5, lines 11-40 of Ono), and activating the lancet device to pierce the skin surface through the target to obtain a blood sample (col 5, lines 11-40 of Ono).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,163,442 (Ono), in view of U.S. Patent No. 5,422,018 (Saunders), and further in view of U.S. Patent No. 6,264,619 (Ferguson).
The combination teaches or suggests that the lancing tape (the patch 7, the adhesive 9, and the sheet 10 in FIGS. 12-13 of Ono) and the transfer cartridge (the tube 1 and the tube of Saunders). Ferguson teaches the use of anticoagulants in blood collection tubes so as to prevent clotting (col. 2, lines 45-56 and col. 3, lines 40-66 of Ferguson). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use anticoagulants in the tube of Saunders since it prevents clotting before centrifugation.
With respect to claim 16, the combination teaches or suggests that the transfer cartridge flow channel (one of the channels that lead to any of the chambers of the tube of Saunders) contains an anti-coagulant therein (the coagulant suggested by Ferguson) and wherein the method further comprises insertion of the cartridge into a centrifuge device to separate a plasma portion out of the sample (the use of centrifuges of Saunders).
With respect to claim 17, the combination teaches or suggests that the transfer cartridge includes a dispensing bulb (one of the compartments in the tube of Saunders is the dispensing bulb) and an exit port (the opening at the top of the tube 2 in FIGS. 1 and 4-5 of Saunders or the opening formed by cutting the walls of the sample tube (col. 5, lines 15-30 of Saunders)) and wherein after centrifuging, the plasma portion is retained within the dispensing bulb (the use of centrifuges of Saunders results in this situation; FIG. 5 and col. 6, lines 1-20 of Saunders).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,163,442 (Ono), in view of U.S. Patent No. 5,422,018 (Saunders), and further in view of U.S. Patent No. 6,264,619 (Ferguson), and further in view of U.S. Patent No. 6,869,405 (Marsden).
Saunders teaches the removal of the fraction of interest through the opening at the top of the tube 2 in FIGS. 1 and 4-5 of Saunders or the opening formed by cutting the walls of the sample tube (col. 5, lines 15-30 of Saunders) and used for further analysis (col. 1, lines 20-31 of Saunders). Marsden teach the use of a point-of-care testing cartridge 12 which can provide further analysis (col. 5, lines 10-40 of Marsden). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the point-of-care testing cartridge 12 of Marsden on the sample of the combination since further analysis is suggested and Marsden teaches on such implementation of such analysis.
With respect to claim 18, the combination teaches or suggests squeezing the dispensing bulb (one of the compartments in the tube of Saunders is the dispensing bulb) to cause the plasma portion to flow through the exit port (the opening at the top of the tube 2 in FIGS. 1 and 4-5 of Saunders or the opening formed by cutting the walls of the sample tube (col. 5, lines 15-30 of Saunders)) into a point-of-care testing device (the point-of-car test cartridge of Marsden).
Claims 19 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,163,442 (Ono), in view of U.S. Patent No. 5,422,018 (Saunders), and further in view of U.S. Patent No. 6,869,405 (Marsden).
Saunders teaches the removal of the fraction of interest through the opening at the top of the tube 2 in FIGS. 1 and 4-5 of Saunders or the opening formed by cutting the walls of the sample tube (col. 5, lines 15-30 of Saunders) and used for further analysis (col. 1, lines 20-31 of Saunders). Marsden teach the use of a point-of-care testing cartridge 12 which can provide further analysis (col. 5, lines 10-40 of Marsden). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the point-of-care testing cartridge 12 of Marsden on the sample of the combination since further analysis is suggested and Marsden teaches on such implementation of such analysis.
With respect to claim 19, the combination teaches or suggests that the transfer device includes a dispensing bulb (one of the compartments in the tube of Saunders is the dispensing bulb) and an exit port (the opening at the top of the tube 2 in FIGS. 1 and 4-5 of Saunders or the opening formed by cutting the walls of the sample tube (col. 5, lines 15-30 of Saunders)) and the method comprises squeezing the dispensing bulb to cause the blood sample to flow through the exit portion into a point-of-care testing device (removal of the fraction of interest through the opening at the top of the tube 2 in FIGS. 1 and 4-5 of Saunders or the opening formed by cutting the walls of the sample tube (col. 5, lines 15-30 of Saunders) and used with the point-of-car test cartridge of Marsden).
Claims 1-5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 3,640,267 (Hurtig), in view of one of U.S. Patent No. 6,869,405 (Marsden) or U.S. Patent No. 6,264,619 (Ferguson).
Hurtig teaches a kit for sampling a biological fluid (FIGS. 1-4 of Hurtig), comprising: a lancet device (the tube end 12a of Hurtig) and a transfer device, the transfer device including a lancing tape (the section 10a of Hurtig) having a flow channel and transfer cartridge (the section 10b of Hurtig) removably connected to the lancing tape.
Marsden or Ferguson teaches the use of blister packaging (FIGS. 1 and 11 of Marsden and its description; FIG. 1 of Ferguson and its description), which is known to protect the devices contained therein and prevent contamination before use. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the packaging of Marsden or Ferguson with the device of Hurtig so as to protect the device and prevent contamination before use.
With respect to claim 1, the combination teaches or suggests a kit for sampling a biological fluid (FIGS. 1-4 of Hurtig), comprising:
a lancet device (the tube end 12a of Hurtig);
a transfer device, the transfer device including a lancing tape (the section 10a of Hurtig) having a flow channel (the coiled section 12c of Hurtig) and transfer cartridge (the section 10b of Hurtig) removably connected to the lancing tape; and
a package having a compartment sized and adapted to receive the lancet device and the transfer device therein (the packaging - FIGS. 1 and 11 of Marsden and its description; FIG. 1 of Ferguson and its description).
With respect to claim 2, Ferguson shows that different components are received in different compartments (see FIG. 1 of Ferguson; col. 3, lines 5-8 of Ferguson). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use different compartments for the lancet device and the transfer device since it prevents impact between the two components during storage and shipping. Thus, the combination teaches or suggests that the package comprises a first compartment adapted to receive the blood sampling transfer device (the first compartment suggested by FIG. 1 of Ferguson) and a second compartment sized and adapted to receive the lancet device (the second compartment suggested by FIG. 1 of Ferguson).
With respect to claim 3, the combination teaches or suggests that the package comprises a blister package (the blister packaging of the combination- FIGS. 1 and 11 of Marsden and its description; FIG. 1 of Ferguson and its description)
With respect to claim 4, the combination teaches or suggests that the package comprises a sealing cover secured over an opening in the compartment, wherein the sealing cover provides a substantially impermeable and sterile enclosure (the cover of Ferguson or Marsden; FIG. 1 and col. 3, lines 5-8 of Ferguson; FIG. 1 of Marsden).
With respect to claim 5, the combination teaches or suggests that the package includes a tamper-indicating member (the cover of Ferguson or Marsden; FIG. 1 and col. 3, lines 5-8 of Ferguson; FIG. 1 of Marsden).
With respect to claim 7, the combination teaches or suggests that the lancing tape of the transfer device comprises a target (the nozzle section 12b of Hurtig) and the flow channel (the coiled section 12c of Hurtig) is in fluid communication with a portion of the target.
With respect to a first interpretation of claim 8, the combination teaches or suggests that the transfer cartridge (the section 10b of Hurtig) is removably connected to the lancing tape via a frangible portion (the construction line 36 of Hurtig) integrally formed between the transfer cartridge and the lancing tape (the section 10a of Hurtig), and wherein the transfer cartridge includes a reservoir (the chamber 14 or the feed end 12d of Hurtig) configured for receiving a fluid sample from the target via the flow channel.
With respect to a second interpretation of claim 8, the combination teaches or suggests that the transfer cartridge (the section 10b of Hurtig) is removably connected to the lancing tape via a frangible portion (the construction line 36 of Hurtig) integrally formed between the transfer cartridge and the lancing tape (the section 10a of Hurtig), and wherein the transfer cartridge includes a reservoir (the chamber 14 of Hurtig) configured for receiving a fluid sample from the target via the flow channel.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 3,640,267 (Hurtig), in view of one of U.S. Patent No. 6,869,405 (Marsden) or U.S. Patent No. 6,264,619 (Ferguson), and further in view of JP 2011-504592 (JP 592). Citations to JP 592will refer to the machine English translation that accompanies this Office Action.
With respect to a second interpretation of claim 8, the combination teaches or suggests that the transfer cartridge (the section 10b of Hurtig) is removably connected to the lancing tape via a frangible portion (the construction line 36 of Hurtig) integrally formed between the transfer cartridge and the lancing tape (the section 10a of Hurtig), and wherein the transfer cartridge includes a reservoir (the chamber 14 of Hurtig) configured for receiving a fluid sample from the target via the flow channel. JP 592 teaches the use of blood stabilizers in channels (page 8 of JP 592). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a blood stabilizer in the feed end 12d of Hurtig so as to provide a sample with higher integrity.
With respect to claim 9, the combination teaches or suggests that the transfer cartridge (the section 10b of Hurtig) includes a transfer cartridge flow channel (the feed end 12d of Hurtig) in fluid communication with the reservoir (the chamber 14 of Hurtig) and the transfer cartridge flow channel comprises sample stabilizer (the stabilizer of JP 592).
With respect to claim 10, the combination teaches or suggests that the transfer cartridge includes a dispensing bulb (the fluid coupling of Hurtig; col. 4, lines 45-50 of Hurtig) in fluid communication with the transfer cartridge flow channel (the feed end 12d of Hurtig), the transfer cartridge flow channel (the feed end 12d of Hurtig) disposed between the dispensing bulb (the fluid coupling of Hurtig; col. 4, lines 45-50 of Hurtig) and the reservoir (the chamber 14 of Hurtig) , and wherein the dispensing bulb includes a valve (the fluid coupling of Hurtig; col. 4, lines 45-50 of Hurtig) transitionable between a closed position and an open position to allow the fluid sample to flow out of the transfer cartridge to a point-of-care testing device (col. 4, lines 45-50 of Hurtig).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
1 Col. 2 of U.S. Patent No. 4,511,349 (Nielsen) similarly discloses the use of a tube and centrifuge for investigating blood serum lipoprotein
2 Col. 2 of U.S. Patent No. 4,511,349 (Nielsen) similarly discloses the use of a tube and centrifuge for investigating blood serum lipoprotein
Prosecution Insights