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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 38-57 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 38, recites limitation of “a vent port in fluid communication with atmospheric pressure and a test sample volume measurement chamber of the plurality of sample processing and testing paths, the vent port being configured to be closed to enable filling of the test sample volume measurement chambers with respective predefined amounts of the test sample and to prevent test sample from reaching a reagent chamber”. Fig. 8A (reproduced below), vents 166a-e and column 14, lines 15-31 of the disclosure in support of this limitation. This portion of the specification describes vents 166a-e as "confluent with the mixing chambers 134a-e respectively. Accordingly, when the vents 166a-e are open to allow airflow therethrough, air from the mixing chambers 134a-e can be readily displaced from the mixing chambers 134a-e as blood flows into the mixing chambers 134a-e. Conversely, when the vents 166a-e are closed to prevent airflow therethrough, blood is inhibited from flowing into the mixing chambers 134a-e because the air within the mixing chambers 134a-e is not allowed to be displaced therefrom."
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Neither the configuration in Fig. 8a nor the description in the specification support the use of "the vent port being configured to be closed to enable filling of the blood test sample volume measurement chamber" as claimed. As depicted and described each of the plurality of vents 166a-e have to be present and closed to enable to filling of the plurality of blood test sample volume measurement chambers and to prevent a blood sample from reaching a reagent chamber. There is no configuration depicted or described wherein closure of a vent port in fluid communication with a blood test sample volume measurement chamber would enable filling of a plurality of blood sample volume measurement chambers without the blood sample reaching a reagent chamber. Claims 39-57 are included in this rejection because they depend from claim 38 and as such include all of the limitations thereof.
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 38-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,327,069 (McKluskey). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claim 38 recites a cartridge having a plurality of sample processing and testing paths arranged (claim 1 of McKuskey), each sample processing and testing path comprising:
a test sample volume measurement chamber having an internal volume to contain a predefined amount of a test sample (claim 1, measurement chamber);
a reagent chamber in fluid communication with the test sample volume measurement chamber and with a reagent, the reagent chamber being configured to receive liquid based on the predefined amount of the test sample for mixing with the reagent to produce a mixture based on the test sample and the reagent (mixing chamber having one reagent, claim 1);
a viscoelastic testing chamber configured to receive the mixture and to enable a viscoelastic test to be performed on the mixture while the mixture resides in the testing chamber (testing chamber of claim 1 preamble; claim 14,15,16, 18, 22) and
conduits creating fluidic connections among the test sample volume measurement chamber, the reagent chamber, and the viscoelastic testing chamber, each conduit having a different three-dimensional structure than each of the test sample volume measurement chamber, the reagent chamber, and the viscoelastic testing chamber (see claim 1, conduits connect each of the measurement chamber, mixing chamber, and testing chamber); and
a vent port in fluid communication with atmospheric pressure and a test sample volume measurement chamber of the plurality of sample processing and testing paths, the vent port being configured to be closed to enable filling of the test sample volume measurement chambers with respective predefined amounts of the test sample and to prevent test sample from reaching a reagent chamber (claim 1, vent port in communication with measuring chamber).
Regarding claim 39, the cartridge of claim 38, wherein the reagent chamber contains reagent beads (claim 15, in solid form that dissolve when contacted with test sample.
Regarding claim 40, the cartridge of claim 39, wherein the reagent beads comprise reagent compositions comprising one or more of CaCl2, ellagic acid/phospholipids, tissue factor, heparinase, polybrene, cytochalasin D, or tranexamic acid (claim 15).
Regarding claim 41, the cartridge of claim 38, wherein each of the sample processing and testing paths comprises a structure associated with a corresponding conduit, each structure being controllable to prevent fluid flow (claim 6).
Regarding claim 42, the cartridge of claim 41, wherein the structure is a valve (claim 6).
Regarding claim 43, the cartridge of claim 38, wherein the reagent chamber is a first reagent chamber and the reagent is a first reagent; wherein the cartridge comprises a second reagent chamber in series with the first reagent chamber, the second reagent chamber being in fluid communication with the test sample volume measurement chamber and with a second reagent; and wherein the mixture is based on both the first reagent and the second reagent (see claim 14, 15).
Regarding claim 44, the cartridge of claim 43, wherein the first reagent and the second reagent comprise different reagents (14-16).
Regarding claim 45, the cartridge of claim 38, wherein each of the sample processing and testing paths comprises a conduit of the conduits for transporting the mixture to a corresponding viscoelastic testing chamber, the conduit being non-linear (claim 1, 14, 15).
Regarding claim 46, the cartridge of claim 38, further comprising: an elastomer associated with each of the processing and testing paths (claim 1, 14,15).
Regarding claim 47, the cartridge of claim 38, further comprising: alignment structures configured to align the cartridge with the testing console, the alignment structures being different from the plurality of sample processing and testing paths (claim 1, 14, 15).
Regarding claim 48, the cartridge of claim 47, wherein the alignment structures comprise two alignment holes (claim 1, 14, 15).
Regarding claim 49, the cartridge of claim 47, wherein at least part each of four of the plurality of sample processing and testing paths is between the alignment structures (claim 1, 14 ,15).
Regarding claim 50, the cartridge of claim 47, wherein the reagent chamber comprises reagent beads in solid form that dissolve when contacted with test sample (claim 15).
Regarding claim 51, the cartridge of claim 50, wherein the reagent beads comprise reagent compositions comprising one or more of CaCl2, ellagic acid/phospholipids, tissue factor, heparinase, polybrene, cytochalasin D, or tranexamic acid (claim 15).
Regarding claim 52, the cartridge of claim 47, wherein the reagent chamber is a first reagent chamber and the reagent is a first reagent; wherein the cartridge comprises a second reagent chamber in series with the first reagent chamber, the second reagent chamber being in fluid communication with the test sample volume measurement chamber and with a second reagent; and wherein the mixture is based on both the first reagent and the second reagent (claim 1, 14, 15).
Regarding claim 53, the cartridge of claim 52, wherein the first reagent and the second reagent comprise different reagents (claim 1, 14, 15).
Regarding claim 54, the cartridge of claim 53, wherein each of the sample processing and testing paths comprises a structure associated with a corresponding conduit, each structure being controllable to prevent fluid flow (claim 6).
Regarding claim 55, the cartridge of claim 54, wherein the structure is a valve (claim 6).
Regarding claim 56, the cartridge of claim 52, wherein each of the sample processing and testing paths comprises a conduit of the conduits for transporting the mixture to a corresponding viscoelastic testing chamber, the conduit being non-linear (claim 1, 14, 15).
Regarding claim 57, the cartridge of claim 56, further comprising: an elastomer associated with each of the sample processing and testing paths (claim 1, 14, 15).
Claims 38-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 14-21 of U.S. Patent No. 10,175,225 (McKluskey).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claim 38 recites a cartridge having a plurality of sample processing and testing paths arranged (claim 1 of McKuskey), each sample processing and testing path comprising:
a test sample volume measurement chamber having an internal volume to contain a predefined amount of a test sample (claim 1, measurement chamber);
a reagent chamber in fluid communication with the test sample volume measurement chamber and with a reagent, the reagent chamber being configured to receive liquid based on the predefined amount of the test sample for mixing with the reagent to produce a mixture based on the test sample and the reagent (mixing chamber having one reagent, claim 1);
a viscoelastic testing chamber configured to receive the mixture and to enable a viscoelastic test to be performed on the mixture while the mixture resides in the testing chamber (testing chamber of claim 1 preamble; claim 14) and
conduits creating fluidic connections among the test sample volume measurement chamber, the reagent chamber, and the viscoelastic testing chamber, each conduit having a different three-dimensional structure than each of the test sample volume measurement chamber, the reagent chamber, and the viscoelastic testing chamber (see claim 1, 14 conduits connect each of the measurement chamber, mixing chamber, and testing chamber); and
a vent port in fluid communication with atmospheric pressure and a test sample volume measurement chamber of the plurality of sample processing and testing paths, the vent port being configured to be closed to enable filling of the test sample volume measurement chambers with respective predefined amounts of the test sample and to prevent test sample from reaching a reagent chamber (claim 7,8 vent port in communication with measuring chamber).
Regarding claim 39, the cartridge of claim 38, wherein the reagent chamber contains reagent beads (claim 9, in solid form that dissolve when contacted with test sample.
Regarding claim 40, the cartridge of claim 39, wherein the reagent beads comprise reagent compositions comprising one or more of CaCl2, ellagic acid/phospholipids, tissue factor, heparinase, polybrene, cytochalasin D, or tranexamic acid (claim 9).
Regarding claim 41, the cartridge of claim 38, wherein each of the sample processing and testing paths comprises a structure associated with a corresponding conduit, each structure being controllable to prevent fluid flow (claim 11).
Regarding claim 42, the cartridge of claim 41, wherein the structure is a valve (claim 5).
Regarding claim 43, the cartridge of claim 38, wherein the reagent chamber is a first reagent chamber and the reagent is a first reagent; wherein the cartridge comprises a second reagent chamber in series with the first reagent chamber, the second reagent chamber being in fluid communication with the test sample volume measurement chamber and with a second reagent; and wherein the mixture is based on both the first reagent and the second reagent (see claim 9).
Regarding claim 44, the cartridge of claim 43, wherein the first reagent and the second reagent comprise different reagents (9).
Regarding claim 45, the cartridge of claim 38, wherein each of the sample processing and testing paths comprises a conduit of the conduits for transporting the mixture to a corresponding viscoelastic testing chamber, the conduit being non-linear (claim 1,14).
Regarding claim 46, the cartridge of claim 38, further comprising: an elastomer associated with each of the processing and testing paths (claim 1, 14).
Regarding claim 47, the cartridge of claim 38, further comprising: alignment structures configured to align the cartridge with the testing console, the alignment structures being different from the plurality of sample processing and testing paths (claim 1, 14).
Regarding claim 48, the cartridge of claim 47, wherein the alignment structures comprise two alignment holes (claim 1, 14).
Regarding claim 49, the cartridge of claim 47, wherein at least part each of four of the plurality of sample processing and testing paths is between the alignment structures (claim 1, 14).
Regarding claim 50, the cartridge of claim 47, wherein the reagent chamber comprises reagent beads in solid form that dissolve when contacted with test sample (claim 9).
Regarding claim 51, the cartridge of claim 50, wherein the reagent beads comprise reagent compositions comprising one or more of CaCl2, ellagic acid/phospholipids, tissue factor, heparinase, polybrene, cytochalasin D, or tranexamic acid (claim 9).
Regarding claim 52, the cartridge of claim 47, wherein the reagent chamber is a first reagent chamber and the reagent is a first reagent; wherein the cartridge comprises a second reagent chamber in series with the first reagent chamber, the second reagent chamber being in fluid communication with the test sample volume measurement chamber and with a second reagent; and wherein the mixture is based on both the first reagent and the second reagent (claim 1, 14).
Regarding claim 53, the cartridge of claim 52, wherein the first reagent and the second reagent comprise different reagents (claim 1, 14).
Regarding claim 54, the cartridge of claim 53, wherein each of the sample processing and testing paths comprises a structure associated with a corresponding conduit, each structure being controllable to prevent fluid flow (claim 5).
Regarding claim 55, the cartridge of claim 54, wherein the structure is a valve (claim 5).
Regarding claim 56, the cartridge of claim 52, wherein each of the sample processing and testing paths comprises a conduit of the conduits for transporting the mixture to a corresponding viscoelastic testing chamber, the conduit being non-linear (claim 1, 14).
Regarding claim 57, the cartridge of claim 56, further comprising: an elastomer associated with each of the sample processing and testing paths (claim 1, 14).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL P SIEFKE whose telephone number is (571)272-1262. The examiner can normally be reached Monday-Friday 8-5.
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/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758