DETAILED CORRESPONDENCE
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 .
Response to Amendment
As to the claim amendments filed on 11/30/25, the previous claim objections are removed.
Based on the claim amendments, the previous 112 rejections are withdrawn.
As to the amended claims and remarks filed on 11/30/25, the previous prior art rejection has been modified to address the claim amendments.
Claim Status
Claims 1-6, 8-11 are pending.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6, 8-9, 11 are rejected under 35 U.S.C. 103 as being unpatentable over Squirrell et al (US 20080274512; hereinafter “Squirrell”; already of record) in view of Bransky et al (US 20140356941; hereinafter “Bransky”; already of record).
As to claim 1, Squirrell teaches a measurement cartridge for use in a biometric system for measuring an analyte existing in a sample (Squirrell teaches a reaction vessel as a measurement cartridge; [42, 45]), the cartridge comprising: a reagent container configured to accommodate a liquid reagent and having an upper portion (Squirrel teaches a reaction vessel as a measurement cartridge; [42, 45]); and a reagent rod located above the reagent container and including a plurality of dry reagent accommodating portions each of which comprising a cavity in which dry reagents are accommodated, where the plurality of dry reagent accommodating portions are vertically spaced apart from each other and configured to be sequentially introduced into the reagent container by a first applied pressure to be sequentially dissolved in the liquid reagent, and the reagent rod and reagent container are configured to be coupled such that the reagent rod is introduced into the reagent container by rupturing a contact portion of a sealing film by an applied pressure (Squirrell teaches a reagent rod which contains dried reagents; [11, 15, 16]. Squirrell teaches that the rod includes dimples or grooves as reagent accommodating portions to separate incompatible reagents and store them at different locations; [18]. Squirrell shows the freeze-dried reagents spaced vertically; Fig. 1. Squirrell teaches that the rod is inserted into the reaction vessel to deliver the reagents into a liquid in the reaction vessel; [16, 36, 42, 43, 22, 82]. Squirrell also teaches cavities 15 which are spaced vertically from each other; Fig. 4, [79-80]. How the reagent rod and corresponding accommodating portions are introduced is a matter of intended use and/or function, not further defining the system beyond that of a capability. The reagent rod of Squirrell is capable of having pressure applied to move into the container, and also is capable of rupturing a sealing film).
Note: The instant Claims contain a large amount of functional language. However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
If it is deemed that Squirrell does not specifically teach that the reagent accommodating portions are vertically separated cavities, then Squirrell does teach vertically orienting the reagent portions (Squirrell; Fig. 1), and teaches that it is known to include cavities to store the reagents (Squirrell; [18], Fig. 4), where this provides the advantage of separating different components for long term storage (Squirrell; [18]). It would have been obvious to one of ordinary skill in the art to have modified the vertically oriented reagents in the rod of Squirrell such that they each included their own distinct cavity as suggested by Squirrell because Squirrell teaches that this ensures that different reagents can be separated from each other (Squirrell; [18]), and also because Squirrell teaches that the cavities help to ensure long term storage with out mixing incompatible reagents (Squirrell; [18]).
Squirrell does not specifically teach the container sealed with a sealing film at an upper portion. However, Bransky teaches the analogous art of a container for holding fluid for analysis (Bransky; [35, 42, 46], Fig. 1-5) where the container is sealed with a sealing film at the upper portion (Bransky teaches a seal at the upper region of the container; [58, 59, 61, 62, 65], Fig. 4-5). It would have been obvious to one of ordinary skill in the art to have modified the container with the fluid of Squirrell to include a seal as in Bransky because Bransky teaches that a seal helps to prevent the flow or leakage of fluid from the container (Bransky; [59, 61]). The resulting combination would result in the reagent rod of Squirrell that can puncture the film of Bransky.
As to claim 2, modified Squirrell teaches the measurement cartridge of claim 1, and where liquids can be added into the reagent container and where the sample is reacted in the reaction vessel (Squirrell; [9, 41, 52]).
Modified Squirrell does not specifically teach a capillary module located above the reagent container and including a capillary tube for collecting the sample through capillary action, the capillary tube being introduced into the reagent container by rupturing the contact portion of the sealing film with a second pressure applied thereto. However, Bransky teaches the analogous art of a container for holding fluid for analysis (Bransky; [35, 42, 46], Fig. 1-5) with a capillary module located above the reagent container and including a capillary tube for collecting the sample through capillary action, the capillary tube being introduced into the reagent container by rupturing the contact portion of the sealing film with a second pressure applied thereto (Bransky teaches a capillary tube 403 which introduces a sample into the container 303; [42, 56, 58, 59, 61, 62, 66], Fig. 4-5. How the capillary rod is introduced is a matter of intended use and/or function, not further defining the system beyond that of a capability). It would have been obvious to one of ordinary skill in the art to have modified the container with the fluid sample of Squirrell to include a capillary to deliver the sample as in Bransky because Bransky teaches that a capillary is a well-known way to provide a sample into the container (Bransky; [42, 56, 58, 59, 61, 62, 66]).
As to claim 3, modified Squirrell teaches the measurement cartridge of claim 1, wherein the reagent rod further includes a solution blocking portion between at least two of the plurality of dry reagent accommodating portions, and the reagent rod is configured to move downward, in response to the first pressure applied thereto, to sequentially introduce the at least parts of the plurality of dry reagent accommodating portions into the reagent container (Squirrell teaches the cavities formed as separated regions, where the portion that protrude outwards are the portions not forming the cavity; Fig. 4. Further, the modification of the vertically oriented reagents in the rod of Squirrell to each include their own distinct cavity as suggested by Squirrell has already been discussed above. Squirrell teaches that this ensures that different reagents can be separated from each other [18] (and Fig. 4), and also because Squirrell teaches that the cavities help to ensure long term storage without mixing incompatible reagents [18]. The portions that do not form the cavity would be protrusions that serve as blocking portions. Squirrell teaches that the rod includes dimples or grooves, and the region between the grooves or dimples is the blocking portion to separate incompatible reagents and store them at different locations; [18]. Squirrell also teaches the rod moving downwards into reaction vessel; [42, 43]. How the reagent rod and corresponding accommodating portions are introduced is a matter of intended use and/or function, not further defining the system beyond that of a capability).
As to claim 4, modified Squirrell teaches the measurement cartridge of claim 2, wherein the capillary tube of the capillary module is introduced into the reagent container by rupturing the contact portion of the sealing film by the second applied pressure to an extent to which the capillary tube does not come into direct contact with the liquid reagent (The modification of Squirrell to include the capillary of Bransky has already been discussed above in claim 2, where the capillary of Bransky punctures the sealing film and then deposits the sample without coming into contact with liquid; see Fig. 5B and claim 2 above. How the capillary tube is introduced is a matter of intended use and/or function, not further defining the system beyond that of a capability. Further, the liquid reagent has not been positively recited and is not part of the claimed system).
As to claim 5, modified Squirrell teaches the measurement cartridge of claim 2, wherein the dry reagents of the reagent rod are dissolved in the liquid reagent and produce a reaction in a state in which particles of the sample coexist in the reagent container (Squirrell teaches the dried reagents that are then placed in a liquid to react with a sample; see claim 1 above and [4, 11]. What the dry reagents do within the liquid reagent or in response to the sample/particles is a matter of intended use and/or function, not further defining the system beyond that of a capability, because the liquid reagent and sample/particles have not been positively recited and are not part of the claimed system).
As to claim 6, modified Squirrell teaches the measurement cartridge of claim 2, wherein part of the dry reagents accommodated in the plurality of dry reagent accommodating portions is dissolved in the liquid reagent by coming into direct contact with the liquid reagent (Squirrell teaches the dried reagents that are then placed in a liquid to react with a sample; see claim 1 above and [4, 11]. What the dry reagent do within the liquid reagent is a matter of intended use and/or function, not further defining the system beyond that of a capability, because the liquid reagent has not been positively recited and is not part of the claimed system).
As to claim 7, modified Squirrell teaches the measurement cartridge of claim 1, wherein at least part of the dry reagents accommodated in the plurality of dry reagent accommodating portions is separated by rotation of a rotor to be dissolved in the liquid reagent (In as much as claimed and as best understood, Squirrell teaches a rod that includes vertically separated dry reagents; see claim 1 above and Fig. 1. Squirrell, if placed into a rotor that creates centrifugal force, would enable the dried reagents to be delivered into the fluid by pulling the rod down or by pulling the reagent beads into the liquid. Or, alternatively, if Squirrell was placed into a rotor which spun back and forth then the fluid would be mixed with the reagents. Further, whether the reagent accommodating portion can rotate by a rotor is a matter of intended use as the rotor has not been positively recited as part of the cartridge).
As to claim 8, modified Squirrell teaches the measurement cartridge of claim 1, wherein the reagent container of the measurement cartridge includes a particle accommodating portion that accommodates particles of the sample (Squirrell teaches the container which accommodates a sample, and any region in which the sample is held is the region of space making up the sample particle accommodation portion; see claim 1 above).
As to claim 9, modified Squirrell teaches the measurement cartridge of claim 2, wherein the capillary module further includes an air outlet configured to discharge air in the capillary tube (Bransky teaches outlet 1403; [115, 116]).
As to claim 11, modified Squirrell teaches the measurement cartridge of claim 1, wherein at least some of the plurality of dry reagent accommodating portions are separated by a solution blocking portion protruding laterally from a surface of the reagent rod (Squirrell teaches the cavities formed as separated regions, where the portion that protrude outwards are the portions not forming the cavity; Fig. 4. Further, the modification of the vertically oriented reagents in the rod of Squirrell to each include their own distinct cavity as suggested by Squirrell has already been discussed above. Squirrell teaches that this ensures that different reagents can be separated from each other [18] (and Fig. 4), and also because Squirrell teaches that the cavities help to ensure long term storage without mixing incompatible reagents [18]. The portions that do not form the cavity would be protrusions that serve as blocking portions).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Squirrell et al (US 20080274512; hereinafter “Squirrell”; already of record) in view of Bransky et al (US 20140356941; hereinafter “Bransky”; already of record) in view of Fukunaga et al (US 20090170210; hereinafter “Fukunaga”; already of record).
As to claim 10, modified Squirrell teaches the measurement cartridge of claim 9, with the capillary tube (see above).
Modified Squirrell does not specifically teach wherein the capillary module further includes: a first sample recognition electrode in contact with the air outlet; and a second sample recognition electrode spaced apart from the first sample recognition electrode and configured to contact with the air outlet, wherein the first sample recognition electrode and the second sample recognition electrode are electrically connected to each other by the sample introduced into the capillary tube and filling the capillary tube. However, Fukunaga teaches the analogous art of a capillary module with a capillary tube for a measurement cartridge (Fukunaga; abstract, Fig. 7) with a first sample recognition electrode in contact with the air outlet; and a second sample recognition electrode spaced apart from the first sample recognition electrode and configured to contact with the air outlet, wherein the first sample recognition electrode and the second sample recognition electrode are electrically connected to each other by the sample introduced into the capillary tube and filling the capillary tube (Fukunaga teaches a capillary tube 104 with an air outlet and outlet; [81, 98], Fig. 7. Fukunaga teaches a first electrode 201a/201b and second electrode 202a/202b are in contact with the first sucking port and are electrically connected to each other by the sample introduced into the capillary tube and completely filling the tube and the meter senses the electrical connection between the first and second electrode; [127, 140]. This prevents mistaken measurements due to a sample shortage; [156]). It would have been obvious to one of ordinary skill in the art to have modified the capillary module of modified Squirrell to incorporate the electrodes of Fukunaga because Fukunaga teaches that providing electrodes helps to prevent short samples which results in inaccurate measurements (Fukunaga; [156]).
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Hirano et al (US 20170023563; hereinafter “Hirano”; already of record) teaches dried reagents can be fixed on a rod and are then put into aqueous solution and a sample is then added; Fig. 6 [45].
Nygaard, L (US 20100233723; hereinafter “Nygaard”; already of record) teaches dried reagents that are placed in different regions due to compatibility; [75]. Yasuda et al (US 20140370492; hereinafter “Yasuda”; already of record) teaches dried reagent on a rod and then placed into a vessel with a sample; Fig. 3, [153].
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11561165 B2 in view of Squirrell et al (US 20080274512; hereinafter “Squirrell”; already of record). Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to instant claim 1 features of a measurement cartridge with a reagent container with a sealing film, and a reagent rod having a plurality of dry reagent accommodating portions vertically arranged (see claim 1 of ‘165). The rest of the of claims of ‘165 teach the features and functions of the reagent rod and capillary module that are recited in instant claims 2-10. The claims of ‘165 do not teach that the reagent accommodating portions are each cavities; however, Squirrell teaches the analogous art of a measurement cartridge for use in a biometric system for measuring an analyte existing in a sample (Squirrell teaches a reaction vessel as a measurement cartridge; [42, 45]) with dimples or grooves as reagent accommodating portions to separate incompatible reagents and store them at different locations; [18]. It would have been obvious to have modified the separated the reagent accommodating portions of the claims of ‘165 with distinct cavities as in Squirrell because Squirrell teaches that reagents are commonly stored in dimples or grooves (Squirrell; [18]).
Response to Arguments
Applicant’s arguments filed on 11/30/25 have been considered, but are moot because the arguments are towards the claim amendments and not the current grounds of rejection. However, because the examiner has relied on the same reference then the examiner will address applicants remarks in order to promote compact prosecution.
Applicants argue on page 7-11 of their remarks that Squirrell fails to teach or suggest dry reagents accommodated within cavities. Applicants also argue on page 10-11 that the grooves are not for dry reagents. The examiner respectfully disagrees. First, Squirrell does teach dried reagents as Squirrell teaches that the device includes dried reagents [11, 15, 16] and includes dimples or grooves as reagent accommodating portions to separate incompatible reagents and store them at different locations; [18]. Further, and alternatively, that the reagent accommodating portions can accommodate reagent is functional language. However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims. Second, Squirrell teaches cavities 15 which are spaced vertically from each other; Fig. 4, [79-80]. Alternatively, if it is deemed that Squirrell does not specifically teach that the reagent accommodating portions are vertically separated cavities, then Squirrell does teach vertically orienting the reagent portions (Squirrell; Fig. 1), and teaches that it is known to include cavities to store the reagents (Squirrell; [18], Fig. 4), where this provides the advantage of separating different components for long term storage (Squirrell; [18]). It would have been obvious to one of ordinary skill in the art to have modified the vertically oriented reagents in the rod of Squirrell such that they each included their own distinct cavity as suggested by Squirrell because Squirrell teaches that this ensures that different reagents can be separated from each other (Squirrell; [18]), and also because Squirrell teaches that the cavities help to ensure long term storage without mixing incompatible reagents (Squirrell; [18]).
Applicants argue on page 11-12 of their remarks that Squirrell lack an inlet or channel structure and that the addition of a film would defeat the purpose of Squirrell. However, the examiner respectfully disagrees. These arguments are not commensurate in scope with the claims as the claims do not require an inlet. Additionally, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Squirrell is used to teach the reaction container and reagent rod, and Bransky is used to modify the container with the fluid of Squirrell to include a seal as in Bransky because Bransky teaches that a seal helps to prevent the flow or leakage of fluid from the container (Bransky; [59, 61]). The examiner disagrees that adding a film would defeat the purpose and maintains that one of ordinary skill in the art would have found it obvious to modify the container with the fluid of Squirrell to include a seal as in Bransky because Bransky teaches that a seal helps to prevent the flow or leakage of fluid from the container (Bransky; [59, 61]).
Applicants argue on page 12 of their remarks that the seal of Bransky is not a container cover. However, the examiner respectfully disagrees. These arguments are not commensurate in scope with the claims. Bransky teaches the container is sealed with a sealing film at the upper portion (Bransky teaches a seal at the upper region of the container; [58, 59, 61, 62, 65], Fig. 4-5).
Applicants argue on page 13 of their remarks that Brasky’s film is for a thin capillary whereas Squirrell has an expanded portion that would be too large to fit through Bransky’s opening. However, the examiner respectfully disagrees. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). First, the container through which the rod fits is taught in Squirrell where the container is only modified by Bransky to include a seal, which would result in the container of Squirrell being sealed. This does not change the size of the opening of the container of Squirrell. Second, an alternative rejection has been provided, where modifying the vertical reagents of Figure 1 of Squirrell to each include cavities to store the reagents as suggested by Squirrell would result in the rod in Figure 1 of Squirrell including cavities (see rejection above).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Benjamin R Whatley whose telephone number is (571)272-9892. The examiner can normally be reached on Mon- Fri 8am-5pm.
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/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798
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