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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the liner is a sealed capsule arranged within the dry reagent storage chamber. (claim 2) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 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 1, 6 and 7 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. This rejection concerns new matter.
Claims 1, 6 and 7 have been amended to recite in part “the dry reagent storage chamber comprises a liner formed from a material having a lower water permeability than the housing material” (claim 1); “wherein each dry reagent storage chamber comprises a respective liner, each liner comprising a material having a lower water permeability than the housing material” (claim 6); and “the barrier formed from a material having a lower water permeability than the housing material” (claim 7). The current remarks urges support therefor may be found at specification [0013], [0022], [0024], [0026], and [0027] and FIGS. 1-3.
The examiner cannot find support for the water permeability in the specification as filed. At best, the specification describes a low fluid permeability material. Accordingly, the disclosure as originally filed provided no implicit or explicit support for this limitation. Applicants are reminded that it is their burden to show where the specification and priority document as appropriate supports any amendments to the disclosure.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 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.
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.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ostgaard et al. (US 5,888,826).
Regarding claim 1, Ostgaard et al. teach:
1. A sample analysis cartridge (e.g., 100), comprising:
a housing (e.g., 60) formed from a housing material (see i.e., Polypropylene is a preferred material for the housing C11/L66-67), the housing comprising:
a reaction chamber (e.g., opening 65) capable of receiving a sample (e.g., blood C7/L49-50),
a dry reagent storage chamber (e.g., sample cup 10) containing a dry reagent (see i.e., one or more reagents are applied to the surface of partition member 6 which will face receiving chamber 18. Partition member 6 is then dried, and opening 9 shown in FIG. 1 is made in the dried membrane. C9/L18-22), and
a fluid reagent storage chamber (e.g., holding chamber 61) containing a fluid reagent (e.g., 11); and
a reagent supply mechanism (e.g., vacuum chuck 15) capable of selectively supplying the dry reagent from the dry reagent storage chamber and the fluid reagent from the fluid reagent storage chamber (see C8/L29-46, L11/L16-35 for example);
wherein the dry reagent storage chamber comprises a liner (e.g., capillary hub 30).
Regarding claim 1, although Ostgaard et al. do not explicitly teach a liner formed from a material having a lower water permeability than the housing material, it would have been obvious to one of ordinary skill in the art at the time the invention was made to select a material having a lower water permeability for the purpose of making them effective barriers against moisture.
With regard to limitations in claims 1, 3 (e.g., [...] for selectively supplying the dry reagent from the dry reagent storage chamber and the fluid reagent from the fluid reagent storage chamber, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claims 2, 3, 5, Ostgaard et al. teach:
2. The sample analysis cartridge according to claim 1, wherein the liner is a sealed capsule arranged within the dry reagent storage chamber (see Fig. 2 for example).
3. The sample analysis cartridge according to claim 2, wherein the sealed capsule comprises a breakable seal (e.g., 6, 70) which can be broken by the reagent supply mechanism to retrieve dry reagent therefrom (see L11/L16-35 for example).
5. The sample analysis cartridge according to claim 1, wherein the dry reagent storage chamber has a region (i.e., region of top seal in Fig. 1) that contains desiccant material (C7/L32).
Regarding claim 4, Ostgaard et al. teach a seal comprising aluminum, see C7/L38-40. However, Ostgaard et al. fail to explicitly teach: 4. The sample analysis cartridge according to claim 1, wherein the material of the liner is a metal, preferably aluminium.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to select the liner material as a metal, such as aluminum to resist moisture (Ostgaard et al. C7/L38-40).
Regarding claims 6, 7, Ostgaard et al. teach:
6. The sample analysis cartridge according to claim 1, further comprising: a plurality of dry reagent storage chambers, each dry reagent storage chamber containing a dry reagent, wherein each dry reagent storage chamber comprises a respective liner; and a respective seal for each of the plurality of dry reagent storage chambers (see Figs. 7-8 & C5/L27-29 for example).
7. The sample analysis cartridge according to claim 1, further comprising a barrier (e.g., 70) between the dry reagent storage chamber and the fluid reagent storage chamber (see Fig. 2 for example).
However, Ostgaard et al. do not explicitly teach: each liner comprising a material having a lower water permeability than the housing material (claim 6); the barrier formed from a material having a lower water permeability than the housing material (claim 7).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to select a material having a lower water permeability for the purpose of making them effective barriers against moisture.
Claim(s) 1-3 and 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable Dumitrescu et al. (EP 0920915 A2).
Regarding claim 1, Dumitrescu et al. teach:
1. A sample analysis cartridge, comprising:
a housing formed from a housing material (e.g., 12), the housing comprising:
a reaction chamber (e.g., 318) configured to receive a sample (see ¶ 0111-0113 for example),
a dry reagent storage chamber (e.g., 312, 314) containing a dry reagent (see i.e., The frangible ampoules 294 are structural and functional equivalents of the glass ampoules 14 of the reagent package 10 and operate in a manner similar to that previously described for the glass ampoules 14 ¶ 0101; The glass ampoule 14 is a known closed cylindrical structure, fusion sealed at one end 57 and contains a reagent 58 (Figs. 5 and 8) which is preferably in a dry lyophilized form ¶ 0038), and
a fluid reagent storage chamber (e.g., 322) containing a fluid reagent (e.g., 248); and
a reagent supply mechanism capable of selectively supplying the dry reagent from the dry reagent storage chamber and the fluid reagent from the fluid reagent storage chamber (see i.e., The package 10C is brought in a known manner to an ampoule activation-breaker device ¶ 0074);
wherein the dry reagent storage chamber comprises a liner (e.g., glass/frangible ampoules 294/14) formed from a material (e.g., glass).
Regarding claim 1, although Dumitrescu et al. do not explicitly teach a liner formed from a material having a lower water permeability than the housing material, it would have been obvious to one of ordinary skill in the art at the time the invention was made to select a material having a lower water permeability for the purpose of making them effective barriers against moisture.
With regard to limitations in claims 1, 3 (e.g., [...] for selectively supplying the dry reagent from the dry reagent storage chamber and the fluid reagent from the fluid reagent storage chamber, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claims 2, 3 and 5, Dumitrescu et al. teach:
2. The sample analysis cartridge according to claim 1, wherein the liner is a sealed capsule arranged within the dry reagent storage chamber (see ¶ 0097 & Fig. 27 for example).
3. The sample analysis cartridge according to claim 2, wherein the sealed capsule comprises a breakable seal (i.e., breakable ampule throughout the reference).
5. The sample analysis cartridge according to claim 1, wherein the dry reagent storage chamber has a region therein that contains desiccant material (e.g., dry powder, Abstract).
Regarding claims 6, 7, Dumitrescu et al. teach:
6. The sample analysis cartridge according to claim 1, further comprising: a plurality of dry reagent storage chambers, each dry reagent storage chamber containing a dry reagent (¶ 0038), wherein each dry reagent storage chamber comprises a respective liner (e.g., glass/frangible ampoules 294/14); and a respective seal for each of the plurality of dry reagent storage chambers (see ¶ 0097 & Fig. 27 for example).
7. The sample analysis cartridge according to claim 1, further comprising a barrier (e.g., filter members 296) between the dry reagent storage chamber and the fluid reagent storage chamber (see Fig. 27 for example).
However, Dumitrescu et al. do not explicitly teach: each liner comprising a material having a lower water permeability than the housing material (claim 6); the barrier formed from a material having a lower water permeability than the housing material (claim 7).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to select a material having a lower water permeability for the purpose of making them effective barriers against moisture.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dumitrescu et al. (EP 0920915 A2) in view of Ostgaard et al. (US 5,888,826).
Regarding claim 4, Dumitrescu et al. do not explicitly teach: 4. The sample analysis cartridge according to claim 1, wherein the material of the liner is a metal, preferably aluminium.
See Ostgaard et al. above.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the cartridge with a liner, such as a filter screen 16 (¶ 0074) comprising a metal as it is known in the art to resist moisture (Ostgaard et al. C7/L38-40).
Response to Arguments
Applicant’s arguments have been considered but are moot in view of the new ground(s) of rejection.
Applicant is thanked for their thoughtful amendments to the claims.
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 DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES CAPOZZI can be reached at (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798