DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 28 January 2025 has been entered.
Claim 1 has been amended. Claims 3 and 9 have been cancelled. Claims 10-15 remain withdrawn. Claims 1, 2, and 4-6 are currently pending and under examination.
The present application is a continuation of U.S. Patent Application No. 16/734826, filed January 6, 2020, now U.S. Patent No. 11,193,158, which is a divisional application of U.S. Patent Application No. 15/472759, filed March 29, 2017, now U.S. Patent No. 10,557,162,
which is a continuation of U.S. Patent Application No. 13/600702, filed August 31, 2012, now U.S. Patent No. 9,631,221, which claims benefit of priority to U.S. Provisional Patent Application No. 61/649483, filed May 21, 2012, and U.S. Provisional Patent Application No.
61/530620, filed September 2, 2011.
Withdrawal of Rejections:
The rejection of claims 1-6 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is withdrawn.
The rejection of claims 1 and 9 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Durussel et al., and further in view of Agar et al., is withdrawn.
New Rejections:
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, 2, and 4-6 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.
The limitation that the kit includes “an applicator for applying a microorganism sample to a MALDI plate,” is new matter. While it is clear that the kit may include one or more reagents and/or buffers, there is no mention of an applicator being present in the kit, as now claimed (see Specification: para. 12, 17, 24, 25, 30-37). While methods are taught that include depositing the sample via direct smear or depositing a microbial suspension (Para. 37), including using a toothpick (para. 43), there is no applicator for performing the direct smear included as part of the kit set forth in the disclosure as originally filed. As such, this limitation is deemed to be new matter.
Claims 2 and 4-6 are included in this rejection, as these claims depend from above-rejected claim 1, and fail to remedy the noted deficiency.
Maintenance/Modification of Rejections:
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1, 2, and 4-6 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Durussel et al. (WO 2011/058131; Published May 19, 2011 – Previously Presented).
With regard to claims 1, 2, 4, and 6, it is noted that the claimed limitation for each kit component, that the component is “provided for application” directly onto the microorganism or the sample smeared onto the MALDI plate, are intended use limitations and do not provide further elements that limit the structure of the component in kit as claimed. For example, ethanol has the same chemical structure and properties regardless of its intended use.
Durussel et al. teach a method for preparing a blood culture sample for identification of microorganisms therein, and a kit for practicing the method (Abs.; p. 5, Line 24-26; p. 6, Line 21-24), including: a lysis solution to lyse red blood cells, which is a lysis buffer that lyses blood cells in a sample while leaving any present microorganism intact (p. 4, Line 17-30); 70% formic acid, which is a volatile acid solution; Matrix-Assisted Laser Desorption Ionization (MALDI) matrix; and 70% ethanol, which is an organic solvent in solution, and a fixative composition (p. 17, Line 11-17). Further, Durussel et al. teach that steps directed to the preparation and/or conducting the hemoculture may be part of the invention (p. 6, line 33-34), which is instructions for performing the method, which thus may be included in the kit as taught. The sample is analyzed by MALDI-TOF MS (Abs.; p. 2, p. 14, line 18-20). As such, the sample must necessarily be applied to the MALDI analysis plate using a device suitable for application, which is an “applicator.” It would have been obvious to an ordinary artisan to provide equipment necessary to perform the taught method, and include this equipment in the kit.
Durussel et al. teach that reference to a method is a reference to all methods and also to the uses and kits, and vice versa, of the invention (p. 6, Line 21-24), and also expressly teaches the above noted components for use in a method. Thus, it would have been obvious to one of ordinary skill in the art to provide a kit with the components that are expressly taught by Durussel et al.
As Durussel et al. teach that each of the noted components are used for performing the taught method, it would have been obvious to one of ordinary skill in the art that a kit containing only these components may the provided, thus the kit may consist of an applicator, a lysis buffer, a fixative including ethanol, 70% volatile acid solution, an organic solvent including ethanol, a MALDI matrix, and instructions for use.
As Durussel et al. render obvious the components of the kit as claimed, and as these components cannot be separated from their functions, the kit of Durussel et al. would necessarily be usable for, and thus provided for, an on-plate extraction method without centrifugation following the claimed instructions. Where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (see MPEP 2112.01, I.-II.). Here, the kit as rendered obvious by Durussel et al. would necessarily be usable in a method that requires these components.
It is further noted that the instructions as claimed in the kit do not distinguish the claimed product from Durussel et al. Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004) (Claim at issue was a kit requiring instructions and a buffer agent. The Federal Circuit held that the claim was anticipated by a prior art reference that taught a kit that included instructions and a buffer agent, even though the content of the instructions differed, explaining "[i]f we were to adopt [applicant’s] position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product.") (see MPEP 2112.01, III.). The instructions as claimed, which specify to combine a positive blood culture sample with the lysis buffer, deposit the sample onto a MALDI plate without centrifugation, apply the volatile acid solution to the positive blood culture sample deposited on the MALDI plate and apply a matrix thereover, are printed matter that is not functionally related to the kit. As such, the content of the instructions does not distinguish the claimed kit from the prior art.
With regard to claim 5, as noted, Durussel et al. teach 70% ethanol, which is an organic solvent in solution, and a fixative (p. 17, Line 11-17). While it is not specifically taught that the ethanol is 100% ethanol, it would have been obvious to one of ordinary skill in the art to adjust the concentration of the ethanol present, to result in a kit containing a desired concentration for the specific end use, including for the specific microorganism(s) to be detected. Additionally, please also note that "the discovery of an optimum value of a variable in a known process is usually obvious." Pfizer v. Apotex, 480 F.3d at 1368. The rationale for determining the optimal parameters for prior art result effective variables "flows from the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)). Accordingly, it would have been obvious to optimize the concentration of the ethanol in the kit, including to 100% ethanol, to result in a kit appropriate for the specific end use, including for the specific microorganism(s) to be detected.
Response to Arguments
Applicant urges that because methods as taught by Durussel et al. include centrifugation steps, the kit necessarily includes additional consumables, such as centrifuge tubes, a centrifuge, and decanting equipment to provide for this method, whereas the claimed kit now consists of the claimed components, including an applicator. Further, the kit of Durussel et al. requires at least one centrifugation step, therefore the kit and method of Durussel et al. do not contemplate depositing the sample onto the MALDI plate by direct application, after which the sample may be fixed with the components. Thus, these components are not provided for application as now claimed. Additionally, Applicant urges that Agar et al. fails to remedy the noted deficiencies.
Applicant’s arguments have been fully considered, but have not been found persuasive.
With regard to Applicant’s argument that because methods as taught by Durussel et al. include centrifugation steps, the kit necessarily includes additional consumables, such as centrifuge tubes, a centrifuge, and decanting equipment, to provide for this method, whereas the claimed kit now consists of the claimed components, including an applicator; it is noted that centrifuge tubes, a centrifuge, and decanting equipment are standard laboratory equipment and devices that would be present in an ordinary MALDI MS laboratory.
While centrifuge tubes can be considered consumables, a centrifuge and decanter are laboratory devices, and centrifuge tubes are standard laboratory consumables expected to already be present in a laboratory equipped with standard consumables for performing MALDI MS procedures. An ordinary artisan would expect a kit for preparing a positive blood culture sample for microbial identification using MALDI to contain the necessary reagents and buffers, but not standard laboratory devices and equipment. In Applicant’s own specification, it is clear that the kit is intended to include one or more reagents and/or buffers, and not standard laboratory equipment and devices (see Specification: para. 12, 17, 24, 25, 30-37). It is also noted that Applicant does not claim that the kit further consists of a MALDI plate or the MALDI MS device itself.
With regard to the applicator as now claimed, Durussel et al. teach that the sample is analyzed by MALDI-TOF MS (Abs.; p. 2, p. 14, line 18-20). As such, the sample must necessarily be applied to the MALDI analysis plate using a device suitable for application, which is an “applicator.” It would have been obvious to an ordinary artisan to provide equipment necessary to perform the taught method, and include this equipment in the kit.
With regard to Applicant’s argument that Durussel et al. requires at least one centrifugation step, therefore the kit and method of Durussel et al. do not contemplate depositing the sample onto the MALDI plate by direct application, thus, the components are not provided for application as now claimed; it is noted that the current claims are directed to a kit, which is a product, and not to a method of using a kit. As Durussel et al. render obvious the components of the kit as claimed, and as these components cannot be separated from their functions, the kit of Durussel et al. would necessarily be usable for, and thus provided for, an on-plate extraction method without centrifugation following the claimed instructions. Further, it is noted that the claimed limitation for each kit component, that the component is “provided for application” directly onto the microorganism or the sample smeared onto the MALDI plate, are intended use limitations and do not provide further elements that limit the structure of the component in kit as claimed. For example, ethanol has the same chemical structure and properties regardless of its intended use.
Where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (see MPEP 2112.01, I.-II.). Here, the kit as rendered obvious by Durussel et al. would necessarily be usable in a method that requires these components.
With regard to Agar et al., the alleged deficiencies of Durussel et al. have been addressed above.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653