FINAL ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Amendments and Status of the Claims
2. This action is in response to papers filed 2 April 2026 in which the specification and claims 1 and 4-11 were amended, no claims were canceled, and no new claims were added. All of the amendments have been thoroughly reviewed and entered.
3. All previous objections and rejections not reiterated below are withdrawn in view of the amendments.
4. Applicant’s arguments have been thoroughly reviewed and are addressed following the rejections necessitated by the amendments.
5. Claims 1-11 are under prosecution.
Claim Interpretation
6. The claims are subject to the following interpretation:
A. It is noted that the courts have held that “while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function.” In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). In addition, “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). Therefore, the various uses recited in the claims (e.g., carrying out molecular biology tests, performing RT-PCR, thermal cycles, etc.) fail to define additional structural elements of the claimed cartridge. Therefore, any prior art that teaches the structural elements of the claims will anticipate and/or render obvious the claims. See MPEP § 2114.
B. Claim 11 is drawn to a “panel.” The specification provides no limiting definition of the claimed “panel,” and only generally refers to a “panel” as more than one cartridge (e.g., Figure 2, “Panel Example” described in paragraphs 00120 ff). Therefore, the “panel” of claim 11 is interpreted as a plurality of cartridges with no other structural limitations, and the claim has been given the broadest reasonable interpretation consistent with the teachings of the specification regarding a “panel” (In re Hyatt, 211 F.3d1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000) (see MPEP 2111).
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 5-10 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.
A. Claims 5-10 are each indefinite because a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, each of claims 5-10 recites the broad recitation “spp” (e.g., Staphylococcus spp in claim 5), meaning multiple species, and each of the claims also recites specific species (e.g., Staphylococcus aureus in claim 5) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
B. In addition, claims 5-9 and 10 are each indefinite in the recitation “comprises the following required detection targets,” and claim 9 is indefinite in the recitation “the following required detection target groups.” It is unclear how the cartridge can carry out molecular biology tests on biological samples when the cartridge already contains the detection targets/target groups to be detected.
For the purposes of examination, claims 5-8 and 10 are interpreted as being configured to detect the listed targets.
C. It is suggested that the claims be amended to reflect to reaction mixtures and/or specific reagents listed in claim 1. Applicant is cautioned, however, against the introduction of new matter in response to the rejections.
D. In addition, with respect to claim 9, it is unclear how there are four “required” detection groups when the claim recited “one or more targets.”
For the purposes of examination, claim 9 in interpreted as merely requiring one target from any of the groups.
Claim Rejections - 35 USC § 103
9. 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.
10. Claims 1, 3-4, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (U.S. Patent Application Publication No. US 2018/0095100 A1, published 5 April 2018) and Miltenyi et al. (U.S. Patent Application Publication No. US 2017/0059458 A1, published 2 March 2017).
Regarding claim 1, Nguyen et al. teach a cartridge (Title) comprising reagents for RT-PCR (paragraph 0445), which carries out thermal cycles (paragraph 0393), and an optical detector (paragraph 0604). Nguyen et al. also teach the cartridge detects multiple pathogenic organisms (paragraph 0661), including Gram-positive and -negative bacteria as well as fungi (paragraph 0217). Nguyen et al. also teach the cartridge has the added advantage of detecting pathogens from a number of different sample solutions (paragraph 0209). Thus, Nguyen et al. teach the known techniques discussed above.
While Nguyen et al. teach disposables (paragraph 0247), Nguyen et al. do not explicitly teach the cartridge is disposable, MEMS technology, or fluorescence detection.
However, Miltenyi et al. teach a disposable cartridge comprising MEMS technology (paragraph 0008) as well as fluorescence detection (paragraph 0074), and that the cartridge has the added advantage of a greatly reduced burden for sterilizing between samples (paragraph 0034). Thus, Miltenyi et al. teach the known techniques discussed above.
It is reiterated that the courts have found that apparatus claims cover what a device is, not what a device does. Therefore, the various uses recited in the claims (e.g., carrying out selective molecular biology tests, performing RT-PCR, thermal cycles, etc.) fail to define additional structural elements of the claimed cartridge. Therefore, because the prior art teaches the structural elements of the claim, the claim is obvious.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Nguyen et al. and Miltenyi et al. to arrive at the instantly claimed cartridge with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a cartridge having the added advantage of detecting pathogens from a number of different sample solutions as explicitly taught by Nguyen et al. (paragraph 0209) and the added advantage of a greatly reduced burden for sterilizing between samples as explicitly taught by Miltenyi et al. (paragraph 0034). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result in cartridges useful for biological assays.
Regarding claim 3, the cartridge of claim 1 is discussed above. Nguyen et al. teach the cartridge comprises an array (paragraph 0028) and the detection of a large number analytes (paragraph 0216), wherein the array comprises 2 to 50 different capture probes on the array (paragraph 0459). Thus, it would have been obvious that in order to capture 36 different targets, reactions mixtures for detecting up to 36 different nucleotide sequences would need to be present.
It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
The courts have also found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Applicant is advised that MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, Applicant should not merely rely upon counsel’s arguments in place of evidence in the record.
It is noted that the Response above should not be construed as an invitation to file an after final declaration. See MPEP 715.09.
Regarding claim 4, the cartridge of claim 1 is discussed above. Nguyen et al. teach providing lyophilized reagents in the cartridge (e.g., paragraph 0442). Thus, it would have been obvious to provide lyophilized RT-PCR reagents in the cartridge.
It is noted that claim 9 merely requires one target from any of the groups.
Regarding claim 9, the cartridge of claim 1 is discussed above.
It is reiterated that claim 9 merely requires one target from any of the groups. Nguyen et al. teach combinations comprising Candida albicans (paragraph 0222).
Regarding claim 11, the cartridge of claim 1 is discussed above, Nguyen et al. teach a panel, in the form of a plurality of cartridges for different specific tests (paragraph 0667). Nguyen et al. also teach testing for (i.e., characterization of) Gram-positive bacteria, Gram-negative bacteria, fungal infections, and antibiotic resistance (paragraph 0217), wherein the fungi include combinations of Fusarium, which is a filamentous fungi, and Candida, which is a non-filamentous fungi. Thus it would have been obvious to have a panel of the three claimed cartridges as each cartridge specifically tests for different types of organisms.
11. Claims 2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (U.S. Patent Application Publication No. US 2018/0095100 A1, published 5 April 2018) and Miltenyi et al. (U.S. Patent Application Publication No. US 2017/0059458 A1, published 2 March 2017) as applied to claim 1 above, and further in view of Freeman-Cook et al. (PCT International Patent Application Publication No. WO 2019/040769 A1, published 28 February 2019) and Wong et al. (J. Clin. Microbiol., vol. 48, pages 3525-3531, published online 28 July 2010).
Regarding claims 2 and 5, the cartridge of claim 1 is discussed above in Section 10.
While Nguyen et al. teach combinations comprising Staphylococcus epidermis and lugdunensis (which constitutes Staphylococcus spp; claim 5), as well as Candida albicans and Candida auris (claim 9; paragraph 0222), neither Nguyen et al. nor Miltenyi et al. teach positive and negative controls.
However, Freeman-Cook et al. teach cartridges (paragraph 0021) and RT-PCR (paragraph 0007), as well as positive controls (paragraph 0023) and negative
controls (i.e., claim 2 and 5; paragraph 00602). Freeman-Cook et al. also teach detection of Staphylococcus aureus, haemolyticus, hominis, saprophyticus, sciuri, simulans, and xylosus (page 41) and Staphylococcus spp., VanA, VanB, and MecC (i.e., claim 5; Figure 14), as well as the added advantage of distinguishing between clinically relevant amplification and background contamination (Abstract). Thus, Freeman-Cook et al. teach the known techniques discussed above.
None of the cited prior art cited above teach SCC mec-orfX.
However, Wong et al. teach PCR assays using SSC mec-orfX (Abstract), as well as internal controls (page 3526, second column), and that detection of SSC mec-orfX has the added advantage of being a surrogate for detection of MRSA (page 3525, column 2). Thus, Wong et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Wong et al. and Freeman-Cook et al. with Nguyen et al. and Miltenyi et al. to arrive at the instantly claimed cartridge with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a cartridge having the added advantage of surrogate testing for MRSA as explicitly taught by Wong et al. (page 3525, column 1) as well as the advantage of distinguishing between clinically relevant amplification and background contamination as explicitly taught by Freeman-Cook et al. (Abstract). In addition, it would have been obvious to the ordinary artisan that the known techniques of Wong et al. and Freeman-Cook et al. could have been combined with the previously cited prior art with predictable results because the known techniques of Wong et al. and Freeman-Cook et al. predictably result in reaction mixtures useful for nucleic acid amplification and monitoring of MRSA.
12. Claims 2 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (U.S. Patent Application Publication No. US 2018/0095100 A1, published 5 April 2018) and Miltenyi et al. (U.S. Patent Application Publication No. US 2017/0059458 A1, published 2 March 2017) as applied to claim 1 above, and further in view of Freeman-Cook et al. (PCT International Patent Application Publication No. WO 2019/040769 A1, published 28 February 2019) and Jung et al. (U.S. Patent Application Publication No. US 2015/0252410 A1, published 10 September 2015).
It is noted that while claim 2 has been rejected as described above, the claim is also obvious using the interpretation outlined below
Regarding claims 2 and 6, the cartridge of claim 1 is discussed above in Section 10.
While Nguyen et al. teach combinations comprising Bacillus subtilis, Enterococcus spp (i.e., faecalis and faecium), Streptococcus spp (i.e., pneumoniae and pyogenes; paragraph 0222), neither Nguyen et al. nor Miltenyi et al. teach positive and negative controls or the remaining species.
However, Freeman-Cook et al. teach cartridges (paragraph 0021) and RT-PCR (paragraph 0007), as well as positive controls (paragraph 0023) and negative
controls (i.e., claim 2 and 6; paragraph 00602). Freeman-Cook et al. also teach detection of Enterococcus spp (paragraph 00313), Listeria monocytogenes (paragraph 00168), Streptococcus spp (paragraph 0027), Streptococcus agalaciae, angiosus, pneumoniae and pyogenes (Table 1), and vanA and vanB (paragraph 00166), as well as the added advantage of distinguishing between clinically relevant amplification and background contamination (Abstract). Thus, Freeman-Cook et al. teach the known techniques discussed above.
None of the cited prior art teach VanC1 of VanC 2/3.
However, Jung et al. teach combinations of primers for VanC1 and Van C2/3 (paragraphs 0026), which have the added advantage of allowing detection of vancomycin resistant Enterococcus (paragraph 0029). Thus, Jung et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Jung et al. and Freeman-Cook et al. with Nguyen et al. and Miltenyi et al. to arrive at the instantly claimed cartridge with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a cartridge having the added advantage of detecting vancomycin resistant Enterococcus as explicitly taught by Jung et al. (paragraph 0029) as well as the advantage of distinguishing between clinically relevant amplification and background contamination as explicitly taught by Freeman-Cook et al. (Abstract). In addition, it would have been obvious to the ordinary artisan that the known techniques of Jung et al. and Freeman-Cook et al. could have been combined with the previously cited prior art with predictable results because the known techniques of Jung et al. and Freeman-Cook et al. predictably result in reaction mixtures useful for nucleic acid amplification and detection of vancomycin resistance.
13. Claims 2 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (U.S. Patent Application Publication No. US 2018/0095100 A1, published 5 April 2018) and Miltenyi et al. (U.S. Patent Application Publication No. US 2017/0059458 A1, published 2 March 2017) as applied to claim 1 above, and further in view of Freeman-Cook et al. (PCT International Patent Application Publication No. WO 2019/040769 A1, published 28 February 2019) and Williams et al. (J. Gen. Microbiol., vol. 129, pages 2181-2191, published 1983).
It is noted that while claim 2 has been rejected as described above, the claim is also obvious using the interpretation outlined below
Regarding claims 2 and 7, the cartridge of claim 1 is discussed above in Section 10.
While Nguyen et al. teach combinations comprising Enterobacter cloacae complex, E. coli, Haemophiles influenzae, Klebsiella oxytoca and pneumoniae; Neisseria menigitidis, Proteus spp (including mirabilis), Pseudomonas aeruginosa, Serratia marcescens, and Stenotrophomonas melophilia (paragraph 0222), neither Nguyen et al. nor Miltenyi et al. teach positive and negative controls or the remaining species.
However, Freeman-Cook et al. teach cartridges (paragraph 0021) and RT-PCR (paragraph 0007), as well as positive controls (paragraph 0023) and negative
controls (i.e., claim 2 and 7; paragraph 00602). Freeman-Cook et al. also teach detection of Acinetobacter Bahmani (Table 2) Enterobacteriaceae (paragraph 00168), Salmonella typhi (Table 39),and Shigella spp (including boydii and flexneri; Table 25), as well as the added advantage of distinguishing between clinically relevant amplification and background contamination (Abstract). Thus, Freeman-Cook et al. teach the known techniques discussed above.
While Nguyen et al. and Freeman-Cook et al. each teach Klebsiella species (paragraph 0222 and paragraph 00183, respectively), none of the cited prior art teach Klebsiella aerogenes.
However, Williams et al. teach Klebsiella aerogenes is an opportunistic organism that is an important cause of bacteremia in compromised patients (Introduction). Thus, Jung et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Williams et al. and Freeman-Cook et al. with Nguyen et al. and Miltenyi et al. to arrive at the instantly claimed cartridge with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a cartridge having the added advantage of detecting van important cause of bacteremia in compromised patients as explicitly taught by Williams et al. (Introduction) as well as the advantage of distinguishing between clinically relevant amplification and background contamination as explicitly taught by Freeman-Cook et al. (Abstract). In addition, it would have been obvious to the ordinary artisan that the known techniques of Williams et al. and Freeman-Cook et al. could have been combined with the previously cited prior art with predictable results because the known techniques of Williams et al. and Freeman-Cook et al. predictably result in reaction mixtures useful for nucleic acid amplification and detection of opportunistic infections in compromised patients.
14. Claims 2 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (U.S. Patent Application Publication No. US 2018/0095100 A1, published 5 April 2018) and Miltenyi et al. (U.S. Patent Application Publication No. US 2017/0059458 A1, published 2 March 2017) as applied to claim 1 above, and further in view of Zhang et al. (Sci. Reports, vol. 8, pages 1-9, published online 27 February 2018), Bogaerts et al. (Int. J. Antimicrobial Agents, vol. 48, pages 189-193, 2016), Pollini et al. (Antimicrob. Agents and Chemotherapy., vol. 57, pages 410-416, published online 28 October 2012), and Freeman-Cook et al. (PCT International Patent Application Publication No. WO 2019/040769 A1, published 28 February 2019), alternatively further in view of McArthur et al. (Antimicrob. Agents and Chemotherapy., vol. 57, pages 3348-3357, published online 6 May 2013), The CARD (i.e., the Comprehensive Antibiotic Research Database; [retrieved on 2025-12-17]. Retrieved from the Internet: <URL: >. http://arpcard.mcmaster.ca).
It is noted that while claim 2 has been rejected as described above, the claim is also obvious using the interpretation outlined below
Regarding claims 2 and 8, the cartridge of claim 1 is discussed above in Section 10.
While Nguyen et al. discuss antibiotic drug resistance (paragraph 0217), neither Nguyen et al. nor Miltenyi et al. teach controls or the instantly claimed genes.
However, Zhang et al. teach Mcr-1,Mcr-2, and Mcr-4 as genes associated with colistin resistance (i.e., claim 8;pages 1-2). Zhang et al. also teach the use of negative controls in PCR assays (“PCR Assays,” page 9), and that colistin resistance is threatened worldwide (Abstract). Thus, Zhang et al. teach the known techniques discussed above.
The cited art does not teach the remaining antibiotic resistance genes.
However, Bogaerts et al. teach the evaluation of beta-lactamases CTX-M, SHV, TEM, GES, OXA-23, CMY-1-like/MOX, KPC, OXA-48, CMY-II, and PER (i.e., claim 8; Table 1), as well as PCR and positive and negative controls (i.e., claim 2; Section 2.1). Bogaert et al. teach identification of the resistant organisms is of great clinical concern (Abstract). Thus, Bogaerts et al. teach the known techniques discussed above.
Further, Pollini et al. teach the beta-lactamase genes IMP, VIM, NDM, and FIM are resistance determinants of increasing clinical importance (page 410, column 1). Thus, Pollini et al. teach the known techniques discussed above.
In addition, Freeman-Cook et al. teach cartridges (paragraph 0021) and RT-PCR (paragraph 0007), positive controls (paragraph 0023) negative
controls (i.e., claim 2 and 7; paragraph 00602), and the added advantage of distinguishing between clinically relevant amplification and background contamination (Abstract). Thus, Freeman-Cook et al. teach the known techniques discussed above.
It is alternatively noted that, McArthur et al. teach the antibiotic resistance genes, CTX-M, SHV, TEM, IMP, NDM, KPC, and VIM, which are all beta-lactamases, as well as referring to the generic classes of beta-lactamases OXA and CMY (Table 1). McArthur et al. also reference the CARD database, which further lists the publication of the specific beta-lactamases GES (e.g., GES-2; 2001), OXA-23 (2000), OXA-48 (2003), CMY-2 (1996), PER (1996), and FIM (2013). McArthur also teach CARD as the power to facilitate a broader and comprehensive antibiotic resistance gene census ((page 3348, column 1). Thus, McArthur et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of the cited prior art with Nguyen et al. and Miltenyi et al. to arrive at the instantly claimed cartridge with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a cartridge having the added advantages of:
Testing for the emerging global resistance to colistin as explicitly taught by Zhang et al. (Abstract);
Identification of the resistant organisms, which is of great clinical concern as explicitly taught by Bogaerts et al. (Abstract);
Detection of resistance determinants of increasing clinical importance as explicitly taught by Pollini et al. (page 410, column 1);
Distinguishing between clinically relevant amplification and background contamination as explicitly taught by Freeman-Cook et al. (Abstract); and alternatively further
Facilitating a broader and comprehensive antibiotic resistance gene census as explicitly taught by McArthur et al. (page 3348, column 1).
In addition, it would have been obvious to the ordinary artisan that the known techniques of the newly cited prior art could have been combined with the previously cited prior art with predictable results because the known techniques of the newly cited prior art predictably result in detection of well-known antibiotic resistance genes.
15. Claims 2 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (U.S. Patent Application Publication No. US 2018/0095100 A1, published 5 April 2018) and Miltenyi et al. (U.S. Patent Application Publication No. US 2017/0059458 A1, published 2 March 2017) as applied to claim 1 above, and further in view of Freeman-Cook et al. (PCT International Patent Application Publication No. WO 2019/040769 A1, published 28 February 2019).
It is noted that while claims 2 and 9 have been rejected as described above, the claims are also obvious in view of the art discussed below.
It is reiterated that claim 9 merely requires one target from any of the groups.
Regarding claims 2 and 9, the cartridge of claim 1 is discussed above in Section 10.
While Nguyen et al. teach combinations comprising Candida albicans and Candida auris (claim 9; paragraph 0222), neither Nguyen et al. nor Miltenyi et al. teach positive and negative controls.
However, Freeman-Cook et al. teach cartridges (paragraph 0021) and RT-PCR (paragraph 0007), as well as positive controls (paragraph 0023) and negative
controls (i.e., claims 2 and 9; paragraph 00602). Freeman-Cook et al. also teach detection of the remaining claimed Candida species (paragraph 00184), as well as the added advantage of distinguishing between clinically relevant amplification and background contamination (Abstract). Thus, Freeman-Cook et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Freeman-Cook et al. with Nguyen et al. and Miltenyi et al. to arrive at the instantly claimed cartridge with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a cartridge having the added advantage of distinguishing between clinically relevant amplification and background contamination as explicitly taught by Freeman-Cook et al. (Abstract). In addition, it would have been obvious to the ordinary artisan that the known techniques of Freeman-Cook et al. could have been combined with the previously cited prior art with predictable results because the known techniques of Freeman-Cook et al. predictably result in reaction mixtures useful for nucleic acid amplification.
16. Claims 2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (U.S. Patent Application Publication No. US 2018/0095100 A1, published 5 April 2018) and Miltenyi et al. (U.S. Patent Application Publication No. US 2017/0059458 A1, published 2 March 2017) as applied to claim 1 above, and further in view of Zhang et al. (Sci. Reports, vol. 8, pages 1-9, published online 27 February 2018) and Freeman-Cook et al. (PCT International Patent Application Publication No. WO 2019/040769 A1, published 28 February 2019).
It is noted that while claim 2 has been rejected as described above, the claim is also obvious using has been rejected as described above, the claim is also obvious in view of the art discussed below.
Regarding claims 2 and 10, the cartridge of claim 1 is discussed above in Section 10.
While Nguyen et al. discuss antibiotic drug resistance (paragraph 0217), neither Nguyen et al. nor Miltenyi et al. teach controls or the instantly claimed genes.
However, Zhang et al. teach Mcr1-5 as genes associated with colistin resistance (pages 1-2). Zhang et al. also teach the use of negative controls in PCR assays (“PCR Assays,” page 9), and that colistin resistance is threatened worldwide (Abstract). Thus, Zhang et al. teach the known techniques discussed above.
Neither Nguyen et al., Miltenyi et al., nor Zhang et al. teach positive controls.
However, Freeman-Cook et al. teach cartridges (paragraph 0021) and RT-PCR (paragraph 0007), as well as positive controls (paragraph 0023) and negative
controls (i.e., claim 2; paragraph 00602). Freeman-Cook et al. also teach detection of the remaining claimed Candida species (paragraph 00184), as well as the added advantage of distinguishing between clinically relevant amplification and background contamination (Abstract). Thus, Freeman-Cook et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Zhang et al. and Freeman-Cook et al. with Nguyen et al. and Miltenyi et al. to arrive at the instantly claimed cartridge with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a cartridge having the added advantage of testing for the emerging global resistance to colistin as explicitly taught by Zhang et al. (Abstract) as well as the advantage of distinguishing between clinically relevant amplification and background contamination as explicitly taught by Freeman-Cook et al. (Abstract). In addition, it would have been obvious to the ordinary artisan that the known techniques of Zhang et al. and Freeman-Cook et al. could have been combined with the previously cited prior art with predictable results because the known techniques of Zhang et al. and Freeman-Cook et al. predictably result in reaction mixtures useful for nucleic acid amplification and monitoring of antibiotic resistance.
Response to Arguments
17. Applicant's arguments filed 2 April 2026 (hereafter the “Remarks”) have been fully considered but they are not persuasive for the reasons discussed below.
A. Pages 9-10 of the Remarks summarize the amendments, claim numbers and art associated with the previous rejections, and refer to previous objections withdrawn in view of the amendments.
B. Pages 10-11 discuss the amendments made in response to the previous indefiniteness rejections. Those rejections not repeated above are withdrawn in view of the amendments.
However, as noted above, clams 5-10 remain rejected because it is unclear of the cartridges can already comprise the detection targets. While the examiner has suggested possible claim amendments to overcome the rejections, it is reiterated that Applicant must avoid the introduction of new matter in response to the rejections.
C. Applicant argues on page 11 that Nguyen et al. teach a proprietary platform, electrosensor array amplicons, multiple areas and mixers, etc., thereby arguing Nguyen et al. individually, and that the claimed invention use a single probe system with fluorescence detection.
Applicant provides no evidence of a “proprietary platform;” thus, the argument is not convincing.
It is noted that the Response above should not be construed as an invitation to file an after final declaration.
Any additional elements taught by Nguyen et al. are encompassed by the open claim language “comprising” found in the instant claims.
It is also reiterated that the courts have held that apparatus claims cover what a device is, not what a device does. Therefore, the various uses argued by Applicant (e.g., performing RT-PCR, acquiring fluorescence signals, etc.) fail to define additional structural elements of the claimed cartridge. Therefore, any prior art that teaches the structural elements of the claims will anticipate and/or render obvious the claims.
In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., single probes) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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).
D. Applicant argues on pages 12-13 that the claimed invention does not discuss the processes allegedly taught by Nguyen et al.
However, the claims are drawn to a cartridge, not a method. As noted above, as long as the structural limitations are taught by the combination of the cited prior art, the claims are obvious.
F. Applicant’s arguments regarding Miltenyi et al. on pages 13-14 again argue a reference individually; one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references.
G. Applicant’s arguments on page 14 of the Remarks again refer to a use of the claimed cartridge rather than any structural limitations, all of which are taught by the cited prior art.
It is also reiterated that the courts have held that apparatus claims cover what a device is, not what a device does. Therefore, the various uses argued by Applicant (e.g., performing a sepsis panel, etc.) fail to define additional structural elements of the claimed cartridge. Therefore, any prior art that teaches the structural elements of the claims will anticipate and/or render obvious the claims.
In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a sepsis panel) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims
H. In response to Applicant’s argument on page 14 of the Remarks that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the reasons for combining each of the references are clearly articulated above.
In addition, it is also noted that the Supreme Court ruling for KSR Int’l Co. v. Teleflex, Inc. (No 04-1350 (US 30 April 2007) forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness. See Ex parte Smith (USPQ2d, slip op. at 20 (Bd. Pat. App. & Interf. June 25, 2007)
I. Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a sepsis panel) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims
J. In response to Applicant's argument on page 15 of the Remarks that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a “selectively” suitable cartridge) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims
It is also reiterated that the courts have held that apparatus claims cover what a device is, not what a device does. Therefore, the various uses argued by Applicant fail to define additional structural elements of the claimed cartridge. Therefore, any prior art that teaches the structural elements of the claims will anticipate and/or render obvious the claims.
K. Applicant argues on page 15 of the Remarks that Miltenyi et al. is non-analogous art.
However, both Miltenyi et al. and Nguyen et al. are both directed to cartridges for use with nucleic acid samples (e.g., paragraph 0074 of Miltenyi et al., and paragraph 0004 of Nguyen et al.).
L. In response to Applicant’s argument on page 15 of the Remarks that there is no teaching, suggestion, or motivation to combine the references, t it is reiterated that the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. In this case, the ordinary artisan would have been motivated to make the combination because said combination would have resulted in a cartridge having the added advantage of detecting pathogens from a number of different sample solutions as explicitly taught by Nguyen et al. (paragraph 0209) and the added advantage of a greatly reduced burden for sterilizing between samples as explicitly taught by Miltenyi et al. (paragraph 0034).
In addition, it is also reiterated that the Supreme Court ruling for KSR Int’l Co. v. Teleflex, Inc. forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness.
M. In response to Applicant's argument on page 16 of the Remarks that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
N. In response to Applicant's argument on page 16 of the Remarks that cited prior is “disparate” (i.e., nonanalogous) art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, all of the cited references are to detection of microorganisms.
O. In response to Applicant’s argument on page 16 of the Remarks that there is no teaching, suggestion, or motivation to combine the references, t it is reiterated that the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. In this case, the reasons for combining each of the references are clearly articulated above.
In addition, it is also reiterated that the Supreme Court ruling for KSR Int’l Co. v. Teleflex, Inc. forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness.
Conclusion
18. No claim is allowed.
19. 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).
20. 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.
21. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert T. Crow whose telephone number is (571)272-1113. The examiner can normally be reached M-F 8:00-4:30.
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, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Robert T. CrowPrimary Examiner, Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
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