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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/15/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner, except where noted.
The information disclosure statement filed 3/15/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Thus, the following references have not been considered: foreign patent documents A and F on page 1 and G and H on page 2, and non-patent literature references BN, BP, BQ, and BR on page 24, FJ and FK on page 34, and IF on page 41.
Specification
It is noted that the specification does not contain a paragraph listing the priority information for the instant application. Though such a paragraph is not required, it is recommended to include in a section titled “Cross-Reference to Relation Applications” that provides this information, or a similarly titled section. See MPEP 608.01(a).
Claim Objections
Claim 36 is objected to because of the following informality: for clarity, it is recommended that in line 2 of step (c), “the detection tube comprising the mixture” simply read “the detection tube.” Appropriate correction is required.
Claim 40 is objected to because of the following informalities: in line 1, “the magnetic particles” should read “wherein the magnetic particles.” Additionally, the comma in line 2 should be removed. Appropriate correction is required.
Claim 43 objected to because of the following informality: in line 2, “about 10 and about 1000” should read “about 10 to about 1000.” Appropriate correction is required.
Claim 48 is objected to because of the following informality: in line 1, the word “the” before “steps (a)” should be removed. Appropriate correction is required.
Claim 53 is objected to because of the following informality: in option (vi), the word “wherein” should be removed, as this is already stated in the preamble of the claim. Appropriate correction is required.
Claim Interpretation
Regarding claim 36, it is noted that the claim encompasses having the first and second target nucleic acid sequences be joined together on a longer sequence, and thus, depending on the primers used, the first and second amplicons may also be joined together on a longer sequence. See Figure 4 of the instant specification, which shows such an exemplary PCR product. The claim also encompasses the use of two wholly separate first and second target nucleic acids.
Regarding claim 44, the phrase “partial run-through of strand synthesis” is not defined in the instant specification, and does not appear to be a phrase that is commonly used in the art, as no known prior art was found using this phrase when looking through search engines. This phrase will thus be interpreted under its broadest reasonable interpretation, where any strand synthesis that does not synthesize the entire starting strand of a nucleic acid will be considered a “partial run-through of strand synthesis.”
Claim Rejections - 35 USC § 112(b)
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.
Claims 43, 45-47, 49-50, and 52 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.
Claim 43 is rejected because it is unclear under what circumstances the first and second target nucleic acids must be separated as claimed – in the third amplicon, within the larger liquid sample, or both. As the claim depends on claim 41, it will be interpreted as though the targets must be separated on the third amplicon.
Claims 45-47 are rejected because they recite a functional limitation without reciting a structure that produces said function. All three claims state that the method must be “capable of detecting” a particular concentration, but these functional limitations are not clearly accompanied by structural limitations that would indicate to the ordinary artisan how to obtain the stated functional results. It is also unclear what, if any, prior art would read on the stated functional limitations without knowing the structure that produces said limitations. See also MPEP 2173.05(g).
Claim 49 is rejected because it is unclear if a Markush group is intended to be recited. The claim states that the species to examined “is selected from” a list, where the final options are separated by the word “and.” If a Markush group is desired, Applicant should ensure the claim language reads “the microbial species is selected from the group consisting of….” If a Markush group is not desired, the claim should end with “E. coli or S. aureus.”
Claim 50 is rejected because it recites the use of a liquid sample (as does claim 36, from which this claim depends), and then in the provided list, the use of a “skin biopsy” is claimed. It is unclear how a skin biopsy alone would classify as a liquid sample.
Claim 52 is rejected because the language of the claim as it relates to claim 36 is unclear. The whole blood sample of claim 52 (which is also recited in claims 50-51, from which claim 52 depends) is used as the liquid sample in claim 36, but by performing the additional steps of claim 52, the whole blood sample is processed, and a lysate remains. It is therefore unclear how the whole blood sample could then be used as the liquid sample in the method of claim 36. It is recommended that Applicant amend claim 52 to depend from claim 36, and specify that the lysate is used as the liquid sample in the method of claim 36.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 114 and 123-125 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claims recite natural laws.
Claim 114 is directed to a method for diagnosing a bloodstream infection or sepsis in a subject, utilizing the method of claim 38 and the results of performing said method to identify microbial species present. The natural law recited is the presence of the microbes and their detection in a sample in relation to a subject’s sepsis or bloodstream infection. This judicial exception is not integrated into a practical application because there is no required active treatment step or other step that integrates the judicial exception into a practical application. See MPEP 2106.04(d)(2). The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because they do not amount to more than well-understood, routine, and conventional activity in view of Neely et al. (US 2013/0244238 A1).
Neely teaches systems and methods for the detection of analytes, as well as methods regarding the treatment and diagnosis of disease (Abstract). The general method of the invention involves detecting the presence of an analyte in a liquid sample, where the sample is contacted with a solution of magnetic particles that contain binding moieties on the surface that alter aggregation of the magnetic particles in the presence of the analyte, placed in a device including a support defining a well holding the liquid sample including the magnetic particles and the analyte, and having an RF coil disposed about the well, the RF coil configured to detect a signal produced by exposing the liquid sample to a bias magnetic field created using one or more magnets and an RF pulse sequence; exposing the sample to a bias magnetic field and an RF pulse sequence; measuring the signal; and, on the basis of the result of the signal, detecting the analyte (para. 7). The analyte can be a pathogen, and the sample containing the pathogen can be placed in a detection tube that is then placed in the device (paras. 9 and 16). Specifically, a Candida species can be detected in the liquid sample utilizing primers that can amplify multiple Candida species and create a Candida amplicon (para. 12). Neely also notes that one or more analytes can be detected with their methods (para. 68). As noted above in the “Claim Interpretation” section, the claimed first and second target nucleic acids may be on the same overall sequence. In the working examples of Neely, a Candida assay was performed to detect particular species, where whole blood samples were used, and target nucleic acids were PCR amplified with primers (paras. 597-601). Probes were used, and it is specifically noted that there are two regions of interest on the target nucleic acid (“two distinct species-specific sequences within the sense strand of the target nucleic acid”; para. 591).
Thus, claim 114 is directed to a judicial exception without significantly more.
Claim 123 is directed to a similar method to claim 114, with the exception of additionally reciting a step involving “administering a bloodstream infection or sepsis therapy.” The natural law recited is the presence of the microbes and their detection in a sample in relation to a subject’s sepsis or bloodstream infection. This judicial exception is not integrated into a practical application because there is no required active treatment step or other step that integrates the judicial exception into a practical application. Though a treatment step is recited, the treatment is very general (any appropriate type of “therapy”). See MPEP 2106.04(d)(2), which requires the use of “particular” treatment or prophylaxis to direct the claim to significantly more than a judicial exception. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because they do not amount to more than well-understood, routine, and conventional activity in view of Neely et al. (US 2013/0244238 A1). See the teachings of this reference as described above in the rejection of claim 114, and additionally, paras. 70-71, 285, and 306-310, which detail various methods involving sepsis treatments such as antiviral, antibiotic, and antifungal medications.
Thus, claim 123 is directed to a judicial exception without significantly more.
Claims 124 and 125 are dependent on claims 114 and 123, respectively, and both require that the bloodstream infection be bacteremia and/or the subject be human. These requirements serve to only further limit the judicial exceptions of claims 114 and 123. These judicial exceptions are not integrated into a practical application because there is no required active treatment step or other step that integrates the judicial exceptions into a practical application. See MPEP 2106.04(d)(2). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exceptions because they do not amount to more than well-understood, routine, and conventional activity.
Thus, claims 124-125 are directed to judicial exceptions without significantly more.
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.
Claims 36-38, 41-53, 114 and 123-125 are rejected under 35 U.S.C. 103 as being unpatentable over Neely et al. (US 2013/0244238 A1).
Neely teaches systems and methods for the detection of analytes, as well as methods regarding the treatment and diagnosis of disease (Abstract). The general method of the invention involves detecting the presence of an analyte in a liquid sample, where the sample is contacted with a solution of magnetic particles that contain binding moieties on the surface that alter aggregation of the magnetic particles in the presence of the analyte, placed in a device including a support defining a well holding the liquid sample including the magnetic particles and the analyte, and having an RF coil disposed about the well, the RF coil configured to detect a signal produced by exposing the liquid sample to a bias magnetic field created using one or more magnets and an RF pulse sequence; exposing the sample to a bias magnetic field and an RF pulse sequence; measuring the signal; and, on the basis of the result of the signal, detecting the analyte (para. 7). The analyte can be a pathogen, and the sample containing the pathogen can be placed in a detection tube that is then placed in the device (paras. 9 and 16). Specifically, a Candida species can be detected in the liquid sample utilizing primers that can amplify multiple Candida species and create a Candida amplicon (para. 12; instant claims 37-38).
Neely also notes that one or more analytes can be detected with their methods (para. 68). As noted above in the “Claim Interpretation” section, the first and second target nucleic acids may be on the same overall sequence. In the working examples, a Candida assay was performed to detect particular species, where whole blood samples were used, and target nucleic acids were PCR amplified with primers (paras. 597-601). Probes were used, and it is specifically noted that there are two regions of interest on the target nucleic acid (“two distinct species-specific sequences within the sense strand of the target nucleic acid”; para. 591).
Though in the working example of paras. 597-601, it is not explicitly stated that the Candida assay was done using the magnetic particle aggregation and magnetic field measurements of paras. 7, 9, and 16 or the detection tube of paras. 9 and 16, it would be prima facie obvious to use these methods described by Neely in the working example of Neely to detect Candida in the whole blood samples, particular as the Candida assay involves pathogen analysis.
Thus, the teachings of Neely render prima facie obvious instant claim 36.
Regarding claim 41, according to the “Claim Interpretation” above, the first and second target nucleic acids may be on the same overall larger sequence. In such an instance, when both the sequences are amplified, the same overall larger sequence would also be amplified. This would thus act as the third amplicon as recited in instant claim 41. In the rejection of claim 36 above, such an arrangement of first and second targets (and amplicons) is recited, and so this method would inherently also create a third amplicon that contains the two smaller amplicons.
Regarding claim 42, Neely specifically teaches that their Candida primers are designed to target specific regions of the genome (para. 684), and thus would be amplifying chromosomal regions.
Regarding claim 43, Neely teaches that in their Candida assays, the first and second target-specific sequences are separated by 10 to 100 nucleotides (para. 591).
Regarding claim 44, as noted above in the “Claim Interpretation” section, any strand synthesis that does not synthesize the entire starting strand of nucleic acids will be considered a “partial run-through of strand synthesis.” As the methods of Neely are not amplifying entire genomes, these methods are considered to meet this limitation (see paras. 684 and 704, which note amplifying particular genomic regions).
Regarding claims 45-47, though these claims are considered indefinite with regards to their requirements as described above in the 35 USC 112(b) Rejections, it is noted that Neely teaches that with their methods, extremely low concentrations of Candida can be detected. See Figure 46A, which notes that even when 0 CFU/mL is present in a sample, detection is still possible (para. 163)
Regarding claim 48, Neely teaches that their assay methods can occur in less than 3 hours, including those assays involving Candida (paras. 9, 12, 14-16, 168, 642, 644, 677, 702, 706).
Regarding claim 49, Neely teaches in their methods involving a sepsis diagnosis the detection and analysis of various microbial analytes, where said analyte(s) may be Acinetobacter baumannii, Enterococcus faecalis, Enterococcus faecium, Klebsiella pneumoniae, Pseudomonas aeruginosa, Escherichia coli, and Staphylococcus aureus (paras. 70-71), and generally teaches the analysis of these bacteria in various embodiments of the invention (paras. 97, 270, 293, 296, 305, and 310). Neely also discloses that their methods may be used for multiplexed detection (e.g. paras. 5, 131, 293, 295-296, and 304). Thus, it would be prima facie obvious to add additional microbial detection, such as detection of the non-Candida microbes discussed by Neely, into the method of Neely described above. For many of these species, more than one bacteria belonging to the genus may be identified with the methods of Neely (e.g. Klebsiella oxytoca and pneumoniae). Neely also teaches that the design of their universal primers for Candida utilized conserved RNA sequences in the genome (para. 684). Such sequences also exist for the bacterial species taught by Neely, such as 16s rRNA. Therefore, it would be prima facie obvious to perform multiplexing with the methods of Neely to also detect at least one of the additional microbial species taught by Neely, particularly as the reference teaches that patients with sepsis can be infected with multiple microbial species other than Candida, such as S. aureus and E. coli (para. 648). By properly determining each of the microbial species present in a sample, more appropriate treatments could be developed for patients. There would be a reasonable expectation of success because universal primer sequences could be made for these additional microbial species described by Neely using highly conserved sequences, as this is already taught by Neely for Candida, and these additional microbial species are well-described.
Regarding claims 50 and 51, Neely teaches that whole blood samples may be used (e.g. paras. 9-11, 13, 67, and 96).
Regarding claim 52, Neely teaches the processing of a whole blood sample by providing said sample, lysing the red blood cells within the sample, centrifuging sample to for a supernatant and a pellet, discarding some or all of the supernatant, resuspending the pellet to form an extract, washing the pellet, resuspending the pellet, and lysing the cells of the pellet extract to form a lysate (e.g. paras. 9, 11, 13, 15).
Regarding claim 53, Neely teaches that the magnetic particles may be substantially monodisperse, that 1x106 to 1x1013 magnetic particles per milliliter of the liquid sample may be provided, and that the T2 relaxivity per particle may be 1x108 to 1x1012 mM-1s-1 (para. 7). As noted above, Neely also teaches methods of performing PCR, and asymmetric PCR may be used (e.g. paras. 371, 607, 664, 684-685, 690, and 704).
Regarding claim 114, Neely teaches performing their method to diagnose sepsis in a subject by detecting a pathogen-associated analyte in the blood of a patient, where said analyte may be a variety of Candida species, Acinetobacter baumannii, Enterococcus faecalis, E. faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus aureus (para. 70). As pathogens generally and Candida specifically are described in the teachings of Neely cited in the rejections above, it would be prima facie obvious to combine the sepsis detecting methods and data of Neely with the microbial data already gathered from the above methods of Neely to detect sepsis in a patient, as such detection can inform treatment plans, and would provide a simple, non-invasive, relatively quick, and effective tool to diagnose sepsis, potentially catching the disease before more intensive therapies are needed.
Regarding claim 123, this claim requires the same limitations as instant claim 114, with the exception that a therapy must be used. In para. 70 of Neely, which describes diagnosing sepsis, the reference also teaches the use of therapeutic agents such as antiviral antibiotic, and antifungal medications (paras. 68 and 70-71). Para. 71 specifically states the treatment of sepsis, as does para. 285. Paras. 306-310 also note the importance of detecting and treating sepsis for patient outcomes. Thus, it would be prima facie obvious to treat a subject who was diagnosed with sepsis using the method of Neely described above in the rejection of claim 114.
Regarding claims 124-125, Neely discloses that their methods may be used on humans (paras. 287, 618-619, 628, 630, 677 and the various human substrates listed in Table 5). The reference also repeatedly makes reference to patients (e.g. para. 12-13). Thus, it would be prima facie obvious that the methods of Neely described above in the rejections of claims 114 and 123 could be used on human samples.
Claims 39 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Neely et al. (US 2013/0244238 A1) in view of Taira et al. (BMC Infectious Diseases, 2014).
Regarding claim 39, with the Candida assay, Neely teaches the use of universal primers, and thus, a single primer pair (see Table 8, for example). However, Neely teaches the use of more than one primer pair generally (Table 5, see “additional primers”), and also teaches that their invention can be used for multiplexing (paras. 466-468). Specifically, a multiplexed PCR may be used to generate different amplicons and then detect the different targets (para. 471), The reference also generally discusses multiplexing throughout (e.g. paras. 5, 131, 293-294, 334-335).
However, the reference does not teach that different primer pairs are used for each target nucleic acid sequence.
Taira teaches the detection of Candida in the context of bloodstream infections (Abstract). The reference teaches a multiplex PCR, where universal primers and species specific primers were used (pages 2-3, “PCR primers” and “Multiplex nested PCR and detection of amplification products”). Table 1 displays the primer sequences used. Taira notes that this PCR method did not amplify unintended species (page 4, column 1, para. 4), and was able to detect the presence of Candida more reliably than blood cultures alone (Table 2). The PCR was also able to detect multiple Candida species when they were present (Table 2). Taira teaches that their method is highly specific, sensitive, quicker compared to other detection methods, and may be used to improve patient outcomes and reduce hospitalization costs (page 6, column 1).
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious for one of ordinary skill in the art to combine the teachings of Neely and Taira to utilize multiple target-specific primer pairs to detect Candida species in the method of Neely. In the method of Neely described above in the rejection of claim 36, a single universal primer set was used to amplify two target regions for a singular Candida species, where capture oligonucleotides/probes are used to hybridize to target specific regions and detect particular Candida species. However, Neely also notes that multiple Candida species may be detected with the methods of their invention, as they teach analyzing panels of Candida species as well as multiplex reactions. Taira shows that multiple Candida species can infect patients simultaneously, and details primers that are species-specific that do not amplify unwanted species. Taira and Neely also teach overlapping Candida species, such as C. albicans, glabrata, tropicalis, parapsilosis, krusei, and lusitaniae (Table 1 of Taira and paras. 97 and 595 of Neely, for example). Thus, Taira provides evidence that species-specific Candida primers would be effective in the method of Neely, and could thus be used in multiplex amplification reactions to detect multiple Candida species, which could provide helpful information for patients and practitioners by specifically amplifying particular species of interest, and would allow for detection of multiple Candida species within a single sample, which may inform treatment plans. Taira teaches that multiplex PCR with these primers has many benefits, such as providing specific and sensitive detection, that would be transferable if the disclosed primers were used in the methods of Neely. The fact that both references teach many of the same Candida species also provides a reasonable expectation of success that these primers could be used in the methods of Neely. This is essentially a substitution of the universal primers of Neely with the species-specific primers of Taira, as well as a combination of the PCR methodologies of the two references. Regarding substitutions, MPEP 2143 I B states, “The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art.” The substitution of the universal primers for target-specific primers would be predictable, as evidenced by the PCR results shown by Taira. MPEP 2143 I A states, “The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art.” By combining the references to arrive at a single reaction multiplex PCR, this would also produce predictable results (i.e. species-specific amplicons), as shown by Taira, that could be used in the further detection methods of Neely, as these methods simply require the use of amplicons that can bind to probes on magnetic particles. The function of the primers and PCR would remain the same overall, as they would still be amplifying target analytes.
Thus, claim 39 is prima facie obvious over Neely in view of Taira.
Regarding claim 40, Neely states in para. 591 for the Candida assay that two magnetic particle populations with probes may be used to capture a single stranded target, where two regions are captured with said probes. Such a setup is also shown in Figures 5C and 32 (see paras. 122 and 591). Neely also teaches the use of many different types of species-specific probes associated with different Candida species (Table 8), and notes that two different types of probes may be conjugated to a single magnetic particle (para. 591).
In the combination of Neely in view of Taira above, a multiplex PCR reaction is used to detect multiple Candida species at once. As the detection of Neely involves probes on magnetic particles, these probes and particles would also be used in the method of Neely in view of Taira. Generally, Neely teaches a maximum of two populations of magnetic particles, and as the reference teaches that two different kinds of probes can be used on a single magnetic particle, it would be prima facie obvious to design the particles to perform multiple sandwich assays to detect two separate target nucleic acids simultaneously. This would result in two distinct targets being sandwiched between the magnetic particles, where each particle has a single probe specific for each of the two targets. This cuts down on the number of magnetic particles that would need to be developed, as two distinct particles are not needed for each individual target, which would decrease costs, and also allows the multiplex PCR and detection reaction to be more efficient, as separation of individual targets would not be needed before detection. There would be a reasonable expectation of success as Neely already teaches Candida probe sequences for multiple species that were successfully used in their methods, the design of magnetic particles with one and two probes attached, and the use of sandwich detection assays.
Thus, claim 40 is prima facie obvious over Neely in view of Taira.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 36-38, 48, and 50-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 13, and 18-19 of U.S. Patent No. 9,046,493 B2 in view of Neely et al. (US 2013/0244238 A1).
Claim 1 of the ‘493 patent steps (b) through (i) state nearly all the limitations of steps (a) through (f) of claim 36 of the instant application, focusing specifically on Candida. The only limitation in the instant claims that is not present in claim 1 of the ‘493 patent is the use of two target nucleic acids. However, it would be obvious to include a second Candida target in claim 1 of the ‘493 patent in view of Neely, which teaches a Candida assay utilizing the same general NMR method as cited in these claims (see paras. 33-35 above). The method of Neely utilizes probes that hybridize to multiple regions on a single strand of a Candida nucleic acid, and so it would be obvious to perform a similar method in the ‘493 patent, which would thus read on instant claim 36.
Claim 1 of the ‘493 patent also reads on instant claims 37-38, as Candida is used.
Claim 1 of the ‘493 patent also reads on instant claims 50-52, as it requires the use of a whole blood sample, and recites the lysing and general extraction methods described in instant claim 52.
Claim 1 of the ‘493 patent also reads on instant claim 53, as the claim recites options (i), (ii), and (iii) of instant claim 53.
Claim 4 of the ‘493 patent also reads on instant claim 53, as it recites option (iv) of the instant claim.
Claim 13 of the ‘493 patent reads on instant claim 48, as both claims require the method be completed within 3 hours.
Claims 18 and 19 of the ‘493 patent also read on instant claim 53, as the ranges for the magnetic particle diameter recited are within the range described by the instant claim.
Claims 36, 50-51, and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 12,077,810 B2 in view of Neely et al. (US 2013/0244238 A1).
Claim 8 of the ‘810 patent steps (a’) through (d’) state nearly all the limitations of steps (a) through (f) of claim 36 of the instant application, focusing specifically on whole blood pathogen as prepared in claim 1 of the ‘810 patent. The only limitation in the instant claims that is not present in claim 1 of the ‘810 patent is the use of two target nucleic acids. However, it would be obvious to include a second target in claim 1 of the ‘493 patent in view of Neely, which teaches an assay utilizing the same general NMR method as cited in these claims (see paras. 33-35 above). The method of Neely utilizes probes that hybridize to multiple regions on a single strand of a target nucleic acid, and so it would be obvious to perform a similar method in the ‘810 patent, which would thus read on instant claim 36.
Claim 8 of the ’810 patent also reads on claims 50-51, as a whole blood sample is used.
Claim 8 of the ‘810 patent also reads on claim 53, as it includes options (i), (ii), and (iii) of the instant claim.
Claims 36-38, 49-51, 114, and 123-125 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-11, and 14 of U.S. Patent No. 9,702,852 B2 in view of Neely et al. (US 2013/0244238 A1).
Claim 1 of the ‘852 patent steps (a) through (f) state nearly all the limitations of steps (a) through (f) of claim 36 of the instant application, focusing specifically on a target nucleic acid in a whole blood sample. The only limitation in the instant claims that is not present in claim 1 of the ‘852 patent is the use of two target nucleic acids. However, it would be obvious to include a second target in claim 1 of the ‘852 patent in view of Neely, which teaches an assay utilizing the same general NMR method as cited in these claims (see paras. 33-34 above). The method of Neely utilizes probes that hybridize to multiple regions on a single strand of a target nucleic acid, and so it would be obvious to perform a similar method in the ‘852 patent, which would thus read on instant claim 36.
Claim 1 of the ‘852 patent also reads on instant claims 50-51, as the claim requires the use of a whole blood sample.
Claim 3 of the ‘852 patent reads on instant claims 37-38, as it requires detection of a microbial species.
Claims 5-11 of the ‘852 patent also read on instant claims 37-38, as they require detection of a microbial species.
Claims 10-11 of the ‘852 patent also read on instant claim 49, as the species recited in the claims overlap with the list presented in the instant claim.
Claim 14 of the ‘852 patent reads on instant claims 114 and 123-125 because it recites the diagnosis and/or treatment of bacteremia or sepsis in a patient utilizing the method of claim 1 of the ‘852 patent, thus meeting the limitations of each of the listed instant claims.
Claims 36-38 and 48-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, 11-14, and 16-18 of U.S. Patent No. 9,488,648 B2 in view of Neely et al. (US 2013/0244238 A1).
Claim 1 of the ‘648 patent steps (a) through (i) state nearly all the limitations of steps (a) through (f) of claim 36 of the instant application, focusing specifically on a target nucleic acid in a whole blood sample. The only limitation in the instant claims that is not present in claim 1 of the ‘648 patent is the use of two target nucleic acids. However, it would be obvious to include a second target in claim 1 of the ‘648 patent in view of Neely, which teaches an assay utilizing the same general NMR method as cited in these claims (see paras. 33-34 above). The method of Neely utilizes probes that hybridize to multiple regions on a single strand of a target nucleic acid, and so it would be obvious to perform a similar method in the ‘648 patent, which would thus read on instant claim 36.
Claim 1 of the ‘648 patent also reads on instant claims 37-38, as it requires the use of a bacterium.
Claim 1 of the ’648 patent also reads on instant claims 50-52, as it requires the use of a whole blood sample, and recites the lysing and general extraction methods described in instant claim 52.
Claim 1 of the ‘648 patent also reads on instant claim 53, as it recites options (i), (ii), and (iii) of the instant claim.
Claim 3 of the ‘648 patent also reads on instant claim 53, as it recites option (iv) of the instant claim.
Claim 6 of the ‘648 patent reads on instant claim 48, as it requires that the method take place within 3 hours.
Claims 11-12 of the ‘648 patent also read on instant claim 53, as the magnetic particle diameters recited overlap with the range listed in option (ii) of the instant claim.
Claims 13-14 and 16-18 of the ‘648 patent read on instant claims 37-38 as they recite that the target may be a microbe.
Claims 13-14, 16, and 18 of the ‘648 patent also read on instant claim 49, as the bacteria recited in these claims overlap with the list of microbes recited in the instant claim.
Claims 36-38 and 49-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 11, and 13-18 of U.S. Patent No. 9,714,940 B2 in view of Neely et al. (US 2013/0244238 A1).
Claim 1 of the ‘940 patent steps (e) through (i) state nearly all the limitations of steps (a) through (f) of claim 36 of the instant application, focusing specifically on a target nucleic acid in a whole blood sample. The only limitation in the instant claims that is not present in claim 1 of the ‘940 patent is the use of two target nucleic acids. However, it would be obvious to include a second target in claim 1 of the ‘940 patent in view of Neely, which teaches an assay utilizing the same general NMR method as cited in these claims (see paras. 33-34 above). The method of Neely utilizes probes that hybridize to multiple regions on a single strand of a target nucleic acid, and so it would be obvious to perform a similar method in the ‘940 patent, which would thus read on instant claim 36.
Claim 1 of the ’940 patent also reads on instant claims 50-52, as it requires the use of a whole blood sample, and recites the lysing and general extraction methods described in instant claim 52.
Claim 1 of the ‘940 patent also reads on instant claim 53, as it recites options (i), (ii), and (iii) of the instant claim.
Claim 11 of the ‘940 patent also reads on instant claim 53, as the claimed limitation is the same as option (iv) of the instant claim.
Claim 13 of the ‘940 patent also reads on instant claim 53, as the magnetic particle diameters recited overlap with the range listed in option (ii) of the instant claim.
Claims 3-5 and 14-18 of the ‘940 patent read on instant claims 37-38 as they recite that the target may be a microbe.
Claims 15-18 of the ‘940 patent also read on instant claim 49, as the bacteria recited in these claims overlap with the list of microbes recited in the instant claim.
Claims 36-38, 48, and 50-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 13, and 18-19 of U.S. Patent No. 8,409,807 B2 in view of Neely et al. (US 2013/0244238 A1).
Claim 1 of the ‘807 patent steps (c) through (i) state nearly all the limitations of steps (a) through (f) of claim 36 of the instant application, focusing specifically on Candida. The only limitation in the instant claims that is not present in claim 1 of the ‘807 patent is the use of two target nucleic acids. However, it would be obvious to include a second Candida target in claim 1 of the ‘807 patent in view of Neely, which teaches a Candida assay utilizing the same general NMR method as cited in these claims (see paras. 33-34 above). The method of Neely utilizes probes that hybridize to multiple regions on a single strand of a Candida nucleic acid, and so it would be obvious to perform a similar method in the ‘807 patent, which would thus read on instant claim 36.
Claim 1 of the ‘807 patent also reads on instant claims 37-38, as Candida is used.
Claim 1 of the ‘807 patent also reads on instant claims 50-52, as it requires the use of a whole blood sample, and recites the lysing and general extraction methods described in instant claim 52.
Claim 1 of the ‘807 patent also reads on instant claim 53, as the claim recites options (i), (ii), and (iii) of instant claim 53.
Claim 4 of the ‘807 patent also reads on instant claim 53, as it recites option (iv) of the instant claim.
Claim 13 of the ‘807 patent reads on instant claim 48, as both claims require the method be completed within 3 hours.
Claims 18 and 19 of the ‘807 patent also read on instant claim 53, as the ranges for the magnetic particle diameter recited are within the range described by the instant claim.
Conclusion
No claims are currently allowable.
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/F.F.G./Examiner, Art Unit 1681
/SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681