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 .
Priority
This application 17/502,344 filed on 10/15/2020 does not claim priority to any domestic or foreign applications. The priority date of claim 1 and its dependent claims is determined to be 10/15/2020, the filing date of the instant application.
Status of Claims
Applicant’s amendments to claims filed 05/26/2026 in response to the Non-Final Rejection mailed 02/24/2026 are acknowledged.
Claim 1 is amended.
Claim 14 has been canceled.
Claims 1-13 and 16 are pending and claims 1-10, 12-13, and 16 are under examination.
Response to Remarks filed 05/26/2026
The amendments and arguments presented in the papers filed 05/26/2026 ("Remarks”) have been thoroughly considered. The issues raised in the Office action dated 02/24/2026 listed below have been reconsidered as indicated.
a) The 35 USC 112(b) indefiniteness rejections of claims 1-10, 12-14 and 16 have been withdrawn in view of the amendments to claims and the cancellation of claim 14.
b) The 35 USC 112( 14 has been withdrawn as moot in view of the cancellation of claim 14.
c) The 35 USC 101 rejection of claim 14 has been withdrawn as moot in view of the cancellation of claim 14.
New and modified grounds of rejection necessitated by amendment are detailed below and this action is made FINAL.
Claim Objections
Claim 1 is objected to because of the following grammatical informality: The claim recites the limitation “--- avoiding a use, as a transplantation material, of any xenotransplantation material infected with a bacterium comprised in the two or more types of bacteria, regardless of a species of the bacterium---”. It is suggested to use “comprising” or “comprised of” in such sentences.
Claim Interpretation
Claim 1 recites the limitation “--- avoiding a use, as a transplantation material, of any xenotransplantation material infected with a bacterium comprised in the two or more types of bacteria, regardless of a species of the bacterium---”. “Avoiding a use” does not exclude the use of a material. Instead this limitation is interpreted under the broadest reasonable interpretation as an intention and does not limit the scope. Further it is noted that there is no conditional limitation linking detection and action, e.g. if infection by a bacterial pathogen is detected then avoid use of the xenotransplantation material.
Under the broadest reasonable interpretation claim 1 is interpreted to require:
(1) performing a genetic test for infection by pathogens including a virus or protozoa with a selective primer (or primers) to identify a virus or protozoa, and (2) performing a genetic test for infection by pathogens including bacteria using a primer (or primers) that targets a common base sequence from a conserved region present in at least two types of bacteria in order to detect the presence of absence of bacteria without identifying a specific bacteria species.
Claim Rejections - 35 USC § 112(a) – New Matter
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 1-10,12-13 and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a new matter rejection necessitated by amendments to the claims.
The claims are broadly drawn to a method for testing a xenotransplantation material for pathogen infection, the method comprising performing a genetic test for infection by pathogens comprising two or more types of bacteria and performing a genetic test for infection by pathogens comprising a virus or a protozoon.
Amended claim 1 recites “avoiding a use, as a transplantation material, of any xenotransplantation material infected with a bacterium comprised in the two or more types of bacteria, regardless of a species of the bacterium”.
The response indicates that the amendment “regardless of a species of the bacterium“ is supported by "species" in paragraph [0019] of the as-filed specification.
The specification has been thoroughly reviewed however no support for this limitation could be found.
Paragraph 19 of the specification teaches “the pathogens to be tested for including two or more types of bacteria and a virus or a protozoon are preferably pathogens including two or more types of bacteria”. The paragraph further recites “examples of the two or more types of bacteria to be tested for include at least two types of bacteria selected from specific examples described below” and provides a list of types of bacteria, some of which are identified as species.
Further, paragraph 8 of the specification states “a xenotransplantation material which has been infected with any bacterium should be avoided as a transplantation material regardless of type”.
A review of the specification fails to provide the specific combination of terms “regardless of a species of the bacterium”. The amendment appears to intend to limit the previous limitation of a type of bacterium to a species of bacterium however, none of the embodiments of the specification recite ““regardless of a species of the bacterium”.
Claim Rejections - 35 USC § 112(b) - Indefinite
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 1-10, 12, 13, and 16 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.
These are new rejections necessitated by amendments to the claims.
Claim 1 recites the limitation “avoiding a use, as a transplantation material, of any xenotransplantation material infected with a bacterium comprised in the two or more types of bacteria, regardless of a species of the bacterium” and is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. Claim 1 recites the active steps “performing a (i) genetic test for infection by pathogens comprising two or more types of bacteria, performing a (ii) genetic test for infection by pathogens comprising a virus or a protozoon --”. The claim requires testing for infection by pathogens comprising two or more types of bacteria and testing for infection by pathogens comprising a virus or a protozoon. It is unclear what additional steps if any are required to avoid the use of transplantation material “infected with a bacterium comprised in the two or more types of bacteria, regardless of a species of the bacterium”. No conditional limitation linking detection and action (avoiding use) is provided. Thus the claims fails to clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
Claim 1 recites the limitation “avoiding a use, as a transplantation material, of any xenotransplantation material infected with a bacterium comprised in the two or more types of bacteria, regardless of a species of the bacterium”. The limitation is unclear. It is unclear how a singular bacterium can be comprised of multiple bacteria. As such the claims does not clearly set forth the metes and bounds of the patent protection desired.
Claim 1 recites “---performing a (i) genetic test for infection by pathogens comprising two or more types of bacteria –“; “---avoiding a use, as a transplantation material, of any xenotransplantation material infected with a bacterium comprised in the two or more types of bacteria, regardless of a species of the bacterium –"; and “--- wherein the (i) genetic test comprises using at least one primer that targets a common base sequence among at least two types of bacteria to perform a detection of the presence or absence of bacteria without identifying a species of the bacteria, the common base sequence is a sequence comprised in a conserved region of the at least two types of bacteria---". First it is noted that “avoiding a use--” is not a required limitation but is, rather, an intended use. It is further unclear if ‘types’ are intended to be a species, genus or class, whether a “type” of bacteria is intended to be a Gram-positive or Gram-negative type, or whether the phrase “type” is intended to be any type of bacteria. It is also unclear what relationship the types of bacteria and species of bacteria of the claim have to each other. For example, the phrase “using at least one primer that targets a common base sequence among at least two types of bacteria to perform a detection of the presence or absence of bacteria without identifying a species of the bacteria, the common base sequence is a sequence comprised in a conserved region of the at least two types of bacteria” alternates between types of bacteria and species of bacteria.
Claims 2-10, 12, 13 and 16 are similarly indefinite because they directly or indirectly depend from claim 1.
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.
Claims 1-10 and 12-13 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Hartline et al. (Xenotransplantation panel for the detection of infectious agents in pigs. 2018. Xenotransplantation. 25: e12427, p. 1-15 and supplementary material wherein) in view of Klindworth et al. (Evaluation of general 16S ribosomal RNA gene PCR primers for classical and next-generation sequencing-based diversity studies.2013. Nucleic Acids Research. (41) 1: e1-e11, and supplementary material wherein) and further in view of Center for Disease Control and Prevention, herein referred to as CDC (“U.S. Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation”. 2001. MWWR. 50(RR15); 1-46).
This maintained rejection has been modified to address claim amendments
As noted above, claim 1 requires the active steps of “performing a (i) genetic test for infection by pathogens comprising two or more types of bacteria, performing a (ii) genetic test for infection by pathogens comprising a virus or a protozoon”. The claim further requires “using at least one primer that targets a common base sequence among at least two types of bacteria to perform a detection of the presence or absence of bacteria without identifying a type species of the bacteria, the common base sequence is a sequence comprised in a conserved region of the at least two types of bacteria“ and “using at least one primer that selectively binds to a nucleic acid sequence of at least one type of a virus or a protozoon to perform an identification of a type of the virus or the protozoon”.
Regarding claim 1, Hartline teaches a method of detecting infectious agents using a screening panel in pigs to ensure safety for transplantation (xenotransplantation) (p. 1, Abstract). Hartline teaches performing qPCR (a genetic test) for infections by pathogens comprising bacteria, including two groups (type) of bacteria (p. 1, Abstract and p. 3, Table 1), satisfying the requirements of “performing a (i) genetic test for infection by pathogens comprising two or more types of bacteria”. Hartline also teaches performing qPCR (a genetic test) for infections by pathogens comprising viruses (p. 1, Abstract and p. 3, Table 1), satisfying the requirement of “performing a (ii) genetic test for infection by pathogens comprising a virus or a protozoon”.
Hartline does not explicitly state avoiding the use of xenotransplantation material infected with a bacterium comprised in the two or more types of bacteria, regardless of a species of the bacterium.
CDC teaches viruses and bacteria are considered infectious agents in the context of xenotransplantation (p. 11, section 1.2). CDC teaches that candidate source animals (i.e. material) should be screened for the presence of infectious agents including bacteria and viruses (p. 26, section 3.5.1.1). CDC further teaches that all procured cells, tissues and organs intended for use in xenotransplantation should be as free of infectious agents as possible. The use of source animals in which infectious agents, have been identified should be avoided (p. 26, section 3.5.2). CDC thus teach elements satisfying the requirement avoiding a use, as a transplantation material, of any xenotransplantation material infected with a bacterium comprised in the two or more types of bacteria, regardless of a species of the bacterium.
Hartline teaches using primers targeting individual viruses, e.g. Porcine cytomegalovirus (p. 3, cols. 1 and 2 and Table S1, p. 2), which reads on “using at least one primer that selectively binds to a nucleic acid sequence of at least one type of a virus or a protozoon to perform an identification of a type of the virus or the protozoon”.
Neither Hartline nor CDC teach “using at least one primer that targets a common base sequence among at least two types of bacteria to perform a detection of the presence or absence of bacteria without identifying a species of the bacteria, the common base sequence is a sequence comprised in a conserved region of the at least two types of bacteria”. However, Hartline teaches adapting previously reported qPCR assay (i.e. primers) for inclusion in the common testing platform (p. 3 col. 1 and p. 4, col. 1).
Klindworth teaches selecting primer pairs for PCR (a genetic test) of bacteria. Klindworth teaches the selection of primers that have high coverage (i.e. a common base sequence comprised in a conserved region of the at least two types of bacteria) among all bacteria (i.e., at least two) (p. 1, Abstract and p 1, col 2). Klindworth teaches that primer pairs (at least one primer) were investigated with respect to overall coverage and phylum spectrum (p. 1, col. 2). Klindworth teaches primer pairs designed to target the Bacteria domain, which includes all bacteria (p. 2, col. 1), and reads on detection of the presence or absence of bacteria without identifying a species of the bacteria.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Hartline, Klindworth and CDC to arrive at the instantly claimed invention. The modification would have entailed selecting the PCR primers of Klindworth to perform the (i) genetic test of Hartline. One would have been motivated by the desire of Hartline to add targets to the assay (p. 13, col. 2) and ensure the safety of material for xenotransplantation. Use of these primers increases the ability of the method of Hartline to detect infectious agents using a screening panel in pigs to ensure safety for human transplantation and, as taught by the CDC, ensure that material is as free of infectious agents as possible. As taught by Hartline, the adaptation of existing primers was known at the time of filing and would have had a reasonable expectation of success. The modification would have further entailed screening for infectious agents (including bacteria and viruses) as taught by the CDC to avoid use of material in which infectious agents have been identified. In the context of material which is either safe or not safe for use, the presence of bacteria, of any type, would have been sufficient to exclude the material as stated by CDC. The universal primers of Klindworth would have provided a tool for screening a broad spectrum of infectious agents, a stated goal of Hartline (p. 2, col. 1). There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Regarding claims 2-4, neither Hartline nor CDC teach the common base sequence (for the (i) genetic test) is a sequence comprised in a conserved region of bacterial 16S rRNA (claim 12); the conserved region is a conserved region at least common to 16S rRNAs of Leptospira species, Mycoplasma species, Campylobacter species, Yersinia species, Escherichia species, and Salmonella species (claim 3); or the conserved region is regions between which V3 variable region and V4 variable regions only are sandwiched as variable regions (Claim 4).
However, Klindworth teaches each of these elements.
Regarding claim 2, Klindworth teaches broad-range primers that target 16s ribosomal RNA genes (p. 1, Abstract). Klindworth states that 16s ribosomal RNA amplicon analysis is the standard approach for the cultivation independent investigation of microbial diversity (p. 1, Abstract).
Regarding claim 3, Klindworth teaches primers with coverage against Leptospira species, Mycoplasma species, Campylobacter species, Yersinia species, Escherichia species, and Salmonella species (Supplemental Table 4). Klindworth specifically teaches the preferred primer S-D-Bact-0341-b-S-17 (p 6, col 1) with coverage of at least 80% against each of Leptospira species, Mycoplasma species, Campylobacter species, Yersinia species, Escherichia species, and Salmonella species (Supplemental Table 4), thus satisfying the requirements of at least one primer that targets a conserved region in the claimed bacteria species.
Regarding claim 4, Klindworth teaches that the best primer pair for bacteria (S-D-Bact-0341-b-S-17/S-D-Bact-0785-a-A-21) in terms of domain and phylum coverage amplifies HV regions 3-4 (i.e. V3 and V4) (p6, col 1). Klindworth further teaches multiple primer pairs covering only the HV regions 3-4 (i.e. V3 and V4) (Supplemental Table 8).
Regarding claims 2-4, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Hartline, Klindworth, and CDC to arrive at the instantly claimed invention. The modification would have entailed using the PCR primers targeting 16s ribosomal RNA of Klindworth in the method of Hartline. The ordinary artisan would have been motivated to use the primers of Klindworth for the added advantage of expanding the detection of a broad spectrum of infectious agents, a stated goal of Hartline (p. 2, col. 1) while using established targets for assaying bacteria. As taught by There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Regarding claim 5, neither Hartline nor CDC teach wherein one primer pair is used in the (i) genetic test.
Klindworth teaches individual primers that target two or more types of bacteria (Supplemental Table 4).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Hartline, Klindworth, and CDC to arrive at the instantly claimed invention. The modification would have entailed using the PCR primers of Klindworth in the method of Hartline. The ordinary artisan would have been motivated to use the primers of Klindworth for the added advantage of expanding the detection of a broad spectrum of infectious agents, a stated goal of Hartline (p. 2, col. 1). The primers of Klindworth would have maximized measurement of the presence of bacteria, while minimizing the effort required to adapt primers to the assay of Hartline (requiring optimization of only one set or primers), allowing Hartline to meet their goals of increasing targets and providing parallel evaluation of a large set of targets (p. 13, col. 2). One would have been motivated to select the known primer pairs taught by Klindworth to expand the number of assayed targets while minimizing the work or adapting primers that could be used with the common amplification protocol of Hartline. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Regarding claim 6, Hartline teaches performing qPCR on all targets in parallel (p3, col 1), using reagents arrayed in 96-well plates (p. 4, col 1, section 2.3), Hartline teaches performing qPCR on two types of Mycoplasma bacteria (i.e. the (i) genetic test) and 29 viruses (i.e., the (ii) genetic test).Hartline states that “qPCR was then performed on a QuantStudio 6 with a Fast block (Applied Biosystems) using an initial 20 seconds denaturation at 95°C, and 45 cycles of 95°C 1 second, 60°C 20 seconds.”, thus satisfying the requirement of “a PCR method with the same thermal cycle conditions using primers among which differences in melting temperature that are 15°C or less”.
Klindworth teaches selecting primer pairs for PCR of bacteria. Klindworth teaches the selection of primers that have high coverage (i.e. common base sequence targets) among all bacteria (i.e., at least two) (p. 1, Abstract and p 1, col 2). Klindworth further teaches evaluating 512 primer combinations (p. 2, col. 2 and Supplementary Table 8).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Hartline, Klindworth, and CDC to arrive at the instantly claimed invention. The modification would have entailed using the PCR primers of Klindworth to perform the (i) genetic test of Hartline. One would have been motivated by the desire of Hartline targets to the assay (p. 13, col. 2) and ensure the safety of material for xenotransplantation. As taught by Hartline, the adaptation of existing primers was known at the time of filing and would have had a reasonable expectation of success. One would have been motivated to select primer pairs taught by Klindworth to expand the number of assayed targets while minimizing the work or adapting primers that could be used with the common amplification protocol of Hartline. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Regarding claim 7, Hartline teaches that infectious agents can transmit zoonotic infections (p. 2, col. 1).
Regarding claim 8, Hartline teaches testing more than 5 viruses by qPCR with specific primers (p. 3, Table 1 and Table S1).
Regarding claim 9, Hartline teaches the xenotransplantation product is pig-derived (p. 1, Abstract and p. 4, col. 2).
Regarding claim 10, Hartline teaches detecting viruses including Porcine cytomegalovirus (p. 3, Table 1).
Regarding claim 12, Hartline teaches that the goal of their method is to generate genetically engineered porcine organs for use in clinical trials to evaluate the potential of xenotransplantation (p. 2, col 1).
Regarding claim 13, Hartline teaches testing by qPCR (p. 1, Abstract and p. 3, Table 1).
Claim 16 remain/is rejected under 35 U.S.C. 103 as being unpatentable over Hartline et al. (Xenotransplantation panel for the detection of infectious agents in pigs. 2018. Xenotransplantation. 25: e12427, p. 1-15 and supplementary material wherein) in view of Klindworth et al. (Evaluation of general 16S ribosomal RNA gene PCR primers for classical and next-generation sequencing-based diversity studies.2013. Nucleic Acids Research. (41) 1: e1-e11) further in view of CDC (“U.S. Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation”. 2001. MWWR. 50(RR15); 1-46) as applied to claims 1-10 and 12-13 above, and further in view of Mansfield et al. (Japanese encephalitis virus infection, diagnosis and control in domestic animals. 2017. Veterinary Microbiology. 201: 85-92).
Regarding claim 16, neither Hartline nor Klindworth or CDC teach the virus comprises at least one type of virus selected from the group containing Geta virus, Japanese encephalitis virus, African swine fever virus, and Swine fever virus.
Mansfield teaches molecular methods for detecting Japanese encephalitis virus (p. 89, Table 1). Mansfield teaches Japanese encephalitis virus is a significant cause of neurological disease in humans and that the impact of Japanese encephalitis virus infection is particularly apparent in pigs (p. 85, Abstract). Mansfield states that it is critical to detect the virus and break the link to zoonotic transmission to the human population (p. 85, Abstract).
Mansfield further teaches primer sets for detecting Japanese encephalitis virus (p. 89, Table 1).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Hartline, Klindworth, and CDC with Mansfield to arrive at the instantly claimed invention. The modification would have entailed additionally using the PCR primers of Mansfield in the method of Hartline. The ordinary artisan would have been motivated to use the primers of Klindworth for the added advantage of adding more targets to the set of agents described (p. 13, col. 2). One would have been further motivated to use the primers of Mansfield that target Japanese encephalitis virus because it poses a zoonotic risk similar to the already taught primers of Hartline, who was motivated to understand the spectrum of infectious agents in donor pigs. Furthermore, the method of Hartline taught adaptation of existing primers for inclusion with the panel of infectious agents. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Response to Arguments against Claim Rejection - 35 U.S. C § 103
The response acknowledges that Hartline indicates that it is desirable "to add more targets to the set of agents but asserts that "more targets are added to the set of agents" cannot be achieved by "at least one primer that targets a common base sequence among bacteria." This is because detection using only "at least one primer that targets a common base sequence among bacteria" cannot determine whether or not the detected bacterium is a newly added bacterium with respect to the bacteria described in Hartline (e.g., Mycoplasma species). Without further identifying what kind of bacterium has been detected, it is impossible to determine whether or not it is a newly added bacterium(p. 8). The response further asserts that Hartline thus provides no motivation to combine it with Klindworth to arrive at the feature of claim 1: "wherein the (i) genetic test comprises using at least one primer that targets a common base sequence among at least two types of bacteria to perform a detection of the presence or absence of bacteria without identifying a type of the bacteria" (p. 8-9).
Applicant's arguments have been fully considered but are not persuasive.
As set forth in the rejection above, the primers of Klindworth target the taxonomic domain of Bacteria, thus encompassing many species (i.e., targets) of bacteria, without identification of the species of bacteria. Adding targets to the method of Hartline is automatically achieved by use of a primer pair that targets all bacteria. Further, the primer of Klindworth fulfills the claim requirement of detecting bacteria regardless of a species. Use of these primers increases the ability of the method of Hartline to detect infectious agents using a screening panel in pigs to ensure safety for transplantation. A person of skill in the art would have been motivated by the advantages of using the primers of Klindworth, namely the detection of a larger number of targets (i.e. not a single species of bacteria) using previously reported primers that can also more easily be integrated into a common testing platform than the addition of multiple primers to individual bacteria (by the modification of a single set of parameters for a single pair of primers).
Regarding claim 6, the response asserts that detection using only "at least one primer that targets a common base sequence among bacteria" cannot determine whether or not the detected bacterium is a newly added bacterium with respect to the bacteria described in Hartline ( e.g., Mycoplasma species) and thus cannot determine whether or not the number of assayed targets has been expanded. Without further identifying what kind of bacterium has been detected, it is impossible to determine whether or not the number of assayed targets is expanded. The response further asserts that even if Hartline discloses "to expand the number of assayed targets while minimizing the work," the objective of "to expand the number of assayed targets while minimizing the work" cannot be achieved by "at least one primer that targets a common base sequence among bacteria", Hartline provides no motivation to combine it with Klindworth to arrive at the feature of claim 1: "wherein the (i) genetic test comprises using at least one primer that targets a common base sequence among at least two types of bacteria to perform a detection of the presence or absence of bacteria without identifying a type of the bacteria" (p. 9).
Applicant's arguments have been fully considered but are not persuasive.
Regarding the argument that “to expand the number of assayed targets while minimizing the work" cannot be achieved by "at least one primer that targets a common base sequence among bacteria”, a primer taught by Klindworth that targets a common base sequence shared among the members of the domain Bacteria expands the number of assayed targets from the Mycoplasma of Hartline by detecting all bacteria (i.e., expanding the number of assayed targets). Further, the expansion is accomplished by the addition of a single primer pair to the method of Hartline, thus minimizing the work required to expand the number of assayed targets. Thus, the use of at least one primer that targets a common base sequence among bacteria, when that primer detects all bacteria, expands the number of assayed targets detected by increasing the number of detected agents beyond the Mycoplasma taught by Hartline. This expansion is accomplished by a single primer, thus minimizing the work of expanding the panel with additional primers.
The response asserts that unless it is known from which bacterium the detected bacterial signal originates, it is impossible to determine whether or not the detected bacterial signal constitutes a new part that forms "a broad spectrum" with respect to the spectrum described in Hartline. And that "to detect a broad spectrum of infectious agents" cannot be achieved by "at least one primer that targets a common base sequence among bacteria." (p. 10).
Applicant's arguments have been fully considered but are not persuasive.
Regarding the argument that “to detect a broad spectrum of infectious agents" cannot be achieved by "at least one primer that targets a common base sequence among bacteria”, a primer taught by Klindworth that targets a common base sequence shared among the members of the domain Bacteria detects a broad spectrum of infectious agents by detecting all bacteria (i.e., a broad spectrum of infectious agents). Thus, the use of at least one primer that targets a common base sequence among bacteria, when that primer detects all bacteria, broadens the spectrum of infectious agents detected by increasing the number of detected agents beyond the Mycoplasma taught by Hartline.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JESSICA GRAY/Examiner, Art Unit 1682
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