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 .
Election/Restrictions
Applicant's election with traverse in the reply filed on 3/25/2026 is acknowledged. The traversal is on the ground(s) that the species election for claim 19 be modified to include claim 18. This is found persuasive. Accordingly, species election 3 has been modified to be directed to require election of silica like chemistry, lecithin, streptavidin, or an amine. Applicant’s election of silica like chemistry is noted. Additionally the election of CNS for species election 4 is acknowledged. The election requirements in species elections 1, 2, 2a, 2b, and 2c are withdrawn and these species are rejoined. In view of these changes, the remaining and amended requirement is deemed proper and is therefore made FINAL.
Claims 1-24 are pending.
Claim 1 is generic to claims 18 and 19. Claim 19 is withdrawn from consideration as being directed to a non-elected species, there being no allowable generic or linking claim. An action on the merits of claims 1-18 and 20-24 is set forth herein.
Claim Rejections - 35 USC § 112
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.
Claims 1-18 and 20-24 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 and its dependents recite the step “employing an aliquot… as a template for primer specific downstream nucleic acid amplification”. It is not clear what the employing step in claim 1 actually requires. For example, is it limited to a step of collecting a bead resuspension from step e, is it an intended use for the bead resuspension, or does it require a nucleic acid amplification step? Does the term ‘downstream” refer to a later step in the method or a section of a DNA target? Additionally, the structural requirements of the term “template” is not clear. Does it refer to a suspension comprising a bacteria and beads or does it refer to a DNA molecule (eg DNA template). Accordingly, the metes and bounds of the claimed methods are unclear.
Claim 22 recites “a point of care molecule test that allows identification… comprising the use of a template…”. Accordingly, claim 22 appears to be directed to a method, and is being interpreted as such. However it does not include any active steps. The phrase “the use of a template for primer specific nucleic acid amplification…” does not actually require any active steps but instead recites an intention or intended use. Additionally, it appears to recite an intended use for a “template” without setting forth the structural limitations of the template. Accordingly, the metes and bounds of the claims are unclear.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 22-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Payne (Payne et al; Journal of Applied Bacteriology, vol 72, pages 41-52, 1992).
The claimed methods do not require any active steps nor do they indicate the structural requirements of the “template”. Accordingly, the claims have been given their broadest reasonable interpretation to encompass obtaining lectin derivatized magnetic beads bound to bacteria from milk samples. Payne teaches assays using lectin immobilized on magnetic microspheres for the isolation of bacteria from cultures and food samples, including milk (see whole document). The intended use recitations are not active steps required by the method. Additionally, the origin of the milk sample does not structurally distinguish a magnetic bead bound to bacteria using lectins as taught by Payne from magnetic beds bound to bacteria using lectins from a sample of a dairy cow with mastitis since the bacteria taught by Payne are also found in dairy cows with mastitis.
Claims 22-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jenkins (Jenkins et al; PeerJ, 2019; DOI 10.7717/peerj.6749; pages 1-25).
The claimed methods do not require any active steps nor do they indicate the structural requirements of the “template”. Accordingly, the claims have been given their broadest reasonable interpretation to encompass obtaining DNA from bacteria that can be found in dairy cows with mastitis. Jenkins teaches isolating DNA from coagulase negative Staphylococcus species (see whole document).
Claim Rejections - 35 USC § 103
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 1-5, 10, 13-17 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Luo (Luo et al; J. Dairy Sci, volume 100, pages 7883-7890; 2017) in view of Jenkins (Jenkins et al; PeerJ, 2019; DOI 10.7717/peerj.6749; pages 1-25).
With regard to claim 1, Luo teaches a method of preparing a milk sample containing bacteria for PCR analysis (see abstract, whole document) so as to detect pathogenic bacteria in milk. Luo teaches that a milk sample with bacteria was contacted with uncoated magnetic beads derivatized with streptavidin (SA-MB) (see figure 1, p7884). This teaching is considered to be encompassed by the term “uncoated magnetic beads” in keeping with the express definition in the instant specification at page 5. Luo teaches that the magnetic beads were incubated in the milk sample to allow the SA-MB particles to bind to a biotin/antibody/bacteria complex (see figure 1, page 7885; a biotin-antibody complex allowed the antibody to bind to the bacteria of interest and the biotin allowed the bacteria bound complex to bind to streptavidin resulting in bacteria bound to magnetic beads). Luo teaches that after incubation, the mixture was separated using an external magnetic field using magnets. With regard to claims 1, 5, 10, and 13 Luo teaches that the SA-MB-biotin-mAb-bacteria were directly resuspended in an aqueous solution (sterilized PBS buffer) and that 400uL solutions of the resuspended bacteria were subject to PCR analysis (see page 7885- 7886). Luo teaches that the method was sensitive and low cost, and useful for rapid screening of pathogenic bacteria in milk.
With regard to claims 1, Luo does not teach preparing a milk sample comprising at least one suspected bacterial pathogen implicated in mastitis or detection of that bacteria, however Jenkins teaches that coagulase negative Staphylococcus (CNS) species are the most prevalent intra-mammary pathogens causing subclinical mastitis in lactating dairy cattle (see abstract, whole document). Jenkins teaches culturing and analysis of CNS isolates from milk samples from lactating dairy cows. Jenkins teaches identification of the different CNS species using PCR to sequence the rpoB gene (see pages 2-5). Therefore it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date, to have used the method of Luo to detect CNS species in the milk of lactating dairy cows for the obvious benefit of detecting bacteria that cause mastitis.
With regard to claim 2, Luo teaches heating the resuspended complex to 90°C and using a magnet to separate the magnetic bead from supernatant (see page 7886, col 1).
With regard to claims 3 and 4, Jenkins teaches analysis for CNS bacteria in raw milk from dairy cows with mastitis (see whole document).
With regard to claim 14, Luo necessarily teaches that the bacteria and magnetic beads are mixed prior to incubation (see whole document).
With regard to claim 15, although Luo does not teach incubation for about 5 to about 10 minutes at room temperature, Luo does exemplify the routine nature of optimizing reaction conditions (see whole document). As set forth in the MPEP 2144.05 II A, “Optimization of Ranges”:
Generally, differences in concentration or temperature will not support the patentability of
subject matter encompassed by the prior art unless there is evidence indicating such
concentration or temperature is critical. “[W]here 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) (Claimed process which was performed at a temperature between 40°C
and 80°C and an acid concentration between 25% and 70% was held to be prima facie
obvious over a reference process which differed from the claims only in that the reference
process was performed at a temperature of 100°C and an acid concentration of 10%.)…
Therefore, the claimed conditions are considered obvious in view of the routine nature of optimization in the relevant cited prior art.
With regard to claim 16, Luo teaches preparing the milk samples in a tube (see figure 1).
With regard to claim 17, although Luo does not teach using a magnetic stand to capture the magnetic beads, it would have been prima facie obvious to the ordinary artisan that the use of any suitable magnet, including a magnetic stand, could be used to capture the magnetic beads given the predictable use of magnets.
With regard to claims 22-24, he claimed methods do not require any active steps nor do they indicate the structural requirements of the “template”. Accordingly, the claims have been given their broadest reasonable interpretation to encompass the teachings of Luo in view of Jenkins.
Claims 1-5, 10, 13-17 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Luo (Luo et al; J. Dairy Sci, volume 100, pages 7883-7890; 2017) in view of Jenkins (Jenkins et al; PeerJ, 2019; DOI 10.7717/peerj.6749; pages 1-25) and Payne (Payne et al; Journal of Applied Bacteriology, vol 72, pages 41-52, 1992).
For this rejection, the claims have been interpreted to require bacteria bound directly to the derivatized surface of magnetic beads in the absence of bridging molecules.
With regard to claim 1, Luo teaches a method of preparing a milk sample containing bacteria for PCR analysis (see abstract, whole document) so as to detect pathogenic bacteria in milk. Luo teaches that a milk sample with bacteria was contacted with uncoated magnetic beads derivatized with streptavidin (SA-MB) (see figure 1, p7884). This teaching is considered to be encompassed by the term “uncoated magnetic beads” in keeping with the express definition in the instant specification at page 5. Luo teaches that the magnetic beads were incubated in the milk sample to allow the SA-MB particles to bind to a biotin/antibody/bacteria complex (see figure 1, page 7885; a biotin-antibody complex allowed the antibody to bind to the bacteria of interest and the biotin allowed the bacteria bound complex to bind to streptavidin resulting in bacteria bound to magnetic beads). Luo teaches that after incubation, the mixture was separated using an external magnetic field using magnets. With regard to claims 1, 5, 10, and 13 Luo teaches that the SA-MB-biotin-mAb-bacteria were directly resuspended in an aqueous solution (sterilized PBS buffer) and that 400uL solutions of the resuspended bacteria were subject to PCR analysis (see page 7885- 7886). Luo teaches that the method was sensitive and low cost, and useful for rapid screening of pathogenic bacteria in milk.
With regard to claims 1, Luo does not teach preparing a milk sample comprising at least one suspected bacterial pathogen implicated in mastitis or detection of that bacteria, however Jenkins teaches that coagulase negative Staphylococcus (CNS) species are the most prevalent intra-mammary pathogens causing subclinical mastitis in lactating dairy cattle (see abstract, whole document). Jenkins teaches culturing and analysis of CNS isolates from milk samples from lactating dairy cows. Jenkins teaches identification of the different CNS species using PCR to sequence the rpoB gene (see pages 2-5). Therefore it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date, to have used the method of Luo to detect CNS species in the milk of lactating dairy cows for the obvious benefit of detecting bacteria that cause mastitis.
With regard to claim 1, Luo and Jenkins do not teach preparing a milk sample comprising at least one suspected bacteria implicated in mastitis which comprises directly binding derivatized uncoated magnetic beads directly to bacteria without any bridging molecules. However Payne teaches the use of immobilized lectins on magnetic beads to bind and separate bacteria from foods, including milk (see whole document). Payne teaches that magnetic beads containing immobilized lectins were able to allow bacteria to absorb to the beads, thus separating the bacteria from cultures and food samples, including milk samples (see pages 42-49). Payne teaches that the method allows for more rapid and sensitive separation of bacteria from food, including milk samples, for further analysis. Therefore, it would have been prima facie obvious to the ordinary artisan prior to the effect filing date to have substituted the magnetic beads derivatized with lectins as taught by Payne, in the method of Luo and Jenkins with a reasonable expectation of success, because Payne teaches that bacteria could be captures and separated from milk samples and that the method allows for rapid and sensitive separation and analysis of bacteria in milk.
With regard to claim 2, Luo teaches heating the resuspended complex to 90°C and using a magnet to separate the magnetic bead from supernatant (see page 7886, col 1).
With regard to claims 3 and 4, Jenkins teaches analysis for CNS bacteria in raw milk from dairy cows with mastitis (see whole document).
With regard to claim 14, Luo necessarily teaches that the bacteria and magnetic beads are mixed prior to incubation (see whole document).
With regard to claim 15, although Luo does not teach incubation for about 5 to about 10 minutes at room temperature, Luo does exemplify the routine nature of optimizing reaction conditions (see whole document). As set forth in the MPEP 2144.05 II A, “Optimization of Ranges”:
Generally, differences in concentration or temperature will not support the patentability of
subject matter encompassed by the prior art unless there is evidence indicating such
concentration or temperature is critical. “[W]here 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) (Claimed process which was performed at a temperature between 40°C
and 80°C and an acid concentration between 25% and 70% was held to be prima facie
obvious over a reference process which differed from the claims only in that the reference
process was performed at a temperature of 100°C and an acid concentration of 10%.)…
Therefore, the claimed conditions are considered obvious in view of the routine nature of optimization in the relevant cited prior art.
With regard to claim 16, Luo teaches preparing the milk samples in a tube (see figure 1).
With regard to claim 17, although Luo does not teach using a magnetic stand to capture the magnetic beads, it would have been prima facie obvious to the ordinary artisan that the use of any suitable magnet, including a magnetic stand, could be used to capture the magnetic beads given the predictable use of magnets.
With regard to claims 22-24, he claimed methods do not require any active steps nor do they indicate the structural requirements of the “template”. Accordingly, the claims have been given their broadest reasonable interpretation to encompass the teachings of Luo in view of Jenkins and Payne.
Claims 1-17 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Luo (Luo et al; J. Dairy Sci, volume 100, pages 7883-7890; 2017) in view of Jenkins (Jenkins et al; PeerJ, 2019; DOI 10.7717/peerj.6749; pages 1-25), or Luo in view of Jenkins and Payne, each further in view of Gopinath (Gopinath et al; The Experiment, vol 4, pages 253-264; 2012).
The teachings of Luo in view of Jenkins, and Luo in view of Jenkins and Payne, are set forth above and incorporated herein. With regard to claims 6-9, 11, and 12, Luo in view of Jenkins [and Payne] to do not teach resuspension into aqueous buffer at a pH between 8 and 9.5, or the particular buffer components set forth in the claims. However Gopinath teaches detecting bacteria that cause mastitis using PCR including the use of buffer comprising 25mM Tris-HCL at pH 8.3. As noted above, the MPEP 2144.05 II A, sets forth “Optimization of Ranges”:
Generally, differences in concentration or temperature will not support the patentability of
subject matter encompassed by the prior art unless there is evidence indicating such
concentration or temperature is critical. “[W]here 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) (Claimed process which was performed at a temperature between 40°C
and 80°C and an acid concentration between 25% and 70% was held to be prima facie
obvious over a reference process which differed from the claims only in that the reference
process was performed at a temperature of 100°C and an acid concentration of 10%.)…
Accordingly, the buffer components, concentrations, and pH are considered routine optimization and obvious over the prior art, absent secondary considerations.
Claims 1-5, 10, 13-17, and 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Luo (Luo et al; J. Dairy Sci, volume 100, pages 7883-7890; 2017) in view of Jenkins (Jenkins et al; PeerJ, 2019; DOI 10.7717/peerj.6749; pages 1-25), or Luo in view of Jenkins and Payne, each further in view of El-Sayed (El-Sayed et al; International Journal of Veterinary Science and Medicine; vol 5, pages 89-97, 2017; cited in the IDS dated 1/24/2024).
The teachings of Luo in view of Jenkins, and Luo in view of Jenkins and Payne, are set forth above and incorporated herein. With regard to claims 20 and 21, Luo in view of Jenkins [and Payne] do not teach analysis of DNA via PCR using real time PCR, however El-Sayed teaches different methods for detecting mastitis causing pathogens, including real time PCR (see whole document, pages 91-92). Therefore, it would have been prima facie obvious to the ordinary artisan prior to the effective filing date to have used real time PCR as taught by El-Sayed, in the method of Luo in view of Jenkins [and Payne] because El-Sayed teaches that real time PCR is faster and more sensitive.
Conclusion
No claims are allowed.
Note on allowable subject matter: The specification at page 5 provides an express definition of the phrase “uncoated magnetic beads”. The prior art of Payne (Payne et al; Journal of Applied Bacteriology, vol 72, pages 41-52, 1992) teaches the use of uncoated magnetic beads derivatized with lectin or streptavidin to bind to bacteria implicated in mastitis. The prior art of Luo (Luo et al; J. Dairy Sci, volume 100, pages 7883-7890; 2017) teaches the use of uncoated magnetic beads derivatized with streptavidin to bind to biotin/antibody/bacteria complexes in milk samples. However, the prior art does not teach or fairly suggest methods that use uncoated magnetic beads comprising silica like surface chemistry to bind to bacteria implicated in mastitis in milk samples. Accordingly, claim 18 is free of the prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to examiner Jehanne Sitton whose telephone number is (571) 272-0752. The examiner can normally be reached Mondays-Fridays from 8:00 AM to 2:00 PM Eastern Time Zone.
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/JEHANNE S SITTON/Primary Examiner, Art Unit 1682
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