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 .
DETAILED ACTION
Claims 1 and 3-20 are pending.
Response to Amendment
Applicant amended claim 1 and replaced the limitation “aging” with “incubating”, added new method step (c), and added the limitations of now canceled claim 2.
Applicant canceled claim 2 and amended claims 3-4, 6-15, 17-18, and 20.
The objection to claims 1, 6-9, 13-15, and 17-18 is withdrawn in view of the amendment.
The rejection of claims 1, 5-7, and 9 under 35 U.S.C. 102(a)(1) is withdrawn in view of the amendment.
The rejection of claims 1-20 on the ground of nonstatutory double patenting is withdrawn in view of the filed Terminal Disclaimer.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d).
Amended claim 1 recites the limitation “aptamer”. Claims 6 and 9 recite the limitations lipid II, trehalose, fucose. Claims 11 and 12 recite the limitations surface-enhanced Raman spectroscopy (SERS) and electrochemical. Claim 15 recites the limitation electrochemical. Claim 18 recites magnetic chain structures, Magchain, magnetic particles having a polydopamine coating.
Foreign application SG10202114470Q filed on 12/29/2021 does not disclose these limitations. However, these limitations are disclosed in the Application PCT/SG2022/050942 filed on 12/29/2022., Accordingly, claims 1 and 3-20 are not entitled to the benefit of the prior application SG10202114470Q, and will be examined as having an effective filing date of 12/29/2022.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 07/09/2026 is acknowledged and has been considered.
New Rejections Necessitated by the amendment
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 13-19 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 13 recites “(i) step (d) comprises placing a portion of the antibiotic challenged bacterial mixture into a well” and “(ii) step (e) comprising providing a stimulus to the captured sample and detecting a signal in response to the stimulus”. Claim 13 is not a proper dependent claim because it fails to include all the limitations of claim 1 from which it depends. Claim 1 does not require the presence of a well, a stimulus, nor a signal. Applicant may consider amending the claim to recite ““(i) step (d) further comprises” and “(ii) step (e) further comprising” to obviate the rejection.
Claim 14 recites “(i) step (d) comprises contacting … with an antibody specific towards the bacterial species” and “(ii) step (e) comprises (ei) contacting the bacteria-antibody conjugate mixture with a labelled protein.. and (eii) providing one or more stimuli”. Claim 14 is not a proper dependent claim because it fails to include all the limitations of claim 1 from which it depends. Claim 1 does not require the presence of an antibody specific towards the bacterial species, a labelled protein, nor a stimulus.
Claim 15 recites “the metabolic precursor comprises a protein binding moiety”, “step (d) comprises placing a portion of the bacterial fragment mixture into a well comprising an antibody specific towards the bacterial species”, “(ei) providing a protein.. conjugated to an enzyme”, and “(eii) providing a suitable substrate”. Claim 15 is not a proper dependent claim because it fails to include all the limitations of claim 1 from which it depends. Claim 1 does not require the presence of a well, an antibody specific towards the bacterial species, a protein conjugated to an enzyme, nor a substrate.
Claim 17 recites “step (d) comprises providing a strip cassette..” and “step (e) comprises adding the bacterial fragment mixture to the sample well, where the bacterial fragment mixture mixes with the protein conjugated to a coloured microsphere or a metal nanoparticle..”. Claim 17 is not a proper dependent claim because it fails to include all the limitations of claim 1 from which it depends. Claim 1 does not require the presence of a strip cassette.
Claim 18 recites “step (d) comprises adding a plurality of magnetic chain structures”, “(ei) introducing the Magchain bound bacterial fragment mixture into a sample well of a microfluidic device and supplying a surface enhanced Raman spectroscopy probe”, “(eii) manipulating the magnetic chain-bacterial fragment-SERS probe sandwich” and (eiii) seeking to detect a Raman spectroscopic signal”. Claim 18 is not a proper dependent claim because it fails to include all the limitations of claim 1 from which it depends. Claim 1 does not require the presence of a magnetic chain structure, a well of a microfluidic device, nor SERS probe or signal.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Maintained Rejections
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.
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.
Claim 1 and 3-12 remain 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 1 requires mixing and incubating antibiotic resistant bacteria, antibiotic, metabolic precursor, and a nutrient, breaking up the cells into fragments, binding an antibody, and detecting the presence or absence of the resistant bacteria. The claim is indefinite because it is not clear how the last two steps are linked in order to lead to the detection of the bacterium. Applicant may consider amending the claim to clarify how the binding of the antibody can lead to the detection of the presence or absence of the resistant bacterium.
Claim 1 recites in step (d) binding an antibody and/or an aptamer to a resistant bacterium, if present, in the antibiotic-challenged bacterial mixture and (e) detecting the presence or absence of the resistant bacterium. The claim is indefinite because the claim requires breaking up the cells to form fragments prior to steps (d) and (e). It is understood from step (c) that the cells were broken up, so no bacteria cell is present to be detected.
Claim 3 recites “separation of the resistant bacterium from the from the antibiotic-challenged bacterial mixture”. The claim is indefinite because claim 1 requires lysing of the cells into fragments, so no cells are present.
Claim 4 recites “a step of increasing a concentration of the resistant bacterium, if present, before conducting a detection step”. The claim is indefinite because claim 1 requires lysing of the cells into fragments, so no cells are present.
Claim 12 recites “the method according the claim 1, wherein in the method comprising the steps of (a) to (e) is a metabolic and immune co-labelling fluorescent assay, a microarray assay, an enzyme-linked immunosorbent assay (ELISA), a lateral flow assay, a chemiluminescence assay, an electrochemical assay, and a surface-enhanced Raman spectroscopy (SERS)-dependent microfluidic assay”. The claim is indefinite because it is unclear if the recited assays add a further step to the method. Claim 1 does not require the presence of fluorescence, lateral-flow assay setup, spectroscopy, or microarray.
Claim 13 recites “placing a portion of the antibiotic-challenged bacterial mixture”. The claim is indefinite because claim 1 requires that the antibiotic-challenged bacterial mixture be lysed to from bacterial fragment mixture. It is not clear what the antibiotic-challenged bacterial mixture refers to.
Claims 5-11 and 14-20 do not cure the indefiniteness and are also rejected.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-12, 14, and 20 remain rejected under 35 U.S.C. 102(a)(2) as being anticipated by Melzer (US 2025/0002970, effective filing date 09/3/2021).
Regarding claims 1, 5-10, and 20, Melzer teaches a method to detect antibiotic resistant strains of bacteria in a subject comprising: a) contacting a sample from a subject suffering from a bacterial infection with an antibiotic; and b) determining the effect, if any, of the antibiotic on incorporation of a single- or di-D-amino acid into peptidoglycan of the bacterial cell or trehalose incorporation into the bacterial cell envelope, wherein the bacteria are resistant to said antibiotic if said bacteria continue to grow and incorporate the D-amino acid into peptidoglycan of the bacterial cell or trehalose incorporation into the bacterial cell envelope (claim 3, FIG. 1). Melzer teaches that the cells can be detected using ELISA assay and that the cells can be lysed ([0061]-[0062]). Melzer teaches Mycobacterium smegmatis was transformed or not with a plasmid bearing a resistance cassette for either kanamycin (kanR) or hygromycin (hygR), were incubated+/- drug for 2.5 doublings (7.5 hours) (i.e., aging the bacterial mixture for a period of time), then labeled for 30 min with a cell surface probe followed by ligation to a fluorophore ([0015]). Melzer teaches that the bacteria were grown in nutrient medium and antibiotic was added, and teaches that the growing bacteria were labeled with biotin D-lysine for 20 or 30 min ([0091]-[0092]). Bacteria were then pelleted by centrifugation and washed in cold PBS (i.e., collecting the bacterial population and resuspending it to provide an antibiotic challenged bacterial mixture) ([0092]). Melzer teaches adding detectable moiety suitable to conjugate to the metabolic precursor to the antibiotic-challenged bacterial mixture (FIG. 1). Melzer teaches the D-amino acid may be conjugated to a detectable label with click chemistry ([0056]). Melzer teaches the detectable label can be fluorescent dye, labeled antibody, biotin or enzyme ([0058], [0125]). Melzer teaches the D-amino acids can have groups functional groups such as azide, alkyne, trans-cyclooctene, tetrazine and tetrazole ([0052]). Melzer teaches capturing metabolically labeled bacteria with an antibody; and detecting said antibody (claim 18). Since Melzer teaches that the resistant bacteria is metabolically labeled by incorporating the probe in cell wall, and teaches that the bacteria is captured by an antibody, then detecting the antibody would also detect the bacteria bound to it (i.e., detecting the presence or absence of the resistant bacterium).
Regarding claim 3, the limitation “wherein the binding of the antibody and/or the aptamer allows for the separation of the resistant bacterium, if present, from the antibiotic-challenged bacterial mixture” is the result of the active step of binding an antibody. A wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. See MPEP 2111.04.
Regarding claim 4, Melzer teaches performing a later flow assay after labeling the bacteria by placing the labeled bacteria on sample pad which contains antibodies that are specific to the target analyte (i.e. binding an antibody) and the sample, together with the conjugated antibody bound to the target analyte, migrates along the strip into the detection zone with specific antibodies immobilized in lines ([0064]). The metabolically labeled bacteria (resistant bacteria) will be captured on that line while the unlabeled cells will not (i.e. concentrated on the line) (FIG. 5-7). Furthermore, Melzer teaches that the labeled cells were added to ELISA well to be captured and then the wells were washed ([0094]) and teaches that ELISA enriches the conjugated reporter for greater signal detection. It is understood that the washing removes unlabeled bacteria thus increasing the concentration of the resistant bacteria in the well.
Regarding claims 11-12, Melzer teaches detecting the resistant bacteria using ELISA with HRP (chemiluminescence assay) ([0062]), lateral flow assay (colorimetric) (FIGs 5-7), and fluorescence ([0060]).
Regarding claim 14, Melzer teaches using LFA to detect the bacteria suspected to be resistant, and teaches that in the LFA, the bacteria are placed on sample pad which contains antibodies that are specific to the target analyte and are conjugated to colored or fluorescent particles and teaches antibodies and enzymes can be used as recognition elements ([0064], [0066]).
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.
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.
Claims 1, 3-12, and 20 remain rejected under 35 U.S.C. 103 as being unpatentable over Gao (Advanced Healthcare Materials 11.6 (2022): 2101736, published online 12/24/2021) in view of Bertozzi (US 10,016,498 B2, published 07/10/2018).
Regarding claims 1, 5-7, and 9-10, Gao teaches a method for detecting antibiotic susceptibly of a bacterial sample by mixing bacteria from a sample with antibiotics, Cyanine5-amino-d-alanine probe (i.e., fluorescent D-amino acid metabolic precursor), and CAMHB medium (i.e., nutrient suspension), incubating for 6h, collecting and resuspending in PBS (page 9 “AST of BALF Samples by Standard BMD and FaAST Methods”, “confocal fluorescence microscopy”, Title, Figure 1, ). Gao teaches the sample comprised bacteria suspected to be resistant to one or more antibiotics (page 7 left column last para.). Gao teaches the fluorescent D-amino acid metabolic precursor is incorporated in the cell wall of the bacteria (Figure 1). Gao does not teach breaking up the bacteria and does not teach the binding an antibody and/or an aptamer nor detecting the presence or absence of the resistant bacterium.
However, Bertozzi teaches modifying the peptidoglycan of the bacterial cell wall by incubating the cells with D-amino acid derivatives (Example 2) and teaches that test agents that inhibit incorporation of a modified D-amino acid into the PG of a bacterial cell are considered candidate anti-microbial agents (column 36 lines 44-47).
Bertozzi teaches labelling the precursor following incubation with bacteria and purifying the labeled peptidoglycan (PG) from the cells for further analysis (column 49 lines 49-52). It is understood that the cells were lysed in order to purify the PG (column 48 lines 1-19). Bertozzi teaches that the D-amino acids can be detected by fluorescence, biotin, or by binding of a detectably labeled antibody or by detection of bound antibody through a sandwich-type assay (column 34 lines 5-15).
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 modify Gao’s method by lysing the bacteria and binding the lysate comprising the D-amino acids to an antibody and detecting the antibody, thus detecting the presence of resistant bacteria, as suggested by Bertozzi. One of ordinary skill in the art would be motivated to do so in order to detect the presence of resistant bacteria. Since Gao and Bertozzi teach a desire to incorporate D-amino acids into cell wall of bacteria and detecting them, there is a reasonable expectation of success.
Regarding claim 3, the limitation “wherein the binding of the antibody and/or the aptamer allows for the separation of the resistant bacterium, if present, from the antibiotic-challenged bacterial mixture” is the result of the active step of binding an antibody. A wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. See MPEP 2111.04.
Regarding claim 4, Gao teaches that the bacteria were enriched by centrifugation of the sample (page 9 “AST of BALF Samples by Standard BMD and FaAST Methods”). Gao teaches that the bacterial cultures were washed twice and resuspended in 10 µl PBS following the labeling and prior to detection by microscopy, which implies centrifugation and resuspension in small volume (page 9 “confocal fluorescence microscopy”).
Regarding claim 8, Bertozzi teaches that the D-amino acid includes a bioorthogonal functional group such as an azide, an alkyne, tetrazine, trans-cyclooctene, dithiol (column 36 lines 21-23, column 49 lines 51-52, column 12 line 30, column 6 line 51).
Regarding claim 11, Gao teaches detecting the presence of resistant bacteria using fluorescence (Figure 2).
Regarding claim 12, Bertozzi teaches that the D-amino acids can be detected via labeled quantum dots (i.e., electrochemical assay).
Regarding claim 20, Bertozzi teaches that D-amino acid is incubated and labeled with tetrazine-fluorescein (column 49 lines 50-2) (i.e., the click handle on the detectable moiety tetrazine)
Claims 13-15 and 19 remain rejected under 35 U.S.C. 103 as being unpatentable over Gao and Bertozzi as applied to claim 2 above, and further in view of Yoon (BioChip Journal 7.4 (2013): 344-352) and Verma (Analyzing microbes: Manual of molecular biology techniques. Berlin, Heidelberg: Springer Berlin Heidelberg, 2012. 169-186).
Regarding claims 13-15 and 19, Gao teaches placing the cells under microscope as well as in a flow cytometer which uses laser as stimulus and teaches detecting a signal in response to the stimulus (Figures 1-2). Gao teaches the bacteria were identified (page 7 left column first para.). Bertozzi teaches that the D-amino acids are labeled and can be detected by antibody binding through sandwich-type assay (column 34 lines 13-15). Bertozzi teaches that the detectable label is biotin (claim 13). Gao and Bertozzi do not teach an antibody specific towards the bacterial species.
However, Yoon teaches using anti-S. aureus IgG to capture and detect S. aureus on a surface (Figure 1). Yoon teaches capturing whole cells of S. aureus as well as fragments of the bacteria (Abstract).
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 further modify the method taught by Gao by capturing the bacteria using species specific IgGs as suggested by Yoon. One of ordinary skill in the art would be motivated to do so in order to identify the species of the antibiotic-resistant bacteria. Since Gao teaches a desire to test antibiotic susceptibility as well as identifying the bacteria, there is a reasonable expectation of success.
Gao, Bertozzi, and Yoon do not teach placing the bacteria in a well comprising the species-specific antibody.
However, Verma teaches that ELISA is used to identify bacteria and teaches using wells coated with bacteria specific antibodies (page 170 second para., Fig. 13.3). Verma teaches contacting the bacteria-antibody conjugate with an antibody labeled with enzyme such as horseradish peroxidase, adding a substrate and detecting a colorimetric signal (i.e. second detectable moiety) (Figure 13.3, para. 13.4.5).
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 further modify the method taught by Gao by capturing the bacteria in a well as suggested by Verma. One of ordinary skill in the art would be motivated to do so in order to localize the detection in a defined area.
Claim 16 remains rejected under 35 U.S.C. 103 as being unpatentable over Gao, Bertozzi, Yoon, and Verma as applied to claim 15 above, and further in view of Ge (AMB Express 7.1 (2017): 177).
Gao, Bertozzi, Yoon, and Verma do not teach the protein suitable to bind to the protein binding moiety is streptavidin conjugated to horse radish peroxidase.
However, Ge teaches an ELISA test and teaches using HRP-labeled streptavidin to detect an antigen.
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 further modify the method taught by Gao by using HRP-labeled streptavidin to detect the bacteria resistant to the antibiotic. One of ordinary skill in the art would be motivated to do so in order to detect the captured bacteria or fragment of the bacteria using colorimetric detection. Since Bertozzi teaches the D-amino acid can be labeled with biotin, one of ordinary skill in the art would be motivated to use a HRP-labeled streptavidin in order to bind the streptavidin to the biotin and thus detect the D-amino acids that is incorporated in the cell wall of the resistant bacteria.
Claim 17 remains rejected under 35 U.S.C. 103 as being unpatentable over Gao and Bertozzi as applied to claim 2 above, and further in view of Yoon (BioChip Journal 7.4 (2013): 344-352) and Sohrabi (Talanta 243 (2022): 123330).
The teachings of Yoon are discussed above and applied herein.
Regarding claim 17, Gao, Bertozzi, and Yoon do not teach providing a strip cassette.
However, Sohrabi teaches detection of bacteria using lateral flow assay (LFA), and teaches that the assay comprises a strip cassette comprising a sample well with sample pad and conjugate pad, a strip membrane with detection line and control line (Scheme 1). Sohrabi teaches that the control line comprises antibody that captures protein conjugated to beads (scheme 1) and teaches that the beads can be latex (i.e. colored microspheres) or gold nanoparticles (i.e., metal nanoparticle) (page 3 left column last para.). Sohrabi teaches that the detection line or test line comprises an antibody specific towards the bacteria (scheme 1). Sohrabi teaches adding a sample comprising the bacteria to the sample well and teaches visually detecting control line and test line (scheme 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 further modify the method taught by Gao by detecting the bacteria or fragment thereof using a lateral flow assay as suggested by Sohrabi. One of ordinary skill in the art would be motivated to do so in order to identify the bacteria using a rapid and sensitive point-of-care test.
Claim 18 remains rejected under 35 U.S.C. 103 as being unpatentable over Gao and Bertozzi as applied to claim 2 above, and further in view of Yoon (BioChip Journal 7.4 (2013): 344-352), Xiong (Nature communications 9.1 (2018): 1743), and Mishra (Journal of Applied Physics 125.16 (2019)).
The teachings of Yoon are discussed above and applied herein.
Regarding claim 18, Gao, Bertozzi, and Yoon do not teach steps (ei)-(eiii).
However, Xiong teaches a method to detect bacteria using magnetic nanochain and microfluidic biochips (Abstract, Fig. 5). Xiong teaches that bacteria bound to magchain comprising polydopamine and antibodies capturing the bacteria are added into a microfluidic device with SERS probe where the bacteria are recognized by the antibodies on the Magchains and the SERS probes to form sandwich immune complexes (Fig. 1). Xiong teaches the mixture is concentrated in a detection chamber (i.e. detection well) and teaches the microfluidic chip has a washing inlet (, Fig. 1 a, Supplementary Figure 1). Xiong teaches detecting a Raman spectroscopic signal (Fig. 1 d and f). Xiong does not teach SERS probe is bound to streptavidin.
However, Mishra teaches that attaching streptavidin to magnetic nanocomposites can act as a substrate for SERS and enhance SERS signal.
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 further modify the method taught by Gao by mixing the bacterial sample with magchain comprising polydopamine and antibodies and SERS probe bound to streptavidin and detecting the presence of the bacteria using a microfluidic device and SERS signal as suggested by Xiong and Mishra. One of ordinary skill in the art would be motivated to do so in order to increase the SERS signal and effectively detect the presence of the resistant bacteria.
Response to Arguments
Applicant's arguments filed 7/20/2026 have been fully considered but they are not persuasive.
Applicant argues that Melzer and Gao do not teach or suggest breaking up the bacteria in the bacterial mixture with a suitable material to provide a bacterial fragment mixture.
In response to the argument, Melzer teaches that the cells can be detected using ELISA assay and that the cells can be lysed ([0061]-[0062]). Bertozzi teaches incubating the bacteria with modified D-amino acid alkDala then purifying the labeled peptidoglycan (PG) from the cells for analysis. It is understood that the cells were lysed in order to purify the PG and detect the presence of alkDala (column 48 lines 1-19).
Applicant argues that the objective of Gao is to provide a rapid and accurate method for providing MICs and that modifying the method of Gao to include additional steps of immune labelling would be considered counterintuitive since adding such additional steps would result in additional experimental time. Applicant argues that combining Gao and Bertozzi requires the unallowable use of hindsight.
In response to the argument, Gao and Bertozzi teach a method to incorporate D-amino acids into cell wall of bacteria and detect them. Gao’s method for rapid detection of MIC does not exclude the use of additional assays to detect the incorporation of the D-amino acids. Bertozzi teaches incorporating D-amino acids into cell wall of bacteria and teaches methods of detecting this incorporation. One of ordinary skill in the art would be motivated to combine the teachings of Gao and Bertozzi in order to detect the incorporation and thus the susceptibility of the microorganism to the antibiotic while improving the sensitivity and lower the limit of detection of the method. In response to applicant's argument regarding improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY A CRUM whose telephone number is (571)272-1661. The examiner can normally be reached M-F 8:00-5:00 CT with alternate Fridays off.
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/MARY A CRUM/ Examiner, Art Unit 1657
/THANE UNDERDAHL/ Primary Examiner, Art Unit 1699
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