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 .
Claims 1, 3, 4, 6, 7, 20, 21 and 27-38 are pending in this application and were examined on their merits.
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 1, 3, 4, 6, 7, 20, 21 and 27-38 remain rejected under 35 U.S.C. § 101
because the claimed invention is directed to the Judicial Exceptions of a Natural
Phenomenon (correlation between differential metabolite presence and certain cell
types and the toxin resistance thereof) and Abstract Ideas (Mental Steps of
identifying/determining the cell type, determining toxin resistance and comparing and
matching metabolites with a reference) without significantly more.
These judicial exceptions are not integrated into a practical application because
the Judicial Exception(s) do not affect a particular treatment or prophylaxis for a disease
or medical condition and at best, merely add append an Abstract Idea
(Identifying/determining) to the aforementioned Natural Phenomenon Judicial
Exception(s).
The claim(s) does/do not include additional elements that are sufficient to amount
to significantly more than the judicial exception because of the following analysis:
Step 1) Is the claim to a process, machine, manufacture of composition of
matter?
Yes, the claims are drawn to a process.
Step 2A, prong 1) Does the claim recite an Abstract Idea, Law of Nature or
Natural Phenomenon?
Yes, as discussed above, Claims 1, 3, 20, 21, 27, 28, 31, 32, 33, 36, 37 and 38
recite a Natural Phenomenon and Abstract Idea(s). That is, the Natural Phenomenon is
the correlation between differential metabolite presence and certain cell types and the
toxin resistance thereof, similar to Mayo, see the MPEP at 2106.04(b), I., iv., and
Abstract Ideas/Mental Steps of identifying/determining the cell type, determining
toxin resistance and comparing and matching metabolites with a reference. Claims 7,
20, 21, 31, 32, 33 and 36-28 are a grouping containing an Abstract Idea ("identifying",
"analyzing", "determining", "comparing").
Step 2A, prong 2) Does the claim recite Additional elements that integrate the
Judicial Exception(s) into a practical application?
No, the steps of incubating a biological sample, such as human blood or urine in
a growth medium containing at least glucose, analyzing the metabolites in the incubated
growth medium by an unspecified/highly generalized chemical analysis, identifying the
cell type and toxin-resistance based in the differential expression of metabolites, and
identifying the cell type based on comparison of the growth media metabolites to
reference/control levels are no more than extra solution data gathering performed to gather data for the mental analysis step of determining the bacteria type in the sample and are necessary precursors for all uses of the recited exception(s). See the MPEP at
2106.05(g), (3). The steps of further analyzing the growth media for another metabolite
biomarker for another bacteria are therefore also extra-solution activity/data gathering
and do not integrate the Judicial Exception(s) into a practical application. Claims 4, 6,
29, 30, 34 and 35 merely define a pretreatment step and the temperature parameter
thereof.
Step 2B) Does the claim recite additional elements that amount to significantly
more than the Judicial Exception(s)?
No, the steps of incubating a sample in a growth medium containing at least
glucose, analyzing the metabolites in the incubated growth medium by chemical
analysis, identifying the cell type based on comparison of the growth media metabolites,
see Palama et al. (2016), cited in the IDS, Pg. 4559, Fig. 1 and Pg. 4560, Fig. 3),
determining toxin-resistance based in the differential expression of metabolites, and
identifying the cell type based on comparison of the growth media metabolites to
reference/control levels, see Hoerr et al. (2016), cited in the IDS, Pgs. 4-5, Figs. 2-3), are no more than what was well-understood, routine and conventional in the art
when appended to the Judicial Exception(s). Claims 4, 6, 29, 30, 34 and 35 and 14
merely define a pretreatment step and the temperature parameter thereof and do not
amount to "significantly more" than the recited Judicial Exceptions.
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 1, 27 and 32 are provisionally rejected on the ground of nonstatutory
double patenting as being unpatentable over claims 1-3 of Application No. 17/615,256, now US 12,503,719 B2, in view of Imanaka et al. (1961), of record.
Instant Claims 1 and 27 are generally drawn to: incubating a human blood or
urine sample in a growth medium containing at least glucose; and after incubation,
analyzing the incubated growth medium by chemical analysis for metabolites including
both succinate and urocanate; identifying/differentiating between the cell type of the cell
as Klebsiella oxytoca and/or Klebsiella pneumoniae when the incubated growth medium
contains levels of both succinate and urocanate above control levels of succinate and
urocanate in the growth medium;
and identifying the cell type of the cell as Escherichia coli when the incubated
growth medium contains a level of succinate above the control level of succinate
observed in the growth medium and a level of urocanate unchanged from the control
level of urocanate in the growth medium.
Instant Claim 32 is drawn to:
A method for identifying Klebsiella oxytoca and/or Klebsiella pneumoniae in a
sample of blood or urine from a human, comprising: incubating the sample in a growth
medium containing at least glucose; after incubation, analyzing the incubated growth
medium by chemical analysis for metabolites including at least succinate and
urocanate; and identifying Klebsiella oxytoca and/or Klebsiella pneumoniae as being in
the sample when the incubated growth medium contains levels of succinate and
urocanate above control levels of succinate and urocanate in the growth medium.
These claims are made obvious by the Claims of the co-pending '256 Application
which are drawn to: A method for identifying a cell type of a cell in a sample,
comprising: culturing the sample in a growth medium comprising niacinamide to obtain
a cultured growth medium; analyzing the cultured growth medium by chemical analysis
to determine a concentration of nicotinate in the cultured growth medium; and
identifying the cell type as at least one of Escherichia, Klebsiella, Pseudomonas,
Enterococcus, Staphylococcus or Streptococcus species when the cultured growth
media contains a higher concentration of nicotinate compared to the growth medium;
wherein the growth medium further comprises carbohydrate and the step of
identifying identifies the cell type as Escherichia or Klebsiella species when the cultured
growth medium contains a higher concentration of succinate compared to the growth
medium and,
wherein the growth medium further comprises carbohydrate and arginine and the
step of identifying identifies the cell type as Klebsiella species when the cultured growth
medium contains a higher concentration of succinate and urocanate compared to the
growth medium.
The '256 application does not specifically teach wherein the method identifies
Klebsiella oxytoca and/or Klebsiella pneumoniae species as being in the sample or
wherein the cell sample is a human blood or urine sample incubated in a growth
medium comprising at least glucose, as required by instant Claims 1, 27 and 32.
Imanaka et al. teaches the incubation of cell samples in growth medium
comprising glucose (Pg. 50, Tables 1-II).
It is inherent in the method of the co-pending '256 application of culturing a
sample in a growth medium comprising carbohydrate/glucose and determining the
presence of Klebsiella in the sample when the cultured growth medium containing a
higher concentration of succinate and urocanate as compared to the growth medium
would identify Klebsiella oxytoca and/or Klebsiella pneumoniae as being in the sample
and wherein the cultured growth medium containing a higher concentration of succinate
and an unchanged level of urocanate as compared to the growth medium the sample
would identify E. coli as being present in the sample because the method of the prior art
performs the same method steps using the same components as claimed. Therefore,
the same results/identification as claimed would be found in the prior art method. Even
if the prior art does not specifically "identify" the claimed species, this is a mental step
on the part of the practitioner in interpreting the results of the assay.
It would have been further obvious to those of ordinary skill in the art to modify
the method of the co-pending '256 application of culturing the sample in a growth
medium comprising niacinamide to utilize a human blood or urine sample as the cell
sample because the '256 application is not limited to any particular source of cell
sample and those of ordinary skill would have found it further obvious to obtain a
cultured growth medium including glucose as the carbohydrate in the growth medium
because the '256 application teaches that any carbohydrate may be used in the growth
medium and Imanaka et al. teaches a specific carbohydrate (glucose) which is suitable
for a cell growth medium.
Those of ordinary skill in the art would have been motivated to make these
modifications in order to screen the cell sample for the presence of a particular bacteria
and insure the cell growth medium contains suitable energy sources for metabolism
which is the basis for determination of the bacteria type in the sample. There would
have been a reasonable expectation of success in making this modification because
both the '256 application and Imanaka reference are drawn to the same field of
endeavor of identifying differential metabolism of different cell types.
This is a provisional nonstatutory double patenting rejection because the
patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 03/02/2026 have been fully considered but they are not persuasive.
The Applicant argues that the claimed invention integrates the Judicial Exceptions into a practical application that amounts to significantly more than the Judicial Exception. Applicant notes that samples (human blood or urine) are removed from the body and grown in a man-made medium for analysis in vitro. Applicant asserts that this involves human manipulation(s), such as the incubation step.
Applicant opines that the technology does not evidence the differential diagnosis of pathogens without these manipulations and while the bacteria can survive in a patient long-term, the limited growth media in the in vitro culture allows the practitioner to make the differential diagnosis (Remarks, Pg. 1, Lines 8-16).
This is not found to be persuasive for the following reasons, the Examiner maintains that the claims do not integrate the Judicial Exceptions into a practical application that amounts to significantly more than the Judicial Exception for reasons of record set forth above and in the prior action. The fact that the bacteria are isolated
and grown/incubated in a man-made medium does not make the process (Judicial Exception/Natural Phenomenon of the differential production of metabolites by
different bacterial species) any less naturally occurring. Further as discussed above, the steps of incubating a sample in a growth medium containing at least glucose, analyzing the metabolites in the incubated growth medium by chemical analysis, identifying the cell type based on comparison of the growth media metabolites, see Palama et al. (2016), cited in the IDS, Pg. 4559, Fig. 1 and Pg. 4560, Fig. 3), are no more than what was well-understood, routine and conventional in the art when appended to the Judicial Exception(s). The interpretation of the data produced by the Natural Phenomenon to "identify" the bacterial species is another Judicial Exception (Mental Step/Abstract Idea on the part of the practitioner and mere extra-solution data gathering).
The Applicant argues that the metabolite urocanate is not naturally circulating in blood or urine even in the presence of Klebsiella bacteria and even when the metabolite succinate is present in blood, it cannot be used to differentiate between pathogens without the human manipulation of in vitro incubation and mental analysis (Remarks, Pg. 1, Lines 17-21).
This is not found to be persuasive for the following reasons, that fact that urocanate is not naturally circulating in blood or urine is immaterial to a finding of non-patent eligibility which is based on the fact that certain bacteria naturally metabolize different substrates to produce different metabolites. As discussed above, the fact that the bacteria are isolated and grown/incubated in a man-made medium does not make the process (Judicial Exception/Natural Phenomenon of the differential production of metabolites by different bacterial species) any less naturally occurring. The interpretation of the data produced by the Natural Phenomenon to "identify" the bacterial species is another Judicial Exception (Mental Step/Abstract Idea on the part of the practitioner and mere extra-solution data gathering) as well as equating to “applying” the Natural Phenomenon.
Applicant references In re Desjardins, which cautions against overbroad rejections under 35 U.S.C § 101 (Remarks, Pg. 1, Lines 22-28).
This is not found to be persuasive for the following reasons, the Examiner notes that Applicant has not provided any explanation as to why the fact pattern in Desjardins is related to the current application and rejection under 35 U.S.C § 101 and further that the decision has not been referenced in the MPEP.
The Applicant argues that the claimed invention reflects an improvement in the technology or technical field, noting that the disclosure examples allows earlier detection of pathogens as compared to conventional methods (Remarks, Pg. 2, Lines 1-20).
This is not found to be persuasive for the following reasons, in this instance the non-claimed “improvement” of a “faster” diagnosis of pathogen based on the analysis of in vitro bacterial production of certain metabolites, is itself based solely on the Judicial Exception. That is, certain bacteria will naturally produce the claimed metabolites for analysis during a certain period of time. If this period of time happens to be faster than conventional methods of bacterial pathogen analysis in allowing the interpretation of the data produced by the Natural Phenomenon to "identify" the bacterial species, the improvement is entirely based on the Judicial Exception, is not patent eligible and does not reflect an improvement to the existing technology or technical field. See the MPEP at 2106.05(a). Further, as discussed above, such a “diagnosis” based on the differential bacterial production of metabolites would be another Judicial Exception (Mental Step/Abstract Idea on the part of the practitioner and mere extra-solution data gathering).
Applicant requests the obviousness double patenting rejection be held in abeyance until a finding of allowable subject matter (Remarks, Pg. 2, Lines 28-31 and Pg. 3, Lines 1-2).
This is not found to be persuasive for the following reasons, the rejection is maintained for reasons of record set forth above and in the prior action.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm EST.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Sharmila G Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL C MARTIN/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653