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 .
Status of the claims
The Preliminary Amendment filed 05/08/24 is acknowledged and has been entered. Claims 4-5, 7-9, 12 and 14 have been amended. Currently, claims 1-14 are pending and under examination.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Abstract
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The instant abstract utilized implied phrases see “The present invention relates to”. This language should be avoided.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas and/or to laws of nature/natural phenomena without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to § 101 (see the MPEP at 2106). Regarding the MPEP at 2106, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
See MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
The claims are directed to a naturally occurring correlation between the levels of PSP/reg in a subject in need of or adjustment of antibiotic treatment.
Step 2A, Prong 2
The additional elements of determining the level of PSP/reg in samples from the subject and comparing to a threshold does not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
Also, with respect to the recitation wherein a level of PSP/reg above the predetermined threshold is an indication that the antibiotic administration is to be initiated or is to be modified; wherein a level of PSP/reg below to predetermined threshold is an indication that the antibiotic administration is to be withheld or is to be stopped”. The “wherein” statement at best articulates the judicial exception, amounting only to a general instruction to apply or use the judicial exception. This could read on mental activity being performed solely in a practitioner’ head, e.g. A mental appreciation of the four detected biomarkers being correlated with a population of subjects. No active method steps are invoked or clearly required; the “identifying” statements do not include any activity that would constitute a practical application, i.e. steps that apply, rely on or use the natural principle in a manner such that the claims amount to significantly more that the natural principal itself.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
Further, the additional elements of the claims are recited with a high level of generality and do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. (the active method steps/limitations recited in addition to the judicial exceptions themselves) and do not add significantly more to the judicial exception(s).
As shown by the art below it is well known routine and conventional in the art determine the level of PSP/reg in a subject and compare it to that of a threshold.
It does not appear to be the case that the active steps recited, which are performed in order to gather the data or perform the assay, are steps recited or performed in an unconventional or non-routine way, such to provide an inventive concept under step 2B.
The claimed limitations as currently presented fail to recite limitations that add a feature that is more than well understood, conventional or routine in the field of diagnostics and biochemical assay methodologies.
For all of these reasons, the claims fail to include additional elements that are sufficient to either integrate the judicial exception(s) into practical application(s) thereof, or amount to significantly more than the judicial exception(s).
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.
Claims 1-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, line 4 is indefinite in reciting “determining a first level of pancreatic..” because the term “determining” appears to intend a mental step; hence, it is unclear if applicant actually intends a positive active method step in the claim. It is suggested but not required to delete the term “determining” and replace it with --detecting--.
Claim 2, line 2 is indefinite in reciting “determining a second level of PSP/reg” because the term “determining” appears to intend a mental step; hence, it is unclear if applicant actually intends a positive active method step in the claim. It is suggested but not required to delete the term “determining” and replace it with --detecting--.
Claim 2 is vague and indefinite in reciting “after a period of time” because it is unclear if the second sample is obtained after a period or time, if the level is determined after a period of time wherein the first and second sample were obtained after each immediately after each other, on the same day or if the applicant intends something else. Applicant is reminded that although the claims are read in light of the specification limitations from the specification are not read into the claims.
Claim 5 is indefinite in reciting “and/or the second level” because claim 1 from which claim 5 depends does not recite a second level. Thus, there is insufficient antecedent basis for the second level. See also deficiencies found in claims 6-7.
Claim 7, lines 2-3 is indefinite in reciting improper Markush language in reciting, “by at least one from” because it appears to intend to limit the scope of the assay but improperly defines it as such. Perhaps, Applicant intends “at least one selected from the group consisting of”.
Claim 10 the recitation “low probability” is vague and indefinite because the specification fails to provide a specific definition for the term and it is unclear what is considered to be a low probability. Therefore, the metes and bounds of the claim cannot be ascertained and thus it is unclear what Applicant intends to encompass. Further, without a specific definition provided in the specification the term “low” is a relative term which renders the claim indefinite. The term "low" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 11 the recitation “high probability” is vague and indefinite because the specification fails to provide a specific definition for the term and it is unclear what is considered to be a low probability. Therefore, the metes and bounds of the claim cannot be ascertained and thus it is unclear what Applicant intends to encompass. Further, without a specific definition provided in the specification the term “high” is a relative term which renders the claim indefinite. The term "high" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 12, line 3 is indefinite in reciting “determining a corporal temperature.” because the term “determining” appears to intend a mental step; hence, it is unclear if applicant actually intends a positive active method step in the claim. It is suggested but not required to delete the term “determining” and replace it with --measuring--.
Claim 14, lines 2-4 is indefinite in reciting improper Markush language in reciting, “at least one from” because it appears to intend to limit the scope of the sample but improperly defines it as such. Perhaps, Applicant intends “at least one selected from the group consisting of”.
Claim Rejections - 35 USC § 102
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 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 1, 5, 7-9 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stolz et al (US 2013/0079296).
Stolz et al discloses a method comprising detecting the level of PSP/reg in a serum sample from a patient and comparing the level to that of a predetermined threshold wherein a level of PSP/reg above the predetermined threshold indicates the need for intensive treatment including costly antibiotic treatment (e.g. para’s0024-0033, 0049). Stolz et al discloses that the level of PSP/reg can be determined by ELISA (e.g. para 0049). Stolz et al discloses that the threshold level can be 200 ng/ml (e.g. para 0031). Stolz et al discloses the subject can be treated with the antibiotic (e.g. para’s 0052, 0065, page 8, claim 1).
Claims 1, 5, 7-9 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Halangk et al (US 2013/0165345).
Halangk et al discloses a method of determining infection and the need for an antibiotic in a human patient. Halangk et al discloses the method comprises detecting the level of PSP/reg in the patient and comparing the level to that of a predetermined threshold wherein a higher level is indicative of antibiotic treatment (e.g. abstract, para 0066) and treating the subject (e.g. para’s 0066, 0069-70). Halangk et al discloses the level of PSP/reg can be determined by ELISA (e.g. para 0066). Halangk et al discloses that the predetermined threshold can be 200 ng/ml (e.g. para’s 0066, 0068).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Stolz et al or Halangk et al in view of Oved et al (US 2019/0011456).
See above for the teachings of Stolz et al and Halangk et al.
Stolz et al and Halangk et al differ from the instant invention in failing teach determining a second level of PSP/reg and comparing to the first level to indicate modification or stoppage of the antibiotic.
Oved et al teaches that it is known and conventional in the art to monitor the effectiveness of an antibiotic in a patient by obtaining a first sample prior to treatment and a second sample after the antibiotic treatment has been given (e.g. abstract, para’s 0035-0036). Oved et al also discloses the method can be for modifying therapy or treatment based on the biomarker (e.g. para 0108).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate the monitoring of the effectiveness of the treatment in the methods of Stolz et al or Halangk et al by including obtaining a second sample from the subject after treatment has been given and comparing the level in the second sample to that of the first sample to determine a change in the level to provide for modifying the treatment because Oved et al shows that it is known and conventional in the art and specifically teaches that this provides for determining if a therapy needs to be modified and one of ordinary skill in the art would recognize that when the level of the biomarker is increased in the second sample in the modified methods of Stolz et al and Halangk et al that the antibiotic is not working and would need to be modified (i.e. increased or change antibiotics) in order to effectively treat the subject. Further, one of ordinary skill in the art would recognize that a decreased level of the biomarker would indicate the antibiotic is working and that the antibiotic is to be stopped. Therefore, one of ordinary skill in the art would have a reasonable expectation of success incorporating the monitoring of the effectiveness of treatment such as taught by Oved et al into the methods of Stolz et al and Halangk et al.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Stolz et al or Halangk et al in view of Oved et al as applied to claims 1-2, 5, 7-9 and 14 above and further in view of Wilson (US 2020/0300864).
See above for the teachings of Stolz et al., Halangk et al. and Oved et al.
Stolz et al., Halangk et al and Oved et al differ from the instant invention in failing teach the period of time is 1 day.
Wilson teaches that a second sample can be obtained from a subject after receiving antibiotic and that the second sample can be obtained 12-36 hours and/or3-5 days after initiating antibiotic treatment (e.g. para’s 0263-268, 0271).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate obtaining the second sample at 24 hours (1 day) such as taught by Wilson into the modified methods of Stolz et al or Halangk et al because Wilson shows that it is known and conventional in the art. Further, the optimum time for obtaining and/or testing the second sample can be determined by routine experimentation and thus would have been obvious to one of ordinary skill in the art. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation.” Application of Aller, 220 F.2d 454,456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation .” Id. At 458,105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Application of Boesch, 617 F.2d 272,276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Therefore, one of ordinary skill in the art would have a reasonable expectation of success incorporating obtaining the second sample at 24 hours (1 day) such as taught by Wilson into the modified methods of Stolz et al or Halangk et al.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Stolz et al or Halangk et al in view of Oved et al as applied to claims 1-2, 5, 7-9 and 14 above and further in view of Blankenberg et al (US 2006/0105419).
See above for the teachings of Stolz et al and Halangk et al.
Stolz et al and Halangk et al differ from the instant invention in failing to explicitly teach an increase cutoff or 50 ng/ml and a decrease cutoff of 50 ng/ml.
However, it was recognized in the prior art that the sensitivity and specificity is a measure of the accuracy of a test, reflecting the number (if any) of false positives and false negatives. Furthermore, sensitivity and specificity may be adjusted by adjusting the value of a threshold or cutoff value, above which (or below which, depending on how a marker changes with the disease/condition) the test is considered to be indicative of one state or condition (e.g., diseased/condition) and below which the test is considered to be indicative of another state or condition (e.g., non-diseased). See Blankenberg et al at [0007], [0028], [0084]. Accuracy need not be 100%; however Blankenberg et al indicates that particularly preferred would be where both the sensitivity and specificity are at least about 75%, more preferably at least about 80%, even more preferably at least about 85%, still more preferably at least about 90%, and most preferably at least about 95% [0028].
The teachings of Blankenberg et al indicate that the sensitivity and selectivity of a diagnostic test was known to be a result-effective variable, impacting the number of individuals who are correctly diagnosed with disease/condition. Furthermore, the teachings of Blankenberg et al indicate that it was known in the prior art to optimize tests for desired levels of sensitivity and specificity, by selecting appropriate threshold or cutoff values. Finally, Blankenberg et al clearly expresses that tests where both the sensitivity and specificity are at least about 80% would be viewed as particularly preferred.
Therefore, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate comparison of the levels and to arrive at the claimed invention by optimizing cutoff levels in order to achieve a desired sensitivity and specificity, given that such percentages were recognized in the art to be particularly preferred for diagnostic tests. One skilled in the art would have been motivated to select such threshold levels for sensitivity and specificity out of the course of routine optimization, given that these measures of test accuracy were recognized in the prior art to be result-effective variables that impact the number of false negatives and false positives for the test. Finally, one skilled in the art would have had a reasonable expectation of success in arriving at the claimed threshold for sensitivity and specificity since means of achieving desired sensitivity and specificity were known, namely by selecting an appropriate threshold or cutoff level (as taught by Blankenberg et al). It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation.” Application of Aller, 220 F.2d 454,456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation .” Id. At 458,105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Application of Boesch, 617 F.2d 272,276, 205 USPQ 215, 218-219 (C.C.P.A. 1980).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Stolz et al or Halangk et al in view of Oved et al as applied to claims 1-2, 5, 7-9 and 14 above and further in view of Prazak et al (Critical Care, May 2021 25:182, pages 1-10).
See above for the teachings of Stolz et al and Halangk et al.
Stolz et al and Halangk et al differ from the instant invention in failing teach the level of PSP/reg is determined at point-of-care.
Prazak et al teaches that PSP is available at point of care (POC) with a turnaround of less than 5 min which makes it highly suitable for situations where time to antibiotic is essential (e.g. page 8).
it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate point of care testing such as taught by Prazak et al into the methods of Stolz et al and Halangk et al because Prazak et al shows that PSP is available at point of care with a turnaround of less than 5 min which makes it highly suitable for situations where time to antibiotic is essential. Therefore, one of ordinary skill in the art would have a reasonable expectation of success incorporating point of care testing such as taught by Prazak et al into the method so Stolz et al and Halangk et al.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Stolz et al or Halangk et al in view of Blankenberg et al (US 2006/0105419).
See above for the teachings of Stolz et al and Halangk et al.
Stolz et al and Halangk et al differ from the instant invention in failing to explicitly teach an increase cutoff or 200 ng/ml and a decrease cutoff of 200 ng/ml for the probability of bacterial infection.
However, it was recognized in the prior art that the sensitivity and specificity is a measure of the accuracy of a test, reflecting the number (if any) of false positives and false negatives. Furthermore, sensitivity and specificity may be adjusted by adjusting the value of a threshold or cutoff value, above which (or below which, depending on how a marker changes with the disease/condition) the test is considered to be indicative of one state or condition (e.g., diseased/condition) and below which the test is considered to be indicative of another state or condition (e.g., non-diseased). See Blankenberg et al at [0007], [0028], [0084]. Accuracy need not be 100%; however Blankenberg et al indicates that particularly preferred would be where both the sensitivity and specificity are at least about 75%, more preferably at least about 80%, even more preferably at least about 85%, still more preferably at least about 90%, and most preferably at least about 95% [0028].
The teachings of Blankenberg et al indicate that the sensitivity and selectivity of a diagnostic test was known to be a result-effective variable, impacting the number of individuals who are correctly diagnosed with disease/condition. Furthermore, the teachings of Blankenberg et al indicate that it was known in the prior art to optimize tests for desired levels of sensitivity and specificity, by selecting appropriate threshold or cutoff values. Finally, Blankenberg et al clearly expresses that tests where both the sensitivity and specificity are at least about 80% would be viewed as particularly preferred.
Therefore, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate comparison of the levels and to arrive at the claimed invention by optimizing cutoff levels in order to achieve a desired sensitivity and specificity, given that such percentages were recognized in the art to be particularly preferred for diagnostic tests because both Stolz et al and Halangk et al teach an association with bacterial infection and one skilled in the art would have been motivated to select such threshold levels for sensitivity and specificity out of the course of routine optimization, given that these measures of test accuracy were recognized in the prior art to be result-effective variables that impact the number of false negatives and false positives for the test. Finally, one skilled in the art would have had a reasonable expectation of success in arriving at the claimed threshold for sensitivity and specificity since means of achieving desired sensitivity and specificity were known, namely by selecting an appropriate threshold or cutoff level (as taught by Blankenberg et al). It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation.” Application of Aller, 220 F.2d 454,456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation .” Id. At 458,105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Application of Boesch, 617 F.2d 272,276, 205 USPQ 215, 218-219 (C.C.P.A. 1980).
NOTE: It is also noted that it is unclear what applicant intends by “low probability” and “high probability” (see 112 (b) supra).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Stolz et al in view of Gotta et al., (PLOS One September 2017, pages 1-15).
See above for the teachings of Stolz et al.
Stolz et al differs from the instant invention in failing teach determining a corporal temperature of the subject.
Gotta et al teaches a correlation of increases body temperature in subjects with lower respiratory tract infections and an indication for antibiotic treatment (e.g. pgs 1, 8-10, & Fig 2).
it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate determining a body temperature of the subject in the method of Stolz et al because Stolz et al teaches upper respiratory infections and Gotta et al shows a correlation of increased body temperatures and the indication for antibiotic treatment to subjects with lower tract infection. Therefore, one of ordinary skill in the art would have a reasonable expectation of success incorporating determining an increased body temperature in the subject and initiating antibiotic treatment. Further, one of ordinary skill in the art would understand that additional tests and assessments known to be correlated with lower tract infection would provide a more confident assessment of lower tract infection and the need for antibiotic treatment in in the subject. It has long been held that it is obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY W COUNTS whose telephone number is (571)272-0817. The examiner can normally be reached M-F 7:00-4:00.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678
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