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
Summary
This is the Non-Final Office Action based on application 18/247865 filed 04/04/2023.
Claims 17-37 have been examined and fully considered.
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 20-21 (with Claims 22-25 that depend from) & 30-31 & (with Claims 32-35 that depend from) and Claims 36-37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature (natural correlation) and abstract idea without significantly more.
Step 1: Claims 20-21 (with Claims 22-25 that depend from) & 30-31 & (with Claims 32-35 that depend from) and Claims 36-37 are directed towards methods.
Step 2A, Prong One: Claims 20-21 (with Claims 22-25 that depend from) & 30-31 & (with Claims 32-35 that depend from) and Claims 36-37 recite natural correlations. These claims follow a classic diagnostic analysis (measuring biomarkers, then diagnosing a disease or condition based on comparison to a control,) which is similar to the claims in Mayo Collaborative Services v. Prometheus Labs. Inc & also Example 29 of the USPTO subject matter eligibility examples. In applicant’s claims, the natural correlation is the correlation between one of the claimed diseases like gut flora dysbiosis, obesity, diabetes, depression, inflammatory disorders, or just general disease or disorder and the presence of one of more of the many claimed possible biomarkers. Applicants recite comparison to a control level/value which marks if the patient has the disease or not. Examiner notes that this is more of a discovery of the natural correlation than a patent eligible invention as claimed for the reasons shown below as it does not currently practically apply nor does it add significantly more to the claimed judicial exceptions.
Further, the comparison to a control is a mental process or at best, a mathematical comparison using an equation. Formulas or equations are mathematical concepts, which are an enumerated abstract idea (MPEP § 2106.04(a)).
Step 2A, Prong Two: These judicial exceptions in Claims 20-21 (with Claims 22-25 that depend from) & 30-31 & (with Claims 32-35 that depend from) and Claims 36-37 are not integrated into a practical application because upon comparison, nothing further is done. Claims 22-25 & 32-25 do involve a treatment, however as claimed, the treatment is not tied to the natural correlation, and therefore does not practically apply it. Further, as claimed it is not clear if the claimed treatments of statins and anti-inflammatory agents are particular and specific treatments.
Further- the claimed measuring/measurement steps as instantly claimed as just data gathering to perform the judicial exceptions and therefore are considered extra-solution activity. See MPEP 2106.05 (g).
Step 2B: There is nothing in Claims 20-21 (with Claims 22-25 that depend from) & 30-31 & (with Claims 32-35 that depend from) and Claims 36-37 which add something which is non routine and conventional to add something significantly more to the claimed judicial exceptions. Both general measurement of the biomarkers as claimed, and also comparison to controls, and also treatment with anti-inflammatory agents and statins are well understood, routine, and conventional in the art and therefore are not significantly more. See MPEP 2106.05(d)- “laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner.”
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 18, 20-25, 28, 30-35 & 37 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.
With respect to Claims 18 & 28, it claims that the biomarkers are “statistically significant,” but it does not say what they are statistically significant for. Is something really statistically significant if it is not said what the significance is in relation to or for? Or what the relationship of statistical significance is for? This is unclear in the claim and makes the claim confusing. Further with respect to Claim 18, “the difference,” fails to have proper antecedent basis as, “difference,” was not mentioned priorly in Claim 18 or in any claim it depends therefrom.
In Claims 20-21, & 30-31, “the subject,” fails to have proper antecedent basis and “subject,” was not in Claims 20 or 21 prior to use of “the,” as was also not in the claims from which they depend. Claims 22-25 & 32-35 depend on Claims 20-21 & 30-31 and do not solve these issues.
Claim 37 is unclear/confusing. It states that “at least one biomarker is selected from…” With respect to this, it is unclear if applicant intends “selected,” to mean that another biomarker is measured or not. Claim 36 which Claim 37 depends therefrom requires measuring at least one biomarker.
Further, for Claim 37, it also claims, “at least two biomarkers are selected from,” “at least three biomarkers are selected from,” and so on through four, six, and eleven biomarkers. With respect to these limitations, again it is not clear if applicant means that all of these biomarkers are measured or if they are just mentally selected. Further, it is unclear with the “at least two biomarkers are selected from,” “at least three biomarkers are selected from,” and so on if applicant is trying to further limit the claim within the claim. Is this trying to claim a broad limitation and then a narrower limitation, all in the same claim? If so, this is not permitted and is unclear.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21 & 31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for diagnosing certain types of “disease or disorder,” does not reasonably provide enablement for the realm of what can be encompassed by these terms. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
This decision was made in taking into consideration all of the Wands Factors including:
(A) The breadth of the claims: It is noted that these claim terms encompass a broader scope than what is actually described in the instant specification. The instant specification focuses, or even inflammatory diseases/disorders, but not all diseases in general (See instant PGPub paragraphs 0003,0010-0014, 0033-0034, 0047-0050, 0069-0074, 0083). There is also some mention of depression, diabetes, and obesity being the diseases that can be diagnosed in the cited paragraphs above.
(B) The nature of the invention: The nature of this invention is such that any and every disease or disorder could be diagnosed by the same biomarkers or treated with the same compounds.
(C) The state of the prior art: There are so many treatments available in the art one would not be able to just guess treatments that fit within the overly broad ones claimed that would work.
(D) The level of one of ordinary skill: The level of ordinary skill in this art is high, though even given that is the case, one would not be able to just guess diseases that the claimed biomarkers would be able to diagnose.
(E) The level of predictability in the art: There are so many diseases in the art that the level of predictability of what might work and what wouldn’t is not high.
(F) The amount of direction provided by the inventor: The inventor does provide some amount of direction, but again it is specific to gut and inflammatory disorders does not provide enough direction to show how one would be able to effectively treat a patient use any and every possibility encompassed by these terms.
(G) The existence of working examples: The inventor does provide working examples, but again there is not direction enough that would support effective use of any and every treatment which could be encompassed by these terms.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure: There are so many treatments which could be encompassed by these terms, that the quantity of experimentation would be high and consequential for someone to determine if any and every treatment encompassed by these terms would work.
It is noted that “immune-modulating agents,” shown in instant PGPub paragraph 0107, the “corticosteroids,” in paragraph 0124, 0128, 0034 and “block copolymers,” in paragraph 0016 & 0127 are enabled. Applicant can note if there are other places where these terms are more fully enabled.
Claim Rejections - 35 USC § 102
(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 17-19, 21, 25-29, 31 & 35-36 are rejected under 35 U.S.C. 102 (a)(1) and 102 (a)(2) as being anticipated by SAVIDGE in US 20140296134.
With respect to Claim 17, SAVIDGE teaches of a method of determining a metabolite profile and then of assessing the status of a subject based on the sample. SAVIDGE focuses on stool, samples, but the sample can also be blood (abstract, paragraph 0031).
SAVIDGE further teaches of measuring at least one metabolic marker as claimed, which includes 3-phenylpropionate (paragraph 0087), anthranilate (paragraph 0088), and p-cresol sulfate (paragraph 0089) among other biomarkers.
SAVIDGE further teaches of comparing the measured level of the biomarker to a control (paragraph 0100, 0127, 0057, 0030).
With respect to Claim 18, SAVIDGE teaches of determining if the biomarkers are elevated or decreased by determining statistically significant differences (paragraph 0119, & 0116-0119, 0030). SAVIDGE teaches of calculating p-values for the measured biomarkers 3-phenylpropionate (paragraph 0087), anthranilate (paragraph 0088), and p-cresol sulfate (paragraph 0089) among other biomarkers.
With respect to Claim 19, SAVIDGE teaches that the sample can be blood (abstract, paragraph 0031).
With respect to Claim 21, SAVIDGE teaches of using the biomarkers 3-phenylpropionate (paragraph 0087), anthranilate (paragraph 0088), and p-cresol sulfate (paragraph 0089) among other biomarkers, to identify and/ or classify (diagnose) CDI (clostridium difficile infection, which is a disease or a disorder as claimed) (paragraph 0092, 0004). SAVIDGE teaches of determining if the biomarkers are elevated or decreased by determining statistically significant differences (paragraph 0119, & 0116-0119, 0030). SAVIDGE teaches of calculating p-values for the measured biomarkers 3-phenylpropionate (paragraph 0087), anthranilate (paragraph 0088), and p-cresol sulfate (paragraph 0089) among other biomarkers.
With respect to Claim 25, SAVIDGE teaches of prescribing/treating a patient with anti-inflammatory therapy at a level which “alleviates clinical symptoms which reads on “effective level,” (paragraph 0139).
With respect to Claim 26, SAVIDGE teaches of a method of determining a metabolite profile and then of assessing the status of a subject based on the sample. SAVIDGE focuses on stool, samples, but the sample can also be blood (abstract, paragraph 0031).
SAVIDGE further teaches of measuring at least one metabolic marker as claimed, which includes 3-phenylpropionate (paragraph 0087), anthranilate (paragraph 0088), and p-cresol sulfate (paragraph 0089) among other biomarkers.
SAVIDGE further teaches of comparing the measured level of the biomarker to a control (paragraph 0100, 0127, 0057, 0030).
With respect to Claim 27, SAVIDGE further teaches of measuring at least one metabolic marker as claimed, which includes 3-phenylpropionate (paragraph 0087), anthranilate (paragraph 0088), and p-cresol sulfate (paragraph 0089) among other biomarkers.
With respect to Claim 28, SAVIDGE teaches of using the biomarkers 3-phenylpropionate (paragraph 0087), anthranilate (paragraph 0088), and p-cresol sulfate (paragraph 0089) among other biomarkers, to identify and/ or classify (diagnose) CDI (clostridium difficile infection, which is a disease or a disorder as claimed) (paragraph 0092, 0004). SAVIDGE teaches of determining if the biomarkers are elevated or decreased by determining statistically significant differences (paragraph 0119, & 0116-0119, 0030). SAVIDGE teaches of calculating p-values for the measured biomarkers 3-phenylpropionate (paragraph 0087), anthranilate (paragraph 0088), and p-cresol sulfate (paragraph 0089) among other biomarkers.
With respect to Claim 29, SAVIDGE teaches that the sample can be blood (abstract, paragraph 0031).
With respect to Claim 31, SAVIDGE teaches of using the biomarkers 3-phenylpropionate (paragraph 0087), anthranilate (paragraph 0088), and p-cresol sulfate (paragraph 0089) among other biomarkers, to identify and/ or classify (diagnose) CDI (clostridium difficile infection, which is a disease or a disorder as claimed) (paragraph 0092, 0004). SAVIDGE teaches of determining if the biomarkers are elevated or decreased by determining statistically significant differences (paragraph 0119, & 0116-0119, 0030). SAVIDGE teaches of calculating p-values for the measured biomarkers 3-phenylpropionate (paragraph 0087), anthranilate (paragraph 0088), and p-cresol sulfate (paragraph 0089) among other biomarkers.
With respect to Claim 35, SAVIDGE teaches of prescribing/treating a patient with anti-inflammatory therapy at a level which “alleviates clinical symptoms which reads on “effective level,” (paragraph 0139).
With respect to Claim 36, SAVIDGE teaches of a method of determining a metabolite profile and then of assessing the status of a subject based on the sample. SAVIDGE focuses on stool, samples, but the sample can also be blood (abstract, paragraph 0031).
SAVIDGE further teaches of measuring at least one metabolic marker as claimed, which includes 3-phenylpropionate (paragraph 0087), anthranilate (paragraph 0088), and p-cresol sulfate (paragraph 0089) among other biomarkers.
SAVIDGE further teaches of comparing the measured level of the biomarker to a control (paragraph 0100, 0127, 0057, 0030).
SAVIDGE teaches of using the biomarkers, to identify and/ or classify (diagnose) CDI (clostridium difficile infection—which can be considered “an inflammatory disorder,” as claimed) (paragraph 0092, 0004). SAVIDGE teaches of determining if the biomarkers are elevated or decreased by determining statistically significant differences (paragraph 0119, & 0116-0119, 0030). SAVIDGE teaches of calculating p-values for the measured biomarkers 3-phenylpropionate (paragraph 0087), anthranilate (paragraph 0088), and p-cresol sulfate (paragraph 0089) among other biomarkers.
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 non-obviousness.
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.
Claims 20, 24, 30 & 33 are rejected under 35 U.S.C. 103 as being obvious over SAVIDGE in US 20140296134 in view of VENEGAS in Short Chain Fatty Acids (SCFAs)-Mediated Gut Epithelial and Immune Regulation and It’s Relevance for Inflammatory Bowel Diseases (as cited on IDS dated 04/24/2023).
With respect to Claim 20, SAVIDGE teaches of the method as shown above, but does not teach of diagnosing gut flora dysbiosis with the method.
VENEGAS is used to remedy this and more specifically teaches of a method of detection of Irritable Bowel Disease (IBD) by investigating microbial short chain fatty acids in the intestinal mucosa (Page 1, abstract). Further, VENEGAS teaches of detecting acetate, propionate and butyrate (Page 1, abstract), and even further of diagnosing gut dysbiosis, especially in relation to clostridium difficile cases (Page 10, column 1, paragraph 1 & abstract).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to diagnosis gut dysbiosis as is done in VENEGAS in the method of SAVIDGE due to the fact that clostridium difficile infections are shown to have more pronounced dysbiosis than in other diseases (VENEGAS, Page 10, column 1, paragraph 1 & abstract) and due to the need in the art to determine how to restore microbiome diversity in patients with dysbiosis (Page 2, column 2, paragraph 2).
With respect to Claim 24, SAVIDGE teaches of prescribing/treating a patient with anti-inflammatory therapy at a level which “alleviates clinical symptoms which reads on “effective level,” (paragraph 0139).
With respect to Claim 30, SAVIDGE teaches of the method as shown above, but does not teach of diagnosing gut flora dysbiosis with the method.
VENEGAS is used to remedy this and more specifically teaches of a method of detection of Irritable Bowel Disease (IBD) by investigating microbial short chain fatty acids in the intestinal mucosa (Page 1, abstract). Further, VENEGAS teaches of detecting acetate, propionate and butyrate (Page 1, abstract), and even further of diagnosing gut dysbiosis, especially in relation to clostridium difficile cases (Page 10, column 1, paragraph 1 & abstract).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to diagnosis gut dysbiosis as is done in VENEGAS in the method of SAVIDGE due to the fact that clostridium difficile infections are shown to have more pronounced dysbiosis than in other diseases (VENEGAS, Page 10, column 1, paragraph 1 & abstract) and due to the need in the art to determine how to restore microbiome diversity in patients with dysbiosis (Page 2, column 2, paragraph 2).
With respect to Claim 33, SAVIDGE teaches of prescribing/treating a patient with anti-inflammatory therapy at a level which “alleviates clinical symptoms which reads on “effective level,” (paragraph 0139).
Claims 22, 32 & 37 are rejected under 35 U.S.C. 103 as being obvious over SAVIDGE in US 20140296134 in view of VENEGAS in Short Chain Fatty Acids (SCFAs)-Mediated Gut Epithelial and Immune Regulation and It’s Relevance for Inflammatory Bowel Diseases (as cited on IDS dated 04/24/2023) and further in view of VOROS in US 20190391131.
With respect to Claim 22, SAVIDGE and VENEGAS teach of the claimed invention as shown above, but do not teach of administering an effective amount of statin.
VOROS is used to remedy this and teaches of methods for evaluating a human subject for having atherosclerotic coronary artery disease (ASCAD) or as having a coronary atherosclerotic plaque (abstract). VOROS further teaches of biomarkers for the disease being guanidinosuccinate, imidazole propionate, and 4-hydroxyphenylacetate (paragraph 0175) among other biomarkers. VOROS further teaches of treating with an effective amount of statin (paragraph 0196). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to treat with an effective amount of statin as is done in VOROS in the methods of SAVIDGE and VENEGAS due to the advantage statins are known to have for improving cardiovascular health (paragraph 0196).
With respect to Claim 32, SAVIDGE and VENEGAS teach of the claimed invention as shown above, but do not teach of administering an effective amount of statin.
VOROS is used to remedy this and teaches of methods for evaluating a human subject for having atherosclerotic coronary artery disease (ASCAD) or as having a coronary atherosclerotic plaque (abstract). VOROS further teaches of biomarkers for the disease being guanidinosuccinate, imidazole propionate, and 4-hydroxyphenylacetate (paragraph 0175) among other biomarkers. VOROS further teaches of treating with an effective amount of statin (paragraph 0196). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to treat with an effective amount of statin as is done in VOROS in the methods of SAVIDGE and VENEGAS due to the advantage statins are known to have for improving cardiovascular health (paragraph 0196).
With respect to Claim 37, SAVIDGE teaches of a method of determining a metabolite profile and then of assessing the status of a subject based on the sample. SAVIDGE focuses on stool, samples, but the sample can also be blood (abstract, paragraph 0031).
SAVIDGE further teaches of measuring at least one metabolic marker as claimed, which includes 3-phenylpropionate (paragraph 0087), anthranilate (paragraph 0088), and p-cresol sulfate (paragraph 0089) among other biomarkers (paragraphs 0008-0035).
SAVIDGE teaches of the method as shown above, but does not teach of diagnosing gut flora dysbiosis with the method, nor does it teach of all the claimed biomarkers.
VENEGAS is used to remedy this and more specifically teaches of a method of detection of Irritable Bowel Disease (IBD) by investigating microbial short chain fatty acids in the intestinal mucosa (Page 1, abstract). Further, VENEGAS teaches of detecting acetate, propionate and butyrate (Page 1, abstract), and even further of diagnosing gut dysbiosis, especially in relation to clostridium difficile cases (Page 10, column 1, paragraph 1 & abstract).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to diagnosis gut dysbiosis and use the biomarkers as is done in VENEGAS in the method of SAVIDGE due to the fact that clostridium difficile infections are shown to have more pronounced dysbiosis than in other diseases (VENEGAS, Page 10, column 1, paragraph 1 & abstract) and due to the need in the art to determine how to restore microbiome diversity in patients with dysbiosis (Page 2, column 2, paragraph 2).
SAVIDGE and VENEGAS do not teach of all the claimed biomarkers.
VOROS is used to remedy this and teaches of methods for evaluating a human subject for having atherosclerotic coronary artery disease (ASCAD) or as having a coronary atherosclerotic plaque (abstract). VOROS further teaches of biomarkers for the disease being guanidinosuccinate, imidazole propionate, and 4-hydroxyphenylacetate (paragraph 0175) among other biomarkers, adding additional biomarkers. VOROS further teaches of treating with an effective amount of statin (paragraph 0196). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to monitor or select more biomarkers as is done in VOROS in the methods of SAVIDGE and VENEGA due to the advantage more biomarkers are known for being able to model and predict and therefore in making an accurate diagnosis (paragraph 0195, 0196). Further – it would have been obvious to one of ordinary skill in the art to “select,” a specific number of biomarkers through routine optimization and experimentation as is shown in SAVIDGE, VENEGAS, and VOROS. Also see MPEP 2144.05.
Claims 23 & 34 are rejected under 35 U.S.C. 103 as being obvious over SAVIDGE in US 20140296134 in view of VOROS in US 20190391131.
With respect to Claim 23, SAVIDGE teaches of the claimed invention as shown above, but do not teach of administering an effective amount of statin.
VOROS is used to remedy this and teaches of methods for evaluating a human subject for having atherosclerotic coronary artery disease (ASCAD) or as having a coronary atherosclerotic plaque (abstract). VOROS further teaches of biomarkers for the disease being guanidinosuccinate, imidazole propionate, and 4-hydroxyphenylacetate (paragraph 0175) among other biomarkers. VOROS further teaches of treating with an effective amount of statin (paragraph 0196). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to treat with an effective amount of statin as is done in VOROS in the methods of SAVIDGE due to the advantage statins are known to have for improving cardiovascular health (paragraph 0196).
With respect to Claim 34, SAVIDGE and VENEGAS teach of the claimed invention as shown above, but do not teach of administering an effective amount of statin.
VOROS is used to remedy this and teaches of methods for evaluating a human subject for having atherosclerotic coronary artery disease (ASCAD) or as having a coronary atherosclerotic plaque (abstract). VOROS further teaches of biomarkers for the disease being guanidinosuccinate, imidazole propionate, and 4-hydroxyphenylacetate (paragraph 0175) among other biomarkers. VOROS further teaches of treating with an effective amount of statin (paragraph 0196). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to treat with an effective amount of statin as is done in VOROS in the methods of SAVIDGE and VENEGAS due to the advantage statins are known to have for improving cardiovascular health (paragraph 0196).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758