DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application is a DIV of 16/736,442 (01/07/2020 ABN),
16/736,442 is a CON of 13/852,573 (03/28/2013 ABN),
13/852,573 has PRO 61/616,583 (03/28/2012).
Claim Status
Claims 1-4, 6-11, 13-16, 18-21, 23-24, 60-63 are pending and under examination. Claims 60-63 were newly presented.
Claim rejections not reiterated in this action are withdrawn.
New Claim Rejections - 35 USC § 112(a)
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.
Claims 60-63 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention.
Applicant added new claims with the language “performed using an MSD protocol platform” while stating support for the added claim limitation is found:
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There is no specific definition of “MSD protocol platform” at the cited pages or anywhere else in the original disclosure to support the new claim language. In addition, based on the original disclosure one of skill in the art would not recognize that Applicant possessed such a scope.
As per MPEP 2163 II A: With respect to newly added or amended claims, applicant should show support in the original disclosure for the new or amended claims. See, e.g., Hyatt v. Dudas, 492 F.3d 1365, 1370, n.4 (Fed. Cir. 2007) (citing MPEP § 2163.04 which provides that a "simple statement such as ‘applicant has not pointed out where the new (or amended) claim is supported, nor does there appear to be a written description of the claim limitation ‘___’ in the application as filed’ may be sufficient where the claim is a new or amended claim, the support for the limitation is not apparent, and applicant has not pointed out where the limitation is supported."); see also MPEP §§ 714.02 and 2163.06 ("Applicant should ... specifically point out the support for any amendments made to the disclosure."); and MPEP § 2163.04 ("If applicant amends the claims and points out where and/or how the originally filed disclosure supports the amendment(s), and the examiner finds that the disclosure does not reasonably convey that the inventor had possession of the subject matter of the amendment at the time of the filing of the application, the examiner has the initial burden of presenting evidence or reasoning to explain why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims."). The inquiry into whether the description requirement is met is a question of fact that must be determined on a case-by-case basis. AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1297, 111 USPQ2d 1780, 1788 (Fed. Cir. 2014) ("Whether a patent claim is supported by an adequate written description is a question of fact."); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) ("Precisely how close [to the claimed invention] the description must come to comply with Sec. 112 must be left to case-by-case development."); In re Wertheim, 541 F.2d at 262, 191 USPQ at 96 (inquiry is primarily factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure).
The examiner could not locate support for such a new limitation, nor does there appear to be a written description of the limitation in the application as filed. See Hyatt v. Dudas, 492 F.3d 1365, 1370, 83 USPQ2d 1373, 1376 (Fed. Cir. 2007) (holding that "[MPEP] § 2163.04 (I)(B) as written is a lawful formulation of the prima facie standard for a lack of written description rejection."). There is no literal support for the added limitation and one of skill in the art would not recognize that Applicant possessed the claim scope. Thus, claim 60-63 are rejected.
New Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 60-63 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The claims include the language “performed using an MSD protocol platform” which is not defined in the specification and does not have an accepted meaning in the art. Thus, the claims are rejected as indefinite. For purposes of examination, the claim phrase is interpreted as “performed using an assay”.
New Claim Rejections - 35 USC § 103
Claims 1-4, 6-7, 60 are rejected under 35 U.S.C. 103 as being unpatentable over Cavet et al. (US20110137851) in view of Aldonyte et al. (J. Chronic Obstructive Pulmonary Disease, 1:2 (2004), p. 155-164) and Pinto-Plata et al. (Thorax 2007;62:595–601.).
Regarding claim 1, Cavet teaches a method for evaluating inflammatory disease biomarkers in a subject to determine the efficacy of treatments comprising measuring the biomarker, comparing to a normal control , and based on the comparison evaluating whether a patient is responsive to a therapeutic regimen ([0015]: “The present teachings relate to biomarkers associated with inflammatory disease, and with autoimmune disease, including RA, and methods of using the biomarkers to measure disease activity in a subject.”; Abstract: biomarkers determine a “disease activity index (DAI)”; claim 1; [0167]: “Reference (normal, control) values can also be derived from, e.g., a control subject or population whose inflammatory disease activity level or state is known.”, “In some embodiments the reference value can be derived from one or more subjects who have not been exposed to treatment; for example, samples can be collected from (a) subjects who have received initial treatment for inflammatory disease, and (b) subjects who have received subsequent treatment for inflammatory disease, to monitor the progress of the treatment.”; [0037]: “In one embodiment, the method further comprises determining a rate of said change in DAI scores, wherein said rate indicates the extent of said first subject's response to a therapeutic regimen.”). Cavet teaches the biomarkers are selected from VEGF (claim 1), ICAM1 (claim 1), Thrombomodulin ([0101]), selectin-P ([0101]), and FGF-2 (basic) ([0101]). Cavet teaches COPD is a comorbidity of inflammation ([0356]-[0358], Table 23).
Cavet does not teach a specific embodiment of measuring VEGF and ICAM1 in a COPD patient.
Aldonyte teaches COPD patients have elevated VEGF and ICAM1 biomarkers (abstract).
Pinto-Plata teaches profiling inflammation biomarkers in COPD patients to assess clinical measures of outcomes (Abstract, p. 597-98).
One of ordinary skill in the art following the teaching of Cavet would have considered utilizing known biomarkers related to inflammation in assessing a patient’s response to therapy because Cavet teaches the technique and as taught by Aldonyte VEGF and ICAM1 were known COPD inflammation biomarkers that would be expected to be useful as demonstrated by Pinto-Plata in assessing COPD. Each of the prior art are in the same field of endeavor of biomarkers for inflammatory disease and thus one of ordinary skill in the art would have readily considered combining their teachings in optimization of a COPD biomarker assay and arrive at the claimed invention with a reasonable expectation of success.
Regarding claim 2, Cavet teaches measuring levels of biomarkers in an assay ([0197]), including multiplex assays ([0221]) which one of ordinary skill in the art would have considered routine in implementing the same technique and arrive at the claimed invention.
Regarding claim 3, as with claim 2, Cavet teaches multiple assays which would measure two or more biomarkers.
Regarding claim 4, Cavet teaches measuring levels of the biomarkers at multiple timepoints including baseline and six-months, etc. ([0133]; [0139]; [0146]; [0167]; [0275]; [0342]).
Regarding claims 6-7, 60, Cavet teaches using an immunoassay to detect the levels of biomarkers which are well-known in the art ([0198]) and would be implemented in a single assay chamber.
With each of the above claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art in the same field of endeavor. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed with a reasonable expectation of success.
Claims 8-11, 13-14, 61 are rejected under 35 U.S.C. 103 as being unpatentable over Cavet et al. (US20110137851) in view of Carrasco et al. (Rheumatology Reports 2010; 2:e3, p. 26-38).
Regarding claim 8, Cavet teaches a method for evaluating inflammatory disease biomarkers, including RA, in a subject to determine the efficacy of treatments comprising measuring the biomarker, comparing to a normal control , and based on the comparison evaluating whether a patient is responsive to a therapeutic regimen ([0015]: “The present teachings relate to biomarkers associated with inflammatory disease, and with autoimmune disease, including RA, and methods of using the biomarkers to measure disease activity in a subject.”; Abstract: biomarkers determine a “disease activity index (DAI)”; claim 1; [0167]: “Reference (normal, control) values can also be derived from, e.g., a control subject or population whose inflammatory disease activity level or state is known.”, “In some embodiments the reference value can be derived from one or more subjects who have not been exposed to treatment; for example, samples can be collected from (a) subjects who have received initial treatment for inflammatory disease, and (b) subjects who have received subsequent treatment for inflammatory disease, to monitor the progress of the treatment.”; [0037]: “In one embodiment, the method further comprises determining a rate of said change in DAI scores, wherein said rate indicates the extent of said first subject's response to a therapeutic regimen.”).
Cavet teaches the biomarkers are selected from ICAM1 (claim 1), TNF-RII ([0101]: aka “tumor necrosis factor receptor superfamily, member 1B (TNFRSF1B)”).
While Cavet teaches all of the biomarkers claimed, Cavet does not teach the particular embodiment of TNF-RII and ICAM-1 as RA biomarkers.
Carrasco teaches TNFRII and ICAM1 are biomarkers of RA (p. 31-33).
One of ordinary skill in the art following the teaching of Cavet would have considered utilizing known biomarkers related to inflammation and RA in assessing a patient’s response to therapy because Cavet teaches the technique and the biomarkers were known inflammation/RA biomarkers as taught by Carrasco and would be expected to be useful in the same manner as taught by Cavet to assess whether a patient was responsive to a therapy. Thus, one of ordinary skill in the art would have readily considered Cavet’s teaching and arrive at the claimed invention with a reasonable expectation of success.
Regarding claim 9, Cavet teaches measuring levels of biomarkers in an assay ([0197]), including multiplex assays ([0221]) which one of ordinary skill in the art would have considered routine in implementing the same technique and arrive at the claimed invention.
Regarding claim 10, as with claim 9, Cavet teaches multiple assays which would measure two or more biomarkers.
Regarding claim 11, Cavet teaches measuring levels of the biomarkers at multiple timepoints including baseline and six-months, etc. ([0133]; [0139]; [0146]; [0167]; [0275]; [0342]).
Regarding claims 13-14, 61, Cavet teaches using an immunoassay to detect the levels of biomarkers which are well-known in the art ([0198]) and would be implemented in a single assay chamber.
With each of the above claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art in the same field of endeavor. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed with a reasonable expectation of success.
Claims 15-16, 18-19, 62 are rejected under 35 U.S.C. 103 as being unpatentable over Cavet et al. (US20110137851) in view of Goix et al. (US 20110003707) and Koh et al. (International Journal of Cardiology 132 (2009) 102–108).
Regarding claim 15, Cavet teaches a method for evaluating inflammatory disease biomarkers in a subject to determine the efficacy of treatments comprising measuring the biomarker, comparing to a normal control , and based on the comparison evaluating whether a patient is responsive to a therapeutic regimen ([0015]: “The present teachings relate to biomarkers associated with inflammatory disease, and with autoimmune disease, including RA, and methods of using the biomarkers to measure disease activity in a subject.”; Abstract: biomarkers determine a “disease activity index (DAI)”; claim 1; [0167]: “Reference (normal, control) values can also be derived from, e.g., a control subject or population whose inflammatory disease activity level or state is known.”, “In some embodiments the reference value can be derived from one or more subjects who have not been exposed to treatment; for example, samples can be collected from (a) subjects who have received initial treatment for inflammatory disease, and (b) subjects who have received subsequent treatment for inflammatory disease, to monitor the progress of the treatment.”; [0037]: “In one embodiment, the method further comprises determining a rate of said change in DAI scores, wherein said rate indicates the extent of said first subject's response to a therapeutic regimen.”; [0124]: inflammatory diseases includes vasculitis). Cavet teaches the biomarkers are selected from VEGF (claim 1), ICAM1 (claim 1), Thrombomodulin ([0101]), selectin-P ([0101]), and FGF-2 (basic) ([0101]). Cavet teaches COPD is a comorbidity of inflammation ([0356]-[0358], Table 23).
Cavet does not teach measuring the biomarker RANTES and the specific condition of coronary artery disease (vasculitis).
Goix teaches biomarker panels for assessing inflammation and coronary artery disease (CAD) (Abstract; [0015]; [0020]: cardiovascular condition / vascular inflammation; [00139]; [0463]; Figs 34-35) including the marker of RANTES ([0127]: “markers of inflammation include ICAM-1, RANTES, … .”).
Koh teaches RANTES is biomarker for coronary artery disease (CAD) (Abstract).
One of ordinary skill in the art following the teaching of Cavet would have considered utilizing known biomarkers related to inflammation and CAD in assessing a patient’s response to therapy because Cavet teaches the technique and as taught by Goix and Koh, RANTES was a known inflammation biomarker that would be expected to be useful in assessing inflammation and CAD. Each of the prior art are in the same field of endeavor of biomarkers for inflammatory disease and thus one of ordinary skill in the art would have readily considered combining their teachings in optimization of a CAD biomarker assay and arrive at the claimed invention with a reasonable expectation of success.
Regarding claim 16, Cavet teaches measuring levels of the biomarkers at multiple timepoints including baseline and six-months, etc. ([0133]; [0139]; [0146]; [0167]; [0275]; [0342]).
Regarding claims 18-19, 62, Cavet teaches using an immunoassay to detect the levels of biomarkers which are well-known in the art ([0198]) and would be implemented in a single assay chamber.
With each of the above claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art in the same field of endeavor. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed with a reasonable expectation of success.
Claims 20-21, 23-24, 63 are rejected under 35 U.S.C. 103 as being unpatentable over Cavet et al. (US20110137851) in view of Frieri et al. (Allergy Asthma Proc 28:614 –619, 2007).
Regarding claim 20, Cavet teaches the inflammatory disease includes asthma ([0124]) and a corresponding biomarker is VEGF (claim 1; [0016]). Cavet does not teach a specific embodiment.
Frieri teaches biomarkers of asthma and that VEGF is elevated in asthma patients (p. 614).
One of ordinary skill in the art following the teaching of Cavet would have considered utilizing known biomarkers related to inflammation and asthma in assessing a patient’s response to therapy because Cavet teaches the technique and the biomarkers were known inflammation/asthma biomarkers as taught by Frieri that would be expected to be useful in the same manner as taught by Cavet to assess whether a patient was responsive to a therapy. Thus, one of ordinary skill in the art would have readily considered Cavet’s teaching and arrive at the claimed invention with a reasonable expectation of success.
Regarding claim 21, Cavet teaches measuring levels of the biomarkers at multiple timepoints including baseline and six-months, etc. ([0133]; [0139]; [0146]; [0167]; [0275]; [0342]).
Regarding claims 23-24, 63, Cavet teaches using an immunoassay to detect the levels of biomarkers which are well-known in the art ([0198]) and would be implemented in a single assay chamber.
Response to Remarks - 35 USC § 103
Applicant argues that an unexpected result of a superior ROC area as compared to any biomarker combination found in the art.
This argument is not persuasive because the claims are not commensurate in scope with any alleged unexpected result.
Conclusion
The claims are not in condition for allowance.
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 ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached on 9am - 6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached on (571) 270-5293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626