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 amendment filed 07/02/26 is acknowledged and has been entered. Claims 1, 3-6 and 9-13 have been amended. Claim 2, 7-8 and 14 have been canceled. Claims 15-20 remain withdrawn as being directed to non-elected inventions. New claim 21 has been added. Accordingly, claims 1, 3-6, 9-13 and 21 are under examination.
Withdrawn Rejections
All rejections of claims not reiterated herein, have been withdrawn.
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, 3-6, 9-13 and 21 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 expression of the recited biomarkers in a subject with SLE undergoing a pre-flare event.
Claims 3-6 describe abstract ideas of forming and index, using log transforming data, determining Spearman correlation values, multiplying and summing.
This limitation falls within the abstract ideas grouping of mathematical concepts such as mathematical formulas or equations and mathematical calculations.
Step 2A, Prong 2
The additional elements of obtaining a sample from the SLE and detecting the level of expression of the recited biomarkers in the patient 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 “determining a Lupus Flare Risk Prediction Index (LFPI) score....” (cl. 1); “determining based upon the LFPI score, whether the patient is undergoing a pre-flare event” (see also “determining” in claims 3-6). The “determining” statements 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 recited markers being correlated with pre-flare event in SLE patients. No active method steps are invoked or clearly required; the “determining” 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 obtain a sample from a SLE patient and detect the level of the recited biomarikers. Further as shown by the art below the assessment of a plurality of biomarkers is routine and conventional.
With respect to the recitation “administering a treatment to the subject based on the determining of the LFPI score” as recited in claim 1. Although the claim invokes administering a treatment to the subject the claim currently recites a treatment step that is generic and allows for anything already known and conventional such as resting. The claim does not require a specific treatment. Also, the claim as currently recited allows for an alternative embodiment wherein based upon the LFPI score the patient is not undergoing a pre-flare event and therefore, the treatment would not be administered to the patient. Therefore, the claims as currently recited do not recite something significantly more than the judicial exception.
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 § 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.
Claims 1, 3-6, 9, 11, 13 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over James et al (US2015/0098940) in view of Wong et al (Rheumatology 2005, 44, pages 602-606)
James et al discloses a method for determining SLE flare comprising obtaining a blood, serum or plasma sample from an SLE patient and assessing the level of a plurality of biomarkers including IL-5, IL-17A, MCP-1, MCP-3, TNF-a, TNFRII, TNFRI, IL-4 and IL-7. James et al discloses that the plurality of biomarkers can include B lymphocyte stimulator (BLyS) (e.g. para 0010), resistin (e.g. para’s 0025-0026, Table 3) and IL-8 (e.g. para’s 0013, 0016, 0074-0075). James et al discloses determining levels of each of the biomarkers and developing soluble mediator scores for the SLE patients and for that of controls (e.g. para’s 0023-0031, 0217-0236). James et al discloses log transforming the data for the biomarkers and standardizing the log-transformed data and dividing by a standard deviation (e.g. para’s 0217-0220). James et al discloses determining Spearman coefficients and the use of SELENA-SLESA( (hsSLEDAI) score (e.g. 0220-0223) and the score is weighted (multiplied) by the Spearman coefficient. James et al discloses determining that the patient is undergoing a pre-flare based on this data. James et al discloses the biomarkers can be detected by use of reagents such as antibodies for the biomarkers (e.g. page 14). James et al discloses that the levels of the markers were log-transformed and used in the calculation (e.g. para 0220). James et al teaches that the immunodetection can be by multiplex bead-based assay (e.g. para’s 0010, 0025-0034, 0137-0139). James et al teaches treating the SLE patient with hydroxychloroquine (e.g. para 0190-0191).
With respect to the recitation “Lupus Flare Risk Prediction Index (LFPI) score. James et al discloses determining levels of each of the biomarkers and developing soluble mediator scores for the SLE patients and for that of controls (e.g. para’s 0023-0031, 0217-0236). James et al discloses log transforming the data for the biomarkers and standardizing the log-transformed data and dividing by a standard deviation (e.g. para’s 0217-0220). Further, the instant specification does not provide a definition for the phrase and the phrase is not well known in the art and the current claim does not provide a specific algorithm or formula which defines what LFPI encompasses. Thus, for the reasons stated above the mediator scores of James et al reads on LFPI score.
With respect to detecting a level of exprssion for at least one of a second plurality of biomarker. The current claim only recites one and James et al specifically teaches BLyS (e.g. para 0010), resistin (e.g. para’s 0025-0026, Table 3) and IL-8 (e.g. para’s 0013, 0016, 0074-0075).
James et al does not expressly teach detecting the level of osteopontin (OPN).
Wong et al., teaches the assessment of osteopontin (OPN) levels in SLE patients and shows the correlation of increased levels of OPN in SLE patients as compared to that of a normal control (e.g. abstract, pgs 603-604).
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 assessment of OPN such as taught by Wong et al into the method of James et al because James et al is specifically teaching panels of biomarkers and Wong et al shows the correlation of OPN with SLE patient and one of ordinary skill in the art would understand that the addition of another marker would provide even more confidence in the assessment of SLE. 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). Therefore, one of ordinary skill in the art would have a reasonable expectation of success to incorporate the assessment of OPN such as taught by Wong et al into the method of James et al.
Claims 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over James et al in view of Wong et al as applied to claims , 3-6, 9, 11, 13 and 21 above, and further in view of Faber-Elman et al (Clin Exp Immunol 2002; 127, pages 393-398).
See above for the teachings of James et al and Wong et al.
James et al and Wong et al differ from the instant invention in failing to teach detecting the level of MMP-9.
Faber-Elman et al., teaches the detection of MMP-9 levels in SLE patients and shows the correlation of increased levels of MMP-9 in SLE patients as compared to that of a normal control (e.g. abstract, pgs 394-397).
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 detection of MMP-9 such as taught by Faber-Elman et al into the modified method of James et al because James et al is specifically teaching panels of biomarkers and Faber-Elman et al shows the correlation of MMP-9 with SLE patienst and one of ordinary skill in the art would understand that the addition of another marker would provide even more confidence in the assessment of SLE flare. 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). Therefore, one of ordinary skill in the art would have a reasonable expectation of success to incorporate the assessment of MMP-9 such as taught by Faber-Elman et al into the modified method of James et al.
Response to Arguments
Applicant's arguments filed 07/02/26 have been fully considered but they are not persuasive.
101 Rejections:
Applicant argues that claim 1 has been amended to recite administration of a treatment to the subject based on the determining of the LFPI score. Claim 21 has been added to focus on embodiments where the treatment comprises administration of at least one of a set of actives understood by one of ordinary skill in the art, including hydroxychloroquine (HCQ), belimumab, a nonsteroidal anti- inflammatory drug, a steroid, and a disease-modifying anti-rheumatic drug (DMARD). This additional element of the claims is not directed to a judicial exception and, accordingly, underscores that the claims are directed to patentable subject matter.
This argument is not found persuasive because although the claim invokes administering a treatment to the subject the claim currently recites a treatment step that is generic and allows for anything already known and conventional such as resting. The claim does not require a specific treatment. Also, the claim as currently recited allows for an alternative embodiment wherein based upon the LFPI score the patient is not undergoing a pre-flare event and therefore, the treatment would not be administered to the patient. Therefore, the claims as currently recited do not recite something significantly more than the judicial exception.
103 Rejections:
Applicant argues that amended claim 1 now recites that the biomarkers may include BLyS, IL-8, Resistin, and matrix metallopeptidase (MMP-9), or a combination thereof. Inasmuch as the prior art fails to fairly teach or suggest this combination of biomarkers, the combination of prior art cannot render obvious the methods of Claim 1.
This argument is not found persuasive because of reasons stated that the art teaches these biomarkers.
Allowable subject matter:
Applicant argues that claim 1 has been amended to include the allowable subject matter of Claims 9-13, and has amended claims 9-13 to describe possible biomarker panels according to claim 1.
This argument is not found persuasive because the applicant did not amend the claims to include the allowable subject matter. The allowable subject matter was directed to panels consisting of very specific panels and the applicant removed the consisting of language and opened the claims up to comprising language. Therefore, no allowable subject matter was amended into claim 1.
Conclusion
No claims are allowed.
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 GARY W COUNTS whose telephone number is (571)272-0817. The examiner can normally be reached M-F 7:00-4:00.
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, Gregory Emch can be reached at 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GARY COUNTS/ Primary Examiner, Art Unit 1678
Prosecution Insights