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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-14 in the reply filed on 02/05/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). After further consideration the species restriction of the combination of biomarkers has been withdrawn. Currently, claims 1-20 are pending. Claims 15-20 are withdrawn as being directed to non-elected inventions. Accordingly, claims 1-14 are under examination.
Specification
The use of the term Tween (e.g. page 31, para. 00126) which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The lengthy 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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Claim limitation(s) “a kit” (cl. 14) has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder "kit” coupled with functional language “configured to assess”. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 14 has been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation: No specific structure is disclosed in the specification for generic place holders.
If applicant wishes to provide further explanation or dispute the examiner's interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 the preamble of the claim recites “for determining whether Systemic Lupus erythematosus (SLE) patient is undergoing a pre-flare event”. The body of the fails to provide any diagnostic steps or any correlation of the amount of the biomarker with a pre-flare event”. Thus, the preamble fails to correlate with the body of the claim. Method claims should clearly set forth the various method steps in a positive, sequential manner using active tense verbs such as mixing, reacting and detecting. Method claims should also clearly state each component used in the method and the relationship of the various components, and should not be a mere cataloging of parts. The claims should also conclude with a step relating the method result to the purpose of the method, preferably to the purpose as also set forth in the preamble of the claim. Appropriate correction is required.
Claim 1 is also objected to because of the following informalities: Claim 1, lines 6-7 the recitation “interleukin (IL-17A)” should be --interleukin-17A (IL-17-A)--.
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
Claim 1 describes an abstract idea, law of nature, or natural phenomenon in the preamble of the claim by requiring determining whether a Systemic lupus erythematosus (SLE) patient is undergoing a pre-flare event comprising the assessment of a plurality of recited biomarkers. The claims are directed to a naturally occurring correlation between the presence, levels of the recited biomarkers in a subject with SLE and undergoing a pre-flare event. Claims 2-6 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 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 “assessing a level of expression for each of a plurality of biomarkers” (cl. 1); “determining a Lupus Flare Risk Prediction Index..” (cl. 2) (see also “determining” in claims 3-7). The “assessing” and “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 “assessing” or “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. Further as shown by the art below the assessment of a plurality of biomarkers is routine and conventional.
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 is indefinite in reciting “assessing a level of each of a plurality of biomarkers…” because the term “assessing” appears to intend a mental step; hence, it is unclear if the applicant actually intends a positive active method step in the claim. It is suggested but not required to delete the term “assessing” and replace it with --detecting--.
Claim 2 the recitation “Lupus Flare Risk Prediction Index (LFPI) is vague and indefinite. The specification does not provide a specific definition for the phrase and the current claims to not provide a specific formula, equation, cutoff or standard to provide what the phrase encompasses. Therefore, the metes and bounds of the claim cannot be ascertained. 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 2 is vague and indefinite in reciting “a plurality of biomarkers” because it is unclear if applicant is referring to the plurality of biomarkers reciting in claim 1 or if the applicant intends something else. Please clarify.
Claim 3 is vague and indefinite in reciting “a plurality of biomarkers” because it is unclear if applicant is referring to the plurality of biomarkers reciting in claim 1, claim 2 or if the applicant intends something else. Please see also deficiencies found in claims 4-6.
Claim limitations “a kit configured to” (cl. 14), invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Claim 14 recite above limitation(s). Therefore, the claims are indefinite and are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 1-8 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) 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).
With respect to the recitation “Lupus Flare Risk Prediction Index (LFPI). 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.
James et al does not expressly teach assessing 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.
With respect to the recitations “for determining whether a Systemic lupus erythematosus (SLE) patient is undergoing a pre-flare event” as recited in claim 1. These limitation occurs in the preamble of the claims and thus has not been given patentable weight. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). Regardless, in the instant case, James et al does teach the method is for determining a pre-flare event in an SLE patient.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over James et al in view of Wong et al as applied to claims 1-8 above, and further in view of Boguslaski et al (US 5,420,016).
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 the reagents packaged into a kit.
Boguslaski et al teaches assembling various components into a kit and also discloses that by assembling these components into kits makes it more convenient and facile for the test operator (col 7).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to package the regents in the modified method of James et al into a kit format such as taught by Boguslaski et al because Boguslaski et al teaches that assembling components into kits makes it more convenient and facile for the test operator. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating the antibodies in the modified method of into a kit such as taught by Boguslaski et al.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18 of U.S. Patent No. 12,510,539. Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and US 12,510,539 recite methods of assessing the level of biomarkers OPN, MCP-1, MCP-3, IL-17A, TNFRI, TNFRII, IL-4, IL5, TNF-a and IL-7 and one of ordinary skill in the art would understand that the more comprehensive claims of US 12,510,539 would encompass the claims of the current application.
Allowable Subject Matter
Claims 9-13 would be allowable if rewritten or amended to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, 35 U.S.C 101 and the Double Patenting rejection set forth in this Office action. The prior art of record does not teach nor fairly suggest measuring the panels consisting of the biomarkers recited in claims 9-13.
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