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 with traverse of Group VI in the reply filed on 12/19/25 is acknowledged. The traversal is on the ground(s) that the elected group shares a single inventive concept with group V. This is not found persuasive for the reasons of record and further established of the lack of a common special technical feature by the prior art rejection below.
The requirement is still deemed proper and is therefore made FINAL.
Claims 43-44, 50 & 66 are considered on the merits.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 43-44 & 50 are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by Cheng (WO 2018/089693).
Cheng discloses treating [0190] a subject with a chronic inflammatory disease wherein they determine the presence of an inflammatory disease (including IBD, and ankylosing spondylitis – [0212] by determining the level of LCN2 or MMP9 in a serum sample [0013]; [0192, 0193]. Cheng discloses that both LCN2 and MMP9 serum levels are indicative of chronic inflammatory disease such as IBD and axial spondyloarthritis.
Cheng further discloses a method for determining or monitoring efficacy of the treatment (with the IL-23R inhibitor) of a subject having an inflammatory disease comprising determining the level of LCN2 in a serum sample, wherein if the level is reduced as compared to a pre-determined cut-off value or the level before treatment, the treatment is considered to be efficacious and adjusting treatment accordingly [0193] (as in claim 50).
The reference anticipates the claim subject matter.
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 43-44, 50 & 66 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng and Mann 20190330328.
Cheng discloses treating [0190] a subject with a chronic inflammatory disease wherein they determine the presence of an inflammatory disease (including IBD, and ankylosing spondylitis – [0212] by determining the level of LCN2 or MMP9 in a serum sample [0013]; [0192, 0193]. Cheng discloses that both LCN2 and MMP9 serum levels are indicative of chronic inflammatory disease such as IBD and axial spondyloarthritis.
Cheng further discloses a method for determining or monitoring efficacy of the treatment of a subject having an inflammatory disease comprising determining the level of LCN2 in a scrum sample, wherein if the level is reduced as compared to a pre-determined cut-off value or the level before treatment, the treatment is considered to be efficacious and adjusting treatment accordingly [0193] (as in claim 50).
Cheng does not specifically teach all the anti-inflammatory drugs claimed by applicant (claim 44) or the clinical observations of successful treatment, e.g. reduction and pain however it would have been obvious at the time the invention was filed to use any old and well known anti-inflammatory drug to treat the inflammation of the patients in Cheng and also to use clinical evaluations to further determine the success of the treatment as the use of conventional treatments, e.g. NSAIDS and clinical observations are notoriously old and well known in the treatment of inflammatory conditions. Mann adds further [0043] that NSAIDS are known for treating axial spondyloarthritis as is the measuring of corresponding pain.
Applicant is directed to pages 12-13 of KSR v Teleflex (500 US 398 2007) “… the Court has held that a “patent for a combination which only unites old elements with no change in their respective functions . . . obviously withdraws what is already known into the field of its monopoly and diminishes the resources available to skillful men.” Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U. S. 147, 152 (1950). This is a principal reason for declining to allow patents for what is obvious. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” “When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one(emphasis added). If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); >see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.");< ** In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Accordingly, the claimed invention was prima facie obvious to one of ordinary
skill in the art at the time the invention was filed especially in the absence of evidence
to the contrary.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
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/BLAINE LANKFORD/Primary Examiner, Art Unit 1657