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 Summary
Filing Receipt and Priority
The filing receipt mailed 04/25/2024 states that the instant application is a 371 of PCT/EP2022/080823, filed 11/04/2022, which claims benefit of provision application 63/342,825, filed 05/17/2021.
The PCT filing of 11/30/2023 indicates the instant application claims priority to provisional application 63/276,147, filed 11/05/2021.
The ‘147 provisional application supports the instant claims. Therefore, the effective filing date is 11/05/2021.
Information Disclosure Statement
The information disclosure statement submitted 06/27/2024 has been considered.
Species Election
Applicant’s election of the following species has been acknowledged.
Applicant has elected ponesimod as the one S1P1 monoselective receptor modulator and multiple sclerosis as the demyelinating disease.
Claim Objections
Claim 1 states “human subject” in l. 1 and then “subject in need thereof” in l. 2. The claim would be in better form if instead of “subject” in l. 2 is preceded by “human” to state “human subject in need thereof”.
Rejections
Claim Rejections - 35 USC § 102
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)(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.
Claim(s) 1-8 and 10-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kappos (JAMA Neurology, May 2021, Vol. 78, No. 5, of the record) as supported by Janssen Pharmaceutica NV (Package Leaflet: Information for the patient – Ponesimod, 1 July 2021, p. 1-10, CP093007780, of the record, herein after JP NV).
Kappos in sec. Methods discloses a study wherein 20 mg ponesimod was administered to patients with relapsed multiple sclerosis. (para. 1, sec. Study Design). Kappos in sec. Patient Population states “Adult patients 18-55 years with RMS as defined by the revised (2010) McDonald diagnostic criteria for MS with a relapsing course (ie RMS or secondary progressive MS with superimposed relapses), and EDS score between 0 and 5.5, and recent clinical or magnetic resonance imaging (MRI) activity were enrolled.”
Kappos on p. 565, left. col., para 3 states “The 14-day up-titration regimen applied in this trial resulted in an overall incidence of first dose heart rate and rhythm AESIs (2.1%).” JP NV discloses the 14-day up-titration regimen on p. 6 discloses the 14-day regimen, shown below.
Regarding the “preserving myelination of axons” limitation of claim 1, the MPEP sec. 2112(I) states:
I. SOMETHING WHICH IS OLD DOES NOT BECOME PATENTABLE UPON THE DISCOVERY OF A NEW PROPERTY
“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.
The claim requires administering ponesimod in an effective amount to a human subject having multiple sclerosis. Therefore, the disclosure of Kappos sufficiently reads on the claim.
PNG
media_image1.png
416
582
media_image1.png
Greyscale
Claim(s) 17 is/are rejected under 35 U.S.C. 102((a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Janssen Pharmaceutica NV (Package Leaflet: Information for the patient – Ponesimod, 1 July 2021, p. 1-10, CP093007780, of the record, herein after JP NV).
JP NV is a leaflet intended to be included with ponesimod in a package for commercial or clinical distribution.
The instant specification in para. [0049] states “Typically, the pharmaceutical product comprises a package, such as bottle, a pouch, or a blister pack.”
JP NV on p. 9-10 further discloses contents of its package.
While JP NV is a leaflet, one of ordinary skill in the art would find it obvious that the leaflet is intended to be included into a pharmaceutical product (blister pack) as the leaflet includes instructions on how to administer the ponesimod.
PNG
media_image2.png
288
500
media_image2.png
Greyscale
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 nonobviousness.
KSR Rationales
The MPEP in section 2143, subsection I gives examples of Rationales for supporting a conclusion of obvious. These rationales are non-exhaustive and include (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Claim(s) 1-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kappos (JAMA Neurology, May 2021, Vol. 78, No. 5, of the record) in view of Subei (CNS Drugs, 2015, 29:565575) as supported by Janssen Pharmaceutica NV (Package Leaflet: Information for the patient – Ponesimod, 1 July 2021, p. 1-10, CP093007780, of the record, herein after JP NV).
Regarding claims 1-8 and 10-17, discussion of Kappos and JP NV from the 102 and 102/103 rejections above is incorporated here.
Claim 9 is drawn to the method of claim 1 wherein the human subject is treatment naїve.
Neither Kappos or JP NV discuss treatment naїve subjects. Subei in its abstract identifies several S1P receptor modulators including fingolimod, ponesimod, ozanimod, ceralifimod, GSK2018682, and MT-1303. Subei in the same section also states that ponesimod is more selective for the S1P receptor than fingolimod.
Subei in sec. 3.3 states “Fingolimod is approved by the FDA in the USA as first-line therapy in relapsing forms of MS.”
One of ordinary skill in the art would find it obvious to combine Kappos and Subei to arrive at a method of preserving myelination of axons in a human subject who is treatment naїve as the art contemplates first-line therapy with fingolimod.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art to administer ponesimod as a first-line therapy in place of fingolimod as ponesimod is also effective in treating RMS as discussed by Kappos. One of ordinary skill in the art would be motivated to make the modification as Subei teaches that Ponesimod is more selective for S1P receptor than fingolimod (KSR B).
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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, Jeffrey Murray can be reached at (571) 272-9023. 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.
/LUISALBERTO GONZALEZ/Examiner, Art Unit 1624
Prosecution Insights