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
Claims 16-35 are pending.
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to Application Serial No. PCT/EP2023/057534, filed 3/23/2023; and further claims priority to FOR application number EP22305345.5, filed 03/23/2022.
Information Disclosure Statement
All references from IDS(s) received on 05/05/2025 have been considered unless marked with a strikethrough.
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.
Claim 1 is 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 recites the following transitional phrases: “comprising, consisting of or consisting essentially of.” Transitional phrases have different interpretations. According to MPEP 2111.03,
The transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) (“[L]ike the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended.”). Invitrogen Corp. v. Biocrest Manufacturing, L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003) (“The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”)
The transitional phrase “consisting of” excludes any element, step, or ingredient not specified in the claim. In re Gray, 53 F.2d 520, 11 USPQ 255 (CCPA 1931); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“consisting of” defined as “closing the claim to the inclusion of materials other than those recited except for impurities ordinarily associated therewith”)….. When the phrase “consisting of” appears in a clause of the body of a claim, rather than immediately following the preamble, there is an “exceptionally strong presumption that a claim term set off with ‘consisting of’ is closed to unrecited elements.”
The transitional phrase “consisting essentially of” limits the scope of a claim to the specified materials or steps “and those that do not materially affect the basic and novel characteristic(s)” of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463…..For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355
Therefore, based on MPEP 2111.03, the Examiner interprets the claims using the broadest reasonable interpretation using “Comprising.”
In order to overcome this rejection, the Examiner suggests the Applicant chooses a single transitional phrase upon amending.
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)(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.
Claims 16-18, 21-22, 24, 27-28, and 32 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by SERKET Pharma (WO2012149478A2; cited in the IDS filed 5/05/2025; “Serket”).
Serket teaches a method of treating neurodegenerative diseases, such as multiple sclerosis (Page 3, para. 0133, Line 18) with a compound of Formula II including an explicit teaching of dyclonine (Claim 6), as required by instant claims 16, 18, 21-22, and 24.
Serket teaches the compounds can cross the BBB (para. 0079) as well as administration of the compounds orally (Claim 11), where the compounds may be taken daily (para. 0105), as required by instant claims 17, 27-28, and 32.
Therefore, the limitations of instant claims 16-18, 21-22, 24, 27-28, and 32 are anticipated by Serket.
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 16-18, 21-22, 24, 27-32 are rejected under 35 U.S.C. 103 as being unpatentable over SERKET Pharma (WO2012149478A2; cited in the IDS filed 5/05/2025; “Serket”).
Claims 16-18, 21-22, 24, 27-28, and 32 are taught by Serket, see 102 analysis above, and incorporated herein.
With respect to claims 29-31, Serket does not explicitly teach the ranges of the instant claims. However, Serket does teach the compound can be administered between 1-1000 mg per patient or 0.1 to 10 mg/kg. This is an overlapping range with the instant claims. In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003): "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." Further, the specific dosage guidelines within these claims would be considered routine optimization of variables. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955): "[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." The applicant has not determined the criticality of these dosage boundaries within the Specification. Therefore, a skilled artisan would be motivated to optimize doses and administration specific to a patient’s response and tolerability. See MPEP 2144.05(II)(A).
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness 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.
Applying KSR example rationale (E) it would have been prima facie obvious to extract the teachings of Serket and optimize the doses specific to patient response and population. Therefore, claims 16-18, 21-22, 24, 27-32 would be obvious to a person skilled in the art at the time.
Claims 16-18, 21-22, 24, 27-34 are rejected under 35 U.S.C. 103 as being unpatentable over SERKET Pharma (WO2012149478A2; cited in the IDS filed 5/05/2025; “Serket”) in further view of Hauser, S. et al. (Am J Med. 2020 Jul 17;133(12):1380–1390.e2; cited in the IDS filed 5/05/2025; “Hauser”).
Claims 16-18, 21-22, 24, 27-32 are taught by Serket, see 102 and 103 analysis above, and incorporated herein.
With respect to claims 33-34, Serket fails to teach the administration of an anti-inflammatory agent.
Hauser teaches that anti-inflammatory agents such as teriflunomide is a known treatment for multiple sclerosis (Table 3).
Therefore, since Serket teaches the treatment of multiple sclerosis with its compounds it would be obvious to a person skilled in the art to add an additional therapeutic also known to treat multiple sclerosis, such as teriflunomide, as required by instant claims 33-34.
Applying KSR example rationale (A) it would have been prima facie obvious to extract the teachings of Serket and add an additional therapeutic also known to treat multiple sclerosis, such as teriflunomide, as taught by Hauser. Therefore, claims 16-18, 21-22, 24, 27-34 would be obvious to a person skilled in the art at the time.
Claims 16-18, 21-24, 27-32, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over SERKET Pharma (WO2012149478A2; cited in the IDS filed 5/05/2025; “Serket”) in further view of Li, X. et al. (Int J Med Sci 2020; 17(6):751-761; “Li”).
Claims 16-18, 21-22, 24, 27-28, and 32 are taught by Serket, see 102 and 103 analysis above, and incorporated herein.
With respect to claims 24 and 35, Serket fails to explicitly teach that the neurodegenerative disease is not associated with folate deficiency.
However, Li teaches that patients with multiple sclerosis did not show a difference in folate levels versus the control group (Results).
Therefore, since Serket teaches the treatment of multiple sclerosis with its compounds it would be obvious to a person skilled in the art that the compounds would treat neurodegenerative disorders that are not related to folate deficiency, as taught by Li.
Applying KSR example rationale (A) it would have been prima facie obvious to extract the teachings of Serket and apply it to neurodegenerative disorders not associated with folate deficiency. A person skilled in the art would be motivated to do so because Serket teaches the compounds for use in treating multiple sclerosis and multiple sclerosis has been reported to not be associated with folate deficiency, as taught by Li. Therefore, the use of the compound in successfully treating a neurodegenerative disorder unassociated with folate deficiency would lead a POSITA to believe the compound does not rely on such mechanism and would apply it to other diseases that rely on myelin pathology without relying on a folate mechanism. Therefore, claims 16-18, 21-24, 27-32, and 35 would be obvious to a person skilled in the art at the time.
Claims 16, 19-20, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Singh, D. et al. (International Journal of Developmental Neuroscience, 2018, 70: 3-11; cited in the IDS filed 5/05/2025; “Singh”) in further view of Paul, S. et al. (Infant, 2011, 7, 5; cited in the IDS filed 5/05/2025; “Paul”).
With respect to claims 16 and 25-26, Singh teaches that hypoxic insults during the perinatal period affect the normal development, differentiation and maturation of the OPCs or cause their death resulting in impaired myelination (Abstract). Further, Singh teaches that melatonin is an effect candidate for treating myelination deficits in the developing brain because it can cross the placental and fetal BBB (page 6, Section 7.1).
With respect to claims 19-20, Singh fails to teach an example using calcium folate or folinic acid.
However, Paul teaches that folate supplements, such as calcium folate and folinic acid (Table 1) show improved myelination in a child with delayed myelination.
Therefore, it would be obvious to a person skilled in the art at the time to use a compound known to improve myelination, such as folinic acid or calcium folate, and use it in a condition with impaired myelination, such as prenatal hypoxia.
Applying KSR example rationale (B) it would have been prima facie obvious to extract the method of Singh in treating prenatal hypoxia with a compound known to improve myelination and substitute the compound for another known compound to improve myelination, such as calcium folate or folinic acid, as taught by Paul. Therefore, claims 16, 19-20, and 25-26 would be obvious to a person skilled in the art at the time.
Conclusion
Claims 16-35 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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, Clint Brooks can be reached at (571) 270-7682. 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.
/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621
Prosecution Insights