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
This Office Action is in response to Applicant's Restriction Requirement remarks filed on December 1, 2025. Claim(s) 16-31 are pending. Claim(s) 17-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant's election of Group I drawn to a drawn to a method of prophylaxis or treatment of myelodysplastic syndromes (MDS) and/or the symptoms associated therewith and election of species of vamifeport of the restriction requirement in the reply 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 § 818.03(a)). The requirement is deemed proper and is therefore made FINAL. Claim(s) 16 and 20-31 are examined herein insofar as they read on the elected invention and species.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16 and 20-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of myelodysplastic syndromes, does not reasonably provide enablement for the prevention of myelodysplastic syndromes. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The instant claims are drawn to a method for the prevention of myelodysplastic syndromes. The instant specification fails to provide information that would allow the skilled artisan to practice the instant invention. Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Nature of the invention:
The instant invention pertains to a method for the treatment and prevention of myelodysplastic syndromes.
The state of the prior art:
The skilled artisan would view that the prevention of myelodysplastic syndromes totally, absolutely, or permanently, is highly unlikely, since one cannot guarantee that the myelodysplastic syndromes will always be prevented.
For example, Fenaux (British Journal of Haematology, 2020) teaches MDS remains largely based on conventional prognostic scores [International Prognostic Scoring System (IPSS), revised IPSS], classifying patients into “lower risk” MDS (LR-MDS) and “higher risk” MDS (HR-MDS). In LR-MDS, treatment mainly aims at improving cytopenias, principally anaemia, while in HR-MDS it aims at delaying disease progression and prolonging survival (abstract). Fenaux further states that while treatment has greatly improved over the last two decades, it’s rarely curative (page 1016, (column 1, 1st ¶).
Furthermore, Rafiq (Cureus, 2024) supports the notion that MDS, while treatment advancements have been made, is still not preventable, due to lack of accurate treatment models (abstract).
The relative skill of those in the art:
The relative skill of those in the art is very high.
The predictability or lack thereof in the art:
The skilled artisan would view that the treatment to prevent myelodysplastic syndromes, absolutely, or permanently is highly unpredictable. As evidenced above, because the cause of myelodysplastic syndromes is yet to be identified, prevention is highly unpredictable.
The amount of direction or guidance presented and the presence or absence of working examples:
In the instant case, in order to demonstrate the preventive effect of the therapy, the protective effect of ferroportin inhibitors were studied on the development of iron overload and related toxicities on 3-month old mice treated for three months (page 47 and 49). These examples do not provide sufficient evidence of the prevention MDS totally, absolutely, or permanently
Note that lack of a working example, is a critical factor to be considered, especially in a case involving an unpredictable and undeveloped art. See MPEP 2164. Genentech, Inc. v. Novo Nordisk, 108 F.3d at 1366, states that "a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion" and "[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable". Therefore, in view of the Wands factors, e.g., the amount of direction or guidance provided, absence of working examples, and the predictability of the art discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test the combination in the instant claims whether preventing low ovulation rate totally, absolutely, or permanently.
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.
Claims 16 and 21-31 are rejected under 35 U.S.C. 103 as being unpatentable over Morris (WO 2018/192973) of record.
Morris teaches compounds of the general formula (I), pharmaceutical compositions and method of treatment thereof (abstract; (page 8).
PNG
media_image1.png
870
562
media_image1.png
Greyscale
Morris teaches the compounds as ferroportin inhibitors, particularly for the use in the treatment of diseases caused by a lack of hepcidin or iron metabolism disorders, such as particularly iron overload states such as in particular thalassemia, sickle cell disease and hemochromatosis. (abstract; pages 41-42).
Morris also teaches associated with ineffective erythropoiesis comprise in particular myelodysplastic syndromes (MDS, myelodysplasia) and polycythemia vera as well as congenital dyserythropoietic anemia (page 41).
Morris teaches wherein the salts are selected from salts of the compounds of formula (I) with acids from the group consisting of benzoic acid, citric acid, fumaric acid, hydrochloric acid, lactic acid, malic acid, maleic acid, methanesulfonic acid, phosphoric acid, succinic acid, sulfuric acid, tartaric acid and toluenesulfonic acid, being characterized by a ratio of compound (I) : acid of 1 to 2 : 1 to 3; and solvates, hydrates and polymorphs thereof (claim 1; page 52-53).
Morris teaches polymorphs of the salt compounds according to formula (I), (II) or (III) (page 30, 5th and 6th ¶).
Morris teaches the compounds may be dosed orally either as a single agent twice daily at 10, 30 and 60 mg/kg or in combination with one of the compounds listed above (second agents) (page 45, 1st ¶).
Morris teaches the specific selected compounds (page 26-27):
PNG
media_image2.png
688
538
media_image2.png
Greyscale
Morris teaches the preferred salts (page 29):
PNG
media_image3.png
336
658
media_image3.png
Greyscale
.
Morris teaches the disease-modifying capacity of the orally administered ferroportin inhibitors exemplified in the following parameters (page 80-81, Table 10):
PNG
media_image4.png
711
480
media_image4.png
Greyscale
Morris teaches administration of said compounds may be combined with blood transfusion (page 44, 2nd ¶).
Morris teaches a fixed dose combination therapy comprising co-administration of the salts of the present invention with the at least one additional pharmaceutically active compound in a fixed-dose formulation. Additionally, combination therapy in a free dose combination therapy comprising co-administration of the salts of the present invention and the at least one additional pharmaceutically active compound in free doses of the respective compounds, either by simultaneous administration of the individual compounds or by sequential use of the individual compounds distributed over a time period. (page 43, 4th ¶).
The difference between Morris and the claimed invention is that it does not teach the invention with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831,15 USPQ2d 1566 (Fed. Cir. 1990)).
However, based on the above, Morris teaches the elements of the claimed invention with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Therefore, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited art.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Morris (WO 2018/192973) of record as applied to claims 16 and 21-31 in the 103 rejection above.
Morris is discussed above.
Morris does not teach assessing the risk of the patient to myelodysplastic syndromes according to the IPSS scoring system as required by the limitations of claim 20.
Greenburg teaches the IPSS is an important standard for assessing prognosis of primary untreated adult patients with myelodysplastic syndromes (MDS) (abstract; page 2461, Table 7).
It would have been obvious to one of ordinary skill in the art at the time of filing to have known that compounds of formula I would be effective in treating MDS as taught by Morris. The skilled would have envisioned employing the IPSS scoring system to select individuals with varying risks of the disease. The motivation, provided by Greenburg, teaches IPSS is an important standard for assessing prognosis of primary untreated adult patients with myelodysplastic syndromes.
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Conclusion
Claims 16 and 20-31 are not allowed.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/Primary Examiner, Art Unit 1622
Prosecution Insights