DETAILED ACTION
Notice of AIA Status
The instant application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ).
Status of the Claims
The listing of claims filed in a preliminary amendment on 12 October 2023 has been examined. Claims 1–12 are pending. Claims 6 and 10 are amended. Claim 12 is new.
Priority
The instant application was filed 12 October 2023; is a national stage application of PCT/KR2022/005404, filed 14 April 2022, and claims priority to KR 10-2021-0048767, filed 14 April 2021. Applicant’s claim for foreign priority is acknowledged, and a copy of the priority document has been received.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12 October 2023; 6 November 2024; and 2 December 2025 are acknowledged and have been considered.
Objections to the Abstract
The abstract of the disclosure is objected to because it recites phrases that can be implied (“The present invention relates to”), terms referring to purported merits of the invention (“novel”), and legal phraseology (“wherein”).
Appropriate correction is required.
For guidelines for the preparation of patent abstracts, see MPEP § 608.01(b) (Explaining: The abstract should be in narrative form and avoid legal phraseology (e.g., means, said), terms referring to purported merits of the invention (e.g., new, novel), and phrases that can be implied (e.g., The disclosure concerns, The disclosure defined by this invention). The language should be clear and concise, and not repeat information given in the title. It should not compare the invention with the prior art. The abstract is generally limited to a single paragraph within the range of 50 to 150 words in length.).
Examiner recommends the following language:
“A method for preparing a compound represented by Formula 4,
PNG
media_image1.png
111
190
media_image1.png
Greyscale
, which can be used for the synthesis of a sphingosine-1-phosphate receptor agonist.”
Objections to the Specification
The specification is objected to because it contains illegible text. For example, the text associated with the structures on pages 3–5, 8, and 22 is blurry and could not be reproduced in the pre-grant publication of the application, US 2024/0228441 A1, as shown below.
PNG
media_image2.png
22
171
media_image2.png
Greyscale
PNG
media_image3.png
308
286
media_image3.png
Greyscale
PNG
media_image4.png
423
274
media_image4.png
Greyscale
PNG
media_image5.png
369
309
media_image5.png
Greyscale
PNG
media_image6.png
398
262
media_image6.png
Greyscale
If this application for patent were to be granted, the issue may delay publication of the patent.
Appropriate correction is required.
Claim Objections
Claim 3 is objected to for minor informalities.
Claim 3 recites, “wherein in step 1), the alkoxide includes the same alkyl group as the alkyl group of the alcohol-based solvent (emphasis added).”
Claim 3 depends from claim 1.
Claim 1 does not refer to an alcohol-based solvent comprising an alkyl group. And while “alkoxide” inherently includes an alkyl group, “alcohol-based solvent” does not. For example, toluene includes an alcohol but does not include an alkyl group.
A claim introducing subject matter for the first time typically recites indefinite article “a” preceding the subject matter. The same claim or a subsequent claim referring back to the same subject matter typically recites definite article “the” preceding the subject matter. Such formal claim drafting provides proper antecedent basis for the claimed subject matter and avoids ambiguity, therefore improving the clarity of the claims.
Appropriate correction is required.
Examiner suggest amending claim 3 to correct the informalities; for example, “wherein in step 1), the alcohol-based solvent includes an alkyl group and the alkoxide includes the same alkyl group as the alkyl group of the alcohol-based solvent.”
Claim Rejections - 35 U.S.C. § 112
The following is a quotation 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.
Claims 10–12 are rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. The claims contain subject matter that was not described in the Specification in such a way as to reasonably convey to one of ordinary skill in the art that Applicant, at the time the application was filed, had possession of the claimed invention.
In Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), the Federal Circuit stated “the hallmark of written description is disclosure.” A specification adequately describes an invention when it “reasonably conveys to those skilled in the art the inventor had possession of the claimed subject matter as of the filing date.” (Id.). “A ‘mere wish or plan’ for obtaining the claimed invention is not adequate written description.” Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1348 (Fed. Cir. 2011).
What is required to meet the written description requirement “varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). In Ariad, the Federal Circuit explained what is required to meet the written description requirement:
This inquiry, as we have long held, is a question of fact. Ralston Purina, 772 F.2d at 575. Thus, we have recognized that determining whether a patent complies with the written description requirement will necessarily vary depending on the context. Capon v. Eshhar, 418 F.3d 1349, 1357–58 (Fed. Cir. 2005). Specifically, the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Id. For generic claims, we have set forth a number of factors for evaluating the adequacy of the disclosure, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue.” Id. at 1359.
(Ariad, at 1351).
The written description of a genus, such as a chemical genus, “requires a precise structure, formula, [or] chemical name” of the claimed subject matter sufficient to distinguish it from other materials. Regents of the Univ. of Cal. v. Eli Lilly & Co., 199 F.3d 1559, 1568 (Fed. Cir. 1997). The Federal Circuit commented on that case in the Ariad decision:
We held that a sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. at 1568-69. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. Id. at 1568 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993)). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001)). But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
(Ariad, at 1350).
The factors outlined in the above Federal Circuit cases are analyzed with respect to the claimed invention in turn below.
(A) The nature and scope of the claim invention in view of the specification: Claim 10 is directed to a method of preparing a compound of Formula 2,
PNG
media_image7.png
147
188
media_image7.png
Greyscale
, from a compound of Formula 5,
PNG
media_image8.png
126
152
media_image8.png
Greyscale
, including a step of “introducing R1 and R2 substituents.” R1 and R2 can be H, alkyl, halogen, CN, CF3, or COCF3.
Claim 10 does not provide reagents or conditions for preparing a compound of Formula 2 from a compound of Formula 5 when R1 and R2 are alkyl, halogen, CN, CF3, or COCF3 [NB: hydrogen (H) is not a substituent and does not require a reaction].
The specification discusses the solvent for preparing a compound of Formula 2 from a compound of Formula 5, and certain potential issues with the solvent of choice when preparing a compound when R2 is chlorine. (Sub. Spec., ¶¶131–143).
The specification discloses reaction conditions for preparing a compound of Formula 2 from a compound of Formula 5 when R1 is H or alkyl, and when R2 is chlorine. (Id., ¶¶159–168), Example 1-1).
The specification does not disclose reaction conditions for preparing a compound of Formula 2 from a compound of Formula 5 when R1 and R2 are CN, CF3, or COCF3.
In view of the above, the nature of the claimed invention is sophisticated, and the scope of the claims is not commensurate with the scope of the disclosure.
(B) The extent and content of the prior art: Examiner is not aware of prior art that shows the claimed but not described subject matter would have been known or obvious to one of ordinary skill in the art. Accordingly, Applicant’s disclosure is critical to show possession.
(C) The maturity of the science or technology: the reduction of an aromatic ester to a benzyl alcohol using a reducing agent such as sodium borohydride is generally known in the art. The use of a reducing agent such as sodium borohydride in an alcohol solvent in the presence of an alkoxide is known in the art. See, e.g., Prasanth et al., J. Org. Chem. (2018), 83, 1431–1440 [IDS]. But the reduction of a compound of Formula 5 when R1 and R2 are CN, CF3, or COCF3 to obtain a compound of Formula 2 is novel. As such, the science relevant to the claimed invention is in its infancy.
(D) The predictability of the aspect at issue: the chemical art is generally recognized as unpredictable. In re Fisher, 427 F.2d 833, 839 (CCPA 1970). The more unpredictable an area is the more specific disclosure is necessary to satisfy the statutory requirement. In this case, there is nothing to suggest the claimed invention is more predictable than the chemical art is generally.
The question of written description
When the above factors and evidence discussed therein are considered as a whole, the specification (in view of the prior art) does not adequately describe the claimed process for preparing a compound of Formula 2 from a compound of Formula 5 when R1 and R2 are CN, CF3, or COCF3. The nature of the claimed invention is sophisticated, the scope of the claims is not commensurate with the scope of the disclosure, the prior art does not substitute for disclosure, the science relevant to the claimed invention is in its infancy, and the chemical is generally unpredictable. Accordingly, the Specification would not reasonably convey to those skilled in the art the inventor had possession of the claimed subject matter as of the filing date.
Appropriate correction is required.
Allowable Subject Matter
Claims 1, 2, and 4–9 are allowed. The claims are directed to a process of preparing a compound of Formula 4 from a compound of Formula 2 via a compound of Formula 3. Close prior art includes WO2014/129796 [IDS], which on page 20 discloses a process of preparing a compound of Formula 3 from a compound of Formula 2 using sodium borohydride or other reducing agents; however, the reference does not disclose or suggest the subsequent conversion of a compound of Formula 3 to a compound of Formula 4.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
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 submit an Automated Interview Request: http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached on 571-270-7674.
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.
/J.M.N./Patent Examiner, Art Unit 1623 /GEORGE W KOSTURKO/ Primary Examiner, Art Unit 1621
Prosecution Insights