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 ACTION
Claims 1-10 are pending in the application. Claims 1 and 6-10 are rejected. Claims 2-5 are objected to.
Priority
This application is a 35 U.S.C. 371 National Stage Filing of International Application No. PCT/KR2023/002638, filed February 24th, 2023, which claims priority under 35 U.S.C. 119(a-d) to KR10-2022-0024800 and KR10-2022-0077699, filed February 25th, 2022 and June 24th, 2022.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement(s) filed on November 26th, 2025, August 5th, 2025 and August 22nd, 2024.
Specification
The amendment filed August 29th, 2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “the disclosures of which are incorporated herein in their entirety by reference” with respect to the foreign priority documents.
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Applicant is directed to MPEP 211.02 (I), which particularly addresses incorporation by references filed after a filing date as follows:
For applications filed on or after September 21, 2004, a claim under 35 U.S.C. 119(e) or 120 and 37 CFR 1.78 for benefit of a prior-filed provisional application, nonprovisional application, or international application designating the United States that was present on the filing date of the continuation or divisional application, or the nonprovisional application claiming benefit of a prior-filed provisional application, is considered an incorporation by reference of the prior-filed application as to inadvertently omitted material, subject to the conditions and requirements of 37 CFR 1.57(a). The purpose of 37 CFR 1.57(a) is to provide a safeguard for applicants when all or a portion of the specification and/or drawing(s) is (are) inadvertently omitted from an application. See MPEP §201.06 and 201.17. However, applicants are encouraged to provide in the specification an explicit incorporation by reference statement to the prior-filed application(s) for which benefit is claimed under 35 U.S.C. 119(e) or 120 if applicants do not wish the incorporation by reference to be limited to inadvertently omitted material pursuant to 37 CFR 1.57(a). See 37 CFR 1.57(b). Se MPEP §§ 201.17 and 608.01(p).
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When a benefit claim is submitted after the filing of an application, and the later-filed application as filed did not incorporate the prior-filed application by reference, applicant cannot add an incorporation by reference statement of the prior application. An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)).
See Dart Indus. v. Banner, 636 F.2d 684, 207 USPQ 273 (C.A.D.C. 1980). See also 37 CFR 1.57(a).
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In the instant application, the incorporation by reference statement is being added after the application's filing date (PCT filing date of February 24th, 2023) which is after September 21st, 2004 when there was a rule change. Therefore, the “incorporation by reference” being added to the specification per the Amendment filed August 29th, 2024 is deemed new matter.
Claim Objections
It is suggested that Applicant amend claim 6 to replace “the resulting product” with “the dried organic layer”. While the Examiner finds the reference to the “product” is only amendable to one interpretation, the proposed amendment would avoid lack of explicit antecedent basis.
Claim Rejections - 35 USC § 112(b)
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 6 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 6 recites the limitation "the solution prepared in (a)" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 2 recites that step (a) concludes with “heating the resulting mixture” such that the product produced by step (a) would not appear to necessarily be a solution. While step (a) begins with “dissolving,” there is no requirement that a solution necessarily be obtained at the end of step (a). It is suggested that Applicant amend claim 2 to replace “the resulting mixture” with “a resulting solution”.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7-10 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Each of these claims is ultimately dependent upon claim 1 and each embraces the optional formation of a pharmaceutically acceptable salt, which option is not recited in claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1 and 7-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 10 of copending Application No. 18/841,330 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending case recite compositions or methods of using the compound of instant claim 1. Claim 10 of the copending case recites a composition comprising a compound of instant claim 1. Regarding instant claims 7-10, these claims embrace both the treatment and prevention of conditions such that any subject would either have a particular condition or be a candidate for prevention. Since the instant claims do not otherwise place any limitations on the subject, the methods of the copending case would anticipate the instant claims irrespective of the subject being treated.
Furthermore, since the instant application and copending case claim priority to PCT applications filed on February 24th, 2023, the instant provisional rejection will not be withdrawn if it is the last remaining rejection in the instant application. See MPEP 804(I)(B)(1)(b)(ii).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 2-5 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Closest Prior Art
The closest prior art appears to be U.S. Patent No. 8,927,725 by Greig et al., which discloses compounds of the following general formula in column 2:
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The prior art teaches that each of the R variables can be (among others) hydrogen and that each of A, B, D, and E can be oxygen or sulfur. Accordingly, the prior art structure is generic to the instantly claimed compound. The closest prior art example in Greig et al. is disclosed in column 11 as follows:
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The prior art teaches in column 9, lines 42-53, that the compounds (of the genus above) are derivates of pomalidomide, which has the following structure:
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The structure above appears to be the closest prior art (as a whole) compound since it only possesses a difference of =O vs =S relative to the instantly claimed compound, which is frequently cited as a type of bioisosteric replacement. A bioisosteric replacement is generally based on the assumption that compounds with similar structures will possess similar properties. During the prosecution of the application that led to the ‘725 patent, however, an inventor filed a declaration (dated April 14th, 2014) addressing bioisoseric replacements and stated the following:
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The declaration then alleges that such replacements on pomalidomide analogs may (paragraph 7) “dramatically and unexpectedly modify” the properties thereof. The tested compounds in the declaration, however, all contained sulfur at either the B and/or D positions of the generic structure above. First, the declaration itself is a publicly accessible document and must be considered as part of the prior art as a whole. The declaration itself establishes two key aspects: (1) the replacement of oxygen with sulfur was not predictable for pomalidomide analogs and (2) the authors of the prior art were particularly focused on compounds having the B and/or D positions modified. Regarding evidence for the particular position modified relative to pomalidomide to arrive at the instant claims, Zhu et al. (J. Med. Chem. 2003, 46, 5222-5229) tested isosteric replacements on thalidomide having the following structure:
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Zhu et al. specifically tested the following compound having the analogous single replacement of one oxygen for sulfur:
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The authors provided the following conclusion on page 5226:
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Zhu et al. further describe the results for compound No. 12 on page 5225 as marginal:
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Accordingly, any case for obviousness would require overlooking the disclosure of Greig et al. and the declaration of Greig that focus largely on the presence of sulfur on the piperidine ring and further demonstrate substantial unpredictability. Similarly, a case for obviousness would require overlooking the demonstrations of Zhu et al. where the analogous single sulfur replacement produced only marginal results.
The instant specification contains comparison data between pomalidomide and the instantly claimed compound. For instance, the specification discloses the following on page 38:
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Even assuming that a person having ordinary skill in the art would have been motivated to modify pomalidomide to contain sulfur at the 3-position, such a motivation would be based on an expectation of obtaining a compound with similar properties rather than a compound having a 10-fold difference in at least one property. The prior art fails establish a 10-fold difference would be expected for the particular structural difference between pomalidomide and the instant compound of claim 1.
For these reasons, the Examiner finds the prior art as a whole fails to support an obviousness rejection over instant claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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