DETAILED ACTION
Claims 7-26 and 33-35 are currently pending in the instant application. Claims 7-18 and 20-26 are rejected. Claims 19 and 33-35 are objected.
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 .
Specification
The disclosure is objected to because of the following informalities:
Each sequence that meets the minimum length threshold must have SEQ ID NO: in parenthesis next to each occurrence in the specification, i.e., (SEQ ID NO: 1). The Sequence Listing filed 3/20/2024 provides two sequences, however, no SEQ ID NOs are found in the specification.
The Table spanning pages 99-106 has multiple compounds that are illegible and missing. For example, see the structures of example 15:
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which is illegible. Most of the compounds in the table are illegible. Additionally, examples 21, 22, 29, 34, 89, 90, 114, 109 and 110 are missing.
The Preliminary Amendment filed 26 September 2023 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 hereby incorporated by reference in their entirety.”
MPEP 211.02 and MPEP 201.06(c)(IV) state the following in regard to “Incorporation by Reference” and PCT Rule 20.6, Rule 20.7 and Rule 4.18 are directed specifically to International applications:
MPEP 211.02, in-part
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, international application designating the United States, or international design 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(b). The purpose of 37 CFR 1.57(b) 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 217. 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(b). See 37 CFR 1.57(c). See also MPEP §§ 217 and MPEP § 608.01(p).
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(b).
MPEP 201.06(c)(IV), in-part
201.06(c) 37 CFR 1.53(b) and 37 CFR 1.63(d) Divisional-Continuation Procedure [R-07.2015]
IV. INCORPORATION BY REFERENCE
An applicant may incorporate by reference the prior application by including, in the continuing application-as-filed, an explicit statement that such specifically enumerated prior application or applications are “hereby incorporated by reference.” The statement must appear in the specification. See 37 CFR 1.57(c) and MPEP § 608.01(p). The inclusion of this incorporation by reference statement will permit an applicant to amend the continuing application to include subject matter from the prior application(s), without the need for a petition provided the continuing application is entitled to a filing date notwithstanding the incorporation by reference. For applications filed prior to September 21, 2004, the incorporation by reference statement may appear in the transmittal letter or in the specification. Note that for applications filed prior to September 21, 2004, if applicants used a former version of the transmittal letter form provided by the USPTO, the incorporation by reference statement could only be relied upon to add inadvertently omitted material to the continuation or divisional 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)). If an incorporation by reference statement is included in an amendment to the specification to add a benefit claim under 35 U.S.C. 120 after the filing date of the application, the amendment would not be proper. When a benefit claim under 35 U.S.C. 120 is submitted after the filing of an application, the reference to the prior application cannot include an incorporation by reference statement of the prior application. See Dart Indus. v. Banner, 636 F.2d 684, 207 USPQ 273 (C.A.D.C. 1980).
20.6 Confirmation of Incorporation by Reference of Elements and Parts
(a) The applicant may submit to the receiving Office, within the applicable time limit under Rule 20.7 , a written notice confirming that an element or part is incorporated by reference in the international application under Rule 4.18 , accompanied by:
(i) a sheet or sheets embodying the entire element as contained in the earlier application or embodying the part concerned;
(ii) where the applicant has not already complied with Rule 17.1(a) , (b) or (b-bis) in relation to the priority document, a copy of the earlier application as filed;
(iii) where the earlier application is not in the language in which the international application is filed, a translation of the earlier application into that language or, where a translation of the international application is required under Rule 12.3(a) or 12.4(a) , a translation of the earlier application into both the language in which the international application is filed and the language of that translation; and
(iv) in the case of a part of the description, claims or drawings, an indication as to where that part is contained in the earlier application and, where applicable, in any translation referred to in item (iii).
(b) Where the receiving Office finds that the requirements of Rule 4.18 and paragraph (a) have been complied with and that the element or part referred to in paragraph (a) is completely contained in the earlier application concerned, that element or part shall be considered to have been contained in the purported international application on the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office.
(c) Where the receiving Office finds that a requirement under Rule 4.18 or paragraph (a) has not been complied with or that the element or part referred to in paragraph (a) is not completely contained in the earlier application concerned, the receiving Office shall proceed as provided for in Rule 20.3(b)(i) , 20.5(b) , 20.5(c) , 20.5bis(b) or 20.5bis(c) , as the case may be.
20.7 Time Limit
(a) The applicable time limit referred to in Rules 20.3(a) and (b) , 20.4 , 20.5(a) , (b) and (c) , 20.5bis(a) , (b) and (c) , and 20.6(a) shall be:
(i) where an invitation under Rule 20.3(a) , 20.5(a) or 20.5bis(a) , as applicable, was sent to the applicant, two months from the date of the invitation;
(ii) where no such invitation was sent to the applicant, two months from the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office.
(b) Where neither a correction under Article 11(2) nor a notice under Rule 20.6(a) confirming the incorporation by reference of an element referred to in Article 11(1)(iii)(d) or (e) is received by the receiving Office prior to the expiration of the applicable time limit under paragraph (a), any such correction or notice received by that Office after the expiration of that time limit but before it sends a notification to the applicant under Rule 20.4(i) shall be considered to have been received within that time limit.
4.18 Statement of Incorporation by Reference
Where the international application, on the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office, claims the priority of an earlier application, the request may contain a statement that, where an element of the international application referred to in Article 11(1)(iii)(d) or (e) , or a part of the description, claims or drawings referred to in Rule 20.5(a) , or an element or part of the description, claims or drawings referred to in Rule 20.5bis(a) is not otherwise contained in the international application but is completely contained in the earlier application, that element or part is, subject to confirmation under Rule 20.6 , incorporated by reference in the international application for the purposes of Rule 20.6 . Such a statement, if not contained in the request on that date, may be added to the request if, and only if, it was otherwise contained in, or submitted with, the international application on that date.
The instant application is a 371 application which has an International filing date of 25 March 2022. The incorporation by reference statement is being added by way of a Preliminary Amendment filed 26 September 2023, which is after the instant application's International filing date of 25 March 2022. Therefore, the “incorporation by reference” statement being added to the instant specification by way of the Preliminary Amendment is deemed new matter.
Applicant is required to cancel the new matter in the reply to this Office Action.
Appropriate correction is required.
Claim Objections
Claim 19 is objected to because of the following informalities: There is unnecessary spacing between some compounds listed in claim 19, see page 13:
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Appropriate correction is required.
Claims 33-35 are objected to as being dependent upon an objected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims including the correction of the spacing in claim 19.
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.
Claims 7 and 14 and their dependent claims 8-13, 15-18, and 20-26 are 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.
. The instant claims 7 and 14 has multiple instances of the term “comprises” in the definition of the compound, for example:
Regarding claim 7, the claim recites the following phrases, for example:
In variable R1:
“5- to 10-membered heteroaryl wherein the heteroaryl moiety comprises one to five heteroatoms…”
“(5-to 10-membered heteroaryl)-(C1-C6)alkyl wherein the heteroaryl moiety comprises”
“(5-to 10-membered heteroaryl)-(C2-C6)alkenyl wherein the heteroaryl moiety comprises”
“(5- to 10-membered heteroaryloxy)-(C1-C6)alkyl wherein the heteroaryl moiety comprises”
“4- to 12-membered heterocycloalkyl wherein said heterocycloalkyl moiety comprises”
“(4- to 12-membered heterocycloalkyl)-C1-C6alkyl wherein aid heterocycloalkyl moiety comprises”
In variable R3
“4- to 12-membered heterocycloalkyl which is optionally fused with a 5-to 6-membered heteroaryl or phenyl and wherein said heterocycloalkyl comprises”
“(4-to 12-membered heterocycloalkyl)-C1-C6 alkyl wherein said heterocycloalkyl moiety comprises”
“5- to 10-membered heteroaryl comprising”
“(5- to 10-membered heteroaryl)-C1-C6 alkyl wherein the heteroaryl moiety comprises”
“(5- to 10-membered heteroaryl)-(C2-C6) alkenyl wherein the heteroaryl moiety comprises”
“(C6-C10 aryl)-(5- to 10-membered heteroaryl)-wherein the heteroaryl moiety comprises”
“(5- to 10-membered heteroaryloxy)-C1-C6 alkyl wherein the heteroaryl moiety comprises”
“(5- to 6-membered heteroaryl)-(5- to 6-membered heteroaryl)-wherein each heteroaryl moiety comprises”
“(4- to 7-membered heterocycloalkyl)-(5- to 6-membered heteroaryl)-wherein the heterocycloalkyl moiety comprises…and the heteroaryl moiety comprises”
“(5- to 6-membered heteroaryl)-(4- to 7-membered heterocycloalkyl)-wherein the heterocycloalky moiety comprises…and the heteroaryl moiety comprises…”
In variable R5
“4- to 7-membered heterocycloalkyl-wherein the heterocycloalky moiety comprises”
“5- to 6-membered heteroaryl- wherein the heteroaryl moiety comprises”
Regarding claim 14
“5- to 10-membered heteroaryl wherein the heteroaryl moiety comprises”
In the abovementioned phrases, the term, “comprises”, is open-ended and thus, does not exclude additional, unrecited elements, according to MPEP 2111.03(I). Subsequently, it is unclear to the Examiner whether the abovementioned heterocycloalkyl, heteroaryloxy and/or heteroaryl rings contain heteroatom(s) outside of the abovementioned recited heteroatoms (e.g. N, O, and S), such as phosphorus (P) or if a larger number of heteroatoms could be present and would read on the abovementioned limitations. Accordingly, the metes and bounds of this claim is unclear, which rendered this claim indefinite.
The term “comprises” or forms of the term are considered open-ended language and therefore include additional subject matter that is not described in the instant specification and is not particularly pointed out or distinctly claimed. The identity of the additional atoms or groups is unknown and how to determine the identity of the additional atoms or groups is not pointed out or distinctly claimed.
The term “compound” contradicts the open language "comprises." A "compound" is defined as a substance whose molecules consist of unlike elements and whose constituents cannot be separated by physical means. Grant & Hackh's Chemical Dictionary (5th Ed. 1987) at page 148. By contrast, a composition is defined as elements or compounds forming a material or produced from it by analysis. Id. In other words, a compound is a molecule with more than one element, and a composition is a mixture of two or more compounds or molecules.
The transitional term "comprises" is synonymous with "includes", "contains", and "characterized by". "Comprises" is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”).
Thus, a contradiction arises within the definition of instant discussed variables in claims 7 and 14 and their dependent claims 8-13, 15-18, and 20-26 because a "compound" requires a definite chemical formula, and the open-ended term "comprises" does not exclude unrecited elements. Furthermore, "comprises", used in conjunction with "compound" fails to articulate exactly what subject matter is excluded from the claimed scope of compounds, thereby rendering the scope of claims 7 and 14 and their dependent claims 8-13, 15-18, and 20-26 indefinite.
It is suggested that an amendment to change “comprises” to a form such as “with”, for example, “5- to 10-membered heteroaryl wherein the heteroaryl moiety comprises one to five heteroatoms…” and
“(5-to 10-membered heteroaryl)-(C1-C6)alkyl wherein the heteroaryl moiety comprises”
could be written as
-5- to 10-membered heteroaryl with one to five heteroatoms…in the heteroaryl moiety-
-(5- to 10-membered heteroaryl)-(C1-C6)alkyl with one to five heteroatoms… in the heteroaryl moiety-
Regarding claims 8-13, 15-18 and 20-26 these claims are dependent on claims 7 or 14, and they failed to correct the indefiniteness issue of claims 7 and 14, which renders these claims indefinite.
Claim 25 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 25 contains the trademark/trade names, for example, ULTOMIRIS, COVI-AMG, COVI DROPS, COVIGUARD, TAKHZYRO, ILARIS, ACTEMRA, KEVZARA. Please check claim 25 for other trademark/trade names as the ones provided are exemplary. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the additional therapeutic agents utilized in the claimed method and, accordingly, the identification/description is indefinite. Additionally, claim 25 has multiple additional therapeutic agents mentioned with parenthesis present, such as bamlanivimab (LY-ZCoV555), it is unclear if the parenthesis is an additional limitation, for example, only bamlanivimab from Lilly, or another name for the same compound. It is suggested that each additional therapeutic agent be mentioned only one way without parenthesis with additional names and excluding by trademark or trade name.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm.
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ December 16 2025
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600