DETAILED ACTION
Claims 1-13 are currently pending in the instant application and are rejected. Claim 5 is 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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “Fig. 1” and “A”, “B”, “C”, and “D.” Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Specifically, the amendment to the specification filed 8 November 2024, deleted “FIG. 1” reference from the specification and inserted “FIGURE” with no mention of what figure number. Additionally, views “A”-“D” are not discussed in the specification.
Specification
The disclosure is objected to because of the following informalities:
The Preliminary Amendment filed 8 November 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: “which is incorporated herein by reference in its 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 22 November 2022. The incorporation by reference statement is being added by way of a Preliminary Amendment filed 8 November 2024, which is after the instant application's International filing date of 22 November 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.
Claim Objections
Claim 5 is objected to because of the following informalities: Claim 5 reads “A pharmaceutical composition, wherein comprising the compound…” The word “wherein” should be deleted. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 6-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Claims 6-13 are improper “use” claims. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the “use” claims are not within one of the 4 categories of invention. According to MPEP 2173.05(q); “Use” claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)(“one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101”). In Ex parteDunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: “The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction.” In Clinical Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), the district court held the following claim was definite, but that it was not a proper process claim under 35 U.S.C. 101: “The use of a sustained release therapeutic agent in the body of ephedrine absorbed upon polystyrene sulfonic acid.”
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 1-13 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 compounds of the formula (I) and (II) or pharmaceutical salts of compounds of the formula I or II does not reasonably provide enablement for an isomer thereof 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 or use the invention commensurate in scope with these claims.
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. § 112, first paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
The nature of the invention
The nature of the invention is a 5-pyridine-1-H-indazole compound of the formula I or II or an isomer, pharmaceutically acceptable salt thereof, or a mixture thereof.
The state of the prior art and the predictability or lack thereof in the art
The state of the prior art is that an isomer is any compound having the same composition, including constitutional isomers, which are compounds whose atoms are connected differently. Constitutional isomers can contain different functional groups in varying positions.
The amount of direction or guidance present and the presence or absence of working examples
The only direction or guidance present in the instant specification is for compounds of formula I or II and the pharmaceutically acceptable salts thereof, see page 7 which provides a list of pharmaceutically acceptable salts.
There is no data present in the instant specification for the preparation or utility of constitutional isomers or any isomer.
The breadth of the claims
The instant breadth of the rejected claims is broader than the disclosure, specifically, the instant claims include any isomer, i.e. any compound with the same number of each atom, and the disclosure does not provide any data for any type of isomer.
The quantity or experimentation needed and the level of skill in the art
While the level of the skill in the pharmaceutical arts is high, it would require undue experimentation of one of ordinary skill in the art to prepare any isomer as instantly claimed since an isomer of the compounds need only have the same composition of atoms, not necessarily the same order of atoms and can have varying functional groups in varying positions. Therefore, the claims lack enablement for isomers.
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 6-13 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. Specifically, claims 6-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: how to use the pharmaceutical composition in the preparation of an inhibitor drug. Specifically, because attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: “[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon” was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parteErlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims. See In rePrater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to impart limitations to the claim that are not recited in the claim.
It is appropriate to reject a claim that recites a use but fails to recite steps under 35 U.S.C. 101 and 35 U.S.C. 112(b)
Claims 1-13 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 claim 1 has states “A 5-pyridine-iH-indazole compound, having a structure of formula I or II, wherein the compound further comprises an isomer thereof, a pharmaceutically acceptable salt thereof, or a mixture thereof…” In the mentioned phrase, 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 how the compounds can comprise something different or larger than the compound itself. Accordingly, the metes and bounds of this claim is unclear, which rendered this claim indefinite. The term “comprising” 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. 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 "comprising" is synonymous with "including", "containing", and "characterized by". "Comprising" 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 claim 1 compound which “comprises” 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 1-13
Regarding claims 2-13 these claims are dependent of claim 1, and they failed to correct the indefiniteness issue of claim 1, which rendered these claims indefinite.
Claims 1 and 4-13 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. Specifically, claim 1 defines R1 as:
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. As the definition of R1 has an “or” and a colon “:” and an additional “or”, it is unclear what variables are “R1” and what variables are the substituents on R1. The paragraph above can be read multiple ways.
R1 is hydrogen, linear or branched C1-10 alkyl, phenyl, a 4-6 membered heterocyclic ring, or a 4-6 membered ring. This R1 is then substituted with one or more of hydrogen, methoxy, trifluoromethyl, nitro, hydroxy, amino, azido, sulfonic acid group, or 3-6 membered ring.
R1 is hydrogen, halogen, methoxy, trifluoromethyl, nitro, hydroxy, amino, azido, sulfonic acid group, or 3-6 membered ring. This R1 is then substituted with one or more of hydrogen, linear or branched C1-10 alkyl, phenyl, a 4-6 membered heterocyclic ring, or a 4-6 membered ring.
The definition of R1 is also indefinite as it is stated that R1 is substituted with one or more, however, hydrogen cannot have a substituent attached to it. When looking at claim 2 for clarification, or the specification paragraph [0016], the claim 1 is still considered indefinite as R1 is defined in claim 2 and in paragraph [0016] to include such as methyl or hydroxy. However, methyl is from linear or branched C1-C10 alkyl, which is after the colon, and hydroxy is from before the colon in the definition of R1. Therefore, claim 1 and its dependent claims 4-13 are considered indefinite as it is unclear what variable R1 is.
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 2 and 3 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. Claims 2 defines R1 as:
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. As discussed above in the 35 USC 112(b) rejection of claims 1 and 4-13, it is unclear if what is before the colon or what is after the colon is the variable R1. Claim 2 fails to limit claim 1 as claim 2 has definitions for R1 which are found before the colon and after the colon, such as methyl and hydroxy. However, methyl is from linear or branched C1-C10 alkyl, which is after the colon, and hydroxy is from before the colon in the definition of R1. Therefore, claim 2 fails to limit parent claim 1 as either way claim 1 is interpreted, claim 2 has variable definitions for R1 outside the scope of R1 of parent claim 1. In regards to claim 3, claim 3 has compounds which vary with R1 and fall within both (1) and (2) ways of interpreting R1 in claim 1. The compound LH-002 has cyclopropyl, which falls within 3-6 membered ring which is before the colon in the definition of R1 in claim 1, however, claim 3 also has the compound LH-039 which has isobutyl, which falls within linear or branched C1-10alkyl, which is after the colon in the definition of R1 in claim 1. Therefore, claim 3 fails to limit parent claim 1 as either way claim 1 is interpreted, claim 3 has variable definitions for R1 outside the scope of R1 of parent claim 1.
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.
Claim(s)s 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 7,728,025.
US Patent No. 7,728,025 discloses the compound of example 156 on column 120:
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Pharmaceutical compositions are disclosed on columns 65 and 66.
The compound of example 156 has the formula:
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which has the molecular formula C25H22N6O2. This compound corresponds to an isomer of the compound LH-001 as seen in instant claim 3:
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which also has a molecular formula of C25H22N6O2.
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.
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, Andrew Kosar can be reached at 571-272-0913. 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.
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 20 August 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
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