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 1-3 and 15-31 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of the species of Compound I in the Example 1, disclosed on pages 13 and 15 of the instant specification (reproduced below),
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in the reply filed on June 5, 2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statements filed on March 12, 2024,
July 7, 2025 and July 9, 2026. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 1-3 and 22-24 are objected to because of the following informalities:
in claim 1, an “and” should be added after the definition of variable “n”;
in claim 2, an “and” should be added after the definition of variable “n”;
in claim 3, an “and” should be added after the definition of variable “n”;
in claim 22, an “and” should be added after the definition of variable “n”;
in claim 23, an “and” should be added after the definition of variable “n”; and
in claim 24, an “and” should be added after the definition of variable “n”.
Appropriate correction is required.
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 17 and 25 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.
Claim 17 lacks antecedent basis from claim 16 because there is no earlier recitation in claim 16 for the compound Tucatinib as listed in claim 17. Tucatinib has the chemical structure,
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. Claim 16 does not state that the instant R3 variable can represent the substituent,
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, as found in Tucatinib in instant claim 17. Therefore, claim 17 is indefinite.
Claim 17 lacks antecedent basis from claim 16 because there is no earlier recitation in claim 16 for the last compound listed in instant claim 17. Claim 16 does not state that the instant R3 variable can represent the substituent,
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, when n is 2 as found in the last compound listed in instant claim 17. Therefore, claim 17 is indefinite.
Regarding claims 25 and 28, the phrases “preferably” and “further preferably”, all occurrences, renders the claims indefinite because it is unclear whether the limitation(s) following these phrases are part of the claimed invention. See MPEP § 2173.05(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.
Claim 17 is 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.
Claim 17 fails to further limit claim 16 because claim 17 is broader in scope than claim 16 for two reasons. Firstly, claim 16 does not state that the instant R3 variable can represent the substituent,
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, as found in Tucatinib in instant claim 17. Secondly, claim 16 does not state that the instant R3 variable can represent the substituent,
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, when n is 2 as found in the last compound listed in instant claim 17.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-3 and 15-31 are rejected on the ground of nonstatutory double patenting as being unpatentable:
over claims 1-8 and 11-17 of U.S. Patent No. 10,828,305 (see especially the compounds in claim 8); and
over claims 1-24 of U.S. Patent No. 11,578,074 (see especially the compounds claim 22).
Although the claims at issue are not identical, they are not patentably distinct from each other because each of the U.S. Patents claim compounds that anticipate instant Chemical formula 1. See, for example, the 4th compound claimed in columns 253-254 in claim 8 of U.S. Patent No. 10,828,305, which is the same as the Compound on page 7, column 1, row 3 in instant claim 17. Also see the compound in column 215, lines 30-40 in claim 22 of U.S. Patent No. 11,578,074 (which compound in this U.S. Patent is the same as the elected species of Compound I in Example 1 in the instant application). Claims 15-17 in U.S. Patent No. 10,828,305 claims a method for inhibiting ErbB2 receptor tyrosine kinase which is being administered for the treatment of breast cancer or gastric cancer. U.S. Patent No. 11,578,074 discloses that the claimed compounds have high inhibitory activity on ErbB2 tyrosine kinase and have good inhibitory activity on human breast cancer cell and human gastric cancer cell (column 2, lines 8-16). Milgram et al. {US 2023/0364070} disclose that ErbB2 is also known as HER2 {paragraphs [0003] and [0007] on page 1}. Milgram et al. disclose that it is already known in the HER2-associated cancer art that breast cancer, for instance, has been associated with mutations D769H, D769Y, V777L and R896C (see Amino Acid Positions 769, 777 and 896, respectively, in Table 3 on page 260 of Milgram et al.).
The instant application and each of the above cited U.S. Patents share at least one common inventor. Further, the instant application is not related to any of the above cited U.S. Patents and thus, no 35 USC 121 shield exists here. See MPEP §804.01. Therefore, the claims in each of the above cited U.S. Patents anticipate and/or render obvious the instant claimed invention.
Claims 1-3 and 15-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 11-20 of copending Application No. 18/839,040 (reference application), US 2025/0163053. Although the claims at issue are not identical, they are not patentably distinct from each other because copending Application No. 18/839,040 claims crystal form C of Compound 1, which Compound 1 in this copending application is a crystalline form of the elected species of Compound I in Example 1 in the instant application. Copending Application No. 18/839,040 also claims a method for inhibiting ErbB2 receptor tyrosine kinase comprising administering crystal form C of Compound 1 to a subject (claim 14) as well as treating cancer, such as breast cancer (claims 12 and 13). Milgram et al. {US 2023/0364070} disclose that ErbB2 is also known as HER2 {paragraphs [0003] and [0007] on page 1}. Milgram et al. disclose that it is already known in the HER2-associated cancer art that breast cancer, for instance, has been associated with mutations D769H, D769Y, V777L and R896C (see Amino Acid Positions 769, 777 and 896, respectively, in Table 3 on page 260 of Milgram et al.).
The instant application and copending Application No. 18/839,040 share at least one common inventor. Further, the instant application is not related to copending Application No. 18/839,040 and thus, no
35 USC 121 shield exists here. See MPEP §804.01. Therefore, the claims in copending Application No. 18/839,040 anticipate and/or render obvious the instant claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. However, copending Application No. 18/839,040 has now been allowed but has not yet been patented as of the time of this Office Action.
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 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.
Claims 1-3 and 15-31 are rejected under
35 U.S.C. 102(a)(1) as being anticipated by:
Xia et al. {WO 2019/042409 A1 – a machine generated English translation has been provided with this Office Action} – who disclose that his compounds (such as Example 44 in paragraph [0809] on page 77 of the provided English translation) have high inhibitory activity on ErbB2 tyrosine kinase and have good inhibitory activity on human breast cancer cell and human gastric cancer cell {paragraph [0008] on page 2 of the provided English translation}
[a compound of instant Chemical formula 1,
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wherein
R1 = C1 alkyl (i.e., methyl);
R2 =
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;
one R3 =
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and the
other R3 =
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; and
n = 2];
Xia et al. {WO 2017/148391 A1 – a machine generated English translation has been provided with this Office Action} – who disclose a method for inhibiting ErbB2 receptor tyrosine kinase for the treatment of breast cancer or gastric cancer by administering to a subject, for instance, the Compound in paragraph [0187], row 1, column 2, on page 23 of the provided English translation,
[a compound of instant Chemical formula 1,
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wherein
R1 = C1 alkyl (i.e., methyl);
R2 =
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;
R3 =
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; and
n = 1]; and
Li et al. {Journal of Medicinal Chemistry (March 23, 2022), 65(7), 5334-5354} – who disclose, for instance, that compound SPH 5030 showed excellent activities against four frequent kinds of HER2 mutants and significant in vivo antitumor efficacy (see the Abstract on page 5334 and the “Conclusions” on page 5344),
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[a compound of instant Chemical formula 1,
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wherein
R1 = C1 alkyl (i.e., methyl);
R2 =
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;
one R3 =
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and the
other R3 =
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; and
n = 2].
Example 44 in Xia et al. {WO 2019/042409 A1} and compound SPH 5030 in Li et al. is the same compound as the elected species of the instant application. The compound disclosed in paragraph [0187], row 1, column 2, on page 23 of Xia et al. {WO 2017/148391 A1 is the same compound as found in instant claim 17 on page 7, 3rd row, 1st column. Milgram et al. {US 2023/0364070} disclose that ErbB2 is also known as HER2 {paragraphs [0003] and [0007] on page 1}. Milgram et al. disclose that it is already known in the HER2-associated cancer art that breast cancer, for instance, has been associated with mutations D769H, D769Y, V777L and R896C (see Amino Acid Positions 769, 777 and 896, respectively, in Table 3 on page 260 of Milgram et al.). A compound and its properties are inseparable. In re Papesch, 137 USPQ 43 (CCPA 1963). See MPEP §2112.01(I) and (II). Therefore, each of the above cited prior art anticipate the instant claimed invention.
The elected species of Compound I in the Example 1, (disclosed on pages 13 and 15 of the instant specification), is not allowable for the instant claimed methods of use. See, for instance, Example 44 in Xia et al. {WO 2019/042409 A1}.
Reminder to Applicant
As a reminder, Applicant should specifically point out the support in the original disclosure {i.e., page number(s) and line number(s)} for any new claims or amended claims and for any amendments made to the disclosure. Making generic statements such as “all amendments are fully supported in the originally filed disclosure or the originally filed claims” without specifying page numbers and originally filed claim numbers are insufficient. See MPEP §714.02 and MPEP §2163.06(I).
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to:
Laura L. Stockton
(571) 272-0710.
The examiner can normally be reached on Monday-Friday from 8:30 am to 6 pm, Eastern Standard Time.
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 acting 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.
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.
/LAURA L STOCKTON/ Primary Examiner, Art Unit 1626 Work Group 1620
Technology Center 1600
August 3, 2026
Book XXIX, page 57
Prosecution Insights