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 .
Claims Status
The amendments and remarks filed 10/16/2025 are acknowledged.
Claims 3, 7, 46-48, 52-56, 58-59, 61-64, 66-71, 88, and 104-105 are pending.
Claims 1-2, 4-6, 8-45, 49-51, 57, 60, 65, 72-87, 89-103,and 106-112 are canceled.
Claim 54 is amended.
Election/Restrictions
Applicant’s election of Group I, claims 3, 7, 52-56, 58-59, 61-64, 66-71, 88, and 104-105, and Applicant’s election of ado-trastuzumab emtansine (T-DM1) for the species of anti-HER2 antibody-drug conjugate in the reply filed on 10/16/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction and election of species requirement, these elections have been treated as elections without traverse (MPEP § 818.01(a)).
Applicant's election with traverse of the following species in the reply filed on 10/16/2025 is acknowledged: 300 mg twice daily for the dosing of tucatinib, and 3.6 mg/kg every 21 days (3 weeks) for the dosing of the anti-HER2 antibody-drug conjugate. The traversal is on the grounds that Applicant does not believe the specific dosing for the tucatinib and the anti-HER2 antibody-drug conjugate limit the ability to search Group I. This is not found persuasive because, as explained in the requirement for restriction mailed 08/19/2025, the species do not share the same or corresponding technical feature because they encompass different doses and dosing schedules for both the tucatinib and the anti-HER2 antibody-drug conjugate, which thus, have different modes of operation and would require different fields of search.
The requirement is still deemed proper and is therefore made FINAL. Therefore,
Claims 46-48, 58-59, 63-64, 71, and 105 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and/or species there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/16/2025.
Therefore, claims 3, 7, 52-56, 61-62, 66-70, 88, and 104 are under examination.
Note: Applicant indicated claims 52 and 54 as withdrawn, but claim 52 is the parent claim for claims 53 and 54, and claims 52-54 encompass the elected species (i.e. 300 mg twice daily of tucatinib). Applicant also indicated claim 61 as withdrawn but it is the parent claim for claim 62 and encompasses the elected species (i.e. 3.6 mg/kg for the anti-HER2 antibody-drug conjugate). Applicant additionally indicated claim 66 as withdrawn but it is the parent claim for claim 67 and encompasses the elected species (i.e. 3.6 mg/kg every 21 days (3 weeks) for the anti-HER2 antibody-drug conjugate). Therefore, while Applicant has indicated claims 52, 54, 61, and 66 as withdrawn, the Examiner has not withdrawn these claims and they will be examined as they encompass the elected species.
Priority
The instant application is a 371 of PCT/US2020/060431 and claims priority to provisional applications 62/935,989, 62/945,321, and 63/071,800. Priority is given with the earliest effective filing date of 11/15/2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/12/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Notably, the disclosure statement filed lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Drawings
The drawings are objected to because:
(1) Figures 1, 2B, 8, and 10 comprise multiple panels. 37 CFR 1.84(u) states that the different views must be numbered in consecutive Arabic numerals and that "partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter". Each panel should be separately numbered.
(2) Figures 1, 3, 7, and 10 have pixelated backgrounds. 37 CFR 1.84(a)(1) which requires that “india ink, or its equivalent that secures solid black lines, must be used for
drawings”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see paragraph 219 of the specification]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 3 is objected to because of the following informalities: Claim 3 recites an acronym (i.e. HER2). The first time an acronym is used, it must be accompanied by the definition of the abbreviation. Appropriate correction is required.
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.
Claims 52-53, 56, 61-62, and 66-67 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.
Claims 52-53, 56, 61-62, and 66-67 recite “about”. Applicant has provided an explicit definition for “about” meaning “an acceptable degree of error for the quantity measured given the nature or precision of the measurements” [see paragraph 083] of the specification]. However, the metes and bounds for “about” are dependent on the interpretation of others for determining what is an “acceptable” error range. Given a single value, one person of ordinary skill in the art could determine that the value is acceptably in the error range. However, another person of ordinary skill in the art could determine that it is unacceptable, leading to two different interpretations on if the claim infringes with “about.” Therefore, these claims are indefinite. The Examiner recommends amending the claims to remove the “about” to overcome the rejections.
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.
Claims 3, 7, 52-56, 61-62, 66-70, 88, and 104 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Borges et al., 2018 (12/12/2022 IDS).
Regarding claims 3 and 104, Borges teaches administering tucatinib and ado-trastuzumab emtansine (T-DM1; anti-HER2 antibody-drug conjugate) to patients with ERBB2/HER2-positive metastatic breast cancer, and the combination had acceptable toxicity and antitumor activity [see Abstract]. Borges further teaches that patients treated with tucatinib plus T-DM1 had a median progression-free survival of 8.2 months (at least 7.5 months) [page 1218, right column, second paragraph]. Since Borges teaches that the combination of tucatinib and T-DM1 had antitumor activity, then an effective amount of the combination therapy was necessarily administered.
Regarding claim 7, Borges teaches administering the combination of tucatinib and T-DM1 to patients with both HER2 positive breast cancer and brain metastases [see Abstract and page 1217, Table 1].
Regarding claims 52-56, Borges teaches administering the tucatinib at a dose of 300 mg twice daily for 21 days, which is the maximum tolerated dosage [see Abstract and page 1219, left column, third paragraph].
Regarding claims 61-62 and 66-67, Borges teaches administering 3.6 mg/kg T-DM1 once every 21 days (i.e. once every 3 weeks) [see Abstract].
Regarding claims 68-70, Borges teaches administering tucatinib at a dose of 300 mg twice daily for 21 days and administering T-DM1 3.6 mg/kg once every 21 days (i.e. 21 day treatment cycle) [see Abstract, Interventions section].
Regarding claim 88, Borges teaches administering tucatinib and T-DM1 to 57 patients with ERBB2/HER2-posiitve metastatic breast cancer, and the combination had acceptable toxicity and antitumor activity [see Abstract]. Borges further teaches that 32 of the 57 patients administered the combination therapy required interruption of tucatinib treatment due to adverse events, but that tucatinib therapy was successfully reinitiated for 22 of the 32 patients, 18 of whom underwent a dosage reduction [page 1217, right column, second-third paragraphs].
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to
applicant's disclosure.
A. Clinical Trial NCT01983501 (instant PTO-892)
- This is pertinent art to the instant application because the clinical trial teaches administering tucatinib combined with ado-trastuzumab emtansine (anti-HER2 antibody-drug conjugate) to patients with HER2+ breast cancer.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675