DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-29 are pending in the instant invention. According to the Amendments to the Claims, filed March 22, 2024, claims 4-13, 18, 20, 22, 24, 25 and 27-29 were amended.
Status of Priority
This invention is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/US2022/045619, filed October 4, 2022, which claims priority under 35 U.S.C. § 119(e) to US Provisional Application No. 63/252,384, filed October 5, 2021.
Restrictions / Election of Species
The inventor’s or joint inventor’s provisional election of the following, without traverse, in the reply filed on June 2, 2026, is acknowledged: Group III - claims 3-13. Affirmation of this election must be made by the inventor or joint inventor in replying to this Office action.
Similarly, the inventor or joint inventor should further note that the requirement is still deemed proper and is therefore made FINAL.
Moreover, the inventor or joint inventor should further note that claims 1, 2 and 14-29 were withdrawn from further consideration, pursuant to 37 CFR 1.142(b), as being drawn to a nonelected or cancelled invention, there being no allowable generic or linking claim.
Thus, a first Office action and prosecution on the merits of claims 3-13 is contained within.
Specification Objection - Disclosure
The inventor or joint inventor is advised to format the specification according to 37 CFR 1.77(c). Revisions should particularly address bold-type, underline, and/or upper case formatting. Appropriate correction may be required.
Specification Objection - Title
The inventor or joint inventor is reminded of the proper content of the title of the invention.
The title of the invention should be brief, but technically accurate and descriptive and should contain fewer than 500 characters. See 37 CFR 1.72(a) and MPEP § 606.
The title of the invention is not technically accurate and descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. In the revised title, the examiner suggests additionally identifying a particular utility for the combination of the KRas G12D inhibitor, MRTX1133, and the PI3Ka inhibitor, BYL719.
The following title is suggested: METHOD FOR TREATING CANCER COMPRISING ADMINISTERING A COMBINATION OF A KRAS G12D INHIBITOR AND A PI3Ka INHIBITOR.
Appropriate correction is required.
Claim Objections
Claim 3 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A method for treating cancer in a subject in need thereof, wherein the method comprises administering to the subject a therapeutically effective amount of a combination of:
(a) the Kirsten rat sarcoma viral oncogene homolog (KRas) G12D inhibitor, MRTX1133, of the following formula:
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MRTX1133
or a pharmaceutically acceptable salt thereof; and
(b) the phosphatidylinositol 3-kinase alpha (PI3Ka) inhibitor, BYL719, of the following formula:
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BYL719
or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 4 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 3, wherein the Kirsten rat sarcoma viral oncogene homolog (KRas) G12D inhibitor, MRTX1133, or pharmaceutically acceptable salt thereof, and the phosphatidylinositol 3-kinase alpha (PI3Ka) inhibitor, BYL719, or pharmaceutically acceptable salt thereof, are independently administered on the same day.
Appropriate correction is required. See MPEP § 2173.02.
Claim 5 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 3, wherein the Kirsten rat sarcoma viral oncogene homolog (KRas) G12D inhibitor, MRTX1133, or pharmaceutically acceptable salt thereof, and the phosphatidylinositol 3-kinase alpha (PI3Ka) inhibitor, BYL719, or pharmaceutically acceptable salt thereof, are independently administered on different days.
Appropriate correction is required. See MPEP § 2173.02.
Claim 6 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 3, wherein the Kirsten rat sarcoma viral oncogene homolog (KRas) G12D inhibitor, MRTX1133, or pharmaceutically acceptable salt thereof, is administered at a maximum tolerated dose.
Appropriate correction is required. See MPEP § 2173.02.
Claim 7 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 3, wherein the phosphatidylinositol 3-kinase alpha (PI3Ka) inhibitor, BYL719, or pharmaceutically acceptable salt thereof, is administered at a maximum tolerated dose.
Appropriate correction is required. See MPEP § 2173.02.
Claim 8 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 3, wherein the Kirsten rat sarcoma viral oncogene homolog (KRas) G12D inhibitor, MRTX1133, or pharmaceutically acceptable salt thereof, and the phosphatidylinositol 3-kinase alpha (PI3Ka) inhibitor, BYL719, or pharmaceutically acceptable salt thereof, are independently administered at a maximum tolerated dose.
Appropriate correction is required. See MPEP § 2173.02.
Claim 9 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 3, wherein the Kirsten rat sarcoma viral oncogene homolog (KRas) G12D inhibitor, MRTX1133, or pharmaceutically acceptable salt thereof, is administered at below maximum tolerated dose.
Appropriate correction is required. See MPEP § 2173.02.
Claim 10 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 3, wherein the phosphatidylinositol 3-kinase alpha (PI3Ka) inhibitor, BYL719, or pharmaceutically acceptable salt thereof, is administered at below maximum tolerated dose.
Appropriate correction is required. See MPEP § 2173.02.
Claim 11 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 3, wherein the Kirsten rat sarcoma viral oncogene homolog (KRas) G12D inhibitor, MRTX1133, or pharmaceutically acceptable salt thereof, and the phosphatidylinositol 3-kinase alpha (PI3Ka) inhibitor, BYL719, or pharmaceutically acceptable salt thereof, are independently administered at below maximum tolerated dose.
Appropriate correction is required. See MPEP § 2173.02.
Claim 12 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 3, wherein relative to administering to the subject a therapeutically effective amount of only the Kirsten rat sarcoma viral oncogene homolog (KRas) G12D inhibitor, MRTX1133, or a pharmaceutically acceptable salt thereof, administering to the subject a therapeutically effective amount of the combination of the Kirsten rat sarcoma viral oncogene homolog (KRas) G12D inhibitor, MRTX1133, or pharmaceutically acceptable salt thereof, and the phosphatidylinositol 3-kinase alpha (PI3Ka) inhibitor, BYL719, or pharmaceutically acceptable salt thereof, results in (a), (b), (c), (d), or (e):
(a) an increased duration of overall survival in the subject;
(b) an increased duration of progression free survival in the subject;
(c) an increase in tumor growth regression in the subject;
(d) an increase in tumor growth inhibition in the subject; or
(e) an increased duration of stable disease in the subject.
Appropriate correction is required. See MPEP § 2173.02.
Claim 13 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 3, wherein relative to administering to the subject a therapeutically effective amount of only the phosphatidylinositol 3-kinase alpha (PI3Ka) inhibitor, BYL719, or a pharmaceutically acceptable salt thereof, administering to the subject a therapeutically effective amount of the combination of the Kirsten rat sarcoma viral oncogene homolog (KRas) G12D inhibitor, MRTX1133, or pharmaceutically acceptable salt thereof, and the phosphatidylinositol 3-kinase alpha (PI3Ka) inhibitor, BYL719, or pharmaceutically acceptable salt thereof, results in (a), (b), (c), (d), or (e):
(a) an increased duration of overall survival in the subject;
(b) an increased duration of progression free survival in the subject;
(c) an increase in tumor growth regression in the subject;
(d) an increase in tumor growth inhibition in the subject; or
(e) an increased duration of stable disease in the subject.
Appropriate correction is required. See MPEP § 2173.02.
Claim Rejections - 35 U.S.C. § 112(b)
The following is a quotation of the second paragraph of 35 U.S.C. § 112:
(b) CONCLUSION. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or joint inventor regards as the invention.
Claim 13 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 13 recites the limitation, The compound according to claim 1, wherein the therapeutically effective amount of the combination… results in… relative to treatment with only the cytotoxic compound, in lines 1-6 of the claim. There is insufficient antecedent basis, in claim 1, for this limitation, with respect to the method of treating cancer in a subject in need thereof, comprising administering… a combination of the KRas G12D inhibitor, MRTX1133, and the PI3Ka inhibitor, BYL719. According to claim 1, a cyctotoxic compound is not recited, with respect to the method of treating cancer in a subject in need thereof, comprising administering… a combination of the KRas G12D inhibitor, MRTX1133, and the PI3Ka inhibitor, BYL719.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Allowable Subject Matter
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS M. WILLIS, whose telephone number is 571-270-5757. The examiner may normally be reached on Monday thru Thursday from 8:00-6:00 EST. The examiner is also available on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Jeffrey Murray, may be reached on 571-272-9023. The fax phone number for the organization where this invention or proceeding is assigned is 571-273-8300.
Information regarding the status of an invention may be obtained from Patent Center. For more information about Patent Center, see https://www.uspto.gov/patents/apply/patent-center. Should you have questions on access to Patent Center, contact the Patent Electronic Business Center (PEBC) at 866-217-9197 (toll-free) or ebc@uspto.gov.
/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624
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