DETAILED ACTION
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 .
Priority
The instant application is a 371 National Stage Entry of PCT/US2023/064143 filed on March 10, 2023 which claims benefit of domestic provisional application No. 63/269,326 filed on March 14, 2022.
Status of Claims
Acknowledgement is made of original (1-2, 4-14, 18-21, 23-25) and amended (3, 15-17, 22), claims filed on August 1, 2025. Claims 1-25 are pending in instant application.
Information Disclosure Statement
The information disclosure statements filed on January 17, 2025 and August 1, 2025 have been considered.
Claim Objections
Claim 7 is objected to because of the following informalities:
Claim 7 recites “taxane” but should read “a taxane” because it is understood in the art to be a class of drugs.
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 4, 9 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 4 recites “The method of claim 4” which is improper since the claim depends from itself. For the purposes of applying art, it is assumed claim 4 is meant to depend from claim 3.
Claim 8 recites “and paclitaxel or docetaxel”. Claim 9 depends from claim 8, and recites “the paclitaxel is administered…and docetaxel is administered”. Claim 8 recites paclitaxel/docetaxel in the alternative “or”, whereas claim 9 appears to recite as a combination “and”. It is unclear if Applicant meant the combination, or was merely indicating if present, the amount of paclitaxel or docetaxel required. For the purposes of applying art, claim 9 is construed to mean the alternative as in claim 8, and is indicating the amount needed if present. If this interpretation is intended, the Examiner recommends amending claim 9 to read as “or docetaxel” instead of “and docetaxel”.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3-4, 17-18, 20, are rejected under 35 U.S.C. 103 as being unpatentable over Lim et. al.1 as evidenced by STN2.
Regarding claim 1 and a combination of pertuzumab, trastuzumab, and giredestrant for ER+ and HER2+ breast cancer, Lim teaches a phase III registration trial investigating the addition of palbociclib to dual HER2-directed (pertuzumab and trastuzumab) and endocrine therapy to treat ER+ HER2+ breast cancer to determine if the addition of a CDK4/6 inhibitor will prolong PFS compared to dual HER2 directed and endocrine therapy (see Lim at p. 18 left col par 2 and p. 16 Table 1, NCT02947685 entry).
Lim also teaches GDC9545 in combination with palbociclib (see Lim at p. 14 left col. par 3 and p. 15 Table 1 NCT0333279 entry). Evidentiary reference STN teaches GDC9545 is also known as giredestrant (see STN).
Regarding claim 3 and advanced breast cancer, Lim teaches phase III study for treating advanced ER+ HER2+ breast cancer after induction treatment with palbociclib, trastuzumab, pertuzumab, and an additional NSAI, SAI or SERD (see Lim at p. 16 Table 1 NCT02947685).
Regarding claims 4, 17-18, and further administering a CDK4/6 inhibitor such as palbociclib, Lim teaches a combination therapy comprising palbociclib as discussed above (see Lim at p. 18 left col par 2 and p. 16 Table 1, NCT02947685). Lim teaches palbociclib for treating metastatic HER2+ breast cancer (see Lim at p. 15 Table 1 NCT02774681), or in a combination therapy to treat advanced ER+ breast cancer (see Lim at p. 15 Table 1 NCT03099174).
Regarding claim 20, and further administering a CDK4/6 inhibitor such as abemaciclib, Lim teaches abemaciclib for treating metastatic ER+ breast cancer (see Lim at p. 15 Table 1 NCT02308020) or in combination therapy to treat advanced ER+ breast cancer or advanced ER+ HER2+ breast cancer (see Lim at p. 15 Table 1 NCT03099174 or NCT02779751 or NCT02675231).
The prior art differs from the instant claims as follows: While Lim teaches various combinations of giredestrant, trastuzumab, pertuzumab, abemaciclib or palbociclib, the prior art does not specify i) the instant combination or ii) effective amounts.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Regarding a combination, per MPEP § 2143(I)(A), a prima facie case of obviousness exists for combining prior art elements according to known methods to yield predictable results, or alternatively, per MPEP § 2144.06(I), "[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). It would have been obvious to an artisan to combine known ER+ HER2+ breast cancer treatments (such as giredestrant, trastuzumab, pertuzumab, and abemaciclib or palbociclib) to treat ER+ HER2+ breast cancer with a reasonable expectation of success because i) each individual component would be preforming its art-recognized purpose of treating ER+ HER2+ breast cancer in combination as it would alone, ii) combination therapy for ER+ HER2+ breast cancer is a known therapeutic strategy and iii) the known components are known to be compatible with at least one other known component for treating ER+ HER2+ breast cancer.
Regarding effective amounts, it would have been obvious to an artisan to administer an effective amount of each component in order to achieve the intended purpose of treating ER+ HER2+ breast cancer.
Furthermore, it is well-within the ordinary skill in art to combine known anti-cancer agents for the same purpose as taught by the prior art (treating cancer). Furthermore, it is well-within the ordinary skill in art to determine an effective amount of a known drug for a specific patient.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claim(s) 2, 13-15, 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Lim as evidenced by STN as applied to claims 1, 3-4, 17-18, 20, above and in further view of Gao et. al.3
The prior art differs from the instant claims as follows: while Lim and STN teach a combination of giredestrant, trastuzumab, pertuzumab, and abemaciclib or palbociclib for treating ER+ HER2+ breast cancer, they do not specify i) wherein trastuzumab and pertuzumab are administered as PH FDC or ii) dosage regimens.
However,
Regarding claims 2, 24-25 and PH FDC, Gao teaches a combination of pertuzumab, trastuzumab, and hyaluronidase zzxf subcutaneous injection, also known as Phesgo and PH FDC SC, for treating metastatic HER2+ breast cancer (see Gao at Abstract and at p.2126 right col. ¶3). Gao teaches 85% of trial patients reported preferring the subcutaneous administration of PH FDC SC over PþH IV, due to reduced time in the clinic (see Gao at p. 2128 left col. “PhranceSCa”). Gao teaches the PH FDC SC administration had similar efficacy compared to intravenous administration (see Gao at p. 2128 right col. ¶1), with pathologic complete response rate of 59.7% in the PH FDC SC arm and 59.5% in the PþH IV arm (see Gao at p. 2128 left col. ¶3). Gao teaches the safety profile of PH FDC SC was comparable with that of intravenous pertuzumab and intravenous trastuzumab (see Gao at p. 2128 right col. ¶3).
Regarding claims 13-15 and loading and maintenance dose regimens, Gao teaches PH FDC as provided in two dosage forms and strengths, both in single-dose vials for subcutaneous administration: (i) 1200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units
hyaluronidase/15 mL (80 mg, 40 mg, and 2,000 units/mL) of solution in a single-dose vial (reading on the instant loading dose) or (ii) 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase/10 mL (60 mg, 60 mg, and 2,000 units/mL) of solution in a single-dose vial (reading on the instant maintenance dose) (see Gao at p. 2127 left col. ¶1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Regarding PH FDC, per MPEP § 2143(I)(D), a prima facie case of obviousness exists for applying a known technique to a known method or product ready for improvement to yield predictable results. It would have been obvious to an artisan to alter the administration of trastuzumab and pertuzumab in the combination taught by Lim and STN to the fixed dose taught by Gao with an expectation of success because the prior art teaches improved, reduced administration time without compromising safety or efficacy (as taught by Gao).
Regarding a dosage regimen, per MPEP §2143(I)(G), a prima facie case of obviousness exists for some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. It would have been obvious to an artisan to incorporate the dosing regimen taught by Gao into the composition taught by Lim and STN with a reasonable expectation of success because Gao teaches the dosing leads to high pathologic complete response.
Moreover, while Gao does not specify administration on day 1 of a 3-week cycle (instant claim 14), per MPEP §2144.05(II), "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). It would have been obvious to an artisan to optimize a treatment cycle for a given patient based of a known dosing regimen because dosing of a drug is an art-recognized result-effective variable (see, e.g. Gao at p. 2127 Table 1, pharmacokinetic parameters or p. 2128 left col. ¶2, noting parameters such as body weight).
Furthermore, it is well-within the ordinary skill in art to combine known anti-cancer agents for the same purpose as taught by the prior art (treating cancer). Furthermore, it is well-within the ordinary skill in art to optimize a treatment cycle for a given patient.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lim as evidenced by STN as applied to claims 1, 3-4, 17-18, 20, above and in further view of Hurvitz et. al.4
The prior art differs from the instant claims as follows: while Lim and STN teach a combination of giredestrant, trastuzumab, pertuzumab, and abemaciclib or palbociclib for treating ER+ HER2+ breast cancer, they do not specify the combination is more effective than treatment with giredestrant.
However,
Regarding claim 5 and more effective, Hurvitz teaches superior anti-proliferative activity of giredestrant in combination with palbociclib compared to anastrozole and palbociclib (see Hurvitz at p. S1285 right col. LBA14 “Conclusions”).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2143(I)(D), a prima facie case of obviousness exists for applying a known technique to a known method or product ready for improvement to yield predictable results. It would have been obvious to an artisan to expect improved results to a combination with giredestrant (as taught by Lim and STN) compared to a combination without with because the prior art teaches giredestrant and palbociclib had superior antitumor effects in breast cancer subjects compared to a combination that did not comprise giredestrant (as taught by Hurvitz).
Furthermore, it is well-within the ordinary skill in art to hypothesize efficacy for a known combination based on other known combinations.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Lim, evidenced by STN, in view of Gao as applied to claims 1-4, 13-15, 17-18, 20, 24-25 above and in further view of Hurvitz.
The prior art differs from the instant claims as follows: while Lim, STN, and Gao teach a combination of giredestrant, PH FDC, and abemaciclib or palbociclib for treating ER+ HER2+ breast cancer, they do not specify the combination is more effective than treatment with giredestrant.
Regarding more effective, Hurvitz teaches superior anti-proliferative activity of giredestrant in combination with palbociclib compared to anastrozole and palbociclib (see Hurvitz at p. S1285 right col. LBA14 “Conclusions”).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2143(I)(D), a prima facie case of obviousness exists for applying a known technique to a known method or product ready for improvement to yield predictable results. It would have been obvious to an artisan to expect improved results to a combination with giredestrant (as taught by Lim, STN, and Gao) compared to a combination without with because the prior art teaches giredestrant and palbociclib had superior antitumor effects in breast cancer subjects compared to a combination that did not comprise giredestrant (as taught by Hurvitz).
Furthermore, it is well-within the ordinary skill in art to hypothesize efficacy for a known combination based on other known combinations.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claims 6-7, 23 are rejected under 35 U.S.C. 103 as being unpatentable over Lim as evidenced by STN as applied to claims 1, 3-4, 17-18, 20, above and in further view of NCT023444725.
Regarding claims 7 and induction therapy with docetaxel or paclitaxel, Lim teaches a combination of ribociclib, pertuzumab, and trastuzumab, with an additional agent such as paclitaxel or docetaxel to treat advanced ER+ HER2+ breast cancer (see Lim at p. 16 Table 1 NCT02344472).
The prior art differs from the instant claims as follows: while Lim and STN teach a combination of giredestrant, trastuzumab, pertuzumab, and abemaciclib or palbociclib for treating ER+ HER2+ breast cancer, they do not specify the combination is a maintenance therapy after an induction therapy.
However,
Regarding claims 6, 23 and maintenance after induction, NCT02344472 teaches an induction treatment of pertuzumab, trastuzumab, and docetaxel (see NCT02344472 at pp.6-7 "Arms and Interventions Experimental: Chemotherapy with docetaxel"), followed by a maintenance therapy.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2143(I)(A), a prima facie case of obviousness exists for combining prior art elements according to known methods to yield predictable results. It would have been obvious to an artisan to administer a known induction therapy (as taught by NCT02344472) before a known maintenance therapy (as taught by Lim and STN), because the prior art teaches administering an induction therapy before a maintenance therapy is a known strategy in the art for treating breast cancer (as taught by NCT02344472).
Furthermore, it is well-within the ordinary skill in art to put in practice known breast cancer treatments for treating breast cancer.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Lim and STN in view of NCT02344472 as applied to claims 1, 3-4, 6-7, 17-18, 20, 23above and in further view of Gao.
The prior art differs from the instant claims as follows: while Lim, STN, and NCT02344472 teach a maintenance therapy combination of giredestrant, trastuzumab, pertuzumab, and abemaciclib or palbociclib for treating ER+ HER2+ breast cancer after an induction therapy, they do not specify i) trastuzumab, pertuzumab as PH FDC or ii) dosing regimen for paclitaxel or docetaxel.
However,
Regarding claim 8 and PH FDC, Gao teaches a combination of pertuzumab, trastuzumab, and hyaluronidase zzxf subcutaneous injection, also known as Phesgo and PH FDC SC, for treating metastatic HER2+ breast cancer (see Gao at Abstract and at p.2126 right col. ¶3). Gao teaches 85% of trial patients reported preferring the subcutaneous administration of PH FDC SC over PþH IV, due to reduced time in the clinic (see Gao at p. 2128 left col. “PhranceSCa”). Gao teaches the PH FDC SC administration had similar efficacy compared to intravenous administration (see Gao at p. 2128 right col. ¶1), with pathologic complete response rate of 59.7% in the PH FDC SC arm and 59.5% in the PþH IV arm (see Gao at p. 2128 left col. ¶3). Gao teaches the safety profile of PH FDC SC was comparable with that of intravenous pertuzumab and intravenous trastuzumab (see Gao at p. 2128 right col. ¶3).
Regarding claims 8-9 and paclitaxel or docetaxel dosage regimen, Gao teaches a dosing of 80 mg/m2 of paclitaxel and 75 or 100 mg/m2 of docetaxel (see Gao at p. 2127 left col. “FeDeriCa”, at (i) and (ii)). Gao teaches the paclitaxel or docetaxel therapies as induction therapies prior to a PH FDC SC maintenance therapy.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Regarding PH FDC, per MPEP § 2143(I)(D), a prima facie case of obviousness exists for applying a known technique to a known method or product ready for improvement to yield predictable results. It would have been obvious to an artisan to alter the administration of trastuzumab and pertuzumab in the combination taught by Lim and STN to the fixed dose taught by Gao with an expectation of success because the prior art teaches improved, reduced administration time without compromising safety or efficacy (as taught by Gao).
Moreover, while Gao does not specify 4 to 8 cycles of PH FDC, per MPEP §2144.05(II), "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). It would have been obvious to an artisan to optimize a treatment cycle for a given patient based of a known dosing regimen because dosing of a drug is an art-recognized result-effective variable (see, e.g. Gao at p. 2127 Table 1, pharmacokinetic parameters or p. 2128 left col. ¶2, noting parameters such as body weight).
Regarding paclitaxel or docetaxel induction therapy, it would have been obvious to an artisan to adopt the known paclitaxel or docetaxel dosing regimen (as taught by Gao) to a known induction therapy (taught by NCT02344472) with an expectation of success because it informs an artisan of acceptable dosing for the known components.
Furthermore, it is well-within the ordinary skill in art to optimize a treatment cycle for a given patient.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lim, STN, Gao, and NCT02344472 as applied to claims 1, 3-4, 6-9, 17-18, 20, 23 above and in further view of NCT033327976 and Hurvitz.
Regarding PH FDC dosing, Recall Gao teaches dose units for subcutaneous administration of PH FDC (see Gao at p. 2126 “Chemistry Manufacturing, and Control”).
The prior art differs from the instant claims as follows: while Lim, STN, and NCT02344472 teach a maintenance therapy combination of giredestrant, trastuzumab, pertuzumab, and abemaciclib or palbociclib for treating ER+ HER2+ breast cancer, they do not specify the instant dosing cycle of giredestrant or PH FDC.
Regarding giredestrant dosage, Hurvitz teaches a 30 mg dose of giredestrant (see Hurvitz at p. S1285 LBA14 “Methods”). NCT03332797 teaches giredestrant administered orally, once daily, on Days 1-28 a 28-day cycle (see NCT03332797 at "Arms and Interventions" Experimental: Dose Escalation: GDC-9545").
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2143(I)(A), a prima facie case of obviousness exists for combining prior art elements according to known methods to yield predictable results. It would have been obvious to an artisan to modify the known maintenance therapy (as taught by Lim, STN, and NCT02344472) to a known dosing regimen (as taught by Hurvitz and NCT03332797) with a reasonable expectation of success because the prior art teaches the regimen is treatment for breast cancer (as taught by Hurvitz and NCT03332797), the same purpose as taught by the maintenance therapy (as taught by Lim, STN, and NCT02344472).
Moreover, while Gao does not specify administering PH FDC on day 1 of a 21-day cycle, and NCT03332797 teaches a 28 day cycle of giredestrant in lieu of a 21 day cycle, per MPEP §2144.05(II), "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). It would have been obvious to an artisan to optimize a treatment cycle for a given patient based of a known dosing regimen because dosing of a drug is an art-recognized result-effective variable (see, e.g. Gao at p. 2127 Table 1, pharmacokinetic parameters or p. 2128 left col. ¶2, noting parameters such as body weight).
Furthermore, it is well-within the ordinary skill in art to modify known dosing regimens and cycles for the same purpose as taught by the prior art (treating breast cancer).
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Lim as evidenced by STN as applied to claims 1, 3-4, 17-18, 20, and in view of NCT03332797 and Hurvitz.
The prior art differs from the instant claims as follows: while Lim and STN teach a combination of giredestrant, trastuzumab, pertuzumab, and abemaciclib or palbociclib for treating ER+ HER2+ breast cancer, they do not specify the dosing of giredestrant.
However,
Regarding claim 16 and giredestrant dosage regimen, NCT03332797 teaches administering GDC-9545 orally, once daily, on days 1-28 of each 28-day cycle (see NCT03332797 at “Arms and Interventions”, Experimental: Dose Escalation: GDC-9545), for treating advanced or metastatic ER+ breast cancer (see NCT03332797 at Title), reading on instant daily for 4-week cycle. Hurvitz teaches administering 30 mg of giredestrant as a single dose for treating ER+ HER2- breast cancer (see Hurvitz at p. S1285 right col. LBA14 “Methods”).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2143(I)(A), a prima facie case of obviousness exists for combining prior art elements according to known methods to yield predictable results. It would have been obvious to an artisan to modify the known breast cancer treatment (as taught by Lim, STN) with a known dosing regimen (as taught by Hurvitz and NCT03332797) with a reasonable expectation of success because the prior art teaches the regimen is treatment for breast cancer (as taught by Hurvitz and NCT03332797), the same purpose as taught by the known breast cancer therapy, comprising the component (as taught by Lim and STN).
Furthermore, it is well-within the ordinary skill in art to modify known dosing regimens and cycles for the same purpose as taught by the prior art (treating breast cancer).
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Lim as evidenced by STN as applied to claims 1, 3-4, 17-18, 20, and in view of NCT029476857.
The prior art differs from the instant claims as follows: while Lim and STN teach a combination of giredestrant, trastuzumab, pertuzumab, and abemaciclib or palbociclib for treating ER+ HER2+ breast cancer, they do not specify the dosing of palbociclib.
However,
Regarding claim 19 and palbociclib dosage regimen, NCT02947685 teaches a starting dose of palbociclib of 125 mg orally daily for 21 days followed by 7 days off to complete a 28 day cycle, with optional dose reductions of 100 mg an 75 mg (see NCT02947685 at “Arms and Interventions Experimental: Arm A”) for treating metastatic breast cancer (see NCT02947685 at Title).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2143(I)(A), a prima facie case of obviousness exists for combining prior art elements according to known methods to yield predictable results. It would have been obvious to an artisan to modify the known breast cancer treatment (as taught by Lim, STN) with a known dosing regimen (as taught by NCT02947685) with a reasonable expectation of success because the prior art teaches the regimen is treatment for breast cancer (as taught by NCT02947685), the same purpose as taught by the known breast cancer therapy, comprising the component (as taught by Lim and STN).
Furthermore, it is well-within the ordinary skill in art to modify known dosing regimens and cycles for the same purpose as taught by the prior art (treating breast cancer).
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Lim as evidenced by STN as applied to claims 1, 3-4, 17-18, 20, and in view of NCT026752318.
The prior art differs from the instant claims as follows: while Lim and STN teach a combination of giredestrant, trastuzumab, pertuzumab, and abemaciclib or palbociclib for treating ER+ HER2+ breast cancer, they do not specify the dosing of abemaciclib.
However,
Regarding claim 21 and abemaciclib dosage regimen, NCT02675231 teaches 150 mg of abemaciclib given orally every 12 hours of a 21-day cycle (see NCT02675231 at "Arms and Interventions Experimental"), for treating advanced or metastatic breast cancer (see NCT02675231 at Title) reading on instant 150 mg twice daily during a 21 day cycle.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2143(I)(A), a prima facie case of obviousness exists for combining prior art elements according to known methods to yield predictable results. It would have been obvious to an artisan to modify the known breast cancer treatment (as taught by Lim, STN) with a known dosing regimen (as taught by NCT02675231) with a reasonable expectation of success because the prior art teaches the regimen is treatment for breast cancer (as taught by NCT02675231) the same purpose as taught by the known breast cancer therapy, comprising the component (as taught by Lim and STN).
Furthermore, it is well-within the ordinary skill in art to modify known dosing regimens and cycles for the same purpose as taught by the prior art (treating breast cancer).
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Lim as evidenced by STN as applied to claims 1, 3-4, 17-18, 20, and in view of NCT035291109.
The prior art differs from the instant claims as follows: while Lim and STN teach a combination of giredestrant, trastuzumab, pertuzumab, and abemaciclib or palbociclib for treating ER+ HER2+ breast cancer, they do not specify wherein the patient had progression on trastuzumab and HER2-ADC treatment.
However,
Regarding claim 22 and disease progression on trastuzumab and HER2-ADC, NCT03529110 teaches treating metastatic breast cancer with trastuzumab and an Anti-HER2 Antibody Drug Conjugate (ADC) (see NCT03529110 at “Arms and Interventions”).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2143(I)(D), a prima facie case of obviousness exists for applying a known technique to a known method or product ready for improvement to yield predictable results. It would have been obvious to an artisan to switch a known treatment (as taught by NCT03529110) that was not working on a subject to a new treatment (as taught by Lim and STN) with an expectation of success because the old treatment would be serving the intended purpose of treating breast cancer in the subject, and the new known treatment could serve the intended purpose of treating breast cancer in the subject. In addition, changing treatment strategies in a subject is an art-recognized technique in the art of treating breast cancer, as taught by NCT03529110 (see NCT03529110 at Title, “…previously treated with trastuzumab and taxane” emphasis added).
Furthermore, it is well-within the ordinary skill in art to administer a known breast cancer treatment in lieu of another breast cancer treatment no longer serving the intended purpose of treating breast cancer.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Conclusion
Claim 7 is objected to.
Claims 1-25 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA J REILLY whose telephone number is (703)756-5669. The examiner can normally be reached 9:00 am - 5:00 pm EST M-F.
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/S.R./ Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
1 Lim et. al. "Emerging data and future directions for CDK4/6 inhibitor treatment of patients with hormone receptor positive HER2-non-amplified metastatic breast cancer." Asia-Pacific Journal of Clinical Oncology, 2018, 14, 4, 12-21. DOI: 10.1111/ajco.13065. Hereinafter Lim.
2 CAS Registry No. 1953133-47-5. CAS Registry File Accessed August 14, 2026 from STN, entered into STN July 15, 2016. Hereinafter STN.
3 Cite No. 482 in the IDS filed 1/17/2025. Gao et. al. "FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase–zzxf Injection for Subcutaneous Use in Patients with HER2-positive Breast Cancer " Clin Cancer Res 2021, 27, 8, 2126-2129. DOI: 10.1158/1078-0432.CCR-20-3474. First published November 13, 2020. Hereinafter Gao.
4 Hurvitz et al. Neoadjuvant giredestrant (GDC-9545) + palbociclib (palbo) vs anastrozole (A) + palbo in post-menopausal women with oestrogen receptor-positive, HER2-negative, untreated early breast cancer (ER+/HER2– eBC): Interim analysis of the randomised, open-label, phase II coopERA BC study. Ann Oncol. 2021, 32, 5, S1283-S1346. DOI: 10.1016/j.annonc.2021.08.2086. Published online September 21, 2021.
5 “A Multicenter, Randomized Phase III Study toCompare Chemo- Versus Endocrine Therapy in Combination With Dual HER2-targeted Therapy of Herceptin® (Trastuzumab) and Perjeta® (Pertuzumab)Plus Kisqali® (Ribociclib) in Patients With HER2 Positive and Hormone-receptor Positive Metastatic Breast Cancer.” Study ID: NCT02344472. October 3, 2019 Study Record retrieved from clinicaltrials.gov on August 14, 2026. Hereinafter NCT02344472.
6 "A Study of GDC-9545 Alone or in Combination With Palbociclib and/ or LuteinizingHormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or MetastaticEstrogen Receptor-Positive Breast Cancer NCT03332797" Study ID: NCT03332797. February 9, 2022 Study Record retrieved from clinicaltrials.gov on August 14, 2026. Hereinafter NCT03332797.
7 "Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to TreatMetastatic Breast Cancer (PATINA)" Study ID: NCT02947685. October 326, 2016 Study Record retrieved from clinicaltrials.gov on August 14, 2026. Hereinafter NCT02947685.
8 "Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ LocallyAdvanced or Metastatic Breast Cancer (monarcHER)" Study ID: NCT02675231. February 4, 2021 Study Record retrieved from clinicaltrials.gov on August 14, 2026. Hereinafter NCT02675231.
9 "DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/ or Metastatic Breast Cancer Previously Treated WithTrastuzumab and Taxane [DESTINY-Breast03]" Study ID: NCT03529110. May 7, 2018 Study Record retrieved from clinicaltrials.gov on August 14, 2026. Hereinafter NCT03529110.
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