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 .
Status of Claims
Claims 1-29 are pending and under examination.
Claim Objections
Claim 24 objected to because of the following informalities: the claim recites “a method of improving patient compliance…in a patient with hormone receptor positive breast cancer comprises.” This statement is grammatically incorrect and should use the term “comprising.” Appropriate correction is required.
Claim Rejections - 35 USC § 112b
Claims 7-9, 12, 17-19, 22, 25 and 28 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 7 is rejected because it depends on claim 1 which recites the options of i) or ii) while only adding a limitation directed to option i) without expressly selecting that option. As such, it is unclear whether the claim requires the selection of option i) or is intended to continue to encompass both options. Claims 8, 9, 17-19, and 25 are included in this rejection for the same reasons with respect to their parent claims. To advance compact prosecution, the claims are interpreted such that they require selection of the option that is further limited. Appropriate correction is required.
Claims 12, 22, and 28 are rejected because the claims recite “further comprising administering to the patient… hormone therapy.” Goserelin is a form of hormone therapy as it induces suppression of the ovaries and reduces estrogen. As such, it is unclear whether the claim requires administering anything beyond the goserelin already required in claim 1 or if it is required to administer an additional hormone therapy in addition to goserelin. To advance compact prosecution, the claim is interpreted such that an additional agent is required. Appropriate correction is required.
Therefore, claims 7-9, 12, 17-19, 22, 25 and 28 are rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 103
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 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.
Claims 1, 2, 5-13, and 24-29 are rejected under 35 U.S.C. 103 as being unpatentable over eviQ, in view of Noguchi et al. [see IDS, 06/04/24], and in further view of Fernandez del Moral et al., and Risbridger et al.
Claims 1, 2, and 5-13 are drawn to a method of treating breast cancer comprising administering goserelin; claims 24-29 are drawn to a method of treating improving patient compliance comprising administering goserelin.
eviQ teaches a method of treating early stage [see p. 5-6 “evidence”] (instant claims 10, 20, and 26) hormone receptor-positive breast cancer in a woman patient [see p. 2, “indications and patient population”] comprising concomitantly administering adjuvant chemotherapy and 3.6mg goserelin [see p. 1-2, “treatment schedule”] implant [see p. 4, “day 1”] (instant claims 1, 14, and 24). eviQ teaches administering goserelin every 28 days [see p. 2-3. “treatment schedule”] (instant claims 1, 14, and 24) and that it can be administered for up to 5 years [see p. 2, “cycles”] (instant claims 1, 5, 14, 24, and 25). eviQ teaches administering the hormone therapy drug exemestane after chemotherapy (instant claims 12, 22, and 28). eviQ teaches that dosage or timing may be altered during treatment because of clinician guidance or side effects [see p. 2-3, “dose modifications”].
eviQ does not teach or suggest discontinuing the 3.6mg formulation and administering 10.8mg goserelin thereafter or that the chemotherapy cycle is administered intravenously.
Noguchi et al. teaches that 10.8mg goserelin administered every three months (about 91 days) is similarly safe and effective for the treatment of both early [see p. 772, col. 1, par. 3] and advanced [see title] estrogen receptor positive breast cancer in women [see abstract] (instant claims 1, 2, 10, 11, 14, 20, 21, 26, and 27). Noguchi et al. teaches that adjuvant chemotherapy comprising 5-fluorouracil, epirubicin, and cyclophosphamide are used in the treatment of HR positive breast cancer [see p. 774, col. 2, par. 5] (instant claims 1 and 6). Noguchi et al. further teaches that repeated injections may be uncomfortable for the patient and that administration every three months may be more convenient and improve compliance [see p. 778, col. 1, par. 2] (instant claims 7-9 and 17-19).
Fernandez del Moral et al. teaches a regimen of administering 3.6mg goserelin every four weeks (about 28 days) for 12 weeks and then administering 10.8mg every 12 weeks (about 84 days) thereafter [see abstract] (instant claims 1, 2, 14, and 24) to patients with advanced prostate cancer. Fernandez del Moral et al. teaches that the resulting regimen produces similar therapeutic effects, offers greater convenience for the patient and physician, and has the potential to reduce healthcare costs [see p. 899, col. 2, par. 2] (instant claim 1).
Risbridger et al. as a whole teaches that breast cancer and prostate cancer are both typically hormone dependent and share substantial underlying biological similarities, including common steroid-hormone pathways. Thus, teachings concerning goserelin pharmacodynamics in prostate cancer would have been relevant to a skilled artisan considering a goserelin depot formulation for hormone-responsive breast cancer.
It would have been obvious to combine these teachings and use IV chemotherapy as the adjuvant or neoadjuvant in the method of eviQ given that Noguchi et al. teaches that 5-fluorouracil, epirubicin, and cyclophosphamide are used in adjuvant treatment of ER positive breast cancer and eviQ teaches that goserelin can be administered with a chemotherapy regimen. A person having ordinary skill in the art would have understood that these chemotherapy drugs are most often administered intravenously over the course of several cycles, and as such, it would have been obvious and expected that one would administer these drugs using these routine administration methods (instant claims 1 and 6).
It would have been obvious to combine these teachings and modify the eviQ regimen by replacing subsequent monthly 3.6mg administration with the 10.8mg depot taught by Fernandez del Moral et al. because Noguchi et al. teaches that 10.8mg goserelin is effective and well tolerated in the treatment of hormone receptor positive breast cancer, Fernandez del Moral et al. teaches that the transition from 3.6mg to 10.8mg maintains comparable pharmacodynamic effects and safety, and Risbridger et al. teaches that at the time of the invention, it was known that breast cancer and prostate cancer share underlying biological similarities that would have been relevant in informing treatment plans for these types of cancers (instant claim 1). One would have been motivated to do so as the art teaches that the higher dose is useful for improving compliance and eviQ emphasizes physician guidance and monitoring. As such, a physician would have understood that a patient that was tolerant to the 3.6mg depot, as indicated by initial or subsequent doses, would benefit from the 10.8mg depot (instant claims 1, 14, and 24).There would have been a reasonable expectation of success as it was known that 10.8mg goserelin was effective in the treatment of hormone receptor positive breast cancer, provided comparable efficacy in treatment and safety compared to the 3.6mg depot, and the art teaches that both diseases overlap in terms of underlying biology and treatment methods.
Similarly, when a patient receiving the monthly 3.6mg regimen fails to return for a subsequent injection, it would have been obvious identify the patient as nonadherent and to administer the known 10.8mg formulation every 3 months because Noguchi et al. identifies the reduced injection frequency as providing greater patient compliance and Fernandez del Moral et al. teaches that patients can be transitioned to 10.8mg without loss of therapeutic effect (instant claims 7-9, 17-19, and 24). Further, it would have been obvious to assess tolerance to the 3.6mg depot first as eviQ teaches that physicians may alter the dosage or schedule based on clinical judgement or adverse events, supporting the notion that clinicians routinely assess tolerance during drug therapy (instant claim 13, 23, and 29).
It would have been obvious to continue administer 10.8mg goserelin throughout the course of chemotherapy (instant claim 2), for at least 8 doses (instant claim 24), or for at least 5 years (instant claim 5) as the 10.8mg depot maintained the pharmacodynamic effect with comparable safety, and as such, one would have reasonably expected that the formulations would behave similarly both during chemotherapy and for the extended durations that fall within the scope of what eviQ teaches is a suitable timeframe for administration. Arriving at the exact claimed doses or times, would have constitutes routine optimization based on clinician judgement. Similarly administering the modified method for a total of 2 years (instant claim 24) would have been obvious for the same reasons above.
Finally, it would have been obvious to administer this treatment to patients with both early and advanced stages of breast cancer as eviQ teaches it is effective for the treatment of early-stage breast cancer and Noguchi et al. teaches that it is useful for both early and late-stage breast cancer (instant claims 10, 11, 20, 21, 26, and 27).
Therefore, claims 1, 2, 5-13, and 24-29 are rejected under 35 U.S.C. 103.
Claims 1, 2, and 3 are rejected under 35 U.S.C. 103 as being unpatentable over eviQ, in view of Noguchi et al. [see IDS, 06/04/24], and in further view of Fernandez del Moral et al., Risbridger et al., and Mercy Health.
Claims 1, 2, and 3 are drawn to a method of treating breast cancer comprising administering goserelin.
The teachings of eviQ, Noguchi et al., Fernandez del Moral et al., and Risbridger et al. are discussed above.
The combination of these references does not teach or suggest a course of chemotherapy between 8 and 12 months.
Mercy Health teaches that adjuvant chemotherapy for the treatment of breast cancer may last as long as 9 months [see p. 1, “what types of cancer is adjuvant chemotherapy used for”] (instant claim 3).
It would have been obvious to combine these teachings and administer adjuvant chemotherapy for between 8 and 12 months as Mercy Health teaches that 9 months was within the scope of adjuvant chemotherapy treatment plans and eviQ teaches that treatment plans can be altered based on the judgement of the overseeing clinician.
Therefore, claims 1, 2, and 3 are rejected under 35 U.S.C. 103.
Claims 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over eviQ, in view of Noguchi et al. [see IDS, 06/04/24], and in further view of Fernandez del Moral et al., Risbridger et al., and Goss et al.
Claims 1 and 4 are drawn to a method of treating breast cancer comprising administering goserelin.
The teachings of eviQ, Noguchi et al., Fernandez del Moral et al., and Risbridger et al. are discussed above.
The combination of these references does not teach or suggest administering goserelin for the life of the patient.
Goss et al. teaches administration of the hormone therapy drug letrozole for the treatment of hormone receptor positive breast cancer and notes that treatment past 5 years has been a demonstrated need in the treatment of breast cancer [see p. 50, col. 1, par. 5 and col. 2, par. 1]. Goss et al. teaches that long-term and potentially life-long hormonal therapy was appropriate for the treatment of hormone receptor positive breast cancer [see p. 50, col. 2, par. 4] (instant claims 4 and 14) because metastasized cancerous cells remain estrogen sensitive beyond 5 years. As such, continuing estrogen suppression can be beneficial, particularly for patients who survive beyond 10 years [see p. 50, col. 2, par. 2].
It would have been obvious to combine these teachings and administer goserelin for the lifetime of the patient as the art recognized that hormone therapy was a potentially life-long treatment plan for individuals with hormone receptor positive breast cancer. There would have been a reasonable expectation of success in the continued administration as goserelin was already known in the art as a long-term treatment and the side effects related to the mechanism of action were well understood in the art such that there would have been no reason to expect an unexpected toxicity to occur. That is, the adverse effects associated with ovarian suppression, including vasomotor and other hypoestrogenic effects, were known and actively monitored [see eviQ], and ovarian suppression is a well-known and common feature of menopause.
Therefore, claims 1 and 4 are rejected under 35 U.S.C. 103.
Claims 14-23 are rejected under 35 U.S.C. 103 as being unpatentable over eviQ, in view of Noguchi et al. [see IDS, 06/04/24], and in further view of Fernandez del Moral et al., Risbridger et al., Goss et al., and Park et al.
Claims 14-23 are drawn to a method of treating breast cancer comprising administering goserelin and long-term chemotherapy.
The teachings of eviQ, Noguchi et al., Fernandez del Moral et al., Risbridger et al., and Goss et al. are discussed above.
The combination of these references does not teach or suggest a long-term course of chemotherapy.
It is noted that the specification draws a distinction between neoadjuvant, adjuvant (between 1 and 12 cycles), and long-term chemotherapy (over 12 cycles) and teaches that long-term chemotherapy also includes maintenance chemotherapy and chemotherapy that is administered in response to reactivation of cancer. Accordingly, the limitations of claims 14-16 are interpreted for the purposes of examination as not requiring uninterrupted administration of the same chemotherapy regimen over the entire claimed timeline, rather it encompasses a treatment plan extending over the patient’s disease course and includes maintenance chemotherapy administered when the cancer reactivates.
Park et al. teaches that metastatic breast cancer is an incurable disease with a 2–3-year median overall survival [see p. 1732, col. 1, par. 1]. Park et al. teaches administering chemotherapy to patients with recurrent ER positive metastatic breast cancer that had previously received adjuvant or neoadjuvant anthracycline-based chemotherapy [see p. 1733, col. 1, par. 6]. For such patients, the method is a maintenance chemotherapy regimen. Park et al. teaches that the maintenance chemotherapy method comprises six cycles of intravenous paclitaxel and gemcitabine administered every 21 days [see p. 1733, col. 2, par. 2] followed by a median of six cycles of additional maintenance chemotherapy [see p. 1734, col. 2, par. 2] and a maximum of 26 cycles [see p. 1735, col. 2, par. 2]; this corresponds to an average of approximately 8.3 months and a maximum of 18 months of maintenance chemotherapy when the completed cycle intervals are counted (instant claim 14). Park et al. teaches that this regimen produces meaningful clinical outcomes in the treatment of metastatic breast cancer, with patients having about a 50% probability of surviving beyond 42 months [see Fig. 2B] and also teaching that the treatment can be optimized according to each patient’s circumstance [see p. 1739, par. 3]. Park et al. teaches that treatment was administered until disease progression, unacceptable toxicity, or patient withdrawal.
It would have been obvious to combine these teachings and utilize the modified 3.6mg-10.8mg goserelin method of eviQ concomitantly with long-term chemotherapy in response to a reoccurrence of cancer because the art teaches that the combination of goserelin and long-term/maintenance chemotherapy are independently is useful in the treatment of estrogen receptor positive breast cancer and also that simultaneous administration of goserelin and adjuvant chemotherapy is known in the art as a useful treatment for estrogen receptor positive breast cancer. It would have been obvious to continue long-term chemotherapy for at least five years or over the lifetime of the patient if said patient remained alive and continued to derive benefits during periods of relapse (instant claims 14-16).
The obviousness rationale for claims 17-23 are discussed above and would be expected to remain successful as the combination of goserelin and long-term chemotherapy would be expected to provide the same therapeutic outcomes as goserelin and neoadjuvant/adjuvant chemotherapy as discussed above given that the combination of goserelin and chemotherapy in general is taught to be useful and safe.
Therefore, claims 14-23 are rejected under 35 U.S.C. 103
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tirone D Johnson whose telephone number is (571)272-1256. The examiner can normally be reached M-F, 9-5 ET.
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/TIRONE D. JOHNSON/ Examiner, Art Unit 1675
/JEFFREY STUCKER/ Supervisory Patent Examiner, Art Unit 1675
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