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 .
Current Status
This action is responsive to the amended claims of 04/28/2026. Claims 1, 3, 5, 12, 14-15, 24, 26, and 28 are pending. Claims 4, 7, 9-10, and 34 have been canceled. Claims 1, 3, 5, 12, 14-15, 24, 26, and 28 have been examined on the merits.
Election/Restrictions
The response of 04/28/2026 did not overcome the rejections of the office action of 12/29/2025. However, the claims have been narrowed to the elected species, onvansertib and abiraterone, thus, the election requirement is rendered moot.
Priority
The effective filing date is 03/28/2019.
Response to Arguments
Examiner acknowledges receipt of and has reviewed the remarks and amendments of 04/28/2026; no new matter is found.
The 102 rejection of claims 1, 3-4, 7, and 9 over ZHANG evidenced by MOSTAGHEL is withdrawn due to amendments. The claims have been narrowed to the PLK1 inhibitor onvansertib. ZHANG only teaches the PLK1 inhibitor BI2536, not onvansertib.
The 103 rejection of claims 1, 3-5, 7, 9-10, 12, 14, 24, and 26 over CARDIFF, evidenced by BERIA, in view of ZHANG, evidenced by MOSTAGHEL is maintained over claims 1, 3, 5, 12, 14, 24, and 26. Claims 4, 7, and 9-10 have been canceled. Applicant's arguments filed 04/28/2026 have been fully considered but they are not persuasive.
Applicant argues the combination of CARDIFF and ZHANG to teach treatment of AR-V7 characterized CRPC by onvansertib and abiraterone is based on hindsight reasoning. Examiner respectfully disagrees. As laid out in the rejection on Pg. 8-10 of the action mailed 12/29/2025, CARDIFF and ZHANG both teach treatment of CRPC with a PLK1 inhibitor and abiraterone. The suggestion to replace one PLK1 inhibitor with another is obvious since the inhibitors are functional equivalents, as taught by the prior art references. Since the suggestion/motivation is grounded in the teachings of the prior art references, the rejection is not made in hindsight.
Further, Applicant argues the instant specification contains unexpected results: Examples 2-4 show, when administered onvansertib + abiraterone, PSA is stabilized or decreased in AR-V7+ patients (n=4), two patients meet the primary efficacy endpoint, and 2 AR-V7+ patients had a ≥80% CTC decrease. Examiner’s review of the specification, Examples 2-4, and corresponding Figures 7-9 did not find evidence of unexpected results.
Examiner finds a total of 6 AR-V7+ patients are listed throughout the specification: see Table 2 (Pg. 14) and Fig. 7:
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wherein Patients 02-003, 03-009, and 03-013 are AR-V7+ at least once during testing. However, patient 02-003 is not listed as AR-V7+ in any other figures. Examiner is counting patient 02-003 in the total AR-V7+ patients based on Table 2. The other AR-V7+ patients are disclosed in Fig. 7: 01-024, 01-025, 01-033, 03-013, and 03-009.
As Applicant stated only 2 AR-V7+ patients met the PSA primary efficacy standpoint (Fig. 7). Of the total 6 AR-V7+ patients, 4 have progressive disease (Fig. 7). Similarly, 2 AR-V7+ patients had a ≥80% CTC decrease (Fig. 8); however, the other 3 AR-V7+ patients shown in Fig. 8 have an increase in CTC ranging from ~50-1500%. Further, 1 patient is not shown in Fig. 8. Regarding Fig. 9, PSA stabilization or decrease is shown for all bars marked as AR-V7+; however, the bars in the graph are not labeled with patient identifiers and there are only 5 shown (not 6). Thus, the treatment has not been shown to result in a consistent outcome.
Further, when comparing to the closest prior art, ZHANG clearly teaches similar results. Examiner previously cited ZHANG Fig. 6 (Pg. 6645):
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wherein the combination of a PLK1 inhibitor (BI2536) and abiraterone clearly reduced both tumor weight and serum PSA. Further, a reduction in PSA and CTC in some patients in the instant examples is not unexpected when ZHANG clearly teaches that PLK1 inhibition enhances AR-V7+ cellular response to abiraterone (Pg. 6643 Fig. 4 Description & Part E). The data in the specification provides no evidence of a superior or unexpected result which arises from the combination treatment of onvasertib and abiraterone, specifically.
The rejection is maintained and is modified below to account for the canceled claims.
The 103 rejection of claims 1 and 15 over CARDIFF, evidenced by BERIA, in view of ZHANG, evidenced by MOSTAGHEL, further in view of ANSEL is maintained. As discussed above, the evidence provided does not amount to unexpected results.
The 103 rejection of claims 1 and 28 over CARDIFF, evidenced by BERIA, in view of ZHANG, evidenced by MOSTAGHEL, further in view of EPIC is maintained. As discussed above, the evidence provided does not amount to unexpected results.
The 103 rejection of claim 34 over CARDIFF, evidenced by BERIA, in view of ZHANG, evidenced by RATHKOPF and CAI is withdrawn. Claim 34 has been canceled.
Response to Amendment
Claim Objections
Claims 1, 3, 5, 12, 14-15, 24, 26, and 28 are objected to because of the following informalities. Appropriate correction is required.
Claim 1 recites “administering to the patient with a polo-like kinase-1 (PLK1) inhibitor with abiraterone”. While not indefinite, claim form/grammar could be improved. Examiner suggests: “administering a polo-like kinase-1 (PLK1) inhibitor and abiraterone to the patient”. Dependent claims 3, 5, 12, 14-15, 24, 26, and 28 are similarly objected to since they do not rectify the issue.
Claim 24 recites “wherein the patient is also administered abiraterone daily.” The word “also” is redundant since parent claim 1 already requires administration of abiraterone. Please strike the word “also”.
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 1, 3, 5, 12, 14-15, 24, 26, 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.
Applicant has struck from claim 1, the steps taken if the patient did not have rising prostate specific antigen (PSA) levels. Thus, claim 1 is rejected as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: if the patient does not have rising PSA levels what course of action is taken? Claim 1 is interpreted as a conditional claim with contingent limitations (see MPEP 2111.04(II)), specifically the phrase “if the patient has rising prostate specific antigen (PSA) levels in the samples over time” There are two embodiments of claim 1: embodiment 1) PSA levels are rising, so the PLK1 inhibitor is administered; embodiment 2) PSA levels are not rising. The claim does not describe what steps are taken in embodiment 2 wherein the patient does not have rising PSA levels. Therefore, the metes and bounds of the claim are undefined rendering it indefinite. Dependent claims 3, 5, 12, 14-15, 24, 26, and 28 are similarly rejected since they do not rectify the issue at hand.
Suggestion to overcome: amend claim 1 to strike the “if” limitation recited above. Applicant could describe the patient as having rising PSA levels; e.g., “A method of treating a patient having rising prostate specific antigen levels…”
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 5, 12, 14, 24, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over:
CARDIFF (Cardiff Oncology, Jan. 2018, NCT03414034, ClinicalTrials.gov,clinicaltrials.gov/study/NCT03414034?intr=Onvansertib&rank=5&a=1&tab=history, accessed 12/20/2024; provided by Examiner 01/16/2025),
as evidenced by:
BERIA (Beria, I., et al., Bioorganic & Medicinal Chemistry Letters, 2011, 21, 2969-6974; provided by Examiner 08/27/2025),
In view of:
ZHANG (Zhang, Z., et al., Cancer Res., 2014, 74(22), 6635-6647; provided in IDS of 10/19/2022),
As evidenced by:
MOSTAGHEL (Mostaghel, E. A. et al., Clin. Cancer Res., 2011, 17(18), 5913-5925; provided by Examiner 12/29/2025).
Determining the Scope and Contents of the Prior Art:
CARDIFF teaches a method of administering PCM-075 (i.e., onvansertib) given orally once daily for 5 consecutive days every 21 days in adult patients with metastatic castration-resistant prostate cancer (mCRPC) who have disease progression while receiving abiraterone and prednisone therapy, to observe the effects of onvansertib in combination with abiraterone and prednisone on disease control (Pg. 8 Brief Summary). CARDIFF also teaches onvansertib is administered at 24 mg/m2 in combination with abiraterone administered orally once daily (Pg. 9-10 Arms and Interventions, Left Box). CARDIFF further teaches the inclusion criteria for patients to receive this treatment includes the subject currently receiving abiraterone and prednisone for CRPC and having two rising prostate specific antigen (PSA) values separated by at least 1 week, one showing a rise of at least 0.5 ng/mL and one confirmatory value not showing a decline (Pg. 12 Inclusion Criteria #6 and 8). Examiner interprets CARDIFF’s method of treatment as necessarily including a recommendation to receive the treatment. Further, Examiner interprets CARDIFF’s teaching of two rising PSA values as indicative of measurement of the patient’s PSA levels in two samples.
Examiner cites BERIA, as an evidentiary reference, wherein onvansertib is disclosed as a potent, selective, and orally available PLK1 inhibitor (Abstract & Pg. 2970 Scheme 4 7g). Thus, onvansertib is known to be a PLK1 inhibitor.
ZHANG teaches PLK1 is elevated in prostate cancer, where its expression is linked to tumor grade (abstract). ZHANG also teaches androgen receptor signaling is essential for prostate cancer development even after castration and there is a need to identify targets to overcome resistance to androgen signaling inhibitors (ASI) such as abiraterone (Pg. 6635 Right Col. ¶2). ZHANG further teaches androgen receptor signaling positively regulates PLK1, in particular, depletion of AR-V7 caused reduction in PLK1 protein levels in a CRPC cell line 22Rv-1 (Pg. 6642 Left Col. P2 & Pg. 6643 Fig. 4 Description & Part C). Moreover, treatment of the 22Rv-1 cells with the PLK1 inhibitor (Pg.6636 Left Col. ¶3) BI2536 and abiraterone inhibited androgen receptor signaling in a synergistic manner, thus, inhibition of PLK1 enhances cellular response to abiraterone in CRPC cells expressing AR-V7 (Pg. 6643 Fig. 4 Description & Part E). ZHANG states the data presented demonstrates that PLK1 plays a critical role in cellular response to ASI and that inhibition of PLK1 overcomes ASI resistance in CRPC (Pg. 6646 Right Col. ¶1).
Furthermore, ZHANG teaches LuCaP35CR tumors were inoculated into castrated mice and the mice were intravenously injected twice per week with BI2536, which is a PLK1 inhibitor (Pg.6636 Left Col. ¶3), and abiraterone (Pg. 6645 Fig. 6 description); tumor volume shrunk relative to the vehicle after administration of the combined BI2536 and abiraterone treatment and serum PSA levels decreased in the treatment group relative to the increasing PSA levels in the vehicle group as measured over 7 weeks (Pg. 6645 Fig. 6 A-B and D, respectively). ZHANG teaches serum PSA levels were measured once a week (Pg. 6638 Left Col. ¶5). ZHANG also teaches the LuCaP35CR tumors are castration-resistant (Pg. 6642 Right Col. Last ¶). MOSTAGHEL discloses LuCaP35CR is characterized by AR-V7 (Pg. 17 Fig. 4).
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
CARDIFF does not teach wherein the CRPC is characterized by AR-V7.
ZHANG does not teach a method of treating a patient with onvansertib.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of methods of treating and evaluating progression of CRPC and possesses the technical knowledge necessary to make adjustments to the methods to optimize/enhance the outcomes of treatment. Said artisan has also reviewed the problems in the art regarding the androgen receptor variants associated with CRPC and understands the treatment solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references CARDIFF (evidenced by BERIA) in view of ZHANG (evidenced by MOSTAGHEL).
The artisan would be motivated to treat a patient having CRPC characterized by AR-V7 by administering onvansertib, as a PLK1 inhibitor, with abiraterone and prednisone in order to overcome abiraterone resistance in CRPC, as recognized by ZHANG (Pg. 6646 Right Col. ¶1). It would have been obvious for the artisan to substitute one functional equivalence (BI2536) with another (onvansertib) with an expectation of success, since both are PLK1 inhibitors. Further, CARDIFF teaches a method of treating a patient with CRPC by administration of onvansertib, abiraterone, and prednisone specifically to observe the effects of said combination on disease control (Pg. 8 Brief Summary). Thus, since ZHANG teaches inhibition of PLK1 enhances response to abiraterone in CRPC cells expressing AR-V7, both in vitro (Pg. 6643 Fig. 4 Description & Part E) and in vivo (Pg. 6645 Fig. 6 A-B and D), the artisan would be motivated, with an expectation of success, to treat AR-V7 characterized CRPC by the method of CARDIFF in order to optimize disease control. Therefore, the practice of claims 1, 3, 5, 12 ,14, 24, and 26 are obvious.
Claims 1 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over:
CARDIFF (Cardiff Oncology, Jan. 2018, NCT03414034, ClinicalTrials.gov,clinicaltrials.gov/study/NCT03414034?intr=Onvansertib&rank=5&a=1&tab=history, accessed 12/20/2024, provided by Examiner 01/16/2025),
as evidenced by:
BERIA (Beria, I., et al., Bioorganic & Medicinal Chemistry Letters, 2011, 21, 2969-6974, provided by Examiner 08/27/2025);
in view of:
ZHANG (Zhang, Z., et al., Cancer Res., 2014, 74(22), 6635-6647, provided in IDS of 10/19/2022),
as evidenced by:
MOSTAGHEL (Mostaghel, E. A. et al., Clin. Cancer Res., 2011, 17(18), 5913-5925; provided by Examiner 12/29/2025) as applied to claim 1 above,
further in view of:
ANSEL (Ansel, H.C. et al. Pharmaceutical Dosage Forms and Drug Delivery Systems, Lippincott Williams & Wilkins, 7th ed., 1999, pages 48-53; provided by Examiner 12/29/2025).
Determining the Scope and Contents of the Prior Art:
CARDIFF (evidenced by BERIA) and ZHANG (evidenced by MOSTAGHEL) teach the method of claim 1 in the rejection above.
ANSEL teaches the safe and effective dose of a drug depends on a number of
factors including characteristics of the drug, the dosage form, and a variety of patient factors (Pg. 48 Left Col. para 2) and the effective dose may be different for different
patients (Pg. 48 Left Col. para 4). ANSEL further teaches the schedule of dosage or the
dosage regimen is determined based on a drug’s duration of action, pharmacokinetics,
and characteristics of the dosage form (Pg. 40 Right Col. para 2).
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
CARDIFF and ZHANG do not teach the instant dosage cycle.
ANSEL does not teach the instant method.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of methods of treating and evaluating progression of CRPC and possesses the technical knowledge necessary to make adjustments to the methods to optimize/enhance the outcomes of treatment. Said artisan has also reviewed the problems in the art regarding the androgen receptor variants associated with CRPC and understands the treatment solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references CARDIFF (evidenced by BERIA) in view of ZHANG (evidenced by MOSTAGHEL) and further in view of ANSEL.
While CARDIFF and ZHANG do not teach exactly the claimed dosing cycle length, the artisan would be motivated to optimize the dosing cycle to optimize disease control and could utilize CARDIFF’s teachings as a starting point (i.e., once daily for 5 consecutive days every 21 days (Pg. 8 Brief Summary)).
MPEP 2144.05(II)(A) provides guidance about the routine optimization of prior art conditions: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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). "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").”
Furthermore, MPEP 2144.05(I) provides guidance about overlapping ranges: “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists…Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.”
CARDIFF’s dosage regimen is considered to approach the instantly claimed PLK1 inhibitor cycle of “more than one administration cycle where there is 9 days or less” between cycles (instant claim 15). Since ANSEL teaches the dosage regimen is based on duration of action, pharmacokinetics, and the dosage form (Pg. 40 Right Col. para 2) and the effective dosing may be different for different patients (Pg. 48 Left Col. para 4), the artisan would recognize the dosage regimen (i.e., cycle lengths) as a result-effective variable, i.e., a variable that achieves a recognized result. Thus, the dosage is analogous to the “concentration or temperature” recited in the MPEP and may be optimized by routine experimentation. Therefore, the determination of the optimum or workable dosage regimen (for both onvansertib and BI2536) would have been well within the practice of the artisan. Furthermore, absent any evidence demonstrating a patentable difference between the instant and prior art compositions and the criticality of the claimed dosage regimen, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the artisan.
Claims 1 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over:
CARDIFF (Cardiff Oncology, Jan. 2018, NCT03414034, ClinicalTrials.gov,clinicaltrials.gov/study/NCT03414034?intr=Onvansertib&rank=5&a=1&tab=history, accessed 12/20/2024, provided by Examiner 01/16/2025),
As evidenced by:
BERIA (Beria, I., et al., Bioorganic & Medicinal Chemistry Letters, 2011, 21, 2969-6974, provided by Examiner 08/27/2025),
in view of:
ZHANG (Zhang, Z., et al., Cancer Res., 2014, 74(22), 6635-6647, provided in IDS of 10/19/2022),
As evidenced by:
MOSTAGHEL (Mostaghel, E. A. et al., Clin. Cancer Res., 2011, 17(18), 5913-5925; provided by Examiner 12/29/2025) as applied to claim 1,
further in view of:
EPIC (WO 2017/053763; provided in IDS of 10/19/2022).
Determining the Scope and Contents of the Prior Art:
CARDIFF (evidenced by BERIA) and ZHANG (evidenced by MOSTAGHEL) teach the method of claim 1, see 103 rejection above.
EPIC teaches a method for selecting a therapy for a metastatic CRPC patient comprising detection of Androgen Receptor Variant 7 (AR-V7) in circulating tumor cells (CTCs) (Pg. 1 Para 2). EPIC further teaches CTCs released from tumors hold important information about the biology of the tumor and quantification and characterization of CTCs assists clinicians in selecting the course of therapy and to monitor how a patient’s cancer evolves; CTCs are a key tool to track tumor changes, treatment response, cancer recurrence, and patient outcome non-invasively (Pg. 2 Para 5).
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
CARDIFF and ZHANG do not teach a method of evaluating CTCs to identify androgen receptor variants.
EPIC does not teach treatment by administration of a PLK1 inhibitor onvansertib.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of methods of treating and evaluating progression of CRPC and possesses the technical knowledge necessary to make adjustments to the methods to optimize/enhance the outcomes of treatment. Said artisan has also reviewed the problems in the art regarding the androgen receptor variants associated with CRPC and how to measure and treat them and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references CARDIFF (evidenced by BERIA) in view of ZHANG (evidenced by MOSTAGHEL) and further in view of EPIC.
The artisan would find it obvious to modify the method of CARDIFF and ZHANG, above, by further evaluating CTCs to identify androgen receptor variants, in view of EPIC. The artisan would be motivated to do so since EPIC teaches CTCs are a key tool to track tumor changes, treatment response, cancer recurrence, and patient outcomes non-invasively (Pg. 2 Para 5). The artisan would have an expectation of success in identifying the androgen receptor variant AR-V7 in CTCs and then treating the patient having AR-V7 CRPC since ZHANG teaches inhibition of PLK1 enhances response to abiraterone in CRPC cells expressing AR-V7 (Pg. 6643 Fig. 4 Description & Part E). Thus, the artisan would expect identification of AR-V7 in CRPC to assist clinicians in selecting the course of therapy, as recognized by EPIC (Pg. 2 Para 5), such as administration of onvansertib and abiraterone, as taught by CARDIFF and ZHANG (above 103 over claim 1).
Conclusion
Claims 1, 3, 5, 12, 14-15, 24, 26, and 28 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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