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 . 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 27 Feb, 2026 has been entered.
Election/Restrictions
Applicant elected tamsulosin and dutasteride as the 5-ARI and alpha blocker without traverse in the reply filed on 18 Oct, 2023.
Claims Status
Claims 1, 3, 5-9, and 14 are pending.
Claims 1, 3, and 14 have been amended.
Withdrawn Rejections
The rejection of claim(s) 1 and 3-9 under 35 U.S.C. 103 as being unpatentable over Shore et al (Ther. Adv. Urol. (2019) 11 p1-16) in view of Roehrborn et al (Eur. Urol. (2010) 57(1) p123-131) and Le Tourneau et al (J. Natl. Canc. Inst. (2009) 101 p708-720) is hereby withdrawn due to amendment.
The rejection of claim(s) 14 under 35 U.S.C. 103 as being unpatentable over Averback (US 20190298731) in view of Roehrborn et al (Eur. Urol. (2010) 57(1) p123-131) and Le Tourneau et al (J. Natl. Canc. Inst. (2009) 101 p708-720) is hereby withdrawn due to amendment.
The provisional rejection of claims 1 and 3-9 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 8 of copending Application No. 16/410,685 (US 20200360466) in view of Roehrborn et al (Eur. Urol. (2010) 57(1) p123-131) and Le Tourneau et al (J. Natl. Canc. Inst. (2009) 101 p708-720) is hereby withdrawn due to amendment.
The rejection of claims 1., 3-9, and 14 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12-14 of U.S. Patent No. 10,835,538 in view of Le Tourneau et al (J. Natl. Canc. Inst. (2009) 101 p708-720) is hereby withdrawn due to amendment.
Maintained/Modified Rejections
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
first rejection
Claims 1, 3, and 5-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of copending Application No. 14/738,551 (US 20160361380) in view of Le Tourneau et al (J. Natl. Canc. Inst. (2009) 101 p708-720).
Competing claim 1 describes a method of treating BPH in a patient who has not received oral medication, comprising administering by intraprostatic injection a sequence IDQQVLSRIKLEIKRCL, followed by administering at least one active agent including both dutasteride and tamsulosin. Note that this sequence is identified by applicant as fexapotide triflutate (paragraph 26 of the instant specification). Competing claim 4 describes the second therapy to be one of a small Markush group that includes a combination of dutasteride and tamsulosin.
The difference between the competing claims and the examined claims is that the competing claims do not give a dose and dose schedule.
Le Tourneau et al discuss dose escalation methods in phase 1 clinical trials (title). The main goal of the phase I clinical trial is to determine the recommended dose and dose schedule of new drugs or drug combinations (abstract). The idea is to maximize efficacy and to minimize toxicity (p708, 2nd column, 1st paragraph). Several different ways of setting up the experiment to optimize these parameters are discussed (fig 2, p711, top of page, for example). This reference discusses how to optimize the dose of a drug or drug combination.
Therefore, it would be obvious to optimize the dose and dose schedule of the drugs administered, to maximize efficacy while minimizing toxicity, as described by Le Tourneau et al. As this must be done for every drug used, an artisan in this field would attempt this optimization with a reasonable expectation of success.
response to applicant’s arguments
Applicant argues that none of the references teach the triple combination, that the combination is unexpectedly superior, that the “state of the art” teaches away from identifying the claimed patient population and treating first with intraprostatic injection.
Applicant's arguments filed 27 Feb, 2026 have been fully considered but they are not persuasive.
Applicant argues that none of the references teach the triple combination. However, that is not a requirement, so long as the combination is obvious from the references cited.
Applicant argues that the combination is unexpectedly superior. This is incorrect. Applicant has demonstrated that it is not as antagonistic as the combination of a 5-ARI and an alpha blocker. But has not explained why a person of skill in the art would expect it to be. The fact that they treat the same condition is not sufficient, as noted by Jia et al (previously cited), synergy and antagonism is due to either the compound or mechanism, not the disorder.
Applicant argues that the state of the art teaches away from the invention. This is not explained; there is no pointing to what part of the cited references teach away from the invention. Without an explanation, this argument is not persuasive.
second rejection
Claims 1, 3, and 5-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of copending Application No. 18/805,214 in view of Roehrborn et al (Eur. Urol. (2010) 57(1) p123-131).
Competing claim 1 describes a method of treating LUTS, comprising administering fexapotide after identifying and selecting patients. If the patients need to be identified, they were not previously diagnosed, and so will not have taken oral drugs for BPH. Competing claim 3 specifies a concentration of 2.5 mg/L of the drug.
The difference between the competing claims and the examined claims is that the competing claims discuss a different disorder, and do not discuss the additional drugs.
Roehrborn et al discuss the combined therapy of dutasteride and tamsulosin on BPH (title), which is associated with LUTS (p124, 1st column, 1st paragraph). The study compared the drugs individually to the combination, with 0.5 mg dutasteride and 0.4 mg tamsulosin orally administered daily for 4 years (p124, 1st column, 3d paragraph). The combination therapy was significantly better than either monotherapy at reducing the clinical progression of the disease and amelioration of symptoms (abstract). This reference introduces the concept of combined therapy, and discusses such a therapy with dutasteride and tamsulosin.
Therefore, it would be obvious to add the dutasteride and tamsulosin of Roehrborn et al to the fexapotide of the competing claims to gain the improved efficacy noted by Roehrborn et al for the combination of the drugs. As the three drugs are all used to treat the same disorder, an artisan in this field would attempt this combination with a reasonable expectation of success. Note that it is also considered obvious to combine therapies used for the same purpose (MPEP 2144.06(I)).
This is a provisional nonstatutory double patenting rejection.
response to applicant’s arguments
Applicant has repeated the same arguments for all double patenting rejections, which was answered above.
New Rejections
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 1, 3, 5-9, and 14 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.
The independent claims require that the patient had not previously taken oral medication for BPH. However, Averback (US 20190298731. previously cited) describes antibiotics for that condition. Antibiotics can also be used to treat infections. Shanshanwal et al (Ind. J. Dermatol. Venereol. Leprol. (2017) 83 p47-54) describe alpha blockers for hair regrowth. Edwards (cited by applicant) describes doxazosin, terazosin, and prazosin as useful for lowering blood pressuer (p1406, 1st column, 3d paragraph). This means that there is a population of patients where the difference between a patient that meets the limitation of not previously taken oral medications for BPH and one that does not is merely the intent of the person prescribing the medication – which is in the head of the medical professional. This renders the claims indefinite, as it is not clear if one of the drugs was prescribed for the purpose of the claims.
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, 5-9, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Averback (US 20190298731) in view of Roehrborn et al (Eur. Urol. (2010) 57(1) p123-131), Edwards (Am. Fam. Phys. (2008) 77(10) p1403-1410, cited by applicants), and Le Tourneau et al (J. Natl. Canc. Inst. (2009) 101 p708-720).
Averback discusses treatment of BPH with antibiotics (title). When administered alone or with fexapotide triflutate, this will give a mean improvement of IPSS score of between 4 and 8 points in the first year (paragraph 25). This is between 20% to about 300% improvement compared to the standard therapy (paragraph 53). Additional active agents can be administered, such as alpha blockers and 5-ARI, including tamsulosin and dutasteride (paragraph 62). An example was given where 977 patients with BPH were administered either fexapotide triflutate or a control intraprostatically after a 7 day course of antibiotics (paragraph 72).
The difference between this reference and the instant claims is that it does not specify applicant’s elected second and third compounds (they are named as members of a Markush group), does not specify dosages, and does not clearly require no other therapeutic intervention first.
Roehrborn et al discuss the combined therapy of dutasteride and tamsulosin on BPH (title). The study compared the drugs individually to the combination, with 0.5 mg dutasteride and 0.4 mg tamsulosin orally administered daily for 4 years (p124, 1st column, 3d paragraph). The combination therapy was significantly better than either monotherapy at reducing the clinical progression of the disease and amelioration of symptoms (abstract). This reference introduces the concept of combined therapy, and discusses such a therapy with dutasteride and tamsulosin, applicant’s elected drugs.
Edwards discusses the diagnosis and management of benign prostate hyperplasia (title). Patients with mild symptoms are to be treated with watchful waiting (p1405, 1st column 3d paragraph, continues to p1406, 1st column, 2nd paragraph). Next line therapy is pharmacological, with alpha blockers and 5-ARI drugs discussed (p1406, 2nd column, 3d paragraph to p1407, 1st column, 1st paragraph). If pharmacological treatment fails, surgical treatment may be appropriate (p1407, 2nd column, 3d paragraph), continues to p1408, 1st column, 1st paragraph). This reference discusses diagnosis and treatment of BPH.
Le Tourneau et al discuss dose escalation methods in phase 1 clinical trials (title). The main goal of the phase I clinical trial is to determine the recommended dose and dose schedule of new drugs or drug combinations (abstract). The idea is to maximize efficacy and to minimize toxicity (p708, 2nd column, 1st paragraph). Several different ways of setting up the experiment to optimize these parameters are discussed (fig 2, p711, top of page, for example). This reference discusses how to optimize the dose of a drug or drug combination.
Therefore, it would be obvious to administer the combined therapy of dutasteride and tamsulosin to the therapy of Averback, to get the improvements of the combined therapy. As Averback explicitly discusses additional therapies, and mentions these specific drugs, an artisan in this field would attempt this addition with a reasonable expectation of success.
Furthermore, it would be obvious to optimize the dose and dose schedule of the drugs administered, to maximize efficacy while minimizing toxicity, as described by Le Tourneau et al. As this must be done for every drug used, an artisan in this field would attempt this optimization with a reasonable expectation of success.
Finally, it would be obvious to use this therapy on the patients of Edwards who are appropriate for pharmacological intervention, to treat these patients. As this is the same disorder as treated by Averback and Roehrborn et al, an artisan in this field would attempt this therapy with a reasonable expectation of success.
Averback discusses administering a course of antibiotics followed by intraprostatic injection of fexapotide triflutate, and discusses adding dutasteride and tamsulosin to the therapy. Roehrborn et al teach administration 0.4 mg tamsulosin and 0.5 mg dutasteride daily for 4 years; this will include all the time between 2 months and 4 years. While the dose of the fexapotide and the timecourse of the antibiotics are not quite the same as claimed, it is considered obvious to optimize those parameters, as described by Le Tourneau et al. The MPEP states that “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or working ranges by routine experimentation" In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“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.”) (MPEP2144.05.II). Edwards discusses diagnosing patients; it is not reasonable to treat a patient for a disorder that they have not been diagnosed for. Thus, the combination of references renders obvious claims 1, 3, 5-9, and 14.
Double Patenting
The legal basis for these rejections was given above, and will not be repeated here.
third rejection
Claims 1, 3, and 5-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 8 of copending Application No. 16/410,685 (US 20200360466) in view of Roehrborn et al (Eur. Urol. (2010) 57(1) p123-131), Edwards (Am. Fam. Phys. (2008) 77(10) p1403-1410, cited by applicants), and Le Tourneau et al (J. Natl. Canc. Inst. (2009) 101 p708-720).
Competing claim 1 describes a method of improvement of lower urinary tract symptoms, comprising administering SEQ ID 1, which is identical with fexapotide triflutate (paragraph 26 of the instant specification). Competing claim 4 specifies a Markush group of administration routes, including intraprostatically. Competing claim 8 mentions that these symptoms include sufferers of BPH.
The difference between the competing claims and the examined claims is that the competing claims do not specify a dose or dose schedule, nor the additional therapeutics of the examined claims.
Roehrborn et al discuss the combined therapy of dutasteride and tamsulosin on BPH (title). The study compared the drugs individually to the combination, with 0.5 mg dutasteride and 0.4 mg tamsulosin orally administered daily for 4 years (p124, 1st column, 3d paragraph). The combination therapy was significantly better than either monotherapy at reducing the clinical progression of the disease and amelioration of symptoms (abstract). This reference introduces the concept of combined therapy, and discusses such a therapy with dutasteride and tamsulosin, applicant’s elected drugs.
Edwards discusses the diagnosis and management of benign prostate hyperplasia (title). Patients with mild symptoms are to be treated with watchful waiting (p1405, 1st column 3d paragraph, continues to p1406, 1st column, 2nd paragraph). Next line therapy is pharmacological, with alpha blockers and 5-ARI drugs discussed (p1406, 2nd column, 3d paragraph to p1407, 1st column, 1st paragraph). If pharmacological treatment fails, surgical treatment may be appropriate (p1407, 2nd column, 3d paragraph), continues to p1408, 1st column, 1st paragraph). This reference discusses diagnosis and treatment of BPH.
Le Tourneau et al discuss dose escalation methods in phase 1 clinical trials (title). The main goal of the phase I clinical trial is to determine the recommended dose and dose schedule of new drugs or drug combinations (abstract). The idea is to maximize efficacy and to minimize toxicity (p708, 2nd column, 1st paragraph). Several different ways of setting up the experiment to optimize these parameters are discussed (fig 2, p711, top of page, for example). This reference discusses how to optimize the dose of a drug or drug combination.
Therefore, it would be obvious to include dutasteride and tamsulosin to the therapy of the competing claims, as that reference shows an improvement when therapies are combined. As the therapies have no obvious commonality in mechanism of action, an artisan in this field would make this combination with a reasonable expectation of success.
Furthermore, it would be obvious to optimize the dose and dose schedule of the drugs administered, to maximize efficacy while minimizing toxicity, as described by Le Tourneau et al. As this must be done for every drug used, an artisan in this field would attempt this optimization with a reasonable expectation of success.
Finally, it would be obvious to use this therapy on the patients of Edwards who are appropriate for pharmacological intervention, to treat these patients. As this is the same disorder as treated by Averback and Roehrborn et al, an artisan in this field would attempt this therapy with a reasonable expectation of success.
fourth rejection
Claims 1, 3, 5-9, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12-14 of U.S. Patent No. 10,835,538 in view of Le Tourneau et al (J. Natl. Canc. Inst. (2009) 101 p708-720) and Edwards (Am. Fam. Phys. (2008) 77(10) p1403-1410, cited by applicants).
Competing claim 1 describes a method of improving the symptoms of BPH, comprising administering a course of antibiotics. Competing claim 12 adds fexapotide triflutate, which competing claim 13 allows for administration intratumorally (interpreted as intraprostatically in the context of BPH). Competing claim 14 specifies further administration of another therapeutic selected from a Markush group comprising combinations of dutasteride and tamsulosin, applicant’s elected additional therapeutics.
The difference between the competing claims and the examined claims is that the competing claims do not specify the dose and dose schedule claimed by applicant.
Le Tourneau et al discuss dose escalation methods in phase 1 clinical trials (title). The main goal of the phase I clinical trial is to determine the recommended dose and dose schedule of new drugs or drug combinations (abstract). The idea is to maximize efficacy and to minimize toxicity (p708, 2nd column, 1st paragraph). Several different ways of setting up the experiment to optimize these parameters are discussed (fig 2, p711, top of page, for example). This reference discusses how to optimize the dose of a drug or drug combination.
Edwards discusses the diagnosis and management of benign prostate hyperplasia (title). Patients with mild symptoms are to be treated with watchful waiting (p1405, 1st column 3d paragraph, continues to p1406, 1st column, 2nd paragraph). Next line therapy is pharmacological, with alpha blockers and 5-ARI drugs discussed (p1406, 2nd column, 3d paragraph to p1407, 1st column, 1st paragraph). If pharmacological treatment fails, surgical treatment may be appropriate (p1407, 2nd column, 3d paragraph), continues to p1408, 1st column, 1st paragraph). This reference discusses diagnosis and treatment of BPH.
Therefore, it would be obvious to optimize the dose and dose schedule of the drugs administered, to maximize efficacy while minimizing toxicity, as described by Le Tourneau et al. As this must be done for every drug used, an artisan in this field would attempt this optimization with a reasonable expectation of success.
Furthermore, it would be obvious to use this therapy on the patients of Edwards who are appropriate for pharmacological intervention, to treat these patients. As this is the same disorder as treated by Averback and Roehrborn et al, an artisan in this field would attempt this therapy with a reasonable expectation of success.
fifth rejection
Claims 1, 3, and 5-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 9 of U.S. Patent No. 10,532,081 in view of Le Tourneau et al (J. Natl. Canc. Inst. (2009) 101 p708-720) and Edwards (Am. Fam. Phys. (2008) 77(10) p1403-1410, cited by applicants).
Competing claim 1 describes a method of treating BPH, comprising administering a sequence applicant has identified as identical with fexapotide triflutate (paragraph 26 of the instant specification). Competing claim 5 specifies a number of dosage routes, including intraprostatically, while competing claim 9 requires an additional drug selected from a Markush group comprising tamsulosin, dutasteride, and mixtures thereof.
The difference between the competing claims and the examined claims is that the competing claims do not specify the dose and dose schedule claimed by applicant.
Le Tourneau et al discuss dose escalation methods in phase 1 clinical trials (title). The main goal of the phase I clinical trial is to determine the recommended dose and dose schedule of new drugs or drug combinations (abstract). The idea is to maximize efficacy and to minimize toxicity (p708, 2nd column, 1st paragraph). Several different ways of setting up the experiment to optimize these parameters are discussed (fig 2, p711, top of page, for example). This reference discusses how to optimize the dose of a drug or drug combination.
Edwards discusses the diagnosis and management of benign prostate hyperplasia (title). Patients with mild symptoms are to be treated with watchful waiting (p1405, 1st column 3d paragraph, continues to p1406, 1st column, 2nd paragraph). Next line therapy is pharmacological, with alpha blockers and 5-ARI drugs discussed (p1406, 2nd column, 3d paragraph to p1407, 1st column, 1st paragraph). If pharmacological treatment fails, surgical treatment may be appropriate (p1407, 2nd column, 3d paragraph), continues to p1408, 1st column, 1st paragraph). This reference discusses diagnosis and treatment of BPH.
Therefore, it would be obvious to optimize the dose and dose schedule of the drugs administered, to maximize efficacy while minimizing toxicity, as described by Le Tourneau et al. As this must be done for every drug used, an artisan in this field would attempt this optimization with a reasonable expectation of success.
Furthermore, it would be obvious to use this therapy on the patients of Edwards who are appropriate for pharmacological intervention, to treat these patients. As this is the same disorder as treated by Averback and Roehrborn et al, an artisan in this field would attempt this therapy with a reasonable expectation of success.
Conclusion
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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