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 present Application, filed October 21, 2022, is a national stage entry under 35 U.S.C. § 371 of International Patent Application No. PCT/EP2021/060441, which claims priority to European Patent Application No. EP20170703, filed April 21, 2020.
Status of the Claims
In the amendment filed December 19, 2025, claims 22-23, 30, and 35-36 are canceled and new claims 37-39 are added. Claims 18-21, 24-29, and 31-34 are amended. Claims 18-21, 24-29, 31-34, and 37-39 are currently pending.
Previous Rejections and/or Objections
Any objections and/or rejections raised in the previous Office Action but not reiterated below are considered to have been withdrawn.
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.
Claims19 is indefinite:
Claims 19 is 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 19 is indefinite for reciting “wherein said splenomegaly is induced cancer and virus-mediated or protein-mediated immunization,” because one of ordinary skill in the art could not reasonably determine the metes and bounds of this limitation. In would be unclear what it means that the splenomegaly “is induced cancer,” and that it is “virus mediated or protein-mediated immunization.” It may be that the claim is intended to recite something along the lines of wherein the splenomegaly is induced by cancer or is induced by virus-mediated or protein-mediated immunization, but this is not clear. For the purpose of compact prosecution, claim 19 will be examined against the prior art according to this construction.
Claim Rejections - 35 USC § 102 – Necessitated by Amendment
The following is a quotation of the appropriate paragraphs of 35 U.S.C. § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 18, 20, 24, 27-29, 32-33, and 37-38 are anticipated by Marchant:
Claims 18, 20, 24, 27-29, and 37-38 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by U.S. Patent No. 10,426,722 to Marchant et al. (hereinafter, “Marchant”).
Claim 18 recites a method for the prevention and/or the treatment of splenomegaly in an individual in need thereof comprising the administration of a therapeutically efficient amount of an alpha-2 adrenergic receptor agonist, wherein the alpha-2 adrenergic receptor agonist is not epinephrin. Similarly, claim 32 recites a method for reducing the volume and/or the weight of a spleen in an individual in need thereof comprising the administration of a therapeutically efficient amount of an alpha-2 adrenergic receptor agonist, wherein the alpha-2 adrenergic receptor agonist is not epinephrin.
Marchant teaches methods for preventing, inhibiting, or treating parasitic flatworm infection in a vertebrate, the method including administering an effective amount of a composition comprising an ergot alkaloid or a lysergic acid amide, where the ergot alkaloid is an agonist or partial agonist of a serotonergic G-protein coupled receptor (Abstract, claim 1). Marchant teaches that the ergot alkaloid can be ergotamine (col. 4, lines 35-36), and that when used in the method, ergotamine reduces splenomegaly in flatworm infected mice (col. 37, lines 1-15). Marchant thus teaches a method for the treatment of splenomegaly – and also for reducing the volume and/or weight of a spleen - in a flatworm-infected mouse (an individual in need of such treatment), comprising administration of ergotamine to the individual. The instant specification indicates that ergotamine is an alpha-2 (α2) adrenergic receptor agonist of instant claim 1 (e.g. pg. 10, lines 20-22, and claim 20), and Marchant therefore anticipates instant claims 18 and 32.
With respect to claims 20 and 33, Marchant teaches that the α2 adrenergic receptor agonist is ergotamine. With respect to claim 24, Marchant teaches that the ergotamine is administered at 95 mg/kg body weight (col. 34, lines 1-4). With respect to claim 27, Marchant teaches that the active agent (e.g. ergotamine) can be combined with an adjuvant such as an antimicrobial agent to optimize the properties for a given use. Claims 28-29, depending from claim 27, specifies types of immunotherapy that may be used, if the α2 adrenergic receptor agonist is co-administered with an immunotherapy, but these claims not require that the α2 adrenergic receptor agonist be co-administered with an immunotherapy. Therefore, claims 28-29 are anticipated for the same reason that claim 27 is anticipated.
With respect to claims 37-38, the ergotamine of Marchant is not xylazine.
Claims 32-34 and 38 are anticipated by Masatomo:
Claims 32-34 and 38 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by International Patent Application No. WO2020050290 to Masatomo (hereinafter, “Masatomo”).
Masatomo teaches an agent for improving obesity-related metabolic diseases, particularly an agent for improving fatty liver, which comprises guanabenz or a salt thereof as an active ingredient (Abstract). More particularly, Masatomo teaches a method for ameliorating an obesity-related metabolic disease by administering a therapeutically effective amount of guanabenz. Masatomo further teaches that guanabenz acetate administration to obese mice decreases the weight of the spleen relative to comparable obese mice not administered guanabenz (paragraph [0031] and Figure 11-A).
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Because Masatomo expressly teaches administration of guanabenz (α2 adrenergic receptor agonist) reduces the splenic weight in obese mice (individuals in need of treatment), Masatomo anticipates claim 32. With respect to claims 33-34, Masatomo teaches administration of guanabenz (i.e. the α2 adrenergic receptor agonist is guanabenz). With respect to claim 37, the guanabenz of Masatomo is not xylazine.
Claim Rejections - 35 USC § 103 – Maintained with Modification
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 18-21, 24, 26-29, and 32-34 are obvious over Hubbell and Cervantes:
Claims 18-21, 24, 26-29, and 32-34 are rejected under 35 U.S.C. § 103 as being unpatentable over the non-patent publication, Effect of xylazine hydrochloride on canine splenic weight: an index of vascular capacity, Am. J. Vet. Res., 43, pgs. 2188-2192 (1982) by Hubbell et al. (hereinafter, “Hubbell”), in view of the non-patent publication, How I treat splenomegaly in myelofibrosis, Blood Cancer J., 1, e37, pgs. 1-6 (2011) by Cervantes (hereinafter, “Cervantes”).
In Applicant’s Remarks of December 19, 2025, Applicant disagrees with the rejections for obviousness over Hubbell, and first argues that Hubbell is deficient because there is no evidence that the spleen size decrease that is observed subsequent to xylazine administration can be specifically attributed to an α2-adrenergic receptor agonistic activity (pg. 10 of Applicant’s Remarks, second to last full paragraph). Further to this point, Applicant asserts that Hubbell monitors the effect of xylazine administration in a canine experimental model in the presence of α-adrenergic and β-adrenergic receptor blocking drugs, and Applicant argues that the notion that Hubbell would even disclose, inherently, a functional link with α2 receptors specifically constitutes a posteriori reasoning (same paragraph). This argument has been fully considered, but is not found persuasive.
As a first matter, while Hubbell does look at the effects of xylazine in the presence of α-adrenergic and β-adrenergic receptor blocking drugs, Hubbell also clearly shows that xylazine administration alone results in a decrease in spleen size (see Fig. 1, reproduced below, and pg. 2190, Results, second paragraph). Furthermore, the rejections over Hubbell and Cervantes do not rely on any mechanistic rationale. The question whether Hubbell discloses or suggests that α2-adrenergic receptor agonist activity causes the observed effect of spleen size decrease is irrelevant to the reasons for rejection. Hubbell teaches the xylazine administration causes a decrease in spleen size and this, in combination with Cervantes, renders it obvious to administer xylazine as a therapeutic for splenomegaly.
Applicant next notes that Hubbell does not itself expressly teach treatment of splenomegaly (pg. 10 of Applicant’s Remarks, last full paragraph). This, however, is why Cervantes is included in the rejection.
With respect to Cervantes, Applicant argues that one would not have concluded that “the utilization of methods to reduce spleen size is a common approach for treating splenomegaly,” because Cervantes teaches that splenic radiation to reduce the spleen size in preparation for splenectomy is not advised. (paragraph spanning the bottom of pg. 10 to the top of pg. 11 of Applicant’s Remarks). Applicant is understood as arguing that this observation, that radiation is not a recommended treatment for preoperative splenomegaly, undermines the obviousness of applying treatments known to reduce spleen size to the treatment of splenomegaly. This argument has been fully considered, but is not found persuasive.
Cervantes expressly teaches that radiation is not recommended to treat preoperative splenomegaly because radiation carries undesirable side effects. Cervantes begins the section in question (pg. 3, Radiation Therapy) by observing that “[s]plenic radiation can be used to reduce the spleen size and procure symptom relief,” but notes that routine use of splenic irradiation in patients with myelofibrosis-associated splenomegaly is not recommended, in part because it carries of risk of long-lasting cytopenias with subsequent infection and bleeding. Thus, this section supports that notion that treatments which reduce spleen size are normally considered for treatment of splenomegaly, but with the caveat that treatments like irradiation which carry significant side effects such as excessive splenic bleeding should generally be avoided. This argument is effective to overcome the previous rationale for rejection of claim 27, which combined the radiation of Cervantes with the xylazine of Hubbell. Otherwise, since there is no evidence of record that the xylazine of Hubbell carries unwanted side effects such as splenic bleeding, the caveat of Cervantes is not relevant to overcome the reasons for rejection.
Finally, with respect to the rejections over Hubbell and Cervantes, Applicant argues that the relatively early publication date (1982) of Hubbell constitutes secondary evidence of nonobviousness (pg. 11, of Applicant’s Remarks, first full paragraph). This is understood as being an argument of a long-felt, and unmet need in the field. However, an early publication date for the teaching of the spleen-size-reducing effect of xylazine is not, itself, sufficient to establish a long felt an unmet need to rebut a prima facie case of obviousness. Rather, there must be an objective showing, inter alia, of (i) objective evidence that an art recognized problem existed in the art for a long period of time without solution, (ii) the long-felt need has not been satisfied by another before the invention by the inventor, and (iii) the invention does in fact satisfy the long-felt need. See MPEP 716.04 and cases cited therein. The publication date of Cervantes does not satisfy these requirements.
For the aforementioned reasons, the rejections, with minor modification for altered dependencies, are maintained.
Modified but substantially reiterated rejection:
Hubbell teaches a study of the effect of xylazine administration on the splenic weight of dogs (Summary). In particular, Hubbell teaches that xylazine, administered at 1 mg/kg, caused significant decreases in splenic weight, an effect that was blocked when xylazine followed administration of the α-adrenergic blocker, phenoxybenzamine, but not when it followed administration of the β-adrenergic blocker, propranolol (Summary, Fig. 1)
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Above: Fig. 1 of Hubbell.
Hubbell teaches that xylazine administration can reduce spleen size, but does not explicitly teach application to the treatment of splenomegaly. It would have been obvious to apply the spleen size reduction taught by Hubbell to individuals with splenomegaly because treatments that reduce spleen size were known to be usefully applied to splenomegaly (enlarged spleen). See, for example, Cervantes.
Cervantes teaches various options for treating an enlarged spleen (splenomegaly), with an aim of reducing the size of the spleen, in patients having myelofibrosis (Abstract). For example, Cervantes teaches administration of splenic radiation (“Radiation therapy,” pg. 3, right column) to reduce the spleen size and procure symptom relief. Because the utilization of methods to reduce spleen size is a common approach for treating splenomegaly (as taught by Cervantes), it would have been obvious to apply the xylazine, shown by Hubbell to reduce spleen size, to the treatment of splenomegaly in myelofibrotic patients, as in Cervantes, thus arriving at the method of claim 18.
Similar to claim 18, claim 32 recites a method for reducing the volume and/or the weight of a spleen in an individual in need thereof comprising the administration of a therapeutically efficient amount of an α-2 adrenergic receptor agonist. As noted with respect to claim 18, Hubbell teaches that administration of xylazine reduces splenic size in dogs, while Cervantes teaches that shrinking of the spleen is a treatment for splenomegaly. Thus, the combination of Hubbell and Cervantes teaches the method of claim 32, with Hubbell teaching the method of reducing weight of a spleen comprising administration of the α-2 adrenergic receptor agonist, and Cervantes identifying the individual having splenomegaly as the individual in need to receive the treatment.
With respect to claims 19 and 26, the method of Hubbell/Cervantes, as discussed above, is particularly directed to treatment of splenomegaly induced by myelofibrosis. With respect to claims 20-21 and 33-34, Hubbell teaches xylazine administration results in spleen shrinkage. With respect to claim 24, Hubbell teaches that 1 mg/kg xylazine resulted in spleen size reduction.
Claims 27-29, 31, and 39 are obvious over Hubbell, Cervantes, and Zeldis:
Claims 27-29, 31, and 39 are rejected under 35 U.S.C. § 103 as being unpatentable over, Hubbell in view of Cervantes and further in view of U.S. Patent Application Publication No. 2006/0165649 to Zeldis (hereinafter, “Zeldis”).
With respect to the previous rejection of claim 31 (applicable to the new reasons for rejection of claims 27-29), Applicant further argues that one would not have been motivated to combine Cervantes with Hubbell or Zeldis because Cervantes (unlike Hubbell) teaches radiation therapy, not xylazine treatment, and because Cervantes teaches treatments for myelofibrosis whereas Zeldis teaches treatments for myeloproliferative diseases. These arguments have been fully considered but are not found persuasive.
Regarding the latter argument, as noted in the original and reiterated rejection, my myelofibrosis is a myeloproliferative disease, and so this argument is not persuasive to overcome the rejection. Regarding the former argument, Cervantes is not cited for the particulars of treatment, but merely for the teaching, arguably per se obvious, that one would be motivated to employ methods known to decrease spleen size for the treatment of an enlarged spleen (splenomegaly). As such, the fact that Cervantes does not expressly discuss xylazine is not relevant to the reasons for rejection. The previous rejection of claim 31 is maintained and the new rejections of claims 27-29 are made on a similar basis.
Modified and reiterated rejections:
Claim 27 recites a method of claim 18 wherein the α2 adrenergic receptor agonist is administered with a primary or secondary treatment selected from the group consisting of antimicrobial agents, anti-inflammatory agents, chemotherapy, immunotherapy, radiation, and a combination thereof.
Hubbell and Cervantes are applied to claim 27 as to claim 18, above, but neither expressly teaches administering the xylazine of Hubbell (an α2 adrenergic receptor agonist) with an additional treatment selected from those recited in claim 27. It would have been obvious, however, to utilize the xylazine of Hubbell in combination with such an agent because the strategy of combining an α2 adrenergic receptor agonist with a chemotherapeutic agent was known in the art. See, for example Zeldis.
Zeldis teaches, inter alia, methods for preventing and/or managing a myeloproliferative disease (Abstract). Notably, the myelofibrosis of Cervantes is a myeloproliferative neoplasm, i.e. a myeloproliferative disease (see Cervantes, Introduction, first paragraph). The methods of Zeldis include administering a selective cytokine inhibitory drug (i.e. a chemotherapeutic) and can further include administration of a second active agent (paragraph [0035]). Zeldis further teaches that the second active agent can be an agent capable of ameliorating one or more symptoms of the MPD and that one example of such a symptom is splenomegaly (paragraphs and [0007] and [0242]). It thus would have been obvious, in view of the teachings of Zeldis, to modify the method of Hubbell and Cervantes, by co-administering a chemotherapeutic agent along with the xylazine of Hubbell, for treating splenomegaly along with other manifestations of a myeloproliferative disease such as myelofibrosis.
With respect to claims 28-29, these claims specify details of the optional immunotherapy of claim 27, but do not require that the primary or secondary treatment be immunotherapy. As such, claims 28-29 are obvious for the same reasons applied to claim 27.
Claim 31 recites a combination kit comprising (i) an alpha-2 adrenergic receptor agonist or a pharmaceutical composition comprising an alpha-2 adrenergic receptor agonist and (ii) a therapeutic agent selected in the group consisting of an antibiotic, an antiparasitic, an antiviral, a chemotherapy agent, an immunotherapy agent, and the like, for the prevention and/or the treatment of a spleen disorder.
Hubbell, Cervantes, and Zeldis are applied to claim 31 as to claim 27, above, and Zeldis further teaches kits (i.e. a combination kit) having a selective cytokine inhibitory drug (i.e. a chemotherapeutic) and a second active ingredient, as described above. It would have been obvious to adapt the kit of Zeldis to the method of Hubbell and Cervantes, by utilizing the xylazine of Hubbell as the second active agent in the kit of Zeldis, to ameliorate the splenomegaly symptom of leukemia by shrinking the spleen of the leukemic patient.
With respect to claim 39, this claim specifies details of the optional immunotherapy of claim 31, but do not require that the primary or secondary treatment be immunotherapy. As such, claim 39 is obvious for the same reasons applied to claim 31.
Claim Rejections - 35 USC § 103 – New in view of amendment
Claims 18, 20-21, and 24, and 27-29 are obvious over Masatomo and Cervantes:
Claims 18, 20-21, and 24, and 27-29 are rejected under 35 U.S.C. § 103 as being unpatentable over Masatomo, in view of Cervantes.
Masatomo is applied to claim 18 as to claim 32, above, and Cervantes is applied to claim 18 as above in the rejections over Hubbell and Cervantes. Thus, Masatomo teaches a method of reducing volume and/or weight of a spleen comprising administering guanabenz (an α2 adrenergic receptor agonist) to an obese mouse (an individual in need thereof); and Cervantes is applied as teaching utilization of methods to reduce spleen size is a common approach for treating splenomegaly. On this basis, it would have been obvious to apply the method of Masatomo, which is known to reduce spleen size in obese mice, as a means to treating splenomegaly.
With respect to claims 20-21, Masatomo teaches administration of guanabenz (i.e. the α2 adrenergic receptor agonist is guanabenz). With respect to claim 24, Masatomo teaches the dose can be in a range of 0.01 to 1000 mg per day (paragraph [0036]). Whether administration is to a mouse or a human, this would be within the dose per body mass range recited in claim 24. With respect to claim 37, the guanabenz of Masatomo is not xylazine.
Double Patenting – Rejections Maintained in Part, Modified in view of Amendment
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.
Claims 18-21, 24, 26-29, 31-34, and 37-39 are provisionally rejected for nonstatutory double patenting over the ’116 application and Cervantes:
Claims 18-21, 24, 26-29, 31-34, and 37-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-34 of copending Application No. 17/920116 (hereinafter, “the ’116 application”) in view of Cervantes. The ’116 application corresponds to U.S. Patent Application Publication No. 2023/0165836, cited in the form 892 attached to this Action.
Applicant asserts that there is “no overlap” between the presently claimed subject matter and that of the ’116 application (pg. 14 of Applicant’s Remarks, first full paragraph). To this point, Applicant notes that the cited claims of the ’116 application are directed toward a method for treating cancer, while the presently claimed methods are directed toward treating splenomegaly. Further, Applicant notes that not all splenomegaly is cancer-related and, similarly, not all cancer necessarily results in splenomegaly. To the latter point, Applicant notes that Cervantes teaches that splenomegaly is a frequent symptom of myelofibrosis, but not necessarily a universal symptom of myelofibrosis. These arguments have been fully considered, but are not found persuasive.
The method of the instant claims and that of the ’116 application have essentially the same method step, and differ only in the patient population: those suffering from cancer vs. those suffering from splenomegaly. And there is overlap between those patient populations. As noted in the rejection, Cervantes teaches that myelofibrosis, which is expressly recited in the ’116 application, frequently manifests splenomegaly as a symptom; and Cervantes further teaches that treating the underlying myelofibrosis is a well-known means of treating the splenomegaly. Thus, there is a clear overlap, at least in this one specific cancer, and one would have had a reasonable expectation of success, in view of the teachings of Cervantes, to use the method of the ’116 application to treat splenomegaly resulting from myelofibrosis.
Thus it is inaccurate to say there is no overlap between the presently claimed subject matter and that of the ’116 application; it would be correct instead to say that the patient populations of the two methods are not coextensive. Coextensivity of scope is not required for obviousness, however, and in the present case, the clear teaching of overlap and reasonable expectation of success within the overlap is regarded as sufficient to support obviousness-type double patenting, particularly where, as here a one-way test for distinctness is appropriate (In re Berg, 140 F.3d 1428 (Fed. Cir. 1998).
Applicant has noted, correctly, that U.S. Patent Application No. 17/286,913 is abandoned. Consequently, all rejections for nonstatutory double patenting over this application are withdrawn. However, the rejections for nonstatutory double patenting over the ’116 application, modified in view of amendments, are maintained.
Reiterated, albeit modified, rejection:
Claim 16 of the ’116 application recites a method for the prevention and/or the treatment of cancer in an individual in need thereof comprising the administration of a therapeutic effective amount of an alpha-2 adrenergic receptor agonist, as an active agent. Claim 16 of the ’116 application is thus substantially identical to instant claim 18, differing in the preambular recitation as being a method for the prevention and/or treatment of a cancer, as opposed to a method for the prevention and/or treatment of a spleen disorder. Thus, in terms of how the method of instant claim 18 and of claim 16 of the ’116 application are practiced, the only difference is in the patient populations/selection of patients. However, Cervantes teaches that treatment of splenomegaly is often undertaken by treating, or in conjunction with treating, the underlying myelofibrosis (i.e. cancer). Furthermore, because splenomegaly is, in many instances, a symptom of cancer such as myelofibrosis, the patient populations of the methods of instant claim 18 and of claim 16 of the ’116 application are overlapping in scope, and the method of instant claim 18 is an obvious variation of the method of claim 16 of the ’116 application.
Similarly, the method of instant claim 32, directed to a method for reducing the volume and/or the weight of a spleen in an individual in need thereof has substantial overlap in scope with claim 16 of the ’116 application; and instant claim 31, directed to a combination kit comprising an α-2 adrenergic receptor agonist and a therapeutic agent has substantial overlap in scope with claim 33 of the ’116 application, directed to a kit for preventing and/or treating cancer comprising an α-2 adrenergic receptor agonist and an anti-tumor compound. The features of instant dependent claims 19-27 and 33-36 are explicitly encompassed in the dependent claims of the ’116 application. The features of instant claims 28-29 recite non-required specific variations of immunotherapy, however, and the feature of claim 30 does not further limit the method. As such, these claims are obvious variations of the claims of the ’116 application as well.
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
Claim 25 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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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/ALEXANDER K. SHOWALTER/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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