DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
According to the filing receipt filed 09/13/2023, the instant application filed 05/19/2023 is a CON of 17/186,559 filed 02/26/2021, which is a CON of 16/413,381 filed 05/15/2019, which is a CON of 15/913,750 filed 03/06/2018, which is a CON of 15/406,344 filed 01/13/2017, which is a CON of 14/679,887 filed 04/06/2015, which is a CON of 11/669,547 filed 01/31/2007, which claims benefit of 60/764,811.
However, a continuation or divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship to continuation-in-part because the application contains the following subject matter not disclosed in the 15/913,750 application or earlier applications: “tenofovir disoproxil salt” and “tenofovir disoproxil succinate”. The 15/913,750 and earlier applications disclose tenofovir salts generally, prodrugs generally, and tenofovir disoproxil fumarate (pars. [0019]-[0020], [0027]). However, this does not constitute as adequate description of tenofovir disoproxil salt generally or tenofovir disoproxil succinate. All of the instant claims are therefore awarded the effective filing date of 16/413,381 filed 05/15/2019.
Information Disclosure Statement
The Information Disclosure Statements filed on 05/19/2023, 09/08/2023, and 08/06/2024 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of list of references cited from the IDS is included with this Office Action.
Specification
The disclosure is objected to because of the following informalities: paragraph [0027], "(NRTI)" should read "(NtRTI)". Examiner additionally suggests that Applicant verify whether each recitation of NRTI and/or NtRTI is made in reference to the correct agents (nucleoside reverse transcriptase inhibitor vs. nucleotide reverse transcriptase inhibitor) throughout the remainder of the specification.
Appropriate correction is required.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see p. 9, par. [0029]). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 12 and 16 are objected to because of the following informalities:
Claim 12: ““a human immunodeficiency virus self-replicating infection of human immunodeficiency virus infection” is redundant;
Claim 16: "tenoforvir disoproxil salt" should read "tenofovir disoproxil salt". Appropriate correction is required.
Claim Rejections - 35 USC § 112 (second paragraph)
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 12-18 and 20 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 12 recites the limitation "the human immunodeficiency retrovirus". There is insufficient antecedent basis for this limitation in the claim as “retrovirus” is never recited. Claims 13-18 and 20 recite similar language including “retrovirus” or otherwise require the limitation at issue and are also rejected.
Claim 12 recites “the self-replicating infection” and “the immunodeficiency virus”. These terms cause confusion as they both seem to refer to the same limitation or portions thereof, “a human immunodeficiency virus self-replicating infection of human immunodeficiency virus infection”, yet differ slightly in scope. It is unclear, therefore, what “the self-replicating infection” and “the immunodeficiency virus” refer to. Clarification is required. Claims 13-18 and 20 recite similar language (e.g., “the immunodeficiency retrovirus”) or otherwise require the limitations at issue and are also rejected.
Claim 14 recites the limitation “the primate host”. There is insufficient antecedent basis for this limitation.
Claim 15 recites the limitation “the host”. There is insufficient antecedent basis for this limitation.
Claim Rejections - 35 USC § 112 (fourth paragraph)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 19 recites "wherein the combination comprises the tenofovir disoproxil salt". This does not further limit claim 1 as claim 1 already recites that the combination comprises tenofovir disoproxil salt. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112 (first paragraph)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for tenofovir disoproxil fumarate, does not reasonably provide enablement for tenofovir disoproxil salts generally, such as tenofovir disoproxil succinate or tenofovir disoproxil citrate. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
The instant claims are directed toward methods of preventing infection by an immunodeficiency virus, such as HIV, in a host comprising administering a combination of emtricitabine and a tenofovir disoproxil salt prior to exposure and a kit comprising emtricitabine and a tenofovir disoproxil salt. However, of the potential hundreds of salts of tenofovir disoproxil that could be envisaged, Applicant has only demonstrated the efficacy and existence of tenofovir disoproxil fumarate and has not contemplated any other species of disoproxil fumarate salt, such as a succinate, citrate, salicylate, etc. These salts cannot simply be willed into existence. As was stated in Morton International Inc. v. Cardinal Chemical Co., 28 USPQ2d 1190 “The specification purports to teach, with over fifty examples, the preparation of the claimed compounds with the required connectivity.” Hence, applicants must show that such salts can be made and used in the instantly claimed methods, or limit the claims accordingly.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1, 7, 9-11, 19, and 22 is/are rejected under 35 U.S.C. 102(a) as being anticipated by Heneine et al. (WO 2007/092326 A2; 2007).
Heneine et al. discloses a method of preventing SHIV-I in male macaques comprising administering a combination of emtricitabine and tenofovir disoproxil fumarate daily for seven to nine days prior to a first exposure to SHIV-I (par. [0041]). Heneine et al. discloses that the macaques were then exposed rectally to SHIV-I for up to 14 weeks (par. [0040], Figure 1). Heneine et al. discloses that the combination of emtricitabine and tenofovir was continued for 28 days after exposure, resulting in absence of persistent viremia and seroconversion which was defined as “protection” (par. [0041], [0042], Figure 2).
Heneine et al. additionally discloses a kit comprising a pharmaceutically effective amount of emtricitabine and tenofovir disoproxil fumarate and instructions for prophylactic administration (par. [0030]).
Claim(s) 1-19 and 22 is/are rejected under 35 U.S.C. 102(a) as being anticipated by Heneine et al. (US 9,579,333 B2; 2017; IDS filed 05/19/2023).
Heneine et al. discloses a method of protecting a primate host from a self-replicating infection by an immunodeficiency retrovirus comprising selecting a primate host not infected with the immunodeficiency retrovirus and administering a combination comprising emtricitabine and tenofovir disoproxil fumarate, wherein the combination is administered prior to exposure and thereby protects the primate host form infection with the immunodeficiency retrovirus (claim 1). Heneine et al. discloses that the primate host is an adult human male (claims 2-3), that the emtricitabine and the tenofovir disoproxil fumarate are administered in a combined single dosage (claim 4), and wherein the immunodeficiency retrovirus is HIV-1 (claims 5-6). Heneine et al. additionally teaches that the combination is administered as preexposure prophylactic treatment prior to rectal or vaginal exposure to the retrovirus (claim 7), that the dose is 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate (claim 9, and wherein the combination is administered for days, weeks, or months before and after exposure (claim 10) and results in absence of persistent viremia and seroconversion (claim 11).
Heneine et al. additionally discloses a method of inhibiting establishment of HIV self-replicating infection in a human comprising selecting an uninfected human and administering a combination of emtricitabine and tenofovir disoproxil fumarate to the human, thereby inhibiting establishment of the self-replicating HIV infection (claim 12), wherein the combination is administered prior to a potential exposure to HIV (claim 13), the combination is in a single formulation (claim 14), wherein inhibition is determined by an absence of persistent viremia and seroconversion (claim 15), and the potential exposure to HIV comprises sexual intercourse, medical worker skin puncture inoculation, hypodermic needle sharing, or blood transfusion (claim 17).
Heine et al. also teaches a kit comprising an effective amount of emtricitabine and tenofovir disoproxil fumarate, and instructions for use as a prophylactic (col. 6, lines 47-58).
Claim(s) 22 is/are rejected under 35 U.S.C. 102(a) as being anticipated by Dahl et al. (WO 2004/064845 A1; 2004; IDS filed 05/19/2023).
Dahl et al. discloses a patient pack (interpreted by Examiner to mean “kit”) comprising 300 mg of tenofovir disoproxil fumarate and 200 mg of emtricitabine, and instructions for use (claims 42, 44, and 46).
Examiner reminds applicant that the content of written instructions is not given patentable weight and does not distinguish a product from the prior art when the prior art product and claimed product are the same (MPEP 2112.01). Moreover, “for use in the method of claim 1” merely recites an intended use and is not given patentable weight for the same reason.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 2-6, 8, 12-18, and 20-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Heneine et al. (US 9,579,333 B2; 2017; IDS filed 05/19/2023) as applied to claims 1, 7, 9-11, 19, and 22 above, and further in view of Dova (US 2011/0009368 A1; 2011).
Heneine et al. teaches as above.
Heneine et al. does not teach that the primate host is human or that the immunodeficiency virus is HIV or HIV-1. Heneine et al. does not teach that the emtricitabine and tenofovir disoproxil fumarate are formulated together or as a tablet, or administering 200 mg of emtricitabine. Heneine et al. does not teach that the potential exposure to HIV is from sexual intercourse, medical worker skin puncture inoculation, hypodermic needle sharing, or blood transfusion. Heneine et al. does not teach that the tenofovir disoproxil salt is tenofovir disoproxil succinate. However, these limitations are obvious over Heneine et al. in view of Dova.
Heneine et al. additionally teaches oral tablet doses of emtricitabine and tenofovir disoproxil fumarate for protection from potential retroviral exposure, wherein for an adult human the preferred dose is 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate (par. [0030]). Heneine et al. discloses that SHIV-I in macaques is a model for HIV-I (par. [0040]). Heneine et al. states, in paragraph [0015] on page 3, “The use of a combination of antiretroviral agents as a prophylactic dosing regime is also provided for the manufacture of a medication is provided for protection against a human immunodeficiency virus infection developing to a level of self-replicating infection.” Heneine et al. teaches that common routes of retrovirus transmission include sexual intercourse, medical worker skin puncture inoculation, hypodermic needle sharing, and blood transfusions (par. [0015], p. 4). Heneine et al. discloses that there is a need for pre-exposure prophylactic regimens to prevent individuals from developing self-propagating retrovirus infections (in particular HIV, see par. [0005]) after initial exposure (par. [0007-0008]).
Dova teaches salt forms of tenofovir disoproxil with improved solubility and strongly reduced hygroscopicity (reducing the need for a desiccant in packaging, par. [0009]) compared to tenofovir disoproxil fumarate (par. [0011]). These salts include tenofovir disoproxil succinate, tenofovir disoproxil tartrate, tenofovir disoproxil saccharate, etc. (pgs. 2-13). Dova additionally discloses that the salt forms can be combined with other anti-HIV medicaments including emtricitabine (Abstract).
It would have been prima facie obvious for one of ordinary skill in the art to administer the prophylactic regimen of Heneine et al. to a human for preventing an HIV (HIV-I) infection, thereby inhibiting the establishment of the virus. One would have been motivated to do so due to a need in the art for pre-exposure prophylactic regimens to prevent HIV, and would have had a reasonable expectation of success as the working examples of Heneine et al. (SHIV-I in male macaques) are a model of HIV-I infection in humans. One would have therefore been apprised to use the tablet formulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate, which contains the preferred dosage in an adult human (such as a human male, per the working examples in male macaques) and that common routes of HIV transmission would include sexual intercourse, medical worker skin puncture inoculation, hypodermic needle sharing, and blood transfusions.
It would have been prima facie obvious for one of ordinary skill in the art to substitute tenofovir disoproxil fumarate for the tenofovir disoproxil succinate, or other salt forms of tenofovir disoproxil, as disclosed by Dova. One would have been motivated to do so, with reasonable expectation of success, as the tenofovir disoproxil salts of Dova are equivalent in function to tenofovir disoproxil fumarate, yet they have improved properties such as higher solubility and lower hygroscopicity which would improve administration and storage.
Claims 20 and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Heneine et al. (US 9,579,333 B2; 2017; IDS filed 05/19/2023) as applied to claims 1-19 and 22 above, and further in view of Dova (US 2011/0009368 A1; 2011).
Heneine et al. discloses as above.
Heneine et al. does not teach that the tenofovir disoproxil salt is tenofovir disoproxil succinate. However, these limitations are obvious over Heneine et al. in view of Dova.
Dova teaches salt forms of tenofovir disoproxil with improved solubility and strongly reduced hygroscopicity (reducing the need for a desiccant in packaging, par. [0009]) compared to tenofovir disoproxil fumarate (par. [0011]). These salts include tenofovir disoproxil succinate, tenofovir disoproxil tartrate, tenofovir disoproxil saccharate, etc. (pgs. 2-13). Dova additionally discloses that the salt forms can be combined with other anti-HIV medicaments including emtricitabine (Abstract).
It would have been prima facie obvious for one of ordinary skill in the art to substitute tenofovir disoproxil fumarate for the tenofovir disoproxil succinate, or other salt forms of tenofovir disoproxil, as disclosed by Dova. One would have been motivated to do so, with reasonable expectation of success, as the tenofovir disoproxil salts of Dova are equivalent in function to tenofovir disoproxil fumarate, yet they have improved properties such as higher solubility and lower hygroscopicity which would improve administration and storage.
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.
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. US 9,044,509 B2, in further view of Dova (US 2011/0009368 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘509 claims a process of protecting a primate host, particularly, human, from immunodeficiency retrovirus, particularly, HIV, comprising a) select a primate host not infected with immunodeficiency retrovirus, and b) orally administering the host a combination of effective amount of a combination comprising a pharmaceutically effective amount of emtricitabine (200 mg) and a pharmaceutically effective amount of tenofovir or tenofovir disoproxil fumarate (300 mg) prior to an exposure of the primate host to the immunodeficiency retrovirus. Regarding claims 20 and 21, reciting tenofovir disoproxil succinate, Dova teaches tenofovir disoproxil succinate and its application in anti-HIV medicaments, particularly in combination with emtricitabine. See Abstract. Thus, it would have been obvious to substitute the tenofovir disoproxil succinate for the tenofovir salt or the tenofovir disoproxil fumarate in the combination of tenofovir/emtricitabine. As to the kit, it would have been within the purview of one of ordinary skill in the art to make a kit comprising the therapeutic dosages for convenience in practice.
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. US 9,937,191 B2, in further view of Dova (US 2011/0009368 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘191 claims a process of protecting a primate host, particularly, human, from immunodeficiency retrovirus, particularly, HIV, comprising a) select a primate host not infected with immunodeficiency retrovirus, and b) orally administering the host a combination of effective amount of a combination comprising a pharmaceutically effective amount of emtricitabine (200 mg) and a pharmaceutically effective amount of tenofovir or tenofovir disoproxil fumarate (300 mg) prior to an exposure of the primate host to the immunodeficiency retrovirus. The combination is in the form of a single tablet and the administration may be carried out daily for days, weeks or months. Regarding claims 20 and 21, reciting tenofovir disoproxil succinate, Dova teaches tenofovir disoproxil succinate and its application in anti-HIV medicaments, particularly, in combination with emtricitabine. See Abstract. Thus, it would have been obvious to substitute tenofovir disoproxil succinate for the tenofovir salt or the tenofovir disoproxil fumarate in the combination of tenofovir/emtricitabine. As to the kit, it would have been within the purview of one of ordinary skill in the art to make a kit comprising the therapeutic dosages for convenience in practice.
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. US 10,335,423 B2, in further view of Dova (US 2011/0009368 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘423 claims a process of protecting a primate host, particularly, human, from immunodeficiency retrovirus, particularly, HIV, comprising a) select a primate host not infected with immunodeficiency retrovirus, and b) orally administering the host a combination of effective amount of a combination comprising a pharmaceutically effective amount of emtricitabine (200 mg) and a pharmaceutically effective amount of tenofovir or tenofovir disoproxil fumarate prior to an exposure of the primate host to the immunodeficiency retrovirus. Regarding claims 20 and 21, reciting tenofovir disoproxil succinate, Dova teaches tenofovir disoproxil succinate and its application in anti-HIV medicaments, particularly, in combination with emtricitabine. See Abstract. Thus, it would have been obvious to substitute tenofovir disoproxil succinate for the tenofovir salt or the tenofovir disoproxil fumarate in the combination of tenofovir/emtricitabine. As to the kit, it would have been within the purview of one of ordinary skill in the art to make a kit comprising the therapeutic dosages for convenience in practice.
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. US 9,579,333 B2, in further view of Dova (US 2011/0009368 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘333 claims a process of protecting a primate host, particularly, human, from immunodeficiency retrovirus, particularly, HIV, comprising a) select a primate host not infected with immunodeficiency retrovirus, and b) orally administering the host a combination of effective amount of a combination comprising a pharmaceutically effective amount of emtricitabine (200 mg) and a pharmaceutically effective amount of tenofovir or tenofovir disoproxil fumarate (300 mg) prior to an exposure of the primate host to the immunodeficiency retrovirus. The combination is administered orally, subcutaneously or vaginally, and may be formulated in a single dosage formulation. Regarding claims 20 and 21, reciting tenofovir disoproxil succinate, Dova teaches tenofovir disoproxil succinate and its application in anti-HIV medicaments, particularly, in combination with emtricitabine. See Abstract. Thus, it would have been obvious to substitute tenofovir disoproxil succinate for the tenofovir salt or in the tenofovir disoproxil fumarate in the combination of tenofovir/emtricitabine. As to the kit, it would have been within the purview of one of ordinary skill in the art to make a kit comprising the therapeutic dosages for convenience in practice.
Claims 1-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of copending Application No. 18/206,281 in view of Dova (US 2011/0009368 A1).
The claims of the ‘281 application are directed toward methods of prohibiting or preventing a human subject from being infected with HIV-1 comprising orally administering a daily dose of tenofovir prodrug (particularly tenofovir disoproxil fumarate) and emtricitabine (200 mg), wherein the human subject does not have HIV-1 prior to the first administration and at least some of the administering occurs before first exposure to HIV-1, and testing the blood serum of the human for HIV-1 after orally administering the daily dose for several days, weeks or months, thereby prohibiting the human subject from being infected with HIV-1. The claims are further directed toward a kit comprising a therapeutically effective amount of a tenofovir prodrug, wherein one of ordinary skill in the art would be apprised that tenofovir disoproxil fumarate would be a preferred prodrug, and emtricitabine in an amount of 200 mg. Regarding instant claims 20 and 21, reciting tenofovir disoproxil succinate, Dova teaches tenofovir disoproxil succinate and its application in anti-HIV medicaments, particularly, in combination with emtricitabine. See Abstract. Thus, it would have been obvious to substitute tenofovir disoproxil succinate for the tenofovir prodrug or in the tenofovir disoproxil fumarate in the combination of tenofovir/emtricitabine.
This is a provisional nonstatutory double patenting rejection.
Claims 1-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of copending Application No. 18/235,295 in view of Dova (US 2011/0009368 A1).
The claims of the ‘295 application are directed toward methods of prohibiting a human subject or inhibiting a primate hose from being infected with HIV-1 comprising orally administering a daily dose of a tablet comprising tenofovir prodrug (particularly tenofovir disoproxil fumarate) and emtricitabine (200 mg), wherein the human subject does not have HIV-1 prior to the first administration and administering the tablet before first exposure to HIV-1, and orally administering the daily dose for several days, weeks or months, wherein the human subject does not develop an HIV-1 infection after exposure to HIV-1. The claims are also directed toward a composition comprising 200 mg emtricitabine and a pharmaceutically effective amount of tenofovir for use in the aforementioned methods, wherein it would be within the purview of one of ordinary skill in the art to make a kit comprising the therapeutic dosages for convenience in practice. Regarding instant claims 20 and 21, reciting tenofovir disoproxil succinate, Dova teaches tenofovir disoproxil succinate and its application in anti-HIV medicaments, particularly, in combination with emtricitabine. See Abstract. Thus, it would have been obvious to substitute tenofovir disoproxil succinate for the tenofovir prodrug or in the tenofovir disoproxil fumarate in the combination of tenofovir/emtricitabine.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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/M.E.B./Examiner, Art Unit 1624 09/26/2025
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624