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.
Claim Interpretation
The examiner notes that the phrase “suitable biological medium” in claims 13-14 is understood to be defined by the specification and therefore not indefinite. See the instant specification on page 28 lines 2-6, as well as the explanation provided on page 5 of the office action mailed on 18 April 2023 in parent application 17/842,876.
As such, the examiner understands a suitable biological medium to refer to a medium comprising buffered saline or cell culture media at the physiologically acceptable ionic strength and/or osmotic pressure. Therefore, the examiner has not written an indefiniteness rejection over the phrase "suitable biological medium" as the disclosure of the instant specification provides sufficient guidance to one of ordinary skill in the art to be able to understand what is meant by the phrase "suitable biological medium."
The examiner further notes that claims 13-14 are understood to further limit what would occur were the nanomedicinal composition to be combined with a suitable biological medium. This is the case regardless of whether the nanomedicinal composition is by itself or combined with the pharmaceutical composition. Claims 13-14 are not understood to further limit what would occur after oral administration.
Non-Statutory 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 2-8, 10-14, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,109,315 in view of Moghaddam et al. (Parasitology Research, Vol. 96, 2005, pages 273-275) and Desai et al. (US Patent 6,103,262).
The instant claims are drawn to a method of orally administering a composition to a patient suffering from blastocystis infection or blastocystis. The administered composition comprises a nanomedicinal composition comprising a metal-organic framework, a porous silicate or aluminosilicate, and an antioxidant selected from resveratrol in phenolic form and curcumin in enolic form. The administered composition also comprises an oral tablet comprising an excipient such as lactose, sucrose, or other excipients.
The conflicting claims are drawn to a method of administering a nanomedicinal composition comprising metal-organic framework, a porous silicate or aluminosilicate, and an antioxidant selected from resveratrol in phenolic form and curcumin in enolic form for treatment of blastocystis.
The conflicting claims do not recite the required oral route of administration, and do not recite a tablet comprising an excipient such as lactose or sucrose.
Moghaddam et al. (hereafter referred to as Moghaddam) is drawn to Blastocystis hominis, and Moghaddam teaches that Blastocystis is found in the intestinal tract of humans, as of Moghaddam, page 273, title and abstract. Moghaddam teaches oral delivery of a particular active agent, as of Moghaddam, page 274, right column, last paragraph, wherein the first active agent taught by Moghaddam is metronidazole.
Desai et al. (hereafter referred to as Desai) is drawn to a modified release composition of metronidazole, as of Desai, title and abstract. Desai teaches the following excipients which include lactose and magnesium stearate, as of figure 1, reproduced below.
PNG
media_image1.png
642
590
media_image1.png
Greyscale
Desai teaches a tablet as of column 13, claim 1 of Desai.
It would have been prima facie obvious for one of ordinary skill in the art to have used the tablet of Desai to have delivered the nanomedicinal composition of the conflicting claims. The conflicting claims are drawn to a method of administering a composition to treat blastocystis. While the conflicting claims are silent as to the route of administration, Moghaddam teaches that blastocystis is a disease of the intestine and that oral administration of an active agent is used to treat blastocystis. Desai is drawn to a tablet intended or oral administration of an active agent. As such, the skilled artisan would have been motivated to have used the tablet of Desai to have predictably delivered the nanomedicinal composition delivered in the method of the conflicting claims for predictably treating a patient having blastocystis with a reasonable expectation of success.
Note Regarding Status as a Divisional Application: The instant application is a divisional of application 18/193,692, which has matured into US Patent 12,109,315. According to MPEP 804.01, the third sentence of 35 U.S.C. 121 prohibits the use of a patent issuing on an application in which a requirement for restriction has been made, or on an application filed as a result of such a requirement, as a reference against any divisional application in a nonstatutory double patenting rejection, if the divisional application is filed before the issuance of the patent.
With that being said, in this case, the status of the instant application as a divisional of application 18/193,692 would not appear to prohibit a double patenting rejection in this case. This is because MPEP 804.01 states the following:
The following are situations where the prohibition against nonstatutory double patenting rejections under 35 U.S.C. 121 does not apply:
(A) The applicant voluntarily files two or more applications without a restriction requirement by the examiner. In order to obtain the benefit of 35 U.S.C. 121, claims must be formally entered, restricted in, and removed from an earlier application before they are filed in a divisional application…
This appears to be the fact pattern in the instant case because there was no restriction in parent application 18/193,692. As such, the instant application appears to be a “voluntary divisional” and the prohibition of a double patenting rejection in view of the third sentence of 35 U.S.C. 121 appears to be inapplicable in this case.
Claims 2-8, 10-14, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,826,477 in view of Moghaddam et al. (Parasitology Research, Vol. 96, 2005, pages 273-275) and Desai et al. (US Patent 6,103,262).
The instant claims are drawn to a method of orally administering a composition to a patient suffering from blastocystis infection or blastocystis. The administered composition comprises a nanomedicinal composition comprising a metal-organic framework, a porous silicate or aluminosilicate, and an antioxidant selected from resveratrol in phenolic form and curcumin in enolic form. The administered composition also comprises an oral tablet comprising an excipient such as lactose, sucrose, or other excipients.
The conflicting claims are drawn to a nanomedicinal composition comprising metal-organic framework, a porous silicate or aluminosilicate, and an antioxidant selected from resveratrol in phenolic form and curcumin in enolic form. The conflicting claims recite that the composition reduces the viability of Blastocystis organism by a particular amount.
The conflicting claims do not recite oral administration and do not recite a tablet comprising an excipient such as lactose or sucrose.
Moghaddam et al. (hereafter referred to as Moghaddam) is drawn to Blastocystis hominis infection, and Moghaddam teaches that Blastocystis is found in the intestinal tract of humans, as of Moghaddam, page 273, title and abstract. Moghaddam teaches oral delivery of a particular active agent, as of Moghaddam, page 274, right column, last paragraph, wherein the first active agent taught by Moghaddam is metronidazole.
Desai et al. (hereafter referred to as Desai) is drawn to a modified release composition of metronidazole, as of Desai, title and abstract. Desai teaches the following excipients which include lactose and magnesium stearate, as of figure 1. Desai teaches a tablet as of column 13, claim 1 of Desai.
It would have been prima facie obvious for one of ordinary skill in the art to have substituted the nanomedicinal composition of the conflicting claims in place of the metronidazole of Desai and to have delivered the resultant tablet via oral administration to a patient suffering from blastocystis. Both the nanomedicinal composition of the conflicting claims and the metronidazole of Desai are useful for treating a patient suffering from blastocystis infection. Moghaddam teaches that blastocystis is in the intestine and that oral administration of metronidazole for blastocystis is useful for its treatment. The tablet of Desai is useful for oral administration of metronidazole. As such, the skilled artisan would have been motivated to have substituted the nanomedicinal composition of the conflicting claims in place of the metronidazole of Desai using the tablet of Desai for predictable oral delivery to have predictably treated a patient suffering from blastocystis with a reasonable expectation of success.
The examiner notes that the third sentence of 35 U.S.C. 121 would not appear to prohibit this double patenting rejection. This is because the instant application is not a divisional of application 17/842,876, which matured into US Patent 11,826,477. In contrast, the instant application is a divisional of application 18/193,692, which is a divisional of application 17/842,876. As such, the instant application is not actually a divisional of the ‘876 application. Therefore, this double patenting rejection is not prohibited in view of the third sentence of 35 U.S.C. 121. See MPEP 804.01 for more information regarding this issue.
Claims 2-8, 10-14, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,280,158 in view of Moghaddam et al. (Parasitology Research, Vol. 96, 2005, pages 273-275) and Desai et al. (US Patent 6,103,262).
The instant claims are drawn to a method of orally administering a composition to a patient suffering from blastocystis infection or blastocystis. The administered composition comprises a nanomedicinal composition comprising a metal-organic framework, a porous silicate or aluminosilicate, and an antioxidant selected from resveratrol in phenolic form and curcumin in enolic form. The administered composition also comprises an oral tablet comprising an excipient such as lactose, sucrose, or other excipients.
The conflicting claims are drawn to a method of making a nanomedicinal composition comprising metal-organic framework, a porous silicate or aluminosilicate, and an antioxidant selected from resveratrol in phenolic form and curcumin in enolic form. The intended use of the composition made by the method of the conflicting claims appears to be for treating blastocystis, as of conflicting claim 13.
The conflicting claims do not recite oral administration and do not recite a tablet comprising an excipient such as lactose or sucrose.
Moghaddam et al. (hereafter referred to as Moghaddam) is drawn to Blastocystis hominis, and Moghaddam teaches that Blastocystis is found in the intestinal tract of humans, as of Moghaddam, page 273, title and abstract. Moghaddam teaches oral delivery of a particular active agent, as of Moghaddam, page 274, right column, last paragraph, wherein the first active agent taught by Moghaddam is metronidazole.
Desai et al. (hereafter referred to as Desai) is drawn to a modified release composition of metronidazole, as of Desai, title and abstract. Desai teaches the following excipients which include lactose and magnesium stearate, as of figure 1. Desai teaches a tablet as of column 13, claim 1 of Desai.
It would have been prima facie obvious for one of ordinary skill in the art to have substituted the nanomedicinal composition made by the method of the conflicting claims in place of the metronidazole of Desai and to have delivered the resultant tablet via oral administration to a patient suffering from blastocystis. Both the nanomedicinal composition made by the method of the conflicting claims and the metronidazole of Desai are useful for treating a patient suffering from blastocystis infection. Moghaddam teaches that blastocystis is in the intestine and that oral administration of metronidazole for blastocystis is useful for its treatment. The tablet of Desai is useful for oral administration of metronidazole. As such, the skilled artisan would have been motivated to have substituted the nanomedicinal composition made by the method of the conflicting claims in place of the metronidazole of Desai using the tablet of Desai for predictable oral delivery to have predictably treated a patient suffering from blastocystis with a reasonable expectation of success.
Claims 2-8, 10-14, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-12 and 15-18 of copending Application No. 19/074,789 in view of Moghaddam et al. (Parasitology Research, Vol. 96, 2005, pages 273-275) and Desai et al. (US Patent 6,103,262).
The instant claims are drawn to a method of orally administering a composition to a patient suffering from blastocystis infection or blastocystis. The administered composition comprises a nanomedicinal composition comprising a metal-organic framework, a porous silicate or aluminosilicate, and an antioxidant selected from resveratrol in phenolic form and curcumin in enolic form. The administered composition also comprises an oral tablet comprising an excipient such as lactose, sucrose, or other excipients.
The copending claims are drawn to a method of making a nanomedicinal composition comprising metal-organic framework, a porous silicate or aluminosilicate, and an antioxidant selected from resveratrol in phenolic form and curcumin in enolic form. The intended use of the composition made by the method of the conflicting claims appears to be for treating blastocystis, as of copending claim 15.
The copending claims do not recite oral administration and do not recite a tablet comprising an excipient such as lactose or sucrose.
Moghaddam et al. (hereafter referred to as Moghaddam) is drawn to Blastocystis hominis, and Moghaddam teaches that Blastocystis is found in the intestinal tract of humans, as of Moghaddam, page 273, title and abstract. Moghaddam teaches oral delivery of a particular active agent, as of Moghaddam, page 274, right column, last paragraph, wherein the first active agent taught by Moghaddam is metronidazole.
Desai et al. (hereafter referred to as Desai) is drawn to a modified release composition of metronidazole, as of Desai, title and abstract. Desai teaches the following excipients which include lactose and magnesium stearate, as of figure 1. Desai teaches a tablet as of column 13, claim 1 of Desai.
It would have been prima facie obvious for one of ordinary skill in the art to have substituted the nanomedicinal composition made by the method of the copending claims in place of the metronidazole of Desai and to have delivered the resultant tablet via oral administration to a patient suffering from blastocystis. Both the nanomedicinal composition made by the method of the copending claims and the metronidazole of Desai are useful for treating a patient suffering from blastocystis infection. Moghaddam teaches that blastocystis is in the intestine and that oral administration of metronidazole for blastocystis is useful for its treatment. The tablet of Desai is useful for oral administration of metronidazole. As such, the skilled artisan would have been motivated to have substituted the nanomedicinal composition made by the method of the copending claims in place of the metronidazole of Desai using the tablet of Desai for predictable oral delivery to have predictably treated a patient suffering from blastocystis with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Relevant Prior Art – No Rejection
As relevant prior art over which the claims are not rejected, the examiner cites the examiner cites Jermy et al. (US 2018/0280303 A1) and Gong et al. (WO 2020/210367 A1). The instant claims are not rejected over these references for at least the following reasons.
Jermy et al. (hereafter referred to as Jermy) is drawn to a mesosilicate nanocarrier, as of Jermy, title and abstract. Said composition may include MCM-41, as of Jermy, paragraphs 0081-0082, though KIT-6 is also suggested in paragraph 0084. Jermy teaches gallic acid inside the pores, as of at least paragraph 0065.
Jermy does not teach a metal organic framework which is a zeolitic imidazolate framework. Jermy also does not teach blastocystis.
Gong et al. (hereafter referred to as Gong) is drawn to a pH responsive silica-metal organic framework, as of Gong, title, abstract, and figure in abstract, which is reproduced below.
PNG
media_image2.png
195
795
media_image2.png
Greyscale
Gong teaches the zeolitic imidazolate metal organic framework known as “ZIF-8” as a metal organic framework, as of page 12, paragraph 0037. This metal organic framework appears to be used in a nanoparticle for delivery of bioactive molecules, as of Gong, abstract. The type of delivery appears to be pH sensitive, as of Gong, abstract; also see Gong, page 33, paragraph 0088.
Gong differs from the claimed invention because Gong does not teach blastocystis. Also, Gong differs from the claimed invention because Gong is drawn to the delivery of hydrophilic drugs. Gong defines hydrophilic drugs as those having a solubility of at least 1 mg/mL, as of Gong, paragraph 0042. Similarly, the examples of Jermy are drawn to gallic acid. Gallic acid has a water-solubility of 11 mg/mL, as of Liu (US 2011/0033525 A1), paragraph 0077. As such, both Gong and Jermy appear to be drawn to delivery of drugs with a water-solubility exceeding 1 mg/mL.
In contrast, the instant claims recite curcumin in its enolic form and/or resveratrol in its phenolic form. The term “phenolic,” with respect to resveratrol, refers to a protonated and neutrally charged phenol group, as opposed to a deprotonated and anionic phenoxide. The term “enolic,” with respect to curcumin, refers to a protonated and neutrally charged enol group, as opposed to a deprotonated and anionic enolate. These forms of curcumin and resveratrol are hydrophobic with water solubilities well below 1 mg/mL. See the following data for curcumin from the CAS Registry Record for curcumin (458-37-7), reproduced below with annotation by the examiner.
PNG
media_image3.png
360
873
media_image3.png
Greyscale
Also see the following data for resveratrol from the CAS Registry Record for resveratrol (CAS# 501-36-0).
PNG
media_image4.png
385
1302
media_image4.png
Greyscale
The examiner notes that 1 g/L is understood to be the same as 1 mg/mL. As such, the above-reproduced data indicates that curcumin in its enolic form and resveratrol in its phenolic form have solubilities well below the 1 mg/mL taught by Gong as being hydrophilic, and would therefore have been understood to have been hydrophobic.
Therefore, as Gong is drawn to specifically a drug delivery vehicle for hydrophilic drugs, there would have been no motivation for the skilled artisan to have substituted curcumin or resveratrol in their phenolic form, which are hydrophobic, in place of the hydrophilic active agents taught by Gong. This is because Gong is drawn to hydrophilic active agents, and curcumin or resveratrol in their phenolic form are hydrophobic rather than hydrophilic. There would have been no motivation for the skilled artisan to have substituted the hydrophobic agents recited by the instant claims in place of the hydrophilic actives recited by the prior art, especially as Gong is specifically drawn to hydrophilic active agents. As the skilled artisan would not have been motivated to have made such a combination, the skilled artisan would therefore not have been motivated to have administered such a combination to a patient population, let alone a patient population suffering from Blastocystis infection or Blastocystis.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612
Prosecution Insights