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 instant application is a 371 National Stage Entry of PC/ US23/63850 filed on March 7, 2023 which claims benefit to domestic application No. 63/317,801 filed on March 8, 2022.
Status of Claims
Acknowledgement is made of original (21, 31-32), amended (1, 3, 6-8, 10, 12-14, 17-18, 20, 22, 33, 36-37, 40), and cancelled (2, 4-5, 9, 11, 15-16, 19, 23-30, 34-35, 38-39, 41-68) claims filed on September 17, 2024. Claims 1, 3, 6-8, 10, 12-14, 17-18, 20-22, 31-33, 36-37, 40 are pending in instant application.
Information Disclosure Statement
The information disclosure statement filed on December 31, 2024 has been considered.
Claim Interpretation
Candida species are understood to not contain Prp8 inteins, as taught by Li et. al.1 (see Li at p. 1 right col. ¶2). Claims drawn to inhibiting Prp8 proteins (e.g. 7, 36) are understood to not encompass Candida species.
Claim Objections
Claims 1, 3, 8, 14, 18, 22, 33, 37, 40 are objected to because of the following informalities:
The claims state “wherein the fungus” or “wherein the bacterium”, but would be more clear with the conjunction “and” to read “and wherein the fungus” or “and wherein the bacterium”.
Appropriate correction is required.
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.
Claims 12, 21, 22, 31, 40 are rejected under 35 U.S.C. 103 as being unpatentable over Mawatwal et. al.2
Regarding a method of treating a disease caused by a microbe with calcimycin, Mawatwal teaches calcimycin is an antimycobacterial agent (see Mawatwal at p. 3192 right col ¶4). Mawatwal teaches Mycobacterium tuberculosis is the causative agent of pulmonary tuberculosis (TB) (see Mawatwal at p. 3190 left col. ¶1). Mawatwal teaches autophagy by calcium ionophores may provide an attractive target for the control of mycobacterial infection for developing better therapeutic interventions against tuberculosis (see Mawatwal at p. 3199 left col ¶2). Mawatwal teaches future experiments involving studying the effect of calcimycin on mycobacterial growth in vivo and either alone or in combination with first-line antitubercular drugs are planned (see Mawatwal at p. 3198 right col ¶2).
The prior art differs from the instant claims as follows: While Mawatwal suggests calcimycin for treating tuberculosis caused by Mycobacterium tuberculosis, Mawatwal does not reduce it to practice or specify inhibiting intein splicing as recited by instant claim 31.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Regarding inhibiting intein splicing, the claimed limitation appears to be a functional limitation, that would occur when the structural limitations of the claim are met (i.e. introducing a composition comprising calcimycin).
Regarding reducing to practice, it would have been obvious to an artisan to treat a subject with Mycobacterium tuberculosis because the prior art suggests calcimycin for treating tuberculosis caused by Mycobacterium tuberculosis (as taught by Mawatwal).
Furthermore, it is well-within the ordinary skill in art to put into practice a suggested treatment method.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claims 1, 8, 10, 12, 13, 18, 20, 31, 32, 37 are rejected under 35 U.S.C. 103 as being unpatentable over Vecchiarelli et. al.3 as evidenced by STN4.
Regarding a method of treating a disease caused by a fungus with calcimycin, Vecchiarelli teaches calcium ionophore A23187 is an anti-Candida agent (see Vecchiarelli at Abstract). Evidentiary reference STN teaches calcium ionophore A23187 is CAS Registry Number 52665-69-7, also known as calcimycin (see STN). Vecchiarelli teaches testing calcimycin against Candida albicans in vitro (see Vecchiarelli at p. 20 right col. ¶1 and at p. 22 Table 2), states calcimycin has been shown to play an important role in priming macrophages against microorganisms or tumoral cells (see Vecchiarelli at p. 24 left col. ¶2), and concludes intracellular killing of Candida albicans is increased by calcimycin (see Vecchiarelli at p. 24 right col. ¶5). Vecchiarelli teaches Candida albicans is sometimes known to cause infection (see Vecchiarelli at p. 19 left col. ¶2), and the corresponding citation teaches oral candidiasis in high-risk patients is the initial manifestation of the acquired immunodeficiency syndrome (see Vecchiarelli at p. 25, left col. reference three title, “Oral candidiasis in high risk patients as the initial manifestation of the acquired immunodeficiency syndrome”).
The prior art differs from the instant claims as follows: While Vecchiarelli teaches calcimycin causes intracellular killing of Candida albicans, Vecchiarelli does not teach treating a disease comprising administering calcimycin.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Regarding administering and treating a disease, it would have been obvious to an artisan to treat a subject with a disease caused by Candida albicans such as candidiasis by administering calcimycin because the prior art suggests calcimycin for killing Candida albicans, the cause of candidiasis (as taught by Vecchiarelli and evidenced by STN).
Furthermore, it is well-within the ordinary skill in art to use a known in vitro candidacidal agent to treat a disease caused by a Candida species.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
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, 3, 6-7, 12-14, 17, 31, 32-33, 36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-29, 32-36 of copending Application No. 19/156,8575 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The applicable analysis for Nonstatutory Double Patenting is set forth in MPEP § 804(II), and specifically MPEP § 804(II)(B). MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis. The instant analysis is an obviousness analysis.
App’857 claims compositions comprising antifungal agents and pharmaceutically acceptable carriers with the intended use of treating a fungal infection caused by the Cryptococcus genus (App’857 claim 25) such as Cryptococcus neoformans (App’857 claim 26) or Cryptoccocus gatti (App’857 claim 27), and the infection may be cryptococcosis (App’857 claim 28) or cryptococcal meningitis (App’857 claim 29).
App’857 further claims a method of treating a fungal infection caused by a Cryptoccocus fungus by administering a composition comprising an antifungal agent and a carrier (App’857 claim 32) such as Cryptococcus neoformans (App’857 claim 33) or Cryptoccocus gatti (App’857 claim 34), and the infection may be cryptococcosis (App’857 claim 35) or cryptococcal meningitis (App’857 claim 36).
The copending claims differ as follows: the instant application i) is drawn only to methods not compositions, ii) specifies functional limitations (such as inhibiting Prp8 proteins) which are not specified in App’857, iii) the instant application specifically claims the agent calcimycin, and iv) the instant claims do not specify a carrier.
However,
Regarding i) and methods vs compositions, it would have been obvious to an artisan to use a composition for its intended use (e.g. in a method) to treat the intended condition (e.g. a fungal infection), because the composition would be serving its intended purpose as claimed by the copending application (a composition fore treating a fungal infection).
Regarding ii) and functional limitations, the instant functional limitations would be a direct result of administering the antifungal agent calcimycin.
Regarding iii) and calcimycin, the instantly claimed calcimycin falls under the copending category of “antifungal agent”; the instant claims are encompassed by the copending claims.
Regarding iv) and a carrier, even though the instant claims do not further specify a carrier, they are still encompassed by the methods of administering an antifungal agent.
Furthermore, it is well-within the ordinary skill in art to use a composition for its intended use.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 3, 6-7, 14, 17, 33, 36 are currently dependent upon a rejected base claim, but would be allowable if a terminal disclaimer over the copending App’857 was filed and rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1, 3, 8, 14, 18, 22, 33, 37, 40 are objected to.
Claims 1, 3, 6-8, 10, 12-14, 17-18, 20-22, 31-33, 36-37, 40 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA J REILLY whose telephone number is (703)756-5669. The examiner can normally be reached 9:00 am - 5:00 pm EST M-F.
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/S.R./Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
1 Li et. al. "Small-molecule inhibitors for the Prp8 intein asantifungal agents" PNAS, 2021, 118, 2, e2008815118, 1-10. DOI: 10.1073/pnas.2008815118. Published Online January 4, 2021. Hereinafter Li.
2 Mawatwal et. al. "Calcimycin mediates mycobacterial killing by inducing intracellular calcium-regulated autophagy in a P2RX7 dependent manner" Biochimica et Biophysica Acta (BBA) - General Subjects, 2017, 1861, 12, 3190-3200. DOI: 10.1016/j.bbagen.2017.09.010. Hereinafter Mawatwal.
3 Cite No 1 in the IDS filed 12/31/24. Vecchiarelli et. al. "Mechanism of Intracellular Candidacidal Activity Mediated by Calcium Ionophore in Human Alveolar Macrophages" AMERICAN JOURNAL OF RESPIRATORY CELL AND MOLECULAR BIOLOGY, 1993, 9, 1-25. DOI: 10.1165/ajrcmb/9.1.19. Hereinafter Vecchiarelli.
4 CAS 52665-69-7 CAS Registry File Accessed August 11, 2026 from STN, entered into STN November 16, 1984. Hereinafter STN.
5 Hereinafter App’857.
Prosecution Insights