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.
Current Status of 18/892,854
This Office Action is responsive to the amended claims of 2 January 2025.
Claims 1-2, 6-10, 13-16, and 19-20 have been examined on the merits. Claims 1-2, 6-7, and 13 are currently amended. Claims 8-10, 14-16, and 19-20 are original.
Priority
The effective filing date is 21 October 2017.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6 February 2025, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 1, 6, and 13 are objected to for not depicting squiggly marks on the amide FI or ester FII where the gemcitabine or cisplatin conjugatively bonds. Please revise accordingly. Claims 2, 7-10, 14-16, and 19-20 are similarly objected to since these claims refer back to claims 1, 6, or 13 but do not resolve the underlying rationale behind the objections against claims 1, 6, or 13.
Claim Rejections - 35 USC § 112
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.
Claim 16 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 16 recites the limitations "DZ-SIM ester, DZ-SIM amide, DZ-Art ester, and DZ-Art amide". There is insufficient antecedent basis for these limitations in the claim.
These limitations render the metes and bounds of claim 16 undefined (hence rendering claim 16 indefinite under 35 USC 112(b) since the artisan does not know where antecedent basis can be found for DRGs: simvastatin (SIM) and/or artemisin (ART) as Applicants deleted those from parent claim 13.
Please cancel the claim 16 to render moot this rejection.
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 16 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.
Dependent claim 16, drawn to limitations "DZ-SIM ester, DZ-SIM amide, DZ-Art ester, and DZ-Art amide", fails to properly further limit parent claim 13. Hence, claim 16 is rejected under 35 USC 112(d). The limitations "DZ-SIM ester, DZ-SIM amide, DZ-Art ester, and DZ-Art amide" of claim 16 are of a different scope than parent claim 13 in which Applicants deleted the DRGs: simvastatin (SIM) and/or artemisin (ART) as Applicants deleted those from parent claim 13.
Please cancel the claim 16 to render moot this rejection.
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 § 102
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.
Claim(s) 1-2 and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
CHUNG (WO 2016/106324 A1, provided by Applicants and referenced in IDS of 6 February 2025).
The prior art reference CHUNG teaches
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(Scheme 1 on page 17), the compound DZ FI with an amide bond conjugated to the DRG of gemcitabine.
The prior art reference CHUNG also teaches
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(see 2/15 of the drawings; see also “Brief Description of the Drawings” page 3 where it describes Fig 1(C) as DZ1-cisplatin), the compound DZ FI with an amide bond conjugated to the DRG of cisplatin.
The limitation “A sensitizer compound which is a DZ-DRG amide or ester conjugate wherein a DZ-residue of Formula FI or FII, via an amide or ester bond is linked to the residue of a drug (DRG)” is interpreted as an inherent property/function. See MPEP 2112.01(I) and (II).
This anticipates instant claims 1-2.
Because the CHUNG reference compounds are “carrier-linker-drug conjugate systems” these are interpreted as “pharmaceutical compositions”. The broad “carrier” of the instant claims could be other DZ-CIS-amide or DZ-Gemcitabine-amide compounds (as no compound is by itself, but rather in a collection/composition), hence anticipating instant claims 6-7.
Claim 8 is interpreted as being an inherent property/function of the DZ-CIS amide, above, and hence is also anticipated by the above analysis. See MPEP 2112.01(I) and (II).
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 1-2 and 6-8 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,307,489 B2. The instant amended claims of 2 January 2025 were used to write this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims. For example, the underlying compound DZ-2 of reference method claim 12:
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, anticipates instant claim 1, drawn to amide FI conjugated to gemcitabine.
Furthermore, the underlying compound DZ-6 of reference method claim 12:
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, anticipates instant claim 1, drawn to amide FI conjugated to cisplatin.
Since reference claim 12 anticipates instant claim 1, per, above, reference claim 12 also anticipates instant claim 2, drawn to DZ-CIS amide.
The limitation “A sensitizer compound which is a DZ-DRG amide or ester conjugate wherein a DZ-residue of Formula FI or FII, via an amide or ester bond is linked to the residue of a drug (DRG)” is interpreted as an inherent property/function. See MPEP 2112.01(I) and (II).
Reference claim 12 is a method of use of the above compounds to treat, diagnose, and/or detect brain tumors (see reference claim 1 upon which reference claim 12 depends), and hence is drawn to “pharmaceutical compositions” and “carriers” since no one compound exists by itself, but rather in a collection/pharmaceutical composition. Thus, the above analysis also proves reference claim 1 and 12, at the minimum, anticipate instant claims 6-7.
Claim 8 is interpreted as being an inherent property/function of the DZ-CIS amide, above, and hence is also anticipated by the above analysis. See MPEP 2112.01(I) and (II).
Claims 1-2, 6-8, 13, and 16 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,878,000 B2. The instant amended claims of 2 January 2025 were used to write this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims. For example, the reference claims 1-3 anticipate DZ1-amide-CIS of instant claims 1-2.
The limitation “A sensitizer compound which is a DZ-DRG amide or ester conjugate wherein a DZ-residue of Formula FI or FII, via an amide or ester bond is linked to the residue of a drug (DRG)” is interpreted as an inherent property/function. See MPEP 2112.01(I) and (II).
The reference claims are all drawn to a method of use of the above compounds to sensitize cancer cells and hence is drawn to “pharmaceutical compositions” and “carriers” since no one compound exists by itself, but rather in a collection/pharmaceutical composition, thereby anticipating instant claims 6-7, 13, and 16.
Claim 8 is interpreted as being an inherent property/function of the DZ-CIS amide, above, and hence is also anticipated by the above analysis. See MPEP 2112.01(I) and (II).
Claims 1-2, 6-8, 13, and 16 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,121,510 B2. The instant amended claims of 2 January 2025 were used to write this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims. For example, the underlying DZ-CIS-amide or DZ-CIS-ester of reference claim 10 anticipates instant claims 1-2.
The limitation “A sensitizer compound which is a DZ-DRG amide or ester conjugate wherein a DZ-residue of Formula FI or FII, via an amide or ester bond is linked to the residue of a drug (DRG)” is interpreted as an inherent property/function. See MPEP 2112.01(I) and (II).
The reference claims (especially reference claim 10) are all drawn to a method of use of the above compounds to sensitize cancer cells and hence is drawn to “pharmaceutical compositions” and “carriers” since no one compound exists by itself, but rather in a collection/pharmaceutical composition, thereby anticipating instant claims 6-7, 13, and 16.
Claim 8 is interpreted as being an inherent property/function of the DZ-CIS amide, above, and hence is also anticipated by the above analysis. See MPEP 2112.01(I) and (II).
Conclusion
Claims 9-10, 14-15, and 19-20 are objected to as containing informalities (see “Claim Objections”, above).
Claims 1-2, 6-8, 13, and 16 are not presently allowable as written.
The co-pending 18/530,467 is drawn to distinct subject matter and disclaims DRG residue of cisplatin, and hence is not a statutory double patent reference.
The application 17/318,802 is drawn to distinct subject matter and hence cannot be a statutory double patent reference.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew D Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
