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 .
Status of Application
Receipt of Applicant’s remarks and amended claims filed on November 24, 2025 13 is acknowledged.
Claims 1-13 are pending in this application.
Claims 1, 3, 6, 7, and 13 have been amended.
No claims have been cancelled.
All pending claims are under examination in this application.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on September 9, 2025 is acknowledged. A signed copy is attached to this office action.
Withdrawn Objections/Rejections
Claim Objections
The objection of claims 13 because long, gum, and gelling need not be capitalized and the claim recites the acronym PEG for polyethylene glycol has been withdrawn in view of the amendment to the claim to correct the capitalization and to recite “polyethylene glycol”.
Claim Rejections - 35 USC § 102
The rejection of claims 1-3, 5-7, 9, and 12 under 35 U.S.C. 102(a)(1) as being anticipated by Pang et al. (CN 104511027, as cited on the IDS dated April 29, 2024) has been withdrawn in view of the amendment to claim 1 to recite “wherein the metal (hydr)oxide composite is essentially free of camptothecin.”
Claim Rejections - 35 USC § 103
The rejection of claims 1-3, 5-7, and 9-13 under 35 U.S.C. 103 as being unpatentable over Pang et al. (CN 104511027, as cited on the IDS dated August 18, 2022) in view of Suhail et al. (Surfactants and their role in Pharmaceutical Product Development: An overview, Journal of Pharmacy and Pharmaceutics, October 7, 2019) has been withdrawn in view of the amendment to claim 1 to recite “wherein the metal (hydr)oxide composite is essentially free of camptothecin.”
Double Patenting
The rejection of Claims 4 and 8 under 35 U.S.C. 101 as claiming the same invention as that of claims 1 and 6 of prior U.S. Patent No. 11,969,440 has been withdrawn in view of the amendment to the claim 1 to recite “wherein the metal (hydr)oxide composite is essentially free of camptothecin.”
Maintained Objections/Rejections
Claim Objections
Claims 3 and 7 are objected to because of the following informalities:
Regarding claims 3 and 7, fulvestrant need not be capitalized.
Claim Rejections - 35 USC § 112
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 1-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to recite “wherein the metal (hydr)oxide composite is essentially free of camptothecin”, while the specification discloses the compound may particularly include camptothecin”, there no disclosure of the compound being “essentially free of”. Applicant is directed to MPEP 2173.05(i) which discloses any negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977). While the claims can negatively recite the presence of camptothecin, the instant claims are drawn to a middle ground where some camptothecin can be present/absent. There is no disclosure or contemplation within the instant specification of a residual amount of the compound being present.
The response did not point out where support for amended claim 1 could be found in the originally filed disclosure. Although the PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims, when filing an amendment an applicant should show support in the original disclosure for new or amended claims. See MPEP 714.02 and 2163.06 (“Applicant should therefore specifically point out the support for any amendments made to the disclosure.”).
This is a new matter rejection.
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 1-13 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.
Regarding claim 1, the claim recites “the metal (hydr)oxide is essentially free of camptothecin”. The term “essentially free of” in the claim is a relative term which renders the claim indefinite. The term “essentially free of” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is suggested the claim be amended to recite “free of”.
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 1-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-8, 10-13 of copending Application No. 17/428,111 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the copending claims recite a metal (hydr)oxide composite comprising a metal hydr(oxide) of formula 1-3 (17/428111) and formulas 3-5 (18/649055). The claims differ in that the instant claims recite a compound comprising at least one or more hydroxyl groups in the compound or a salt thereof, whereas the copending claims recite the poorly soluble drug or prodrug. However, many of the instant claimed compounds and the copending drugs overlap. Therefore, the instant claims and the copending claims the same scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,969440. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to the same metal (hydr)oxide components. The independent claims recite a generic hydroxyl compound, however, the specific compounds are recited in dependent claims. Therefore, the patented claims anticipate the instant claims.
Response to Arguments
The applicant’s acknowledgement of the rejections is noted. However, they will not be held in abeyance. As detailed in MPEP 714.02 “[t]he reply by the applicant or patent owner must be reduced to a writing which distinctly and specifically points out the supposed errors in the examiner’s action and must reply to every ground of objection and rejection in the prior Office action. The reply must present arguments pointing out the specific distinctions believed to render the claims, including any newly presented claims, patentable over any applied references. If the reply is with respect to an application, a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated. Double patenting rejections are not “objections or requirements as to form not necessary to further consideration of the claims” and are not eligible to be held in abeyance.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 5:30 am to 4 pm EST.
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, Robert A Wax can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615