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 .
Applicants' arguments, filed June 23, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
The duty of disclosures related to various co-pending Applications is noted but Terminal Disclaimers over each of these issued U.S. patents have already been filed and approved in this application.
Claim Rejections - 35 USC § 112 – New Matter
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, 4 – 7 and 12 – 16 were 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. This new matter rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed March 26, 2026 and those set forth herein.
Applicants have amended claim 1 in an attempt to remove the new matter and argue that claim 1 has been amended to clarify the structure of the prodrug can be present in pharmaceutically acceptable salts but not that the prodrug is encapsulated with a pharmaceutically acceptable salt.
These arguments are unpersuasive. Claim 1 now clearly sets off “pharmaceutically acceptable salt” as a separate step with nothing in the logic or grammar of the claim linking it to the specific compound present in the nanocarrier composition that is administered in step (i) of claim 1. Therefore the interpretation set forth in the arguments does not align with the claim as currently presented. The presence of any pharmaceutically acceptable salt not in combination with the specific compound of step (i) is not disclosed in the disclosure as originally filed and there is no disclosure of a method step (ii) of “a pharmaceutically acceptable salt”. Therefore claim 1 as currently presented still contains new matter. The dependent claims fall therewith.
If Applicant is in disagreement with the Examiner regarding support for the amended claim, Applicant is respectfully requested to point to page and line number wherein support may be found for the instant invention.
Claim Rejections - 35 USC § 112 – Indefiniteness
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, 4 – 7 and 12 – 16 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.
As presently amended, claim 1 requires a method of treating with two steps: step (i) of administering to a subject diagnosed with cancer in need of treatment a nanocarrier composition as recited in claim 1 and step (ii), “a pharmaceutically acceptable salt”. A step in a method claim requires a verb. There is an active step of administering in step (i). There is no action in “a pharmaceutically acceptable salt” of step (ii). A pharmaceutically acceptable salt is a thing but what action is taking using or with the pharmaceutically acceptable salt is not set forth in the claim and therefore the metes and bounds of the claims cannot be determined as some action is required but no action at all is set forth in required step (ii).
The dependent claims fall therewith.
Please clarify.
For the purposes of applying art below, claim 1 is being interpreted as requiring the presence of a pharmaceutically acceptable salt of anything in the formulation that is administered.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4 – 7 and 12 – 16 were rejected under 35 U.S.C. 103 as being unpatentable over Klinman et al. (WO 2014/201245; cited on May, 2, 2024 IDS) in view of Mehnert et al. (Adv Drug Del Rev, 2012). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed March 26, 2026 and those set forth herein.
As discussed on p 9 of the March 26, 2026 Office Action, Klinman et al. discloses pharmaceutically acceptable salts of the imidazoquinoline compounds (p 30, ln 3 – 17), and the compound of instant claim 1 is amongst the imidazoquinoline compounds disclosed by this reference. Therefore compositions comprising “a pharmaceutically acceptable salt” are disclosed and it would have been obvious to administer the composition to a subject diagnosed with cancer such a salt as required by the instant claims.
Applicants traverse this rejection on the grounds that Klinman is outside the scope of the instant claims as this reference does not teach various limitations of the claims as conceded by the Examiner including administration to a human of the liposomal formulation and the size and zeta potential of the nanoparticles. The Examiner attempts to correct this fatal error using Mehnert which has no reference to a specific size or formulation or even requiring a specific prodrug. The Examiner is interpreting the claims contrary to patent law as all claim limitations must be considered and Applicant is pointing out that the references do not teach all of the limitations found in the claims and the rejection is not proper. The Examiner is not viewing the claim as a whole.
These arguments are unpersuasive. The significance of Klinman falling outside the scope of the claims is not understood as the rejection is not made over Klinman alone and any obviousness rejection takes into account the knowledge of one of ordinary skill in the art and the explicit, implicit and inherent teachings of all the applied prior art documents. So even if Klinman et al. alone does not explicitly disclose all of the claim limitations, the rejection is not made based on the explicit teachings of Klinman et al. alone. Klinman et al. and Mehnert et al. are both analogous art to the claimed rejection as being at least in the same field of endeavor and therefore are proper for use in an obviousness rejection. All of the claim limitations have been considered and addressed in the rejection of record as set forth in greater detail in the Office Action mailed March 26, 2026.
Applicants also argue that Klinman does not teach a liposomal formulation or specific Zav size/zeta potential formulations and Mehnert does not disclose any specific liposomes but rather broad factors to use in the evaluation of lipid technologies so the number of predictable solutions is not finite. Each prodrug and liposome specifically reacts to a tumor in a different manner. While an “obvious to try” rationale may support a conclusion of obviousness, a finite number of identified, predictable solutions with a reasonable expectation of success is required. The lack of specific teachings in the cited art makes the instant claims nonobvious and not a reasonably predictable outcome.
These arguments are unpersuasive. Only a reasonable expectation of success that a liposomal formulation of the 3M-052 compound, the same compound as in the instant claims, of Klinman et al., taught for use in treating a tumor that can be formulated as a liposome and administered to a subject in need of cancer treatment, is required for a prima facie case of obviousness. The broadest reasonable interpretation of the claims in light of the specification is any reduction of killing of cancer cells is sufficient to meet the recitation “[a] method of treating a subject diagnosed with cancer”. While Klinman et al. does not specifically use a liposomal formulation of a therapeutic agent such as 3M-052, liposomal formulations are disclosed at p 36, ln 14 (see ¶ 2 on p 9 of the March 26, 2026 Office Action). The claims do not specify any particular lipids that comprise the liposome and only a particular size and zeta potential. Those factors are known results effective variables to those of ordinary skill in the art that one of ordinary skill in the art would routinely optimize as taught by Mehnert. Applicants have not presented any evidence of record as to the criticality of the claimed parameters. Arguments without factual support are mere allegations and are not found persuasive. If the arguments regarding the differences in the interaction between tumor cells and the prodrug/liposome formulation were found persuasive, it could also lead to a scope of enablement issue with the instant claims given the level of detail specified in the claims and the limited nature of the liposomes prepared in the disclosure as originally filed (examples 6 - 10, beginning at ¶ [0637] of the PGPub of the instant application). But given the teachings of the prior art, one of ordinary skill in the art would have reasonable expected that size and seta potential optimized liposomes comprising a prodrug such as that of instant claim 1 could be prepared and administered to a subject diagnosed with cancer.
Applicant also argues that level of skill in the relevant area is high and the present invention is not mere simple substitution of one known element for another but a method of using a specific novel prodrug formulation to teach the cancer with a combination that has not been disclosed in the art. There was no apparent reason to combine the known elements in the fashion claimed by the instant invention. There are no interrelated teachings used as references and as a high level of skill is needed, the background knowledge of one of ordinary skill in the art would require a complete understanding of both lipid-based formulation technology and prodrug chemistry to make the claimed invention. None of the references alone or in combination teach the claimed invention as a whole.
These arguments are unpersuasive. A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton (MPEP 2141(II)(C) and their level of skill is high and therefore the knowledge of one of ordinary skill in the art that is also taken into consideration when making a determination of obviousness is also large. There need not be an explicit teaching, suggestion or motivation in order to do something to render something obvious. Rationale for combining the references and optimization of liposome size and zeta potential has been set forth but Applicants do not present any arguments regarding that rationale set forth by the Examiner. The use of carriers such as liposomes for a prodrug such as the claimed compound are contained in Klinman et al. but no additional specifics regarding liposomal formulations is given. Mehnert et al. provides an overview of solid lipid nanoparticles including production and quality considerations, how to incorporate drug and methods of administration for in vivo usage that one of ordinary skill can use to prepare a liposomal formulation of the drugs disclosed by Klinman et al. including the compound of instant claim 1. Taken together, there is a reasonable expectation of success that one of ordinary skill in the art to prepare a liposomal formulation of the prodrug known for the treatment of cancer with an optimized size and zeta potential and there is no evidence of record as to the criticality of the claimed values for the liposomes administered in the claimed method.
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, 4 – 7 and 12 – 16 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 6, 8, 10 – 13, 15, 17 and 18 of copending Application No. 18/445,036 in view of Klinman et al. (WO 2014/201245; cited on May, 2, 2024 IDS), and Mehnert et al. (Adv Drug Del Rev, 2012). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed March 26, 2026 and those set forth herein.
Applicants request that this rejection be held in abeyance until the current claims have been allowed, at which time this rejection should be withdrawn.
As the claims are not in condition for allowance, this rejection is maintained for the reasons of record.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 4 – 7 and 12 – 16 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 19 of copending Application No. 19/052,641 Klinman et al. (WO 2014/201245; cited on May, 2, 2024 IDS), and Mehnert et al. (Adv Drug Del Rev, 2012). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed March 26, 2026 and those set forth herein.
Applicants request that this rejection be held in abeyance until the current claims have been allowed, at which time this rejection should be withdrawn.
As the claims are not in condition for allowance, this rejection is maintained for the reasons of record.
This is a provisional nonstatutory double patenting rejection.
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 Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
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, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618
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