DETAILED ACTION
RESPONSE TO AMENDMENT
1. Receipt of Applicants’ amendments/remarks filed 6/23/2026 are acknowledged.
INFORMATION DISCLOSURE STATEMENT
2. No new Information Disclosure Statement has been submitted for review.
WITHDRAWN REJECTIONS
3. Rejections not reiterated from previous Office Actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections- 35 USC § 112
4. 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 23 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 23 recites the hydrophobic therapeutic agent is PIK75, doxorubicin, vincristine, gemcitabine, paclitaxel, docetaxel, andrographolide, sutent, tamoxifen or combination thereof, however claim 1 defines the therapeutic agent as PIK75,.
Claim Rejections- 35 USC § 103
5. 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.
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.
Claims 1-4, 7-12, 15, 20, 23, 26 are rejected under 35 U.S.C. 103 as being unpatentable over Henrich et al. (WO 2020/154705) in view of Gualberto et al. (US 20220002396).
Henrich et al. (WO 2020/154705)-(as cited on the IDS 8/6/2024) teach a high-density lipoprotein nanoparticle comprising an organic core, a shell surrounding and attached to the core, wherein the core comprises a hydrophobic phospholipid conjugated scaffold and a hydrophobic anticancer therapeutic agent (paclitaxel) (abstract, page 1, page 2 and page 16). The HDL-NP has an apolipoprotein (page 2, paragraph 9). Henrich et al. disclose in some embodiments, the apolipoprotein is apolipoprotein A-I (page 2, paragraph 9). Henrich et al. disclose covalent attachment (page 6, paragraph 4). The shell is a lipid bilayer or monolayer (page 1, 3rd paragraph from the bottom). The PL4 comprises a headgroup-modified phospholipid. The headgroup-modified phospholipid comprises a ring-strained alkyne, 1,2-dipalmitoyl-sn-glycero-3-phosphoethan-olamine-N-dibenzocyclooctyl (page 2, paragraph 11). The organic core scaffold comprises an amphiphilic DNA-linked small molecule-phospholipid conjugate (DNA- PL4) (page 2, paragraph 12). Henrich et al. disclose in some embodiments, the shell has a zeta potential closer to human HDL than a synthetic HDL nanoparticle with an inorganic core (page 2, paragraph 8). In some embodiments the spherical HDL-NP has a diameter of about 5-30 nm. Henrich et al. disclose in an aspect, the disclosure relates to a pharmaceutical composition.
Henrich et al. disclose hydrophobic therapeutic agents such as paclitaxel but does not disclose the therapeutic agent of claim 25 known as PIK-75.
Gualberto et al. (US 20220002396) (hereinafter Gualberto et al.) disclose treating cancer with paclitaxel and PIK-75 agents (para 0319). Both of these are hydrophobic drugs. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute one known hydrophobic drug, the paclitaxel of Henrich et al. for the PIK-75 in Gualberto et al. Substitution of one known hydrophobic agent for another would obtain predictable results as both are hydrophobic drugs for use in treatment of cancer.
6. Claims 1 and 15 are rejected under 35 U.S.C. 103 as being unpatentable Henrich et al. (WO 2020/154705) in view of Gualberto et al. (US 20220002396) as applied to claims above, and further in view of Sirianni et al. (WO 2018208993).
Henrich et al. has been discussed supra and does not disclose partition coefficient. Sirianni et al. (WO 2018208993) (hereinafter Sirianni et al.) disclose the term water insoluble refers to an active ingredient having a partition coefficient of at least 0 (para 0040). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the active ingredient have a partition coefficient of at least 0 for the purpose of providing a therapeutic agent that is water insoluble.
DOUBLE PATENTING
7. 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, 7-12, 15, 20, 23, and 26 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 7, 10, 13, 14, 17, 51 and 52 of copending Application No. 17/425401. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to a spherical nanoparticle comprising a core comprising a lipid conjugated organic core scaffold such as an amphiphilic DNA-linked small molecule-phospholipid conjugate or a ring-strained alkylene, 1,2-dipalmitoyl-sn-glycero-3 phosphoethan-olamine-N-dibenzocyclooctyl.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
RESPONSE TO ARGUMENTS
8. Applicants’ arguments have been fully considered and are not persuasive for the reasons below.
Applicant argues that Gualberto does not provide any examples of the efficacy of PIK75 (F7) in killing cancer cells or treating cancer. Applicants argue that Example 1 demonstrates that HDL-NPS encapsulated PIK75/F7 retained the drug sensitivity of free F7 while also demonstrating increased cytotoxic efficacy. One of ordinary skill in the art would not have predicted that a nanoparticle as claimed conjugated with F7 would have a different effect than F7 alone, showing both improved cytotoxicity and potentially targeting different cell types and neither Henrich or Gualberto disclose the effects of free F7.
In response, the Examiner respectfully submits that the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991) (discussed below).
Applicants’ unexpected results are not commensurate in scope with the claims. ApoA-1 was added at a 2:1 ratio which is not claimed in claim 1 and the concentrations as tested and shown by table 1 are not recited in claim 1. There is no evidence to suggest any concentration as encompassed in claim 1 performs the same.
With regards to the double patenting rejection applicants argue that F7 is not mentioned or suggested by the ‘354 application.
In response, inclusion of a drug of choice in the HDL-NP would have been prima facie obvious to one of ordinary skill in the art in view of Gualberto et al. and Henrich et al. as discussed above. Gualberto et al. disclose treating cancer with paclitaxel and PIK-75 agents (para 0319). Both of these are hydrophobic drugs. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute one known hydrophobic drug, the paclitaxel of Henrich et al. for the PIK-75 in Gualberto et al. Substitution of one known hydrophobic agent for another would obtain predictable results as both are hydrophobic drugs for use in treatment of cancer. Claim 31 also recites a therapeutic agent is associated with the nanoparticle of which could be any therapeutic agent.
CONCLUSION
9. 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.
CORRESPONDENCE
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANAH AL-AWADI/ Primary Examiner, Art Unit 1615
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