DETAILED ACTION
Notice of 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 the Claims
The amendments filed on 1/05/2024 have been entered.
Requirement for Restriction
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or correspond-ing special technical features. The expression “special technical features” shall mean those technical features that define a contri-bution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made with-out regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
As provided in 37 CFR 1.475(b), a national stage application containing claims to different categories of invention will be con-sidered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manu-facture of said product; or
(2) A product and process of use of said product; or
(3) A product, a process specially adapted for the manufac-ture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufac-ture of the said product, and an apparatus or means specifically designed for carrying out the said process.
5. Otherwise, unity of invention might not be present. See 37 CFR 1.475(c).
Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-10, drawn to a nanoparticle comprising a hydrophilic PEG polymer linked to a hydrophobic polymer lipid core and one or more polykinase inhibitors and compositions thereof, classified in Cooperative Patent Classification A61K 9/1271.
II. Claims 11-20, drawn to a method of using the invention of Group I for treating cancer, classified in Cooperative Patent Classification A61K 9/1271.
As set forth in Rule 13.1 of the Patent Cooperation Treaty (PCT), "the international application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept.” Moreover, as stated in PCT Rule 13.2, "where a group of inventions is claimed in one and the same international application, the requirement of unity of invention referred to in Rule 13.1 shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features." Furthermore, Rule 13.2 defines "special technical features" as "those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art."
The inventions listed as Groups I-II do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
The technical feature of Group I is a nanomicelle comprising a hydrophilic PEG polymer linked to a hydrophobic polymer lipid core and one or more polykinase inhibitors and, optionally, a chemotherapy agent. The nanomicelle of Group I does not present a contribution over the prior art in view of Gu et al (Int J Nanomedicine 11:5757-5770, 2016) which teach said nanomicelles, as discussed in detail in the rejection below. As such, Group I does not share a special technical feature with the instant claims of Group II. Therefore, the claims are not so linked within the meaning of PCT Rule 13.2 so as to form a single inventive concept, and unity between Groups I-II is broken.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
The examiner has required restriction between product and process claims. Where applicant elects claims directed to the product, and the product claims are subsequently found allowable, withdrawn process claims that depend from or otherwise require all the limitations of the allowable product claim will be considered for rejoinder. All claims directed to a nonelected process invention must require all the limitations of an allowable product claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product are found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product claim will not be rejoined. See MPEP § 821.04(b). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product claims. Failure to do so may result in a loss of the right to rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Telephonic Response to Requirement for Restriction
Applicant’s election without traverse of Group I by telephone on October 23, 2025 is acknowledged. The requirement is still deemed proper and is therefore made FINAL.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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.
Claims 4-5 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites “[a] nanoparticle comprising… one or more polykinase inhibitors”.
Claim 4 is drawn to “[t]he nanoparticle of claim 1, wherein the one or more kinase inhibitors is…”
And claim 5 drawn to “[t]he composition of claim 1, wherein…”
Claim 1 does not provide antecedent basis for the recitation of “one or more kinase inhibitors” in claim 4. And claim 1 also does not provide antecedent basis for the recitation of “[t]he composition” in claim 5.
As such, claims 4-5 are rejected.
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.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gu et al (Int J Nanomedicine 11:5757-5770, 2016).
Claim 1 is drawn to a nanoparticle (more specifically, having a size of about 20 nm to about 50 nm (claim 3)) comprising a hydrophilic PEG polymer (more specifically, PEG2000 (claim 2)) linked to a hydrophobic polymer lipid core (e.g., distearoyl-phosphatidylethanolamine (DSPE) (see Specification, Paragraph 0024)) and one or more polykinase inhibitors (more specifically, a curcuminoid or curcuminoid analog (claim 4)) and, optionally, a chemotherapy agent (more specifically, doxorubicin (claim 5)).
Gu et al teach “[n]anomicelles loaded with doxorubicin and curcumin” (Title), specifically disclosing a “(DOX + CUR)-loaded polymeric micelle (PM)… assembled using 1,2-disteroyl-sn-glycero-3-phosphoethanolamine-N-methoxy-poly(ethylene glycol)2000 (DSPE-PEG2000) and D-tocopheryl polyethyleneglycol1000 succinate (TPGS1000)” wherein “[t]he DSPE-PEG2000 component in PMs contributes to the construction of a hydrophobic core for loading both DOX and CUR and, at the same time, to the formation of a hydrophilic shell” (Page 5758, Columns 1-2; see also Page 5759, Figure 1), wherein “these micelles had sizes of ~20 nm” (Page 5761, Column 2).
Accordingly, claims 1-5 are anticipated.
Claim 6 is drawn to a pharmaceutical composition comprising a micelle construct of a curcuminoid complex co-loaded with doxorubicin (more specifically, wherein the micelle construct is between 10 nm and 20 nm (claim 7), between 20 nm and 60 nm (claim 8), and/or less than 30 nm (claim 9)) and, as further recited by claim 10, further comprising a pharmaceutically acceptable carrier comprising PEG2000.
As discussed above, Gu et al teach “[n]anomicelles loaded with doxorubicin and curcumin” (Title), specifically disclosing a “(DOX + CUR)-loaded polymeric micelle (PM)… assembled using 1,2-disteroyl-sn-glycero-3-phosphoethanolamine-N-methoxy-poly(ethylene glycol)2000 (DSPE-PEG2000) and D-tocopheryl polyethyleneglycol1000 succinate (TPGS1000)” wherein “[t]he DSPE-PEG2000 component in PMs contributes to the construction of a hydrophobic core for loading both DOX and CUR and, at the same time, to the formation of a hydrophilic shell” (Page 5758, Columns 1-2; see also Page 5759, Figure 1), wherein “these micelles had sizes of ~20 nm” (Page 5761, Column 2).
And as further taught by Gu et al, “[m]ice… were injected with… (DOX + CUR)-PMs vila the tail vein” (Page 5761, Column 1).
Accordingly, claims 6-10 are also anticipated.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,819,571.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘571 claims are similarly drawn to a composition comprising a micelle construct having a diameter of less than 30 nm (more specifically, less than 20 nm (claim 6)) comprising DSPE-PEG2000, curcumin and a chemotherapy agent (more specifically, doxorubicin (claim 3)).
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 18/696,333.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘333 claims are drawn to a regimen comprising a micelle construct comprising a polykinase inhibitor (more specifically, a curcuminoid (claim 3)) and a chemotherapeutic agent (more specifically, doxorubicin (claim 5)) and, in particular, wherein the micelle is formed by PEG2000-DSPE (claim 6) and wherein the size is between 10 nm and 20 nm (claim 7), between 20 nm and 60 nm (claim 8) or less than 30 nm (claim 9).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET. 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, Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611