Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 3/22/2026 wherein claims 1, 2, 14, 15, 34, and 36 were amended and claims 5-8, 10, 13, 16, 18-21, 25, 29, and 31-33 were canceled.
Note(s): Claims 1-4, 9, 11, 12, 14, 15, 17, 22-24, 26-28, 30, and 34-36 are pending.
Priority
Once again, this application is a CON of 15/240,780 filed 8/18/2016 (now US Patent No. 11,344,633); 15/240,780 is a CON of 14/122,617 filed 2/26/2014 (now US Patent No. 9,452,219); 14/122,617 is a 371 of PCT/US2012/040577 filed 6/1/2012; and PCT/US2012/040577 claims benefit to PRO 61/492,683 filed 6/2/2011.
Note(s): The earliest effective filing date is 6/2/2011 as the pending invention is fully supported by provisional application 61/492,683.
Response to Applicant’s Amendment and/or Arguments
The Applicant's arguments and/or amendment filed 3/22/2026 to the rejection of claims 1-4, 9, 11, 12, 14, 15, 17, 22-24, 26, 34, and 36 made by the Examiner under 35 USC 103, 112, and/or double patenting have been fully considered and deemed persuasive-in-part for the reasons set forth below.
Double Patenting Rejections
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.
I. Claims 1-4, 9, 11, 12, 14, 15, 17, 22-24, 26, 34, and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,452,219. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a composition comprising an anti-nucleolin agent conjugated to nanoparticles as set forth in the pending invention. While the patented invention is directed to a specific composition, the composition comprises the components of the pending invention. Thus, the pending claims encompass the patented invention.
APPLICANT’S ASSERTIONS
In summary, it is asserted that the rejections include only two sentences and a prima facie case of obviousness has not been established to clear articulate why the claimed invention is obvious.
EXAMINER’S RESPONSE
Applicant’s arguments were considered, but deemed non-persuasive for reasons of record. As indicated in the rejection both cases disclose overlapping products. Applicant is respectfully requested to review both inventions. The patented invention comprise and anti-nucleolin agent conjugated to nanoparticles, just like the pending claims. The nanoparticles are non-magnetic, not iron oxide, and not polyacrylamide. In addition the claims comprise at least one member selected from metals, elemental silicon, elemental boron, elemental carbon and oxides. The patented composition comprises a metal (gold). Thus, as the Examiner indicated in the previous rejection, the claims are directed to overlapping products. The rejection is still deemed proper.
II. Claims 1-4, 9, 11, 12, 14, 15, 17, 22-24, 26, 34, and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,344,633. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a composition comprising an anti-nucleolin agent conjugated to nanoparticles as set forth in the pending invention. While the patented invention is directed to a specific composition, the composition comprises the components of the pending invention. Also, it is noted that the patented invention does not give the specific diameter of the nanoparticle. However, based on the general definition of a nanoparticle, a particle measuring between approximately 1 – 100 nanometers, the skilled artisan would recognize that the diameter range discloses in the pending invention is encompassed by the patented claims. Thus, the inventions disclose overlapping subject matter.
APPLICANT’S ASSERTIONS
In summary, it is asserted that the rejections include only two sentences and a prima facie case of obviousness has not been established to clear articulate why the claimed invention is obvious.
EXAMINER’S RESPONSE
Applicant’s arguments were considered, but deemed non-persuasive for reasons of record. As indicated in the rejection both cases disclose overlapping products. Applicant is respectfully requested to review both inventions. The patented invention comprise and anti-nucleolin agent conjugated to nanoparticles, just like the pending claims. The nanoparticles are non-magnetic, not iron oxide, and not polyacrylamide. In addition the claims comprise at least one member selected from metals, elemental silicon, elemental boron, elemental carbon and oxides. The patented composition comprises a metal (gold, silver, platinum, iridium, and palladium, or an alloy thereof). Thus, as the Examiner indicated in the previous rejection, the claims are directed to overlapping products. The rejection is still deemed proper.
Written Description Rejection
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 1-3, 9, 11, 12, 14, 15, 23, 24, 26, 34, and 36 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.
Applicant is reminded that an inventor is entitled to a patent to protect his work only if he/she produces or has possession of something truly new and novel. The invention being claimed must be sufficiently concrete so that it can be described for the world to appreciate the specific nature of the work that sets it apart from what was before. The inventor must be able to describe the item to be patented with such clarity that the reader is assured that the inventor actually has possession and knowledge of the unique composition that makes it worthy of patent protection. The pending application does not sufficiently describe the invention as it relates to anti-nucleolin agents other that anti-nucleolin oligonucleotides, antibodies, nucleolin targeting proteins, and guanosine rich oligonucleotides. Thus, what the reader gathers from the instant application is a desire/plan/first step for obtaining a desired result. While the reader can certainly appreciate the desire for achieving a certain end result, establishing goals does not necessarily mean that an invention has been adequately described.
While compliance with the written description requirements must be determined on a case-by-case basis, the real issue here is simply whether an adequate description is necessary to practice an invention described only in terms of its function and/or based on a disclosure wherein a description of the components necessary in order for the invention to function are lacking. In order to satisfy the written description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. In other words, the specification should describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that the inventor created what is the claimed. Thus, the written description requirement is lacking in the instant invention since the various terms as set forth above are not described in a manner to clearly allow persons of ordinary skill in the art to recognize that Applicant invented what is being claimed.
APPLICANT’S ASSERTIONS
In summary, it is asserted that that a prima facie case regarding the lack of written description is not provided. In addition, it is asserted that the written description is adequate as there is a strong presumption that an adequate written description is present when the application is filed.
EXAMINER’S RESPONSE
All of Applicant’s arguments were considered, but deemed non-persuasive for reasons of record and those set forth below. While it is asserted that adequate written description was present when the application was filed, the following things are duly noted.
On page 4, paragraph [0023] of the submitted specification, it is disclosed that “An “anti-nucleolin agent” includes any molecule or compound that interacts with nucleolin. Such agents include for example anti-nucleolin antibodies, aptamers such GROs and nucleolin targeting proteins”. This section gives details regarding terminology and depth regarding the pending invention.
Review of other portions of the disclosure (e.g., “Summary”, pages 2-3, specification) are very general and lack written description regarding establishing written description for pending claim 1. The information on page 4, paragraph [0023], is supported by the brief description of the drawings on pages 5-6 (specification). In addition, page 4,paragraph [0023], pages 7-24 of the specification, support page 4,paragraph [0023] wherein the anti-nucleolin agent is anti-nucleolin antibodies, aptamers (GROs, nucleolin targeting proteins, and anti-nucleolin oligonucleotides). For the reasons herein, the written description rejection is still deemed proper.
112 Second Paragraph Rejections
The outstanding 112 second paragraph rejections are WITHDRAWN.
103 Rejection
Regarding the 103 rejection, Applicant asserted that the rejection should be made without using hindsight. In addition, it is asserted that there were several deficiencies to the rejection. Those deficiencies asserted include even though the rejection sets forth product components being identified in the cited prior art, sufficient evidences of motivation of suggestion to choose limitation within the document Applicant did not believe to be sufficient. Also, it is asserted that the rational was insufficient as to why one of ordinary skill in the art would modify the cited prior art. Still, it is asserted that Chen et al (Molecular Therapy, January 2011, Vol. 19, No. 1, pages 93-102) do not teach the limitations of the amended claims.
First, Applicant is respectfully requested to re-review the rejection in regards to hindsight. Specific areas of the document were pointed out to disclose the location of the anti-nucleolin composition. Thus, hindsight was not a part of the rejection. Second, the limitations of the claims and what is disclosed in the cited prior art was compared and discussed. Rational naturally flows for products wherein documents are directed to the same type of compositions and comprise overlapping components. Third, the rejection is only being WITHDRAWN because Applicant has amended independent claim 1 to contain additional limitations that are not present in Chen et al.
NEW GROUNDS OF REJECTIONS
102 Rejection
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 the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1, 4, 14,17, 22, and 34 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Hwang et al (Journal of Nuclear Medicine, January 2010, Vol. 51, No. 1, pages 98-105).
Independent claim 1 is directed to a composition comprising an anti-nucleolin agent conjugated to nanoparticles wherein (a) the nanoparticles are non-magnetic, not iron oxide and not polyacrylamide and (b) the nanoparticles comprise at least one member selected from the group consisting of metals, elemental silicon, elemental boron, elemental carbon, and oxides.
Claims 4 and 17 are directed to anti-nucleolin agents comprising anti-nucleolin oligonucleotides, antibodies, nucleolin targeting proteins, and GRO (guanosine-rich oligonucleotides).
Claim 14 is directed to a pharmaceutical composition comprising a composition comprising an anti-nucleolin agent conjugated to nanoparticles, and a pharmaceutically acceptable carrier.
Claim 22 is directed to the pharmaceutical composition of claim 14 wherein the anti-nucleolin agent comprises AS1411.
Claim 34 is directed to an agent for imaging comprising the composition of claim 1 and a pharmaceutically acceptable carrier.
Hwang et al is directed to nucleolin targeted multimodal nanoparticle imaging probe for tracking cancer cells using an aptamer. In particular, Hwang et al disclose a nanoparticle comprising 67Ga-citrate MF-AS1411 which meets the limitations of Applicant’s claim 1 (AS1411 is the anti-nucleolin agent and 67Ga is a Group IIIb metal; MF is fluorescent rhodamine). The nanoparticle is surrounded by fluorescent rhodamine which is conjugated to the AS1411 aptamer. The MF-AS1411 particles were labeled with 67Ga-citrate after the introduction of the NOTA chelating agents to yield a MFR-AS1411 complex. The nanoparticles measured about 68.1 nm (see entire document, especially, page 98 left and right columns, bridging paragraph; pages 99-100, bridging paragraph; page 100, right column third complete paragraph; page 101, Figure 1; page 102, left column, second and third complete paragraphs; page 102, Figure 3). Thus, the limitations of claim 1 are met as both Applicant and the prior art disclose overlapping compositions.
Hwang et al disclose that 67Gallium citrate MFR-AS1411 was administered and in vivo imaging and MRI were performed (pages 102-103, bridging paragraph; page 103, Figure 4). 67Ga was found in the thighs of mice injected with 67Ga MFR-AS1411 composition. Different concentrations generate through a serial dilution method were produced and evaluated in subjects and cells. It was concluded that administering compositions of MFR-AS1411 (mutant and non-mutant) illustrated that the substances specifically targeted cancer cells in vivo and in vitro (abstract; pages 99-100, bridging paragraph; page 100, left column, first and second complete paragraphs; page 100, left and right columns, bridging paragraph; page 102, Figure 3).
Based on the teachings of Hwang et al as set forth herein, both the prior art and pending claims disclose pharmaceutical compositions that meet the limitations of pending claims 1, 4, 14, 17, 22, and 34. In addition, it is noted that both Applicant’s inventio and that of Hwang et al are used for imaging cancer (see page 103, Figure 4).
Applicant’s Election
Once again, Applicant's election with traverse of Group I (pending claims 1-4, 9, 11, 12, 14, 15, 17, 22-24, 26, 34, and 36) filed 6/17/2025 is acknowledged. The restriction requirement was traversed and not found persuasive. As a result, the restriction requirement was still deemed proper and made FINAL.
Note(s): The Examiner acknowledges Applicant’s election of the species wherein a guanosine-rich oligonucleotide (GRO) is the anti-nucleolin agent; the nanoparticle comprises a metal and camptothecin. Applicant selected breast cancer as the cancer of interest. Applicant’s elected Group I is directed to a composition (product). Claims 1-4, 9, 11, 12, 14, 15, 17, 22-24, 26, 34, and 36 read on the elected species. Initially, Applicant’s elected species was searched. However, prior art was not found which could be used to reject the claims. Thus, the search was extended and Applicant amended the claims to overcome the previous rejection. Hence, due to the amending of the claims on 3/22/2026 to overcome the prior art rejection, the search of Group I was once again extended. However, since additional prior art was found to reject the claims, the search was not further extended (see the 102 rejection above).
Claim Objections
Claims 2, 3, 9, 11, 12, 15, 23, 24, 26, and 36 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Note(s): The claims are only allowable over the prior art of record to the extent that they read on the elected species.
Withdrawn Claims
Claims 1, 4, 14,17, 22, and 34 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Evidentiary Reference
Once again, Auffan et al (Nature Nanotechnology, 2009, Vol. 4, pages 634-641) was previously made of record for its definition of “nanoparticle”. Specifically, according to Auffan et al, the definition of “nanoparticle” is “a particle between about 1 and 100 nm”.
Palestro (Semin. Nucl. Med., 2019, Vol, 50, pages 23-34) is made of record for its teachings regarding gallium-67. Specifically, it is disclosed that gallium-67 is a Group IIIb metal (see entire document, especially, page 24, left column, first paragraph).
Comments/Notes
Applicant is respectfully reminded that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In particular, it is noted that the composition/product of the prior art is the same/similar as that being claimed by Applicant. Although the cited prior art may not disclose the particular use, the composition/product would be capable of having the same use as Applicant's invention since a composition/product and its properties are inseparable. Thus, Applicant's composition/product would be 'capable of' performing the same function.
It should be noted that the full scope of elected Group I was not searched.
Conclusion
Claims 1, 4, 14, 17, 22, and 34 are rejected. Claims 2, 3, 9, 11, 12, 15, 23, 24, 26, and 36 are objected. Claims 27, 28, 30, and 35 are withdrawn from consideration.
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.
Future Correspondences
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F.
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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
May 28, 2026
Prosecution Insights