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
Applicant’s cancellation of claim(s) 14-19 in the reply filed on 6/12/2026 is acknowledged.
Applicant’s amendments of claim(s) 3 and 8 in the reply filed on 6/12/2026 is acknowledged.
Applicant’s addition of new claim(s) 20 in the reply filed on 6/12/2026 is acknowledged.
Claims 1-13 and 20 are under examination.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-13) and addition of claim 20 in the reply filed on 06/12/2026 is acknowledged.
Claims 15, 17-18, and 20-21 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group II (claims 15, 17-18, and 20-21), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/12/2026.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in The Kingdom of the Netherlands on 02/25/2021. It is noted, however, that applicant has not filed a certified copy of the NLN2027653 application as required by 37 CFR 1.55.
Drawings
The drawings are objected to because:
Fig 3a, 3c, 3d, 3e, 4a, 4b, and 5 are blurry and difficult to read.
Fig 41, 4b, and 5 have legends in gray scale and no longer enable identifying bar scales to which they belong.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 13 is objected to because of the following informalities: typographical error. The claim recites “cyanine, linker, and radionuclide is selected from”, however the subsequent list specifies cyanine, chelator and radionuclide. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: grammatical errors. The use of commas and prepositions should be corrected. Appropriate correction is required.
Claim Interpretation
Claim 13 recites the phrase, “cyanine, linker, and radionuclide” on line 2. The examiner notes that the subsequent list shows cyanine, chelator, and radionuclide. The examiner interprets this phrase as a typographical error and interprets the linker to be chelator. Therefore, for the purposes of examination, any prior art that reads on the specified cyanine, chelator, and radionuclides, reads on this claim.
Claim 20 recites the phrase “and attached to the chelator a compound selected a ferromagnetic compound”. This phrase indicates that the chelator selects a ferromagnetic compound. As written, the chelator performs the verb. The examiner acknowledges that the specification provides more context for the claim. From the specification, the examiner notes that it recites “attached to the chelator a compound selected from a ferromagnetic compound” (pg 7, lines 19). Therefore, the examiner interprets this phrase to more clearly read, “and the chelator is attached to a compound selected from a ferromagnetic compound, …”.
Claim 20 further recites “and from an alloy comprising magnetic components (A,B)”. The examiner interprets the “and, from” is a continuation of options to which the chelator may attach.
Claim 20 further recites “, and from ferrimagnetic compound” (lines 6-7). The examiner notes that the specification indicates that this phrase also extends the options to which the chelator may attach.
Therefore, for the purposes of examination, the examiner interprets claim 20 to read as follows, “The targeting system according to claim 1, wherein the chelator is attached to a compound selected from a ferromagnetic compound, an alloy comprising magnetic components (A,B), ferrimagnetic compounds, and alloys from ferrimagnetic compounds; wherein the alloy comprising magnetic components (A,B), wherein at least one of component A and component B comprise(s) at least one magnetic material are selected from Groups 3-12, Periods 4-6 elements, and combinations thereof, and wherein component A and component B comprise(s) a material selected from lanthanoids, scandium, yttrium, and combinations thereof.” For the purposes of examination, any prior art which reads on this, reads on the claim.
Claim Rejections - 35 USC § 112(b)
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 7 recites the limitation "the cyanine (tetramethylindo(di)-carbocyanines)" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the targeting molecule-chelator" in line. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the targeting molecule-chelator" in line. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chung, L. W. K.; et al. (US 2014/0248213 A1).
Chung, L. W. K.; et al. (hereafter referred to as Chung) is drawn to compositions and methods for tumor imaging and targeting using cyanine dyes attached to chelators using spacers for dual detection (title; abstract). Chung teaches that the targeting molecules have an affinity for necrotic cells (pg 2, para [0026], lines 1-5; pg 2, para [0026], col 2, lines 1-2; pg 9, para [0115], structure PC-006; pg 39, para [0306], lines 19-22), a variety of cyanine dyes pg 1, para [0007], formulae I and II; pg 9, para [0115], structure PC-006; pg 24, para [0217]-[0223]; pg 39, para [0306], lines 19-22; claims 1-8), linkers (pg 7, para [0111]; pg 9, para [0115], structure PC-006), drug uptake molecules (pg 7, para [0111]; pg 9, para [0115], structure PC-006), and radionuclides (pg 6, para [0083]-[0093]).
As to claim 1, Chung teaches a targeting system comprising a targeting molecule for binding to necrotic cells (pg 2, para [0026], lines 1-5; pg 2, para [0026], col 2, lines 1-2; pg 9, para [0115], structure PC-006; pg 39, para [0306], lines 19-22), the targeting molecule being selected from cyanines (pg 1, para [0007], formulae I and II; pg 9, para [0115], structure PC-006; pg 24, para [0217]-[0223]; pg 39, para [0306], lines 19-22; claims 1-8), wherein the cyanine is attached to a linker (pg 7, para [0111]; pg 9, para [0115], structure PC-006 ) wherein the linker is attached to a drug uptake molecule (pg 7, para [0111]; pg 9, para [0115], structure PC-006) wherein the drug uptake improving molecule is attached to a chelator (pg 2, para [0026], lines 1-5; pg 2, para [0026], col 2, lines 1-2; pg 7, para [0112]; pg 8, para [0114]; pg 8-12, para [0115]; pg 9, para [0115], structure PC-006; pg 39, para [0306], lines 19-22), and wherein the drug uptake improving molecule is selected from aromatic compounds comprising at least one amino acid residue (pg 7, para [0111]; pg 9, para [0115], structures PC-001 and PC-006).
Chung does not expressly teach a single embodiment comprising all the features of the claimed product. However, it would have been prima facie obvious prior to the effective filing date of the claimed invention to combine the embodiments of the cyanine structures, linkers, drug uptake improving molecules taught by Chung as a person of ordinary skill in the art recognizes that these claim elements are known in the art. A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
A person of ordinary skill in the art would have had a reasonable expectation of success in substituting features of different parts of the compounds because they are all drawn to the same class of molecules and the general formulas and specific examples demonstrate success with substituting components with each other. The skilled artisan would have been motivated to make these substitutions because it enables tailoring the properties of the targeting molecule to the specific need.
Claim(s) 2-13 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chung as applied to claim 1 above, and further in view of Eder, M.; et al. (US 11,638,765 B2). The teachings of Chung as applied in the previous rejection is incorporated in this rejection.
As to claim 2, Chung teaches the drug uptake improving molecule is phenyl (pg 7, para [0111]; pg 9, para [0115], structures PC-001 and PC-006).
Chung does not teach the drug uptake improving molecule has a napthyl.
Eder, M.; et al. (hereafter referred to as Eder) is drawn to targeting molecules for imaging containging a chelator, a dye, a linker, and radiometals (title; abstract). Eder teaches a variety of chelators such as DOTA and NOTA (col 21, lines 10-20; col 21, lines 30-40; col 38, lines 5-25) which may be attached to a dye such as cyanines (col 25, lines 30-45; claim 18, col 46, lines 15-35; col 4, lines 10-19; col 8, lines 6-15; col 25, lines 5-65; col 26, lines 1-19) attached through a linkers containing aromatic and amino acid residues (col 15, lines 59-66, col 16, lines 1-20). Eder also teaches a a method of targeting using targeting moieties (col 27, lines 25-44).
Regarding the napthyl moieties, Eder teaches napthyl moieties in the linker (col 38, lines 5-25; claims 1, 7, 10, and 20).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the compounds of Chung to include linker moieites as taught by Eder because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of a linker containing a napthyl moiety.
A person of ordinary skill in the art would have had a reasonable expectation of success in combining the components of the linkers of Eder with the linkers of Chung because both linkers serve similar purposes in the art. The skilled artisan would have been motivated to use napthyl moieties in the linker because of the improved tailoring that the difference in uptake that napthyl and phenyl moieties provide the cyanine.
As to claim 3, Eder teaches amino acid residues: Alanine, Arginine, Asparagine, Aspartic acid, Cysteine, phenylalanine, glutamine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine, methionine, proline, serine, threonine, tryptophan, tyrosine, and valine (col 15, lines 59-66, col 16, lines 1-20).
As to claim 4, Chung teaches the linker is a PEG (pg 1, para [0009]-[0010]; pg 23, para [0211], lines 4-8; claim 1).
As to claim 5, Eder teaches DOTA (col 21, lines 10-20, col 38, lines 5-25) and NOTA (col 21, lines 30-40).
As to claim 6, Chung teaches a targeting molecule is neutral (pg 8, para [0115], structure PC-001, pg 10, para [0115], structure PC-1006) and negatively charged (pg 9, para [0115], structure PC-002; pg 10, para [0115], structures PC-1004, PC-1005).
As to claim 7, Eder teaches a tetramethylindo(di)-carbocyanine (col 25, lines 30-45; claim 18, col 46, lines 15-35), closed cyanines wherein at least one functional end group of the cyanine is protected (col 4, lines 10-19; col 8, lines 6-15; col 25, lines 5-65; col 26, lines 1-19).
As to claim 8, Chung teaches the radionuclide is selected from Cu (pg 6, para [0083]), In (pg 6, para [0084]), Ga (pg 6, para [0086]), Lu (pg 6, para [0088]), Y (pg 6, para [0087]), I (pg 6, para [0093]), and Ac (pg 6, para [0092]).
As to claim 9, Eder teaches 800CW-DOTA (col 26, lines 1-25; col 27, lines 1-20) and 800CW-NOTA (col 26, lines 1-25; col 21, lines 10-50).
As to claim 10, Chung teaches any isotope of the radionuclide selected from Cu, In, Ga, Lu, Y, I, and Ac (pg 6, para [0083]-[0093]), and specifically teaches 64Cu (pg 6, para [0083]), 114In (pg 6, para [0084]), 70Ga (pg 6, para [0086]), 177Lu (pg 6, para [0088]), 90Y (pg 6, para [0087]), and 123I and 124I (pg 6, para [0093]).
As to claim 11, Chung teaches chelator-radionuclides 111In-DOTA (pg 9, para [0115], structure PC-003), 64Cu-DOTA (pg 10, para [0115], structure PC-1001), and 64Cu-NOTA (pg 10, para [0115], structure PC-1006) and generally teaches the chelator-radionuclides (pg 6, para [0078]-[0079]).
Alternatively, Eder teaches chelators DOTA and NOTA (claim 9) combined with radionuclides 111In, 90Y, 67Ga, 68Ga, 177Lu, 64Cu, 67Cu, 153Gd, and 225Ac (claim 39).
As to claim 12, Eder teaches radionuclides 111In, 90Y, 67Ga, 68Ga, 177Lu, 64Cu, 67Cu, 153Gd, and 225Ac (claim 39) combined with cyanines 800CW (col 21, lines 10-50; col 26, lines 1-25; col 27, lines 1-20).
As to claim 13, Eder teaches the combination of cyanine, linker, and radionuclide (111In, 90Y, 67Ga, 68Ga, 177Lu, 64Cu, 67Cu, 153Gd, and 225Ac (claim 39) combined with chelators DOTA and NOTA (claim 9) and combined with cyanines 800CW (claim 18, col 46, lines 50-65; col 21, lines 10-50; col 26, lines 1-25; col 27, lines 1-20).
As to claim 20, Eder teaches ferromagnetic compounds Fe and Gd attached to the chelator (claim 39 and claim 9; col 7, line 26) and the use of metals from Groups 3-12 and Periods 4-6 (claim 39; col 7, line 26) that can be used for MRI (col 30, lines 58-67; col 31, lines 15-23).
Eder does not expressly teach a single embodiment comprising all the features of the claimed product. However, it would have been prima facie obvious prior to the effective filing date of the claimed invention to combine the embodiments (targeting cyanine molecule, Fe or Gd attached to the chelator, various metals radioactive or not from groups 3-12 and periods 4-6 for use in the MRI taught by Eder as a person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
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.
Copending Application No. 19/128,946
Claims 1-13 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 15 of copending Application No. 19/128,946 in view of Chung and Eder.
The instant claims are drawn to a targeting system comprising a cyanine-based molecule for targeting necrotic cells, where the cyanine is attached to a linker attached to a drug uptake improving molecule aromatic compounds comprising at least one amino acid residue) attached to a chelator, where the linker is a PEG, the chelator comprises at least one of DOTA, NOTA, DOTAGA, or NOTAGA, the cyanine is neutral or negatively charged, a radionuclide, and any combinations thereof. And the instant claims are drawn to ferromagnetic, ferrimagnetic or their alloys attached to the chelator.
The conflicting claims of U.S. Application No. 19/128,946 (hereafter referred to as '946) is drawn to cyanine targeting molecule selected from streptocyanines, hemicyanines, closed cyanines, neutrocyanines, merocyanines, azacyanines, and apocyanines, with a linker of amino acid residues and PEG and phenyl, and radionuclides.
The conflicting claims of ‘771 do not teach drug uptake improving molecules.
The conflicting claims of ‘771 do not teach the chelator.
The conflicting claims of ‘771 do not teach a ferromagnetic, ferrimagnetic, or their alloys attached to the chelator.
Regarding drug uptake improving molecules, Chung teaches the drug uptake improving molecule is phenyl (pg 7, para [0111]; pg 9, para [0115], structures PC-001 and PC-006).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the compounds of ‘771 to drug uptake improving moieties as taught by Chung because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of conflicting claims of ‘771 having a drug uptake improvement moiety.
A person of ordinary skill in the art would have had a reasonable expectation of success in combinging a drug uptake improving moiety with the cyanine of the ‘771 because the drug uptake improving moiety is in the linker. The skilled artisan would have been motivated to include it because the prior art shows that these moieties improve the cyanine uptake in necrotic tissue.
Regarding chelators, Eder teaches chelators such as DOTA (col 21, lines 10-20, col 38, lines 5-25) and NOTA (col 21, lines 30-40).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the compounds of ‘771 to include the chelators as taught by Eder because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of cyanines with chelators.
A person of ordinary skill in the art would have had a reasonable expectation of success in combining the chelators of Eder with the cyanines of ‘771 because ‘771 has radioisotopes and chelators are a known way of helping delivery radioisotopes to a target tissue. The skilled artisan would have been motivated to combine the chelators of Eder with ‘771 because of the facile combination and flexibility of mixing and matching radionuclides with chelators.
Regarding ferromagnetic, ferrimagnetic, or their alloys attached to the chelator, Eder teaches ferromagnetic compounds Fe and Gd attached to the chelator (claim 39 and claim 9; col 7, line 26) and the use of metals from Groups 3-12 and Periods 4-6 (claim 39; col 7, line 26) that can be used for MRI (col 30, lines 58-67; col 31, lines 15-23).
Eder does not expressly teach a single embodiment comprising all the features of the claimed product. However, it would have been prima facie obvious prior to the effective filing date of the claimed invention to combine the embodiments (targeting cyanine molecule, Fe or Gd attached to the chelator, various metals radioactive or not from groups 3-12 and periods 4-6 for use in the MRI taught by Eder as a person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Additionally, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the compounds of ‘771 to include ferromagnetic, ferrimagnetic, or alloys thereof on the chelator as taught by Eder because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of chelators with attached ferromagnetic, ferrimagnetic, or alloys thereof.
A person of ordinary skill in the art would have had a reasonable expectation of success in attaching ferromagnetic, ferrimagnetic, or alloys thereof to the chelator because the prior art shows that the necessary metals can already be used with the chelators. The skilled artisan would have been motivated to attach ferromagnetic, ferrimagnetic, or alloys thereof to the chelator because of the ability to image with MRI which would add an orthogonal imaging technique.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evan M Lewoczko whose telephone number is (571)272-9830. The examiner can normally be reached Monday-Friday 9-5PM.
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/EVAN M LEWOCZKO/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
Prosecution Insights