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 .
Drawings
The drawings are objected to because the scale bar in Fig 2 is not informative in gray scale. 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 Interpretation
Claim 17 recites “exposing the subject… to an image scanner”. The examiner notes that exposing could merely mean proximity. Therefore, the examiner interprets any prior art where the subject is near the image scanner to read on this limitation.
Claim 17 recites “recognizing the agent”. The examiner notes that “recognizing” is a result of the image scanner production of an image and is inherent to the image scanner. Therefore, the examiner interprets any prior art which involves an image scanner of a subject to read on “recognizing the agent”.
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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Merbl, Y.; et al. (IL728394).
Merbl, Y.; et al. (hereafter referred to as Merbl) is drawn to agents binding peptides and their uses in detecting cancer (title, pg 1, lines 5-6; pg 1, lines 19-20). Merbl teaches peptides capable of binding to a target (pg 2, lines 19-25) and can be attached to a therapeutic moiety pg 3, lines 14-18), methods of imaging (pg 342, lines 1-12; pg 371, lines 21-26).
As to claim 1, Merbl teaches an agent for detecting cancer (pg 416, lines 29-32; claim 29) comprising a peptide from thymosin beta-10 with fewer than 20 amino acids (table, 3, entries 1135, 1166, 1331-1333, 1341, 1439, 1510-1511, 1514, 2457, 3626, 9544, and 9550; claim 29) covalently attached to an imaging agent (pg 358, lines 19-22; pg 358, lines 31-32; pg 359, line 1; pg 342, lines 1-4).
Merbl does not expressly teach a single embodiment comprising all the features of the claimed product. However, it would be prima facie obvious prior to the effective filing date of the claimed invention to combine the embodiments of an thymosin beta-10 peptide with fewer than 20 amino acids for detecting cancer with an imaging agent taught by Merbl as a skilled artisan recognizes that these claim elements are known in the art and a finder that 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).
As to claim 2, Merbl teaches a peptide comprises the amino acid sequence ADKPDMGEIASFDK (Table 3, pg 269, entry 9550).
As to claim 3, Merbl teaches an imaging agent is selected as a radionuclide (pg 341, lines 12-13; pg 342, lines 1-4; claim 12).
Claim(s) 4-8, 10-12, 14-16, 18, 20-22, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Merbl as applied to claims 1-3 above, and further in view of Von Guggenberg Zu Riedhofen, E.; et al. (WO 2018/224665 A1, as cited in the IDS filed on 05/08/2024). The teachings of Merbl as applied in the previous rejection are incorporated in this rejection.
As to claim 4, Merbl teaches imaging agents (pg 342, lines 10-12; pg 371, lines 21-26; pg 416, lines 29-32; claim 29).
Merbl does not teach chelators.
Von Guggenberg Zu Riedhofen, E.; et al. (hereafter referred to as Von) is drawn to peptides for imaging and targeting cancers (title; abstract). Von teaches a peptide that can recognize CCK2R (pg 3, lines 9-12; pg 3, lines 31-35) and attaching a chelator to the peptide (pg 3, lines 29; pg 7, lines 11-18; pg 28, lines 7-14) and complexing a radioisotope (pg 19, lines 5-9; pg 21, lines 21-26) which can be used in detection and imaging cancers (pg 22, lines 7-25; pg 30, lines 10-15).
Regarding chelators, Von teaches chelators (pg 3, lines 29; pg 7, lines 11-18; pg 28, lines 7-14).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the peptide-radioisotope imaging agents of Merble to include the chelators as taught by Von 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 peptide attached to a chelator with a radioisotope for detecting and treating cancer targeted by the choice of peptide.
A person of ordinary skill in the art would have had a reasonable expectation of success in combining the chelators of Von with the peptide system of Merbl because both Merbl and Von teach modification of the peptides with detection moieties while maintaining the cancer targeting capabilities. The skilled artisan would have been motivated to combine the chelators of Von with the peptide of Merbl because of the targeting capability of the peptide and the flexibility of the radioisotope chosen when using chelators instead of covalently binding the radioisotope.
As to claim 5, Von teaches the chelator may be selected from the group consisting of NOTA (pg 28, lines 10-11), DTPA (pg 28, line 2), and DOTA (pg 28, line 9-10).
As to claim 6, Von teaches the imaging agent comprises a radionuclide (pg 19, lines 5-9; pg 21, lines 21-26).
As to claim 7, Von teaches the radionuclide is a gamma or positron emitting radionuclide (pg 21, lines 27-29).
As to claim 8, Von teaches the radionuclide is 123I, 99mTc, or 124I (pg 21, lines 27-29) and 18F (pg 21, line 26).
As to claim 10, Merbl teaches a composition comprising the agent of claim 1 (pg 6, lines 5-8; pg 361, lines 18-22).
As to claim 11, Merbl teaches a conjugate of an agent of claim 1 (pg 356, lines 13-14; pg 358, lines 19-22; pg 359, line 1).
Merbl does not teach the imaging agent is a chelator.
Merbl does not teach a radionuclide bound to the chelator.
Regarding a chelator, Von teaches the imaging agent is a chelator (pg 3, lines 29; pg 7, lines 11-18; pg 28, lines 7-14).
Regarding a radionuclide, Von teaches radionuclides bound to chelators (pg 19, lines 5-9; pg 21, lines 21-26).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the peptide-radioisotope imaging agents of Merble to include the chelators and radionuclides as taught by Von 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 peptide attached to a chelator with a radioisotope for detecting and treating cancer targeted by the choice of peptide.
A person of ordinary skill in the art would have had a reasonable expectation of success in combining the chelators of Von with the peptide system of Merbl because both Merbl and Von teach modification of the peptides with detection moieties while maintaining the cancer targeting capabilities. The skilled artisan would have been motivated to combine the chelators of Von with the peptide of Merbl because of the targeting capability of the peptide and the flexibility of the radioisotope chosen when using chelators instead of covalently binding the radioisotope.
As to claim 12, Von teaches the chelator may be selected from the group consisting of NOTA (pg 28, lines 10-11), DTPA (pg 28, line 2), and DOTA (pg 28, line 9-10).
As to claim 14, Von teaches the radionuclide is 18F (pg 21, line 26).
As to claim 15, Von teaches a method of detecting or diagnosing cancer comprising contacting cells (pg 30, lines 26-36) with an effective amount of the agent or composition or conjugate (pg 4, lines 5-11; pg 22, lines 7-21; claims 11-12) and identifying the agent (pg 4, lines 7-8; claim 11).
Von does not expressly teach a single embodiment comprising all the features of the claimed product. However, it would be prima facie obvious prior to the effective filing date of the claimed invention to combine the embodiments of a method of detecting by contacting tumor cells with an effective amount of the agent and then identifying the agent as taught by Von as a skilled artisan recognizes that these claim elements are known in the art and that 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).
As to claim 16, Von teaches contacting comprises administering to a subject (pg 4, lines 9-11; claim 12).
As to claim 18, Von teaches the subject has cancer (pg 4, lines 9-11; pg 30, lines 35-36; claim 12) or is suspected of having cancer (pg 30, lines 10-15).
As to claim 20, Merbl teaches the cancer is a breast cancer (pg 345, line 1; pg 346, lines 11-13).
As to claim 21, Von teaches a kit comprising an agent, chelator, and radionuclide (abstract; pg 29, lines 31-33; pg 30, lines 1-9).
As to claim 22, Von teaches the chelator may be selected from the group consisting of NOTA (pg 28, lines 10-11), DTPA (pg 28, line 2), and DOTA (pg 28, line 9-10).
As to claim 24, Von teaches the radionuclide is 18F (pg 21, line 26).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Merbl and Von as applied to claims 1-8, 10-12, 14-16, 18, 20-22, and 24 above, and further in view of Nimmagadda, S.; et al. (US 2023/0271923 A1, with a priority date of 08/07/2020). The teachings of Merbl and Von as applied in the previous rejection are incorporated in this rejection.
As to claim 17, Von teaches a method of imaging comprising visualizing (or recognizing) the agent in contact with the cancer (claim 11).
Von does not expressly teach exposing the subject or a region of the subject to an image scanner.
Von does not expressly teach obtaining an image of the subject or the region of the subject
Nimmagadda, S.; et al. (hereafter referred to as Nimmagadda) is drawn to imaging agents that can detect cancers using peptides (title; abstract). Nimmagadda teaches peptide-based imaging agents (abstract; pg 4, para [0047]-[0048]; pg 19, para [0079]) attached to chelators (pg 6-8, structures, pg 8, para [0055]) and complexing a radioisotope (pg 8, para [0056]) which can be used in detection and imaging of cancers (pg 19, para [0071]; pg 19, para [0074]).
Regarding exposing to an image scanner, Nimmagadda teaches scanning the entire subject or a particular region of the subject to an image scanner (pg 19, para [0079], lines 1-4).
Regarding obtaining an image, Nimmagadda teaches obtaining an image of the subject or the region of the subject (pg 19, para [0079], lines 1-4) and Nimmagadda teaches recognizing the agent (pg 19, para [0079], lines 5-6; pg 19, para [0080], lines 1-2).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the method of Von to include methods as taught by Nimmagadda 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 the method of imaging by exposing the subject to a image scanner and obtaining a resultant image.
A person of ordinary skill in the art would have had a reasonable expectation of success in combining these methods because the methods of imaging in both Von and Nimmagadda are drawn to peptides with chelators complexing radioisotopes for use in imaging cancers. The skilled artisan would have been motivated to combine the methods because of the increased detail outlined in Nimmagadda compared to Von which would better enable a person of ordinary skill to perform the task.
Conclusion
No claims are 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EVAN M LEWOCZKO/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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