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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/28/26 has been entered.
Claims 1, 2, 7-9, 11, 13, 16-19, 23-27, and 32 are pending.
Claim 1 has been amended by Applicant.
Claims 1, 2, 7-9, 11, 13, 16-19, 23-27, and 32 are currently under consideration.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This Office Actions contains New Rejections.
Rejections Withdrawn
All previous rejections are withdrawn.
New Rejections
Claim Rejections - 35 USC § 103
Claims 1, 2, 9, 11-13, and 16-19 are rejected under 35 U.S.C. 103(a) as being unpatentable over Thompson et al (Drug Discovery Today, 2010, 15(11/12): 468-473) in view of Georgianna et al (Bioconjugate Chem, 2010, 21: 1404-1407).
Thompson et al teaches molecules comprising reversibly inhibited therapeutic antibodies for treating cancer that are bound to photolabile moieties which when subjected to light are released from the antibodies which thereby regain their ability to provide therapeutic benefit to treat cancer (pages 469-470 and Figure 1, in particular). Thompson et al teaches such therapeutic antibodies include anti-CD3 antibodies, wherein such molecules bind CD3 and activate T-cells after UV light treatment (left column on page 470 and Figure 2, in particular). In vivo, such reversibly inhibited anti-CD3 antibodies reduced tumor growth when injected into subjects with cancer and irradiated with UV light (right column on page 470, in particular). Thompson et al teaches the benefit of using such molecules comprising reversibly inhibited therapeutic antibodies is they can reduce side-effects by using light to make activity of the antibodies region-specific (Abstract, in particular). Thompson et al further teaches 1-(2-nitrophenyl)ethanol (NPE) residues as such photolabile moieties (left column on page 470 and Figure 1, in particular).
Thompson et al does not specifically teach photolabile moieties of the reversibly inhibited therapeutic antibodies are linked to the antibodies via the hydrophilic polymer polyethylene glycol (PEG), which contributes to reversible inhibition of binding by steric masking prior to illumination. However, these deficiencies are made up in the teachings of Georgianna et al.
Georgianna et al teaches sterically masking proteins by using photolabile moieties to link PEG to the proteins to block protein function by providing a PEG photocage that can inhibit protein activity, wherein protein function is restored upon illumination that removes the PEG photocage (Figure 1 and Scheme 1, in particular). In addition to the special and temporal activity control also found in the photolabile moieties of Thompson et al, the PEG photocage of the photolabile moieties of Georgianna et al have additional advantage of increased half-life and circulation time (left column on page 1404 and right column on page 1406, in particular). Georgianna et al further suggest such a photocage has a wide range of potential applications, including activation of protein therapeutics (right column on page 1407, in particular). The photolabile moiety of Geogianna et al is a nitrobenzyl derivative substituted by amide comprising PEG (Scheme 1 and paragraph spanning pages 1404-1405, in particular). See Figure 1a of Geogianna et al:
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One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to treat a subject with cancer comprising performing a combined method comprising administering reversibly inhibited therapeutic antibodies of Thompson et al to the subject wherein the photolabile moieties linked to the therapeutic antibodies are either the nitrobenzyl derivative substituted by amide comprising PEG of Georgianna et al that form a PEG photocage or the nitrophenyl derivative of Thompson et al substituted by amide comprising PEG to form a PEG photocage because Thompson et al teaches molecules comprising reversibly inhibited therapeutic antibodies for treating cancer that are bound to photolabile moieties provide therapeutic benefit to treat cancer when subjected to light when the photolabile moieties are released from the antibodies, one of skill in the art would recognize antibodies are proteins and Georgianna et al teaches sterically masking proteins by using such photolabile moieties to link PEG to the proteins to block protein function by providing a “PEG photocage” that can inhibit protein activity, wherein protein function is restored upon illumination that removes the PEG photocage (Figure 1 and Scheme 1, in particular). Further, in addition to the special and temporal activity control also found in the photolabile moieties of Thompson et al, the PEG photocage of the photolabile moieties of the combined method have additional advantage of increased half-life and circulation time (left column on page 1404 and right column on page 1406 of Georgianna et al, in particular). This is an example of some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art to combine prior art reference teachings to arrive at the claimed invention. Further, substituting either the nitrobenzyl derivative substituted by amide comprising PEG of Georgianna et al that form a “PEG photocage” or the nitrophenyl derivative of Thompson et al substituted by amide comprising PEG to form a PEG photocage in place of the photolabile moieties of Thompson et al is an example of combining prior art elements according to known methods to yield predictable results and a simple substitution of one known element for another to obtain predictable results. See MPEP 2143. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Claim Rejections - 35 USC § 103
Claim(s) 1, 2, 7-9, 11-13, 16-19, 23-27, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Thompson et al (Drug Discovery Today, 2010, 15(11/12): 468-473) in view of Georgianna et al (Bioconjugate Chem, 2010, 21: 1404-1407), as applied to claims 1, 2, 9, 11-13, and 16-19 above, and further in view of Ngo et al (Cell Reports, 2016, 16: 1701-1716).
Teachings of Thompson et al and Georgianna et al are discussed above.
Thompson et al and Georgianna et al do not specifically teach methods of treating melanoma. However, these deficiencies are made up in the teachings of Ngo et al.
Ngo et al teaches methods of treating subjects with malignant melanoma comprising administering anti-CD47 antibodies to the subjects, which inhibit a “don’t-eat-me signal” on cancer cells, in combination with anti-CD271 antibodies (Figure 3 and left column on page 1702, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform the combined method of Thompson et al and Georgianna et al wherein the subject has malignant melanoma and the administered therapeutic antibodies of the reversibly inhibited therapeutic antibodies are an effective dose of anti-CD47 and anti-CD271 antibodies of Ngo that are irradiated with UV light at any tumor site of the subject because the combined method efficiently targets therapeutic antibodies with UV light at tumor sites and Ngo teaches anti-CD47 and anti-CD271 antibodies therapeutically target melanoma tumors. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Conclusion
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