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 .
Election/Restrictions
Claims 1-13,15-23,25-43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/24/2026.
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.
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 24 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In particular the recitation in the claim that the linker group is a single atom but the Markush group for the linkers include groups with more than one atom is indefinite. All the linkers should only include one atom, not multiple atoms such as polyethylene. A suggestion to include all the species in the Markush group would be to simply delete the recitation that the linker fragment Z is a single atom.
Claim 24 is also rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
The recitation of "derivative" found in the claim when referring to the type of linkers renders the claim indefinite. The term “derivative” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what is encompassed and excluded by the limitation "derivative”. The Merriam-Webster' s Dictionary defines “derivative” as “a chemical substance related structurally to another substance and theoretically derivable from it” ([online], retrieved on 12/9/2015, at: http://www.merriamwebster.com /dictionary/derivative. Hence, one of ordinary skill would clearly recognize that derivatives of the linkage groups claimed in claim 24, would read on any of those compounds having any widely varying groups that possibly substitute the linkers claimed. One of ordinary skill could not ascertain and interpret the metes and bounds of the patent protection desired as to these terms. Thus, it is unclear and indefinite as to how the “derivative” herein are encompassed thereby.
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) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duval et al. “Indium-Labeled Macrocyclic Conjugates of Naltrindole: High-Affinity Radioligands for In Vivo Studies of Peripheral δ Opioid Receptors”, J. Med. Chem. 2007, 50, 2144-2156.
Duval teaches Naltrindole and DOTA conjugates seen below:
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216
118
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Greyscale
, within the scope of Formula IV when Z is a substituted carbon or alkyl group. See entire disclosure, especially abstract and schemes 2-3. The only difference between formula IV and the structure above is that indium is not a lanthanide series metal. However, the reference suggests that depending upon nuclear properties desired for the radiolabeled opioids several types of metals may be bound including the lanthanide 177Lu for radiotherapy. See 2nd ¶ page 2144. Thus, substitution of the lanthanide would be readily obvious to one of ordinary skill in the art and they would have a reasonable expectation of success of making such a modification. Reason to make such a modification would be to produce an opioid receptor antagonist DOTA conjugate also useful for radiotherapy. Thus the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES W ROGERS/Primary Examiner, Art Unit 1618
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