Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed 12/18/2024 has been entered. Claim 41 has been amended.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 41, 42, 45, and 46 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Shaw et al (from IDS; 1987 Biochimica et Biophysica Acta 924: 167-174; "Shaw"), for the reasons set forth in the office action mailed 6/21/2024.
Shaw teaches disclose the catabolism of neurotensin in the epithelial layer of porcine small intestine. In particular, experimental studies were conducted wherein epithelial cells were incubated with [3-125lJiodotyrosyl)neurotensin (a radiohalogenated peptide) in the presence of phosphoramidon (a neutral endopeptidase NEP, inhibitor) (abstract; page 168, left column, first complete paragraph; page 169, left paragraph, first complete paragraph). Thus, both Applicant and Shaw et al disclose a composition comprising a neutral endopeptidase (NEP) inhibitor in combination with a radiolabeled neurotensin peptide.
New Grounds of Rejection
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.
Claims 41-49 are 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.
The amendment to claim 41 that recites “the composition comprises a therapeutic or diagnostic compound” is unclear as used in this context. The claim previously recited that “composition is a therapeutic or diagnostic compound” which basically is an intended use recitation that the composition is in a form to be used as a therapeutic or diagnostic compound, such as, that the “radiolabled” recitation is what renders this intended functionality. The amendment adds confusion if it changes the scope of the claim. For example, it is unclear if the claim now requires an additional therapeutic or diagnostic compound. If so, the claim should be amended to recite “the composition further comprises a therapeutic or diagnostic compound” to clarify. The use of “comprises” usually signifies the presence of a component, but it is not clear in this situation if this is the case or if the claim still only requires the components recited above. When a claim can be interpreted in two different ways, the metes and bounds are unclear.
If the limitation is meant only to be an intended use, it is suggested that the last line of claim 41 is deleted and the intended use is added to the preamble of the claim. See above for the suggestion if an additional component is what was meant by the amendment.
Note: for examination purposes the claim is being interpreted that this is an intended use recitation.
The dependent claims fall therewith.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 41, 42, 45, 46 and 47 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shaw et al (from IDS; 1987 Biochimica et Biophysica Acta 924: 167-174; "Shaw") in view of Goodman US 7837982 B2.
The disclosure of Shaw is discussed above.
While Shaw teaches use of I-125 as the radionuclide, Shaw fails to specifically teach a radionuclide from instant claim 47, such as I-123 and/or that such an isotope specifically for diagnostic use.
However, Goodman clearly teaches that I-125 and I-123 are functional equivalents and may be used interchangeably in order to provide the desired radioactive emissions for various diagnostic uses (SPECT), see for example, the abstract, col. 4-5, col. 8, etc.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition disclosed by Shaw by substituting I-125 with I-123 because these two iodine radioisotopes are known to be interchangeable and/or functional equivalents as taught by Goodman that are useful for diagnostic use, such as SPECT imaging.
Response to Arguments
Applicant’s arguments filed 12/18/2024 have been considered but are not persuasive.
Applicant asserts that Shaw does not disclose compounds for diagnostic or therapeutic use.
This is not found persuasive first because Shaw discloses a composition having the same components as instantly claimed. 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.
Shaw discloses I-125 which is a diagnostic compound (as supported by applicant, see claim 46) as well as shown by Goodman. Further, Goodman clearly teaches I-125 and the claimed, I-123, are diagnostic radionuclides and functional equivalents.
Conclusion
No claims are allowed at this time.
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/Michael G. Hartley/ Supervisory Patent Examiner, Art Unit 1618