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
Applicant's election with traverse of group I and the species E-2A and L-4 in the reply filed on 4/13/26 is acknowledged. The traversal is on the ground(s) that the remaining species are closely related in subject matter and could be searched and examined simultaneously without placing a serious burden on the examiner. This is not found persuasive because the compounds of formula I have various chelators, radioactive or non-radioactive cations, various linking groups, various R2L moieties, etc. that provide very different structures and different imaging or treating agents. Therefore, the search of the variety of structures with radioactive or non-radioactive cations for the methods of imaging and/or treating will cause a search burden to the Office.
The requirement is still deemed proper and is therefore made FINAL.
Claims 16-17,20,22 and 24-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/13/26.
The species L-4 was not found in the prior art and therefore, the search was extended to include L-3.
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 1-12 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Claims 1,3 and 6 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 phrases “preferably” and “more preferably” stated throughout the claims are confusing and unclear and renders the claim indefinite as to the intended scope of the claim whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 1-12 and 14 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 claimed Markush structure contains so many possible variation that the scope of the claim cannot be determined. While breadth alone is not indefinite, the instant claims have an almost unlimited number of possible combinations of chemical moieties that it is not possible to determine the metes and bounds of the claims.
The dependent claims fall therewith.
Claims 1-12 and 14 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes
species of the claimed invention that do not share both a substantial structural feature and a common
use that flows from the substantial structural feature.
A Markush claim contains an “improper Markush grouping” if: (1) the species of the Markush
group do not share a single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a "single structural similarity” when they belong to the same recognized physical or chemical class or to the same recognized physical or chemical class or to the
same art-recognized class. Members of a Markush group share a common use when they are disclosed
in the specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No.
27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph).
The claims are directed to the compounds of Formula I having many different chemical structures comprising phosphonate urea or DUPA urea moieties having different chemical scaffolds, biological target, etc. The different chemical structures comprise numerous possible alternative variation of R1L, R2L, R3L, X1, L1, X2, R2, R3, R4, X3, RM, EDS, etc. The compounds of Formula I comprise chelators to chelate radioactive or non-radioactive cations that are used for different methods, such as imaging or treatment. There is nothing of record to show a common chemical core that is specifically tied to a function in the almost unlimited breadth of the claimed compounds.
Applicant attention is directed to the third paragraph of MPEP 803.02 which discloses: “Since
the decisions in In re Weber, 580 F.2d 455, 198 USPQ 328 (CCPA 1978) and In re Haas, 580 F.2d 461, 198
USPQ 334 (CCPA 1978), it is improper for the Office to refuse to examine that which Applicants regard as
their invention, unless the subject matter in a claim lacks unity of invention. In re Harnisch, 631 F.2d 716, 206 USPQ 300 (CCPA 1980); and Ex parte Hozumi, 3 USPQ2d 1059 (Bd. Pat. App. & Int. 1984). Broadly, unity of invention exists where compounds included within a Markush group (1) share a
common utility, and (2) share a substantial structural feature essential to that utility.”
In the instant case, if it is asserted that the claims share a common utility, it is noted the only
shared structure is a chelator moiety bound to the urea derivatives via a variety of linking groups
comprising a various X2-L1-X1 moieties and various substituents that does not allow the genus to have an art recognized classification. Hence, the Markush grouping is improper.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual
species or grouping of species that share a substantial structural feature as well as a common use that
flows from the substantial structural feature, or present a sufficient showing that the species recited in
the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that
flows from the substantial structural feature. This is a rejection on the merits and may be appealed to
the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1)
(emphasis provided).
The dependent claims fall therewith.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-10 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Robu et al. (J. Nucl. Med. 2017, 58, 235-242)
Robu et al. (J. Nucl. Med. 2017, 58, 235-242) teaches of 111In-DOTAGA(3-iodo-y)-f-k-Sub(KuE
(PSMA I&T)
PNG
media_image1.png
122
466
media_image1.png
Greyscale
for PSMA-targeted therapy and radioguided surgery of small metastatic prostate cancer soft-tissue lesions (abstract; p235, right column, last paragraph; p236, left column, first paragraph; Figure 1).
The DOTAGA of the disclosure anticipates the RM of the instant claims, such as
PNG
media_image2.png
114
127
media_image2.png
Greyscale
.
The 111In of the disclosure anticipates the radioactive cation of the instant claims.
The
PNG
media_image3.png
65
236
media_image3.png
Greyscale
of the disclosure anticipates the –X2-L1-X1- (L-3) of the instant claims.
The
PNG
media_image4.png
90
99
media_image4.png
Greyscale
of the disclosure anticipates the
PNG
media_image5.png
189
195
media_image5.png
Greyscale
of the instant claims when R1L and R3L is NH and R2L is C.
The
PNG
media_image6.png
122
129
media_image6.png
Greyscale
of the disclosure anticipates the
PNG
media_image7.png
117
270
media_image7.png
Greyscale
of the
instant claims when R2 is an aryl group; R3 is an optionally substituted aryl group comprising an EDS
PNG
media_image8.png
106
162
media_image8.png
Greyscale
; R5B is –OH; r is 0; and X3 is an amide bond.
Claim(s) 1-10 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lutje et al. (Theranostics 2015, 5, 1388-1401).
Lutje et al. (Theranostics 2015, 5, 1388-1401) teaches of prostate-specific membrane antigen (PSMA) is a promising target for specific imaging of prostate cancer (PCa) and is a target for therapeutic applications (abstract).
[177Lu]DOTAGA- (I-y)-fk-(SubKuE) (PSMA I&T) has improved tumor uptake and allowed for partial remission of many intense PSMA-positive metastatic lesions (p1398, left column, last paragraph; p1389, right column, first paragraph).
The DOTAGA of the PSMA I&T anticipates the RM of the instant claims, such as
PNG
media_image2.png
114
127
media_image2.png
Greyscale
.
The 177Lu of the PSMA I&T anticipates the radioactive cation of the instant claims.
The
PNG
media_image3.png
65
236
media_image3.png
Greyscale
of the PSMA I&T anticipates the –X2-L1-X1- (L-3) of the instant claims.
The
PNG
media_image4.png
90
99
media_image4.png
Greyscale
of the PSMA I&T anticipates the
PNG
media_image5.png
189
195
media_image5.png
Greyscale
of the instant claims when R1L and R3L is NH and R2L is C.
The
PNG
media_image6.png
122
129
media_image6.png
Greyscale
of the PSMA I&T anticipates the
PNG
media_image7.png
117
270
media_image7.png
Greyscale
of the instant claims when R2 is an aryl group; R3 is an optionally substituted aryl group comprising an EDS
PNG
media_image8.png
106
162
media_image8.png
Greyscale
; R5B is –OH; r is 0; and X3 is an amide bond.
Claim(s) 1-10 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chatalic et al. (Theranostics 2016, 6, 849-861).
Chatalic et al. (Theranostics 2016, 6, 849-861) teaches of 177Lu-PSMA I&T
PNG
media_image9.png
159
501
media_image9.png
Greyscale
used for SPET/CT imaging and radionuclide therapy of prostate cancer (PCa) (abstract; p850, right column; p851, left column, first paragraph; Figure 1; p852, SPECT/CT imaging).
The DOTAGA of the disclosure anticipates the RM of the instant claims, such as
PNG
media_image2.png
114
127
media_image2.png
Greyscale
.
The 177Lu of the disclosure anticipates the radioactive cation of the instant claims.
The
PNG
media_image10.png
55
229
media_image10.png
Greyscale
of the disclosure anticipates the –X2-L1-X1- (L-3) of the instant claims.
The
PNG
media_image4.png
90
99
media_image4.png
Greyscale
of the disclosure anticipates the
PNG
media_image5.png
189
195
media_image5.png
Greyscale
of the instant claims when R1L and R3L is NH and R2L is C.
The
PNG
media_image11.png
118
120
media_image11.png
Greyscale
of the disclosure anticipates the
PNG
media_image7.png
117
270
media_image7.png
Greyscale
of the instant claims when R2 is an aryl group; R3 is an optionally substituted aryl group comprising an EDS
PNG
media_image8.png
106
162
media_image8.png
Greyscale
; R5B is –OH; r is 0; and X3 is an amide bond.
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.
Claims 1-12,14 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 11,497,819B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds of U.S. Patent No. 11,497,819B2 encompass the compounds of the instant claims wherein the DOTAGA of U.S. Patent No. 11,497,819B2 encompasses the RM of the instant claims, such as
PNG
media_image2.png
114
127
media_image2.png
Greyscale
.
The 177Lu of U.S. Patent No. 11,497,819B2 encompasses the radioactive cation of the instant claims.
The linker moieties of U.S. Patent No. 11,497,819B2 encompass the –X2-L1-X1- (L-3) optionally substituted with EDS groups of the instant claims.
The
PNG
media_image4.png
90
99
media_image4.png
Greyscale
of U.S. Patent No. 11,497,819B2 anticipates the
PNG
media_image5.png
189
195
media_image5.png
Greyscale
of
the instant claims when R1L and R3L is NH and R2L is C.
The compound
PNG
media_image12.png
212
658
media_image12.png
Greyscale
comprising a radioactive cation of U.S. Patent No. 11,497,819B2 encompasses the
PNG
media_image13.png
164
504
media_image13.png
Greyscale
chelated with 225Ac of the instant claims.
Conclusion
No claims are allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA JEAN PERREIRA whose telephone number is (571)272-1354. The examiner can normally be reached M9-3, T9-3, W9-3, Th9-2, F9-2.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MELISSA J PERREIRA/Examiner, Art Unit 1618
Prosecution Insights