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 .
Response to Election/Restrictions
With regards to the restriction, Examiner agrees that the two inventions can be examined together, therefore the restriction requirement dated 7/15/2025 is withdrawn.
Applicant’s election without traverse of PSMA-7.3-SiOH as the compound, reading on claims 1-7 and 9-15 in the reply filed 11/14/2025 is acknowledged.
Claims 7 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
As the elected species appears to be free of the prior art, Examiner expanded the species search to include (3S)-4-[[2-[[(2S)-1-amino-5-(diaminomethylideneamino)-1-oxopentan-2-yl]amino]-2-oxoethyl]amino]-3-[[1-carboxy-2-[2,5-dioxo-1-[3-oxo-3-(3-trihydroxysilylpropylamino)propyl]pyrrolidin-3-yl]sulfanylethyl]carbamoylamino]-4-oxobutanoic acid:
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Claim Rejections - 35 USC § 112 – Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 17-19 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for treatment of prostate cancer, does not reasonably provide enablement for treating or diagnosing disease in a subject generally. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).1
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention, state and predictability of the art, and relative
skill level
The invention relates to treatment and diagnosis of diseases by administration of a compound claimed as a targeting group, chelating group, and Si-OH functional moiety. The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art.
The breadth of the claims
The claims are broad insofar as the disease to be treated or diagnosed is not limited in any way for claim 17, and includes all cancers in claim 18. Further, the compounds to be used are broad insofar as they are claimed generically as functional groups as a compound claimed as a targeting group, chelating group, and Si-OH functional moiety.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for practicing the claimed invention in its “full scope”. No reasonably specific guidance is provided concerning useful therapeutic protocols for treatment or diagnosis of all diseases, other than the tumor xenografts, LNCaP cell line. The latter is corroborated by the working examples for a limited number of compounds.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed agents could be predictably used to treat or diagnose all diseases as inferred by the claim and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the claimed invention in its “full scope” a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
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 4, 5, 6, 8, 10, and 11 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation in (i) and (ii): “of which 2 or more”, and the claim also recites “preferably 3 or more” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 5, m is “2 to 6”, “preferably 2 to 4”, and “more preferably 2”; similar issues as well for n, R1P, R3P, and R2P.
Claim 6, X3A contains “preferably a methyl”.
Claim 8, contains “18F” and “such as 18F-[AIF]2+”.
Claim 10, L2 includes “preferably a linear alanediyl group”.
Claim 11, L3 includes “preferably a linear alanediyl group”.
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.
Claims 1, 4, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lukas et al (J of Medicinal Chem, vol 56, no 19, 2013, pp 7552-7563), in view of Pubchem ((3S)-4-[2-[(2S)-1-Amino-5-(diaminomethylideneamino)-1- oxopentan-2-ylJamino]-2-oxoethyl]amino]-3-[1-carboxy-2-[2,5-dioxo-1-I3- oxo-3-(3-trihydroxysilylpropylamino)propyl]pyrrolidin-3- yl]sulfanylethyl]carbamoylamino]-4-oxobutanoic acid", 18 June 2019, XP055759023), Cook (WO 02/096913), and Hopkins (WO 2010/108125).
Lukas et al teaches peptides (targeting goup) linked to peptide moieties, such as Ala(SO3H)-Ala(SO3)H) which are capable of chelating a cation, and phenyl(tBu)2Si-OH group. (fig 2, pg 7555, compound 44).
Lukas et al does not teach the species under examination or use of the compounds for treatment of cancers.
Pubmed discloses a compound having a silanol group, a cysteine derivative (chelating group) and a peptide derivative (targeting group).
Cook teaches compounds comprising targeting groups, phthalocyanine macrocycle (chelating groups), and an Si-OH group for treatment of cancers, such as prostate cancer. (claims 1, 8, 9, 26, 27, 42-46).
Hopkins teaches it was known to use heterocyclic rings as chelating conjugates, such as PSMA-binding conjugate with DOTA chelating group and a phenylamine residue, with a fee carboxylate group. The conjugates can be radio labelled and used for imaging applications.
It would have been obvious to one of ordinary skill in the art to combine the Lukas and pubmed references to result in a compound which reads on the instant claims, and then to use them in a manner consistent with the class of compounds as taught by Cook.
It further would have been obvious to vary the chelating conjugates using known groups, such as DOTA taught by Hopkins in the conjugated compound.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri (9am-6pm + mid-day flex).
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, Sandy 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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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612
1 As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is “undue”, not “experimentation”.