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 .
Status of Application
Claims 1-24 are under examination.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The disclosure is objected to because of the following informalities: drawings of some structures are blurry and difficult to read (pg 8, third structure; pg 23, structure (3); pg 32, structure gGlu-4125I-FMA).
Appropriate correction is required.
Claim Objections
Claim 7 is objected to because of the following informalities: grammar in line 3 should change from “a saccharide, a part” to “a saccharide, or a part”.
Claim 11 is objected to because of the following informalities: grammar of the particle should be “an hydrogen” instead of “a hydrogen”. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: grammar use of “and” should be “or” in “a[n] hydrogen atom [or] a fluorine atom”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a) – Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 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 1-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the instant specification teaches nuclear probes according to formula (I) where X is selected from a group consisting of fluorine atom, ester, carbonate, carbamate, phosphoric acid, and its ester, sulfuric acid and its ester, Y is a group containing a partial structure of an amino acid or saccharide or one of those containing a self-cleaving linker, R1 and R2 are hydrogen or monovalent substituents, R3 is hydrogen or monovalent substituents, R4 is hydrogen or a substituent or molecule, Z is a single bond or linking group and A is a radionuclide (e.g.).
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See MPEP 2163(II)(A)(3)(a)(ii). The drawings (pg 32, gGlu-4125I-FMA, EP-4215I-FMA, Z-FR-4125I-FMA; Fig 1) and synthesis (pg 47, para [0087]; pg 48, para [0088]; pg 49, para [0090]) in the specification demonstrate possession of formula (I) where Y is an amino acid, R1, R2, R3, and R4 are hydrogen atoms, and where Z is a single bond and where A is a radionuclide. However, the instant specification has not demonstrated possession through a reduction to practice, reduction to drawings, disclosure of relevant, identifying characteristics, or by a combination of identifying characteristics of the nuclear probes of general formula (I) when Y is not amino acids, when R1, R2, R3, and R4 is not hydrogen, and when Z is not a single bond.
A person of ordinary skill in the art would appreciate that there are many different structural elements that would constitute the nuclear probe to facilitate the functions recited in the instant claims and different structures would require different synthetic routes and would modify the self-immobilization strategy. However, the instant specification is silent as to which structural elements the inventor has determined to be sufficient to characterize nuclear probe. Therefore, the instant specification does not provide a disclosure of corresponding structure in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention including how the inventor intended what features constitute the nuclear probes to allow the function recited in the instant claims.
Regarding claim 3, this claim recites the substituent or molecule capable of altering pharmacokinetics. This limitation is not shown in reduction to practice, reduction to drawings, or disclosure of relevant, identifying characteristics (structure or physical or chemical properties or combination of such) (MPEP 2163(II)(A)(3)(a)(ii)) sufficient to show the inventor was in possession of the claimed genus. There is no indication as to the degree or statistical significance to which the pharmacokinetic alteration must occur as to enable identifying physical properties nor is there a chemical structure so as to determine the pharmacokinetic alteration.
Regarding claims 4-5, these claims recite “arbitrarily bonding two or more groups selected from these groups. While the instant specification teaches a nuclear probe that contains a variety of substituents such as the five options for L and L’ of the Y group and the one option for the A group, the instant specification does not offer sufficient description of the common structural elements or identifying characteristics that constitute a linker formed from a group “arbitrarily bonding two or more groups selected from these groups” as recited in claims 4 and 5.
Regarding the limitation for “arbitrarily bonding two or more groups selected from these groups”, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See MPEP 2163(II)(A)(3)(a)(ii). There instant specification is silent as to any conditions of arbitrarily bonding two or more groups together through reduction to practice, reduction to drawings or by disclosure of relevant, identifying characteristics to establish a written description.
A person of ordinary skill in the art would appreciate that there are many different structural elements that would constitute arbitrarily bonding two or more groups selected from the groups as recited in claims 4 and 5 to facilitate the functions recited in the instant claims. However, the instant specification is silent as to which structural elements the inventor has determined to be sufficient to characterize these linkers. Therefore, the instant specification does not provide a disclosure of corresponding structure in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention including how the inventor intended how the features would constitute the arbitrarily bonding of two or more groups selected from the groups as recited in claims 4 and 5.
Regarding claim 6, this claim recites peptides, amino acids, and partial structures of amino acids. The written description provides three examples of amino acids (pg 8, structures 1-3; Figure 1) but is silent as to a representative number of species of larger peptides or partial structures of amino acids. The written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. The instant specification does not provide a disclosure of corresponding structure in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention of large peptides.
Regarding claim 7, this claim recites saccharides and partial structures of saccharides. The written description provides two examples of monosaccharides (pg 8, structures 4 and 5) but is silent as to a representative number of species of other types of saccharides. The written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. The instant specification does not provide a disclosure of corresponding structure in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention of non-monosaccharides.
Regarding claims 12-16, these claims recite R3 groups. The disclosure does not provide any of claims 12-16 R3 groups in a reduction to practice, reduction to drawings, or disclosure of relevant, identifying characteristics (structure or physical or chemical properties or combination of such). Therefore, the instant specification does not provide a disclosure of corresponding structure in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention including how the inventor intended the R3 substituents of claims 12-16.
Additionally, claims dependent on claim 1 which fail to further limit claim 1 written description deficiencies in such a way as to impart written description are also rejected as failing to comply with the written description requirement. Therefore, claims 2-24 are rejected as failing to comply with the written description requirement.
Claim Rejections - 35 USC § 112(b)
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, 3-4, and 12 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 term “substituted” in claims 1 and 12 is an ambiguous term which renders the claim indefinite. The term “substituted” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite structure, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The substituent could be an atom or a small molecule or a polymer or a nanoparticle. There is no clear-cut indication as to the scope of the claim and so the X group is rendered indefinite by the undefined term “substituted”.
The term “altering” in claim 3 is a relative term which renders the claim indefinite. The term “altering” is not defined by the claim, 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. The substituent or molecule is rendered indefinite since the degree to which the pharmacokinetics is altered is not defined.
Claim 3 recites the limitation “substituent” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "linker" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claims 1-5 and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01.
The omitted structural cooperative relationships are:
Regarding claim 1, placement of the self-cleaving linker in the saccharide or the peptide.
Regarding claim 1, connectivity between the R4 substituent or molecule capable of altering pharmacokinetics binding to the benzene ring or the connectivity between the R4 substituent or molecule and the linker or the connectivity between the linking group and the benzene ring.
Regarding claim 2, the connectivity between the substituent or molecule capable of altering pharmacokinetics and the direct bond to the benzene ring or to the linker. Or the connectivity between the substituent or molecule capable of altering pharmacokinetics and the linker. Or, the connectivity between the linker and the benzene ring.
Regarding claim 3, the connectivity of the substituent or molecule into the benzene ring. These groups could be R4 or they could be attached through other means by the linkers of other groups.
Regarding claims 4, arbitrary bonding of two or more groups contains boundaries that are not clearly delineated and the scope is unclear. Additionally, it is unclear due to the arbitrary bonding of more than two groups how many different genera are considered in the scope.
Regarding claim 5, arbitrary bonding of two or more groups contains boundaries that are not clearly delineated and the scope is unclear. Additionally, it is unclear due to the arbitrary bonding of more than two groups how many different genera are considered in the scope.
Regarding claim 9, the connectivity of the recited structures of Y to the aryl group. It is unclear if the methyl group on the methyl amides are part of the structure or whether the methyl groups are to be replaced with the aryl group.
Improper Markush Grouping Rejection
Claims 1-24 are rejected on the 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). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
In claim 1, the Markush grouping of “X” is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the fluorine atom is not in the same art-recognized class as the ester, carbonate, carbamate class which are not the same as the phosphoric acid and its ester, sulfuric acid and its ester group primarily because of the R’ and R’’ are substituted or unsubstituted alkyl or aryl groups. The substituted or unsubstituted alkyl or aryl groups includes a wide array of structures from simple methyl groups to polymer chains.
In claim 1, the Markush groupings of R1, R2, and R3 are improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: hydrogen atom substituents vs large monovalent substituents would be in different chemical classes and would not be known in the art to be functionally equivalent.
In claims 1 and 3, the Markush grouping of R4 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: a substituent or molecule capable of altering pharmacokinetics contains no structural limitations that would keep the benzene ring as the common structural element. When the substituent or molecule capable of altering pharmacokinetics is large enough, the benzene ring would become an insignificant portion of the overall structure which would make the whole compound no longer part of the same art-recognized class.
In claims 2-24, the Markush grouping of dependency on claim 1 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the compound according to claim 1 contains improper Markush groupings.
In claim 4, the Markush grouping of the linker is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the linker includes alkylene groups where -CH2- could be replaced by -O-, -S-, -NH-, or -CO-, arylene, cycloalkylene, alkoxyl, or polyethylene glycol chains and any arbitrary bonding of two or more of these groups. The linker includes possibilities that would alter the art-recognized class so thoroughly as to make the claim no longer belong to the same structural class. For example, if every -CH2- in dodecane linker were replaced by -O-, or where all possible combinations were combined arbitrarily.
In claim 5, the Markush grouping of the linking group of Z is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the linker includes alkylene groups where -CH2- could be replaced by -O-, -S-, -NH-, or -CO-, arylene, cycloalkylene, alkoxyl, or polyethylene glycol chains and any arbitrary bonding of two or more of these groups. The linker includes possibilities that would alter the art-recognized class so thoroughly as to make the claim no longer belong to the same structural class. For example, if every -CH2- in dodecane linker were replaced by -O-, or where all possible combinations were combined arbitrarily.
In claim 12, the Markush grouping of R3 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the Ra groups may be substituted alkyl or aryl groups with no limitation on the size of the substituent of the alkyl or aryl group. These groups can be so different in structure from a nitro group amino group, hydroxyl group or halogen as to make the whole compound no longer belong to the same art-recognized structural class.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Interpretation
Claim 1 recites a substituted or unsubstituted alkyl or aryl group (line 6) but does not specify the substituents. The examiner notes that specification gives examples of substituents but does not limit to these substituents. Further, the examiner notes that substituents exemplified in the specification are small moieties and large alkyl, aryl, etc (pg 14, para [0012]-[0014]). Therefore, for the purposes of examination, the examiner interprets that a substituted alkyl or aryl group or any sort regardless of the size of the substituent is contemplated. Therefore, any prior art which reads on an alkyl or aryl group regardless of the substituent reads on this claim limitation.
Claim 1 recites L is a “partial structure of an amino acid” and L’ is a “partial structure of a saccharide” or L’ is a “partial structure of a saccharide having a self-cleaving linker”. The examiner notes that the specification refers to a “partial structure of an amino acid of L means that L, together with C=O to which L is bonded, constitutes an amino acid, amino acid residue, peptide, or part of an amino acid” (pg 19, para [0021]); and, that the partial structure of L’ “refers to a structure corresponding to the remaining partial structure obtained by removing one hydroxyl group from the saccharide” (pg 21, para [0026]). For the purposes of examination, any prior art reading on an amino acid to peptide or a saccharide attached to an aryl reads on this claim regardless of missing carbonyl or hydroxyl groups.
Claim 1 recites R1 through R3 may be monovalent substituents. The examiner notes that monovalent substituent of R1 and R2 is described as a halogen or alkyl group (pg 24, para [0033]) and R3 is described as an halogen, alkyl, alkoxycarbonyl, nitro, amino, hydroxyl, alkylamino, alkoxy, ester, amide, boryl, and cyano groups (pg 25, para [0035]). For the purposes of examination, the examiner interprets any prior art which reads on a substituent as described in the spec reads on this claim limitation.
Claim 1 recites “self-cleaving linker”. The examiner notes that the specification states that a self-cleaving linker means a linker that is spontaneously cleaved and decomposed (pg22, para [0029]). The examiner notes that this is functional language. Therefore, there is no clear indication of the scope of the subject matter embraced by the claim. However, for the purposes of examination, the examiner interprets “self-cleaving linker” to refer to any functional group that can break bonds spontaneously or can be acted upon to break bonds. Therefore, for the purposes of examination, the examiner interprets any functional group in the prior art regardless of whether it can spontaneously cleave or is acted upon to cleave reads on this claim.
Claim 1 recites “may be bonded” which is optional language. Therefore, for the purposes of examination, the examiner interprets any prior art regardless of bonding via a linker as reading on this claim limitation.
Claims 1 and 3 recites functional language, “a substituent or molecule capable of altering pharmacokinetics”. The examiner notes that the specification describes such substituents or molecules as “any substituent or molecule known to alter pharmacokinetics. (pg 27, para [0042]) but does not define the substituent or molecule in non-exemplary language. When claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. See MPEP 2173.05(g). For the purposes of examination, the examiner interprets any prior art with a substituent or molecule as R4 as reading on this limitation.
Claims 3-5 recite a linker. The examiner notes that the specification describes a linker as selected from an alkylene where one or more -CH2- groups may be replaced by -O-, -S-, -NH-, or -CO-), arylene, cycloalkylene, alkoxyl, polyethylene glycol, and any group formed by arbitrarily bonding two or more of these groups (pg 5, para [0009]). The examiner notes that no provision is given for the metes and bounds of the combinations of these groups. Therefore, for the purposes of examination, the examiner interprets any prior art contains R4 or A regardless of what structure links it to the aryl, as reading on this limitation.
Claims 4-5 recite arbitrarily bonding two or more groups selected from these groups. The examiner notes that the specification is silent as to additional context for what structures are considered or the connectivity considered in the arbitrarily bonding two or more groups. The examiner further notes that arbitrarily bonding more than two groups has no upper limit of the number of groups which can be combined. And, the two or more groups could be combined in such a way as to make the benzene ring an insignificant part of the molecule, altering the art-recognized class of the molecule. The examiner interprets “arbitrarily bonding two or more groups” to mean any prior art containing substituents that could be formed in any fashion from two or more groups as reading on this limitation.
Claims 1 and 6 recite an amino acid. The examiner notes that the specification states that this is both natural and non-natural amino acids (pg 18, para [0022]). Therefore, the examiner interprets any prior art containing natural or non-natural amino acids reads on this limitation.
Claim 6 recites “a part of an amino acid”. The examiner notes that any subunit of an amino acid reads on this claim limitation. Therefore, the examiner interprets any prior art containing that any subunit of an amino acid as reading on this claim limitation.
Claim 9 recites several structures but does not denote the point of attachment to the aryl group. The examiner notes that as the structures are drawn, there are methyl amides drawn. The examiner notes that the drawing shows an example where the amide is attached to the aryl through the nitrogen and that the methyl group is not present. The bond to the methyl becomes the bond to the aryl. Therefore, for the purposes of examination, the examiner interprets the point of attachment for each structure as through the nitrogen of the amide bond. Similarly, the -O-Me in the saccharide of the fourth structure is bound to the aryl or linking group through the bond to the methyl. Any prior art containing groups bound to the aryl or linking groups reads on these claim limitations.
Claim 18 recites “used in nuclear medical examination”. This is a use claim. The examiner interprets any prior art containing the pharmaceutical composition as reading on this claim.
Claim 19 recites “acts cell-selectively…”. This is functional language. The examiner interprets any prior art containing the pharmaceutical composition as reading on this claim.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 1-2 and 5-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urano, Y.; et al. US 2020/0399305 A1 and Phenix, C.; et al. WO 2015/123783 A1.
Urano, Y.; et al. (hereafter referred to as Urano) is drawn to prodrug anticancer agents using cancer-specific enzymatic activity (title; abstract). Urano discloses fluorescent probes that undergo enzymatic cleavage at a glycosidic linkage to undergo a reaction to immobilize on a cell and then start fluorescing (Figure 1; pg 1, para [0006]). Urano teaches probes that utilize similar structural features to undergo cleavage by peptidases or glycosidases (pg 2, para [0023]) to form quinone methide type molecules which can self-immobilize onto nearby cancer cells through cell-specific enzyme activity (pg 2, para [0022]). Urano teaches structures with the general formula (I)
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, where X is fluorine, ester, carbonate, carbamate, phosphoric acid or its ester, sulfuric acid or its ester, where Y is -NH-CO-L, -NH-L', or -OL' where L is a partial amino acid, L' is a saccharide or a partial saccharide or a saccharide or peptide with a self-cleaving linker, where R1 and R2 are independently selected from hydrogen atom or monovalent substituent, where R3 is a hydrogen atom or one to four independently selected monovalent substituents connected to the aryl group. (pg 1, para [0010]-[0012]) Urano specifically teaches Y may be selected as
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,
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, and
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(pg 1, para [0016]; pg 2, para [0016]). Urano teaches various compounds related to the general formula (pg 5, para [0076]), pharmaceutical compositions (pg 6, para [0088]), and methods of synthesis (pg 7, para [0100]).
As to claim 1, Urano teaches the instant claim 1 general formula (I) with Urano, formula (I)
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, where Urano teaches X is fluorine, ester, carbonate, carbamate, phosphoric and its ester, sulfuric and its ester groups (pg 1, para [0010]), where Y is -NH-CO-L, -NH-L’, or -OL’ where L is a is a partial structure of an amino acid (pg 1, para [0011]) and where L’ is a saccharide or a partial structure of a saccharide or a partial structure of a saccharide having a self-cleaving linker, or an amino acid or a peptide having a self-cleaving linker (pg 1, para [0012]), where R1 and R2 are each independently selected from a hydrogen atom or a monovalent substituent (pg 1, para [0012]), where R4 is R3 and R3 is 1 to 4 substituents and is a hydrogen atom or a monovalent substituent on the benzene ring (pg 1, para [0012]).
Urano does not teach Z.
Urano does not teach A.
Phenix, C.; et al. (hereafter referred to as Phenix) is drawn to compounds that target Cathepsin B and can be modified to be probes for PET or fluorescence (title; abstract). Phenix teaches a variety of compounds useful for use as imaging probes (pg 1, para 1, lines 1-3) and that Cathepsin B (CTB) is produced by a variety of tumor-associated cells and that CTB is a useful cancer cell marker (pg 1, para 3, lines 1-2). Phenix teaches peptide-based probes that can be cleaved by CTB to yield either a fluorophore or a PET imaging agent that is immobilized to the cancer (pg 2, para 3, lines 1-5). Phenix teaches a peptide which may be bound to a self-cleaving linker (pg 2, para 4, formula (I)) which is attached to a series of phenyls which may have either a fluorescent dye attached (pg 4, para 2, line 1) or a radiolabeled PET substituent (pg 5, para 2, lines 1-5). Phenix teaches pharmaceutical compositions of the PET compounds and a method of diagnosing and imaging (pg 5, para 7-8; pg 6, para 1, lines 1-7). Phenix teaches several specific structures as enzyme-cleavable nuclear probes for PET (pg 17, para 2, structures 38 and 39) which may be non-immobilizing (pg 17, para 2, structure 38) and immobilizing (pg 17, para 2, structure 39). Phenix teaches synthesis of the compounds (pg 19, Scheme 1; pg 21, Scheme 2; pg 24, Scheme 4; pg 25, Scheme 5).
Regarding the linker group, Z, and the radionuclide, A, Phenix teaches a radionuclide attached to a linker group (pg 17, structures 38 and 39).
It would have been prima facie obvious to a person of ordinary skill in the art before the
effective filing date to modify the compounds of Urano to include the radionuclide as taught by Phenix because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of a compound containing a radionuclide attached to an aryl group through a linker.
A person of ordinary skill in the art would have had a reasonable expectation of success in combining the radionuclide of the nuclear probe of Phenix to the probe of Urano because the prior art of Urano disclosed an aryl-based probe known to have a moiety that is cleaved and immobilized on cancer cells enabling either imaging of that cancer (figure 1) or cytotoxicity to the cancer cell (pg 5, para [0076]). The additional prior art of Phenix also taught an aryl-based probe suggested to have similar enzyme-cleavable and immobilization behavior enabling emerging of the cancer cells because of the overlap of structure between the probes involves known aryl-based moieties and known cleavable moieties, and known synthetic methods to add the tags (PET or fluorescent) and because both Urano and Phenix teach the probes behave through similar mechanisms, it would have been prima facie obvious to modify the probes of Urano with the radionuclide of Phenix. The skilled artisan would have been motivated to combine the radiolabeled probe of Phenix with the probe of Urano because the radiolabeled section enables imaging of deep tissue and enables monitoring of cancer cell-type tissues.
As to claim 2, Phenix teaches a radionuclide is 18F (pg 5, para 2, line 1; pg 17, para 2, lines 1-2; claim 5).
As to claim 5, Phenix teaches a linker between the aryl group and the radionuclide (pg 17, structure 39).
As to claim 6, Urano teaches L is a partial structure of an amino acid, together with C=O to which L is bonded, constitutes an amino acid, an amino acid residue, a peptide, or a part of an amino acid (pg 1, para [0013]; claim 2).
As to claim 7, Urano teaches L’ is a partial structure of a saccharide together with O to which L’ is bonded, constitutes a saccharide or a part of a saccharide (pg 1, para [0014]; claim 3).
As to claim 8, Urano teaches -Y is bonded to the ortho or para position of the benzene ring with respect to -C(R1)(R2)X (pg 4, para [0070]; claim 4).
As to claim 9, Urano teaches structure 1,
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, (pg 1, para [0016]) and structure 4,
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, (pg 2, para [0016]; claim 5).
As to claim 10, Urano teaches X is a fluorine atom or an ester group (pg 1, para [0010]; claim 1).
As to claim 11, Urano teaches R1 and R2 hydrogen atoms (pg 1, para [0012]; claim 1).
As to claim 12, Urano teaches R3 is selected from the group consisting of an alkyl, alkoxycarbonxyl, nitro, amino, hydroxyl, alkylamino, alkoxy, ester, boryl, or cyano group, or a halogen atom (claim 8).
As to claim 13, Urano teaches R3 is selected from an alkyl or an alkoxycarbonyl group (claim 8).
As to claim 14, Urano teaches R3 is a halogen atom (claim 8).
As to claim 15, Urano teaches R3 is at least an alkyl group and at least an halogen atom (pg 5, para [0076]; claim 8).
As to claim 16, Urano teaches substituents labeled R3 and R4 in the instant application are hydrogen atoms (pg 5, para [0076], structure gGlu-FMA).
As to claim 17, Urano teaches a pharmaceutical composition (pg 1, para [0001]; pg 5, para [0083]).
As to claim 18, Phenix teaches a pharmaceutical composition used in nuclear medical examination (pg 5, para 7, lines 1-4; claim 16).
As to claim 19, Urano teaches a pharmaceutical composition that acts cell-selectively by cancer cell-specific enzyme activity (pg 5, para 0079]; claim 11).
As to claim 20, Urano teaches the enzyme is peptidase or glycosidase (claim 12).
As to claim 21, Phenix teaches PET (pg 5, para 7, lines 1-4; claim 16).
As to claim 22, Phenix teaches a method for diagnosing a disease comprising A) administering to a subject in need thereof (pg 5, para 8, lines 1-5; pg 6, para 1, lines 1-7; claim 18) and B) examining the presence of cancer tissue in a target tissue of a subject by measuring irradiation emitted from the absorbed compound within the tissue (pg 6, para 1, lines 1-7).
As to claim 23, Urano teaches pharmaceutical composition is administered intravenously (pg 6, para [0091], lines 20-22).
As to claim 24, Urano teaches a kit including the compound wherein the kit is the product containing the pharmaceutical composition (pg 6, para [0088], lines 9-17).
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urano and Phenix as applied to claims 1-2 and 5-23 above, and further in view of and Cheng, T-C.; et al. An Activity-Based Near-Infrared Glucuronide Trapping Probe for Imaging β-Glucuronidase Expression in Deep Tissues. J. Am. Chem. Soc. 2012, 134, 3103-3110. The teachings of Urano and Phenix as applied in the previous rejection are incorporated in this rejection.
As to claim 3, Urano teaches a substituent directly attached to the aryl (pg 5, para [0076]) or a dye can be used (Figure 1).
Urano does not teach a dye directly attached to the aryl group.
Cheng, T-C.; et al. (hereafter referred to as Cheng) is drawn to probes for imaging cancer cells through enzyme-induced cleavage of the probes (title; abstract). Cheng teaches molecules with a enzyme cleavable moiety, and a prodrug using tumor marker enzymes (specifically β-Glucuronidase) to trap the probe at cancer cells (abstract; pg 3103, col 1, para 1, lines 1-4). Cheng teaches a molecule (NIR-TrapG) that upon enzyme mediated hydrolysis generates a reactive quinine methide intermediate that can then undergo nucleophilic attack to trap the NIR-probe to the cancer cells (pg 3104, col 1, para 1; pg 3104, Fig 1). Cheng states that many probes have been developed for profiling enzymatic activities (pg 3104, col 1, para 1, lines 9-11). Cheng teaches the probes characterization in vitro with cell selectivity for the β-glucuronidase containing cells (pg 3105, col 1, para 1, lines 1-9; pg 3104, Figure 2) and in vivo efficacy for subcutaneous tumors (pg 3105, col 1, para 3, lines 10; pg 3106, Figures 5-6) and synthesis of the probes (pg 3107, Schemes 1-2; pg 3108, Schemes 3-4).
Regarding attachment of a dye to the aryl group, Cheng teaches a substituent introduced via a linker is a dye (pg 3108, Scheme 3, structure 10; pg 3108, Scheme 4, structure 13).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the compounds of Urano to include dyes directly attached to the aryl group as taught by Cheng because these claim elements were known in the art and one
of skill in the art could have combined these elements by known methods with no change in
their respective functions, and the combination would have yielded the predictable outcome
of a dye attached to the aryl group to alter pharmacokinetics.
A person of ordinary skill in the art would have had a reasonable expectation of success in modifying the aryl group to include a dye because the prior art of Urano disclosed compounds of aryl groups to have a variety of substituents and the additional prior art of Cheng disclosed a method of synthesizing the dye substituent on an aryl group (pg 3107, Scheme 1 and Scheme 2). The overlap of structural base and mechanism of the quinone methide cleavage is still affective with the dye between them due to overlap of structure and mechanism of the enzymatic cleavage, it would be prima facie obvious to modify the aryl group of Urano and Phenix with the dye of Cheng. The skilled artisan would have been motivated to modify the aryl groups with a dye because it would enable modification of the pharmacokinetics and add an orthogonal imaging method.
As to claim 4, Cheng teaches the linker is a -NH- group which falls within one -CH2- is replaced by an -NH- group (pg 3107, Scheme 2, structure 6 and structure 8).
Pertinent Art
The prior art of Asanuma, D.; et al. Sensitive β-galactosidase-targeting fluorescence probe for visualizing small peritoneal metastatic tumours in vivo, Nat. Comm. 2015, 6, 6463 (as cited in the IDS filed on 09/27/2024) is deemed pertinent to the application.
Asanuma, D.; et al. (hereafter referred to as Asanuma) is drawn to probes that detect cancer through fluorescence using a galactosidase enzyme (title; abstract). Asanuma teaches that β-galactosidase is a good target for visualizing cancers (pg 2, col 1, para 3, lines 1-7) and that a saccharide (β-galactoside) works well (pg 3, Figure 2). Asanuma teaches that their probe can detect cancer through imaging in mice (pg 5, col 1, para 3, lines 9-14) and that the chemical substitution of β-galactoside moieties has the potential to target other glycosidases in other types of cancers (pg 5, col 2, para 3, lines 1-7) and that the molecular design enables a series of probes (pg 5, col 2, para 3, lines 8-12).
The examiner considers the overlap of structures of the probes and the enzyme cleavage by the beta-galactosidase as a means for visualizing cancer of fluorescent probes containing saccharides to render this art pertinent to this application.
The prior art of Wang, Y.; et al. Hydrogen peroxide activated quinone methide precursors with enhanced DNA cross-linking capability and cytotoxicity towards cancer cells, Euro. J. Med. Chem., 2017, 133, 197-207 is deemed pertinent to the application.
Wang, Y.; et al. (hereafter referred to as Wang) is drawn to quinone methide precursors for self-immobilization and cytotoxicity toward cancer cells (title; abstract). Wang teaches quinone methide precursors can be used to have endogenous cleavage of a site to create the quinone methide through hydrogen peroxide (pg 197, col 2, para 1, lines 2-5) enzymatic oxidation, reduction (pg 197, col 2, para 2, lines 7-9) and other methos (pg 198, col 1, para 1, lines 1-6). Wang teaches several aryl substituents on quinone methide precursors (pg 198, Scheme 1; pg 199, Schemes 2 and 3). Wang teaches (halogens, alkyl, alkoxy, boryl, and ester substituents (pg 199, Schemes 2 and 3).
The examiner considers the disclosure of studies on substituents to quinone methides relevant to discussions involving aryl group substituents of the instant application.
The prior art of Rempel, B. P.; et al. Molecular Imaging of Hydrolytic Enzymes Using PET and SPECT, Molecular Imaging, 2017, 16, 1-30 is deemed pertinent to the application.
Rempel, B. P.; et al. (hereafter referred to as Rempel) is drawn to using radiolabeled substrats which can image hydrolytic enzymes using PET or SPECT (title; abstract). Rempel discloses that the substrates for imaging the hydrolytic enzymes should be enzymatically hydrolysable to create 2 fragments where the radioactive label should become trapped in nearby cells or tissues so that accumulation of the radioactive signal correlates with areas of high enzymatic processing (pg 3, col 1, para 2, lines 1-7). Rempel discloses multiple enzyme targets and compounds that have been successful in imaging such as esterases (pg 7, col 1, para 1-2); glycosylases (pg 9, col 2, para 2; pg 10, col 1, para 2; pg 10, Figure 12; pg 11, Figures 13-14; pg 12, Figures 15-16); ether hydrolases (pg 14, col 2, para 3); proteases (pg 15, col 1, para 2); hydrolases (pg 15, col 2, para 3).
The examiner considers the section on glycosylases to be of particular relevance to the instant application.
Nonstatutory 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.
Patent No. 11,655,269 B2
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,655,269 B2 in view of Urano, Phenix, and Cheng.
The instant claims are drawn to a general formula (I)
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, where X is a fluorine, ester, carbonate, carbamate, phosphoric acid or its ester, sulfuric acid or its ester, and where Y is -NH-CO-L, -NH-L', or -OL' where L is a partial amino acid, L' is a saccharide or partial saccharide, where R1 and R2 are hydrogen or monovalent substituent, where R3 is hydrogen or 1 or 2 independently selected substituents, where R4 is a hydrogen or a substituent, where Z is a single bond or a linker, where A is a radionuclide. The instant claims teach Y is
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. The instant claims teach a pharmaceutical composition that is accumulated in cancer cells. The instant claims teach an enzyme is peptidase or glycosidase, imaging is PET or SPECT, a method for diagnosing, a route of administration, and a kit.
The conflicting claims of U.S. Patent No. 11,655,269 B2 (hereafter referred to as '269) are drawn to a compound represented by a general formula (I)
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, wherein X is fluorine, ester, or carbamate, Y is -NH-CO-L, -NH-L', or -OL', where L together with CO is an amino acid or peptide and where L' is a saccharide or partial structure of a saccharide or a peptide, R1 and R2 are hydrogen atoms, R3 is 1-4 aryl substituents independently selected from alkyl, alkoxy, ester groups or halogen atoms, substituted or unsubstituted alkyl or aryl groups. And the conflicting claims of '269 are more specifically drawn to when Y is
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.
The conflicting claims of '269 do not teach a radionuclide.
The conflicting claims of '269 do not teach a pharmaceutical composition.
The conflicting claims of '269 do not teach an enzyme is peptidase or glycosidase.
The conflicting claims of '269 do not teach PET or SPECT.
The conflicting claims of '269 do not teach a method for diagnosing a disease.
The conflicting claims of '269 do not teach administration.
The conflicting claims of '269 do not teach a kit.
However, these features are known in the art. As noted in the current rejections, the combined teachings of Urano, Phenix, and Cheng render obvious claims 1-24.
Regarding a radionuclide, Phenix teaches a radionuclide attached to a linker group (pg 17, structures 38 and 39).
It would have been prima facie obvious to a person of ordinary skill in the art before the
effective filing date to modify the compounds of conflicting claims ‘269 to include the radionuclide as taught by Phenix because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of a compound containing a radionuclide attached to an aryl group through a linker.
A person of ordinary skill in the art would have had a reasonable expectation of success in combining the radionuclide of the nuclear probe of Phenix with the aryl group of conflicting claims of ‘269 because the conflicting claims disclosed an aryl-based probe known to have a moiety that is cleaved and immobilized on cancer cells enabling the imaging of that cancer. Additional prior art of Phenix also taught aryl-based probe suggested to have similar enzyme-cleavable and immobilization behavior enabling emerging of the cancer cells because of the overlap of structure between the probes involves known aryl-based moieties and known cleavable moieties, and known tags (PET) and because both the conflicting claims and Phenix teach the probes behave through similar mechanisms.
The skilled artisan would have been motivated to combine the radiolabeled probe of Phenix with the probe of the conflicting claims because the radiolabeled section enables deep tissue penetration and increases the type of cleavable moieties available.
Regarding a pharmaceutical composition, Phenix teaches a pharmaceutical composition (pg 5, para 7, lines 1-4; claim 16).
Regarding peptidase or glycosidase, Urano teaches the enzyme is glycosidase (pg 2, para [0023]; claim 12).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to combine the glycosidase target of the Urano with the combined teachings of Phenix and the conflicting claims because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of targeting glycosidase.
A person of ordinary skill in the art would have had a reasonable expectation of success in targeting glycosidase because the compound of conflicting claims includes glycosidase cleavable linkages. The skilled artisan would have been motivated to glycosidase because of the presence of glycosidase on many cells and especially cancer cells.
Regarding PET or SPECT, Phenix teaches PET (pg 5, para 7, lines 1-4; claim 16).
Regarding a method of diagnosing a disease, Phenix teaches a method for diagnosing a disease comprising A) administering to a subject in need thereof (pg 5, para 8, lines 1-5; pg 6, para 1, lines 1-7; claim 18) and B) examining the presence of cancer tissue in a target tissue of a subject by measuring irradiation emitted from the absorbed compound within the tissue (pg 6, para 1, lines 1-7).
Regarding a route of administration, Urano teaches pharmaceutical composition is administered intravenously (pg 6, para [0091], lines 20-22).
Regarding a kit, Urano teaches a kit including the compound wherein the kit is the product containing the pharmaceutical composition (pg 6, para [0088], lines 9-17).
Co-pending Application No. 18/277,623
Claims 1-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-18, and 20-22 of copending Application No. 18/277,623 in view of Urano, Phenix, and Cheng.
The instant claims are drawn to a general formula (I)
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, where X is a fluorine, ester, carbonate, carbamate, phosphoric acid or its ester, sulfuric acid or its ester, and where Y is -NH-CO-L, -NH-L', or -OL' where L is a partial amino acid, L' is a saccharide or partial saccharide, where R1 and R2 are hydrogen or monovalent substituent, where R3 is hydrogen or 1 or 2 independently selected substituents, where R4 is a hydrogen or a substituent, where Z is a single bond or a linker, where A is a radionuclide. The instant claims teach Y is
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. The instant claims teach a pharmaceutical composition that is accumulated in cancer cells. The instant claims teach an enzyme is peptidase or glycosidase, imaging is PET or SPECT, a method for diagnosing, a route of administration, and a kit.
The conflicting claims of U.S. Application No 18/277,623 (hereafter referred to as '623) are drawn to a compound with the general formula (I),
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, where X is a fluorine atom, ester, carbonate, carbamate, phosphoric acid, ester, sulfuric acid or ester group, where Y is -NH-CO-L, -NH-L', or -OL' where L is a partial amino acid, L' is a saccharide or partial saccharide or peptide, where R1 and R2 are hydrogen or a monovalent substituent, where R3 is a hydrogen or one to three independently selected substituents, where Z is a single bond or a linking group, where B is a radionuclide, 10B. The conflicting claims of '623 teach Y may be one of the following:
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. The conflicting claims of '623 teach a pharmaceutical composition, accumulation in cancer cells, enzyme is peptidase or glycosidase, a method for diagnosing a disease.
The conflicting claims of '623 do not teach the route of administration.
The conflicting claims of '623 do not teach a kit.
However, these features are known in the art. As noted in the current rejections, the combined teachings of Urano, Cheng, and Phenix render obvious claims 1-24.
Regarding the route of administration, Urano teaches pharmaceutical composition is administered intravenously (pg 6, para [0091], lines 20-22).
It would have been prima facie obvious to a person of ordinary skill in the art before the
effective filing date to modify the method of the conflicting claims and Phenix to the route of administration as taught by Urano because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of an intravenous route of administration.
A person of ordinary skill in the art would have had a reasonable expectation of success in using an intravenous route of administration because the combined prior art taught methods of diagnosis involving administration and the prior art of Urano taught a similar pharmaceutical composition using an intravenous route of administration. The skilled artisan would have been motivated to use an intravenous route of administration because many clinicians are very familiar with intravenous routes of administration for the compounds used in clinics.
Regarding the kit, Urano teaches a kit including the compound wherein the kit is the product containing the pharmaceutical composition (pg 6, para [0088], lines 9-17).
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evan M Lewoczko whose telephone number is (571)272-9830. The examiner can normally be reached Monday-Friday 9-5PM.
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/EVAN M LEWOCZKO/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
Prosecution Insights