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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 19, 2026 has been entered.
Claim Status
Claims 7-9 have been canceled.
Thus, claims 1-6 and 10-22 are examined on the merits herein.
Withdrawn Objections and Rejections
With respect to the objections and/or rejections mailed in the final office action on March 19, 2026:
(I) The rejection of claims 1-6, 10 and 13-22 under 35 U.S.C. 102(a)(1) or 102(a)(2); and
(II) The rejection of claims 11-12 under 35 U.S.C. 103 are each withdrawn in view of Applicant’s remarks on pp. 5-10 which are found persuasive.
(III) The provisional rejection of claims 1-6, 10, 12-16 and 17-22 on the ground of nonstatutory double patenting is withdrawn in view of Applicant’s arguments on pp. 10-11 which are found persuasive.
Claim Interpretation
Independent claims 1 and 22 each recite the limitation “L1 represents a linking group”, see claim 1, line 12 and claim 22, line 12. The Examiner also respectfully notes claim 1 and claim 22 each recite Formula (I), wherein Formula (I) represents X-L1-A, see claim 1, line 6 and claim 22, line 6.
The Examiner also respectfully notes L1 is recited as a limitation defined by its function, e.g. L1 is a structure that links the tissue binding moiety (e.g. X) to the active agent (e.g. A) within Formula (I) as recited in both claim 1 and claim 22.
Consequently, the Examiner reasonably interprets any structure linking the tissue binding moiety (e.g. X) to the active agent (e.g. A) is encompassed by the scope of the phrase “a linking group”.
The Examiner further respectfully notes Applicant’s specification does not explicitly define the phrase “linking group” within the disclosure, but does exemplify “the linking group” on pp. 19-21.
However, the Examiner respectfully notes exemplification is not an explicit definition, especially in view of the specification stating “when present, the linking group can be any suitable group or moiety which is at minimum bivalent, and connects the two radical moieties to which the linking group is attached in the compounds described herein” (pg. 19, linking groups, paragraph 1).
The Examiner respectfully notes the two radical moieties to which the linking group is attached are the tissue binding moiety (e.g. X) and the active agent (e.g. A) as recited within Formula (I) of claim 1 and claim 22.
Accordingly, the Examiner reasonably interprets in view of the disclosures of the specification and the recitations of independent claim 1 and claim 22, the limitation “L1” as recited within Formula (I) of claim 1 and claim 22 is any structure linking the tissue binding moiety (e.g. X) to the active agent (e.g. A).
Thus, in view of the recitations of independent claims 1 and 22, and in view of the specification as a whole, the Examiner reasonably interprets that if any structure links the tissue binding moiety to the active agent as discussed above it will read on Formula (I) of both claim 1 and claim 22.
Response to Arguments
After consideration of the claim set entered as discussed above the Examiner notes a new 112(a)-written description rejection and 103 rejections have been made.
Claim Rejections - 35 USC § 112
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 1-6 and 10-22 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 claims contain 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.
The Examiner notes instant claims 1-6 are drawn to a method of delivering an active agent to a target tissue in a subject by administering the generic compound of formula (I).
The Examiner notes instant claim 22 is drawn to a method of maintaining or reducing the size of a tumor in a subject by administering the generic compound of formula (I).
The MPEP states for a generic claim drawn to a genus, the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. See MPEP § 2163(II)(3)((a)(ii). If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163(II)(3)((a)(ii).
The MPEP further states satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See MPEP § 2163(II)(3)((a)(ii).
Although the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad genus. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
Additionally, in Carnegie Mellon University v. Hoffman-La Roche Inc., Nos. 07-1266, -1267 (Fed. Cir. Sept. 8, 2008), the Federal Circuit affirmed that a claim to a genus described in functional terms was not supported by the specification’s disclosure of species that were not representative of the entire genus. Furthermore, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Accordingly, the instant claims have been analyzed in accordance with the methodology for determining adequacy of written description, see MPEP 2163(II):
1. For each claim, determine what the claim as a whole covers, e.g. the first step is to determine what the claim as a whole covers, i.e., discussion of the full scope of the claim.
(I) Claim 1 and dependent claims therefrom are drawn to a method for delivering any active agent to any target tissue into any subject by contacting the tissue with any compound consisting of Formula (I) where said formula is represented by X-L1-A,
where:
X represents any tissue binding moiety that is chemically configured to react with any extracellular matrix protein in said target tissue which forms any covalent bond with the target tissue;
L1 is either absent or represents any linking group; and
A represents any active agent.
(II) Claim 22 is drawn to a method of maintaining or reducing the size of any tumor in any subject in need thereof comprising injecting into the tumor any compound consisting of Formula (I).
The Examiner notes the scope of Formula (I) recited in claim 1 and claim 22 are highly similar if not identical.
2. Review the entire application to understand how Applicant provides support for the claimed invention including each element and/or step, e.g. the second step is to fully review the application to understand how Applicant provides support for the claimed invention including each element and/or step, i.e., compare the scope of the claim(s) with the scope of the description.
The genus of Formula (I) recited in claim 1 and claim 22 is broader than what is supported in the disclosure which is discussed in greater detail below.
The Examiner notes within Applicant’s specification exemplified lists of the tissue binding moiety (see pp. 18-19); the linking group (see pg. 19-21); and the active agent (see pp. 21-29) are provided.
However, a “laundry list” disclosure of many or even every possible species does not constitute a written description of every species in a genus because it would not “reasonably lead” those skilled in the art to any particular species. MPEP 2163.I.A. and Fujikawa v. Wattanasin, 93 F. 3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996). Therefore, there is no disclosure of species (e.g. by disclosure of structural/chemical formulae) in addition to the considerations discussed below which were reduced to practice.
3. Determine whether there is sufficient written description to inform a skilled artisan the Inventor was in possession of the claimed Invention as a whole at the time the application was filed, e.g. the third step is to determine whether the Applicant was in possession of the claimed invention as a whole at the time of filing.
This should include the following considerations: (1) actual reduction to practice, (2) disclosure of drawings or structural chemical formulas, (3) sufficient relevant identifying characteristics such as complete structure, partial structure, physical and/or chemical properties and functional characteristics when coupled with a known or disclosed correlation between function and structure, (4) method of making the claimed invention, (5) level of skill and knowledge in the art and (6) predictability of the art.
The preceding six considerations have been considered, with the most relevant factors discussed below.
Actual Reduction to Practice:
For claims 1-6 and 10-21, other than paclitaxel and aldoxorubicin which will be discussed with respect to claim 22; the other examples include:
Figure 6 of the Drawings (filed as discussed above) illustrating the synthesis of doxorubicin with the specified photocleavable linker containing a nitrobenzyl group to release doxorubicin and sulfo-NHS as the tissue binding moiety.
Figure 9 of the Drawings (filed as discussed above) illustrating the synthesis of erlotinib with an aryl sulfone linker.
Figure 12 showing a plot of the percentage of the initial dose (% ID) maintained one day and one week after injection of cyanine 7 (a fluorophore) conjugated to maleimide, the tissue binding moiety, as discussed in the specification (see pg. 31, Example 2, paragraphs 1-2).
For Claim 22, the specification allegedly provides support in Examples 2 and 3:
With respect to Example 2, Figure 14A-14D show aldoxorubicin functionalized with maleimide, a tissue binding moiety, intratumorally injected into mice with U87 tumor cells resulting in delayed progression of tumor volume as compared to saline and aldoxorubicin administered intravenously as discussed in the specification (see pg. 31, Example 2, last paragraph – pg. 32, first paragraph).
With respect to Example 3, the example describes a method of tissue-reactive anchoring pharmaceuticals (TRAP) as a method to create intratumoral drug depots that can easily diffuse into tissue and attach locally for sustained drug release, where TRAP are modified with ECM-reactive groups (NHS esters), and, when intratumorally injected, quickly react with accessible amines in the extracellular matrix (ECM) to create local drug depots (see pg. 32, Example 3, paragraph 1).
The specification further discloses the synthesis and characterization of paclitaxel-sNHS Esters (PTX-sNHS) (see pg. 35, last paragraph – pg. 36, first paragraph); where PTX-sNHS induction of apoptosis in vivo in a fibrous, syngeneic KPC pancreatic adenocarcinoma mouse model was demonstrated in Figures 18A-18C, and wherein PTX-sNHS increased the percent apoptotic area by 3-5 fold over administration of vehicle or free paclitaxel (see pg. 40, last paragraph – pg. 41, lines 1-6).
Applicant also notes further improvements to TRAP technology including the identification of alternative TRAP chemistries could provide even better anti-tumoral immunity efficacy and animal survival (see pg. 42, second paragraph).
Sufficient Relevant Identifying Characteristics:
The Examiner reiterates the examples of actual reduction to practice as discussed above.
However, the Examiner would also like to particularly note within said examples the disclosure of the Applicant states “the identification of alternative TRAP chemistries could provide even better anti-tumoral immunity efficacy” as discussed above, which the Examiner reasonably interprets as an open area of research, e.g. delivering any anti-tumoral agents into any tumor as recited in claim 22 or more broadly any active agent into any target tissue as recited in claim 1; with any drug delivery method or with Applicant’s proposed tissue-reactive anchoring pharmaceuticals (TRAP) platform as exemplified above.
Moreover, the Examiner reiterates the extremely broad scope of claim 1 and claim 22 and reiterates for convenience that Formula (I) is represented by X-L1-A,
where:
X represents any tissue binding moiety that is chemically configured to react with any extracellular matrix protein in said target tissue which forms any covalent bond with the target tissue;
L1 is either absent or represents any linking group; and
A represents any active agent.
The Examiner also notes claims 2-6 and 10-21, which depend or rely on claim 1, do not sufficiently describe relevant identifying characteristics, for example:
Claim 3 limits the extracellular matrix protein functional group to an amine group in a peptide;
Claims 4 and 6 limit the tissue binding moiety to comprise a sulfo-hydroxysuccinimidyl (sNHS) or a maleimide group, respectively;
Claim 10 limits the extracellular matrix protein to comprise collagen;
Claim 12 limits the linker to comprise a specific functional aspect (e.g. cleavable, either hydrolytically, photolytically, or enzymatically);
Claims 13-19 limit the active agent to comprise a specific functional aspect (e.g. therapeutic or diagnostic); and
Claim 20 limits the target tissue to comprise any solid tumor.
Accordingly, in view of the claimed scope of claims 1 and 22 and the level of disclosure in the specification as discussed above; the specification does not recite a sufficient number of representative species to adequately describe the broadly claimed genus associated with Formula (I) recited in either claim 1 or claim 22.
Furthermore, Applicant’s disclosure does not describe in sufficient detail how the broadly claimed scope of Formula (I) can be used to practice each method recited in claim 1 and claim 22; how one skilled in the art could make the broadly claimed Formula (I) used for the recited purpose in claim 1 and claim 22; and what if any considerations are required in relating the physical, chemical, or functional aspects of a compound to its structure per se, let alone in considering how to perform the method of delivering any active agent recited in claim 1 or in maintaining or reducing the size of any tumor recited in claim 22 with the recited compound of Formula (I).
Consequently, having analyzed the claims with regard to the written description guidelines as discussed above, it is clear that the specification does not disclose a representative number of species of Formula (I) that have similar functional aspects to either deliver an active agent as required in claim 1 or in maintaining or reducing the size of a tumor as required in claim 22.
Thus, one skilled in the art would reasonably be lead to conclude that Applicant only has support for a limited number of species and not for the full scope as presently claimed, and as a result Applicant was not in possession of the claimed invention at the time the application was filed.
Henceforth, the 103 rejection as written below captures what Applicant has support for as discussed above.
Claim Rejections - 35 USC § 103
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.
(I) Claims 1-6, 10-11, and 14-22 are rejected under 35 U.S.C. 103 as being unpatentable over Ezrin et al. (Published 30 September 1999, WO-9948536-A2, PTO-892 mailed 03/19/2026).
Regarding claims 1-6, 10-11, and 14-22, Ezrin teaches a method of and compositions for localized delivery of therapeutic agents which are capable of forming covalent bonds with a site of interest, see abstract.
Ezrin exemplifies a method of treating a tumor (e.g. the target tissue, required in claim 1, lines 1-2; the tumor, required in claim 20; and maintaining or reducing the size of a tumor, required in claim 22, lines 1-2) by applying (e.g. contacting, required in claim 1, line 3) a compound of the formula X-Y-Z, wherein:
X is an anti-cancer agent (e.g. the active agent, required in claim 1, line 12 and claim 22, line 12);
Y is a linking group of 0-30 atoms (e.g. L1 is absent or represents a linking group, required in claim 1, line 11, claim 11 and claim 22, line 11); and
Z is a chemically reactive entity capable of reaction with a reactive functionality on fixed blood components to form covalent bonds therewith, wherein said compound is applied at or near said tumor to permit covalent bond formation of said compound to a reactive functionality at or near said tumor (e.g. the tissue binding moiety, required in claim 1, lines 8-10 and claim 22, lines 8-10), see pp. 67-68, claim #52.
Ezrin teaches X can be selected from anti-cancer agents (e.g. a method for delivering an active agent, required in claim 1, line 1 and claims 14-16), wound-healing agents (e.g. required in claim 17), anti-restenosis agents (e.g. required in claim 18), and anti-infectives (e.g. required in claim 19), see pg. 6, lines 5-10.
Ezrin teaches the compounds may be administered to a human (e.g. the subject, required in claim 1, lines 1-2 and claim 22, line 1-2), see pg. 28, lines 20-21.
The Examiner reasonably interprets the method of Ezrin in treating a tumor as discussed above reasonably includes administering the compounds of Ezrin in a therapeutically effective amount (e.g. required in claim 1, line 3 and claim 22, line 3).
Ezrin teaches Z may be selected from and including N-hydroxy sulfosuccinamide (sNHS) (e.g. sNHS, required in claim 4), or selected from maleimide-benzoyl-succinimide, gamma-maleimido-butyryloxy succinimide ester and maleimidopropionic acid (e.g. the maleimide, required in claims 5-6), see pg. 6, lines 13-14.
Ezrin teaches there are several delivery options for localized delivery of therapeutic agents, see pg. 37, lines 15-20, which include direct injection and application, and could include intratumor (e.g. injecting into the tumor, required in claim 22, line 3), see pg. 38, lines 10-15.
The Examiner notes the preceding paragraphs discussing the teachings of Ezrin collectively correspond to the limitations recited in claim 21.
Ezrin teaches slow and sustained intratumor release of anticancer agents is possible using this NHS/linker technology in order to achieve sustained killing of tumor cells; can be achieved by intratumor injection of anti-proliferative agents coupled via linker technology to reactive NHS esters; and the NHS coupled drugs will react following injection with stomal elements of the tumor and can be release slowly into the tumor from these anchored sites by breaking down the attached site, see pg. 33, lines 20-30.
With respect to the limitation “X represents a tissue binding moiety configured to chemically react with a functional group in an extracellular matrix protein, thereby forming a direct bond with the target tissue”, see claim 1, lines 8-10 and claim 22, lines 8-10; and specifically to form “a covalent bond”, recited in claim 1 and claim 22, last line of each claim; the Examiner reasonably interprets these limitations to be physical/functional limitations of the structure recited in claim 4, specifically “wherein the tissue binding moiety comprises a sulfo-hydroxylsuccinimidyl (sNHS) group”.
Additionally, as evidenced by the specification, said specification discloses chemically reacting an amine group in a peptide with a sulfo-hydroxysuccinimidyl (sNHS) group forms a covalent bond (see pg. 2, lines 5-7); and discloses N-hydroxysuccinimide (NHS) is reactive to the numerously accessible amines sites of tumors rich in collagen (see pg. 37, last paragraph).
Accordingly, the Examiner reasonably interprets in view of the two preceding paragraphs and the teachings of Ezrin, wherein Ezrin specifically and explicitly teaches N-hydroxy sulfosuccinamide (sNHS) as the chemical entity to form covalent bonds in the compounds used by Ezrin to treat tumors, fulfills all physical/functional aspects of the tissue binding moiety (e.g. X) in Formula (I) as recited in claim 1, lines 8-10 and 13-14; claim 2, claim 3, claim 10, and claim 22, lines 8-10 and 14-15.
With respect to the limitation “thereby maintaining or reducing the size of the tumor”, required in claim 22, line 3; the Examiner reasonably interprets this limitation to be a functional consequence of administering a therapeutically effective amount of the compound of Formula (I) by injecting said compound into said tumor, and since Ezrin’s compounds teach all structural requirements required of claim 22 by their physical, chemical and/or functional characteristics and where said compounds of Ezrin are injected intratumorally as discussed above to treat a tumor; the Examiner reasonably interprets the functional consequence of maintaining or reducing the size of the tumor is met by the teachings of Ezrin as discussed above.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have included the functional aspect of the tissue binding moiety chemically reacting with a functional group in an extracellular matrix protein in the target tissue, as taught by Ezrin, into the method of treating a tumor as taught by Ezrin as within the scope of the artisan as combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to incorporate this functional aspect into the compounds taught by Ezrin to create compounds comprising N-hydroxy sulfosuccinamide as the chemically reactive entity as taught by Ezrin to bind to and treat the tumor of Ezrin as discussed above. One of ordinary skill in the art would have had a reasonable expectation of success to have incorporated the functional aspect as discussed above into the compounds and methods taught by Ezrin, because Ezrin explicitly teaches N-hydroxy sulfosuccinamide (sNHS) as the chemical entity to form covalent bonds in the compounds used by Ezrin to treat tumors as discussed above.
Thus, the claimed invention would have been prima facie obvious over the combined teachings of the prior art.
(II) Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ezrin et al. (Published 30 September 1999, WO-9948536-A2, PTO-892 mailed 03/19/2026) as applied to claims 1-6, 10-11, and 14-22 above, and further in view of Brundo et al. (Published 08 October 2015, WO-2015154082-A1, PTO-892).
Ezrin addresses claims 1-6, 10-11 and 14-22 as written above.
Ezrin further teaches each vial of therapeutic compound will contain an overage of therapeutic material required to treat each of the indications for the compound or to diagnose indications for the disease or condition, see pg. 37, lines 10-15.
Although Ezrin does not teach (a) the cleavable linker, required in claim 12 or (b) where the active agent is a diagnostic agent, required in claim 13.
However, in the same field of endeavor of drug delivery of drug conjugates, Brundo teaches refillable drug delivery devices and methods of use thereof, see title.
Brundo teaches drugs or diagnostic agents (e.g. required in claim 13) are conjugated to target motifs through cleavable linkers (e.g. required in claim 12), and exemplifies said cleavable linker as a disulfide linker, see pg. 34, paragraph [00146].
Brundo teaches cleavable linkers are cleaved very slowly, e.g. on a time frame much slower than the clearance rate of the drug from the body or the degradation rate of the drug itself, see pg. 24, paragraph [0147], paragraph 2.
Consequently, it would have been prima facie obvious to one of ordinary skill in the art at the invention’s effective filling date to have incorporated the teachings of Brundo into the compounds of Ezrin as within the scope of the artisan as combining prior art elements according to known compounds and methods to yield predictable results. One of ordinary skill in the art would have been motivated to:
(a) incorporate the cleavable linker into the compounds of Ezrin in order to change the clearance rate of the drug from the body as taught by Brundo, as one of ordinary skill in the art would have had a reasonable expectation of success to incorporate this teaching of Brundo into the teachings of Ezrin; because Brundo exemplifies said cleavable linker as a disulfide linker which the Examiner notes corresponds to the teaching of Ezrin where the linker is 0-30 atoms as discussed above; and
(b) to have substituted the therapeutic agent of Ezrin for the diagnostic agent as taught by Brundo in order to provide the therapeutic material to diagnose the disease or condition, particularly the tumor treated by the compounds of Ezrin, as taught by Ezrin above; and where one of ordinary skill in the art would have had a reasonable expectation of success to have substituted the conjugated therapeutic agent of Ezrin in the compounds taught by Ezrin for the diagnostic agent as taught by Brundo; because Brundo teaches conjugating drugs or diagnostic agents to target motifs with cleavable linkers is a known consideration in the art as discussed above.
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have (a) incorporated the cleavable linker taught by Brundo as the linker taught in the compounds of Ezrin and (b) to have substituted the therapeutic agent taught by Ezrin for the diagnostic agent taught by Brundo into the compounds of Ezrin as discussed above as within the scope of the artisan as combining prior art elements according to known methods to yield predictable results as one of ordinary skill in the art would have been motivated by and would have had a reasonable expectation of success for the reasons already discussed above.
Thus, the claimed invention would have been prima facie obvious over the combined teachings of the prior art.
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARET J CREWS whose telephone number is (571)270-0962. The examiner can normally be reached Monday-Friday: 9:00am-5:30pm EST.
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, Renee Claytor can be reached at (571) 272-8394. 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.
/JARET J CREWS/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
Prosecution Insights