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 .
Claims 1-18 are pending and under examination.
Priority
Acknowledge is made that this application is divisional application of US patent application 17835684, filed on 06/08/2022; which claims priority from US provisional application 63/208390, filed on 06/08/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/30/2025, 07/15/2025 and 02/17/2026 is being considered by the examiner.
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.
Claim 15 is 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 15 recites the broad recitation “thienopyrimidine derivatives” and the claim also recites “thienopyrimidine derivatives ORG 43553” 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.
Regarding claim 15, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-4, 8-13, 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Gong et al. (US20220177494) in view of Basu et al. (US20100297262).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Gong et al. teaches silica metal organic framework (SMOF) nanoparticles that are pH-responsive for delivery of bioactive molecules. The nanoparticles include a organosilica network comprising a plurality of imidazolyl and/or carboxyl groups; a metal organic framework component comprising a transition metal coordinated to a coordinating ligand, wherein the transition metal is selected from the group consisting of zinc, iron, zirconium, copper, and cobalt, and the coordinating ligand is selected from an imidazolate ligand or a carboxylate ligand; a bioactive payload selected from the group consisting of a hydrophilic drug, a polynucleic acid, a protein and a protein-polynucleic acid complex; and a surface-modifying polymer conjugated to the same or a different organosilica network and forming at least part of an exterior surface of the nanoparticle, wherein the surface-modifying polymer is selected from polyethylene glycol and/or a polyzwitterion; and wherein the zinc also coordinates the imidazolyl or carboxyl group of the organosilica network (abstract). The technology provides a new nanoplatform for delivering bioactive payloads to cells. The nanoplatform comprises silica metal organic framework hybrid nanoparticles. Thus in one aspect, the present technology provides nanoparticles comprising: an organosilica network (e.g., polysiloxane) including a plurality of imidazolyl groups and/or carboxyl groups. The organosilica network further includes a plurality of surface-modifying moieties selected from the group consisting of polyethylene glycol (PEG), a polycation, a polyzwitterion, or functional groups that form cations at a pH of 8 or below. The nanoparticles also include metal organic framework components that include a transition metal ion coordinated to a coordinating ligand, wherein the transition metal ion is selected from the group consisting of zinc, iron, zirconium, copper, and cobalt ions, and the coordinating ligand is selected from an imidazolate ligand or a carboxylate ligand. The nanoparticles further include a bioactive payload selected from the group consisting of a hydrophilic drug, a polynucleic acid, a protein and a protein-polynucleic acid complex. The nanoparticle has an exterior surface with a plurality of surface-modifying groups. Nanoparticles of the present technology provide for comparable or higher loading and comparable or more efficient delivery of the bioactive payload along with lower toxicity than some traditional delivery platforms such as Lipofectamine. Further, with the present platform, there is no need to conjugate the polynucleic acid to the protein as in, e.g., S1mplex. The present technology also provides methods of making and using the new nanoparticles ([0007]). “Hydrophilic drug” as used herein refers to non-polymeric molecules that exert a therapeutic effect in an animal in the treatment of a disorder, disease or condition, and are soluble in water at 25° C. to at least 1 mg/mL. In any embodiments, a hydrophilic drug may have water solubility of at least 5 mg/ml, at least 10 mg/mL, at least 15 mg/mL, at least 20 mg/mL or at least 33 mg/mL at 25° C. Hence, hydrophilic drugs include doxorubicin hydrochloride (“DOX.HCl”), Y-27632 dihydrochloride ((1R,4r)-4-((R)-1-aminoethyl)-N-(pyridin-4-yl)cyclohexane-1-carboxamide dihydrochloride; a Rho-Associated Coil Kinase (ROCK) inhibitor). Hydrophilic drugs do not include biomacromolecule therapeutics such as DNA, mRNA, proteins or complexes of such biomolecules (e.g., cas9/sgRNA) ([0037]). “Metal organic framework” or “MOF” as used herein refers to the three-dimensional, porous, crystalline structure formed by metal ions and small organic ligands that coordinate to the metal ions. Thus, a “metal organic framework component” refers collectively to the individual component parts of the MOF, i.e., a metal ion and a coordinating ligand. For example, a zinc ion and 2-methylimidazole would be, respectively, the metal ion and coordinating ligand of the metal organic framework component for the MOF, zeolitic imidazolate framework-8, i.e., ZIF-8 ([0038]). The phrase “targeting ligand” refers to a ligand that binds to “a targeted receptor” that distinguishes the cell being targeted from other cells. The ligands may be capable of binding due to expression or preferential expression of a receptor for the ligand, accessible for ligand binding, on the target cells. Examples of such ligands include GE11 peptide, anti-EGFR nanobody, cRGD ((cyclo (RGDfC)), KE108 peptide, octreotide, glucose, folic acid, prostate-specific membrane antigen (PSMA) aptamer, TRC105, a human/murine chimeric IgG1 monoclonal antibody, mannose, and cholera toxin B (CTB). Additional examples of such ligands include Rituximab, Trastuzumab, Bevacizumab, Alemtuzumab, Panitumumab, RGD, DARPins, RNA aptamers, DNA aptamers, analogs of folic acid and other folate receptor-binding molecules, lectins, other vitamins, peptide ligands identified from library screens, tumor-specific peptides, tumor-specific aptamers, tumor-specific carbohydrates, tumor-specific monoclonal or polyclonal antibodies, Fab or scFv (i.e., a single chain variable region) fragments of antibodies such as, for example, an Fab fragment of an antibody directed to EphA2 or other proteins specifically expressed or uniquely accessible on metastatic cancer cells, small organic molecules derived from combinatorial libraries, growth factors, such as EGF, FGF, insulin, and insulin-like growth factors, and homologous polypeptides, somatostatin and its analogs, transferrin, lipoprotein complexes, bile salts, selecting, steroid hormones, Arg-Gly-Asp containing peptides, microtubule-associated sequence (MTAS), various galectins, δ-opioid receptor ligands, cholecystokinin A receptor ligands, ligands specific for angiotensin AT1 or AT2 receptors, peroxisome proliferator-activated receptor γ ligands, β-lactam antibiotics, small organic molecules including antimicrobial drugs, and other molecules that bind specifically to a receptor preferentially expressed on the surface of targeted cells or on an infectious organism, or fragments of any of these molecules ([0041]). The phrase “a targeted receptor” refers to a receptor expressed by a cell that is capable of binding a cell targeting ligand. The receptor may be expressed on the surface of the cell. The receptor may be a transmembrane receptor. Examples of such targeted receptors include EGFR, αvβ3 integrin, somatostatin receptor, folate receptor, prostate-specific membrane antigen, CD105, mannose receptor, estrogen receptor, and GM1 ganglioside ([0042]). A “dye” refers to small organic molecules having a molecular weight (actual, not number average) of 2,000 Da or less or a protein which is able to emit light. Non-limiting examples of dyes include fluorophores, chemiluminescent or phosphorescent entities. For example, dyes useful in the present technology include but are not limited to cyanine dyes (e.g., Cy2, Cy3, Cy5, Cy5.5, Cy7, and sulfonated versions thereof), fluorescein isothiocyanate (FITC), ALEXA FLUOR® dyes (e.g., ALEXA FLUOR® 488, 546, or 633), DYLIGHT® dyes (e.g., DYLIGHT® 350, 405, 488, 550, 594, 633, 650, 680, 755, or 800) or fluorescent proteins such as GFP (Green Fluorescent Protein) ([0044]). The present nanoparticles also include a bioactive payload selected from the group consisting of a hydrophilic drug, a polynucleic acid, a protein and a protein-polynucleic acid complex. The nanoparticle includes an exterior surface with a plurality of surface-modifying groups as described herein ([0045]). In any embodiments, the surface-modifying moieties that are polymeric (e.g., PEG, polycation, and polyzwitterion) may have a Mn of about 1,000 to about 50,000 Da. For example, the PEG, polycation, or polyzwitterion may have a Mn of about 1,000, about 2,000, about 3,000, about, 4,000, about 5,000, about 7,500, about 10,000, about 15,000, about 20,000, about 30,000, about 40,000, about 50,000 Da or a value within a range between and including any two of the foregoing values. For example, the PEG, polycation, or polyzwitterion may have a Mn of about 2,000 to about 10,000 Da ([0048]). The present nanoparticles may also include a targeting ligand and/or an imaging agent attached to the organosilica network. The targeting ligand and/or imaging agent may be attached to the organosilica network via bonds to amino groups in the organosilica network. By way of a non-limiting example, the bonds may be amide bonds, N—C bonds, imino bonds and the like ([0049]). Suitable payloads for the present nanoparticle delivery systems include hydrophilic drugs, proteins, polynucleic acids and complexes of the two such as ribonucleoproteins (RNP), e.g., Cas9 with guide RNA. Examples of hydrophilic small molecule therapeutics include DOX.HCl and Y-27632 dihydrochloride. In any embodiments, the bioactive payload may include DOX.HCl, DNA, RNA (e.g., mRNA), ribonucleoprotein (RNP), and combinations of two or more thereof. In any embodiments, the bioactive payload may be selected from the group consisting of plasmid DNA (pDNA), single-stranded donor oligonucleotide (ssODN), complementary (cDNA), messenger RNA (mRNA), small interfering RNA (siRNA), microRNA (miRNA), short hairpin RNA (shRNA), single guide RNA (sgRNA), transfer RNA (tRNA), ribozymes, and combinations of two or more thereof. In certain embodiments, the bioactive payload may be selected from the group consisting of Cas9 RNP, RNP+ssODN where ssODN serves as a repair template, RNP+donor DNA up to 2 kb, and other Cas9-based protein/nucleic acid complexes. It will be appreciated that with the present nanoparticles, Cas9 or RNP need not be conjugated to any repair template as either may simply be mixed with the desired polynucleic acid instead during the nanoparticle formation process. NLS peptides may be used to direct payload to the nucleus if desired. For example, polynucleic acids as described herein as well as proteins such as Cas9 or RNP+ donor DNA complexes may be covalently tagged with NLS peptides using techniques well known in the art ([0052]). The present nanoparticles have a hydrodynamic diameter ranging from 10 nm to 500 nm. For example, they may have a hydrodynamic diameter of 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 130, 150, 170, 200, 250, 300, 350, 400, or 500 nm or a range between and including any two of the foregoing values. In any embodiments herein, they may have a hydrodynamic diameter of 20 to 200 nm or even 30 to 150 nm. In any embodiments, the hydrodynamic diameter may be an average hydrodynamic diameter or a median hydrodynamic diameter selected from the foregoing ranges ([0053]). The feed weight ratio between the payload and the SMOF NP reactants is important, as insufficient SMOF NP forming materials may lead to a limited encapsulation volume and, subsequently, a low loading efficiency and the premature release and degradation of the payloads. On the other hand, too much MOF NP forming materials could result in insufficient/slow release of the payload within the target cells. For instance, SMOF NPs with a relatively lower feed ratio between DNA and the SMOF reactants (i.e., 1:20 by weight) exhibited a significantly higher transfection efficiency, thus indicating successful encapsulation of the payload within the SMOF NPs and an efficient intracellular release thereafter (FIG. 6A) ([0078]).
Basu et al. teaches the anti-cancer agent is selected from aspirin, docetaxol, 5-fluorouracil, vinblastine sulfate, estramustine phosphate, suramin, buserelin, chlorotranisene, chromic phosphate, cisplatin, satraplatin, carboplatin, cyclophosphamide, dexamethasone, doxorubicin, estradiol, estradiol valerate, estrogens conjugated and esterified, estrone, etoposide, ethinyl estradiol, floxuridine, goserelin, hydroxyurea, melphalan, methotrexate, mitomycin, prednisone, trichostatin A, trapoxin B, phenylbutyrate, valproic acid, Belinostat/PXD101, MS275, LAQ824/LBH589, CI994, and MGCD0103 (claim 15).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Gong et al. is that Gong et al. do not expressly teach buserelin. This deficiency in Gong et al. is cured by the teachings of Basu et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gong et al., as suggested by Basu et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to include buserelin in the nanoparticle because buserelin is a known and alternative to doxorubicin is a known and alternative to doxorubicin. MPEP 2144.06, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Under guidance from Gong et al. teaching doxorubicin in the nanoparticle; Basu et al. teaching both buserelin and doxorubicin as anticancer drug, it is obvious for one of ordinary skill in the art to include buserelin in the nanoparticle comprising doxorubicin and produce instant claimed invention with reasonable expectation of success.
Regarding claims 1-4,8 and 16-17, prior art teaches nanoparticles comprising a cage (ZIF-8), PEG (surface modifying agent), buserelin, doxorubicin (active agent, encapsulated in the cage); Since buserelin is a known agonist for GnRH receptor and binds (target) GnRH receptor, thus buserelin is a suitable targeting ligand, since Gong et al. teaches targeting ligand attached to the organosilica network (exterior of cage), it is obvious that buserelin is exterior of cage and exposed to a surrounding environment. The “preventing or reducing peri-/post menopausal bone loss and / or obesity in a subject” is intended use, not limiting.
Regarding claims 9 -10 and 13, Gong et al. teaches PEG Mn of about 2,000 to about 10,000 Da, and nanoparticle diameter 10 nm to 500nm.
Regarding claim 11, it is within skill of one artisan in the art to adjust amount surface modifying agent PEG and optimize the surface density to have claimed range through routing experimentation. MPEP 2144.05. Especially in the absence of showing criticality of claimed range.
Regarding claim 12, Gong et al. teaches RNA (nucleic acid).
Regarding claim 18, Gong et al. teaches imaging agent (fluorescent) molecule.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Gong et al. (US20220177494) in view of Basu et al. (US20100297262), as applied for the above 103 rejection for claims 1-4, 8-13, 16-18, further in view of Qin et al. (“pH-Responsive Polymer-Stabilized ZIF‑8 Nanocomposites for Fluorescence and Magnetic Resonance Dual-Modal Imaging-Guided Chemo-/Photodynamic Combinational Cancer Therapy”, ACS Appl. Mater. Interfaces 2019, 11, 34268−34281; cited in IDS) and Veronese et al. (“The Impact of PEGylation on Biological Therapies”, BioDrugs 22, 315–329 (2008)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Gong et al. and Basu et al. teaching have already been discussed in the above 103 rejection and are incorporated herein by reference.
Qin et al. teaches ZIG-8 nanoparticles (abstract). PEG−FA (folic acid) is a suitable stabilizer for drug nanocarriers (page 34269).
Veronese et al. teaches PEGylation also increases drug stability and the retention time of the conjugates in blood, and reduces proteolysis and renal excretion, thereby allowing a reduced dosing frequency. In order to benefit from these favorable pharmacokinetic consequences, a variety of therapeutic proteins, peptides, and antibody fragments, as well as small molecule drugs, have been PEGylated (abstract).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Gong et al. is that Gong et al. do not expressly teach PEG- buserelin and PEG-FA. This deficiency in Gong et al. is cured by the teachings of Qin et al. and Veronese et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gong et al., as suggested by Qin et al. and Veronese et al., and produce the instant invention.
Regarding claim 5, one of ordinary skill in the art would have been motivated to include have PEG-FA (folic acid) PEG- buserelin because PEGylation also increases drug stability and the retention time of the conjugates in blood, and reduces proteolysis and renal excretion, thereby allowing a reduced dosing frequency as suggested by Veronese et al. Since it is advantage to have such benefit, it is obvious to have PEG- buserelin and produce instant claimed invention with reasonable expectation of success.
Regarding claims 6-7. One of ordinary skill in the art would have been motivated to have PEG-FA (folic acid) because PEG-FA is a suitable stabilizer for ZIG-8 nanoparticles as suggested by Qin et al. Thus, it is obvious for one of ordinary skill in the art to have PEG-FA (folic acid) and produce instant claimed invention with reasonable expectation of success. In the neutral pH, folic acid in PEG-FA has negative charge and is folate.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12350384. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches the same nanoparticle comprising ZIF cage, surface modifying agent PEG, GnRH receptor agonist targeting ligand and active agent, the “preventing or reducing peri-/post menopausal bone loss and / or obesity in a subject” is intended use, not limiting.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12521354. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches the same nanoparticle comprising ZIF cage, surface modifying agent PEG, GnRH receptor agonist targeting ligand and active agent, the “preventing or reducing peri-/post menopausal bone loss and / or obesity in a subject” is intended use, not limiting.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19221570(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application same nanoparticle comprising ZIF cage, surface modifying agent PEG, FSH receptor agonist targeting ligand and active agent, the “preventing or reducing peri-/post menopausal bone loss and / or obesity in a subject” is intended use, not limiting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19333358 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application same nanoparticle comprising ZIF cage, surface modifying agent PEG, FSH receptor agonist targeting ligand and active agent, the “preventing or reducing peri-/post menopausal bone loss and / or obesity in a subject” is intended use, not limiting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613
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