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 .
Claim Status
Claims 1-10 were pending in the present application. By virtue of a Preliminary Amendment, filed by Applicant on 01 March 2023, claims 1, 3, and 6-9 were amended. Therefore, claims 1-10 are still pending and currently under examination.
Priority
This application is a national stage 371 application of PCT/CN2021/097356 filed 31 May 2021. This application also claims foreign priority of CN202011061905.1.4 filed 30 September 2020.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386 (c) is acknowledged. Receipt of certified copies of papers required by 37 CFR 1.55 is acknowledged. However, the foreign priority document received on 01 March 2023 is not in English, and therefore, the examiner cannot ascertain whether said document discloses the invention for purposes of priority. Consequently, the effective filing date for applying prior art is 31 May 2021 (the date PCT/CN2021/097356 was filed).
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Accordingly, the filing date of the PCT/CN2021/097356 application, filed 31 May 2021, will be used for the purpose of applying prior art.
Information Disclosure Statement (IDS)
The IDS (1) filed on 08 March 2023 has been considered by the examiner. A signed copy is enclosed.
Applicant is reminded of their duty to disclose to the Office all information known to the
person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach
individual associated with the filing and prosecution of a patent application has a duty of candor
and good faith in dealing with the Office, which includes a duty to disclose to the Office all
information known to that individual to be material to patentability as defined in this section.”
Claim Rejections - 35 USC § 112(b)
Claim 3 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.
Claim 3 recites the limitation: “wherein an overlap rate between a nucleotide sequence of the aptamer and any one of sequences shown in SEQ ID NOs: 1-10 is higher than or equal to 50%,” The term ‘overlap rate’ is not widely known in the art and can have various meanings depending on the context. In the context of claim 3, ‘overlap rate’ could mean % local similarity or % match and the specification is silent regarding the definition of this term. Therefore, claim 3 is rejected as being indefinite because one of ordinary skill in the art could not ascertain the meaning of ‘overlap rate’ in this context and therefore, would be unable to identify the metes and bounds of claim 3.
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.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US 2017/0362229 A1; published: 21 December 2017).
Chen discloses crystalline solid forms of a BET inhibitor (title) that can be used to treat autoimmune and inflammatory conditions such as atherosclerosis ([0210]) and cancers (abstract). Specifically –
Regarding instant claim 1, Chen discloses the following:
A rapamycin composition (RAPA) comprising the following active ingredients in part by weight: RAPA (“In some embodiments, Compound 1 can be administered in combination with one or more agents ([0239]) …Other examples of agents, one or more of which a provided compound may also be combined with include…an immunomodulatory agent, including immunosuppressive agents, such as…rapamycin ([0240]));
a polymer carrier (“The application also includes pharmaceutical compositions which contain, as the active ingredient, Compound 1 or a pharmaceutically acceptable salt thereof, in combination with one or more pharmaceutically acceptable carriers (excipients) ([0244])…some examples of suitable excipients include…polyvinylpyrrolidone ([0247]));
a lymphatic target wherein the lymphatic target is at least one selected from the group consisting of sodium hyaluronate (“For treating autoimmune or inflammatory conditions, Compound 1 can be administered in combination with one or more additional agents selected from…sodium hyaluronate ([0238])).
Chen does not explicitly disclose the ingredients in parts by weight, but does disclose the compound can be formulated in a unit dosage form containing a desired amount of active ingredient suitable for human subjects and containing a predetermined quantity of active material calculated to produce the desired therapeutic effect ([0249]). Furthermore, Chen discloses the proportion or concentration of a compound in a pharmaceutical composition can vary depending on a number of factors including dosage, chemical characteristics, and route of administration ([0257]). Since Chen discloses a composition with the various components recited in instant claim 1 and further states the dosages, proportions, and concentrations of compounds within the pharmaceutical composition can be manipulated depending on dosage, chemical characteristics, and route of administration, one of ordinary skill in the art could easily manipulate the proportions of components to arrive at the currently claimed active ingredients in part by weight. One would be motivated to do so because Chen teaches these components can successfully be manipulated depending on a number of factors.
Regarding instant claim 2, Chen discloses the following:
The RAPA composition according to claim 1, wherein the polymer carrier is at least one selected from the group consisting of…polyvinylpyrrolidone (PVP) (“The application also includes pharmaceutical compositions which contain, as the active ingredient, Compound 1 or a pharmaceutically acceptable salt thereof, in combination with one or more pharmaceutically acceptable carriers (excipients) ([0244])…some examples of suitable excipients include…polyvinylpyrrolidone ([0247])).
Chen discloses a composition containing rapamycin, PVP, and sodium hyaluronate used to treat autoimmune and inflammatory conditions such as atherosclerosis, thereby meeting the limitations of instant claims 1 and 2. Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to select from the various embodiments presented by Chen to arrive at the currently claimed invention. One of ordinary skill would have predicted the prior art embodiments in Chen are capable of being combined because Chen taught success in doing so.
Claims 1-2 and 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Koenig (WO 2017/053807 A2; published: 30 March 2017) in further view of Eloy (“Rapamycin-loaded immunoliposomes functionalized with trastuzumab: a strategy to enhance cytotoxicity to HER2-positive breast cancer cells,” published: 01 January 2018).
Koenig discloses antibodies and compositions that include anti-VEGF antibodies and anti-HER-2 antibodies and uses thereof (abstract; p. 37, lines 18-22).
Specifically, regarding instant claim 1, Koenig discloses the following:
A rapamycin composition (RAPA) comprising the following active ingredients in part by weight: RAPA (“In a further example, in some instances, an antibody of the invention, or an antibody conjugate, fusion protein and/or polymeric formulation thereof, can be administered in combination with an agent that has activity against neovascularization for treatment of an ocular disorder, such as a mammalian target of rapamycin (mTOR) inhibitor (e.g., rapamycin) (p. 88, lines 19-22));
a polymer carrier (“In some embodiments, the pharmaceutical formulation further comprises a polymer. In some embodiments, the polymer is a biodegradable polymer. In some embodiments, the polymer is a polylactic acid polyglycolic acid (PLGA) copolymer (p. 9, lines 38-40; p. 10, lines 1-3));
a lymphatic target wherein the lymphatic target is at least one selected from the group consisting of an antibody that is a lymphatic vessel endothelial hyaluronic acid receptor antibody (“As used herein, the term ‘fusion protein’ refers to a protein in which a first peptide, protein, or polypeptide, e.g., an antibody is linked, directly or indirectly, to a second peptide, protein, or polypeptide, e.g. an HA binding domain…” (p. 43, lines 39-40; p. 44, lines 1-5); “In some instances, the HA binding domain is a link module. For example, in some instances, the link module is selected from the group consisting of lymphatic vessel endothelial hyaluronan receptor 1 (LYVE-1) (p. 107, lines 5-7)).
Koenig does not explicitly disclose the ingredients in parts by weight, but does disclose a suitable dose range of the antibody, antibody conjugate, fusion protein, or polymeric formulation (p. 93, lines 10-25).
Regarding instant claim 2, Koenig discloses the following:
The RAPA composition according to claim 1, wherein the polymer carrier is at least one selected from the group consisting of… (“Exemplary, non-limiting hydrophilic polymers that can be used include polyethylene glycol (PEG)…poly(amino acids)…polyvinylpyrrolidone (PVP)… poly(lactic-co-glycolic acid) (PLGA) (p. 99, lines 9-26)).
Eloy discloses various embodiments of a composition containing rapamycin, an antibody trastuzumab, and various formulations encapsulating rapamycin including SPC, Chol, DSPE-PEG, DOPE, OA, DPPS, or DSPC (p. 4) to treat cancer (abstract). The following rapamycin-loaded liposomes are disclosed by Eloy in parts by weight:
1 part antibody (p. 15, Fig. 1)
10:2:0.5:1 parts SPC:Chol:DSPE-PEG2000:RAP (p. 22, Table 1)
Therefore, Eloy discloses a rapamycin-loaded liposome containing 1 part rapamycin, 0.5 parts DSPE-PEG2000, and 1 part antibody, which further meets the limitations in instant claims 2, 4, and 5 (PEG, DSPE, and cholesterol).
A combination of Koenig and Eloy disclose the limitations of instant claims 1-2 and 4-5. Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to use the combined teachings of the references to arrive at the claimed invention. Both Koenig and Eloy disclose rapamycin-containing pharmaceutical vehicles to transport active compounds useful in the treatment of cancer, including anti-VEGF antibodies and anti-HER-2 antibodies. Koenig discloses embodiments that include an antibody, polymer carrier PEG, and rapamycin. Eloy discloses embodiments that include an antibody, polymer carrier PEG, and rapamycin in specific ratios. Eloy further discloses cholesterol is important for liposomal stability (p. 7) and DSPE-PEG2000 is added to the surface of liposomes for extended blood circulation times by increased biological half-life (p. 7). Therefore, Eloy provides not only the specific component ratios as required by instant claim 1, but also teaches motivation to incorporate additional components such as cholesterol and DSPE into the liposomal vehicle. Therefore, one of ordinary skill in the art could improve on the base composition disclosed by Koenig with the specific active ingredients in parts by weight and additional components cholesterol and DSPE to arrive at what is currently claimed in instant claims 1-2 and 4-5 with reasonable expectation of success.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Domenyuk (WO 2018/183395 A1; published: 04 October 2018).
Domenyuk discloses methods and compositions of oligonucleotides that bind targets of interest (abstract).
Specifically, regarding instant claim 1, Domenyuk discloses the following:
A rapamycin composition (RAPA) comprising the following active ingredients in part by weight: RAPA (“In some embodiments of the invention, an active agent is conjugated to the aptamer. For example, the active agent may be a therapeutic agent or a diagnostic agent. The therapeutic agent may be selected from the group consisting of…rapamycin” ([00506])).
a polymer carrier (“The oligonucleotide of the invention can also be modified by conjugation to a polymer, for example, to reduce the rate of excretion when administered to an animal” ([00362]); (PEG4000 or PEG8000 may be used at a concentration of 1 to 10% ([00233]); The PEG can be used at a concentration of 1 to 15% ([00472]));
a lymphatic target wherein the lymphatic target is at least one selected from the group consisting of an aptamer (“The invention relates generally to the field of aptamers capable of binding to microvesicle surface antigens, which are useful as therapeutics in and diagnostics of cancer and/or other diseases or disorders in which microvesicles implicated” ([0005]) such as atherosclerosis ([00493], claims 44 and 45); The concentration of the oligonucleotide of the invention ranges from 2 to 20% by weight of the pharmaceutical composition ([00382]));
With regard to the aptamer having a specific binding capacity to lymphatic endothelial cells greater than or equal to 50%, Domenyuk teaches oligonucleotides comprising a sequence according to any one of SEQ ID NOs 4151-14156 (claim 1). SEQ ID NO: 7405 shares 100% local similarity to instant SEQ ID NO: 1 as shown below and therefore, the oligonucleotide disclosed by Domenyuk inherently contains this limitation. See MPEP 2112 (I)(III).
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With regard to the active ingredients in parts by weight, Domenyuk discloses the percentage of oligonucleotide and PEG in the composition, but does not explicitly disclose rapamycin in parts by weight. However, since Domenyuk disclosed 2 of the 3 active ingredients in a range suitable for formulation, one of ordinary skill could ascertain the parts by weight of rapamycin that would fall within the range of that which is instantly disclosed. For example, 1 part lymphatic target, 1 part polymer carrier, and 10 parts RAPA would meet the limitations of instant claim 1 while staying in the parameters of % concentration by weight disclosed by Domenyuk.
Regarding instant claim 2, Domenyuk discloses the following:
The RAPA composition according to claim 1, wherein the polymer carrier is at least one selected from the group consisting of polyethylene glycol (“The oligonucleotide of the invention can also be modified by conjugation to a polymer…for example, the oligonucleotide can be PEGylated, i.e., conjugated to polyethylene glycol (PEG)” ([00362])).
Regarding instant claim 3, Domenyuk discloses the following:
The RAPA composition according to claim 1, where an overlap rate between a nucleotide sequence of the aptamer and any one of sequences shown in SEQ ID NOs: 1-10 is higher than or equal to 50% (“An oligonucleotide comprising a sequence according to any one of SEQ ID NOs 4151-14156,” claim 1);
SEQ ID NO: 7405 shares 100% local similarity to instant SEQ ID NO: 1 as shown below:
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Regarding instant claim 4, Domenyuk discloses the following:
The RAPA composition according to claim 1, wherein the RAPA composition further comprises a phospholipid… (“In one embodiment, the pharmaceutical composition comprises a pharmaceutically acceptable organic solvent and further comprises a phospholipid, a sphingomyelin, or a phosphatidyl choline…[which] facilitates formation of a precipitate when the pharmaceutical composition is injected into water and can also facilitate controlled release of the oligonucleotide from the resulting precipitate” ([00368])).
Regarding instant claim 5, Domenyuk discloses the following:
The RAPA composition according to claim 1, wherein the RAPA composition further comprises cholesterol (“Modifications to the one or more oligonucleotides of the invention can be made to alter the desired characteristics, including without limitation in vivo stability, specificity, affinity, avidity or nuclease susceptibility. Modifications to improve in vivo stability, specificity, affinity, avidity or nuclease susceptibility or
alter the half-life to influence in vivo toxicity may be at the 5' or 3' end and include but are not limited to the following: cholesterol TEG” ([00327]); “In certain embodiments, the oligonucleotide of the invention is linked (covalently or noncovalently) to one or more moieties or conjugates that enhance activity, cellular distribution, or localization. Such moieties include, without limitation, lipid moieties such as a cholesterol moiety” ([00340])).
Domenyuk discloses a composition containing rapamycin, PEG, and an aptamer used to treat autoimmune and inflammatory conditions such as atherosclerosis, thereby meeting the limitations of instant claims 1 and 2. Domenyuk further discloses an aptamer sharing 100% local similarity with SEQ ID NO: 1 of instant claim 3. Finally, Domenyuk discloses the composition further comprises sphingomyelin and cholesterol. Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to select from the various embodiments presented by Domenyuk to arrive at the currently claimed invention. One of ordinary skill would have predicted the prior art embodiments in Domenyuk are capable of being combined because Domenyuk taught success in doing so.
Claims 6, 7, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Pengke (CN108815160A; published: 16 November 2018) in further view of Qiangbin (CN111632039A; published: 08 September 2020).
Pengke discloses a rapamycin liposome nanoparticle comprising rapamycin and phospholipids. Specifically, regarding the creation of these liposome nanoparticles as applicable to claim 6, Pengke discloses:
Preparing an organic phase solution by adding RAPA to an organic phase solvent to obtain the organic phase solution (“Dissolve the raw materials rapamycin, phospholipids or stabilizers in an organic solvent according to the specified ratio to obtain an oil phase solution” (p. 3, claim 7));
Preparing an emulsion by adding a polymer carrier to an aqueous phase solvent and adding the organic phase solution dropwise to the aqueous phase solvent to obtain the emulsion (“The above oil phase solution is slowly added to the aqueous phase solution…” (p. 3, claim 7); “Then, the organic mixture was slowly added dropwise to …aqueous phase…” (Examples 1-23));
Conducting homogenization by adding a lymphatic target to the emulsion, mixing, and homogenizing to obtain the RAPA composition (“…stirred at room temperature, homogenized, and evaporated by rotary evaporation at 40°C to obtain the nanoparticles” (p. 3, claim 7).
Pengke does not explicitly disclose the addition of a polymer during the aqueous phase or the addition of a lymphatic target after emulsification.
Regarding instant claim 7, Pengke discloses a method of preparing a RAPA composition comprising:
Wherein in the preparation of the organic phase solution, the organic phase solvent is at least one selected from the group consisting of…dichloromethane (DCM) (“The preparation method…wherein the organic solvent is dichloromethane” (p. 3, claim 8)).
Regarding instant claim 9, Pengke discloses a method of preparing a RAPA composition comprising:
Conducting lyophilization by adding a lyophilization protective agent to the RAPA composition, filtering a resulting mixture through a microporous filter membrane for sterilization, and lyophilizing (“Add 5% lactose, aseptically filter, can, and freeze dry” (Examples 1-23)).
Regarding instant claim 10, Pengke discloses a method of preparing a RAPA composition comprising:
Wherein in the lyophilization, the lyophilization protective agent is added at an amount of 5 to 20 g per 100 mL of RAPA composition (“The lyophilized powder injection of the present invention further includes a lyophilization protectant, which accounts for 3%-10% of the mass of the nanoparticles. The lyophilization protectant is one or more of lactose, glucose, mannitol, or sucrose” ([0017]); lactose was added after mixing and homogenization at 5% before aseptically filtering and free-drying (see Examples 1-23 starting on p. 8)).
Qiangbin discloses a multifunctional nano delivery system, preparation method, and application thereof (p. 1). Specifically, regarding the deficiencies of Pengke with respect to the limitations of claim 6, Qiangbin discloses an alternate method of formulating nano delivery systems whereby a polymer (e.g., a mixture of polyβ-amino ester and polyvinyl alcohol) is mixed during the aqueous phase and before the oil phase is added dropwise (see Examples 1-3 starting on p. 16). Qiangbin further discloses a final step of mixing the multifunctional nano delivery system with a targeting peptide and/or antibody, so that the targeting peptide and/or antibody bind to the surface of the nano delivery system ([0070]). Regarding instant claim 7 and similar to what was disclosed in Pengke, Qiangbin also discloses the organic solvent is dichloromethane (DCM) ([0072]).
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to select from the various embodiments disclosed by Pengke and Qiangbin as methods to formulate nano delivery systems containing a drug, polymer, and targeting peptide or antibody. It is widely known in the art that tweaking various aspects of the nano delivery system formulation will produce delivery systems with desired characteristics (e.g., hydrophobic drug encapsulated by a hydrophilic polymer shell is produced by adding the hydrophobic drug during the oil phase dropwise to the aqueous phase containing the hydrophilic polymer). Furthermore, Qiangbin finds success in producing a nano delivery system with a targeting antibody in polymer shell by adding the targeting antibody after the oil phase is added to the aqueous phase. Therefore, what is currently claimed in instant claims 6, 7, 9, and 10 is disclosed by prior art and is merely a combination of elements that are widely known in the field of emulsion science to produce nano delivery systems.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Pengke (CN108815160A; published: 16 November 2018) in further view of Qiangbin (CN111632039A; published: 08 September 2020) and Ortiz de Solorzano (“Continuous synthesis of drug-loaded nanoparticles using microchannel emulsification and numerical modeling: effect of passive mixing,” published: 25 July 2016).
The disclosures of Pengke and Qiangbin are discussed above. Specifically, regarding claim 8, Pengke and Qiangbin disclose the following:
Regarding instant claim 8, Pengke discloses a method of preparing a RAPA composition comprising:
Wherein in the preparation of the emulsion, the mixing is achieved by stirring for 30min to 3h at room temperature and a stirring speed of 300 rpm to 1,200 rpm (“Then, the organic mixture was slowly added dropwise to…aqueous phase and mechanically stirred for 60 min” (Examples 1-23)).
Pengke does not explicitly disclose a stirring speed of 300 rpm to 1,200 rpm at room temperature. However, it is widely known in the art that ‘mechanically stirring’ a formulation falls within the range limitation of instant claim 8.
Regarding the deficiencies of Pengke with respect to the limitations of claim 8, Qiangbin discloses the mixing step prior to purification at room temperature for 4 to 10 hours.
Therefore, a combination of Pengke and Qiangbin disclose a method of preparing nano delivery systems by mechanically mixing the emulsion at room temperature for a time period that falls within the range currently claimed in instant claim 8. See MPEP 2144.05 (I).
Regarding the deficiencies of Pengke and Qiangbin with respect to the limitations of claim 8, Ortiz de Solorzano discloses a method of producing drug-loaded, monodisperse poly(D,L lactic-co-glycolic acid) nanoparticles (abstract). The method disclosed by Ortiz de Solorzano involved preparing PLGA nanoparticles by oil-in-water emulsion and continuously stirring at 600 rpm for 3 hours. This disclosure by Ortiz de Solorzano indicates PLGA nanoparticles can tolerate mixing speeds up to 600 rpm for 3 hours at room temperature (p. 3399).
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to select from the various embodiments disclosed by Pengke, Qiangbin, and Ortiz de Solorzano as methods to formulate nano delivery systems containing a drug, polymer, and targeting peptide or antibody. As stated above, it is widely known in the art that tweaking various aspects of the nano delivery system formulation will produce delivery systems with desired characteristics (e.g., hydrophobic drug encapsulated by a hydrophilic polymer shell is produced by adding the hydrophobic drug during the oil phase dropwise to the aqueous phase containing the hydrophilic polymer). Furthermore, Ortiz de Solorzano finds success in producing nanoparticles by mixing the emulsion (600 rpm) for 3 hours at room temperature. Therefore, what is currently claimed in instant claim 8 is disclosed by prior art and is merely a combination of elements that are widely known in the field of emulsion science to produce nano delivery systems.
Pertinent Art
Application 18/016,865, filed 19 January 2023, contains pertinent art that was found in a search. However, Applicant has not filed a response to the Non-Final Office Action dated 07 May 2025 (mailed over 6 months ago) and therefore, 18/016,865 is considered abandoned.
Conclusion
Claims 1-10 are rejected. No claim is allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Julia A Rossi whose telephone number is (571)272-0138. The examiner can normally be reached M-F 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel E Kolker can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIA A ROSSI/Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644