DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on March 2 2026 is acknowledged. Claims 1-19 are pending in the application. Claims 12-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 2 2026. Accordingly, claims 1-11 are being examined on the merits herein.
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 .
Priority
This application claims benefit of 63/436,802 (01/03/2023) and claims priority to Foreign Application INDIA 202211072553 (12/15/2022) as reflected in the filing receipt issued on August 2 2023.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in India on 12/15/2022. It is noted, however, that applicant has not filed a certified copy of the 202211072553 application as required by 37 CFR 1.55. The examiner noted that communication issued on May 15 2024 indicates that retrieval was unsuccessful. Applicants remain responsible for the submission of the certified copy of the foreign application.
Since the FOR priority document has not been filed, the current effective filing date of the instant claims is January 3 2023 (the filing date of the provisional application).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 6 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 11 is objected to because of the following informalities: the claim recites the Eph4 receptor tyrosine controls Wnt signaling. However, this claim depends from claim 10 and that claim merely recites “an Ephb4 receptor”. Therefore, for consistency, claim 11 should recites wherein the Ephb4 receptor controls Wnt signaling. Appropriate correction is required.
Claim Rejections - 35 USC § 112-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.
Claim 4 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
While EphB4 is a known therapeutic target for RNAi (see for example Merchant et al. (Blood Adv., 2017)) and while shRNA RNAi is known (see for example Zhou et al. (Pharmaceuticals (Basel), 2013)), claim 4 is directed to EphB4-shRNA-800 whose structure is never described in the instant specification. EphB4 shRNA sequences are known in the art (see for example Li et al. USPGPUB No. 20230132526 which teaches 5′-GTTATGATCCTCACGGAAT-3’ in paragraph 0033). However, nothing in the instant specification indicates how the structure of EphB4-shRNA-800 differs from any other shRNA such as that taught in Li et al.
The instant specification (examples) indicates that Ephb4-shRNA was obtained from Origene, USA. But never indicates if this is just any shRNA or shRNA-800. Looking at the Origene website there are 8 different RNAi disclosed that target EphB4 (see attached print out from the Origene website). None of them indicate they have the name EphB4-shRNA-800.
This claim fails to meet the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, due to lacking chemical structural information for what the chemical structure of EphB4-shRNA-800 corresponds to and chemical structures are highly variant and encompass a myriad of possibilities. The specification provides insufficient written description to support the genus encompassed by the claim. Note: MPEP 2163.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, (Fed. Cir. 1991), makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
Univ. of Rochester v. G.D. Searle, 69 USPQ2d 1886, 1892 (CAFC 2004), further supports this by stating that:
The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. A description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) described even in terms of its functioning of lessening inflammation of tissues fails to distinguish any steroid from others having the same activity or function. A description of what a material does, rather than of what it is, usually does not suffice…. The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. (Emphasis added).
With the exception of the above specifically disclosed chemical structures, the skilled artisan cannot envision the detailed chemical structure of the encompassed shRNA, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The chemical structure itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Circ. 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016, (Fed. Cir. 1991). In Fiddes v. Baird, 30 USPQ2d 1481, 1483, (Bd. Pat. App. & Int. 1993), claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence. Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 (Fed. Cir. 1997) held that:
...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
Furthermore, to the extent that a functional description can meet the requirement for an adequate written description, it can do so only in accordance with PTO guidelines stating that the requirement can be met by disclosing “sufficiently detailed, relevant identifying characteristics,” including “functional characteristics when coupled with a known or disclosed correlation between function and structure.” Univ. of Rochester v. G.D. Searle, 68 USPQ2d 1424, 1432 (DC WNY 2003).
Therefore, only the above chemically structurally defined chemicals, but not the full breadth of the claim(s) meet the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. The species specifically disclosed are not representative of the genus because the genus is highly variant. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC § 112 is severable from its enablement provision. (See page 1115.)
Claim Rejections - 35 USC § 112-Indefiniteness
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 1-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the Nep" in line 8. There is insufficient antecedent basis for this limitation in the claim. The claim never previously refers to a Nep. The claim recites a nanoencapsulate but never indicates that Nep and nanoencapsulate are the same thing. Therefore, there is insufficient antecedent basis for the claimed term.
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 5 recites the broad recitation cellulose derivatives, and the claim also recites including cellulose acetate, hydroxypropyl methylcellulose, hydroxylpropyl cellulose which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 5 as currently written is vague and indefinite. The punctuation and conjugations in the claim make it unclear where the species for the coating agent end. Firstly the claim recites “or” 3-hydroxyethylmethacrylate which would seem to indicate the end of the list. This is then followed by a semi-colon which would also seem to indicate the end of the list of coating agent. But then the claim goes on to recite cellulose derivatives or combinations thereof. Therefore, it isn’t clear what coatings must be selected from and whether the “or combinations therefore” is modifying all the choices or only the cellulose derivatives.
Claims 2-4 and 6-11 are included in the rejection as they depend on a rejected base claim and they do not clarify the issues.
Claim Rejections - 35 USC § 112-Failure to Further Limit
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 11 recites the Ephb4 receptor tyrosine kinase controls Wnt signaling. This claim depends from claim 10 which claim the composition suppresses an Ephb4 receptor. Claim 10 depends from claim 1 which requires an RNA interference silencer. The instant specification states that shutting down Ephb4 gene using its shRNA not only controlled the upregulated Ephb4 but also other oncogenes in the Wnt signaling pathway (paragraph 0005). This suggests that the control of Wnt signaling would necessarily happen upon silencing of EphB4 gene. Therefore, claim 11 fails to further limit and merely recites the result of silencing of Ephb4 which is already recited in claim 10.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 and 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Chaudhary et al. (WO2016046845) in view of Yang (USPGPUB No. 20140105828).
Applicant Claims
The instant application claims a RNAi-nanoparticle conjugate, wherein the RNAi-nanoparticle conjugate comprises: a hydrophobic active ingredient; a polysaccharide; an RNA interference (RNAi) silencer; and a coating agent, wherein the hydrophobic active ingredient is encapsulated by the polysaccharide to form a nanoencapsulate, and the RNAi silencer is immobilized on the Nep and coated by the coating agent.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Chaudhary et al. is directed to stealth, targeted nanoparticles (STN) for oral drug delivery. Claimed is a composition comprising stealth targeted nanoparticles wherein the nanoparticles comprise 1) a nonlipidic polymer matrix comprising of at least one stealth polymer and at least one polysaccharide; ii) a nonprotein target agent/ligand, ii) one or more poorly bioavailable therapeutic agent wherein said target ligand and said poorly bioavailable therapeutic agent are physically entrapped inside the nonlipidic polymer matrix (claim 1). Taught is using an effective amount of one or more poorly bioavailable therapeutic agents (paragraph 0020). Large amounts of the poorly bioavailable therapeutic agent can be delivered (paragraph 00080). It is taught that the STNs are stable, have capacity to load high therapeutic agent concentrations, targeted delivery, bursting into smaller nanoparticles for longer systemic circulation, preventing opsonization, reducing dosing frequency, reducing adverse effects and potential to encapsulate a variety of small molecules for said therapeutic effects with varied concentrations (paragraph 000147). It is taught that the STN can be enteric coated which imparts pH sensitive nature to the nanoparticles (paragraph 000136; 000131).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Chaudhary et al. suggests nanoparticles with the same core therapeutic, polysaccharide coating and an enteric coating can be utilized. Chaudhary et al. does not expressly teach an RNAi. However, this deficiency is cured by Yang.
Yang is directed to nanoparticles carrying nucleic acid cassettes for expressing RNA. Claimed is a nanoparticle comprising a core with a polymer coating wherein the polymer coating is conjugated to a nucleic acid that encodes a RNA capable of RNA interference in operable combination with a promoter (claim 1; Figure 1). As claimed the RNA is one that forms a hairpin (claim 4). Treating cancer is claimed (claim 9). Polymers include polysaccharides (paragraph 0094). Solid dosage forms can be prepared with coatings and shells such as enteric coatings (paragraph 0086). Examples of coating include acrylic acid polymer, methacrylic resins, etc. (paragraph 0094). Effective amounts typically include 0.01 to 1000 mg per kg body weight (paragraph 0091). The dosage forms usually contain between 1 and 1000 mg (paragraph 0090). It is taught that the nanoparticles at a ratio of 1 nanoparticle to 10 or 20 DNA cassettes (paragraph 0116). Taught is the combination of the RNAi with second anticancer agents such as doxorubicin, vincristine, etc. (paragraph 0077). DNA cassettes expressing a shRNA gene is taught (paragraph 0057). Enteric coatings which release the particles in a certain part of the intestinal tract in a delayed manner (paragraph 0086).
Finding of Prima Facie Obviousness Rationale 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 combine the teachings of Chaudhary et al. and Yang and utilize an expression cassette expressing a shRNA gene for RNA interference on the surface of the nanoparticle. One skilled in the art would have been motivated to attach a nucleic acid that encodes an RNA capable of RNA interference to aid in treatment of cancer by gene silencing. One skilled in the art would have a reasonable expectation of success as Chaudhary et al. teaches the therapeutic agent can be an anti-cancer agent and Yang teaches the use of the shRNA in combination with additional anticancer agents (the same ones taught in Chaudhary et al.). Since Yang teaches the DNA cassette on the surface of the nanoparticle, one skilled in the art would have been motivated to attach the DNA cassette at this position.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Chaudhary et al. and Yang and utilize an enteric coating over the RNAi attached nanoparticle. One skilled in the art would have been motivated to utilize an enteric coating as Chaudhary et al. teaches an enteric coating on the nanoparticles. Yang also teaches an enteric coating can be utilized when the nanoparticles are made into solid dosage forms. One skilled in the art would have been motivated to utilize an enteric coating which imparts pH sensitive nature to the nanoparticles as taught by Chaudhary et al. and Yang.
Regarding claim 2, Chaudhary et al. claims the drug is an anticancer drug and is selected from curcumin, doxorubicin, vincristine, quercetin, daunorubicin, bleomycin, sorafenib, erlotinib, cisplatin, oxaliplatin, carboplatin, etc. (claim 15).
Regarding claim 3, Chaudhary et al. claims polysaccharide such as chitosan, pectin, carrageenan, hyaluronic acid, guar gum, alginates, etc. (claim 4). It would have been obvious to one of ordinary skill in the art to try any of the specifically taught polysaccharides as a person with ordinary skill has good reason to pursue known options within his or her technical grasp. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
Regarding claim 4, Yang teaches examples of coating include acrylic acid polymer, methacrylic resins, etc. (paragraph 0094). t would have been obvious to one of ordinary skill in the art to try any of the specifically taught polymers as a person with ordinary skill has good reason to pursue known options within his or her technical grasp. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
Regarding claim 7, Chaudhary et al. teaches the composition may further comprise certain adjuvants or excipient known to a person skilled in the art and well established in the industry (paragraph 0082).
Regarding claims 6 and 8-9, Chaudhary et al. teaches using an effective amount of one or more poorly bioavailable therapeutic agents (paragraph 0020). Large amounts of the poorly bioavailable therapeutic agent can be delivered (paragraph 00080). It is taught that the STNs are stable, have capacity to load high therapeutic agent concentrations, targeted delivery, bursting into smaller nanoparticles for longer systemic circulation, preventing opsonization, reducing dosing frequency, reducing adverse effects and potential to encapsulate a variety of small molecules for said therapeutic effects with varied concentrations (paragraph 000147). Yang teaches effective amounts typically include 0.01 to 1000 mg per kg body weight (paragraph 0091). The dosage forms usually contain between 1 and 1000 mg (paragraph 0090). It is taught that the nanoparticles at a ratio of 1 nanoparticle to 10 or 20 DNA cassettes (paragraph 0116).
Therefore, Yang teaches a ratio of nanoencapsulate to RNAi silencer that falls within the scope claim. Both Chaudhary et al. and Yang teach administering an effective amount. Yang teaches amounts which are suitable. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. The amount of an active ingredient is a parameter that a person of ordinary skill in the art would routinely optimize based on the condition being treated, severity of the condition and desired dosing frequency, among other factors.
It would have been obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). NOTE: MPEP 2144.05.
Claims 4 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Chaudhary et al. in view of Yang as applied to claims 1-3 and 5-9 set forth above and in further view of Kumar et al. (The American Journal of Pathology, 2006).
Applicant Claims
The instant application claims the pharmaceutical composition specifically suppresses an Ephb4 receptor.
Although the recitation EphB4-shRNA-800 lacks written description, for the purposes of compact prosecution, claim 4 is interpreted as being directed to any EphB4-shRNA.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The teachings of Chaudhary et al. and Yang are set forth above. Yang teaches the cancer can be breast cancer (paragraph 0076).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While using a shRNA to target a gene is taught for treating cancer, an shRNA to target EphB4 is not taught. However, this deficiency is cured by Kumar et al.
Kumar et al. is directed to receptor tyrosine kinase EphB4 is a survival factor in breast cancer. EphB4, a member of the largest family of receptor tyrosine kinases, is normally expressed on endothelial and neuronal cells. Although aberrant expression of EphB4 has been reported in several human tumors, including breast cancer, its functional significance is not understood. We report here that EphB4 is expressed in 7 of 12 (58%) human breast cancer specimens and 4 of 4 (100%) breast tumor cell lines examined. Overexpression of EphB4 in breast cancer cells was driven by gene amplification and by the erbB family of receptors via activation of Janus tyrosine kinase-signal transducers and activators of transcription and protein kinase B. The aberrantly expressed receptor was phosphorylated by its natural ligand, EphrinB2, and signaled via the protein kinase B pathway. Targeted knockdown of EphB4 expression by small interference RNA (and antisense oligodeoxynucleotides (ODNs)) led to dose-dependent reduction in cell survival, increased apoptosis, and sensitization to tumor necrosis factor-related apoptosis-inducing ligand (TRAIL). Antisense ODN-mediated EphB4 knockdown resulted in reduced tumor growth in a murine tumor xenograft model (abstract; page 289).
Finding of Prima Facie Obviousness Rationale 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 combine the teachings of Chaudhary et al., Yang and Kumar et al. and utilize an shRNA that targets EphB4. One skilled in the art would have been motivated to utilize EphB4 as the target gene as Chaudhary et al. and Yang both teach using the nanoparticles for treating cancer, including breast cancer, and Kumar et al. teaches that EphB4 knockdown by oligonucleotides reduces tumor growth in breast cancer. Therefore, one skilled in the art would have been motivated to utilize a small molecule anti-cancer agent, such as doxorubicin, in the core and shRNA that targets EphB4 on the surface of the nanoparticle as both are taught for treating cancer. As a general principle 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, the idea of combining them flows logically from their having been individually taught in the prior art. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) MPEP 2144.06.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABIGAIL VANHORN whose telephone number is (571)270-3502. The examiner can normally be reached M-Th 6 am-4 pm EST.
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/ABIGAIL VANHORN/Primary Examiner, Art Unit 1636
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