DETAILED ACTION
Claims 1 and 4-20 are pending. Of these, claims 19-20 are withdrawn as directed to a nonelected invention. Therefore, claims 1 and 4-18 are under consideration on the merits.
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 .
Election/Restriction
Applicant’s election of Group I, claim 1-18, with traverse, is acknowledged. The basis of the traversal is that the specification discloses as paragraph 95 that the complex of claim 1 can load 3 to 9 times the amount that was loaded by the composition disclosed by D1 (CN106038512), which is allegedly unexpected result such that Groups I and II share a special technical feature.
In response, this argument is not persuasive because paragraph 95 shows the drug loading for docetaxel, while D1 discloses loading of “antineoplastic drugs” without identifying the drug. Since it is unclear which drug was loaded into the D1 composition, it is not possible to compare the loading capacity with that exemplified by the present specification, since the loading capacity may vary by drug. Additionally, the claims are presently rejected under Fan et al. (RSC Adv., 2017, 7, 32786-32794) which discloses drug loading capacities within the presently claimed range ranges (see 1-3 rejections, supra). Therefore, there is no evidence of a special technical feature shared by Groups I and II that defines over the prior art. Consequently, the restriction requirement is still considered proper and is made FINAL.
Applicant’s election of lysine or a polymerized/copolymerized molecule thereof as the species of compensator and PLGA as the species of hydrophobic molecule is acknowledged. Since Applicant did not point to any alleged deficiencies in the species election requirement, the requirement is still considered proper and is made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/24/24 and 5/29/24 was filed prior to the mailing date of a first Action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, it was 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.
Claims 1 and 4-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as 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 that the fucoidan has a “peak molecular,” the meaning of which is unclear. The specification does not appear to provide any definition for this term, nor does this term have an art-accepted definition. Clarification is required. For the purpose of examination in view of the prior art, this limitation has been interpreted as referring to the molecular weight of the fucoidan. Dependent claims 4-18 do not clarify the point of confusion so are also rejected.
Claim 7 recites the trademark/trade name PLURONIC three times in line 8.Where a trademark or trade name is used in a claim as a limitation to identify ordescribe a particular material or product, the claim does not comply with therequirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a chemical compound and, accordingly, the identification/description is indefinite. Clarification is required.
Additionally, claim 7 recites Markush language (i.e., “selected from the group consisting of,” followed by a list of species which includes the recitations “lysine or a polymerized/copolymerized molecule thereof,” “histidine or a polymerized/copolymerized molecule thereof,” “glutamine or a polymerized/copolymerized molecule thereof,” and “p-selectin or a p-selectin modification thereof,” which renders the claim indefinite due to the repeated use of “or” which should not be used in a list of Markush specie. Clarification is required. It is suggested that claim 7 should read lysine and a polymerized/copolymerized molecule thereof,” “histidine and a polymerized/copolymerized molecule thereof,” “glutamine and a polymerized/copolymerized molecule thereof,” and “p-selectin and a p-selectin modification thereof.
Additionally, claim 7 recites “and p-selectin or a p-selectin modification thereof,” which renders the metes and bounds of the claim unclear, because the scope of “a p-selectin modification” is unknown, as this term is not an art-accepted term nor does it appear to be defined by the present specification. Clarification is required.
Claim 10 recites the trademark/trade name LABRAFAC.Where a trademark or trade name is used in a claim as a limitation to identify ordescribe a particular material or product, the claim does not comply with therequirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a chemical compound and, accordingly, the identification/description is indefinite. Clarification is required.
Claim 11 recites the composition of claim 1 comprising “fucoidan, PLGA, and lysine.” This limitation is unclear because PLGA is a “hydrophobic molecule” which is already recited by claim 1, and lysine is a “compensator” which is already recited by claim 1. If these limitations are referring to structural elements already present in claim 1, then claim 11 should make this clear by reciting that “the compensator is lysine” and that “the hydrophobic molecule is PLGA.” Since dependent claims 12 and 14 do not clarify the point of confusion they are also rejected.
Claim 13 recites the composition of claim 1 comprising “PLGA, lysine, and soybean oil.” This limitation is unclear because PLGA and soybean oil are “hydrophobic molecules” which are already recited by claim 1, and lysine is a “compensator” which is already recited by claim 1. If these limitations are referring to structural elements already present in claim 1, then claim 11 should make this clear by reciting that “the compensator is lysine” and that “the hydrophobic molecule comprises PLGA and soybean oil.” Since dependent claim 13 does not clarify the point of confusion it is also rejected.
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.
Claims 1, 4-12, and 15-18 are rejected under 35 U.S.C. 103 as unpatentable over Fan et al. (RSC Adv., 2017, 7, 32786-32794) in view of Veerabadran et al. (Macromol. Biosci. 2007, 877-882).
As to claims 1, 4-12, and 15-18, Fan discloses core-shell nanocarriers (a “complex” of claim 1) comprising a polysaccharide shell comprising negatively charged fucoidan and positively charged polyornithine (a “compensator having affinity to the fucoidan” of claim 1 and having a positively charged functional group and an amine-containing ligand as recited by claim 4 and which form hydrogen bonds with the fucoidan (claim 6), wherein the shell is produced by a layer by layer electrolyte self-assembly process in which one or more polyvalent materials in a polymer solution are adsorbed to each other through electrostatic interactions, the nanocarrier further comprising a core comprising nanoprecipitated nanoparticles (claim 16) comprising PLGA (the elected species of “hydrophobic molecule” of claims 1 and 9-10)(Abstract. 1st paragraph of introduction, and Section 2.2). The fucoidan has a molecular weight of 30-70 KDa, which is within the range of claim 1 (Section 2.1 on page 32787). Fan teaches that polyornithine is similar to poly-lysine in that it is a biocompatible and low immunogenic polyelectrolyte with a primary amine side chain, and which is charged when exposed to a physiological environment (page 32786, last paragraph).
Regarding claims 15 and 17, Fan teaches using the nanocarrier to encapsulate doxorubicin as a therapeutic agent for delivery (Abstract), and teaches that the nanocarrier possesses good sustained drug release ability and so could be used as a drug delivery vehicle (Conclusion section on page 32793).
Regarding claim 18, Fan discloses that the drug loading capacity of the composition was, at various drug concentrations, 2.1%, 3.5%, and 4.8%, which is within the recited range (Section 3.4 on page 32790).
As to claims 1, 4-12, and 15-18, Fan does not further expressly disclose that the compensator is the elected species, i.e., lysine or a polymerized/copolymerized molecule thereof of claims 1, 7, and 11-13. Nor does Fan expressly disclose that the ratio of negative charges in the fucoidan to the positive charges in the compensator is within the range of claim 5, or that the molar ratio of the fucoidan to compensator is within the range of claim 8, nor that the molar ratios of fucoidan to PLGA or between the fucoidan to lysine is within the range of claims 12.
Veerabadran discloses the nanoencapsulation of stem cells within polyelectrolyte multilayer shells formed by layer-by-layer assembly of poly-lysine and hyaluronic acid for targeted delivery applications (Abstract), and teaches that the polyelectrolyte shells can contain proteins, enzymes, and drugs which release from the shell to influence cellular behavior (Conclusion section on pages 881-882).
As to claims 1, 4-12, and 15-18, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the Fan core-shell nanocarriers by selecting as the positively charged electrolyte an electrolyte comprising lysine such as polylysine, instead of, or in addition to, the polyornithine positively charged electrolyte, because Fan itself teaches that polyornithine is functionally similar to poly-lysine as a positively charged electrolyte because it is a biocompatible and low immunogenic polyelectrolyte with a primary amine side chain and which is charged when exposed to a physiological environment, and Veerabadran teaches that poly-lysine is suitable for use as the positively charged electrolyte for the layer by layer construction of nanocapsules encapsulating a therapeutic agent for delivery, such that the skilled artisan reasonably would have expected that poly-lysine could be used as the positive electrolyte for layer by layer assembly of the Fan core-shell nanocarriers which encapsulate a drug for delivery. Such a modification is merely the simple substitution of one known element for another according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143.
Regarding claims 5 and 8, since Fan teaches that the shell is produced by a layer by layer electrolyte self-assembly process in which one or more polyvalent materials in a polymer solution are adsorbed to each other through electrostatic interactions, the skilled artisan would have recognized that a molar ratio of negative charges in the fucoidan to the positive charges in the compensator suitably could be within the range of claim 5, such as a molar ratio near 1:1, and that a molar ratio of the fucoidan to compensator suitably could be within the range of claim 8, such as a molar ratio near 1:1, with a reasonable expectation of success since such molar ratios would result in a balanced amount of the fucoidan and compensator that would provide a sufficient number of negatively charged moieties in the fucoidan to interact electrostatically with the positively charged moieties in the compensator and vice versa. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As to claim 12, it further would have been prima facie obvious to select a molar ratio of fucoidan to PLGA that is within the within the recited ranges with a reasonable expectation of success, because these ingredients are serving the same purpose in the Fan composition as in the claimed composition, i.e., the fucoidan is serving as a positively charged compound that is forming a shell and the PLGA is forming a core inside the shell which holds a therapeutic agent, such that the skilled artisan would have been optimizing the amounts of these ingredients for the same function. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 13-14 are rejected under 35 U.S.C. 103 as unpatentable over Fan et al. (RSC Adv., 2017, 7, 32786-32794) in view of Veerabadran et al. (Macromol. Biosci. 2007, 877-882) as applied to claims 1, 4-12, and 15-18 above, and further in view of Lee et al. (Korean J. Chem. Eng., 38(2), 354-365 (February 2021)).
The teachings of Fan and Veerabadran are relied upon as discussed above, but they do not further expressly disclose that the complex comprises soybean oil as recited by claims 12-14 and wherein the molar ratio of the fucoidan to the soybean oil is within the range of claim 14.
Lee discloses polyelectrolyte complexed nanoparticles self-assembled using fucoidan and chitosan electrolytes, wherein the nanoparticles are loaded with curcumin as the active by dissolving the curcumin in soybean oil and then forming an oil in water emulsion comprising the curcumin (Abstract and Section 2 on page 355).
As to claims 13-14, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the core-shell nanocarriers of Fan and Veerabadran as combined supra by incorporating soybean oil as a carrier/solvent for the therapeutic agent in those cases where the therapeutic agent is hydrophobic, because Lee teaches that a hydrophobic active such as curcumin can be incorporated into self-assembled polyelectrolyte complexed nanoparticles comprising fucoidan as one of the electrolytes by dissolving the curcumin in soybean oil followed by formation of an oil in water emulsion, such that the skilled artisan reasonably would have expected that a hydrophobic active could be incorporated into the self-assembled polyelectrolyte complexed nanoparticles comprising fucoidan of Fan and Veerabadran as combined supra using the Lee method.
As to claim 14, it further would have been prima facie obvious to select a molar ratio of fucoidan to soybean oil that is within the recited ranges with a reasonable expectation of success, because these ingredients are serving the same purpose in the Fan composition as in the claimed composition, i.e., the fucoidan is serving as a positively charged compound that is forming a shell and the soybean oil is part of the core inside the shell which holds a therapeutic agent, such that the skilled artisan would have been optimizing the amounts of these ingredients for the same function. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAREN GOTFREDSON whose telephone number is (571)270-3468. The examiner can normally be reached on M-F 9AM-6PM.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/BENNETT M CELSA/Primary Examiner, Art Unit 1600
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