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 .
In the event the determination of the status of the application as subject to AIA 35
U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any
correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will
not be considered a new ground of rejection if the prior art relied upon, and the rationale
supporting the rejection, would be the same under either status.
Claim Status
Claims 1-20 are currently pending and are examined on the merits herein.
Priority
The instant application claims domestic benefit to U.S. Application No. 63/492,377 filed on 03/27/2023 as reflected in the filing receipt dated on 05/02/2024.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/17/2024 and 08/07/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the Examiner.
Claim Rejections - 35 USC § 112(b)
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 18-20 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 18 recites a “kit comprising: a syringe containing a block copolymer…; and a templating agent”. Due to the format of the claim, it is unclear whether the kit comprises one component, e.g. a syringe containing both a block copolymer and a templating agent, or whether the kit comprises two separate components, e.g. (1) a syringe containing a block copolymer and (2) a templating agent. The claim is indefinite because one of ordinary skill in the art could not readily ascertain the metes and bounds of the claimed invention. Because the claim could be interpreted as comprising only one component wherein the syringe contains the templating agent, claim 19 would not further limit the scope of parent claim 18, which would raise an issue under 35 U.S.C. 112(d). In light of claim 19, the Examiner is interpreting the claim to mean that the kit comprises two components.
Claims 19-20 are rejected by virtue of their dependency on claim 18, as they fail to undoubtedly resolve the ambiguity in question.
Claim 18 recites the parenthetical phrase “(cationic or anionic)” in line 4. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by the parenthetical language is an example or a required feature of the claims. For the purpose of compact prosecution, the claim is broadly interpreted to mean that the charged amino acid must be cationic or anionic at a pH in the range of about 3 to about 10, whether or not the amino acid is charged under all conditions, as is consistent with guidance provided in Applicant’s instant specification (Paragraph 0036-0038).
Claims 19-20 are rejected by virtue of their dependency on claim 18, as they fail to resolve the ambiguity in question.
Claim 19 recites the limitation wherein the templating agent is “disposed within” the syringe. It is unclear whether this term is intended to add a further structural limitation to the arrangement of the templating agent within the syringe. Claim 19 depends from claim 18, wherein the syringe simply “contains” a block copolymer. Because the language used in claim 19 differs from the parent claim, it raises the question as to whether the templating agent “disposed within” the syringe is distinct from the syringe simply containing the templating agent. For the purposes of compact prosecution and consistent with Applicant’s instant specification, which states that the block copolymer may be “disposed in” the syringe (Instant Specification, Paragraph 0051), the Examiner is interpreting “disposed within” as meaning “contained within”.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15 and 18-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The specification discloses chemicals, such as gelatin, hyaluronic acid, carboxy methylcellulose, etc. which meet the written description and enablement provisions of 35 USC 112, first paragraph. However, claims 1, 15, and 18 are directed to encompass any templating agent, which only corresponds in some undefined way to specifically instantly disclosed chemicals. Only the specifically disclosed chemicals (see Instant Specification, Paragraphs 0048-0049) meet the written description provision of 35 USC § 112, first paragraph. The broad genus however does not due to lacking chemical structural information for what they are and chemical structures are highly variant and encompass a myriad of possibilities. The specification provides no guidance as to determine compounds which fulfill this description especially since any compound present in a composition could, to some extent, influence the structure of the di-block or tri-block copolymer. The specification provides insufficient written description to support the genus encompassed by the claim.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, 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.)
With the exception of the above specifically disclosed chemical structures, the skilled artisan cannot envision the detailed chemical structure of the encompassed derivatives, analogs, etc., 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 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, 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 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 (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.
Therefore, only the above structurally defined chemicals, but not the full breadth of the claim(s) meet the written description provision of 35 USC § 112, 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.)
Claims 2-14 are rejected by virtue of their dependency on claim 1, as they do not resolve the written description deficiency.
Claims 19-20 are rejected by virtue of their dependency on claim 18, as they do not resolve the written description deficiency.
Claim Interpretation
Absent any limiting definition of the term “charged block” provided in Applicant’s instant disclosure, the Examiner is interpreting the term to mean that any polymer block that is cationic or anionic at a pH in the range of about 3 to about 10 meets the claim limitation, whether or not the polymer block is “charged” under all conditions, as is consistent with guidance provided in Applicant’s instant specification (Paragraph 0036-0038).
Absent any limiting definition of the term “templating agent” provided in Applicant’s instant disclosure, the Examiner is interpreting the term broadly to mean any additional compound, as any molecule present together with the instantly claimed copolymer is capable of influencing the structure and/or behavior of the copolymer to some extent.
Claim 11 recites the limitation “pKa”, which the Examiner is interpreting to mean the pKa of the amino acid side chain, as opposed to the pKa of the carboxyl or amino groups within the amino acid backbone, which would be embedded within the copolymer backbone and, thus, not available for protonation/deprotonation.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6-14, and 16-17 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Deming et al. (US20140286865A1; published: 09/25/2014; PTO-892) as evidenced by DeRuiter (Principles of Drug Action 1, p. 1-11; published: 2005; PTO-892).
Deming teaches a composition suitable for administration to the central nervous system comprising a diblock copolypeptide hydrogel “DCH”, which comprises a biologically active material that is mixed with the hydrogel or attached to the polypeptide chain of the hydrogel (Abstract, Claims, and Paragraph 0006).
Regarding claim 1: Deming teaches that DCH is injected as a liquid, which is prepared in double distilled sterile water (Paragraph 0170), and thus reads on the limitation “aqueous liquid” composition.
Regarding the composition of the instantly claimed diblock polymer: Deming, in Claim 14, recites a diblock copolypeptide comprising: poly-L-leucine as the hydrophobic domain, which reads on the instantly claimed hydrophobic block as evidenced by instant claim 11, and poly-L-lysine as the hydrophilic domain, which reads on the instantly claimed charged block as evidenced by instant claim 2.
Regarding the instantly claimed templating agent: Under broadest reasonable interpretation (see “Claim Interpretation” above), the biologically active material in the DCH of Deming that is mixed with the diblock copolypeptide meets the claim.
Regarding claim 2: Poly-L-lysine meets the claim.
Regarding claims 3-4 and 6-7: Deming teaches that the hydrophilic block may comprise: poly-L-lysine, poly-L-ornithine, poly-L-arginine, poly-L-homoarginine, poly-L-glutamate, poly-L-aspartic acid, poly-L-histidine, or a mixture of these (Paragraphs 0062-0066). Therefore, an ordinarily skilled artisan could at once envisage an embodiment wherein the hydrophilic domain comprises poly-L-ornithine, poly-L-arginine, poly-L-glutamate, or poly-L-aspartic acid in addition to or in place of poly-L-lysine.
Regarding claim 8: The side chain of poly-L-lysine has a pKa of 10.53, the side chain of poly-L-glutamate has a pKa of 4.25, and the side chain of poly-L-aspartic acid has a pKa of 3.86 as evidenced by DeRuiter (Page 10), which each lie within and thus read on the instantly claimed range.
Regarding claim 9: Poly-L-leucine meets the claim as evidenced by Deming and instant claim 11 above.
Regarding claims 10-11: Deming teaches that the hydrophobic block may comprise: poly-L-leucine, poly-L-isoleucine, poly-L-phenylalanine, poly-L-alanine, poly-L-valine, poly-L-serine, poly-L-threonine, poly-L-glutamine, or a mixture of these amino acids (Paragraphs 0067-0071). Therefore, an ordinarily skilled artisan could at once envisage an embodiment wherein the hydrophilic domain comprises poly-L-phenylalanine or poly-L-isoleucine in addition to or in place of poly-L-leucine.
Regarding claim 12: Poly-L-leucine and poly-L-isoleucine have pendant aliphatic side chains, and poly-L-phenylalanine has a pendant aromatic side chain.
Regarding claim 13: Deming teaches that DCH can be deformed by stress, such as extrusion through a small gauge needle, allowing them to be injected as liquids that rapidly re-assemble into gels (Paragraph 0083). Thus, the DCH is capable of becoming a gel when injected into a vasculature of a patient.
The Examiner notes, however, that the instant claim is drawn to a product, not a method of using the claimed product. The recitation “becomes a gel when injected into a vasculature of a patient” is a mechanistic outcome that would flow naturally upon injection of the instantly claimed composition into a vasculature of a patient. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Note MPEP 2112.01.
Regarding claim 14: The composition of Deming comprises a diblock copolymer and thus meets the claim.
Regarding claim 16: The DCH of Deming reads on the instantly claimed composition for the same reasons as discussed in relation to claim 1 above.
Regarding claim 17: The diblock copolypeptide of Deming comprises a diblock copolymer and thus meets the claim.
It is noted that the recitation “embolic” in the instant claims is an intended use of the claimed composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since the structure of the composition of Deming is capable of performing the intended use (i.e., is suitable for injection into the body), then it meets the claim. Note: MPEP 2111.02.
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 and 6-20 are rejected under 35 U.S.C. 103 as being unpatentable over Deming et al. (US20140286865A1; published: 09/25/2014; PTO-892), as applied to claims 1-4, 6-14, and 16-17, as evidenced by DeRuiter (Principles of Drug Action 1, p. 1-11; published: 2005).
Deming as evidenced by DeRuiter anticipates the invention(s) of claims 1-4, 6-14, and 16-17 as discussed in detail above and further incorporated herein.
Regarding claim 15: Deming further recites that the biologically active material mixed with the hydrogel may be a peptide, polypeptide, sugar, oligosaccharide, polysaccharide, glycoprotein, oligonucleotide, MRI contrast agents, radioisotope or fluorescent probe (Claim 8) and notes that natural polymers like hyaluronic acid are useful in central nervous system applications but may lack optimal mechanical properties (Paragraph 0174).
Therefore, 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 composition of Deming by using hyaluronic acid, which is a polysaccharide, as the biologically active material because it is known to be useful in central nervous system applications, such as brain lesion and traumatic brain injury (Paragraph 0174), and Deming teaches that the diblock copolypeptide component of the DCH can be fine-tuned to achieve desired mechanical properties (Paragraph 0175), which would improve upon existing hyaluronic acid-based hydrogel technology.
Regarding claim 18: Deming further recites a kit comprising lyophilized copolypeptide and, optionally, an aqueous solution comprising a therapeutic agent, an imaging agent, or a submicron particle encapsulating an agent of interest, with which the lyophilized block copolypeptide can be reconstituted (Claim 19). Under broadest reasonable interpretation (see “Claim Interpretation” above), the therapeutic agent, imaging agent, or submicron particle encapsulating an agent of interest that is mixed with the diblock copolypeptide reads on the claim limitation “templating agent”. Deming further teaches the reagents of the kit may be in containers in which the reagents are stable, e.g., in lyophilized form or stabilized liquids (Paragraph 0112).
Because Deming further teaches that its composition can be administered with a syringe (Paragraph 0109), 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 kit of Deming by preloading the diblock copolypeptide into a syringe (i.e. a type of container) so that it is readily available for reconstitution and expeditious administration when using the kit.
Regarding claim 19: 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 kit of Deming by preloading diblock copolypeptide that has already been reconstituted with the aqueous solution comprising a therapeutic agent, an imaging agent, or a submicron particle encapsulating an agent of interest into a syringe so that the composition is readily available for expeditious administration when using the kit.
Regarding claim 20: 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 kit of Deming by preloading the diblock copolypeptide into one syringe and preloading the aqueous solution comprising a therapeutic agent, an imaging agent, or a submicron particle encapsulating an agent of interest into a second syringe so that it is easier to reconstitute the block copolypeptide and expeditiously administer the composition when using the kit.
An ordinarily skilled artisan would reasonably expect success in modifying the prior art as proposed because all components are known to be safe and effective in formulating hydrogels for use in the central nervous system, and Deming explicitly teaches a kit comprising all claimed chemical components, which may be in containers such as the syringe and may be in either lyophilized form or liquid form.
It is noted that the recitation “for embolization” in claim 18 is an intended use of the claimed kit. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since the structure of the kit of Deming is capable of performing the intended use (i.e., contains all claimed components necessary for injecting a composition that is, itself, suitable for injection into the body), then it meets the claim. Note: MPEP 2111.02.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Deming et al. (US20140286865A1; published: 09/25/2014; PTO-892), as applied to claims 1-4 and 6-20 above and further in view of Evich et al. (Protein Science, vol. 25, p. 479-486; published: 11/05/2015; PTO-892) and as evidenced by DeRuiter (Principles of Drug Action 1, p. 1-11; published: 2005; PTO-892).
Deming as evidenced by DeRuiter teaches the invention(s) of claims 1-4 and 6-20 as discussed in detail above and further incorporated herein.
However, Deming does not expressly teach that the charged block includes polymethylarginine as recited in claim 5.
Evich, also drawn to the use of arginine in biological systems, teaches that methylation does not markedly change the pKa of the guanidinium head group of arginine, indicating that in a biological environment, the arginine side chain is fully charged regardless of methylation state while hydrophobicity of arginine significantly increases upon methylation (Page 483 and Fig. 5).
Regarding claim 5: 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 poly-L-arginine of Deming by methylating the guanidinium group to produce polymethylarginine. An ordinarily skilled artisan would be motivated to methylate polyarginine in order to adjust the relative hydrophilicity of the hydrophilic block while maintaining the overall charge of the block.
An ordinarily skilled artisan would reasonably expect success in modifying Deming with the prior art teachings as proposed because arginine methylation is routinely practiced in the art to modulate the biophysical properties of the residue.
The Examiner further notes that it is well established that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 126 U.S.P.Q. 477, 53 U.S.P.Q. 40 (C.C.P.A. 1942); In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C.P.A. 1963); In re Lohr, 317 F.2d 388, 137 U.S.P.Q. 548 (C.C.P.A. 1963): In re Hoehsema, 399 F.2d 269, 158 U.S.P.Q. 598 (C.C.P.A. 1968); In re Wood, 582 F.2d 638, 199 U.S.P.Q. 137 (C.C.P.A. 1978); In re Hoke, 560 F.2d 436, 195 U.S.P.Q. 148 (C.C.P.A. 1977); Ex parte Fauque, 121 U.S.P.Q. 425 (P.O.B.A. 1954); Ex parte Henkel, 130 U.S.P.Q. 474, (P.O. B.A. 1960). Note: MPEP 2144.08.
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 6, and 11-14 of copending Application No. 18/618262 in view of Deming et al. (US20140286865A1; published: 09/25/2014; PTO-892) and Evich et al. (Protein Science, vol. 25, p. 479-486; published: 11/05/2015; PTO-892) and as evidenced by DeRuiter (Principles of Drug Action 1, p. 1-11; published: 2005; PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application also recites an aqueous liquid embolic composition comprising: di-block or tri-block copolymer including a hydrophobic monomer block and a charged block; and a templating agent; and wherein the composition becomes a gel when injected into a vasculature of a patient.
While the claims of App. ‘262 do not explicitly recite that the hydrophobic block includes the amino acids recited in instant claims 9-12 or 16, that the charged block includes the amino acids recited in instant claims 2-8 or 16, or the exact kit recited in instant claims 18-20, the combination of Deming and Evich as evidenced by DeRuiter cures these deficiencies.
The teachings of Deming and Evich as evidenced by DeRuiter are as set forth above and further incorporated herein.
Regarding the hydrophobic and charged blocks recited in instant claims 2-4, 6-12 and 16: It would have been obvious to one of ordinary skill in the art to select any of poly-L-leucine, poly-L-phenylalanine, or poly-L-isoleucine, which each comprise a hydrophobic monomer, to be included in the hydrophobic monomer block and to select any of poly-L-lysine, poly-L-ornithine, poly-L-arginine, poly-L-glutamate, or poly-L-aspartic acid to be included in the charged block. It would have been obvious and one of ordinary skill in the art would reasonably expect success because Deming teaches that these amino acids, when combined into a diblock copolymer, are suitable for forming hydrogels when injected into a patient and can be co-administered in a composition further comprising polysaccharides like hyaluronic acid, which is recited as a suitable templating agent.
Regarding instant claim 5: It would have been obvious to one of ordinary skill in the art to modify the poly-L-arginine taught by the combination of App. ‘262 claims and Deming by methylating the guanidinium group to produce polymethylarginine. An ordinarily skilled artisan would be motivated to methylate polyarginine in order to adjust the relative hydrophilicity of the hydrophilic block while maintaining the overall charge of the block.
The Examiner further notes that it is well established that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 126 U.S.P.Q. 477, 53 U.S.P.Q. 40 (C.C.P.A. 1942); In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C.P.A. 1963); In re Lohr, 317 F.2d 388, 137 U.S.P.Q. 548 (C.C.P.A. 1963): In re Hoehsema, 399 F.2d 269, 158 U.S.P.Q. 598 (C.C.P.A. 1968); In re Wood, 582 F.2d 638, 199 U.S.P.Q. 137 (C.C.P.A. 1978); In re Hoke, 560 F.2d 436, 195 U.S.P.Q. 148 (C.C.P.A. 1977); Ex parte Fauque, 121 U.S.P.Q. 425 (P.O.B.A. 1954); Ex parte Henkel, 130 U.S.P.Q. 474, (P.O. B.A. 1960). Note: MPEP 2144.08.
Regarding claim 18: It would have been obvious to one of ordinary skill in the art to utilize a kit, such as the one taught by Deming, in order to package and ship the formulation. Further, it would have been prima facie obvious to preload the diblock copolymer into a syringe (i.e. a type of container) so that it is readily available for reconstitution and expeditious administration when using the kit.
Regarding claim 19: It would have been obvious to one of ordinary skill in the art to modify the kit taught by the combination of App. ‘262 claims and Deming by preloading diblock copolymer that has already been reconstituted with the polysaccharide into a syringe so that the composition is readily available for expeditious administration when using the kit.
Regarding claim 20: It would have been obvious to one of ordinary skill in the art to modify the kit taught by the combination of App. ‘262 claims and Deming by preloading the diblock copolymer into one syringe and preloading the aqueous solution comprising the polysaccharide so that it is easier to reconstitute the block copolymer and expeditiously administer the composition when using the kit.
An ordinarily skilled artisan would reasonably expect success because all composition ingredients and kit components are known in the art to be useful for administering diblock copolymer-based hydrogels to patients.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/SARAH C WISTNER/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616