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
Applicant’s amendment of 06/19/2026 is acknowledged. Claims 1-2, 14-16, and 18-20 are amended; claims 3-8 are cancelled; and claims 21-26 are new. Claims 1-2 and 9-26 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.
Previous Rejections/Objections
Applicant’s arguments filed 06/19/2026 have been fully considered. Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied as necessitated by Applicant’s amendment to the claims. They constitute the complete set of rejections and/or objections presently being applied to the instant application. Applicant’s arguments insofar as they pertain to the present grounds of rejections and/or objections are addressed herein.
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 1-2 and 9-26 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.
Claims 1, 16, and 18 each recite the limitation “a charged polypeptide block that includes amino acids having pendant functional groups that are charged at pH of 3-10”. It is unclear whether the pendant functional groups are required to be charged at all pH values within the claimed range or are required to be charged at least one pH value, but not necessarily all pH values, within the claimed range. Claims 2, 9-15, and 21-22 are rejected by virtue of their dependency on claim 1, claims 17 and 23-24 are rejected by virtue of their dependency on claim 16, and claims 19-20 and 25-26 are rejected by virtue of their dependency on claim 18, as they fail to resolve the ambiguity in question. For examination purposes, the Examiner interprets the claim broadly to mean that the pendant functional groups are required to be charged at least one pH value, but not necessarily all pH values, within the claimed range.
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 is currently naming 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 1-2 and 9-26 are rejected under 35 U.S.C. 103 as being unpatentable over Deming et al. (US20140286865A1; published: 09/25/2014; PTO-892 of 03/19/2026) in view of Richard et al. (US20090169471A1; published: 07/02/2009; PTO-892 of instant action) and as evidenced by DeRuiter (Principles of Drug Action 1, p. 1-11; published: 2005; PTO-892 of 03/19/2026).
Deming teaches a composition suitable for site-specific administration to the central nervous system comprising a diblock copolypeptide hydrogel “DCH”, which comprises a biologically active material, such as a therapeutic agent, that is mixed with the hydrogel or attached to the polypeptide chain of the hydrogel [abstract; claims; 0006].
Regarding the composition of instant claims 1-2, 9, 11, 14, 16-17, and 21-24: Deming teaches that DCH is injected as a liquid, which is prepared in double distilled sterile water [0170], and thus reads on the limitation “aqueous liquid” composition comprising a “di-block” copolymer. In claim 14, Deming recites a diblock copolypeptide comprising: poly-L-leucine as the hydrophobic domain, which reads on the instantly claimed hydrophobic block including a hydrophobic amino acid, and poly-L-lysine as the hydrophilic domain, which reads on the instantly claimed charged block polypeptide. Lysine’s pendant functional group has a pKa of 10.53, as evidenced by DeRuiters [pg. 10], and thus is protonated/charged within the instantly claimed pH range of 3-10.
However, Deming does not expressly teach that the composition comprises a templating agent as defined in instant claims 1, 15-16, 21, and 23.
Richard, also drawn to injectable particles, teaches that porous polymeric particles such as hydrogels can be combined with a pore-filling composition, which includes at least one therapeutic agent and at least one pore-filling polymer, to modulate release of therapeutic agent from the injectable particles [abstract; 0031; claims 1 and 10]. Suitable pore-filling polymers include charged polymers, such as salts of poly(2-acrylamido-2-methyl-1-propanesulfonic acid), poly(4-styrenesulfonic acid), and poly(vinyl sulfonic acid), among others, which facilitate electrostatic interactions with charged therapeutic agents [0036-0037]. The porous polymeric particles can be exposed to the pore-filling solution containing the therapeutic agent and the pore-filling polymer to create filled porous particles [0059-0063].
Regarding the templating agent recited in instant claims 1, 15-16, 21, and 23: Deming teaches that the DCH is a porous interconnected membranous network of assembled polypeptides [0081]. When the biologically active material is mixed with the hydrogel, it is suspended in, dispersed in, or dissolved in the porous network of the DCH [0030]. 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 further including a pore-filling polymer, such as a salt of poly(2-acrylamido-2-methyl-1-propanesulfonic acid), poly(4-styrenesulfonic acid), and/or poly(vinyl sulfonic acid), as taught by Richard to modulate the release of a charged therapeutic agent from the porous network of the DCH. There is a reasonable expectation of success because all of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
Regarding instant claim 10: 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 [0067-0071]. Therefore, an ordinarily skilled artisan could readily envision an embodiment wherein the hydrophilic domain comprises poly-L-phenylalanine in addition to or in place of poly-L-leucine.
Regarding instant claim 12: Poly-L-leucine has a pendant aliphatic side chain, and poly-L-phenylalanine has a pendant aromatic side chain.
Regarding instant 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 [0083]. Thus, the composition 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 the kit of instant claims 18-19 and 25-26: Deming 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]. 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 [0112]. Because Deming also teaches that the composition can be administered with a syringe [0109], it would have been obvious to one of ordinary skill in the art to preload the diblock copolypeptide comprising poly-L-leucine and poly-L-lysine that has already been reconstituted with an aqueous pore-filling solution containing the therapeutic agent and a salt of poly(2-acrylamido-2-methyl-1-propanesulfonic acid), poly(4-styrenesulfonic acid), and/or poly(vinyl sulfonic acid) as the pore-filling polymer into a syringe (i.e., a type of container) so that the composition is readily available for expeditious administration when using the kit.
Regarding claim 20: Alternatively, it would have been obvious to one of ordinary skill in the art to preload the diblock copolypeptide into one syringe and preload an aqueous pore-filling solution containing the therapeutic agent and pore-filling polymer into a second syringe so that each composition is storage stable and ready for expeditious reconstitution of the block copolypeptide with the pore-filling solution and subsequent administration.
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 porous therapeutic particles for injection into the human body. Additionally, Deming teaches that kits are a useful means for packaging lyophilized forms or stabilized liquids of the compositions, and Richard supports storage of injectable particles in dry form or in aqueous suspension, which may be supplied and shipped in the form of a kit [Richard, 0066-0067].
It is noted that the recitations “embolic” and “for embolization” in the instant claims are intended uses of the claimed composition and kit, respectively. 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 taught by the combination of Deming and Richard is capable of performing the intended use (i.e., is suitable for injection into the body) and the structure of the kit taught by the combination of Deming and Richard 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 they meet the claims. Note: MPEP 2111.02.
Response to Arguments
Applicant’s arguments submitted on 06/19/2026 with respect to rejections under 35 U.S.C. 103 have been fully considered in so far as they apply to the new or modified rejections of the instant Office action but were not found to be persuasive.
Applicant argues that Deming et al., DeRuiter, and Evich et al. do not render obvious the instantly claimed templating agent that comprises one or more of poly(2-acrylamido-2-methyl-1-propanesulfonic acid), sulfonated polystyrene, and polyvinyl sulfonic acid. This argument was not found to be persuasive in view of Richard et al. for reasons discussed in detail in the prior art rejections above. Accordingly, the prior art rejections of record are maintained.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CLINKSCALES WISTNER whose telephone number is (571)270-7715. The examiner can normally be reached Monday - Thursday 8:00 AM - 5:00 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH C WISTNER/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616
Prosecution Insights