DETAILED ACTION
Applicant’s remarks filed August 1, 2025 are acknowledged and entered. The elected species are: activating a pattern recognition receptor, chitosan and variants thereof.
Claims Summary
Claim 1 is directed to a method the comprises a step of administering a composition comprising an innate immunity modulatory component to a target site in a tumor section subject, wherein the component is a polymeric biomaterial agonist of innate immunity. The innate immunity is mediated by activating a pattern recognition receptor (claim 2). The specification provides examples of such receptors in paragraph [0010] of the published application (US 20220218822). The administration excludes administration of a tumor antigen, a microparticle, and/or adoptive transfer of T cells to the subject (claim 35). The method does not comprise administration of an immunomodulatory payload (claim 38).
The polymeric biomaterial is or comprises a hydrogel (claim 34), or is biodegradable in vivo (claim 39). In another embodiment, the polymeric biomaterial agonist is or comprises a carbohydrate polymer (claim 10), such as chitosan, a variant of chitosan (claims 9 and 11), such as modified chitosan (see paragraphs [0131] and [0133] of the published application). The composition is liquid and the agonist, upon injection administration, forms a polymer network biomaterial in situ at the target site (claim 24). The agonist is thermo-responsive (claim 25) and forms a polymer network biomaterial in situ at the target site when exposed to the body temperature of the subject upon administration (claim 26). The agonist comprises at least one innate immunity immunomodulatory polymer and at least one non-immunomodulatory polymer or a crosslinking agent (claim 27). The agonist comprises a carbohydrate polymer and a thermo-responsive crosslinking agent (claim 28) that is or comprises a thermo-responsive polymer (claim 29). The polymer network biomaterial comprises or is a crosslinked polymer network biomaterial (claim 30) or non-crosslinked (claim 31). The agonist is characterized in that when tested in vivo by administering a polymeric biomaterial to a test subject, at least 10% of the agonist remains at the target site in vivo 3 days after the administration (claim 32). The agonist is characterized by a storage modulus of about 10 Pa to about 50,000 Pa (claim 33).
The target site is a tumor resection site, a site within 4 inches, and/or a sentinel lymph node (claim 14). Administration is by injection (claim 17). Prior to administering, the method comprises a step of performing tumor resection on the subject (claim 19) intraoperatively (claim 22). The resection site is characterized by absence of gross residual tumor antigen (claim 40). The subject is suffering from metastatic cancer (claim 41) and the method further comprises a step of monitoring at least one metastatic site in the subject after the administration (claim 42). The composition is a liquid and the agonist is a viscous polymer solution (claim 23). The composition consists essentially of the innate immunity modulatory component (claim 47). According to the MPEP 2111.03 (III) the transitional phrase “consisting essentially of” limits the scope of the claim to the specified materials or steps and those that do not materially affect the basic and novel characteristics of the claimed invention.
Claim 43 is directed to a method of characterizing a composition comprising an immunomodulatory component comprises an innate immunity modulatory component. The component is a polymeric biomaterial agonist of innate immunity or component(s) thereof. The method comprises the steps of:
Administering to a target site of a test subject a composition comprising a polymeric biomaterial agonist of innate immunity; and,
Determining whether, when assessed at 24 hours after administration, more proinflammatory cytokine(s) is present at the target site and/or in body circulation of the test subject than is observed without administration of the agonist to the target site.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 43 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature without significantly more. The claim is directed to a method of characterizing a composition comprising an immunomodulatory component comprising an innate immunity modulatory component. The component is a polymeric biomaterial agonist of innate immunity or component(s) thereof. The method comprises the steps of:
Administering to a target site of a test subject a composition comprising a polymeric biomaterial agonist of innate immunity; and,
Determining whether, when assessed at 24 hours after administration, more proinflammatory cytokine(s) is present at the target site and/or in body circulation of the test subject than is observed without administration of the agonist to the target site.
The judicial exception is observing whether more proinflammatory cytokine(s) is present at the target site and/or in body circulation of the test subject than is observed without administration of the agonist to the target site. This limitation sets forth a judicial exception, because this type of correlation is a consequence of natural processes, similar to the naturally occurring correlation found to be a law of nature by the Supreme Court in Mayo. Additionally, the determining step could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams).
This judicial exception is not integrated into a practical application because after determining whether more proinflammatory cytokine is present, there are no other method steps. All that has taken place is that the agonist has been characterized, which is not a practical application.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the act of administering a candidate polymeric biomaterial agonist of innate immunity to a test subject is routine and conventional in the art, as seen in WO 2018/045058 A1 (see abstract, cited in the IDS filed 6/7/2022) where a biomaterial and an activator of innate immunity are administered to subjects having tumor resection, for example, and looking for proinflammatory cytokines (see paragraphs [0006], [00017] and [000687]). Therefore, the claim is directed to a judicial exception without significantly more and is thus patent eligible.
Applicant’s remarks filed August 1, 2025 have been carefully considered but fail to persuade. With reference to the flowchart in MPEP 2106, Applicant notes that the method of claim 43 is directed to a process. Applicant asserts that the streamlined eligibility analysis in MPEP 2106.06(a) is appropriate here because claim 43 does not seek to tie up any law of nature such that it cannot be practiced by others, and that the patent-eligibility of the claim is self-evident. Applicant states that a proper analysis of the claim thus ends at Step 1 and need not proceed to Step 2A.
In response, it is not self-evident that the claim is patent eligible, for reasons set forth above concerning the judicial exception, the lack of its integration into a practical application, and the lack of any additional elements that are sufficient to amount to significantly more than the judicial exception. While the Office and Applicant disagree on this matter of the claim’s patent eligibility being self-evident, MPEP 2106.06 states that the results of the streamlined analysis will always be the same as the full analysis, thus the streamlined analysis is not a means of avoiding a finding of ineligibility that would occur if a claim were to undergo the full eligibility analysis.
Applicant argues that the analysis at Step 2A Prong One is in error because claim 43 recites a step of determining whether more proinflammatory cytokine(s) is present, not a step of observing the same. Applicant argues that determining does not describe the consequence of a natural process because it follows a step of administering to a target site a composition comprising an immunomodulatory component. Applicant additionally argues that a number of methods for determining a level of proinflammatory cytokine(s) are known to those of ordinary skill in the art, none of which can be performed by a human using mental steps or basic critical thinking alone.
In response, it is recognized that prior to the determining step, one must administer the immunomodulatory component. The administering step is addressed as an additional element of the claim in another part of the rejection. Thus, the Office is not saying that the administering step itself can be performed in the human mind using mental steps of basic critical thinking. It is the determining step that could be performed by looking at the results of the tests and thinking about them.
Applicant also argues that even if the determining step did describe the consequence of a natural process, that alone would not be sufficient to establish that the claim as a whole is directed to a judicial exception.
In response, the Office has provided a full analysis, as outlined above.
Applicant argues, with respect to Step 2A Prong Two, that there is no legal requirement that a practical application of a judicial exception must involve further method steps which are performed after the judicial exception. Applicant argues that the practical application is the characterization of a composition.
In response, the Office was merely stating a fact that no further method steps are performed after the judicial exception. It can also be stated another way, that there is no practical application of the judicial exception, period. Once the determination step has been done, no part of the claim is directed to a practical application of that determination. Characterization of the composition is not a practical application because nothing is actually done.
Applicant argues, with respect to Step 2B, that Goldberg (WO 2018/045058 A1, cited in the IDS filed 6/7/2022) is not evidence that administering a candidate polymeric biomaterial agonist of innate immunity to a test subject is routine and conventional. Goldberg discloses a biomaterial and an activator of innate immunity administered to subjects having tumor resection, for example, and looks for proinflammatory cytokines (see abstract, paragraphs [0006], [00017] and [000687]). Applicant argues that Goldberg focuses on compositions comprising biomaterials and immunomodulators, in contrast with the instant claim wherein the biomaterial is an immunomodulator.
In response, Applicant’s immunomodulator biomaterial is, for example, a hydrogel. Goldberg administers a hydrogel. Whether Goldberg characterizes the hydrogel as being an immunomodulator or not, the fact remains that Goldberg administers the same biomaterial that Applicant uses. Goldberg is evidence that it is routine and conventional to administer a biomaterial to a subject having tumor resection.
Therefore, the claim is directed to a judicial exception without significantly more and is thus patent ineligible.
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.
Claims 1, 2, 9-11, 14, 17, 19, 22-35, 38-43 and 47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goldberg et al. (WO 2018/045058 A1, cited in the IDS filed 6/7/2022, “Goldberg”). The claims are summarized above and correlated with the teachings of the prior art in bold font below.
Goldberg discloses methods of treating cancer, including metastatic, by administering a drug delivery composition that comprises a biomaterial and an activator of innate immune response, such as a ligand or agonist of a pattern recognition receptor, to a site of tumor resection after surgery via implantation in the absence of gross residual tumor antigen, for example (see abstract and paragraphs [0006], [00017], [000169], [000187], [000188], [000637] and [000716]) (claims 1, 2, 14, 19, 22, 40 and 41). The biomaterial is, for example, a biodegradable hydrogel comprising chitosan, hyaluronic acid, alginate, etc., or a derivative thereof (see paragraph [000172] and [000558]) (claims 1, 9-11, 34 and 39). The composition is in liquid form and comprises an emulsifier, such as Poloxamer-188 (a thermo-responsive polymer, non-immunomodulatory, cross-linking), which would result in an emulsion (viscous) (see paragraphs [000596] and [000622]) (claim 23). Injection administration is contemplated following tumor resection (see paragraph [00091]) (claim 17). It is expected to form a polymer network in situ, thus thermo-responsive to the body temperature of the subject, at the target site because the same biomaterial (e.g., hydrogel comprising chitosan and Poloxamer-188) is being injected at the same site (claims 24-30). The storage modulus is about 500 Pa to about 3000 Pa (see paragraph [000179]) (claim 33). While cross-linking is contemplated, it is not required in every embodiment since it is presented as an option (see paragraph [000174] for example) (claim 31). Adoptive transfer of T cells is not included in the method, nor tumor antigens, nor microparticles (see paragraph [000621]) (claims 35, 38 and 47). Metastasis is monitored (see paragraph [000676]) (claim 42).
Regarding claim 32, directed to a future testing outcome, this result would be inherent to the method since the same materials are administered in the same manner.
Regarding claim 43, the method of characterizing the composition by administering to a target site of a test subject and determining whether, after 24 hours, more proinflammatory cytokine is present compared to a test subject not receiving the composition, Example 6 of Goldberg discloses such a method that measures pro-inflammatory cytokines (see paragraph [000687]). Therefore, the claimed embodiments are anticipated by the prior art.
Applicant’s arguments filed August 1, 2025 have been carefully considered but fail to persuade. Applicant argues that Goldberg focuses on compositions comprising biomaterials and immunomodulators, in contrast with the instant claims wherein the biomaterial is an immunomodulator.
In response, Applicant’s immunomodulator biomaterial is, for example, chitosan. Goldberg’s biomaterial is, for example, a biodegradable hydrogel comprising chitosan, hyaluronic acid, alginate, etc., or a derivative thereof (see paragraph [000172] and [000558]). Whether Goldberg characterizes chitosan or a hydrogel as being an immunomodulator or not, the fact remains that Goldberg administers the same biomaterial that Applicant uses. Therefore, the claims remain rejected for reasons of record.
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.
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Claims 1, 2, 9-11, 14, 17, 19, 22-24, 30-35 and 38-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,413,612 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Patent claim 1 is directed to treating cancer comprising intraoperative administration at a tumor resection site of a subject suffering from cancer, an effective amount of a combination of a biomaterial comprising hyaluronic acid, and a TLR7 and/or TLR8 agonist. The instant claims do not require the administration of a TLR7 and/or TLR8 agonist. However, the instant claims are open to additional components and do not preclude administration of a TLR7 and/or TLR8 agonist, except for claims 38 and 47 (embodiments of no immunomodulatory agent, and “composition consists essentially of”, respectively). In that respect, the patented claims are a species of the instantly claimed genus. A species anticipates a genus. Other claim limitations are found throughout the patented claims. Regarding claim 19, directed to an embodiment wherein tumor resection is performed, it would have been obvious to have claimed this embodiment in the patent since the patented claims are directed to intraoperative administration of the composition at a tumor resection site. Regarding claim 32, directed to a future testing outcome, this result would be inherent to the method since the same materials are administered in the same manner in the patented claims.
Claims 1, 2, 9-11, 14, 17, 19, 22-24, 30-35 and 38-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 17-28 of U.S. Patent No. 10,435,469 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Patent claim 1 is directed to treating cancer comprising intraoperative administration at a tumor resection site of a subject suffering from cancer, an effective amount of a combination of a biomaterial comprising hyaluronic acid, and a STING agonist. The instant claims do not require the administration of a STING agonist, rather, they are generic to any agonist of innate immunity. In that respect, the patented claims are a species of the instantly claimed genus. A species anticipates a genus. Other claim limitations are found throughout the patented claims. Regarding claim 19, directed to an embodiment wherein tumor resection is performed, it would have been obvious to have claimed this embodiment in the patent since the patented claims are directed to intraoperative administration of the composition at a tumor resection site. Regarding claim 32, directed to a future testing outcome, this result would be inherent to the method since the same materials are administered in the same manner in the patented claims.
Claims 1, 2, 9-11, 14, 17, 19, 22-24, 30-35 and 38-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 15-26 of U.S. Patent No. 10,836,826 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Patent claim 1 is directed to treating cancer comprising intraoperative administration at a tumor resection site of a subject suffering from cancer, an effective amount of a combination of a biomaterial comprising hyaluronic acid, and a COX2 inhibitor. The instant claims do not require the administration of a COX2 inhibitor, rather, they are generic to an agonist of innate immunity. In that respect, the patented claims are a species of the instantly claimed genus. A species anticipates a genus. Other claim limitations are found throughout the patented claims. Regarding claim 19, directed to an embodiment wherein tumor resection is performed, it would have been obvious to have claimed this embodiment in the patent since the patented claims are directed to intraoperative administration of the composition at a tumor resection site. Regarding claim 32, directed to a future testing outcome, this result would be inherent to the method since the same materials are administered in the same manner in the patented claims.
Claims 1, 2, 9-11, 14, 17, 19, 22-24, 30-35 and 38-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 11-24 of U.S. Patent No. 11,021,539 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Patent claim 1 is directed to treating cancer comprising intraoperative administration at a tumor resection site of a subject suffering from cancer, an effective amount of a combination of a biomaterial comprising hyaluronic acid, and an activator of NOD1 and/or NOD2. The instant claims do not require the administration of an activator of NOD1 and/or NOD2, rather, they are generic to an agonist of innate immunity. In that respect, the patented claims are a species of the instantly claimed genus. A species anticipates a genus. Other claim limitations are found throughout the patented claims. Regarding claim 32, directed to a future testing outcome, this result would be inherent to the method since the same materials are administered in the same manner in the patented claims.
Claims 25-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,413,612 B2, claims 1-10 and 17-28 of U.S. Patent No. 10,435,469 B2, claims 1-9 and 15-26 of U.S. Patent No. 10,836,826 B2
claims 1-6 and 11-24 of U.S. Patent No. 11,021,539 B2, as applied to their respective claims above, and further in view of Goldberg et al. (WO 2018/045058 A1, “Goldberg”). Claims 25-29 are directed various embodiments of thermo-responsive biomaterials and cross-linking agents. The patented claims do not recite these limitations, however it would have been obvious to have claimed thermo-responsive biomaterials and cross-linking agents with a reasonable expectation of success, such as those used in the similar method described in Goldberg. Goldberg’s composition is in liquid form and comprises an emulsifier, such as Poloxamer-188 (a thermo-responsive polymer, non-immunomodulatory, cross-linking), which would result in an emulsion (viscous) (see paragraphs [000596] and [000622]). It is expected to form a polymer network in situ, thus thermo-responsive to the body temperature of the subject, at the target site because the same biomaterial (e.g., hydrogel comprising chitosan and Poloxamer-188) is being injected at the same site.
Applicant’s arguments filed August 1, 2025 have been carefully considered but fail to persuade. Applicant argues that Goldberg focuses on compositions comprising biomaterials and immunomodulators, in contrast with the instant claims wherein the biomaterial is an immunomodulator.
In response, Applicant’s immunomodulator biomaterial is, for example, chitosan. Goldberg’s biomaterial is, for example, a biodegradable hydrogel comprising chitosan, hyaluronic acid, alginate, etc., or a derivative thereof (see paragraph [000172] and [000558]). Whether Goldberg characterizes chitosan or a hydrogel as being an immunomodulator or not, the fact remains that Goldberg administers the same biomaterial that Applicant uses.
Claims 1, 2, 9-11, 14, 17, 19, 22-24, 30-35 and 38-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 145-151, 156 and 158-171 of copending Application No. 17/241,935 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. Copending claim 145 is directed to treating cancer comprising intraoperative administration at a tumor resection site during surgery of a subject suffering from cancer, an effective amount of a combination of a biomaterial comprising hyaluronic acid, and an activator innate immunity. Copending claim 145 recites a variety of biomaterials, including chitosan, which is instantly claimed. Other claim limitations are found throughout the patented claims. Regarding claim 32, directed to a future testing outcome, this result would be inherent to the method since the same materials are administered in the same manner in the copending claims. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 25-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 145-151, 156 and 158-171 of copending Application No. 17/241,935 (reference application), as applied to claims 1, 17 and 24 above, and further in view of Goldberg et al. (WO 2018/045058 A1, “Goldberg”). Although the claims at issue are not identical, they are not patentably distinct from each other. Claims 25-29 are directed various embodiments of thermo-responsive biomaterials and cross-linking agents. The patented claims do not recite these limitations, however it would have been obvious to have claimed thermo-responsive biomaterials and cross-linking agents with a reasonable expectation of success, such as those used in the similar method described in Goldberg. Goldberg’s composition is in liquid form and comprises an emulsifier, such as Poloxamer-188 (a thermo-responsive polymer, non-immunomodulatory, cross-linking), which would result in an emulsion (viscous) (see paragraphs [000596] and [000622]). It is expected to form a polymer network in situ, thus thermo-responsive to the body temperature of the subject, at the target site because the same biomaterial (e.g., hydrogel comprising chitosan and Poloxamer-188) is being injected at the same site. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s arguments filed August 1, 2025 have been carefully considered but fail to persuade. Applicant argues that Goldberg focuses on compositions comprising biomaterials and immunomodulators, in contrast with the instant claims wherein the biomaterial is an immunomodulator.
In response, Applicant’s immunomodulator biomaterial is, for example, chitosan. Goldberg’s biomaterial is, for example, a biodegradable hydrogel comprising chitosan, hyaluronic acid, alginate, etc., or a derivative thereof (see paragraph [000172] and [000558]). Whether Goldberg characterizes chitosan or a hydrogel as being an immunomodulator or not, the fact remains that Goldberg administers the same biomaterial that Applicant uses.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
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/STACY B CHEN/Primary Examiner, Art Unit 1671