DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed January 20, 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103 (Maintained)
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 1-2, 4-6, 8, 15, 17, 21, 23, 27-28, 37, 41, and 43 are rejected under 35 U.S.C. 103 as being as being obvious over Bromberg et al. (WO 97/00275).
Regarding claim 1, Bromberg discloses a polymer network exhibiting gelation in response to a change in an environmental stimulus such as temperature (abstract). The network exhibits gelation at a temperature of 32-37°C (pg. 9, lines 20-21; 37°C being body temperature). In response to the change in temperature, the liquid composition becomes crosslinked through intermolecular associations, such as hydrogen bonding, to form a gel (pg. 8, lines 23-25, line 31; pg. 9, lines 27-31). The polymer network includes a solvophilic component (such as the carbohydrate polymer, hyaluronic acid; pg. 11, line 11) in an amount of 0.01-20 wt.% and an associating component (such as poloxamer; pg. 5, lines 24-25) in an amount of 0.01-20 wt.% (abstract).
Bromberg is not believed to be anticipatory because Bromberg could be construed as not clearly and unequivocally disclosing the claimed invention or directing those skilled in the art to the claimed invention without any need for picking, choosing and combining various disclosures not directly related to each other by the teachings of the cited reference. Namely, one skilled in the art would need to choose poloxamer as the associating component (pg. 5, lines 24-25) and hyaluronic acid as the solvophilic component (pg. 11, line 11).
Nevertheless, claim 1 is rendered prima facie obvious over the teachings of Bromberg, because it is prima facie obvious to combine prior art elements according to known methods, to yield predictable results. In the instant case, all the claimed elements (i.e., a solvophilic component, such as hyaluronic acid, and an associating component, such as poloxamer, in amounts overlapping with those claimed) were known in the prior art (e.g., Bromberg) 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 yielding nothing more than predictable results (e.g., a polymer combination preparation) to one of ordinary skill in the art. MPEP 2143.A.
In regards to the amounts of the components, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05 A.
Claim 2 is rendered prima facie obvious because Bromberg discloses that covalent-crosslinking in the responsive polymer network is not required (pg. 11, lines 13-16) and associating mechanisms such as hydrogen bonding and van der Waals forces are present (pg. 8, lines 31-32).
Furthermore, a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the prior art discloses a polymer network with the same components (e.g., a solvophilic component, such as hyaluronic acid, and an associating component, such as poloxamer, in amounts overlapping with those claimed), the properties the applicant discloses and/or claims (does not comprise covalent crosslinks) are necessarily present.
Claims 4 and 5 are rendered prima facie obvious because Bromberg discloses the polymer network includes a solvophilic component (such as hyaluronic acid; pg. 11, line 11) in an amount of 0.01-20 wt.% and an associating component (such as poloxamer; pg. 5, lines 24-25) in an amount of 0.01-20 wt.% (abstract). A prima facie case of obviousness exists because of overlap as previously discussed.
Furthermore, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of the amount of poloxamer and hyaluronic acid have been taught by the prior art; as such, it would not have been inventive for the skilled artisan to have discovered the optimum ratio and total polymer content via routine experimentation.
Claim 6 is rendered prima facie obvious because Bromberg discloses the composition is a semi-solid polymer network (i.e., a hydrogel) (abstract; pg. 27, lines 16-22).
Regarding claim 8, while it is not explicitly disclosed that more than 60% of a lipophilic agent incorporated in the polymer combination can be retained for at least 24 hours when tested at 37°C, Bromberg does teach any hydrophobic biological active compound can be used (pg. 20, lines 28-29) and the polymer network exhibits extended/controlled release (pg. 27, line 20; pg. 31, lines 10-28). Therefore, it would be reasonably expected that the polymer networks of Bromberg would retain more than 60% of a lipophilic agent for at least 24 hours when tested at 37°C.
Furthermore, a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the prior art discloses a polymer network with the same components (e.g., a solvophilic component, such as hyaluronic acid, and an associating component, such as poloxamer, in amounts overlapping with those claimed) and generally teaches extended/controlled release of hydrophobic biological active compounds, the properties the applicant discloses and/or claims are necessarily present.
Claim 15 is rendered prima facie obvious because Bromberg discloses the polymer network includes a solvophilic component (such as the carbohydrate polymer, hyaluronic acid; pg. 11, line 11) in an amount of 0.01-20 wt.% (abstract). A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 17 is rendered prima facie obvious because Bromberg discloses hyaluronic acid as the solvophilic component (pg. 11, line 11).
Claim 21 is rendered prima facie obvious because Bromberg discloses chitosan as a solvophilic component (pg. 11, lines 10-11).
Regarding claim 23, while it is not explicitly disclosed that the storage modulus, as measured at 37°C, is substantially the same after its precursor state has been stored at 2-8°C for a period of 1 month, Bromberg does teach the polymer networks compositions are highly stable and do not exhibit any phase separation upon standing or upon repeated cycling between a liquid and a gel state (pg. 11, lines 20-22; gelling disclosed at 32-37°C; pg. 9, lines 20-21). Bromberg teaches samples have stood for more than three months without any noticeable decomposition, clouding, phase separation or degradation of gelation properties (pg. 11, lines 20-24). Therefore, it would be reasonably expected that no more than 20% of the polymer combination preparation would be degraded over a period of 1 month when measured at 37°C.
Furthermore, a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the prior art discloses a polymer network with the same components (e.g., a solvophilic component, such as hyaluronic acid, and an associating component, such as poloxamer, in amounts overlapping with those claimed) and generally teaches the stability of the polymer network, the properties the applicant discloses and/or claims are necessarily present.
Claim 27 is rendered prima facie obvious because Bromberg discloses Poloxamer 407 (pg. 35, line 13).
Claim 28 is rendered prima facie obvious because Bromberg discloses the preparation includes a therapeutic agent, such as an antibiotic (pg. 21, line 31).
Claim 37 is rendered prima facie obvious because Bromberg discloses the preparation includes an NSAID (pg. 22, line 3).
Regarding claim 41, the limitation of the polymer combination being delivered to a tumor resection site by intraoperatively administering the preparation that is in a precursor state which transitions to the polymer network state after administration is viewed as an intended use limitation. Bromberg teaches the responsive polymer network composition may be used as a liquid vehicle at ambient temperature, and after administration, the responsive polymer network becomes viscous to facilitate the delivery of actives (pg. 26, lines 27-29), such as therapeutic agents for a tumor (pg. 25, lines 29-30). Bromberg’s teachings appear to be capable of meeting the intended use of the instant claim.
Claim 43 is rendered prima facie obvious because Bromberg discloses the polymer network includes an associating component (such as poloxamer; pg. 5, lines 24-25) in an amount of 0.01-20 wt.% (abstract). A prima facie case of obviousness exists because of overlap, as previously discussed.
Response to Arguments
Applicant's arguments filed 01/20/2026 have been fully considered but they are not persuasive
Applicant argues at pg. 12-13 that given the vast number of possible conditions disclosed by Bromberg for combining different types of associating components and solvophilic components across a broad range of concentrations, it would not be a matter of routine experimentation for a person of ordinary skill in the art to arrive at the present claims.
The Examiner disagrees. Patents are relevant as prior art for all that they contain and nonpreferred or alternative embodiments constitute prior art. See MPEP 2123. Therefore, although Bromberg has many teachings, the large number of teachings does not detract from teaching the claimed components (i.e. a solvophilic component, such as hyaluronic acid, and an associating component, such as poloxamer, in amounts overlapping with those claimed).
Analysis of Unexpected Results
Applicant argues at pg. 13-14 that the present application provides a large number of exemplary compositions comprising a poloxamer and a carbohydrate polymer in concentrations within and across the presently claimed ranges that form a gel around body temperature (the Examiner is directed to Example 2) and the present application provides experimental data showing in vivo efficacy of compositions having the claimed features for delivering payloads to a tumor resection site (the Examiner is directed to Example 5). Applicant argues that in view of Bromberg’s lack of specific teachings of compositions comprising carbohydrate polymers and poloxamer with concentrations within the claimed ranges, the present results are unexpected.
The Examiner has fully reviewed and considered the unexpected results alleged by the applicant. Example 2 shows that mixtures of 6-12 wt.% Poloxamer 407 and 0.7-9 wt.% hyaluronic acid form gels at 37°C. The Examiner notes that no values outside these ranges were tested. Example 5 shows that mice receiving gels of hyaluronic acid and P407 incorporated with TLR7/8 show a higher survival rate than the control group without the TLR7/8 agonist (i.e., the hydrogels are able to deliver TLR7/8 to tumor resection sites).
However, these results do not appear to be unexpected over the prior art. First, in regards to the result that mixtures of 6-12 wt.% P407 and 0.7-9 wt.% hyaluronic acid form gels at 37°C, Bromberg discloses a polymer network exhibiting gelation at a temperature of 32-37°C (pg. 9, lines 20-21). Bromberg discloses the polymer network includes a solvophilic component (such as hyaluronic acid; pg. 11, line 11) in an amount of 0.01-20 wt.% and an associating component (such as poloxamer 407; pg. 5, lines 24-25; pg. 35, line 13) in an amount of 0.01-20 wt.% (abstract). Therefore, one of ordinarily skill in the art would reasonable expect the instantly claimed range of hyaluronic acid and poloxamer (which lies within the ranges taught by Bromberg) to gel at 37°C. To establish unexpected results over a claimed range, applicant should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range See MPEP 716.02(d). The applicant has not provided data both inside and outside the claimed ranges to show unexpected/advantageous results of the claimed range in comparison to the broader ranges taught by Bromberg. In regards to the result that the hydrogel is able to deliver an active agent to a tumor resection site, Bromberg teaches the responsive polymer network composition may be used to facilitate the delivery of actives (pg. 26, lines 27-29), such as therapeutic agents for a tumor (pg. 25, lines 29-30). Therefore, this result also does not appear to be unexpected over the prior art’s teachings.
Finally, assuming purely arguendo that unexpected results have been established, (the Examiner does not believe at this time that they have), the claims would still not be “commensurate in scope” with the showing. See MPEP § 716.02(d). It is unclear that a comparative composition containing these specific components (e.g., hyaluronic acid) would be reasonably representative of compositions containing other components falling within the broader scope currently claimed (e.g., carbohydrate polymers).
Claim 35 is rejected under 35 U.S.C. 103 as being as being obvious over Bromberg et al. (WO 97/00275) in view of Leoni et al. (US 2016/0008477 A1).
The 35 U.S.C. 103 rejection over Bromberg was previously discussed.
Bromberg discloses the active compound which can be loaded into the responsive polymer network includes anti-cancer substances (pg. 21, lines 29-31).
Bromberg does not disclose a TLR7/8 agonist, such as resiquimod, as recited in claim 35.
Leoni teaches imidazoquinolin(amines), such as the TLR7/8 agonist, resiquimod [0126] are used as anti-cancer substances and have antitumor effects [abstract] [0007]-[0009] [0512]. Leoni also teaches that they can be combined with thermosensitive polymers such as poloxamers [0037]-[0039] [0308].
Since Bromberg generally taught a formulation with poloxamers and anti-cancer substances, it would have been prima facie obvious to one of ordinary skill in the art to include an imidazoquinolin(amine), such resiquimod, within the teachings of Bromberg, because Leoni teaches imidazoquinolin(amines) can be combined with thermosensitive polymers such as poloxamers [0037]-[0039] [0308]. An ordinarily skilled artisan would be motivated to use an imidazoquinolin(amine), such as resiquimod, for its anti-cancer and antitumor effects as taught by Leoni [abstract] [0007]-[0009] [0512].
Furthermore, generally it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. In the instant case, since Bromberg generally taught anti-cancer substances, it is prima facie obvious to select resiquimod for incorporation into the formulation based on its recognized suitability for the intended use as an anti-cancer agent, as taught by Leoni.
Response to Arguments
Applicant's arguments filed 01/20/2026 have been fully considered but they are not persuasive
Applicant argues that present claim 1 is patentable over Bromberg, and therefore, present claim 35 is patentable over Bromberg in view of Leoni.
The Examiner disagrees because present claim 1 is not patentable over Bromberg, as discussed above.
Claims 1-2, 4-6, 8, 15, 17, 23, 27-28, 37, 41, and 43 are rejected under 35 U.S.C. 103 as being as being obvious over Jhan et al. (US 2015/0366975 A1) in view of Bromberg et al. (WO 97/00275).
Regarding claim 1, Jhan discloses a thermosensitive hydrogel based on hyaluronic acid and a copolymer of polyethylene oxide (PEO) and polypropylene oxide (PPO) (a poloxamer [0009] [0035] [0043]), which uses a temperature trigger [abstract] to induce crosslinking and transfer from a liquid state to a gelled state [0038] [0053]. Jhan discloses a gel formation temperature from 30° C to 37°C [abstract; 37°C being body temperature]. Crosslinking refers to intramolecular and/or intermolecular crosslinks [0029]. Jhan teaches the hyaluronic concentration is from 0.005% w/v to 0.3% w/v and the copolymer (poloxamer) concentration is from 12% w/v to 20% w/v [0007] and the hydrogels can be used for topical applications [0039] [Claim 11].
Jhan does not disclose the concentration of the poloxamer or the hyaluronic acid in terms of w/w.
Bromberg teaches a thermosensitive gel (abstract) for topical application (pg. 20, lines 14-17; pg. 10, lines 5-6) which includes a solvophilic component (such as hyaluronic acid; pg. 11, line 11) in an amount of 0.01-20 wt.% and an associating component (such as poloxamer; pg. 5, lines 24-25) in an amount of 0.01-20 wt.% (abstract). Bromberg teaches that this polymer concentration provides clear, colorless gels, both before and after viscosification, making them particularly well-suited for a variety of applications. In addition, with this concentration, very little residue is formed upon evaporation and the gel remains clear and translucent above and below the critical temperature (pg. 10, lines 1-8). Bromberg teaches the solvophilic component improves stability of the polymer network and discourages phase separation (pg. 14, lines 22-24) and that adjusting the concentration of the poloxamer gives the desired liquid-gel transition temperature and viscosity (pg. 2, lines 13-21).
Since Jhan generally teaches a thermosensitive gel for topical application with poloxamer and hyaluronic acid, it would have been prima facie obvious to one of ordinary skill in the art to include 0.01-20 wt.% poloxamer and 0.01-20 wt.% hyaluronic acid, within the teachings of Jhan, because Bromberg teaches this amount of solvophilic component (such as hyaluronic acid) and associating component (such as poloxamer) in a thermosensitive gel. An ordinarily skilled artisan would be motivated to use this amount of poloxamer and hyaluronic acid because Bromberg teaches that this polymer concentration provides clear, colorless gels, both before and after viscosification, making them particularly well-suited for a variety of applications. In addition, with this concentration, very little residue is formed upon evaporation and the gel remains clear and translucent above and below the critical temperature (pg. 10, lines 1-8).
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05 A.
Furthermore, it would have been prima facie obvious to optimize the amount of poloxamer and hyaluronic acid, within the teachings of Jhan, as taught by Bromberg.
The differences in the claimed subject matter and the prior art are from 5% w/w to 12.5% w/w (instant claim 1), versus 12% w/v to 20% w/v (Jahn; [0007]) of the poloxamer and from 1% w/w to 10% w/w (instant claim 1), versus 0.005% w/v to 0.3% w/v (Jahn, [0007]) of the hyaluronic acid.
Jahn is not silent as to the amount of the poloxamer and hyaluronic acid present in polymer combination. Jahn teaches 12% w/v to 20% w/v of the poloxamer and 0.005% w/v to 0.3% w/v of the hyaluronic acid. However, Bromberg teaches a weight percentage of poloxamer of 0.01-20 % and a weight percentage of hyaluronic acid of 0.01-20 %. The amount of poloxamer and hyaluronic acid is recognized to have different effects (poloxamer - liquid-gel transition temperature and viscosity; Bromberg, pg. 2, lines 13-21; hyaluronic acid - stability of the polymer network and amount of phase separation, pg. 14, lines 22-24) with changing amounts used. Thus, the general condition (weight percent of poloxamer and hyaluronic acid) is known and the amount of this ingredient is recognized to be result effective. As such, result effective variables can be optimized by routine experimentation, and it would have been prima facie obvious to optimize the weight percentage of poloxamer and hyaluronic acid within the teachings of Jahn, as taught by Bromberg. See MPEP 2144.05.
Claim 2 is rendered prima facie obvious because Jhan discloses the crosslinks arise through noncovalent bonding [0029].
Regarding claims 4 and 5, Jhan does not teach a total polymer content of the least 10% in terms of w/w, as recited in claim 4 or that a ratio of the first polymer component to the second polymer component is 1:1 to 14:1, as recited in claim 5.
However, following the combined teachings of Jahn and Bromberg the ordinarily skilled artisan would arrive at the claimed amount and ratio of poloxamer and hyaluronic acid, as discussed above.
Claim 6 is rendered prima facie obvious because Jhan discloses the polymer network state is a hydrogel [abstract] [0001] [0014].
Regarding claim 8, while it is not explicitly disclosed that no more than 40% of a lipophilic agent incorporated in the polymer combination can be released therefrom within 24 hours when tested at 37°C, Jahn does teach various release percentages (from around 10 to 100 percent) of the drug doxorubicin (Fig 7; varies based on pH) at 37°C at 24 hours [0020], and teaches the active agent can be any substance that can be released from the composition to treat an undesirable physiological condition [0040]. Therefore, it would be reasonably expected that if a lipophilic active agent were incorporated in the polymer network no more than 40% of it could be released therefrom within 24 hours when tested at 37°C (based on the pH value) following the teachings of Jahn (Fig 7, [0040]).
Claim 15 is rendered prima facie obvious because following the combined teachings of Jahn and Bromberg the ordinarily skilled artisan would arrive at the claimed amount of hyaluronic acid, as discussed above.
Claim 17 is rendered prima facie obvious because Jhan discloses hyaluronic acid [abstract] [0034].
Regarding claim 23, while a storage modulus within a range of 100 Pa to about 10,000 Pa as measured at 37° C and pH 5-8 is not explicitly disclosed, Jahn does show in Figure 6 [0019] an elastic modulus (G') of around 100 Pa at 37° C. As the elastic modulus and storage modulus are similar properties, it would be reasonably expected that the polymer networks of Jhan would have a storage modulus overlapping with or close to 100 Pa as measured at 37° C and pH 5-8.
Furthermore, a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the prior art discloses a polymer network with the same components (e.g., poloxamer and hyaluronic acid), the properties the applicant discloses and/or claims are necessarily present.
Claim 27 is rendered prima facie obvious because Jhan discloses poloxamer 407 [0043].
Claim 28 is rendered prima facie obvious because Jhan discloses a therapeutic agent, such as an antibiotic [0040].
Claim 37 is rendered prima facie obvious because Jhan discloses the NSAID, ibuprofen [0040].
Regarding claim 41, the limitation of the polymer combination being delivered to a tumor resection site by intraoperatively administering the preparation that is in a precursor state which transitions to the polymer network state after administration is viewed as an intended use limitation. Jhan teaches the composition can be administered in a liquid state [0011], used for intratumoral injection, and after administration crosslinking is induced by body temperature to form a hydrogel [0038]. Jahn’s teachings appear to be capable of meeting the intended use of the instant claim.
Regarding claim 43, while Jahn does not teach the first polymer component is present in the polymer combination at a concentration of 11% w/w or below, following the combined teachings of Jahn and Bromberg the ordinarily skilled artisan would arrive at the claimed amount of poloxamer, as discussed above.
Response to Arguments
Applicant's arguments filed 01/20/2026 have been fully considered but they are not persuasive
Applicant argues at pg. 15-16 that one of ordinary skill in the art would not be motivated to modify Jhan to arrive at the presently claimed concentration range in view of Bromberg.
The Examiner disagrees. An ordinarily skilled artisan would be motivated to use the amount of solvophilic component, such as hyaluronic acid, and associating component, such as poloxamer, taught by Bromberg because Bromberg teaches that this polymer concentration provides clear, colorless gels, both before and after viscosification, making them particularly well-suited for a variety of applications. In addition, with this concentration, very little residue is formed upon evaporation and the gel remains clear and translucent above and below the critical temperature (pg. 10, lines 1-8). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05 A.
Applicant argues at pg. 16 that Jhan’s teachings are at odds with the allegation that the general condition (weight percent of poloxamer and hyaluronic acid) is known and the amount of these ingredients is recognized to be result effective because Jhan appears to teach that modifying the amount of hyaluronic acid in a hydrogel composition does not result in a significant change in gelation properties.
The Examiner disagrees. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See MPEP 2145 IV. Bromberg teaches the solvophilic component, such as hyaluronic acid, improves stability of the polymer network and discourages phase separation (pg. 14, lines 22-24) and that adjusting the concentration of the poloxamer gives the desired liquid-gel transition temperature and viscosity (pg. 2, lines 13-21). Thus, the general condition is known and the amount of these ingredients is recognized to be result effective as taught by Bromberg. As such, result effective variables can be optimized by routine experimentation, and it would have been prima facie obvious to optimize the weight percentage of poloxamer and hyaluronic acid within the teachings of Jahn, as taught by Bromberg. See MPEP 2144.05.
Claim 21 is rejected under 35 U.S.C. 103 as being as being obvious over Jhan et al. (US 2015/0366975 A1) in view of Bromberg et al. (WO 97/00275) and further in view of Kelly et al. (WO 2019/092049 A1).
The 35 U.S.C. 103 rejection over Jahn in view of Bromberg was previously discussed.
Additionally, Jahn discloses hyaluronic acid is a polysaccharide [0003].
Jahn does not disclose chitosan, as recited in claim 21.
Kelly discloses a thermo-responsive poloxamer based hydrogel with chitosan (abstract). Chitosan is disclosed as a polysaccharide (pg. 17, line 21) and is taught to act as a strengthening agent in the hydrogel (pg. 5, line 21).
Since Jhan generally teaches a thermosensitive gel with poloxamer, it would have been prima facie obvious to one of ordinary skill in the art to include chitosan, within the teachings of Jhan, because Kelly teaches chitosan in a thermosensitive gel with poloxamer. An ordinarily skilled artisan would be motivated to use chitosan because Kelly teaches it acts as a strengthening agent in the hydrogel (pg. 5, line 21).
Furthermore, generally it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. In the instant case, since Jahn generally taught polysaccharides to be used in combination with poloxamers, it is prima facie obvious to select chitosan for incorporation into the polymer network based on its recognized suitability for the intended use as a polysaccharide to be used in combination with poloxamers, as taught by Kelly.
Response to Arguments
Applicant's arguments filed 01/20/2026 have been fully considered but they are not persuasive
Applicant argues that present claim 1 is patentable over Juan in view of Bromberg, and therefore, claim 21 is patentable.
The Examiner disagrees because claim 1 is not patentable over Juan in view of Bromberg, as discussed above.
Claim 35 is rejected under 35 U.S.C. 103 as being as being obvious over Jhan et al. (US 2015/0366975 A1) in view of Bromberg et al. (WO 97/00275) and further in view of Leoni et al. (US 2016/0008477 A1).
The 35 U.S.C. 103 rejection over Jahn in view of Bromberg was previously discussed.
Jahn discloses the active compound which can be loaded into the polymer network includes anti-cancer agents [0040].
Jahn does not disclose a TLR7/8 agonist, such as resiquimod, as recited in claim 35.
Leoni teaches imidazoquinolin(amines), such as the TLR7/8 agonist, resiquimod [0126] are used as anti-cancer substances and have antitumor effects [abstract] [0007]-[0009] [0512]. Leoni also teaches that they can be combined with thermosensitive polymers such as poloxamers [0037]-[0039] [0308].
Since Jahn generally taught a formulation with poloxamers and anti-cancer agents, it would have been prima facie obvious to one of ordinary skill in the art to include an imidazoquinolin(amine), such resiquimod, within the teachings of Jahn, because Leoni teaches imidazoquinolin(amines) can be combined with thermosensitive polymers such as poloxamers [0037]-[0039] [0308]. An ordinarily skilled artisan would be motivated to use an imidazoquinolin(amine), such as resiquimod, for its anti-cancer and antitumor effects as taught by Leoni [abstract] [0007]-[0009] [0512].
Furthermore, generally it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. In the instant case, since Jahn generally taught anti-cancer agents, it is prima facie obvious to select resiquimod for incorporation into the formulation based on its recognized suitability for the intended use as an anti-cancer agent, as taught by Leoni.
Response to Arguments
Applicant's arguments filed 01/20/2026 have been fully considered but they are not persuasive
Applicant argues that present claim 1 is patentable over Juan in view of Bromberg, and therefore, claim 35 is patentable.
The Examiner disagrees because claim 1 is not patentable over Juan in view of Bromberg, as discussed above.
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 1-2, 4-6, 8, 15, 17, 21, 23, 27-28, 35, 37, 41, and 43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10-12, 14, 16-19, 21, 24-26, 30, 32, and 56-59 of U.S. Patent Application No. 18/716,267.
Although the claims at issue are not identical, they are not patentably distinct from each other because the species (composition) recited in the claims of the copending application falls within the genus (preparation) recited in the claims of the instant application, and thus read on the instant claims.
The weight percentages of each component, as recited in the instant claims, would be achieved by one of ordinary skill in the art through routine optimization. See MPEP 2144.05(II)(A).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Conclusion
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashlee E Wertz whose telephone number is (571)270-7663. The examiner can normally be reached Monday - Friday, 8 AM - 5 PM.
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, Sahana Kaup can be reached at 571-272-6897. 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.
/ASHLEE E WERTZ/Examiner , Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612