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.
Priority
The instant application is a 371 PCT/GB2021/050345 filed on 02/12/2021 and claims foreign priority to British application no. GB2001963.4 filed on 02/13/2020. The certified copy of the foreign priority application GB2001963.4 is acknowledged.
Status of the Claims
The claim amendments and remarks filed on 05/19/2026 is acknowledged. Claims 1, 3-18, 20-22, and 24-26 are cancelled. Claim 27 is newly added.
The declaration by Melinda Jane Duer filed on 01/27/2026 is acknowledged, and the contents are discussed in the response to argument section below.
Accordingly, claims 2, 19, 23, and 27 are pending and being examined on the merits herein.
Withdrawn Objections
The objection to the specification is withdrawn in view of the removal of the “https://” on page 40 line 2.
The following grounds of rejections are maintained with amendments to address newly added claim 27.
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.
Claim(s) 2, 19, 23, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al. (WO2019092049 in PTO-892) and as evidenced by Satio-Diaz et al. (bioRxiv, 2023 in PTO-892 dated 06/17/2025).
Kelly discloses a thermo-responsive hydrogel for intratumoral administration as a treatment in solid tumor cancers (see Abstract).
Kelly discloses that systemic chemotherapy for cancer treatment is generally associated with a range of toxic, off-site side effects, and therefore there is interest in developing drug delivery systems which can facilitate retention within the tumor and controlled release of chemotherapeutics from inside the tumor (see page 1 lines 15-35 and page 2 lines 6-15). Kelly discloses that intratumoral administration of chemotherapeutics incorporated in thermo-responsive hydrogels can confer a localized and sustained release of drug directly within the tumor, potentially negating the need for repeated dosing (page 2 lines 6-15). Kelly discloses that since such hydrogels are directly implantable in the target tissue, they may help to circumvent tumor microenvironment (TME) barriers to tissue penetration and reduce non-target tissue exposure and rapid drug clearance associated with systemic delivery and IT instillation (page 2 lines 6-15).
Kelly discloses that current hydrogel formulations suffer from inaccessibility to treatment of sites, inability to image after delivery, along with challenges related to their often-rapid disintegration at their site of action, and poor ability to solubilize non-aqueous drug systems (page 2 lines 15-20). Kelly discloses that current drug delivery formulations such as Gliadel wafers, which are used to deliver chemotherapeutic drug carmustine to the resection site of glioblastoma patients, are markedly different from their hydrogels (page 2 lines 20-35 through page 3 lines 1-5). Therefore, Kelly proposes their hydrogel formulations to overcome at least one of the aforementioned problems with their thermo-responsive hydrogels (page 3 line 31).
Kelly discloses that their room temperature injectable thermos-responsive hydrogel comprises 15-25% (w/w) poloxamer polymer, 0.1-1.0% (w/w) chitosan, 5-20% inclusion complexer (w/w), and 0.05-0.20% (w/w) genipin, and an aqueous base (see Abstract and claim 1 page 36). 0.05-0.20% (w/w) genipin converts to 2.2mM to 8.85 mM based on genipin having a molecular weight of 226 g/mol and a solution density of 1 g/mL. Furthermore, Table 2 in Example 1 on page 23 provides specific gel formulations that contain the recited amounts of genipin.
Kelly also discloses that their hydrogels can comprise 0.05% - 1.0% (w/w) genipin (lines 31-35 page 17), which converts to 2.2 mM to 44.4 mM based on genipin having a molecular weight of 226 g/mol and a solution density of 1 g/mL.
Kelly discloses that their hydrogel can be administered intratumorally to the subject or administered to a tumor resection site to inhibit solid tumor growth in a subject (claim 15 page 37). Kelly discloses that the chitosan and genipin form an interpenetrating scaffold within the hydrogel in which the chitosan is crosslinked with genipin (see Abstract) Kelly discloses that the tumor resection site is from a post-surgical resection (page 9 lines 1-5). Kelly discloses that intratumoral administration means delivery to an existing cavity formed as a result of surgical resection of all or part of a solid tumor, and that administration generally involves injection using a suitable syringe (see page 15 lines 26-30). Kelly discloses the cancer selected for treatment can include glioma, oligodendroglioma, and among others (page 14 lines 22-35 through page 15 lines 1-3).
Kelly demonstrates in Example 17 (pages 31-35) that their hydrogels from Example 1 as well as their hydrogels loaded with chemotherapeutic drugs (Examples 4 and 5) were effective for tumor treatment in in vivo mouse xenograft models. The hydrogels were injected into the tumor of the mice and allowed to gelate (page 32 lines 25-35 through page 33 lines 1-2). Figs 14A-C shows that both the blank loaded hydrogel and drug loaded hydrogel facilitated localized gelation at site administration with retention for at least 14 days. Figs 15A-B show that both blank and drug loaded hydrogels were effective in significantly reducing tumor volume increase in two different types of solid tumors over a period of 14 - 28 days. Figs 16A-D demonstrates that both hydrogels did not induce acute off-site toxicity.
Lastly, as evidenced by Satio-Diaz, genipin is a known agent for crosslinking ECM proteins (see Abstract on page 3 and first paragraph on page 14 in Satio-Diaz). Therefore, the genipin disclosed in Kelly is also capable of cross-linking extracellular matrix in and/or around the site of the resected tumor.
Even though Kelly does not demonstrate administering their hydrogels to the site of a resected primary brain cancer tumor, it would have been prima facie obvious before the effective filing date of the claimed invention to have administered the hydrogels of Kelly to a primary brain tumor cavity that is formed after surgical resection as disclosed in Kelly. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Kelly demonstrates that their hydrogels are effective in inhibiting tumor growth in vivo, and further discloses that glioma and oligodendroglioma can be selected for treatment using their hydrogels. Additionally, Kelly discloses that their hydrogels can be administered via syringe to an existing cavity formed as a result of surgical resection of all or part of a solid tumor.
Furthermore, the teachings of Kelly suggest that the genipin in the hydrogel impedes the movement and/or proliferation of cancer cells, thus inhibiting migration of cancer cells away from the site of the resected tumor because Kelly discloses that their hydrogel can be administered to a resected tumor site to inhibit solid tumor growth, and further discloses that their hydrogels are allowed to gelate at the resected site, in which the genipin and chitosan form an interpenetrating scaffold via crosslinking. Furthermore, as evidenced by Satio-Diaz, genipin is a known agent for crosslinking ECM proteins (see Abstract on page 3 and first paragraph on page 14 in Satio-Diaz). Therefore, the genipin disclosed in Kelly would necessarily crosslink within the hydrogel matrix as well as crosslink ECM components in/around the resected tumor site thereby impeding migration of cancer cells away from the site of the resected tumor.
Additionally, even though Kelly suggests that their genipin in the hydrogel has the described mechanism of action against cancer cells, this mechanism would also flow naturally from the teachings of Kelly because Kelly teaches administering a composition comprising the same concentrations of genipin to the resected site of a primary brain cancer tumor, and as evidenced by Satio-Diaz, genipin is a known agent for crosslinking ECM proteins as described above.
MPEP 2145 II recites “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
In regards to instant claim 23, it would have also been prima facie obvious before the effective filing date of the claimed invention to have administered the hydrogel of Kelly described above to the resected site of a glioblastoma multiforme (GBM) tumor as suggested in Kelly to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Kelly suggests that their hydrogels are an alternative to current drug delivery systems such as Gliadel wafers, which are used to deliver chemotherapeutic drug carmustine to the resection site of glioblastoma patients. Furthermore, Kelly discloses that their hydrogels can be administered to treat glioma and oligodendroglioma as well as to the cavity of a surgical resected tumor. Therefore, an ordinary skilled artisan could have predictably considered administering the hydrogel to a GBM resected site with a reasonable expectation of success.
In regards to instant claim 27, it would have also been prima facie obvious before the effective filing date of the claimed invention to have prepared the hydrogels of Kelly by using 0.05% - 1.0% (w/w) (2.2 mM to 44.4 mM) genipin as disclosed in Kelly to arrive at the claimed invention.
One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Kelly provides guidance of using 0.05% - 1.0% (w/w) (2.2 mM to 44.4 mM) genipin to form their hydrogels.
Response to Arguments
Applicant’s arguments filed on 05/19/2026 and declaration under 35 CFR 1.132 filed on 01/27/2026 have been fully considered but were not persuasive.
Applicant notes that Satio-Diaz is not prior art to the present application.
However, Satio-Diaz was used as evidence to establish that the genipin compound possesses the inherent structure property to cross-link ECM proteins, and as stated in MPEP 2113 II, an inherent feature does not need to be recognized at the relevant time but only that the subject matter is in fact inherent in the prior art reference. In this case, Satio-Diaz provides evidence that genipin possesses the ability to crosslink ECM proteins, and Kelly demonstrates administering a hydrogel containing genipin that gelates at the site of a tumor. Therefore, the genipin during the gelation process at the tumor site would not only crosslink within the hydrogel composition but would also necessarily be capable of crosslinking the surrounding ECM components at the tumor site.
Applicant states that Kelly does not teach or suggest that their hydrogels impede the movement of cancer cells. Applicant states that at most, the hydrogels of Kelly are a solid gelled entity that can be seen to inhibit cancer cell proliferation (tumor growth), but no effects in regards to cancer cell migration away from a resected tumor site and/or that the genipin itself has any direct effect on cell proliferation or cell migration.
Applicant’s arguments described above was not found persuasive because as described above, MPEP 21331 II states that an inherent feature does not need to recognized at the relevant time but only that the subject matter is in fact inherent in the prior art reference. In this case, while Kelly may not have recognized or explicitly disclosed that their hydrogels impede cancer cell migration, the disclosure of Kelly suggests that this function occurs and/or that this function would have flown naturally.
As described above, Kelly demonstrates a mouse tumor model in which the hydrogel solution was kept on ice until administration, which indicates the genipin has not yet crosslinked or the crosslinking reaction has significantly slowed as the crosslinking reaction was shown to occur at physiological temperatures (page 5 lines 10-15). Once administered to the tumor site, the hydrogel was allowed time (30 seconds) for gelation, in which the hydrogel forms an interpenetrating scaffold of chitosan crosslinked with genipin.
Furthermore, as seen in FIG 14B, the size of the tumor volume decreased in both the blank loaded and drug loaded gels, and further shows that both gels remained in place after 14 days. More importantly, the data in FIG. 14B also provides evidence that no cancer cells migrated away from the tumor site after 14 days of the hydrogel injection because FIG 14A-C are overlay images of bioluminescent A549-luc cells (cancer cells) and the fluorescently tagged hydrogel, and as seen in FIG 14B, none of the labeled cancer cells migrated away from the gel and tumor site after 14 days. Therefore, while this feature may not have been recognized by Kelly, there is sufficient evidence to suggest that the hydrogels of Kelly have this function and/or that this function would have flowed naturally.
Applicant further notes that while Kelly may teach the same concentrations (0.01-0.20% w/w) of genipin, Applicant states that this is the concentration in the pre-gelled formulation. Applicant states that the genipin in Kelly would have rapidly crosslinked with the chitosan in the hydrogel, causing a much lower amount of active genipin available to crosslink the ECM than the disclosed concentration. Applicant further notes that the gelation times for the hydrogel of Kelly occurred within 30 minutes as seen in their in-vitro release profile assay of Example 12 and within 30 seconds in the in-vivo study from Example 17. In contrast, Applicant points to the filed Declaration on 01/27/2026 in which the amount of time required for measurable crosslinking of the ECM via genipin is on the order of at least two to six or more hours. Applicant further states that higher concentrations of genipin (greater than 1 mM) is also required to achieve the technical effect of crosslinking the ECM to prevent cancer cell migration. Therefore, Applicant states that there would not be sufficient active genipin in the hydrogel of Kelly to contact the resected tumor and cross-link ECM to any meaningful extent in and/or around the resected tumor thereby impeding the movement and/or proliferation of cancer cells thus inhibiting migration of cancer cells away from the site of the resected tumor.
Applicant’s arguments described above were not found persuasive because even though the genipin disclosed in Kelly may primarily crosslink to the chitosan due to a quicker crosslinking reaction, there is still a reasonable expectation that some amounts of the genipin would still crosslink the ECM in/and around the tumor site and necessarily contribute to the inhibition of the cancer cell migration.
It is noted that the ECM crosslinking absorbance data in Figure 7 of the Declaration establishes that some amounts of ECM crosslinking by genipin can still occur at shorter time scales since absorbance values were detected at less than 2 hours. Furthermore, as discussed above, the hydrogel of Kelly was allowed to gelate after injecting to the tumor site, and their data in FIG. 14B shows that the labelled cancer cells did not migrate away from the hydrogel and tumor site after 14 days. Additionally, genipin has an inherent ability to crosslink ECM components as evidenced by Satio-Diaz.
Therefore, even if a majority of the genipin in Kelly may have crosslinked to the chitosan, there is sufficient evidence to conclude that some amounts of the genipin disclosed in Kelly during the gelation at the tumor site would have crosslinked the ECM in/and around the tumor site and would have necessarily contributed to the inhibition of the cancer cell migration. Furthermore, it is noted that the claims recite “a composition comprising an agent which impedes the movement and/or proliferation of cancer cells, thus inhibiting migration of cancer cells away from the site of the resected tumour”, which means that any unrecited method steps and/or elements can be included in the recited composition regardless of whether or not these components can impede the movement of the cancer cells away from the tumor site. See MPEP 2111.03 I. Furthermore, the recited inhibition of the cancer cell migration does not necessarily require that only the recited genipin performs this function, which means that the composition can include other unrecited method steps and/or elements that also perform this function.
Applicant states that the ordinary skilled artisan would not be motivated to adapt the Kelly hydrogels to retain sufficient levels of genipin (2.2 mM to 44.0 mM) following gelation because the skilled artisan would not consider increasing the concentration of genipin as Kelly discloses that lowering the amount of genipin to typically less than 0.2% (8.85 mM) improved the usability of the gel with a clinically translatable sol-gel transition temperature. Therefore, Applicant sates that an increase in initial genipin concentration within the pre-gelled Kelly hydrogel in order to have the technical effect of crosslinking the ECM and inhibit cancer cell migration would have disrupted the advantages disclosed in Kelly.
Applicant’s arguments described above were not found persuasive because MPEP 2123 II states that “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments and "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use”.
While Kelly teaches an added advantage of using hydrogels containing less than 0.2% w/w genipin, Kelly still discloses that the amount of genipin that can be included into their hydrogel compositions can be 0.05% - 1.0% (w/w) genipin (lines 31-35 page 17), which converts to 2.2 mM to 44.4 mM. Furthermore, the added advantage of using lower concentrations of genipin in Kelly is directed toward the useability of the hydrogel product, and does not teach away from using higher concentrations of genipin to achieve the overall effect of treating the tumor site. Therefore, the ordinary skilled artisan would have a reasonable expectation of success in using higher concentrations of genipin for the hydrogels of Kelly.
Furthermore, in regards to needing higher amounts of genipin to crosslink the ECM and inhibit cancer cell migration, there is sufficient evidence to conclude that the hydrogels of Kelly, even at lower concentrations of genipin, would have crosslinked the ECM in/and around the tumor site during the gelation process at the tumor site as discussed above, and would have necessarily contributed to the inhibition of the cancer cell migration seen in the FIG. 14B data of Kelly as discussed above. Furthermore, as described above, the claims recite “a composition comprising an agent which impedes the movement and/or proliferation of cancer cells, thus inhibiting migration of cancer cells away from the site of the resected tumour” and “a cross-linking agent which is capable of cross-linking extracellular matrix in and/or around the site of the resected tumour”. Therefore, even if most of the genipin in Kelly crosslinks the chitosan in their hydrogels, this composition of Kelly would still be sufficient to inhibit cancer cell migration as claimed, and the genipin would still be capable of crosslinking to the ECM to some degree as described 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 2, 19, 23, and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 12-13, 15-17, 19, and 21-23 of copending Application No. 18/682,559 (‘559) in view of Kelly et al. (WO2019092049 in PTO-892) and as evidenced by Satio-Diaz et al. (bioRxiv, 2023 in PTO-892 dated 06/17/2025).
Claim 1 of ‘559 recites “An in vivo method of killing brain tumour cells in a brain tumour or at a site of a resected brain tumour in a subject, the method comprising the step of: (a) directly contacting brain tumour cells in the brain tumour or at the site of the resected brain tumour with a composition comprising a cytotoxic agent, wherein the cytotoxic agent is a polyamine, and wherein has the structure: NH2—[(CH2)a—NH]—[(CH2)b—NH]x—[(CH2)c—NH]y—H, wherein a, b and c are each independently 3, 4 or 5; and x and y are each independently 0 or 1; wherein the concentration of the cytotoxic agent in the composition if 100 micromolar to 50 millimolar”. Claim 17 of ‘559 recites that the brain tumour is a glioblastoma multiforme (GBM). Claim 19 of ‘559 recites that the cytotoxic agent additionally comprises a target moiety which is specific for the brain or brain tumor to be targeted. Claim 21 of ‘559 recites the composition is applied to some or all of the brain tumor cells in all or part of: (i) the brain tumor; (ii) the vicinity of the brain tumor; (iii) the site of the resected brain tumor; and/or (iv) vicinity of the site of resected brain tumor. Claim 22 of ‘559 recites the composition is applied by spraying or by swabbing, Claims 21-22 of ‘559 meet the limitations “(iv) the composition is applied after a surgical step to remove all or part of the tumor” recited in instant claim 17, and “(iii) the composition is applied after a surgical step to remove all or part of the tumor, wherein the composition is administered topically in to the tumor cavity after removal of the tumor” recited in instant claim 22.
The difference between the claims of ‘559 and the claimed invention is that the claims of ‘558 do not recite administering genipin at 2.2 to 44 mM concentration.
The independent teachings of Kelly and Satio-Diaz et al. are as described above.
It would have been prima facie obvious to combine the claims of ‘559 and Kelly before the effective filing date of the claimed invention by substituting the composition comprising the cytotoxic agent recited in the claims of ‘559 with the hydrogels of Kelly compressing genipin at 2.2mM to 8.85 mM to arrive at the claimed invention. One of ordinary skill in the art would have made this substitution with a reasonable expectation of success because both the claims of ‘559 and Kelly recite the use of their respective composition for treating the same resected brain tumors. See MPEP 2144.06 section II.
Furthermore, even though the combination of the claims of ‘558 and Kelly suggests that genipin impedes the movement and/or proliferation of cancer cells, thus inhibiting migration of cancer cells away from the site of the resected tumor, this functional limitation would also flow naturally from this combination because the combination teaches administering a composition comprising the same concentrations of genipin to the resected site of a primary brain cancer tumor, and as evidenced by Satio-Diaz, genipin is a known agent for crosslinking ECM proteins (see Abstract on page 3 and first paragraph on page 14 in Satio-Diaz). Furthermore, Kelly discloses that the genipin in their hydrogels form an interpenetrating scaffold when the chitosan is crosslinked with genipin (see Abstract), and that these hydrogels are allowed to gelate at the site of the resected tumor. Therefore, the genipin disclosed in Kelly would necessarily crosslink within the hydrogel matrix as well as crosslink ECM components in/around the resected tumor site.
MPEP 2145 II recites “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
In regards to instant claim 27, it would have also been prima facie obvious before the effective filing date of the claimed invention to have prepared the hydrogels as disclosed by the combination of the claims of ‘558 and Kelly described above by using 0.05% - 1.0% (w/w) (2.2 mM to 44.4 mM) genipin as disclosed in Kelly to arrive at the claimed invention.
One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Kelly provides guidance of using 0.05% - 1.0% (w/w) (2.2 mM to 44.4 mM) genipin to form their hydrogels.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant proposes to evaluate the present claims as well as the pending claims in the ‘559 application when the instant claims are placed in allowable condition.
Since no allowable claims have been found, the double patenting rejection over ‘559 is maintained.
Conclusion
No claim is found allowable.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H CHO whose telephone number is (571)270-0691. The examiner can normally be reached M-F 8AM-5PM.
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, Scarlett Goon can be reached at 571-270-5241. 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.
/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner
Art Unit 1693
Prosecution Insights