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 .
Election/Restrictions
To summarize the current election, the applicant elected Group I, without traverse.
Terminal Disclaimer
The terminal disclaimer filed on October 30, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent No. 12,083,242 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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.
Claims 1, 118-119, 125-129, and 132-135 are rejected under 35 U.S.C. 103 as being unpatentable over Kunjukunju et al. in view of Boyan et al. (previously cited), Dowling et al. (Langmuir 2013 29:7993-7998), and Smrdel et al. (previously cited) as evidenced by Bakaltcheva at al. (previously cited).
Kunjukunju et al. teach alginate particles crosslinked with calcium ions (metal ions) that include native alginate lyase or an aggregate of alginate lyase stabilized with ammonium sulfate that can be employed for drug delivery, cell encapaulation, and tissue engineering (see page 176 first column and page 178 first column first paragraph and second column second full paragraph; instant claims 1, 125-126, 128, and 134-135). There is no clear distinction between divalent calcium ions acting as crosslinking metal cations and divalent calcium ions that are alginate lyase inhibitors, thus the presence of divalent calcium ions in the particles acting as crosslinking metal ions meets both limitations (see instant claim 126 and 128). Bakaltcheva at al. detail that ammonium sulfate is a cryoprotectant (see paragraph 52; instant claim 129). The alginate has a molecular weight of 80,000 to 120,000 Da which meets the limitations of containing alginate with a molecular weight greater than about 100 kDa and a ratio of M units to G units of 61:39 which meets the limitations of about 60:40 (see page 177 first column first full paragraph; instant claims 1 and 119). The native alginate lyase encapsulating particles degrade (self-degrading) in about 5 days (6 days) while those that encapsulate the alginate lyase aggregate degrade in 21 to 28 days in pH 7.4 phosphate buffer (see page 178 first column third full paragraph, page 182 second column last partial paragraph-page 183 first column first full paragraph; instant claim 1). The alginate lyase aggregate containing particle is pictured in cross-section to have a long axis diameter of about 2100 mm and a short axis diameter of about 1600 mm (see figure 7c). Kunjukunju et al. further teach the utility of the particles as controlled release vehicles for contained cells and/or drugs (see abstract and page 183 first column last full paragraph). They do not explicitly teach a size between about 40 and about 1000 mm, an alginate molecular weight of greater than 200 kDa, or the inclusion of an oxidized alginate.
Boyan et al. teach alginate microspheres for cell encapsulation that generate desirable bioactive proteins for therapeutic use (see paragraphs 10-12). The microspheres are made via a process to control their size to be less than 200 mm so as to facilitate injection delivery without damage via standard surgical needles (see paragraphs 10 and 12). The microspheres are generated via ionic crosslinking of size controlled droplets of an alginate solution in a solution of calcium chloride (see paragraph 69 and examples 1-2). Additionally, the alginate may have a molecular weight of 50,000 to 400,000 Da (see paragraphs 158 and 190). They exemplify alginate microspheres made with at least 60% guluronate (G units) or least 60% mannuronate (M units) and a greater or less than 200,000 Da molecular weight (see paragraph 190 and table 2). An exemplary alginate is employed with a 150 kDa molecular weight and 60:40 M:G ratio (see example 6). These varieties of alginate produced cell loaded microspheres sized at 176±0.2 mm to 194±0.7 mm that were intact for at least two weeks (see example 2; instant claim 1). They teach to include alginate lyase so as to induce controlled degradation for biological applications and note that the rate of degradation increases with increasing concentration (see paragraphs 23-26, 66, 69, 172, and 176, examples 26-27, and figure 15). Thus the concentration of alginate lyase, on a mass or per particle basis, is a result effective variable. Boyan et al. further teach that including oxidized alginate permits added control over the rate of degradation, where the process can be expedited due to its presence and the additional hydrolysis susceptible sites oxidation introduced (see paragraphs 26, 169, and 234).
Dowling et al. teach self degrading microcapsules where the capsules encapsulate an enzyme for the polysaccharide that composes its shell (see abstract). They detail that the size can be adjusted downward by making smaller droplets of capsule material during production (see page 7995 first column first partial paragraph). Degradation times that span from minutes to hours are detailed and Dowling et al. note that the time shortened with increasing enzyme concentration (see page 7994 first column first partial paragraph, page 7995 second column and figure 3). As an example, they show spherical microcapsules sized at about 2750 mm, based on the scale bar, with 1.5 U/ml enzyme in the lumen (see figure 2). This corresponds to approximately 5.2 mU enzyme per particle (as calculated by the examiner).
Smrdel et al. discuss the desire for uniformity in shape amongst calcium crosslinked alginate particles employed for drug delivery (see abstract and page 84 first full paragraph). They go on to detail parameters involved in dropwise particle production techniques that directly influence sphericity such as the temperature of the calcium ion bath and hardening time (see figure 1). Here sphericity values of about 0.9 are achieved at higher hardening times (e.g., 30 minutes) and higher bath temperatures (e.g., 40⁰C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to size the microparticles of Kunjukunju et al. to the size range exemplified/taught by Boyan et al. so as to permit delivery via injection for a cell cargo without damage. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. It additionally, would have been obvious the adjust the choice of alginate molecular weights and M to G ratios for Kunjukunju et al. within the ranges taught by Boyan et al. because they teach them to be useful for similar alginate microparticle applications. The M to G ratio and molecular weight employed by Kunjukunju et al. are embraced by the ranges of Boyan et al., thereby indicating the recognized utility of more sizes and ratios beyond that employed by Kunjukunju et al. The result is a range of molecular weights and M to G ratios that overlap with those instantly claimed, thereby rendering the claimed range obvious. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)” (see MPEP 2144.05). It also would have been obvious to prepare the microspheres employing production parameters that yield particles with a higher sphericity so as to have uniformity for use in drug delivery. This modification would have been obvious in light of Smrdel et al. as the application of the same technique to a similar product in order to yield the same improvement. The parameters and sphericity outcome are result effective variables and therefore are obvious to optimize as a matter of routine experimentation. Optimization of the degradation rate of the microspheres via enzyme concentration/amount per particle would have been obvious as matter of routine experimentation in light of Dowling et al. and Boyan et al. (see instant claim 1). Additionally, it would have been obvious to add oxidized alginate as taught by Boyan et al. in the alginate lyase aggregate or native alginate lyase containing particles in Kunjukunju et al. to permit additional control of the rate of release of a contained active. This modification would have been obvious as the application of the same technique to a similar product to yield the same improvement. Therefore claims 1, 118-119, 125-129, and 132-135 are obvious over Kunjukunju et al. in view of Boyan et al., Dowling et al., and Smrdel et al. as evidenced by Bakaltcheva at al.
Claims 1, 125-130, and 133-135 are rejected under 35 U.S.C. 103 as being unpatentable over Islan et al. in view of Kunjukunju et al., Dowling et al., and Smrdel et al.
Islan et al. teach microspheres composed of alginate encapsulating alginate lyase and a drug (see abstract). The microparticles are generated via ionic crosslinking of droplets of an alginate solution in a solution of calcium chloride in a 50:50 mixture of water and propylene glycol, thereby incorporating propylene glycol into the microparticles (see page 1240 first column first paragraph and page 1242 first column last partial paragraph-page 1243 first column and figure 1; instant claims 125-126 129-130). There is no clear distinction between divalent calcium ions acting as crosslinking metal cations and divalent calcium ions that are alginate lyase inhibitors, thus the presence of divalent calcium ions in the particles acting as crosslinking metal ions meets both limitations (see instant claim 126 and 128). The presence of the propylene glycol improved the sphericity and eliminated cracking of the particles when freeze dried (see page 1242 first column last partial paragraph-page 1243 first column and figure 1). The propylene glycol containing microparticles are shown to have diameter of 580 mm (see figure 1c; instant claims 1 and 127). They detail that at least 90% of the feed alginate lyase was incorporated into the microparticles starting from a 2 wt% 120 kDa alginate solution with 40 U/ml alginate lyase feed stock (see page 120 first column first paragraph and page 1246 first column first column first partial paragraph; instant claim 1). The bulk mixture of alginate and alginate lyase yields alginate lyase that is temporarily “entrapped” by the crosslinked alginate molecules (see instant claim 135). Release of the contained drug is detailed to occur over a few hours at 7.4 pH (see figure 3 and 5). The monomer ratio of the alginate is not detailed by Islan et al.
Kunjukunju et al. teach alginate particles crosslinked with calcium ions that include native alginate lyase or an aggregate of alginate lyase stabilized with ammonium sulfate to act as controlled release carriers for drugs (see page 178 first column first paragraph and second column second full paragraph and page 183 first column last full paragraph). The alginate has a molecular weight of 80,000 to 120,000 Da and a ratio of M units to G units of 61:39 which meets the limitations of about 50:50 and about 60:40 (see page 177 first column first full paragraph; instant claims 1 and 119). The native alginate lyase encapsulating particles degrade (self-degrading) in about 5 days (6 days) (see page 182 second column last partial paragraph-page 183 first column first full paragraph; instant claim 1).
Dowling et al. teach self degrading microcapsules where the capsules encapsulate an enzyme for the polysaccharide that composes its shell (see abstract). They detail that the size can be adjusted based down by making smaller droplets of capsule material during production (see page 7995 first column first partial paragraph). Degradation times that span from minutes to hours are detailed and Dowling et al. note that the time shortened with increasing enzyme concentration (see page 7994 first column first partial paragraph, page 7995 second column and figure 3). As an example, they show spherical microcapsules sized at about 2750 mm, based on the scale bar, with 1.5 U/ml enzyme in the lumen (see figure 2). This corresponds to approximately 5.2 mU enzyme per particle (as calculated by the examiner).
Smrdel et al. discuss the desire for uniformity in shape amongst calcium crosslinked alginate particles employed for drug delivery (see abstract and page 84 first full paragraph). They go on to detail parameters involved in dropwise particle production techniques that directly influence sphericity such as the temperature of the calcium ion bath and hardening time (see figure 1). Here sphericity values of about 0.9 are achieved at higher hardening times (e.g., 30 minutes) and higher bath temperatures (e.g., 40⁰C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ an alginate in the microspheres of Islan et al. that has a monomer ratio already envisioned to be useful for drug delivery. Kunjukunju et al. detail such a ratio for a similar molecular weight alginate used in microparticles for drug delivery controlled via alginate lyase. Thus it would have been obvious to employ a 61:49 M:G ratio alginate as taught by of Kunjukunju et al. for the microspheres of Islan et al. This modification would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. The product provides the claimed components in the claimed configuration; thus its associated functionality should follow. According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor 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. 1985). It also would have been obvious to prepare the microspheres employing production parameters that yield particles with a higher sphericity so as to have uniformity for use in drug delivery. This modification would have been obvious in light of Smrdel et al. as the application of the same technique to a similar product in order to yield the same improvement. The parameters and sphericity outcome are result effective variables and therefore are obvious to optimize as a matter of routine experimentation. Optimization of the degradation rate of the microspheres via enzyme concentration/amount per particle would have been obvious as matter of routine experimentation in light of Dowling et al. (see instant claim 1). Therefore claims 1, 125-130, and 133-135 are obvious over Islan et al. in view of Kunjukunju et al., Dowling et al., and Smrdel et al.
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.
The following are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Claims 1, 125-129, and 133-135 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Application No. 19/109241 in view of Kunjukunju et al., Lecler et al. (previously cited), Dowling et al., and Smrdel et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a particle of crosslinked alginate with alginate lyase. The crosslinker in the copending claims may be a divalent metal cation. The alginate lyase is entrapped by the method employed to make the crosslinked alginate microspheres of the copending claims. Also, the copending claims recite particles that are substantially free of water and include a cryoprotectant. The degradation durations of both set of claims are the same. The copending microspheres are recited as carriers for anti-inflammatory compounds or anticancer compounds, but their size as well as details of the alginate and crosslinking cation are not recited.
Kunjukunju et al. teach alginate particles crosslinked with calcium ions that include native alginate lyase or an aggregate of alginate lyase stabilized with ammonium sulfate to act as controlled release carriers for drugs (see page 178 first column first paragraph and second column second full paragraph and page 183 first column last full paragraph). There is no clear distinction between divalent calcium ions acting as crosslinking metal cations and divalent calcium ions that are alginate lyase inhibitors, thus the presence of divalent calcium ions in the particles acting as crosslinking metal ions meets both limitations (see instant claim 126 and 128). Bakaltcheva at al. detail that ammonium sulfate is a cryoprotectant (see paragraph 52; instant claim 129). The alginate has a molecular weight of 80,000 to 120,000 Da and a ratio of M units to G units of 61:39 which meets the limitations of about 50:50 and about 60:40 (see page 177 first column first full paragraph; instant claims 1 and 119). The native alginate lyase encapsulating particles degrade (self-degrading) in about 5 days (6 days) (see page 182 second column last partial paragraph-page 183 first column first full paragraph; instant claim 1).
Lecler et al. teach hydrogel microbeads that comprise alginate (see abstract). The microbeads are further taught to carry pharmaceutically active compounds such as anti-inflammatory compounds and anticancer compounds (see paragraphs 71-73). Their diameter is between 100 and 900 mm (see paragraph 22).
Dowling et al. teach self degrading microcapsules where the capsules encapsulate an enzyme for the polysaccharide that composes its shell (see abstract). They detail that the size can be adjusted based down by making smaller droplets of capsule material during production (see page 7995 first column first partial paragraph). Degradation times that span from minutes to hours are detailed and Dowling et al. note that the time shortened with increasing enzyme concentration (see page 7994 first column first partial paragraph, page 7995 second column and figure 3). As an example, they show spherical microcapsules sized at about 2750 mm, based on the scale bar, with 1.5 U/ml enzyme in the lumen (see figure 2). This corresponds to approximately 5.2 mU enzyme per particle (as calculated by the examiner).
Smrdel et al. discuss the desire for uniformity in shape amongst calcium crosslinked alginate particles employed for drug delivery (see abstract and page 84 first full paragraph). They go on to detail parameters involved in dropwise particle production techniques that directly influence sphericity such as the temperature of the calcium ion bath and hardening time (see figure 1). Here sphericity values of about 0.9 are achieved at higher hardening times (e.g., 30 minutes) and higher bath temperatures (e.g., 40⁰C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select an alginate as taught by Kunjukunju et al. for the microspheres of the copending claims because both are alginate lyase containing alginate microparticles envisioned as drug carriers. The modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome. In addition, the selection of a size as taught by Lecler et al. would have been obvious because the size taught by Lecler et al. was known to be useful for similar alginate containing microparticles. It also would have been obvious to prepare the microspheres employing production parameters that yield particles with a higher sphericity so as to have uniformity for use in drug delivery. This modification would have been obvious in light of Smrdel et al. as the application of the same technique to a similar product in order to yield the same improvement. The parameters and sphericity outcome are result effective variables and therefore are obvious to optimize as a matter of routine experimentation. Optimization of the degradation rate of the microspheres via enzyme concentration/amount per particle would have been obvious as matter of routine experimentation in light of Dowling et al. (see instant claim 1). Therefore claims 1, 125-129, and 133-135 are unpatentable over claims 1-7 of U.S. Application No. 19/109241 in view of Kunjukunju et al., Lecler et al., Dowling et al., and Smrdel et al.
Claims 1, 118-119, 125-129, and 132-135 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Application No. 19/109241 in view of Kunjukunju et al., Lecler et al., Dowling et al., and Smrdel et al. as applied to claims 1, 125-129, and 133-135 above, and further in view of Boyan et al.
Claims 1, 125-129, and 133-135 are taught by claims 1-7 of U.S. Application No. 19/109241 in view of Kunjukunju et al., Lecler et al., Dowling et al., and Smrdel et al.
in an active agent containing alginate microsphere. Alginate of a different monomer composition and size are not explicitly detailed nor is oxidized alginate.
Boyan et al. teach alginate microspheres for delivery of desirable bioactive proteins for therapeutic use from cell encapsulation (see paragraphs 10-12). The microspheres are crosslinked via the inclusion of calcium ions (see paragraph 69 and examples 1-2). The alginate may have a molecular weight of 50,000 to 400,000 Da (see paragraphs 158 and 190). They exemplify alginate microspheres made with at least 60% guluronate (G units) or least 60% guluronate (M units) mannnuronate and a greater or less than 200,000 Da molecular weight (see paragraph 190 and table 2). An exemplary alginate is employed with a 150 kDa molecular weight and 60:40 M:G ratio (see example 6). These varieties of alginate produced cell loaded microspheres sized at 176±0.2 mm to 194±0.7 mm that were intact for at least two weeks (see example 2; instant claim 1). They teach to include alginate lyase so as to induce controlled degradation for biological applications and note that the rate of degradation increases with increasing concentration (see paragraphs 23-26, 66, 69, 172, and 176, examples 26-27, and figure 15). Theus the concentration of alginate lyase on a mass or per particle basis is a result effective variable. Boyan et al. further teach that including oxidized alginate permits added control over the rate of degradation, where the process can be expedited due to its presence and the additional hydrolysis susceptible sites oxidation introduced (see paragraphs 26, 169, and 234).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the choice of alginate molecular weights and M to G ratios for the modified copending claims within the ranges taught by Boyan et al. because they teach them to be useful for similar alginate microparticles. The M to G ratio and molecular weight employed by the modified copending claims is embraced by the ranges of Boyan et al., thereby indicating the recognized utility of more sizes and ratios beyond that employed by the modified copending claims. The result is a range of molecular weights and M to G ratios that overlap with those instantly claimed, thereby rendering the claimed range obvious (see MPEP 2144.05). Optimization of the degradation rate of the microspheres via enzyme concentration would have been obvious as matter of routine experimentation with this result effective variable. It also would have been obvious to add oxidized alginate as taught by Boyan et al. with the alginate of the modified copending claims to permit additional control of the rate of release of a contained active. This modification would have been obvious as the application of the same technique to a similar product to yield the same improvement. Therefore claims 1, 118-119, 125-129, and 132-135 are obvious over claims 1-7 of U.S. Application No. 19/109241 in view of Kunjukunju et al., Lecler et al., Dowling et al., Smrdel et al., and Boyan et al.
Claims 1, 125-130, and 133-135 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Application No. 19/109241 in view of Kunjukunju et al., Lecler et al., Dowling et al., and Smrdel et al. as applied to claims 1, 125-128, and 133-135 above, and further in view of Hernandez Martin et al. (previously cited).
Claims 1-7 of U.S. Application No. 19/109241 in view of Kunjukunju et al. and Lecler et al. render obvious over the limitations of instant claims 1, 125-129, and 133-135. The copending claims recite particles that are substantially free of water and include a cryoprotectant. They do not include a claimed cryoprotectant.
Hernandez Martin et al. teach alginate microparticles employed to encapsulate a protein (biologic) for delivery in pharmaceutical applications (see abstract). They detail that the microparticles are freeze dried and include a common cryoprotectant such as sorbitol, trehalose, sucrose, or glycerol (see paragraph 116).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the modified particles of the copending claims and freeze dry them in the presence of a particular cryoprotectant, as taught by Hernandez Martin et al. This modification would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 1, 125-130, and 133-135 are obvious over claims 1-7 of U.S. Application No. 19/109241 in view of Kunjukunju et al., Lecler et al., Dowling et al., Smrdel et al., and Hernandez Martin et al.
Response to Arguments
Applicant's arguments filed October 30,2025 have been fully considered. In light of the amendment to the claims, the previous grounds of rejection are withdrawn. New grounds of rejection are detailed to address the new claim limitations and new combinations of previous claim limitations.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARALYNNE E HELM whose telephone number is (571)270-3506. The examiner can normally be reached Mon-Fri 9-5.
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/CARALYNNE E HELM/Examiner, Art Unit 1615
/MELISSA S MERCIER/Primary Examiner, Art Unit 1615