Prosecution Insights
Last updated: April 19, 2026
Application No. 18/593,526

METHODS AND COMPOSITIONS OF CRYOABLATION WITH DRUG DELIVERY

Non-Final OA §102§103§112
Filed
Mar 01, 2024
Examiner
SOLOMON, JOSHUA BRENDON
Art Unit
3792
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Theromics, Inc.
OA Round
1 (Non-Final)
82%
Grant Probability
Favorable
1-2
OA Rounds
2y 7m
To Grant
99%
With Interview

Examiner Intelligence

Grants 82% — above average
82%
Career Allow Rate
227 granted / 276 resolved
+12.2% vs TC avg
Strong +21% interview lift
Without
With
+20.7%
Interview Lift
resolved cases with interview
Typical timeline
2y 7m
Avg Prosecution
34 currently pending
Career history
310
Total Applications
across all art units

Statute-Specific Performance

§101
2.0%
-38.0% vs TC avg
§103
56.9%
+16.9% vs TC avg
§102
20.2%
-19.8% vs TC avg
§112
10.1%
-29.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 276 resolved cases

Office Action

§102 §103 §112
DETAILED ACTION Notice of Pre-AIA or AIA Status 1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. Claim Rejections - 35 USC § 112 2. Claim 28 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 28 is recites the limitation "the cryoprobe" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim Rejections - 35 USC § 102 3. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 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. 4. Claims 1-2 ,4, 7, 12-13, and 16-21 are rejected under 35 U.S.C. 102 (a) (1) and (a) (2) as being anticipated by Bright (US 2021/0205501 A1). Regarding claim 1, Bright teaches a method for cryoablation of a tissue of a patient (the cryoablation is provided in combination with a drug-loaded gel formulation that may be delivered to the target tissue (e.g., lesion site) of a patient [0019, 0086, 0092-0093, 0113]), comprising: positioning a cryoablation gel composition adjacent to a tissue of the patient (the cryoablation is provided in combination with a drug-loaded gel formulation that is delivered to the target tissue (e.g., lesion site) of a patient [0019, 0086, 0092-0093, 0113]); and cryoablating the tissue and cryoablation gel composition with a cryoprobe (the cryoablation is provided in combination with a drug-loaded gel formulation that is delivered to the target tissue (e.g., lesion site) of a patient [0086, 0092-0093, 0113, 0123]. Specifically, the cryoablation is provided by a catheter or probe [0092-0093, 0113]), the cryoablation gel composition comprising a thermal accelerant (Applicant states that the thermal accelerant comprises albumin within claim 2. Similarly Bright teaches the gel to be cross-linked with an accelerator or crosslinking agent (e.g., albumin and/or ionic components) [0092, 0152, 0157-0158, 0195]). Regarding claim 2, Bright teaches wherein the thermal accelerant comprises: a carrier comprising an albumin (the gel is cross-linked with an accelerator or crosslinking agent (e.g., albumin and/or ionic components) [0152, 0157-0158, 0195]. Specifically, the accelerator or crosslinking agent (e.g., albumin) is delivered by a carrier (e.g., catheter-based administration or needle-based administration [0086, 0092, 0157-0158, 0176]. For example, the gel is delivered through the lumen of a catheter [0086]); an ionic component (the gel is cross-linked with an accelerator or crosslinking agent (e.g., albumin and/or ionic components) [0152, 0158, 0195]); and an imaging component (as stated previously above the gel is cross-linked with an accelerator or crosslinking agent (e.g., albumin and/or ionic components) [0152, 0158, 0195]. Furthermore, the gel may include an imaging component (e.g., contrast agent) which allows the gel to be visualized by imagining modality (e.g., ultrasound or fluoroscopic imaging) [0021, 0023, 0038]. Specifically, the imaging modality (e.g., ultrasound or fluoroscopic imaging) is used to monitor delivery of the gel to the target tissue or nerve [0021, 0023] The Examiner respectfully submits that Applicant defines the imaging components to be contrast agents [specification: page 3 lines 12-14]). Regarding claim 4, Bright teaches wherein positioning the cryoablation gel composition comprises injecting the cryoablation gel composition into the tissue ([0019, 0021, 0083, 0092]). Regarding claim 7, Bright teaches wherein the cryoablation gel composition further comprises a drug (the gel comprises a drug or agent [0092]). Regarding claim 12, Bright teaches cryoablation gel composition (the cryoablation is provided in combination with a drug-loaded gel formulation that may be delivered to the target tissue (e.g., lesion site) of a patient [0019, 0086, 0092-0093, 0113]) comprising: a polymer ([0092, 0158, 0195]); and a thermal accelerant comprising an ionic component and an imaging component (the gel is cross-linked with an accelerator or crosslinking agent (e.g., albumin and/or ionic components) [0152, 0158, 0195]. Furthermore, the gel may include an imaging component (e.g., contrast agent) which allows the gel to be visualized by imagining modality (e.g., ultrasound or fluoroscopic imaging) [0021, 0023, 0038]. Specifically, the imaging modality (e.g., ultrasound or fluoroscopic imaging) is used to monitor delivery of the gel to the target tissue or nerve [0021, 0023]. The Examiner respectfully submits that Applicant defines the imaging components to be contrast agents [specification: page 3 lines 12-14]). Regarding claim 13, Bright teaches wherein the thermal accelerant further comprises: a carrier comprising an albumin (the gel is cross-linked with an accelerator or crosslinking agent (e.g., albumin and/or ionic components) [0152, 0157-0158, 0195]. Specifically, the accelerator or crosslinking agent (e.g., albumin) is delivered by a carrier (e.g., catheter-based administration or needle-based administration [0086, 0092, 0157-0158, 0176]. For example, the gel is delivered through the lumen of a catheter [0086]). Regarding claim 16, Bright teaches wherein the polymer comprises one or more of naturally occurring biopolymers (the gel is crosslinked with biopolymers, such as polymerizing polyethylene glycol (PEG) [0158, 0336]). Regarding claim 17, Bright teaches wherein the polymer comprises: ionic functionalities (the gel is crosslinked with biopolymers, such as polymerizing polyethylene glycol (PEG) [0158, 0336]. Specifically, the PEG-based gel is formed through ionic interactions [0181]); and the ionic functionalities comprise other ionic groups (as stated previously above, the PEG-based gel is formed through ionic interactions [0181]. The Examiner respectfully submits that the ionic interactions would inherently require one or more ionic groups [0181]). Regarding claim 18, Bright teaches wherein the ionic component comprises alkaline earth metal ions (the gel formulation may include calcium which known to be an alkaline earth metal ion [0235]). Regarding claim 19, Bright teaches wherein the albumin comprises human serum albumin (HSA) ([0158]). Regarding claim 20, Bright teaches wherein the HSA serves as a drug delivery vehicle (the crosslinked PEG hydrogels (e.g., PEG crosslinked with human serum albumin) are selected for the delivery of drugs [0158]). Regarding claim 21, Bright teaches wherein the HSA drug delivery vehicle delivers the drug via one or more of non-covalently binding or covalently binding (the crosslinked PEG hydrogels (e.g., PEG crosslinked with human serum albumin) are selected for the delivery of drugs [0158]. Specifically, the hydrogel can be designed to covalently or noncovalently adhere to the target tissue [0141]). Claim Rejections - 35 USC § 103 5. 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. 6. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Bright in view of Sliwa, Jr. et al. (US 2007/0224169 A1). Regarding claim 3, Bright teaches the method of claim 1, wherein the cryoablation gel composition undergoes a phase change ([0092-0093, 0131, 0244]). However, Bright does not explicitly teach wherein the cryoablation gel composition undergoes the phase change as the cryoablation gel composition components rearrange themselves in response to lowering the temperature of the cryoablation gel composition to less than -20 oC; and the phase change event is complete within about 5 oC. The prior art by Sliwa, Jr. is analogous to Bright, as they both teach a gel formulation that is applied during a cryoablation treatment ([0058-0059, 0104]). Sliwa, Jr. teaches the wherein cryoablation gel composition undergoes the phase change as the cryoablation composition components rearrange themselves in response to lowering the temperature of the cryoablation gel composition ([0104, 0163]). Sliwa, Jr. does not explicitly teach temperature of the cryoablation gel composition to be lowered to less than -20 oC; and the phase change event is complete within about 5 oC. However, the Examiner respectfully submits that Sliwa, Jr. teaches the use of a cryotherapy and heating procedure which allows the gel to undergo a phase-change (the gel may be cooled to solidify and then rewarmed to reliquefy [0101, 0104, 0163]). Thus, a person having ordinary skill in the art would have found it obvious to lower the temperature of the cryoablation get compostion to less than -20 oC and further regulate the temperature (e.g., rewarming or heating) such that the phase change event is complete within about 5 oC. The advantage of such modification will allow the gel to converted from an unflowable state to a flowable state within the patient’s body by using a cryotherapy and heating procedure (see paragraphs [0051, 0101, 0104, 0163] by Sliwa, Jr.). The Examiner further submits that the skilled artisan could arrive at the claimed temperatures via routine experimentation (MPEP 2144.05). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Bright’s cryoablation gel composition to undergo a phase change when temperature that is lowered to less than -20 oC and the phase change event being completed within about 5 oC, as further suggested by Sliwa, Jr. The advantage of such modification will allow the gel to converted from an unflowable state to a flowable state within the patient’s body by using a cryotherapy and heating procedure (see paragraphs [0051, 0101, 0104, 0163] by Sliwa, Jr.) 7. Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Bright in view of Clark et al. (US 2017/0143409 A1). Regarding claim 5, Bright teaches the method of claim 1. Bright does not explicitly teach wherein the wherein the cryoablation gel composition has a viscosity value of between about 500 cP and about 7,000 cP. The prior art by Clark is analogous to Bright, as they both teach a gel formulation that is applied during a cryogenic ablation treatment ([0032, 0043, 0046, 0066]). Clark teaches wherein the cryoablation gel composition has viscosity value that ranges up to 100,000 cP ([0032, 0043, 0046]). Clark does not explicitly teach wherein the viscosity value is between about 500 cP and about 7,000 cP. However, Applicant’s claimed viscosity value of about 500 cP to about 7,000 cP lies within Clark’s velocity value that ranges up to 100,000 cP. Therefore, a prima facie case of obviousness exists. Based on the overlapping range, a person having ordinary skill in the art would have found it obvious to the modify the velocity value to range between 500 cP to about 7000 cP (MPEP 2144.05). The advantage of such modification may improve the viscosity particle dispersion of the gel (see paragraph [0046] by Clark). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Bright’s cryoablation gel to include a velocity value that is between about 500 cP and about 7,000 cP, as suggested by Clark. The advantage of such modification may improve the viscosity particle dispersion of the gel (see paragraph [0046] by Clark). Regarding claim 6, Bright teaches wherein the injected cryoablation gel composition remains at the target site (the gel is delivered or injected into the target tissue or nerve [0019, 0083, 0086, 0092]. Specifically, the drug-loaded gel remains in contact with the target tissue or nerve [0063, 0092]). 8. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Bright in view of Askew et al. (US 2009/0192505 A1). Regarding claim 8, Bright teaches the method of claim 7. Bright does not explicitly teach wherein the drug comprises a cytotoxic or immune modulatory anti-tumor agent. The prior art by Askew is analogous to Bright, as they both teach a gel formulation that is applied during a cryoablation treatment ([0125, 0156, 0165, 0220]). Askew teaches wherein the drug comprises a cytotoxic or immune modulatory anti-tumor agent ([0165, 0220, 0258]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Bright’s drug to comprise a cytotoxic or immune modulatory anti-tumor agent, as taught by Askew. The advantage of such modification will allow Bright’s cryotherapy to be used in conjunction with the immune modulatory anti-tumor agent to destroy treat a tumor or cancerous lesion (see paragraphs [0157, 0165, 0220, 0258] by Askew). 9. Claims 14-15 and 25-30 are rejected under 35 U.S.C. 103 as being unpatentable over Bright in view of Jackson (US 2010/0272779 A1). Regarding claim 14, Bright teaches the composition of claim 13, further comprising a drug configured to be associated with the carrier (the drug-loaded gel is delivered by a carrier (e.g., catheter-based administration or needle-based administration [0092, 0157-0158, 0176]. For example, the drug loaded gel is delivered through the lumen of a catheter [0086]); and wherein cryoablation to be applied in combination with the drug to the target site (the cryoablation is provided in combination with a drug-loaded gel formulation that may be delivered to the target tissue (e.g., lesion site) of a patient [0019, 0086, 0092-0093, 0113]). However, Bright does not explicitly teach wherein the drug being configured to be eluted out following exposure of the drug and the carrier to a cryoablation. The prior art by Jackson is analogous to Bright, as they both the administration of a drug during a cryotherapy treatment ([abstract, 0081]). Jackson teaches wherein the drug being configured to be eluted out following exposure of the drug and the carrier to a cryoablation (the eluting device or carrier (e.g., lumen) is configured to release the drug after being exposed to change in temperature (e.g., cryotherapy) [0011, 0081]). Therefore, a person having ordinary skill in the art would have found it obvious to modify Bright’s drug to be eluted following the exposure of the drug and the carrier to the cryoablation, as taught by Jackson. This modification is beneficial as the temperatures can be adjusted during cryoablation to provide a controlled-release of the drug (see paragraphs [0011, 0081] by Jackson). Specifically, this ensures that a specific amount of the drug is released to produce the desired therapeutic effect (see paragraph [0081] by Jackson). Regarding claim 15, Jackson teaches wherein the drug is eluted out to mitigate a disease directly ([0036, 0081]) or play a role as a modulator of patients’ immune responses while minimizing adverse effects ([abstract, 0141]). Regarding claim 25, Bright teaches a drug configured to be associated with the cryoablation gel composition (the cryoablation is provided in combination with a drug-loaded gel formulation that may be delivered to the target tissue (e.g., lesion site) of a patient [0019, 0086, 0092-0093, 0113]); and the drug is associated with cryoablation gel composition being covalently tethered (the gel (e.g. hydrogel) is covalently bonded or tethered to the drug to synthesize the PEG-based hydrogels [0178]); and wherein cryoablation to be applied in combination with the drug and the cryoablation gel composition to the target site (the cryoablation is provided in combination with a drug-loaded gel formulation that may be delivered to the target tissue (e.g., lesion site) of a patient [0019, 0086, 0092-0093, 0113]). Bright does not explicitly teach the drug to be eluted out after being exposed to the cryoablation. However, Jackson teaches the drug being configured to be eluted out after being exposed to the cryoablation (the drug is released after being exposed to change in temperature (e.g., cryotherapy) [0011, 0081]). Therefore, a person having ordinary skill in the art would have found it obvious to modify the Bright’s drug to be eluted following the exposure to the cryoablation, as taught by Jackson. This modification is beneficial as the temperatures can be adjusted during cryoablation to provide a controlled-release of the drug (see paragraphs [0011, 0081] by Jackson). Specifically, this ensure that a specific amount of the drug is released to produce the desired therapeutic effect (see paragraph [0081] by Jackson). Regarding claim 26, Bright teaches a cryothermally-activated combined treatment composition (the cryoablation is provided in combination with a drug-loaded gel formulation that may be delivered to the target tissue (e.g., lesion site) of a patient [0019, 0086, 0092-0093, 0113]), comprising: a therapeutic agent (the cryoablation is provided in combination with a drug-loaded gel formulation that may be delivered to the target tissue (e.g., lesion site) of a patient [0019, 0086, 0092-0093, 0113]); and a thermal accelerant (the drug-loaded gel is configured to be cross-linked with an accelerator or crosslinking agent [0092, 0152, 0157-0158, 0195]) configured to: enhance ablation treatment (the drug-loaded gel includes a crosslinking agent (e.g., accelerator) which is provided in conjunction with the delivery of cryoablation [0019, 0092, 0158]. Specifically, the combination of cryoablation and the gel improves the treatment of pain [0019]); be impregnated with the therapeutic agent (the drug-loaded gel includes a crosslinking agent (e.g., accelerator) [0019, 0092, 0158]); and wherein a cryogenic source is configured to apply cryogenic temperatures in combination with the therapeutic agent to the target site (the cryoablation catheter is configured to provide cryoablation in combination with a drug-loaded gel formulation that may be delivered to the target tissue (e.g., lesion site) of a patient [0019, 0086, 0092-0093, 0113]). Bright does not explicitly teach elute the therapeutic agent after exposure to cryogenic temperatures from the cryogenic source, wherein the combined treatment composition is cryogenically activated by exposure to energy from the cryogenic source. The prior art by Jackson is analogous to Bright, as they both the administration of a drug during a cryotherapy treatment ([abstract, 0081]). Jackson teaches elute the therapeutic agent after exposure to cryogenic temperatures from the cryogenic source, wherein the combined treatment composition is cryogenically activated by exposure to energy from the cryogenic source (the eluting device is configured to release the drug after being exposed to change in temperature (e.g., cryotherapy) [0011, 0081]). Therefore, a person having ordinary skill in the art would have found it obvious to modify the Bright’s drug to be eluted following the exposure cryotherapy, as taught by Jackson. This modification is beneficial as the temperatures can be adjusted during cryotherapy to provide a controlled-release of the drug (see paragraphs [0011, 0081] by Jackson). Specifically, this ensure that a specific amount of the drug is released to produce the desired therapeutic effect (see paragraph [0081] by Jackson). Regarding claim 27, Bright teaches wherein the therapeutic agent is associated with the thermal accelerant by at least one of protein binding or covalent bonding (the drug-loaded gel is configured to be covalently crosslinked with the accelerator or crosslinking agent [0092, 0151-0152, 0158, 0178]). Regarding claim 28, Bright teaches after the thermal accelerant is exposed to the cryoprobe (as stated previously in claim 26, the drug-loaded gel is configured to be crosslinked with the accelerator or crosslinking agent [0092, 0151-0152, 0158, 0178]. Specifically, the crosslinked drug-loaded gel is exposed to cryoablation from a cryogenic catheter or cryoprobe [0019, 0092-0093, 0152, 0113]); the thermal accelerant is configured to solidify and becomes coupled with the ablated tissue (the crosslinked gel consists of accelerator or crosslinking agent that is configured to solidify and become coupled with the target tissue during the cryoablation ([0019, 0141, 0152]); and the thermal accelerant is configured to begin to elute a portion of therapeutic agent (the gel consists of an accelerator or crosslinking agent (e.g., crosslinked PEG hydrogel) that is selected to elute or deliver the drugs during the cryoablation [0019, 0152, 0158]). Regarding claim 29, Bright teaches wherein: the thermal accelerant comprises: a carrier comprising an albumin (the gel is cross-linked with an accelerator or crosslinking agent (e.g., albumin and/or ionic components) [0152, 0157-0158, 0195]. Specifically, the accelerator or crosslinking agent (e.g., albumin) is delivered by a carrier (e.g., catheter-based administration or needle-based administration [0086, 0092, 0157-0158, 0176]. For example, the gel is delivered through the lumen of a catheter [0086]).; an ionic component comprising at least one chaotrope (the gel is cross-linked with an accelerator or crosslinking agent (e.g., albumin and/or ionic components) [0152, 0157-0158, 0195]. Specifically, the ionic components of the gel may include a chaotrope (e.g., octanoic acid) [0132]. The Examiner respectfully submits that Applicant defines the chaotrope to include octanoic acid [specification: page 4 lines 21-25]) and an imaging component (as stated previously above the gel is cross-linked with an accelerator or crosslinking agent (e.g., albumin and/or ionic components) [0152, 0158, 0195]. Furthermore, the gel may include an imaging component (e.g., contrast agent) which allows the gel to be visualized by imagining modality (e.g., ultrasound or fluoroscopic imaging) [0021, 0023, 0038]. Specifically, the imaging modality (e.g., ultrasound or fluoroscopic imaging) is used to monitor delivery of the gel to the target tissue or nerve [0021, 0023]. The Examiner respectfully submits that Applicant defines the imaging components to be contrast agents [specification: page 3 lines 12-14]). Regarding claim 30, Bright teaches wherein the albumin comprises human serum albumin ([0158]); the chaotrope comprises octanoic acid ([0132]); and the imaging component comprises iohexol (the imaging component (e.g., contrast agent) comprises iohexol which allows the gel to be visualized by an imaging modality (e.g., ultrasound or fluoroscopic imaging) [0021, 0038, 0110]). 10. Claims 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Bright in view of Zhang et al. (US 2019/0046557 A1). Regarding claim 22, Bright teaches the composition of claim 21. Bright does not explicitly teach wherein the drug comprises one or more of Albiglutide, Semaglutide, Abraxane, or Levemir. The prior art by Zhang is analogous to Bright, as they both teach agents or drugs that are administered during a cryoablation treatment ([0042, 0044, 0053]). Zhang teaches wherein the drug comprises Abraxane ([0044]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Bright’s drug to comprise Abraxane, as taught by Zhang. This modification is beneficial, as Abraxane can be used to provide a cancer treatment (see paragraphs [0042, 0044, 0053] by Zhang). Regarding claim 23, Bright teaches the composition of claim 12. Bright does not explicitly teach wherein the thermal accelerant further comprises an anti-tumor drug. However, Zhang teaches wherein the thermal accelerant further comprises an anti-tumor drug (anti-tumor drugs (e.g., cytotoxic agents) are administered during the cryoablation [0042, 0053]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Bright’s thermal accelerant to comprise an anti-tumor drug, as taught by Zhang. This modification is beneficial, as the anti-tumor drug (e.g., cytotoxic agents) can be used to provide a cancer treatment (see paragraphs [0042, 0053] by Zhang). Regarding claim 24, Zhang teaches wherein the anti-tumor drug comprises a cytotoxic agent ([0042, 0053]). Allowable Subject Matter 11. Claim 9-11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: The Examiner has provided an explanation below that describes how the prior art of record fails to the suggest the corresponding claim. Regarding claim 9, Bright in view of Askew suggests the method of claim 8. Askew teaches wherein the cytotoxic anti-tumor agent directly targets tumor cells ([0165, 0220, 0258]). However, Bright and Askew do not explicitly teach wherein the cytotoxic anti-tumor agent directly targets FcRn over expressed tumor cells using pinocytosis of the albumin with the cytotoxic anti-tumor agent. The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements. Claims 10-11 are considered to contain allowable subject matter, as claims 10-11 depend upon claim 9. Statement on Communication via Internet 12. Communications via Internet email are at the discretion of the applicant. All Internet communications between USPTO employees and applicants must be made using USPTO tools. Without a written authorization by applicant in place, the USPTO will not respond via Internet email to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. A paper copy of such correspondence and response will be placed in the appropriate patent application. Except for correspondence that only sets up an interview time, all correspondence between the Office and the applicant including applicant's representative must be placed in the appropriate patent application. If an email contains any information beyond scheduling an interview such as an interview agenda or authorization, it must be placed in the application. For those applications where applicant wishes to communicate with the examiner via Internet communications, e.g., email or video conferencing tools, the following is a sample authorization form which may be used by applicant: "Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file." Please refer to MPEP 502.03 for guidance on Communications via Internet. Conclusion 13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached on 7:30am -4:30pm. 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, Gary Jackson can be reached on (571)272-4697. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792
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Prosecution Timeline

Mar 01, 2024
Application Filed
Dec 22, 2025
Non-Final Rejection — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
82%
Grant Probability
99%
With Interview (+20.7%)
2y 7m
Median Time to Grant
Low
PTA Risk
Based on 276 resolved cases by this examiner. Grant probability derived from career allow rate.

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