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
Claims 36, 43-47, and 51-52 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/25/2025.
Applicant’s election without traverse of claims 30 in the reply filed on 11/25/2025 is acknowledged.
Claim Interpretation
At the outset, with regard to Claim 30, it is noted that the limitation “wherein the individual has been administered a dose of an energy-based therapy” is broadly and reasonably understood to be outside the scope of the claim. That is, as understood, the limitation is given no patentable weight as it a condition precedent to claimed method. Accordingly, no prior art is required (although a prior art rejection is still provided herewith) for the limitation, Claims 34 and 36.
Claim Objections
Claim 44 is objected to because of the following informalities:
With regard to Claim 44, “toll-like receptor” should be changed to --toll receptor-- as the limitation “like” may introduce potential indefiniteness issues.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 85 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.
Regarding Claim 85, it is unclear whether the claimed “radiation therapy” refers to the same “energy-based therapy” prescribed in Claim 30. For present purposes of examination, the therapies shall be considered separate and distinct.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 30-31, 34,43, 49, 53-55, and 85 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guha et al. (WO 2019094802 A1, of record, hereinafter "Guha").
Regarding claim 30, Guha teaches a method of treating a tumor or a cancer in an individual (The combination of energy-based therapies with pharmaceutical and biotechnology materials can be used to treat cancer patient [0315]), the method comprising administering to the individual a dendritic cell activating molecule (The dendritic cell targeted therapy may comprise a material selected from the group consisting of Flt3L, CD40L, GM-CSF, ligands and agonists, RIG1 helicase activators, anti- CD40, NKG2D ligand, anti-CSFlR,anti-TLR, TLR ligands, INF-a, and TNF-β [0265]), wherein the individual has been administered a dose of an energy-based therapy, wherein the dose of the energy-based therapy is selected from the list consisting of Irreversible Electroporation (IRE), Microwave, Low-Intensity Focused Ultrasound (LOFU) (dendritic cell targeted therapy, effector T cell targeting or immune checkpoint inhibition, can be combined … Low-Intensity Focused Ultrasound (LOFU) [0264]), High- Intensity Focused Ultrasound (HIFU), Radiofrequency energy, and cryotherapy.
Regarding claim 31, Guha teaches the method of claim 30, as discussed above. Guha further teaches wherein the dose of the energy-based therapy comprises a plurality of doses of energy-based therapy (Figure 8A-8D: LOFU and RT treatment of murine prostate cancer and breast cancer models. Two treatments with LOFU (5W, 100%) and/or radiation (lOGy) were performed on two days with a 24 hour gap between (8A) [0017]).
Regarding claim 34, Guha teaches the method of claim 30, as discussed above. Guha further teaches wherein the energy-based therapy is Low-Intensity Focused Ultrasound (LOFU) and wherein the LOFU is administered at an intensity of between 10 and 1000 W/cm2 in the area of treatment (The ultrasound system comprised of multiple transducers can deliver 100 to 10,000 W/cm2 at 1 Mhz and 250 k [0343]).
Regarding claim 43, Guha teaches the method of claim 30, as discussed above. Guha further teaches wherein the dendritic cell activating molecule activates dendritic cell activation through a toll-like receptor, a NOD-like receptor, a RIG-1 or MDA-5 receptor, a C-type lectin receptor, a costimulatory molecule (The dendritic cell targeted therapy may comprise a material selected from the group consisting of Flt3L, CD40L, GM-CSF, ligands and agonists, RIG1 helicase activators, anti- CD40, NKG2D ligand, anti-CSFlR,anti-TLR, TLR ligands, INF-a, and TNF-β [0265]; the costimulatory molecule is anti-cd40 in light of the list of costimulatory molecules recited in claim 48), a cytokine receptor, or a STING pathway.
Regarding claim 48, Guha teaches the method of claim 30, as discussed above. Guha further teaches wherein the dendritic cell activating molecule is a costimulatory molecule agonist selected from the list consisting of a CD40 agonist (The dendritic cell targeted therapy may comprise a material selected from the group consisting of Flt3L, CD40L, GM-CSF, ligands and agonists, RIG1 helicase activators, anti- CD40, NKG2D ligand, anti-CSFlR,anti-TLR, TLR ligands, INF-a, and TNF-β [0265]), a_CD80 agonist, a CD86 agonist, an OX40 agonist, and combinations thereof.
Regarding claim 49, Guha teaches the method of claim 30, as discussed above. Guha further teaches wherein the CD40 agonist is an anti-CD40 agonistic antibody. (The dendritic cell targeted therapy may comprise a material selected from the group consisting of Flt3L, CD40L, GM-CSF, ligands and agonists, RIG1 helicase activators, anti- CD40, NKG2D ligand, anti-CSFlR,anti-TLR, TLR ligands, INF-a, and TNF-β [0265]).
Regarding claim 53, Guha teaches the method of claim 30, as discussed above. Guha further teaches wherein the dendritic cell activating molecule is administered to a tumor being treated with the dose of the energy-based therapy (The combination of energy-based therapies with pharmaceutical and biotechnology materials can be used to treat cancer patients. These combination treatments comprising "energy primed immunity" can address a broad array of cancers, initially guided by clinical use of the given bioactive. The bioactive may be selected from the group consisting of CTLA-4 and PD- (L)l axis, myeloid growth factor Flt3L, CD27, toll Like Receptor (TLR) agonists, agents that modulate myeloid cells such as CSF-IR inhibitors, inflammatory damage/danger sensing agents, including cytostolic DNA sensing pathway STING agonists, and chaperones including PDI, calnexin, calreticulin, CD74, Hsp54, Hsp60, Hsp70, Hsp72, BiP, Hsp90, Gp96, clusterin and other cell surface proteins including CD47.. The mechanisms may stem in part from APT's ability to disrupt cellular processes and induce UPR, which can also account in part for AP synergy with RT [0315]).
Regarding claim 54, Guha teaches the method of claim 30, as discussed above. Guha further teaches wherein the tumor or the cancer is a solid tissue tumor or cancer ([0185] discloses treatment of solid tumors; [0066] lists tumors/cancers treated).
Regarding claim 55, Guha teaches the method of claim 54, as discussed above. Guha further teaches wherein the solid tissue tumor or cancer is of breast, prostate (tumor is a tumor of the prostate, breast [0066]), lung, or pancreas, or a glioma, or a melanoma.
Regarding claim 85, Guha teaches the method of claim 30, as discussed above. Guha further teaches wherein the method further comprises administering to the individual a dose of a radiation therapy (LOFU may serve as a radiosensitizer for cancer radiation therapy. Cancer cells were first treated with LOFU and then exposed to radiation (5Gy) 1 hour later [0015]).
Claim Rejections - 35 USC § 103
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.
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 39, 50, and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Guha et al. (WO 2019094802 A1, of record, hereinafter "Guha") in view of Keler et al. (WO 2019147982 A1, of record, hereinafter "Keler").
Regarding claim 39, Guha teaches the method of claim 30, as discussed above. Guha further teaches wherein the dendritic cell activating molecule is administered… after the dose of the energy-based therapy (the LOFU is administered to the subject prior to the immunotherapy being administered [0057]; [0307] discloses there is a five day window following treatment).
While Guha is silent on wherein the dendritic cell activating molecule is administered at least three days after the dose of the energy-based therapy.
Guha, however, does not explicitly state wherein the dendritic cell activating molecule is administered at least three days after the dose of the energy-based therapy.
Keler is considered analogous to the instant application as “Methods of treating cancer with dendritic cell mobilizing agents” is disclosed. Keler teaches wherein the dendritic cell activating molecule is administered at least three days after the dose of the energy-based therapy (the dendritic cell mobilizing agent is administered within 3 days before or after the first day of radiation therapy, page 34, Para. 3 lines 2-4).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Guha to include wherein the dendritic cell activating molecule is administered at least three days after the dose of the energy-based therapy, as taught by Keler. Doing so would improve overall survival and progression free survival of cancer patients, as suggested by Keler (Page 5, Paragraph 3 lines 2-3).
Regarding claim 50, Guha teaches the method of claim 49, as discussed above. Guha, however, does not teach wherein the anti-CD40 agonistic antibody comprises dacetuzumab, CP-870,893, ADC-1013, 2141-v11, APX005M, Chi Lob 7/4, BG9588 (NIAMS), CFZ533, PG10, BMS-986004, lucatumumab, HCD122, JNJ-64457107,selicrelumab, ASKP1240, CDX-1140, or SEA-CD40.
Keler is considered analogous to the instant application as “Methods of treating cancer with dendritic cell mobilizing agents” is disclosed. Keler discloses wherein the anti-CD40 agonistic antibody comprises dacetuzumab (Other exemplary agents that modulate one of the above proteins and may be combined with dendritic cell mobilizing agents, e.g., those described herein, for treating cancer (e.g., lung cancer), include: …Dacetuzumab (to CD40), Page 26, paragraph 4 lines 1-7).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Guha to include wherein the anti-CD40 agonistic antibody comprises dacetuzumab, as taught by Keler. Doing so would improve overall survival and progression free survival of cancer patients, as suggested by Keler (Page 5, Paragraph 3 lines 2-3).
Regarding claim 56, Guha teaches the method of claim 30, as discussed above. Guha, however, does not teach wherein the tumor or cancer is resistant to checkpoint inhibitor therapy.
Keler is considered analogous to the instant application as “Methods of treating cancer with dendritic cell mobilizing agents” is disclosed. Keler teaches wherein the tumor or cancer is resistant to checkpoint inhibitor therapy (the method comprises treating cancer in a subject who has become or been determined to be resistant to an immune checkpoint inhibitor, by administering a Flt3 ligand or nucleic acid coding therefor, page 2, paragraph 3 lines 7-9).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Guha to include wherein the tumor or cancer is resistant to checkpoint inhibitor therapy, as taught by Keler. Doing so would improve overall survival and progression free survival of cancer patients, as suggested by Keler (Page 5, Paragraph 3 lines 2-3).
Conclusion
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/N.B./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798