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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 21 January 2026 has been entered.
Status of Application, Amendments and/or Claims
The amendment of 21 January 206 has been entered in full. Claims 1, 5, 8, 12, and 32 are amended. Claims 6, 9, and 10 are cancelled.
Claims 1-5, 7, 8, and 11-32 are under consideration in the instant application.
Withdrawn Objections and/or Rejections
1. The objection to claim 32 as set forth at page 3 of the previous Office Action of 23 September 2025 is withdrawn in view of the amended claim (21 January 2026).
2. The rejection of claim 32 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as set forth at pages 3-4 of the previous Office Action of 23 September 2025 is withdrawn in view of the amended claim (21 January 2026).
3. The rejection of claims 1, 3, 6-10, 12, 16-26, and 29 under 35 U.S.C. 102(a)(1) as being anticipated by Mansour et al. (US 2011/0070298) as set forth at pages 9-12 of the previous Office Action of 23 September 2025 is withdrawn in view of amended claim 1 (21 January 2026). Specifically, Mansour et al. do not teach a composition wherein the composition does not include an immunogen.
4. The rejection of claims 1, 3, 4, 6-10, 12, 16-26, and 29 under 35 U.S.C. 103 as being unpatentable over Mansour et al. (US 2011/0070298) and Jia et al. (Oncol Res 23: 321-326, 2016) as set forth at pages 17-19 of the previous Office Action of 23 September 2025 is withdrawn in view of amended claim 1 (21 January 2026). Specifically, Mansour et al. do not teach a composition wherein the composition does not include an immunogen.
5. The rejection of claims 1, 3, 6-10, 12-14, 16-26, and 29 under 35 U.S.C. 103 as being unpatentable over Mansour et al. (US 2011/0070298) and Hardt et al. (US 2016/0151453) as set forth at pages 20-22 of the previous Office Action of 23 September 2025 is withdrawn in view of amended claim 1 (21 January 2026). Specifically, Mansour et al. do not teach a composition wherein the composition does not include an immunogen.
6. The rejection of claims 1, 3, 6-10, 12, 16-26, 29, 31, and 32 under 35 U.S.C. 103 as being unpatentable over Mansour et al. (US 2011/0070298) and Mian et al. (J Leukoc Biol 84: 1025-1036, 2013) as set forth at pages 25-27 of the previous Office Action of 23 September 2025 is withdrawn in view of amended claim 1 (21 January 2026). Specifically, Mansour et al. do not teach a composition wherein the composition does not include an immunogen.
7. The rejection of claims 1, 3, 6-10, 12, 16-30 under 35 U.S.C. 103 as being unpatentable over Mansour et al. (US 2011/0070298) and Florin-Christensen et al. (“Liposome Applications in the Veterinary Field” in Advances in Liposome Research, Nova Science Publishers 123-146, 2014) as set forth at pages 31-33 of the previous Office Action of 23 September 2025 is withdrawn in view of amended claim 1 (21 January 2026). Specifically, Mansour et al. do not teach a composition wherein the composition does not include an immunogen.
Claim Rejections - 35 USC § 112(b)
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.
8. Claims 1-5, 7, 8, and 11-32 are 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.
8a. Claims 1-5, 7, 8, and 11-32 are rejected as being indefinite because the term “immunostimulatory pharmaceutical composition” in claim 8 is a relative term which renders the claim indefinite. The term “immunostimulatory pharmaceutical composition” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Additionally, claim 1, lines 7-8 recite, “wherein the composition comprises an immunostimulatory pharmaceutical composition”. The preamble of claim 1 is also directed to “a pharmaceutical composition”. Therefore, is the “immunostimulatory pharmaceutical composition” recited in line 8 referring to the claimed pharmaceutical composition as simply having immunostimulatory activity? Or, does the claimed pharmaceutical composition comprise an additional immunostimulatory pharmaceutical composition?
Claim 1 also recites “composition” (line 7), “immunostimulatory pharmaceutical composition” (line 8), and “pharmaceutical composition” (lines 1, 8). The recitation of three different “compositions” lends to the confusion of the claim.
Maintained 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.
9. Claims 1-3, 7, 8, 11, 12, 15-28, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dow et al. (US 2005/0013812; cited on the IDS of 27 January 2023). The basis for the rejection is set forth for claims 1-3, 6-12, 15-28, and 30 at pages 4-9 of the previous Office Action of 23 September 2025.
Dow et al. teach a vaccine that includes the following components: (a) at least one ligand that is recognized by a pattern recognition molecule (receptor); and (b) a delivery vehicle, wherein the delivery vehicle is a cationic liposome (page 3, [0023]; page 4, [0026, 0028]; Examples 1, 2, 4; pages 16-17, [0118-0123]). Dow et al. disclose that the ligand(s) may be selected for recognition by Toll-like receptors, including TLR-3 and TLR-9 (page 3, [0024]). Dow et al. indicate that a ligand for TLR-3 is double-stranded RNA and poly I:C while a ligand for TLR-9 is bacterial DNA (CpG), meeting the limitations of instant claims 1 and 3 (page 3, [0024]; page 5, [0049]; page 20, [0144]; page 28, Examples 1, 2, 4). Dow et al. disclose that mixtures of the ligands are used to prepare liposome-TLR ligand complexes, meeting the limitations of instant claim 1 (page 3, [0024]; claims 63 and 110).
Dow et al. teach that the liposome element of the composition may include cholesterol complexed with the cationic lipids, including DOTAP and cholesterol (in a 1:1 ratio); and a cholesterol backbone conjugated to polyethylene glycol, meeting the limitations of instant claims 1 and 2 (page 4, [0026]; pages 5-6, [0054]; page 17, [0123]; page 31, [0228]).
Dow et al. teach the therapeutic composition of the invention comprising at least one ligand recognized by a pattern recognition molecule receptor (including a TLR-3 and TLR-9 ligand) and a liposome delivery vehicle may be combined with a pharmaceutically or pharmacologically acceptable excipient, meeting the limitations of instant claim 1 (page 3, [0023-0024]; page 4, [0025]; pages 16-17, [0118-0123]; page 22, [0156, 0161]). Dow et al. disclose that standard excipients include polyethylene glycols, carboxymethylcellulose calcium, carboxymethylcellulose sodium, gelatin and collagen, meeting the limitations of instant claims 1, 11, and 12 (page 4, [0027]; page 22, [0157], [0161]). Dow et al. also disclose that the invention relates to a method to elicit a systemic, non-immunogenic-specific immune response by administering the vaccine (such as to a subject with cancer or an infectious disease), meeting the limitations of instant claims 16, 17, 19, and 20 (page 4, [0028]; page 7, [0060]; page 9, [0076]; page 10, [0078]; page 16, [0114, 0116, 0117]). Dow et al. teach that the step of administering can be by any route, including, but not limited to, intravenous, intraperitoneal, subcutaneous, intradermal, intranodal, intramuscular, transdermal, inhaled, intranasal, rectal, vaginal, urethral, topical, oral, intraocular, intraarticular, intracranial, and intraspinal, meeting the limitations of instant claims 18 and 21 (page 4, [0028]; page 6, [0055]). Dow et al. disclose that the therapeutic compositions can be administered to any member of the Vertebrate class, including livestock, domestic pets, humans, dogs, cats, mice, rats, sheep, horses, and pigs, meeting the limitations of instant claims 25-28 and 30 (page 19, [0139]). Dow et al. also teach that the invention provides kits that comprise one or more containers, meeting the limitations of instant claim 24 (page 23, [0163-0164]).
(i) At the middle of page 7 of the Response of 21 January 2026, Applicant argues that the formulations of Dow et al. require an immunogen not required by the instantly claimed invention. Applicant states, “Prior art that discloses and requires more elements than the claims of which it is asserted does not anticipate an invention that requires less than the disclosed/required elements in the asserted art”.
Applicant’s arguments have been fully considered but are not found to be persuasive. Specifically, Dow et al. teach two different compositions, wherein one composition comprises an immunogen (page 4, [0025]) and one composition does not. Dow et al. clearly disclose a vaccine that “includes the following components: (a) at least one ligand that is recognized by a pattern recognition molecule (receptor); and (b) a delivery vehicle”, wherein the delivery vehicle is a cationic liposome (page 3, [0023]; page 4, [0026, 0028]; Examples 1, 2, 4; pages 16-17, [0118-0123]).
Dow et al. also disclose “a therapeutic composition that includes: (a) a liposome delivery vehicle; and (b) a pattern recognition receptor ligand”, meeting the limitations of instant claim 1 (page 22, [0156]).
Dow et al. indicate that the ligand(s) may be selected for recognition by Toll-like receptors, including TLR-3 and TLR-9 (page 3, [0024]). Dow et al. indicate that a ligand for TLR-3 is double-stranded RNA and poly I:C while a ligand for TLR-9 is bacterial DNA (CpG), meeting the limitations of instant claims 1 and 3 (page 3, [0024]; page 5, [0049]; page 20, [0144]; page 28, Examples 1, 2, 4). Dow et al. disclose that mixtures of the ligands are used to prepare liposome-TLR ligand complexes, meeting the limitations of instant claim 1 (page 3, [0024]; claims 63 and 110).
Furthermore, it is noted that the Examiner is unable to locate support in the MPEP or relevant case law for Applicant’s sweeping statement that “[p]rior art that discloses and requires more elements than the claims of which it is asserted does not anticipate an invention that requires less than the disclosed/required elements in the asserted art”. Without an adequate citation/reference, the Examiner is unable to independently evaluate and draw conclusions regarding the purported legal standard of anticipation put forth by Applicant.
(ii) At the middle of page 7 of the Response, Applicant asserts that Dow et al. fails to teach a pharmaceutical composition that requires (c) a cellular adhesion agent comprising one or more of carboxymethylcellulose (CMC), chitosan, polyglycol, a poloxamer, or hyaluronan (a required element of claim 1).
Applicant’s arguments have been considered but are not found to be persuasive. Dow et al. teach the therapeutic composition of the invention comprising at least one ligand recognized by a pattern recognition molecule receptor (including a TLR-3 and TLR-9 ligand) and a liposome delivery vehicle may be combined with a pharmaceutically or pharmacologically acceptable excipient (page 3, [0023-0024]; page 4, [0025]; pages 16-17, [0118-0123]; page 22, [0156, 0161]). Dow et al. disclose that standard excipients include polyethylene glycols, carboxymethylcellulose calcium, and carboxymethylcellulose sodium, meeting the limitations of instant claim 1 (page 22, [0161]).
Maintained 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.
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.
10. Claims 1-4, 7, 8, 11, 12, 15-28, 30 are rejected under 35 U.S.C. 103 as being unpatentable over Dow et al. (US 2005/0013812; cited on the IDS of 27 January 2023) and Jia et al. (Oncol Res 23: 321-326, 2016). The basis for this rejection is set forth for claims 1-4, 6-12, 15-28, and 30 at pages 13-16 of the previous Office Action of 23 September 2025.
The teachings of Dow et al. are set forth above and in the previous Office Action.
Dow et al. do not teach that the TLR9 agonist CpG oligonucleotide in the composition comprises the polynucleotide of instant SEQ ID NO: 3.
Jia et al. teach that CpG oligodeoxynucleotides (ODN) containing CpG motifs, which activate the innate immune system through TLR9, have been proven to play a role in the antitumor effect in extensive studies (page 321, bottom of column 1 through the top of column 2). Jia et al. disclose that CpG ODNs can induce innate or adaptive T-cell immunity whether they are used as a monotherapy or an adjuvant (page 321, top of column 2). Jia et al. teach that CpG ODNs have been shown to inhibit Treg production and downregulate TGF-β levels in the peripheral blood of NSCLC patients (page 322, column 2). Jia et al. indicate that treatment of CpG “YW002” raises the survival rate and improves antitumor response in mice orthotopically transplanted with hepatocellular carcinoma (HCC) (abstract; page 322, column 1, last paragraph). Jia et al. also disclose that “YW002” might be an immunotherapeutic for treatment [of HCC] in the clinic (page 326, top of column 1). It is noted that the “YW002” sequence is 100% identical to the polynucleotide sequence of SEQ ID NO: 3 of the instant application (see Jia et al., page 323, top of column 1; see also sequence alignment provided in the previous Office Action of 23 September 2025).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to modify the therapeutic composition comprising at least one ligand recognized by a pattern recognition molecule receptor (including a mixture of TLR3 ligand and TLR9 ligand (CpG oligonucleotides)), a liposome delivery vehicle, and a pharmaceutically or pharmacologically acceptable excipient (including polyethylene glycols, carboxymethylcellulose calcium, and carboxymethylcellulose sodium) as taught by Dow et al. by utilizing the TLR9 agonist CpG oligonucleotide of “YW002”, as taught by Jia et al. It would have been obvious to one skilled in the art to substitute one TLR9 ligand for the other because CpG oligonucleotides designated “YW002” are able to activate the immune system and efficiently generate strong antigen-specific CD8+ T cell responses (Jia et al., page 325, columns 1-2, 1st and 3rd paragraph under “discussion”). The person of ordinary skill in the art would have expected success because CpG “YW002” raises the survival rate and improves antitumor response in mice orthotopically transplanted with hepatocellular carcinoma (HCC) (Jia et al., abstract; page 322, column 1, last paragraph). Therefore, the claimed invention as a whole was clearly prima facie obvious over the prior art.
(i) At the middle of page 9, Applicant argues that the impropriety of Dow et al. has been demonstrated and that Dow et al. requires an immunogen which is specifically excluded from the claimed invention. Applicant asserts that Dow et al. fails to teach a pharmaceutical composition that requires (c) a cellular adhesion agent comprising one or more of carboxymethylcellulose (CMC), chitosan, polyglycol, a poloxamer, or hyaluronan (a required element of claim 1). Applicant indicates that Jia et al. fails to make up for the missing teachings of Dow et al. Applicant also submits that combining the inventions of Dow et al. and Jia et al. would require an immunogen.
Applicant’s arguments have been considered but are not found to be persuasive. First, as discussed above, Dow et al. teach two different compositions, wherein one composition comprises an immunogen (page 4, [0025]) and one composition does not. Dow et al. clearly disclose a vaccine that “includes the following components: (a) at least one ligand that is recognized by a pattern recognition molecule (receptor); and (b) a delivery vehicle”, wherein the delivery vehicle is a cationic liposome (page 3, [0023]; page 4, [0026, 0028]; Examples 1, 2, 4; pages 16-17, [0118-0123]).
Dow et al. also disclose “a therapeutic composition that includes: (a) a liposome delivery vehicle; and (b) a pattern recognition receptor ligand”, meeting the limitations of instant claim 1 (page 22, [0156]).
Second, Dow et al. further teach the therapeutic composition of the invention comprising at least one ligand recognized by a pattern recognition molecule receptor (including a TLR-3 and TLR-9 ligand) and a liposome delivery vehicle may be combined with a pharmaceutically or pharmacologically acceptable excipient (page 3, [0023-0024]; page 4, [0025]; pages 16-17, [0118-0123]; page 22, [0156, 0161]). Dow et al. disclose that standard excipients include polyethylene glycols, carboxymethylcellulose calcium, and carboxymethylcellulose sodium, meeting the limitations of instant claim 1 (page 22, [0161]).
11. Claims 1-3, 7, 8, 11, 12, 15-28, and 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Dow et al. (US 2005/0013812; cited on the IDS of 27 January 2023) and Mian et al. (J Leukoc Biol 84: 1025-1036, 2013). The basis for this rejection is set forth for claims 1-3, 6-12, 15-28, and 30-32 at pages 22-25 of the previous Office Action of 23 September 2025.
The teachings of Dow et al. are set forth above and in the previous Office Action.
Dow et al. do not teach that the poly(I:C) in the composition is low molecular weight (LMW) poly(I:C) that is 0.2 kilobases (kb) to 1.0 kb.
Mian et al. teach that poly(I:C) is a TLR3 ligand that has long been known as a strong inducer of innate immune responses against infectious diseases and cancers (page 1025, column 2, 1st paragraph). Mian et al. disclose that different polyI:C induce differential cytokine and antiviral responses in myeloid and nonmyeloid cells (abstract; page 1026, column 1, 1st full paragraph). Specifically, poly I:C-S (short; about 0.5-1.5 kb) displays a stronger response in myeloid cells while poly I:C-L (long; ~2.0-8.0 kb) has a better response in fibroblasts, meeting the limitations of instant claims 31 and 32 (page 1027, column 2, 1st full paragraph; Figure 2; page 1027, column 2, last paragraph through page 1028, column 1; Figure 3; page 1032, column 2). Mian et al. also teach that the level of entry of poly I:C into cells, which is thought to be an important mechanistic determinant linked to innate responses, is length dependent (page 1029). Mian et al. indicate that poly I:C-S exhibits better entry into macrophages which is mediated by Raftlin, whereas poly I:C-L has better entry into fibroblasts, where SR-As are suggested to play an important role (page 1029; page 1032, column 2).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to modify the therapeutic composition comprising at least one ligand recognized by a pattern recognition molecule receptor (including a mixture of TLR3 ligand and TLR9 ligand (CpG oligonucleotides)), a liposome delivery vehicle, and a pharmaceutically or pharmacologically acceptable excipient (including polyethylene glycols, carboxymethylcellulose calcium, and carboxymethylcellulose sodium) as taught by Dow et al. by utilizing a low molecular weight poly(I:C) (or short poly(I:C), about 0.5-1.5 kb) for the TLR3 ligand, as taught by Mian et al. The person of ordinary skill in the art would have been motivated to make this modification to design cell-specific potent adjuvants (see Mian et al., abstract; page 1035, column 1, 2nd full paragraph). The person of ordinary skill in the art would have expected success because poly(I:C) has long been known as a strong inducer of innate immune responses and LMW poly(I:C) displays a stronger response in myeloid cells and better entry into macrophages (Mian et al., page 1025, column 2, 1st paragraph; page 1027, column 2, 1st full paragraph; Figure 2; page 1027, column 2, last paragraph through page 1028, column 1; Figure 3; page 1029; page 1032, column 2). Therefore, the claimed invention as a whole was clearly prima facie obvious over the prior art.
(i) At the bottom of page 10, Applicant argues that the impropriety of Dow et al. has been demonstrated and that Dow et al. requires an immunogen which is specifically excluded from the claimed invention. Applicant asserts that Dow et al. fails to teach a pharmaceutical composition that requires (c) a cellular adhesion agent comprising one or more of carboxymethylcellulose (CMC), chitosan, polyglycol, a poloxamer, or hyaluronan (a required element of claim 1). Applicant indicates that Mian et al. fails to make up for the missing teachings of Dow et al. Applicant also submits that combining the inventions of Dow et al. and Mian et al. would require an immunogen.
Applicant’s arguments have been considered but are not found to be persuasive. First, as discussed above, Dow et al. teach two different compositions, wherein one composition comprises an immunogen (page 4, [0025]) and one composition does not. Dow et al. clearly disclose a vaccine that “includes the following components: (a) at least one ligand that is recognized by a pattern recognition molecule (receptor); and (b) a delivery vehicle”, wherein the delivery vehicle is a cationic liposome (page 3, [0023]; page 4, [0026, 0028]; Examples 1, 2, 4; pages 16-17, [0118-0123]).
Dow et al. also disclose “a therapeutic composition that includes: (a) a liposome delivery vehicle; and (b) a pattern recognition receptor ligand”, meeting the limitations of instant claim 1 (page 22, [0156]).
Second, Dow et al. further teach the therapeutic composition of the invention comprising at least one ligand recognized by a pattern recognition molecule receptor (including a TLR-3 and TLR-9 ligand) and a liposome delivery vehicle may be combined with a pharmaceutically or pharmacologically acceptable excipient (page 3, [0023-0024]; page 4, [0025]; pages 16-17, [0118-0123]; page 22, [0156, 0161]). Dow et al. disclose that standard excipients include polyethylene glycols, carboxymethylcellulose calcium, and carboxymethylcellulose sodium, meeting the limitations of instant claim 1 (page 22, [0161]).
12. Claims 1-3, 7, 8, 11, 12, and 15-30 are rejected under 35 U.S.C. 103 as being unpatentable over Dow et al. (US 2005/0013812; cited on the IDS of 27 January 2023) and Florin-Christensen et al. (“Liposome Applications in the Veterinary Field” in Advances in Liposome Research, Nova Science Publishers 123-146, 2014). The basis for this rejection is set forth for claims 1-3, 6-12, and 15-30 at pages 28-31 of the previous Office Action of 23 September 2025.
The teachings of Dow et al. are set forth above and in the previous Office Action.
Dow et al. do not teach that the therapeutic compositions are administered to a bird or fish.
Florin-Christensen et al. teach that in the field of veterinary medicine, liposomes are the most widespread nanotechnological tool and are well-tolerated (page 1). Florin-Christensen et al. disclose that they have been applied in animal therapies to improve delivery of different drugs, comprising analgesic, antiviral, antimicrobial, antifungal, and anticancer agents (page 1). Florin-Christensen et al. also state liposomes have been included in veterinary vaccine formulations to entrap antigen-encoding DNAs, siRNAs, peptide, recombinant antigens, and effectors of the innate immune system in order to elicit protective responses against viruses, bacteria, and parasites (page 1). Florin-Christensen et al. teach that applications include liposome use in companion and productive animals, such as horse, dog, cattle, poultry, and fish, meeting the limitations of instant claim 29 (page 1; page 4, Table 1; page 7; page 9, Table 2).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to modify the subject population (that includes livestock and domestic pets) receiving a therapeutic composition comprising at least one ligand recognized by a pattern recognition molecule receptor (including a mixture of TLR3 ligand and TLR9 ligand (CpG oligonucleotides)), a liposome delivery vehicle, and a pharmaceutically or pharmacologically acceptable excipient (including polyethylene glycols, carboxymethylcellulose calcium, and carboxymethylcellulose sodium) as taught by Dow et al. by administration to a bird or fish, as taught by Florin-Christensen. The person of ordinary skill in the art would have been motivated to make this modification because (i) Dow et al. indicate that the therapeutic can be administered to any member of the Vertebrate class, including livestock and domestic pets (page 19, [0139]), and (ii) Florin-Christensen et al. teach that in the field of veterinary medicine, liposomes are the most widespread nanotechnological tool and are well-tolerated (page 1). The person of ordinary skill in the art would have expected success because liposomes comprising a variety of agents have been successfully administered to treat many different companion and productive animals, including birds and fish (page 1; page 4, Table 1; page 7; page 9, Table 2).
Therefore, the claimed invention as a whole was clearly prima facie obvious over the prior art.
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.
13. Claims 1-5, 7, 8, and 11-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,512,687 in view of Zaks et al. (J Immunol 176: 7335-7345. 2006; cited on the IDS of 27 January 2023), Jia et al. (Oncol Res 23: 321-326, 2016), and Hardt et al. (US 2016/0151453).
The basis for this rejection is set forth in-depth for claims 1-32 at pages 34-35 of the previous Office Action of 23 September 2025 and at pages 20-25 of the Office Action of 13 March 2025.
14. Claims 1-5, 7, 8, and 11-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,400,152 in view of Zaks et al. (J Immunol 176: 7335-7345. 2006; cited on the IDS of 27 January 2023), Jia et al. (Oncol Res 23: 321-326, 2016), Hardt et al. (US 2016/0151453), Mian et al. (J Leukoc Biol 84: 1025-1036, 2013) and Christensen et al. (“Liposome Applications in the Veterinary Field” in Advances in Liposome Research, Nova Science Publishers 123-146, 2014).
The basis for this rejection is set forth in-depth for claims 1-32 at pages 35-38 of the previous Office Action of 23 September 2025 and for claims 1-25 at pages 26-31 of the Office Action of 13 March 2025.
15. Claims 1-5, 7, 8, and 11-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 12,508,279 in view of Zaks et al. (J Immunol 176: 7335-7345. 2006; cited on the IDS of 27 January 2023), Jia et al. (Oncol Res 23: 321-326, 2016), Hardt et al. (US 2016/0151453), and Mian et al. (J Leukoc Biol 84: 1025-1036, 2013). Please note that the ‘279 patent issued from co-pending Application No. 17/733,640. At pages 38-40 of the previous Office Action of 23 September 2025 and pages 26-31 of the Office Action of 13 March 2025, the Examiner made a provisional nonstatutory double patenting rejection with Application 17/733,640 because it was allowed, but not yet issued. Since the '640 application has now issued, the rejection is no longer a provisional nonstatutory double patenting rejection.
(A) At pages 12-13 of the Response of 21 January 2026, Applicant respectfully defers responding to all of the double patenting rejections until allowable subject matter has been found.
The double patenting rejections are maintained. Applicant is reminded that only objections or requirements as to form not necessary to further consideration of the claims may be held in abeyance until allowable subject matter is indicated (see 37 CFR 1.11(b)). Applicant is encouraged to submit terminal disclaimers at Applicant’s earliest convenience.
Conclusion
No claims are allowable.
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BEB
Art Unit 1647
29 May 2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
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