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 .
Priority
The instant application, filed on 29 February, 2024, is a 371 of PCT/AU2022/051062 filed on 31 August, 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 29 February, 2024 has been considered by the examiner.
Status of Application, Amendments, and/or Claims
The response filed on 22 October, 2024 has been entered in full. These are the amended claims of the original claim set received on 29 February, 2024. In the amendment, claims 2, 5-7, 9, 10, 13, 14, 19-21, 23, 24, 32, 33, 40, and 46-48 are amended and claims 3, 4, 8, 11, 12, 15-18, 22, 25-29, 31, 34-39, 41-45, and 49-52 are cancelled. Therefore, claims 1, 2, 5-7, 9, 10, 13, 14, 19-21, 23, 24, 30, 32, 33, 40, and 46-48 are pending and are the subject of this Office Action.
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.
Claims 1, 14, and 30 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claims 1, 14, and 30 recite the phrase “comprising, consisting essentially of, or consisting of.” The use of multiple, alternative transitional phrases in a single claim element renders the scope of the claim unclear, because “comprising” , “consisting essentially of”, and “consisting of” each have different legal meanings which define different mutually exclusive scopes with respect to additional, unrecited components (See MPEP 2111.03). In the instant claims it is unclear which transitional phrase governs the scope of the claims making them indefinite. For the purpose of further examination, the claims will be interpreted under the transitional phrase “comprising.” Under this interpretation, the scope of the claims is inclusive and does not exclude the presence of additional, unrecited components.
Claim Rejections - 35 USC § 102
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.
Claims 1, 2, 5-7, 9, 10, 13, 14, 19, 20, 30, 32, 33, 46, and 47 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Jackson et al (US 2017/0274068) as evidenced by Honma et al. (1996) Allergenic epitopes of ovalbumin (OVA) in patients with hen’s egg allergy: inhibition of basophil histamine release by haptenic ovalbumin peptide Clin Exp Immunol 103:446-453 (hereafter Honma).
In regards to claim 1 Jackson anticipates an immunogenic composition (TLR2 moiety) comprising a charged antigen electrostatically associated with a Toll-Like Receptor (TLR) targeting moiety, wherein the TLR targeting moiety comprises a TLR-2 agonist covalently attached to polyethylene glycol and to a hyper-branched charged peptide (pg.1, col 1, line 55 – pg.1, col 2, line 3 /Claim 1), wherein in some embodiments the TLR2 agonist is a lipopeptide or comprises a lipid moiety (pg.2, col 2, lines 58-59). Jackson lists lipid moieties used to target cell surface TLRs includes palmitoyl, myristoyl, stearoyl, lauroyl, or decanoyl (pg.3, col 1, lines 22-24).
In regards to claims 1, 2, and 30 Jackson anticipates the method of inducing an antibody response by the administration of a composition of antigens (allergen) mixed with the immunogenic composition R4Pam2Cys into male BALB/c mice, wherein the antigen is ovalbumin (OVA) (pg.6, Example 2), which is a common allergen as evidenced by Honma, which recites egg white frequently induces hypersensitivity and among the 40 different egg white proteins OVA is a major allergen (pg.446, col 1, lines 1-4).
In regards to claim 5 Jackson anticipates a list of lipid moieties which includes palmitoyl (pg.3, col 1, lines 22-24), further Jackson anticipates and exemplary lipopeptide is Pam2Cys which contains palmitoyl (pg.2, col 2, lines 60-62/ claim 5).
In regards to claim 6 Jackson anticipates the immunogenic composition (TLR2 moiety) having a TLR2 agonist which is a lipoprotein (Example 2/ claim 4).
In regards to claim 7 Jackson anticipates the following lipopeptides, Pam2Cys, Pam3Cys, Ste2Cys, Lau2Cys, and Oct2Cys, as specific contemplations of the invention (pg.3, col 1, lines 25-27 /claim 4).
In regards to claims 9 and 10 Jackson anticipates a hyper-branched charged peptide (claim 8) and further wherein the peptide is selected from the group consisting of R4, R8, K4, K8, E4, E8, D4, D8, H4, or H8 (claim 8) .
In regards to claim 13 Jackson anticipates the TLR2 agonist being attached to the hyper-branched charged peptide by two serine residues (claims 9-16).
In regards to claim 14 Jackson anticipates the TLR2 moiety being R4Pam2Cys with or without the addition of PEG (Example 2/claim 9).
In regards to claims 19, 20, and 21 Jackson anticipates inducing an antibody response by administering an antigen wherein, the antigen OVA is used (Example 2) which is the main protein in egg white and associated with an egg (food) allergy and not associated with rhinovirus, as evidenced by Honma as referenced above.
In regards to claim 32 Jackson anticipates the immunogenic composition (TLR2 moiety) is preferably present as a pharmaceutical composition containing any pharmaceutically acceptable carriers, diluents, or excipients (pg.5, col 1, lines 3-8).
In regards to claim 33 Jackson anticipates the immunogenic composition (TLR2 moiety) can be administered by any means known to those skilled in the art including intranasally, orally, subcutaneously, intramuscularly, and intravenously (pg.5, col 1, lines 28-31).
In regards to claim 46 Jackson anticipates the immunogenic composition (TLR2 moiety) and the allergen (OVA) being administered at the same time as a mixture (example 2).
In regards to claim 47 Jackson anticipates immunogenic composition (TLR2 moiety) and the allergen (OVA) being administered twice on day 0 and day 21 (example 2).
Claims 1 and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Laino et al. (of record, IDS 02/29/2024).
In regards to claim 1 Laino anticipates the attenuation of an allergic immune response using Pam2CysK4 (a TLR2 moiety comprising a lipopeptide TLR2 agonist and a polar polypeptide) (pg.2, col 1, line 53 – pg.2, col 2, line 5).
In regards to claim 40 Laino anticipates the administration of Pam2CysK4 in the presence of OVA does not significantly increase IFN-γ at two concentrations in BALB/c BMDC mice (figure 2, top left).
Claims 1 and 48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tsai et al. (2010) TLR2 Agonists Enhance CD8+Foxp3+ Regulatory T Cells and Suppress Th2 Immune Responses during Allergen Immunotherapy The Journal of Immunology, 184(12), 7229–7237 (hereafter Tsai).
In regards to claim 1 Tsai anticipates the attenuation of an allergic immune response using Pam3CSK4 (a TLR2 moiety comprising a lipopeptide TLR2 agonist and a polar polypeptide) (pg.7229, col 2, lines 18-27).
In regards to claim 48 Tsai anticipates administering Pam3CSK4 monthly over the course of a year (pg.7230, col 1, line 2-4).
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.
Claims 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al. as applied to claim 1 above, and further in view of Larsen et al. (2016) Allergy Immunotherapy: the future of allergy treatment Drug Discovery Today 21(1), 26-37 (hereafter Larsen).
Jackson fails to teach the subject having one or more symptoms associated with the allergy of claim 23 and the subject having received or currently receiving a treatment in the form of an allergen of claim 24.
Larsen, however, in regards to claim 23 teaches an “allergy is a systemic priming of the immune system with subsequent dynamic manifestations of symptoms in multiple organs” (pg.28, col 1, lines 12--15). Further Larsen teaches allergic symptoms are hard to control, with many treatments controlling symptoms and not actually treating the disease (pg.29, col 1, lines 9-22) and further these symptoms significantly affect the quality of life of a patient (pg.29, col 1, lines 49-52).
In regards to claim 24 Larsen teaches the sublingual or subcutaneous administration of a high dose of an allergen as an immunotherapy results in a profound effect on the immune system which induced immunological tolerance to the allergen (pg.30, col 1, lines 1-9).
Thus, Jackson discloses a method of treating an allergic immune response using a TLR2 moiety comprising a TLR2 agonist and a polar polypeptide, and Larsen teaches allergies are associated with a variety of symptoms, which current approved therapeutics struggle to manage and which affect the quality of life of the patient experiencing them, and further that treatment with an allergen as an immunotherapy allows for the development of immunological tolerance. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the teachings of Jackson with the teachings of Larsen with a reasonable expectation of success to develop a method of treating an allergic immune response using a TLR2 moiety comprising a TLR2 agonist and a polar polypeptide wherein patient has been or is being treated with an allergen to induce tolerance and improve treatment efficacy and further wherein the patient has symptoms which are hallmarks of allergies and in which alleviation by the treatment would improve a patients quality of life.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 6, 7, 9, 10, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10,406,100 in view of Jackson et al.
Claim 1 of the U.S. Patent recites claim to a method for treating or minimizing the progression of a respiratory condition comprising administering a TLR2 moiety which comprises a TLR2 agonist and a solubilizing agent (polar polypeptide). This significantly overlaps with instant application claim 1.
Claim 2 of the U.S. patent recites claim to the TLR2 agonist being selected from a group consisting of Pam2Cys, Pam3Cys, Ste2Cys, Lau2Cys, and Oct2Cys. This significantly overlaps with instant application claim 7 which is dependent upon claim 6.
Claim 3 of the U.S. patent recites claim to the TLR2 agonist being Pam2Cys which significantly overlaps with instant application claim 6.
Claim 4 of the U.S. patent recites claim to the TLR2 moiety further comprises any one of R4, K4, H4, E8, branched E8, and H8. This significantly overlaps with instant application claim 10 which depends on claim 9, and further encompasses the Pam2CysR4 of instant claim 14.
The U.S. patent fails to teach the TLR2 moiety for treating, attenuating, or preventing an allergic immune response of the instant application. Jackson, however, teaches a TLR2 moiety with the same properties can be used to treat an allergic immune response as outlined above in the 102 rejection.
Thus, U.S. patent discloses a TLR2 moiety which is structurally the same as the TLR2 moiety of the instant application, and Jackson teaches this TLR2 moiety has been successful in treating an allergic immune response. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the teachings of the U.S. patent with the teachings of Jackson with a reasonable expectation of success to develop a method of treating an allergic immune response.
Claims 1, 6, 7, 9, 10, 13, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11, 12 and 21-25 of U.S. Patent No. 11,351,114 in view of Jackson et al.
Claim 1 of the U.S. Patent recites claim to a method for treating or preventing a respiratory condition comprising administering a composition which comprises a TLR2 agonist and a solubilizing agent (polar polypeptide). This significantly overlaps with instant application claim 1.
Claim 2 of the U.S. patent recites claim to the TLR2 agonist being selected from a group consisting of Pam2Cys, Pam3Cys, Ste2Cys, Lau2Cys, and Oct2Cys. This significantly overlaps with instant application claim 7 which is dependent upon claim 6.
Claim 3 of the U.S. patent recites claim to TLR2 agonist being Pam2Cys which significantly overlaps with instant application claim 6.
Claim 5 of the U.S. patent which depends on claim 4, and Claim 11 of the U.S. patent recite claim to the solubilizing agent can be PEG and/or a polar polypeptide (claim 4) selected from any one of R4, K4, H4, E8, branched E8, and H8 (claim 5). Further claim 6 of the U.S. patent recites the polar polypeptide is K4. This significantly overlaps with instant application claim 10 which depends on claim 9, and further encompasses the Pam2CysR4 of instant claim 14.
Claims 7, 8, and 9 of the U.S. patent recites claim to the TLR2 agonist being Pam2Cys and being attached to K4 via at least one serine residue. This significantly overlaps with instant application claim 13.
Claims 12 and 21-25 of the U.S. patent recite claim to specific TLR2 and solubilizing agent compositions, all of which meet the criteria of instant application claims 1, 6, 7, 9, 10, 13, and 14.
The U.S. patent fails to teach the TLR2 moiety for treating, attenuating, or preventing an allergic immune response of the instant application. Jackson, however, teaches a TLR2 moiety with the same properties can be used to treat an allergic immune response as outlined above in the 102 rejection.
Thus, U.S. patent discloses a TLR2 moiety which is structurally the same as the TLR2 moiety of the instant application, and Jackson teaches this TLR2 moiety has been successful in treating an allergic immune response. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the teachings of the U.S. patent with the teachings of Jackson with a reasonable expectation of success to develop a method of treating an allergic immune response.
Claims 1, 6, 7, 9, 10, 13, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11, 12, and 20-24 of U.S. Patent No. 11,786,458 in view of Jackson et al.
Claim 1 of the U.S. Patent recites claim to a method for treating or preventing a respiratory condition comprising administering a composition which comprises a TLR2 agonist and a solubilizing agent (polar polypeptide). This significantly overlaps with instant application claim 1.
Claim 2 of the U.S. patent recites claim to the TLR2 agonist being selected from a group consisting of Pam2Cys, Pam3Cys, Ste2Cys, Lau2Cys, and Oct2Cys. This significantly overlaps with instant application claim 7 which is dependent upon claim 6.
Claim 3 of the U.S. patent recites claim to TLR2 agonist being Pam2Cys which significantly overlaps with instant application claim 6.
Claim 5 of the U.S. patent which depends on claim 4, and Claim 11 of the U.S. patent recite claim to the solubilizing agent can be PEG and/or a polar polypeptide (claim4) selected from any one of R4, K4, H4, E8, branched E8, and H8 (claim 5). Further claim 6 of the U.S. patent recites the polar polypeptide is K4. This significantly overlaps with instant application claim 10 which depends on claim 9, and further encompasses the Pam2CysR4 of instant claim 14.
Claims 7, 8, and 9 of the U.S. patent recites claim to the TLR2 agonist being Pam2Cys and being attached to K4 via at least one serine residue. This significantly overlaps with instant application claim 13.
Claims 12 and 20-24 of the U.S. patent recite claim to specific TLR2 and solubilizing agent compositions, all of which meet the criteria of instant application claims 1, 6, 7, 9, 10, 13, and 14.
The U.S. patent fails to teach the TLR2 moiety for treating, attenuating, or preventing an allergic immune response of the instant application. Jackson, however, teaches a TLR2 moiety with the same properties can be used to treat an allergic immune response as outlined above in the 102 rejection.
Thus, U.S. patent discloses a TLR2 moiety which is structurally the same as the TLR2 moiety of the instant application, and Jackson teaches this TLR2 moiety has been successful in treating an allergic immune response. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the teachings of the U.S. patent with the teachings of Jackson with a reasonable expectation of success to develop a method of treating an allergic immune response.
Claim 1, 6, 7, 9, 10, and 14 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6-8 of U.S. Patent No. 12,569,431 in view of Jackson et al.
Claims 1 and 2 of the U.S. Patent recites claim to a method for treating or preventing a respiratory condition comprising administering a composition which comprises a TLR2 agonist and a solubilizing agent (polar polypeptide). This significantly overlaps with instant application claim 1.
Claim 4 of the U.S. patent which depends on claim 3, and Claim 6 of the U.S. patent recite to the solubilizing agent can be PEG and/or a polar polypeptide (claim 3) selected from any one of R4, K4, H4, E8, branched E8, and H8 (claim 4). This significantly overlaps with instant application claim 10 which depends on claim 9, and further encompasses the Pam2CysR4 of instant claim 14.
Claim 7 of the U.S. patent recites claim to the TLR2 agonist being selected from a group consisting of Pam2Cys, Pam3Cys, Ste2Cys, Lau2Cys, and Oct2Cys. This significantly overlaps with instant application claim 7 which is dependent upon claim 6.
Claim 8 of the U.S. patent recites claim to TLR2 agonist being Pam2Cys which significantly overlaps with instant application claim 6.
The U.S. patent fails to teach the TLR2 moiety for treating, attenuating, or preventing an allergic immune response of the instant application. Jackson, however, teaches a TLR2 moiety with the same properties can be used to treat an allergic immune response as outlined above in the 102 rejection.
Thus, U.S. patent discloses a TLR2 moiety which is structurally the same as the TLR2 moiety of the instant application, and Jackson teaches this TLR2 moiety has been successful in treating an allergic immune response. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the teachings of the U.S. patent with the teachings of Jackson with a reasonable expectation of success to develop a method of treating an allergic immune response.
Double Patenting – Provisional
Claims 1, 5-7, 9, 10, 13, and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, 12, 14, 15, and 17 of copending Application No. 18/688,369 (Claim set 03/25/2025)(reference application) in view of Jackson et al.
Claim 1 of the reference application recites a pharmaceutical composition of comprising a compound comprising a TLR2 agonist moiety conjugated with a solubility moiety. This significantly overlaps with instant application claim 1.
Claim 11 of the reference application recites the TLR2 agonist moiety comprises a lipopeptide or a lipid moiety. This significantly overlaps with instant application claim 1.
Claim 12 of the reference application recites the TLR2 binding moiety comprises at least one of palmitoyl, myristoyl, stearoyl, lauroyl, octanoyl, or decanoyl group. This significantly overlap with instant application claim 1 and 5.
Claims 14 and 15 of the reference application recite a structure with a variety of substitutions to yield different compositions which structurally meet the requirement of instant application claims 1, 6, 7, 9, 10, 13, and 14.
Claim 17 of the instant application recites a list of compositions of which many meet the structural requirements of the instant application claims 1, 6, 7, 9, 10, 13, and 14.
The reference application fails to teach the composition for treating, attenuating, or preventing an allergic immune response of the instant application. Jackson, however, teaches a TLR2 moiety with the same properties can be used to treat an allergic immune response as outlined above in the 102 rejection.
Thus, the reference application discloses TLR2 moieties which is structurally the same as the TLR2 moiety of the instant application, and Jackson teaches this TLR2 moiety has been successful in treating an allergic immune response. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the teachings of the reference application with the teachings of Jackson with a reasonable expectation of success to develop a method of treating an allergic immune response.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 6, 7, 9, 10, 13, and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 15, 17, 21, 25, 28, and 29 of copending Application No. 18/012,364 (Claim set 06/10/20256)(reference application) in view of Jackson et al.
Claim 1 of the reference application recite a structure with a variety of substitutions to yield different compositions which structurally meet the requirement of instant application claims 1, 6, 7, 9, 10, 13, and 14.
Claim 15 of the instant application recites a list of compositions of which many meet the structural requirements of the instant application claims 1, 6, 7, 9, 10, 13, and 14.
Claims 17, 21, 25, and 29 of the reference application refer to methods of use of the compound to treat a disease, reduce airway inflammation, treat a disease of condition associated with the TLR2-receptor, and agonize TLR2 activity, respectively. This significantly overlaps with instant application claim 1.
Claim 28 of the reference application refer to a kit containing the compound and instruction without any further structural limitations and thus the kit does not preclude the composition.
The reference application fails to teach the composition for treating, attenuating, or preventing an allergic immune response of the instant application. Jackson, however, teaches a TLR2 moiety with the same properties can be used to treat an allergic immune response as outlined above in the 102 rejection.
Thus, the reference application discloses TLR2 moieties which is structurally the same as the TLR2 moiety of the instant application, and Jackson teaches this TLR2 moiety has been successful in treating an allergic immune response. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the teachings of the reference application with the teachings of Jackson with a reasonable expectation of success to develop a method of treating an allergic immune response.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 5, and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 48, 68, 71, and 73 of copending Application No. 16/768,278 (claim set 04/29/2026) (reference application) in view of Jackson et al.
Claims 8 and 71 of the reference application recites a method of inhibiting, delaying, or reducing the progression of an infectious agent from the respiratory tract (claim 8) or a premeasured unit dosage dispenser (claim 71) comprising a TLR2 agonist which comprises a lipopeptide further comprising a lipid moiety selected from the group consisting of palmitoyl, myristoyl, and stearoyl and a solubilizing agent (polar polypeptide) comprising PEG. This significantly overlaps with instant application claims 1 and 6.
Claim 48 of the reference application recites a formula for a TLR2 agonist. This significantly overlaps with instant application claims 1 and 6.
Claims 68 and 73 of the reference application recite the lipid moiety is palmitoyl. This significantly overlaps with instant application claim 5.
The reference application fails to teach the composition for treating, attenuating, or preventing an allergic immune response of the instant application. Jackson, however, teaches a TLR2 moiety with the same properties can be used to treat an allergic immune response as outlined above in the 102 rejection.
Thus, the reference application discloses TLR2 moieties which is structurally the same as the TLR2 moiety of the instant application, and Jackson teaches this TLR2 moiety has been successful in treating an allergic immune response. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the teachings of the reference application with the teachings of Jackson with a reasonable expectation of success to develop a method of treating an allergic immune response.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 5, 6, 7, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 17, 18, 43, and 44 of copending Application No. 16/768,278 (claim set 04/29/2026) (reference application) in view of Jackson et al.
Claim 2 of the reference application recites a method of treating a rhinovirus mediated exacerbation of chronic obstructive pulmonary disease comprising a TLR2 agonist which comprises a lipopeptide conjugated to a solubilizing moiety (polar polypeptide) and further wherein the lipopeptide comprises a lipid moiety selected from the group consisting of palmitoyl, myristoyl, and stearoyl and the solubilizing agent (polar polypeptide) comprises PEG and the lipopeptide and solubilizing moiety are linked by one of two amino acids selected from a list which includes serine. This significantly overlaps with instant application claims 1, 5, 6, and 13.
Claim 17 of the reference application recite the lipopeptide moiety is selected from the group consisting of Pam2Cys, Pam3Cys, and Ste2Cys, and further claim 18 of the reference application recites the lipopeptide is Pam2Cys. This significantly overlaps with instant application claim 7.
Claims 43 and 44 of the reference application recites a formulas for a compositions of claim 2. This significantly overlaps with instant application claims 1 and 6.
The reference application fails to teach the composition for treating, attenuating, or preventing an allergic immune response of the instant application. Jackson, however, teaches a TLR2 moiety with the same properties can be used to treat an allergic immune response as outlined above in the 102 rejection.
Thus, the reference application discloses TLR2 moieties which is structurally the same as the TLR2 moiety of the instant application, and Jackson teaches this TLR2 moiety has been successful in treating an allergic immune response. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the teachings of the reference application with the teachings of Jackson with a reasonable expectation of success to develop a method of treating an allergic immune response.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DASIA A ALDARONDO whose telephone number is (571)272-1977. The examiner can normally be reached on Monday – Thursday from 8am to 6pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama, can be reached at telephone number (571)272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.A.A/Examiner, Art Unit 1647 /JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647
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