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 .
Note from Examiner
The art unit location of your Application at the USPTO has changed. To aide in correlating any
papers for this application, all further correspondence regarding this application should be directed to
Examiner Judith Kamm in Art Unit 1611.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to lipidoid compositions, in the reply filed on 06/24/2026 is acknowledged.
Applicant’s further election of 93-O17S (structure shown below) as the species of lipidoid and cGAMP as the species of adjuvant in the reply filed on 06/24/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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Claim 88 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being
drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made
without traverse in the reply filed on 06/24/2026.
Claims 23-24, 26, 50-51, 56, 58-59, 67, and 70 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 06/24/2026.
Claims 2, 5-9, 11, 13-16, 18-21, 27, 29-49, 52-55, 57, 60-66, 68-69, 71-83, 85-87, 89-115, and 117-121 are cancelled.
Claims 1, 3-4, 10, 12, 17, 22, 25, 28, 84, and 116 are under current examination. The claims were read in view of the species election detailed above.
Priority
This application is a national stage entry of PCT/US21/62273, filed 12/07/2021. Priority has been claimed to US PRO 63/122,229, filed 12/07/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/06/2023, 07/28/2025, 10/29/2025, and 03/20/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the Examiner.
Claim Objections
Claim 12 is objected to because of the following informalities: it is suggested that a space should be inserted between “C1-C30” and “alkyl chain”, between “C1-C30” and “alkylacyl chain”, and between “C1-C30” and “alkylamide chain”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10, from which claim 12 depends, recites “each hydrophobic tail independently comprises a C1-C30alkyl chain, a C1-C30alkylacyl chain, a C1-C30 alkylester chain, or a C1-C30alkylamide chain”.
Claim 12 recites the limitation, “wherein at least one carbon atom of the C1-C30 alkyl is replaced with a heteroatom”. Claim 12 fails to include all of the limitation of claim 10 because a C1 alkyl where the carbon atom is replaced with a heteroatom no longer comprises a C1-C30 alkyl, which is required by claim 10.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1, 3-4, 10, 12, 17, 22, 25, 28, 84 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. (WO 2019/152848 A1, published August 8th, 2019; included on IDS submitted 03/20/2026) in view of Karathanasis (US 2021/0038633 A1, filed August 10th, 2020).
Regarding instant claims 1, 3-4, 10, 12, 17, 22, 25, and 28, which read on the elected lipidoid species, Xu teaches lipid-like nanocomplexes formed of lipid-like compounds (referred to as lipidoids) of formula (I) (see entire document, particularly Abstract, claims 1, 31, and 37, and table beginning at pg. 27). Nanocomplexes are shown to be formed of a plurality of lipidoids (Figure 18). Xu teaches that lipidoid nanoparticles can be used as a versatile platform for anticancer drugs (pg. 9, lines 13-16 and Figure 9).
One class of lipid-like compounds were synthesized by the route shown below:
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from head amines Ra-NH2 selected from those including compound 93
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and lipid molecules including O17S
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, resulting in the elected lipidoid species 93-O17S (see pg. 26-29, including lipidoid code 93-O17S in the table at pg. 28).
Regarding instant claim 84, Xu teaches a pharmaceutical composition comprising a nanocomplex and a protein, nucleic acid, or a small molecule (claims 31 and 37). The pharmaceutical composition typically contains a pharmaceutically acceptable carrier and one or more solubilizing agents can be utilized as pharmaceutical excipients (pg. 7, lines 23-30).
Xu does not teach that the lipidoid composition comprises the elected adjuvant species cGAMP.
Karathanasis teaches an immuno-nanoparticle construct including a nanocarrier, a stimulator of interferon gene (STING) pathway agonist, and a toll-like receptor 4 (TLR4 agonist) (see entire document, particularly abstract and claim 1). The nanoparticle carrier can comprise a lipid-based carrier (claims 2-4), and the STING pathway agonist comprises a cyclic dinucleotide selected from those including cGAMP (claims 10-11). Liposome nanocarriers can include components such as PEGylated lipids and cholesterol and can facilitate intracellular delivery (paragraph [0053]). Co-encapsulating anti-tumor agents within the nanoparticle carriers to form an immuno-nanoparticle construct can prevent toxic dissemination of the therapeutic agents and allow for their co-delivery to the same target cell, leading to effective APC-driven local and systemic anti-tumor immunity (paragraph [0049]) and producing a significant anticancer therapeutic outcome (paragraph [0050]). The immuno-nanoparticle constructs can be administered for the treatment of cancer (paragraph [0091]), particularly breast cancer (paragraph [0096]), and can be administered in combination with cytotoxic compounds such as doxorubicin (paragraphs [0097]-[0098]).
It would have been prima facie to one of ordinary skill in the art before the effective filing date of the instant invention to modify the nanocomplex-containing composition of Xu with the cGAMP STING pathway agonist and TLR4 agonist suggested by Karathanasis. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of in order to achieve a construct that can achieve local and systemic anti-tumor immunity and a significant anticancer outcome via intracellular delivery, particularly in difficult to cure metastatic triple-negative breast cancer treatment, as suggested by Karathanasis (paragraphs [0003]-[0004], [0049]-[0050], and [0096]). There is a reasonable expectation of success as Karathanasis teaches that lipid-containing nanocarriers comprising components such as cholesterol can be used to intracellularly deliver chemotherapeutic agents (paragraph [0053]) and that the agonists can be used in combination with cytotoxic compounds such as doxorubicin (paragraph [0098]); Xu similarly teaches lipid-like nanocomplexes in combination with cholesterol for the intracellular delivery of anticancer drugs (see pg. 9, lines 13-16 and Figure 9) and the inclusion of chemotherapeutic agents such as doxorubicin (claims 37-40).
Claim 116 is rejected under 35 U.S.C. 103 as being unpatentable over Xu in view of Karathanasis as applied to claims 1, 3-4, 10, 12, 17, 22, 25, 28, 84 above, and further in view of Baumhof et al. (US 2019/0336608 A1, published November 7, 2019), hereafter “Baumhof”
The teachings of the modified Xu are set forth above. Particularly regarding instant claim 116, Xu teaches a pharmaceutical composition comprising a nanocomplex and a protein, nucleic acid, or a small molecule (claims 31 and 37) and the inclusion of chemotherapeutic agents such as doxorubicin (claims 37-40).
The combination of Xu and Karathanasis does not teach the limitation of instant claim 116 of a kit.
Baumhof teaches compositions for nucleic acid delivery comprising a lipidoid (see entire document, particularly abstract and claim 1) and a kit for preparing the compositions for the use of prophylaxis, treatment and/or amelioration of diseases such as cancer (paragraphs [0026]-[0027]). The kits provide the components in sterile form and can include liquid carriers for dissolving or dispersing the lipidoid formulations; kits can also include technical instructions on administration and dosage (paragraphs [0563]-[0570]).
It would have been prima facie to one of ordinary skill in the art before the effective filing date of the instant invention to contain the chemotherapeutic agent and lipidoid composition of the modified Xu in a kit as suggested by Baumhof. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to maintain the sterility of the components prior to administration and to include instructions on administration and dosage of the lipidoid compositions, as suggested by Baumhof. There is a reasonable expectation of success as the modified Xu similarly arrives at a lipoidal composition for the delivery of anticancer drugs, and Xu suggests formulating a sterile injectable composition (pg. 24, lines 9-10).
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, 3-4, 10, 12, 17, 22, 25, 28, 84, and 116 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6, 31, and 37-40 of copending Application No. 18/205,096 in view of Karathanasis (US 2021/0038633 A1, filed August 10th, 2020) and Baumhof et al. (US 2019/0336608 A1, published November 7, 2019), hereafter “Baumhof”.
The claims of copending Application No. 18/205,096 recite a compound of formula (I), encompassing the elected species (see copending claim 1, reproduced below), and a pharmaceutical composition comprising a nanocomplex formed of a compound of formula (I). The pharmaceutical composition is recited to comprise a protein or nucleic acid, and recited to comprise a small molecule chemotherapeutic agent.
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Copending Application No. 18/205,096 does not recite that the composition comprises the elected adjuvant species cGAMP. Copending Application No. 18/205,096 does not recite a kit comprising the lipidoid composition and a chemotherapeutic agent, as required by instant claim 116.
Karathanasis teaches an immuno-nanoparticle construct including a nanocarrier, a stimulator of interferon gene (STING) pathway agonist, and a toll-like receptor 4 (TLR4 agonist) (see entire document, particularly abstract and claim 1). The nanoparticle carrier can comprise a lipid-based carrier (claims 2-4), and the STING pathway agonist comprises a cyclic dinucleotide selected from those including cGAMP (claims 10-11). Liposome nanocarriers can include components such as PEGylated lipids and cholesterol and can facilitate intracellular delivery (paragraph [0053]). Co-encapsulating anti-tumor agents within the nanoparticle carriers to form an immuno-nanoparticle construct can prevent toxic dissemination of the therapeutic agents and allow for their co-delivery to the same target cell, leading to effective APC-driven local and systemic anti-tumor immunity (paragraph [0049]) and producing a significant anticancer therapeutic outcome (paragraph [0050]). The immuno-nanoparticle constructs can be administered for the treatment of cancer (paragraph [0091]), particularly breast cancer (paragraph [0096]), and can be administered in combination with cytotoxic compounds such as doxorubicin (paragraphs [0097]-[0098]).
Baumhof teaches compositions for nucleic acid delivery comprising a lipidoid (see entire document, particularly abstract and claim 1) and a kit for preparing the compositions for the use of prophylaxis, treatment and/or amelioration of diseases such as cancer (paragraphs [0026]-[0027]). The kits provide the components in sterile form and can include liquid carriers for dissolving or dispersing the lipidoid formulations; kits can also include technical instructions on administration and dosage (paragraphs [0563]-[0570]).
It would have been prima facie to one of ordinary skill in the art before the effective filing date of the instant invention to modify the pharmaceutical composition of Copending Application No. 18/205,096 with the cGAMP STING pathway agonist and TLR4 agonist suggested by Karathanasis. One of ordinary skill in the art would have been motivated to do so in order to achieve a composition that can achieve local and systemic anti-tumor immunity and a significant anticancer outcome via intracellular delivery particularly in difficult to cure metastatic triple-negative breast cancer treatment, as suggested by Karathanasis (paragraphs [0003]-[0004], [0049]-[0050], and [0096]).
It would further have been prima facie to one of ordinary skill in the art before the effective filing date of the instant invention to contain the chemotherapeutic lipoidal composition in a kit, as suggested by Baumhof. One of ordinary skill in the art would have been motivated to do so in order to maintain the sterility of the components prior to administration and to include instructions on administration and dosage of the lipidoid compositions, as suggested by Baumhof.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3-4, 10, 12, 17, 22, 25, 28, 84, and 116 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-7, 9-10, 32-33, and 39 of copending Application No. 18/839,185 in view of Karathanasis (US 2021/0038633 A1, filed August 10th, 2020) and Baumhof et al. (US 2019/0336608 A1, published November 7, 2019), hereafter “Baumhof”.
The claims of copending Application No. 18/839,185 are drawn to a method of delivering a pharmaceutical agent to cells in an inner ear comprising administering a pharmaceutical agent and a lipid composition. Similar to the composition of the instant claims, the lipid composition claimed by copending Application No. 18/839,185 comprises an ionizable lipid consistent with the elected lipidoid (an amine head group and at least one hydrophobic tail having a structure of Formula (A), reproduced below).
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The amine head group is chosen from those including
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, consistent with the elected species (see copending claim 6). The ionizable lipid comprises at least two hydrophobic tails which are identical. The elected species is consistent with hydrophobic tail recited in copending Application No. 18/839,185 where Z is O, m is 2, X is S, Y is CH2, and Rc is an alkyl. The pharmaceutical agent of copending Application No. 18/839,185 is recited to be a vaccine and can comprise a polynucleotide, oligonucleotide, a polypeptide, an oligopeptide, a small molecule compound, or any combination thereof. The lipid composition is recited to comprise cholesterol.
Copending Application No. 18/839,185 does not recite that the composition comprises the elected adjuvant species cGAMP. Copending Application No. 18/839,185 does not recite a kit comprising the lipid composition and a chemotherapeutic agent, as required by instant claim 116.
Karathanasis teaches an immuno-nanoparticle construct including a nanocarrier, a stimulator of interferon gene (STING) pathway agonist, and a toll-like receptor 4 (TLR4 agonist) (see entire document, particularly abstract and claim 1). The nanoparticle carrier can comprise a lipid-based carrier (claims 2-4), and the STING pathway agonist comprises a cyclic dinucleotide selected from those including cGAMP (claims 10-11). Liposome nanocarriers can include components such as PEGylated lipids and cholesterol and can facilitate intracellular delivery (paragraph [0053]). Co-encapsulating anti-tumor agents within the nanoparticle carriers to form an immuno-nanoparticle construct can prevent toxic dissemination of the therapeutic agents and allow for their co-delivery to the same target cell, leading to effective APC-driven local and systemic anti-tumor immunity (paragraph [0049]) and producing a significant anticancer therapeutic outcome (paragraph [0050]). Active specific cancer immunotherapy is a therapeutic vaccination approach (paragraph [0106]).
Baumhof teaches compositions for nucleic acid delivery comprising a lipidoid (see entire document, particularly abstract and claim 1) and a kit for preparing the compositions for the use of prophylaxis, treatment and/or amelioration of diseases such as cancer (paragraphs [0026]-[0027]). The kits provide the components in sterile form and can include liquid carriers for dissolving or dispersing the lipidoid formulations; kits can also include technical instructions on administration and dosage (paragraphs [0563]-[0570]).
It would have been prima facie to one of ordinary skill in the art before the effective filing date of the instant invention to modify the vaccine containing composition in the method of Copending Application No. 18/839,185 with the cGAMP STING pathway agonist and TLR4 agonist suggested by Karathanasis. One of ordinary skill in the art would have been motivated to do so in order to achieve a composition that can achieve local and systemic anti-tumor immunity and a significant anticancer outcome via intracellular delivery as suggested by Karathanasis (paragraphs [0003]-[0004], and [0049]-[0050].
It would further have been prima facie to one of ordinary skill in the art before the effective filing date of the instant invention to contain the chemotherapeutic lipoidal composition in a kit as suggested by Baumhof. One of ordinary skill in the art would have been motivated to do so in order to maintain the sterility of the components prior to administration and to include instructions on administration and dosage of the lipidoid compositions, as suggested by Baumhof.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUDITH M KAMM whose telephone number is (703)756-4575. The examiner can normally be reached M-F 8:00 am-4:30 pm EST.
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, Bethany Barham can be reached at (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611
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