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 .
Claims 1, 2, 12-22 are pending in the application.
This office action is in response to the amendment filed on 9/22/2025.
All rejections in previous office action not reiterated in this office action are withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/22/2025 has been considered by the examiner.
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.
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.
Claim(s) 1, 2, 12-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halperin, in view of Roizman (US 2019/0015521). This rejection is rewritten to address the amendment.
Halperin discloses a method for introducing a therapeutic agent into a cell of a subject together with membrane attacking complex transmembrane channel forming agent, to increase the cellular uptake of the agent (col.2, lines 2-4 and 5-7). Halperin discloses C5b-6 complex is essential and first component for forming the MAC transmembrane channel, together with subsequence component of C7, C8 and C9 (col.5, lines 22-28). Halperin discloses C7, C8 and C9 should be administered after administration of C5b-6 (col.5, line 39-40). Halperin discloses the source of C7, C8, and C9 proteins may be isolated from endogenously from the subject (col.5, line 41). Halperin discloses the therapeutic agents is used to treat a wide variety of human diseases including vascular thrombotic diseases, acquired immune deficiency syndrome and non-neoplastic pathological conditions (col. 15, lines 60-66). Although Halperin does not specify MAC components are isolated from human, the above disclosure infers that MAC components are from human subject. Halperin discloses the therapeutic agent may be RNA (col.15, line 56) such as ribozyme (col.14, lines 30-31). Halperin also teaches antisense oligonucleotides that arranged so as to interfere with transcription or a translation of a desired target may be delivered (col.12, lines 41-43). Halperin discloses nucleic acid molecules including antisense RNA or DNA may be delivered by using MAC, and any agent can be delivered as long as it can pass through the transmembrane channel (col.11, lines 42-56).
However, Halperin does not specifically teaches that the therapeutic cargo is siRNA.
Roizman teaches various therapeutic agents for the treatment of age related macular degeneration (AMD) (see abstract) (claim 17). Roizman teaches neovascularization is one of the phenotype of AMD (wet AMD, see abstract) (claim 19). Roizman teaches contacting choroidal blood vessels of the eye with treatment routes including intravitreal (claim 14, 17 and 20). Roizman teaches the therapeutic agent for treating AMD may be a polypeptide, a small molecule, a polynucleotide including siRNA (paragraph [0113]).
It would have been obvious to an ordinary skilled in the art that siRNA agent for treating AMD (taught by Roizman) may also be delivered by using MAC as taught by Halperin because Halperin teaches antisense RNA or DNA may be delivered by using MAC, and any agent can be delivered as long as it can pass through the transmembrane channel. It would have been obvious to an ordinary skilled in the art that siRNA may pass through transmembrane channel, so that there would have been reasonable expectation of success to use the MAC complex taught by Halperin to deliver siRNA following combined teaching from Halperin and Roizman. Therefore, the claimed invention of claim 1 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Regarding claim 2, Halperin discloses delivering therapeutic or diagnostic agent simultaneously with MAC transmembrane forming agent, and C5b-6 and therapeutic agents are delivered prior to contact with C7, C8 and C9 (col.5, line 5-6, and 33-40). The disclosure meets the limitation of delivering C5b-6 in combination with the therapeutic or diagnostic agent.
Regarding claim 12, Halperin discloses the MAC is used in delivering therapeutic agent to improve treatment of a wide variety including cancer, such as primary tumor by control of tumoral cell proliferation, angiogenesis, metastatic growth, or apoptosis (col.16, lines 2-5). It would have been inherent the antitumor agent is delivered to a cancer cell.
Regarding claim 13, although Halperin does not specify the therapeutic agent is delivered to pancreatic or breast cancer, Halperin teaches a number of chemotherapeutic agents to be delivered by MAC, including taxol, fluorouracil (col.15, line 29-30), both is approved for treating breast cancer and pancreatic cancer. It would have been obvious to an ordinary skilled in the art that said agent needs to be targeted to breast cancer and pancreatic cancer cells using MAC as claimed.
Regarding claim 15, various diseases disclosed by Halperin (bridging paragraph of col.15 and 16) are all human disease. As such, it is inherent the cell of a subject is from human.
Regarding claim 16, although Halperin does not specify the origin of C5b-6 being isolated, Halperin teaches C7, C8 and C9 would be endogenous to the subject being treated, which meets the limitation of autologous. It would have been obvious to an ordinary skilled in the art that C5b-6 would also be autologous so that the MAC formed by all of the components is autologous to avoid degradation by immune system of the host subject.
Regarding claim 14, 17, 19 and 20, Halperin does not teach contacting choroidal blood vessels of the eye with MAC formed by C5-6, C7, C8 and C9, or injecting said MAC in the vitreous of eye.
Halperin teaches the therapeutic agents formed with MAC may target specific cell types that is diseased (col.11, line 48-64). Halperin teaches the agents to be delivered may be any therapeutic or diagnostic agents which pass through the MAC transmembrane channels, and the properties of the molecules comprising the therapeutic agent is of no importance so long as the molecule can pass through the MAC transmembrane channels.
It would have been obvious to an ordinary skilled in the art that delivering agents for treating neovascularization disorder as disclosed by Roizman may be modified by using MAC method taught by Halperin. The ordinary skilled in the art would be motivated to do so to improve drug delivery as taught by Halperin. Therefore, the claimed invention of claim 14, 17, 19 and 20 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Regarding claim 18, Halperin discloses delivering therapeutic or diagnostic agent simultaneously with MAC transmembrane forming agent, and C5b-6 and therapeutic agents are delivered prior to contact with C7, C8 and C9 (col.5, line 5-6, and 33-40). The disclosure meets the limitation of delivering C5b-6 in combination with the therapeutic or diagnostic agent.
Regarding claim 21, various diseases disclosed by Halperin (bridging paragraph of col.15 and 16) are all human disease. As such, it is inherent the cell of a subject is from human.
Regarding claim 22, although Halperin does not specify the origin of C5b-6 being isolated, Halperin teaches C7, C8 and C9 would be endogenous to the subject being treated, which meets the limitation of autologous. It would have been obvious to an ordinary skilled in the art that C5b-6 would also be autologous so that the MAC formed by all of the components is autologous to avoid degradation by immune system of the host subject.
Response to Arguments
Applicant asserts that the specification demonstrates that MAC is an effective tool for delivering siRNAs for treatment of human diseases. Applicant argues that Halperin makes no discussion of siRNA, but merely provides a general teaching of therapeutic or diagnostic agents with long lists of classes of agents and no specific mention of siRNA. Applicant argues the combined teaching from Halperin and Roizman does not arrive at delivering siRNA using MAC as recited in present claims.
The above argument has been fully considered but deemed unpersuasive. As discussed in above rejection, Halperin teaches antisense oligonucleotides (wherein oligonucleotide includes both deoxyribonucleotides as well as ribonucleotides, col.12, lines 54-56) that can inhibit transcription and agents of any kind that can pass through transmembrane channel may be delivered by MAC. Since siRNA are short RNA sequences inhibit transcription, they are encompassed by the agent (structurally and functionally) that Halperin’s MAC would be able to deliver. Since Roizman teaches siRNA for treating AMD, it would have been obvious to an ordinary skilled in the art to introduce said siRNA using the MAC taught by Halperin. Therefore, for reasons discussed in previous office action and set forth above, this rejection is still considered proper and thus maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CELINE X QIAN whose telephone number is (571)272-0777. The examiner can normally be reached M-F (8-4:00).
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/CELINE X QIAN/Primary Examiner, Art Unit 1637