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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/11/2025 has been entered.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 1-3,6-10,17-21,24-26 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gao et al. (US 2010/0178699), cited previously, in view of Barber (WO 2010/017248 A2), cited previously, in view of Meltzer et al. “Chain Dynamics in Poly(amido amine) Dendrimers. A Study of 13C NMR Relaxation Parameters”, Macromolecules 1992, 25, 4541-4548, cited previously, in view of Khan et al. “Ionizable Amphiphilic Dendrimer-Based Nanomaterials with Alkyl-Chain-Substituted Amines for Tunable siRNA Delivery to the Liver Endothelium In Vivo”, Angew. Chem. Int. Ed. 2014, 53, 14397 –14401, cited previously, in view of Matai et al. “Hydrophobic myristic acid modified PAMAM dendrimers augment the delivery of tamoxifen to breast cancer cells”, RSC Adv., 2016, 6, 24808-24819.
Gao teaches lipophilic polyamines including PAMAM generation 1 dendrimers modified by oleic and stearic acid (considered to read on fatty acid ester claimed) used in compositions containing amphiphilic helper lipids including DOPE for delivery of nucleic acids including DNA and RNA. See entire disclosure, especially abstract, [0045],[0047], Fig 1 and claims, especially 1-2 and 5-8,11-18.
Gao while teaching the dendrimers were useful in delivering polynucleotides is silent with respect to delivery of Sting proteins of SEQ 1.
Barber is used only for the disclosure within that STING nucleic acids (SEQ 1 within same as claimed sequence 1) were well known before the time of the claimed invention to be useful in treating immune related disorders. See entire disclosure, especially abstract and claims. Since Gao already teaches delivery of polynucleic acids one of ordinary skill in the art would have a high expectation of success in using the dendrimers within to deliver STING polynucleotides. Reason to make such a modification would be to treat a subject in need for an immune disorder treatable by STING with the dendrimer carrier of Gao.
Gao is silent with respect to 13C isotope tracker on the dendrimer as recited in claims 7-10. The Meltzer reference is used only for the disclosure within that dendrimers naturally contained 13C and are NMR active. Since the PAMAM dendrimer of Meltzer is the same one of ordinary skill would find it obvious that the same PAMAM dendrimers of Gao also contain 13C and could be studied with NMR.
Gao while teaching use of helpful lipids such as DOPE is silent with respect to 1,2-dimyristoyl-sn-glycero-3-phosphoethanolamine-N- [methoxy (poly- ethylene glycol)-2000] as recited in claim 27 and the amount in claim 28.
However use of this lipid in the amounts claimed with dendrimer compositions was well known and understood as taught by Khan, who teaches its use in a 4:1 (25 wt%) ratio with dendrimer. See Khan in its entirety, especially page 14398 left col 1st full ¶. Since Gao already teaches use of “helpful lipids” one of ordinary skill could reason numerous lipophilic substances such as 1,2-dimyristoyl-sn-glycero-3-phosphoethanolamine-N- [methoxy (poly- ethylene glycol)-2000] could be substituted in the composition with similar results. An obviousness rejection based on similarity in chemical structure and function entails the reason for one of ordinary skill in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.
While the examiner believes stearyl acid reads on the claimed steric acid ester, applicants newly recited Markush group of fatty acid esters would also be obvious when the disclosure of Matai is considered.
Matai teaches PAMAM dendrimers such as those of Gao could be substituted on the surface amine by the fatty acid ester myristic acid. See entire disclosure, especially abstract and conclusion. Matai found that the hydrophobic modified dendrimers showed enhanced stability and solubility of active in polar conditions and showed improved cellular uptake. Since Gao and Matai teach substitution of PAMAM dendrimers with hydrophobic tails one of ordinary skill would have a very high expectation of success in substituting myristic acid on the dendrimer. One of ordinary skill would recognize from the disclosure of Gao and Matai that numerous fatty acids could be substituted with similar results as these fatty acids are generally considered art recognized equivalents. Further by substituting myristic acid the dendrimers would be expected to have the advantageous properties noted in Matai, including enhanced stability, solubility and cellular uptake.
Thus the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Response to Arguments
Applicant's arguments filed 7/11/2025 have been fully considered but they are not persuasive.
Applicants assert Gao requires DOPE and applicants believe this is a teaching away from their composition that does not require DOPE.
The relevance of this assertion is unclear. First applicants transitional phrase “comprising” does not exclude additional elements such as DOPE from being present in the composition. The transitional term “comprising”, which is synonymous with “including”, “containing”, or “characterized by”, is inclusive or open ended and does not exclude additional elements or method steps recited in the prior art. Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003). Additionally, as noted above it would be obvious that DOPE could be substituted for another lipid including the claimed lipid 1,2-dimyristoyl-sn-glycero-3-phosphoethanolamine-N- [methoxy (poly- ethylene glycol)-2000].
Applicants assert Barber, Meltzer and Khan do not teach the same fatty acid modified dendrimer or other aspects of the claimed invention.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Clearly the examiner did not use these secondary references for teaching all aspects of the claimed invention. Barber was used only for its teaching of STING proteins of SEQ ID 1, Meltzer was used for its teaching of 13C isotope tracker on dendrimers and Khan was used for teaching lipophilic 1,2-dimyristoyl-sn-glycero-3-phosphoethanolamine-N- [methoxy (poly- ethylene glycol)-2000].
Applicants assert they have compared Khan to their own invention with regard to SEAP expression in vitro and their invention showed higher SEAP expression. Applicants note Khan does not teach dendrimers conjugated to fatty acids.
The relevance of this assertion is unclear, are applicants trying to make an allegation of unexpected results? If so, it is inadequate as applicants do not compare their results to the closest prior art Gao which teaches fatty acid modified dendrimers. Additionally, the significance of the results is not clearly explained, from the graph the difference does not appear to be significant. Why is SEAP expression important, what is the difference from the closest prior art? Without establishing the significance and comparing the results to the closest prior art the allegation cannot be persuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
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/JAMES W ROGERS/Primary Examiner, Art Unit 1618