DETAILED ACTION
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 1 to 3, 5, 6, 8, 10 to 14, 18 to 25 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/243370 (cited by applicants in the IDS).
For ease in citation the Examiner will refer to the PGPub version of this reference
since citing specific paragraph numbers makes the rejection easier to explain.
Note that this reference is applicants’ own work and was cited in the ISR such that applicants should be well versed in the teachings therein.
Lee et al. 2022/0340712 teaches a hydrolysable polymer backbone that has a hydrophobic sidechain. See paragraph 20 and note the monomer units (a) as they are hydrophobic units meeting claimed (i). This can also include side chain units that have a polyamine group (Iii). See for instance paragraph 23.
This paragraph shows units that clearly meet the unit (iii) such as
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39
353
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This paragraph also shows units that have a terminal R5 group such as
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342
431
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As found in paragraph 79 R5 is independently various groups including groups such as
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102
382
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This is a polyalkylene oxide group that meets the claimed R5.
The fact that Lee et al. refers to the groups as being selected independently, one having ordinary skill in the art would have found the selection of two different polyamine containing units such as those meeting claimed (ii) and (iii) would have been obvious.
In view of the above, claim 1 is rendered obvious.
Thus, for instance, in the polymers shown in paragraph 98 the backbone and units of claimed (i) and (iii) are specifically shown. Given the teachings noted supra the skilled artisan would have found it obvious to include units of claimed (ii) obvious.
For claims 2 and 3 see paragraph 22 which teaches these units. See also the hydrocarbon units the polymers in paragraph 98.
For 5 again see the combination of units referenced above as they meet this limitation.
For claim 6, again see the units referenced above as well as the specific poly-amine units shown in the polymers in paragraph 98.
For claim 8, see the backbone in the polymers in paragraph 98 as well as the teaching of backbones as found in paragraph 21.
For claims 10 to 14, once again see the polymers in paragraph 98 and note that they compare to those claimed with the (obvious) exception of the claimed units (ii).
For claim 18 see paragraphs 100 to 102 which teach amounts of each units referenced by Lee et al. as “a” to “f” but corresponding to claimed units “m1-4” and “n1-2”. Adjusting the amounts and types of these units in an effort to optimize the properties associated therewith would have been well within the skill of the ordinary artisan such that a ratio within the range of .3 to 3 would have been obvious.
Where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
For claim 19 see paragraph 79 again and note that the corresponding “n” group can be from 0 to 50 (paragraph 85) which is almost completely encompassed by the t1 range such that the skilled artisan would have immediately envisioned a value with the claimed 2 to 200 range.
For claims 20, 21 and 24, see the method of preparation teachings starting on para-graph 106 of Lee et al. This teaches providing a polymer (meeting claimed step (a)) and reacting with a compound having the formula shown in paragraph 160, in which R5 is any of the groups previously described, i.e. the polyalkylene oxide group noted in the rejection rationale above and additionally shown in paragraph 210.
For claims 22 and 23, these compounds are not specifically taught in Lee et al. However paragraphs 158 to 160 generally teaches a reaction in which a displacement group attached to the desired R5 group is reacted with the polymer corresponding to the one in claim 20. From this one having ordinary skill in the art would have recognized that the selection of the specific leaving group is not a critical aspect of this process. As such selecting a useful and appropriate reactant for the preparation of the desired R5 group in the displacement reaction described therein would have been within the skill of the ordinary artisan with the expectation of obtaining a useful and predictable result. As such selecting such known displaceable groups would have been obvious.
For claims 25 and 36, note that this polymer is used to deliver nucleic acids and peptides. See paragraph 5.
Conclusion
Kim et al. is cited as being of general interest.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARGARET MOORE whose telephone number is (571)272-1090. The examiner can normally be reached on Monday to Friday, 10 am to 5 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heidi Kelly, can be reached at 571-270-1831.
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Mgm
8/22/26
/MARGARET G MOORE/Primary Examiner, Art Unit 1765
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