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 .
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.
Claim 152 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 152 recites the broad recitation L2 comprises heteroalkylene, and the claim also recites other identities of L2 that fall within the scope of the term heteroalkylene which is the narrower statement of the range/limitation. See for example (iii), (iv), (viii) The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Additionally claim 152 is indefinite because while reciting identities of L2 as alternative embodiments, the claim also comprises limitations comprising the phrase “L2 further comprises” (see (v) (vi)). It is unclear what the term further refers to, which definition of L2 is the term augmenting?
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 159 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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 159 limits R3 to H or the depicted structure, however this does not limit the definition of R3 recited in claim 156. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 147, 148, 149, 152, 153, 154, 155, 157, 161 and 162 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matray et al (WO 2020/210694; submitted with IDS 6/11/26).
Scope of prior art
Matray teaches preparation of polymeric drugs using the following DNA synthesis cycle (page 141):
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This is the same approach as described by the applicants on page 139 of the specification and requires preparation of the monomer to use in the coupling reaction. Said monomer is the subject of current claims. With regards to the monomer, Matray preparation of the following generic monomer in Example 2 on page 128:
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In the above structure, ODMTr represents the triphenyl portion of compound II, L1 is CH2, L3 is CH2-O, L2 is La-Lb-NCO and M is M. The currently claimed options for La-Lb are taught on page 26. Currently claimed anti-cancer therapeutics are taught on pages 58-64.
Ascertaining the difference
While Matray teaches a general method for preparing the anti-cancer therapeutic containing monomer, a skilled artisan would have to select from a various disclosed embodiments in order to arrive at the currently claimed compound.
Obviousness
A person of ordinary skill in the art, prior to the earliest effective filing date of the current application, would have found it obvious to prepare the compound recited in the herein rejected claims by following the teachings of Matray. Matray provides a method of preparing the compound on page 128 and identifies the currently claimed variables throughout the document and on the specifically indicated pages. It would have been obvious to prepare the monomer recited on page 128 with M being an anti-cancer therapeutic and La-Lb corresponding to CH2-O-(CH2)3N. This linker is disclosed by Matray on page 26. One would have expectation that the monomer would find utility in preparation of polymeric anti-cancer agent according the method described on page 141.
Claim objections
Claims 150, 151, 156, 158, 160, 163, 164 and 165 are objected to. Closest art is Matray et al described above. Art teaches L3 as CH2-O and does not provide for variations in this group. In objected claims, L3 is O. Matray provides no motivation to make the necessary modification.
Allowed claims
Claim 166 is allowed, Closest art is Matray et al described above. Art teaches L3 as CH2-O and does not provide for variations in this group. In objected claims, L3 is O. Matray provides no motivation to make the necessary modification.
Conclusion
Claims 147-166 are pending
Claim 166 is allowed
Claims 150, 151, 156, 158, 160, 163, 164 and 165 are objected to
Claims 147, 148, 149, 152, 153, 154, 155, 157, 159, 161 and 162 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
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