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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 5, 2026 has been entered.
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.
Claims 1-5 and 8-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Regarding claim 1, the chemical structure provided in the claim contains a variable “n,” but does not provide acceptable values therefor. One having ordinary skill in the art would therefore be unable to determine which of the genus of poly(ethylene glycol) diacrylates are included within the claimed method.
For the sake of examination, the value of “n” will be interpreted as including values of 1 or more, as the prefix “poly” within “poly(ethylene glycol)” implies a minimum of two ethylene glycol units and no upper limit is specified.
Regarding claims 2-5 and 8-9, the claims are rendered indefinite because they directly depend on claim 1, which is indefinite as described above.
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.
Claims 1, 3-4, and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Green (US 2015/0273071 A1).
Regarding claim 1, Green teaches degradable cationic polymers (Abstract, [0051]), formed by conjugate addition of amine-containing molecules onto acrylates or acrylamides ([0041]). The polymerization process is exemplified by a two-step synthesis: in the first step, a diacrylate is polymerized with a first amine-containing molecule; in the second step, the acrylated product of the first step is endcapped with a second amine-containing molecule (e.g., Example 1, [0166], and Scheme 1 on p. 4). These method steps read on the claimed steps “(a)” and “(b),” respectively. Furthermore, Green exemplifies the usage of a molar ratio (diacrylate to first amine-containing molecule) of 1.01:1.
Regarding the components utilized within the claimed method steps, Green teaches the specific use of 3-amino-1-propanol (p. 7, molecule S3 which is indicated as a side-chain molecule suitable for forming the cationic polymer in step 1 of the aforementioned synthetic method). Green further teaches the use of amine-capping molecules such as 2,2-dimethylpropane-1,3-diamine (p. 6, molecule E2 which is indicated as an end-group molecule suitable for capping the cationic polymer formed in step 1 of the aforementioned synthetic method). Finally, Green teaches the incorporation of di(ethylene glycol) diacrylate, which reads on the claimed “poly(ethylene glycol) diacrylate” monomer as claimed because it is the same as claimed wherein “n” equals 1 (see claim interpretation set forth in the 35 USC 112(b) rejection of claim 1, above).
In each case, these materials are taught as suitable alternatives for their respective uses within the inventive polymerization process; furthermore, it is prima facie obvious to substitute equivalents known in the art as suitable for the same purpose (see MPEP 2144.06). It therefore would have been obvious to one having ordinary skill in the art at the time of filing to incorporate the di(ethylene glycol) diacrylate, 3-amino-1-propanol, and 2,2-dimethylpropane-1,3,-diamine within the exemplified method of Green, thereby arriving at the same process as claimed. The inventive scheme of Green illustrates that the cationic polymer produced in the first step contains terminal acrylate groups, and illustrates the complete end-capping of the cationic polymer (c.f. p. 4, Scheme 1), and therefore no acrylate groups remain in the final product; the method of Green therefore meets the claimed limitations requiring “the cationic polymer comprises one or more terminal acrylate groups” and “the capped cationic polymer does not comprise any acrylate groups.” One having ordinary skill in the art would recognize that the chemistries involved in the reaction steps of Green comprise Michael addition reactions.
Regarding claim 3, as described above, Green teaches the use of 2,2-dimethylpropane-1,3-diamine (p. 6, molecule E2).
Regarding claim 4, as described above, Green exemplifies that the ratio of diacrylate to the first amine-containing compound is 1.01:1 ([0166]).
Regarding claims 8-9, as described above, Green teaches a capped cationic polymer produced by the claimed method. Furthermore, Green teaches the incorporation of a labeling molecule such as a fluorescent molecule ([0058]), which reads on the claimed “fluorescent dye.”
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Green (US 2015/0273071 A1) in view of Yu (US 2003/0215395 A1).
Regarding claim 2, Green teaches all of the limitations of claim 1 as described above. Green differs from claim 2 because it is silent with regard to the incorporation of di(trimethylolpropane) tetraacrylate, as claimed.
In the same field of endeavor, Yu teaches controllably degradable cationic polymers for delivery of biomolecules (Abstract), which contain a linker molecule ([0021]) and thereby increase the molecular weight of the cationic polymer to facilitate delivery ([0013]). The linker molecule is exemplified as including di(trimethylolpropane) tetraacrylate (p. 7, Table 2). The resulting crosslinked cationic polymer comprises more than two terminal acrylate groups ([0077] and Figure 1).
Green contemplates degradable polymers for drug delivery (Abstract), contemplates efficient delivery ([0039]), and even contemplates crosslinking of the inventive degradable polymers ([0063]). It therefore would have been obvious to one having ordinary skill in the art at the time of filing to incorporate the linker of Yu into the cationic polymer synthesis of Green for the purpose of increasing the molecular weight of the cationic polymer to further facilitate drug delivery. Doing so would read on the claimed step “(a).”
Allowable Subject Matter
Claim 5 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 6 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claims 5 and 6 require relatively high amounts of capping molecules on a mass basis relative to the mass of cationic polymer. The claimed ratio range of “100:100 to 100:500” requires that the mass of the capping agent used in the capping step of the claimed method range from amounts equal to and up to 5 times the mass of the cationic polymer.
In contrast, Green is silent with regard to the claimed range. However, another document, Green-782 (US 2012/0128782 A1) exemplifies a corresponding ratio range of about 100:6.23 (see [0182], where 321 mg of cationic polymer are capped with 800 microliters of a 0.25 M solution of amine; using 2,2-dimethylpropane-1,3-diamine, which would have been obvious as described above, this corresponds to 321 mg of cationic polymer and about 20 mg of amine; a mass ratio of about 100:6.23). This range differs highly from the claimed range, falling nearly two entire orders of magnitude short of the upper range thereof, and over an order of magnitude short of the lower range thereof. The representative scheme of Green-782 appears to indicate that complete endcapping of the inventive cationic polymer occurs under these conditions. One having ordinary skill in the art would therefore not be motivated to modify the amount of amine utilized to reach the claimed range for the purpose of completely endcapping the cationic polymer; doing so would apparently include an excess of amine which far exceeds the amount required to achieve complete endcapping.
Response to Arguments
Applicant contends that Green does not anticipate the present invention because its polymers “are designed for a fundamentally different purpose, employ a fundamentally different backbone architecture, and possess chemical properties incompatible with the requirements of the presently claimed barcoding polymers.”
As an initial matter, regarding that Green is asserted to be “designed for a fundamentally different purpose,” this is recognized as a stipulation on intended use of the claimed method/polymer. However, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction (see MPEP 2111.02.II.).
Regarding the remaining contentions, listed above, Applicant argues that the polymers of Green are designed to degrade whereas those of the instant disclosure are designed to remain intact. Applicant states that, as a matter of chemistry, the degradable/in-tact polymers cannot be inherently the same. Applicant states that the polymers of the instant application are designed to stably retain conjugated moieties and avoid the cleavage pathways that Green intentionally builds into its inventive polymer architecture.
However, the polymers of the present application contain ester linkages (e.g., within the PEG diacrylate and di(trimethylolpropane) tetraacrylate monomers). Green specifically indicates that ester linkages are degradable (c.f. [0047] of Green). Furthermore, while disulfide linkages are also specifically contemplated and exemplified within Green (c.f. [0047] and p. 4, Scheme 1), these linkages are not required by Green. Importantly, the exemplified scheme and polymer formula of Green are not the only polymers/schemes with fit therein (c.f. [0041] and [0042] – these are indicated as some embodiments of the inventive polymers). Patents are relevant as prior art for all of the information that they contain, and non-preferred and alternative embodiments nonetheless constitute prior art (see MPEP 2123.I and II).
As described above, Green teaches an array of backbone, side-chain, and end group monomers which are devoid of disulfide linkages. The combination of the claimed combination of PEG diacrylate, 3-amino-1-propanol, and a terminal amino group falls squarely within the teachings of Green and, while Green contemplates the degradability of these polymers, the definition of degradability within the teachings of Green plainly includes chemical linkages which are required by the Applicant’s polymers. Therefore, in contrast to Applicant’s assertion, Green does not require a “fundamentally different backbone architecture” (although the teachings of Green do include optional degradable linkages which fall outside of the claimed method), and likewise do not require “chemical properties incompatible with the requirements of the presently claimed barcoding polymers.” It is the Office’s position that the ester linkages of Green, which Green defines as a degradable linkage, is inherently the same as the ester linkages within the instant disclosure, regardless of whether the Applicant considers ester linkages to be “degradable” in the same way that Green does.
While Applicant’s arguments regarding the rejection of the claims under 35 USC 102 were unpersuasive as described above, one having ordinary skill in the art would be required to select the claimed compounds from broad ranges of components disclosed by Green in order to meet the claimed method. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection under 35 USC 103 is made of claims 1,3-4, and 8-9 view of Green and of claim 2 in view of Green and further in view of Yu, as described above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA CALEB BLEDSOE whose telephone number is (703)756-5376. The examiner can normally be reached Monday-Friday 8:00 a.m. - 5:00 p.m. EST.
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/JOSHUA CALEB BLEDSOE/Examiner, Art Unit 1762
/ROBERT S JONES JR/Supervisory Patent Examiner, Art Unit 1762