DETAILED ACTION
Status of Application
Claims 156-175 are pending
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
The following amendments and cancelations as submitted on 08/14/2026 are acknowledged:
Claims 1-155 are cancelled.
Claims 156 and 159 are amended.
Claims 162-175 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/17/2026.
Claims 156-161 are being examined.
Claim Objections
The previous objection of claim 159 due to the recitation of “…polylactic acid (PLA), or poly-e-caprolactone (PCL)…..polypropylene oxide (PPO), or polyhydroxybutyrate…” is hereby withdrawn by virtue of Applicant’s amendment.
Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA )
(previous rejection, withdrawn) Claims 156-161 were previously rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly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. In view of the amendment of claim 156, this rejection is hereby withdrawn.
Claim Rejections - 35 USC § 102 (AIA )
Claims 156-157 and 159-161 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoo et al. (Journal of pharmaceutical sciences 90.2 : 194-201 Published 02/02/2001) (hereby “Yoo”).
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of claims 156-157 and 159-161 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Applicant has amended claim 156, to include dextran sulfate, rendering the rejection of 156-157 and 159-161 moot. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendment of claim 156.
Claim Rejections - 35 USC § 103 (AIA )
Claim 158 was previously rejected under 35 U.S.C. 103 as being unpatentable over Yoo et al. (Journal of pharmaceutical sciences 90.2 : 194-201 Published 02/02/2001) (hereby “Yoo”) in view of Suk et al. (Advanced drug delivery reviews 99 (2016): 28-51) (hereby “Suk”).
Response to Arguments
Applicant’s arguments, with respect to the rejection(s) of claim 158 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Applicant has amended claim 156 to include dextran sulfate, rendering the rejection of claim 158 moot, due to claim 158 being dependent on claim 156. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) for rejection is made in view of Applicant’s amendment of claim 156.
Claim Rejections - 35 USC § 103 (AIA )
(new rejection, necessitated by amendment) Claims 156-161 are rejected under 35 U.S.C. 103 as being unpatentable over Yoo et al. (Journal of pharmaceutical sciences 90.2 : 194-201 Published 02/02/2001) (hereby “Yoo”) in view of White et al. (US-20170151339-A1 published 06/01/2017) (hereby “White”), and Suk et al. (Advanced drug delivery reviews 99 (2016): 28-51) (hereby “Suk”).
The teachings of Yoo, Suk, and White have been discussed in the 05/14/2016 office action. Yoo teaches a protein-fatty acid complex which is a hydrophobic ion pairing complex made of lysozyme and sodium oleate (Page 195, left column, last paragraph). Yoo teaches making nanoparticles with PLGA (Page 196, left column, last paragraph). Yoo teaches making nanoparticles under vigorous stirring conditions (Page 196, right column, first paragraph). Yoo teaches dissolving the ion-pairing complex in a water-miscible organic solvent into biodegradable nanoparticles based on a spontaneous emulsion solvent diffusion method (Page 195, right column, first paragraph). Yoo teaches mixing lysozyme with oleate in tris or acetate buffer to get the hydrophobic ion pairing complex, and centrifugation to recover the complex (Page 195, right column, paragraph 3).
Regarding claim 156-161, Yoo does not teach the use of dextran sulfate. Regarding claim 158, Yoo does not teach the use of polyethylene glycol (PEG).
White discloses sodium oleate and dextran sulfate as counterions suitable for preparing hydrophobic ion-pairing complexes [0278].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the sodium oleate used in Yoo with Dextran Sulfate taught as taught by White. A person of ordinary skill in the art is motivated to make this substitution because sodium oleate and dextran sulfate are counterions suitable for preparing hydrophobic ion-pairing complexes as taught by white. Accordingly, one of ordinary skill in the art would have reasonably considered Dextran Sulfate as an obvious alternative for the counterion in Yoo.
Regarding claim 158, Suk teaches that coating the surface of nanoparticles with polyethylene glycol (PEG), or “PEGylation”, is a commonly used approach for improving the efficiency of drug and gene delivery (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate PEG in the method taught by Yoo. A person of ordinary skill in the art is motivated to incorporate PEG in the method taught by Yoo to improve efficiency of nanoparticle drug and gene delivery. One of ordinary skill in the art has a reasonable expectation of success at arriving to using a polymer that comprises a hydrophobic polymer and polyethylene glycol (PEG) because all that is required is adding PEG to the nanoparticle preparation method taught by Yoo.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
(previous rejection, maintained) Claims 156-161 were previously rejected under 35 U.S.C. 103 as being unpatentable over White et al. (US-20170151339-A1 published 06/01/2017) (hereby “White”) in view of Ristroph et al. (Nanoscale Advances published 2019) (hereby “Ristroph”).
Response to Arguments
Applicant’s arguments, with respect to the rejection(s) of claims 156-161 U.S.C. 103 have been fully considered and are not persuasive.
Applicant acknowledges that dextran sulfate is used as a counterion in White but argues that there is no preference for selecting dextran sulfate. As stated previously, White expressly identifies dextran sulfate as a counterion suitable for preparing hydrophobic ion-pairing complexes [0278]. The fact that White discloses other suitable counterions does not negate the teaching of dextran sulfate. Further, Ristroph teaches that dextran sulfate is used for hydrophobic ion-pairing as well, involving protein structures (Table 3). Ristroph teaches that dextran sulfate is the most common polyvalent counterion used for complexing drugs and it can form a complex coacervate that may be encapsulated using methods that also encapsulate hydrophobic ion pairs (Page 4229, left column, second full paragraph). Thus Ristroph provides guidance for selecting dextran sulfate for complexation and encapsulation and both the cited references provide teachings directed to the incorporation of dextran sulfate.
The Applicant argues that White does not teach mixing dextran sulfate and an enzyme to form a hydrophobic ion paring complex. Applicant also argues that Ristroph’s general teaching that hydrophobic ion paring may be used with enzymes, and that dextran sulfate being used for complexation with proteins, do not specifically teach mixing dextran sulfate with an enzyme to form the claimed complex. The rejection is based on the combined teachings of White and Ristroph, not of White and Ristroph alone. White expressly identifies dextran sulfate as a counterion suitable for preparing hydrophobic ion-pairing complexes [0278], while Ristorph teaches that hydrophobic ion pairing is a useful tool for complexing and encapsulating small molecules, peptides, protein fragments, and full proteins such as antibodies and enzymes into nano-scale delivery vehicles (Page 4230; left column; last paragraph). Ristroph also provides guidance for selecting dextran sulfate for complexation and encapsulation as discussed above. Accordingly, the references must be considered for their combined teachings, and the combined teachings teach the claimed method. Applicant reiterates that White and Ristroph, alone or in combination, do not specifically teach a method of preparing enzyme loaded nanoparticles as claimed. As stated in the previous office action, White teaches a method of preparing conjugates and particles comprising these conjugates comprising mixing the complex in a solution (Page 137 [0568]-[0572]). White teaches a method of preparing conjugates and particles comprising these conjugates comprising centrifuging the solution to separate the hydrophobic ion pairing complex (Page 194 [0763]). White teaches a method of preparing conjugates and particles comprising these conjugates comprising mixing polymer with the hydrophobic ion pairing complex (Page 113 [0329]). White teaches a method of preparing conjugates and particles comprising these conjugates comprising mixing polymer wherein the polymers are loaded in nanoparticles (Page 115 [0346]). Risptroph teaches the applicability of hydrophobic ion-pairing to enzymes and the use of dextran sulfate. Thus, in combination White and Ristroph disclose the claimed method. Therefore, this rejection is hereby maintained.
Conclusion
No claim is in condition for allowance
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 SYNPHANE SHELTON whose telephone number is (571)272-6318. The examiner can normally be reached 8:30am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached at (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. /S.L.S./Examiner, Art Unit 1652
/ROBERT B MONDESI/ Supervisory Patent Examiner, Art Unit 1652
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