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 .
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-18, 23 and 28, drawn to a therapeutic composition.
Group II, claim(s) 19-22 and 24-27, drawn to a method of treating joint pain in a patient in need thereof.
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a therapeutic composition comprising a polymeric nanoparticle, a ligand selected to activate an EGFR receptor, and a linker associating the nanoparticle and the ligand, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Zale et al (US 2019/0029960 A1) as discussed below in detail (see Paragraph 10 below).
During a telephone conversation with Mr. Aaron Rabinowitz (attorney for applicant) on October 30, 2025, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-18, 23 and 28. Affirmation of this election must be made by applicant in replying to this Office action. Claims 19-22 and 24-27 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 14 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.
The term “essentially” in claim 14 is a relative term which renders the claim indefinite. The term “essentially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The amount of change in the hydrodynamic diameter of the therapeutic composition after being exposed to water for 1 week has been rendered indefinite by the use of the term.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 12 and 23 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Zale et al (US 2019/0029960 A1).
Zale teaches (see abstract) a therapeutic nanoparticle that includes a biocompatible polymer, a polymer-EGFR ligand conjugate, wherein the EGFR ligand is covalently bound through a chemical linker to the polymer, and a therapeutic agent.
Zale gives (see [0139]) an exemplary embodiment where nanoparticles comprising PLA-PEG (polylactic acid-polyethylene glycol), PLA-PEG-azide and PLA-Cy5 (fluorescent label – see [0138]) are first generated through a nano-emulsion process (Zale thus teaches instant polymeric nanoparticle of claim 1). Then, epidermal growth factor (“EGF” of instant claim 2, which is instant ligand of claim 1 selected to activate an EGFR receptor), a naturally occurring EGFR ligand, is covalently tethered to DBCO (dibenzocyclooctyne – instant linker of claim 1 which associates the polymeric nanoparticle and the ligand) to allow for conjugation of DBCO (instant linker) to the azide moieties (instant anchor species of claim 5 that associates with the linker) on the nanoparticles using click chemistry (see [0142], [0144], Figs.3, 4 and 5, [0136] and claim 7).
Thus, Zale teaches instant claims 1, 2 and 12.
With respect to instant claim 23, Zale teaches (claim 13) a pharmaceutically acceptable composition comprising a plurality of therapeutic nanoparticles (as discussed above) and a pharmaceutically acceptable excipient. Thus, Zale teaches instant claim 23.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Zale et al (US 2019/0029960 A1).
With respect to instant claim 13, Zale teaches ([0046]) that its nanoparticles may have a hydrodynamic diameter of about 50 – about 140 nm. Such range overlaps with instant range about 10 – about 80 nm for the hydrodynamic diameter, thus rendering instant range prima facie obvious. In the case “where the [claimed] ranges overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness would exist which may be overcome by a showing of unexpected results, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Thus, Zale renders obvious instant claim 13.
With respect to instant claim 14, since Zale teaches instant therapeutic composition of claim 1 comprising all of instant components, the hydrodynamic diameter for Zale’s therapeutic nanoparticles would inherently remain essentially unchanged following the therapeutic nanoparticles’ exposure to water for 1 week as instantly recited (besides, Zale also aims for a long-term storage of its nanoparticle stocks in aqueous suspensions – see [0135]). Thus, Zale renders obvious instant claim 14.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Zale et al (US 2019/0029960 A1) in view of Qin et al (“EGFR Signaling: Friend or Foe for Cartilage?”, JBMR Plus. Vol.3(2) (Feb. 13, 2019) : e10177, obtained from the website: https://pmc.ncbi.nlm.nih.gov/articles/PMC6383702/ ).
As discussed above, in Zale, EGF is used as the EGFR ligand (instant ligand selected to activate an EGFR receptor). Although Zale does not teach instant TGFa as its EGFR ligand, as evidenced by Qin (see the 2nd paragraph under “Introduction” and the caption under Fig.1), EGF and TGFa are well known in the art as equivalent ligands that bind only to EGFR (and activate the receptor). Thus, it would be obvious to one skilled in the art to use TGFa as Zale’s EGFR ligand with a reasonable expectation of success. Thus, Zale in view of Qin renders obvious instant claim 3.
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Zale et al (US 2019/0029960 A1) in view of Engel et al (“A highly efficient peptide substrate for EGFR activates the kinase by inducing aggregation”, Biochem J. vol.453(3) (Aug. 1, 2013): pg.337-44, obtained from the website: https://pmc.ncbi.nlm.nih.gov/articles/PMC4048812/ ).
Zale does not teach instant ligand which differs from a naturally-occurring ligand by one or more amino acids. Zale, however, teaches ([0070]) that its EGFR ligand can be a modified EGFR peptide having a Mw of about 1,200 to 1,900. Engel teaches (see abstract) that Peptide C, a synthetic peptide substrate of EGFR, can increase EGFR kinase activity (i.e., activates an EGFR receptor). Engel further teaches (see pg.3, the paragraph under “Peptide substrates”) that the sequence of Peptide C is RAHEEIYHFFFAKKK, which Mw is 1,802 (as calculated by the Examiner) which falls within the Mw range of about 1,200 to 1,900 (as taught by Zale). Since Zale teaches that its EGFR ligan can be a modified EGFR peptide having a Mw of about 1,200 to 1,900, it would be obvious to one skilled in the art to use Engel’s synthetic Peptide C (instant ligand of claim 4 which differs from a natural-occurring ligand by one or more amino acids) as Zale’s EGFR ligand with a reasonable expectation of success in increasing EGFR kinase activity. Thus, Zale in view of Engel renders obvious instant claim 4.
Claim(s) 5, 6, 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Zale et al (US 2019/0029960 A1) in view of Qian et al (“Polycaprolactone-Based Mimetic Antimicrobial Peptide Copolymers Vesicles as an Effective Drug-Carrier for Cancer Therapy”, Polymers (Basel), Vol.11(11) (Oct. 31, 2019): 1783, obtained from the website: https://pubmed.ncbi.nlm.nih.gov/31683611/ ) (with Wikipedia article on “Polylysine” obtained from the website: https://en.wikipedia.org/wiki/Polylysine , which is being cited here merely to support the Examiner’s assertion that polylysine is a polymer containing a positively charged hydrophilic amino group).
With respect to instant claims 5, 6 and 8, as already discussed above, Zale teaches nanoparticles comprising PLA-PEG (polylactic acid-polyethylene glycol), PLA-PEG-azide and PLA-Cy5. Zale’s PLA-PEG and PLA-PEG-azide teach instant first polymer (1) of claim 5, and the azide moiety teaches instant anchor species (3) that associates with the linker.
Zale does not teach instant second polymer (2) comprising at least one positively charged group. Zale, however, teaches ([0048]-[0049]) that its therapeutic nanoparticle can include one or more additional, unfunctionalized polymers that can be natural or synthetic, homopolymers or copolymers. Among examples for such additional polymers, Zale include ([0056]) poly(caprolactone) (“PCL”), PEGylated poly(caprolactone) (“PEG-PCL”), polylysine (“PLL”) and PEGylated polylysine (“PEG-PLL”). Zale further teaches ([0093] and claim 14) that its therapeutic nanoparticle can be used to treat cancer and contains a therapeutic agent. Qian teaches (see the 1st paragraph under “3.2 Self-Assembly of PCL16-b-Kn Copolymers” and Conclusions) PCL16-b-Kn copolymers (where K stands for polylysine (“PLL”)), which exhibit broad antibacterial activity and can self-assemble into vesicles, with the hydrophilic PLL forming the corona of the vesicles and the hydrophobic PCL forming the membrane of the vesicles. Qian teaches that these vesicles can encapsulate and release drugs and can achieve controlled intracellular drug release and effective killing capabilities of cancer cells with low cytotoxicity to normal cells. Since Zale teaches that its therapeutic nanoparticles can be used in treating cancer and contains a therapeutic agent, and since Zale also teaches that the additional polymers that can be included in its nanoparticle can be homopolymers or copolymers and can be chosen from PCL and PLL, it would be obvious to one skilled in the art to use Qian’s PCL16-b-Kn Copolymers (where K stands for PLL) as the additional polymer in Zale’s therapeutic nanoparticle so as to encapsulate Zale’s therapeutic agent with a reasonable expectation of achieving controlled intracellular drug release and effective killing capabilities of cancer cells with low cytotoxicity to normal cells. As evidenced by the Wikipedia article on Polylysine (see the paragraph under “Chemical structure”), polylysine is a polymer containing a positively charged hydrophilic amino group. Thus, Qian’s PCL16-b-Kn Copolymers (where K stands for PLL) teaches instant second polymer (2) comprising at least one positively charged group. Thus, Zale in view of Qian renders obvious instant claims 5, 6 and 8 (Zale’s PLA-PEG and PLA-PEG-azide teaches instant first polymer of claim 6 comprising PEG and PLA; Qian’s PCL16-b-Kn Copolymers (where K stands for PLL) teaches instant second polymer of claim 8 comprising PLL).
With respect to instant claim 9, Qian gives examples (see section 3.2 that starts on pg.4) of its PCL16-b-Kn diblock copolymers (where K is PLL and n ranges from 11 to 27). Such diblock copolymers teach instant PLL-PCL diblock copolymer of claim 9. As to instant Mw range of about 1500 – about 30,000, since there are 16 repeating caprolactone units and 11-27 repeating lysine units in Qian’s PCL16-b-Kn diblock copolymers (with K being PLL and n ranging from 11 to 27), this gives Mw range of 3,232 – 5,280 (as calculated by the Examiner). Such range falls within instant Mw range, thus teaching instant Mw range. Thus, Zale in view of Qian renders obvious instant claim 9.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Zale et al (US 2019/0029960 A1) in view of Qian et al (“Polycaprolactone-Based Mimetic Antimicrobial Peptide Copolymers Vesicles as an Effective Drug-Carrier for Cancer Therapy”, Polymers (Basel), Vol.11(11) (Oct. 31, 2019): 1783, obtained from the website: https://pubmed.ncbi.nlm.nih.gov/31683611/ ) as applied to claim 6 above, and further in view of Yu et al (US 10,172,796 B2).
With respect to instant claim 7, as already discussed above, Zale’s nanoparticles comprise PLA-PEG, PLA-PEG-azide and PLA-Cy5, and as also discussed above, Zale’s PLA-PEG and PLA-PEG-azide teach instant first polymer of claim 6 comprising PEG and PLA. Although Zale’s PLA-PEG and PLA-PEG-azide do not teach instant PEG-PCL diblock copolymer of claim 7, Zale teaches ([0056]) the equivalence of PEGylated PLA and PEGylated PCL. Thus, it would be obvious to one skilled in the art to replace Zale’s PLA-PEG with PCL-PEG (Instant PEG-PCL diblock copolymer of claim 7) with a reasonable expectation of success. As to instant Mw range of about 3,000 to about 30,000, Zale does not explicitly teach such limitation. However, as evidenced by Yu et al (claims 1-3), PEG-PCL diblock copolymers, which form polymer micelles (encapsulating a drug) used in a pharmaceutical formulation for treating cancer, are known to have molecular weight that ranges from 1,000 to 5,000. It would be obvious to one skilled in the art to use PCL-PEG diblock copolymer having Mw range from 1,000 to 5,000 (instead of PLA-PEG) to form Zale’s nanoparticles with a reasonable expectation of success. The Mw range of 1,000-5,000 overlaps with instant Mw range of about 3000 – about 30,000, thus rendering instant range prima facie obvious. In re Wertheim, supra. Thus, Zale in view of Qian, and further in view of Yu renders obvious instant claim 7.
Claim(s) 10, 11, 15, 17 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Zale et al (US 2019/0029960 A1) in view of Wang et al (“Preferential tumor accumulation and desirable interstitial penetration of poly(lactic-co-glycolic acid) nanoparticles with dual coating of chitosan oligosaccharide and polyethylene glycol-poly(D,L-lactic acid)”, Acta Biomaterialia, vol.29 (2016), pg.248-260, obtained from the website: https://pubmed.ncbi.nlm.nih.gov/26476340/ ) .
Zale is silent about the surface charge of its therapeutic nanoparticles. After stating that rapid clearance from blood and poor penetration capacity in heterogeneous tumors represent great challenge for polymeric nanoparticles as effective delivery systems for anticancer drugs, Wang states that through his study he discovered that polymeric nanoparticles with a slight positive charge (+ 3.54 mV) showed an improved accumulation and interstitial penetration capacity to/in tumor site, and thus led to an enhance antitumor efficacy (see ABSTRACT and Statement of significance on pg.248). Since Zale is silent as to the surface charge of its therapeutic nanoparticles, it would have been obvious to one skilled in the art to prepare Zale’s therapeutic nanoparticles with a slight positive charge (about + 3.54 mV) (which falls within instant range of about -5 mV to about 30 mV) in order to improve accumulation and interstitial penetration capacity to/in tumor site and thus to achieve an enhanced antitumor efficacy for tis therapeutic nanoparticles, as taught by Wang. Thus, Zale in view of Wang renders obvious instant claims 10, 11, 15, 17 and 28 (all the limitations of claims 15, 17 and 28 other than the surface charge limitation of claim 15 were already discussed in Paragraph 10 above).
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Zale et al (US 2019/0029960 A1) in view of Wang et al (“Preferential tumor accumulation and desirable interstitial penetration of poly(lactic-co-glycolic acid) nanoparticles with dual coating of chitosan oligosaccharide and polyethylene glycol-poly(D,L-lactic acid)”, Acta Biomaterialia, vol.29 (2016), pg.248-260, obtained from the website: https://pubmed.ncbi.nlm.nih.gov/26476340/ ) as applied to claim 15 above, and further in view of Qin et al (“EGFR Signaling: Friend or Foe for Cartilage?”, JBMR Plus. Vol.3(2) (Feb. 13, 2019) : e10177, obtained from the website: https://pmc.ncbi.nlm.nih.gov/articles/PMC6383702/ ).
As discussed above, in Zale, EGF is used as the EGFR ligand (instant ligand selected to activate an EGFR receptor). Although Zale does not teach instant TGFa as its EGFR ligand, as evidenced by Qin (see the 2nd paragraph under “Introduction” and the caption under Fig.1), EGF and TGFa are well known in the art as equivalent ligands that bind only to EGFR (and activate the receptor). Thus, it would be obvious to one skilled in the art to use TGFa as Zale’s EGFR ligand with a reasonable expectation of success. Thus, Zale in view of Wang, and further in view of Qin renders obvious instant claim 16.
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Zale et al (US 2019/0029960 A1) in view of Wang et al (“Preferential tumor accumulation and desirable interstitial penetration of poly(lactic-co-glycolic acid) nanoparticles with dual coating of chitosan oligosaccharide and polyethylene glycol-poly(D,L-lactic acid)”, Acta Biomaterialia, vol.29 (2016), pg.248-260, obtained from the website: https://pubmed.ncbi.nlm.nih.gov/26476340/ ) as applied to claim 15 above, and further in view of Qian et al (“Polycaprolactone-Based Mimetic Antimicrobial Peptide Copolymers Vesicles as an Effective Drug-Carrier for Cancer Therapy”, Polymers (Basel), Vol.11(11) (Oct. 31, 2019): 1783, obtained from the website: https://pubmed.ncbi.nlm.nih.gov/31683611/ ) (with Wikipedia article on “Polylysine” obtained from the website: https://en.wikipedia.org/wiki/Polylysine , which is being cited here merely to support the Examiner’s assertion that polylysine is a polymer containing a positively charged hydrophilic amino group).
As already discussed above, Zale teaches nanoparticles comprising PLA-PEG (polylactic acid-polyethylene glycol), PLA-PEG-azide and PLA-Cy5. Zale’s PLA-PEG and PLA-PEG-azide teach instant first polymer (1) of claim 18, and the azide moiety teaches instant anchor species (3) that associates with the linker.
Zale does not teach instant second polymer (2) comprising at least one positively charged group. Zale, however, teaches ([0048]-[0049]) that its therapeutic nanoparticle can include one or more additional, unfunctionalized polymers that can be natural or synthetic, homopolymers or copolymers. Among examples for such additional polymers, Zale include ([0056]) poly(caprolactone) (“PCL”), PEGylated poly(caprolactone) (“PEG-PCL”), polylysine (“PLL”) and PEGylated polylysine (“PEG-PLL”). Zale further teaches ([0093] and claim 14) that its therapeutic nanoparticle can be used to treat cancer and contains a therapeutic agent. Qian teaches (see the 1st paragraph under “3.2 Self-Assembly of PCL16-b-Kn Copolymers” and Conclusions) PCL16-b-Kn copolymers (where K stands for polylysine (“PLL”)), which exhibit broad antibacterial activity and can self-assemble into vesicles, with the hydrophilic PLL forming the corona of the vesicles and the hydrophobic PCL forming the membrane of the vesicles. Qian teaches that these vesicles can encapsulate and release drugs and can achieve controlled intracellular drug release and effective killing capabilities of cancer cells with low cytotoxicity to normal cells. Since Zale teaches that its therapeutic nanoparticles can be used in treating cancer and contains a therapeutic agent, and since Zale also teaches that its additional polymers that can be included in its nanoparticle can be homopolymers or copolymers and can be chosen from PCL and PLL, it would be obvious to one skilled in the art to use Qian’s PCL16-b-Kn Copolymers (where K stands for PLL) as the additional polymer in Zale’s therapeutic nanoparticle so as to encapsulate Zale’s therapeutic agent with a reasonable expectation of achieving controlled intracellular drug release and effective killing capabilities of cancer cells with low cytotoxicity to normal cells. As evidenced by the Wikipedia article on Polylysine (see the paragraph under “Chemical structure”), polylysine is a polymer containing a positively charged hydrophilic amino group. Thus, Qian’s PCL16-b-Kn Copolymers (where K stands for PLL) teaches instant second polymer (2) comprising at least one positively charged group. Thus, Zale in view of Wang, and further in view of Qian renders obvious instant claim 18.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
January 22, 2026