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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 30, 2026 has been entered.
Summary
Claims 1, 3-5, 7-14, and 16-27 are pending in this office action. Claims 2, 6, and 15 are cancelled. All pending claims are under examination in this application.
Priority
The current application filed on March 22, 2023 claims domestic priority to a provisional patent application 63/322,346 filed on March 22, 2022.
Claim Objections
Claims 1, 3-5, 7-14, and 16-27 are objected to because of the following informalities:
Claims 1, 3, 14, and 16 are listed as “currently amended” within the claim set. However, the claims listed have no underlined text indicating where an addition occurred.
Dependent claims 3-5, 7-13, and 27 fail to cure the defect of claim 1.
Dependent claims 16-26 fail to cure the defect of claim 14.
Appropriate correction is required.
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 non-obviousness.
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.
Claims 1, 3-5, 7-14, and 16-27 are rejected under 35 U.S.C. 103 as being unpatentable over Shin et al. (Biomaterials, 2010) in view of Shi et al. (Expert Opinion on Drug Delivery, 2005), Gower et al. (US2017/0367974A1), and Yantasee et al. (US2021/0030679A1).
[The Examiner is going to introduce each reference and then combine them in the rejection of the instant claims.]
1. Shin et al.
Shin et al. is considered to be the closest prior art to the present invention and teaches phosphatidylserine immobilization of lentivirus for localized gene transfer (see title). In addition, Shin et al. disclose localized and efficient gene transfer can be promoted by exploiting the interaction between the vector and biomaterial. Regulation of the vector–material interaction was investigated by capitalizing on the binding between lentivirus and phosphatidylserine (PS), a component of the plasma membrane. PS was
incorporated into microspheres composed of the copolymers of lactide and glycolide (PLG) using an emulsion process. Increasing the weight ratio of PS to PLG led to a greater incorporation of PS. Lentivirus, but not adenovirus, associated with PS-PLG microspheres, and binding was specific to PS relative to PLG alone or PLG modified with phosphatidylcholine. Immobilized lentivirus produced large numbers of
transduced cells, and increased transgene expression relative to virus alone. Microspheres were subsequently formed into porous tissue engineering scaffolds, with retention of lentivirus binding. Lentivirus immobilization resulted in long-term and localized expression within a subcutaneously implanted scaffold. Microspheres were also formed into multiple channel bridges for implantation into the spinal cord. Lentivirus delivery from the bridge produced maximal expression at the implant and a gradient of
expression rostrally and caudally. This specific binding of lentiviral vectors to biomaterial scaffolds may provide a versatile tool for numerous applications in regenerative medicine or within model systems that investigate tissue development. (see abstract).
2. Shi et al.
Shi et al. teach current advances in sustained release systems for parenteral drug delivery (see title). Furthermore, Shi et al. disclose that major progresses in the development of parenteral sustained-release systems have been made in recent years as evidenced by the regulatory approval and market launch of several new products. Both the availability of novel carrier materials and the advances in method of fabrication have contributed to these commercial successes. With the formulation challenges associated with biologics, new delivery systems have also been evolved specifically to address the unmet needs in the parenteral sustained release of proteins. In this
review paper, different new carriers systems and preparation methods are discussed with special focus on their applications to biologicals (see abstract).
3. Gower et al.
Gower et al. teach polymer implants for treatment of metabolic disorders (see title). Furthermore, Gower et al. disclose implantable devices including a biocompatible matrix configured for long term location in adipose tissue and a biologically active agent that can be carried by the matrix and delivered to the adipose tissue following implant therein. The biologically active agent can include a modulator or a precursor thereof that can directly or indirectly modify the gene expression of adipose cells, e.g., adipocytes, and thereby modify the presence or quantity of one or more expression products of the adipose tissue that may act locally on distant from the implant site in an endocrine fashion. Modulators can include small molecules (e.g., resveratrol), polynucleotides (e.g., RNAi), or polypeptides (e.g., antibodies or functional fragments thereof) (see abstract).
4. Yantasee et al.
Yantasee et al. teach therapeutic constructs for co-delivery of mitotic kinase inhibitor and immune checkpoint inhibitor (see title). Furthermore, Yantasee et al. disclose therapeutic constructs including a delivery particle, at least one mitotic kinase inhibitor, and at least one immune checkpoint inhibitor. Also disclosed are therapeutic constructs including a mitotic kinase inhibitor, an immune checkpoint inhibitor, and a chemical linker. These therapeutic constructs cause cancer death by both therapeutic and immune effects and promote targeted delivery of more therapeutics to the surviving cancer cells in a positive feed-back loop. They enhance therapeutic index of free drugs and can be used intratumorally or systemically. This strategy can treat broad cancer types and is particular useful for cancer without obvious receptors for cancer-targeted delivery of otherwise toxic therapeutics (see abstract).
Additionally, Yantasee et al. disclose micro- and nano-spheres comprising PLG as part of the therapeutic agents delivery system (see paragraph [0180] within Yantasee et al.).
Combination of Shin et al., Shi et al., and Gower et al.
Regarding instant claim 1, Shin et al., Shi et al., and Gower et al. teach a method for forming a polymeric particle. The necessary citations within Shin et al., Shi et al., and Gower et al. that correspond to instant claim 1 are compiled within Table I.
Table I
Instant Claim 1
Shin et al., Shi et al., and Gower et al. Citations
A method for forming a polymeric particle comprising:
Shin et al. disclose phosphatidylserine (PS) was
incorporated into microspheres (particles) composed of the copolymers of lactide and glycolide (PLG) using an emulsion process (see abstract within Shin et al.).
combining an aqueous phase with an organic phase to form an emulsion,
Shi et al. disclose the following systematic description of the microencapsulation:
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(see Figure 2, within Shi et al.) An organic and aqueous phase are combined in the presence of an emulsifier (polyvinyl alcohol; PVA) to form an emulsion.
Furthermore, Shin et al. disclose that PLG was dissolved in dichloromethane to 3% (w/w) solution, which was then emulsified in 1% poly(vinyl alcohol)
(PVA) at 7000 rpm to create microspheres. After 3h of stirring, microspheres were then washed with deionized water three times to remove PVA and lyophilized overnight. Phosphatidylserine (PS) or phosphatidylcholine (PC) modified PLG
(PS-PLG or PC-PLG) microspheres were prepared using the same procedure except that PS was co-dissolved with PLG in dichloromethane with a weight ratio of 1:10 (PC or PS:PLG) (see page 4354, left column, 2.0 Materials and methods within Shin et al.)
Gower et al. disclose that the (PLG) microspheres
were prepared as schematically illustrated in FIG. 2. Briefly, PLG (75:25 mol ratio d,I-lactide to glycolide, 0.76 dL/g) (Evonik) was dissolved in dichloromethane to make a 6% (w/w) solution, which was then emulsified in 1% poly(vinyl
alcohol) to create microspheres. The microspheres were collected by centrifugation, washed with deionized water, and lyophilized overnight (see paragraph [0077] within Gower et al.). This experimental further is an example of step 1 prior to the addition of the phospholipid emulsifier (PS) illustrated directly above.
the aqueous phase comprising a first emulsifier, the organic phase comprising a second emulsifier comprising a functionalized phospholipid and a biocompatible polymer dissolved in a solvent, the emulsion comprising droplets of the organic phase dispersed in the aqueous phase;
The above experimental disclosure within Shin et al. uses PVA as the emulsifier for PLG. PVA could also be added to the aqueous phase owing to its water-solubility (see PTO-892 NPL W). This experimental could be easily adapted to Figure 2 shown within Shi et al. (see above). This combination would lead to an emulsion comprising droplets of the organic phase dispersed in the aqueous phase (after full addition of the aqueous phase to the organic phase).
and removing at least a portion of the solvent from the organic phase upon which the biocompatible polymer solidifies to form a polymeric particle, wherein the functionalized phospholipid is present at a surface of the solidified polymeric particle wherein the weight ratio of the second emulsifier to the biocompatible polymer is from about 1:20 to about 1:500.
Solvent removal is standard protocol within synthetic organic chemistry. Techniques include rotary evaporators, lyophilization, and nitrogen flow to remove volatile solvents.
Shin et al. disclose lyophilization of the PLG microspheres after removal of the PVA (see page 4354, left column, 2.0 Materials and methods within Shin et al.).
The second emulsifier (PS) is present on the surface of the PLG microspheres (see PTO-892 NPL U). Shin et al. disclose a scanning electron microscopy (Hitachi 3500N) was used to image the surface morphology of the microspheres (see page 4354, left column, 2.0 Materials and methods within Shin et al.). The use of the emulsion method with co-dissolved PLG and PS ensures the PS is present at the surface of the microspheres (see PTO-892 NPL U). This is validated within Shin et al. through binding studies which would not occur without surface interaction (see page 4354, 3.2 Specific Binding of Lentivirus to PS-PLG, right column within Shin et al.).
The PS content of the microspheres was approximately 10 mg PS per mg microsphere at a weight ratio of PS:PLG of 1:100. Increasing the
PS:PLG weight ratio led to a greater incorporation of PS, with a PS content equal to 80 mg per mg microsphere at a weight ratio of 1:10 (Fig. 1B) (see page 4354, 3.1 Polymer Modification with PS, right column within Shin et al.).
The combination of the Shin et al., Shi et al., and Gower et al. references make instant claim 1 obvious to a skilled artisan (POSITA; person of ordinary skill in the art).
[The remainder of the instant claims are either directly or indirectly dependent on instant claim 1, which is taught in full by the combination of Shin et al., Shi et al., and Gower et al.]
Regarding instant claims 3 and 16, Shin et al., Shi et al., and Gower et al. teach wherein the weight ratio of the second emulsifier to the biocompatible polymer is from about 1:5 to about 1:500. Shin et al. disclose a weight ratio of PS:PLG of 1:10 (see page 4354, left column, 2.0 Materials and methods within Shin et al.; also see Figure 1B within Shin et al.).
Regarding instant claims 4 and 17, Shin et al., Shi et al., and Gower et al. teach wherein the first emulsifier comprises polyvinyl alcohol, hydroxyethyl cellulose, carboxymethyl cellulose, methyl cellulose, gelatin, alkylarylsulfonates, alkylsulphates, fatty acid salts of alkali metals, polyethylene glycol, poly(ethylene-alt-maleic acid), didodecyldimethylammonium bromide, or a combination thereof. Shin et al. disclose the use of the first emulsifier polyvinyl alcohol (PVA) (see page 4354, left column, 2.0 Materials and methods within Shin et al.). Additionally, a skilled artisan (POSITA) could under routine experimental conditions add or substitute additional known (common) emulsifiers selected from this claim limitation list.
Regarding instant claims 5 and 18, Shin et al., Shi et al., and Gower et al. teach wherein the first emulsifier is present in the aqueous phase in an amount of from about 0.1 wt.% to about 3 wt.%. Shin et al. disclose a weight ratio for PVA of 1% (w/w) (see page 4354, left column, 2.0 Materials and methods within Shin et al.). PVA is soluble in water (see PTO-892 NPL W).
Regarding instant claims 7 and 19-20, Shin et al., Shi et al., and Gower et al. teach wherein the second emulsifier comprises a functionalized phospholipid. Shin et al. disclose the use of a second emulsifier phosphatidylserine or phosphatidylcholine (see page 4354, left column, 2.0 Materials and methods within Shin et al.). Furthermore, a skilled artisan (POSITA) could under routine experimental conditions add or substitute additional known phospholipids described within instant claims 7 and 20.
Regarding instant claims 8 and 21, Shin et al., Shi et al., and Gower et al. teach wherein the biocompatible polymer comprises poly(ethylene oxide)-poly(propylene oxide)-poly(ethylene oxide) copolymer, poly(lactide-co-glycolide), polycaprolactone, poly(lactic acid), poly(glycolic acid), polyethylene glycol, polysorbate, or a combination thereof. Shin et al. disclose the use of poly(lactide-co-glycolide) (PLG) (see page 4354, left column, 2.0 Materials and methods within Shin et al.). In addition, a skilled artisan (POSITA) could under routine experimental conditions add or substitute additional known biocompatible polymers described within the instant claim limitation.
Regarding instant claims 9 and 22, Shin et al., Shi et al., and Gower et al. teach wherein the solvent comprises toluene, xylene, dichloromethane, chloroform, trichloroethylene, tetrachloroethylene, tetrachloroethane, chlorobenzene, dichlorobenzene, ethyl acetate, butyl acetate, ethyl formate, methylethyl ketone, or a combination thereof. Shin et al. disclose the use of the organic solvent dichloromethane (DCM) (see page 4354, left column, 2.0 Materials and methods within Shin et al.). Shi et al. disclose the use of the organic solvent ethyl acetate (EtOAc) (see Figure 2 within Shi et al.). Additionally, a skilled artisan (POSITA) could under routine experimental conditions add or substitute additional known organic solvents described within the instant claim limitation based on known solubility data.
Regarding instant claims 10, 23, and 27, Shin et al., Shi et al., and Gower et al. teach wherein the solidified polymeric particle size is from about 100 nm to about 20 mm. Shin et al. disclose the diameter of the microspheres was substantially decreased, from 12.8 ±2.5 mm to 3.6 ±1.6 mm, with addition of PS (p < 0.05) (see page 4354, right column, 3.0 Results within Shin et al.). A diameter of 3.6 ±1.6 mm would encompass 2.0 mm to 5.2 mm, creating an overlapping range with instant claim 27.
Combination of Shin et al., Shi et al., Gower et al., and Yantasee et al.
Regarding instant claims 11-12 and 25, Shin et al., Shi et al., Gower et al., and Yantasee et al. teach the organic phase further comprising a biologically active agent and/or a detectable label. Gower et al. disclose the use of the trans-stilbene, resveratrol, which is a polyphenol (see instant claim 24). Yantasee et al. disclose therapeutic oligonucleotides (see paragraphs [0146-0150] within Yantasee et al.), anti-cancer agents (see paragraphs [0158-0160] within Yantasee et al.), immune checkpoint inhibitors (see paragraphs [0114-0130] within Yantasee et al.), mitotic kinases and inhibitors (see paragraphs [0088-0113] within Yantasee et al.), and general therapeutic constructs (see paragraphs [0084-0087] within Yantasee et al.) that encompass many of the biologically active agents within instant claims 12 and 25. In addition, Gower et al. disclose the use of small molecules (e.g., resveratrol), polynucleotides (e.g., RNAi), or polypeptides (e.g., antibodies or functional fragments thereof) (see abstract within Gower et al.).
Regarding instant claims 13 and 26, Shin et al., Shi et al., Gower et al., and Yantasee et al. teach wherein the biologically active agent is a tyrosine kinase inhibitor. Yantasee et al. disclose the use of …tyrosine kinase inhibitors such as inhibitors of one or more of EGFR, HER2, KDR, FLT4, EphB4, and Src (e.g., gefitinib (Iressa™), erlotinib (Tarceva™), cetuximab (Erbitux™), lapatinib (Tykerb™), panitumumab (Vectibix™) vandetanib (Caprelsa™), afatinib/BIBW2992, CI-1033/canertinib, neratinib/H KI-272, CP-724714, TAK-285, AST-1306, ARRY334543, AG-1478, dacomitinib/PF299804, OSI-420/desmethyl erlotinib, AZD8931, ARRY-380, AEE788, pelitinib/EKB-569, CUDC-101, WZ8040, WZ4002, WZ3146, AG-490, XL647, P0153035, BMS-599626, sorafenib, imatinib (Gleevec®), sunitinib, and dasatinib (see paragraph [0158] within Yantasee et al.).
Regarding instant claim 14, Shin et al., Shi et al., Gower et al., and Yantasee et al. teach a method for forming a polymeric particle comprising: combining an aqueous phase with an organic phase to form an emulsion, the aqueous phase comprising a first emulsifier, the organic phase comprising a second emulsifier, a biocompatible polymer, a biologically active agent, and a solvent, the emulsion comprises droplets of the organic phase dispersed in the aqueous phase; and removing at least a portion of the solvent from the organic phase, upon which the biocompatible polymer solidifies to form a polymeric particle, wherein the second emulsifier is present at a surface of the solidified polymeric particle.
Please see the citations and discussion within instant claim 1 for the necessary rejection text. Furthermore, Yantasee et al. disclose the addition of numerous biological agents that can be used with a PLG construct (see paragraphs [0158-0160] within Yantasee et al.). This is not identical to the PLG-PS motif of the present invention, although the incorporation of a biological agent is the next logical step of a skilled artisan (POSITA).
Regarding instant claim 24, Shin et al., Shi et al., Gower et al., and Yantasee et al. teach wherein the biologically active agent comprises an amphiphilic phenolic compound. Gower et al. disclose the use of the trans-stilbene, resveratrol, which has been encapsulated within PLG microspheres (see paragraph [0083] within Gower et al.). The phenolic groups is hydrophilic at the oxygen atom and the remainder of the molecule is hydrophobic. Thus, exhibiting amphiphilic characteristics.
In the context of instant method claims 1, 3-5, 7-14, and 16-27, the desired purpose defines an effect that arises from, and is implicit in the method step(s). Thus, where the purpose is limited to stating a technical effect that inevitably occurs during the performance of the claimed method step(s), and is therefore inherent in that/those step(s), that technical effect is not limiting to the subject-matter of the claim. Thus, the present method claim, defining the application/use of the composition according to the cited prior art and defining its purpose as "use", is anticipated by any document of the state of the art describing a method of application/use although not mentioning this specific use.
Analogous Art
The Shin et al., Shi et al., Gower et al., and Yantasee et al. references are all applicable to the endeavor of the instant application. Therefore, these teachings make the references relevant to instant claims 1, 3-5, 7-14, and 16-27.
Obviousness
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the PLG-PS microsphere disclosed by Shin et al. using the teachings of Shi et al., Gower et al., and Yantasee et al. to incorporate the necessary claim limitations. Starting with Shin et al., the skilled person only had to try the necessary claim limitations disclosed by Shi et al., Gower et al., and Yantasee et al. The combination of Shin et al., Shi et al., Gower et al., and Yantasee et al. would allow one to arrive at the present application without employing inventive skill. This combination of the PLG-PS microsphere taught by Shin et al. along with the use of the necessary claim limitations taught by Shi et al., Gower et al., and Yantasee et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application. It would have only required routine experimentation to modify the PLG-PS microsphere disclosed by Shin et al. with the use of the necessary claim limitations taught by Shi et al., Gower et al., and Yantasee et al. This combined modification would have led to an enhanced PLG-PS microsphere that would be beneficial for patients.
Response to Arguments
Applicant's arguments filed January 30, 2026 have been fully considered but they are not persuasive.
The Applicant’s claim amendments did not necessitate a new ground of rejection.
Applicant Argument: The Applicant argues that the functionalized phospholipid is not present at the surface of the solidified polymeric particle.
Examiner’s Rebuttal: The Examiner submits that the PLG and the PS are co-dissolved to form microspheres, and then lyophilized. However, it is evident that the PS is incorporated on the surface of the microsphere via the emulsion process set forth in Shin et al. (see the emulsion discussion and citations therein within instant claim 1). The use of the emulsion method with co-dissolved PLG and PS ensures the PS is present at the surface of the microspheres (see PTO-892 NPL U-V).
Figure 4 within Shin et al. presents some ambiguity to the reader, as discussed by the Applicant. Transduction is induced through a cascade of events. A better representation of a binding study is discussed further in section 3.2 specific binding of lentivirus to PS-PLG (see page 4354, right column within Shin et al.):
Incubation of the lentivirus and adenovirus with PLG or PC modified PLG resulted in few transduced cells (Fig. 2B, C, F, G), consistent with previous reports [13]. Lentivirus association with the PS-PLG microspheres, however, produced substantial quantities of transduced cells (Fig. 2D), which was not observed with adenovirus (Fig. 2H).
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Fig. 2. Specific binding of lentivirus to PS-PLG microspheres LV-GFP (A–D) and rAd-GFP (E–H) were incubated with PLG (B, F), PC-PLG (C, G), or PS-PLG (D, H) microspheres for 30 min and centrifuged to remove the unbound viruses. After wash with PBS, the microspheres were mixed with 293 cells and seeded on the plate. GFP expression was visualized at 2 days after seeding. Viruses without mixing with microspheres were used as control (A, E). Bar represents 100 mm.
The surface availability of the PS on PLG is also confirmed within the Applicant’s instant specification (see paragraphs [0069] and [00106] within the instant specification).
The Examiner agrees with the Applicant that encapsulation is not the same as
surface binding. Furthermore, the Examiner acknowledges that “[T]the small size of PS allows for substantial encapsulation and can enable numerous interactions between the microsphere and vector” (see page 4357, right column within Shin et al.). No total confirmation by Shin et al. is made regarding the surface decoration of PS or encapsulation of PS within PLG. However, it is the Examiners position that both surface modification and encapsulation can occur with PLG similar to what is cited within Yantasee et al. (see paragraph [0162] within Yantasee et al.).
One or more targeting moieties (a.k.a., targeting molecules) can be loaded into, attached to the surface of, and/or enclosed within the delivery vehicle. In embodiments, the targeting moiety is displayed on the exterior surface of the delivery vehicle. Such targeting moieties may be particularly beneficial for systemic delivery.
Additionally, Yantasee et al. identifies PLG(A) as a delivery system (see paragraph [0180] within Yantasee et al.) and identifies PS as a shell component [or surface component] (see paragraph [0231] within Yantasee et al.).
Applicant Argument: The Applicant argues that the secondary references of Shi et al., Gower et al., and Yantasee et al. would not be cited by a skilled artisan (POSITA).
Examiner’s Rebuttal: The Examiner respectfully disagrees. The Examiner relies on the Shi et al., Gower et al., and Yantasee et al. references to meet all of the Applicant’s additional claim limitations, and support the primary reference of Shin et al.
Therefore, the 35 U.S.C. § 103 rejection is maintained for instant claims 1, 3-5 and 7-14, and 16-27.
Conclusion
No claims are allowed.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615