DETAILED ACTION Claims 21-40 are pending in the instant application. 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. Priority The instant application claims priority to 371 of PCT/EP2022/056977 filed 03/17/2022 which claims priority to United Kingdom 2103785.8 filed on 03/18/2021. Information Disclosure Statement The information disclosure statement (IDS) submitted are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement was considered by the examiner. Please see attached initialed Forms 1449 . 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 appl icant regards as his invention. Claim 40 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. Claim 40 includes both “comprising” or “consisting” of the active ingredient. The examiner cannot determine if the filament process will include other ingredients or the ingredients explicitly listed in the claim. In addition, it is unclear to what “the filament” and “the at least one stabilizer” are referring. Claim Rejections - 35 USC § 102 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 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 21-23, 26-27, 29, 33-34, and 36 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Stankovic et al. (Tailored protein release from biodegradable poly(e-caprolactone-PEG)-b-poly(e-caprolactone) multiblock-copolymer implants. European Journal of Pharmaceutics and Biopharmaceutics, 2014) . Stankovic discloses that biodegradable polymers such as poly(DL-lactide-co- glycolide ) (PLGA) or poly(DL-lactide) (PDLA)) have been widely applied as release controlling polymers in microparticle and implant-based depot formulations for peptides and proteins ( pg 329). Stankovic teaches that the combination of hydrophilic (PCL-PEG)-b-(PCL) polymers and low temperature hot melt extrusion (HME) allows incorporation of proteins into the implants without protein degradation and controlled release of fully intact protein ( pg 330). When formulating proteins and peptides into polymeric implants, one needs to take into account the various factors that affect the release kinetics. Protein release from polymeric matrices is governed by the physico -chemical properties of both polymer and drug , as well as by the conditions at the site of release ( pg 330). Stankovic experiments with (PCL-PEG)-b-(PCL) multiblock co-polymers with different PCL-PEG/PCL ratios and prepared protein-loaded implants thereof by HME ( pg 330). The release of five proteins with different molecular weight, i.e. goserelin (1.2 kDa ), recombinant human insulin (5.8 kDa ), lysozyme (14 kDa ), carbonic anhydrase (29 kDa ) and bovine serum albumin (66 kDa ) from [PCL-PEG]-b-[PCL] polymers with varying PEG content was evaluated ( pg 330). The protein/inulin loading is 11 wt % (Table 1). Claim s 21-23, 25-31, and 36-39 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Pereira et al. (Polymer Selection for HME Coupled to FDM in Pharmaceutics, pharmaceutics , 2020). Pereira discloses that 3D printing offers a great potential to revolutionize the future of pharmaceutical manufacturing; of many technologies available, fusion deposition modelling (FDM) is considered the lowest cost and higher reproducibility and accessibility for drug delivery. FDM requires in-house production of filaments of drug-containing thermoplastic polymers by hot-melt extrusion (HME). The ability to integrate HME and FDM and predict and tailor the filaments’ properties will extend the range of printable polymers/formulations (Abstract). Drug loading into the filament can be achieved by incorporation into the powder mixture before the extrusion process ( pg 3). Drug-loaded filaments produced by HME are suitable for 3D printing ( pg 4). Plasticizers, the most extensively used adjuvants, are added to the polymeric formulations to enhance their processing conditions ( pg 10). Pereira discloses that main matrix-former polymers include PCL:PVA:PEG, PVA:PEG, and other polymer combinations ( pg 21, Table 3). For PCL:PVA:PEG, PEG polymers (10% w/w) can be used as the plasticizer ( pg 21, Table 3). Claim Rejections - 35 USC § 103 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 21-40 are rejected under 35 U.S.C. 103 as being unpatentable over Stankovic et al. (Tailored protein release from biodegradable poly(e-caprolactone-PEG)-b-poly(e-caprolactone) multiblock-copolymer implants. European Journal of Pharmaceutics and Biopharmaceutics, 2014) and Pereira et al. (Polymer Selection for HME Coupled to FDM in Pharmaceutics, pharmaceutics , 2020). Stankovic discloses that biodegradable polymers such as poly(DL-lactide-co- glycolide ) (PLGA) or poly(DL-lactide) (PDLA)) have been widely applied as release controlling polymers in microparticle and implant-based depot formulations for peptides and proteins ( pg 329). Stankovic teaches that the combination of hydrophilic (PCL-PEG)-b-(PCL) polymers and low temperature hot melt extrusion (HME) allows incorporation of proteins into the implants without protein degradation and controlled release of fully intact protein ( pg 330). When formulating proteins and peptides into polymeric implants, one needs to take into account the various factors that affect the release kinetics. Protein release from polymeric matrices is governed by the physico -chemical properties of both polymer and drug, as well as by the conditions at the site of release ( pg 330). Stankovic experiments with (PCL-PEG)-b-(PCL) multiblock co-polymers with different PCL-PEG/PCL ratios and prepared protein-loaded implants thereof by HME ( pg 330). The release of five proteins with different molecular weight, i.e. goserelin (1.2 kDa ), recombinant human insulin (5.8 kDa ), lysozyme (14 kDa ), carbonic anhydrase (29 kDa ) and bovine serum albumin (66 kDa ) from [PCL-PEG]-b-[PCL] polymers with varying PEG content was evaluated ( pg 330). The protein/inulin loading is 11 wt % (Table 1). Pereira discloses that 3D printing offers a great potential to revolutionize the future of pharmaceutical manufacturing; of many technologies available, fusion deposition modelling (FDM) is considered the lowest cost and higher reproducibility and accessibility for drug delivery. FDM requires in-house production of filaments of drug-containing thermoplastic polymers by hot-melt extrusion (HME). The ability to integrate HME and FDM and predict and tailor the filaments’ properties will extend the range of printable polymers/formulations (Abstract). Drug loading into the filament can be achieved by incorporation into the powder mixture before the extrusion process ( pg 3). Drug-loaded filaments produced by HME are suitable for 3D printing ( pg 4). Plasticizers, the most extensively used adjuvants, are added to the polymeric formulations to enhance their processing conditions ( pg 10). Pereira discloses that main matrix-former polymers include PCL:PVA:PEG, PVA:PEG, and other polymer combinations ( pg 21, Table 3). For PCL:PVA:PEG, PEG polymers (10% w/w) can be used as the plasticizer ( pg 21, Table 3). Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have combined teachings of above to create a pharmaceutical composition comprising a stabilizer wherein the stabilizer is a block copolymer formed from the combination of at least one PEG and at least one other polymer and an active ingredient. Thi s is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. Regarding claim 22, the block copolymer PCL-PVA-PEG is taught by Pereira above. Furthermore, Pereira discloses that one of ordinary skill in the art would, through routine experimentation, test different polymeric formulations for both HME and printing ( pg 23, 2 nd paragraph). Regarding claim 23, filaments created from one stabilizer and an active ingredient is taught above. Regarding claim 24, one of ordinary skill in the art would routinely experiment with various polymeric formulations to optimize both HME and printing process. Regarding claim 25, polymeric material and a plasticizer is taught by Pereira. Regarding claims 26-27, Pereira teaches that PVA, PLA, and PVP are the most commonly used pharmaceutical grade polymers for FDM ( pg 10, 2 nd paragraph). Furthermore, PEG can be used as a plasticizer as discussed above. Regarding claim 28, Pereira discloses a polymer comprising PCL:PVA:PEG (50-100% w/w) and a plasticizer of PEG 400 (10% w/w). Regarding claim 29, a block copolymer of PEG-PCL and/or PCL-PVA-PEG and/or PVA-PEG are taught by Stankovic and Pereira. Regarding claim 30, a block copolymer is taught above. Regarding claim 31, 55 to 85% (w/w) of polymer is taught by Pereira (Table 3). Regarding claim 32, Pereira teaches that HME efficiently dispersed indomethacin within the polymeric chains ( pg 42). Additionally, Pereira discloses that one of ordinary skill in the art would routinely check to confirm that the model drug is molecularly dispersed in the polymer matrices ( pg 43). Regarding claim 33, a therapeutic protein such as goserelin acetate, insulin, lysozyme, carbonic anhydrase, bovine serum albumin are taught by Stankovic ( pg 330, left col, 3rd paragraph). Regarding claim 34, Stankovic discloses protein/inulin loading of 11 wt % (Table 1). Regarding claim 35, one of ordinary skill in the art would routinely experiment with a proper blend of polymer/stabilizer/active ingredient within a filament composition. Likewise, a various ratio of protein:stabilizer would be experimented. Regarding claim 36, Pereira discloses that the filaments can be used to make an implant (See Figure 2). Regarding claim 37, Pereira discloses that T-shaped prototypes of intrauterine devices, containing indomethacin embedded in PCL were developed by FDM 3D-printing filaments. The study demonstrated the possibility of printing medical devices ( pg 46, last paragraph). Likewise, one of ordinary skill in the art would experiment with various shapes and sizes for the printed medical devices. Pereira teaches hollow cylinders ( pg 46). Regarding claim 38, one of ordinary skill in the art would envisage that a solid implant would be possible through HME and 3D printing. Regarding claim 39, 3D printing is discussed above. Regarding claim 40, Stankovic discloses that freeze-dried powder blends containing protein/inulin and polymer at a weight ratio of 11/89 were manually mixed using a mortal and pestle and then fed into the pre-heated barrel of the extruder (Section 2.6). Pereira discloses a process of producing filaments consisting of Eudragit RL, theophylline, and stearic acid as a solid plasticizer; mixtures were extruded using an extruder, and the powder blend was gravimetrically fed and then extruded. In short, depending on the type of polymer and the ratio of the plasticizer, the processing temperature varied ( pg 44, 2 nd paragraph). One of ordinary skill in the art would immediately envisage that filaments can be produced by feeding powders comprising a polymer, plasticizer, and active ingredient into an extruder. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT JOHN SEUNGJAI KWON whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-7737 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon - Fri 8:00 - 5:00 . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Robert A. Wax can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-0623 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JOHN SEUNGJAI KWON/ Examiner, Art Unit 1615 /Robert A Wax/ Supervisory Patent Examiner, Art Unit 1615