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 .
Summary
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/20/2026 has been entered.
Receipt of Applicants’ Amendments and Remarks filed on 08/20/2026 are acknowledged.
Claims 1-2, 19-23, 25-26, 28-31, 34-35 and 37-40 are pending.
Claims 3-18, 24, 27, 32-33 and 36 are cancelled.
Claims 1 and 28 are amended. Claims 39, 40 are new.
Claims 1-2,19-23, 25-26, 28-31, 34-35 and 37-40 are pending and are included in this examination.
Priority
Instant application 17/281,902 is a §371 National Stage entry of PCT/NL2019/050660, filed 10/02/2019, which in turn claims priority to
U.S. Provisional Application No. 62/740,145 filed 10/02/2018.
Claim Rejections - 35 USC § 112 – Withdrawn
The rejection of claim 28 under 35 U.S.C. § 112(b) as indefinite is WITHDRAWN. Claim 1 has been amended to recite that X has a block length of “about 10 to about 20” p-dioxanone monomer units and claim 28 has been correspondingly amended to recite that p is “10 to 20.” Claim 28 is no longer broader than claim 1, and the internal inconsistency previously identified is resolved.
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.
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 1-2,19-23, 25-26, 28-31 and 37-40 are rejected under 35 U.S.C. 103 as being unpatentable over Steendam et al. (US 2014/0199385 A1 hereinafter “Steendam”) in view of Prasad et al. (WO 2012110886 A1 hereinafter “Prasad”), in view of Kacker et al. (US 20180214507 A1 hereinafter “Kacker”) (both references are cited in IDS filed on 03/31/2021), and Zhou et al. (Biomaterials 2003, 24, 3563-3570, hereinafter “Zhou”) and further in view of Steendam et al. (US 9,364,442 B2, hereinafter “Steendam ’442”; originally published as US 2013/0209568 A1 on August 15, 2013).
Steendam teaches (in abstract) a biodegradable, semi-crystalline, phase separated thermoplastic multi-block copolymer, a process for preparing said multi-block copolymer, a composition for the delivery of at least one biological active compound, and to a method for delivering a biologically active compound to a subject in need thereof. A multi-block copolymer of the invention is characterized in that:
a) it comprises at least one hydrolysable pre-polymer (A) segment and at least one hydrolysable pre-polymer (B) segment,
b) said multi-block copolymer having a T g of 37° C. or less and a 110-250° C. under physiological conditions;
c) the segments are linked by a multifunctional chain-extender;
d) the segments are randomly distributed over the polymer chain;
e) at least part of the pre-polymer (A) segment is derived from a water-soluble polymer.
Prasad teaches a controlled-release formulation comprising human chorionic gonadotropin (hCG) or hCG variants, a process of preparation and use of the formulation, wherein the formulation avoids the need for repeated injections (abstract). Furthermore, Prasad teaches human chorionic gonadotropin (hCG) or hCG variants, a process of preparation and use of the formulation, wherein the formulation is directed to water-soluble polymer selected from the group consisting of polyethylene glycol (PEG) (page 5, line 15-17) and a controlled release formulation comprising biodegradable non-toxic FDA approved polymers nano-systems are an attractive alternative to liposomes since they have the advantages of longer circulation in the blood stream and generally higher drug carrying capacity, along with polymers, for example, poly (lactic acid) (PLA), poly (lactic co-glycolic acid) (PLGA) have been extensively investigated for their biocompatibility and potential capability of releasing therapeutically proteins in a controlled way even over a prolonged period of time (page 4, lines 13-18), coupled with human chorionic gonadotropin (hCG) or hCG variant loaded in microspheres (page 6, lines 5-7) and smart bio-degradable polymers and/or nanoparticle protein absorption, bioconjugation, and encapsulation are excellent alternatives for ensuring that the structure–activity relationship (SAR) of proteins from natural sources such as hCG that are not degraded during the course of administration by parenteral routes (page 5, lines 21-24). Furthermore, Prasad teaches microspheres facilitates controlled and sustained release (page 15, line 1) and the formulation could be administered as a depot injection containing the active drug embedded in the nanoparticles (nanospheres, nano-capsules, and nano particles) (page 15, lines 4-6). Notably, Prasad disclose prior art teaches protein delivery systems is often characterized by low entrapment efficiency, decrease burst release, instability of encapsulated hydrophilic protein and partial protein release and to improve performance of these polymer nanoparticles, polysaccharides, for example as alginate (ALG) and chitosan (CS) could be applied, CS and its derivatives have been intensively studied as carriers for proteins and drugs (page 4, lines 23-28). Prasad further disclose the controlled-release formulation comprising hCG is stable effective and advantageous over the hCG formulation known in the art, containing multiple uses to include therapy for increasing the levels of hCG in maintenance of pregnancy, taking care of the needs of a stable and preserved solutions, formulations, and products comprising of hCG or hCG variants and using these product in the field of gynecology (page 8, lines 1-6) and polymeric nano/microparticles offer specific advantages over liposomes or other carrier by increasing the stability of the drug and its variants, and possess useful controlled release properties, wherein the particle size varies from 10 to 1000 nm, and the hCG loaded microsphere is prepared by dissolving, entrapping, encapsulating or attached to polymer matrix and depending on the method of preparation microparticles, microspheres, nanoparticles, nanospheres or nano-capsules or a combination of all can be obtained (page 8, lines 15-21). Prasad fails to specifically teach a [poly(ε-caprolactone)-co-polyethylene glycol-co-poly(ε-caprolactone)]-b-[poly(p-dioxanone)] multi-block copolymer.
Kacker teaches microspheres formulation (¶s 0014, claims 42, 45, and 49) comprising gonadotropin-releasing hormone (GnRH) also known as luteinizing hormone releasing hormone (LHRH), controls the secretion of the gonadotropins, luteinizing hormone (LH) and follicle stimulating hormone (FSH) from the anterior pituitary gland, wherein analogues of GnRH are currently used to treat many medical conditions that require manipulation of the production of the sex hormones, testosterone and estrogen (¶ 0003). In another aspect of the composition, Kacker disclose a therapeutically effective amount of a GnRH antagonist in combination with a multi-block copolymer, wherein said multi-block copolymer comprises randomly or non-alternatingly arranged hydrolysable segments, wherein each segment comprises pre-polymer A or pre-polymer B, and wherein said segments are operably linked to each other by a multifunctional chain extender, and in an exemplary embodiment, the multi-block copolymer is a phase separated multiblock copolymer comprising one or more segments of a linear soft biodegradable pre-polymer A having a glass transition temperature (Tg) lower than 37 °C, and one or more segments of a linear hard biodegradable pre-polymer B having a melting point temperature (Tm) of 40-100 °C (¶ 0010) wherein the biodegradable multiblock copolymers comprising therapeutically effective amount of a GnRH antagonist in combination with poly(ε-caprolactone) (PCL) (¶ 0007), poly-ethylene-glycol (PEG) (¶ 0007), poly(L-lactide) or a combination thereof (¶ 0006). Furthermore, Kacker discloses polyether is polyethylene glycol (PEG), poly-propylene-glycol (PPG) and combinations thereof (¶ 0081, claim 62).
Zhou teaches poly(ε-caprolactone)-poly(ethylene glycol) copolymers in microspheres directed as carriers and that these matrix polymers may be optimized as carriers in the protein (antigen) delivery system for different purposes (abstract).
Steendam ‘442 is directed to biodegradable, thermoplastic, phase separated segmented multi-block copolymers, wherein the copolymers use in various biomedical applications as well as in pharmaceutical applications, for example, a composition for the controlled release of at least one biologically active polypeptide to a host, comprising the at least one biologically active polypeptide encapsulated in a matrix comprising at least one phase separated, thermoplastic multi-block copolymer, the copolymer being characterized in part (i) it comprises at least two hydrolysable segments chosen from prepolymer (A) and prepolymer (B), prepolymer (A) having a Tg lower than 37° C. and prepolymer (B) having a Tm of 40°C.-100° C. (abstract).
Regarding claim 1, Steendam discloses an extended release dosage form comprising a biodegradable, phase-separated, thermoplastic multi-block copolymer comprising at least one amorphous hydrolysable pre-polymer (A) segment and at least one semi-crystalline hydrolysable pre-polymer (B) segment (Abstract; ¶0016-0021), wherein the segments are linked by a multifunctional (diisocyanate) chain-extender (¶0019, ¶0064) and are randomly distributed over the polymer chain (¶0020, ¶0048), and wherein at least part of pre-polymer (A) is derived from a water-soluble polymer, preferably PEG (¶0021, ¶0061).
Steendam further discloses that pre-polymer (B) may comprise poly(p-dioxanone) (“PDS”) (¶0037-0038, ¶0042), and that the block length of the crystallizable segment is a result-effective variable controlling microsphere processability, storage stability, and degradation/release rate (¶0039-0042). While Steendam's own PDS-based working examples are not narrowed to “about 10 to about 20” p-dioxanone monomer units, it would have been obvious to a person of ordinary skill in the art before the effective filing date to optimize the poly(p-dioxanone) block length, including within the presently claimed 10-20 monomer unit range, as routine optimization of a result-effective variable under In re Aller, 220 F.2d 454 (CCPA 1955), motivated by Steendam's own teaching that block length governs microsphere processability and storage stability (¶0039-0040).
Regarding the amended limitation that the pre-polymer (B) segment has a number average molecular weight (Mn) of from about 2000 to about 4000 g/mol and a weight average molecular weight (Mw) of from about 3000 to about 4200 g/mol, Kacker discloses pre-polymer molecular weight ranges of about 300 to about 30,000 g/mol (Kacker, ¶0081), which fully encompasses the instant, narrower ranges. Selection of a molecular weight within this disclosed range, including the specific narrowed ranges now claimed, would have been an obvious matter of routine optimization of a result-effective variable, absent a showing of unexpected results commensurate in scope with the claimed ranges (see Response to Declaration, below).
Regarding the amended limitation that the pre-polymer (A) segment comprises PEG having a length of from about 1000 to about 5000 g/mol, Steendam discloses that the water-soluble polymeric segment is derived from PEG having a number average molecular weight (Mn) of 150-5000 g/mol (¶0063), which fully encompasses the instant range.
Regarding the amended limitation that the pre-polymer (A) segment comprises PEG in an amount of from about 60 to about 85% by total weight of the pre-polymer (A) segment, claims 1, 2, 19-23, 25, 26, and 28-31 stand further rejected in view of Steendam et al. (US 9,364,442 B2, “Steendam '442”), which shares at least one common inventor (Steendam) with the primary Steendam reference and which published as US 2013/0209568 A1 on August 15, 2013 — more than five years prior to the effective filing date of the instant application — and is therefore available as prior art under 35 U.S.C. 102(a)(1) notwithstanding any common inventorship or assignee, as the exception of 35 U.S.C. 102(b)(2)(C) applies only to subject matter disqualified solely under 102(a)(2) and does not reach public prior art under 102(a)(1).
Steendam ’442 discloses biodegradable phase-separated multi-block copolymers having the same amorphous pre-polymer (A) / semi-crystalline pre-polymer (B) architecture, wherein pre-polymer (A) is derived from a water-soluble polymer including PEG (col. 1:15-20; col. 14:60-15:5; claim 1(vii)). Steendam '442 discloses working examples 30CLPEG15CL20-b-CL40, 50CLPEG15CL20-b-CL40, and 70CLPEG15CL20-b-CL40 (Table 8, col. 19:15-30) in which pre-polymer (A) constitutes 30%, 49%, and 70% by weight of the copolymer, respectively, and PEG constitutes 22.5%, 37.5%, and 52.5% by weight of the copolymer, respectively. Calculating the weight of PEG as a percentage of the weight of pre-polymer (A) itself for each disclosed example yields ratios of approximately 75%, 76.5%, and 75%, respectively — each squarely within the presently claimed range of about 60 to about 85% by weight of the pre-polymer (A) segment. It would have been obvious to a person of ordinary skill in the art before the effective filing date to combine this teaching with the Steendam/Prasad/Kacker/Zhou combination applied to claim 1, as both Steendam references are directed to the same class of biodegradable phase-separated multi-block copolymers for controlled release of biologically active compounds, sharing common inventorship, and Steendam '442 further confirms that PEG content within pre-polymer (A), independent of the crystalline block length of pre-polymer (B), is a recognized result-effective variable for tuning swelling, degradation rate, and release rate (col. 9:25-45; col. 19:35-20:10, Figs. 10-11).
Regarding claims 1, 2 and 37, as noted above, Prasad teaches hCG, biodegradable polymer microspheres and controlled-release formulation. Furthermore, Prasad teaches a controlled release hCG formulation, wherein the formulation exhibits in-vitro rate of release of hCG or hCG variant in the range of 1000 IU (International Units) to 8000 IU within 24 hours. of administration and 10 IU to 1000 IU per 24 hours. for remaining period (claim 13) and wherein in-vivo rate of release is in the range of 0.1 IU/ml to 3.0 IU/ml of plasma within 24 hours of administration and 0.0002 IU/ml to 0.21 IU/ml of plasma for remaining period (claim 14). Furthermore, Prasad discloses the addition of sodium chloride (NaCl) to the hCG loaded microsphere drastically reduced the burst release from 90% to 43% (Example 4) and the decrease in the initial burst release of hCG in presence of NaCl is because of a denser structure of the resulting microsphere (Table 3, example 4; page 19, lines 14-15; page 20, lines 12-14). The disclosed reduction to 43% burst release, resulting from routine formulation optimization (addition of NaCl), reads on or renders obvious the claimed release characteristics of claims 1 and 2. Thus, the reduction of the burst release rate above would reasonably result in a controlled-release rate of hCG content of the microsphere in the range of 10% to 57%. Therefore, the limitation and structural features overlap instant release range of 3% to about 40% and would reasonably overlap with the amended 1/7 of hCG content of the microspheres within about the first 24 hours.
Furthermore, as noted above, Kacker teaches biodegradable multiblock copolymers, phase separated multi-block copolymers (also in claim 63), a biodegradable thermoplastic polyester (¶ 0008) with hydrolysable segments.
Regarding claim 30, Prasad teaches a controlled release hCG formulation that releases hCG or hCG variants for at least 15 days or more (page 13, lines 1-20 and claims 12 and 15).
Regarding claim 31, Prasad teaches encapsulated hCG molecule, wherein the formulation is with or without excipient (page 9, lines 19-21), active drug along with excipients (page 15, line 9), and PLA and PLGA are FDA-approved as excipients to achieve sustained release of the active ingredient (page 4, lines 22-23).
Regarding claims 34-35, Prasad teaches a method of treating a subject in need of hCG comprising the microsphere-controlled release formulation for fertility treatment (page 2, line 9) in ovulation induction (page 5, line 27).
Regarding claim 38, Prasad discloses (administration routes — intradermal, intramuscular, transdermal, subcutaneous): Prasad expressly teaches intramuscular or subcutaneous injection as the administration route for hCG microsphere formulations (page 15, line 10). These routes are among the specific routes recited in claim 38. Accordingly, this limitation is fully taught by Prasad.
Regarding claim 19, as noted above, Kacker teaches temperature (Tg) lower than 37 °C and melting point temperature (Tm) of 40-100 °C, and therefore overlaps with instant range of multi-block copolymer (Tg) of 37 °C or less and a Tm of 50-110 °C; a multifunctional chain extender and randomly distributed segments are taught. Additionally, Kacker teaches dioxanone (¶s 0007, 0044, 0074, claims 11, 60 and 61) and pre-polymers A or B comprise a hydrolysable polyester, poly ether ester, polycarbonate, polyester carbonate, polyanhydride or copolymers thereof, derived from cyclic monomers of lactide (L, D or L/D), 1, 4-dioxane-2-one (para-dioxanone) (¶ 0074, claim 60) and pre-polymers A and B are selected in such a way that the segments would exhibit significantly different properties, for example, but not limited to thermal, degradation and hydrophilic properties (¶ 0073), characteristics of microspheres may be altered during preparation by manipulating the water soluble polymer concentration, reaction temperature, pH, concentration of therapeutic agent (¶ 0096) and the amount of pre-polymer in the composition can be any suitable amount, known to one skilled in the art, wherein the amount may be of about 10-90 wt % (¶ 0084).
Regarding claims 20 and 21, Kacker teaches in one embodiment, each pre-polymers A and B has an average molecular weight between 300 and 30,000 (¶ 0081). Therefore, overlaps with instant molecular weight range of about 1300 to about 10080 g/mol.(¶ 0050), for example, the suitable biodegradable polymer is 50:50 DL-lactide co-glycolide having a carboxy terminal group or is 75:25 poly (DL-lactide-co-glycolide) with a carboxy terminal group that is protected, and other suitable copolymers known to one of skilled in art can also be used (¶ 0049).
Regarding claims 22 and 23, Kacker teaches multi-block copolymer is a phase separated multiblock copolymer comprising one or more segments of a linear soft biodegradable pre-polymer A having a glass transition temperature (Tg) lower than 37°C and one or more segments of a linear hard biodegradable pre-polymer B having a melting point temperature (Tm) of 40-100°C) (¶ 0010). A person having ordinary skill in the art (PHOSITA) would be able to select a pre-polymer B having an additional parameter of Tg of less than about 0 °C.
Regarding claim 25, Kacker teaches chain-extender can be any suitable multifunctional chain extender, known to one of skilled in the art, and the pre-polymers are linked by di-functional chain-extender, and example includes but not limited to, a di-isocyanate chain-extender (¶ 0083).
Regarding claim 26, Kacker teaches pre-polymer comprises at least two different cyclic monomers (¶ 0079) and examples of non-cyclic initiator include but not limited to, succinic acid, glutaric acid, adipic acid, sebacic acid, lactic acid, glycolic acid, hydroxybutyric acid, ethylene glycol, diethylene glycol, 1,4-butanediol and/or 1,6-hexanediol (para. 0080), and wherein cyclic monomers examples are glycolide, lactide, (L, D or DL), ε-caprolactone, 1\-valerolactone, trimethylene carbonate, tetramethylene
carbonate, 1,4-dioxane-2-one (para-dioxanone), 1,5-dioxepane-2-one and cyclic anhydrides (¶ 0078).
Regarding claims 28 and 29, Zhou teaches multiblock copolymers, triblock copolymers comprising poly(ε-caprolactone)-poly(ethylene glycol) copolymers in microspheres (abstract) and ABA-type block copolymers (PELA) comprising poly(D,L-lactide) and (A) poly(ethylene glycol) (B) segments obtained by ring-opening polymerization, wherein the second component PEG was widely used to improve the biocompatibility of the blood contacting materials (page 3563, right column, ¶ 1).
Regarding claim 39 (release of hCG or a biologically active derivative or isoform thereof for a period of from 1 week to about 2 months), Prasad discloses a hCG-loaded multi-block copolymer dosage form exhibiting extended release of at least 15 days or more (Prasad, page 13, claims 12 and 15), which overlaps the claimed 7–60-day range. A prima facie case of obviousness exists for claimed ranges that overlap with ranges disclosed in the prior art. In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003).
Regarding claim 40 (polymer microspheres having a diameter of from about 20 µm to about 80 µm), Steendam discloses microspheres having “an average size of from 1 µm to 200 µm, preferably from 5 µm to 100 µm, most preferably from 10 µm to 50 µm” (¶0133), which substantially overlaps and subsumes the claimed range. Steendam's working examples further report actual reduction-to-practice microsphere sizes within the claimed range, including 33-57 µm (Example 19), approximately 30 µm (Example 20), 67-71 µm (Example 22), and 59 µm (Example 23). No additional reference is relied upon for this limitation.
Steendam's teaching regarding a Tm of 110-250°C for the multi-block copolymers of that reference's own preferred embodiments (Steendam, claim 1) does not teach away from the presently claimed subject matter. A reference does not teach away merely by disclosing a different, and possibly optimal, embodiment; Steendam's paragraphs 0037-0038 and 0042 expressly contemplate poly(p-dioxanone) as an alternative pre-polymer (B) chemistry yielding a lower Tm range (80-90°C), consistent with the instantly claimed Tm of 50-110°C. Applicant's teach-away argument was previously addressed in the Final Office Action mailed 04/21/2026 and is not persuasive for the same reasons, which are incorporated herein by reference.
Double Patenting
Claims 1, 2, 19-23, 25, 26, 28-31, 34, 35, and 37-40 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12,325,776 B2 (“the '776 patent”; Haitjema et al., assignee InnoCore Technologies Holding B.V.). Although the conflicting claims are not identical, they are not patentably distinct from each other, as set forth in the representative claim mapping below.
Representative mapping: instant claim 1's pre-polymer (B) Mn of about 2000-4000 g/mol and Mw of about 3000-4200 g/mol correspond to '776 claims 29-30 (Mn 2200-3200 g/mol; Mw 3000-4200 g/mol); instant claim 1's PDO block length of about 10-20 corresponds to '776 claim 28 (block length 11-14, within the broader disclosed 7-35/9-20 embodiments); instant claim 28's Markush formula corresponds to '776 claim 22; instant claim 40's microsphere diameter of about 20-80 µm corresponds to the '776 specification's disclosed microsphere embodiment of 20-80 µm (such as 30-70 µm); and instant claim 1's overall biodegradable, phase-separated, thermoplastic multi-block copolymer architecture corresponds to '776 claim 1.
The instant application (effective filing date 10/02/2018) and the '776 patent share at least one common inventor (Zuidema) and a common assignee lineage (InnoCore Technologies), and the '776 patent (filed as PCT/NL2020/050606 on 09/30/2020; priority EP19200879 filed 10/01/2019; issued 06/10/2025) is a later-filed, later-issuing application. Absent a terminal disclaimer, allowance of the instant claims would result in an unjustified timewise extension of patent term for patentably indistinct subject matter. A terminal disclaimer in compliance with 37 CFR 1.321(c) or (d) may be used to overcome this rejection.
Response to Remarks/Amendments
Applicant's arguments filed 08/20/2026 have been fully considered but are not persuasive.
Applicant argues that Steendam teaches away from using a poly(p-dioxanone) (B) segment because the multi-block copolymers of Steendam's own invention should have a Tm of 110-250°C (Steendam, claim 1), whereas a PDO-based (B) segment yields a Tm of only 80-90°C (Steendam, ¶0038), and further that Steendam teaches PDO is hampered by limited polymerization, limited solubility, and low ceiling temperature leading to conversion of less than 80% (¶0042). This argument is not persuasive. A reference does not teach away from a claimed combination merely because it expresses a preference for a different embodiment, or discloses a broader genus alongside a narrower, less-preferred species. See MPEP § 2145(IV); MPEP § 2123 (a reference is not disqualified as prior art merely because it expresses a general preference for an alternative embodiment, so long as the reference does not criticize, discredit, or otherwise discourage the claimed solution). Steendam's paragraphs 0037-0038 and 0042 do not criticize or discourage the use of PDO as pre-polymer (B); rather, they expressly identify PDO, alongside PCL and PVL, as a known pre-polymer (B) chemistry available in the art, and paragraph 0038 affirmatively states that “When PDS is used as segment B, multi-block copolymers with a Tm of 80-90°C ... are obtained,” citing U.S. Pat. No. 5,711,958 as evidencing that PDO-based multi-block copolymers were already known to be obtainable and functional prior to Steendam's own invention. Steendam's stated preference for a broader 110-250°C Tm range to access additional pre-polymer (B) chemistries (PLLA, PDLA, PGA, PHB) does not amount to teaching away from the previously-known and expressly-acknowledged PDO embodiment; a finding of teaching away requires that the reference criticize, discredit, or otherwise discourage the claimed combination, not merely disclose a different preferred embodiment. Further, the conversion and solubility limitations of paragraph 0042 describe processing challenges known in the art at the time and addressed by routine optimization (see also Steendam '442, discussed above, confirming that PDO-based multi-block copolymers with controlled block length are readily obtainable at conversions exceeding 80%).
Applicant further argues that Prasad does not teach a multiblock copolymer comprising at least one amorphous pre-polymer (A) segment and at least one semi-crystalline pre-polymer (B) segment, and that Kacker and Zhou are each silent as to a poly(p-dioxanone) pre-polymer (B) segment. This argument attacks the references individually and is not persuasive, because the rejection is based on the combined teachings of Steendam, Prasad, Kacker, and Zhou, not on any single reference in isolation. Nonobviousness cannot be established by attacking references individually where the rejection is predicated on a combination of references, each relied upon for what it fairly teaches. See In re Keller, 642 F.2d 413, 425 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). As set forth above, Steendam is relied upon for the overall phase-separated multi-block copolymer architecture, including the poly(p-dioxanone) pre-polymer (B) chemistry and block length as a result-effective variable; Prasad is relied upon for the hCG-specific extended-release dosage form and release-rate teachings; Kacker is relied upon for pre-polymer molecular weight ranges; and Zhou and Steendam '442 are relied upon for their respective, narrower teachings as detailed above. Applicant's characterization of what each individual reference fails to disclose in isolation does not address what the combination as a whole would have taught or suggested to a person of ordinary skill in the art.
Applicant's arguments regarding the previously-submitted Declaration and the asserted unexpected results of the narrowed block length range are addressed in the Response to Declaration section, below.
Response to Declaration / Unexpected Results
Applicant argues that the amended block length range of “about 10 to about 20” p-dioxanone monomer units has been restricted to better embody the examples of the previously-filed Declaration, and that the processability improvement observed above a block length of about 10 is unexpected. This argument is not persuasive. As previously noted in the Final Office Action, the Declaration data show that at a block length of X=10.5, processability is characterized only as “moderate,” with clearly good, non-agglomerating processability first observed beginning at approximately X=11.8 and above. Because the low end of the newly claimed range (“about 10”) continues to capture this moderate-processability region rather than being commensurate in scope with the region of asserted unexpected results, the narrowing amendment does not overcome the rejection. See In re Harris, 409 F.3d 1339 (Fed. Cir. 2005) (evidence of unexpected results must be commensurate in scope with the claimed range).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDRE MACH whose telephone number is (571)272-2755. The examiner can normally be reached 0800 - 1700 M-F.
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, Robert A Wax can be reached at 571-272-0323. 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.
/ANDRE MACH/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
Prosecution Insights