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 .
Response to Amendment
The Amendment filed 09/02/2026 has been entered. Applicant’s amendments are in response to the Non-Final Office Action mailed 06/02/2026. Applicant’s claims have been amended in the following manner: independent claim 1 has been modified by inclusion of a wherein clause that characterizes the “ratio of melt flow index” of “the core ethylene vinyl acetate copolymer” with “the membrane ethylene vinyl acetate copolymer”, as between 1 to 20 (interpreted to mean 1:1 or 20:1, such that the core is equal or more flowable compared to the membrane), which finds support in Applicant’s Specification [0040].
A new ground of rejection is prompted by the amendment, due to the narrowing of claim 1, that involves the rearrangement of Govender and De Nijs to now address claim 1, as the newly-amended melt flow index (MFI) ratio range limitation is found in De Nijs specifically. Furthermore, a new 112b rejection is prompted by amendment (see below), and a new double patenting rejection is prompted by new IDS reference disclosure (see below).
The following objections/rejections are withdrawn: Drawing objection (based on amended drawings), claim objection (based on amendment), 112b rejection (based on amendment), 103 rejection for Cao alone (no longer required in this Action, because it cannot stand alone due to a lack of melt flow index teachings).
The Examiner further acknowledges the following:
Claims 1-10 and 12-28 are pending.
Claims 23-28 are withdrawn from consideration as directed to non-elected inventions.
Claims 1-10 and 12-22 are presented for examination and rejected as set forth below.
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.
Claims 1-10 and 12-22 are 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 1 recites a ratio range of from 1 to 20; however, this recitation does not precisely describe a ratio range, nor does it make clear that a range is being discussed (e.g., if “from” was disregarded, the ratio could be considered 1:20 core MFI to membrane MFI (i.e., where the ‘colon’ or the ratio has been substituted by ‘to’), whereby that 1:20 ratio is the only ratio under consideration, and no other). The appropriate notation to explicitly define the “range” (e.g., in Applicant’s Specification the L/D ratio is explicitly in a “range from…” [0031]) would be “from 1:1 to 20:1” or something of this nature. Appropriate correction for clarification is required.
All other claims that depend from claim 1 are additionally rejected.
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 1-2, 4, 6-10,12, 15, and 17-22 are rejected under 35 U.S.C. 103 as being unpatentable over Wong (US 5443505), and in further view of Blizzard (WO2021195163A1), Zarnitsyn (US20150258120A1), Govender (Advanced Drug Delivery Reviews, 2021), and De Nijs (US4957119A).
Applicant’s claims are directed to an implantable device comprising a core that defines an outer peripheral surface, wherein the core comprises a core polymer matrix within which is dispersed a tyrosine kinase inhibitor (TKI), the polymer matrix containing an ethylene vinyl acetate copolymer. In the BRI, having the “core that defines an outer peripheral surface” as stated in claim 1, encompasses a monolithic object, because the core reaches the outer peripheral surface.
Although the categories claimed are interpreted by their BRI (i.e., the categories of “hydrophilic compound” of claim 10 and “water-soluble particle” of claim 16 can cover a broad range of materials), examples of these terms are considered in Applicant’s Specification to understand Applicant’s intent of meaning. Thus, the Specification includes examples of “hydrophilic compounds” such as alginates, gelatin etc. [0026] and examples of “water-soluble particles” as hydroxy-functional ingredients such as monosaccharides, disaccharides, sugar alcohols, etc. as non-limiting examples [0028]. Further note that a chemical species and its properties are inseparable.
Wong teaches eye implants comprising active agents for treating eye conditions (including macular degeneration in col 9, last paragraph) in a controlled release fashion into the suprachoroidal space (abstract, Wong- claim 1).
Regarding claim 1: Wong teaches an implant, where an active agent (i.e., drug) is dispersed in biocompatible, non-biodegradable polymers (col 3, lines 35-46) such as ethylene vinyl acetate (EVA) copolymer (col 3, lines 64-70; col 4, lines 1-15). Furthermore, Wong teaches drug-loaded implantable eye devices, that may employ “any pharmacologically active agent for which sustained release is desirable” (see col 8, lines 27-70), including agents for macular degeneration (col 9, last paragraph).
Regarding claim 2: Wong teaches the active agent as 20-40 wt% (col 9, lines 4-46).
Regarding claims 7-9: The implants may also be of any geometry including fibers, sheets, films, microspheres, circular discs, plaques and the like, and in the case of fibers (which have circular cross sections and a linear length, and are thus, cylindrical in shape), the general size is a diameter of 0.1-1 mm by a length of 0.5-5 mm (col 10, lines 11-30), wherein with regard to the numerical range, a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (see 2144.05(I)). See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”).
Regarding claim 10: Wong teaches incorporation of gelatin, silicones (col 3, lines 35-46), alginates, different celluloses, polyvinyl alcohols, (col 5, lines 35-46), etc., which are recognized by Applicant’s Specification as suitable hydrophilic compounds [0026].
Regarding claim 12: Wong teaches surrounding membranes (in addition to monolithic structures) that can control release of the drug (col 7, lines 57-69). Wong teaches the membrane may be composed of any of the biocompatible materials indicated above (in the disclosure) and may vary with the drug employed, and thus, EVA would be selected (col 4, lines 48-70).
Regarding claim 15: There is no requirement for the drug to be in a membrane layer, whereby a membrane is affixed to the polymer layer comprising the drug (col 4, lines 48-70).
Regarding claim 17: Wong teaches 10 mg of drug loading (col 14, lines 58-70).
Regarding claim 18-21: Wong teaches eye implantation between at least 2 weeks (14 days) to 8 weeks (about 2 months). However, 6 months or more of implant is possible (col 6, lines 57-70) (thus, the release period of 6 months or more overlaps with the instant release period of 12 months or more).
Regarding claim 22: Wong teaches release of therapeutic drug levels in the eye (col 17, lines 35-53).
In summary, Wong teaches an implantable eye device suitable for various types of drug active agents, including “any pharmacologically active agent for which sustained release is desirable may be employed” (see col 8, lines 27-70, and col 9, lines 1-40), including active agents for macular degeneration (col 9, last paragraph), and also comprising EVA. However, Wong does not teach specifically tyrosine kinase inhibitors (TKIs) (instant claims 1 and 6), or the melt flow index and ratio (instant claims 1 and 4).
Blizzard teaches ocular implant, containing a dispersed tyrosine kinase inhibitor (TKI) for sustained release delivery (abstract), and names specifically axitinib, gefitinib, imatinib, etc. (line item #25 on pg 77) (reads on axitinib, gefitinib, imatinib, etc. of instant claim 6). These TKIs can be used in combination with synthetic polymers (without limitation) [00148] for various types of implantation administration (including suprachoroidal) [00334]. The implant can be cylindrical, and size is 0.3-0.4 mm [000213]. Blizzard teaches there is an urgent need for an improved treatment of ocular diseases such as AMD, DME, and RVO with TKIs, which is effective over an extended period of time avoiding the need for frequent (monthly or even daily) injections which are currently required for common anti-VEGF therapies, especially for individuals not responding to anti-VEGF therapies (e.g. up to 33% of subjects with DME) [00013].
Zarnitsyn teaches injections into the suprachoroidal space for macular degeneration [0298], that can comprise implants [0216] and tyrosine kinase inhibitors (TKI) [0177-0178] such as axitinib, imatinib, etc. [0192].
Govender teaches melt flow index (MFI, aka melt index or MI) (‘rheological techniques’, Table 4) and melting temperature (‘thermal techniques’, Table 4) as a fundamental tool to measure rheological properties of polymers (Table 4) such as ethylene vinyl acetate when used in solid dispersions (Table 2). Thermal properties and rheological properties are inter-related and important for both the process or making and the final product properties (pg 20-21), including pharmaceutical products (abstract, Fig 3), whereby the polymer physical properties modify the drug release rate of dosage forms (pg 11).
De Nijs teaches drug-loaded implants, intended for local drug administration, made of an EVA core with an EVA membrane (abstract). De Nijs teaches a cylindrical implant with a melt-flow index (MFI) of the core is greater than 10 gram per 10 minutes (reads on instant claim 4), and a vinyl acetate content of 20% by weight or more; and the membrane has a melt index is less than 10 gram per 10 minutes (reads on instant claim 4), and an acetate content of less than 20% by weight (col 2, lines 1-26). This particular configuration allows for a release system that combines a core of active material with a release-rate regulating membrane (col 1, lines 50-58), and for example, providing a release duration of up to 5 years (col 3, lines 44-55).
Thus, the core having a MFI of greater than 10 gram per 10 min (e.g., 20 gram per 10 min) vs. the membrane having a MFI of less than 10 gram per 10 min (e.g., 5 gram per 10 min), leads to a core/membrane MFI ratio of >1 (e.g., from above, 20 ÷ 5 = 4), which reads on the newly amended instant claim 1 language of “wherein the ratio of the melt flow index of the core ethylene vinyl acetate copolymer to the melt flow index of the membrane ethylene vinyl acetate copolymer is from 1 to 20” (i.e., presumed to be 1:1 to 20:1; see 112b rejection above). De Nijs provides no indication that they have used a non-standard method for melt flow index measurements (that would be contradicted by the standard ASTM D1238-20 method, that is known to a PHOSITA to be a standard method for measuring MFI), and therefore the method is likely similar to the method of instant claim 1.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug-loaded cylindrical ocular implants taught by Wong by selecting a tyrosine kinase inhibitor as the drug, as taught by Blizzard, because Blizzard teaches TKI-loaded implants as effective formulations to provide sustained release of medication to treat disease such as macular degeneration such as AMD [00012-00013]; Zarnitsyn teaches injections into the suprachoroidal space for macular degeneration [0298], that can comprise implants [0216] and tyrosine kinase inhibitors (TKI) [0177-0178] such as axitinib, imatinib, etc. [0192]; and Wong teaches drug-loaded implantable eye devices, that may employ “any pharmacologically active agent for which sustained release is desirable” (see col 8, lines 27-70), including agents for macular degeneration (col 9, last paragraph). The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cylindrical implant comprising a TKI taught by the combined Prior Art with the specific EVAs and EVA properties taught by Govender and De Nijs, because these EVAs are useful for eye implant devices, and specifying the makeup or properties of the EVA in the device can modulate drug release rates. Furthermore, Wong teaches that rate of release (i.e., by diffusion) is governed by polymer properties, such as cross-linking, hydrophilicity, etc. (col 4, lines 49-70), and thus it would make sense to alter the drug rate of release in Wong’s implants by chemically modifying the polymer (as described by Govender and De Nijs) to alter the polymer properties and therefore, modify drug release rate. For example, De Nijs teaches implants of specific MFI ratios (De Nijs – claim 1) provide a release duration of up to 5 years (col 3, lines 44-55). Additionally, Govender, and De Nijs collectively establish melt flow index, as a result-effective variables, that a person of ordinary skill in the art would routinely optimize in order to improve release rate. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation).Thus, a PHOSITA would seek to optimize the EVA properties (of both the core and the membrane) in search of the desired properties of the drug-device product, such as drug release rate.
As far as the ASTM protocols of claims 4 and 5, it should be noted that the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise. “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Blizzard and Zarnitsyn also provide motivation to incorporate TKIs (i.e., useful for macular degeneration) into the implants of Wong (that incorporate active agents to treat macular degeneration), because Blizzard teaches there is an urgent need for an improved treatment of ocular diseases such as AMD, DME, and RVO with TKIs, which is effective over an extended period of time avoiding the need for frequent (monthly or even daily) injections which are currently required for common anti-VEGF therapies, especially for individuals not responding to anti-VEGF therapies (e.g. up to 33% of subjects with DME) [00013].
Claims 1-10 and 12-22 are rejected under 35 U.S.C. 103 as being unpatentable over Wong (US 5443505), Blizzard (WO2021195163A1), Zarnitsyn (US20150258120A1), Govender (Advanced Drug Delivery Reviews, 2021), and De Nijs (US4957119A), as applied to claims 1-2, 4, 6-10, 12, 15, and 17-22 above, and in further view of Garcia-Estrada (Pharmaceutics, 2021), and Thakur (WO2020128062A1).
As discussed above, the combined Prior Art teaches a tyrosine kinase inhibitor (TKI) drug-loaded cylindrical implant, comprising EVA, that further comprise an EVA membrane (abiding by the MFI ratio of instant claim 1). Note that Wong generally teaches incorporation of “other agents” including enhancers that affect the rate of drug delivery (col 9, lines 47-70), and that rate of release (e.g., by diffusion) is governed by polymer properties, such as cross-linking, hydrophilicity, etc. (col 4, lines 49-70). However, the Prior Art does not teach the EVA monomer ratio (instant claim 3, 13-14), melting temperature (instant claims 5), nor the water-soluble (hydrophilic) particle (instant claim 16) (where the categorical term is understood using examples of the Specification, as previously discussed in the claim interpretation section above).
Garcia-Estrada teaches common non-biodegradable materials for drug eye implant formulations to treat eye disease (abstract). Garcia-Estrada teaches EVA is a transparent thermoplastic, ethylene monomer copolymer (Figure 3) that normally contains from 1 to 40% of vinyl acetate (VA) monomer (overlapping with the instant vinyl acetate monomer content of 10-60 wt% in claim 3, 13-14). Depending on the percentage of VA, EVA may take on different physical properties; the more VA, the higher polarity, adhesion, impact resistance, flexibility, and compatibility with other polymers. However, when increasing VA, a decrease in crystallinity, stiffness, softening, and melting point is also observed, as exemplified in Tables 1 and 2 [20,21], where melting points of 60 °C is known (reads on instant claim 5). Thus, knowing that EVA properties are impacted by monomeric amount, one would modulate monomeric content based on desired property of the core and membrane, thus making claim 14 obvious. Garcia-Estrada also teaches a cylinder as a common shape for eye implants (Table 6).
Thakur teaches drug release modulating excipients such as glucose, lactose, mannitol (Thakur – claims 8-9, pg 12-13), as applied as excipients within solid eye implants (pg 1).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cylindrical implant comprising a TKI taught by the combined Prior Art with the specific EVAs and EVA properties taught by Garcia-Estrada, because these EVAs are useful for eye implant devices, and specifying the makeup or properties of the EVA in the device can modulate drug release rates. Furthermore, Wong teaches that rate of release (i.e., by diffusion) is governed by polymer properties, such as cross-linking, hydrophilicity, etc. (col 4, lines 49-70), and thus it would make sense to alter the drug rate of release in Wong’s implants by chemically modifying the polymer (as described by Garcia-Estrada) to alter the polymer properties and therefore, modify drug release rate. Additionally, Garcia-Estrada collectively establishes melt flow index, as a result-effective variables, that a person of ordinary skill in the art would routinely optimize in order to improve release rate. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation).Thus, a PHOSITA would seek to optimize the EVA properties (of both the core and the membrane) in search of the desired properties of the drug-device product, such as drug release rate.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cylindrical implant comprising a TKI taught by Wong and Blizzard with the release modulating excipients of glucose, lactose, mannitol, as taught by Thakur, because Thakur teaches these ingredients as useful release modulating excipients for solid eye implants (‘summary of invention’), where Wong teaches modulation of active agent release in a controlled release fashion into the suprachoroidal space (abstract, Wong- claim 1; col 3, lines 20-34) by implant/membrane structure (col 4-5), polymer choice (col 4, last paragraph), various agents (col 9, lines 47-70), etc.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 and 12-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over, and in further view of Blizzard (WO2021195163A1) and Cao (Drug Discov. Today, 2019):
claims 1-8, 19, 21-29, and 31-35 of copending Application No. 17/982,556 (reference application)
Although the claims at issue are not identical, they are not patentably distinct from each other because all claim sets teach an implantable device for eye implant comprising an ethylene vinyl acetate copolymers. The copending application differs only significantly by incorporating a steroid agent instead of the tyrosine kinase inhibitor (TKI) of the instant claims.
This is remedied by Blizzard, who teaches eye implants comprising specific TKIs for treatment of disease (abstract, pg 77), including treatment of ocular inflammation [0134]. Cao also teaches TKIs for ocular implant (pg 4, paragraph 1), where the drug is suspended (i.e., dispersed) within the EVA polymer for sustained delivery (pg 4). One of ordinary skill in the art would have been motivated to modify the teachings of copending application ‘556 by substituting the steroid for the TKI because both active agents are useful for treating ocular inflammation, with the device formulation remaining essentially the same otherwise.
This is a provisional nonstatutory double patenting rejection.
Claims 1-10 and 12-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-27 of copending Application No. 18/157,134 (reference application)
Although the claims at issue are not identical, they are not patentably distinct from each other because all claim sets teach basically the same invention (i.e., eye implant comprising a TKI) except the copending application contains slight variations of the instant device (e.g., incorporation of an additional steroid active agent, etc.).
Thus, the copending application claim set teaches the limitations of the instant claim set.
This is a provisional nonstatutory double patenting rejection.
Claims 1-10 and 12-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over, and in further view of Wong (US 5443505), Blizzard (WO2021195163A1), Zarnitsyn (US20150258120A1), Govender (Advanced Drug Delivery Reviews, 2021), and De Nijs (US4957119A), Garcia-Estrada (Pharmaceutics, 2021), and Thakur (WO2020128062A1):
claims 1-38 of Pat No. US12472148B2
Although the claims at issue are not identical, they are not patentably distinct from each other because all claim sets teach an implantable drug delivery device comprising a core matrix and a membrane layer positioned adjacent to the core that specifies melt flow character of the core and membrane. However, patent ‘148 does not discuss a TKI inhibitor, or specific limitation variants of the instant claims.
This is remedied by the combined Prior Art. Thus, Blizzard teaches eye implants comprising specific TKIs for treatment of disease (abstract, pg 77), including treatment of ocular inflammation [0134]. Cao also teaches TKIs for ocular implant (pg 4, paragraph 1), where the drug is suspended (i.e., dispersed) within the EVA polymer for sustained delivery (pg 4). Furthermore, De Nijs teaches the instant melt flow index ratio between the core and membrane for controlled drug release. One of ordinary skill in the art would have been motivated to modify the teachings of copending application ‘148 by substituting the macromolecular drug for the TKI because both active agents are useful for treating disease with the device formulation remaining similar otherwise.
Note, US12472148B2 is discussed in the newly-considered IDS (filed 05/08/26; and was not considered in the Office Action mailed 06/02/26) under IDS disclosure of US20260021049A1. Therefore, the new double patenting rejection has been prompted by the new IDS.
Response to Arguments
Applicant’s arguments, see pg 7-11, filed 09/02/2026, with respect to the 103 rejection of claims 1-22 under rejection have been fully considered and are persuasive. Therefore, the 103 rejection has been withdrawn. However, upon further consideration and in view of applicant’s amendments to the claims, a new ground of rejection is made by pointing to different portions of De Nijs to provide rationale that teaches the wherein clause that characterizes the “ratio of melt flow index” of “the core ethylene vinyl acetate copolymer” with “the membrane ethylene vinyl acetate copolymer”, as between 1 to 20 (interpreted to mean 1:1 or 20:1, such that the core is equally flowable or more flowable compared to the membrane, under melt conditions), and rearrangement of the rejection.
On page 7, Applicant discusses the drawing objection and amendments, which are suitable to withdraw the drawing objection. (based on amended drawings), claim objection (based on amendment), 112b rejection (based on amendment), 103 rejection for Cao alone (no longer required in this Action, because it cannot stand alone due to a lack of melt flow index teachings).
On page 7, Applicant discusses the claim objections and amendments, which are suitable to withdraw the claim objection.
On page 7, Applicant discusses the nonstatutory obviousness-type double patenting rejection, whereby Applicant will push consideration of a potential terminal disclaimer to a later date. This is not a substantive argument and the rejections set forth previously are maintained for the reasons of record. . Note the new non-statutory double patenting rejection based on IDS disclosure. US12472148B2 is discussed in the newly considered IDS (filed 05/08/26; and was not considered in the Office Action mailed 06/02/26) under IDS disclosure of US20260021049A1. Therefore, the new double patenting rejection has been prompted by the new IDS.
On page 8, Applicant discusses the 112b rejection and amendments, which are suitable to withdraw the 112b rejection. Note the new 112b issue that considers language describing the MFI ratio of claim 1 (see 112b rejection above).
On page 8-9, Applicant argues that the combined Prior Art does not teach the importance of the MFI ratio between the core and membrane polymers. In response, the Examiner points to De Nijs for teaching the MFI ratio between the core and membrane polymers for implants intended for local administration, that are able to deliver drug locally (De Nijs – claim 1). Furthermore, this particular configuration allows for a release system that combines a core of active material with a release-rate regulating membrane (col 1, lines 50-58) and for example, providing a release duration of up to 5 years (col 3, lines 44-55). Additionally, if Applicant considers the motivation for the instant invention as different, note: In an obviousness analysis, it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991).
On page 9, Applicant argues the newly amended claim limitation is not taught by the implants of De Nijs (i.e., see particularly De Nijs – claim 1), which are intended for local drug administration (abstract), because Applicant considers a hypothetical scenario, whereby De Nijs could produce an MFI ratio of 25 or 100 (e.g., with a core MFI of 50 g/10 min; with a membrane MFI of 2 g/10 min), which results in a range outside of the instant range of 1 to 20 (instant claim 1). In this instance, Applicant has merely selected values that favorably argue their case, but ignores other values within the range taught by De Nijs. “Further, since in a patent it is presumed that a process if used by one skilled in the art will produce the product or result described therein, such presumption is not overcome by a mere showing that it is possible to operate within the disclosure without obtaining the alleged product. In re Weber, 405 F.2d 1403, 160 USPQ 549 (CCPA 1969).” Thus, De Nijs teaches any value >10g/ 10 min for the core MFI, and also teaches any value <10 g/ 10 min for the membrane MFI, which provides a ratio range of > 1:1, which overlaps the instant range of the ratio of MFI core to ratio of MFI membrane from 1:1 to 20:1 (i.e., which Applicant does not consider in their analysis and specific selection of a core MFI of 50 g/10 min and the specific selection of a membrane MFI of 2 g/10 min to afford a ratio of 25:1). With regard to the numerical range, a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (see 2144.05(I)). See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”).
On page 9-10, Applicant further criticizes each individual reference for not teaching all elements of the instant claim. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. Thus, these arguments are not persuasive because of the combined teachings of the Art, as found in the 103 rejection above.
On page 10, Applicant summarizes and concludes. The claims remain under rejection, primarily because claim 1 is still found non-obvious, including the amended language that incorporates the MFI ratio range, which is taught as obvious by De Nijs.
Correspondence
Applicant's amendment necessitated the new ground of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/R.P./Examiner, Art Unit 1614 9/21/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
