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
Claims 1-9 and 11-26 are pending in this office action. All pending claims are under examination in this application.
Priority
The current application was filed on June 12, 2023. The current application claims domestic priority to provisional patent applications 63/358,345 and 63/351,471 filed on July 5, 2022 and June 13, 2022, respectively.
Information Disclosure Statement
Receipt of the Information Disclosure Statements on September 26, 2025 and January 16, 2026 are acknowledged. A signed copy of the two documents are attached to this office action.
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 1-9 and 11-26 are rejected under 35 U.S.C. 103 as being unpatentable over Schneider (US2019/0358167A1) in view of Dadey et al. (US2008/0299168A1), Yeung et al. (US2019/0263877A1), and Alessi et al. (US2014/0378900A1).
[The Examiner is going to introduce each reference and then combine them where appropriate to reject the instant claims.]
1. Schneider
Schneider is considered the closest prior art as it teaches an implantable device for sustained release of a macromolecular drug compound (see title). Furthermore, Schneider discloses an implantable device for delivery of a macromolecular drug compound is provided. The device comprises a core having an outer surface and a membrane layer positioned adjacent to the outer surface of the core. The core comprises a core polymer matrix within which is dispersed a drug compound having a molecular weight of about 0.5 kDa or more, the polymer matrix containing a hydrophobic polymer. Further, the membrane layer comprises a membrane
polymer matrix within which the macromolecular drug compound is optionally dispersed. The concentration of the macromolecular drug compound in the core is greater than
the concentration of the macromolecular drug compound in the membrane layer (see abstract).
2. Dadey et al.
Dadey et al. teach a stabilized polymeric delivery system (see title). In addition, Dadey et al. disclose that the invention relates to a delivery system for the sustained
and controlled delivery of a group of bioactive agents. More particularly, the invention relates to a delivery system and a method for delivery of a bioactive agent containing a nucleophilic functional group by means of a biodegradable, sustained-release implant. The implant may be a preformed implant, microparticles or an in situ formed implant. The implant includes a biodegradable thermoplastic polymer, the bioactive agent having a nucleophilic group substituent and a stabilizing associate as well as other optional components. The combination of the stabilizing associate with the bioactive agent prevents and/or minimizes and/or lessens degradation of the thermoplastic polymer by the bioactive agent (see abstract).
3. Yeung et al.
Yeung et al. teach IL-15 variants and uses thereof (see title). Additionally, Yeung et al. disclose that the present invention relates to human interleukin 15 (IL-15) variants that have therapeutic and diagnostic use, and methods for making thereof. The present invention also provides fusion proteins comprising a human IL-15 variant. Also provided are methods of stimulating or suppressing immune responses in a mammal, and methods of treating a disorder (e.g., cancer) using the IL-15 variants or the fusion
protein of such IL-15 variants (see abstract).
4. Alessi et al.
Alessi et al. teach osmotic delivery systems and piston assemblies for uses therein (see title). Also, Alessi et al. disclose an osmotic delivery system is disclosed for delivering an active agent formulation to a fluid environment. The osmotic delivery system typically comprises a reservoir having a lumen that contains the active agent formulation and an osmotic agent formulation and a piston assembly positioned in the lumen to isolate the active agent formulation from the osmotic agent formulation. The piston assembly typically comprises a body constructed and arranged for positioning in
the lumen. The body is typically made of a polymeric material that is, for example, resistant to leaching in an organic solvent. In one embodiment, the body is a columnar body having a rim at a distal end thereof for engaging and sealing against a wall of the reservoir and the piston assembly farther comprises a spring retained at the distal end of the columnar body for biasing the rim of the columnar body against the wall of the reservoir (see abstract).
Combination of Schneider and Dadey et al.
Regarding instant claim 1, Schneider and Dadey et al. teach a monolithic implantable device for delivery of an antibody. The necessary citations of Schneider and Dadey et al. that pertain to instant claim 1 are presented in Table I.
Table I
Instant Claim 1
Schneider and Dadey et al. Citations
A monolithic implantable device for delivery of an antibody, the implantable device comprising
Schneider discloses an implantable device for delivery of an antibody (an implantable device for delivery of a macromolecular drug compound is provided. Particular examples of suitable macromolecular drug compounds may include, for instance... antibodies…(see abstract and paragraph [0037] both within Schneider),
a polymer matrix within which is dispersed a pharmaceutical formulation that includes one or more therapeutic agents and optionally, one or more excipients,
Furthermore, Schneider discloses that the implantable device that comprises a polymer matrix within which is dispersed a pharmaceutical formulation that includes one or more therapeutic agents and optionally, one or more excipients (one or more drug compounds are also be dispersed within the core polymer matrix that are capable of prohibiting and/or treating a condition, disease, and/or cosmetic state a patient...the one or more drug compounds include suitable antibodies (e.g., monoclonal antibodies) (see paragraphs [0003], [0028], and [0037] within Schneider)
wherein the therapeutic agents contain the antibody and the polymer matrix contains a hydrophobic polymer, wherein the hydrophobic polymer comprises an ethylene vinyl acetate copolymer,
Schneider disclose these antibodies may include, without limitation, HIV monoclonal antibody 2F5, rituxumab, infliximab, trastuzumab, adalimumab, omalizumab, tositumomab, efalizumab, and cetuximab (see paragraphs [0036-0038] within Schneider), wherein the therapeutic agents contain the antibody (particular examples of suitable macromolecular drug compounds may include, for instance antibodies (see paragraph [0037] within Schneider) and the polymer matrix contains a hydrophobic polymer (the core comprises a core polymer matrix within which is dispersed a drug compound... the polymer matrix containing a hydrophobic polymer (see abstract within Schneider).
Schneider discloses the use of ethylene vinyl acetate copolymer (see claim 16 within Schneider).
wherein within a time period of 35 days, the device exhibits a cumulative weight-based release ratio of the antibody of from about 20% to about 60%.
Schneider discloses that through selective control over the particular nature of the core and membrane layer(s) as noted above, and the manner in which they are formed, the present inventors have discovered that the resulting device can be effective for
sustained release over a macromolecular drug compound over a prolonged period of time. For example, the implantable device can release the drug compound for a time period of about 5 days or more, in some embodiments about 10
days or more, in some embodiments from about 20 days to about 60 days, and in some embodiments, from about 25 days to about 50 days (e.g., about 30 days). Further, the
present inventors have also discovered that the drug compound can be released in a controlled manner (e. g. zero order or near zero order) over the course of the release time period. After a time period of 15 days, for example, the
cumulative release ratio of the implantable device may be from about 20% to about 70%, in some embodiments from about 30% to about 65%, and in some embodiments, from about 40% to about 60%. Likewise, after a time period of 30 days, the cumulative release ratio of the implantable device may still be from about 40% to about 85%, in some embodiments from about 50% to about 80%, and in some
embodiments, from about 60% to about 80% (see paragraph [0030] within Schneider).
Therefore, a skilled artisan (POSITA; person of ordinary skill in the art) would under routine experimental conditions be able to determine wherein within a time period of 35 days, the device exhibits a cumulative weight-based release ratio of the antibody of from about 20% to about 60%.
Schneider fails to explicitly disclose a monolithic implantable device.
However, Dadey et al., in the analogous field of a stabilized polymeric delivery system for the sustained and controlled delivery of a group of bioactive agents (see abstract within Dadey et al.), teaches a monolithic implantable device (The invention is directed to a controlled release polymeric delivery system for administration of a nucleophilic bioactive agent. The delivery system may be formulated as an implantable monolithic material, microparticles, or a flowable composition (see paragraph [0009] within Dadey et al.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Schneider with the teachings of Dadey for the purpose of forming a monolithic implantable device for delivery of a bioactive agent, such as an antibody. The motivation for doing so would have been to obtain a preformed polymeric delivery system that resists degradation and provides sustained· bioactive agent release, as suggested by Dadey et al.
Therefore, a skilled artisan (POSITA) would use the Schneider and Dadey et al. references to teach every element of instant claim 1.
The remaining instant claims within this 35 U.S.C. § 103 section are either directly or indirectly dependent on instant claim 1 and are taught in full by the combination of Schneider and Dadey et al.
Regarding instant claims 2-4, Schneider and Dadey et al. teach wherein the weight ratio of the one or more therapeutic agents to the polymer matrix is from about 0.7 to about 1 or from about 0.3 to about 1. Schneider fails to explicitly disclose wherein the weight ratio of the pharmaceutical formulation (containing the one or more therapeutic agents) to the polymer matrix is from about 0.7 to about 1 or from about 0.3 to about 1. It would have been obvious to one of ordinary skill in the art at the time the invention was made to prepare a monolithic implantable device wherein the weight ratio of the pharmaceutical formulation (containing the one or more therapeutic agents) to the polymer matrix is from about 0.7 to about 1 or from about 0.3 to about 1, since where the general conditions of the claim are disclosed in the prior art (see paragraph [0029] within Schneider), teaching that "Typically, macromolecular drug compounds will constitute from about 5 wt.% to about 60 wt.%, in some embodiments from about 10 wt.% to about 50 wt.%, and in some embodiments, from about 15 wt. % to about 45 wt. % of the core, while the core polymer matrix constitutes from about 40 wt. % to about 95 wt. %, in some embodiments from about 50 wt.% to about 90 wt.%, and in some embodiments, from about 55 wt.% to about 85 wt.% of the core"), discovering the optimum or workable ranges involves only routine skill in the art [a pharmaceutical formulation (containing the one or more therapeutic agents) of about 30 wt.% and a polymer matrix of about 45 wt. % would yield a weight ratio of about 0.7, a pharmaceutical formulation (containing the one or more therapeutic agents) of about 50 wt. % and a polymer matrix of about 50 wt. % would yield a weight ratio of about 1, and a pharmaceutical formulation (containing the one or more therapeutic agents) of about 10 wt. % and a polymer matrix of about 40 wt. % would yield a weight ratio of about 0.3)]. The motivation for doing so would have been to create a monolithic implantable device having concentrations of a pharmaceutical formulation and polymer matrix for optimal sustained release of the pharmaceutical formulation.
Regarding instant claim 5, Schneider and Dadey et al. teach wherein the pharmaceutical formulation constitutes from about 30 wt.% to about 50 wt.% of the device and the polymer matrix constitutes from about 50 wt.% to about 70 wt.% of the device. Please see the wt% values cited and discussed within instant claims 2-4 for the necessary rejection values.
Regarding instant claim 6, Schneider and Dadey et al. teach wherein within a time period of 15 days, the device exhibits a cumulative weight-based release ratio of the antibody of from about 10% to about 55%. Schneider discloses that through selective control over the particular nature of the core and membrane layer(s) as noted above, and the manner in which they are formed, the present inventors have discovered that the resulting device can be effective for sustained release over a macromolecular drug compound over a prolonged period of time. For example, the implantable device can release the drug compound for a time period of about 5 days or more, in some embodiments about 10 days or more, in some embodiments from about 20 days to about 60 days, and in some embodiments, from about 25 days to about 50 days (e.g., about 30 days). Further, the present inventors have also discovered that the dmg compound can be released in a controlled manner (e. g.. zero order or near zero order) over the course of the release time period. After a time period of 15 days, for example, the cumulative release ratio of the implantable device may be from about 20% to about 70%, in some embodiments from about 30% to about 65%, and in some embodiments, from about 40% to about 60%. Likewise, after a time period of 30 days, the cumulative release ratio of the implantable device may still be from about 40% to about 85%, in some embodiments from about 50% to about 80%, and in some embodiments, from about 60% to about 80% (see paragraph [0030] within Schneider). Therefore, a skilled artisan (POSITA) would under routine experimental conditions be able to determine wherein within a time period of 15 days, the device exhibits a cumulative weight-based release ratio of the antibody of from about 10% to about 55%.
Regarding instant claim 7, Schneider and Dadey et al. teach wherein the hydrophobic polymer is a copolymer that contains a polar monomer and an olefin monomer. Schneider discloses that such copolymers are generally derived from at least one olefin monomer (e.g., ethylene, propylene, etc.) and at least one
polar monomer that is grafted onto the polymer backbone and/or incorporated as a constituent of the polymer (e.g., block or random copolymers). Suitable polar monomers
include, for instance, a vinyl acetate, vinyl alcohol, maleic anhydride, maleic acid, (meth)acrylic acid (e.g., acrylic acid, methacrylic acid, etc.), (meth)acrylate (e.g., acrylate, methacrylate, ethyl acrylate, methyl methacrylate, ethyl methacrylate,
etc.), and so forth. A wide variety of such copolymers may generally be employed in the polymer composition…(see paragraph [0034] within Schneider).
Regarding instant claim 8, Schneider and Dadey et al. teach wherein the ethylene vinyl acetate copolymer comprises a polar monomer content from 10 wt.% to about 60 wt.% of the copolymer. Schneider discloses the polar monomeric content of the copolymer may be selectively controlled to be within a range of from about 10 wt. % to about 60 wt.% …(see paragraph [0034] within Schneider). Furthermore, Schneider discloses the use of ethylene vinyl acetate copolymer (see claim 16 within Schneider).
Regarding instant claim 9, Schneider and Dadey et al. teach wherein the hydrophobic polymer has a melt flow index of from about 0.2 to about 100 grams per 10 minutes as determined in accordance with ASTM D1238-20 at a temperature of 190°C and a load of 2.16 kilograms and/or a melting temperature of from about 20°C to about 70°C as determined in accordance with ASTM D3418-21. Schneider discloses the identical claim limitation as shown (see claim 17 within Schneider) before the “and/or”. However, Schneider does cite the use of ASTM D1238-13 within the claim, suggesting a slightly different protocol than ASTM D1238-20.
Regarding instant claim 11, Schneider and Dadey et al. teach wherein hydrophobic polymers constitute the entire polymer matrix. Schneider disclose where the hydrophobic polymers constitute the entire polymer matrix (see claim 18 within Schneider).
Regarding instant claim 12, Schneider and Dadey et al. teach wherein the antibody includes a monoclonal antibody. Schneider disclose use of a monoclonal antibody (see paragraph [0037] within Schneider).
Regarding instant claim 16, Schneider and Dadey et al. teach wherein the pharmaceutical formulation includes one or more excipients. Schneider disclose the core may also optionally contain one or more excipients if so desired…(see paragraph [0038] within Schneider).
Regarding instant claims 19-20, Schneider and Dadey et al. teach wherein the excipients include a saccharide. Dadey et al. disclose the use of the saccharides sucrose, dextrose, and sorbitol (see paragraphs [0241] and [0244] within Dadey et al.). [Dadey et al. disclose the use of “additive(s)” indicating one or more used within the formulation.]
Regarding instant claim 21, Schneider and Dadey et al. teach wherein the excipients include a surfactant. Schneider disclose one or more nonionic, anionic, and/or amphoteric surfactants may also be employed to help create a uniform dispersion (see paragraph [0050] within Schneider).
Regarding instant claim 22, Schneider and Dadey et al. teach wherein the surfactant includes a sorbitan fatty acid ester modified with a polyoxyethylene. Schneider disclose the use of sorbitan fatty acid ester modified with a polyoxyethylene (see paragraph [0050] within Schneider).
Regarding instant claims 24-25, Schneider and Dadey et al. teach wherein the device has a generally circular cross-sectional shape and/or in the form of a cylinder. Schneider disclose wherein the device has a generally circular cross-sectional shape (see claim 2 within Schneider) and/or in the form of a cylinder (see claim 4 within Schneider).
Regarding instant claim 26, Schneider and Dadey et al. teach wherein the device has a thickness of from about 0.1 to about 10 millimeters and/or a length of from about 1 to about 250 millimeters. Schneider disclose wherein the device has a diameter (thickness) of from about 0.5 to about 50 millimeters (overlapping region; see claim 3 within Schneider).
Combination of Schneider, Dadey et al., and Yeung et al.
Regarding instant claims 13-15, Schneider, Dadey et al., and Yeung et al. teach wherein the monoclonal antibody includes an anti-PD-1 antibody, anti-PD-L1 antibody, anti-HER2 antibody, anti-VEGF antibody, or a combination thereof thereof. Schneider only discloses a limited amount of monoclonal antibodies that can be used by a skilled artisan (see paragraph [0037] within Schneider). However, Yeung et al. disclose wherein the monoclonal antibody includes an anti-PD-1 antibody, anti-PD-L1 antibody, anti-HER2 antibody, and anti-VEGF antibody (see paragraph [0023] within Yeung et al.). Motivation to add the Yeung et al. reference would be to increase the number of antibodies available for a researcher. A skilled artisan (POSITA) would under routine experimental conditions would use two or more of the antibodies in order to expand the therapeutic area of the monolithic implantable device. Although Yeung et al. does not explicitly disclose examples of anti-VEGF and anti-HER2 antibodies, common choices upon searching by the Examiner revealed specific antibodies within the instant claim limitations (instant claims 14-15) (see PTO-892 NPL-U and V). Therefore, a skilled artisan (POSITA) would select from these examples. The Yeung et al. reference is analogous art and would be selected by a skilled artisan (POSITA).
Combination of Schneider, Dadey et al., and Alessi et al.
Regarding instant claims 17-18, Schneider, Dadey et al., and Alessi et al. teach wherein the excipients include a buffering agent such as histidine. Alessi et al. disclose the use of excipients including a buffering agent such as histidine (see paragraphs [0140] and [0144] within Alessi et al.). Motivation to add the Alessi et al. reference would be to expand the list of excipients to include a buffering agent. Therefore, a skilled artisan (POSITA) would combine the teachings of Alessi et al. with those of Schneider and Dadey et al. to incorporate the buffering agent histidine into the monolithic implantable device. The Alessi et al. reference is analogous art and would be selected by a skilled artisan (POSITA).
Regarding instant claim 23, Schneider, Dadey et al., and Alessi et al. teach wherein the formulation is the form of a dehydrated particulate material. Alessi et al. disclose wherein the formulation is the form of a dehydrated particulate material (desiccation is equivalent to dehydrated; see paragraph [0136] within Alessi et al.). Motivation to add the Alessi et al. reference would be to increase the drug formulation options available to a researcher. Therefore, a skilled artisan (POSITA) would combine the teachings of Alessi et al. with those of Schneider and Dadey et al. to incorporate the buffering agent histidine into the monolithic implantable device. The Alessi et al. reference is analogous art and would be selected by a skilled artisan (POSITA).
Analogous Art
The Schneider, Dadey et al., Yeung et al., and Alessi et al. references are directed to the same field of endeavor as the instant claims, that is, a monolithic implantable device for delivery of an antibody.
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 implantable device containing an antibody for delivery disclosed by Schneider, using the teachings of Dadey et al., Yeung et al., and Alessi et al. to incorporate the necessary claim limitations. Starting with Schneider, the skilled person only had to try the necessary claim limitations disclosed by Dadey et al., Yeung et al., and Alessi et al. The combination of Schneider, Dadey et al., Yeung et al., and Alessi et al. would allow one to arrive at the present application without employing inventive skill. This combination of the implantable device containing an antibody for delivery taught by Schneider along with the use of the necessary claim limitations taught by Dadey et al., Yeung et al., and Alessi 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 implantable device containing an antibody for delivery disclosed by Schneider with the use of the necessary claim limitations taught by Dadey et al., Yeung et al., and Alessi et al. This combined modification would have led to an enhanced monolithic implantable device containing an antibody for delivery that would be beneficial for patients. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify Schneider with the teachings of Dadey et al. for the purpose of forming a monolithic implantable device for delivery of a bioactive agent, such as an antibody. One would have been motivated to do so to obtain a preformed polymeric delivery system that resists degradation and provides sustained bioactive agent release, as suggested by Dadey et al.
Response to Arguments
Applicant's arguments filed November 11, 2025 have been fully considered but they are not persuasive.
The Applicant’s amendments fully addressed the 35 U.S.C. §112(b) rejection from the non-final rejection dated September 19, 2025. Thus, the rejection is withdrawn.
Furthermore, the claim amendments did not necessitate the Examiner to use a new ground of rejection.
Applicant Argument: Applicant argues that Dadey et al. does not teach or suggest utilizing an ethylene vinyl acetate copolymer, namely because ethylene vinyl acetate copolymers are hydrophobic and are not biodegradable systems. This is contrary to Schneider, which does not utilize a biodegradable polymer, but instead uses a hydrophobic polymer.
Examiner’s Rebuttal: Instant claim 1 is rejected under 35 U.S.C. §103 using two references, Schneider and Dadey et al. The ONLY reason Dadey et al. is cited is for the monolithic shape of the implantable device. Below is a portion of Table I that illustrates this point.
wherein within a time period of 35 days, the device exhibits a cumulative weight-based release ratio of the antibody of from about 20% to about 60%.
Schneider discloses that through selective control over the particular nature of the core and membrane layer(s) as noted above, and the manner in which they are formed, the present inventors have discovered that the resulting device can be effective for
sustained release over a macromolecular drug compound over a prolonged period of time. For example, the implantable device can release the drug compound for a time period of about 5 days or more, in some embodiments about 10
days or more, in some embodiments from about 20 days to about 60 days, and in some embodiments, from about 25 days to about 50 days (e.g., about 30 days). Further, the
present inventors have also discovered that the drug compound can be released in a controlled manner (e. g. zero order or near zero order) over the course of the release time period. After a time period of 15 days, for example, the
cumulative release ratio of the implantable device may be from about 20% to about 70%, in some embodiments from about 30% to about 65%, and in some embodiments, from about 40% to about 60%. Likewise, after a time period of 30 days, the cumulative release ratio of the implantable device may still be from about 40% to about 85%, in some embodiments from about 50% to about 80%, and in some
embodiments, from about 60% to about 80% (see paragraph [0030] within Schneider).
Therefore, a skilled artisan (POSITA; person of ordinary skill in the art) would under routine experimental conditions be able to determine wherein within a time period of 35 days, the device exhibits a cumulative weight-based release ratio of the antibody of from about 20% to about 60%.
Schneider fails to explicitly disclose a monolithic implantable device.
However, Dadey et al., in the analogous field of a stabilized polymeric delivery system for the sustained and controlled delivery of a group of bioactive agents (see abstract within Dadey et al.), teaches a monolithic implantable device (The invention is directed to a controlled release polymeric delivery system for administration of a nucleophilic bioactive agent. The delivery system may be formulated as an implantable monolithic material, microparticles, or a flowable composition (see paragraph [0009] within Dadey et al.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Schneider with the teachings of Dadey for the purpose of forming a monolithic implantable device for delivery of a bioactive agent, such as an antibody. The motivation for doing so would have been to obtain a preformed polymeric delivery system that resists degradation and provides sustained· bioactive agent release, as suggested by Dadey et al.
Furthermore, Schneider discloses that the implantable device may have a variety of different geometric shapes, such as cylindrical (rod), disc, ring, doughnut, helical, elliptical, triangular, ovular, etc (see paragraph [0028] within Schneider). A cylindrical shape is not that big of a stretch to move to a monolithic implantable device as disclosed within Dadey et al.
Therefore, the argument supplied by the Applicant is viewed as non-applicable to this prosecution because the relevant combination issue is the shape of the implantable device disclosed by Dadey et al. This modification would be within the scope of a skilled artisan (POSITA).
Yes, the two polymeric systems are different. However, the bar for motivation to combine becomes extremely low. The Applicant’s arguments concerning the biodegradable polymer system of Dadey et al. versus that of a nonbiodegradable/ hydrophobic system of Schneider hold little weight.
Therefore, the Examiner has maintained the 35 U.S.C. § 103 rejection of instant claims 1-9 and 11-26.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615 /Robert A Wax/Supervisory Patent Examiner, Art Unit 1615