DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 19, 2026 has been entered.
Summary
Claims 1-6, 8-9, 11-22, and 24-26 are pending in this office action. Claims 7, 10, and 23 are cancelled. 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 March 18, 2026 and May 8, 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 1-6, 8-9, 11-22 and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Schneider (US2019/0358167A1) in view of Dadey et al. (US2008/0299168A1), Alessi et al. (US2014/0378900A1), and Yeung et al. (US2019/0263877A1).
[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. 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).
4. 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).
Combination of Schneider, Dadey et al., and Alessi et al.
Regarding instant claim 1, Schneider, Dadey et al., and Alessi et al. teach a monolithic implantable device for delivery of an antibody. The necessary citations of Schneider, Dadey et al., and Alessi et al. that pertain to instant claim 1 are presented in Table I.
Table I
Instant Claim 1
Schneider, Dadey et al., and Alessi et al. Citations
A monolithic implantable device for delivery of an antibody, the implantable device comprising
Schneider discloses a monolithic implantable device (see Examples 1-27 within Schneider) 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, in the form of a dehydrated particulate material, 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).
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.). Furthermore, despite Alessi et al. disclosing an implantable osmotic delivery system, the use of dehydrated pharmaceutical formulations is not new (see for example, US2018/0237501A1, paragraph [0426]). Motivation to add the Alessi et al. reference would be to increase the drug formulation options available to the skilled artisan (POSITA; person of ordinary skill in the art). Therefore, a skilled artisan (POSITA) would combine the teachings of Alessi et al. with those of Schneider and Dadey et al. to incorporate a dehydrated pharmaceutical formulation into the monolithic implantable device.
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%.
Further support of the devices structure is supplied by Dadey et al. 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.), supports Schneider, and 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 both the teachings of Dadey for the purpose of forming a monolithic implantable device for delivery of a bioactive agent (such as an antibody), and Alessi et al. to incorporate a dehydrated pharmaceutical formulation. The motivation for doing so would have been to obtain a monolithic implantable device for the sustained release of a dehydrated active formulation.
Therefore, a skilled artisan (POSITA) would use the Schneider, Dadey et al., and Alessi 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, Dadey et al., and Alessi et al.
Regarding instant claims 2-4, Schneider, Dadey et al., and Alessi 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, Dadey et al., and Alessi 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, Dadey et al., and Alessi 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 8, Schneider, Dadey et al., and Alessi 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, Dadey et al., and Alessi 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, Dadey et al., and Alessi 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, Dadey et al., and Alessi 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, Dadey et al., and Alessi 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 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 similar to instant claim 1.
Regarding instant claims 19-20, Schneider, Dadey et al., and Alessi 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, Dadey et al., and Alessi 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, Dadey et al., and Alessi 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, Dadey et al., and Alessi 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, Dadey et al., and Alessi 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., Alessi et al., and Yeung et al.
Regarding instant claims 13-15, Schneider, Dadey et al., Alessi 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).
Analogous Art
The Schneider, Dadey et al., Alessi et al., and Yeung 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., Alessi et al., and Yeung 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., Alessi et al., and Yeung et al. The combination of Schneider, Dadey et al., Alessi et al., and Yeung 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., Alessi et al., and Yeung 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., Alessi et al., and Yeung 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 using 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, Alessi et al. for the incorporation of a dehydrated pharmaceutical formulation, and Yeung et al. to expand the set of antibodies. 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 May 19, 2026 have been fully considered but they are not persuasive.
The claim amendments did not necessitate the Examiner to use a new ground of rejection.
Applicant Argument: The Applicant argues a skilled artisan seeking to formulate a stable, non-degrading implant like that based on Schneider's EVA polymer would have no reason to look to the teachings of Dadey, which concern the completely different field of formulating biodegradable polymers. The principles governing stability and release in a non-degrading, diffusion-controlled system (Schneider) are fundamentally different from those in a degrading, erosion-based system (Dadey). One art does not inform the other. Therefore, the Examiner's stated motivation is not rational and fails to provide the required "articulated reasoning with some rational underpinning to support the legal conclusion of obviousness." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
Examiner’s Rebuttal: The Examiner respectfully disagrees.
In order for a reference to be proper for use in an obviousness rejection under 35 U.S.C. 103, the reference must be analogous art to the claimed invention. In re Bigio, 381 F.3d 1320, 1325, 72 USPQ2d 1209, 1212 (Fed. Cir. 2004). A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). Note that "same field of endeavor" and "reasonably pertinent" are two separate tests for establishing
analogous art; it is not necessary for a reference to fulfill both tests in order to qualify as analogous art. See Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212. The examiner must determine whether a reference is analogous art to the claimed invention when analyzing the obviousness of the subject matter under examination. When more than one prior art reference is used as the basis of an obviousness rejection, it is not required that the references be analogous art to each other. See Sanofi-Aventis Deutschland GMbH v. Mylan Pharms. Inc., 66 F.4th 1373, 1380, 2023 USPQ2d 552 (Fed. Cir. 2023) and Corephotonics, Ltd. v. Apple Inc., 84 F.4th 990, 1007, 2023 USPQ2d 1202 (Fed. Cir. 2023). If a reference is not analogous art to the claimed invention, it may not be used in an obviousness rejection under 35 U.S.C. 103. [see M.P.E.P. §2141.01(a)].
In this instance, the Dadey et al. reference merely supports the Schneider citation for forming a monolithic implantable device. For this reason, the Dadey et al. reference is analogous art.
Applicant Argument: The Applicant argues that the Examiner's proposal to make Schneider's device "monolithic" is not a simple modification. It requires the complete deconstruction of the Schneider device. Schneider's invention is explicitly and repeatedly defined as a multi-layered, core-membrane device, not a monolithic one. The core principle of Schneider's invention is the use of a concentration gradient between the drug-rich core and the outer membrane layer to control release. As such, to make Schneider's device "monolithic," a skilled artisan would have to eliminate the membrane layer. This would destroy the very principle of operation disclosed and claimed by Schneider. Such a modification, which renders the primary reference "unsatisfactory for its intended purpose," is legally improper. See In re Gordon, 733 F.2d 900 (Fed. Cir. 1984). Accordingly, a skilled artisan would have no motivation to destroy the essential, rate-controlling feature of Schneider's device to make it monolithic.
Examiner’s Rebuttal: The Examiner respectfully disagrees. Schneider discloses a monolithic implantable device (see Examples 1-27 within Schneider) 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). Schneider discloses several examples of the monolithic implantable device. Thus, supporting the use of that structure.
Applicant Argument: The Applicant argues the Examiner has used impermissible hindsight in constructing the 35 U.S.C. §103 rejection.
Examiner’s Rebuttal: The Examiner respectfully disagrees. It must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, there is ample motivation to use the Dadey et al. reference to support the purpose of forming a monolithic implantable device for delivery of a bioactive agent, such as an antibody, Alessi et al. for the incorporation of a dehydrated pharmaceutical formulation, and Yeung et al. to expand the set of antibodies.
Applicant Argument: The Applicant argues the skilled artisan would have no reason to look to Alessi's osmotic pump formulation technology when designing a solid, monolithic implant. A skilled artisan would have no rational motivation to combine the "desiccation particulate" feature from Alessi with Schneider's matrix because it would be technically nonsensical from Alessi's perspective. The skilled artisan would recognize that Alessi's teachings on formulations are specific to, and inseparable from, the osmotic pump mechanism of delivery. There is no suggestion in the art that a formulation designed for an osmotic pump would be suitable for, or provide any advantage in, a solid monolithic EVA matrix.
Examiner’s Rebuttal: The Examiner respectfully disagrees. The Alessi et al. citation is an example where the inventors used a dehydrated pharmaceutical formulation. This is common (lyophilization) within the drug delivery industry. Incorporation of this formulation within an implantable device would require no more than routine experimentation.
Applicant Argument: The Applicant argues that the dependent claims are also patentable based on the above arguments.
Examiner’s Rebuttal: The Examiner respectfully disagrees. All arguments have been addressed, and the dependent claims remain rejected.
Therefore, the Examiner has maintained the 35 U.S.C. § 103 rejection of instant claims 1-6, 8-9, 11-22 and 24-26.
Conclusion
No claims are allowed.
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