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 .
Status of claims
Claims 1-3, 5, 9-15, 18-19, 22, 24-25, 27, 29-30 are original. Claims 4, 6-8, 16-17, 20-21, 23, 26, 28, and 31 are previously presented. Claims 17-31 are withdrawn by applicant due to a restriction requirement. Claims 1-16 are pending and under examination.
Priority
This application is a 371 of PCT/US2023/061929, filed on 02/03/2023. It claims priority to and the benefit of United States patent application no. 63/306,647, filed on 02/4/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/07/2024, 11/07/2024, 06/24/2025, 11/13/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election of Group I (i.e., claims 1-16) in the response filed on 06/22/2026 is acknowledged. Claims 17-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, here being no allowable generic or linking claim. The election is treated as without traverse per applicant’s request.
Claim Objections
Claims 5 and 13 are objected to because of the following informalities:
Claim 5 recites both “polyethylene oxide” and “polyethylene glycol” as biocompatible polymers. These two structures are identical, which renders it a redundancy.
Claim 13 states that “the article is configured to effect rupture of…”. Proper syntax is “the article is configured to effect the rupture of…”
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-11 and 13-16 are rejected under 35 U.S.C. 101 because they are directed to products of nature and amount to nothing significantly more than that. Per claims 1, 4, and 5, naturally-occurring extracellular matrices surrounding cells (i.e., sealed compartments) in mammalian tissues comprise collagens, elastins and hyaluronic acids, and produce multiple layers arranged in various directions (see image below) or naturally occurring cocoon structures made up of silk (fibroin and sericin) among other fibrous materials that get wrapped around cocoons such as leaves and bark where cocoons fibers are made to house/surround the larvae. Additionally items like seed shells/husks or egg shell structures can be considered. Claims 2-3, 6, 8 merely state geometries and arrangements of such cell-containing matrices, which can also naturally occur. Per claim 7, 9, and 13-16, the plurality of cells within the matrix are sealed compartments with different compositions and contain various particles which rupture upon varying forces and stimuli. Per claims 10-11, cells within the matrix contain biologically active factors, enzymes and cytokines. Therefore, the above claims are all directed to products of nature, and there is not a limitation to provide the structure or its composition has any quality, attributes, or characteristic that makes it markedly different than its naturally occurring counterparts.
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Claim Rejections - 35 USC § 112 (b)
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 3, 8, and 13 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 3 recites that “the first direction and the second direction are at an angle to another”. However, It is dependent to claim 2, and claim 2 states that “the first direction and the second direction are parallel to one another”. These two statements are contradictory, as two parallel directions have no angle, thus rendering claim 3 indefinite. A suggested amendment is to alter the dependency of claim 3 from claim 2 to claim 1.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitation “from about 0.5 to about 10 mm”, and the claim also recites “from about 2 to about 7 mm” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 13 recites the limitation "the first population of delivery particles", which is a broader limitation than the recited “a first population of mechanically-responsive delivery particles” per independent claim 1, as it may also include other types of delivery particles (e.g., non-mechanoresponsive). There is therefore insufficient antecedent basis for this limitation in claim 13. A suggested amendment is to alter the claim language to “the first population of mechanically-responsive delivery particles”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, and 5 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Pepper et al. (US20110111012A1).
“A localized therapeutic delivery” is an intended use of the article (MPEP 2111.02). If the prior art teaches the structure and components of applicant’s claim then it will read on the claim.
Where “optionally” is used whatever follows will be considered as being an option, but not a necessary limitation that has to be part of applicant’s invention. Thus, if prior art teaches all other elements of the claim besides the optional part, it will still read on the claim.
Pepper et al. discloses wound dressing assemblies and methods of producing the wound dressing assemblies. The wound dressing assemblies comprise individual layers of nanomaterials that have been formed according to an electrospinning process [¶abstract]. Pepper et al. teaches the following in a single embodiment:
Regarding Claim 1:
Pepper et al. teaches a first fibrous layer comprising a first plurality of nanofibers, namely a first layer {212} comprising micro dispersed oxidized cellulose material formed by an electrospinning process, wherein Pepper et al. explains that the electrospinning process produces a plurality of nanofibers that are deposited to form a nanofiber mat ¶¶158-160, 175].
Pepper et al. teaches a second fibrous layer comprising a second plurality of nanofibers, namely a second layer {214} comprising chitosan material formed by an electrospinning process, wherein the electrospinning process produces a plurality of nanofibers that are deposited to form a nanofiber mat [¶¶158-160, 175].
Pepper et al. teaches that the first fibrous layer and the second fibrous layer are sealed to one another so as to define at least one sealed compartment therebetween, because the edges of the first layer {212} and second layer {214} are joined by an adhesive, heat pressing, welding, or combinations thereof while leaving a central area between layers open for receipt of material, after which opening is sealed by an adhesive, heat pressure, welding, or another sealing process [¶¶176-177, figures 15-22].
Regarding claims 4 and 5, Pepper et al. teaches that the layers of the electro-spun nanomaterials comprise chitosan/PEO [¶¶170-175].
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Pepper et al. (US20110111012A1) in view of Mauck et al. (US20110098826A1).
Pepper et al. teaches all required limitations of present claims 1, 4, and 5.
However, Pepper et al. fails to teach the required limitations of claims 2 and 3.
Mauck et al. discloses implant scaffolds comprising angle-ply arrays of two or more layers of substantially aligned fiber, methods of making and using said scaffolds, and kits comprising such scaffolds [¶abstract]. Mauck et al. teaches that the scaffold can be used for medical application [¶120].
Regarding Claim 2:
Mauck et al. discloses an article comprising first and second fibrous layers, namely a bilayer formed from adjacent nanofibrous lamellae [¶¶128-131].
Mauck et al. teaches that the first fibrous layer comprises a plurality of aligned nanofibers and that the second fibrous layer comprises a second plurality of aligned nanofibers, as Mauck et al. forms aligned nanofibrous scaffolds by electrospinning and subsequently brings two such nanofibrous lamellae into apposition to form a bilayer [¶¶128-131].
Mauck et al. teaches that the nanofibers of the first fibrous layer are aligned along a first direction, that the nanofibers of the second fibrous layer are aligned along a second direction, and that the first and second directions are parallel to one another, because Mauck et al. expressly forms bilayers in which the nanofibers in adjacent lamellae run parallel at +30° [¶131]. Mauck et al. Further defines the major axis of a fibrous layer as the direction of fiber alignment within that layer and explains that substantially aligned fibers generally run in the same direction [¶¶52-53].
Regarding Claim 3:
Mauck et al. teaches that a first nanofibrous layer having nanofibers aligned along a first direction and a second nanofibrous layer having nanofiber aligned along a second direction, wherein the two directions are angularly offset from one another, as Mauck et al. expressly forms bilayers in which the nanofibers of adjacent lamellae extend in opposing directions of +30° and −30 [¶131]. Mauck et al. more generally discloses an implant scaffold comprising at least two overlapping layers, each layer comprising aligned fibers, wherein the major axis of the first layer forms an oblique angle with respect to the major axis of the second layer [¶6], with oblique specifying that the major axes of the two fibrous layers are neither parallel nor perpendicular to another [¶54].
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the first and second electrospun nanofibrous layers of Pepper et al. such that the nanofibers within each layer are aligned and the respective fiber directions are either parallel, as recited in claim 2, or angularly offset, as recited in claim 3, in accordance with Mauck et al. This is because Mauck et al. expressly teaches forming multilayer medical scaffolds from electrospun lamellae having substantially aligned nanofibers and arranging adjacent lamellae with either parallel fiber directions or different angular orientations. A person of ordinary skill in the art would have been motivated to apply Mauck et al.’s known fiber-orientation arrangements to Pepper et al.’s sealed nanofibrous to tailor its direction-dependent strength, stiffness, flexibility, and load distribution for the intended therapeutic or wound treatment application. A person of ordinary skill in the art would have had a reasonable expectation of success in doing so because Pepper et al. and Mauck et al. both employ electrospun nanofibrous layers for medical applications, and Mauck et al. expressly demonstrates that such layers can be assembled in the claimed parallel and angular configurations. The modification therefore would have required only the predictable arrangement of known electrospun layers according to their established functions, without altering Pepper et al.’s sealing or therapeutic-containment operation.
Claims 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Pepper et al. (US20110111012A1) in view of McKean et al. (WO2020070484A1 {published 04/09/2020}; in-text citations shall be used from its related U.S. pre-grant publication US20220071920A1 {priority date of 10/01/2018}).
Pepper et al. teaches all required limitations of present claims 1, 4, and 5.
However, Pepper et al. fails to teach the required limitations of claims 6 and 8.
McKean et al. discloses a therapeutic composition comprising an inner portion and a biocompatible membrane fully or partially surrounding the inner portion. McKean et al. teaches that the composition may be used for wound care [¶228]. McKean et al. teaches that the composition comprises two layers with the first and second layers formed by electrospinning [¶abstract]. McKean et al. teaches that the fibers of the composition may be nanofibers [¶86].
Regarding claim 6: McKean et al. discloses sealed pouches and bags having shapes based on squares and polygons, including cuboids and polyhedral [¶79]. McKean et al. further teaches that the therapeutic composition may have the shape of a polygonal prism, including triangular, tetragonal prism, pentagonal, hexagonal, heptagonal, octagonal, nonagonal, or a decagonal prism [¶122]. McKean et al. further teaches that the therapeutic composition may have the shape of a cylindrical prism [¶123]. A sealed interior compartment conforming to a polygonal-prism pouch necessarily defines a polygonal cross-section. The aspect ratios of many of the above shapes (e.g., hexagonal) are different than 1.
Regarding claim 8: McKean et al. discloses that when the therapeutic composition has the shape of a cylinder or polygonal prism, its diameter is typically from 2 mm to 5 cm [¶125]. McKean et al. further teaches diameter ranges beginning at 4 mm and 6 mm [¶126].
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the sealed compartment of Pepper et al. with the polygonal cross-sectional shape and dimensions taught by McKean et al. This is because McKean et al. expressly teaches sealed electrospun therapeutic pouches having polygonal-prism configurations and dimensions beginning at approximately 2 mm, which overlap the claimed ranges of about 0.5 to 10 mm and about 2-7 mm. A person of ordinary skill in the art would have been motivated to employ McKean et al.’s known compartment geometries and dimensions in Pepper et al.’s sealed nanofibrous article to tailor the article’s therapeutic capacity, fit, handling, mechanical behavior, and placement at the intended treatment site. A person of ordinary skill in the art would have had a reasonable expectation of success in doing so because Pepper et al. and McKean et al. both concerns layered electrospun therapeutic articles for wound-care applications, and changing the shape of Pepper et al.’s sealed compartment in accordance with McKean et al. would have constituted only the predictable selection of known geometries and overlapping dimensions using conventional sealing techniques.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Pepper et al. (US20110111012A1) in view of So et al. (US20140257515A1).
Pepper et al. teaches all required limitations of present claims 1, 4, and 5.
However, Pepper et al. fails to teach the required limitations of present claim 7.
So et al. discloses a patch-shaped or flat-sheet implantable device capable of delivering biologically active materials [¶118]. So et al. teaches these assemblies can prevent human recipients from rejecting allografts and xenografts (e.g., skin grafts), and can be further used for local treatment [¶120]. So et al. teaches that the device can contain matrix scaffolds with internal welds (i.e., seals), and the whole membrane may be welded to create one or more lumens and further compartmentalizing the enclosed lumens using one or more internal welds. [¶¶123, 146]. So et al. teaches that the encapsulating device may be comprised of biocompatible nanofiber mats [¶136].
Regarding claim 7: So et al. discloses providing 2, 3, 4, 5, 6, 7, 8, 9, 10 or more welds extending across the device, including intersecting horizontal and vertical welds that are parallel and equidistant, thereby forming 2, 3, 4, 5, 6, 7, 8, 9, or 10 wholly separated chambers [¶123].
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Pepper et al.’s sealed nanofibrous therapeutic article to include the plurality of sealed compartments taught by So et al. This is because So et al. expressly teaches forming multiple wholly separated chambers within a biocompatible nanofiber device by providing internal welds, including parallel and equidistant horizontal and vertical welds that produce a periodic compartment arrangement. A skilled artisan would have been motivated to employ So et al.’s compartmentalized configuration in Pepper et al. to spatially distribute and retain therapeutic material, limit migration or aggregation of contents, permit separate loading of different materials, and provide a more uniform localized treatment across the article. A person of ordinary skill in the art would have had a reasonable expectation of success in doing so because Pepper et al. and So et al. both concerns sealed, biocompatible nanofibrous devices for localized therapeutic applications, and So et al. expressly demonstrates that conventional welding techniques reliably divide such devices into multiple sealed chambers. The modification therefore would have amounted to the predictable use of a known compartment-forming technique for its established purpose.
Claims 9-11 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Pepper et al. (US20110111012A1) in view of Lee et al. (US20180169024A1).
Pepper et al. teaches all required limitations of present claims 1, 4, and 5.
However, Pepper et al. fails to teach the required limitations of present claims 9-11 and 14-16.
Lee et al. discloses mechanically-activated microcapsules (MAMCs) for controlled drug-delivery, wherein the MAMCs release one or more active ingredients in response to mechanical stimuli in a subject's body [¶abstract]. Lee et al. teaches that the MAMCs comprise polymeric shells such as poly(lactic-co-glycolic) acid (PLGA) [claim 18 of Lee et al.].
Regarding claim 9: Lee et al. discloses activated microcapsules comprising shells configured to rupture when a minimum pressure, stress, deformation, or mechanical-load threshold is applied, thereby releasing the encapsulated contents [¶¶34-35, 43, 49-50].
Regarding claim 10: Lee et al. teaches that each mechanically responsive microcapsule contains one or more therapeutically active ingredients within its enclosed core and releases a therapeutically effective amount upon rupture [¶34-37].
Regarding claim 11: Lee et al. teaches that the encapsulated therapeutic may comprise a growth factor, including transforming growth factors, fibroblast growth factors, connective tissue growth factors, insulin-like growth factors, and bone morphogenetic proteins [¶¶36, 87, 90].
Regarding claim 14: Lee et al. discloses mixtures comprising multiple MAMC populations having different rupture profiles, including at least two different minimum mechanical load thresholds [¶¶45, 51].
Regarding claim 15: Lee et al. teaches that some MAMCs have higher minimum pressure or load thresholds than other MAMCs, thereby teaching that first and second populations have different rupture forces [¶¶45, 51].
Regarding claim 16: Lee et al. teaches MAMC populations differing in shell composition and shell thickness, including PLGA with no plasticizer, PLGA with plasticizer, and PLGA with different plasticizer concentrations. Because claim 16 requires a difference in only one of composition, size or contents, the expressly different compositions satisfy the limitation. [¶¶47-48, 51, 60].
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to dispose the mechanically responsive therapeutic microcapsules of Lee et al. within the sealed nanofibrous compartment of Pepper et al. This is because Pepper et al. expressly provides a sealed electrospun article having an interior compartment configured to receive and retain therapeutic material, while Lee et al. teaches biocompatible, mechanically activated microcapsules that encapsulate therapeutic agents and rupture upon exposure to predetermined mechanical loads. Lee et al. further teaches multiple capsule populations having different rupture thresholds, compositions, shell thickness, and therapeutic contents. A person of ordinary skill in the art would have been motivated to incorporate Lee et al.’s microcapsules into Pepper et al.’s compartment to securely localize the therapeutic payload at the treatment site and provide controlled, load-responsive release during movement or mechanical loading, thereby reducing unintended release while permitting staged or differential delivery of one or more therapeutics. A person of ordinary skill in the art would have had a reasonable expectation of success in doing so because Pepper et al. expressly contemplates loading therapeutic material into its sealed compartment, while Lee et al.’s capsules (i.e., sealed compartments) are taught as discrete biocompatible therapeutic carriers intended to function within the body. The combination therefore would have involved the predictable use of Lee et al.’s mechanically responsive delivery particles within Pepper et al.’s known therapeutic-retaining compartment according to their established function.
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Pepper et al. (US20110111012A1) in view of Lee et al. (US20180169024A1) in further view of Peredo et al. (Peredo AP, Jo YK, Duan G, Dodge GR, Lee D, Mauck RL. Mechano-activated biomolecule release in regenerating load-bearing tissue microenvironments. Biomaterials. 2021;265:120255. doi:10.1016/j.biomaterials.2020.120255).
Pepper et al. and Lee et al. collectively teach all required limitations of claims 1, 9, and 10.
However, Pepper et al. and Lee et al. fail to collectively teach the required limitations of present claims 12 and 13.
Peredo et al. teaches polymeric mechanically activated microcapsules incorporated into tissue constructs to encapsulate a therapeutic agent and release it locally in response to physiological mechanical loading [page 3, left column, ¶1; page 8, left column, ¶¶1-2; figures 4E and 5].
Regarding claim 12: Peredo et al. teaches that the therapeutic comprises anakinra. Specifically, Peredo et al. fabricates mechanically activated microcapsules having an inner phase containing interleukin-1 receptor antagonist (“IL-1ra”) supplied as Sobi/Kineret [p. 3, left column, ¶2]. Peredo et al. further expressly states that Kineret is a recombinant form of human IL-1ra that contains 100 mg of anakinra per syringe, and that the Kineret solution was used during mechanically-activated microcapsules (MAMC) fabrication [p. 4, right column, ¶2]. Peredo et al. additionally identifies the encapsulated IL-1ra as being clinically used as Anakinra [p. 8, left column, ¶2; p. 9, figure 5].
Regarding Claim 13: Peredo et al. discloses an article containing mechanically activated microcapsules configured to rupture under strain and loading-cycle conditions within the claimed ranges. Peredo et al. subjects MAMC-loaded constructs to unconfined cyclic compression for 60 or 180 minutes, first applying 2% pre-strain and thereafter applying 20% cyclic strain at 5 Hz [p. 3, right column, ¶3]. At 5 Hz, 60 and 180 minutes correspond to 18,000 and 54,000 loading cycles, respectively. Figure 2C and the associated results show loss of capsule contents and increasing mechano-activation with increasing loading cycles under dynamic compression at 2-20% strain at 5 Hz. [figure 2C, page 4; page 5, right column, ¶2]. Thus, rupture occurs at 20% strain and at a number 18,000 and 54,000 loading cycles, which falls within the claimed ranges of 1-35% strain and 1-1,0000,0000 loading cycles.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate the anakinra-loaded mechanically activate microcapsules and loading-responsive release conditions taught by Peredo et al. into the sealed nanofibrous therapeutic article of Pepper et al., using the mechanically responsive capsule system of Lee et al. This is because Lee et al. teaches mechanically activated microcapsules configured to encapsulate therapeutic agents and rupture in response to physiological mechanical loading, while Peredo et al. expressly demonstrates fabrication of such microcapsules using Kineret containing anakinra and demonstrates rupture and loss of capsule contents under cyclic compression at 20% strain and 5 Hz over approximately 18,000 to 54,000 loading cycles, which are values falling within the claimed ranges. A person of ordinary skill in the art would have been motivated to make such combination to provide localized, mechanically triggered delivery of anti-inflammatory therapeutics at a repeatedly loaded treatment site, thereby releasing anakinra in response to physiological movement while limiting premature or systemic delivery. A person of ordinary skill in the art would have had a reasonable expectation of success in doing so because Pepper et al. expressly provides a sealed compartment for retaining therapeutic material, Lee et al. establishes the suitability of mechanically activated microcapsules for load-responsive therapeutic delivery, and Peredo et al. experimentally demonstrates both successful encapsulation of anakinra and rupture of such capsules under strain and cycle conditions encompassed by claim 13. The combination would have thus constituted the predictable use of demonstrated mechanically responsive therapeutic delivery system with Pepper et al.’s known localized therapeutic article.
Conclusions
No claim is found allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARYA AHMADI BAZARGANI whose telephone number is (571)272-0211. The examiner can normally be reached Monday - Friday 9:00AM - 5:00 PM.
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Arya A. Bazargani, Ph.D.
Patent Examiner
Art Unit 1613
/MARK V STEVENS/ Primary Examiner, Art Unit 1613
Prosecution Insights