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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 34 is 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.
Regarding claim 34, the term “therapeutic dose” renders the claim indefinite. It is not specified in the claim or specification what is considered a “therapeutic dose”.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grinstaff (US 2015/0297316), as cited in applicant’s IDS.
Regarding claim 25, Grinstaff discloses an implantable marker configured to deliver a therapy to a patient (paragraph [0039] “flexible polymer matrix to be implanted at the target tissue site can comprise at least one active agent.”), the implantable marker comprising:
an elongate flexible radiopaque filament (paragraph [0035] “a radiopaque material” paragraph [0032] “The shape-memory alloy material and/or elastic material can be provided in any shape, e.g., but not limited to, straight or curved wire, ribbon, coil, an intertwining structure, or any combinations thereof. In one embodiment, the flexible polymer matrix can comprise at least one or more nitinol wires.” Paragraph [0028] “While the flexible polymer matrix can be in any format (e.g., but not limited to, a film, or a collection of fibers such as a woven or non-woven mat or mesh)” The examiner notes wires and fibers are filaments.) configured to facilitate visibility of tissue in a treatment region of the patient when implanted in the patient and viewed with an imaging modality (paragraph [0035] “the flexible polymer matrix can comprise at least one contrast agent detectable by at least X-ray imaging”); and
a therapeutic agent coupled to the elongate flexible radiopaque filament and configured to provide the therapy to target tissue in the patient (paragraph [0130] “Active agents can be incorporated into the tissue marker or the flexible polymer matrix, e.g., as a coating of the flexible polymer matrix, and/or dispersed within the flexible polymer matrix.”).
Regarding claims 26, Grinstaff discloses the implantable marker of claim 25, wherein the therapeutic agent is configured to emit a localized therapeutic dose of radiation to the target tissue. (paragraph [0039] “Examples of an active agent include, but are not limited to a therapeutic agent, a radioisotope for radiation therapy”)
Regarding claim 27, Grinstaff discloses the implantable marker of claim 25, and wherein the therapeutic agent comprises one or more of an antimicrobial, an antibacterial, an anti-inflammatory, a hemostatic agent, a serous fluid reducing agent, a hormone, a pain management agent, an anesthetic, a radioactive agent, and a chemotherapeutic agent. (paragraph [0039] “Examples of an active agent include, but are not limited to a therapeutic agent, a radioisotope for radiation therapy, a chemotherapeutic, an antimicrobial agent (e.g., antibiotics or an antiseptic agent), an anesthetic, a cell growth factor, a peptide, a steroid, a carbohydrate, a lipid, a non-steroidal anti-inflammatory drug (NSAID), a peptidomimetic, an antibody or a portion thereof, an antibody-like molecule, nucleic acid, and any combinations thereof.”)
Regarding claim 28, Grinstaff discloses the implantable marker of claim 25, wherein the treatment region is a tumor or a post-resection tumor bed, and wherein the therapy is delivered locally to an area of malignancy in the tumor or the tumor bed after surgery. (paragraph [0012] “For example, the target tissue site can be at, or in close proximity to, a void space or cavity, a lesion, a wound, a biopsy site, a diseased tissue area, a tissue area to be diagnosed, or any combinations thereof.“ paragraph [0085] “where the tissue is diagnosed with cancer, the tissue can be treated with radiation, chemotherapy and/or surgical removal.” The examiner notes a biopsy site leaves an void space or cavity that is a tumor bed.)
Regarding claim 31, Grinstaff discloses the implantable marker of claim 25 and wherein the elongate flexible radiopaque filament comprises a radiopaque dopant configured to enhance radiopacity of the elongate flexible radiopaque filament. (paragraph [0035] “Exemplary X-ray-detectable contrast agent(s) include, but not limited to, a radiopaque material (e.g., loxaglate or iodine (HEXABRIX® or CYSTO CONRAY™II), bromine, salts (e.g., an iodinated salt, barium salts (e.g., barium sulfate), bismuth salts (e.g., bismuth oxychloride), or any combinations thereof), metal or alloy materials (e.g., nitinol, titanium, tantalum, tungsten, or any combinations thereof), metal oxide particles, and any combinations thereof.” The examiner notes that these materials listed are radiopaque dopants contributing to radiopacity of the implantable marker.)
Regarding claim 33, Grinstaff discloses a method for treating tissue, comprising:
attaching an implantable elongate flexible radiopaque filament to the tissue (paragraph [0039] “flexible polymer matrix to be implanted at the target tissue site can comprise at least one active agent.” paragraph [0007] “a flexible polymeric film can adopt a compact configuration or form, e.g., a rolled-up hollow cylinder” paragraph [0035] “a radiopaque material”), wherein the implantable elongate flexible radiopaque filament is configured to facilitate visibility of tissue in a treatment region when implanted in a patient and viewed with an imaging modality (paragraph [0007] “the flexible polymeric film can be adapted to be visible by at least one or more imaging modalities.”);
viewing the implantable elongate flexible radiopaque filament with the imaging modality and identifying the tissue in treatment region (paragraph [0015] “Marking a target tissue site with one or more tissue markers described herein can also facilitate treating and/or monitoring or examining a condition of the same tissue at, or in close proximity to, the target tissue site marked by the tissue marker(s).”); and
delivering a therapy from the implantable elongate flexible radiopaque filament to the treatment region (paragraph [0127] “active agent to be delivered to the target tissue site and/or surrounding tissue”).
Regarding claim 34, Grinstaff discloses the method of claim 33, but fails to disclose wherein delivering the therapy comprises emitting a localized therapeutic dose of radiation from the implantable elongate flexible radiopaque filament to the tissue in the treatment region (paragraph [0039] “Examples of an active agent include, but are not limited to a therapeutic agent, a radioisotope for radiation therapy” The examiner notes that since that since the agent is for radiation therapy, that the dose of radiation therapy is considered a therapeutic dose.).
Regarding claim 35, Grinstaff discloses the method of claim 33, and wherein delivering the therapy comprises delivering one or more of an antimicrobial, an antibacterial, an anti-inflammatory, a hemostatic agent, a serous fluid reducing agent, a hormone, a pain management agent, an anesthetic, a radioactive agent, and a chemotherapeutic agent to the treatment region (paragraph [0039] “Examples of an active agent include, but are not limited to a therapeutic agent, a radioisotope for radiation therapy, a chemotherapeutic, an antimicrobial agent (e.g., antibiotics or an antiseptic agent), an anesthetic, a cell growth factor, a peptide, a steroid, a carbohydrate, a lipid, a non-steroidal anti-inflammatory drug (NSAID), a peptidomimetic, an antibody or a portion thereof, an antibody-like molecule, nucleic acid, and any combinations thereof. In one embodiment, the active agent to be delivered to the target tissue site and/or surrounding tissue can comprise an antimicrobial agent (e.g., antibiotics or an antiseptic agent).”).
Regarding claim 36, Grinstaff discloses the implantable marker of claim 33, wherein the treatment region is a tumor or a post- resection tumor bed, and wherein delivering the therapy comprises delivering the therapy locally to an area of malignancy in the tumor or the tumor bed after surgery. (paragraph [0012] “For example, the target tissue site can be at, or in close proximity to, a void space or cavity, a lesion, a wound, a biopsy site, a diseased tissue area, a tissue area to be diagnosed, or any combinations thereof.“ paragraph [0085] “where the tissue is diagnosed with cancer, the tissue can be treated with radiation, chemotherapy and/or surgical removal.” The examiner notes a biopsy site leaves an void space or cavity that is a tumor bed.)
Regarding claim 39, Grinstaff discloses an implantable marker configured to deliver a therapy to a patient (paragraph [0039] “flexible polymer matrix to be implanted at the target tissue site can comprise at least one active agent), the implantable marker comprising:
a radiopaque clip configured to be coupled to tissue (paragraph [0120] “In one embodiment, the flexible polymer matrix can comprise a metal material (e.g., nitinol) in any form, e.g., but not limited to, a wire, a clip, a coil, particles, or any combinations thereof” and paragraph [0121] “Additionally or alternatively, the flexible polymer matrix can comprise at least one or more contrast agents detectable by at least X-ray imaging, e.g., a radiopaque material”) and configured to facilitate visibility of tissue in a treatment region of the patient when implanted in the patient and viewed with an imaging modality; (The examiner notes x-ray imaging as the imaging modality.)
and a therapeutic agent coupled to the radiopaque clip and configured to provide the therapy to target tissue in the patient (paragraph [0130] “Active agents can be incorporated into the tissue marker or the flexible polymer matrix, e.g., as a coating of the flexible polymer matrix, and/or dispersed within the flexible polymer matrix.”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 29, 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grinstaff in view of Sioshansi (WO 0027477), as cited in the applicant’s IDS.
Regarding claim 29, Grisntaff teaches the implantable marker of claim 25 but fails to teach wherein the therapeutic agent is configured to be activated in order to deliver the therapy to the target tissue.
Sioshansi teaches an implantable radiotherapy device that can be activated to be radioactive. (Pg 6, line 12 “The nature of the radiotherapy device disclosed herein allows it to be fabricated to virtually any desired net or near-net size and shape while it is in a non-radioactive state, and then all or a portion of the device rendered radioactive.” And pg 6, line 22 “The use of accelerated beam technology to make all or a portion of the device radioactive”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Grinstaff in view of Sioshansi to have an active and passive state. One of ordinary skill in the art would have been able to recognize that the use of accelerated beam technology to make all or a portion of the device radioactive lowers the unit cost of the device, allows greater flexibility in the design and use of the device, eliminates the need for laborious wet chemistry separation procedures, and provides solutions to the problems of heat management and transmutation efficiency during fabrication of the device. See pg 6, line 22 of Sioshansi.
Regarding claim 37, Grinstaff teaches the method of claim 33, but fails to teach wherein delivering the therapy further comprises activating a therapeutic agent in order to deliver the therapy to the treatment region.
Sioshansi teaches an implantable radiotherapy device that can be activated to be radioactive. (Pg 6, line 12 “The nature of the radiotherapy device disclosed herein allows it to be fabricated to virtually any desired net or near-net size and shape while it is in a non-radioactive state, and then all or a portion of the device rendered radioactive.” And pg 6, line 22 “The use of accelerated beam technology to make all or a portion of the device radioactive”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Grinstaff in view of Sioshansi to have an active and passive state. One of ordinary skill in the art would have been able to recognize that the use of accelerated beam technology to make all or a portion of the device radioactive lowers the unit cost of the device, allows greater flexibility in the design and use of the device, eliminates the need for laborious wet chemistry separation procedures, and provides solutions to the problems of heat management and transmutation efficiency during fabrication of the device. See pg 6, line 22 of Sioshansi.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grinstaff in view of Alqathami (US 2017/0368209).
Regarding claim 30, Grinstaff teaches the implantable marker of claim 25, but fails to teach that the marker further comprises further comprising a binding layer configured to couple the therapeutic agent to the elongate flexible radiopaque filament.
Alqathami teaches an implantable capsule with a hydrogel to act as an adhesion layer. (paragraph [0081] “It can be envisioned that the capsule would be administered with a pharmaceutically acceptable carrier or lubricant in order to assist in injection or implantation. Such carrier or lubricant may include, but is not limited to, a hydrogel… For modes of administration involving injection, it is envisioned that a pharmaceutically active molecule may be injected simultaneously with the capsule. This pharmaceutically active molecule may be a local anesthetic or an antineoplastic agent, and may make up 0.001-10, preferably 0.01-7, more preferably 0.1-5% of the total weight of the carrier or lubricant.” The examiner is modifying the system in Grinstaff to have a hydrogel layer with the pharmaceutically active agent embedded in it thus proving a binding layer coupling the therapeutic agent to the radiopaque filament.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system in Grinstaff in view of Alqathami. One of ordinary skill in the art would have been able to recognize that having a hydrogel layer would assist in injection or implantation. See paragraph [0081] of Alqathami.
Claim(s) 32, 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grinstaff in view of Boyden (US 2008/0058786).
Regarding claim 32, Grinstaff teaches the implantable marker of claim 25, but fails to teach wherein the therapy comprises an ablative therapy.
Boyden teaches a system to implant a marker in target tissue and apply treatment, one of which can be ablation therapy. (paragraph [0073] “the electromagnetic energy may be provided only in a single direction, for example 90 degrees from the horizontal axis of a device, or toward a lumen wall, a lesion, or an internal location.” Paragraph [0075] “Electromagnetic energy and/or particle beam energy configured to ablate one or more targets” paragraph [0048] “"lumen" are man-made lumens within the body, including vascular catheters, spinal fluid shunts, vascular grafts, bowel re-anastomoses, bypass grafts, indwelling stents of various types (e.g., vascular, gastrointestinal, tracheal, respiratory, urethral, genitourinary, etc.) and surgically created fistula”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Grinstaff in view of Boyden to have ablation therapy. One of ordinary skill in the art would have been able to recognize that combining ablation therapy with the implanted markers would allow for a minimally invasive form of treatment that would not require constant daily monitoring by a physician and allow the user to move freely while not having to depend on being in close proximity to a treatment machine.
Regarding claim 38, Grinstaff teaches the method of claim 33 but fails to teach wherein delivering the therapy comprises delivering an ablative therapy to the treatment region.
Boyden teaches a system to implant a marker in target tissue and apply treatment, one of which can be ablation therapy. (paragraph [0073] “the electromagnetic energy may be provided only in a single direction, for example 90 degrees from the horizontal axis of a device, or toward a lumen wall, a lesion, or an internal location.” Paragraph [0075] “Electromagnetic energy and/or particle beam energy configured to ablate one or more targets” paragraph [0048] “"lumen" are man-made lumens within the body, including vascular catheters, spinal fluid shunts, vascular grafts, bowel re-anastomoses, bypass grafts, indwelling stents of various types (e.g., vascular, gastrointestinal, tracheal, respiratory, urethral, genitourinary, etc.) and surgically created fistula”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Grinstaff in view of Boyden to have ablation therapy. One of ordinary skill in the art would have been able to recognize that combining ablation therapy with the implanted markers would allow for a minimally invasive form of treatment that would not require constant daily monitoring by a physician and allow the user to move freely while not having to depend on being in close proximity to a treatment machine.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Weadock (US 2018/0110964) teaches an implantable system that can apply various therapies to a target site.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA JOY LACAY DECASTRO whose telephone number is (571)272-8316. The examiner can normally be reached Monday - Friday 9:00 AM - 5:30.
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/A.L.D./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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