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 .
Specification
The disclosure is objected to because of the following informalities:
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1, 3-6, 8, 10-14, 19-20, 22-23, 27, 31, 33-34, 36-37, 39, 43, 44 are objected to because of the following informalities:
-Claim 1 recites “the lung” in line 9. Examiner recommends amending to –the patient’s lung—
-Claim 1 recites “the at least a diseased portion” in line 18. Examiner recommends amending to –the diseased portion—
-Claim 3 recites “the chest cavity” in line 4. Examiner recommends amending to –the patient’s chest cavity—
-Claim 4 recites “the film” in lines 2 and 3. Examiner recommends amending to –the flexible film—
-Claim 5 recites “the film” in line 2. Examiner recommends amending to –the flexible film—
-Claim 6 recites “the film” in lines 2 and 3. Examiner recommends amending to –the flexible film—
-Claim 6 recites “the film from and the second” in line 2. Examiner recommends amending to –the film and the second—
-Claim 8 recites “the lung” in line 2. Examiner recommends amending to –the patient’s lung—
-Claim 10 recites “the lung” in line 2. Examiner recommends amending to –the patient’s lung—
-Claim 11 recites “the lung” in lines 2 and 4. Examiner recommends amending to –the patient’s lung—
-Claim 11 recites “the film” in line 2. Examiner recommends amending to –the flexible film—
-Claim 12 recites “the lung” in lines 2 and 3-4. Examiner recommends amending to –the patient’s lung—
-Claim 13 recites “the lung” in line 3. Examiner recommends amending to –the patient’s lung—
-Claim 14 recites “the lung” in line 2. Examiner recommends amending to –the patient’s lung—
-Claim 19 recites “the at least a diseased portion” in lines 4-5. Examiner recommends amending to –the diseased portion—
-Claim 20 recites “the at least a diseased portion” in line 2. Examiner recommends amending to –the diseased portion—
-Claim 22 recites “the film” in line 2. Examiner recommends amending to –the biocompatible film—
-Claim 23 recites “the film” in line 1. Examiner recommends amending to –the biocompatible film—
-Claim 27 recites “wherein the biocompatible” in line 2. Examiner recommends amending to –and wherein the biocompatible—
-Claim 31 recites “via a multiple ports” in lines 2-3. Examiner recommends amending to –via multiple ports—
-Claim 33 recites “the lung” in line 3. Examiner recommends amending to –the patient’s lung—
-Claim 34 recites “wherein the structure” in line 3. Examiner recommends amending to –and wherein the structure—
-Claim 36 recites “wherein the substance” in line 6. Examiner recommends amending to –and wherein the substance—
-Claim 36 recites “a volume the fluid” in line 3. Examiner recommends amending to –a volume of the fluid—
-Claim 37 recites “the lung” in lines 4, 6, 8. Examiner recommends amending to –the patient’s lung—
-Claim 39 recites “the lung” in lines 3 and 4. Examiner recommends amending to –the patient’s lung—
-Claim 43 recites “the lung” in line 4. Examiner recommends amending to –the patient’s lung—
-Claim 44 recites “the at least a diseased portion” in line 15. Examiner recommends amending to –the diseased portion—
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claims 1-4, 7-16, 18, 20-24, 26-28, 30-37, 39-40, 42-46 recites “therapeutic element” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to be disposed on an outer surface of a diseased portion of a patient’s lung. According to the specification the therapeutic element includes a film [0036] and equivalents thereof.
Claim 39 recites “sensor” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to monitor perfusion. According to the specification the sensor can include a doppler probe, flow sensor, pressure sensor [0060] and equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-46 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
-Claim 1 recites “the patient’s chest cavity” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
-Claim 1 recites “the chest cavity” in line 7. There is insufficient antecedent basis for this limitation in the claim.
-Claim 11 recites “the lung tissue” in line 2. There is insufficient antecedent basis for this limitation in the claim.
-Claim 11 recites “the fastener comprises a thicker portion of the film” in line 2. It is unclear what this limitation requires in terms of structure. Further clarification should be provided to identify whether this requires a thicker portion of the fastener, the film, the fastener making up a thicker portion of the film or a separate embodiment.
-Claim 11 recites “the rest of the film” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. It is also unclear whether this is referring to the rest of the film not including the thicker portion of the film or a separate embodiment.
-Claim 13 recites “the lung tissue” in line 3. There is insufficient antecedent basis for this limitation in the claim.
-Claim 14 recites “the passage of air” in line 5. There is insufficient antecedent basis for this limitation in the claim.
-Claim 14 recites “the open end portion” in lines 4-5. There is insufficient antecedent basis for this limitation in the claim. It’s also unclear whether this term is referring to the end portion originally referenced in claim 14, line 3.
-Claim 15 recites “substantially impermeable” in line 2. It is unclear what substantially encompasses in terms of impermeability. Further clarification should be provided.
-Claim 18 recites “the lung tissue” in line 3. There is insufficient antecedent basis for this limitation in the claim.
-Claim 19 recites “the liquid or gel substance” in line 2. There is insufficient antecedent basis for this limitation in the claim.
-Claim 19 recites “the film” in line 2. There is insufficient antecedent basis for this limitation in the claim.
-Claim 19 recites “the other side of the film from the tissue-facing side” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
-Claim 19 recites “substantially rigid form” in line 4. It is unclear what substantially encompasses in terms of film rigidity and whether this includes completely rigid, partially rigid or other embodiments. Further clarification should be provided.
-Regarding claim 19, the phrase “(i.e., on the other hand…side)” in parentheses renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
-Claim 20 recites “tension” in line 5. It is unclear whether this is the same or different from tension originally referenced in claim 1, line 18.
-Claim 20 recites “the lung tissue” in line 5. There is insufficient antecedent basis for this limitation in the claim.
-Claim 20 recites “substantially flat” in line 3. It is unclear what substantially encompasses in terms of configuration and whether this includes completely flat, partially flat or other embodiments. Further clarification should be provided.
-Claim 20 recites “substantially greater than” in line 3. It is unclear what substantially encompasses in length and width values in comparison to thickness. Further clarification should be provided.
-Claim 24 recites “the lung tissue” in line 3. There is insufficient antecedent basis for this limitation in the claim.
-Claim 28 recites “thoracoscopic delivery” in line 2. It is unclear whether this is the same or different from thoracoscopic delivery originally referenced in claim 1, line 3.
-Claim 28 recites “the wall of the chest of the patient” in line 3. There is insufficient antecedent basis for this limitation in the claim.
-Claim 30 recites “thoracoscopic delivery” in line 2. It is unclear whether this is the same or different from thoracoscopic delivery originally referenced in claim 1, line 3.
-Claim 31 recites “thoracoscopic delivery” in line 2. It is unclear whether this is the same or different from thoracoscopic delivery originally referenced in claim 1, line 3.
-Claim 36 recites “the lung tissue” in line 2. There is insufficient antecedent basis for this limitation in the claim.
-Claim 36 recites “a contact force” in line 4. It is unclear whether this is the same or different from contact force originally referenced in claim 1, line 16.
-Claim 37 recites “the native geometry of the portion of the lung” in line 4. There is insufficient antecedent basis for this limitation in the claim.
-Claim 37 recites “the contained portion” in line 6. There is insufficient antecedent basis for this limitation in the claim.
-Claim 37 recites “the remainder of the lung” in line 6. There is insufficient antecedent basis for this limitation in the claim.
-Claim 37 recites “the vasculature” in line 7. There is insufficient antecedent basis for this limitation in the claim.
-Claim 37 recites “the portion of the lung contained by the therapeutic element” in line 4. There is insufficient antecedent basis for this limitation in the claim.
-Claim 39 recites “perfusion” in line 3. It is unclear whether this is the same or different from perfusion originally referenced in claim 1, line 17.
-Claim 39 recites “the portion of the lung” in line 3. There is insufficient antecedent basis for this limitation in the claim.
-Claim 39 recites “the contained portion” in line 4. There is insufficient antecedent basis for this limitation in the claim.
-Claim 43 recites “expanded configuration” in lines 3-4. It is unclear whether this is the same or different from expanded configuration originally referenced in claim 1, line 4.
-Claim 44 recites “the patient’s chest cavity” in line 4. There is insufficient antecedent basis for this limitation in the claim.
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.
(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) 1-3, 7-14, 16-18, 20, 27-30, 32, 33, 40, 44-46 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Karino (U.S. 20130289339).
Regarding Claim 1, Karino teaches a system for treating a patient having emphysema via thoracoscopic lung volume reduction [0099]—reference to treatment of emphysema and lung volume being reduced, the system comprising: a therapeutic element having a low-profile configuration for thoracoscopic delivery to the patient's chest cavity and an expanded configuration in which the therapeutic element is configured to be disposed on an outer surface of a diseased portion of a patient's lung [Figs. 9 and 10, element 10 (cover member)]—depicts expanded [Fig. 10] and shrunken [Fig. 9] configurations of the cover member and [0089]; and an applicator configured to manipulate the therapeutic element within the chest cavity to place the therapeutic element in contact with the diseased portion of the patient's lung when the lung is collapsed [Fig. 10, elements 110 and 120 (first and second introduction member)], wherein the therapeutic element is configured to apply a compressive load to and/or restrict expansion of the diseased portion of the patient's lung [0055]—where the compressive load includes the contact between the inner surface of the accommodating section with the outer surface of the lung, and wherein the therapeutic element is configured to, upon reinflation of the patient's lung, restrict airflow to the diseased portion of the patient's lung [0099]—reference to hyperinflation state being mitigated and ventilation efficiency of the lung being enhanced, thereby achieving a lung volume reduction [0099]—describes achieved lung volume reduction, and wherein interaction between the patient's lung and the therapeutic element produces a contact force and the therapeutic element is configured to distribute the contact force so as to maintain perfusion to the diseased portion of the patient's lung and/or minimize tension in the at least a diseased portion of the patient's lung [0104].
Regarding Claim 2, Karino teaches wherein the therapeutic element comprises a flexible film [0056]—describes the use of a flexible net as the covering member.
Regarding Claim 3, Karino teaches wherein the applicator comprises a plurality of arms [Fig. 10, elements 110 and 120] and is configured to transform the therapeutic element from the low-profile configuration [Fig. 9] to the expanded configuration [Fig. 10] while the therapeutic element is disposed within the chest cavity [0090-0091]—reference to the introduction members being advanced and placed onto the lung.
Regarding Claim 7, Karino teaches wherein the therapeutic element comprises a tubular sleeve [Fig. 1, element 10].
Regarding Claim 8, Karino teaches wherein the therapeutic element is configured to be wrapped around the lung at least one once [Fig. 10, element 10 (cover member) and 210 (lung)].
Regarding Claim 9, Karino teaches wherein the therapeutic element is configured to adhere to itself [0063]—describing attachment means of the holding member to the cover member including adhesion.
Regarding Claim 10, Karino teaches wherein the therapeutic element is configured to be wrapped around the lung at least once and secured via a fastener [Fig. 10, element 20 (holding member)].
Regarding Claim 11, Karino teaches wherein the therapeutic element is a film and the fastener comprises a thicker portion of the film [Fig. 1, element 24 (engaging parts) and 26 (groove) and 30 (lock member)] and [0060] that generates friction with the lung tissue having a magnitude that is greater than a magnitude of friction generated between the rest of the film and the lung tissue and [0102]—references that cover member having the lock member and prevented from falling off the lung to be retained within the living body long term and [0064]—discloses the rigidity of the holding member being higher than that of the cover member.
Regarding Claim 12, Karino teaches wherein the therapeutic element is configured to be positioned on a lobe of the lung such that the fastener is aligned with a lower edge of the lobe [Fig. 10] and [0090].
Regarding Claim 13, Karino teaches further comprising a fastener, and wherein the fastener is configured to secure the therapeutic element to itself such that the lung tissue is compressively engaged and/or captured within the therapeutic element without the fastener directly engaging the lung tissue [Fig. 12, element 20 (holding member)] and [0094]—which describes the opening of the aperture area being slightly greater than the diameter of the primary bronchus, and wherein the fastener comprises at least one of: an adhesive [0063], a mechanical fastener [Fig. 3A-C], and/or a weld in situ (not interpreted to be required by the claim).
Regarding Claim 14, Karino teaches wherein, when the therapeutic element is positioned over the diseased portion of the lung [Fig. 11], the therapeutic element has an end portion that is open and exposing the diseased portion to the pleural cavity [Fig. 11]—depicting the cover exposing an area of the lung and [0090]—describing device placement in reference to the pleura, and wherein the system further includes a band configured to be positioned around the open end portion to close the end portion [Fig. 3A-c, element 20 (holding member)], thereby limiting or preventing the passage of air between the pleural cavity and the diseased portion and limiting or preventing herniation of the diseased portion [0084]—describes air tight type slit valve preventing inflow of air into the thoracic cavity during device insertion.
Regarding Claim 16, Karino teaches wherein the therapeutic element comprises a film [0056] and a substance comprising a liquid or gel [0074] and [0063].
Regarding Claim 17, Karino teaches wherein the substance comprises a biological or polymeric resin and/or glue [0063] and [0074]
Regarding Claim 18, Karino teaches wherein the substance is configured to be applied to fill interstitial voids between the film and healthy and/or diseased lung tissue to improve attachment and/or sealing between the therapeutic element and the lung tissue [0063]—describes attachment using adhesion and fusion bonding.
Regarding Claim 20, Karino teaches wherein the therapeutic element is configured to secure the at least a diseased portion of the patient's lung in a substantially flat configuration (i.e., length and/or width are substantially greater than the thickness) [0027]—reference to lung deflation, and wherein the substantially flat configuration minimizes the contact force and attenuates tension in the lung tissue [0055].
Regarding Claim 27, Karino teaches wherein the therapeutic element comprises a biocompatible material, wherein the biocompatible material: (a) is either non-degradable, partially-degradable or fully-degradable material [0056], (b) comprises a polymeric or biological material [0074], and/or (c) comprises at least one of silicone, polyurethane, PTE, PTFE, polyester, nylon, PLGA, PLA, PCL (polycaprolactone), PLCL and combinations thereof [0056 and 0074].
Regarding Claim 28, Karino teaches wherein the therapeutic element is configured for thoracoscopic delivery through at least one port in the chest wall of the chest of the patient [0088] and [0089].
Regarding Claim 29, Karino teaches wherein the system includes a thoracoscope camera [0088]—reference to image taken by a thoracoscope.
Regarding Claim 30, Karino teaches wherein the therapeutic element is configured for thoracoscopic delivery via a single port [Fig. 10, element 40 (port)].
Regarding Claim 32, Karino teaches wherein the therapeutic element comprises a mesh [0110].
Regarding Claim 33, Karino teaches wherein the therapeutic element further comprises a polymer film and/or adhesive configured to secure the mesh to the diseased portion of the lung [0104]—description of the mesh net and advantages thereof and [0063]—describing the use of adhesives for the holding and cover members which would include the mesh net.
Regarding Claim 40, Karino teaches further comprising an imaging device for monitoring the patient following placement of the therapeutic element [0088].
Regarding Claim 44, Karino teaches a device for treating a patient having emphysema via thoracoscopic lung volume reduction [0099]—reference to treatment of emphysema and lung volume being reduced, the device comprising: a therapeutic element having a low-profile configuration for thoracoscopic delivery to the patient's chest cavity and an expanded configuration in which the therapeutic element is configured to be disposed on an outer surface of a diseased portion of a patient's lung [Figs. 9 and 10, element 10 (cover member)]—depicts expanded [Fig. 10] and shrunken [Fig. 9] configurations of the cover member and [0089]; and wherein the therapeutic element is configured to apply a compressive load to and/or restrict expansion of the diseased portion of the patient's lung [0055]—where the compressive load includes the contact between the inner surface of the accommodating section with the outer surface of the lung, and wherein the therapeutic element is configured to, upon reinflation of the patient's lung, restrict airflow to the diseased portion of the patient's lung [0099]—reference to hyperinflation state being mitigated and ventilation efficiency of the lung being enhanced, thereby achieving a lung volume reduction [0099]—describes achieved lung volume reduction, and wherein interaction between the patient's lung and the therapeutic element produces a contact force and the therapeutic element is configured to distribute the contact force so as to maintain perfusion to the diseased portion of the patient's lung and/or minimize tension in the at least a diseased portion of the patient's lung [0104].
Regarding Claim 45, Karino teaches wherein the therapeutic element comprises a cover [0014]—reference to the cover member.
Regarding Claim 46, Karino teaches wherein the therapeutic element comprises a fastener [Fig. 10, element 20 (holding member)].
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.
Claim(s) 4, 5, 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karino (U.S. 20130289339) in view of Totten (CN 113924050).
Regarding Claim 4, Karino is silent on wherein the therapeutic element comprises a flexible film, and wherein, when the film is in the low-profile configuration, the film is rolled up. Totten teaches wherein the therapeutic element comprises a flexible film [n0205]—reference to polymer film and [n0198], and wherein, when the film is in the low-profile configuration, the film is rolled up [n0201].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to deploy the flexible film in a rolled and unrolled configuration as taught by Totten to allow for adjustment of the sections of the cover and tool as suggested by Karino, as Karino discusses adjustment of the sections of the device after introduction into the living body [0087] with Totten because Totten teaches the use of this function to promote air sealing by applying contact pressure to the airway wall when pressure differences are high [n0201].
Regarding Claim 5, Karino is silent on wherein the applicator is configured to transform the film from the low-profile configuration to the expanded configuration by unrolling the film. Totten teaches herein the applicator is configured to transform the film from the low-profile configuration to the expanded configuration by unrolling the film [Figs. 7A and B] showing the applicator arms (element 116) in a low profile and rolled configuration [Fig. 7A] and in an expanded configuration [Fig. 7B].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to deploy the flexible film in a low-profile configuration as taught by Totten to allow for control and manipulation through a delivery device as suggested by Karino, as Karino discusses advancement of the device through a port [0088] with Totten because Totten teaches delivery the device via advancement through a delivery sheath [n0218].
Regarding Claim 6, Karino is silent on wherein the applicator comprises a first arm and a second arm, and wherein the first arm is configured to unroll the film from and the second arm is configured to stabilize the film. Totten teaches wherein the applicator comprises a first arm and a second arm [Figs. 7A and 7B, elements 116 (spokes) and 104 (barbs)], and wherein the first arm is configured to unroll the film from and the second arm is configured to stabilize the film [n0218], [n0201] and [0256].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the arms to deploy the flexible film in a low profile configuration as taught by Totten to allow for control and manipulation through a delivery device as suggested by Karino, as Karino discusses preventing the structure from being inadvertently deformed or caught on the lung [0090] with Totten because Totten teaches positioning and orienting the device at the target location in the patient’s airway [0256].
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karino (U.S. 20130289339) in view of Gonzalez (U.S. 6328689).
Regarding Claim 15, Karino is silent on wherein the therapeutic element is configured to be substantially impermeable to air to seal the lung tissue and prevent leaks. Gonzalez teaches wherein the therapeutic element is configured to be substantially impermeable to air to seal the lung tissue and prevent leaks [Col 7, lines 20-30]—describing seal of a lip at the end of the device to create vacuum suction and leakage suppression.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to providing a sealing means on the end of the cover as taught by Gonzalez to control airflow and suction characteristics as suggested by Karino, as Karino discusses preventing inflow of air into the thoracic cavity during device insertion [0084] with Gonzalez because Gonzalez teaches constricting lung tissue in the device [Col 7, lines 27-30].
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karino (U.S. 20130289339) in view of Tanaka (JP 2004358257).
Regarding Claim 19, Karino is silent on wherein the liquid or gel substance is configured to be applied outside the film (i.e., on the other side of the film from the tissue-facing side), and wherein the liquid or gel substance is configured to cure and set the film in a substantially rigid form to restrict expansion of the at least a diseased portion of the patient's lung. Tanaka teaches wherein the liquid or gel substance is configured to be applied outside the film (i.e., on the other side of the film from the tissue-facing side) [Pg. 60-61; “In another exemplary variant embodiment, a sealing method between the air transport conduit 704 and the outer pleural layer includes the use of various glues to facilitate the adhesion/tightness of the air transport conduit 704.”], and wherein the liquid or gel substance is configured to cure and set the film in a substantially rigid form to restrict expansion of the at least a diseased portion of the patient's lung [Pg. 61; “Thorex is a two-component sealant that has a set curing time after mixing the two components.”] and [Pg. 60; “the use of various glues to facilitate the adhesion/tightness of the air transport conduit 704.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an adhesive or glue as taught by Tanaka to apply closure and sealing means as suggested by Karino, as Karino discusses using adhesives [0063] with Tanaka because Tanaka teaches using these features to facilitate adhesion/tightness of the structure [Pg. 61].
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karino (U.S. 20130289339) in view of Laufer (U.S. 20040073155).
Regarding Claim 21, Karino is silent on wherein the therapeutic element comprises a polymer coating configured to adhere to the diseased portion of the patient's lung, and wherein the polymer coating is configured to be sprayed onto the patient's lung when the patient's lung is in a collapsed state. Laufer teaches wherein the therapeutic element comprises a polymer coating configured to adhere to the diseased portion of the patient's lung, and wherein the polymer coating is configured to be sprayed onto the patient's lung when the patient's lung is in a collapsed state [0132].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an adhesive or glue to seal between the device and the lung tissue as taught by Laufer to apply closure and sealing means as suggested by Karino, as Karino discusses using adhesives [0063] with Laufer because Laufer teaches spray coating applied to ensure uniformity and improved control of substance applied [0132].
Claim(s) 22, 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karino (U.S. 20130289339) in view of Laufer (U.S. 20040073155) and in further view of Tanaka (U.S. 20100170507).
Regarding Claim 22, Karino and Laufer are silent on wherein the therapeutic element further comprises a biocompatible film, and wherein the film is configured to be applied to and/or wrapped around the polymer coating. Tanaka teaches wherein the therapeutic element further comprises a biocompatible film [0178], and wherein the film is configured to be applied to and/or wrapped around the polymer coating [0179]—reference to a transitional adhesive.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use layered materials as taught by Tanaka to support and provide seal/closure means as suggested by Karino and Laufer, as Karino discusses using adhesives [0063] and Laufer which discloses spraying a polymer coating onto the structure [0132] with Tanaka because Tanaka teaches strengthening and maintain the dimensions of the patch [0179].
Regarding Claim 23, Karino and Laufer are silent on wherein the film is configured to be a buttress for the polymer coating to enhance fixation and/or sealing of the therapeutic element. Tanaka teaches wherein the film is configured to be a buttress for the polymer coating to enhance fixation and/or sealing of the therapeutic element [0178-0179].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use layered materials as support mechanisms as taught by Tanaka to support and provide seal/closure means as suggested by Karino and Laufer, as Karino discusses using support members [0078] and Laufer which discloses the use of a conduit to bolster the structure [0174] with Tanaka because Tanaka teaches strengthening and maintain the dimensions of the patch [0179].
Claim(s) 24, 25, 26, 34, 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karino (U.S. 20130289339) in view of Tanaka (U.S. 20100170507).
Regarding Claim 24, Karino is silent on wherein the therapeutic element includes a therapeutic agent and is configured to deliver the therapeutic agent to the lung tissue while the therapeutic element is secured to the lung tissue. Tanaka teaches wherein the therapeutic element includes a therapeutic agent and is configured to deliver the therapeutic agent to the lung tissue while the therapeutic element is secured to the lung tissue [0079]—reference to antibiotics delivered to the pleura.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to deliver antibiotics via the structural device as taught by Tanaka to provide lung treatment as suggested by Karino, as Karino discusses typical treatments for emphysema including pharmacotherapy [0007] with Tanaka because Tanaka teaches desirability of using medicated irrigation fluid [0129].
Regarding Claim 25, Karino is silent on wherein the therapeutic agent is at least one of any anti-inflammatory, an antibiotic, and/or an anesthetic. Tanaka teaches wherein the therapeutic agent is at least one of any anti-inflammatory, an antibiotic, and/or an anesthetic [0079].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to deliver antibiotics via the structural device as taught by Tanaka to provide lung treatment as suggested by Karino, as Karino discusses typical treatments for emphysema including pharmacotherapy [0007] with Tanaka because Tanaka teaches desirability of using medicated irrigation fluid [0129].
Regarding Claim 26, Karino is silent on wherein the therapeutic element comprises a polymeric coating or film that is loaded with the therapeutic agent. Tanaka teaches wherein the therapeutic element comprises a polymeric coating or film that is loaded with the therapeutic agent [0079]—where the adhesion is interpreted as the film where antibiotics and other chemical agents are introduced.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to deliver antibiotics via the structural device as taught by Tanaka to provide lung treatment as suggested by Karino, as Karino discusses typical treatments for emphysema including pharmacotherapy [0007] with Tanaka because Tanaka teaches sealing the pleural cavity to prevent lung collapse [0078].
Regarding Claim 34, Karino is silent on wherein the therapeutic element comprises a structure configured to be disposed on and around the diseased portion of the patient's lung, wherein the structure includes a channel configured to receive a fluid therethrough. Tanaka teaches wherein the therapeutic element comprises a structure configured to be disposed on and around the diseased portion of the patient's lung, wherein the structure includes a channel configured to receive a fluid therethrough [0127]—describing an irrigation and suction conduit.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include irrigation and suction features as taught by Tanaka to provide lung treatment as suggested by Karino, as Karino discusses typical treatments for emphysema including pharmacotherapy [0007] with Tanaka because Tanaka teaches removal of materials after treatment is performed [0135].
Regarding Claim 35, Karino is silent on wherein a size and/or shape of the structure can be adjusted by controlled delivery of the fluid to and withdrawal of the fluid from the structure, thereby enabling in-situ customization of the therapeutic element. Tanaka teaches wherein a size and/or shape of the structure can be adjusted by controlled delivery of the fluid to and withdrawal of the fluid from the structure, thereby enabling in-situ customization of the therapeutic element [0151].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include control shape and size of the balloon via fluid as taught by Tanaka to provide variations customizable to the patient as suggested by Karino, as Karino discusses the use of arbitrary shapes [0069] with Tanaka because Tanaka teaches the cavity typically conforming to the shape of the device [0077].
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karino (U.S. 20130289339) in view of Ingenito (WO 0113908).
Regarding Claim 31, Karino is silent on wherein the therapeutic element is configured for thoracoscopic delivery via a multiple ports. Ingenito teaches wherein the therapeutic element is configured for thoracoscopic delivery via a multiple ports [Pg. 16, lines 19-22].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize multiple ports as taught by Ingenito to provide thoracoscope delivery as suggested by Karino, as Karino discusses the use of a thoracoscope or associated method to deform the aperture shape of the opening [0088] with Ingenito because Ingenito teaches use of these ports to inject or insert materials via lumens [Pg. 16, lines 19-22].
Claim(s) 36, 37, 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karino (U.S. 20130289339) in view of Tanaka (U.S. 20100170507) and in further view of Evans (U.S. 20080293996).
Regarding Claim 36, Karino and Tanaka are silent on wherein upon initial placement of the therapeutic element against the lung tissue, the channel is configured to receive a volume the fluid to confirm apposition of the therapeutic element and the lung tissue and/or a contact force between the therapeutic element and the lung tissue, and, after the fluid is evacuated from the channel, the channel is configured to receive a volume of a substance equal to the volume of fluid, wherein the substance is configured to solidify in-situ and take a permanent shape consistent with the confirmed apposition and/or contact force. Evans teaches wherein upon initial placement of the therapeutic element against the lung tissue, the channel is configured to receive a volume the fluid to confirm apposition of the therapeutic element and the lung tissue and/or a contact force between the therapeutic element and the lung tissue, and, after the fluid is evacuated from the channel, the channel is configured to receive a volume of a substance equal to the volume of fluid, wherein the substance is configured to solidify in-situ and take a permanent shape consistent with the confirmed apposition and/or contact force [0058]—references the use of a filler material with liquid that is cured or hardened after being delivered via catheter.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize include a filler material to cure within the system as taught by Evans to provide thoracoscope delivery as suggested by Karino, and Tanaka, as Karino discusses the use of a thoracoscope or associated method to deform the aperture shape of the opening [0088] and Tanaka which discloses the use of fluids to fill the balloon [0151] with Evans because Evans teaches the use of the filler material to provide curing to the shape conforming to the anatomy of the ventricle [0058].
Regarding Claim 37, Karino and Tanaka are silent on wherein the structure is configured to assume a triangular two-dimensional (2D) shape and/or a conical and/or pyramidal three-dimensional (3D) shape when the fluid is delivered to the channel to approximate the native geometry of the portion of the lung contained by the therapeutic element, and wherein the 2D and/or 3D shape enables the therapeutic element to prevent or limit twisting of the contained portion of the lung upon re-inflation of the remainder of the lung, and wherein the therapeutic element is configured to limit or prevent constriction of the vasculature perfusing the contained portion of the lung. Evans teaches wherein the structure is configured to assume a triangular two-dimensional (2D) shape and/or a conical and/or pyramidal three-dimensional (3D) shape when the fluid is delivered to the channel to approximate the native geometry of the portion of the lung contained by the therapeutic element, and wherein the 2D and/or 3D shape enables the therapeutic element to prevent or limit twisting of the contained portion of the lung upon re-inflation of the remainder of the lung [Figs. 10-12]—depicting the conical and pyramidal shape of the frame and [0078], and wherein the therapeutic element is configured to limit or prevent constriction of the vasculature perfusing the contained portion of the lung [0017]—reference to the system reducing the chamber volume and effective volume of the ventricle.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to indicate the possible shapes that the system can assume as taught by Evans to provide thoracoscope delivery as suggested by Karino, and Tanaka, as Karino discusses the use of a thoracoscope or associated method to deform the aperture shape of the opening [0088] and Tanaka which discloses the cavity conforming/adapting to the size and shape of the device [0080] with Evans because Evans teaches the reduction in volume of the ventricular chamber [0058].
Regarding Claim 38, Karino and Tanaka are silent on further comprising a substance configured to be delivered into the channel and solidify within the channel to rigidize the structure in a desired shape. Evans teaches further comprising a substance configured to be delivered into the channel and solidify within the channel to rigidize the structure in a desired shape [0058]—references the use of a filler material with liquid that is cured or hardened after being delivered via catheter.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize include a filler material to cure within the system as taught by Evans to provide thoracoscope delivery as suggested by Karino, and Tanaka, as Karino discusses the use of a thoracoscope or associated method to deform the aperture shape of the opening [0088] and Tanaka which discloses the use of fluids to fill the balloon [0151] with Evans because Evans teaches the use of the filler material to provide curing to the shape conforming to the anatomy of the ventricle [0058].
Claim(s) 39, 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karino (U.S. 20130289339) in view of Swanson (U.S. 6786905).
Regarding Claim 39, Karino is silent on further comprising a sensor, incorporated into or independent of the therapeutic element, wherein the sensor is configured to monitor perfusion to the portion of the lung contained by the therapeutic element to reduce a risk of ischemia and necrosis of the contained portion of the lung. Swanson teaches further comprising a sensor, incorporated into or independent of the therapeutic element, wherein the sensor is configured to monitor perfusion to the portion of the lung contained by the therapeutic element to reduce a risk of ischemia and necrosis of the contained portion of the lung [Col 33, lines 48-62].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a sensor in the system as taught by Swanson to provide thoracoscope delivery as suggested by Karino, as Karino discusses the use of a thoracoscope or associated method to deform the aperture shape of the opening simultaneously while the operation is underway [0088] with Swanson because Swanson teaches preventing char by monitoring tissue temperature [Col 42, lines 12-18].
Regarding Claim 41, Karino is silent on wherein the imaging device is configured to obtain image data via computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), ultrasound, X-ray, or combinations thereof. Swanson teaches wherein the imaging device is configured to obtain image data via computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), ultrasound, X-ray, or combinations thereof [Col 43, lines 37-44].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to using imaging techniques as listed in the limitation and as taught by Swanson to provide thoracoscope delivery as suggested by Karino, as Karino discusses the use of a images obtained via thoracoscope [0088] with Swanson because Swanson teaches eliminating the need for fluoroscopy imaging and radiation required [Col 6, lines 45-51].
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karino (U.S. 20130289339) in view of Swanson (U.S. 6786905) and in further view of Laufer (U.S. 20040073155).
Regarding Claim 42, Karino and Swanson are silent on wherein the therapeutic element includes an enhancing agent for enhancing visualization of the therapeutic element when imaged by the imaging device. Laufer teaches wherein the therapeutic element includes an enhancing agent for enhancing visualization of the therapeutic element when imaged by the imaging device [0111].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to using agents to enhance visualization for the provider as taught by Laufer for use during the procedure as suggested by Karino and Swanson, as Karino discusses the use of a images obtained via thoracoscope [0088] and Swanson which discusses eliminating the need for fluoroscopy imaging and radiation required [Col 6, lines 45-51] with Laufer because Laufer teaches use of markers to facilitate alignment and deployment of the conduits [0111].
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karino (U.S. 20130289339) in view of Evans (U.S. 20080293996).
Regarding Claim 43, Karino is silent on wherein the therapeutic element is configured to have a triangular two-dimensional (2D) shape and/or a conical and/or pyramidal three-dimensional (3D) shape when in an expanded configuration and restricting expansion of the lung. Evans teaches wherein the therapeutic element is configured to have a triangular two-dimensional (2D) shape and/or a conical and/or pyramidal three-dimensional (3D) shape when in an expanded configuration and restricting expansion of the lung [Figs. 10-12]—depicting the conical and pyramidal shape of the frame and [0078].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to indicate the possible shapes that the system can assume as taught by Evans to provide thoracoscope delivery as suggested by Karino, as Karino discusses the use of a thoracoscope or associated method to deform the aperture shape of the opening [0088] with Evans because Evans teaches the reduction in volume of the ventricular chamber [0058].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-Adler (U.S. 20060102186)—includes reference to an apparatus for placement in airways for use in lung volume reduction procedures
-Zwolinski (U.S. 20090306683)—collapsible structure for specimen retrieval with described arm structure-
-Rebuffat (WO 9801084)—includes a surgical device for treatment of emphysema with the use of a sheath that surrounds the lung
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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