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 .
Status of the Claims
Claims 2, 4, 6-7, 9-10, and 21-24 have been cancelled. New claims 37-46 have been added.
Claims 1,3,5,8,11-20 and 25-46 are pending and currently under examination.
All rejections not reiterated have been withdrawn.
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 3, 8, and 11 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 “wherein the patient has a cancer that is present in an internal organ or in a body cavity of the patient”. This language is indefinite because it is unclear that since the cancer can alternatively be in the body cavity of the patient, does that mean that cancer in a patient in need thereof is not peritoneal carcinomatosis, because peritoneal carcinomatosis is a condition where cancer cells spread to the peritoneum, which is the lining of the abdominal cavity or is there an additional cancer in the patient?
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
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.
Claims 1, 3, 5, 8, 11-16, 25-26, 37-41 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Laub (US20180169012A1, Published 06/21/2018) in view of Samimi et al. (US20150147340A1, Published 05/28/2015).
Applicant’s Invention
The claims are drawn to a method for treating peritoneal carcinomatosis in a patient in need thereof, the method comprising administering to a patient a foam composition comprising a liquid component, a foaming agent, and one or more therapeutic agents, wherein the one or more therapeutic agents are selected from one or more Bacillus Calmette-Guerin (BCG), valrubicin, doxorubicin, paclitaxel, mitomycin C, gemcitabine, vinorelbine, taxotere, carboplatin, cisplatin, oxaliplatin, and pemetrexed.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1, 12-13, and 37-38 Laub teaches a method for administering an active agent to a patient (abstract), wherein the active agent (i.e., therapeutic agent) that can be administered by methods and compositions that include cancer-treating agents (paragraph [0031]). Laub also teaches a medical foam for delivering an active agent to a patient in some embodiments, the medical foam includes a biocompatible composition configured to form a foam (i.e., foam composition), a therapeutically effective amount of an active agent in the biocompatible composition, and a gas including nitrous oxide (i.e., bubble-forming component) (paragraph [0004]). Laub further teaches the compositions may include one or more liquid components (paragraph [0013]), wherein the liquid component includes one or more surfactants. The one or more surfactants may include a biocompatible foaming agent (paragraph 0017]).
Regarding claim 3, Laub teaches delivering one or more active agents to a body cavity, organ, or tissue of a patient wherein the compositions are administered to the patient as a foam (paragraph [0001]). Laub further teaches the active agent (i.e., therapeutic agent) that can be administered by methods and compositions that include cancer-treating agents (paragraph [0031]).
Regarding claims 14-15, and 39-40 Laub teaches gases useful in the foamed compositions of the present invention preferably include gases that can be readily instilled into the body of the patient without substantial adverse (e.g., toxic) effects. In some embodiments, the gas is selected from the group consisting of air, nitrous oxide, carbon dioxide, oxygen, hydrogen, helium, argon (i.e., single gas), and mixtures thereof (i.e., mixture of gasses) (paragraph [0015]).
Regarding claims 16 and 41, Laub teaches the gas may include one or more fluorocarbons and/or hydrofluorocarbons (i.e., fluorinated hydrocarbons) (paragraph [0016]). The examiner notes that the instant specification defines volatile liquid as “remaining a liquid under pressure, but forms a gas under ambient pressure and/or ambient temperature or body temperature”, therefore Laub’s hydrofluorocarbons fall in the scope of volatile liquids as defined in the instant application.
Regarding claim 25, Laub teaches the container, catheter, and any other equipment that contacts the liquid component should be sterile (paragraph [0027]).
Regarding claim 26, Laub teaches the liquid component is configured to be administered to a patient in an unfoamed state and foamed within the patient's body (e.g., within a body cavity of the patient) (paragraph [0014]).
Regarding claim 46, Laub teaches The active agent, in some embodiments, includes one or more agents selected from the group consisting of bioadhesives (paragraph [0007]).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Laub does not teach a method for treating peritoneal carcinomatosis in a patient in need thereof, wherein the one or more therapeutic agents are selected from one or more Bacillus Calmette-Guerin (BCG), valrubicin, doxorubicin, paclitaxel, mitomycin C, gemcitabine, vinorelbine, taxotere, carboplatin, cisplatin, oxaliplatin, and pemetrexed (instant claim 1); where the cancer is present in an internal organ or in a body cavity of the patient (instant claim 3); wherein the cancer is bladder cancer, lung cancer, or ovarian cancer (instant claim 5); wherein the cancer is metastasized (instant claim 8); wherein the cancer is localized (instant claim 10); wherein the cancer is stage 3 or stage 4 (instant claim 11). However these deficiencies are cured by Samimi et al.
Samimi teaches the present invention provides a method of treating a subject with peritoneal carcinomatosis, the method comprises the administration to the subject of an effective amount of an anti-connective tissue growth factor (CTGF) agent, thereby treating the peritoneal carcinomatosis, wherein the peritoneal carcinomatosis results from a cancer selected from the group consisting of gall bladder cancer, liver cancer, bladder cancer, pancreatic cancer, ovarian cancer, stomach cancer (i.e., internal organs) (paragraph [0005]). Samimi also teaches the term “peritoneal carcinomatosis,” as used herein, refers to the neoplastic involvement of the peritoneum, wherein primary peritoneal carcinomas arise from peritoneum cells and since the mesothelium of the peritoneum and the germinal epithelium of the ovary have the same embryologic origin, the peritoneum retains the multipotentiality allowing for the development of a primary carcinoma that can then spread within the peritoneal cavity (i.e., body cavity) (paragraph [0026]). Samimi continues to teach that peritoneal carcinomatosis results from a cancer that arises in an anatonomically separate location and later metastasizes to the peritoneal cavity (paragraph [0027]). Samimi further teaches at least one additional therapeutic agent is administered, wherein the therapeutic agent is a chemotherapy agent, such as, doxorubicin, paclitaxel, mitomycin C, gemcitabine, vinorelbine, carboplatin, cisplatin, and oxaliplatin (paragraphs [0086-0087]). Samimi also teaches survival analyses was performed on individuals with stage 3 and 4 serous ovarian cancer (paragraph [0148]).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the time of filing to treat peritoneal carcinomatosis by administering Laub’s medical foam composition. Laub teaches administering cancer treating agents as the active agent in the medical foam by introducing the foam into a patient (paragraph [0004]), such as delivering one or more active agents to a body cavity, organ, or tissue of a patient (paragraph [0001]). One would have understood in view of Samimi that peritoneal carcinomatosis can be treated, wherein the peritoneal carcinomatosis results from a cancer selected from the group consisting of gall bladder cancer, liver cancer, bladder cancer, pancreatic cancer, ovarian cancer, stomach cancer (i.e., internal organs) (paragraph [0005]) and a therapeutic agent can administered, wherein the therapeutic agent is a chemotherapy agent, such as, doxorubicin, paclitaxel, mitomycin C, gemcitabine, vinorelbine, carboplatin, cisplatin, and oxaliplatin (paragraphs [0086-0087]). It would have been obvious to one of ordinary skill in the art to treat a cancers such as lung, ovarian or bladder with Laub’s medical foam composition because Samimi teaches a method of treating a subject with peritoneal carcinomatosis, the method comprises the administration to the subject of an effective amount of an anti-connective tissue growth factor (CTGF) agent, thereby treating the peritoneal carcinomatosis (abstract), wherein the treatment method further comprises the administration of another therapeutic modality selected from the group consisting of chemotherapy (paragraph [0008]) and Laub teaches delivering one or more of the cancer-treating agents to a body cavity, organ, or tissue of a patient in the form of a medical foam (paragraph [0001]).
With regards to claim 12, a foam composition comprising a liquid component, a foaming agent, a bubble-forming component, and one or more therapeutic agents to treat cancer, would have been prima facie obvious to one of ordinary skill in the art at the time of filing to the composition because Laub proposes this in the broader teachings.
With regards to claim 25, wherein the composition is sterile, it would have been obvious to one of ordinary skill in the art to have a sterile composition because Laub teaches method for administering an active agent to a patient (abstract) and the container, catheter, and any other equipment that contacts the liquid component should be sterile (paragraph [0027]), therefore, the composition will be used for biomedical purposes, so it is obvious to sterilize the composition.
Claims 17-20 and 42-45 are rejected under 35 U.S.C. 103 as being unpatentable over Laub (US20180169012A1, Published 06/21/2018) in view of Samimi et al. (US20150147340A1, Published 05/28/2015) further in view of Bowman et al. (WO2007002703A2, Published 01/04/2007; as cited in IDS filed 08/03/2022).
Applicant’s Invention
Laub renders obvious all the limitations of claim 12. Applicant’s claims 17 and 42 further adds the limitation wherein the one or more fluorinated hydrocarbons is selected from one or more of a trifluoromethane, difluoromethane, difluoroethane, tetrafluoroethane, heptafluoroethane, perfluorobutane, perfluorocyclobutane, perfluoropentane, perfluorohexane, perfluoroheptane, perfluorooctane, perfluorocyclopentane, perfluorocyclohexane, heaxafluoropropane, and heptafluoropropane. Applicant’s claims 18 and 43 further adds the limitation wherein the volatile liquid is a haloalkane. Applicant’s claims 19 and 44 further adds the limitation wherein the volatile liquid comprises H134A. Applicant’s claims 20 and 45 further adds the limitation wherein the volatile liquid comprises ze1234.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 17 and 42, Laub teaches the gas may include one or more fluorocarbons and/or hydrofluorocarbons (i.e., fluorinated hydrocarbons) (paragraph [0016]). The examiner notes that the instant specification defines volatile liquid as “remaining a liquid under pressure, but forms a gas under ambient pressure and/or ambient temperature or body temperature”, therefore Laub’s hydrofluorocarbons fall in the scope of volatile liquids as defined in the instant application.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Laub does not teach wherein the one or more fluorinated hydrocarbons is selected from one or more of a trifluoromethane, difluoromethane, difluoroethane, tetrafluoroethane, heptafluoroethane, perfluorobutane, perfluorocyclobutane, perfluoropentane, perfluorohexane, perfluoroheptane, perfluorooctane, perfluorocyclopentane, perfluorocyclohexane, heaxafluoropropane, and heptafluoropropane; wherein the volatile liquid is a haloalkane; wherein the volatile liquid comprises H134A; and wherein the volatile liquid comprises ze1234. However these deficiencies are cured by Bowman et al.
Bowman teaches types of hydrofluorocarbons such as difluoromethane (HFC-32), difluoroethane (HFC-152), tetrafluoroethane (HFC-134), hexafluoropropane (HFC-236), and heptafluoropropane (HFC-227ea) (page 15, 1st paragraph). Bowman further teaches hydrofluorocarbon isomers such as 1 ,1 ,1 ,2-tetrafluoroethaπe (HFC-134a) (i.e., haloalkane) (page 15, last paragraph). Bowman also teaches tetrafluoropromenes such as both cis- and trans-1 , 1 , 1 , 3-tetrafluoropropene (HFO-1234ze) (page 8, 1st paragraph).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have volatile liquids such as fluorinated hydrocarbons in Laub’s medical foam composition. Laub teaches the gas may include one or more fluorocarbons and/or hydrofluorocarbons (i.e., fluorinated hydrocarbons) (paragraph [0016]). The examiner notes that the instant specification defines volatile liquid as “remaining a liquid under pressure, but forms a gas under ambient pressure and/or ambient temperature or body temperature”, therefore Laub’s hydrofluorocarbons fall in the scope of volatile liquids as defined in the instant application. One would have understood in view of Bowman that hydrofluorocarbons can be difluoromethane (HFC-32), difluoroethane (HFC-152), tetrafluoroethane (HFC-134), hexafluoropropane (HFC-236), and heptafluoropropane (HFC-227ea) (page 15, 1st paragraph); hydrofluorocarbon isomers such as 1 ,1 ,1 ,2-tetrafluoroethaπe (HFC-134a) (i.e., haloalkane) (page 15, last paragraph); and tetrafluoropropenes (i.e., hydrofluorocarbon) such as both cis- and trans-1 , 1 , 1 , 3-tetrafluoropropene (HFO-1234ze) (page 8, 1st paragraph). It would have been obvious to one of ordinary skill to have volatile liquids such as the instantly claimed fluorinated hydrocarbons in Laub’s medical foam composition because Laub teaches the composition comprising hydrofluorocarbons, and Bowman teaches the specific hydrofluorocarbons that are instantly claimed as blowing agents (i.e., bubble-forming component) in foam materials.
Claims 27-36 are rejected under 35 U.S.C. 103 as being unpatentable over Laub (US20180169012A1, Published 06/21/2018) in view of Samimi et al. (US20150147340A1, Published 05/28/2015) further in view of Patt et al. (WO2019032756A1, Published 02/14/2019).
Applicant’s Invention
Laub renders obvious all the limitations of claim 12. Applicant’s claim 27 further adds the limitation wherein a device for delivering of the composition of claim 12, comprising a reservoir for the therapeutic agent and propellant, a foam generator, regulator, actuator, and patient interface. Applicant’s claim 28 further adds the limitation wherein a device comprises one or more containers. Applicant’s claim 29 further adds the limitation wherein the device comprises two containers. Applicant’s claim 30 further adds the limitation wherein the device comprises a container comprising a foamable composition with one or more therapeutic agents and a pressurized gas canister. Applicant’s claim 31 further adds the limitation wherein the device containers comprising a foamable composition and one or more therapeutic agents and pressurized gas. Applicant’s claim 32 further adds the limitation wherein the compositions of the containers are configured to be combined prior to delivery to the patient. Applicant’s claim 33 further adds the limitation wherein the compositions of the containers are configured to be combined during administration to the patient. Applicant’s claim 34 further adds the limitation wherein the device comprises a single container containing a foaming agent, one or more therapeutic agents, and one or more dissolved gases. Applicants claim 35 further adds the limitation wherein the device comprises a single container containing a foaming agent, one or more therapeutic agents, and propellant. Applicant’s claim 36 further adds the limitation wherein the device is a single-use device.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 27, Laub teaches the gas forms a foam with the liquid component as the gas (i.e., propellant) and liquid component (i.e., therapeutic agent) are dispensed from the container (i.e., reservoir) and the container outlet may be further attached to a catheter such that the foam is delivered from the container to the patient through the catheter (i.e., patient interface) (paragraph [0027]). Laub further teaches the liquid component includes surfactants which may include a biocompatible foaming agent (i.e., foam generator)(paragraph [0017]).
Regarding claim 28, Laub teaches the mixture is stored in a container and the gas is stored in a pressurized cartridge (paragraph [0009]).
Regarding claims 29-30, Laub teaches the gas and liquid components (i.e., foamable composition with one or more therapeutic agent) are contained in separate containers (paragraph [0027]).
Regarding claim 31, Laub teaches preparing a mixture comprising a foamable liquid and the active agent, incorporating a gas including nitrous oxide into the mixture to create a foam containing the active agent (paragraph [0006]), and wherein the gas forms a foam with the liquid component as the gas and liquid component are dispensed from the container (i.e., single container).
Regarding claim 32, Laub teaches the liquid component is admixed with a gas to form a foam prior to administration to the patient (paragraph [0014]).
Regarding claim 33, Laub teaches the gas and liquid components are contained in separate containers until just prior to administration to the patient (i.e., combined during administration) (paragraph [0027]).
Regarding claims 34-35, Laub teaches administering an active agent to a patient includes preparing a mixture comprising a foamable liquid and the active agent, incorporating a gas including nitrous oxide into the mixture to create a foam containing the active agent (paragraph [0006]), and wherein the gas forms a foam with the liquid component as the gas and liquid component are dispensed from the container (i.e., single container), wherein the gas is dissolved in the liquid component (paragraph [0027]). Laub also teaches the gas may include one or more fluorocarbons and/or hydrofluorocarbons (i.e., propellant) (paragraph [0016]).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Laub does not teach a regulator and an actuator. However these deficiencies are cured by Patt et al.
In the analogous art of infusing a gas into a composition for treatment, Patt teaches a container that has a small oxygen cylinder fitted into its base. The connector allows attachment of the gas cartridge and also acts as a regulator to regulate pressure and an actuator which activates gas flow when the plunger is depressed (paragraph [0081]).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have a regulator and an actuator with the container used to deliver Laub’s medical foam. Laub teaches the gas forms a foam with the liquid component as the gas (i.e., propellant) and liquid component (i.e., therapeutic agent) are dispensed from the container (i.e., reservoir) and the container outlet may be further attached to a catheter such that the foam is delivered from the container to the patient through the catheter (i.e., patient interface) (paragraph [0027]). One would have understood in view of Patt that a container used in provided an oxygenated mousse (i.e., foam) has a small oxygen cylinder fitted into its base. The connector allows attachment of the gas cartridge and also acts as a regulator to regulate pressure and an actuator which activates gas flow when the plunger is depressed (paragraph [0081]). It would have been obvious to one of ordinary skill in the art to have a regulator and an actuator with the container used to deliver Laub’s medical foam because Patt teaches that a container used in provided an oxygenated mousse (i.e., foam) has a small oxygen cylinder fitted into its base. The connector allows attachment of the gas cartridge and also acts as a regulator to regulate pressure and an actuator which activates gas flow when the plunger is depressed (paragraph [0081]). Therefore, it is known in the art for a container that can deliver a foam may have a regulator and an actuator as taught by Patt et al.
It is noted that Laub falls in the scope of claim 31, it is also noted that in so much as claim 31 reads on a device wherein the foaming composition is in one container and the therapeutic agent and pressurized gas is in a separate container, any arrangement is obvious to try because there is only a finite number of options for the combination of the foaming composition, the therapeutic agent, and the pressurized gas. See MPEP 2143(I)(E).
With regards to claim 36, wherein the device is a single-use device, it would have been obvious to one of ordinary skill in the art to make the device a single use device for delivery Laub’s medical foam. Laub teaches all of the limitations of the foam composition. The device being a single use device is not patentably defining over the Laub because the device being a single use device does not identify the amount that is to be delivered, as well as depending on how much of the composition was needed. The examiner also points out that the limitation of single-use device does not limit the foam composition and is an intended use of the device.
Response to Arguments
Applicant’s arguments with respect to claim(s) under 35 USC 103 have been considered
but are moot because the new ground of rejection does not apply to the rationale underlying the
obviousness conclusion. The new grounds of rejection necessitated by amendment have addressed the arguments.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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AFUA BAMFOAA BOATENG Examiner, Art Unit 1617
/ALI SOROUSH/ Supervisory Patent Examiner, Art Unit 1614