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 .
Response to Amendments
The Amendment filed 12/15/2025 has been entered. Claims 1, 16-20, 23, and 25 were amended, and claims 2, 5-7, and 28-36 were canceled. Thus, claims 1, 3-4, and 8-27 are pending in the application.
Claim Objections
Claims 1 and 19 are objected to because of the following informalities:
Claim 1 recites “each of the inhalers being configured to be driven” in lines 17-18, and is suggested to read --wherein each of the inhaler devices is configured to be driven-- in order to be grammatically correct and to more clearly reference how the limitation was originally claimed.
Claim 19 recites “being configured to be” in line 4, and is suggested to read -- configured to be-- in order to be grammatically correct.
Appropriate correction is required.
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 16-17 and 23-25 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.
Regarding claim 16, the limitation “said therapy” in line 6 is confusing, as it is unclear whether this limitation is referencing the “polytherapy” of claim 14, the “one therapy” of claim 15, or the “additional therapy” of claim 15.
Regarding claim 23, the limitation “administered during a period” in line 5 is confusing, as it is unclear whether this limitation is the same as or different from “an administration period” in line 4.
Any remaining claims are rejected based on their dependency on a rejected base claim.
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.
Claims 1 and 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Chan et al. (US 2014/0318539 A1) in view of Cook et al. (US 2010/0319694 A1) and Tsutsui et al. (US 2011/0045088 A1).
Regarding claim 1, Chan discloses a kit for an inhaled chemotherapy by a pulmonary route and to treat lung cancer (powder aerosolization apparatus that delivers aerosolized powder to a patient’s lungs, wherein the active agent delivered can include anti-cancer agents) (abstract; paras. [0113-0114]), the kit comprising:
a) a single hermetically packaged therapeutic dose of a dry powder for inhalation (a receptacle 130 has sealed openings 150 and inlets 160, and is full of powder pharmaceutical formulation 140) (Figs. 2A-3B, 5A-5G, 9A-9C, 11; paras. [0088-0089]), the dry powder containing i) at least one anti-neoplastic agent (active agent can include antineoplastics) (para. [0114]), ii) a lipid matrix (matrix of phospholipids) (para. [0133]), and iii) an excipient and/or a carrier (one or more excipients) (paras. [0122-0123]);
b) a disposable dry powder inhaler device (apparatus is a single use device with the powder formulation to be aerosolized being pre-contained, and so can be disposed of after its single use) (Figs. 2A-2B, 8, 10A-10F; paras. [0088-0089]), wherein
i) each single hermetically packaged therapeutic dose having a close state and an open state (receptacle 130 is closed when the openings 150 and inlets 160 are sealed; receptacle 130 is open when punctured to form the openings 150 and inlets 160) (Figs. 2A-3B, 5A-5G, 9A-9C, 11; para. [0089]; para. [0096]),
ii) each disposable dry powder inhaler device having a close position and an open position (device 100 as version 400 has a cap 410; when cap 410 is on the device 400 is closed, and when cap 410 is off the device 400 is open; alternatively, the device 400 has a position before rotation and after rotation for puncturing, which are closed and open positions, respectively) (Figs. 8, 10A-10F; para. [0094]; para. [0096]),
iii) each single hermetically packaged therapeutic dose being provided for being accommodated in said close state in one disposable dry powder inhaler device (a receptacle 130 is sealed closed in the device 100, 400 before it is punctured) (Figs. 2A-3B, 5A-5G, 9A-9C, 11; para. [0089]; para. [0096]), and
iv) each single disposable dry powder inhaler device is provided to be in said close position before or once each single hermetically packaged therapeutic dose is in said open state (the device 400 has its cap 410 on before the receptacle 130 is punctured open; alternatively, the receptacle 130 is sealed closed before the device 400 is rotated) (Figs. 8, 10A-10F; para. [0094]; para. [0096]), wherein said single hermetically packaged therapeutic dose is a capsule (receptacle 130 is a capsule) (Figs. 2A-3B, 5A-5G, 9A-9C, 11), each of the inhalers being configured to be driven by the patient's inspiratory flow only (the device is a passive inhaler device, and so the patient’s inspiratory effort is what disperses the power into aerosol) (para. [0037]; para. [0145]).
Chan does not disclose the at least one anti-neoplastic agent is chosen from the group consisting of cisplatin, carboplatin, oxaliplatin and nedaplatin.
However, Cook teaches a hand-held inhalation device (Cook; abstract) wherein the at least one anti-neoplastic agent is chosen from the group consisting of cisplatin, carboplatin, and oxaliplatin (suitable antineoplastic agents include carboplatin, cisplatin, and oxaliplatin) (Cook; para. [0051]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Chan at least one antineoplastic agent to be chosen from the group consisting of cisplatin, carboplatin, and oxaliplatin, as taught by Cook, for the purpose of providing the invention with a specific antineoplastic agent capable of treating a patient with cancer (Cook; para. [0051]).
Chan does not disclose a series of single hermetically packaged therapeutic doses and a series of disposable dry powder inhaler devices.
However, Tsutsui teaches a device for the delivery of dry powder formulations (Tsutsui; abstract) including a series of single hermetically packaged therapeutic doses (each single-use device having a powdered therapeutic formulation M; powder is protected in packaging such as hermetically sealed foils) (Tsutsui; Figs. 1-4; abstract; para. [0014]; para. [0017]; para. [0034]; para. [0130]) and a series of disposable dry powder inhaler devices (single-use devices or applicators individually packaged, the devices for the delivery of powdered formulation) (Tsutsui; Figs. 1-4; abstract; para. [0014]; para. [0183]). Moreover, the MPEP 2144.04(VI)(B) recites, “that mere duplication of parts has no patentable significance unless a new and unexpected result is produced”.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Chan device by duplicating its single hermetically packaged therapeutic dose and disposable dry powder inhaler device, such that the invention includes a series of single hermetically packaged therapeutic doses and a series of disposable dry powder inhaler devices, as taught by Tsutsui and the MPEP, as this constitutes a mere duplication of parts which would be obvious to one of ordinary skill in the art to perform in order to provide a patient with more doses of formulation for their treatment and devices to dispense those doses.
Regarding claim 8, the modified Chan teaches wherein said disposable dry powder inhaler device is ready to use (apparatus can be a single use device with the formulation 140 pre-contained within, and thus be ready to use) (Chan; para. [0089]) and comprises a dispersion chamber in fluid connection with an inhalation channel (diffuser 425 would be in fluid communication with the channel inside mouthpiece 415) (Chan; Fig. 8; para. [0094]) and connected to a loading chamber comprising said single hermetically packaged therapeutic dose inside said disposable dry powder inhaler device (diffuser 425 and mouthpiece 415 are connected to receptacle support 135 having a tray 445 for holding the receptacle 130 inside the device) (Chan; para. [0094]).
Regarding claim 9, the modified Chan teaches wherein said single hermetically packaged therapeutic dose comprises a therapeutic dose in the form of a dry and fine powder having a geometric particle size distribution (PSD) d50 lower than or equal to 5 um and a geometric particle size distribution (PSD) d90 lower than or equal to 7 um (dry powder can have a particle size of less than 5 um, such as from 1.0-5.0 um) (Chan; Figs. 6-7; para. [0147]).
Regarding claims 10-13, the modified Chan teaches wherein each single hermetically packaged therapeutic dose comprises a total powder weight content between 2 to 100 mg, wherein each single hermetically packaged therapeutic dose comprises between 1 and 40 mg of said anti-neoplastic agent, wherein each single hermetically packaged therapeutic dose comprises from 1 to 49 mg of said lipid matrix, wherein each single hermetically packaged therapeutic dose comprises from 0.01 to 5 mg of the excipient, wherein the excipient is a PEGylated excipient (formulation can contain 5%-85% by weight active agent; the excipient can be present in a range of 15%-99% by weight; the active agent can be a dose of 0.01-75 mg/day; assuming an example where the excipient is 25% of the formulation weight and the active agent is a dose of 5 mg and constitutes 50% of the total formulation weight, the total weight of the whole formulation would be 10 mg, and the remaining 5 mg can be split between the lipid matrix and the excipient wherein each of the lipid matrix and the excipient is 2.5 mg) (Chan; paras. [0119-0120]; para. [0122]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Chan in view of Cook and Tsutsui as applied to claim 1 above, and further in view of Davis et al. (US 2020/0197335 A1).
Regarding claim 3, the modified Chan teaches the invention as previously claimed, but does not teach wherein the lipid matrix is a mixture of triglycerides.
However, Davis teaches drug combinations which can be for treating cancer (Davis; abstract; para. [0490]; para. [0500]) wherein the lipid matrix is a mixture of triglyceride (agents are entrapped or dissolved in an insoluble matrix such as a lipid matrix of medium-chain triglycerides) (Davis; para. [0393]; para. [0426]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Chan lipid matrix to include a mixture of triglycerides, as taught by Davis, for the purpose of providing the dose with an easy to manufacture material capable of controlling the release of the therapeutic agents therein (Davis; para. [0423-424]; para. [0426]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Chan in view of Cook and Tsutsui as applied to claim 1 above, and further in view of Rigas (US 2013/0225529 A1).
Regarding claim 4, the modified Chan teaches the invention as previously claimed, but does not teach wherein the excipient is a PEGylated excipient derived from one of vitamin E and phospholipids.
However, Rigas teaches a pharmaceutical composition administered by the respiratory route to treat cancer (Rigas; abstract) wherein the PEGylated excipient is derived from phospholipids (carriers such as liposomes can be used; liposomes can be pegylated phospholipids in the resulting composition; compounds to be delivered can be a powder mix) (Rigas; paras. [0458-0459]; para. [0481]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Chan excipient such that it includes a PEGylated excipient derived from phospholipids, as taught by Rigas, for the purpose of helping to ensure the drug composition has a longer circulation time by avoiding uptake and clearance by the reticuloendothelial system, thereby helping it reach and treat cancer tumors (Rigas; para. [0481]).
Claims 14-27 are rejected under 35 U.S.C. 103 as being unpatentable over Chan in view of Cook and Tsutsui as applied to claim 1 above, and further in view of Jungnelius et al. (US 2009/0082295 A1).
Regarding claim 14, the modified Chan teaches the invention as previously claimed, but does not teach configured for a polytherapy.
However, Jungnelius teaches a combination of therapies for treating cancer (Jungnelius; abstract) including being configured for polytherapy (sequential administration of therapeutic agents through multiple routes, such as oral routes, intravenous routes, and absorption though mucous membrane tissues via inhalation, which can also be in combination with non-drug therapies such as surgery and radiation) (Jungnelius; para. [0063]; para. [0065]; para. [0324]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Chan device to be configured for polytherapy, as taught by Jungnelius, for the purpose of helping to provide a beneficial effect from the co-action of therapeutic agents and/or treatments (Jungnelius; para. [0062]; para. [0065]).
Regarding claim 15, the modified Chan teaches wherein said polytherapy comprises one therapy chosen from the group consisting of intravenous infusion or oral chemotherapy, tumor ablative surgery, ablative surgery for removing a part of or a full organ bearing a tumor, a curative surgery, a radiotherapy and their combination, further to said at least one chemotherapy by inhalation as additional therapy (in a combination therapy, the absorption though mucous membrane tissues via inhalation can be added to other treatments using oral routes, intravenous routes, surgery to remove tumor mass, and/or radiotherapy) (Jungnelius; para. [0063]; para. [0065]; para. [0284-0285]).
Regarding claim 16, as best understood, the modified Chan teaches wherein said additional therapy, further to the inhaled chemotherapy, comprises at least the intravenous infusion chemotherapy or the oral chemotherapy administered for a series of cycles, each cycle comprising an administration period and an off-period, said at least one chemotherapy by inhalation being provided to be administered in a period before said therapy and/or during said off-period (chemotherapeutic agents can be administered intravenously and/or orally; chemotherapeutic agents and chemotherapy are administered in cycles having a treatment period followed by a recovery period; a chemotherapeutic agent can be administered through the mucosal membrane via inhalation in the time before or after another therapeutic agent such as CpG ODN is administered intravenously and/or orally) (Jungnelius; para. [0015]; para. [0063]; para. [0074]; para. [0147]; para. [0307]; para. [0324]).
Regarding claim 17, the modified Chan teaches wherein said administration period is less than one day, and wherein said off-period is a period of time from 2 to 5 weeks (chemotherapeutic agent can be administered intravenously over an hour and a half to five hours; chemotherapy cycles of a period of treatment followed by recovery last 21-28 days or 3-4 weeks; there can be up to 3 weeks passing after a chemotherapeutic agent was delivered, which would be the rest period) (Jungnelius; para. [0015]; para. [0074]; para. [0147]; para. [0328]).
Regarding claim 18, the modified Chan teaches wherein said at least one chemotherapy by inhalation is configured to be administered at a rate of at least 1 single hermetically packaged therapeutic dose of anti-neoplastic agent per week of period before said therapy and/or during an off-period (the inhaled dose of the Chan antineoplastic agent in sealed receptacle 130 can be administered in weekly cycles before or after another therapeutic agent such as CpG ODN is administered) (Chan, paras. [0088-0089], para. [0114]; Jungnelius, para. [0015], para. [0063], para. [0074], para. [0147], para. [0307], para. [0324]).
Regarding claim 19, the modified Chan teaches wherein said polytherapy comprises at least tumor ablative surgery, ablative surgery for removing a part of or a full organ bearing a tumor, a curative surgery, or a radiotherapy followed by a recovery period, said at least one chemotherapy by inhalation being configured to be administered on a period before, during or after said polytherapy (in a combination therapy, the absorption though mucous membrane tissues via inhalation delivery of a therapeutic agent can be performed preceding or following other treatments such as surgery to remove tumor mass and/or radiotherapy, and the other treatments would have recovery periods afterwards) (Jungnelius; para. [0063]; para. [0065]; paras. [0284-0285]).
Regarding claim 20, the modified Chan teaches wherein said at least one chemotherapy by inhalation is configured to be administered at a rate of at least 1 single hermetically packaged therapeutic dose of anti-neoplastic agent per week of period before, during or after said polytherapy (the inhaled dose of the Chan antineoplastic agent in sealed receptacle 130 can be administered during the week preceding or following other treatments such as surgery and/or radiotherapy) (Chan, paras. [0088-0089], para. [0114]; Jungnelius, para. [0063], para. [0065], paras. [0284-0285]).
Regarding claim 21, the modified Chan teaches a use of the kit for the inhaled chemotherapy according to claim 1 (see rejection of claim 1 above), in a polytherapy for the treatment of lung cancer (sequential administration of therapeutic agents though multiple routes, such as oral routes, intravenous routes, and absorption though mucous membrane tissues via inhalation to treat lung cancer which can also be in combination with non-drug therapies such as surgery and radiation) (Jungnelius; para. [0063]; para. [0065]; para. [0071]; para. [0324]).
Regarding claim 22, the modified Chan teaches wherein said polytherapy comprises one therapy chosen from the group consisting of intravenous infusion or oral chemotherapy, tumor ablative surgery, ablative surgery for removing a part of or a full organ bearing a tumor, a curative surgery, a radiotherapy and their combination, further to said at least one chemotherapy by inhalation as additional therapy (in a combination therapy, the absorption though mucous membrane tissues via inhalation can be added to other treatments using oral routes, intravenous routes, surgery to remove tumor mass, and/or radiotherapy) (Jungnelius; para. [0063]; para. [0065]; paras. [0284-0285]).
Regarding claim 23, as best understood, the modified Chan teaches wherein said polytherapy comprises, further to the inhaled chemotherapy, at least the intravenous infusion chemotherapy or the oral chemotherapy administered for a series of cycles, each cycle comprising an administration period and an off-period, said chemotherapy by inhalation being administered during a period before said polytherapy and/or during said off-period (chemotherapeutic agents can be administered intravenously and/or orally; chemotherapeutic agents and chemotherapy are administered in cycles having a treatment period followed by a recovery period; a chemotherapeutic agent can be administered through the mucosal membrane via inhalation in the time before or after another therapeutic agent such as CpG ODN is administered intravenously and/or orally) (Jungnelius; para. [0015]; para. [0063]; para. [0074]; para. [0147]; para. [0307]; para. [0324]).
Regarding claim 24, the modified Chan teaches wherein said administration period extends over less than one day, and wherein said off-period extends over a period of time from 2 to 5 weeks (chemotherapeutic agent can be administered intravenously over an hour and a half to five hours; chemotherapy cycles of a period of treatment followed by recovery last 21-28 days or 3-4 weeks; there can be up to 3 weeks passing after a chemotherapeutic agent was delivered, which would be the rest period) (Jungnelius; para. [0015]; para. [0074]; para. [0147]; para. [0328]).
Regarding claim 25, the modified Chan teaches at a rate of at least 1 single hermetically packaged therapeutic dose of anti-neoplastic agent per week of the period before said polytherapy and/or during said off-period (the inhaled dose of the Chan antineoplastic agent in sealed receptacle 130 can be administered in weekly cycles before or after another therapeutic agent such as CpG ODN is administered) (Chan, paras. [0088-0089], para. [0114]; Jungnelius, para. [0015], para. [0063], para. [0074], para. [0147], para. [0307], para. [0324]).
Regarding claim 26, the modified Chan teaches wherein said polytherapy comprises at least tumor ablative surgery, ablative surgery for removing a part of or a full organ bearing a tumor, a curative surgery, or a radiotherapy followed by a recovery period, said at least one chemotherapy by inhalation being provided to be administered in a period before, during or after said therapy (in a combination therapy, the absorption though mucous membrane tissues via inhalation delivery of a therapeutic agent can be performed preceding or following other treatments such as surgery to remove tumor mass and/or radiotherapy, and the other treatments would have recovery periods afterwards) (Jungnelius; para. [0063]; para. [0065]; paras. [0284-0285]).
Regarding claim 27, the modified Chan teaches wherein said chemotherapy by inhalation is provided to be administered at a rate of at least 1 single hermetically packaged therapeutic dose of anti-neoplastic agent per week (the inhaled dose of the Chan antineoplastic agent in sealed receptacle 130 can be administered in the week preceding or following other treatments such as surgery and/or radiotherapy) (Chan, paras. [0088-0089], para. [0114]; Jungnelius, para. [0063], para. [0065], paras. [0284-0285]).
Response to Arguments
Applicant's arguments filed 12/15/2025 have been fully considered but they are not persuasive.
On page 8 in the “Claim Objections” section of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome claim objections of the previous office action. The Examiner agrees, and has thus withdrawn those claim objections. However, the newly amended claims have raised new claim objections as detailed above.
On page 8 in the “Rejections Under 35 U.S.C. 112” section of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome the 35 U.S.C. 112(b) rejections of the previous office action. The Examiner partially agrees, and has thus withdrawn those 35 U.S.C. 112(b) rejections which were addressed. However, those 35 U.S.C. 112(b) rejections which were not addressed are being maintained as detailed above.
On page 8 in the “Rejections Under 101 and Section 33(a) of the America Invents Act” section of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome the 35 U.S.C. 101 rejections of the previous office action. The Examiner agrees, and has thus withdrawn those 35 U.S.C. 101 rejections.
On page 9 in the last paragraph of the Applicant’s remarks, the Applicant argues that Chan does not teach the blister pack is provided in said close position before or once each single hermetically packaged therapeutic dose is in said open state, and thus cannot teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. Chan does teach the blister pack is provided in said close position before or once each single hermetically packaged therapeutic dose is in said open state (the device 400 has its cap 410 on before the receptacle 130 of a blister 500 is punctured open; alternatively, the receptacle 130 of a blister 500 is sealed closed before the device 400 is rotated) (Chan; Figs. 8, 10A-10F; para. [0094]; para. [0096]). Thus, the Chan reference can still be used to teach the Applicant’s claimed invention.
On page 10 in the first paragraph of the Applicant’s remarks, the Applicant argues that Chan teaches away from using capsules, instead teaching blisters, and thus cannot be used to teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. According to the Collins Online Dictionary, a capsule can be defined as “a small container with a drug or other substance inside it, which is used for medical or scientific purposes”. Similarly, according to Merriam-Webster, a capsule can be defined as “a shell usually of gelatin for packaging something (such as a drug or vitamins)”. With these definitions in mind, the Chan receptacle 130, which can be of a blister pack 500, is a capsule, as the receptacle 130 is a container packaging a dose of powder medicament 140 (Chan; Figs. 2A-3B, 5A-5G, 9A-9C, 11; para. [0069]; para. [0095]). Thus, the Chan reference can still be used to teach the Applicant’s claimed invention.
On page 10 in the second paragraph of the Applicant’s remarks, the Applicant argues that Chan is not suitable to limit the dangers of platinum-drugs as claimed, and thus cannot teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. Chan teaches all of the claimed structures for a dry powder inhaler device with a single hermetically packaged dose that would be used to deliver the dry powder with the platinum-drug recited in claim 1, save for device being one of a series of duplicate devices which is taught by Tsutsui and the MPEP 2144.04(VI)(B), and so should be structurally safe enough to use with platinum based drugs as asserted by Applicant. Thus, the current prior art of record can still be used to teach the Applicant’s claimed invention.
On page 10 in the last paragraph of the Applicant’s remarks, the Applicant argues that Cook is not designated for single use, and does not give a reason to select the cisplatin compound for use as an anticancer agent, and thus cannot teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. Firstly, Cook is not being used to teach the device being single-use, so this argument is moot. Secondly, Chan already teaches the dose of dry power contains an anti-neoplastic agent (active agent can include antineoplastics) (Chan; para. [0114]). Cook is simply used to teach carboplatin, cisplatin, or oxaliplatin can be used as specific chemotherapeutic/antineoplastic agents (Cook; para. [0051]). Thus, the Cook reference can still be used to teach the Applicant’s claimed invention.
On page 11 in the second paragraph of the Applicant’s remarks, the Applicant argues that there was no publication about the possibility to administer cisplatin in the form of a dry powder by inhalation, and thus the current prior art of record cannot teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. Cook teaches an inhalation device for delivering powdered active agents to the respiratory system (Cook; abstract; para. [0017]) wherein the agents can include cisplatin (Cook; para. [0051]). Thus, Cook reference can still be used to teach the Applicant’s claimed invention.
On page 11 in the third paragraph of the Applicant’s remarks, the Applicant argues that Tsutsui teaches a pump, which is excluded in the Applicant’s claim 1, and thus Tsutsui cannot be used teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. Tsutsui is not being used to teach including a pump in the Chan device. Rather, Tsutsui is merely being used to teach the concept of duplicating the parts of the Chan device such that there are a series of Chan single hermetically packaged therapeutic doses and a series of Chan disposable dry powder inhaler devices. Thus, the current prior art of record can still be used to teach the Applicant’s claimed invention.
On page 12 in the “Dependent Claim 8” section of the Applicant’s remarks, the Applicant argues that the Chan para. [0089] for teaching the single use aspect of claim 8 is directed to a different embodiment, and thus cannot teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. Firstly, Chan allows for the various features of its versions to be combined in various ways to provide additional variations of the present invention (Chan; para. [0177]). In this case, the version recited in Chan para. [0089] which has the apparatus as a single use device can therefore incorporate that single use feature into its other versions. Secondly, the claimed “said disposable dry powder device is ready to use” limitation is taught with the Chan Fig. 8 embodiment regardless. The Chan Fig. 8 embodiment is ready to use since it is a functional embodiment of the Chan invention, and so a user would have to be able to ready this device for use to deliver the dose of medicament (Chan; Fig. 8; para. [0094-0096]). Thus, the Chan reference can still be used to teach the Applicant’s claimed invention.
On pages 12-13 in the “Dependent Claim 11” section of the Applicant’s remarks, the Applicant argues that the Chan reference reciting between 0.001 mg/day and 100 mg/day does not equate to the claimed range as there is no indicate of how often the formula is administered, the values differ, and the claimed range is narrow, and thus Chan cannot teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. Firstly, In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., how often the formula is administered) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Secondly, Chan does recite the active agent is delivered in the dose range of 0.01-75 mg/day (Chan; para. [0119]), and so does indicate how often the formula is administered, as the delivered dose of active agent is per day. Thirdly, the Applicant’s claimed range of 1-40 mg of antineoplastic agent falls entirely within Chan’s range for the active agent being 0.01-75 mg (Chan; para. [0119]). According to the MPEP 2144.05(I), “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Thus, the Chan reference can still be used to teach the Applicant’s claimed invention.
On pages 13-14 in the “Dependent Claims 14-27” section of the Applicant’s remarks, the Applicant argues that Jungnelius is not teaching a combination of chemotherapies, but rather a synergy between oligonucleotides and chemotherapies, and thus cannot teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. While Jungnelius does teach a synergy between oligonucleotides and chemotherapies, it also recites in para. [0065], “’Combination therapy’ also can embrace the administration of the therapeutic agents as described above in further combination with other biologically active ingredients (such as, but not limited to, a second and different antineoplastic agent, a dendritic vaccine or other tumor vaccine) and non-drug therapies (such as, but not limited to, surgery or radiation treatment or both)”. Please note that one of ordinary skill in the art would recognize an antineoplastic agent as being synonymous with a chemotherapeutic agent, and that having “a second and different antineoplastic agent” means that there is a first antineoplastic agent used already in the treatment which can be therefore be combined with a second different antineoplastic agent, surgery, and/or radiation. Thus, the current prior art of record can still be used to teach the Applicant’s claimed invention.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE M PINDERSKI whose telephone number is (571)272-7032. The examiner can normally be reached Monday-Friday 7:00-4:00.
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785