DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/25/2023 has been considered by the examiner.
Claim Objections
Claim 8 is objected to because of the following informalities:
Claim 8 line 5: “the” is repeated twice
Appropriate correction is required.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 6-9 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 13 and 14 of U.S. Patent No. 11,752,282. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the current application broaden the scope of the granted patent.
Regarding claim 6, claim 13 of the co-pending application discloses an apparatus, comprising: a body having an upper portion and a lower portion, the body defining a disaggregation chamber, a bottom portion of the disaggregation chamber being within the lower portion and containing a dry powder drug; a removable partition disposed between the upper portion and the lower portion, the partition including a tab portion that extends outside of the body and obstructs a mouthpiece when the partition is disposed between the upper portion and the lower portion, the partition retaining the dry powder drug within the bottom portion of the disaggregation chamber when the upper portion and lower portion are coupled together; an air intake passage configured to place an external volume in fluid communication with the disaggregation chamber when the partition is removed; and an exit passageway configured to place the external volume in fluid communication with the disaggregation chamber when the partition is removed such that upon inhalation by a patient on the exit passageway, air is drawn from the air intake passage to the disaggregation chamber and on to the exit passageway to disaggregate the dry powder drug within the disaggregation chamber and convey the dry powder drug via the exit passageway to the patient.
Regarding claim 9, claim 13 of the co-pending application discloses An apparatus, comprising: a body having an upper portion and a lower portion, the body defining a disaggregation chamber, a bottom portion of the disaggregation chamber being within the lower portion and containing a dry powder drug; a removable partition disposed between the upper portion and the lower portion, the partition including a tab portion that extends outside of the body and obstructs a mouthpiece when the partition is disposed between the upper portion and the lower portion, the partition retaining the dry powder drug within the bottom portion of the disaggregation chamber when the upper portion and lower portion are coupled together; an air intake passage configured to place an external volume in fluid communication with the disaggregation chamber when the partition is removed; and an exit passageway configured to place the external volume in fluid communication with the disaggregation chamber when the partition is removed such that upon inhalation by a patient on the exit passageway, air is drawn from the air intake passage to the disaggregation chamber and on to the exit passageway to disaggregate the dry powder drug within the disaggregation chamber and convey the dry powder drug via the exit passageway to the patient.
Dependent claim 7 is recited within claim 13 of the co-pending application and claim 8 is recited within claim 14 of the current application.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-3 and 5-9 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Lucking et al. US 2008/0190424
Regarding claim 1, Lucking teaches a method of manufacturing an inhalation device, comprising: positioning a body of the inhalation device (Figure 6, body 2) within a filling device (0038 states “the medicament chamber (18) is filled with a unit dose of powdered medicament” The body can be positioned within a filling device to fill chamber 18, as depicted in figure 1 ), the body having an upper portion (Second body member 14) and a lower portion (First body member 12), the body being in an open position in which the upper portion and the lower portion are disposed in a linear configuration in substantially the same plane (Depicted in figure 1), the lower portion of the body defining a chamber (Chamber 18), the body defining an intake channel (Channel 22) and an exit channel (Outlet 24), the exit channel fluidically coupled to the chamber via an exit opening at a first end portion of the body (Outlet 24 has an opening and is connected to chamber 18 via well 20), the intake channel fluidically coupled to the chamber via an intake opening at a second end portion of the body (0043 states “Air is drawn into the inhaler body (2) via the gap through which the sealing tape (6) was withdraw”); conveying a dry powder drug into the chamber of the lower portion (0038 states “the medicament chamber (18) is filled with a unit dose of powdered medicament”); positioning a removable partition on an interior surface of the body and covering the chamber to retain the dry power drug within the chamber (0038 states “the medicament chamber (18) is then sealed by application to the first body member (12) of the foil (6)”); and folding the upper portion relative to the lower portion to move the body from the open configuration into a closed configuration (0041 states “In a final stage of assembly (FIG. 5), the first body member (12) and the second body member (14) are brought together by folding about the hinge (16). “) in which the upper portion is disposed over the lower portion and at least a portion of the removable partition is disposed between the upper portion and the lower portion of the body (Figure 6 depicts the closed configuration of the body, if this body is flipped 180 degrees, the upper portion will be disposed over the lower portion. Furthermore, the foil is disposed between both portions of the body).
Regarding claim 2, Lucking teaches the method of manufacturing the inhalation device of claim 1, wherein: the folding includes folding the upper portion relative to the lower portion about a living hinge (Figure 1, living hinge 16).
Regarding claim 3, Lucking teaches the method of manufacturing the inhalation device of claim 1, further comprising: during the folding the upper portion relative to the lower portion, folding the removable partition such that a portion of the removable partition extends outside an end of the body when the body is in the closed configuration (Figure 6 depicts a portion of the removable partition in tab 8 extending outside of the body).
Regarding claim 5, Lucking teaches the method of manufacturing the inhalation device of claim 1, further comprising: after the folding, joining a first side edge and a second side edge of the upper portion of the body with a first side edge and a second side edge of the lower portion of the body (Paragraph 0063 states “the first and second body members preferably have formations that cooperate to provide a snap or interference fit. The first and second body members may be further secured together, e.g. by adhesive, or more preferably by the application of heat.”) such that an air gap between the upper portion and the lower portion is reduced (The act of fully sealing both pieces together would inherently reduce the air gap).
Regarding claim 6, Lucking teaches an apparatus, comprising: a body (Figure 6, body 2) having an upper portion (Second body member 14) and a lower portion (First body member 12), the body defining a disaggregation chamber (Chamber 18), a bottom portion of the disaggregation chamber being within the lower portion (Figure 1 depicts this chamber within the lower portion 12), the lower portion including a raised section extending from an inner surface of the disaggregation chamber (Ridge 124, figure 12), the raised section configured to guide a flow of a dry powder drug within the disaggregation chamber (0048 states “The airway leads from the constriction (124) into the dispersion chamber (109), and out of the inhaler housing (111) though the air/powder outlet (108).”); a removable partition disposed between the upper portion and the lower portion (foil 6, figure 5), the partition retaining the dry powder drug within the body when the upper portion and lower portion are coupled together (0038 states “the medicament chamber (18) is then sealed by application to the first body member (12) of the foil (6)”); an air intake passage (Gap between both bodies which is exposed once the tab 8 is pulled) configured to place an external volume in fluid communication with the disaggregation chamber, and an exit passageway configured to place the external volume in fluid communication with the disaggregation chamber such that upon inhalation by a patient on the exit passageway, air is drawn from the air intake passage to the disaggregation chamber and on to the exit passageway to disaggregate the dry powder drug within the disaggregation chamber and convey the dry powder drug via the exit passageway to the patient (0043 states “The user places the outlet (24) between their lips and inhales through it. Air is drawn into the inhaler body (2) via the gap through which the sealing tape (6) was withdrawn. Medicament in the medicament collection well (20) is entrained in the airflow, undergoes turbulent flow within the swirl chamber made up of the medicament chamber (18) and the medicament collection well (20), is drawn out of the inhaler body (2) via the channel (22) and the outlet (24), and is inhaled by the user”).
Regarding claim 7, Lucking teaches the apparatus of claim 6, wherein a tab portion of the partition extends outside of the body and obstructs a mouthpiece when the partition is disposed between the upper portion and the lower portion (0038 states “the medicament chamber (18) is then sealed by application to the first body member (12) of the foil (6)” Since the medicament chamber is sealed by way of the entire foil portion that sits in front of the mouthpiece, the tab portion also obstructs the mouthpiece as air flow from the exterior towards the mouthpiece cannot occur if the partition has not been removed.).
Regarding claim 8, Lucking teaches the apparatus of claim 6, wherein: the mouthpiece is at a first end portion of the body (Figure 6 depicts outlet 24 at one portion of the body); an intake opening into the air intake passage is at a second end portion of the body, the second end portion opposite the first end portion (Air opening covered by the partition is at the second end opposite the first end as depicted by figure 6); and a tab portion of the partition extends from the body (Figure 6 depicts it extending from the body).
Regarding claim 9, Lucking teaches an apparatus, comprising: a body (Figure 6, body 2) having an upper portion (Second body member 14) and a lower portion (First body member 12), the body defining a disaggregation chamber (Chamber 18), a bottom portion of the disaggregation chamber being within the lower portion (Figure 1 depicts this chamber within the lower portion 12); a removable partition disposed between the upper portion and the lower portion (foil 6, figure 5), the partition including a tab portion that extends outside of the body when the partition is disposed between the upper portion and the lower portion (Tab 8, figure 6), the partition retaining a dry powder drug within the body when the upper portion and lower portion are coupled together (0038 states “the medicament chamber (18) is then sealed by application to the first body member (12) of the foil (6)”); an air intake passage (Gap between both bodies which is exposed once the tab 8 is pulled) configured to place an external volume in fluid communication with the disaggregation chamber when the partition is removed (Figure 7 depicts this gap in fluidic communication with the outlet); and an exit passageway configured to place the external volume in fluid communication with the disaggregation chamber when the partition is removed such that upon inhalation by a patient on the exit passageway, air is drawn from the air intake passage to the disaggregation chamber and on to the exit passageway to disaggregate the dry powder drug within the disaggregation chamber and convey the dry powder drug via the exit passageway to the patient (0043 states “The user places the outlet (24) between their lips and inhales through it. Air is drawn into the inhaler body (2) via the gap through which the sealing tape (6) was withdrawn. Medicament in the medicament collection well (20) is entrained in the airflow, undergoes turbulent flow within the swirl chamber made up of the medicament chamber (18) and the medicament collection well (20), is drawn out of the inhaler body (2) via the channel (22) and the outlet (24), and is inhaled by the user”).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 4 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lucking in view of Bonney et al. 6,929,004
Regarding claim 4, Lucking teaches the method of manufacturing the inhalation device of claim 1 wherein, the positioning includes positioning the body in the filling device, and the conveying includes conveying a dry powder drug into a chamber of a lower portion of each body (Figure 1 depicts a filling of chamber 18, which is located in a lower portion of the body, the medicament would be filled with some sort of filling device). Lucking fails to teach wherein: the body is one of a plurality of bodies coupled together. Bonney discloses an analogous medicament carrier that does teach wherein: the body is one of a plurality of bodies coupled together (Figures 1d and 2 depict a multi dose setup). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lucking with Bonney and include wherein: the body is one of a plurality of bodies coupled together as this allows for a multi-dose form of the medicament to be provided to the user (Column 6 line 40). The combination now teaches wherein the positioning includes positioning the plurality of bodies in the filling device, and the conveying includes conveying a dry powder drug into a chamber of a lower portion of each of the bodies simultaneously.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Connelly et al. 2002/0092523
Genosar et al. 2010/0059049
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/ROHAN PATEL/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785