CTNF 18/557,727 CTNF 101600 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 12-151 AIA 26-51 12-51 Status of Claims This Office Action is in response to the preliminary amendment filed on 05/14/2024. As directed by the Preliminary amendment, claims 1-7 were cancelled, and claims 8-11 have been added. Thus, claims 8-11 are currently pending in this application. Claim Objections Claim 8 is objected to because it recites “the second cylinder section” in line 19. This limitation has insufficient antecedent basis. Examiner suggests rewriting to “a second cylinder section”. Claim 9 is objected to because it includes reference characters which are not enclosed within parentheses. Claim 9 recites “17a and 17b” in line 3, which is not enclosed in parentheses. Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m). Claim 9 also recites “according to claim 1” in line 1, but claim 1 has been cancelled. Examiner suggests rewriting “according to claim 1” to “according to claim 8”. Claim 10 is objected to because claim 10 recites “according to claim 1” in line 1, but claim 1 has been cancelled. Examiner suggests rewriting “according to claim 1” to “according to claim 8”. Claim 11 is objected to because claim 11 recites “according to claim 1” in line 1, but claim 1 has been cancelled. Examiner suggests rewriting “according to claim 1” to “according to claim 8”. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 8-11 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. Regarding claim 8, the claim recites “arranged towards the proximal section of the inhalation chamber” in lines 3-4, “arranged in the middle section of the inhalation chamber” in lines 6-7, and “arranged in the distal section of the inhalation chamber” in lines 8-9. However, it is unclear which structures these limitations are modifying. It is unclear if all of the mixed connector, anterior body, and exhalation membrane are all arranged in a proximal section or just the mixed connector. The same indefiniteness applies to the inhalation membrane, valve seal, cylinder, coupling port, and flow indicator being arranged in the middle section and the chamber lid and coupling port arranged in the distal section. Since it is unclear of all these structures are arranged in their respective sections, this renders the claim indefinite. For examination purposes, examiner interprets that all the structures are to be arranged in their respective sections. Examiner suggests rephrasing to “which are arranged towards the proximal section of the inhalation chamber”, “which are arranged in the middle section of the inhalation chamber”, and “which are arranged in the distal section of the inhalation chamber”, respectively. Claim 8 also recites “the pressure indicator” in line 6. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear what structure the pressure indicator is referring to. The reference character “20” seems to refer to the coupling port based on Fig. 14. Therefore, it is unclear if “the pressure indicator” is a separate structure that is intended to be positively recited but is not disclosed in the drawings nor specification, or if the coupling port is configured to attach to “the pressure indicator” which is not positively recited. For examination purposes, examiner interprets that the pressure indicator is not positively recited, and therefore the port is configured to attach a pressure indicator and attach a flow indicator. Claim 8 also recites “the coupling port” in lines 15 and 20. However, it is unclear which coupling port is being referred to in this limitation. There are two different coupling ports recited in claim 8, “a coupling port” in line 5 and “a coupling port” in line 8, therefore it is not clear which of the two coupling ports is being further limited in lines 15 and 20 of the claim. For examination purposes, examiner interprets “the coupling port” in lines 15 and 20 to both refer to “a coupling port” in line 5 for the pressure indicator and a flow indicator. Examiner suggests rewriting “a coupling port” in line 5 to “a first coupling port”, “a coupling port” in line 8 to “a second coupling port”, “the coupling port” in line 15 to “the first coupling port”, and “the coupling port” in line 20 to “the first coupling port”. Claim 8 also recites the limitation "the metered dose inhaler" in line 8. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests rephrasing to “a metered dose inhaler”. Regarding claim 9, claim 9 recites the limitation "a flow passage conduit" in line 2. It is unclear if applicant intends to claim a new flow passage conduit or refer to the previously introduced flow passage conduit of claim 8 since both have the reference character “13”. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim s 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Key (DE 8400001 U1) . Regarding claim 8, Key teaches a n inhalation flow chamber (Figs. 1-3) comprising: a mixed connector (Fig. 2 and 3, mouthpiece 50), an anterior body (Fig. 3, tube 20) with an exhalation window (paragraph 0043 “The inhalation tube 20 has an exhalation opening 52 at its end facing away from the mouthpiece”) housing an exhalation unidirectional membrane (paragraph 0043 “a second non-return valve 54 that allows air to pass only from the inside of the inhalation tube 20 into the ambient air, as indicated by the arrows in Fig. 2”), arranged towards the proximal section of the inhalation chamber (Figs. 2-3, where mixed connector 50 is arranged at a proximal section of the entire device); an inhalation unidirectional membrane (paragraph 0040 “At the end of the tube 44 a check valve 48 is arranged, which only allows air to pass from the direction of the collection chamber 12 into the inhalation tube 20, but blocks it in the opposite direction”), a valve seal (paragraph 0043 teaches 48 can be a flap valve, which one skilled in the art would reasonably expect to have a valve seal being the flap), a cylinder (Fig. 2, chamber 12) arranged in the middle section of the inhalation chamber; a chamber lid (Fig. 2, adapter 30) and a coupling port for the metered dose inhaler (Fig. 2 where there must be a coupling port on the end of adapter 30 in order to fit inhaler 14), arranged in the distal section of the inhalation chamber (Fig. 1 and 2 where the chamber lid 30 and the coupling port on the end of 30 are on a distal section of the entire device); wherein the mixed connector is coupled to the anterior body (Fig. 3, connector 50 coupled to anterior body 20), which is coupled to the proximal end of the cylinder (Fig. 2, 20 is coupled to cylinder 12), within which the unidirectional inhalation membrane and the valve seal, which supports said membrane are arranged (Fig. 2 where inhalation membrane 48 and the implicit seal of membrane 48 are on cylinder 12); wherein the cylinder is in connection with the chamber lid at its distal end (Fig. 2, cylinder 12 connected to chamber lid 30 at distal end); wherein a flow indicator (Figs. 1-2, spirometer 22) is in connection through the connection of a flow passage conduit (paragraph 0044 “The inner tube 62 is in direct connection with the inside of the inhalation tube 20”; One skilled in the part would reasonably expect that the tube 62, which is a flow passage conduit, has to be connected via a coupling port on the tube 20) with the coupling port; wherein the cylinder comprises two dismantlable sections (paragraph 0033-0034 “The collection chamber 12 consists of two hemispheres 34 and 36, which are taken apart for cleaning purposes”). Key further teaches a coupling port for the pressure indicator (Figs. 2-3, where there must a port coupled to 22 in order to attach the structure of 22 to the tube, wherein this port is configured to attached to a pressure indicator and a flow indicator) and a flow indicator (Fig. 3, spirometer 22). However, Key is silent wherein the coupling port and flow indicator are arranged in the middle section of the inhalation chamber, the flow indicator is specifically in connection with the cylinder, and wherein the flow indicator is in connection with a second cylinder section, through the connection of the flow passage conduit with the coupling port. However, the product disclosed by the prior art is identical to the claimed product, even though it is arranged differently. The flow indicator 22 of the prior art is connected to a structure analogous to a mixed connector through a flow passage conduit and coupling port as shown in Figs. 2 and 3 as described above. However, the flow indicator could also reasonably be connected to the cylinder hemisphere 36 via the same mechanism. One skilled in the art could modify the location of flow indicator 22 to be in the middle section of the device and attached to cylinder hemisphere 36. There is no evidence to show that the claimed arrangement and location of parts imparts any patentable distinction between the claimed product and that of the prior art. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 and In re Kuhle, 526 F.2d 553, 188 USPQ 7. See also MPEP § 2144. Key is silent wherein the flow indicator comprises a flow level of 30 L/min (11) and a flow level of 60 L/min (12). One skilled in the art could arrive at these flow levels through routine optimization. Key teaches using the flow indicator to visually determine the strength of inhalation at the appropriate rate (see paragraph 0047). Therefore, it would been obvious to modify and optimize the exact levels of the flow rate to visually indicate the range where a patient should keep the float as taught in paragraph 0050. See also MPEP § 2144. Regarding claim 11, Key teaches the chamber of claim 1. Key further teaches comprising a metered dose inhaler (Figs. 1 and 2, inhaler 14 coupled with spray bottle 15) . 07-21-aia AIA Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Key (DE 8400001 U1) in view of Khan (US 20170274161 A1) . Regarding claim 9, Key teaches the chamber of claim 1. Key further teaches wherein the flow indicator comprises a plurality of flow levels (paragraph 0022 teaches the spirometer being a device to display measurements of pressure which is directly related to the flow during inhalation; One skilled in the art would reasonably expect that there would be a plurality of displayed measurements), a ball (Fig. 3, floating body 66), a ball retainer (paragraph 0044 teaches the ball 66 is retained within tube 60), a flow passage conduit (paragraph 0044 “The inner tube 62 is in direct connection with the inside of the inhalation tube 20”; One skilled in the part would reasonably expect that the tube 62, which is a flow passage conduit). Key is silent on a flow orifice and a housing. However, Khan teaches an analogous inhalation chamber (Fig. 1) with a flow indicator (Fig. 4, spirometer 101) with a flow orifice (Fig. 4, entrainment ports 107) and a housing (Fig. 4 where flow indicator 101 is within a housing). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Key to include so that the flow indicator has a flow orifice and a housing. The flow orifice helps create a continuous passage for the air within the device and create the pressure difference to help driving the movement of the floating ball within the flow indicator (paragraph 0056 “As the patient begins to inspire the aerosolized drug particles through the mouthpiece, air is simultaneously withdrawn from the top of the holding chamber and through entrainment ports 107. This creates a pressure difference within the spirometer chamber, allowing float 106 to rise”). It would have been obvious to add a housing to protect the flow indicator during use . 07-21-aia AIA Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Key (DE 8400001 U1) in view of Bruce (US 20050274379 A1) . Regarding claim 10, Key teaches the chamber of claim 1. Key is silent on the chamber comprising an oronasal mask coupled to the mixed connector. However, Bruce teaches an analogous inhalation flow chamber (Fig. 1, holding chamber 102) with an oronasal mask (Fig. 4, mask 144) coupled to a mixed connector (Fig. 4, adapter 140). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Key to include an oronasal mask coupled to the mixed connector. The mask creates a tighter seal between a user’s face and the device (paragraph 0078) and also allows the device to deliver air to a user’s nose instead of just a user’s mouth. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to AKHIL A JAYAN whose telephone number is (571)272-6099. The examiner can normally be reached Monday-Friday 8am-5pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at 5712729034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /AKHIL A JAYAN/Examiner, Art Unit 3785 /KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785 Application/Control Number: 18/557,727 Page 2 Art Unit: 3785 Application/Control Number: 18/557,727 Page 3 Art Unit: 3785 Application/Control Number: 18/557,727 Page 4 Art Unit: 3785 Application/Control Number: 18/557,727 Page 5 Art Unit: 3785 Application/Control Number: 18/557,727 Page 6 Art Unit: 3785 Application/Control Number: 18/557,727 Page 7 Art Unit: 3785 Application/Control Number: 18/557,727 Page 8 Art Unit: 3785