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 .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “1” has been used to designate both smart inhaler 1 (shown but not numbered in Fig. 1) and outer casing 1 (Fig. 2). Also, reference character “9” has been used to designate both desktop computer 9 (Fig. 1) and guide 9 (Fig. 2). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: smart inhaler 1 (should be shown in Fig. 1). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the converging-diverging nozzle (claim 7) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
¶025 reads “are n one” which should read “are in one”
Appropriate correction is required.
Claim Objections
Claim(s) 1-13 is/are objected to because of the following informalities:
Claim 1 ends with a semicolon instead of a period
Claim 3, Ln. 2 recites “for receiving medicine cannister nozzle” which should read “for receiving a medicine cannister nozzle”
Claim 8, Ln. 1-2 recites “the mobile software app” which should read “the mobile software application” for consistency with claim 1
Claim 10, Ln. 2 recites “for governing sensors” which should read “for governing the sensors” following after claim 1
Claim 12, Ln. 2 recites “the software app” which should read “the mobile software application” for consistency with claim 1
Claim 13, Ln. 2 recites “a cloud network” which should read “the cloud network” following after claim 1
Claim 13, Ln. 4 includes a semicolon which appears should be replaced with a comma for consistency with the remainder of the claim
Claim 13, Ln. 4 recites “and encrypted data collection” where the word “and” should be removed since it is not the final limitation of the claim
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 2 recites “the inhaler having outer casings with guides.” While the disclosure clearly identifies outer casings 1 and 5 the specification only describes outer casing 5 as including a guide 9. The is no guide either discussed or illustrated for outer casing 1. Thus, there is doubt that applicant was in possession of the claimed invention including “outer casings with guides,” with a requirement for guides on each outer casing. Because the disclosed invention only includes a guide on one outer casing there is found to be lack of sufficient written description in the application as originally filed to support the full scope of what is recited in claim 2.
Claim 3 recites the limitation “a vapor accelerator.” The term “vapor accelerator” is not a common term of art and the specification does not describe or illustrate the vapor accelerator 12 in a manner that one of ordinary skill in the art would know what coverage applicant intends by the limitation. One of ordinary skill in the art would not be readily apprised on how to suitably make and use the claimed invention without a better understanding of what structure applicant intends by the claimed “vapor accelerator.” There is thus lack of sufficient written description support in the application as originally filed for the recitations of claim 3.
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.
Claim(s) 1-13 is/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 pre-AIA the applicant regards as the invention.
Claim 1 recites the limitations “a web portal” in Ln. 5 and “a mobile software application” in Ln. 6 which deems the claim indefinite. In plain language a web portal and a mobile software application are functional limitations and not structural limitations since neither an online platform nor software has a tangible form. The claim is thus indefinite as it recites functions without reciting sufficient structure in order to perform the functions (see MPEP 2173.05(g)). The claim needs to be amended to recite the structure which retains both the web portal and the mobile software application. For the purposes of examination the limitations will be interpreted as reading “a web portal, hosted on a server,” and “a mobile software application stored on a non-transitory computer readable medium” as discussed in ¶¶007, 021, 026 of the instant specification.
Claim 3 recites the limitation “a vapor accelerator” in Ln. 2 which deems the claim indefinite. The term “vapor accelerator” is not a common term of art and the specification does not describe or illustrate the vapor accelerator 12 in a manner that one of ordinary skill in the art would know what coverage applicant intends by the limitation.
Claim 8 recites the limitation “the mobile software app being a non-transitory computer readable medium including computer readable instructions” which deems the claim indefinite. As discussed in the above 35 U.S.C. 112(b) rejection of claim 1 a software app in plain language has no tangible form. Based upon a review of the instant specification it appears the present limitation inadvertently has missed including the word “on” to specify the mobile software app as “on” a non-transitory computer readable medium (¶021). For the purposes of examination the limitation will be interpreted as reading “the mobile software app being on a non-transitory computer readable medium including computer readable instructions.”
Claim 11 recites the limitation “sensors … that measure … partial pressure; nitric oxide; oxygen” which deems the claim indefinite. The disclosure of the instant application only indicates the measuring of partial pressure and oxygen as being one single measure of partial pressure oxygen (¶¶005, 0021). It is thus unclear whether the claim has been incorrectly written with “partial pressure” and “oxygen” inadvertently separated from each other or whether applicant truly intends those are two separate measures (despite not appearing to have written description support for two separate measures). The former interpretation appears most accurate. For the purposes of examination the limitation will be interpreted as reading “sensors … that measure … partial pressure oxygen; nitric oxide.”
Claim 13 recites the limitation “web portal with logins for stakeholders” in Ln. 3 which deems the claim indefinite. It is unclear if the present limitation is intended to refer to a layering within the previously recited web portal or is advertently duplicating use of the term “web portal.” It appears the latter interpretation is most accurate. For the purposes of examination the limitation will be interpreted as reading “logins for stakeholders.”
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4-6 and 8-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thomas et al. (U.S. Pub. 2021/0045657).
Regarding claim 1, Thomas discloses a system for delivering medicine and tracking respiratory health of a patient (e.g. Fig. 5; ¶0045) comprising the following parts: a) an inhaler (Fig. 3 #302, 304, 200; ¶0028) for delivering respiratory medication; b) microcontroller (¶0027 – processor) for governing sensors; c) a web portal, hosted on a server, for accessing a cloud network (Fig. 5 #518; ¶0045 – cloud server 518 being accessed by caregiver 520 requires a web portal); and d) a mobile software application (e.g. Figs. 6A-6B; ¶0046) stored on a non-transitory computer readable medium (Fig. 5 #508; ¶0046 – mobile device will have memory to store software application). It is noted that the sensors are not read as positively recited by the claim (because of how has recited the microcontroller as “for governing sensors”).
Regarding claim 2, Thomas discloses the inhaler having outer casings (Fig. 3 #310, 304, 200) with guides (Fig. 3 – the opposed ends of #304 are readable as guides which interface respectively with #310 and #200; ¶0030).
Regarding claim 4, Thomas discloses the inhaler having a mouthpiece (Fig. 3 #204; ¶0030).
Regarding claim 5, Thomas discloses the inhaler having a liner (any internal portion of #302, 304 or #200 can be read as a liner).
Regarding claim 6, Thomas discloses the inhaler having an integrated spacer for enhancing medication delivery (Fig. 3 #310, 304; ¶0030). The recitation of “enhancing medication delivery” represents an intended outcome and is given limited patentable weight (see MPEP 2114).
Regarding claim 8, Thomas discloses the mobile software application being on a non-transitory computer readable medium including computer readable instructions (Fig. 5 #508; ¶0046 – mobile device will have memory to store software application).
Regarding claim 9, Thomas discloses the inhaler also includes an onboard battery (Fig. 2D #214; ¶0027).
Regarding claim 10, Thomas discloses the microcontroller having a wireless transmitter (Fig. 2D #222, 224; ¶0027), onboard memory (Fig. 2D #216; ¶0027), and firmware for governing the sensors (¶0026 – processor and flow sensor operate together).
Regarding claim 11, Thomas discloses the sensors are capable of including those that measure temperature, partial pressure oxygen; nitric oxide; peak flow; and forced expiratory volume. It is noted that the sensors are not read as positively recited by the claim (because of how claim 1 has recited the microcontroller as “for governing sensors”). Thus, the microcontroller of claim 1 only needs to be capable of governing the types of sensors recited by the instant claim. The device of Thomas is capable of being programmed to operate various types of sensors.
Regarding claim 12, Thomas discloses the mobile software application tracking respiratory status in real time (¶¶0040, 0045, 0047).
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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(s) 3 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al. (U.S. Pub. 2021/0045657) in view of Wang et al. (U.S. Pub. 2019/0111222).
Regarding claim 3, Thomas is silent as to whether the inhaler having a vapor accelerator for receiving a medicine cannister nozzle. Thomas has limited discussion of its internal inhaler components.
Wang teaches an inhaler (Fig. 1) including a vapor accelerator (Fig. 1 where #31 seats into #20) for receiving a medicine cannister nozzle (Fig. 1 nozzle of #30). One of ordinary skill in the art would have obviously recognized this design in Wang where an inhaler canister is fitted into a housing nozzle as a common manner of receiving the inhaler canister within a housing.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Thomas the inhaler having a vapor accelerator for receiving a medicine cannister nozzle based upon the common recognized design where an inhaler canister is fitted into a housing nozzle in view of Wang.
Regarding claim 7, Thomas is silent as to whether the integrated spacer having a converging-diverging nozzle for slowing medication molecules. The recitation of “slowing medication molecules” represents an intended outcome and is given limited patentable weight (see MPEP 2114). Thomas has limited discussion of its internal inhaler components.
Wang teaches an inhaler (Fig. 1) including a converging-diverging nozzle (Fig. 1 where #31 seats into #20 converges into a narrow throat and then diverges). One of ordinary skill in the art would have obviously recognized this design in Wang where an inhaler canister is fitted into a housing nozzle as a common manner of receiving the inhaler canister within a housing.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Thomas the integrated spacer having a converging-diverging nozzle based upon the common recognized design where an inhaler canister is fitted into a housing nozzle in view of Wang.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al. (U.S. Pub. 2021/0045657) in view of Lacour-Gayet et al. (U.S. Pub. 2020/0342507).
Regarding claim 13, Thomas discloses the web portal for accessing the cloud network also having functions that include administrative routines (¶0045 – access by caregiver or respiratory specialist implies administrative routines are performed), initializations (¶0045 – access by caregiver or respiratory specialist implies initializations are performed), artificial intelligence algorithms for trend detection and condition predictions (¶0045 – machine learning, AI chat bot, training feedback module), and automated notifications for stakeholders (¶0045 – automated reports).
Thomas fails to disclose the web portal also having functions that include logins for stakeholders, and encrypted data collection stored on a block chain.
However, one of ordinary skill in the art of web interfaces would have considered it prima facie obvious that providing remote access for a caregiver or respiratory specialist would include requiring a secure login for those individuals to ensure personal health data can only be accessed by authorized individuals.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Thomas the web portal also having the function of logins for stakeholders based upon the commonly expected use in web interfaces of a secure login for a caregiver or respiratory specialist to ensure personal health data can only be accessed by authorized individuals, as would be readily recognized by one of ordinary skill in the art of web interfaces.
Lacour-Gayet teaches an inhaler (Fig. 1; ¶0001) as part of a network (Fig. 13; ¶0168) and teaches communication of patient data across that network as performed by using blockchain transmission of encrypted data (¶¶0177-0181). Lacour-Gayet teaches blockchain as providing the benefits of greater transparency of data transmission, enhanced security, improved traceability, and increased efficiency and speed and data transmission (¶¶0177-0181).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Thomas the web portal also having the function of encrypted data collection stored on a block chain in order to provide the benefits of greater transparency of data transmission, enhanced security, improved traceability, and increased efficiency and speed and data transmission in view of Lacour-Gayet.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references. Particular attention is drawn to the inhaler network configurations of the following references: Samson et al. (U.S. Pub. 2016/0325058; Fig. 8), Costella et al. (U.S. Pub. 2017/0296772; Figs. 69-73), Jackson et al. (U.S. Pub. 2019/0240430; Fig. 1), Riebe et al. (U.S. Pub. 2020/0086069; Figs. 15A-15C), Milton-Edwards et al. (U.S. Pub. 2021/106776; Fig. 2), Naumov et al. (U.S. Pub. 2022/0148730, Fig. 4A), and Batista et al. (U.S. Pub. 2024/0395383, Fig. 6).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785