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 .
Drawings
The drawings have been received on 5/25/2023 and these drawings have been objected to under 37 CFR 1.84 for the following reasons: lines, numbers and letters are not uniformly thick and well defined; and numbers and reference characters are not plain and legible for all figures (especially figures 5-11). New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because of the reasons stated above. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
In claim 1:
-intelligent main control module
-a plurality of functional modules
-an identity information input module
-a vaccine information input module
-a temporary vaccine storage module
-a dosing transfer module
-an aerosol output module
-a mist storage tank management module
-a human-computer interaction module
In claim 2:
-an inhalation quality detection module
In claim 4 and 15:
-a disposable mist storage tank recovery device
In claim 5:
-a mist storage tank output device
In claim 7:
-an audio guide module
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
The claims are replete with errors. Several examples follow below. This listing should not be considered to be an exhaustive list and applicant's cooperation is required to review the file to ensure the claims are in proper form.
The claims are objected to because of the following informalities:
Claim 1 recites “the functional modules” multiple times after introducing the limitation as “a plurality of functional modules”. For claim language consistency this should read “the plurality of functional modules”.
Claim 1, line 12 recites “send to the cloud”. This should read “send the ID information of the vaccinator to the cloud”
Claim 1, line 18 recites “for vaccine and ensure”. This should read “for the vaccine containers and to ensure an”.
Claim 1, line 19 reads “of vaccine during the entire vaccination process”. This should read “of a vaccine within the vaccine container during an entire vaccination process”.
Claim 1, line 20 reads “extract specified”. This should read “extract a specified”.
Claim 1, lines 21 reads “of vaccine and to deliver the measured amount of vaccine”. This should read “of the vaccine and to deliver the specified dose of the vaccine”.
Claim 1, line 22 reads “of vaccines”. This should read “of the vaccine”.
Claim 1, line 24 reads “of vaccines, which is provided with”. This should read “of the vaccine, the aerosol output module is provided with”.
Claim 1, second page, line 1 reads “perform detection”. This should read “perform detection before nebulization”.
Claim 1, second page, lines 2-4 reads “and to distribute the mist storage tank in which vaccine after nebulization by the aerosol output module is filled into vaccinator for inhalation, in which”. This should read “and to distribute the aerosol from the mist storage tank to the vaccinator for inhalation, wherein”.
Claim 1, second page, line 8 “vaccinator” should read “the vaccinator”.
Appropriate correction is required.
Claim 1, second page, line 11 “vaccinator” should read “the vaccinator”.
Claim 1, second page line 16 “which is inhaled by vaccinator” should read “which is configured to be inhaled by the vaccinator”.
Claim 2, line 2 “wherein further comprises” should read “further comprising”.
Claim 4, line 2 “wherein further comprises” should read “further comprising”.
Claim 4, lines 3 “vaccinator” should read “the vaccinator”.
Claim 4, lines 4-5 recites “to put used mist storage tank to designated recycling place.” This should read “to put a used mist storage tank to a designated recycling place”.
Claim 5, line 7 recites “the vaccine temporary storage module”. This should read “the temporary vaccine storage module”.
Claim 5, line 10 “maintain the” should read “maintain a”.
Claim 9, line 3 “the portion” should read “located”.
Claim 9, line 4 “connected” should read “connects”.
Claim 10, line 3 “ID information of vaccinator” should read “the ID information of the vaccinator”.
Claim 10, Step 2 “required dosage of vaccine” should read “the specified dose of the vaccine”
Claim 10, Step 2, “to dosage requirement of vaccine nebulization” should read “to the dosage requirement of the vaccine”.
Claim 10, Step 3 “storage tank 11” should read “storage tank”.
Claim 10, Step 4 “and fill it” should read “and fill the aerosol”.
Claim 10, Step 4 “of nebulizer provided by vaccine manufactures and vaccine nebulization” should read “of a nebulizer”.
Claim 10, Step 5 “vaccinator” two times and this should read “the vaccinator”.
Claim 10, Step 6 recites “vaccine nebulization”. This should read “the vaccine nebulization”.
The examiner notes in the remainder of the claims “vaccinator” should read “the vaccinator”.
Claim 12, line 5, “the human-machine interaction module” should read “the human-computer interaction module”.
Claims 13 and 18 recite “according to according to”. This should read “according to”.
Claim 13 and 18 recite “nebulization parameters and usage guidelines”. This should read “the nebulization parameters and usage guidelines”.
Claim 14 and 19, line 3, “the age” should read “an age”.
Claim 15, line 1, “wherein further comprises” should read “further comprising”.
Claim 17, lines 2-3 starting with “wherein” and ending with “module” need to be reworded.
Claim 17, line 5 “the aerosol locked in the mist storage tank and not lost” should read “the aerosol is locked within the mist storage tank”.
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 1-19 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.
The claims are replete with errors. Several examples of indefiniteness/clarity issues follow below. This listing should not be considered to be an exhaustive list and applicant's cooperation is required to review the file to ensure the claims are in proper form.
Claim 1, second page lines 11-12 recite “the information and record of vaccinator and nebulization related information and record”. There is a lack of antecedent basis for these claimed limitations. Is applicant referring to the ID information recited earlier in claim 1? Is the information and record uploaded/downloaded or is something being recorded? The examiner recommends rewriting this to make the metes and bounds of the claim clear. It is also unclear if the nebulization related information is the same as the nebulization guidelines previously recited.
Claim 1, line 14 recites “vaccinator information and vaccine information”. It is unclear if applicant is introducing more information or if applicant is attempting to refer to previous limitations in the claim such as “ID information of vaccinator” and the information recited in claim 1, lines 13-14.
Claim 1, second page line 19 recites “vaccination information, vaccine information, and vaccinator information”. It is unclear if applicant is claiming additional information or if this is referring to information previously recited in the claim.
Claim 1, second page, line 21 recites “to output the mist storage tank”. It is unclear what this means.
Claim 7 recites “the camera device” in line 5. There is a lack of antecedent basis for this claimed limitation.
Claim 7 recites “the shell” in the last line of the claim. There is a lack of antecedent basis for this claimed limitation.
Claim 9 recites “once the mist storage tank is unplugged…, the one way valve ensures…” “when the user opens…” making it a hybrid claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Claim 9 also refers to the user and vaccinator. It is unclear if these are the same individuals or different people. The examiner recommends rewording lines 4-8 of the claim.
Claim 10 recites “the mist storage tank extraction outlet 9” in step 5. There is a lack of antecedent basis for this claimed terminology. Further, the examiner notes to remove “9”.
Claim 11 recites “the inhalation quality detection module”. There is a lack of antecedent basis for this claimed terminology.
Claim 12 refers to the step 5A however, claim 12 is dependent on 10 while the step 5A is introduced in claim 11 thus making the claim unclear. There is also a lack of antecedent basis for the disposable mist storage tank recovery device, the mist storage tank recovery opening.
Claim 13 and 18 recite “detecting whether vaccines are put in”. It is unclear where they are being put in.
Claims 14 and 19, it is unclear whose age is being referred to, it is unclear who “they” is referring to in lines 3 and 4. “The vaccination record” in line 5 lacks antecedent basis.
Claims 14 and 19 recites “the next step, otherwise exit”. It is unclear what “the” next step is and it is unclear what is being exited.
Claim 15 recites “vaccinator is guided…” reciting steps, making it a hybrid claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Claim 16, line 4 recites “the vaccine storage chamber”. There is a lack of antecedent basis for this claimed limitation.
Claim 17 recites steps “once the mist storage tank is unplugged…” “when the user opens…”, making it a hybrid claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
The examiner notes that all dependent claims inherit the rejections from the claims which they depend from.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 4-6, 15 and 17 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 4 recites “vaccinator is guided” which positively recites the vaccinator. The examiner recommends amending the claim to read “and configured to guide the vaccinator”.
Claim 15 recites “vaccinator is guided” which positively recites the vaccinator and thus a human organism.
Claim 17 recites “when the user opens the cover to inhale” and “which is convenient for vaccinator to inhale” which positively recites the use and thus a human organism.
The examiner notes that all dependent claims inherit the rejections from the claims which they depend from.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 6571790 B1; US 5692640 A1; US 20220148701 A1; US 20220016365 A1; US 20210030979 A1; US 20180308569 A1; US 20140322682 A1; US 20090076650 A1; US 20040260700 A1; US 20030221687 A1; US 20110238432 A1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VICTORIA MURPHY whose telephone number is (571)270-7362. The examiner can normally be reached M-F 8:00am-4:00pm.
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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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/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785