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 are objected to because:
Reference characters 31, 35, 35’, 35’’, 35’’’, 35’’’’, 35’’’’’, 45, and 40 are not found in the specification (Figs 9, 13, and 14).
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 “plug” in Claim 3 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:
The abstract of the disclosure is objected to because the abstract of the disclosure does not commence on a separate sheet in accordance with 37 CFR 1.52(b)(4) and 1.72(b). A new abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. Currently, the abstract is over 150 words in length.
The amendment filed February 13, 2023 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the incorporation by reference of the international patent application PCT/EP2021/061531 and of the foreign patent application EP20190395.2 is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case PCT/EP2021/061531, see MPEP 1893.03(b). Therefore, the specification amendment of February 13, 2023 to include the incorporation by reference is new matter, per MPEP 608.01(p). Applicant is required to cancel the new matter in the reply to this Office Action.
Appropriate correction is required.
Claim Objections
Claims 1-7 are objected to because of the following informalities:
The phrase “the inhalation” should be changed to –an inhalation—since this is the first time this is mentioned (Claim 1, Line 14).
The phrase “the region” should be changed to –a region—since this is the first time this is mentioned (Claim 1, Line 19).
The phrase “the airflows” should be changed to –airflows—since this is the first time this is mentioned (Claim 1, Line 21).
The phrase “the interior” should be changed to –an interior—since this is the first time this is mentioned (Claim 1, Line 22).
The phrase “the end face” should be changed to –an end face—since this is the first time this is mentioned (Claim 1, Line 22).
The phrase “the shell surface” should be changed to –a shell surface—since this is the first time this is mentioned (Claim 1, Lines 25-26).
The phrase “air flows” should be changed to –airflows—for consistency (Claim 1, Line 26).
The phrase “an air passage” should be changed to –one of the air passages—for consistency (Claim 1, Line 32).
The phrase “the access” should be changed to –an access—since this is the first time this is mentioned (Claim 2, Line 3).
The phrase “the outer contour” should be changed to –an outer contour—since this is the first time this is mentioned (Claim 2, Line 4).
The phrase “the inner contour” should be changed to –an inner contour—since this is the first time this is mentioned (Claim 2, Line 5).
The phrase “the surface of the hollow body” should be changed to –a surface of the retaining body—since this is the first time this is mentioned and to correctly label the reference character 13 (Claim 4, Lines 3-4).
The phrase “air” should be changed to –the airflows—for consistency (Claim 4, Line 4).
The phrase “the direction” should be changed to –a direction—since this is the first time this is mentioned (Claim 5, Line 4).
The phrase “the hollow body” should be changed to –the retaining body—to correctly label the reference character 13 (Claim 6, Line 3).
The phrase “the correct” should be changed to –a correct—since this is the first time this is mentioned (Claim 6, Line 9).
The phrase “a woven fabric made of these materials” should be changed to –a woven fabric made of metal and/or hard plastic—to make it clear what materials are in the woven fabric (Claim 7, Lines 4-5).
Claim 3 is objected for being dependent on objected Claim 1.
Appropriate correction is required.
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:
The at least one oscillating body in Claim 1. The corresponding structures are 11 and 12 as shown in the Figures. 12 corresponds to one of two forms: the oscillating body similar to 11 (Fig 3b) and the body with a swiveling joint 16 (Figs 3a and 3b).
The retaining body in Claim 1. The corresponding structure is 13 which is a mount or body to hold the oscillating bodies 11 and 12.
The external device in Claim 6. The corresponding structure is 26 which is an electronic display or a mobile phone (Specification: Page 18, Lines 5-16).
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 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 1-7 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.
Claim 1 states “at least one oscillating body” and “characterized in that” (Lines 12 and 16). This statement is indefinite because it is unclear if the “characterized” is further defining the oscillating body. It appears the applicant was trying to say the structures following “characterized” are further defining the oscillating body. However, the wording and layout of the claim does not make it clear that the oscillating body is being “characterized”. Additionally, the details of the stenosis in the claim do not further define the oscillating body since the stenosis is a separate component of the device. Therefore, the structures detailing the oscillating body and what is being “characterized” cannot be determined. For examination purposes, the claim limitation will be interpreted as the oscillating body is characterized by the retaining body and oscillating tongue and that the stenosis is a separate component from the oscillating body.
Claim 5 states “the first and second oscillating bodies” (Line 3). This statement is indefinite because it is unclear how many oscillating bodies are being claimed. It appears the applicant was trying to say the at least one oscillating body is a first oscillating body and a second oscillating body. However, it is unclear how many oscillating bodies are being positively claimed since Claim 1 only requires one oscillating body to be positively claimed. Therefore, the number of oscillating bodies cannot be determined. For examination purposes, the claim limitation will be interpreted as at least two oscillating bodies are required. Similar rejections are applied to Claim 6 (Lines 7-8).
Claim 6 states “the openings” (Line 10). This statement is indefinite because it is unclear if the openings are the same as the through openings mentioned in Claim 1. It appears the applicant was trying to say they’re different. However, it is possible that these openings are the same as the through openings. Therefore, the identity of the openings cannot be determined. For examination purposes, the claim limitation will be interpreted as the openings are different from the through openings.
Claim 6 states “the housing” (Line 11). This statement is indefinite because it is unclear if the housing is the same as the hollow body. It appears the applicant was trying to say they’re different. However, it is possible the housing and hollow body are the same. Therefore, the identity of the housing cannot be determined. For examination purposes, the claim limitation will be interpreted as they’re different.
Claim 6 states “the valves” (Lines 11-12). This statement is indefinite because it is unclear if the valves are the same as the oscillating bodies mentioned in Claim 1. It appears the applicant was trying to say they’re the same. However, it is possible that the valves are completely different from the oscillating bodies. Therefore, the identity of the valves cannot be determined. For examination purposes, the claim limitation will be interpreted as they’re the same.
Claim 7 states “preferably” (Line 4). This statement is indefinite because it is unclear if the materials listed are positively claimed to be the flexible material. It appears the applicant was trying to say the listed materials are optional and are merely preferences. However, the use of “preferably” creates confusion regarding whether or not these materials need to be positively claimed. Therefore, whether or not the materials listed are positively claimed cannot be determined. For examination purposes, the claim limitation will be interpreted as the listed materials are optional and are merely preferences.
Claims 2-4 are rejected for being dependent on rejected Claim 1.
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 1-7 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 1 states “connected to the patient” and “is set into oscillating vibration by the inhalation and/or exhalation of the patient” (Lines 9, 13, and 14). This statement is directed to or encompasses a human organism since the mouthpiece or nosepiece of the apparatus is required to connect to a human and the oscillating body is required to be vibrated by an inhalation/exhalation of the human. Without the human, there is nothing for the mouthpiece or nosepiece to connect to and the oscillating body is not vibrated by anything. For examination purposes, the claim limitation will be interpreted as the device being configured to be connected to the patient and that the oscillating body is configured to be vibrated by an inhalation/exhalation of the patient.
Claims 2-7 are rejected for being dependent on rejected Claim 1.
Allowable Subject Matter
Claims 1-7 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 1-7 contain allowable subject matter.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 1 discusses a respiratory therapy device that has an oscillating body that is set into an oscillating vibration. The oscillating body is characterized as having a retaining body and oscillating tongue. The device also has a stenosis that is adjustable. The instant disclosure defines the vibrations as creating acoustics or tones that a patient can perceive to correct their breathing (Specification: Page 6, bottom paragraph and Page 7, top paragraphs). In other words, the oscillating vibrations are rapidly oscillating faster than a patient’s inhalation/exhalation. Brugger (English Machine Translation of EP0262239A1 provided by Espacenet) discusses a breathing apparatus. Though Brugger does have most of the claimed components, Brugger lacks the oscillating body that is being claimed because the inlet/outlet valves in Brugger do not vibrate in the same manner as the claimed invention. Rather, the valves of Brugger only open and close dependent on the inhalation/exhalation of the patient. There is no motivation to modify the valves to perform in this specific manner as there is no reason to produce this vibration. Additionally, Brugger requires the use of two valves and cannot operate with just a single valve. Other prior art lack the specific structure of the oscillating body and do not perform in the same manner as the claimed invention. Therefore, Brugger does not disclose the claimed invention of Claim 1.
Claims 2-7 contain allowable subject matter due to their dependency on Claim 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for art cited of interest including:
US-20020029779-A1 discusses a device that has a rotatable valve that adjusts the opening to control the resistance flow.
US-10004872-B1 discusses a device with an oscillating valve.
US 20180353715 A1 discusses a device with a flap valve.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN THAI-BINH KHONG whose telephone number is (571)272-1857. The examiner can normally be reached Monday to Thursday 9:00 am-6:00 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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/BRIAN T KHONG/Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785