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 .
Claim Objections
Claim(s) 1-3 is/are objected to because of the following informalities:
Claim 1, Ln. 7 recites “a user” which should read “the user” following after Ln. 2
Claim 3 accidentally ends with a double period
Appropriate correction is required.
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.
Claim(s) 1-2 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 limitation “said exhalant is suctioned from the sealed volume through the exhaust port” in Ln. 8-9 which deems the claim indefinite. The active verbiage “is suctioned” leaves it indefinite whether the suction device, which would perform the suctioning, should be read as positively recited by the claim. For the purposes of examination the limitation will be interpreted as reading “said exhalant is configured to be suctioned from the sealed volume through the exhaust port” in order to avoid needing to read the suction device as positively claimed.
Claim 2 recites the limitation “said nebulizer mask is further adapted to receive an aerosol into the nebulizer volume and expel the exhalant from the user into the sealed volume” in Ln. 4-6 which deems the claim indefinite. The claim recites functions of the nebulizer mask (i.e. receiving an aerosol and expelling the exhalant) without reciting any structure of the nebulizer mask to perform the claim functions. The claim is thus indefinite as it attempts to claim the structure of the nebulizer mask by what it does instead of what it is (see MPEP 2173.05(g)). The claim should be amended to recite an inlet of the nebulizer mask for receiving an aerosol and an outlet of the nebulizer mask for expelling the exhalant.
Claim Interpretation - 35 USC § 112(f)
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: “a structure configured to create a sealed volume when worn by a user” in claim 1.
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.
The corresponding structure for the “structure” is best understood from the specification as at least: an outer shell mask, corresponding to outer shell 110 (Fig. 1), mask 210 (Figs. 2-3), or outer shell 410 (Fig. 4).
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 § 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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moenning Jr. (U.S. Pub. 2010/0122705).
Regarding claim 1, Moenning Jr. discloses an apparatus (Figs. 4-5 #110; ¶0047-0054) comprising: a structure (Fig. 4 #112; ¶0053) configured to create a sealed volume when worn by a user (¶0038 – seal 20); and an exhaust port (Fig. 5 #22; ¶0052) disposed on the structure and sealably communicative through the structure with the sealed volume (Fig. 5) and further adapted to be connected to a suction device (¶¶0036, 0052; Fig. 5 – scavenger circuit 72), whereby, when worn by a user, the sealed volume collects and contains an exhalant from the user and said exhalant is configured to be suctioned from the sealed volume through the exhaust port (¶¶0036, 0052; Fig. 5).
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) 1-2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brady et al. (U.S. Patent 12083273) in view of Moenning Jr. (U.S. Pub. 2010/0122705).
Regarding claim 1, Brady discloses an apparatus (Figs. 1-3 #10; e.g. Col. 3-4) comprising: a structure (Fig. 1 #11; Col. 3) configured to create a volume when worn by a user (Fig. 1); and an exhaust port (Figs. 1-3 #21; Col. 3, Ln. 20-51) disposed on the structure and sealably communicative through the structure with the volume (Fig. 1) and further adapted to be connected to a suction device (Fig. 1 – vacuum tube; Col. 3, Ln. 20-39), whereby, when worn by a user, the volume collects and contains an exhalant from the user (Fig. 2 exhalant passes through two upper circular holes on existing mask when under vacuum) and said exhalant is configured to be suctioned from the sealed volume through the exhaust port (Fig. 1 – vacuum tube; Col. 3, Ln. 20-39). Note is also made to the embodiment of Fig. 12 of Brady.
Brady fails to disclose the structure creates a sealed volume when worn.
Moenning Jr. teaches a scavenging mask (Fig. 3 #10; ¶0033) which creates a sealed volume when worn (¶0034). Moenning Jr. teaches creating a sealed volume inside a scavenging mask as providing the benefit of ensuring all exhaled gases from a patient are drawn along a scavenger circuit to a vacuum pump instead of being able to escape into a room environment (¶¶0035-0036).
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 Brady the structure creates a sealed volume when worn in order to provide the benefit of ensuring all exhalant from the user is drawn by the suction device instead of being able to escape into a room environment in view of Moenning Jr.
Regarding claim 2, Brady teaches the invention as modified above and further teaches a nebulizer mask (Figs. 1-3 “existing mask”) adapted to cover a nose and mouth of the user (Fig. 1) and defining a nebulizer volume, where the nebulizer volume is entirely contained within the sealed volume of the structure (Brady – Fig. 1 and Moenning Jr. – Fig. 3), and said nebulizer mask is further adapted to receive an aerosol into the nebulizer volume (Fig. 3 – from nebulizer) and expel the exhalant from the user into the sealed volume (Figs. 1-3 – exhalant passes through two upper circular holes on existing mask when under vacuum).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nesti (U.S. Patent 4807617) in view of Moenning Jr. (U.S. Pub. 2010/0122705).
Regarding claim 3, Nesti discloses an apparatus (Fig. 1-3 #14, 62; Col. 2-3) adapted for use in medical respiratory treatments that utilize a mask (Fig. 3 #12), the apparatus comprising: an outer shell (Fig. 3 #14; Col. 2) adaptable to enclose a mask (Figs. 1-4 #12) and configured to collect an exhalant from the mask (Fig. 4 via #54; Col. 3, Ln. 48-54); an inhalation tube (Fig. 3 #62; Col. 2, Ln. 65-68) disposed through the outer shell (Figs. 3-4) and configured to be sealably communicative with an inlet (Fig. 3 #26) of the mask (Col. 2, Ln. 65-68); an exhaust tube (Figs. 3-4 #18; Col. 2, Ln. 35-38) disposed through the outer shell and configured to be communicative with the exhalant from the mask and adapted to sealably connect to a suction device (Figs. 3-4 #18; Col. 2, Ln. 35-38 – vacuum hose leads to vacuum device). It is noted that the intention of the mask as a nebulizer mask is given limited patentable weight at least because a) the nebulizer mask is not positively recited by the claim, b) no nebulizer is positively recited, and c) there are no structures recited of the nebulizer mask which are only specific to a mask used for nebulizer treatment (see MPEP 2114).
Nesti fails to disclose at least one elastic strap attached to the outer shell and configured to keep the outer shell in place over the mask.
Moenning Jr. teaches a scavenging mask (Fig. 1 & 3 #10; ¶0033) including an elastic strap (Figs. 1 & 3 #34; ¶0037) attached to an outer shell (Fig. 1) and configured to keep the mask in place. Moenning Jr. teaches an elastic strap as providing the benefit of securing the mask to the patient’s head during use (¶0037).
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 Nesti at least one elastic strap attached to the outer shell and configured to keep the outer shell in place over the mask in order to provide the benefit of securing the apparatus to the patient’s head during use in view of Moenning Jr.
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.
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