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 .
Amendment
This office action is responsive to the amendment filed on 3/18/23. As directed by the amendment: claims 1-6 and 8-12 have been amended, claims 7 and 13-22 have been canceled, and no new claims have been added. Thus, claims 1-6 and 8-12 are presently pending in the application. Claims 11-12 are withdrawn as being directed towards a non-elected group and species.
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:
“retaining elements” in claim 9 (corresponding structure is gripping hooks, Page 10, lines 12-13).
“ejection means” in claim 10 (corresponding structure is spring-loaded ejection plunger, Page 10, lines 16-18).
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 1-6 and 8-10 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 recites “which” in line 2, however it is unclear what structure this language is referring to. As best understood which should be amended to recite --the nebulizer head--.
Claim 5 recites “bayonet-like” however it is unclear what the scope of this language includes. The “like” language is relative terminology and therefore the scope of the language is unclear. See MPEP 2173.05(b)
Any remaining claims are rejected as being dependent on a rejected base claim.
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 (i.e., changing from AIA to pre-AIA ) 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, 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.
Claims 1-4 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Pieters et al. (2018/0140789) in view of Gallem et al. (2015/0238712), Leonard (2021/0100965) and Harrison (2005/0028813).
Regarding claim 1, in fig. 1-5 Pieters discloses mesh nebulizer (1 includes mesh 30, the device is a nebulizer as it emits a spray of medicament) comprising a dosing unit (24 and 14) for providing a predetermined amount of a therapeutic agent (within medicament container 4), and a head 6, but is silent regarding that the head is a nebulizer head, which comprises an aerosol generator for generating an aerosol made from said therapeutic agent. However, in fig. 5 Gallem teaches an aerosol generator 106 within a nebulizer head 102 downstream of a therapeutic agent ampoule 118 and Leonard teaches aerosol generators in which the therapeutic agent is a powder [0017][0021]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pieters’ head with the addition of an aerosol generator, as taught by Gallem and Leonard, for the purpose of further dispersing the therapeutic agent to the user. The modified Pieters discloses that said therapeutic agent is delivered in a portion container 4 to be opened by pressure (against piercing member 70, Pieters); wherein the dosing unit comprises an uptake chamber (65, Pieters) with a dosing opening (opening to 65 through 70, Pieters) for dispensing the therapeutic agent into the aerosol generator (Fig. 5, Gallem), an opening (64, Pieters) for inserting the portion container (4, Pieters), a body (24, Pieters), but is silent regarding that the body is a locking body for locking the opening for inserting the portion container. However, in fig. 2 Harrison teaches a locking body 23 for locking an opening for inserting a portion container 3 that portion 21 locks with [0035]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Pieter’s opening and body finger 82 with interlocking structures, as taught by Harrison, for the purpose of preventing unwanted detachment. The modified Pieters discloses that the locking body is adapted to be moved from an open position in which the locking body releases the opening for inserting the portion container to a closed position in which the locking body closes the opening for inserting the portion container (Fig. 4-5 Pieters, Fig. 2-3a Harrison); and wherein the locking body is further adapted to be moved from the closed position (just before 70 pierces 28 of Pieters) to a drainage position (Fig. 5, [0098] Pieters) in which the locking body applies pressure to the portion container to open the portion container and release the therapeutic agent into the aerosol generator (Fig. 5, [0098] Pieters, Fig. 5 Gallem), in which the aerosol is then generated upon demand ([0129] Gallem).
Regarding claim 2, the modified Pieters discloses that the movement of the locking body from the open position to the closed position is or comprises a linear movement (the linear movement occurs during locking as upper facing surface 21a is linear and slides along linear surface 23, Harrison).
Regarding claim 3, the modified Pieters discloses that the movement of the locking body from the open position to the closed position is or comprises a rotating movement (Fig. 4-5 shows 24 pivotably rotating from an open to a closed position, Pieters).
Regarding claim 4, the modified Pieters discloses that the movement of the locking body from the closed position to the drainage position is or comprises a rotating movement (Fig. 4-5 shows 24 pivotably rotating from a closed position to the final drainage position, Pieters).
Regarding claim 8, the modified Pieters discloses that the dosing unit comprises a removal handle (82, 84, 99 and portion connecting 82 and 84 [0102] Fig. 6 Pieters) for discharged portion containers.
Regarding claim 9, the modified Pieters discloses that the removal handle comprises retaining elements (82 and 84, Pieters, Fig. 6) which engage the portion container during movement of the locking body from the open to the closed position and/or from the closed position to the drainage position (Fig. 6 Pieters), and retain the portion container during movement of the locking body back to the open position ([0102] Pieters).
Claims 1, 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Pieters et al. (2018/0140789) in view of Gallem et al. (2015/0238712), Leonard (2021/0100965) and Boyes et al. (2020/0179626).
Regarding claim 1, in fig. 1-5 Pieters discloses mesh nebulizer (1 includes mesh 30, the device is a nebulizer as it emits a spray of medicament) comprising a dosing unit (24 and 14) for providing a predetermined amount of a therapeutic agent (within medicament container 4), and a head 6, but is silent regarding that the head is a nebulizer head, which comprises an aerosol generator for generating an aerosol made from said therapeutic agent. However, in fig. 5 Gallem teaches an aerosol generator 106 within a nebulizer head 102 downstream of a therapeutic agent ampoule 118 and Leonard teaches aerosol generators in which the therapeutic agent is a powder [0017][0021]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pieters’ head with the addition of an aerosol generator, as taught by Gallem and Leonard, for the purpose of further dispersing the therapeutic agent to the user. The modified Pieters discloses that said therapeutic agent is delivered in a portion container 4 to be opened by pressure (against piercing member 70, Pieters); wherein the dosing unit comprises an uptake chamber (65, Pieters) with a dosing opening (opening to 65 through 70, Pieters) for dispensing the therapeutic agent into the aerosol generator (Fig. 5, Gallem), an opening (64, Pieters) for inserting the portion container (4, Pieters), a body (24, Pieters), but is silent regarding that the body is a locking body for locking the opening for inserting the portion container. However, in fig. 3 Boyes teaches a locking body (2, bayonet fit or screw fit [0025]) for locking an opening that portion (opening at 26) locks with [0035]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pieter’s opening and body with interlocking bayonet or screw fit structures, as taught by Boyes, for the purpose of preventing unwanted detachment. The modified Pieters discloses that the locking body is adapted to be moved from an open position in which the locking body releases the opening for inserting the portion container to a closed position in which the locking body closes the opening for inserting the portion container (Fig. 3-4 Boyes); and wherein the locking body is further adapted to be moved from the closed position (just before 70 pierces 28 of Pieters) to a drainage position (Fig. 5, [0098] Pieters) in which the locking body applies pressure to the portion container to open the portion container and release the therapeutic agent (Fig. 5, [0098] Pieters) into the aerosol generator (Fig. 5, [0098] Pieters, Fig. 5 Gallem), in which the aerosol is then generated upon demand ([0129] Gallem).
Regarding claim 4, the modified Pieters discloses that the movement of the locking body from the closed position to the drainage position is or comprises a rotating movement ([0025] Boyes).
Regarding claim 6, the modified Pieters discloses that the uptake chamber and the locking body have inter-acting threaded portions ([0025] Boyes).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Pieters, Gallem, Leonard and Boyes, as applied to claim 4 above, in further view of Findley (1,824,808).
Regarding claim 5, the modified Pieters discloses that the uptake chamber and the locking body have bayonet-like guiding elements ([0025] Boyes), but is silent regarding a pin that is arranged on the locking body and a guiding groove in a wall of the uptake chamber, said guiding groove extends straight down from the upper edge of the wall to a depth corresponding to the closed position and then runs at an angle. However, in fig. 3 Findley teaches a pin (at 19) that is arranged on a locking body and a guiding groove (at 19) in a wall of a chamber, said guiding groove extends straight down from the upper edge of the wall to a depth corresponding to the closed position and then runs at an angle (see fig. 3, Page 1, lines 75-58). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pieter’s bayonet with a bayonet having a pin and groove, as taught by Findley, for the purpose of providing an alternate bayonet structure having the predictable results of preventing unwanted removal.
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments, see pages 5-7, filed 3/18/26, with respect to the rejections of claim 1 under Pieters in view of Harrison and Pieters in view of Boyes have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, new grounds of rejection have been made in view of Pieters in view of Gallem, Leonard and Harrison and Pieters in view of Gallem, Leonard and Boyes.
On page 6, applicant argues that Pieters’ portion container is inserted into the locking body and not in the uptake chamber.
Examiner disagrees since Pieters’ portion container 4 is inserted into the uptake chamber 65 during use, see fig. 5.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL T SIPPEL whose telephone number is (571)270-1481. The examiner can normally be reached M-F 9:00-5:00 PM.
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, Timothy Stanis can be reached at (571) 272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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