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
Claims 60 and 62-64 are objected to because of the following informalities:
Claims 60, 62, 63 and 64, insert “,” before “wherein”.
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: “engagement member” in claim 76.
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 73-78 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 73 recites the limitation “an inlet opening spaced apart from the outlet opening” in line 12 which is indefinite as claim 59, which claim 73 depends upon, also recites “an inlet opening in line 6. As such, it is unclear if claim 73 and claim 59 are referencing the same inlet opening or two different inlet openings. Examiner is interpreting the claims to be referencing the same inlet opening, Examiner suggest amending claim 73 to read “the inlet opening spaced apart from the outlet opening”.
Claims 74-78 are rejected by virtue of their dependency on a rejected claim.
Claim Rejections - 35 USC § 102
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) 59-67, 69, 72, 73, and 75 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Puderbaugh et al. (US 6026807 A).
Regarding claim 59, Puderbaugh discloses a sealable backpiece (resilient elastomeric or plastic material sleeve 52; col 3 ln51-56; figure 1 and 3-6) for a holding chamber (spacer 100; col 3 ln 45-46; figure 1 and 5-6) comprising:
a flexible membrane comprising a plurality of flexible sections separated by a plurality of slits defining free edges of the flexible sections (a plurality of radially extending cuts 54 in the sleeve which extend outwardly from the center to form a plurality of resilient "fingers" 53; col 3 ln 54-56; figure 3), wherein the flexible sections are moveable relative to each other from a closed configuration (a portion of which closes the open distal end 51 of the cloud chamber by means of a plurality of radially extending cuts 54 in the sleeve which extend outwardly from the center to form a plurality of resilient "fingers" 53; col 3 ln 53-56; figure 3), wherein the free edges of adjacent flexible sections are positioned proximate each other (see figure 3), and an open configuration (when a discharge outlet 17 of the container 10 is pushed through the distal end 51 of the cloud chamber 50, the holder 15 will be removably secured to the cloud chamber 50 by the action of the "finger" portions 53 of the sleeve 52 engaging the outer surfaces of the discharge outlet 17; col 3 ln 57-62 ; figure 1), wherein the flexible sections are deformed to define an inlet opening (see figure 1, the action of the "finger" portions 53 of the sleeve 52 engaging the outer surfaces of the discharge outlet 17 and defining an inlet opening at distal end 51 of cloud chamber 50), wherein the slits define the only opening through the flexible membrane in the closed configuration (a plurality of radially extending cuts 54 in the sleeve which extend outwardly from the center to form a plurality of resilient "fingers" 53; col 3 ln 54-56; figure 3), wherein the free edges of at least two of the flexible sections are spaced apart and do not intersect when the flexible sections are in the closed configuration (Examiner notes there are eight resilient “fingers” 53, wherein each of the eight resilient “fingers” 53 is directly adjacent to two other resilient “fingers” 53. Select one of the eight resilient “fingers” 53 and the radially extending cuts 54 that forms it is spaced apart and does not intersect the radially extending cuts 54 that forms another of the non-adjacent resilient “fingers” 53).
Regarding claim 60, Puderbaugh discloses the sealable backpiece of claim 59 wherein the inlet opening defined by the flexible sections in the open configuration defines a first area (see figure 1, opening at distal end 51 of cloud chamber 50), and wherein the slits define a second area (see figure 3, area of the eight radially extending cuts 54), wherein the second area is less than the first area (see figure 1 and 3, opening formed at distal end 51 of cloud chamber 50 is larger than area of the eight radially extending cuts 54).
Regarding claim 61, Puderbaugh discloses the sealable backpiece of claim 60 further comprising a relief opening positioned at a terminal end of at least some of the slits (a plurality of radially extending cuts 54 in the sleeve which extend outwardly from the center to form a plurality of resilient "fingers" 53; col 3 ln 54-56; figure 3. see figure 3, the center of the radially extending cuts 54 forms a relief opening).
Regarding claim 62, Puderbaugh discloses the sealable backpiece of claim 59 wherein the plurality of flexible sections comprise at least four flexible sections (eight resilient “fingers” 53; figure 3) including a pair of end flexible sections having a triangular shape (see Examiner Annotations 1 below, “end flexible sections”).
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Examiner Annotations 1
Regarding claim 63, Puderbaugh discloses the sealable backpiece of claim 62 wherein the at least four flexible sections comprises six flexible sections (eight resilient “fingers” 53; figure 3).
Regarding claim 64, Puderbaugh discloses the sealable backpiece of claim 63 wherein four of the six flexible sections (see Examiner Annotations 1 above, “1st, 2nd, 3rd, and 4th flexible sections”) are located between the end flexible sections (see Examiner Annotations 1, “end flexible sections”) and define a cross-shaped opening therebetween (see Examiner Annotations 1, highlighted “cross-shaped opening” formed by radially extending cuts 54 between “1st, 2nd, 3rd, and 4th flexible sections”).
Regarding claim 65, Puderbaugh discloses the sealable backpiece of claim 59 further comprising a carrier configured as ring surrounding the flexible membrane (resilient elastomeric or plastic material sleeve 52; col 3 ln51-56; figure 1 and 3-6).
Regarding claim 66, Puderbaugh discloses the sealable backpiece of claim 65, wherein the carrier comprises at least one tab protruding therefrom for releasable engagement with an opening of the holding chamber (A raised portion 55 of the sleeve 52, having an opening 31a complementary to the opening 31 in the distal end 51 of the cloud chamber 50, covers the whistle 30 securing the whistle in place in the opening 31; col 3 ln 67-col 4 ln 3; figure 1 and 3).
Regarding claim 67, Puderbaugh discloses the sealable backpiece of claim 65, wherein the carrier defines an end border portion spaced apart from the flexible membrane (see figure 3, top rim portion of sleeve 52), the flexible membrane being recessed relative to the end border portion (see figure 3, plurality of resilient "fingers" 53 recessed relative to top rim portion of sleeve 52).
Regarding claim 69, Puderbaugh discloses the sealable backpiece of claim 59, wherein the flexible sections form a seal relative to ambient environment in the closed configuration (The distal end 51 of the cloud chamber 50 carries a resilient elastomeric or plastic material sleeve 52, a portion of which closes the open distal end 51 of the cloud chamber by means of a plurality of radially extending cuts 54 in the sleeve which extend outwardly from the center to form a plurality of resilient "fingers" 53 ; col 3 ln 51-56; figure 4-5).
Regarding claim 72, Puderbaugh discloses a holding chamber (spacer 100; col 3 ln 45-46; figure 1 and 5-6) comprising the sealable backpiece of claim 59 (see claim 59 above).
Regarding claim 73, Puderbaugh discloses the holding chamber (spacer 100; col 3 ln 45-46; figure 1 and 5-6) of claim 72, further comprising:
a first housing component (cloud chamber 50; col 3 ln 51; figure 1 and 3-6);
a second housing component pivotally connected to the first housing component about a pivot axis (The proximal end 56 of the cloud chamber 50 is closed by a chamber cap 60 which is hingedly connected to the cloud chamber 50 by means of a semi-rigid resilient strap 62; col 4 ln 19-30; figure 3-6), wherein the first and second housing components are pivotable relative to each other about the pivot axis between a closed position (figure 1 and 4-5), wherein the first and second housing components define an enclosed interior space (see figure 3 and 6, interior of cloud chamber 50 and chamber cap 60), and an open position (see figure 6), wherein the first and second housing components are spaced apart and define an access opening communicating with the interior space (In this manner the strap 62 forms a hinge connection to the cloud chamber 50 about which the chamber cap 60 is swingable in the direction of the arrow shown in FIG. 4, and shown open in FIG. 6, to provide access to the interior of the chamber 50 for storing the medication container 10 and holder 15 when they are not in use; col 4 ln 25-30; figure 6);
wherein one of the first housing component and the second housing component comprises a user interface comprising an outlet opening (The chamber cap 60 includes a mouthpiece 70 through which a user withdraws inspiratory air and expels expiratory air; col 4 ln 31-33; figure 1-3);
wherein one of the first housing component and the second housing component comprises an inlet opening spaced apart from the outlet opening (the distal end 51 of the cloud chamber; col 3 ln 56-62; figure 3); and,
wherein the inlet opening comprises the sealable backpiece (The distal end 51 of the cloud chamber 50 carries a resilient elastomeric or plastic material sleeve 52, a portion of which closes the open distal end 51 of the cloud chamber by means of a plurality of radially extending cuts 54 in the sleeve which extend outwardly from the center to form a plurality of resilient "fingers" 53; col 3 ln 51-56; figure 1 and 3-6).
Regarding claim 75, Puderbaugh discloses the holding chamber of claim 73, wherein when the flexible sections of the flexible membrane are in the closed configuration, and the first housing component and the second housing component are in the closed position, the interior space is sealed from ambient environment (The distal end 51 of the cloud chamber 50 carries a resilient elastomeric or plastic material sleeve 52, a portion of which closes the open distal end 51 of the cloud chamber by means of a plurality of radially extending cuts 54 in the sleeve which extend outwardly from the center to form a plurality of resilient "fingers" 53 ; col 3 ln 51-56; figure 4-5).
Claim Rejections - 35 USC § 103
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.
Claim(s) 71 and 74 is/are rejected under 35 U.S.C. 103 as being unpatentable over Puderbaugh et al. (US 6026807 A).
Regarding claim 71, Puderbaugh discloses the sealable backpiece of claim 59, but is silent as to further comprising a plug tethered to and removably insertable into the sealable backpiece.
However, Puderbaugh teaches a plug tethered to and removably insertable into an open end of the device (A cover or mouthpiece cap 90 is provided to close the open end of the mouthpiece 70 to keep the mouthpiece clean and to prevent foreign objects from entering. The mouthpiece cap 90 includes a connecting strap 91 which is removeably attachable to a portion 62a of the hinge strap 62, best shown in FIG. 3, for connecting the mouthpiece cap 90 to the cloud chamber cap 60 to prevent the mouthpiece cap from being lost. In this manner the mouthpiece cap 90 can be placed over the open end of the mouthpiece 70 in the manner illustrated by the arrows of FIG. 1; col 4 ln 33-42; figure 1 and 3-6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the other end of the device of Puderbaugh to implement a cover tethered to and removably insertable into the sleeve in order to keep the mouthpiece clean and to prevent foreign objects from entering, as taught by Puderbaugh col 4 ln 33-42.
Regarding claim 74, Puderbaugh discloses the holding chamber of claim 73, but is silent as to wherein the backpiece is removably insertable in the inlet opening.
Puderbaugh teaches The distal end 51 of the cloud chamber 50 carries a resilient elastomeric or plastic material sleeve 52; col 3 ln 51-53; figure 1 and 3-6. Figure 3 shows an exploded view of the components.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to make the resilient elastomeric or plastic material sleeve removable from the cloud chamber in order to obtain access to the distal end of the cloud chamber and the resilient elastomeric or plastic material sleeve for cleaning, maintenance or replacement, since it has been held that it would be obvious to make a component removable if it were considered desirable for any reason to obtain access to an element that the component is applied to, In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Claim(s) 68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Puderbaugh et al. (US 6026807 A) as applied to claim 59 above, and further in view of Conlon et al. (US 20190366018 A1).
Regarding claim 68, Puderbaugh discloses the sealable backpiece of claim 59, but is silent as to wherein at least a portion of the flexible membrane is bowl shaped.
However, Conlon teaches a valved spacer for inhalation device (title; figure 1-23) comprising a sealable backpiece ([0087] MDI adapter 60; figure 16-20) comprising a bowl shaped flexible membrane ([0087] flexible elastomeric wings 66; figure 18 and 20. see figure 16-17 and 20, concave bowl shape of membrane).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the Puderbaugh device to include a bowl shape flexible membrane, as taught by Conlon, as it would have been obvious substitution of one known element for another, using the bowl shape taught by Conlon in place of the cylindrical disc shape of Puderbaugh, and would provide predictable results, preventing prevent dirt, debris, or other foreign material from entering the interior space of the chamber when not in use and/or when an inhaler is not inserted into the MDI aperture (see Conlon [0087]).
Claim(s) 70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Puderbaugh et al. (US 6026807 A) as applied to claim 59 above, and further in view of Von Hollen et al. (US 20110232636 A1).
Regarding claim 70, Puderbaugh discloses the sealable backpiece of claim 59, but is silent as to wherein the flexible membrane comprises silicone.
However, Von Hollen teaches a valved holding chamber (title; figure 1-6) comprising a sealable backpiece([0064] MDI adapter 118; figure 42) including a flexible membrane comprising silicone ([0064] The MDI adapter 118 further includes an alternative flexible inner portion 120 made of a flexible material, such as, without limitation, silicone, rubber, TPE, or foam, among other suitable materials; figure 42-46).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the flexible membrane of Puderbaugh to be made of silicone as it is a known material for forming a flexible inner portion of an MDI adapter, as taught by Von Hollen [0064].
Claim(s) 76-78 is/are rejected under 35 U.S.C. 103 as being unpatentable over Puderbaugh et al. (US 6026807 A) as applied to claim 73 above, and further in view of Durkin et al. (US 6230704 B1).
Regarding claim 76, Puderbaugh discloses the holding chamber of claim 73, wherein the interior space is dimensioned to receive the medicament delivery device when the first and second housing components are in the closed position (In this manner the strap 62 forms a hinge connection to the cloud chamber 50 about which the chamber cap 60 is swingable in the direction of the arrow shown in FIG. 4, and shown open in FIG. 6, to provide access to the interior of the chamber 50 for storing the medication container 10 and holder 15 when they are not in use; col 4 ln 25-30; figure 5) but is silent as to wherein at least one or both of the first and second housing components comprises an engagement member disposed in the interior space, wherein the engagement member is adapted to engage a medicament delivery device disposed in the interior space.
However, Durkin teaches an inhalation device (title; figure 1) wherein the inner surface of the housing 11 is provided with a number of inwardly projecting ribs 49 which serve to locate the medicament container 12 centrally within the housing 11 (col 5 ln 6-10; figure 3-5 and 8; Examiner Annotations 2).
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Examiner Annotations 2
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inner surface of spacer of Puderbaugh to implement inwardly projecting ribs in order to locate the medicament container as taught by Durkin col 5 ln 6-10. Since the container 10 and holder 15 of Puderbaugh are held in the cloud chamber 50 and the holder 15 is partially held in the chamber cap 60 (see figure 5-6), one of ordinary skill in the art would implement a set inwardly projecting ribs of Durkin in the cloud chamber 50 and a set inwardly projecting ribs in the chamber cap 60 in order to effectively secure the container 10 and holder 15, thereby preventing any rattling of the medicament delivery device.
Regarding claim 77, modified Puderbaugh teaches the holding chamber of claim 76, wherein the engagement member comprises a first rib (inwardly projecting ribs 49 of Durkin; Examiner Annotations 2) disposed on the first housing component (see modification above, cloud chamber 50 of Puderbaugh), wherein the first rib is shaped and dimensioned to engage the medicament delivery device (Durkin: the inner surface of the housing 11 is provided with a number of inwardly projecting ribs 49 which serve to locate the medicament container 12 centrally within the housing 11; col 5 ln 6-10; figure 3-5 and 8; Examiner Annotations 2).
Regarding claim 78, modified Puderbaugh teaches the holding chamber of claim 77 further comprising a second engagement member comprising a second rib (inwardly projecting ribs 49 of Durkin; Examiner Annotations 2) disposed on the second housing component (see modification above chamber cap 60 of Puderbaugh), wherein the second rib is shaped and dimensioned to engage the medicament delivery device (Durkin: the inner surface of the housing 11 is provided with a number of inwardly projecting ribs 49 which serve to locate the medicament container 12 centrally within the housing 11; col 5 ln 6-10; figure 3-5 and 8; Examiner Annotations 2).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Snyder et al. (US 7360537 B2) teaches a holding chamber with a backpiece.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mautin I Ashimiu whose telephone number is (571)272-0760. The examiner can normally be reached Monday - Friday, 7:30 a.m. - 4:30 p.m. ET.
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, 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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/M.I.A./Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
