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 .
Response to Amendment
This office action is in response to the amendment filed 12/3/2025. As directed by the amendment, claims 1-3, 5-13, 16, 17 and 20 have been amended, claim 4 has been cancelled and claim 21 has been added. As such, claims 1-3 and 5-21 are pending in the instant application.
Applicant has amended the title to be more descriptive; the objection to the specification is withdrawn.
Applicant has amended the claims such that the claimed subject matter is depicted in the drawings; the objection to the drawings is withdrawn.
Applicant has amended the claims to address the majority of the previous objections thereto; any previous objection not maintained below has been withdrawn.
Applicant has amended the claims to clarify the claimed subject matter and provide antecedent basis; the previous rejections of the claims under 35 USC 112(b)/second paragraph are withdrawn.
Response to Arguments
Applicant's arguments filed 12/3/2025 (hereinafter “Remarks”) have been fully considered but they are not persuasive.
Applicant argues on page 8 of Remarks that claim 7 should not have a comma after the preamble because it is followed by the term “which” not “wherein” and claims 8 and 9 were not given a similar objection.
The Examiner apologizes for previously omitting claims 8 and 9 from the objection regarding a comma at the end of the preamble. Both “which” and “wherein” are terms that offset clauses and should be preceded by a comma. The objections to the claims have been updated below.
Applicant alleges on page 11 of Remarks that Jones “discloses a first group of embodiments (Figures 1-7 and 16-18) in which…the inlet for the clean air is not defined by the mouthpiece but is instead simply a hole in the lid,” then states that Jones “gives no detail regarding how inlets for the clean air are formed…appears these inlets are simply created when the lid is opened to access the mouthpiece.”
The Examiner disagrees with these mischaracterizations of Jones. First, the embodiment of Figs. 16-18 is not groupable with those of Figs. 1-7, because no holes are formed in the lid 62 of the embodiment of Figs. 16-18/the lid is not “opened to access the mouthpiece” in the embodiment of Figs. 16-18. Second, regarding the embodiment of Figs. 16-18, Jones para [0047] explicitly states, “pull the mouthpiece toward the right…causing the housing 6 to separate into two parts at a break line 66…movement of the mouthpiece may cause a portion of the mouthpiece to pierce the housing 6 to form an opening…cause the dose chamber 2 to be opened…movement of the mouthpiece 5 may also form other openings in the housing 6, e.g. for a dose chamber inlet passage 24” (emphasis added). Thus, detail is given on how accommodation for an inlet passage 24 is to be formed in embodiment of Figs. 16-18, namely, it is formed in the housing when the mouthpiece is pulled to the right as depicted in Fig. 18, and is suggested to be achievable by piercing the housing because this is the same way the opening through which outlet 52 extends is formed. Therefore, looking to the other embodiments for a suitable location for the dose chamber inlet passage 24 (for which the opening in housing 6 of Fig. 18 is explicitly disclosed as discussed above), an artisan would have obviously looked to the Jones embodiments that depict a dose chamber inlet passage 24, e.g. Fig. 15, and thus placed said dose chamber inlet passage 24 in a similar location, as previously asserted by the Examiner and depicted in Fig. 18 modified below. Therefore, the Examiner maintains that Jones renders obvious exposure of an air inlet to the bowl as claimed and discussed in the maintained/updated rejections below.
Applicant argues on page 12 of Remarks that “the embodiments of the Jones 865 reference either have only three components but do not meet the limitations of the air inlet of the present claims or alternatively require an additional fourth component (beyond the three components of claim 1) to define an air inlet.”
The Examiner disagrees. As discussed above and maintained in the updated rejection below, the embodiment of Jones Fig. 16-18 is taught to include an air inlet passage positioned on the mouthpiece by Jones para [0047] in view of e.g. Jones Fig. 15, see Jones Fig. 18 modified below. Whether or not this constitutes “an additional fourth component” according to Applicant, there is nothing in the claims that excludes the inclusion “an additional fourth component,” and the Examiner asserts that this element is not a “fourth component” but rather is a subcomponent of the mouthpiece/tube (“an inlet to the bowl”), as taught by Jones and as instantly claimed. Therefore, the Examiner maintains that Jones renders obvious a tube providing an air inlet to the bowl as claimed.
Applicant argues on pages 12-13 of Remarks that the result of a combination of Jones Figs. 15 and 18 “would not be a functional inhaler…if the inhaler of Figure 18 were modified as the Examiner argues, the mouthpiece would not be able to slide to the right, because it would be blocked by the sloping wall of the powder chamber...the air inlet would not be exposed…[t]he two embodiments cannot be simply combined without re-designing the inhaler.”
The Examiner disagrees that the inhaler of modified Jones would not be functional or that a “re-design” is necessary. Jones para [0047] clearly indicates that sliding the mouthpiece to the right “form[s] an opening through which the outlet 52 may extend…[m]ovement of the mouthpiece may also form other openings in the housing 6, e.g. for a dose chamber inlet passage 24” (emphasis added); therefore, in the same way an opening is provided for the outlet 52, e.g. by piercing an opening in the right side of the housing in Jones Figs. 17-18, a similar opening (e.g. on the sloping wall) is taught to be provided for the inlet passage 24 depicted in modified Jones Fig. 18 below. This does not require a “re-design;” it only requires the provision of a dose chamber inlet passage 24 and the formation of an associated opening therefor, which is easily achievable through an almost-bodily incorporation of the dose chamber inlet passage 24 of Jones Fig. 15 with Jones Fig. 18, as previously asserted by the Examiner and depicted in Fig. 18 modified below. Therefore, the Examiner maintains that Jones renders obvious an air inlet to the bowl as claimed.
Applicant argues on pages 13-14 that “the Bittigkoffer reference relates to quite a different type of device and is therefore not properly combinable with the Jones 865 reference…it is not even an inhaler.”
In response to applicant's inferred argument that Bittigkoffer is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Bittigkoffer is in the same field of mouthpieces for delivering respiratory therapy as the instant invention, and Bittigkoffer also solves the same problem with which the inventor was concerned, namely, a desirable shape for a mouthpiece for delivering respiratory therapy, particularly one that lends itself to stacking as taught by Horstmann. Applicant has not proffered any convincing reason why the mouthpiece of Bittigkoffer (albeit not that of “an inhaler”) is not “properly combinable” with that of Jones. They both disclose mouthpieces for delivering respiratory therapy, the structures of which are unaffected by the nature of the respiratory therapy. As such, the Examiner maintains that the teachings of Bittigkoffer (in combination with Horstmann) educate Jones to arrive at the contested tube shape, as maintained in the updated rejections below.
Applicant argues on page 14 of Remarks that “the Horstmann reference is a very different type of inhaler than the inhaler of the Jones 865 reference…not properly combinable with either the inhaler of the Jones 865 reference of the PRP device of the Bittigoffer references…relates to a nicotine inhaler…not a dry powder inhaler.”
The Examiner fails to see how the nature of the inhaler of Horstmann has any effect on Horstmann’s teaching that a D-shape with the flat part facing away from a blister bowl allows two blister dispensers to be stacked for simultaneous delivery therefrom. Applicant has not proffered any convincing reason why the orientation of the D-shape taught by Horstmann is not “properly combinable” with the D-shape mouthpiece of Jones in view of Bittigoffer; Jones and Bittigoffer both disclose mouthpieces for delivering respiratory therapy and Horstmann educates the D-shape of a respiratory-therapy-delivering tube (i.e. as taught by Bittigoffer) to be oriented specifically as claimed, i.e. flat side up and away from the bowl, which is unaffected by the nature of the respiratory therapy of Horstmann. As such, the Examiner maintains that the teachings of Horstmann (in combination with Bittigkoffer) educate Jones to arrive at the contested tube shape, as maintained in the updated rejections below.
Applicant argues on page 15 of Remarks that “the sections on either side of the main channel [of Richardson] are air outlets and are not air inlets as required by claim 1.”
The Examiner disagrees. The Examiner respectfully notes that claim 1 does not specify where air from the air inlet sections is “let in” from or directed/“let in” to, e.g. claim 1 does not describe/require any connection between the single “air inlet to the bowl” and the “two air inlet sections” of the tube. Jones teaches bypass openings 23 (Jones para [0047] in view of Jones Fig. 15), which direct/let in bypass air into the mouthpiece, and Richardson educates Jones to associate mouthpiece bypass openings, which are inlets, see the entry flow arrows 15 in Richardson Fig. 1 into bypass air holes 45 of Richardson Fig. 3, with air inlet sections on either side of a central air outlet section as discussed in the maintained/updated rejection below. Therefore, in as far as the bypass openings of Jones and Richardson both allow air into the mouthpiece, they comprehend air inlets, rendering their associated sections “air inlet sections,” and thus meeting the instant claim language. As such, the rejections in view of Richardson are maintained/updated below.
No additional substantive arguments are presented with regards to the rejections of the claims in further view of Beller; as such, the rejections in view of Beller are maintained below.
Claim Objections
Claims 7-13, 16, 17 and 20 are objected to because of the following informalities:
Claims 7-9 should have a comma after the preambles thereof, in keeping with the other claims and for grammatical correctness
Claims 7, 16 and 17, line 2 of each claim (three instances total) should read “between the at least one detachable portion” because it is understood to be referring to that of claim 1, line 6
Claim 10, line 9 should read “and further wherein each tube is divided” for clarity
Claims 11 and 12, the period that was deleted from the end of each claim should be re-included
Claims 12 and 20, line 2 of each claim (two instances total) should read “between the at least one detachable portion” for clearer antecedent basis
Claim 13, line 2 should read “each tube” for clarity
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 8 is 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 8 recites the limitation "The pair of dispensers" in line 1. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, claim 8 will be considered to read “A pair”.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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) 1-3, 7, 8, 14-17 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. (US 2013/0291865 A1; hereinafter “Jones”) in view of Bittigkoffer (EP 3919107 A1; hereinafter “Bittigkoffer”, wherein the citations below refer to the translation provided with the Office Action mailed 9/15/2025), Horstmann et al. (US 2007/0062548 A1; hereinafter “Horstmann”), and Richardson (US 2019/0358414 A1; hereinafter “Richardson”) (and as evidenced by Jones et al. US 2017/0119982 A1; hereinafter “Jones ‘982”).
Regarding claim 1, Jones discloses/teaches/suggests a unit dose dispenser in the form of a blister containing a dry powder for inhalation (Figs. 16-18; paras [0002] and [0047-48]), wherein the blister comprises:
a base material (base 61) in which a cavity is formed (Fig. 18 in view of para [0033]), wherein the cavity comprises a bowl (dose chamber 2) that contains the powder and a channel that opens into the bowl (the channel to the right of dose chamber 2 in Figs. 16-18, in which mouthpiece 5 is located);
a lid material (lid 62), which seals the cavity (Fig. 18 in view of para [0033]); and
at least one detachable portion (the right half of the housing 6 in Jones Fig. 16) (pull the mouthpiece toward the right…causing the housing 6 to separate into two parts at a break line 66, para [0047]; which thus discloses/infers/would have reasonably suggested to an artisan before the effective filing date of the claimed invention that the right portion of the housing in Jones Fig. 16 is detachable from the left portion, because the lead line for break line 66 is clearly misdrawn in Jones Fig. 16, as it should be pointing to the notches that are clearly visible in the middle of Jones Fig. 16 as modified below, in accordance with well-established means for providing the functionality of Jones para [0047], as evidenced by Jones ‘982 Fig. 17 and Jones ‘982 para [0068]) which, when removed from the remainder of the blister, exposes an air inlet to the bowl (the entrance of a dose chamber inlet passageway 24) (see e.g. Jones Fig. 15) and an air outlet from the bowl (at the right end of mouthpiece 5 in Jones Fig. 18) via the channel (Fig. 18; pull the mouthpiece toward the right…causing the housing 6 to separate into two parts at a break line 66…cause the dose chamber 2 to be opened…may also form other openings in the housing 6, e.g. for a dose chamber inlet passage 24, Jones para [0047]);
wherein the channel contains a tube (mouthpiece 5) that has separate sections which provide the air outlet and the air inlet (see e.g. the left section and the right section of the mouthpiece 5, respectively, in Jones Fig. 15, which would have reasonably suggested to an artisan the configuration of modified Jones Fig. 18 below in order to provide the same functionality/arrangement, as taught/suggested by Jones para [0047]), and the air outlet is farther from the bowl than the air inlet (see Jones Fig. 15, which teaches locating the entrance to the inlet passageway 24 of Jones para [0047] immediately to the right of dose chamber 2/in a location that is initially closed by dose chamber 2, see Jones Fig. 18 modified below).
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While Jones further discloses wherein the tube has an upper side which is level with a top of the channel (Jones Fig. 17), Jones is silent regarding wherein said upper side is flat. However, a change in shape is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.IV.B, Bittigkoffer demonstrates that it was well known in the inhaler mouthpiece art before the effective filing date of the claimed invention for a mouthpiece to have at least one flat side (e.g. Fig. 10; top and/or bottom can be designed as a flat or curved surface…[b]oth sides can be designed as flat…shape of duck’s bill…so it can be held comfortably in the mouth…one side can be designed as a flat and the other sides as a curved surface, such as the mouthpiece of a whistle or a recorder, first full para on page 5), and Horstmann teaches that it was known in the inhaler mouthpiece art before the effective filing date of the claimed invention to orient the flat side of a mouthpiece (forming outlet aperture C) on the side opposite the bowl (see the bulge in outer wall 2) of the blister (Figs. 2A-E). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify the mouthpiece of Jones to include wherein the tube has a flat upper side which is level with the top of the channel as taught by Bittigkoffer and Horstmann, in order to provide the predictable results of a mouthpiece that has at least one flat side for increased comfort in the mouth (Bittigkoffer top of page 5) at least when used singly, and wherein the at least one flat side includes the upper side in Jones Fig. 17 in order to allow two blisters to be easily stacked with their flat upper sides facing each other (with dose chambers facing out) to predictably deliver either an increased dose of a single medicament or different medicaments held in the two blisters simultaneously as taught by Horstmann Figs. 2E and Horstmann paras [0067-69].
Jones further teaches the inclusion of two bypass inlets (bypass openings 23) (para [0047] in view of Fig. 15), but modified Jones is silent regarding wherein the tube is divided longitudinally into a central air outlet section and two air inlet sections, one on either side of the central section. However, Richardson teaches that it was known in the inhaler mouthpiece art before the effective filing date of the claimed invention to include wherein the tube/mouthpiece 40 (Fig. 1) is divided longitudinally into a central air outlet section (air channel 35) and two air inlet sections (bypass channels) connected to bypass air holes 45, one on either side of the central section (Figs. 1 and 3). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Jones to include wherein the tube is divided longitudinally into a central air outlet section and two air inlet sections, one on either side of the central section as taught by Richardson, in order to utilize a known construction to predictably accommodate the bypass air taught by Jones.
Regarding claim 2, Jones in view of Bittigkoffer, Horstmann and Richardson teaches the unit dose dispenser according to claim 1, wherein Bittigkoffer and Horstmann further educate modified Jones to include wherein the tube has a semi-circular cross-section and a curved lower side corresponds in size and shape to the channel so that it is held in the channel by an interference fit (Jones Fig. 17 in view of Bittigkoffer top of page 5 and Horstmann Figs. 2A-E), because Jones Figs. 16-17 would have reasonably suggested to an artisan before the effective filing date of the claimed invention a snug fit/that the channel matches the shape of the tube the tube/mouthpiece 5 to avoid leakage, such that the semi-circular tube taught by Bittigkoffer and Horstmann is taught to be held in a similarly shaped channel in modified Jones by an interference fit as claimed, in order to predictably prevent leakage from around the mouthpiece.
Regarding claim 3, Jones in view of Bittigkoffer, Horstmann and Richardson teaches the unit dose dispenser according to claim 1, wherein Jones further teaches wherein the lid material is bonded to the upper side of the tube (mouthpiece and housing may be attached by bonding…attach the foil layer…to the mouthpiece, para [0006]), such that it would it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Jones to include wherein the lid material is (at least temporarily) bonded to the flat upper side of the tube, in order to provide the predictable result of ensuring that the user does not remove the right portion of the housing in Fig. 17 without also concurrently pulling the mouthpiece to the right as described in Jones para [0047].
Regarding claim 7, Jones in view of Bittigkoffer, Horstmann and Richardson teaches the unit dose dispenser according to claim 1, which Jones further discloses/teaches has a line of weakness (break line 66), between the at least one detachable portion and the rest of the blister, wherein the location of the line of weakness is selected from the group consisting of the base material, the lid material, and combinations thereof (see Jones Fig. 16 modified above and Jones para [0047], where the break line is necessarily located in at least one of the base material and the lid material, because these are the two materials that form the housing 6).
Regarding claim 8, it has been held that duplication of the essential working parts of a device involves only routine skill in the art, see MPEP 2144.04.VI.B, and Horstmann further educates Jones in view of Bittigkoffer, Horstmann and Richardson to include [a] pair of dispensers according to claim 1 which are joined together so that the powders in both blisters can be inhaled simultaneously (Jones Fig. 18 in view of Horstmann Figs. 2A-E) as discussed above regarding claim 1, in order to predictably deliver either an increased dose of a single medicament or different medicaments held in the two blisters simultaneously (Horstmann Figs. 2E and paras [0067-69]).
Regarding claim 14, Jones in view of Bittigkoffer, Horstmann and Richardson teaches the unit dose dispenser according to claim 7, wherein Jones further discloses/teaches wherein the line of weakness is comprised of perforations (break line 66 may be formed by a perforation, para [0066]) because it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art, see MPEP 2144.04.VI.B., and a line of weakness formed by a line of multiple perforations would provide the predictable result of an easily tearable line of weakness.
Regarding claim 15, Jones in view of Bittigkoffer, Horstmann and Richardson teaches the unit dose dispenser according to claim 7, wherein Jones further discloses/teaches wherein the line of weakness is comprised of scores (break line 66 may be formed by…scoring, para [0066]) because it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art, see MPEP 2144.04.VI.B., and a line of weakness formed by a line of multiple scores would provide the predictable result of an easily tearable line of weakness.
Regarding claims 16 and 17, Jones in view of Bittigkoffer, Horstmann and Richardson teaches the unit dose dispenser according to claim 1 and claim 7, which Jones further discloses has an at least one notch (see the notches in Jones Fig. 16 modified above and discussed in Jones para [0047]) between the at least one detachable portion and the rest of the blister, wherein the location of the at least one notch is selected from the group consisting of a first edge (e.g. top edge in Jones Fig. 16) of the base material, the first edge of the base material and a second edge (e.g. the bottom edge in Jones Fig. 16) of the base material, a first edge (e.g. top edge in Jones Fig. 16) of the lid material, the first edge of the lid material and a second edge (e.g. the bottom edge in Jones Fig. 16) of the lid material and combinations thereof (see Jones Fig. 16 modified above and Jones para [0047], where the notches are located in the edges of at least one of the base material and the lid material, because these are the two materials that form the housing 6/are present in the locations of the notches in Jones Fig. 16).
Regarding claim 21, Jones in view of Bittigkoffer, Horstmann and Richardson teaches the unit dose dispenser in the form of a blister containing a dry powder for inhalation of claim 1, wherein Jones further discloses wherein the lid material is a foil or foil laminate (para [0033]).
Claim(s) 9-13 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jones in view of Bittigkoffer, Horstmann and Richardson as applied to claim 1 above, and further in view of Beller (US 2017/0312458 A1; hereinafter “Beller”).
Regarding claim 9, Jones in view of Bittigkoffer, Horstmann and Richardson teaches the unit dose dispenser according to claim 1, but modified Jones is silent regarding a strip comprising a plurality of dispensers according to claim 1 which provide a multi-day supply of powder, wherein each dispenser is detachable from the rest of the strip. However, it has been held that duplication of the essential working parts of a device involves only routine skill in the art, see MPEP 2144.04.VI.B., and Beller teaches that it was known in the inhaler art before the effective filing date of the claimed invention to provide a strip (comprising film 10) (Fig. 16) comprising a plurality of dispensers (parts 1) which provide a multi-day supply of powder (the dispensers are fully capable of providing this intended use, as they each include a supply of powder which is fully capable of corresponding to a day supply, and it would have been obvious to an artisan before the effective filing date of the claimed invention for each dispenser to include a day supply depending on therapy needs), wherein each dispenser is detachable from the rest of the strip (Fig. 16; para [0082]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Jones to include a strip comprising a plurality of dispensers according to claim 1 which provide a multi-day supply of powder, wherein each dispenser is detachable from the rest of the strip as taught by Beller, in order to provide the predictable result of a standard batched manufacturing method for speed of production and/or convenient multi-day dosing packaging.
Regarding claim 10, Jones in view of Bittigkoffer, Horstmann, Richardson and Beller teaches a process for producing unit dose dispensers (see claim 9 discussion above) according to claim 1 (see claim 1 discussion above), the process comprising:
forming cavities in a base material (base 61) (Jones Fig. 18 in view of Jones para [0033], with multiple cavities in the same strip of base material taught in view of Beller Fig. 16 as discussed above regarding claim 9), each cavity comprising a bowl (dose chamber 2), and a channel that opens into the respective bowl (the channel to the right of dose chamber 2 in Jones Figs. 16-18, in which mouthpiece 5 is located);
filling a powder (dose 3) into the respective bowls (Jones Fig. 18 and Jones paras [0031] and [0055], in view of the multiple cavities/bowls taught in view of Beller);
placing a tube (mouthpiece 5) that has separate sections which provide an air outlet and an air inlet into each channel (see e.g. the left section and the right section of the mouthpiece 5, respectively, in Jones Fig. 15, which would have reasonably suggested to an artisan the configuration of modified Jones Fig. 18 above in order to provide the same functionality/arrangement, as taught/suggested by Jones para [0047]), wherein each air outlet is farther from the respective bowl than each air inlet (see Jones Fig. 15, which teaches locating the entrance to the inlet passageway 24 of Jones para [0047] immediately to the right of dose chamber 2/in a location that is initially closed by dose chamber 2, see Jones Fig. 18 modified above) and wherein each tube has a flat upper side which is level with the top of the respective channel (Jones Fig. 17 in view of the teachings of Bittigkoffer and Horstmann regarding a flat upper side as discussed above regarding claim 1) and further wherein the tube is divided longitudinally into a central air outlet section and two air inlet sections, one on either side of the central section (see claim 1 discussion above in view of Richardson);
sealing each cavity with a lid material (lid 62) (Jones Figs. 16 and 18 in view of para Jones [0033] and in view of the multiple cavities taught in view of Beller), because it would have been obvious to an artisan before the effective filing date of the claimed invention to batch-produce the cavities of modified Jones and seal them with a single lid material that is subsequently divided into the individual dose dispensers, in order to predictably utilize standard batch production techniques for speed of production; and, simultaneously or in either order:
forming at least one detachable portion (the right half of the housing 6 in Jones Fig. 16) (pull the mouthpiece toward the right…causing the housing 6 to separate into two parts at a break line 66, para [0047]; which thus discloses/infers/would have reasonably suggested to an artisan before the effective filing date of the claimed invention that the right portion of the housing in Jones Fig. 16 is detachable from the left portion, because the lead line for break line 66 is clearly misdrawn in Jones Fig. 16, as it should be pointing to the notches that are clearly visible in the middle of Jones Fig. 16 as modified above, in accordance with well-established means for providing the functionality of Jones para [0047], as evidenced by Jones ‘982 Fig. 17 and Jones ‘982 para [0068]) which, when removed from the remainder of an associated unit dose dispenser, exposes an associated air inlet and an associated air outlet (Jones Fig. 18; pull the mouthpiece toward the right…causing the housing 6 to separate into two parts at a break line 66…cause the dose chamber 2 to be opened…may also form other openings in the housing 6, e.g. for a dose chamber inlet passage 24, Jones para [0047]);
cutting the base and lid materials to form individual dispensers, or pairs of dispensers, or strips with a plurality of dispensers (Beller para [0082]), because cutting would have been an obvious means by which to predictably achieve the separation taught by Beller, in order to utilize a standard, well-known process for dividing the batch-produced dispensers as desired.
Regarding claim 11, Jones in view of Bittigkoffer, Horstmann, Richardson and Beller teaches the process according to claim 10, wherein Jones further discloses wherein the at least one detachable portion is formed by creating a line of weakness (break line 66), wherein the location of the line of weakness is selected from the group consisting of the base material, the lid material, and combinations thereof (see Jones Fig. 16 modified above and Jones para [0047], where the break line is necessarily located in at least one of the base material and the lid material, because these are the two materials that form the housing 6).
Regarding claims 12 and 20, Jones in view of Bittigkoffer, Horstmann, Richardson and Beller teaches the process according to claim 10 and claim 11, wherein Jones further discloses wherein the at least one detachable portion is formed by creating at least one notch (see the notches in Jones Fig. 16 modified above and discussed in Jones para [0047]) between the [at least one] detachable portion and the rest of an associated unit dose dispenser, wherein the location of the at least one notch is selected from the group consisting of a first edge (e.g. top edge in Jones Fig. 16) of the base material, the first edge of the base material and a second edge (e.g. the bottom edge in Jones Fig. 16) of the base material, a first edge (e.g. top edge in Jones Fig. 16) of the lid material, the first edge of the lid material and a second edge (e.g. the bottom edge in Jones Fig. 16) of the lid material and combinations thereof (see Jones Fig. 16 modified above and Jones para [0047], where the notches are located in the edges of at least one of the base material and the lid material, because these are the two materials that form the housing 6/are present in the locations of the notches in Jones Fig. 16).
Regarding claim 13, Jones in view of Bittigkoffer, Horstmann, Richardson and Beller teaches the process according to claim 10 wherein Jones further teaches comprising bonding the lid material to the upper side of [each] tube (mouthpiece and housing may be attached by bonding…attach the foil layer…to the mouthpiece, para [0006]), such that it would it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Jones to include (at least temporarily) bonding the lid material to the flat upper side of each tube, in order to provide the predictable result of ensuring that the user does not remove the right portion of the housing in Jones Fig. 17 without also concurrently pulling the mouthpiece to the right as described in Jones para [0047].
Regarding claim 18, Jones in view of Bittigkoffer, Horstmann, Richardson and Beller teaches the process according to claim 11, wherein Jones further discloses/teaches wherein the line of weakness is comprised of perforations (break line 66 may be formed by a perforation, para [0066]) because it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art, see MPEP 2144.04.VI.B., and a line of weakness formed by a line of multiple perforations would provide the predictable result of an easily tearable line of weakness.
Regarding claim 19, Jones in view of Bittigkoffer, Horstmann, Richardson and Beller teaches the process according to claim 11, wherein Jones further discloses/teaches wherein the line of weakness is comprised of scores (break line 66 may be formed by…scoring, para [0066]) because it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art, see MPEP 2144.04.VI.B., and a line of weakness formed by a line of multiple scores would provide the predictable result of an easily tearable line of weakness.
Allowable Subject Matter
Claims 5 and 6 are 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.
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.
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785