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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-28, in the reply filed on 2/6/2026 is acknowledged.
Claims 29-42 are withdrawn (cancelled by Applicant) from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/6/2026.
Response to Amendment
This office action is in response to the amendment filed 2/6/2026. As directed by the amendment, claims 29-42 have been cancelled. As such, claims 1-28 are pending in the instant application.
Applicant did not address the previous claim objections/warnings regarding unclear/inconsistent subject matter; the claims stand objected to and rejected as detailed below.
Claim Objections
Claims 5-14 and 18-28 are objected to under 37 CFR 1.75(c) as being in improper form because they are multiple dependent claims that depend on other multiple dependent claims, i.e. claims 3, 5-13 and 17-27. See MPEP § 608.01(n). Accordingly, the claims 5-14 and 18-28 have not been further treated on the merits.
Claims 1, 3, 4 and 15-17 are objected to because of the following informalities:
Claim 1, line 13 should read “spaced apart”
Claim 1, line 16 appears to have an extra space between ‘each’ and ‘are’
Claim 1, line 17 should read “with the capsule” because it is clearly referring to the aforementioned capsule of lines 3/8/9
Clam 3, line 6 should read “is configured to direct
Claim 3, line 9 should read “airflow…does not cross” for grammatically correctness
Claim 4, line 1 should read “inhaler of
Claim 4, line 2 should read “is configured to be directed” to make it clearer that an improper method step is not being recited in an apparatus claim
Claim 4, line 3 would have clearer antecedent basis if it were to read “the first and second pairs”, because the “at least four” language in claim 1 leaves room for the presence of other pairs
Claim 15, line 13 should read “spaced apart”
Claim 15, line 16 appears to have an extra space between ‘each’ and ‘are’
Claim 15, line 17 should read “with the capsule” because it is clearly referring to the aforementioned capsule of lines 3/7/8
Claim 15, line 20 should read “the first pair…is” for grammatically correctness
Claim 15, line 21 should read “the second pair…is” for grammatically correctness
Claim 16, line 4 should read “is configured to direct
Claim 16, lines 7-8 should read “airflow…does not cross” for grammatically correctness
Claim 16, lines 20 and 21 should read “pair of
Claim 17, line 2 should read “is configured to be directed” to make it clearer that an improper method step is not being recited in an apparatus claim
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 15-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 15 (and thus its dependent claims 16 and 17) and claim 17, the pair of two capsule-directed nozzles of claim 15 are recited as configured to direct airflow into the same capsule segment (“the first pair…direct airflow into a first one of the capsule segments”), but this subject matter is not supported by the specification as originally filed, because each capsule segment (10a/b) is depicted as receiving airflow directly from only a single nozzle at any given time, see instant Figs. 5A-B. Also, this renders the subject matter of claim 17 unsupported, because the instant specification does not disclose two nozzles that direct airflow into the same capsule segment in combination with airflow that does not cross an imaginary centerline. To address these rejections, Applicant could amend claim 15 to read “wherein each of the first pair of the nozzles is sized and configured to direct airflow into a is sized and configured to direct airflow into
Regarding claims 16 and 17, the pairs in claim 15 are described as being two bypass nozzles and two capsule-directed nozzles, whereas the pairs in claims 16 and 17(when dependent on claim 16) are described as each having one bypass nozzle and one capsule-directed nozzle. The assignment of which nozzles are within which pair in claim 15 [which is in conflict with the assignment in the specification as originally filed, see pairs 130p in e.g. instant Fig. 5A] means that “a first nozzle of the second pair…direct airflow only into the second capsule segment/the second nozzle of the first pair…directs airflow across the inner cavity” in claim 16 (dependent on claim 15) and “air flow from each pair of nozzles is directed such that it does not cross an imaginary centerline extending laterally…between the two pairs” in claim 17 (dependent on claim 15 or 16) is not supported in combination by the specification as originally filed, because the assignment in claim 15 conflicts with the assignment in claim 16 as well as with the presence of a centerline between the two pairs in claim 17. To address this rejection, Applicant could either amend claim 15 to recite “wherein one of each of the s of the nozzles is sized and configured to direct airflow into a the other one of each of the s of the nozzles is sized and configured to direct bypass air” OR amend claim 16 to read “a first nozzle of the first pair…direct airflow only into [a] first capsule segment…the second nozzle of the first pair of nozzles…direct airflow only into [a] second capsule segment…a first nozzle of the second pair” while also amending claim 17 to read “
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 3, 4, 16 and 17(when dependent on claim 16) 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 3 (and thus its dependent claim 4) recites the limitation "the first capsule segment" in line 4. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the claim will be considered to read “a first capsule segment.
Claim 3 (and thus its dependent claim 4) recites the limitation "the second capsule segment" in line 5. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the claim will be considered to read “a second capsule segment.
Regarding claims 3 and 4, it is unclear how the result of “whereby airflow from the second nozzles do[es] not cross about the inner cavity” in claim 3 and the non-crossing in claim 4 arises from the claimed or disclosed structure, since the second nozzles are described in claim 3 as “direct[ing] airflow across the inner cavity” (emphasis added) and airflow from the nozzles is depicted as circulating and crossing within the inner cavity in e.g. instant Fig. 5B, and there is no physical boundary disclosed along the line CL in e.g. Fig. 5C that would prevent airflow from crossing. As best understood, for purposes of examination, claim 3 will be considered to read “whereby airflow exiting from the second nozzle of the first pair of nozzles does not cross airflow exiting from the second nozzle of the second pair of nozzles” (i.e. this limitation is concerned with the directions in which the nozzles point, not the airflow once it is in the cavity) and claim 4 will be considered to read “wherein airflow exiting from each pair”.
Claim 16 (and claim 17 when dependent on claim 16) recites the limitation "the first capsule segment" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the claim will be considered to read “a first capsule segment.
Claim 16 (and claim 17 when dependent on claim 16) recites the limitation "the second capsule segment" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the claim will be considered to read “a second capsule segment.
Regarding claims 16 and 17, it is unclear how the result of “whereby airflow from the second nozzles do[es] not cross about the inner cavity” in claim 16 and the non-crossing in claim in claim 17 arises from the claimed or disclosed structure, since the second nozzles are described in claim 16 as “direct[ing] airflow across the inner cavity” (emphasis added) (and see also the issue with the assignment of the nozzles in claim 16 versus claim 15 as discussed above) and airflow from the nozzles is depicted as circulating and crossing within the inner cavity in e.g. instant Fig. 5B, and there is no physical boundary disclosed along the line CL in e.g. Fig. 5C that would prevent airflow from crossing. As best understood, for purposes of examination, claim 16 will be considered to read “whereby airflow exiting from the second nozzle of the first pair of nozzles does not cross airflow exiting from the second nozzle of the second pair of nozzles” (i.e. this limitation is concerned with the directions in which the nozzles point, not the airflow once it is in the cavity) and claim 17 will be considered to read “wherein airflow exiting from each pair”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 already recites “A inhaler…comprising…at least four…nozzles,” such that “the inhaler comprises four nozzles” in claim 2 does not further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Applicant could address this rejection by amending claim 2 to recite e.g. “wherein the at least four longitudinally spaced apart nozzles consists of four nozzles.”
Allowable Subject Matter
Claim 1 is allowable, pending correction of the minor informalities noted in the Claim Objections section above.
Claims 2-4 and 15-17 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(a/b/d) or 35 U.S.C. 112 (pre-AIA ), first, second and/or fourth paragraphs, set forth in this Office action.
The following is an examiner’s statement of reasons for allowance: The closest prior art of Mercandelli (WO 2019/215767 A9; hereinafter “Mercandelli”) only discloses two longitudinally spaced apart nozzles (32) (Figs. 4 and 6a), and while Ventura et al. (US 2018/0036497 A1; hereinafter “Ventura”) teaches four longitudinally spaced nozzles (e.g. Fig. 2F), Ventura does not teach orienting said nozzles in pairs that are positioned and configured to direct airflow into capsule segments and as bypass air as instantly claimed, see e.g. instant Figs. 5A-B. Accordingly, claims 1 and 15 are considered to patentably define over the prior art by reciting the features discussed above in combination with all the other features recited by the claim. Claims 2-4 and 16-17 depend from claim 1 or 15 and are considered patentable by virtue of their dependence from claim 1 or 15.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Additional references regarding inhalers that separate capsules: Colosio (US 2015/0283338 A1); Baillet et al. (US 2013/0152927 A1); Baum et al. (US 4,446,862); Kirk et al. (US 4,860,740); James et al. (US 4,210,140); Abiko et al. (US 4,846,168); Hallworth et al. (US 4,206,758); Martin (EP 0581473 A1); Hisatomo et al. (JP H08103499 A); Iizuka et al. (JP 2006-280676 A). Reference regarding separate airflows for capsule segments: Harris et al. (WO 2015/110832 A1); Hemy et al. (US 2018/0264208 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E DITMER whose telephone number is (571)270-5178. The examiner can normally be reached M 7:30a-3:30p, T/Th 8:30a-2:30p, W 11:30a-4:30p, F 1-4p ET.
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785