Prosecution Insights
Last updated: April 19, 2026
Application No. 18/288,761

PORTABLE COMBINED INHALATION DEVICE SUITABLE FOR VIALS

Non-Final OA §103§112
Filed
Oct 27, 2023
Examiner
SIPPEL, RACHEL T
Art Unit
3785
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Changzhou Zhengyuan Medical Techonlogy Co. Ltd.
OA Round
1 (Non-Final)
53%
Grant Probability
Moderate
1-2
OA Rounds
3y 10m
To Grant
99%
With Interview

Examiner Intelligence

Grants 53% of resolved cases
53%
Career Allow Rate
416 granted / 791 resolved
-17.4% vs TC avg
Strong +57% interview lift
Without
With
+57.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 10m
Avg Prosecution
43 currently pending
Career history
834
Total Applications
across all art units

Statute-Specific Performance

§101
4.1%
-35.9% vs TC avg
§103
46.6%
+6.6% vs TC avg
§102
18.7%
-21.3% vs TC avg
§112
25.4%
-14.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 791 resolved cases

Office Action

§103 §112
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. Information Disclosure Statement The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. See reference CN111840715A found on page 1 of applicant’s specification. Drawings The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the motor in claim 14 must be shown or the feature canceled from the claim. No new matter should be entered. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. 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 appl icant regards as his invention. Claims 1-15 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 “ if the vial, the connecting device (1), and the atomizing device (2) are connected, one end of the liquid channel (111) communicates with the vial, …” however the “if” statement makes it unclear if the language following is positively claimed. The word “if” is suggested to be changed to --when-- for clarity . Claim 1 recites “the other” in the third to last line, which lacks proper antecedent basis and is suggested to be changed to --another--. Claim 1 recites “the other end” in the last line, however it is unclear if this is referring back to the other end previously recited. The language is suggested to be changed to --another end of the gas channel-- for clarity. Claims 4, 6 and 11 recite “the bottom,” which lacks proper antecedent basis. Claim 6 recites “the process,” which lacks proper antecedent basis. Claims 9, 11 and 12 also recite “if” statements suggested to be changed to --when--. Claim 9 recites “the other end,” however is it unclear if applicant is referring back to the other end in claim 1. The language is suggested to be changed to --another end of the vertical rod-- for clarity. Any remaining claims are rejected as being dependent on a rejected base claim. 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: “an atomizing device” in claim 1 (correspon ding structure includes motor, channel , sheet, see page 11, line 2-4 includes) . 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 § 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. Claim s 1-4 and 10- 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hsieh (WO 2020216254 see English translation provided by examiner ) in view of Papania et al. (2009/0223513) and Anderson (5,934,510) . Regarding claim 1, in fig. 3 Hsieh teaches portable combined inhalation device suitable for vials, wherein the inhalation device comprises: an atomizing device 2 ; and a connecting device 12 detachably connected to the atomizing device ( see threaded connection in fig. 1 ), the connecting device comprising: a support 121 on which an accommodating groove ( space that 11 occupies ) capable of accommodating a vial 11 is formed, and a puncture device 122 that is arranged on the support ( Fig. 3 ) and can puncture a stopper of the vial (Fig. 3 , Page 6, lines 13-15) , but is silent regarding that the stopper is rubber. However, Papania teaches a rubber stopper [0070]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hsieh ’s stopper material with rubber, as taught by Papania, for the purpose of providing an alternate puncturable material having the predictable results of delivering medicament from a vial. The modified Hsieh is silent regarding that the puncture device comprises a liquid channel and a gas channel . However, in fig. 6 Anderson teaches a puncture device comprises a liquid channel 28 and a gas channel 80 (Col. 6, ll. 26-27). 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 Hsieh’s puncture device with the addition of a gas channel, as taught by Anderson, for the purpose of preventing a pressure differential. The modified Hsieh discloses that if the vial, the connecting device, and the atomizing device are connected, one end of the liquid channel communicates with the vial (Fig. 3 Hsieh ) , and the other end communicates with the atomizing device ( Fig. 3 Hsieh ); one end of the gas channel communicates with the vial (Fig. 6, Anderson) , and the other end communicates with air (Fig. 6, Anderson) . Regarding claim 2, the modified Hsieh discloses that the liquid channel has a diameter of 0.4-7 mm (Page 6, lines 26-27), that the liquid channel and gas channel appear to have the same or similar diameters (Fig. 6, Anderson) and that the puncture device length appears to be 2-30 mm based upon the diameter of the liquid channel in fig. 3 of Hsieh, but is silent regarding that puncture device has a length of 2-30 mm, and the liquid channel and the gas channel each independently have a diameter of 0.4-7 mm. However, i t would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the gas channel diameter with a diameter of 0.4-7 mm and a puncture device having a length of 2-30 mm , since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art , and it appears that a gas channel diameter with a diameter of 0.4-7 mm and a puncture device having a length of 2-30 mm would perform equally as well at venting and providing medicament . In re Aller, 105 USPQ 233 . Regarding claim 3, the modified Hsieh discloses that an upper end of the liquid channel and an upper end of the gas channel are integrally formed as a sharp end of the puncture device, or the liquid channel and the gas channel are separately arranged, and the upper end of the liquid channel and the upper end of the gas channel form a sharp end, respectively (Fig. 6, Anderson) . Regarding claim 4, the modified Hsieh discloses that the puncture device is fixedly connected to the support (Fig. 3 Hsieh) , extends upwards from the bottom of the support (Fig. 3 Hsieh) , and is positioned in the accommodating groove (Fig. 3 Hsieh) . Regarding claim 10, the modified Hsieh discloses that an upper-end opening of the gas channel is higher than an upper-end opening of the liquid channel ( Fig. 6 Anderson ). Regarding claim 11, the modified Hsieh discloses that if the connecting device is connected to the atomizing device, a gap facilitating the communication of the gas channel with the air exists between the bottom of the support and the atomizing device (see gap at 82 of Anderson, fig. 6, that extends between a support portion 18 and a dose valve 34, the gap extending through the modified Hsieh’s structure 2 below the support and above the atomizing device 3) . Regarding claim 12, the modified Hsieh discloses that the bottom of the support is provided with a position-limiting block (threads on outside of 12, see fig. 1 Hsieh) ; if the connecting device is connected to the atomizing device, a lower end portion of the position-limiting block abuts against the atomizing device (Fig. 3 Hsieh) . Regarding claim 13, the modified Hsieh discloses that the connecting device is detachably connected to the atomizing device through threads (Fig. 1 Hsieh) . Regarding claim 14, the modified Hsieh discloses that the atomizing device comprises a medicinal liquid channel (C1, fig. 3 Hsieh) , an atomizing sheet 31 arranged in the medicinal liquid channel in an intercepting manner (Fig. 4 Hsieh), when the connecting device is connected to the atomizing device, the liquid channel communicates with the medicinal liquid channel (Fig. 4, Hsieh), but is silent regarding a motor . However, Papania teaches an atomizing device including a motor [0060]. 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 Hsieh’s vibrating actuator with a motor, as taught by Papania, for the purpose of providing an alternate vibrating actuator having the predictable results of atomizing a medicament. Regarding claim 15, the modified Hsieh discloses that the atomizing device is detachably assembled from a plurality of parts (Page 3, 4 th to last paragraph Hsieh) . Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hsieh, Papania and Anderson (5,934,510), as applied to claim 4 above, in further view of Cortez et al. (2008/0224336) . Regarding claim 5, the modified Hsieh is silent regarding that the puncture device is sleeved with a detachable protective sleeve. However, in fig. 2 Cortez teaches a puncture device 114 is sleeved with a detachable protective sleeve 124 [0022] . 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 Hsieh’s puncture device with the addition of a detachable protective sleeve, as taught by Cortez, for the purpose of preventing accidental injury or contamination. Allowable Subject Matter Claims 6-9 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Huang (CN 112058522) directed towards a puncture device, Aneas (5,879,345) directed towards a puncture device, Pittet et al. (2015/0352012) directed towards a puncture device and Yamashita et al. (2006/0057106) directed towards a puncture device. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT RACHEL T SIPPEL whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-1481 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 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, FILLIN "SPE Name?" \* MERGEFORMAT Timothy Stanis can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-5139 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /RACHEL T SIPPEL/ Primary Examiner, Art Unit 3785
Read full office action

Prosecution Timeline

Oct 27, 2023
Application Filed
Mar 20, 2026
Non-Final Rejection — §103, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
53%
Grant Probability
99%
With Interview (+57.2%)
3y 10m
Median Time to Grant
Low
PTA Risk
Based on 791 resolved cases by this examiner. Grant probability derived from career allow rate.

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