Prosecution Insights
Last updated: October 25, 2026
Application No. 19/119,527

DEVICE AND METHOD FOR GENERATING A RADIOLABELED DRY AEROSOL

Non-Final OA §112
Filed
Apr 09, 2025
Priority
Oct 14, 2022 — DE 10 2022 127 030.0 +1 more
Examiner
PENG, BO JOSEPH
Art Unit
3797
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Almedis Altmann GmbH
OA Round
1 (Non-Final)
70%
Grant Probability
Favorable
1-2
OA Rounds
2y 0m
Est. Remaining
83%
With Interview

Examiner Intelligence

Grants 70% — above average
70%
Career Allowance Rate
541 granted / 778 resolved
-0.5% vs TC avg
Moderate +14% lift
Without
With
+13.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
44 currently pending
Career history
826
Total Applications
across all art units

Statute-Specific Performance

§101
8.3%
-31.7% vs TC avg
§103
42.3%
+2.3% vs TC avg
§102
14.2%
-25.8% vs TC avg
§112
29.1%
-10.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 778 resolved cases

Office Action

§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 . 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 1, 7 and dependent claims thereafter 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. The Examiner cannot find any apparatus in Applicant’s possession to support the “control unit,” and “a current pulse generator.” The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 1 and dependent claims thereafter 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. In re claim 1, it is unclear what the metes and bound “suitable for …” are. Who determines and what guidance are used to determine what is suitable? It is unclear what a flash heating is. It is unclear what is “which can then be passed” referring to. Is it for the particles, or something else like carbon crucible. It is unclear what the metes and bounds of “which can then be passed from” are. Is this an intended use function or is it a necessary function of this apparatus or another apparatus? It is unclear what apparatus a control unit is. It is unclear what the metes and bounds of “is characterized in that” are. Is it a necessary function or a capability that something is capable of? The filing volume lack antecedent basis. It is unclear what is the relationship between “a probe,” “a vacuum pump,” “an air compressor,” “a camera,” “a gamma counter,” “at least one battery …,” “an inverter,” “an intelligent power electronics unit,” and the combustion chamber or the apparatus. Applicant only claims an apparatus that is “for” or “is capable of doing” without reciting any structure relationship, i.e. to the combustion chamber. So can a combustion chamber just happen to be in some vicinity as a probe that is capable of doing “measuring the oxygen content in the combustion chamber”? Like a probe on a shelf? It is unclear what the metes and bounds of “at least one battery and/or powercap/buffer capacitor and/or high-performance capacitor are. What is Applicant claiming? At least one battery, or at least one powercap, or at least one buffer capacitor, etc.? Or at least one of: battery, powercap, buffer capacitor, high performance capacitor. Furthermore, what is high-performance capacitor? How high is high performance? The amount of radioactivity lacks antecedent basis. The direct current lacks antecedent basis. It is unclear what “which is configure to analyze” is referring to. Is the transformer? Or the apparatus with transformer? Or the intelligent power electronics unit? Is the sine wave the same sine wave in “an alternating voltage sine wave? Is AC voltage referring to an alternating voltage in the whole term an alternating voltage sine wave? An alternating voltage is Different than an alternating voltage sine wave. It is unclear what the AC voltage of the grid current is. The grid current lacks antecedent basis. The mains current lacks antecedent basis. What is a “mains current”? The increase in radioactivity lacks antecedent basis. “The produced radioactive dry aerosol” is NOT the same as “producing a radioactively labeled dry aerosol.” If Applicant intends to have the same name, then keep them the same. If they are different, then Applicant need to clearly state that they are different. Limitations of “preferably exhibits a standard frequency of 50 - 60 Hz and the AC voltage of the mains current is preferably 100 to 400 volts, preferably 110 - 260 volts, in particular 230 volts” is unclear. What is preferably? Who determines what is preferably? What does exhibit mean? Something could happen but is not necessary? What is a standard frequency? What is standard? A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation 100 to 400 volts, and the claim also recites 110-260, and then 230 volts which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. In re claim 5, it is also unclear what the metes and bounds “exhibit” are. In re claim 6, it is unclear what the scope of “preferably” are. It is unclear what “looping-in” with quotation mark mean. Furthermore, the Spec only teach “looping” but not “looping-in.” So what is “looping-in”? And how is it different that “looping”? And claim 6 is also a broad range or limitation together with an narrow range or limitations with words “preferably.” In re claim 7, it is unclear if claim 7 is using all and complete limitation of claim 1 with the same apparatus. “providing an apparatus” is not the same as providing THE apparatus of claim 1. It is unclear if this a new and different apparatus. It is unclear what the metes and bounds of “a breathing test (pre-breathing)” are. Is it just a pre-breathing test? What’s the meaning of the bracket? The patient lacks antecedent basis. What is their referring to? What is camera-monitored filling .. mean? Does it mean monitoring the filling of a carbon crucible .. with the camera? The air lacks antecedent basis. Claim 1 has an air compressor, not air. The outflowing air also lacks antecedent basis. It is unclear when “preheating” the carbon crucible take place. Claim 1 already claims a radioactively labeled dry aerosol, then what is this same term in claim 7 use for? It is unclear what “either by .. by .. by” mean. Normaly, either is used for one of two choices. Now we have three choices. Furthermore, there are multioples of “and,” “/,” “or” in either … by … by …by” phrase. It is confusing. The inrush load lacks antecedent basis. It is unclear what the metes and bounds of “favorable ‘point” are. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation less than 2 seconds, and the claim also recites 1.8 seconds, and then 1.2 seconds which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claim 1 has a radioactivity sensor, now claim 7 also has a radioactivity sensor. Are they the same or different? What’s the scope of “preferably”? Optionally? What’s the scope of “optional monitoring”? They are possible further limiting ranges in the same broader range claim. Similarly for claim 9, “preferably” is unclear. And “means of pulse” is unclear. It is unclear what the scope of “means” are. Is it a structure interpretation or a functional guidance? Claim 10, if which is referring to “flow meter,” then define as wherein the flow meter measures. However, claim 1 has a flow meter. Claim 10 depends from claim 7 and claim 7 includes the apparatus of claim 1. Then we have TWO flow meters? The inhaled volume per breaths lacks antecedent basis. In re claim 12, what’s the scope of “integrating”? In re claim 13, what’s the scope of “can be connected”? Is that intended use or a capability? In re claim 15, it is unclear what the metes and bounds of “preferably exhibit” are. The seal lacks antecedent basis. In re claim 18, does “drying of” mean the acting to dry? Claims 1 and dependent claims thereafter 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 pre-AIA the applicant regards as the invention. Claim limitation: “a current pulse generator …;” recited in claims 1 and dependent claims thereafter has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “generator” coupled with functional language “enables” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. Claim element a is an limitation that invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to clearly link or associate the disclosed structure, material, or acts to the claimed function such that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function. It is unclear what the structure would be for each of the claim element above. It is unclear whether they are circuits, processor, software, etc. For the purpose of the examination, examiner interprets as processor circuits or the like. Applicant may: (a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph; or (b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the claimed function, without introducing any new matter (35 U.S.C. 132(a)). If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function applicant should clarify the record by either: (a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or (b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181. Claim limitation “means for” in claims 6 has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it follows with functional language “bringing” but is unsure if it is modified by the structure, the carbon crucible or electrical contacts. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may: (a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function; (b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function; (c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or (d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Tsang et al.(US 2005/0106098) teaches an apparatus for producing a radioactively labeled dry aerosol comprising: a carbon crucible with an open cavity suitable for filling with radioactive nuclide (0061, 0064), a combustion chamber which is suitable for holding a carbon crucible (0051, quartz tube), a control unit, wherein the apparatus is characterized in that the filling volume of the carbon crucible is at least 0.1 mL - 1 mL (0059), and the apparatus further comprising: a camera that enables the filling of the carbon crucible to be monitored (0015), a gamma counter which is capable of measuring a change in the amount of radioactivity in the carbon crucible and/or the combustion chamber (0015), Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO JOSEPH PENG whose telephone number is (571)270-1792. The examiner can normally be reached Monday thru Friday: 8:00 AM-5:00 PM EST. 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, ANNE M KOZAK can be reached at (571) 270-0552. 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. /BO JOSEPH PENG/Primary Examiner, Art Unit 3797
Read full office action

Prosecution Timeline

Apr 09, 2025
Application Filed
Aug 27, 2026
Non-Final Rejection mailed — §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
70%
Grant Probability
83%
With Interview (+13.6%)
3y 7m (~2y 0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 778 resolved cases by this examiner. Grant probability derived from career allowance rate.

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