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 Arguments
Applicant’s arguments, see remarks, filed 12/4/25, with respect to traversal of the lack of unity requirement have been fully considered and are persuasive. The lack of unity requirement has been withdrawn.
Election/Restrictions
Applicant's election with traverse of invention 1 in the reply filed on 12/4/25 is acknowledged. The traversal is on the ground(s) that unity of invention is present as shown by the prosecution history. This is found persuasive and the lack of unity requirement is withdrawn.
Claim Objections
Claims 1, 2, 4-8, 15, 17 and 18 are objected to because of the following informalities: The recitation of “human” needs to be removed from claim 1. Claims 2, 4-8, 15, 17 and 18 are included due to their dependency on claim 1, either directly or indirectly. 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 1, 2, 4-8, 15, 17, 18, 31, and 36 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification does not enable the full scope of alternatives and combinations introduced by “and/or” without undue experimentation.
Wands factors analysis:
Breadth of claims: Numerous alternatives and combinations across sterilization, classification, removal/irradiation, single/multiple radiation sources, fractional dosing, acquisition methods, GUI/robotics.
Nature of invention: Multidisciplinary system (mechanical/fluids, imaging/ML, radiation dosimetry, HMI) where specific parameters are outcome-critical.
State of the art: The record does not identify teachings that supply missing details for all alternatives/combos.
Working examples: No examples showing each key alternative and representative combinations.
Quantity of experimentation: Significant empirical work needed across alternatives/combos; exceeds routine optimization.
The specification fails to enable the full scope of claims 1, 8, 15, 31, and 36 (and any dependent claims thereon). A person skilled in the art, reading the specification, cannot make and use the claimed invention across the breadth of alternatives and their combinations without undue experimentation.
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, 2, 4-8, 15, 17, 18, 31 and 36 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.
With specific regards to claims 1, 8, 15, 31, and 36 are indefinite because they recite multiple limitations joined with “and/or.” For each “and/or” limitation the claim must (under 35 U.S.C. 112(b)) unambiguously inform a person of ordinary skill in the art of the metes and bounds of (i) feature A alone, (ii) feature B alone, and (iii) features A and B together. The claims identified above fail that requirement for the reasons set forth below.
A claim reciting “A and/or B” is only definite if a person skilled in the art, reading the claim in light of the specification, can understand the metes and bounds of A alone, B alone, and A and B together. If the specification does not make these metes and bounds clear, or if A and B are mutually exclusive (such that A and B together cannot sensibly identify a single physical embodiment), the “and/or” phrase renders the claim indefinite under 35 U.S.C. 112(b).
Regarding claim 1, the claim permits numerous permutations of operations (sterilization, classification, removal, irradiation) joined with “and/or.” The scope of each combination (e.g., sterilization + classification together) and the metes and bounds of how these operations combine are not set forth in the claim itself, and the instant disclosure does not clearly identify embodiment(s) showing each alternative in combination.
For example, the limitation that permits both “removing an individual insect if determined to be of a first sex and/or irradiating said individual insect if determined to be of a second sex” raises a clarity problem: a person of ordinary skill, reading the claim in light of the specification cannot understand the metes and bounds of a single insect being both removed if determined to be a first sex and irradiating a single insect if determined to be a second sex at the same time, and the instant disclosure does not clearly identify this combined embodiment.
The other combinations in claim 1 are also similarly indefinite for the same reasons as discussed above.
Furthermore, in the instance that every alternative is a combination: a person of ordinary skill, reading the claim in light of the specification cannot understand the metes and bounds of sterilization, classification, classification with verification, removal, irradiation, sterilization with one radiation source, sterilization with two radiation sources and fractional dose sterilization all at the same time, and the instant disclosure does not clearly identify this combined embodiment.
Claim 8 recites a long list of alternative operations joined by multiple “and/or” recitations, which renders claim 8 indefinite for similar reasons as discussed in claim 1 above.
The obtaining steps as recited in claim 15 are mutually exclusive steps and the combined steps renders claim 15 indefinite, for similar reasons as discussed in claim 1 above.
Claim 31 recites many different combinations of apparatus elements (camera + robot actuated device, robot + radiation source, etc.), these combinations render claim 31 indefinite, for similar reasons as discussed in claim 1 above.
The operation steps of the GUI in claim 36 are mutually exclusive steps and the combined steps renders claim 36 indefinite, for similar reasons as discussed in claim 1 above.
For the reasons set forth above, the above-identified claims recite limitations joined by “and/or” without clearly defining the metes and bounds of each combination in the claim as read in light of the specification, the claims are indefinite under 35 U.S.C. 112(b). The claims do not reasonably apprise the public of the scope of the claimed invention.
Claims 2, 4-7, 17 and 18 are included in this rejection as they depend either directly or indirectly on the claims listed above and therefore inherit the indefiniteness issues and they also do not remedy the indefiniteness issues.
Allowable Subject Matter
Claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(a) & 112(b), set forth in this Office action.
Claims 2, 4-8, 15, 17, 18, 31 and 36 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) and 112(b), set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 30, 43 and 44 are allowed.
See Reasons for Allowance in the Non-Final Office Action dated 11/21/24.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT W HODGE whose telephone number is (571)272-2097. The examiner can normally be reached M-F 8-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Thomas can be reached at (571) 272-8004. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT W HODGE/ Supervisory Patent Examiner, Art Unit 3654