Prosecution Insights
Last updated: April 19, 2026
Application No. 19/274,924

STEREOTACTIC MBI-GUIDED BIOPSY USING A VARIABLE-ANGLE SLANT-HOLE COLLIMATOR

Final Rejection §101§112
Filed
Jul 21, 2025
Examiner
SAKAMOTO, COLIN T
Art Unit
3798
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Smart Breast Corporation
OA Round
2 (Final)
66%
Grant Probability
Favorable
3-4
OA Rounds
3y 6m
To Grant
91%
With Interview

Examiner Intelligence

Grants 66% — above average
66%
Career Allow Rate
307 granted / 465 resolved
-4.0% vs TC avg
Strong +25% interview lift
Without
With
+25.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
17 currently pending
Career history
482
Total Applications
across all art units

Statute-Specific Performance

§101
6.0%
-34.0% vs TC avg
§103
38.8%
-1.2% vs TC avg
§102
15.5%
-24.5% vs TC avg
§112
32.4%
-7.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 465 resolved cases

Office Action

§101 §112
FINAL REJECTION 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 On 2/20/2026, Applicant submitted an amendment to the application which contains remarks/arguments. It is noted that the amendment does not contain an amended claim set; the claims remain unchanged since the previous Office Action. 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. Claims 1-7 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claim 1 recites in part “wherein the electronic circuitry is configured to control the slant angles of the VASH collimator” (limitation “A”) and then further recites “wherein the VASH collimator is positioned such that the two different slant angles are in a plane generally parallel to a coronal plane of the patient” (limitation “B”). It is unclear to the ordinarily skilled artisan how to interpret limitation B. For example, it is unclear whether limitation should be construed as: (1) a structural limitation of the collimator itself; i.e., necessarily requiring that the two different slant angles be in particular angle or range of angles (in this case, specifically in a plane generally parallel to a coronal plane of a patient), (2) a limitation of the election circuitry; i.e., further limiting limitation A (in this case, that the electronic circuitry is configured to control slant angles to be in a plane generally parallel to a coronal plane of a patient), or (3) a recitation of intended use; i.e., not given patentable weight beyond the capability of the VASH collimator to be positioned such that the two different slant angles are in a plane generally parallel to a coronal plane of a patient. It is noted however, that none of the aforementioned options appear to be a good fit because interpretation (1) seems to imply a subject matter eligibility issue by indirectly claiming a human organism, interpretation (2) does not seem to be supported by the Specification as originally filed, and interpretation (3) does not seem to meaningfully limit the claimed invention. Since the claim is written in an ambiguous manner giving rise to three differing interpretations of different claim scope and the evidence of record does not appear to favor any one interpretation over the others, the ordinarily skilled artisan would not be reasonably apprised of the metes and bounds of the claimed invention. Dependent claims thereof inherit the aforementioned indefiniteness by virtue of their dependency on claim 1 and therefore are rejected for the same reason. Claim 2 recites similar language to that of limitation B but further recites a specific range of “within 30 degrees”. The discussion above regarding claim 1 similarly applies to claim 2; i.e., in it unclear whether the limitation of claim 2 should be interpreted as a structural limitation of the collimator itself, a limitation of the electronic circuitry, or a recitation of intended use. Response to Arguments Applicant's arguments filed 2/20/2026 have been fully considered but they are not persuasive. Applicant argues against the §112(b) rejection. Applicant describes the structure and operation of the VASH collimator. Furthermore, Applicant states, in particular, the following: “The position of the VASH collimator in a molecular imaging system including the VASH collimator thus determines the orientation of the slant angles relative to the patient, when the patient is placed in connection with the system. In the presently claimed system, the VASH collimator is positioned within the system such that the two different slant angles are in a plane generally parallel to a coronal plane of the patient. The coronal plane of the patient is illustrated in FIG. 4A. As, for example, described in paragraph [0064] of the specification, the slant angle of the VASH collimator may, for example, be controlled via a software command from the electronic circuitry of the system hereof.” Examiner response: This is not found to be persuasive. Applicant’s explanation does not disambiguate the scope of the claims because Applicant has not actually amended the claim to make clear which one of the three aforementioned interpretations1 the scope of the claim was intended to have. Even if, for argument’s sake, interpretation (2) is excluded from being considered a reasonable possibility (especially since interpretation (2) seems to lack §112(a) written description support), it still leaves the ambiguity as to which of the possible remaining interpretations --(1) or (3)-- the claim should be treated as. For example, from a grammatical point of view: It is unclear whether the limitation in question should be treated as describing the state of the collimator itself in the grammatical form of “[subject/noun] [linking verb] [predicative adjective or predicative adjective phrase]”. Grammatical examples include: The chicken is fried (not grilled). The paint is black. He is broken. You look tired. The collimator is positioned such that the two different slant angles are in a plane generally parallel to a coronal plane of a patient. In other words, is the phrase “positioned such that…” an adjective phrase that describes the collimator via the linking verb “is”? Otherwise, it is unclear whether the limitation in question should instead be treated as a narrative such as procedural or operational step in the form of “[subject/noun] [verb: present tense, passive voice, indicative mood]” Grammatical examples include: A car wash procedure in passive voice: The vehicle is pulled into the bay by the conveyor belt. While in the bay, the vehicle is washed by the brush rollers. Then, the vehicle is dried by the blowers. An imaging procedure in passive voice: The patient is registered by an intake nurse and logged into the PACS workflow. The patient is brought into the imaging room by a rad tech. The patient is told by the rad tech to stand next to the imaging machine, the imaging machine includes a collimator having two different slant angles. The collimator is positioned such that the two different slant angles are in a plane generally parallel to a coronal plane of the patient. The patient is imaged by the imaging machine under the control of the rad tech. In other words, is the phrase “is positioned such that…” a verb (present tense, passive voice, indicative mood) thereby implying a procedural and operational step? It is noted that the former grammatical case would therefore imply interpretation (1) and the latter grammatical case would therefore imply interpretation (3). As discussed above, interpretations (1) and (3) lead to significant difference in claim scope. Therefore, the grammatical ambiguity in this case can lead to an ambiguity in claim scope. Further, the examiner notes that even if, for argument’s sake, we look past the aforementioned ambiguity issue, interpretations (1) and (3) each individually have problematic aspects: Interpretation (1) would seem to include the patient as part of the scope of the claimed invention2 because it requires the collimator to be in a certain position relative to the patient. Stated from another point of view, this is same as requiring the patient to be in a certain position relative to the collimator. In this sense, if the patient doesn’t exist, then the collimator isn’t in the required position. Therefore, the patient himself/herself is implicitly a requirement of the claim and therefore indirectly part of the claimed invention. The examiner is not certain, but this does not appear to be what Applicant intended. Even if, for argument’s sake, the patient himself/herself is not considered not part of the claimed invention, limitation in question would at best still be a reference to unclaimed/variable object (the patient) where its relationship is not sufficiently defined (see MPEP 2173.05(b)) leading to absurd situations where infringement of an apparatus/machine claim depends on how the structure is used instead of purely the structure itself. Again, the examiner is not certain, but this does not appear to be what Applicant intended. So, if not Interpretation (1), what about interpretation (3)? Interpretation (3) does not seem to be meaningful in that interpreting the limitation as a recitation of “intended use” would mean that the claim does not actually require the collimator to be in the specific position recited in the claim; rather, it only requires that the collimator be capable of being positioned there. However, this begs the question, why include an unmeaningful limitation in the first place? The examiner is not certain, but this does not appear to be what Applicant intended. The ordinarily skilled artisan would not be able to reasonably disambiguate the ambiguity short of rewriting the claim. Even if, for argument’s sake, the ordinarily skilled artisan could improperly rewrite the claim in his/her head using improper speculation, he/she wouldn’t even know where to start since none of the aforementioned interpretations seem to fit. Since the ordinarily skilled artisan would not be reasonably apprised of the metes and bounds of the claim, the claim is therefore rejected under §112(b) as being indefinite. Examiner Remarks MPEP 2173.06 recites in part: II. PRIOR ART REJECTION OF CLAIM REJECTED AS INDEFINITE All words in a claim must be considered in judging the patentability of a claim against the prior art. In re Wilson, 424 F.2d 1382, 165 USPQ 494 (CCPA 1970). The fact that terms may be indefinite does not make the claim obvious over the prior art. When the terms of a claim are considered to be indefinite, at least two approaches to the examination of an indefinite claim relative to the prior art are possible. First, where the degree of uncertainty is not great, and where the claim is subject to more than one interpretation and at least one interpretation would render the claim unpatentable over the prior art, an appropriate course of action would be for the examiner to enter two rejections: (A) a rejection based on indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph; and (B) a rejection over the prior art based on the interpretation of the claims which renders the prior art applicable. See, e.g., Ex parte Ionescu, 222 USPQ 537 (Bd. App. 1984). When making a rejection over prior art in these circumstances, it is important for the examiner to point out how the claim is being interpreted. Second, where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims. The first approach is recommended from an examination standpoint because it avoids piecemeal examination in the event that the examiner’s 35 U.S.C. 112, second paragraph rejection is not affirmed, and may give applicant a better appreciation for relevant prior art if the claims are redrafted to avoid the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph rejection. There is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of the claims as discussed above and therefore it would not be proper to reject the claims on the basis of prior art. Any attempt to reject the claims in their current form on the basis of prior art would necessarily be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as the scope of the claim (e.g., whether limitation B should be interpreted as a structural limitation of the collimator itself, a limitation of the electronic circuitry, or a recitation of intended use). Note: Although the claims are not currently rejected on the basis of prior art, the claims may not necessarily be allowable upon overcoming the §112(b) rejection. Based on the nature of the concept of what it seems Applicant is trying to claim here (i.e., the position and/or positioning of the collimator relative to the patient), it seems as if a method/process claim is a more appropriate statutory category to more sufficiently capture the inventive subject matter. For example, see claim 1 of US Patent 12,383,216 to same Applicant/Inventors, which recites a similar limitation but in the form of a method/process instead of a system/apparatus/machine. Claim 1 of the patent was allowed without any of the issues raised in this application because claim 1 of the patent is to a method/process. Conclusion THIS ACTION IS MADE FINAL. 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN T. SAKAMOTO whose telephone number is (571)272-4958. The examiner can normally be reached Monday - Friday, ~9AM-5PM Pacific. 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, KEITH M. RAYMOND can be reached at (571) 270-1790. 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. COLIN T. SAKAMOTO Primary Examiner Art Unit 3798 /COLIN T. SAKAMOTO/Primary Examiner, Art Unit 3798 7 March 2026 1 See §112(b) rejection above. 2 Including the patient (understood to be a human organism) as part of the claim scope is not allowed under 35 USC §101 and §33(a) of the AIA .
Read full office action

Prosecution Timeline

Jul 21, 2025
Application Filed
Oct 18, 2025
Non-Final Rejection — §101, §112
Feb 20, 2026
Response Filed
Mar 07, 2026
Final Rejection — §101, §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

3-4
Expected OA Rounds
66%
Grant Probability
91%
With Interview (+25.3%)
3y 6m
Median Time to Grant
Moderate
PTA Risk
Based on 465 resolved cases by this examiner. Grant probability derived from career allow rate.

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