NON-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 .
Attempted Examiner Interview
On 2/24/2026, the examiner called David Schreiber1 at his phone number of record in an attempt to schedule an interview to discuss an examiner’s amendment to place the application in condition for allowance. The examiner was not able to get in touch with Mr. Schreiber and left a voicemail message asking him to return the examiner’s call. As of the drafting of this Office Action, Mr. Schreiber has not called the examiner back. Therefore, the examiner is issuing this Non-Final Rejection.
Claim Interpretation - 35 USC § 112(f)
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 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) 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):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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) 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) 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) 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: “treatment applicators” first recited in claims 1, 14, and 15.
Generic structural placeholder: The term “applicator” itself can be considered a generic structural placeholder because the term is a nonce term in a structural sense because it is structurally generic (i.e., not structurally specific). The term “applicator” says nothing about that what it structurally is; rather, the term says only about what it functionally does, i.e., it performs the function of applying something (in this case, treatment) to something else (in this case, presumably a patient) without any notion of what it structurally is.
Claimed function: the “term treatment applicator” itself implies the function of applying treatment.
Insufficient structure, materials, or acts to perform the claimed function: With regards to the treatment applicators, the claims do not recite the structure itself.
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.
Insertable thermal ablation probes for cancer treatments (e.g., non-resectable tumors) have been identified from the Specification as corresponding to the claimed function of the “treatment applicators”. See Specification pages 1, 5, 6, and 7, and Fig. 1. In particular, the paragraph bridging pages 6 and 7 recites in part: “The ablation treatment applicators 20 may utilize for example Focused Ultrasound (FU), Microwave (MW), Radiofrequency (RF), Focal Laser Ablation (FLA), Cryo-ablation, Irreversible Electroporation (IRE) or Brachytherapy. All these therapy modalities require the insertion of applicators 8 into the tumor or affected organ. In order to facilitate positioning the applicators 8, a grid template 14 comprising grid holes 12 is utilized. The applicators 8 are inserted into the grid holes 12 of the grid template 14. The grid holes 12 are an example of entry points 10. Depending on a therapy plan, applicators 8 are inserted into certain grid holes 12 to treat the affected organ or tumor.” In combination with what is illustrated in Fig. 1, the ordinarily skilled artisan would understand that the treatment applicators are described as elongated insertable probes such as having the form factor of a needle, wherein the business end of the probe has implied necessary structures in accordance with a respective ablation type. For example, in the case of focused ultrasound, it is understood that the applicator would have an ultrasound transducer; in the case of brachytherapy, it is understood that the applicator would have a radioactive seed; in the case of microwave, it is understood that the applicator would have an antenna; etc.
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 § 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 1-13, 16, and 17 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.
Regarding claim 1: The claim is drawn to (1) “[a] planning device for positioning treatment applicators comprising a comprising a processor”. The claim further recites that (2) the processor is “configured to execute a computer program”. The claim further recites that (3) “when the computer program is executed the processor is caused to: determine an applicator configuration comprising an applicator entry point, …”
It is unclear to what extent limitation (3) should be given patentable weight. Limitation (3) appears to limit the computer program itself by describing what the processor is caused to do when it executes the computer program. However, the way limitation (2) is written, it reads as if the computer program isn’t part of the claimed invention. For example, the claim doesn’t recite that the device comprises memory having stored thereon the computer program. On the contrary, limitation (2) merely states that the processor is configured to execute a computer program, but --as the ordinarily skilled artisan would understand-- any arbitrary off-the-shelf computer processor would be configured to execute the claimed computer program or any other arbitrary computer program for that matter.
On the other hand, if limitation (3) isn’t given patentable weight, then it is unclear what the point of the claim even is anymore. However, if limitation (3) should be given weight, why isn’t the claim written as such?
Dependent claims thereof are rejected for at least the same reasons by virtue of their dependency on claim 1.
In accordance with compact prosecution practice (see MPEP 2173.06), limitation (3) is being construed for purpose of applying prior art as being given patentable weight.
Regarding claim 4: The claim appears to further limit the entry points to more specifically be grid holes of a grid template, and/or skin entry points. However, it is unclear to what extent this should be given patentable weight because the entry points are not part of the claimed invention.
Regarding claim 7: The claim reads as narrative but does not appear to be structurally tied to the claimed invention. It is unclear what entity performs the further optimization iteration steps, let alone if it is even the claimed invention that performs said steps.
Regarding claim 10: There is a lack of antecedent basis for the term “the refinement iterations”. It is unclear what refinement iterations this refers to.
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.
Claim 15 is rejected under 35 U.S.C. 112(d) 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 15 depends on claim 14. However, claim 15 is to a non-transitory computer readable medium and claim 14 is a method comprising method steps. Claim 15 does not require all the limitations of claim 14 because claim 15 does not require any of the method steps of claim 14 to actually be performed in order to infringe on claim 15. For example, claim 15 could be infringed by making unauthorized copies of the claimed non-transitory computer readable medium (e.g., in the manner of software piracy) without actually performing any of the method steps themselves.
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.
In this case, the examiner recommends rewriting claim 15 in independent form by explicitly listing the method steps in the body of the claim instead of referencing claim 14.
Allowable Subject Matter
Claims 1-13, 16, and 17 would be allowable if rewritten or amended to overcome the rejections under 35 U.S.C. 112(b) set forth in this Office action.
Claim 14 is allowed.
Claim 15 would be allowable if rewritten or amended to overcome the rejection under 35 U.S.C. 112(d) by rewriting the claim in independent form.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1: The prior art of record does not teach or reasonably suggest to the ordinarily skilled artisan a planning device for positioning treatment applicators, comprising a processor configured to execute a computer program such that when the computer program is executed, the processor is caused to:
determine an applicator configuration comprising a first applicator entry point,
inactivate all entry points within a distance (r) from the first applicator entry point such that these entry points are unavailable to a subsequent applicator configuration determination, wherein the distance (r) is a distance between applicator entry points, and
determine a subsequent applicator configuration comprising a further applicator entry point.
Sparks et al., US 2019/0209245 A1 (hereinafter Sparks) is cited as prior art closest to the claimed invention. Sparks, at ¶ [0067], appears to describe a similar technique of sequentially determining applicator trajectory/entry points taking into account a current/previous applicator trajectory before determining a subsequent trajectory/entry point (e.g., for another applicator):
“In many practical applications, it is generally desired to implant multiple electrodes. These electrodes should not interfere with one another. Accordingly, the placement of each entry point should also take into consideration the placement of the other entry points (for other target locations). One way of achieving this is to determine an entry point using the above approach for each target point in turn. Trajectories that have already been determined for previous target points can then be treated as critical structures to be avoided (as for the other critical structures), as each new trajectory is determined.”
While this does indeed sound similar to the claimed invention, Sparks is not concerned with ablation applicators for treating cancer/tumors2; rather, ¶ [0002] of Sparks indicates that the applicators in Sparks are electrode probes inserted into the brain of a subject for measuring electrical signals of the brain (i.e., EEG signals) and/or for neurological stimulation studies (i.e., understood as injecting small amounts of current to induce action potentials in one or more neuron(s)).
Even considering a potential modification of Sparks to arrive at the claimed invention (i.e., obviousness analysis under §103), such a modification would have involved improper hindsight because the context of Sparks’ disclosure of the aforementioned sequential individual trajectory planning process (wherein order matters) appears to be to the extent that Sparks is teaching away from it in favor of a multiple trajectory planning process (wherein order doesn’t matter):
“Although this approach is feasible, it is dependent on the ordering in which the target points are chosen for determining a trajectory, and may therefore not provide the best overall solution. The system 100 therefore incorporates a multiple trajectory planning process which avoids such sensitivity on target point ordering. The process starts with the user selecting the desired set of N target points Ti: i∈{1, . . . , N}. For each target point in this set, the entry point search and risk analysis procedure is run independently to obtain a set of M potential entry points Ei,j: j∈{1, . . . , M}—i.e. entry points that are not excluded or filtered out by virtue of being too long, having an unacceptable entry angle, or going directly through a critical structure to get to the target point. Each potential target/entry point pair in a set M is represented by a trajectory
T
i
E
i
,
j
-
. The risk analysis procedure described above then returns a risk score Ri,j that describes the overall quality for each
T
i
E
i
,
j
-
trajectory in M (note Ri,j corresponds to Rtotal in Equation (6) above).” (¶ [0067])
“The multiple trajectory planning procedure seeks to find an optimal combination of trajectories for all of the N target points such that they do not interfere with one other. Trajectory interference is considered to occur if the minimum distance between any two trajectories is smaller than a “Trajectory Margin” distance: dmin This trajectory margin distance can be configured by the user, and may be set as appropriate to be the same as, or different from, the dmin used to specify the safety margin around the critical structures.” (¶ [0068])
Here we can see that Sparks appears to discourage the sequential planning process in favor of the multiple trajectory planning process because the sequential planning process, according to Sparks, does not provide the best overall solution. Despite Sparks using the phrase “[a]lthough this approach is feasible”, the examiner still considers Sparks to teach away from the sequential planning process because Sparks criticizes or otherwise discourages it due to it not providing the best overall solution (see MPEP 2145, X., D.). Even if, for argument’s sake, Sparks is determined to not teach away, it still would not have been obvious to modify Sparks to implement a sequential planning process such as in the claimed invention because such a modification would have resulted in a change in the principal of operation by changing the planning process on a fundamental level from a multiple trajectory planning process to a sequential trajectory planning process (see MPEP 2143.01, VI.).
Further, even considering Sparks as a secondary teaching in an effort to improve the trajectory planning process of another prior art reference (e.g., Desai et al., US 2019/0008591 A1): The ordinarily skilled artisan, reading Sparks trying to figure out how to improve Desai, would not have implemented a sequential planning process invention in Desai because the ordinarily skilled artisan would have chosen the multiple trajectory planning process over any sequential planning process such as the claimed invention because the sequential planning process does not provide the best overall solution as discussed in ¶ [0067] Sparks.
The discussion above similarly applies to claims 14 and 15 which recite subject matter that is substantially the same as claim 1, albeit in the form of a method and a non-transitory computer readable medium respectively.
Conclusion
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.
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COLIN T. SAKAMOTO
Primary Examiner
Art Unit 3798
/COLIN T. SAKAMOTO/Primary Examiner, Art Unit 3798
5 March 2026
1 David Schreiber (Reg. No. 35,672) is an attorney of record and is the person who signed the power of attorney dated 5/23/2024.
2 See above regard 112(f) interpretation. The treatment applicators are being construed in accordance with 112(f) as encompassing elongated insertable ablation probes for treating cancer/tumors.