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 (e.g., paragraph 0011, JP2019136167) 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.
Drawings
The drawings are objected to because of the following:
The drawings are generally cluttered, with multiple portions of the drawings, including lines and reference characters, overlapping in such a way that makes the drawings difficult to understand. The figure labels for many of the drawings are also difficult to distinguish due to the proximity and similar size of the figure labels to the reference characters and also as a result of the cluttered nature of the drawings.
FIGs. 3(a), 3(b): element 11(i+1) appears to be mis-labeled as element 11(i-1).
FIG. 3(d): element 11i should be formatted horizontally, and should read 11.i.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
(Y,Z)j
D100.i
Wij
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
FIGs. 3(a), 3(b): 11(i+2), 11(i+1), 11(i-1), 11(i-2)
It appears these reference characters are likely meant to be 11.(i+2), 11.(i+1), 11.(i-1), 11.(i-2).
FIGs. 3(e), 3(f): 3h
FIGs. 4(b), 4(g), 5(b), 5(g): Vi1, Vi2, Vi3
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application.
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.
Specification
The abstract of the disclosure is objected to because of the following:
The abstract exceeds 150 words in length.
The abstract includes an extraneous figure label.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The disclosure is objected to because of the following informalities:
It is unclear what numerical values are covered by the indexing variables (i.e., f, i, j, k, m, and N).
In particular, N is inconsistently defined as “three, six, an ‘infinite number’ of degrading subunits” (paragraphs 0066, 0073) and “a finite number N of degrading subunits” (paragraph 0070)
Indexing variables f and m are defined neither explicitly nor by example; indexing variable k is defined only as being “not equal to i”
Paragraph 0056: “the beam (100.i) at a single spot (100.i)” should read “the beam (100.i) at a single spot (Si)”.
Paragraph 0062: “the cross-sectional area (Axi(j+1)) of the degrading unit (Axi(j+1))” is unclear; the reference (Axi(j+1)) should not be used to represent both a cross-sectional area and a degrading unit.
Paragraph 0075: variable W11 is not defined in the specification.
The fluence is inconsistently defined as both F(y,z) and Fi(y,z).
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities:
The line “Designing the energy degrading units corresponding to all remaining subvolumes (Vi)” ends with a period but is followed by a further limitation of the claim.
Claim 1 defines F(y,z) as a fluence at a position (y,z), i.e., at one single spot, of the beam. Claims 3 and 4 define the fluence at one single spot as Fi(y,z), which is inconsistent with the definition in claim 1. For the purpose of compact prosecution, the Examiner has interpreted “Fi(y,z)” to mean “F[[i]](y,z)”.
Regarding claims 4 and 8, “an energy degrading unit comprises at least two subunits” should read “an energy degrading unit comprises at least two degrading subunits”.
Reference character “Ai” has been used to designate both a maximum of the fluence of a spot (Si) (claim 4) and the cross-sectional areas of the degrading subunits in the form of orifices having a generalized cylindrical geometry (claim 5).
Regarding claims 6 and 8, the limitation “wherein one or more structures formed by two or more degrading subunits aligned in series along the corresponding beam axis (Xi)” is unclear. For the purpose of compact prosecution, the Examiner has interpreted “wherein one or more structures formed by two or more degrading subunits aligned in series along the corresponding beam axis (Xi)” to mean “wherein one or more structures are formed by two or more degrading subunits aligned in series along the corresponding beam axis (Xi)”.
Regarding claim 7, “a generalized cylindrical geometry of cross-sectional areas (Aij)”) should read “a generalized cylindrical geometry of cross-sectional areas (Ai[[j]])”, based on the disclosure of reference characters Aij in claim 1 and Ai in claim 5.
Appropriate correction is required.
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 applicant regards as his invention.
Claims 1-10 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 term “substantially” is a relative term which renders the claim indefinite. Furthermore, the claim language immediately following the phrase “substantially parallel” (i.e., “diverging from parallelism…”) appears to contradict the “substantially parallel” limitation. For the purpose of compact prosecution, the Examiner has interpreted “beam axes (Xi) substantially parallel to an irradiation axis (X), diverging from parallelism from the irradiation axis (X) by an angle comprised within ± 5°” to mean “beam axes (Xi)within ± 5° of parallelism with an irradiation axis (X)
Claim 1 recites the following limitations for which there is insufficient antecedent basis in the claim:
“the corresponding furthest water equivalent thickness (d1)”; for the purpose of compact prosecution, the Examiner has interpreted “the corresponding furthest water equivalent thickness (d1)” to mean “the corresponding longest water equivalent thickness (d1)”.
"the area (Aij) of a degrading subunit"; for the purpose of compact prosecution, the Examiner has interpreted "the area (Aij) of a degrading subunit" to mean "the area (Aij) of the base of a degrading subunit".
“the subunit base area (Aij)”; for the purpose of compact prosecution, the Examiner has interpreted “the subunit base area (Aij)” to mean “the degrading subunit base area (Aij)”.
“a base area (Abi) of the degrading unit”; for the purpose of compact prosecution, the Examiner has interpreted “a base area (Abi) of the degrading unit” to mean “a base area (Abi) of the energy degrading unit”.
“a sum of the subunit areas (Aij)”; for the purpose of compact prosecution, the Examiner has interpreted “a sum of the subunit areas (Aij)” to mean “a sum of the degrading subunit base areas (Aij)”.
“the N degrading subunits”; for the purpose of compact prosecution, the Examiner has interpreted “the N degrading subunits” to mean “a number N of degrading subunits”.
“the required doses (Dij)”; for the purpose of compact prosecution, the Examiner has interpreted “the required doses (Dij)” to mean “the specific doses (Dij)”.
Claims 2-10 are rejected because of their dependence on claim 1.
Claims 3 and 4 recite the limitation “the fluence (F(y,z)) of the beam going through the base area (Abi)”. There is insufficient antecedent basis for this limitation in the claim. Claim 1, upon which claims 3 and 4 depend, defines the fluence F(y,z) as the fluence of the beam at a position (y,z) of the beam, not as the fluence of the beam passing through the base area as a whole. For the purpose of compact prosecution, the Examiner has interpreted “the fluence (F(y,z)) of the beam going through the base area (Abi)” to mean “the fluence (F(y,z)) of the beam going through the base area (Abi) at a position (y,z) of the beam”.
Claims 4 and 5 inconsistently define the reference character “Ai” as “a maximum (Ai) of the fluence of the spot (Si)” (claim 4) and “orifices having a generalized cylindrical geometry of cross-sectional areas (Ai)” (claim 5), rendering the definition of the reference character “Ai” unclear.
Claim 5 recites the limitation “the support block”. There is insufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, the Examiner has interpreted “the support block” to mean “the support base”. Claims 6 and 9-10 are rejected because of their dependence on claim 5.
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, claims 6 and 8 recite the broad recitation “at least two degrading subunits”, and the claims also recite “three or more degrading subunits” which is the narrower statement of the range/limitation. The claims 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 6 recites the limitations “at least two subunits” and “the subunit base area (Aij)”. There is insufficient antecedent basis for these limitations in the claim. For the purpose of compact prosecution, the Examiner has interpreted “at least two subunits” to mean “at least two degrading subunits”, and “the subunit base area (Aij)” to mean “the degrading subunit base area (Aij)”.
Claim 6 recites the limitation “the cross-sectional area (Axij) between the given degrading unit (11.ij) and the cross-sectional area (Axi(j+1)) of the degrading unit (Axi(j+1)) circumscribed within the given degrading unit”. There is insufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, the Examiner has interpreted “the cross-sectional area (Axij) between the given degrading unit (11.ij) and the cross-sectional area (Axi(j+1)) of the degrading unit (Axi(j+1)) circumscribed within the given degrading unit” to mean “the cross-sectional area (Axij) between the given degrading subunit (11.ij) and the cross-sectional area (Axi(j+1)) of a degrading subunitsubunit”.
Regarding claim 6, the term "optionally" renders the claim indefinite because it is unclear whether the limitations following the term are part of the claimed invention. For the purpose of compact prosecution, the Examiner has interpreted the claim as not including the limitation following the term “optionally”.
Regarding claim 8, the terms “preferably” and “optionally” render the claim indefinite because it is unclear whether the limitations following the terms are part of the claimed invention. For the purpose of compact prosecution, the Examiner has interpreted the claim as not including the limitations following the terms “preferably” and “optionally”, i.e., “preferably coaxially and with the pin having the longest length (Lsi1) being positioned at a central position” and “optionally; one or more individual degrading subunits, are arranged side-by-side within the base area (Abi)”.
Regarding claim 8, the limitation “the cross sectional area (Axi(j-1)) of the degrading unit (Axi(j-1)) circumscribed within the given degrading unit” is unclear due to the use of the reference (Axi(j-1)) for both the “cross sectional area” and the “degrading unit”. Furthermore, there is insufficient antecedent basis for the limitations “the subunit base area (Aij)…the cross sectional area (Axij) between the given degrading unit…the degrading unit…circumscribed within the given degrading unit”. For the purpose of compact prosecution, the Examiner has interpreted “the subunit base area…the cross sectional area (Axij) between the given degrading unit and the cross sectional area (Axi(j-1)) of the degrading unit (Axi(j-1)) circumscribed within the given degrading unit” to mean “the degrading subunit base area…the cross sectional area (Axij) between the given degrading subunit and the cross sectional area (Axi(j-1)) of a degrading subunit subunit”.
Claim 9 recites the limitation “the length (L11 = W11 / Wu) of the first degrading subunit”. There is insufficient antecedent basis for this limitation in the claim; neither claim 9 nor claims 5 and 1, upon which claim 9 depends, have previously defined a length L11. Furthermore, neither the claims nor the specification define reference character W11. For the purpose of compact prosecution, the Examiner has interpreted “the length (L11 = W11 / Wu) of the first degrading subunit” to mean “the length
Regarding claim 9, the term “preferably” renders the claim indefinite because it is unclear whether the limitation following the term is part of the claimed invention. For the purpose of compact prosecution, the Examiner has interpreted “to vary, preferably decrease the value” to mean “to vary
Regarding claim 9, the limitation “the length of a corresponding first energy subunit made of the second material” (emphasis added) is inconsistent with the limitation “a second material of a second degrading subunit” (emphasis added). Furthermore, there is insufficient antecedent basis for the phrase “energy subunit”. For the purpose of compact prosecution, the Examiner has interpreted “the length of a corresponding first energy subunit made of the second material” to mean “the length of a corresponding second degrading subunit made of the second material”.
Claim 9 contains a variable W11 which is not defined by the claims nor the specification, rendering the formula (L11 = W11 / Wu) unclear.
Claim 10 is rejected because of its dependence on claim 9.
Regarding claim 10, the term “preferably” renders the claim indefinite because it is unclear whether the limitation following the term is part of the claimed invention. For the purpose of compact prosecution, the Examiner has interpreted the claim as not including the limitations following the term “preferably”.
The claims use a hyphen/dash symbol “-“ to indicate both a range (e.g., “T1-TN”) and subtraction (e.g., “Lij = Bi-Lsij”), which renders the claims unclear.
The claims inconsistently define the fluence as both F(y,z) and Fi(y,z). For the purpose of compact prosecution, the Examiner has interpreted all instances of “Fi(y,z)” to mean “F[[i]](y,z)”.
The claims inconsistently define the lengths of the degrading subunits as “Lij” (claims 1, 10; e.g., “a degrading subunit…of generatrixes of length (Lij)”) and “Lsij” (claims 5-8; e.g., “degrading subunits…extending along the corresponding beam axis…over lengths (Lsij)”), where “Lij” is set equal to Bi ± Lsij in claims 5 and 7.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the abstract idea of a mental process without significantly more. The independent claim recites a mental process as 9 steps:
“defining a boundary inscribing the treatment volume (V) by defining areas (Aj)…”;
“defining an array of subvolumes (Vi)…”;
“…defining a cell (Cij) defined as a portion of the subvolume (Vi) comprised within the corresponding slice (Tj)”;
“…determining a cell water equivalent thickness (dij)…”;
“designing the ridge filter with a set of energy degrading units…”;
“…dimensioning a degrading subunit having a generalized cylindrical geometry…”;
determining “the area (Aij) of a degrading subunit…”;
“combining the N degrading subunits…”; and
“Designing the energy degrading units…”.
The courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). As the Federal Circuit explained, "methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work’ that are open to all.’" 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 ("‘[M]ental processes[] and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work’" (quoting Benson, 409 U.S. at 67, 175 USPQ at 675)); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978) (same). Further, the courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind." Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) (holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer").
In the instant case, the 9 steps of the independent claim can be performed by the human mind or by a human using pen and paper. For instance, the step “for each slice (Tj) of the N slices (T1-TN), comprised within a subvolume (Vi), defining a cell (Cij) defined as a portion of the subvolume (Vi) comprised within the corresponding slice (Tj)” is easily performed in the human mind or drawn by a human using pen and paper to visualize a volume of space (subvolume) which is divided into numerous slices of said volume, wherein each slice contains a portion (cell) of the original volume of space (subvolume).
Furthermore, the dependent claims do not recite any features that would change the abstract idea into something more. Dependent claims 2-4 describe design steps defining the dose deposition rates and locations, but these design decisions can also be performed mentally. Dependent claims 5-9 add further details to the design steps defining the shape/size, location, and material of the energy degrading units, but such details do not alter the fact that the underlying abstract idea may be performed as a mental process.
The claims recite various features, but none of them, taken alone or in an ordered combination, is significantly more than just the above noted mental process. Simply put, the claims do not require that anything other than a mental process occur. To the extent that the process must occur in a computer, this is a requirement that a generic computer perform generic computer functions, e.g., running an algorithm. Such a requirement to apply an abstract idea using a generic computer does not render an abstract idea patent eligible. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 223, 110 USPQ2d 1976, 1983 (2014).
Finally, this judicial exception is not integrated into a practical application because it is not applied to anything external to the abstract idea.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Prieels (U.S. Patent Application Publication No. 2018/0099153 A1), hereinafter Prieels, teaches a method for designing a charged particle accelerator for depositing within beams of accelerated particles specific doses into specific locations within a treatment volume of the tissue comprising tumoral cells, spot by spot according to a predefined treatment plan, wherein the beams extend along corresponding beam axes substantially parallel to an irradiation axis, and wherein the tissue is characterized by a maximum beam range, defined as the water equivalent distance at which the beam stops propagating through the tissue, the method comprising the following, defining a boundary inscribing the treatment volume by defining areas over upstream planes of N slices, wherein the planes are normal to the irradiation axis, wherein a shortest water equivalent thickness and longest water equivalent thickness to a skin of a patient are defined as the points of the boundary closest to and furthest away from the skin, respectively, measured along the irradiation axis, for each slice of N slices, defining a cell defined as a portion of the subvolume comprised within the corresponding slice; for each cell of the given subvolume, and determining a cell water equivalent thickness dij from the skin to a geometrical center of the cells.
Glimelius et al. (U.S. Patent Application Publication No. 2017/0333733 A1), hereinafter Glimelius, teaches designing a ridge filter with a set of energy degrading units, the energy degrading units having a degrading subunit being made of a material having a subunit water equivalent thickness per unit length along the corresponding beam axis, wherein the length is determined such that the degrading subunit has a subunit water equivalent thickness equal to a product of the subunit water equivalent thickness per unit length Wu and of the length Lij, wherein a sum of the subunit water equivalent thickness and of the cell water equivalent thickness is equal to the maximum beam range.
Harada (U.S. Patent No. 7,525,104 B2), hereinafter Harada, teaches the fluence of the beam going through the base area Abi is approximated to being constant over all values of the planes defining the boundary inscribing the volume.
Nagamoto et al. (JP Patent No. 2020081425 A), hereinafter Nagamoto (English machine translation provided), teaches energy degrading units in the form of pins (and/or orifices) arranged side-by-side according to the array of spots in a support base of thickness Bi measured along the beam axis, each pin (orifice) extending from (an aperture opening at a surface of) the support base (and penetrating to a given depth measured along the corresponding beam axes), wherein each energy degrading unit is formed by one or more degrading subunits in the form of pins (orifices) having cross-sectional areas, and extending along the corresponding beam axis from the (aperture in the) support base. Nagamoto also teaches an energy degrading unit comprising at least two subunits which are arranged in the base area in a mixed construction both in parallel and in series wherein three or more degrading subunits are arranged both in series and in parallel, wherein one or more structures formed by two or more degrading subunits aligned in series along the corresponding beam axis are arranged side-by-side within the base area.
Takayanagi et al. (U.S. Patent Application Publication No. 2015/0352372 A1), hereinafter Takayanagi, teaches a first degrading subunit made of a first material different from a second material of a second degrading subunit, the first material having a value of the subunit water equivalent thickness per unit length which is different from the second material, such as to vary the value of the length of the first degrading subunit compared with the length of a corresponding first energy subunit made of the second material.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALINA R KALISZEWSKI whose telephone number is (703)756-5581. The examiner can normally be reached Monday - Friday 8:00am - 5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Kim can be reached at (571)272-2293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.K./Examiner, Art Unit 2881
/WYATT A STOFFA/Primary Examiner, Art Unit 2881