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 information disclosure statement (IDS) submitted on 10/31/2023 is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
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 following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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: “drive mechanism” in claim 17.
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.
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.
Applicant's specification shows the drive mechanism in figure 4 and is described in paragraphs 47-48 and 72-73 of the specification. The drive mechanism includes circuits that control actuators (paragraph 48 describes several actuator types with motors being one example).
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 1-20 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.
Claim 1 recites the limitation "the radiation treatment plan" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-16 inherit the deficiencies of claim 1 and are also rejected.
Claim 5 recites the limitation "the treatment planning process" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the radiation treatment plan" in line 12. There is insufficient antecedent basis for this limitation in the claim.
Claims 18-19 inherit the deficiencies of claim 17 and are also rejected.
Claim 20 recites the limitation "the radiation treatment plan" in line 14. There is insufficient antecedent basis for this limitation in the claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-18 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-13, and 15-20 of U.S. Patent No. 11,730,977 in view of US 2009/0256078 (Mazin).
Claims 1, 17, and 20 of U.S. Patent No. 11,730,977 discloses species with elements having specifics of the claims except for the limitation of the pairs being “uncovered by a jaw”. In a related area, Mazin discloses shows a method and apparatus for radiation therapy (title and abstract). Of note are paragraphs 37-38 and figure 5 which shows the use of collimator jaws (551) in a multi-leaf collimator to restrict divergence of radiation. The gap shown in figure 5 between the jaws can be considered as an uncovering of the collimator leaves (553) to the radiation source. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the method and apparatus of the US 11,730,977 to include the process of uncovering leaf pairs by a jaw, as shown by Mazin, in order to restrict divergence of radiation.
Claims 2-16 and 18 recite the same components present in U.S. Patent No. 11,730,977 and are mapped as follows.
Claim 2 is disclosed by claim 2 of U.S. Patent No. 11,730,977.
Claim 3 is disclosed by claim 3 of U.S. Patent No. 11,730,977.
Claim 4 is disclosed by claim 5 of U.S. Patent No. 11,730,977.
Claim 5 is disclosed by claim 6 of U.S. Patent No. 11,730,977.
Claim 6 is disclosed by claim 7 of U.S. Patent No. 11,730,977.
Claim 7 is disclosed by claim 9 of U.S. Patent No. 11,730,977.
Claim 8 is disclosed by claim 10 of U.S. Patent No. 11,730,977.
Claim 9 is disclosed by claim 11 of U.S. Patent No. 11,730,977.
Claim 10 is disclosed by claim 12 of U.S. Patent No. 11,730,977.
Claim 11 is disclosed by claim 13 of U.S. Patent No. 11,730,977.
Claim 12 is disclosed by claim 8 of U.S. Patent No. 11,730,977.
Claim 13 is disclosed by claim 15 of U.S. Patent No. 11,730,977.
Claim 14 is disclosed by claim 16 of U.S. Patent No. 11,730,977.
Claim 15 is disclosed by claim 17 of U.S. Patent No. 11,730,977.
Claim 16 is disclosed by claim 18 of U.S. Patent No. 11,730,977.
Claim 18 is disclosed by claim 19 of U.S. Patent No. 11,730,977.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4, 5, 6, 15, 17, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2012/0043482 (Prince et al., hereinafter Prince).
In regards to claim 1, Prince discloses a multi-level collimator system and its method of use (title and abstract). Paragraph 30 states that the motion of the multi-leaf collimator leaves during a treatment process according to a treatment plan is controlled by a computer, which would have a processor and a memory (storage device). Paragraphs 9, 25, 30, 32, and 42-44 and figure 1 show closed leaf pairs and state that the leaf pairs arrangements are off-set and move according to a treatment plan where the leaf pairs are uncovered by collimation jaws (paragraphs 45-47 and figures 8A-C and 9A-C; jaws cover the leaves and are opened to allow radiation through). Moving leaf pairs according to treatment plan would require the step of determining at least one closed leaf pair from the one or more closed leaf pairs and the step of determining an offset for each closed leaf pair and cause the leaf pair to move based on the determined offset before and during the treatment process.
In regards to claim 4, Prince discloses the limitations of claim 1. In addition, generating the offset for each of the at least one closed leaf pair before or at a beginning of a beam delivery in at least one treatment fraction of the one or more would be a required step due to the offset pair arrangements implemented during execution of therapies as noted in paragraphs 9, 25, 30, 32, and 42-44.
In regards to claim 5, Prince discloses the limitations of claim 1. Princes discloses the step of determining the offset for the closed leaf pairs in paragraphs 9, 25, 30, 32, and 42-44 and is part of the treatment plan. Thus, the offset is used to generate the treatment plan before the treatment process.
In regards to claim 6, Prince discloses the limitations of claim 5. While Prince does not explicitly state the step of evaluating or adjusting the treatment plan based on a leakage distribution associated with a dose leakage of each of the at least one closed leaf pair, Prince shows in paragraphs 5, 27, 34, 36, and 42-47 that leakage is controlled by shaping the radiation beam via the control method used on the leaves (which requires evaluation and adjustment of beam parameters of the treatment plan after offset determination). Paragraphs 42-47 and figures 8A-C and 9A-C show differences in leakage based on different arrangements and that that beam shaping reduces radiation leakage to acceptable levels (which shows leakage distributions associated with a dose leakage of each of the at least one closed leaf pair). Thus, the beam shaping process would require the step of evaluating or adjusting the treatment plan based on a leakage distribution associated with a dose leakage of each of the at least one closed leaf pair after determination of the offset.
In regards to claim 15, Prince discloses the limitations of claim 1. In addition, paragraphs 32-47 and figure 4 show that there are gaps between each closed leaf pair. Prince as noted in claim 1 shows the step of causing the at least one closed leaf pair to move based on the determined at least one offset. Any leaf movement would result in a position of the gap between each closed leaf pair being adjusted by a corresponding determined offset.
In regards to claims 17 and 20, Prince discloses a multi-level collimator system and its method of use (title and abstract). Paragraph 30 states that the motion of the multi-leaf collimator leaves during a treatment process according to a treatment plan is controlled by a computer (the controller), which would have a processor in communication with a memory (storage device that stores the instructions). Paragraphs 9, 25, 30, 32, and 42-44 and figure 1 show closed leaf pairs and state that the leaf pairs arrangements are off-set and move according to a treatment process according to a treatment plan where the leaf pairs are uncovered by collimation jaws (paragraphs 45-47 and figures 8A-C and 9A-C; jaws cover the leaves and are opened to allow radiation through). Paragraph 30 states the presence of drive motors that move the leaves, which meets the drive mechanism limitation. This would require the processor/controller be configured to execute the instructions for determining an offset for each closed leaf pair and causing the leaf pair to move based on the determined offset before and during the treatment process.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2012/0043482 (Prince et al., hereinafter Prince) as applied to claim 1 above, and further in view of US 6,052,430 (Siochi et al., hereinafter Siochi).
In regards to claims 7 and 8, Prince discloses the limitations of claim 1. In addition, the treatment process would naturally have one treatment fraction and as mentioned in claim 1 above, causes the at least one closed leaf pair to move based on the determined at least one offset. However, Prince does not state that the at least one closed leaf pair moves dynamically within the treatment fraction. In a related area, Siochi discloses a collimator that has dynamic modulation (title and abstract). Siochi states that dynamic intensity modulation moves the leaves during beam delivery of the therapy to match tumor volume and allows for avoidance of healthy tissue during beam delivery (column 1, line 47-column 3, line 26). Thus, it would be obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the method of Prince to have the at least one closed leaf pair more dynamically during within a treatment fraction during a beam delivery, as taught by Siochi, in order to have the delivered therapy to match the tumor volume and allow for avoidance of healthy tissue during beam delivery.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2012/0043482 (Prince et al., hereinafter Prince).
In regards to claim 11, Prince discloses the limitations of claim 1. In addition, paragraph 30 states that the leaves can be independently moved, and that the movements are based on the beam direction based on a treatment plan. This independent movement can allow for the synchronous or asynchronous movement of leaf pairs depending on the treatment plan. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify method of Prince to have leaf pairs to move in a synchronous and/or asynchronous manner because one of ordinary skill would be motivated to customize a radiation treatment plan for optimal outcomes.
Conclusion
The examiner notes that, though no art has been applied against claims 2, 3, 9, 10, 12, 13, 14, 16, 18, and 19 at this time, they are not presently allowable. The question of prior art will be revisited upon resolution of the numerous issues noted above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791
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