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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 31, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on May 31, 2024 are accepted.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
The abstract of the disclosure is objected because it is written in a claim format. It should be a single narrative paragraph. The component No. and the parenthesis should be deleted. The last line “Figure of the abstract: Figure 1” should be deleted.
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) for guidelines for the preparation of patent abstracts.
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:
The claim limitation in claim 19: “a control unit configured to advance said push member, retract said push member and advance the push cable”; claim 23: “the control unit is configured to ensure the movement”; claim 24: “the control unit is configured to determine the retracted initial position”; and claim 26: “the control unit is configured to determine the retracted position” have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “unit” coupled with functional language “to advance/retract/ensure/determine” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “unit”.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification, PG Pub US 2-25/0018222 A1, for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Claims19, 23, 24 and 26: “a control unit” refers to the specification [0115]: the control unit may comprise a computer, this computer comprising a memory for storing program instructions that can be loaded into a circuit, and able to cause the circuit to execute the method of the present disclosure when the program instructions are managed by the circuit.
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.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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 19-37 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 pre-AIA the applicant regards as the invention.
Claims that have dependency should practice proper antecedent basis for the terms recited more than once.
The word “which” should be avoided in the claims as they often introduce indefiniteness issues. It is suggested to amend all the which clauses to wherein clauses.
Phrases connected with the punctuation comma also likely to introduce indefiniteness issues. It is suggested to amend them to use wherein clauses.
In the claims, the word “said” and “the” are mixedly used for antecedent basis practice. Though there is no requirement that only one of them may be used, it is suggested to only use one or the other throughout the claims for claim language consistency purpose.
Applicant is requested to check the entire claim set carefully to ensure all the above issues are identified and corrected.
Claim 19, line 3 recites “radioactive seeds” (plural), yet claims 19, 21 and 23 recite “the radioactive seed” or “the seed” (singular). It is unclear if they refer to the same or what is the relationship between them.
Claim 19, line 4 recites “a flexible push cable”. The term “the push cable” recited in claims 19, 26, 27, 28, 29 and 33 should be corrected to --the flexible push cable--.
Claim 19, line 7 recites “a motor-driven guide and drive device” that should be corrected to --a motor-driven guide and drive device--.
Claim 19, line 10 recites “… inside which upstream branch a push end of the push cable”. This phrase is grammatically incorrect and the meaning of it is unclear. It is unclear what the term “which” refers to.
Claim 19, line 11 recites “a retracted position of the push cable”. It is unclear if it refers to the same as “a retracted position” recited in line 5.
Claim 19, line 12 recites “the reservoir” that should be corrected to –the seed reservoir--.
Claim 19, line 13 recites “the treatment apparatus” that should be corrected to –the brachytherapy treatment apparatus--.
Claim 19, line 14 recites “the catheter” that should be corrected to –the flexible catheter--.
Claim 19, line 15 recites “the loading and pushing device…” that should be corrected to –the radioactive seed loading and pushing device,…--.
Claim 19, line 16: “the at least one tip of the hollow needle” lacks proper antecedent basis.
Claim 19, lines 16, 18, 22, 25 and 27 and claim 23, recite “a seed”. It is unclear whether it refers to the “radioactive seeds” recited in line 3 of claim 19.
Claim 19 recites in lines 25-26: “a push member configured to switch from a retracted initial position, beyond the proximal end…to a deployed position for which said push member moves the radioactive seed…” that renders the scope of the claim indefinite. (1) it is unclear what the push member is configured to switch, or it is the push member that is being switched from one position to another. (2) it is unclear what “for which” refers to.(3) it is unclear what object the “proximal end” refers to. (4) it is unclear whether “a deployed position” refer to the same as the identical term recited in claim 19, line 6.
Claim 20 recites starting line 3 “for example….”. The phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purpose, the “for example” phrase is considered not being part of the claimed invention.
Claim 21, line 3: “the reloading area” lacks proper antecedent basis.
Claim 21, line 3 recites “(in particular an upper opening)”. This phrase renders the claim indefinite because it is unclear whether the limitation in the parenthesis is part of the claimed invention. See MPEP § 2173.05(d). For examination purpose, the “for example” phrase is considered not being part of the claimed invention.
Claim 23, line 3 recites “…to detect a presence in the loading area” that renders the scope of the claim indefinite. It is unclear what object the “presence” refers to.
Claim 23, line 4 recites “the input” that lacks proper antecedent basis.
Claim 23, line 5 recites “the movement” that lacks proper antecedent basis.
Claim 23, line 6 recites “…until detection of the by the seed detector in the loading area” is grammatically incorrect and the meaning is unclear.
Claim 24, line 5 recites “the seed detector in the loading area” that lacks proper antecedent basis. In claim 23, line 3 recites “a seed detector targeting the loading area”. These two phrases have distinct scope.
Claim 24, line 7: “on the basis of the obtained actual position” should be corrected to –on a basis of the obtained actual position--.
Claims 24 and 26 recite “at least in an initialization mode”. It is unclear what kind mode the initialization mode. Note that claims 24 and 26 are both apparatus claims that do not carry any functional steps of operating the claimed apparatus or any sub-devices comprised within.
Claim 27 recites in line 2 “a pair comprising a motor-driven drive roller…”. It is unclear what the “a pair” refers to.
Claim 28 recites in line 2 “a second pair comprising a motor-driven drive roller…”. It is unclear what the “a second pair” refers to.
Claim 29, line 2: “the pressure” and “the first and second pressing rollers” that lack proper antecedent basis. Note that claim 27 only recites a pressing roller. “a first pressure roller” has not been recited.
Claim 30 recites in lines 1-2 “the loading device” that lacks proper antecedent basis.
Claim 30 recites in line 2 “upstream of the first upstream branch a system for accumulating the push cable in the retracted position comprising a rigid sheath” is grammatically incorrect and the meaning is unclear. Further it is unclear the rigid sheath is comprised in what object.
Claim 30, line 3: “the sheath” should be corrected to –the rigid sheath--.
Claim 31, lines 2-3: “the area to be treated” that renders the scope of the claim indefinite. It is unclear whether it refers to the treatment area recited in claim 19, lines 7 and 14.
Claim 31 recites in line 3 “at least one seed”. It is unclear whether it refers to the plural radioactive seeds or the singular seed in claim 19.
Claim 31 recites in line 6 “insert the latter into the area to be treated” that renders the scope of the claim indefinite. It is unclear what “the latter” refers, and it unclear whether the area to be treated refers to the treatment area recited in claim 19, line 7.
Claim 33 recites in line 2 “the end of the push cable” that renders the scope of the claim indefinite. It is unclear whether it refers to “a push end” recited in claim 19, line 10.
Claim 33 recites in line 3 “the cable”. It is unclear whether it refers to the flexible push cable recited in claim 19, line 4.
Claim 33 recites in line 3 :the radioactive end” that lacks proper antecedent basis.
Claim 33 recites in line 4 “the tip”. It is unclear whether it refers to the “at least one tip” recited in claim 19, line 16.
Claims 34 and 35 recite “(T)”. The meaning of it is unclear.
Claim 35 recites “The brachytherapy equipment by magnetic resonance imaging guidance according to claim 34”. Yet claim 34 is set forth for a brachytherapy treatment equipment comprising a magnetic resonance imaging device. The scope of claim 35 hence is unclear.
Claim 35 recites in line 2 “for which”. It is unclear what it refers to.
Claim 35 recites in lines 2 and 3 “the/said tunnel of the magnet” that is unclear whether it refers to “a magnet tunnel” recited in line 3 of claim 34.
Claim 36 depends on claim 31 that depends on claim 19. The following terms render the scope indefinite as it is unclear whether they refer to the same as the identical terms recited in claim 19: “at least one radioactive seed” and “a treatment area”.
Claim 36 recites in line 3 “said deposition method being imaged in real-time…” that renders the scope of the claim indefinite. It is unclear how a method may be imaged. The same rejection applies to claim 37.
Claim 36 recites in line 5 and claim 37 in line 6 recite “the tissues” that lacks proper antecedent basis.
Claim 36 recites in lines 5-6 “inserting said hollow needle into the tissues of the patient comprised in the treatment area under control of the imaging device”. The phrase “under control of the imaging device” is unclear. It is unclear whether it is the insertion, the hollow needle, the tissues, the patient, or the treatment area that is under control of the imaging device, and further it is unclear how an imaging device may control any of them. The same rejection applies to the limitation of step /c1/ and claim 37, steps /a1/ and /c1/..
Claim 37, lines 3 and 4: “said/the imaging device” should be corrected to –the magnetic resonance imaging device--.
Claims 36 and 37, second line from the end: “the tip” should be corrected to –the at least one tip--.
The dependent claims of the above rejected claims are rejected due to their dependency.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 19-21, 25, 34-35 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Green et al., US 2004/0162458 A1, hereinafter Green, in view of Liang et al., US 11,031,120 B2, hereinafter Liang, further in view of Amthor et al., US 2014/0303423 A1, hereinafter Amthor.
Claim 19. Green teaches in FIGS.2-6 a brachytherapy treatment apparatus comprising a radioactive seed loading and pushing device ([0002]: methods and apparatus for loading radioactive seeds into brachytherapy needles), the radioactive seed loading and pushing device comprising:
a seed reservoir (134, 136) containing radioactive seeds ([0055]: at least one cartridge (containing seeds and/or spacers) 134, 136), free with respect to one another ([0055]: containing seeds and/or spacer),
a flexible push cable (118, 184, 186) ([0053]: loading plunger 118 is disposed proximal to and aligned with collection chamber 160 and needle 16, such that distal advancement of the plunger passes its distal end through collection chamber 160, pushing the contents therein into needle 16; and [0055]: loading styles 184 and 186 is preferred to be sufficiently flexible to adapt to deviations from linearity during advancement and retraction), and
an automated guide and drive device of the push cable ([0057]: the movement of the loading stylets may be controlled by a mechanism associated with each stylet, such as a handle, button, knob, lever, spring, solenoid or switch. These mechanisms may be actuated by a user or by automated means) configured to
make the push cable switch from a retracted position ([0055]: the distal end of each stylet may be…retraced towards the proximal end) clearing a loading area for a radioactive seed ([0063]: loading stylet 184 is then proximally retracted, leaving seed 20 and spacer 22 in collection chamber 160)
into a deployed position ([0055]: the distal end of each stylet may be advanced towards the distal end) ensuring pushing of the seed from the loading area up to a downstream treatment area ([0063]: further advancement of first stylet 184 will push seed 20 and spacer 22 to the distal end of collection chamber 160; and [0053]: distal advancement of the plunger passes its distal end through collection chamber 160, pushing the contents therein into needle 16),
the guide and drive device comprising a first actuator and a guide system ([0057]: the movement of the loading stylets may be controlled by a mechanism associated with each stylet, such as a handle, button, knob, lever, spring, solenoid or switch. These mechanisms may be actuated by a user or by automated means) for the push cable comprising
a downstream branch (FIG.6A: the portion of the body 120 that comprises the collection chamber 160 and the needle 16) forming the loading area (160, the collection chamber) for the radioactive seed and
an upstream branch (FIG.6A: the proximal portion of the body 120 that comprises the stylets 184 and 186, and the plunger 118), extending the downstream branch at a proximal end of the downstream branch (FIG.6A), inside which upstream branch a push end of the push cable is configured to retract, in a retracted position of the push cable ([0055]: the distal end of each stylet may be advanced towards the distal end; and [0063]: loading stylet 184 is then proximally retracted, leaving seed 20 and spacer 22 in collection chamber 160),
and a system ensuring loading of a seed from the reservoir up to the loading area ([0063]: further advancement of first stylet 184 will push seed 20 and spacer 22 to the distal end of collection chamber 160; and [0053]: distal advancement of the plunger passes its distal end through collection chamber 160, pushing the contents therein into needle 16),
the treatment apparatus comprises a flexible catheter which extends up to a hollow needle ([0053]: collection chamber 160 may contain the predetermined arrangement of radioactive seeds and spacers prior to loading into brachytherapy needle 16; FIG.6B: the region between 160 and 16 – the spacer is considered the “flexible catheter” as claimed) configured to be inserted into the treatment area ([0008]: the radioactive seeds are placed inside thin needles, which are inserted through the skin of the perineum into the prostate),
the catheter extending a distal end of the downstream branch of the loading and pushing device (FIG.6B) and wherein
the push cable is configured to push the radioactive seed from the loading area up to the at least one tip of the hollow needle ([0063]: further advancement of first stylet 184 will push seed 20 and spacer 22 to the distal end of collection chamber 160; and [0053]: distal advancement of the plunger passes its distal end through collection chamber 160, pushing the contents therein into needle 16), and
in that the upstream branch is a first upstream branch, the system ensuring the loading of a seed from the seed reservoir up to the loading area comprising:
a second upstream branch (FIG.6A: the portion of the body 120 that comprises the first and second conduit 154 and 156),
the downstream branch extending at its proximal end by splitting into said first upstream branch (154) and said second upstream branch (156) (FIG.6A) and wherein
the seed reservoir (134, 136) opens into the second upstream branch, at a pre-loading area of a seed ([0056]: continued distal advancement of the stylet pushes the seeds and/or the spacers to the distal end of collection chamber 160 via conduit 154 – the area between the cartridges and the conduits is the “pre-loading area” as claimed),
an actuation device comprising a second actuator and a push member ([0046]: the positioning of cartridges 34 and 36, as well as actuation of plunger 18, may be controlled by automated means and the portion of the plunger 118 that extends to the second upstream branch is the “push member” as claimed) configured to switch from a retracted initial position, beyond the proximal end, clearing the pre-loading area by enabling exit of a seed from the seed reservoir into the second branch up to a deployed position for which said push member moves the radioactive seed from the pre-loading area up to the loading area while preventing exit of a seed from the seed reservoir in the pre-loading area ([0050]: by advancing plunger 18, or by controllably opening the aperture, a seed or spacer may enter lumen 44 from the cartridge via the aperture; FIG.4: the plunger 118 is in the retracted initial position aligned with the radioactive seeds in the spacer. Upon advancement, the plunger pushes through the spacers to advance the radioactive seeds and block the path, hence prevents exit of other seeds still in the cartridge),
a control unit ([0057]: automated means to mechanically or electrically transmit motion) configured,
starting from the retracted position of the push cable and the retracted initial position of the push member (FIG.4 illustrates the retracted position of the push cable and the push member – as considered above, both the push cable and the push member refer to different portion of the plunger 118), to:
/a/ advance said push member by the second actuator so as to push the radioactive seed from the pre-loading area into the second upstream branch up to the loading area in the downstream branch ([0050]: by advancing plunger 18, or by controllably opening the aperture, a seed or spacer may enter lumen 44 from the cartridge via the aperture),
/b/ retract said push member into the second upstream branch by the second actuator so as to clear the proximal end of the downstream branch (FIG.4: the plunger 118 is in the retracted initial position and the proximal end of the downstream branch is cleared up (the space below the plunger and the cartridge is empty)), and
/c/ advance the push cable by the first actuator so as to push the radioactive seed from the loading area up to said at least one tip of the hollow needle inserted into the treatment area in order to deposit the seed in line with the tip in the tissues of the patient ([0055]: the distal end of each stylet may be advanced towards the distal end; [0063]: further advancement of first stylet 184 will push seed 20 and spacer 22 to the distal end of collection chamber 160; [0053]: distal advancement of the plunger passes its distal end through collection chamber 160, pushing the contents therein into needle 16; and [0008]: the radioactive seeds are placed inside thin needles, which are inserted through the skin of the perineum into the prostate).
Green does not teach that the automated mechanism is a motor-driven mechanism.
However, in an analogous brachytherapy radioactive seed delivery field of endeavor, Liang teaches
a motor-driven guide and drive device of the push cable (Col.5, ll.15-18: the external pin driving mechanism 31 includes a universal linear sliding table, which performs linear transmission of the external pin by a servo motor driving a screw nut).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the apparatus of Green employ such a feature of a motor-driven guide and drive device as taught in Liang for the advantage of providing an automated means for pushing the radioactive seed for delivery.
In regard to the catheter being a flexible catheter that connects to the needle, both catheter and needle are conventionally acknowledged tools for radioactive seeds delivery. Whether to use a catheter or a needle or a combination of both and whether to have it rigid or flexible depends on the design and utility of the radioactive seed delivery apparatus for brachytherapy treatment. For example, Green teaches using a combination of a catheter and a needle as indicated above ([0053] and FIG.6B), and Amthor teaches using either a flexible catheter or a rigid needle in [0189]: depending on the applicator type (e.g. rigid needles or flexible catheters) control of the precise localization and orientation can be done differently.
Since both a catheter and a needle are used for radioactive seeds delivery, it would have been obvious for one of ordinary skills in the art before the effective filing date of the claimed invention to have alternatives of the type and material of delivery means as taught in Green and Amthor depending on the design and manufacture of the radioactive seed delivery apparatus for the advantage of “controlling the precise localization and orientation of the delivery”, as suggested in Amthor, [0189].
Claim 20. Green further teaches that
the radioactive seed loading and pushing device is fixed, while the hollow needle can be moved ([0053]: main body 120 to which standard brachytherapy needle 16 may be removably coupled), for example movable by means of a robot, thanks to the flexible catheter which allows for a freedom of movement between the movable hollow needle and the fixed radioactive seed loading and pushing device.
Claim 21. Green further teaches that
the seed reservoir is a removable cartridge (FIG.6A: the cartridges 134 and 136 are disposed in their respective space in their respective loading chamber 144 and 146), and wherein
the second upstream branch comprises at the reloading area, a lateral opening (in particular an upper opening) as well as a support configured to ensure fastening of the cartridge, in a removable manner, at the lateral opening (FIG.6A: the opening at the top of the loading chambers 144 and 146 receive the cartridges 134 and 136 and secure the cartridges).
Claim 25. Liang further teaches
a motor, as well as a transmission comprising a gear comprising a gear wheel driven by the motor, and a rack secured to the push member (Col.6, ll.58: a method suitable for clinical use of a targeted seed implanting robot on a human patient having specific steps as follows: driving the big arm reduction motor to cause motion of the driving gear; the driving gear, the driven gear, the pinion gear and the large gear; lower sliding rack, when moving horizontally in a transverse direction, drives the upper sliding rack to move horizontally in an opposite direction).
Claim 34. Green and Liang combined teaches all the limitations of claim 19 that is the brachytherapy treatment apparatus.
Neither Green nor Liang teaches a brachytherapy treatment equipment, comprising the brachytherapy treatment apparatus and a magnetic resonance imaging device comprising an imaging scanner comprising a magnet and a magnet tunnel (T).
However, in an analogous seed localization guiding field of endeavor, Amthor teaches the brachytherapy treatment apparatus and a magnetic resonance imaging device comprising an imaging scanner comprising a magnet and a magnet tunnel (T) ([0082]: optimized placement of catheters used for high dose rate brachytherapy using magnetic resonance imaging guidance; and [0083]: with a real-time MR-guided interventional technique, the placement of brachytherapy catheters can be improved significantly compared to conventional procedures; FIG.2 shows a magnet pair 204 and a magnet tunnel 206).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the apparatus of Green and Liang combined employ such a feature of having an MR scanner together as a treatment equipment as taught in Amthor for the advantage of significantly improving the placement of brachytherapy catheters, as suggested in Amthor, [0082].
Claim 35. Amthor further teaches that
The hollow needle is positioned internally to the tunnel of the magnet while the seed loading and pushing device is external to said runnel of the magnet (FIG.2: the MR image shows only the catheter and no other components, indicating that the apparatus components other than the seed delivery catheter or needle are positioned externally to the magnet tunnel while the catheter or the needle is positioned internally to the magnet tunnel).
In regard to the relative location of the apparatus components and the MR scanner components, whether to have the components internally or externally positioned in the magnet tunnel depends on (1) whether the material of the apparatus of component is suitable for being placed internally or in a close proximity of a magnetic field, i.e., whether it is anti-ferromagnetic, and (2) the accessibility or the need of accessing of the components for operation.
The claimed limitation hence is considered among various common practices that normally requires only ordinary skill in the art and hence are considered routine expedients. Such an alternate configuration is considered merely rearrangement of parts, which the court has held normally require only ordinary skill in the art and hence is considered routine expedients. It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to arrive such a configuration through routine experimentation with reasonable expectation of success. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). MPEP 2144.04.VI.C.
Claim 37. Green further teaches a method for depositing at least one radioactive seed in a treatment area of a patient, said method comprising
/al/ inserting said hollow needle into the tissues of the patient comprised in the treatment area ([0008]: the radioactive seeds are placed inside thin needles, which are inserted through the skin of the perineum into the prostate),
/bl/ loading said at least one radioactive seed into the loading area ([0055]: the distal end of each stylet may be…retraced towards the proximal end; [0063]: loading stylet 184 is then proximally retracted, leaving seed 20 and spacer 22 in collection chamber 160),
/cl/ pushing said at least one radioactive seed from the loading area up to said at least one tip of the hollow needle in order to deposit said at least one seed in line with the tip in the tissues of the patient ([0053]: distal advancement of the plunger passes its distal end through collection chamber 160, pushing the contents therein into needle 16).
Amthor further teaches that
said patient being installed within said imaging device and said deposition method being imaged in real-time by the imaging device which operates continuously, and the needle insertion and the deposition of the seeds is under control of the imaging device ([0083]: with a real-time MR-guided interventional technique, the placement of brachytherapy catheters can be improved significantly compared to conventional procedures; FIG.2 shows a real-time and continuous imaging guided catheter insertion; and FIG.23).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Green et al., US 2004/0162458 A1, hereinafter Green, in view of Liang et al., US 11,031,120 B2, hereinafter Liang, further in view of Amthor et al., US 2014/0303423 A1, hereinafter Amthor, further in view of Sing et al., US 2012/0022314 A1, hereinafter Sing.
Claim 22. Green, Liang and Amthor combined teaches all the limitations of claim 19.
Green further teaches that
the push member is a rectilinear rod, wherein the downstream branch and the second upstream branch extend rectilinearly (FIGS.4 and 6).
Neither of Green, Liang and Amthor teaches that downstream branch and the first upstream branch form a bend therebetween.
However, in an analogous brachytherapy apparatus configuration field of endeavor, Sing teaches
downstream branch and the first upstream branch form a bend therebetween ([0073]: FIGS.1A-1D: the center catheter may include a malleable section between the hub 66 and the distal tip 68, such that the angle, bend, and/or other shape of the center catheter 64 may be adjusted as desired based upon the particular anatomy encountered during a procedure).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the apparatus of Green, Liang and Amthor combined employ such features associated with “downstream branch and the first upstream branch form a bend therebetween” as taught in Sing for the advantage of being adjusted as desired based upon the particular anatomy encountered during a procedure, as suggested in Sing, [0073].
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Green et al., US 2004/0162458 A1, hereinafter Green, in view of Liang et al., US 11,031,120 B2, hereinafter Liang, further in view of Amthor et al., US 2014/0303423 A1, hereinafter Amthor, further in view of Shanks et al., ES2298153 T3, hereinafter Shanks.
Claim 23. Green, Liang and Amthor combined teaches all the limitations of claim 19.
Neither of Green, Liang and Amthor teaches the claimed features associated with the seed detector.
However, in an analogous brachytherapy seed delivery field of endeavor, Shanks teaches
a seed detector targeting the loading area configured to detect a presence in the loading area, the seed detector emitting a signal at the input of the control unit, and wherein, in /a/, the control unit is configured to ensure the movement of the seed by the push member from the pre-loading area until detection of the by the seed detector in the loading area (p.9, ¶-5: a first post and a second post support respectively a laser emitting device and a device laser detector that is positioned to observe the end of cannula 128. In this way, the presence of a seed in the end of cannula is detected before extending the clamp of suture from suture clip).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the apparatus of Green, Liang and Amthor combined employ such features associated with “a seed detector targeting the loading area configured to detect a presence in the loading area, the seed detector emitting a signal at the input of the control unit, and wherein, in /a/, the control unit is configured to ensure the movement of the seed by the push member from the pre-loading area until detection of the by the seed detector in the loading area” as taught in Shanks for the advantage of providing a monitoring of the seed delivery as a conventional utility of a laser detector when being used in brachytherapy seed delivery purpose.
Claims 31, 32 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Green et al., US 2004/0162458 A1, hereinafter Green, in view of Liang et al., US 11,031,120 B2, hereinafter Liang, further in view of Amthor et al., US 2014/0303423 A1, hereinafter Amthor, further in view of Su et al., “real-time MRI-guided needle placement robot with integrated fiber optic force sensing”. IEEE International Conference on Robotics and Automation, 2011, Shanghai, China, hereinafter Su.
Claim 31. Green, Liang and Amthor combined teaches all the limitations of claim 19, including the feature of inserting the needle into the area to be treated (Green: [0008]; and Amthor: FIG.2),
Neither of Green, Liang and Amthor teaches the claimed features associated with the additional guide assistance.
However, in an analogous brachytherapy radioactive seed delivery configuration field of endeavor, Su teaches
a guide assistance configured to guide the insertion of the hollow needle into the area to be treated and to guide the deposition of at least one seed, said guide assistance comprising a guide robot configured to be coupled with an imaging device (Abstract: an MRI compatible piezoelectric actuated robot integrated with a high-resolution fiber optic sensor for prostate brachytherapy with real-time in situ needle steering capability in 3T MRI; FIGS.1-2),
said guide robot being configured to be placed within or proximate to the imaging device (FIG.1) and
being further configured to move the hollow needle (FIG.1 legend: 6-DOF piezoelectric actuated needle placement robot consisting of needle driver module and Cartesian gross positioning module. The needle driver module provides 8cm insertion stroke),
said imaging device being configured to visualise the movement and the insertion of the hollow needle into the area to be treated, as well as the deposition of the radioactive seed (Abstract: a dynamic needle insertion is performed and bevel tip needle steering capability is demonstrated under continuous real-time MRI guidance).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the apparatus of Green, Liang and Amthor combined employ such features associated with the above identified claimed features as taught in Su for the advantage of providing a guidance for proper needle insertion to minimize the needle placement error, as suggested in Su, Introduction, ¶-1.
Claim 32. Su further teaches that
the guide robot is further configured to be compatible with said imaging device when said imaging device uses magnetic field values comprised between 0 and 5 Teslas (Abstract: MRI compatibility of the robot is evaluated under 3T MRI using standard prostate imaging sequences and average signal noise ratio (SSNR) loss is limited to 2% during actuator motion).
Claim 36. Green further teaches a method for depositing at least one radioactive seed in a treatment area of a patient to be treated using the brachytherapy treatment apparatus, said method comprising:
/al/ inserting said hollow needle into the tissues of the patient comprised in the treatment area ([0008]: the radioactive seeds are placed inside thin needles, which are inserted through the skin of the perineum into the prostate),
/bl/ loading said at least one radioactive seed into the loading area ([0055]: the distal end of each stylet may be…retraced towards the proximal end; [0063]: loading stylet 184 is then proximally retracted, leaving seed 20 and spacer 22 in collection chamber 160),
/cl/ pushing said at least one radioactive seed from the loading area up to said at least one tip of the hollow needle in order to deposit said at least one seed in line with the tip in the tissues of the patient ([0053]: distal advancement of the plunger passes its distal end through collection chamber 160, pushing the contents therein into needle 16).
Amthor further teaches that
said patient being installed within said imaging device and said deposition method being imaged in real-time by the imaging device which operates continuously, and the needle insertion and the deposition of the seeds is under control of the imaging device ([0083]: with a real-time MR-guided interventional technique, the placement of brachytherapy catheters can be improved significantly compared to conventional procedures; FIG.2 shows a real-time and continuous imaging guided catheter insertion; and FIG.23).
Allowable Subject Matter
Claims 24, 26-30 and 33 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The limitations recited in claim 24 in regard to the features of “/d/ controlling the second actuator so as to move the push member until detection of the push member by the seed detector in the loading area, /e/ obtaining an actual position of the push member in the loading area, and /f/ determining said retracted initial position of the push member on the basis of the obtained actual position", in combination with the other claimed elements, are not taught or disclosed in the prior arts.
The limitations recited in claim 26 in regard to the features of “cable detector targets a detection area in said first upstream branch and wherein the control unit is configured to determine the retracted position of the push cable, at least in an initialisation mode, for which the first actuator moves the push cable until detection of the push end by the cable detector", in combination with the other claimed elements, are not taught or disclosed in the prior arts.
The limitations recited in claim 27 in regard to the features of “the first actuator comprises a pair comprising a motor-driven drive roller and a pressing roller between which the push cable is pinched", in combination with the other claimed elements, are not taught or disclosed in the prior arts.
The limitations recited in claim 30 in regard to the features of “upstream of the first upstream branch a system for accumulating the push cable in the retracted position comprising a rigid sheath for the push cable, the sheath being shaped according to a helicoid ", in combination with the other claimed elements, are not taught or disclosed in the prior arts.
The limitations recited in claim 33 in regard to the features of “a radioactive head removably coupled to the end of the push cable by a fastening means and wherein the cable is configured to be deployed by the first actuator until the radioactive end protrudes from the tip of the hollow needle", in combination with the other claimed elements, are not taught or disclosed in the prior arts.
Claims 28-29 are allowable by virtue of their dependency to an allowable claim.
Conclusion
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798
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