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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Objections
Claims 2 and 14 are objected to because of the following informalities:
-In claim 2: “extent” should read “extend”
-In claim 14: “a the thread” should read “the thread”
Appropriate correction is required.
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.
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 1-15 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 clockwise direction" in Lines 15-16 and 17. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the direction" in Line 16. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the longitudinal direction" in Lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites “having each time” and it is unclear what this is referring to. Is it a structural reference or a time point in use of the structure? For the purposes of examination it will be treated as if the term ‘each time’ is not present in the claim as it would appear removing that language would not change the intended scope.
Claim 7 recites ‘its’ and it is unclear what the term ‘its’ is meant to refer to.
Claim 10 recites ‘its’ and it is unclear what the term ‘its’ is meant to refer to.
Claim 13 recites the limitation "the radial extension" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 15: Claim limitation “locking means” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There appears to be no corresponding structure provided in the disclosure for “locking means”. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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) 1-2 and 8-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nelson et al. (EP 3772317 B1).
Regarding claim 1, Nelson teaches a steerable device for use inside of a mammalian body (Abstract), comprising:
a flexible elongated element (22), elongated along a device longitudinal axis (Paragraph 0037) and configured to enter soft tissue of the mammalian body (Claim 1; Paragraph 0049);
a magnetic element (steering magnet 36) placed in a distal end portion of the elongated element (Paragraph 0049) and configured for allowing steering of the elongated element by way of an external magnetic field, a proximal end of the elongated element extending out of the mammalian body in use (Paragraph 0049),
wherein a structured section (spiral reinforcement 12) arranged proximal to the magnetic element (Figures 1-4) and comprising a plurality of elongated protrusions formed on an outer surface of the elongated element and having each a protrusion longitudinal axis (Figures 2-4), each protrusion longitudinal axis forming an angle with the device longitudinal axis, the plurality of elongated protrusions forming a plurality of angles with the device longitudinal axis, wherein each angle of the plurality of angles is less than 90°, as measured in the clockwise direction from the device longitudinal axis oriented in the direction from proximal to distal, such that rotation of the elongated element in the clockwise direction around the device longitudinal axis effects a movement of advancement of the elongated element relative to the soft tissue along the device longitudinal axis (Figures 2-4; Paragraphs 0035, 0043, and 0045; the elements spiral around the longitudinal axis and parts of each coil is considered a protrusion).
Regarding claim 2, Nelson teaches wherein the plurality of elongated protrusions extent each over less than one turn around the elongated element as seen in the longitudinal direction (Figures 2-4; Paragraphs 0035, 0043, and 0045; the elements spiral around the longitudinal axis and each coil is considered a protrusion).
Regarding claim 8, Nelson teaches wherein the plurality of elongated protrusions have a triangular cross section or a circular cross section or a hump-shaped cross (Figures 1-4; circular)
Regarding claim 9, Nelson teaches wherein the structured section is interrupted by a plurality of unstructured sections that are free from elongated protrusions (the flexible membrane; Paragraph 0035; “The endoscope comprises a tubular structure 10, which is made of a metallic spiral reinforcement 12 and a flexible membrane closing the gaps between adjacent sections of the spiral reinforcement 12.”)
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) 3-4 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (EP 3772317 B1) in view of Klint (US Patent No. 6383146).
Regarding claim 3, Nelson is silent on wherein the plurality of angles have each a same single angle value chosen between 5° and 80°.
Klint teaches the pitch angle as being a design choice and having a value between 5 degrees and 80 degrees (Column 4, Lines 36-58).
The applicant’s specification provides no specifical reasoning or critical functionality for the use of wherein the plurality of angles have each a same single angle value chosen between 5° and 80°, thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the wherein the plurality of angles have each a same single angle value chosen between 5° and 80° as desired by the user as these characteristic are noted to be a matter of routine engineering design choice to achieve desired flexibilities as taught by Klint (Column 4, Lines 36-58 of Klint).
Regarding claim 4, Nelson teaches wherein the plurality of elongated protrusions are aligned along a thread (2) extending along the elongated element (Paragraph 0015; Figure 3), the thread having a thread path angle (Paragraph 0038).
While Nelson is silent on the thread path angle equal to the single angle value, the applicant's specification provides no specifical reasoning or critical functionality for the use of the thread path angle equal to the single angle value, thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the thread path angle equal to the single angle value as desired by the user as a matter of routine engineering design choice.
Regarding claim 7, Nelson teaches wherein an outer tubular structure (2) surrounds a section of the elongated element (Figures 2-4), the tubular structure comprising an engaging element configured to engage with the plurality of elongated protrusions such that rotation of the elongated element around its device longitudinal axis effects a movement of the elongated element relative to the tubular structure along the device longitudinal axis. (Paragraphs 0038-0039).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (EP 3772317 B1) in view of Klint (US Patent No. 6383146) and Sudin et al. (US 2019/0240457).
Regarding claim 5, Nelson is silent on wherein the plurality of angles are distributed according to at least two angle values, the at least two angle values being chosen between 5° and 80°.
Klint teaches the pitch angle as being a design choice and having a value between 5 degrees and 80 degrees (Column 4, Lines 36-58).
Sudin teaches having multiple pitch angles (Paragraph 0047).
The applicant’s specification provides no specifical reasoning or critical functionality for the use of wherein the plurality of angles are distributed according to at least two angle values, the at least two angle values being chosen between 5° and 80°, thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the wherein the plurality of angles are distributed according to at least two angle values, the at least two angle values being chosen between 5° and 80° as desired by the user as these characteristic are noted to be a matter of routine engineering design choice to achieve desired flexibilities as taught by Klint (Column 4, Lines 36-58 of Klint) and Sudin (Paragraph 0047 of Sudin).
Regarding claim 6, Nelson is silent on wherein the plurality of elongated protrusions are aligned along at least two threads having each time a thread path angle equal to an angle value of the at least two angle values.
Klint teaches the pitch angle as being a design choice (Column 4, Lines 36-58).
Sudin teaches having multiple pitch angles (Paragraph 0047).
The applicant’s specification provides no specifical reasoning or critical functionality for the use of wherein the plurality of elongated protrusions are aligned along at least two threads having each time a thread path angle equal to an angle value of the at least two angle values, thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the wherein the plurality of elongated protrusions are aligned along at least two threads having each time a thread path angle equal to an angle value of the at least two angle values as desired by the user as these characteristic are noted to be a matter of routine engineering design choice to achieve desired flexibilities as taught by Klint (Column 4, Lines 36-58 of Klint) and Sudin (Paragraph 0047 of Sudin).
Claim(s) 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (EP 3772317 B1) in view of Griffin et al. (US 2009/0227983).
Regarding claim 10, Nelson teaches the steerable device for use inside of a mammalian body (Abstract), comprising:
a flexible elongated element (22), elongated along a device longitudinal axis (Paragraph 0037) and configured to enter soft tissue of the mammalian body (Claim 1; Paragraph 0049);
a magnetic element (steering magnet 36) placed in a distal end portion of the elongated element (Paragraph 0049) and configured for allowing steering of the elongated element by way of an external magnetic field, a proximal end of the elongated element extending out of the mammalian body in use (Paragraph 0049),
a structured section (thread structure 2) in the form of an outer thread structure being formed on an outer surface of the elongated element (Figures 2-4) and having a radial extension beyond the outer surface of the elongated element (Figures 2-4), wherein the thread structure is arranged proximal to the magnetic element (Figures 2-4) wherein the thread structure is configured to engage with soft tissue surrounding the elongated element inside the mammalian body such that rotation of the elongated element around its device longitudinal axis effects a movement of the elongated element relative to the soft tissue along the device longitudinal axis (Figures 2-4; Paragraphs 0035, 0043, and 0045).
Nelson is silent on the material of the thread structure.
Griffin teaches the thread structure is made of a magnetically non-responsive material (Paragraphs 0057 and 0035).
It would have been obvious to one of ordinary skill in the art to have modified Nelson with Griffin because Griffin teaches the material as being a design choice (Paragraphs 0057 and 0035) and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. MPEP 2144.07.
Regarding claim 11, Nelson teaches wherein the thread structure has a triangular cross section or a circular cross section or a hump-shaped cross (Figures 2-4; circular).
Regarding claim 12, Nelson teaches wherein the structured section is interrupted by a plurality of unstructured sections that are free from the thread structure (Figures 2-4; spaces without the thread).
Regarding claim 13, Nelson is silent on wherein the radial extension of the thread structure measured from the outer surface of the elongated element has a first value in a first portion of the structured section and a second value different from the first value in a second portion of the structured section such that the first portion has a different flexibility from the second portion.
Griffin teaches wherein the radial extension of the thread structure measured from the outer surface of the elongated element has a first value in a first portion of the structured section and a second value different from the first value in a second portion of the structured section such that the first portion has a different flexibility from the second portion as being options that are considered a design choice (Paragraph 0057). Thus it would have been obvious to one of ordinary skill in the art to have modified Nelson with Griffin to have these desired characteristics as determining them would only require routine experimentation to achieve predictable desired flexibility results.
Regarding claim 14, Nelson is silent on wherein the thread structure is freely wound around the elongated element, wherein a distal end of the thread structure is fixed to the elongated element and a proximal end of the thread structure is removably fixed to the elongated element to provide for a different thread pitch by displacing proximally or distally the proximal end in the longitudinal direction.
Griffin teaches wherein the thread structure is freely wound around the elongated element, wherein a distal end of the thread structure is fixed to the elongated element and a proximal end of the thread structure is removably fixed to the elongated element to provide for a different thread pitch by displacing proximally or distally the proximal end in the longitudinal direction as being options that are considered a design choice (Paragraph 0057). Thus it would have been obvious to one of ordinary skill in the art to have modified Nelson with Griffin to have these desired characteristics as determining them would only require routine experimentation to achieve predictable desired flexibility results.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (EP 3772317 B1) in view of Griffin et al. (US 2009/0227983) and in further view of Melsheimer (US 2008/0051676).
Regarding claim 15, Nelson is silent on wherein the thread structure is freely wound around the elongated element, wherein the elongated element comprises locking means that engages the thread structure in a first direction of rotation of the elongated element to transfer rotational movement of the elongated element to the thread structure and that disengages from the thread structure in a second direction of rotation opposed to the first direction of rotation to allow free rotation of the thread structure.
Melsheimer teaches wherein the thread structure is freely wound around the elongated element, wherein the elongated element comprises locking means that engages the thread structure in a first direction of rotation of the elongated element to transfer rotational movement of the elongated element to the thread structure and that disengages from the thread structure in a second direction of rotation opposed to the first direction of rotation to allow free rotation of the thread structure (Paragraphs 0031-0034). It would have been obvious to one of ordinary skill in the art to have modified Nelson with Melsheimer because it enables an improved system for connecting an elongated element with a thread structure (Paragraphs 0008 and 0031-0034 of Melsheimer).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Binmoeller et al. (US 2006/0270978).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK FERNANDES whose telephone number is (571)272-7706. The examiner can normally be reached Monday-Thursday 9AM-3PM EST.
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
