The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Specification
The disclosure is objected to because of the following informalities:
On page 20, in the paragraph beginning “Referring to FIG. 11a, a drap 1260…” and thereafter, the word “drap” appears to be a misspelling of “drape”. This should be fixed throughout.
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.
The following claim limitations have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (any paragraphs cited come from PGPUB 2024/0188945, representative of the specification of the instant application):
Claims 1 and 17
A rotation unit configured to allow a … tool … to be wound in a circumferential direction about the second axis…
This limitation utilizes the generic placeholder “unit”, transitional phrase “configured to” and functional language “allow a… tool… to be wound… about the second axis”. The preceding term “rotation” does not apply specific structure that performs the function.
The specification states the following in paragraph 53: “The rotation unit 1110 may be configured to receive the surgical tool 1400. For example, the rotation unit 1110 may include a first reception part 1111a formed in an upper portion of the rotation unit 1110, a second reception part 1111b, and a third reception part 1111c formed in a lower portion of the rotation unit 1110.” This is all illustrated in Figures 3-4.
Claims 4 and 18
A reception part … configured to allow at least a portion of the surgical tool to be wound and received
This limitation utilizes the generic placeholder “part”, transitional phrase “configured to” and functional language “allow at least a portion of the surgical tool to be wound and received”. The preceding term “reception” does not apply specific structure that performs the function.
The specification states the following in paragraph 53: “The rotation unit 1110 may be configured to receive the surgical tool 1400. For example, the rotation unit 1110 may include a first reception part 1111a formed in an upper portion of the rotation unit 1110, a second reception part 1111b, and a third reception part 1111c formed in a lower portion of the rotation unit 1110.” This is all illustrated in Figures 3-4.
Claim Rejections - 35 USC § 112, First Paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 20 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 20 recites that “the portion of the passage is defined by an inclined surface formed obliquely on the rib”. In paragraph 67, it states that “For example, the second passage 1121c may be partially defined by an inclined surface formed on the rib 1121b. For another example, the second passage 1121c may be provided in the form of an inclined slit formed in the rib 1121b.” There is no other mention of an inclined surface with respect to the portion of the passage, or the passage at all within the specification. There is absolutely no use of the word “obliquely” in the specification as originally filed, with the exception of within originally filed claim 20. The figures do not clearly illustrate a “rib”, nor an “inclined surface”, nor an obliquely formed inclined surface (see figure 5e, which illustrates rib 1121b in the exploded view which is simply white space). Therefore, it is not clearly described or illustrated how “an inclined surface [may be] formed obliquely on the rib”, such that one of ordinary skill in the art could make or use the invention as claimed in claim 20.
Claim Rejections - 35 USC § 112, Second Paragraph
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 6-8 and 19-20 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.
Claims 6-8 and 19 are rejected because “a rib inserted into the reception part and defining at least a portion of the passage” is unclear. According to the specification, numeral 1121b as illustrated in Figure 5e is “a rib”. However, this illustrates white space within Figure 5e, making it unclear what exactly the claimed “rib” entails or requires. Additionally, this is not clearly “inserted into the reception part” based on Figure 5e. As such, it is unclear what “a rib” refers to in the claim.
Claim 20 is rejected for the same reason stated immediately above for claim 19, since both the fact that it depends from claim 19, and also because it provides further limitations to the claimed “rib”.
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.
Claims 1-4, 9 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song et al. (CN 111281544 A).
Song discloses “an in-vivo medical appliance automatic guiding robot system, comprising: a driver, connected with the flexible instrument drive for driving the flexible instrument to generate linear motion and rotary motion in an anatomical structure” (see Abstract). Specifically, Song teaches:
A fixed frame (see multi-joint arm 8 in Figure 2);
A steering assembly coupled to the fixed frame so as to be rotatable about a first axis (see housing portions 18, 22 and 23 in Figure 3, which form a housing within which components of the drum assembly reside; and note that “second bevel gear 12 to drive the whole catheter insertion device to rotate, the catheter 2 about its axis”, see page 9, paragraph beginning “tube rotating device…” in Machine Translation, thereby teaching that the rotational axis is illustrated and coaxial with the portion 2 of the catheter that is exiting the device in Figures 4-5), and including a first introduction/discharge port aligned with the first axis (see “opening” 27 in Figure 4); and
A drum assembly coupled to the steering assembly so as to be rotatable about a second axis extending in a direction that is transverse to the first axis (see “drum” 9 in Figure 4, as well as housing 10 which holds the drum 9; where the drum rotates about its center point in an axis clearly transverse to that of the axis created by catheter 2 in the same figure), including a rotation unit configured to allow a flexible wire-type or tubular surgical tool that is insertable into a vessel to be wound in a circumferential direction about the second axis (see catheter 2 in Figure 4 and note that on page 8 of the Machine Translation and in the paragraph beginning “FIG. 4…” it states that “For example, the insertion device can be as shown in FIG. 1, the catheter is inserted into the vascular system”’; also note that the same paragraph states “conduit 2 is detachably wound on the drum 9, is inserted into the motor 16 with conduit 2 is connected for driving the conduit 2 along a linear direction (forward and backward) motion to the conduit inserting dissection structure or removed from the anatomical structure”), and configured to guide the surgical tool such that the surgical tool is withdrawn outward or inserted inward through the first introduction/discharge port when the rotation unit rotates about the second axis (see the previous quotes from page 8 of the Machine Translation).
Regarding claim 2, it is noted that Figures 4 and 5 clearly illustrate a second introduction/discharge port at the center of the drum:
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Regarding claim 3, it is noted that numeral 27 the above reproduction of Figure 4 illustrates one half of the “guide unit” which is part of the drum assembly, which is illustrated in Figure 3 as a component of the housing portion 10. Additionally, the other half of this portion 27 is on housing unit 18 as illustrated in Figure 3, which is part of the steering assembly as it is defined by the rejection of claim 1. Therefore, the “guide unit” is coupled to both the steering assembly and the drum assembly, as claimed. Additionally, Figure 4 above shows the rotation assembly rotatably coupled to the guide unit.
Regarding claim 4, the above reproduction of Figure 4 illustrates “a reception part” as claimed, where it can be seen that the catheter is introduced through second introduction/discharge port and fed through “reception part” from which it begins to wind around the drum 9. The catheter then winds around the drum assembly until it exits and is ready for introduction into the patient via opening 27.
Regarding claim 9, Figure 3 illustrates a gearing system (see gears 11 and 12, bracket 13 and ball bearing 20), which is a steering driving unit configured to rotate the steering assembly about the first axis with respect to the fixed frame (where again, the fixed frame is the multi-joint arm 8 in Figure 2), wherein the steering driving unit includes: a steering driving shaft extending along the first axis from one side of the steering assembly and rotatably coupled to the fixed frame (see component 20 in Figure 3); and a steering actuator mechanically connected to the steering driving shaft (see second bevel gear 12 in Figure 3).
Regarding claim 13, Song teaches that “During operation, the conduit 2 reaches the anatomical structure in the target position (e.g., the vascular system of the patient), the user can open the second shell of the reel 18, and the catheter 2 is removed from the drum 9, when the second shell of the drum 18 is removed, the drum 9 also can be removed from the drum the first shell 10” (see page 8, 2nd-to-last paragraph, emphasis added).
Claims 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhao et al. (CN 113350662 A).
Zhao discloses catheter controller comprises: a base and a conveying turntable rotatably set on the base (see Abstract). The device of Zhao includes:
A guide unit including an introduction/discharge port aligned on a first axis (see numeral 18 in Figure 8, which is “a second guide member”);
A rotation unit coupled to the guide unit (see conveying turntable 13 in Figure 5) so as to be rotatable about a second axis extending in a direction that is transverse to the first axis (note that the conveying turntable 13 rotates about an axis that extends into/out of the page in Figure 8), and configured to allow a flexible wire-type or tubular surgical tool that is insertable into a vessel to be wound in a circumferential direction about the second axis (“the conveying turntable 13 is provided with a groove spirally extending along the circumferential direction for the conduit 300 coiled” see page 5 in paragraph beginning “Referring to FIG. 1, FIG. 1 shows…” of Machine Translation, noting that the conduit 300 is a catheter that is introduced into the patient’s blood vessels),
Wherein the guide unit is configured to guide the surgical tool such that the surgical tool advances outward or retracts inward through the introduction/discharge port when the rotation unit rotates about eh second axis with respect to the guide unit (“two guide pieces are located on the same axis, so as to guide the conduit 300 when in use, by rotating the conveying turntable 13, pushing the distal end of the catheter 300 through the first guide member 17, at this time, the distal end of the catheter 300 is exposed to the first guide member 17; Then, as the catheter 300 is further pushed, the distal end of the catheter 300 passes through the second guide 18, and finally enters into the patient”, see paragraph spanning pages 7-8 of Machine Translation).
Regarding claim 18, in Figure 10, there is illustrated an “outlet end 104” which reads on the claims “reception part”, as this feeds the conduit/catheter into the first guide member 17.
Regarding claims 19-20, Zhao illustrates first guide member 17, which is “a passage” as claimed, as this guides the surgical tool between the introduction/discharge port (see second guide member 18 of Zhao) and the reception part (see numeral 104 of Zhao). As shown in Figure 8 of Zhao, numerals 17 and 104 are proximate to one another and therefore they are interpreted such that first guide member 17 is defined at least a portion by the outlet 104. Below is illustrated Figure 10 of Zhao, which illustrates a rib(s), which, as best understood in view of the rejections under 35 USC 112(a) and (b) above, equates to rib 1121b as illustrated in Figure 5e of the instant application.
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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.
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Song in view of Zhao.
Song is described above with respect to claim 4. While there is clearly illustrated to be a sharp bend in the catheter immediately before exiting opening 27 (see both numeral 2 in Figure 3, and also see Figure 4), there is no clear description about how the catheter makes this bend.
Zhao teaches a similar catheter control device (see the rejections of claims 17-20 above). At the point where the catheter/conduit of Zhao exits the conveying turntable, Zhao teaches an outlet end 104 (see Figure 10), which guides the catheter to first guide member 17, and ultimately to second guide member 18 (see numerals 17 and 18 in Figures 6 and/or 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide explicitly structured guiding members to lead the catheter off the drum 9 of Song, in a similar manner as Zhao provides guides 104 and 17 to direct its conduit/catheter off the conveying turntable and to the outlet 18 and then into the patient, as there would be a clear need to create the illustrated bend in Song, yet Song fails to teach how this is performed such that the catheter would then exit the opening 27 in a straight line as illustrated. Zhao fills in this missing piece, which would be obvious to one of ordinary skill in the art.
Regarding claims 6-8, Zhao illustrates first guide member 17, which is “a passage” as claimed, as this guides the surgical tool between the introduction/discharge port (see second guide member 18 of Zhao) and the reception part (see numeral 104 of Zhao). As shown in Figure 8 of Zhao, numerals 17 and 104 are proximate to one another and therefore they are interpreted such that first guide member 17 is defined at least a portion by the outlet 104. Below is illustrated Figure 10 of Zhao, which illustrates a rib(s), which, as best understood in view of the rejections under 35 USC 112(a) and (b) above, equates to rib 1121b as illustrated in Figure 5e of the instant application.
Allowable Subject Matter
Claims 10-12 and 14-16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Additional discovered prior art is made of record in the PTO-892 as considered pertinent to applicant's disclosure, but not relied upon in the rejections above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES KISH/ Primary Examiner, Art Unit 3792
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