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 .
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: “driving device” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-4, 6-11, 13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 2020/0205845) in view of Neracher (US 5,135,482).
Regarding claim 1, Yang et al. disclose a medical water jet scalpel device (Figures 21A-23B; ¶[0197]-[0201]), comprising: an outer tube (2102 or 2202 or 2302); a water jet tube (2124 or 2204 or 2304; a media jet tube is capable of producing a water jet) extending through the outer tube and configured to input medical liquid, wherein a gap is provided between an outer wall of the water jet tube and an inner wall of the outer tube (the lumen of the outer tube is much wider than the water jet tube diameter thereby forming a gap as claimed and evident from Figures 21A-23B); an opening (opening shown at distal end of each water jet tube - e.g. 2210) arranged at a distal end of water jet tube and configured to output the medical liquid ¶[0197]-[0201]; and a driving device (¶[0237]; Figure 29; the motorized driver of Yang is interpreted under 35 U.S.C. 112(f) as being equivalent to Applicant’s driving device - see ¶[0016] of Applicant’s published application) connected with at least part of the water jet tube, and configured to drive a distal end part of the water jet tube to swing reciprocally or revolve around a central axis of the outer tube (¶[0184]; the water jet tube is the agitator 1900 - ¶[0048], [0049], [0196]).
Yang et al. fail to disclose that a water jet nozzle is arranged at a distal end of water jet tube. Yang intends to use a media jet to help remove a vessel obstruction (¶[0201], [0239]).
Neracher discloses providing a nozzle (13; Figure 4) at the end of a water jet tube in order to control the properties of a fluid jet and the type of obstruction removal mechanism (col. 2, lines 49-53).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Neracher to have provided a nozzle at the end of the water jet tube in order to control the properties of the fluid jet and the type of obstruction removal mechanism.
Regarding claim 2, Yang et al. disclose that a proximal end part of the water jet tube comprises a connecting part (2604; Figures 28 and 29) fixedly connected with at least part of the driving device (¶[0236], [0237]), the distal end part of the water jet tube and the connecting part of the water jet tube are not coaxial with each other, so that the driving device drives the proximal end part of the water jet tube to rotate around a central axis of the water jet tube and enables the distal end part of the water jet tube to revolve around the central axis of the outer tube (evident from Figures 21A-23B of Yang et al.).
Regarding claim 3, the water jet tube is integrally bent so that the distal end part and the connecting part are not coaxial with each other (evident from Figures 21A-23B of Yang et al.).
Regarding claim 4, the distal end part of the water jet tube is configured as a bending part, and the distal end part has at least two segments (e.g. see segments on either side of each loop in Figure 20C of Yang et al.) which are not coaxial with each other, so that the distal end part and the connecting part are not coaxial with each other.
Regarding claim 6, when the distal end part of the water jet tube abuts against an inner wall of a first side of the outer tube along a radial direction, the proximal end part of the water jet tube is arranged with a gap relative to an inner wall of the other side of the outer tube opposite to the first side along the radial direction (evident from Figure 21A of Yang et al.; noting that Applicant’s “proximal end part” 121b is at an approximately middle part of the water jet tube - Figure 6A).
Regarding claim 7, the proximal end part of the water jet tube is configured to be fixed relative to the outer tube, and the driving device is configured to drive the distal end part of the water jet tube to swing reciprocally in one dimension along a radial direction of the water jet tube relative to the outer tube, or to swing circumferentially in two dimensions around the central axis of the outer tube (Figures 27A-29 and ¶[0236], [0237] of Yang et al.).
Regarding claim 8, the device further comprises a supporting body (2620 or 2620+2950; Figures 27A and 29 of Yang et al.), wherein the supporting body is sleeved outside a proximal end of the outer tube, and the supporting body is fixedly connected with the proximal end of the outer tube (via 2630).
Regarding claim 9, the supporting body comprises a handle (either or both of 2620 and the housing of 2950 can be used as a handle), the handle is fixedly connected with the driving device (the housing of 2950 must be fixed to a motorized driver - ¶[0237]), and the handle is configured to be driven by an external driving source to move in a direction of the central axis of the outer tube, so that the distal end part of the water jet tube moves in the direction of the central axis of the outer tube (the handle is capable of being axially driven by some driving source as claimed).
Regarding claim 10, the driving device comprises a driving motor (¶[0237] of Yang et al.), and the driving motor is connected with the connecting part of the water jet tube to drive the proximal end part of the water jet tube to rotate around the central axis of the water jet tube (via 2604).
Regarding claim 11, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided an electrical line or driver connecting line to power and signal the motor of 2950 (¶[0237]). Yang et al. clearly depict a shell housing the components of 2950. The shaft connecting to the motor is shown tightly sleeved within the collar of 2602 in Figure 29. Furthermore, the connecting part is shown without any socket or other female connection (Figure 26). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a female connection to the motor to sleeve over the connecting part.
Regarding claim 13, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a liquid supply line of some form and configured as claimed to connect to the media injection port 2610 of Yang et al.
Regarding claim 17, Yang et al. fail to explicitly disclose a liquid supply unit as claimed. Yang et al. disclose that media for the jet may be supplied through a port (2610).
Neracher discloses a liquid supply unit (12; col. 3, lines 11-12) and pressure pump (11D; col. 2, line 56) for providing pressure to medical liquid to form a fluid jet.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the liquid supply unit and pump of Neracher to the device of Yang et al. in order to supply the device with the high pressure fluid necessary for forming the jet.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 2020/0205845) in view of Neracher (US 5,135,482), as applied to claim 3 above, and further in view of Bonnette et al. (US 2008/0319386).
Regarding claim 5, Yang et al. disclose that the distal end part of the water jet tube abuts against an inner wall of a first side of the outer tube along a radial direction (evident from Figure 21A) but fail to disclose that the proximal end part of the water jet tube abuts against an inner wall of the other side of the outer tube opposite to the first side along the radial direction.
Bonnette et al. disclose abutting a proximal end part of a water jet tube against an inner wall of an outer tube opposite a side abutted by a distal end part of the water jet tube (Figures 9a-9c; noting that Applicant’s “proximal end part” 121b is at an approximately middle part of the water jet tube - Figure 6A) in order to allow an adjustment of the angle of the water jet via longitudinal movement of the water jet tube (¶[0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the water jet tube of Yang et al. with the abutting configuration of Bonnette et al. in order to allow longitudinal movement of the water jet tube to control an angle of the fluid jet.
Allowable Subject Matter
Claims 12, 14, 15 and 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
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771