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.
Power of Attorney
It appears applicant has legal representation, but no valid power of attorney has been filed in the present application. Providing representative information in an Application Data Sheet (ADS) does not constitute a power of attorney. See 37 CFR 1.76(b)(4) and MPEP § 408. For information on appointing a power of attorney, see MPEP § 402.02 et seq.
Drawings
The drawings were received on 13 November 2024. These drawings are unacceptable.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the grinding wheel such that “the shape of the grinding wheel includes [a] sphere” recited in claim 13 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are further objected to for failing to comply with the requirements of 37 CFR 1.84(a)(1), which states Black and white drawings are normally required in utility patent applications. India ink, or its equivalent that secures solid black lines, must be used for drawings. The drawings provided do not use solid black lines to differentiate between structural elements as claimed.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: claim 15 recites the limitation “wherein the grit size defines the abrasive surface geometry with a grit height between 40-120 microns”. There is no antecedent basis for this limitation in the specification. Furthermore, although fig. 2c does use grit size as an axis, it does not recite grit height.
Claim Objections
Claim 6 is objected to because of the following informalities: The limitation of “griding wheel” in claim 6 is grammatically improper. Consider ––grinding wheel––. 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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “drive source” in claims 1 and 16, and “fluid source” in claim 4.
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.
Additionally, claims 1, 3, 8-10, and 20-21 contain reference to “drive logic”. Applicant is advised that one of ordinary skill in the art would understand the term “drive logic” as a non-structural element (e.g. a computer program including those not necessarily fixed in tangible media). As no actual structure for carrying out the drive logic (e.g. a controller, a processor, or the like) is disclosed, these limitations are being interpreted as an intended use rather than a positively recited structural limitation.
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 20 and 21 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 20 recites the limitation “the drive logic”. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation “the drive logic for rotating the flexible shaft, the flexible shaft configured for a rotation speed for attaining an orbit of the grinding wheel based on a grit size of the abrasive surface geometry, a rotational speed of the grinding wheel and a viscosity of the fluid.” This limitation appears to suggest some relationship between the drive logic and the flexible shaft but is grammatically unclear in a fashion that makes the nature of such a relationship indefinite.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-14 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gurm et al. (US 10945757, "Gurm").
1. Gurm teaches a polishing device capable of use for surface treatment of an interior surface of a conduit, comprising:
a grinding wheel (12) adapted for rotation (see Gurm figs. 9a-9b);
a flexible shaft (14) attached to the grinding wheel (see Gurm figs. 9a-9b);
an abrasive surface geometry defined by an exterior of the grinding wheel (front half of 12 has an abrasive coating, Gurm 5:21-28); and
a drive source responsive to drive logic for rotating the flexible shaft, the flexible shaft configured for a rotation speed for attaining an orbit of the grinding wheel based on the abrasive surface geometry (Gurm teaches that the shaft is rotated within a range of speeds depending on a specific applications, Gurm 5:8-47; such rotation necessarily has some sort of source, and the adjustability of the wheel speed teaches that the source must be responsive to some sort of logical control. Furthermore, an adjustable speed drive source would be capable of driving the shaft at the speed for attaining the described orbit).
2. Gurm teaches the device of claim 1 wherein the abrasive surface geometry further comprises a grit size (the disclosed abrasive material will inherently have a size describable as a grit size), the flexible shaft configured for a rotation speed for attaining the orbit of the grinding wheel based on the grit size of the abrasive surface geometry (the flexible shaft would be capable of operating at the claimed rotation speed).
3. Gurm teaches the device of claim 2 further comprising a fluid within the conduit, wherein the drive logic is configured for controlling the rotation speed based on at least the grit size and a viscosity of the fluid (the drive source would be capable of being operated with the claimed drive logic).
4. Gurm teaches the device of claim 1, further comprising a fluid source (saline is supplied through a sheath, Gurm 5:8-21), the fluid source configured to deliver a fluid having a viscosity and a density into the conduit (as a fluid, saline will inherently have both a viscosity and a density), the orbit responsive to at least one of the viscosity and density for achieving a predetermined percentage of coverage of the interior surface based on consistent grinding wheel dynamics (an orbit would be responsive to changes if the viscosity or density of the fluid changes, as either will result in a change in the reaction forces of the fluid against the grinding wheel, which are a factor in the orbital dynamics).
5. Gurm teaches the device of claim 1 wherein the abrasive surface further comprises an abrasive height, the abrasive height indicative of a variation of the abrasive surface geometry based on the grit size (abrasive surfaces will necessarily have variations of surface geometry, as a perfectly smooth surface would be incapable of removing material through abrasion. such variations of geometry will include dimensions describable as a height, and such variations would be correlated with grit size).
6. Gurm teaches the device of claim 5 wherein the abrasive surface geometry further comprises a distribution, orientation and patterning of an abrasive material adhered to the surface of the griding wheel.
7. Gurm teaches the device of claim 1 wherein the rotation is capable of inducing an elastic force in the flexible shaft, the elastic force resulting from a nonlinear path of the conduit, the orbit based on the abrasive surface geometry and the elastic force (driven rotation will involve forces, such forces would include elastic forces in the shaft so as to allow for the orbital pathway).
8. Gurm teaches the device of claim 3, wherein the device is capable of being used with drive logic configured to generate, based on the rotational speed, grinding forces and hydrodynamic forces, the drive logic configured to ensure the grinding forces and hydrodynamic forces are unequal and opposed.
9. Gurm teaches the device of claim 3, wherein the device is capable of being used with drive logic configured to generate, based on the rotational speed, grinding forces and hydrodynamic forces; and generate a net force acting in the direction of an intended orbital motion.
10. Gurm teaches the device of claim 3, wherein the device is capable of being used with drive logic configured to generate, based on the rotational speed: a hydrodynamic force resulting from the viscosity and the grit size, the hydrodynamic force having components normal and outward to the interior surface, and tangential to the interior surface; and a grinding force having components inward and normal to the interior surface, and tangential to the interior surface and aligned with a rotation of the grinding wheel.
11. Gurm teaches the device of claim 1 wherein the orbit defines a cyclic path around the interior of the conduit, the orbit having a radius less than a radius of the conduit (orbital pathway, see Gurm fig. 9b, the orbit has a radius defined by a center of the grinding device, which is necessarily radially inward from an outer radius of a conduit, see Gurm fig. 9b).
12. Gurm teaches the device of claim 11 wherein the orbit is capable of defining an irregular path, the irregular path based on at least the rotation speed, the abrasive surface geometry, a viscosity of fluid in the conduit, and a shape of the grinding wheel (an irregular internal conduit surface or irregular grinding wheel shape would result in an irregular path).
13. Gurm teaches the device of claim 1 wherein the shape of the grinding wheel includes at least one of an ellipsoid with a circular cross section, sphere, fluted, finned and triangular with radiused edges (grinder may be an ellipsoid or triangular with radiused edges, see Gurm figs 1a-1b).
14. Gurm teaches the device of claim 1 wherein the device is usable with a conduit having an internal diameter of between 0.5-300 mm (the device of Gurm suggests a grinding wheel with a diameter of 1.25-2.5mm, which would be usable for grinding the inside of a conduit having an internal diameter in the claimed range, Gurm 5:49-59).
21. Gurm teaches a system for surface treatment of an interior surface of a conduit, comprising:
a grinding wheel (12) adapted for rotation (see Gurm figs. 9a-9b);;
a flexible shaft (14) attached to the grinding wheel (see Gurm figs. 9a-9b) and responsive to drive logic for rotation of the grinding wheel (Gurm teaches that the shaft is rotated within a range of speeds depending on a specific applications, Gurm 5:8-47; such rotation necessarily has some sort of source, and the adjustability of the wheel speed teaches that the source must be responsive to some sort of logical control which would be capable of driving the shaft at the speed for attaining the described orbit);
a fluid supply for providing fluid to an interior of the conduit (saline is supplied through a sheath, Gurm 5:8-21); and
an abrasive surface geometry on an exterior of the grinding wheel (front half of 12 has an abrasive coating, Gurm 5:21-28), the drive logic for rotating the flexible shaft, the flexible shaft configured for a rotation speed for attaining an orbit of the grinding wheel based on a grit size of the abrasive surface geometry, a rotational speed of the grinding wheel and a viscosity of the fluid (the system of Gurm would be usable with a variety of drive logic, including the claimed form).
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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Gurm in view of Ronaldson et al. (US 2966766, “Ronaldson).
15. Gurm teaches the device of claim 1, but does not teach a specific grit size, and therefore does not teach that the grit size defines the abrasive surface geometry with a grit height between 40-120 microns.
However, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gurm to have an abrasive surface geometry with a grit height between 40-120 microns, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05(II) The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is abrasive grit size which achieves the recognized result of grinding at a different degree of fineness (the use of different grit sizes to achieve different qualities of finish is known in the art, see, e.g. Ronaldson 1:62-68 and 2:29-36), therefore, one of ordinary skill in the art before the effective filing the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980). Further, the disclosure provides no evidence indicating the claimed range is critical.
Claim 16 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Gurm.
16. Gurm teaches a method for smoothing a surface of internal channels capable of being used in a material fabrication environment for forming internal channels with curvilinear portions in a machined body, comprising:
attaching a grinding wheel (12) at a distal end of a flexible shaft (14, that the grinding 12 wheel is on shaft 14 implicitly teaches a step of attachment, see Gurm figs. 9a-9b);
engaging a drive source with a proximal end of the flexible shaft for rotation of the grinding wheel via the flexible shaft (Gurm teaches that the shaft is rotated within a range of speeds depending on a specific applications, Gurm 5:8-47; such rotation necessarily has some sort of source);
inserting the grinding wheel into the channel (grinding wheel inserted into a channel such as a vessel, Gurm fig. 1a);
creating a fluid media in communication with the channel and the grinding wheel (distributing saline through a flexible sheath, see Gurm 5:8-21); and
rotating the flexible shaft at a rotation speed for controlling an orbit of the grinding wheel against the surface of the channel (Gurm claim 1, 7:40-48, and 9:1-25).
Although the method of Gurm for smoothing a surface of internal channels with curvilinear portions in a machined body in a material fabrication environment, this appears to describe an intended use of the method, and it is not apparent from the disclosure that the intended use of the method would result in a manipulative difference from the method steps disclosed by Gurm. Therefore Gurm anticipates claim 16.
Under an alternate theory of the claim, even if the preamble were to result in a manipulative difference from the method disclosed by Gurm (e.g., the specific variety of fluid media in a material fabrication environment might not involve a fluid such as saline or blood), it would have been obvious for one of ordinary skill in the art before the effective filing date to modify the method of Gurm to make it suitable for use in a material fabrication environment for forming internal channels with curvilinear portions in a machined body, as it has been held that known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art. The process of abrading plaque buildups in blood vessels via atherectomy is substantially similar to the process of cleaning or grinding internal surfaces of channels in a machined body, such that people of ordinary skill in one field would reasonably have some awareness of the other field. to the extent that there would be differences in the methods, those differences would be encompassed in principles known in the prior art. Because the problem addressed by applicant is closely analogous to that of Gurm, one of ordinary skill in the abrading arts would have recognized the similar class of problem and the known solutions of the prior art and it would have been well within the ordinary skill level to implement the system in the different environment. Furthermore, the results of such an adaptation would have been predictable to one of ordinary skill. See Dann v. Johnston, 425 U.S. 219, 189 USPQ 257 (1976).
Allowable Subject Matter
Claims 17-19 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.
Claim 20 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 following is a statement of reasons for the indication of allowable subject matter:
Higgins et al. (US PGPub 2020/0107855, "Higgins") teaches improvements to known grinding systems (see, e.g. Higgins [0004]-[0013] and figs. 1-6). The improvements taught by Higgins include the observation that orbital motion is driven by an interaction between oscillating motion of a shaft, fluid media in a conduit, and orbital motion of the shaft (Higgins [0068]), and further teaches that the motion of the shaft may be controlled such that the orbital motion of the shaft is in the same direction or an opposite direction to a shaft rotation, which may be useful for moving removed materials relative to the conduit and/or grinding wheel (Higgins [0079]-[0086]). Higgins further teaches that the orbit may be affected by surface geometry of the abrasive section (adjusting drag coefficients change orbital properties, see Higgins [0086]-[0090]). However, although Higgins teaches a relationship between a fluid and orbital properties (Higgins [0068]) and that different fluids may be supplied (cooling and/or lubrication fluids, Higgins [0008]), it does not teach the steps of “selecting a viscosity of a fluid flowing through the channel; and controlling the orbit of the grinding wheel based on...the selected viscosity” and therefore would not have inspired one of ordinary skill to modify the method of Gurm to reach the invention of claim 17. Therefore, claim 17 (and claims 18-20 depending therefrom) contains allowable subject matter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Higgins et al. (US PGPub 2020/0107856), Kallok et al. (US 11253290), Savastano et al. (US 10960178), Kohler et al. (US 10299820), McBroom et al. (US 8795303), Narveson (US 8628550), Shturman (US 8353923), and Nash et al. (US 7666161) teach relevant devices and methods associated with rotational and/or orbital atherectomy.
Grode et al. (US 12678837), Laker (US 6792641), Ignatiev et al. (US 6174381), Lehmann (US 5111623), Dreiling (US 3388505), Emerson (US 3044220), Prince (US 2745231), Whealy (US 2095725), Albright (US 2090174), Joseph (US 1539742), and Joseph (US 1534393) teach relevant devices and methods associated with cleaning or abrading internal surfaces of pipes and related structures.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN R ZAWORSKI whose telephone number is (571)272-7804. The examiner can normally be reached Monday-Thursday 8:00-5:00, Fridays 9:00-1:00.
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/JONATHAN R ZAWORSKI/Examiner, Art Unit 3723
