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 .
Claim Objections
Claim 14 is objected to because of the following informalities:
Claim 14, line 2: “a” (between “about” and “longitudinal”) should be changed to --the--.
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: output member in claims 6, 9, 13, 14, 15, 16 and 17.
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 § 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 12 and 15-17 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 12 recites the limitation "the mass" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the first cam system" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 6, 13 and 14 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Bono et al., U.S. PG-Pub 2018/0168757.
Regarding claim 6, Bono et al. discloses a method of operating a surgical instrument, the surgical instrument including a housing (204), a first harmonic oscillator (206) contained in the housing, an output member (226) at least partially received in the housing, and a dissection head (38), the method comprising: activating the first harmonic oscillator so as to drive the output member and the dissection head to reversibly rotate about a longitudinal axis of the surgical instrument in alternating rotational directions (Figs. 16-18 and paragraphs [0057]-[0059]); and manipulating the surgical instrument to remove material from a target bone using the dissection head (paragraph [0048]).
Regarding claim 13, Bono et al. discloses a method of operating a surgical instrument, the surgical instrument including a housing (204), a motor (202) contained in the housing, an output member (226) at least partially received in the housing, and a dissection head (38), the method comprising: activating the motor so as to drive the output member and the dissection head to reversibly rotate about a longitudinal axis of the surgical instrument in alternating rotational directions (Figs. 16-18 and paragraphs [0057]-[0059]); and manipulating the surgical instrument to remove material from a target bone using the dissection head (paragraph [0048]).
Regarding claim 14, Bono et al. discloses wherein the output member (226) is configured to be driven by the motor (202) to reversibly rotate about the longitudinal axis in alternating directions by engaging with the motor via a first cam system (206) (Figs. 16-18 and paragraphs [0057]-[0059]).
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) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bono et al., U.S. PG-Pub 2018/0168757 in view of Collerais, U.S. PG-Pub 2019/0142439.
Regarding claim 9, Bono et al. discloses the invention essentially as claimed except for further including a clutch configured to selectively engage the harmonic oscillator with the output member.
Collerais discloses a surgical tool having a clutch such that a drill-head and a rotating member, in an engaged position, are engaged in rotation when the rotating member is put into rotation and, in an idle position, the drill-head and the rotation member are not linked when the rotation member is put into rotation (paragraph [0050]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Bono et al. to include a clutch configured to selectively engage the harmonic oscillator with the output member in view of Collerais to permit preventing the dissection head from inadvertently damaging tissue when not intended by a surgeon.
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bono et al., U.S. PG-Pub 2018/0168757 in view of Sartor et al., U.S. PG-Pub 2015/0018815.
Regarding claims 10-12, Bono et al. discloses wherein the dissection head (38) rotates clockwise in response to movement of the harmonic oscillator (206) in a first direction and rotates counterclockwise in response to movement of the harmonic oscillator in a second direction opposite the first direction (Figs. 16-18 and paragraphs [0057]-[0059]).
Bono et al. does not disclose the first harmonic oscillatory comprising a mass-spring system and activating the first harmonic oscillator comprises applying a magnetic field to the mass.
Sartor et al. discloses a surgical instrument having a harmonic oscillator (240) that is a mass-spring system (246) comprising a magnetic material (244) that is engaged by applying a magnetic field to the mass (Fig. 8 and paragraphs [0014], [0045]-[0046]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the first harmonic oscillator of Bono et al. with harmonic oscillator having a mass-spring system activated by applying a magnetic field to the mass in view of Sartor et al. to permit a functionally equivalent means for driving the output member and dissection head.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 6-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,957,361 in view of Bono et al., U.S. PG-Pub 2018/0168757.
Regarding claims 6-17, claims 1-18 of U.S. Patent No. 11,957,361 recited all of the structure of the claims, but do not recite method steps of activating the first harmonic oscillator/motor and manipulating the surgical instrument to remove material from a target bone using the dissection head.
Bono et al. discloses a method of operating a surgical instrument that includes activating a first harmonic oscillator (206)/motor (202) and manipulating the surgical instrument to remove material from a target bone using a dissection head (38) (Fig. 16 and paragraphs [0048], [0057]-[0059]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify claims 1-18 of U.S. Patent No. 11,957,361 to be used in a method of operating the surgical instrument that includes steps of activating the first harmonic oscillator/motor and manipulating the surgical instrument to remove material from a target bone using the dissection head in view of Bono et al. as such is normal, ordinary operation for a surgical instrument meant for cutting bone.
Claims 6-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,295,594 in view of Bono et al., U.S. PG-Pub 2018/0168757.
Regarding claims 6-17, claims 1-15 of U.S. Patent No. 12,295,594 recited all of the structure of the claims, but do not recite method steps of activating the first harmonic oscillator/motor and manipulating the surgical instrument to remove material from a target bone using the dissection head.
Bono et al. discloses a method of operating a surgical instrument that includes activating a first harmonic oscillator (206)/motor (202) and manipulating the surgical instrument to remove material from a target bone using a dissection head (38) (Fig. 16 and paragraphs [0048], [0057]-[0059]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify claims 1-15 of U.S. Patent No. 12,295,594 to be used in a method of operating the surgical instrument that includes steps of activating the first harmonic oscillator/motor and manipulating the surgical instrument to remove material from a target bone using the dissection head in view of Bono et al. as such is normal, ordinary operation for a surgical instrument meant for cutting bone.
Allowable Subject Matter
Claims 1-6 are allowed.
Claims 7 and 8 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 and with the filing of a terminal disclaimer to overcome the non-statutory double patenting rejections set forth above.
Claims 15-17 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 and with the filing of a terminal disclaimer to overcome the non-statutory double patenting rejections set forth above.
The following is a statement of reasons for the indication of allowable subject matter: Regarding claim 1, the prior art of record, alone or in combination, does not disclose a method with steps of determining a set of parameters associated with a procedure to be performed, determining an optimum frequency according the set of parameters and associated with a desired speed of operation of the bone drill, determining an optimum range of rotation according to the set of parameters and associated with a degree of rotation between reversals of the bone drill, and configuring the bone drill to operate at the optimum frequency and the optimum range of rotation as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571) 272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ERIC S GIBSON/ Primary Examiner, Art Unit 3775
Prosecution Insights