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 .
Specification
The disclosure is objected to because of the following informalities:
In the Brief Description of the Drawings, at page 7/12, “Fig. 1 to 4 show an example of a dilator 1 according to the present disclosure.” is out of place and it differs from the description already set forth on page 6/12. The description on page 7/12 should be consolidated with the existing brief description of Figs. 1-4 on page 6/12.
Appropriate correction is required.
Claim Objections
Claim 7 is objected to because of the following informalities:
Claim 7, line 2, before “shield”, --the-- should be inserted.
Claim 7, line 2, before “body”, --the-- should be inserted.
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.
Therefore, in clam 7, the limitation “retention means” (of the shield and also of the main body) are being interpreted under 35 U.S.C. 112(f).
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 1-12 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.
In claim 1, it is unclear if the following two limitations define the same transverse cross section:
Claim 1, line 4: “the main body and the shield define a transverse cross section of the dilator,” apparently defining a combined transverse cross section of the dilator comprising both the cross section of the main body and the cross section of the shield.
Claim 1, lines 8-9: “a combined transverse cross section of the main body and of the shield”, which introduces what appears to be the same cross section already introduced at line 4.
Claim 1, line 7, “a hole” creates inconsistent antecedent basis because a “through-hole” was previously established in the claim.
Claim 2, line 2, “the transverse cross section of the dilator” lacks clear antecedent basis.
Claim 2, line 3, “the transverse cross section” lacks clear antecedent basis.
Claim 4, line 2, “the transverse cross section” lacks clear antecedent basis.
Claim 7, line 4, “the transverse cross section of the shield” lacks clear antecedent basis.
Dependent claims are also rejected because they depend from and include the limitations of their respective parent claim(s).
Claim 12, line 2 recites a “guide cable” in the kit, which depends from claim 1; however, claim 1 includes a through-hole for receiving a “guide rod”. Therefore, claim 12 is unclear. As best understood, and for purposes of examination, claim 12 will be considered as reciting a guide rod, as established in claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
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 1-10 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prado (9,028,522; cited by Applicant).
Regarding claim 1, Prado discloses a dilator 100, 200, 300 (Figs. 1-4) capable of being used for percutaneous spinal surgery with a transforaminal approach, if desired, which comprises a main elongate dilator body 100,200 and an elongate nerve shield 300 capable of protecting a nerve root, the main dilator body 100, 200 and the shield 300 each comprising mutually complementary contact surfaces (cf. Figs. 1 and 4) and in which the main body 100, 200 and the shield 300 define a transverse cross section of the dilator (Fig. 5), it being possible for the main body 100, 200 and the shield 300 to slide one relative to each other along an axial axis of the dilator (Figs. 1-4), the dilator also comprising a through-hole 140 (Figs. 4 and 5) for receiving a guide rod 50, wherein the through-hole is placed eccentrically with respect to a combined transverse cross section of the main body 100, 200 and of the shield 300 (Fig. 5).
Regarding claim 2, the transverse cross section of the dilator 100, 200, 300 is oblong and elongate in shape (Fig. 5), the shield 300 being arranged on one of elongate faces of the transverse cross section of the main body 100, 200 of the dilator 100, 200, 300 (Fig. 5).
Regarding claim 3, the shield 300 has a curved laminar (i.e., thin and low-profile) shape (Figs. 4C, 5 and 6A).
Regarding claim 4, the transverse cross section of the shield 300 has a central area of constant thickness (e.g., the straight central portion; Fig. 4C).
Regarding claim 5, the shield 300 has no recesses extending into its body for interlocking with the main body 100, 200 (Figs. 1-4).
Regarding claim 6, the shield 300 has no projections extending from its body for interlocking with the main body 100, 200 (Figs. 1-4).
Regarding claim 7, both the shield 300 and the main body 100, 200 have retention means 112, 212, 312 to restrict relative movement between the main body 100, 200 and the shield 300 (col. 11, lines 57-63, describing a tool that engages the retention means of the device, which would restrict relative movement), the retention means 312 of the shield 300 being situated at both ends of the transverse cross section of the shield (Fig. 2, at left and right sides; i.e., both ends of the transverse cross section of the shield 300).
Regarding claim 8, the retention means 312 of the shield 300 further comprises a shape of both ends which have a curved shape (Figs. 1 and 6A).
Regarding claim 9, the faces have a curved shape (Fig. 4).
Regarding claim 10, Prado discloses a kit of tools (the components provided together) capable of being used for percutaneous spinal operations by a transforaminal approach, if desired, characterized in that it comprises a dilator 100, 200 according to claim 1.
Regarding claim 12, the kit comprises a guide rod12. The kit according to claim 10, further comprising a guide rod 50 (Fig. 1).
Claim Rejections - 35 USC § 103
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.
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 11 is rejected under 35 U.S.C. 103 as being unpatentable over Prado (9,028,522; cited by Applicant), as applied to claim 10 above, in view of Hynes et al. (2015/0265265).
Prado discloses the claimed invention except for the kit comprising a drill bit.
Hynes et al. teaches a similar kit (e.g., Fig. 1 and para. 0001) and discloses that such tools as a drill bit can be included (para. 0073). A drill bit would enable a surgeon to remove bone and/or create access where necessary or desired to facilitate a surgical procedure.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to provide the kit of Prado et al. with a drill bit, in view of Hynes et al., to enable a surgeon to remove bone and/or create access where necessary or desired to facilitate a surgical procedure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773