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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/31/2025 is being considered by the examiner.
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.
Claim 12 reciting “means for attaching and/or exchanging” has been interpreted to invoke 112(f) as a means plus function limitation because of the combination of a non-structural term “means” and functional language “for attaching and/or exchanging” without reciting sufficient structure to achieve the function.
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. The specification discloses in Pages 7, lines 30-31 and Page 8, lines 1-3 that the “means for attaching and/or exchanging the at least one cutting blade” is one or more screws, bolts, or grooves. The language in claim 8 will be interpreted as requiring the disclosed structure in in Pages 7, lines 30-31 and Page 8, lines 1-3, or equivalents.
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 § 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) 1, 2, 5, 12, 15, 16, 17, and 19-20 is/are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Pimenta et al. (US 20180000604 A1) herein referred to as “Pimenta”.
Regarding claim 1, Pimenta discloses a surgical device (resector 82, Paragraph [0029], Figure 9-12), comprising: an elongated handle (elongated handle 84,86, Figure 9-12, Paragraph [0029]); and a cutting assembly at an end of the handle (distal head 88 comprising blade 97, Figures 9-12, Paragraph [0029]); wherein the cutting assembly comprises: an elevator (finger 92, Figure 9-12, Paragraph [0029]), wherein a top side or edge and/or a bottom side or edge of the elevator has an upward curvature extending along a length of the elevator to an outer or distal end (finger 92 is curved upwards, Figure 12), a retainer positioned or located above the elevator (finger 90, Figures 9-12, Paragraph [0029]), wherein the retainer is angled with respect to a longitudinal axis formed by the handle (finger 90 is angled, Figures 11 and 12), and at least one cutting blade between the elevator and the retainer and recessed from an opening formed by distal ends of the elevator and retainer (blade 97 is recessed from the distal end of fingers 90 and 92, Figures 11-12).
Regarding claim 2, Pimenta discloses the surgical device of claim 1, wherein the elevator has a length that is greater than that of the retainer (finger 92 is greater in length than finger 90, Figures 11-12, Paragraph [0029]).
Regarding claim 5, Pimenta discloses the surgical device of claim 1, wherein the at least one cutting blade is angled (cutting blade 97 is angled, Figures 11-12, Paragraph [0030]).
Regarding claim 12, Pimenta discloses the surgical device of claim 1, further comprising means for attaching and/or exchanging the at least one cutting blade (A slot 99 formed along a side of the distal head 88 allows a cutting blade 97 to be inserted and removed from the distal head 88, Thus, the cutting blade 97 may be disposable and the remainder of the ALL resector 82 may be reusable, Paragraph [0030], Figures 9-12).
Regarding claim 15, Pimenta discloses the surgical device of claim 1, wherein the device has no power source and/or is not connectable to a power source (resector 82 has no power source and is not connectable to a power source, Paragraph [0029], Figures 9-12).
Regarding claim 16, Pimenta discloses the surgical device of claim 1, wherein there is no cutting blade shield and/or no rotator mechanism (resector 82 does not comprise a cutting blade shield or rotator mechanism, Paragraph [0029], Figures 9-12).
Regarding claim 17, Pimenta discloses a method of cutting tissue, comprising: providing the surgical device of claim 1 (resecting the ALL, Paragraph [0029]); making an opening in tissue (incision is made in the tissue to expose the spine, Paragraphs [0024] and [0030]); and cutting the tissue with the at least one cutting blade (In use, the ALL resector 82 is preferably positioned such that the second finger 92 is aligned along the anterior side of the ALL and the first finger 90 is aligned along the posterior side of the ALL, thus, at least partially bounding the ALL on either side. The ALL resector 82 is advanced forward so that the cutting blade 97 cuts through the ALL from one lateral edge to the other, Paragraph [0030]).
Regarding claim 19, Pimenta discloses claim 17, wherein the method is performed by a single surgeon (single tool is used by a single surgeon, Paragraphs [0029]-[0030]) .
Regarding claim 20, Pimenta discloses the method of claim 17, wherein the method is performed without a power source for the surgical device (resector 82 has no power source and is not connectable to a power source, Paragraph [0029], Figures 9-12).
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) 7, 10, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pimenta.
Regarding claim 7, Pimenta discloses the surgical device of claim 1.
Pimenta discloses the claimed invention except for wherein the opening has a height of about 2 mm to about 5 mm. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the opening as disclosed by Pimenta to have a height of about 2 mm to about 5 mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 10, Pimenta discloses the surgical device of claim 1.
However Pimenta does not explicitly disclose wherein the retainer has a length of about 0.5 cm to about 1.5 cm.
Pimenta discloses the claimed invention except for wherein the retainer has a length of about 0.5 cm to about 1.5 cm. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the length of the retainer as disclosed by Pimenta to have a length of about 0.5 cm to about 1.5 cm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 14, Pimenta discloses the surgical device of claim 1.
Pimenta does not explicitly disclose wherein the elevator is configured to elevate dural tissue and the retainer is configured to retain dural tissue during brain surgery, however the device of Pimenta is capable of being used wherein the elevator is configured to elevate dural tissue and the retainer is configured to retain dural tissue during brain surgery. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim.
Claim(s) 8, 9, 11, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pimenta in view of Zhu et al. (CN 217186340) herein referred to as “Zhu” (see attached).
Regarding claim 8, Pimenta discloses the surgical device of claim 1.
However Pimenta does not explicitly disclose wherein the handle has a length of about 10 cm to about 20 cm.
Zhu discloses wherein the handle has a length of about 10 cm to about 20 cm (height of the handle of tool holder 10 is set up to be 15 cm, Page 3, Paragraph 10, see attached).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the handle as disclosed by Pimenta to have a length of about 10 cm to about 20 cm as disclosed by Zhu, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 9, Pimenta discloses the surgical device of claim 1.
However Pimenta does not explicitly disclose wherein the handle has a diameter of about 0.3 cm to about 1.0 cm.
Zhu discloses wherein the handle has a diameter of about 0.3 cm to about 1.0 cm (the width of the cross section of the tool holder 1 is set to be 0.3 cm, Page 3, Paragraph 10, see attached).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the handle as disclosed by Pimenta to have a diameter of about 0.3 cm to about 1.0 cm as disclosed by Zhu, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 11, Pimenta discloses the surgical device of claim 1.
However Pimenta does not explicitly disclose wherein the elevator has a length of about 0.5 cm to about 2.0 cm.
Zhu discloses wherein the elevator has a length of about 0.5 cm to about 2.0 cm (the length of the tool bit 14 is set to be 0.5 cm, Page 5, Paragraph 2, see attached).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the elevator as disclosed by Pimenta to have a length of about 0.5 cm to about 2.0 cm as disclosed by Zhu, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 18, Pimenta discloses the method of cutting tissue according to claim 17.
However Pimenta does not explicitly disclose wherein the tissue comprises dura tissue and said method further comprises lifting the dura tissue off at least one of the brain, skin or fat with the elevator, while maintaining a lifted position of the dura tissue with the retainer.
Zhu discloses a similar structured device wherein the tissue comprises dura tissue (dura tissue, Page 4, Paragraph 13, See attached) and said method further comprises lifting the dura tissue off at least one of the brain, skin or fat with the elevator, while maintaining a lifted position of the dura tissue with the retainer (In the use process, the handle is held by hand, the blunt cutter head is inserted into the dural incision point, so that the dura mater is clamped by the 'tiger mouth area', and meanwhile, the dura mater is slightly lifted, so that the dura mater and the cerebral cortex are dissociated; then, the knife head is pushed forward along the range of the dura mater to cut the dura mater with a sharp edge. In the process, due to the existence of the inactive region of the cutter head, the dura mater can be separated from the cerebral cortex, and the cerebral cortex and the vascular structure can be prevented from being accidentally injured, Page 5, Paragraph 5, see attached).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pimenta to incorporate
the teachings of Zhu by including wherein the tissue comprises dura tissue and said method further comprises lifting the dura tissue off at least one of the brain, skin or fat with the elevator, while maintaining a lifted position of the dura tissue with the retainer. The motivation to do so being to conveniently and safely cut the dura matter (Zhu, Page 5, Paragraph 5, see attached).
Claim(s) 13 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pimenta in view of Stien et al. (US 20150012024 A1) herein referred to as “Stien”.
Regarding claim 13, Pimenta discloses the surgical device of claim 1.
However Pimenta does not explicitly disclose wherein the at least one cutting blade comprises an electrocautery blade.
Stien discloses a medical cutting assembly (Abstract) wherein the at least one cutting blade comprises an electrocautery blade (At the cutting location 34, at least one cautery component 36 is provided. In this embodiment, there is a single cautery component 36. The cautery component 36 contacts the body part at the cutting location 34 and is operable to generate a current that heats a contacted portion of the human body part at the cuffing location 34, Paragraph [0074]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pimenta to incorporate
the teachings of Stien by including wherein the at least one cutting blade comprises an electrocautery blade. The motivation to do so being to cauterize the body part contacting the blade (Stien, Paragraph [0074]).
Regarding claim 21, Pimenta discloses the surgical device of claim 1.
However Pimenta does not explicitly disclose wherein the cutting assembly is angled upwards from 20° to 50° with respect to a longitudinal axis of the handle.
Stien discloses wherein the cutting assembly is angled upwards from 20° to 50° with respect to a longitudinal axis of the handle (the angle projection of the tip 24 (any angle) can be changed depending upon the particular application and geometry at the operation site, Paragraph [0080], Figures 9-11).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pimenta to incorporate the teachings of Stien by including wherein the cutting assembly is angled upwards from 20° to 50° with respect to a longitudinal axis of the handle. The motivation to do so being to modify the angle projection of the cutter depending upon the particular application and geometry at the operation site (Stien, Paragraph [0072]).
Regarding claim 22, Pimenta discloses the surgical device of claim 1.
However Pimenta does not explicitly disclose wherein the cutting assembly is movable or adjustable with respect to a longitudinal axis of the handle.
Stien discloses wherein the cutting assembly is movable or adjustable with respect to a longitudinal axis of the handle (the tip 24 is movable in a range between a first position, as shown in FIG. 2, and a second position, as shown in FIG. 4. The actual range could be less than that shown or greater than that shown, but is preferably selected so that the tip 24 can be placed in at least the first and second positions depicted, Paragraph [0071]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pimenta to incorporate the teachings of Stien by including wherein the cutting assembly is movable or adjustable with respect to a longitudinal axis of the handle. The motivation to do so being to controllably move the instrument to a cutting location (Stien, Paragraph [0072]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. LaFauci et al. (US 20110106123 A1) discloses a scalpel for performing complex surgeries, Nordt (US 20060149267 A1) discloses a cutting instrument comprising an elevator and a retainer, and Pajunk-Schelling et al. (US 2021030513 A1) discloses a surgical instrument comprising a blade.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dana Stumpfoll whose telephone number is (703)756-4669. The examiner can normally be reached 9-5 pm (CT), M-F.
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/D.S./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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