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 .
Election/Restrictions
Applicant's election with traverse of Group I, drawn to a surgical cutting instrument, and Species A, embodiment drawn to Figures 1-6, in the reply filed on 10/8/25 is acknowledged.
The traversal is on the ground(s) of the following:
“…all of the claims do relate to a single general inventive concept, as the common technical features recited in the claims do make a contribution over the cited prior art”
“While the Nohilly device includes locking means to allow the safety sleeve to be arranged at these various different positions, the device does not include locking means that automatically engages when the safety sleeve is in the extended position, preventing further movement of the safety sleeve from the extended position to the retracted position. In the Nohilly device the surgeon is able to lock and unlock the safety sleeve, moving it back and forth at will, to allow the surgeon to selectively expose portions of the cutting blade.
“By contrast, in the present application, after the apparatus has been used to remove a biopsy sample from a patient, the surgeon slides the safety sleeve over the cutting tip and the shield automatically locks in place over the cutting tip. Retraction of the safety sleeve is prevented by the locking means so that health professionals are protected from accidental contact with the cutting tip after use. This is embodied in the recitation in claim 1 of “the instrument further comprises locking means for preventing further axial movement of the safety sleeve with respect to the elongate shaft when the safety sleeve is in the extended position.” Nohilly does not disclose or suggest such a locking means, and therefore both claim 1 and claim 14 (reciting a method of using the instrument of claim 1) recite a common special technical feature that makes a contribution over the prior art (Nohilly), and relate to a single general inventive concept.”
The Examiner respectfully disagrees and this is not found persuasive because of at least the following:
Features relied upon are not recited in the claims, i.e. “automatically engages”, “surgeon is able to lock and unlock the safety sleeve”, “selectively expose portions of the cutting blade” and thus cannot form a basis for unity of invention.
Nohilly explicitly states: “[0052] The shield 108 of the anti-coring device of the present invention may be locked in preferably three positions. As stated previously, the shield 108 in one position (shown in FIGS. 8 and 9) would cover the entire circumference of the sharpened edge 102 of the cutting blade 100 to protect the blade 100 from inadvertent contact with other surgical instruments and to prevent the inadvertent cutting of tissues during positioning and movement of the morcellator. In an intermediate position (shown in FIGS. 3-7 and 13-15), the shield 108 exposes preferably about two-thirds to about three-quarters of the circumference of the sharpened edge 102 of the cutting blade 100, with preferably about one-quarter to about one-third of the circumference of the sharpened edge 102 covered by the shield's 108 protrusion 112 or "tooth", in order to effect proper "orange peeling", that is, to cause the cutting blade 100 edge to remain at the surface of the organ being morcellated without "coring" into the organ. In the third position (shown in FIGS. 10-12), the shield 108 is withdrawn axially on the cutting blade 100 to expose the entire circumference of the sharpened edge 102 when techniques other than "orange peeling" are used by the surgeon during the laparoscopic procedure.”
Nohilly as emphasized above clearly demonstrates at least the structural equivalent of “the instrument further comprises locking means for preventing further axial movement of the safety sleeve with respect to the elongate shaft when the safety sleeve is in the extended position” is well known routine and conventional such that it cannot be the basis of a special technical feature and instead is a known technical feature such that unity of invention is not present.
The requirement is still deemed proper and is therefore made FINAL.
Claims 10, 14, and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/8/25.
Information Disclosure Statement
The information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 at least the following:
“cutting element” in claim 1;
“first and second cooperating elements” in claim 1;
“third and fourth cooperating elements” in claim 4; and
“male/female cooperating elements” in claim 6.
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(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9 and 11-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 positively recites “locking means for preventing”. Claim 4 positively recites “means for maintaining”. Although the means-plus-function claim limitations find support as originally filed in the claims, in the abstract, and on page 2’s summary of the instant Specification, the means-plus-function claim limitations are not further disclosed or described as corresponding to any particular disclosed structures. One of ordinary skill would be guessing as to which element(s) and/or part(s) of the disclosure may or may not correspond to the “locking means for preventing” and/or to the “means for maintaining”. The claimed invention lacks written description because the claimed “locking means for preventing” and/or to the “means for maintaining” fail to correspond to described structure(s) as disclosed in the instant Specification. Thus, written description is lacking since the claimed invention lacks demonstrated possession with described corresponding structure(s) to the means-plus-function limitations of claims 1 and 4. Claims 2, 3, 5-9 and 11-13 inherit and do not remedy the lack of written description issues noted above.
As set forth hereinabove regarding 112(f) interpretation for claim limitations, Claim 1 positively recites “cutting element” and “first and second cooperating elements”. Claim 4 positively recites “third and fourth cooperating elements”. Claim 6 positively recites “male/female cooperating elements”. Although the 112(f) invoking claim limitations find support as originally filed in the claims, in the abstract, and on pages 2-3’s summary of the instant Specification, the 112(f) invoking claim limitations are not further disclosed or described as corresponding to any particular disclosed structures. One of ordinary skill would be guessing as to which element(s) and/or part(s) of the disclosure may or may not correspond to the “cutting element”, “first and second cooperating elements”, “third and fourth cooperating elements”, and “male/female cooperating elements”. The claimed invention lacks written description because the claimed cutting element”, “first and second cooperating elements”, “third and fourth cooperating elements”, and “male/female cooperating elements” fail to correspond to described structure(s) as disclosed in the instant Specification. Thus, written description is lacking since the claimed invention lacks demonstrated possession with described corresponding structure(s) to the 112(f) invoking claim limitations of claims 1, 4, and 6. Claims 2, 3, 5, 7-9 and 11-13 inherit and do not remedy the lack of written description issues noted above.
Claim Rejections - 35 USC § 112(b)
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 1-9 and 11-13 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 1 positively recites “locking means for preventing”. Claim 4 positively recites “means for maintaining”. Although the means-plus-function claim limitations find support as originally filed in the claims, in the abstract, and on page 2’s summary of the instant Specification, the means-plus-function claim limitations are not further disclosed or described as corresponding to any particular disclosed structures. One of ordinary skill would be guessing as to which element(s) and/or part(s) of the disclosure may or may not correspond to the “locking means for preventing” and/or to the “means for maintaining”. The scope of the claimed invention is indeterminate, especially in light of the lack of written description. In light of deficient corresponding structure(s), one of ordinary skill would not be apprised of the scope of the claimed invention, particularly what may or may not be explicitly, implicitly, inherently, or inferentially required and/or excluded by the recitations of the “locking means for preventing” and/or to the “means for maintaining”. The scope of claim 1 is indefinite given the lack of corresponding structure to the means-plus-function recitation.
Claims 2, 3, 5-9 and 11-13 inherit and do not remedy the indefiniteness issues noted above.
Claim 1 positively recites Claim 1 positively recites “cutting element” and “first and second cooperating elements”. Claim 4 positively recites “third and fourth cooperating elements”. Claim 6 positively recites “male/female cooperating elements”. Although the 112(f) invoking claim limitations find support as originally filed in the claims, in the abstract, and on page 2-3’s summary of the instant Specification, the means-plus-function claim limitations are not further disclosed or described as corresponding to any particular disclosed structures. One of ordinary skill would be guessing as to which element(s) and/or part(s) of the disclosure may or may not correspond to the “cutting element”, “first and second cooperating elements”, “third and fourth cooperating elements”, and “male/female cooperating elements”. The scope of the claimed invention is indeterminate, especially in light of the lack of written description. In light of deficient corresponding structure(s), one of ordinary skill would not be apprised of the scope of the claimed invention, particularly what may or may not be explicitly, implicitly, inherently, or inferentially required and/or excluded by the recitations of the “cutting element”, “first and second cooperating elements”, “third and fourth cooperating elements”, and/or “male/female cooperating elements”. The scope of claims 1, 4, and 6 is indefinite given the lack of corresponding structure to the 112(f) invoking claim limitations. Claims 2, 3, 5, 7-9 and 11-13 inherit and do not remedy the indefiniteness issues noted above.
The term “substantially cylindrical channel” in claim 1 is a relative term which renders the claim indefinite. The term “substantially cylindrical channel” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim is indeterminate with respect to what may be required and/or excluded by the degree of required cylindrical-ness of the channel and/or to what degree the channel may not be cylindrical. Claims 2-9 and 11-13 inherit and do not remedy the indefiniteness issues noted above.
Claim 1 recites the limitation "the cylindrical channel" in line 7. There is insufficient antecedent basis for this limitation in the claim. For the purposes of compact prosecution and examination on the merits, consistent with the instant Specification the examiner is treating "the cylindrical channel" in line 7 as “the substantially cylindrical channel”. Claims 2-9 and 11-13 inherit and do not remedy the indefiniteness issues noted above.
Claim 8 recites the limitation "the first cooperating means " in line 2. There is insufficient antecedent basis for this limitation in the claim. The scope of the claim is indeterminate with respect to what the first cooperating means necessarily refers to.
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) 1-9 and 11-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nohilly (US 2008/0039883 A1).
For claim 1, Nohilly discloses a surgical cutting instrument (Figs 2,5-15) ([0037-0057]), comprising inter alia:
a handle portion (Fig 2) ([0037-0057]) and an elongate shaft (100) (Fig 2) ([0037-0057]), the shaft having a distal end and a proximal end and a longitudinal axis extending therebetween (Fig 2) ([0037-0057]), the shaft mounting a cutting element (100) at the distal end (Fig 3) ([0037-0057]),
a safety sleeve (108) (Fig 3) ([0037-0057]) including a substantially cylindrical channel through which the elongate shaft extends (Fig 3) ([0037-0057]), wherein the safety sleeve is moveable axially along the shaft between a retracted position in which a cutting tip is exposed ([0045]), and an extended position in which the cutting tip is located within the cylindrical channel of the safety sleeve ([0045]);
a locking means (some of the plurality of slots and resilient tabs 114,116) (Figs 5-12) ([0037-0057]) for preventing further axial movement of the safety sleeve with respect to the elongate shaft when the safety sleeve is in the extended position ([0052-0057]); and wherein the locking means comprises first (one of 114) and second (one of 116) cooperating elements each located on a respective one of the distal end of the shaft and the safety sleeve (Figs 5-12) ([0037-0057]).
For claim 2, Nohilly discloses the surgical cutting instrument according to Claim 1, wherein the shaft is rotatably mounted onto the handle portion at the proximal end, allowing for rotation of the shaft about the longitudinal axis (Fig 2) ([0037-0057, especially 0041-0044]).
For claim 3, Nohilly discloses the surgical cutting instrument according to Claim 2, wherein, when the safety sleeve is in the retracted position, the safety sleeve is configured to rotate the elongate shaft (Figs 2,5-12) ([0037-0057, especially 0052-0057]).
For claim 4, Nohilly discloses the surgical cutting instrument according to Claim 2, wherein the instrument further comprises means for maintaining a static connection (the other of the plurality of slots and resilient tabs 114,116) (Figs 5-12) ([0037-0057]) between the safety sleeve and the elongate shaft, and wherein the means for maintaining a static connection comprises third (another of the 114) and fourth (another of the 116) cooperating elements each located on a respective one of the proximal end of the shaft and the safety sleeve (Figs 5-12) ([0037-0057]).
For claim 5, Nohilly discloses the surgical cutting instrument according to Claim 4, wherein rotation of the safety sleeve effects rotation of the elongate shaft when the safety sleeve is in the retracted position (Figs 2,5-12) ([0037-0057, especially 0052-0057]).
For claim 6, Nohilly discloses the surgical cutting instrument according to Claim 4, wherein the third and fourth cooperating elements comprise male/female cooperating elements (Figs 5-12) ([0037-0057]).
For claim 7, Nohilly discloses the surgical cutting instrument according to Claim 6, wherein one of the third and fourth cooperating elements is a protrusion and the other of the third and fourth cooperating elements is a slot shaped to accommodate the protrusion (Figs 5-12) ([0037-0057]).
For claim 8, Nohilly discloses the surgical cutting instrument according to Claim 1, wherein the first cooperating means comprises: a collar (115) located at the distal end of the elongate shaft, adjacent the cutting tip (Figs 5-12) ([0037-0057]); at least one resilient tab (yet another of the 116) located on the safety sleeve (Figs 5-12) ([0037-0057]); and an annular channel (yet another of the 114) shaped to receive the collar located within the cylindrical channel of the safety sleeve (Figs 5-12) ([0037-0057]).
For claim 9, Nohilly discloses the surgical cutting instrument according to Claim 8, wherein the at least one resilient tab includes a protrusion (116) and one edge of the annular channel is defined by the protrusion (Figs 5-12) ([0037-0057]).
For claim 11, Nohilly discloses the surgical cutting instrument according to Claim 1, wherein the safety sleeve further comprises a portion (112) of increased diameter located adjacent the proximal end of the elongate shaft (Figs 5-12) ([0037-0057]).
For claim 12, Nohilly discloses the surgical cutting instrument according to Claim 11, wherein the portion of the safety sleeve with increased diameter is configured to be gripped and includes a plurality of ridges (Figs 5-12) ([0037-0057]).
For claim 13, Nohilly discloses the surgical cutting instrument according to Claim 1, configured to be used for extracting a biopsy sample (Figs 5-12) ([0037-0057]).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for configuring surgical cutting instrument for sample retrieval with locking and safety features.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791