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 filed June 29, 2023, fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It is noted, in particular, that no copies of any of the cited foreign patent documents WO 98/05261, WO 2012/040183, WO 2014/0142948, and WO 01/060261 were provided. That said, in order to make sure a copy of those references is found in the case file, these references are also being cited on the Notice of References Cited (PTO-892) accompanying this Office Action.
Response to Amendment
The preliminary amendment filed June 29, 2023, is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the express incorporation by reference of PCT/EP2022/053345 and of British patent application No. 2101870.0.
Applicant is required to cancel the new matter in the reply to this Office Action.
In particular, note that the preliminary amendment to the specification was filed June 29, 2023, and that since the present application is merely a stage of the PCT (i.e., the national stage of the PCT), the filing date of the present application is the filling date of the PCT application, which is February 11, 2022, which is prior to the amendment of June 29, 2023. See, for example, MPEP section 1893.03(b), which states:
An international application designating the U.S. has two stages (international and national) with the filing date being the same in both stages. Often the date of entry into the national stage is confused with the filing date. It should be borne in mind that the filing date of the international stage application is also the filing date for the national stage application.
To add an express incorporation by reference statement after the original filing date constitutes new matter.
See MPEP section 608.01 (p), which teaches the following:
As a safeguard against the omission of a portion of a prior application for which priority is claimed under 35 U.S.C. 119(a)-(d) or (f), or for which benefit is claimed under 35 U.S.C. 119(e) or 120, applicant may include a statement at the time of filing of the later application incorporating by reference the prior application. See MPEP § 201.06(c) and § 211 et seq. where domestic benefit is claimed. See MPEP §§ 213-216 where foreign priority is claimed. See MPEP §217 regarding 37 CFR 1.57(b). The inclusion of such an incorporation by reference statement in the later-filed application will permit applicant to include subject matter from the prior application into the later-filed application without the subject matter being considered as new matter. For the incorporation by reference to be effective as a proper safeguard, the incorporation by reference statement must be filed at the time of filing of the later-filed application. An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a).
Specification
The disclosure is objected to because of the following informalities:
It is noted that there are several inconsistencies regarding reference characters throughout the specification, such as instances in which one element is referred to with plural different reference characters, and such as instances in which one reference character is referred to as plural different elements. Examples of these issues include, but are not necessarily limited to:
On page 26, in the paragraph beginning “[A]s shown in the embodiment of Figure 4,…”, element 402 was referenced as both a “body” and a “reamer” and possibly a “proximal end” (though the “proximal end” was also referenced as element 410 in the specification) of a reamer (and in the very next paragraph on page 26, element 402 was twice referred to as a reamer), and on page 29 (the paragraph spanning pages 28-29), 402 was twice referred to as a “reamer”. However, it is also noted that a variety of reference characters were used in the specification to reference a (i.e., apparently the same) “reamer”, such as 400, 402, 310, and 301. See, for example, page 25, which has two occurrences of “reamer 310” and one occurrence of “reamer 301”; page 26, which includes at least three occurrences of “reamer 402”, and at least five occurrences of “reamer 400”; page 27, which includes at least twelve occurrences of “reamer 400”; page 28, which includes at least seven occurrences of “reamer 400”; page 29, which includes at least five occurrences of “reamer 400”; page 29, which includes at least two occurrences of “reamer 402”; page 30, which includes at least six occurrences of “reamer 400”; page 30, which includes at least one occurrence of “reamer 301”; and page 31, which includes at least five occurrences of “reamer 400”.
Additionally, regarding the reamer of the embodiment of Figures 9a-9c, it is noted that the specification utilizes both of the reference characters 1310 and 1400 to refer to the reamer. See pages 32-33.
Also, on page 27, the first full paragraph, it appears that “outer sleeve 353” should be changed to –outer sleeve 352—to be consistent with the rest of the specification and with the drawings.
On page 30, in the paragraph beginning “[F]igure 9a is a perspective…”, it appears that none of the reference characters are consistent with what is shown in the referenced Figure 9a. Likewise, on page 30, in the paragraph beginning “[I]n this embodiment a single arm 900…”, it appears that none of the reference characters are consistent with the described Figure 9b. Likewise, on page 30, in the paragraph beginning “[I]n place of a second deformable arm…”, it appears that none of the reference characters are consistent with the described Figure(s) (i.e., 9a and/or 9b). The same is also true for the paragraph spanning pages 30-31, and the first through third full paragraphs on page 31.
Appropriate correction is required.
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: the specification does not provide (literal) antecedent basis for the one or more arms including a “body” (with the radially-extending section 384 being at a distal end of the “body”) as set forth in claim 45, nor does the specification provide antecedent basis for the term “interconnecting surface” re the limitation in new claim 45 “an interconnecting surface extending distally from the retraction transition surface, and an insertion transition surface extending radially inwardly from the interconnecting surface”. It is noted that this is not a new matter objection or rejection, and Applicant may wish to consider amending, for example, the paragraph on page 25 beginning “[Towards or at the arm distal end 382…” to provide express antecedent basis for these new claim terms (considered to have support in at least Figure 3b).
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "400" (Figures 4 and 7a-b), “402” (possibly Figure 4; also Figures 5a-b), and "301" (Figure 3a) have all been used to designate a reamer. 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "402" (possibly Figure 4), “410” (possibly Figures 5a-b) have all been used to designate a proximal end of a reamer. 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 404 (page 26); 900 (pages 30-31, many occurrences); 902 (pages 30-31, several occurrences); and 904 (page 30). 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. 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.
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:
“locking element” in at least claim 1, 12-13, and 42-43.
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 1-14 and 39-52 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.
Throughout the claims (including expressly in at least claims 1-5, 7, 10, 39, 44, 45, and 49-50), terms “proximal” and “distal” (or “distally” or “proximally”) are relative terms which renders the claims indefinite. The terms “proximal” and “distal” are 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. In particular, it is unclear how close to some unspecified-in-the-claim frame of reference a given element has to be in order to be considered “proximal”, how far away from some unspecified-in-the-claim frame of reference a given element has to be in order to be excluded by the term “proximal”, it is unclear how far away from some unspecified-in-the-claim frame of reference a given element has to be in order to be considered “distal”, and how close to some unspecified-in-the-claim frame of reference a given element has to be in order to be excluded by the term “distal”. Furthermore, it is unclear as claimed relative to what axis, element, or frame of reference things are to be considered “proximal” vs. “distal”, i.e., “proximal” to what, “distal” to what?
In claim 1, lines 4-5, the claim sets forth “an outer sleeve positioned towards the distal end of the elongate body”. However, it is unclear as set forth in the claim what is meant by the outer sleeve being “positioned towards” the distal end of the elongate body, and thus, it is unclear as set forth in the claim what configuration(s) of outer sleeve are encompassed by the present claim language vs. what configuration(s) of outer sleeve are excluded by the present claim language. For example, it is unclear as set forth in the claim whether such is intended to refer to an orientation of some (unspecified in the claim language) axis or frame of reference of the outer sleeve with respect to the distal end of the elongate body, whether such is instead intended to indicate some sort of relative location of the outer sleeve with respect to the distal end of the elongate body (as in the outer sleeve is provided at a location that is closer to the distal end of the elongate body than to some other unspecified in the claim object or frame of reference), or whether such is instead intended to refer to something else entirely.
In claim 1, line 6, in the limitation “a distal end facing the internal bore”, it is unclear as set forth in the claim whether “facing” is intended to require a particular (unspecified in the claim) angular range of the “distal” end with respect to the internal bore, or whether such is intended to require a particular (unspecified in the claim) degree of proximity of the “distal” end with respect to the internal bore. Regardless of which meaning of “facing” is intended, given that no such angular range and no such degree of proximity are set forth in the claim, it is unclear what configuration(s) of “distal” end meet the limitation " a distal end facing the internal bore” and what configuration(s) of “distal” end are excluded by the limitation.
In claim 1, last four lines, the claim recites “a second position in which the locking element is retracted from the first position such that the terminal end of the locking element moves proximally away from the distal portion of the one or more arms”. Noting the tense of the verb “moves” in the limitation “the locking element moves proximally away”, it is unclear as set forth in the claim whether the second position is an actual (i.e., one) position, vs. whether the claimed second position is a plurality of positions through which the locking element moves during the act of being retracted. In the event that the second position is intended to refer to a/one second position, Applicant may wish to consider changing “in which the locking element is retracted from the first position such that the terminal end of the locking element moves” to –to which the locking element is retracted from the first position such that the terminal end of the locking element has been moved…--. Additionally, it is unclear as set forth in the claim what is meant by “proximally away from”, particularly noting that the term “proximally” would typically mean close to/near (or the like). Note that the limitation does not indicate that the locking element moves (or has been moved) away from the distal portion of the one or more arms and towards the proximal end of the elongate body, for example.
In claim 2, the claim recites “wherein the distal ends of the one or more of the arms is recessed within the internal bore”. However, it is unclear as set forth in the claim what configuration(s) of distal end of the one or more arms relative to the internal bore is/are intended to be encompassed vs. excluded by this limitation. For example, it is unclear as set forth in the claim with respect to what frame of reference the distal end of the one or more arms is “recessed”. For example, it is unclear as set forth in the claim whether this limitation refers to the fact that (regardless of whether the arms 374, for example, are in the position shown in Figure 7a, or are instead in the position shown in Figure 7b) a left (for example) end of the arms 374 is located away from the left end of the sleeve 352 and within the bore 354. Alternatively, it is unclear as set forth in the claim whether such is instead intended to refer to the sort of bulbous shape of the left end of the arms 374 re Figures 7a-7b, which can be considered to have portions which are “recessed” in the outer sleeve 352 within the internal bore 354 with respect to some unspecified frame of reference.
In claim 6, the claim recites “wherein the one or more internal surface portions, in combination, extend around at least half of an internal perimeter of the inner surface of the outer sleeve”. However, noting that the limitation “one or more” encompasses an arrangement in which there is only one such internal surface portion, it is unclear as set forth in the claim how or in what regard one internal surface portion is to be considered to “in combination” extend around at least half of an internal perimeter of the inner surface of the outer sleeve.
In claim 9, the claim sets forth “wherein each of the six internal surface portions defines a flat surface”. However, it is unclear as set forth in the claim whether the claim intends to require each of the six internal surface portions to define a respective flat surface (for a total of six flat surfaces), vs. whether the claim intends to require that each of the six internal surface portions defines (collectively) one/a flat surface (i.e., for a total of one flat surface).
In claim 14, it is unclear as set forth in the claim what is being set forth as “from the mounting system to the surgical procedural element”.
In claim 39, the claim sets forth “wherein the one or more arms includes a first am and a second arm that each extend distally from the distal end of the inner element…” However, it is unclear as set forth in the claim how or in what regard the first arm and the second arm are to be considered to “extend distally”. To the extent that the claim is intended to set forth a direction in which the two arms extend from the distal end of the inner element, such is further unclear, noting that no direction or axis that is “distal” or “distally oriented” has been set forth in the claim. The same situation exists in claim 45, which sets forth “an interconnecting surface extending distally from the retraction transition surface”. A similar situation and lack of clarity exists in claim 50, re the limitation “the radially-extending section being located distally of the plurality of internal surface portions”.
In claim 45, the limitation “the body” (plural occurrences) lacks sufficient antecedent basis in the claim, noting that the claim previously recited plural bodies, i.e., the body of the one or more arms, set forth in claim 45, line 2, and the “elongate body” (which is, nonetheless, a body) set forth in claim 1, line 3. The same situation exists in claim 46 re the limitation “the body”.
In claim 48, the claim sets forth “wherein each of the plurality of internal surface portions defines a flat surface”. However, it is unclear as set forth in the claim whether the claim intends to require each of the plurality of internal surface portions to define a respective flat surface (thus requiring plural flat surfaces), vs. whether the claim intends to require that each of the internal surface portions defines (collectively) one/a flat surface (i.e., for a total of one flat surface).
In claim 50, the limitation “the distal end thereof” lacks sufficient antecedent basis in the claim. While it is noted that claim 1 previously set forth “a distal portion of the one or more arms”, no “distal end” of the one or more arms was previously recited.
In claim 52, the claim sets forth “wherein the outer sleeve further includes second indicia axially spaced apart from one another on the outer surface thereof…”. However, it is unclear as set forth in the claim from what the recited outer sleeve second indicia are axially spaced apart. For example, it is unclear as set forth in the claim whether the claim intends to recite that the outer sleeve has plural second indicia that are axially spaced apart from each other on the outer surface of the outer sleeve, vs. whether the claim instead intends to recite that the outer sleeve includes second indicia that are axially spaced apart from the previously-recited first indicia of the outer sleeve.
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 8-9, 44, and 52 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.
In the response filed 5/21/2026, claim 8 was amended to recite “wherein the one or more internal surface portions includes six internal surface portions spaced apart from one another about an internal periphery of the outer sleeve”. However, the specification as originally filed does not appear to provide support for such. In particular, while the specification as filed does appear to provide support for the one or more internal surface portions 360 including six internal surface portions, it does not appear that the specification as filed expressly teaches that those six surface portions are “spaced apart from one another” about the internal periphery (re inner surface 356) of the outer sleeve 352, nor is it inherent that the six internal surface portions 360 are ”spaced apart from one another about an internal periphery of the outer sleeve” 352, as opposed to the six internal surface portions 360 being in contact with one another to form a continuous hexagonal shape. See, for example, page 24, the paragraph beginning “[T[he extension element 330…”.
Regarding new claim 44, the claim sets forth “wherein…a proximal end of the inner element is annular”. It *appears* that the inner element may be intended to refer to element 350 (given the limitations in limitation “iii” of claim 1), and that the “proximal” end may be intended to refer to the right end re Figures 4 and 7a-8b, for example. That said, to the extent that claim 44 is intended to indicate that the right (re Figures 4 and 7a-8b) end of the inner element 350 is “annular”, it does not appear that the specification as filed provides support for such. That said, the specification as filed does appear to provide support for the left end (re Figures 4 and 7a-8b) (which is the upper end re Figure 3a) of the element 350 being annular.
In new claim 52, the claim sets forth “wherein the outer sleeve further includes second indicia axially spaced apart from one another on the outer surface thereof that align with corresponding second indicia on the surgical procedural element to indicate a proper axial position of the mounting system and the surgical procedural element relative to one another”. However, it is unclear as set forth in the claim from what the recited outer sleeve second indicia are axially spaced apart. For example, it is unclear as set forth in the claim whether the claim intends to recite that the outer sleeve has plural second indicia that are axially spaced apart from each other on the outer surface of the outer sleeve, vs. whether the claim instead intends to recite that the outer sleeve includes second indicia that are axially spaced apart from the previously-recited first indicia of the outer sleeve. That said, to the extent that the former is intended, it does not appear that the specification as originally filed provides support for such. While it is noted that Figure 6 appears to possibly depict an element (labeled as 426c* in the annotated reproduction of Figure 6 below) that *might* be a further second indicia 426c on the outer sleeve 352, firstly, the specification as originally filed does not expressly teach such, nor is such inherent. Furthermore, the specification does not teach, nor do the drawings show, a further axially spaced second indica on the sleeve 352 that aligns with a (further) corresponding second indicia on the surgical procedural element to indicate a proper axial position of the mounting system and the surgical procedural element relative to one another, as set forth in claim 52.
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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.
Claims 1-3, 5-14, and 39-50, as best understood in view of the above rejections based on 35 USC 112, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2012/040183 A1 (hereinafter, “WO ‘183”).
The following is representative of one (or more) example of an interpretation(s) of WO ‘183 that meets the present claim language, but is not intended to be indicative that such is the only interpretation of WO ‘183 that meets the present claim language, particularly in light of the breadth of many of the claim terms.
WO ‘183 teaches:
a mounting system “for” connection to a surgical procedural element (such as the jawed tissue gasper end effector portion 32 of the end effector 30; see Figure 4, as well as page 4, lines 29-31, page 5, lines 1-5, and page 5, line 26 through page 6, line 3, for example), the mounting system comprises:
i) an elongate body (for example, portion EB, labeled below in the annotated reproduction of Figure 7, of the sleeve element labeled in the annotated reproduction of Figure 7 below as S1) having a proximal end (such as, for example, the right “end”/portion re Figures 7-8, which is “more” proximal to the handle 21, for example; see Fig. 1) and a distal end (such as, for example, the left “end”/portion re Figures 7-8, which is “more” distal to the handle 21, for example; see Fig. 1);
ii) an outer sleeve (such as the portion of S1 that is labeled below as OS1, for example, or alternatively, such as the portion of S1 that is labeled below as OS2, for example) being “positioned towards” the distal (left re Figures 7-8) end of the elongate body (EB) (see annotated Figure 7 below, noting that both OS1 and OS2 can be considered to be “positioned towards” the left end of EB at least in that they are located to the left of EB), the outer sleeve (OS1, or alternatively, OS2) defining an internal bore (see Figure 7);
iii) an inner element (22+42A/B; see Fig. 8) with a “distal end” (such as the end/portion labeled in the annotated reproduction of Figure 5 below as “DE”) “facing” the (aforedescribed) internal bore (see Figures 7-8) (see Figures 5-8, noting that the distal end DE of inner element 22+42A/B is at a left end/portion of element 22+42A/B, which left end/portion of 22+42A/B is an end of 22+42A/B that is closer to the aforedescribed internal bore OS1 or OS2, i.e., as compared to the right “end”/portion of 22+42A/B re Figures 5-8), the inner element (22+42A/B) including one or more arms (such as, for example, 42A and/or 42B; see Figures 6-7 and 8 and page 7, lines 8-22) that extend from the distal end (DE) of the inner element (22+42A/B) into the (aforedescribed) internal bore, the one or more arms (42A, 42B) being spaced from the (aforedescribed) outer sleeve to define a gap between the one or more arms (42A, 42B) and the (aforedescribed) outer sleeve (see Figure 8), the inner element (22+42A/B) at least partially defining a second bore (in which 41 is slidably provided; see Figures 7-8); and
iv) a locking element (41) slidably positioned in the second bore (see Figures 7-8), the locking element being movable between a first position (see Fig. 7A) in which a terminal “end” of the locking element (41) is adjacent to a distal portion of the one or more arms (42A, 42B) and a second position (see Fig. 7) in which the locking element (41) is retracted from the first position (Fig. 7A) such that the terminal end of the locking element (41) “moves proximally” away from the distal portion of the one or more arms (42A, 42B). See Figures 7-8. See also page 7, line 8 through page 8, line 4, for example.
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Regarding claim 2, WO ‘183 teaches that the outer sleeve (OS1 or OS2) has a “distal” (left) end (end/portion) and the distal portion of the one or more arms (42A, B) has a “distal” (left) end(/portion), and wherein the distal end of the one or more of the arms (42A and/or B) is recessed within the (aforedescribed) internal bore. See Figures 7-8A. For example, it is noted that the arms 42A and/or B, along with the distal end(s) thereof, are “recessed” within the internal bore of the outer sleeve (OS1 and/or OS2) in that they are radially spaced from the surface of that internal bore. Alternatively, see the recessed portions 43A, 43B of the left/distal ends of the arms 42A and/or 42B re Figures 5-8, which 43A, 43B are “within” the aforementioned internal bore. Such are but a few examples of interpretations of the reference that meet the language of claim 2.
Regarding claim 3, the (aforedescribed) outer sleeve (OS1 or OS2) has a “distal” end (left re Figures 7-8A) and the distal portion (left “portion” re Figures 5-8) of the one or more arms (42A and/or 42B) has a “distal end” (left end/portion re Figures 5-8), and wherein the distal end of the outer sleeve (OS1, OS2) extends “beyond” the distal end of the one or more arms (42A and/or B). See, for example, Figure 7, noting that it can be seen in at least Figure 7 that the aforedescribed distal/left “end”/portion of the outer sleeve OS1 or OS2 extends “beyond” the distal/left portion of the distal left “end” of the one or more arms 42A and/or B, as broadly claimed, such as “beyond”, in both the radial direction extending perpendicular to the longitudinal direction of 42A/B, as well as in the direction towards the right from the left end face of 44, for example, the “distal” (left) ends/portion(s) of 42A and/or B, for example (though again, such is but one example of an interpretation meeting the present claim language).
Regarding claim 5, the (aforedescribed) outer sleeve (OS1 or OS2) has one or more internal surface “portions”(such as, for example, any one or more of the six points or portions that are labeled as IS1, IS2, IS3, IS4, IS5, IS6 in the annotated reproduction of a portion of Figure 8 below, of the surface that extends radially inwardly from the inner surface IS labeled below; that said, as broadly claimed, it is noted that there are an infinite number of such “internal surface portions”) (that are) “proximal” (as broadly claimed) to “a” (such as either the left or the right re Figures 7-8, noting that the left end of OS1 or OS2 is distal from 21 as described above, and is also “proximal” to the element 30, and noting that the right end of OS1 or OS2 is “proximal” to 21 and “distal” from element 30, for example) “distal” end of the outer sleeve (OS1, OS2) and extending “inwardly” (such as radially inwardly re the longitudinal axis of 22/41, for example) into the (aforedescribed) internal bore from an inner surface (such as, for example, the surface labeled in the annotated reproduction of Figure 8 below as “IS”) of the (aforedescribed) outer sleeve (OS1 or OS2). See Figures 7-8, and particularly the annotated enlarged partial reproduction of Figure 8 below.
[AltContent: textbox (IS)][AltContent: connector][AltContent: textbox (ISP6[img-media_image4.png])][AltContent: textbox (ISP5[img-media_image4.png])][AltContent: textbox (ISP4[img-media_image4.png])][AltContent: textbox (ISP3[img-media_image4.png])][AltContent: textbox (ISP2[img-media_image4.png])][AltContent: textbox (ISP1)][AltContent: connector][AltContent: connector][AltContent: connector][AltContent: connector][AltContent: connector][AltContent: connector]
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Regarding claim 6, the one or more internal surface portions (such as any one or more of ISP1, ISP2, ISP3, ISP4, ISP5, ISP6) in combination, extend “around” (e.g., along or in the vicinity of) at least half of an internal perimeter of the inner surface (such as the internal surface labeled above as IS) of the (aforedescribed) outer sleeve (OS1 or OS2). See Figures 7-8, and particularly the above annotated reproduction of Figure 7 and the partial annotated reproduction of Figure 8 above.
Regarding claim 7, the gap between the one or more arms (42A and/or 42B) and the (aforedescribed) outer sleeve (OS1 or OS2) has an extent (such as in the left/right direction re Figure 7), the extent being from a distal end (such as the left end re Figures 7-8) of the one or more arms (42A and/or 42B) to “the” distal end (DE, described and labeled above) of the inner element (22+42A/B), and wherein the extent is at least a third of “the” distance between the distal end (DE) of the inner element (22+42A/B) and “a” distal end (such as the leftmost end re Figure 7) of the outer sleeve (OS1 or OS2). See the annotated reproduction of Figure 7 above.
Regarding claim 8, the one or more internal surface portions (as noted above, as broadly claimed, there are an infinite number of such surface “portions”) includes six internal surface portions (such as the internal surface portions labeled in the annotated partial reproduction of Figure 8 above as ISP1, ISP2, ISP3, ISP4, ISP5, and ISP6) spaced apart from one another about “an” internal periphery of the outer sleeve (OS1 or OS2). See the annotated partial reproduction of Figure 8 above and the annotated reproduction of Figure 7 above, for example.
Regarding claim 9, each of the six internal surface portions (such as the internal surface portions labeled in the annotated partial reproduction of Figure 8 above as ISP1, ISP2, ISP3, ISP4, ISP5, and ISP6) “defines” (as broadly claimed) a “flat” surface (e.g., the radially extending flat surface at the left end of the rib labeled in Figure 8 as 32, radial being with respect to a longitudinal axis of 22/41, for example). See Figure 8, for example.
Regarding claim 10, the one or more arms (42A and/or 42B) includes an intermediate “section” (as broadly claimed) (such as, for example, any portion of 42A and/or B that is between, in the left/right direction re Figures 5-8, the distal end DE and the left “end” or left portion of 42A and/or B; such as, for example, 43A and/or B, and/or such as the portion of arm 42A and/or B that is to the right of 43A and/or 43B and to the left of DE re Figures 5-8) “between” a distal end (such as the left end/portion re Figures 7-8) of the one or more arms (42A and/or B) and the distal end (DE, labeled above) of the inner element (22+42A/B). See Figures 5-8.
Regarding claim 11, (which depends from claim 1) “the” gap includes a gap “profile” that “corresponds” (as broadly claimed), “plus a tolerance”, with “the” profile of the (aforedescribed) surgical procedural element at one or more locations. It is noted that the gap is a space/air, and that air can be considered to have a “profile” that “corresponds” (as broadly claimed) at any of an infinite number of locations thereof, “plus a tolerance” (of an amount to make that profile correspond” in, for example, size and/or shape), with “the” profile of, for example, the aforedescribed surgical element, simply by adding a desired (positive or negative) amount to a dimension of the gap/air/space so as to “correspond” in size and/or shape to some location/portion of a surgical procedural element capable of being attached via the mounting system.
Regarding claim 12 (which depends from claim 1), in the (aforedescribed) first position (Figure 7A), the locking element (41) abuts an inner surface of the one or more arms (42A and/or 42B) (see Figure 7A) and an outer surface of the one or more arms (42A and/or 42B) is spaced from an inner surface of the outer sleeve (OS1 or OS2) by the gap (described above re claim 1). See Figure 7A.
Regarding claim 13, in the (aforedescribed) second position (shown in Figure 7), the locking element (41) does not abut the inner surface of the one or more arms (42A and/or 42B) and the outer surface of the one or more arms (42A and/or 42B) is spaced from the inner surface of the outer sleeve (OS1 or OS2) by the gap (described above re claim 1). See Figure 7.
Regarding claim 14, the one or more arms (42A and/or 42B) includes a pair of arms (42A and 42B), the pair of arms configured to “axially” (such as in the direction of the longitudinal axis of 22/41) retain the (aforedescribed) surgical procedural element on the mounting system and the outer sleeve (OS1 or OS2) “providing” (as broadly claimed) rotational drive (by being configured to be able to be grasped by an operator/end user who can thus manually manipulate the overall device 20 of Figure 1 with the aforedescribed surgical procedural element such as the jawed tissue grasper of 30, which jawed tissue grasper is shown at 32 in Fig. 4) about an axis (extending) from the mounting system to the surgical procedural element (simply by having an end user/operator manually grasp OS1 or OS2 and manipulate 20 and the jawed tissue grasper about such an axis).
Regarding claim 39, the one or more arms (42A and/or 42B) includes a first arm (such as one of 42A and 42B) and a second arm (the other of 42B and 42A) that each “extend distally” from the (aforedescribed) distal end (DE) of the inner element (22+42A/42B) (see Figures 5-8) in spaced apart relation to one another (see Figures 5-8, and especially Figure 6) and the outer sleeve (OS1 or OS2) (see Figures 7-8) such that each of the (aforedescribed) first arm and the (aforedescribed) second arm “defines” (as broadly claimed) the gap between the respective arm and the outer sleeve (OS1 or OS2) (see Figures 5-8).
Regarding claim 40, “the” (aforedescribed) surgical procedural element is configured to be received “in” the (aforedescribed) gap (as broadly claimed). See Figures 1, 4, and 5-8, noting that the aforedescribed surgical procedural element is at least ultimately received “in” (such as “in” the gap in the “radial” direction with respect to the longitudinal axis of 22/41, when viewed along a longitudinal center axis of 22/41, for example) the gap (see Figures 4 and 7-8, for example, i.e., the surgical procedural element is received in a manner so as to be at a location that is within, in the aforedescribed radial direction, the gap).
Regarding claim 41, the (aforedescribed) first arm (one of 42A or 42B) and the second arm (the other of 42B and 42A) are deflectable toward one another. See Figures 7-8, particularly when 41 is located at the position shown in Figures 7 and 8. See also page 7, line 8 through page 8, line 4. See also page 8, lines 28-30, for example. See also page 10, lines 10-16, for example.
Regarding claim 42¸ the first arm (one of 42A, 42B) and the second arm (the other of 42B, 42A) are blocked from deflection toward one another while the locking element (41) is in the (aforedescribed) first position (shown in Figure 7A). See Figure 7A and page 7, line 8 through page 8, line 4, for example, and particularly page 7, lines 16-18, for example.
Regarding claim 43, the (aforedescribed) first arm and the (aforedescribed) second arm are free to deflect toward one another while the locking element (41) is in the (aforedescribed) second position (shown in Figure 7). See Figures 7-8, as well as at least page 7, line 8, through page 8, line 4, as well as at least page 10, lines 10-16, for example.
Regarding claim 44, the outer sleeve (OS1 or OS2, described above) is annular (see Figures 7-8, for example) and a “proximal” end (such as the right end/portion/section re Figure 7) of the inner element (22+42A/42B) is annular (as can be seen in at least Figures 5-8, noting the annular configuration thereof due to the bore therein in which element 41 is received).
Regarding claim 45, the one or more arms (42A and/or 42B) extends “along” an axis (such as, for example, the longitudinal center axis of 22 and/or 41) and (42A and/or 42B) includes a body (such as, for example, the “body” labeled in the annotated reproduction of Figure 6 below as “B”) and a radially-extending section at a distal (such as left re Figures 5-8) end of the body, the radially-extending section including a retraction transition surface (such as the surface labeled in the annotated reproduction of Figure 6 below as RTS, extending from 43A to ICS) extending radially outwardly from the body (B) (see Figure 6), an interconnecting surface (such as the surface labeled in the annotated reproduction of Figure 6 below as ICS) extending “distally” from the retraction transition surface (RTS) (see Fig. 6), and an insertion transition surface (such as the surface labeled in the annotated reproduction of Figure 6 below as ITS) extending radially inwardly from the interconnecting surface (ICS) (see Figure 6).
[AltContent: textbox (RTS)][AltContent: textbox (ICS)]
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Regarding claim 46, an outer surface (such as the outer surface of the body B at 43A and/or 43B) of the body (B) is located radially inward of an outer surface of the interconnecting surface (ICS) of the radially-extending section. See the annotated reproduction of Figure 6 above.
Regarding claim 47¸ the outer sleeve (OS1 or OS2) includes a plurality of internal surface portions (such as any two of ISP1, ISP2, ISP3, ISP4, ISP5, ISP6, labeled in the above partial annotated reproduction of Figure 8, and discussed above re claims 5-6, 8, and 9, for example) extending inwardly from an inner wall of the (aforedescribed) outer sleeve toward the one or more arms (42A and/or 42B) of the inner element (22+42A/42B). See the annotated partial reproduction of Figure 8 above, as well as the annotated reproduction of Figure 7 above. Alternatively regarding claim 47, the outer sleeve (OS1 or OS2) includes a plurality of internal surface “portions” (such as any two of the surface “portions” ISP7, ISP8, or ISP9, labeled in the below partial annotated reproduction of Figure 8, having a circumferential dimension, and extending longitudinally in the direction of the longitudinal axis of 22/42 from one flat surface FS1 to another FS2) extending “inwardly” from an inner wall (IW, labeled below) of the (aforedescribed) outer sleeve toward the one or more arms (42A and/or 42B) of the inner element (22+42A/42B). See the annotated partial reproduction of Figure 8 below, as well as the annotated reproduction of Figure 7 above.
Regarding claim 48, each of the plurality of internal surface portions (such as any two of ISP1, ISP2, ISP3, ISP4, ISP5, ISP6, labeled in the above partial annotated reproduction of Figure 8, and discussed above re claims 5-6, 8, and 9, for example) “defines” (as broadly claimed) a “flat” surface (e.g., the radially extending flat surface at the left end of the rib labeled in Figure 8 as 32, radial being with respect to a longitudinal axis of 22/41, for example). See the partial annotated reproduction of Figure 8 above, for example. Alternatively, regarding claim 48, each of the plurality of internal surface portions (ISP7, ISP8, ISP9, labeled in the below partial annotated reproduction of Figure 8, and discussed above re claim 47, for example) “defines” (as broadly claimed) a “flat” surface (e.g., either of flat surfaces FS1, FS2, labeled below). See the partial annotated reproduction of Figure 8 below, for example.
[AltContent: textbox (RES)][AltContent: connector][AltContent: ][AltContent: textbox (FS2)][AltContent: connector][AltContent: textbox (FS1)][AltContent: connector][AltContent: textbox (IW)][AltContent: connector][AltContent: connector][AltContent: connector][AltContent: connector][AltContent: textbox (L3)][AltContent: connector][AltContent: connector][AltContent: arrow][AltContent: connector][AltContent: arrow][AltContent: arrow][AltContent: connector][AltContent: connector][AltContent: connector][AltContent: connector][AltContent: textbox (ISP9)][AltContent: textbox (ISP8[img-media_image4.png])][AltContent: textbox (ISP7[img-media_image4.png])]
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Regarding claim 49, the outer sleeve (OS1, labeled in the above annotated reproduction of Figure 7) “defines” a first length (such as the length labeled in the above annotated partial reproduction of Figure 8 as “L1”) from “a” distal end (such as the left end face of OS1 re Fig. 8) thereof to a distal end (at FS1) of each of the plurality of internal surface portions (ISP7, ISP8, ISP9, for example, labeled and described above), a second length (such as the length labeled in the above annotated partial reproduction of Figure 8 as “L2”) from the distal end (e.g., at FS1) of each of the plurality of internal surface portions (ISP7, ISP8, ISP9) to a “proximal” end (e.g., at FS2) of each of the (aforedescribed) plurality of internal surface portions (ISP7, ISP8, ISP9), and a third length (L3, labeled above) from the proximal end (at FS2) of each of the plurality of internal surface portions (ISP7, ISP8, ISP9) to the (aforedescribed) distal end (DE, labeled in the above annotated reproduction of Figure 5) of the inner element, and the first length (L1) is greater than each of the second length (L2) and third length (L3) (as can be seen in the annotated reproduction of Figure 8 above in which L1, L2, L3 are labeled).
Regarding claim 50, the one or more arms (42A and/or 42B) includes a radially-extending section (such as, for example, the section labeled in the annotated reproduction of Figure 8 above as “RES”, though it is noted that the arms 42A and/or 42B are three-dimensional objects that have “radial” dimensions at locations all along their length, i.e., not just at the portion labeled above as “RES”) at “the” distal (such as left re Figure 8) end thereof, the radially-extending section (RES) being located “distally of” the plurality of internal surface portions (any two or more of ISP1, ISP2, ISP3, ISP4, ISP5, ISP6, ISP7, ISP8, ISP9, labeled above). See Figures 5-8.
Claim Rejections - 35 USC § 102/103
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 4, as best understood in view of the above rejections based on 35 USC 112, 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 WO 2012/040183 A1 (hereinafter, “WO ‘183”).
Regarding claim 4, WO ‘183 teaches that the “distal” (left re Figures 7-8) “end” (i.e., “portion”, no specific boundaries on such end/section/portion) of the outer sleeve (OS1 or OS2) extends “beyond” (as described above re claim 3) the distal (left) “end”(/section) of the one or more arms (42A and/or 42B) by at least a quarter of “the” length (such as “the” length of 42A/B from the left end face of 44 to the left end face of 42A/B re Fig. 7) of the one or more arms (42A and/or B), as can be seen in at least Figure 7.
In the alternative, WO ‘183 is silent as to the specific dimensions, and in the event that it is held that WO ‘183 does not teach that the distal end of the outer sleeve extends beyond the distal end of the one ore more arms by, specifically, “at least a quarter of the length of the one or more arms”, then it is noted that such is considered to be an obvious modification of WO ‘183. In particular, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have caused broadly-recited “distal end of the outer sleeve” to extend in some direction/manner “beyond” “the” broadly-recited “distal end” of the one or more arms by, specifically, at least a quarter of “the” (i.e., some) length of the one or more arms, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the mounting system of WO ‘183 would not operate differently with the claimed degree of extension of “the” broadly recited distal “end” of the outer sleeve relative to “the” broadly-recited distal “end” of the one or more arms 42A and/or B, noting that as shown in at least Figure 7, the degree of extension already appears to be shown to be within the claimed range. Further, applicant places no criticality on the range claimed, merely indicating that “the” distal end of the outer sleeve “may” extend beyond the distal ends of one or more arms by at least a quarter of the length of one or more arms, potentially by at least a third of the length of one or more arms” (see page 2 of the present specification, the paragraph beginning “[T]he outer sleeve may have a distal end…”).
Allowable Subject Matter
Claim 51, as best understood in view of the above rejections based on 35 USC 112, 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.
Comment Regarding Non-Indication of Allowable Subject Matter
A thorough search has been conducted re the elected invention/claims. That being said, though no art rejections are considered to presently apply to claim 52, no indication regarding the allowability of the subject matter of elected claim 52 with respect to the prior art is being made at this time due to the rejection(s) thereof based on 35 USC 112(a), set forth above, particularly given that is unclear what changes to the claims might be necessary to overcome the above-described issues with respect to 35 USC 112(a).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. For example, it is noted that U.S. Pat. No. 5,888,200 is in the same patent family as WO 98/05261 A2, which was cited as an “A” in the international application of which the present application is the national stage. It is also noted that U.S. Patent Application Publication No. 2016/0022282 is in the same patent family as WO 2014/142948 A1, which was cited as an “A” in the international application of which the present application is the national stage. It is also noted that U.S. Patent Application Publication No. 2002/0058958 is in the same patent family as WO 01/60261 A2, which was cited as an “A” in the international application of which the present application is the national stage.
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/ERICA E CADUGAN/Primary Examiner, Art Unit 3722
eec
September 1, 2026
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