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 (Claims 1-16) in the reply filed on 01/14/2026 is acknowledged. The traversal is on the ground(s) that examination of all the claims together places no undue burden on the Examiner. This is not found persuasive because MPEP 808.02 states “Where the inventions as claimed are shown to be independent or distinct under the criteria of MPEP § 806.05(c) - § 806.06, the examiner, in order to establish reasons for insisting upon restriction, must explain why there would be a serious search and/or examination burden on the examiner if restriction is not required. In order to demonstrate a serious search burden, the examiner must show by appropriate explanation one of the following:
Separate classification thereof: This shows that each invention has attained recognition in the art as a separate subject for inventive effort, and also a separate field of search. Patents need not be cited to show separate classification.
A separate status in the art when they are classifiable together: Even though they are classified together, each invention can be shown to have formed a separate subject for inventive effort when the examiner can show a recognition of separate inventive effort by inventors. Separate status in the art may be shown by citing patents which are evidence of such separate status, and also of a separate field of search.
A different field of search: Where it is necessary to search for one of the inventions in a manner that is not likely to result in finding art pertinent to the other invention(s) (e.g., searching different classes/subclasses or electronic resources, or employing different search queries), a different field of search is shown, even though the two are classified together. The indicated different field of search must in fact be pertinent to the type of subject matter covered by the claims. Patents need not be cited to show different fields of search.
In the Restriction Requirement, mailed 11/26/2025, the Examiner indicated (with new emphasis added):
the inventions have acquired a separate status in the art in view of their classification (Group I is classified in A61F2/2466 and Group II is classified in A61B17/0487);
the inventions have acquired a separate status in the art due to their recognized divergent subject matter (Claim 1 does not recite a suture);
the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries) (Because Claim 1 does not positively require a suture and the apparatus of Claim 1 can be used in a method where you are securing tissue in a joint space).
Claims 17-20 have been withdrawn from further consideration and claims 1-16 are pending. The requirement is still deemed proper and is therefore made FINAL.
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:
Proximal securing component in claims 2-4, 6, 8, 9, 10-16.
Securing members in claim 3-4, 6-16.
Locking component in claim 6, 8, 10.
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.
Claim 9, 11-14 and 16 is 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.
Regarding Claim 9, the limitation “one or more suture tunnels disposed along the first surface” renders the claim indefinite because it is unclear to the Examiner how the suture is configured to extend through the second surface along the passageway (as recited in Claim 1, Lines 5-6) and the suture tunnels, which are designed for the suture to pass through, is disposed on the first surface. It appears that this limitation should read “one or more suture tunnels disposed along the second surface”.
Regarding Claim 11, the limitation “wherein the second surface is configured to receive one or more hemostats” renders the claim indefinite because it is unclear to the Examiner how the second surface is configured to receive hemostats when Claim 1 recites “a first surface configured for passage of a surgical instrument” and the hemostats are that surgical instrument, as best understood by the Examiner. It appears this limitation should read “wherein the first surface is configured to receive one or more hemostats”.
Claims 12-14 and 16 are rejected for incorporating errors from the parent claim by dependency.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-7, 9, and 11-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spivey (US PGPub 2016/0301125).
Regarding Claim 1, Spivey teaches a cannula (100; Figure 2A-2B) comprising:
an elongated body (114) having a proximal end (112; handle end in Figures 2A-2B), a distal end (near elements 124/128 in Figures 2A-2B), and a longitudinal axis extending therebetween (“l” in Figure 2B), a first surface configured for passage of a surgical instrument along the first surface (the first surface is the half circumference opposite to the eyelet 126 in Figure 2B, essentially it’s the opposite side of that which has eyelet 126), and a second surface opposite the first surface (the second surface is the half circumference aligned with eyelet 126 in Figure 2B, essentially it’s the side which has eyelet 126);
a passageway extending along the second surface, the passageway configured for passage of a suture (suture can extend from eyelet 126 to the suture engaging feature 118 in Figure 2C and thus is a passageway, there is no structure yet recited in the claims as the Examiner is interpreting passageway to mean a path for the suture along the second surface); and
an eyelet (126) at least partially defined through the second surface (as best seen in Figure 1D in which the eyelet 26 is clearly shown to extend through the surface of the cannula) at the distal end of the body (114) for receiving the suture at the distal end (near element 124; The Examiner notes that as seen in Figure 2A, an suture is capable of extending through lumen 113 and out of the eyelet (126; as seen in Figure 2B) and up along the second surface towards suture engaging feature 118 (as seen in Figure 2C).
Regarding Claim 2, Spivey teaches thee cannula of claim 1, further comprising:
a proximal securing component (118) defined at the proximal end of the elongated body (114; Figure 2C; Paragraph 0061).
Regarding Claim 3, Spivey teaches the cannula of claim 2, wherein the proximal securing component includes one or more securing members (See element 118 which has two members that form the slit/cleat) against the second surface for securing limbs of the suture passed through the passageway and received at the distal end (Paragraph 0061 also discloses that the suture engaging feature can be disposed directly on the shaft 114 (which is not shown) or on the handle 112 as shown in Figure 2C).
Regarding Claim 4, Spivey teaches the cannula of claim 3, wherein the proximal securing component (118) is configured to secure the limbs of the suture to the elongated body via a knot and/or a cleat (Paragraph 0061).
Regarding Claim 5, Spivey teaches the cannula of claim 4, wherein the one or more securing members (118) include two or more wings configured to secure the limbs of the suture to the elongated body via the knot and/or the cleat (Paragraph 0061; it’s the Examiner’s position that the two elements which form either side of the slit are wings).
Regarding Claim 6, Spivey teaches the cannula of claim 4, wherein the proximal securing component (118) is configured to secure the limbs of the suture to the elongated body via a locking component (it’s the Examiner’s position that the cleat 118 is a locking component; Paragraph 0061).
Regarding Claim 7, Spivey teaches the cannula of claim 6, wherein the locking component includes a foot (It’s the Examiner’s position that the term “foot” is not a term in the art and it’s the Examiner’s position that the slit formed in Figure 2C can be interpreted as a foot, particularly a foot of a split hooved animal).
Regarding Claim 9, Spivey teaches the cannula of claim 4, further comprising one or more suture tunnels (113) disposed along the first surface, the one or more suture tunnels (113) configured for passage of limbs of the suture therethrough (The Examiner is interpreting the lumen 113 to be a suture tunnel which is disposed along both the first and second surface as interpreted above).
Regarding Claim 11, Spivey teaches the cannula of claim 9, wherein the second surface is configured to receive one or more hemostats (the Examiner notes that the hemostats are not positively recited in the claims and thus the second surface need only be capable of receiving hemostats and Applicant’s attention should be drawn to Figure 2B which shows the bone engaging teeth (124) and it’s the Examiner’s position that hemostats can be received along the second surface or the first surface in between those teeth or alternatively just along the second outside surface along the entire length of the elongate body, as this limitation is merely an intended use).
Regarding Claim 12, Spivey teaches the cannula of claim 11, wherein the one or more hemostats compress the suture and the second surface at an insertion site to create elevation of a tissue, wherein the one or more hemostats are further configured to maintain contact with a patient at an insertion site to further secure the limbs of the suture during use of the cannula (the Examiner notes that the hemostats are not positively recited in the claims and thus the device need only be capable of meeting this limitation. It’s the Examiner’s position that hemostats are capable of grabbing/engaging with the suture that’s disposed on the second surface to grab both the suture and the elongate body to elevate tissue that’s attached to the suture. The limitation regarding the hemostats configured to maintain contact with a patient is also an intended use and the Examiner notes that the hemostats are not positively recited in the claims).
Regarding Claim 13, Spivey teaches the cannula of claim 12, wherein a location of the suture at the eyelet is selected to prevent interference with the surgical instrument and/or a surgical implant (the Examiner notes that the eyelet is spaced away slightly from the bone-engaging teeth (124) and thus the suture extending out of the eyelet would prevent interference with the hemostats when they are placed within the bone engaging teeth 124).
Regarding Claim 14, Spivey teaches the cannula of claim 13, wherein the location of the suture at the eyelet is more distal to facilitate insertion of the cannula through the insertion site to the tissue (as seen in Figure 2B, the eyelet is more distal than the bone-engaging teeth 124).
Regarding Claim 15, Spivey teaches the cannula of claim 3, wherein the proximal end of the elongated body (114) comprises a textured gripping surface (handle 112 in Figures 2A-2B has texture and is not completely smooth rounded tube as the distal portion of the handle 112 in Figure 2B has a tapered portion and thus is textured and the handle is a gripping surface).
Regarding Claim 16, Spivey teaches the cannula of claim 9, wherein the one or more suture tunnels (113) includes a grooved chamber (it’s the Examiners position that a lumen is a grooved chamber).
Allowable Subject Matter
Claims 8 and 10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art of record fails to disclose: wherein the locking component is slidably configured along the second surface to further secure the suture (Claim 8).
Claim 10 is objected for depending on Claim 8.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771