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
Applicants’ election of species A, without traverse, including claims 1-9, 12-18 and 20 is noted. Claims 10-11 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 5, 2026.
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:
the support member in claims 1, 13 and all dependent claims
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. In this case, the support member is interpreted as “support beam, … stiffening strut, etc”, as described in the specification in pg 11 lines 12-13.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 9, 12-15 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zenz-Olson et al. US 20170189164 A1, herein referred to as Zenz-Olson.
Regarding claim 1, Zenz-Olson discloses an implant delivery system (Fig 2,40), the implant delivery system comprising: an elongate shaft (42); and a frame (52) coupled to a distal end region of the elongate shaft (Fig 6), the frame including a body portion (Fig 4b, 56) and a plurality of attachment arms (Fig 4b, 64) extending from the body portion (Fig 4b, 56), wherein each of the attachment arms includes a support member (Fig 4a, 66) configured to extend through an aperture of an implant (Fig 5c, implant 12 and 76 forms a hole though the implant; see [0093]); and wherein each of the attachment arms includes a stop (See annotated figure below; this element is interpreted under 112(f) as a “node”, see pg 18 lines 14-24 of the instant application, and equivalents thereof) disposed on a free end region of the support member ([0096]), wherein the stop is configured to releasably secure the implant to the frame ([0096]).
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Regarding claim 2, Zenz-Olson discloses wherein the stop is configured to engage a bottom surface of the implant to releasably secure the frame to the implant (bottom surface being the implant see [0096]).
Regarding claim 9, Zenz-Olson discloses wherein the stop includes an upper face configured to engage a bottom surface of the implant (Fig 7).
Regarding claim 12, Zenz-Olson discloses wherein the implant is configured to be positioned between the stop and a distal portion (portions further down) of one of the plurality of attachment arms (Fig 7).
Regarding claim 13, Zennz-Olson discloses an implant delivery system (Fig 2,40), the implant delivery system comprising: a tether (Fig 16, 96; [0014]) including a proximal end and a distal end (Annotated Fig 16 below); and a frame (52) coupled to the distal end of the tether ([0014]), the frame including a body portion (Fig 4b, 56) and a plurality of attachment arms (Fig 4b, 64) extending from the body portion (Fig 4b), wherein each of the attachment arms includes a support member (annotated Fig 7 above) configured to extend through an aperture of an implant (Fig 5c, implant 12 and 76 forms a hole though the implant; see [0093]); and wherein each of the attachment arms includes a stop (See annotated figure 7 above; this element is interpreted under 112(f) as a “node”, see pg 18 lines 14-24 of the instant application, and equivalents thereof) disposed on a free end (Fig 5c, 68) region of the support member ([0076] and [0096]), wherein the stop is configured to releasably secure the implant to the frame ([0096]) .
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Regarding claim 14, Zenz-Olson discloses wherein the stop is configured to engage a bottom surface of the implant to releasably secure the frame to the implant [0096].
Regarding claim 15, Zenz-Olson discloses wherein retraction of the tether is configured to pull the stop through the aperture of the implant [0028].
Regarding claim 20, Zenz-Olson discloses the implant delivery system (Fig 2,40) comprising: a frame (52) including an upper surface and a bottom surface (Fig 2, top and bottom); and a stabilizer (Fig 12, 94) coupled to the frame (Fig 4a), wherein the stabilizer is positioned below the bottom surface of the frame (Fig 4a), wherein the stabilizer is spaced away from the bottom surface of the frame to permit an implant (12) to be releasably secured between the bottom surface of the frame and the stabilizer ([0124] and [0096]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3-8 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zenz-Olson in view of Tran et al. US 20170189014 A1, herein referred to as Tran.
Regarding claim 3, Zenz-Olson does not disclose wherein the stop is configured to pass through the aperture of the implant.
However, Tran teaches an implant delivery system (Fig 8, 80; [0083]) comprising a shaft (Fig 12, 202), a frame (204) including, a body portion (203), an implant (310) and a stop (Figs 18 and 20, 272); wherein the stop is configured to pass through the aperture of the implant (see annotated Fig 20 below; [0044]).
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Tran annotated Fig 20.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Zenz-Olson to incorporate a stop configured to pass through the aperture of the implant, as taught by Tran in order to establish pilot holes in the implant and tissue of interest (Tran [0044]).
Regarding claim 4, Zenz-Olson as modified by Tran does not disclose wherein the stop is configured to shift from a first configuration prior to passing through the aperture to a second configuration as it passes through the implant, wherein the first configuration is different from the second configuration.
However, in another embodiment, Tran also teaches wherein the stop (Fig 4, 120a/120b) is configured to shift from a first configuration prior to passing through the aperture to a second configuration as it passes through the implant (122a/122c projections meet Webster’s1 definition of node: “ a point at which a curve intersects itself in such a manner that the branches have different tangents”; [0059] and [0068]; Tran teaches projection on nodes will change configuration as nodes pass through implant), wherein the first configuration is different from the second configuration (depending on the depth will impart different configuration see [0068]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Zenz-Olson to incorporate a stop is configured to shift from a first configuration prior to passing through the aperture to a second configuration as it passes through the implant, wherein the first configuration is different from the second configuration, as taught and suggested by Tran in order to prevent the implant/nodes from being displaced (Tran [0068]).
Regarding claim 5, Zenz-Olson as modified by Tran discloses wherein the stop includes a node (Tran Fig 4, 122a/122c) extending laterally away from the support member.
Regarding claim 6, Zenz-Olson as modified by Tran teaches wherein a distal tip (Tran Fig 4, point) portion of the support member extends beyond the node (Tran Fig 4).
Regarding claim 7, Zenz-Olson as modified by Tran teaches wherein the distal tip portion of the support member is configured to be removed from the node subsequent to attaching the implant to the frame (Tran teaches removing the node see [0045]) and [0121]).
Regarding claim 8, Zenz-Olson as modified by Tran teaches wherein the node includes a first projecting portion extending a laterally away from a first lateral side of the support (Tran Fig 4).
Regarding claim 16, Zenz-Olson does not explicitly disclose wherein the stop includes a node extending laterally away from the support member.
However, in the same field of invention, Tran teaches an implant delivery system (Fig 8, 80; [0083]) comprising a shaft (Fig 12, 202), a frame (204) including, a body portion (203), an implant (310) and a stop (Figs 18 and 20, 272); wherein the stop is configured to pass through the aperture of the implant (Fig 20; [0044]); and wherein the stop includes a node (Tran Fig 4, 122a/122c) extending laterally away from the support member.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Zenz-Olson to incorporate wherein the stop includes a node extending laterally away from the support member, as taught and suggested by Tran in order to prevent the implant/nodes from being displaced (Tran [0068]).
Regarding claim 17, Zenz-Olson as modified by Tran teaches wherein a distal tip (Tran Fig 4, point) portion of the support member extends beyond the node (Tran Fig 4).
Regarding claim 18, Zenz-Olson teaches wherein the distal tip portion of the support member is configured to be removed from the node subsequent to attaching the implant to the frame (Tran teaches removing the node see [0045]) and [0121]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Roslin et al. US 20100069930 A1 discloses a system for implanting prosthetic tissue
Regauer et al US 20130030479 A1 discloses a bone wedge implantation system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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, Jerrah Edwards can be reached at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.F./Patent Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
1 “Node.” Merriam-Webster.com Dictionary, Merriam-Webster, https://www.merriam-webster.com/dictionary/node. Accessed 14 Aug. 2026.
Prosecution Insights