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/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-16, drawn to a bone anchor, classified in A6F12/0059.
II. Claims 17-26, drawn to a bone anchoring method, classified in A61B17/0401.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product as claimed can be used in a materially different process of using that product, as the product does not require surgically exposing a bone tissue beneath a periosteum tissue; (b) forming a hole in the bone tissue; (c) inserting an implant shaft of a bone anchor into the hole formed in the bone tissue such that the shaft compresses as it is inserted into the hole to retain the bone anchor in the hole. For example, the implant could be implanted in another area of the body.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Group I require a search in at least A61F2/0059, along with a unique text search. Group II would not be searched as above and would instead require a search in at least A61B17/0401, along with a unique text search.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Michael Bertelson on 07/24/2026 a provisional election was made without traverse to prosecute the invention of Group II, claim 17-26. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-16 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 21-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 recites the limitation "wherein the tensioning the suture" in line 1. There is insufficient antecedent basis for this limitation in the claim, as this step is not introduced in the claim nor in the claim that it depends from. For purposes of expedited prosecution, the Examiner is interpreting this claim to depend from claim 20, as tensioning the suture is introduced in this claim. Claim 22 is rejected due to its dependency on claim 21.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 17-20 and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over US 20060235413 A1 (hereafter –Denham--) in view of US 20120089193 A1 (hereafter –Stone--).
Regarding Claim 17, Denham discloses a bone anchoring method comprising:
(a) surgically exposing a bone tissue beneath a periosteum tissue (see paragraph [0071 denoting that the anchor is inserted in a pre-drilled hole, the periosteum tissue being on the top surface 82 of the bone structure 16, as periosteum tissue layers all bones);
(b) forming a hole in the bone tissue (see paragraph [0061] and [0062]);
(c) inserting an implant shaft (34, 20) of a bone anchor (10) into the hole formed in the bone tissue such that the shaft compresses as it is inserted into the hole to retain the bone anchor in the hole (see paragraph [0074] denoting that the sleeve 20 has expanding components, being made of a material that can also be compressed (if it can expand it can compress), and also that the sleeve portion goes around the shaft portion 34 and therefore around the through hole, squeezing the shaft and facilitating a lock of the suture into the device),
wherein the bone anchor comprises:
(i) an implant head comprising a lower surface and an upper surface (see annotated lower and upper surface in Figure 3 below), wherein the lower surface is flat or concave (see annotated lower surface in Figure 3 below);
(ii) the implant shaft extending down from the lower surface of the implant head (see annotated shaft and head in Figures 1-4C below);
(iii) a through hole (22) extending laterally through the implant shaft below the implant head (see annotated through hole, shaft, head in Figures 1-4C below).
PNG
media_image1.png
601
1047
media_image1.png
Greyscale
Denham fails to disclose (iv) wherein the bone anchor is made of a porous material.
Stone discloses a bone anchor (210) that is configured to connect a suture to bone (see paragraph [0049]). Stone teaches that it is known in the art for a bone anchor to made of a porous material (see paragraph [0049]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the bone anchor of Denham to be made of a porous material, as by doing so would allow bony ingrowth of the surrounding bone into the anchor, as taught by Stone (see paragraph [0049]). Additionally, it would have been obvious to one of ordinary skill in the art at the time the invention was made to use a porous material for forming the bone anchor, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding Claim 18, Denham as modified by Stone discloses the bone anchoring method of claim 17, wherein, after inserting the implant shaft of the bone anchor into the hole, the implant shaft is in contact with cancellous bone tissue, the lower surface of the implant head is in contact with cortical bone tissue, and the upper surface of the implant head is in contact with the periosteum tissue (see Figure 4C above wherein shaft portion 20 is in contact with bone tissue). Since the bone is one integral structure, the components of the bone anchor being the shaft and surfaces of the head are indirectly in contact with all three claimed bone tissues. The pathway between the three bone tissues is continuous and direct, as the cancellous bone is tightly connected to the cortical bone, and the cortical bone is completely surrounded by the periosteum. The tension applied to any of the sections of the bone anchor would be felt on all layers of bone, and therefore all components of the anchor are in contact with, indirectly or directly, each claimed layer of bone tissue.
Regarding Claim 19, Denham as modified by Stone discloses the bone anchoring method of claim 18, wherein, after inserting the implant shaft of the bone anchor into the hole, pores of the implant shaft allow ingrowth of the cancellous bone tissue and pores of the upper surface of the implant head allow ingrowth of the periosteum tissue (as modified by Stone, see claim 17 rejection above, see also paragraph [0049] of Stone).
Regarding Claim 20, Denham as modified by Stone discloses the bone anchoring method of claim 17, further comprising: (a) wherein a suture (30) extends through the through hole of the bone anchor prior to insertion of the shaft of the bone anchor into the hole (see paragraph [0071]); and (b) after inserting the implant shaft of the bone anchor into the hole, tensioning the suture (see paragraphs [0071] and [0074]).
Regarding Claim 23, Denham as modified by Stone discloses the bone anchoring method of claim 17, wherein a positioner pin (48) extending upwardly from the implant head is used to insert the shaft of the bone anchor into the hole (see paragraph [0066]); and, wherein, after inserting the shaft of the bone anchor into the hole, the positioner pin is broken off from the implant head (see Figure 4C below, see also paragraph [0065] describing breakaway section).
Regarding Claim 24, Denham as modified by Stone discloses the bone anchoring method of claim 17, wherein forming the hole in the bone tissue comprises forming a hole of a first diameter in the bone tissue, wherein the implant shaft comprises a second diameter, wherein the first diameter is smaller than the second diameter (see shaft and hole in bone tissue in Figure 4C above).
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over US 20060235413 A1 (hereafter –Denham--) in view of US 20120089193 A1 (hereafter –Stone--), as applied to claim 20 above, in even further view of US 20090216251 A1 (hereafter --Levine--).
Regarding Claim 21 and 22, Denham as modified by Stone discloses the bone anchoring method of claim 20.
Denham as modified by Stone fail to disclose wherein tensioning the suture comprises passing the suture through a portion of the periosteum tissue and adjusting suspension of the portion of the periosteum tissue, and wherein the bone tissue is cranial tissue.
Melvin discloses suture and anchoring within the cranial area (see Abstract, see also paragraphs [0123] and paragraph [0139] that this suture technique is used with anchoring techniques that use bone channels, screws, and staples, see also paragraph [0124] and Abstract). Melvin teaches wherein tensioning the suture comprises passing the suture through a portion of the periosteum tissue and adjusting suspension of the portion of the periosteum tissue, and wherein the bone tissue is cranial tissue (see paragraphs [0123] and [0124], see also see also paragraph [0124] and Abstract denoting this can be the in the facial area, and see paragraph [0139] that this suture technique is used with anchoring techniques that use bone channels, screws, and staples).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention for the method of Denham, as modified by Stone, to tension the suture by passing the suture through a portion of the periosteum tissue and adjusting suspension of the portion of the periosteum tissue, and wherein the bone tissue is cranial tissue. The modification merely involves a combination of known suture tensioning methods (tensioning of Denham) and location of said method (“boney structure” of Denham, location in the human body not specified) with another suture tensioning method (tensioning the suture through passing the suture through the periosteum of Levine) and location of said method (boney structure in cranial area as taught by Levine), that yields predictable results, namely, anchoring of the device of modified Denham in the cranial area and tensioning the sutures of by threading the suture through the periosteum tissue, as Melvin teaches that it is known in the art that periosteum within the cranial area (face) can serve as a rung of strong tissue for anchoring a tissue-supporting device (see paragraph [0123] of Melvin).
Claims 17 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over US 20200214747 A1 (hereafter --Bonutti--), in view of US 20120089193 A1 (hereafter –Stone--).
Regarding Claim 17: Bonutti discloses a bone anchoring method comprising: (a) surgically exposing a bone tissue beneath a periosteum tissue (see paragraph [0314] denoting that the anchor can be inserted in a pre-drilled hole, the periosteum tissue being on the top surface of any bone structure, as periosteum tissue layers all bones); (b) forming a hole in the bone tissue (see paragraph [0314); (c) inserting an implant shaft of a bone anchor (682) into the hole formed in the bone tissue such that the shaft compresses as it is inserted into the hole to retain the bone anchor in the hole (see paragraph [0218]), wherein the bone anchor comprises: (i) an implant head comprising a lower surface and an upper surface (see annotated lower and upper surface in Figure 45 below), wherein the lower surface is flat or concave (see annotated lower surface in Figure 45 below); (ii) the implant shaft extending down from the lower surface of the implant head (see annotated shaft and head in 45 below); (iii) a through hole (688) extending laterally through the implant shaft below the implant head (see annotated through hole, shaft, head in Figure 45 below).
PNG
media_image2.png
296
563
media_image2.png
Greyscale
Bonutti fails to disclose wherein the bone anchor is made of a porous material.
Stone discloses a bone anchor (210) that is configured to connect a suture to bone (see paragraph [0049]). Stone teaches wherein the bone anchor is made of a porous material (see paragraph [0049]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing invention for the bone anchor of Bonutti to be made of a porous material, as by doing so would allow bony ingrowth of the surrounding bone into the anchor as taught by Stone (see paragraph [0049]). Additionally, it would have been obvious to one of ordinary skill in the art at the time the invention was made to use a porous material for forming the bone anchor, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding Claim 26, Bonutti as modified by Stone discloses the bone anchoring method of claim 17, further comprising, prior to implantation, impregnating the bone anchor with progenitor cells (see paragraphs [0329] and [0330]).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over US 20200214747 A1 (hereafter --Bonutti--), in view of US 20120089193 A1 (hereafter –Stone--), in even further view of US 20190269514 A1 (hereafter – Sidebotham--).
Regarding Claim 25, Bonutti as modified by Stone discloses the bone anchoring method of claim 17.
Bonutti as modified by Stone discloses wherein the material could be non-resorbable (see paragraph [0318]), but not non-resorbable and porous. Therefore, Bonutti fails to disclose wherein the porous material is a non-resorbable material.
Sidebotham discloses a bone anchor for implantation into a human bone (see Abstract). Sidebotham teaches wherein the porous material is a non-resorbable material (see paragraph [0125]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing invention for the bone anchor of Bonutti to have the porous material is a non-resorbable material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20090216252 A1: This reference discloses methods involving threading sutures through periosteal tissue.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
Prosecution Insights