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 .
Drawings
The replacement drawings filed 12/10/25 have not been entered as they contain new matter.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “the notch” and the “at least one recessed portion” of the first coupling mechanism (in Claim 24), must be shown or the feature(s) canceled from the claim(s). If the newly added claimed feature(s) are not properly depicted in the original drawings or disclosed in the original disclosure, they cannot be added to the drawings as no new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Specification
The specification amendment filed 12/10/25 has not been entered as it contains new matter.
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 disclose the claimed term “tab”, or “extension”, regarding the insertion members second coupling mechanism of any embodiment. The specification also does not disclose that the first coupling mechanism comprises “a notch”, or wherein “the first coupling mechanism comprises at least one recessed portion configured to accept the insertion of a complementary second coupling mechanism comprising at least one rounded extension”. If the newly added claimed feature(s) are not properly depicted in the original drawings or disclosed in the original disclosure, they cannot be added to the specification as no new matter should be entered. Appropriate correction is required.
Claim Objections
Claim 21 is objected to because of the following informalities and should be amended as follows in order to keep the terminology consistent throughout: “21. (Currently amended) The system of claim 20, wherein the second coupling mechanism comprises two tabs, and wherein the second coupling mechanism further comprises two extensions configured to be compressed or pinched to disengage the second coupling mechanism from the first coupling mechanism, wherein each extension comprises one of the two tabs.” Appropriate correction is required.
Claim 24 is objected to because of the following informalities: In Line 22, the word --the-- should be added before the words “medical device”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 4, 14, 24, 25 & 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 4 recites “wherein the first coupling mechanism comprises a notch” which seeks to introduce new matter as, based on the Applicant’s arguments in the response filed on 05/15/25 the insertion member 502 from Figs. 5-6 is the embodiment which is now being recited, the interbody spacer engaged with insertion member 520 is not clearly depicted in Figs. 5-6 and none of the other spacer embodiments are depicted having a notch which is complementary to the tab(s) of 520 depicted in Fig. 6. Appropriate correction is required.
Claim 14 recites “wherein the first coupling mechanism comprises a notch” which seeks to introduce new matter as, based on the Applicant’s arguments in the response filed on 05/15/25 the insertion member 502 from Figs. 5-6 is the embodiment which is now being recited, the interbody spacer engaged with insertion member 520 is not clearly depicted in Figs. 5-6 and none of the other spacer embodiments are depicted having a notch which is complementary to the tab(s) of 520 depicted in Fig. 6. Furthermore, since the specification does not disclose this limitation there is no support in the disclosure for this newly added limitation. Appropriate correction is required.
Claim 24 at Lines 13-16 recites “the first coupling mechanism comprises at least one recessed portion configured to accept the insertion of a complementary second coupling mechanism comprising at least one rounded extension,” which seeks to introduce new matter as, based on the Applicant’s arguments in the response filed on 05/15/25 the insertion member 502 from Figs. 5-6 is the embodiment which is now being recited, the interbody spacer engaged with insertion member 520 is not clearly depicted in Figs. 5-6 and none of the other spacer embodiments are depicted having at least one recessed portion which is complementary to the tab(s) of 520 depicted in Fig. 6. Furthermore, since the specification does not disclose this limitation there is no support in the disclosure for this newly added limitation. Appropriate correction is required.
Claim 25 recites “wherein the first coupling mechanism comprises at least one edge at an inside portion of the interbody spacer.” which seeks to introduce new matter as, based on the Applicant’s arguments in the response filed on 05/15/25 the insertion member 502 from Figs. 5-6 is the embodiment which is now being recited, the interbody spacer engaged with insertion member 520 is not clearly depicted in Figs. 5-6 and thus at least one edge at an inside portion of the interbody spacer is not shown. Furthermore, since the specification does not disclose this limitation there is no support in the disclosure for this newly added limitation. Appropriate correction is required.
Claim 26 recites “wherein the tab comprises a flexible extension coupled to the insertion member, wherein the flexible extension is configured to be compressed or pinched to disengage the insertion member from an edge at the inside portion of the interbody spacer.” which seeks to introduce new matter as the specification does not disclose a tab comprising a flexible extension coupled to the insertion member, or the word "flexible" at all, and although the drawings depict tab structures and extensions depicted in Fig. 6, the specification does not disclose that the extensions are flexible. It is suggested that Claim 26 be amended similarly to Claim 8. Appropriate correction is required.
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 24 & 26 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 24 at Lines 12-16 recites “wherein: the first coupling mechanism comprises at least one recessed portion configured to accept the insertion of a complementary second coupling mechanism comprising at least one rounded extension,” which renders the claim indefinite as it is unclear if the recited “a complementary second coupling mechanism” is the same as the second coupling mechanism previously recited in Line 5, or something else. For purposes of examination, the complementary second coupling mechanism is being interpreted as being the same as previously recited in Line 5, specifically “wherein: the first coupling mechanism comprises at least one recessed portion configured to accept the insertion of at least one rounded extension of the second coupling mechanism
Claim 26 at Lines 1-2 recites “wherein the tab comprises a flexible extension coupled to the insertion member,” which renders the claim indefinite as:
it is unclear which tab is being referred to since Claim 5, from which claim 8 depends, previously recites that the second coupling mechanism comprises two tabs.
It is unclear, based on the Applicant's arguments in the response filed on 05/15/25 the insertion member 502 from Figs. 5-6 is the embodiment which is now being recited, if the insertion member comprises the second coupling mechanism, how the tab further comprises a flexible extension coupled to the insertion member. It appears that the insertion member itself as a whole comprises two extensions which each comprises a protrusion or "tab" as recited, and thus each extension is not coupled to the insertion member but a part of the insertion member. For purposes of examination, the claim is being interpreted as "wherein the second coupling mechanism further comprises two extensions configured to be compressed or pinched to disengage the insertion member from an edge at the inside portion of the interbody spacer, wherein each extension comprises one of the two tabs." Appropriate correction is required.
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, 4, 6, 9, 11-14, 16-18, 20 & 22-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Petersheim et al. (US PG Pub No. 2013/0060337).
Regarding Claims 1, 4, 22 & 25, Petersheim et al. discloses a system (10, 100, 300, 400, 500, Figs. 10 & 14, Paragraphs [0077-0086]) comprising: an interbody spacer (10, Fig. 10, Paragraphs [0078-0079]) having a first coupling mechanism (notch 32, Fig. 11 & 14, Paragraph [0079, 0087]); a medical device plate (100, Fig. 10) comprising an opening (non-circular central hole 104, Fig. 10) having a non-circular cross section; and an insertion member (400 & 500, Fig. 10, Paragraphs [0082, 0085-0086]) comprising a non-threaded second coupling mechanism (pressure press fit end portion 419, Fig. 11, Paragraph [0087]) and a body (shaft portion 402, Fig. 11), wherein the body includes a proximal end (smooth cylindrical portion of 402 adjacent 408, Fig. 11) and a distal end (free tip portion of 419, Fig. 11), the distal end of the body positioned adjacent to the second coupling mechanism (Fig. 11), wherein the body comprises a non-circular cross section corresponding to the opening of the medical device plate (non-circular polygonal portion between 419 and 408 which is inserted into non-circular central hole 104 of 100, Fig. 11, Paragraph [0085]), wherein the non-circular cross section of the body is configured to accept the medical device plate and the medical device plate is configured to slide over the insertion member and operably connect to the interbody spacer (the polygonal portion of 402 between 419 and 408 corresponds in shape to the non-circular central hole 104 (e.g. square or rectangular and/or with edges) to prevent rotation of the plate as it travels along the insertion member 400, and via sliding 100 via the hole 104 along shaft portion 402 towards spacer 10, Fig. 11, Paragraphs [0085-0086]), wherein: the first coupling mechanism is a notch comprising at least one edge at an inside of the interbody spacer (notch 32, Fig. 11 & 14, Paragraph [0079]) and the second coupling mechanism is a complementary tab (pressure-fit front section of 419 for connecting to 32, Fig. 11, Paragraph [0087]); the interbody spacer is configured to be inserted between adjacent vertebrae of a spinal column (Paragraph [0085]); the insertion member is configured to be connected to the interbody spacer by mating of the first coupling mechanism and the second coupling mechanism (Paragraph [0087]); and after the medical device plate is connected to the at least one vertebra adjacent to the interbody spacer, the insertion member is configured to be detached from the interbody spacer and the medical device plate at the first coupling mechanism and the second coupling mechanism (Paragraphs [0085, 0087 & 0094).
Regarding Claim 6, Petersheim et al. discloses wherein the medical device plate is configured to be attached to at least one vertebrae with at least one screw (fasteners 300, Fig. 10, Paragraphs [0077, 0081]).
Regarding Claim 9, Petersheim et al. discloses wherein the interbody spacer is configured to be at least one of a cervical, thoracic or lumbar spacer (Spacer 10 is for use in vertebral fusion where the spacer is inserted into a disc space, Paragraphs [0012-0013, 0049]. Thus the spacer is fully and structurally capable of being inserted into the cervical, thoracic and lumbar portion of the spine.).
Regarding Claims 11-14, Petersheim et al. discloses a method (Paragraphs [0085-0086]) comprising: inserting an interbody spacer (10, Fig. 10, Paragraphs [0078- 0079]) between adjacent vertebrae of a spinal column, the interbody spacer having a first coupling mechanism comprising a notch (notch 32, Fig. 11 & 14, Paragraph [0079, 0087]); operably connecting an insertion member (400 & 500, Fig. 10, Paragraphs [0085-0086)]) to the interbody spacer (via inserting pressure press-fit end portion 419 into 32, Paragraph [0087]), the insertion member comprising a body (shaft portion 402, Fig. 11, Paragraph [0082]) and a non-threaded second coupling mechanism comprising a tab (pressure-fit front section of 419 for connecting to 32, Fig. 11, Paragraph [0087]) complementary to the first coupling mechanism, wherein the body includes a proximal end (smooth cylindrical portion of 402 adjacent 408, Fig. 11) and a distal end (free tip portion of 419, Fig. 11), the distal end of the body positioned adjacent to the second coupling mechanism (Fig. 11), wherein the body comprises a non-circular cross section (non-circular polygonal portion between 419 and 408 which is inserted into non-circular central hole 104 of 100, Fig. 11, Paragraph [0085]); sliding a medical device plate (100, Fig. 10) having an opening (non-circular central hole 104, Fig. 11) comprising a non-circular cross section corresponding to the non-circular cross section of the body along the body of the insertion member from the proximal end toward the distal end to position the medical device plate over the interbody spacer (non-circular polygonal portion of 402 which is inserted into non-circular central hole 104, Fig. 11, Paragraphs [0085-0087]); the non-circular cross section of the body preventing rotation of the medical device plate when the medical device plate is adjacent to the interbody spacer (the polygonal portion of 402 between 419 and 408 corresponds in shape to the non-circular central hole 104 (e.g. square or rectangular and/or with edges) to minimize rotation of the plate as it travels along the insertion member 400, Fig. 11, Paragraphs [0085-0087]); the medical device plate self-aligning at the adjacent vertebra via alignment of the opening of the medical device plate with the non-circular cross section of the body and the sliding (the polygonal portion of 402 between 419 and 408 corresponds in shape to the non-circular central hole 104 (e.g. square or rectangular and/or with edges) to minimize rotation of the plate as it travels along the insertion member 400, Fig. 11, Paragraphs [0085-0087]); attaching the medical device plate to the adjacent vertebra (via fasteners 300, Paragraphs [0085-0086]); and detaching the insertion member from the interbody spacer (Paragraph [0094]); wherein the insertion member is operably shaped to receive the medical device plate (Figs 10-11), and wherein the insertion member is operably shaped to receive the interbody spacer (Figs. 10-11).
Regarding Claim 16, Petersheim et al. discloses wherein the medical device plate is configured to be attached to at least one vertebrae with at least one screw (fasteners 300, Fig. 10, Paragraphs [0077, 0081]).
Regarding Claim 17, Petersheim et al. discloses removing the insertion member from the opening (non-circular hole 104, Fig. 11, Paragraphs [0081, 0085]) in the medical device plate; exposing the opening in the medical device plate (when the insertion member is removed from the hole 104 of the plate 100, the hole 104 is exposed. Paragraph [0094]); and attaching the medical device plate to at least one vertebrae of the adjacent vertebrae at the exposed opening (The plate 100 is attached at and around the hole 104 along the vertebrae in the same manner as the instant application via fasteners 300 inserted into holes 101, Fig. 11).
Regarding Claim 18, Petersheim et al. discloses wherein the interbody spacer is configured to be at least one of a cervical, thoracic or lumbar spacer (Spacer 10 is for use in vertebral fusion where the spacer is inserted into a disc space, Paragraphs [0012-0013, 0049]. Thus the spacer is fully and structurally capable of being inserted into the cervical, thoracic and lumbar portion of the spine.).
Regarding Claims 20 & 23, Petersheim et al. discloses a system (10, 100, 300, 400, 500, Figs. 10 & 14, Paragraphs [0077-0086]) comprising: an interosseous spacer (10, Fig. 10, Paragraphs [0078-0079]) having a first coupling mechanism (notch 32, Fig. 14, Paragraphs [0079 & 0087]), the interosseous spacer configured to be inserted between two or more bone elements of a spinal column (Paragraph [0085]); a medical device plate (100, Fig. 10) comprising an opening (non-circular central hole 104, Fig. 10) having a non-circular cross section; and an insertion member (400 & 500, Fig. 11, Paragraphs [0082, 0085-0087]) comprising a body (shaft portion 402, Fig. 11, Paragraph [0082]) and a non-threaded second coupling mechanism comprising a tab (pressure press fit end portion 419, Fig. 11, Paragraph [0087]) complementary to the first coupling mechanism, wherein the body includes a proximal end (smooth cylindrical portion of 402 adjacent 408, Fig. 11) and a distal end (free tip portion of 419, Fig. 11), the distal end of the body positioned adjacent to the second coupling mechanism (Fig. 11), wherein the body comprises a non-circular cross section corresponding to the opening of the medical device plate (non-circular polygonal portion between 419 and 408 which is inserted into non-circular central hole 104, Fig. 11, Paragraph [0085]), wherein the non-circular cross section of the body is configured to accept the medical device plate and the medical device plate is configured to slide over the insertion member, operably connect to the interbody spacer and align with the two or more bone elements (the polygonal portion of 402 between 419 and 408 corresponds in shape to the non-circular central hole 104 (e.g. square or rectangular and/or with edges) to prevent rotation of the plate as it travels along the insertion member 400, and via sliding 100 via the hole 104 along shaft portion 402 towards spacer 10, Fig. 11, Paragraphs [0085-0087]), wherein: the first coupling mechanism is a notch (notch 32, Fig. 11 & 14, Paragraph [0079, 0087]) and the second coupling mechanism is a complementary male coupling mechanism (pressure press fit end portion 419, Fig. 11, Paragraph [0087]); the insertion member is configured to be connected to the interosseous spacer by mating of the first coupling mechanism and the second coupling mechanism (Fig. 11); and after the medical device plate is connected to the two or more bone elements, the insertion member is configured to be detached from the interosseous spacer and the medical device plate at the first coupling mechanism and the second coupling mechanism (Paragraphs [0085 & 0094]).
Regarding Claim 24 as best understood, Petersheim et al. discloses a system (10, 100, 300, 400, 500, Figs. 10 & 14, Paragraphs [0077-0086]) comprising: an interbody spacer (10, Fig. 10, Paragraphs [0078-0079]) having a first coupling mechanism (notch 32, Fig. 14, Paragraphs [0079 & 0087]); a medical device plate (100, Fig. 10) comprising an opening having a non-circular cross section (non-circular central hole 104, Fig. 10); and an insertion member (400 & 500, Fig. 10, Paragraphs [0082, 0085-0086]) comprising a body (shaft portion 402, Fig. 10, Paragraph [0082]) and a non-threaded second coupling mechanism (pressure press fit end portion 419, Fig. 11, Paragraph [0087]), wherein the body includes a proximal end (smooth cylindrical portion of 402 adjacent 408, Fig. 11) and a distal end (free tip portion of 419, Fig. 11), the distal end of the body positioned adjacent to the second coupling mechanism (Fig. 11), wherein the body comprises a non-circular cross section corresponding to the opening of the medical device plate (non-circular polygonal portion between 419 and 408 which is inserted into non-circular central hole 104, Fig. 11, Paragraph [0085]), wherein the non-circular cross section of the body is configured to accept the medical device plate and the medical device plate is configured to slide over the insertion member and operably connect to the interbody spacer (the polygonal portion of 402 between 419 and 408 corresponds in shape to the non-circular central hole 104 (e.g. square or rectangular and/or with edges) to prevent rotation of the plate as it travels along the insertion member 400, and via sliding 100 via the hole 104 along shaft portion 402 towards spacer 10, Fig. 11, Paragraphs [0085-0087]), wherein: the first coupling mechanism comprises a recessed portion (32, Fig. 11) configured to accept a rounded extension of the second coupling mechanism (rounded corners of 419 to pressure fit the rounded corners of 32, Figs. 11 & 14), the interbody spacer is configured to be inserted between adjacent vertebrae of a spinal column (Paragraph [0085]), the insertion member is configured to be connected to the interbody spacer by mating of the first coupling mechanism and the second coupling mechanism (Fig. 11), and after the medical device plate is attached to the adjacent vertebrae, the insertion member is configured to be detached from the interbody spacer and medical device plate at the first coupling mechanism and the second coupling mechanism (Paragraphs [0085 & 0094).
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.
Claim(s) 7, 10 & 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petersheim et al. (US PG Pub No. 2013/0060337) in view of Keegan et al. (US PG Pub No. 2012/0136392).
Regarding Claim 7, Petersheim et al. discloses the claimed invention as stated above, except wherein the interbody spacer is at least one of a plastic, ceramic, metal, autograft, or allograft spacer. Petersheim et al. does not disclose what material the spacer is made from.
Keegan et al. discloses a system and method for stabilizing vertebra in a spine (Abstract, Fig. 14), wherein the system comprises a spacer (18, Figs. 10-11) for insertion into a disc space, a bone plate (220, Fig. 12) configured to be attached to the spacer and to adjacent vertebrae via fasteners (62, Fig. 14), and an insertion device (222) for inserting the space and bone plate into a disc space (Figs. 13A-13B), wherein “the spacer 18 may be formed from a range of biocompatible materials, such as metals, including stainless steel and titanium, polymers, such as polyether ether ketone (PEEK), composite materials, allograft bone, or the like.” (Paragraph [0033).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the spacer of the system of Petersheim et al. to comprise stainless steel, titanium, PEEK, or allograft bone as taught by Keegan et al. in order to provide a spacer made from a well-known and commonly used implant material that is known to be durable and extremely biocompatible.
Regarding Claims 10 & 19, Petersheim et al. discloses the claimed invention as stated above in claims 1 & 11, except wherein the medical device plate is in contact with a plurality of interbody spacers simultaneously to attach the medical device plate to a plurality of vertebrae adjacent to the plurality of interbody spacers.
Petersheim et al. does disclose in Paragraph [0048] that “When a single device or article is described herein, it will be readily apparent that more than one device or article may be used in place of a single device or article. Similarly, where more than one device or article is described herein, it will be readily apparent that a single device or article may be used in place of the more than one device or article.”
Keegan et al. discloses in Paragraph [0050] that “The system 10 may alternatively utilize a single two-level plate as would be apparent to one having ordinary skill in the art.” One having ordinary skill in the art would recognize that a two-level plate is one plate attached with two spacers placed at two adjacent levels of a vertebral column.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system and method of Petersheim et al. to include two spacers, where the plate is in contact with the two spacers simultaneously to attach the plate with a plurality of vertebrae as taught by Keegan et al. in order to allow multiple adjacent disc spaces of the vertebral column that need to be treated to be stabilized by a single system during the same procedure.
Response to Arguments
Applicant’s amendments, filed on 12/10/25, have overcome the objections to claims 1, 20 & the Line 14 objection of claim 24.
Applicant’s amendments, filed on 12/10/25, have overcome the 112(b) rejections for claims 8, 21 & 24. The newly amended claims include a change in scope and bring about further 112(b) rejection for claim 24 as seen in the office action above.
In regards to the Applicant’s argument with respect to the drawing objection and the filing of new/replacement drawings on 12/10/25: The drawings have not been entered as they contain new matter. There is no support in the original disclosure for the first coupling mechanism of the interbody spacer being “a notch” which corresponds with “at least one tab” of the second coupling mechanism of the insertion member, specifically with respect to the insertion member embodiment 502 depicted in originally filed Figs. 5-6. The spacer is not clearly depicted in Fig. 5 and since a female coupling mechanism is not inherently a notch, a notch cannot be added to the drawings without adding new matter.
In regards to the Applicant’s argument with respect to the specification objection and the filing of a specification amendment on 12/10/25: The specification amendment has not been entered as it contains new matter. There is no support in the original disclosure for the first coupling mechanism of the interbody spacer being “one or more notches positioned in the opening 516 of an inside portion of the interbody spacer” which corresponds with “at least one tab” of the second coupling mechanism of the insertion member, specifically with respect to the insertion member embodiment 502 depicted in originally filed Figs. 5-6. The spacer is not clearly depicted in Fig. 5 and since a female coupling mechanism is not inherently a notch/notches within an opening, a notch/notches cannot be added to the specification without adding new matter.
In regards to the Applicant’s arguments, filed 12/10/25, with respect to the 112(a) rejection of claims 4 & 14 and the contention that “Because Fig. 5 depicts the male coupling mechanism as a tab, the female coupling mechanism must necessarily be a notch that corresponds to the tab”: As stated above, there is no support in the original disclosure for the first coupling mechanism of the interbody spacer being “a notch” which corresponds with “at least one tab” of the second coupling mechanism of the insertion member, specifically with respect to the insertion member embodiment 502 depicted in originally filed Figs. 5-6. The spacer is not clearly depicted in Fig. 5 and since a female coupling mechanism is not inherently a notch, a notch cannot be added to the drawings without adding new matter. A tab, specifically the tabs shown in Fig. 6, could correspondingly engage with an aperture or another type of female coupling mechanism instead of a notch and thus a notch is not necessarily the female coupling structure that corresponds to the tab. Thus, the 112(a) rejection is upheld as seen above and the Applicant’s argument is not persuasive
In regards to Applicant’s arguments, filed on 12/10/25, with respect to the Petersheim 102(a)(1) rejection of independent claims 1, 11, 20 & 24: The Applicant’s arguments have been fully considered but are moot in view of the new grounds of rejection based on the newly amended claims, using a new interpretation of Petersheim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WEISS/Primary Examiner, Art Unit 3775