Detailed Action
This is the first office action on the merits for US application number 19/126,753.
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 of Invention I, the product of claims 1-15, 17-19, and 22, in the reply filed on July 21, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s election of Species 4), Figs. 17-21, in the reply filed on July 21, 2026 is acknowledged, which indicated that claims 1-5, 13-15, 17-19, and 22 read on the elected species. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Accordingly, claims 6-12 and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
As to claim 2, the limitation of “the means for focusing bone growth comprises at least one trephine to harvest bone internally within the medical device” does not read on the elected species as there is no structure shown that appears to be reasonable to interpret as “a surgical instrument for cutting out circular sections (as of bone or corneal tissue)” (https://www.merriam-webster.com/dictionary/trephine). Further, the walls surrounding the pores harvest the autograft and act as trephines for screws 300,400,500 (¶125), i.e. Figs. 5-16 of non-elected species 1), 2), and 3). Therefore, claim 2 does not read on the elected species.
As to claim 3, the limitation of “configured in arcuate cross-section patterns varied from a proximal end to a distal tip” does not read on the elected species as there is no structure shown that appears to be reasonable to interpret as having such a pattern other than the apparent thread that does not vary from end to tip as claimed. Further, the only mention of “arcuate” relative to any specific embodiment is in a laundry list of potential features of the distal tip of pedicle screw 200,300,400,500 in paragraph 127, i.e. Figs. 5-16 of non-elected species 1), 2), and 3). Therefore, claim 3 does not read on the elected species.
Claim 4 depends from claim 3 and subsequently does not read on the elected species.
As to claim 5, the limitation of “threads having a concave profile” does not read on the elected species as there is no structure shown that appears to be reasonable to interpret as having a concavity in the threads as claimed. Further, the only mention of “concave” is in paragraphs 61 and 132 with respect to unshown and non-elected “certain embodiments” but Fig. 39 does appear to shown a surface of the threads that includes concave curvatures, i.e. Figs. 36-41 of non-elected species 6). Therefore, claim 5 does not read on the elected species.
Claim 13 depends from claim 5 and subsequently does not read on the elected species.
As to claim 22, the limitation of “threads having a concave profile” does not read on the elected species as there is no structure shown that appears to be reasonable to interpret as having a concavity in the threads as claimed. Similarly, “the threads near the proximal end are textured” does not read on the elected species as there is no structure shown that appears to be reasonable to interpret as having textured threads as claimed. Further, the only mention of “concave” is in paragraphs 61 and 132 with respect to unshown and non-elected “certain embodiments” but Fig. 39 does appear to shown a surface of the threads that includes concave curvatures, i.e. Figs. 36-41 of non-elected species 6). Similarly, “textured threads” are disclosed in paragraph 91 in reference to Fig. 36, i.e. non-elected species 6). Therefore, claim 22 does not read on the elected species.
Accordingly, claims 2-5, 13, and 22 are withdrawn from further consideration along with claims 6-12 and 21.
Information Disclosure Statement
The information disclosure statements filed May 19, 2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. Examiner notes that there were 124 NPL citations and 24 foreign patent citations included in the IDSes dated May 19, 2025; however, only 34 NPL documents and 13 foreign patent documents were received. Thus, Examiner directs Applicant to see the lined out citations on the attached copies of the IDSes for those NPL and FOR copies not received.
Examiner further notes that a copy of WO 2024/098048 was received but was not cited on an IDS.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
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:
As to claim 1, the specification appears to lack proper antecedent basis for “a scaffold in the body” in line 4. That is, the specification appears to be silent as to a description of a scaffold for the elected species, the drawings do not provide any labeling thereof, and no views have been provided to enable one to determine what is in the shown body. Further, descriptions of “scaffold” for “certain embodiments” or other embodiments do not appear to refer to any structures shown for the elect embodiment of Figs. 17-21. Paragraph 60 goes so far as to assert that “In certain embodiments, the medical device is configured for placement into an internal cavity of a vertebral body. Upon coaxial rotation of the medical device, an autograft is harvested within the scaffold.” and yet the elected embodiment is shown to have a pointed/closed tip and an unshown head and thus it does not appear that one can access or harvest anything from within the body. Further, paragraph 72 discloses porous 3-D printed scaffolds provide a particular function, but if one interprets the shown potentially porous structure in Figs. 17 and 18 as the scaffold, then there does not appear to be a lattice present as disclosed in ¶175. Thus, the specification fails to provide proper antecedent basis for “a scaffold in the body” in line 4 for the elect embodiment of Figs. 17-21. Examiner suggests amending to clarify AND identify where support can be found in the original disclosure for support of the claimed limitations or filing a CIP with a complete disclosure of the intended structure as described using consistent language between the claims and specification.
As to claim 1, the specification appears to lack proper antecedent basis for “a means for focusing bone growth” in line 4 as such does not appear to be disclosed in a manner to enable one to ascertain the intended structure and thereby the scope and equivalents thereof. That is, paragraph 58 discloses that “the means for focusing bone growth in the medical device comprises at least one trephine”; however, there is nothing described as a “trephine” for the elected embodiment, i.e. “a surgical instrument for cutting out circular sections (as of bone or corneal tissue)” (https://www.merriam-webster.com/dictionary/trephine) nor are the structures shown for the elected embodiment labeled, identified, or described. However, Fig. 17 shows that there is a pointed tip on the elected screw and therefore not a trephine in the elected embodiment and there does not appear to be an alternative definition provided. Instead, paragraph 119 discloses that “In certain embodiments, the internal core of the screw is a trephine” and paragraph 125 discloses that “Referring to FIGS. 5-16, the structure of the pedicle screw 300,400,500 …. The walls surrounding the pores harvest the autograft and act as trephines.”. However, the elected species have been described as having “Referring to FIG. 17, bone harvesting features (scoops) are located on the minor diameter of the screw. These pull bone and cells into the lattice structure as the screw is inserted.” (¶175), but none of such are labeled or identified to enable one to ascertain if the purported “scoops” are within the BRI of “pores” to enable one to ascertain if such could be reasonably interpreted the claimed scaffold or the claimed “means for focusing bone growth”. Further, the specification is silent to “a supporting framework” (https://www.merriam-webster.com/dictionary/scaffold) to enable a determination as to what is intended to be claimed or the BRI of the claim terms. Thus, the specification fails to provide proper antecedent basis for “a means for focusing bone growth” in line 4 for the elect embodiment of Figs. 17-21. Examiner is interpreting this very broadly referring to structures shown in Figs. 17-21 as can best be guessed from the figures due to the lack of description and suggests amending to clarify AND identifying where support can be found in the original disclosure for support of the claimed limitations or filing a CIP with a complete disclosure of the intended structure as described using consistent language between the claims and specification.
As to claim 14, the specification appears to lack proper antecedent basis for “configured to house one or more biologic agents” in lines 1-2. That is, the specification appears to be silent as to an elected structure being so configured and is silent as the intended structure that would provide such a function. Further, the only mention is “In certain embodiments, the medical device is configured to house one or more biologic agents, regardless of its other features.” (¶67), i.e. which is not disclosed to represent any shown or elected species. Thus, the specification fails to provide proper antecedent basis for “configured to house one or more biologic agents” in lines 1-2 for the elect embodiment of Figs. 17-21. Examiner is interpreting this very broadly referring to structures shown in Figs. 17-21 as can best be guessed from the figures due to the lack of description and suggests amending to clarify AND identifying where support can be found in the original disclosure for support of the claimed limitations or filing a CIP with a complete disclosure of the intended structure as described using consistent language between the claims and specification.
As to claim 15, the specification appears to lack proper antecedent basis for “further comprising at least one autologous product sprayed on or injected through the medical device” in lines 1-2. That is, the specification appears to be silent as to an elected structure including such a product. Further, the only mention is “In certain embodiments, the medical device further comprises at least one autologous product sprayed on or injected through the device.” (¶67), i.e. which is not disclosed to represent any shown or elected species. Thus, the specification fails to provide proper antecedent basis for “further comprising at least one autologous product sprayed on or injected through the medical device” in lines 1-2 for the elect embodiment of Figs. 17-21. Examiner is interpreting this very broadly referring to structures shown in Figs. 17-21 as can best be guessed from the figures due to the lack of description and suggests amending to clarify AND identifying where support can be found in the original disclosure for support of the claimed limitations or filing a CIP with a complete disclosure of the intended structure as described using consistent language between the claims and specification.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(1) because Figs. 17-21 include no reference character(s) to identify the structures that appear to be shown.
The drawings are objected to because Fig. 17 has a region labeled as an area “without bone harvesting features” and well as “bone harvesting features” where the structure labeled as “bone harvesting features” is clearly present in the area “without bone harvesting features”.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “bone harvesting features” has been used to designate both on structure in Fig. 18 and another structure in Fig. 19.
The drawings are objected to because Fig. 20 has a region labeled as “ramp feature” that shows no evidence of a ramp or slope”.
The drawings are objected to because Fig. 20 has a region labeled as “bone harvesting feature at the leading edge of each opening….” that shows no evidence of an opening or a structural feature beyond a potential surface.
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 “a scaffold in the body” of claim 1 line 3, “disposed on the body, a means for focusing bone growth” of claim 1 line 4, “configured to house one or more biologic agents” of claim 14 lines 1-2, “further comprising at least one autologous product sprayed on or injected through the medical device” of claim 15 lines 1-2 must be shown or the feature(s) canceled from the claim(s). 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.
Claim Objections
Claim(s) 17 is/are objected to because of the following informalities:
Claim 17 should read “The medical device of claim 6.
Appropriate correction is required.
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.
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(s) 1, 14, 15, and 17-19 is/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 pre-AIA the applicant regards as the invention.
Claim(s) 1 is/are unclear with regards to “a means for focusing bone growth” in line 4 as such does not appear to be disclosed in a manner to enable one to ascertain the intended structure and thereby the scope and equivalents thereof. That is, paragraph 58 discloses that “the means for focusing bone growth in the medical device comprises at least one trephine”; however, there is nothing described as a “trephine” for the elected embodiment, i.e. “a surgical instrument for cutting out circular sections (as of bone or corneal tissue)” (https://www.merriam-webster.com/dictionary/trephine) nor are the structures shown for the elected embodiment labeled, identified, or described. However, Fig. 17 shows that there is a pointed tip on the elected screw and therefore not a trephine in the elected embodiment and there does not appear to be an alternative definition provided. Instead, paragraph 119 discloses that “In certain embodiments, the internal core of the screw is a trephine” and paragraph 125 discloses that “Referring to FIGS. 5-16, the structure of the pedicle screw 300,400,500 …. The walls surrounding the pores harvest the autograft and act as trephines.”. However, the elected species have been described as having “Referring to FIG. 17, bone harvesting features (scoops) are located on the minor diameter of the screw. These pull bone and cells into the lattice structure as the screw is inserted.” (¶175), but none of such are labeled or identified to enable one to ascertain if the purported “scoops” are within the BRI of “pores” to enable one to ascertain if such could be reasonably interpreted the claimed scaffold or the claimed “means for focusing bone growth”. Further, the specification is silent to “a supporting framework” (https://www.merriam-webster.com/dictionary/scaffold) to enable a determination as to what is intended to be claimed or the BRI of the claim terms. Examiner is interpreting this very broadly referring to structures shown in Figs. 17-21 as can best be guessed from the figures due to the lack of description and suggests amending to clarify AND identifying where support can be found in the original disclosure for support of the claimed limitations or filing a CIP with a complete disclosure of the intended structure as described using consistent language between the claims and specification.
Claim(s) 14 is/are unclear with regards to “configured to house one or more biologic agents” in lines 1-2 and the missing word prior to this phrase that would identify what structure is so configured. Nonetheless, the specification appears to be silent as to an elected structure being so configured and is silent as the intended structure that would provide such a function. Further, the only mention is “In certain embodiments, the medical device is configured to house one or more biologic agents, regardless of its other features.” (¶67), i.e. which is not disclosed to represent any shown or elected species. Examiner is interpreting this very broadly referring to structures shown in Figs. 17-21 as can best be guessed from the figures due to the lack of description and suggests amending to clarify AND identifying where support can be found in the original disclosure for support of the claimed limitations or filing a CIP with a complete disclosure of the intended structure as described using consistent language between the claims and specification.
Claim(s) 18 is/are unclear with regards to “having reduced one or more of screw loosening, screw backout, rod breakage, and lowered bone mineral density” in lines 1-2 and the missing word prior to this phrase that would identify what structure is so configured as well as to what such is being compared, how such could reasonably reduce rod breakage for an unclaimed an unshown rod, and to what is intended to be claimed by “bone mineral density” and if this is intended to refer to a human body as prohibited under 35 USC 101. Examiner is interpreting this as referring to, and suggests amending as, “The medical device of claim 17[[,]] having reduced one or more of screw loosening[[,]] and screw backout,
Claim(s) 15, 17, and 19 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for its/their dependence on one or more rejected base claims.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 14, 17, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shen et al. (US 2022/0175432, hereinafter “Shen”).
As to claim 1, Shen discloses a medical device (400, Figs. 8-13, ¶37; where ¶37 discloses that 400 differs from 300 as described) comprising: a body (400); a scaffold (320) in the body (Figs. 8-13, ¶s 31, 32, 35, and 37); and disposed on the body, a means for focusing bone growth throughout the body (240, Fig. 13) capable of minimizing shear stresses on a distal tip and spreading micromotion throughout the medical device to encourage bony ingrowth (due to the shown structure, Fig. 13, ¶29 discloses that 240 can avoid the stress shielding effect and have an osseointegration effect to induce the growth of bone cells and promotes bone ingrowth).
As to claim 14, Shen discloses that the device is capable of housing one or more biologic agents (due to the void/channel as shown in Fig. 9, Fig. 9).
As to claim 17, Shen discloses that the device is a bone screw (¶37).
As to claim 18, Shen discloses that the device has reduced one or more of screw loosening and screw backout (¶29 discloses that 240 achieves fixation and osseointegration).
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 of this title, 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) 15 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shen in view of Sutika (US 2019/0262048).
As to claim 15, Shen discloses the invention of claim 1.
Shen is silent to that the device further comprises at least one autologous product sprayed on or injected through the medical device.
Sutika teaches a similar medical device (30, Figs. 1A-5) comprising: a body (Figs. 1A-5) and comprises at least one autologous product (¶45) sprayed on or injected through the medical device (¶45).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the medical device as disclosed by Shen be adding the autologous product as taught by Sutika in order to promote bony ingrowth to enhance new bone growth and rapid fusion with bone (Sutika ¶45).
As to claim 19, Shen discloses the invention of claim 17.
Shen is silent to that the device comprising a fluted tip.
Sutika teaches a similar medical device (30, Figs. 1A-5) comprising: a body (Figs. 1A-5) and comprises a fluted tip (46, Figs. 1A-4, ¶52).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the medical device as disclosed by Shen be adding flutes to the tip as taught by Sutika in order to cut bone to facilitate insertion of the screw (Sutika ¶52).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY R SIPP/Primary Examiner, Art Unit 3775
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