Prosecution Insights
Last updated: October 04, 2026
Application No. 19/183,896

ALIGNMENT GUIDES, CUT GUIDES, SYSTEMS AND METHODS OF USE AND ASSEMBLY

Non-Final OA §101§102§112§DP
Filed
Apr 20, 2025
Priority
Dec 06, 2017 — provisional 62/595,155 +4 more
Examiner
GIBSON, ERIC SHANE
Art Unit
Tech Center
Assignee
Paragon 28 Inc.
OA Round
1 (Non-Final)
85%
Grant Probability
Favorable
1-2
OA Rounds
10m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 85% — above average
85%
Career Allowance Rate
761 granted / 891 resolved
+25.4% vs TC avg
Strong +17% interview lift
Without
With
+17.2%
Interview Lift
resolved cases with interview
Typical timeline
2y 3m
Avg Prosecution
23 currently pending
Career history
908
Total Applications
across all art units

Statute-Specific Performance

§101
6.2%
-33.8% vs TC avg
§103
28.6%
-11.4% vs TC avg
§102
21.8%
-18.2% vs TC avg
§112
31.6%
-8.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 891 resolved cases

Office Action

§101 §102 §112 §DP
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 . Claim Objections Claims 16 and 20 are objected to because of the following informalities: Claim 16, line 6: “a” (between “from” and “bottom”) should be changed to --the--. Claim 20, line 2: “the” (between “obtaining” and “cut”) should be changed to --the--. Claim 20, line 3: “a” (before “base”) should be changed to --the--. Claim 20, line 4: “an” (before “extension”) should be changed to --the--. Claim 20, line 4: “a” (between “from” and “bottom”) should be changed to --the--. Claim 20, line 6: --the-- should be added before “at”. Claim 20, line 6: “an” (between “from” and “end”) should be changed to --the--. 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. 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: position rotation device in claim 15. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 20 recites the limitation "the orientation" in line 10. There is insufficient antecedent basis for this limitation in the claim. Claim 20 recites the limitation "the desired correction" in line 19. There is insufficient antecedent basis for this limitation in the claim. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 17 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 17 recites “further comprising at least one arm extending away from an end of the base portion,” wherein such limitations are previously recited in line 7 of claim 16; therefore, claim 17 fails to further limit the subject matter of the claim 16 upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. 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) 1-7 and 9-19 are is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Bays et al., U.S. PG-Pub 2017/0079669. Regarding claim 1, Bays et al. discloses a system, comprising: a cut guide, wherein the cut guide comprises a base portion (16); an extension member extending away from a bottom surface of the base portion; and at least one arm (40 or 42) extending away from an end of the base portion; and an alignment guide (80) configured to releasably engage with the cut guide (examiner annotated Fig. 1 below and Fig. 6A). PNG media_image1.png 662 466 media_image1.png Greyscale Regarding claims 2-5, Bays et al. discloses wherein the base portion (16) of the cut guide comprises four slots positioned on or between a first end of the base portion and a second end of the base portion and extending between a first side of the base portion and a second side of the base portion; and wherein the alignment guide (80) is configured to removably engage with at least one slot such that the alignment guide is releasably coupled with the cut guide (examiner annotated Fig. 6A below). PNG media_image2.png 571 508 media_image2.png Greyscale Regarding claims 6 and 7, Bays et al. discloses wherein at least one slot is angled as it extends from the second side to the first side of the base portion (16); and wherein at least one slot is angled as it extends from a top surface through the bottom surface of the base portion (paragraph [0032]). Regarding claims 9-13, Bays et al. discloses wherein the at least one arm comprises: a first arm (40) extending away from a first end of the base portion; and a second arm (42) extending away from a second end of the base portion; wherein the first and second arms are tapered bodies (tapered on the top and where attached to base portion 16) with first ends coupled to the first and second ends of the base portion, respectively, and a second end; each arm having a first/third opening respectively (openings that 46 and 48 extend through) positioned near the second ends of the tapered bodies; and a second/fourth opening respectively (44 on each arm) positioned near the second ends of the tapered bodies and spaced apart from the first/third openings; wherein the first/third openings extend through the first and second arms from a top surface through a bottom surface of the arms and extend parallel to the extension member; and wherein the second/fourth openings extend through the first and second arms from the top surface through the bottom surface of each arm and is angled relative to the extension member (examiner annotated Fig. 1 above). Regarding claims 14 and 15, Bays et al. discloses wherein the base portion (16) further comprises a recessed region extending into the base portion from the bottom surface toward a top surface of the base portion (examiner annotated Fig. 1 above); and the system further comprises a position rotation device (410) (Fig. 4B). Regarding claim 16 and 17, Bays et al. discloses a cut guide, comprising: a base portion (16) comprising at least one slot (26 or 28) extending between a first side and a second side of the base portion, wherein at least one slot is angled as it extends form a top surface through to a bottom surface of the base portion; an extension member extending away from the bottom surface of the base portion; at least one arm (40) extending away from an end of the base portion; and a recessed region extending into the base portion from the bottom surface and toward a top surface of the base portion (examiner annotated Fig. 1 above and paragraph [0032]). Regarding claim 18, Bays et al. discloses wherein the at least one arm further comprises: a first arm (40) extending away from a first end of the base portion; and a second arm (42) extending away from a second end of the base portion; wherein the first and second arms are tapered bodies (tapered on the top and where attached to base portion 16) with first ends coupled to the first and second ends of the base portion, respectively, and a second end; each arm having a first/third opening respectively (openings that 46 and 48 extend through) positioned near the second ends of the tapered bodies; and a second/fourth opening respectively (44 on each arm) positioned near the second ends of the tapered bodies and spaced apart from the first openings (examiner annotated Fig. 1 above). Regarding claim 19, Bays et al. discloses a cut guide, comprising: a base portion (16); an extension member extending away from a bottom surface of the base portion; at least one arm (40 or 42) extending away from an end of the base portion; and at least one slot (26 or 28) disposed on the base portion configured to removably engage with an alignment guide (examiner annotated Fig. 1 above). Double Patenting A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957). A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101. Claim 8 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of prior U.S. Patent No. 11,696,767. This is a statutory double patenting rejection. Claim 8 recites A guide system, comprising: “a cut guide, wherein the guide comprises:” (see claim 1 line 2 of the patent) “a base portion;” (see claim 1 line 3 of the patent) “an extension member extending away form a bottom surface of the base portion;” (see claim 1 lines 5-6 of the patent) and “at least one arm extending away from an end of the base portion;” (see claim 1 lines 9-10 of the patent) and “an alignment guide configured to releasably engage with the cut guide” (see claim 1 lines 11-12 of the patent), “wherein the base portion further comprises: a hole extending into the base portion from the top surface” (see claim 1 lines 3-5 of the patent), and “wherein the hole extends into the extension member” (see claim 1 lines 7-8 of the patent). It appears claim 1 of the patent is coextensive in scope with claim 8 of the application. Claim 20 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 20 of prior U.S. Patent No. 10,856,886. This is a statutory double patenting rejection. Claim 20 of the application recites A method for using the guide system of claim 1, comprising: “obtaining a cut guide, wherein the cut guide comprises:” (see claim 20 line 2 of the patent) “a base portion” (see claim 20 line 3 of the patent), “an extension member extending away from a bottom surface of the base portion” (see claim 20 lines 4-5 of the patent), “at least one arm extending away from an end of the base portion” (see claim 20 lines 6-7 of the patent), “inserting the extension member into a joint space” (see claim 20 line 8 of the patent), “coupling the alignment guide to the cut guide” (see claim 20 line 9 of the patent), “inserting a direction wire into at least one opening in the alignment guide” (see claim 20 lines 10-11), “inserting a first wire into a hole in the cut guide and check the orientation of the cut guide” (see claim 20 lines 12-13 of the patent), “inserting at least two second wires through the at least one arm of the cut guide and into the at least one bone” (see claim 20 lines 14-15 of the patent), “removing the alignment guide and first wire” (see claim 20 line 16 of the patent), “cutting at least one of a first bone and a second bone using at least one slot of the cut guide” (see claim 20 lines 17-18 of the patent), “removing at least one of the at least two second wire from the at least one bone and the cut guide” (see claim 20 lines 19-20 of the patent), “moving the first and second bone to the desired correction” (see claim 20 line 21 of the patent). It appears claim 20 of the patent is coextensive in scope with claim 20 of the application. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp. For the below non-statutory double patent rejection, like-elements will be bolded and additional element will not be bolded. Claims 1-7, 9-11 and 14-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 13-16 of U.S. Patent No. 11,696,767. Although the claims at issue are not identical, they are not patentably distinct from each other because: Regarding claim 1 of the application, claim1 of U.S. Patent No 11,696,767 recites “A guide system, comprising: a cut guide, wherein the cut guide comprises: a base portion, wherein the base portion further comprises: a hole extending into the base portion from a top surface; an extension member extending away from a bottom surface of the base portion, wherein the hole extends into the extension member; and at least one arm extending away from an end of the base portion; and an alignment guide configured to releasably engage with the cut guide.” It is clear that all the elements of claim 1 of the application are to be found in claim 1 of the patent. The difference between claim 1 of the application and claim 1 of the patent lies in the fact that the patent claim includes more elements and is thus more specific. Thus the invention of claim 1 of the patent is in effect a “species” of the “generic” invention of claim 1 of the application. It has been held that the generic invention is “anticipated” by the “species.” See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the application is anticipated by claim 1 of the patent, it is not patentably distinct from claim 1 of the patent. Claims 2-7 of the patent are identical to claims 2-7 of the application. Claims 8-10 of the patent are identical to claims 9-11 of the application. Claims 13 and 14 of the patent are identical to claims 14 and 15 of the application. Regarding claim 16 of the application, claim 15 of U.S. Patent No. 11,696,767 recites “A cut guide, comprising: a base portion comprising: at least one slot disposed between a first end and a second end of the base portion and extending between a first side and a second side of the base portion, wherein the at least one slot is angled as it extends from a top surface through to a bottom surface of the base portion; and a hole extending into the base portion from the top surface; an extension member extending away from the bottom surface of the base portion, wherein the hole extends into the extension member; at least one arm extending away from an end of the base portion; and a recessed region extending into the base portion from the bottom surface and toward the top surface of the base portion.” It is clear that all the elements of claim 16 of the application are to be found in claim 15 of the patent. The difference between claim 16 of the application and claim 15 of the patent lies in the fact that the patent claim includes more elements and is thus more specific. Thus the invention of claim 15 of the patent is in effect a “species” of the “generic” invention of claim 16 of the application. It has been held that the generic invention is “anticipated” by the “species.” See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 16 of the application is anticipated by claim 15 of the patent, it is not patentably distinct from claim 16 of the patent. Claim 17 of the application can be found in line 14-15 of claim 15 of the patent, and claim 16 of the patent is identical to claim 18 of the application. Regarding claim 19 of the application, claim 17 of U.S. Patent No. 11,696,767 recites “A cut guide, comprising: a base portion, wherein the base portion further comprises: a hole extending into the base portion from a top surface; an extension member extending away from a bottom surface of the base portion; wherein the hole extends into the extension member; at least one arm extending away from a bottom surface of the base portion; and at least one slot disposed on the base portion configured to removably engage with an alignment guide.” It is clear that all the elements of claim 19 of the application are to be found in claim 17 of the patent. The difference between claim 19 of the application and claim 17 of the patent lies in the fact that the patent claim includes more elements and is thus more specific. Thus the invention of claim 17 of the patent is in effect a “species” of the “generic” invention of claim 19 of the application. It has been held that the generic invention is “anticipated” by the “species.” See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 19 of the application is anticipated by claim 17 of the patent, it is not patentably distinct from claim 17 of the patent. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST). If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin 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. /ERIC S GIBSON/ Primary Examiner, Art Unit 3775
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Prosecution Timeline

Apr 20, 2025
Application Filed
Sep 25, 2026
Non-Final Rejection mailed — §101, §102, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
85%
Grant Probability
99%
With Interview (+17.2%)
2y 3m (~10m remaining)
Median Time to Grant
Low
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