Prosecution Insights
Last updated: October 04, 2026
Application No. 18/800,646

SEALED SINGLE-DOSE BREAK-OPEN PACKAGE, DEVICE AND METHOD FOR MAKING

Final Rejection §103§112
Filed
Aug 12, 2024
Priority
Jun 14, 2019 — IT 102019000009036 +2 more
Examiner
MACFARLANE, EVAN H
Art Unit
3724
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
V-SHAPES S.R.L.
OA Round
2 (Final)
51%
Grant Probability
Moderate
3-4
OA Rounds
8m
Est. Remaining
93%
With Interview

Examiner Intelligence

Grants 51% of resolved cases
51%
Career Allowance Rate
256 granted / 505 resolved
-19.3% vs TC avg
Strong +42% interview lift
Without
With
+42.2%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
52 currently pending
Career history
553
Total Applications
across all art units

Statute-Specific Performance

§101
0.1%
-39.9% vs TC avg
§103
40.1%
+0.1% vs TC avg
§102
18.6%
-21.4% vs TC avg
§112
38.6%
-1.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 505 resolved cases

Office Action

§103 §112
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 . DETAILED ACTION Response to Amendment The Amendment filed 13 July 2026 has been entered. Claims 13-18 and 25 are pending. Applicant's amendments have overcome each and every objection and rejection under 35 USC 112 previously set forth in the Non-Final Office Action mailed 12 March 2026. Priority Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 17/617,145, filed on 7 December 2021. Drawings The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Claim 13 encompasses the first position at which at least one straight incision is made as being adjacent, but not at, an edge of the sheet material (see claim 13 at lines 6-8), and claim 14 similarly encompasses the first and second straight incisions as being adjacent, but not at, opposite edges of the sheet (see claim 14 at lines 4-6). However, the present drawings only illustrate the first and second straight incisions ‘6’ and ‘8’ as being at opposing edges ‘9’ and ‘11’, respectively, of the sheet. The present drawings do not illustrate the straight incisions ‘6’ and ‘8’ as being adjacent to, and not at, the opposing edges ‘9’ and ‘11’. Therefore, the feature of the first position being adjacent, but not at, an edge of the sheet as encompassed by claim 13 and the feature of the first and second straight incisions being adjacent, but not at, opposite edges of sheet as encompassed by claim 14 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 The claims are objected to because of the following informalities: Claim 14 at the penultimate line recites, “opposite edges”. Claim 13 at line 7 already introduces, “an edge”. Claim 14 should be amended to make clear that the ‘opposite edges’ are inclusive of, rather than in addition to, the edge already introduced in claim 13. Claim 25 at line 4 recites that the second incision tool makes the at least one non-linear shaped “protrusion” on the sheet. The word “protrusion” at line 4 should be replaced with – incision – since the incision, not the protrusion, is made on the sheet by the incision tool. In view of the present specification, the use of “protrusion” is a clear typographical error. 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. Claim(s) 13-18 and 25 is/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 13 at lines 7-8 recites, “the first position [at which the at least one straight incision is made] at or adjacent an edge of the sheet of semirigid plastic material” (emphasis added). The first position being adjacent, rather than at, the edge of the sheet was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. The present specification as originally filed only contemplates the first position being at the edge of the sheet material. For example, paragraph 45 of the present specification states, “According to the invention, the first sheet 2 of the package 1 comprises at least one substantially straight pre-weakened incision 6 positioned at a first edge 9 of the first sheet 2.” As another example, paragraph 54 of the present specification states, “In the embodiment shown in Figure 2, the first sheet 2 comprises a central incision 7 shaped as a curved line, a first straight incision 6 at the first edge 9 and a second straight incision 8 at the opposite edge 11.” The present specification does not use the term ‘adjacent’, and the present specification does not contemplate the incisions ‘6’ and ‘8’ as being formed at any positions other than at respective edges of the sheet. Turning to the drawings, Figs. 2 and 3 of the present drawings illustrate two first incisions ‘6’ and ‘8’ that are at respective edges ‘9’ and ‘11’, while no drawing illustrates the incisions ‘6’ and ‘8’ being adjacent to, but not at, the edges ‘9’ and ‘11’ of the sheet. Finally, the claims as originally filed only contemplate the straight incision being at an edge of the sheet (see originally filed claims 1-2, 19, and 21). Claim 13 as amended encompasses the at least one straight incision being positioned slightly laterally inward of an edge of the sheet, without the at least one straight incision being at the edge of the sheet; however, the present application as originally filed only contemplates the at least one straight incisions as being at the edge of the sheet. Since claim 13 as amended encompasses the at least one straight incision slightly spaced inward from an edge of the sheet, without being at the edge of the sheet, claim 13 as amended fails to comply with the written description requirement of 35 USC 112(a). Claim 14 at the penultimate line recites that the first and second straight incisions are “at or adjacent opposite edges” of the sheet. Claim 14 fails to comply with the written description requirement because the present application as originally filed fails to disclose the first and second straight incisions being adjacent, but not at, the opposite edges of the sheet. The discussion with respect to claim 13 in the preceding paragraph is equally applicable to claim 14. 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) 13-18 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over EP 2 944 579 A2 to Burattini (hereinafter referred to as ‘EP759’) in view WO 2008/038074 A2 also to Burattini (hereinafter referred to as ‘WO074’) and US Pub. No. 2010/0155284 A1 to Gerstle et al. Regarding claim 13, EP579 discloses a device for making a weakening in a sheet of semirigid plastic material (see the device described in paragraph 3 of EP579), the device comprising: a first incision device having at least one incision tool for making at least one first incision in a first position of the sheet of semirigid plastic material (see paragraph 3 of EP579, where the first incision device is one of the ‘two incision devices’, and where the incision tool is the portion of the first incision device responsible for forming the incision produced by the first incision device per paragraph 3); and a second incision device having at least one second incision tool for making at least one shaped incision in the sheet of semirigid plastic material (see paragraph 3 of EP579, where the second incision device is the other of the ‘two incision devices’, and where the incision tool of the second incision device is the portion of the second incision device responsible for forming the incision produced by the second incision device per paragraph 3; since this incision has some shape, the at least one incision tool of the second incision device does make a ‘shaped’ incision, even if that shape is merely linear). Regarding claim 15, EP579 discloses a first incision station and a second incision station (see paragraph 3, where each of the incision devices is an incision station because the two devices are ‘arranged one next to the other in the conveying device’, and because the broadest reasonable interpretation of ‘station’ includes any of the places in a manufacturing operation at which one part of the work is done per merriam-webster.com), with one of the first and second incision stations following the other of the first and second incision stations (see paragraph 3). Regarding claim 16, EP579 discloses that the second incision station follows the first incision station (see paragraph 3; whichever of the incision stations is downstream of the other in the conveying direction can be considered as the ‘second incision station’). Regarding claim 25, EP579 discloses that the at least one first incision tool is arranged to make the at least one incision on a first surface of the sheet of semirigid plastic material and the at least one second incision tool is arranged to make the at least one shaped protrusion [sic, incision] on a second surface of the sheet of semirigid plastic material opposite the first surface (see paragraph 3). Even though EP579 references the structure of WO074, at least for the purposes of this rejection EP579 is considered as failing to explicitly disclose the structures of the first incision device and the second incision device. As such, at least for purposes of this rejection, EP579 is considered as failing to disclose: at least one first plate connected to the at least one first incision tool, the at least one first incision tool having at least one straight protrusion for making at least one straight incision, when viewed in a first direction orthogonal to a major surface of the sheet of semirigid plastic material, in a first position of the sheet of semirigid plastic material, the first position at or adjacent an edge of the sheet of semirigid plastic material; and at least one second plate connected to the at least one second incision tool, the at least one second incision tool having at least one non-linear shaped protrusion for making at least one non-linear shaped incision, when viewed in the first direction, in a central position of the sheet of semirigid plastic material, as required by claim 13. Similarly, EP579 fails to disclose: that the at least one straight incision includes first and second straight incisions and the at least one straight protrusion includes first and second straight protrusions spaced apart from each other for making the first and second straight incisions, at or adjacent opposite edges of the sheet of semirigid plastic material as required by claim 14; that the at least one first plate is positioned at the first incision station and the at least one second plate is positioned at the second incision station as required by claim 15; that the second incision station comprising the at least one second plate and the first incision station comprising the at least one first plate as required by claim 16; a first opposing plate opposite to said at least one first plate, wherein said at least one first plate is movable from a first position away from the first opposing plate to a first predetermined position near the first opposing plate for making the at least one straight incision in the sheet of semirigid material placed between the at least one first plate and the first opposing plate, thus deforming the sheet without cutting the sheet as required by claim 17; a second opposing plate opposite to said at least one second plate, wherein said at least one second plate is movable from a second position away from the second opposing plate to a second predetermined position near the second opposing plate for making the at least one non-linear shaped incision in the sheet of semirigid material placed between the at least one second plate and the second opposing plate, thus deforming the sheet without cutting the sheet as required by claim 18; and that the at least one incision made by the at least one first incision tool is straight and that the at least one shaped incision made by the at least one second incision tool is non-linear as required by claim 25. While EP579 generically discloses two incision devices arranged one after another, WO074 teaches a particular structure of an incision device. In particular, WO074 at Figs. 11-13 teaches an incision device 21 that includes at least one plate 26 connected to the at least one incision tool 27 (see Fig. 13), the at least one first incision tool 27 having at least one straight protrusion (see the ‘sharp blade’ of page 14, lines 13-18; the blade is a protrusion in order to form the incision 6 having the geometry of Figs. 2 and 3) for making at least one straight incision 6 (see Figs. 2, 3, and 13), when viewed in a first direction orthogonal to a major surface of the sheet 2 of semirigid plastic material (see Fig. 2, the incision 6 is straight when viewing from orthogonal to an upper surface of the sheet 2), in a first position of the sheet 2 of semirigid plastic material (see Figs. 2 and 3), the first position at or adjacent an edge of the sheet 2 of semirigid plastic material (the straight incision 6 extends to both edges of the sheet 2; see Figs. 2 and 3). [Claim 13] WO074 further teaches that the at least one plate 26 is positioned at an incision station [claim 15] and that the incision station comprises the at least one plate 26 [claim 16] (see Figs. 11-13; the incision device 21 can be considered as an incision station due to the broadest reasonable interpretation of ‘station’ set forth above). WO074 further teaches an opposing plate 26 opposite to the at least one plate 26 (see Figs. 12 and 13), wherein said at least one plate 26 is movable from a first position away from the opposing plate 26 to a predetermined position near the opposing plate 26 for making the at least one straight incision 6 (the incision shown in Figs. 2 and 3; see also page 14, lines 13-18) in the sheet 2 of semirigid material placed between the at least one plate 26 and the opposing plate 26 (see page 14, lines 23-26; the predetermined position is a position sufficient to form the incision 6 having the depth illustrated in Figs. 3-5 – e.g., the incision 6 does not extend all the way through the sheet in Fig. 3 such that the movement ends at a predetermined position), thus deforming the sheet 2 without cutting the sheet 2 (see the deformation of the sheet 2 in Figs. 2 and 3, where the sheet 2 is not cut through). [Claims 17 and 18] It would have been obvious to one of ordinary skill in the art to provide each of the incision devices of EP579 with the structure of the incision device 21 taught by WO074 (i.e., to provide EP579 with two of the incision devices taught by WO074, where the two incision devices are arranged one next to the other in the conveying direction of the material consistent with paragraph 3 of EP579). This modification is obvious under KSR Rationale B – simple substitution of one known, equivalent element for another to obtain predictable results. EP579 differs from the claimed device because EP579 only generically discloses the two incision devices without describing particular structures of the incision devices. EP579 thus differs from the claimed device by the substitution of two of the particular incision device of WO074 in place the incision devices of EP579. One of ordinary skill in the art could have substituted a pair of the specific incision device of WO074 in place of the generically disclosed incision devices of EP579 and the results of the substitution would have been predictable. The results of the substitution would have been particularly predictable in this case, since EP579 already contemplates the incision device of WO074 (see EP579 at paragraph 3). EP579 itself contemplates the use of the incision device of WO074. Following this modification, EP579 as modified by WO074 discloses two of the incision devices of WO074 arranged one next to the other in the conveying direction. As such, EP579 as modified by WO074 discloses at least one first plate connected to at least one first incision tool in one of the incision devices and at least one second plate connected to at least one second incision tool in the other of the incision devices as required by claim 13, since each of the incision devices of EP579 as modified by WO074 has the structure of the incision device taught by WO074. Further, the first and second plates are positioned at the two different incision stations with the second plate being the downstream plate (such that the second plate follows the first plate), satisfying the requirements of claims 15 and 16, since the first and second plates are members of the different incision devices. Finally, each of the incision devices of EP579 as modified by WO074 comprises a respective opposing plate because each of the incision stations of EP579 as modified by WO074 includes the structure having the opposing plate as disclosed by WO074, such that EP579 as modified by WO074 discloses first and second opposing plates that satisfy the requirements of claims 17 and 18. Still, EP579 as modified by WO074 discloses that each of the protrusion on the first plate and the protrusion of the second plate is a linear protrusion, since each of the protrusions of EP579 as modified by WO074 produces a linear incision as can be seen in Figs. 2 and 3 of WO074. As such, EP579 as modified by WO074 fails to disclose: the at least one second incision tool having at least one non-linear shaped protrusion for making at least one non-linear shaped incision, when viewed in the first direction, in a central position of the sheet of semirigid plastic material, as required by claim 13. that the at least one straight incision includes first and second straight incisions and the at least one straight protrusion includes first and second straight protrusions spaced apart from each other for making the first and second straight incisions, at or adjacent opposite edges of the sheet of semirigid plastic material as required by claim 14; that the shaped incision made by the at least one second plate and the second opposing plate is non-linear as required by claim 18; and that the at least one shaped incision made by the at least one second incision tool is non-linear as required by claim 25. Gerstle, though, teaches an incision 25 formed in a sheet of semirigid plastic material 15, where the incision 25 includes a first straight incision, a second straight incision, and a non-linear shaped incision (see the annotated Fig. 1 below), when viewed in a first direction orthogonal to a major surface of the sheet 15 (i.e., when viewed orthogonal to both the X and Y directions in Fig. 1), where the first and second straight incisions are spaced apart from one another and are at or adjacent to edges of the sheet 15 (see the annotated Fig. 1 below), and where the non-linear shaped incision is at a central position of the sheet 15 (see the annotated Fig. 1 below). [Relevant to claims 13, 14, 18, and 25] Gerstle teaches that the shape of its incision 25 is important because the shape of the incision 25, when the package 10 is opened, defines an opening 30 into the package 10. Gerstle teaches that the shape of the incision 25 – i.e., the incision includes first and second straight incisions and also including a non-linear shaped central incision – is advantageous because when the sheet of semirigid plastic material is opened, the opening provided by the incision is of adequate size to allow access to the interior of the package (see paragraphs 29 and 41). Put more plainly, the shape of the incision of Gerstle provides a large access opening into the package than an entirely linear incision. PNG media_image1.png 763 988 media_image1.png Greyscale Therefore, it would have been obvious to one of ordinary skill in the art to modify the shape of the blades on the first and second plates of EP579 as modified by WO074 to each produce an incision having the shape disclosed by Gerstle. This modification includes providing the blade on the first plate of EP579 as modified by WO074 with a shape corresponding to the shape of the incision taught by Gerstle and also providing the blade on the second plate of EP579 as modified by WO074 with a shape corresponding to the shape of the incision taught by Gerstle. As such, the first plate includes first and second straight protrusions at outer portions of the blade of the first plate in order to form the first and second straight incisions, and similarly the second plate includes a non-linear protrusion to form the central, non-linear shaped incision. This modification is advantageous because it provides a package which, when opened, provides easier access to the interior of the package, since the opening formed by the incision is larger. This modification includes providing each of the blades of the plates of EP579 as modified by WO074 with a shape to produce the incision of Gerstle because EP579 as modified by WO074 already discloses that the incisions produced on opposing sides of the sheet having the same shape. Moreover, as a result of this modification, EP579 as modified by WO074 and Gerstle discloses: that the at least one second incision tool having at least one non-linear shaped protrusion for making at least one non-linear shaped incision as required by claim 13 (this feature is satisfied because the portion of the blade on the second plate shaped to produce the non-linear shaped incision in annotated Fig. 1 of Gerstle above is a non-linear shaped protrusion); that the at least one straight incision includes first and second straight incisions at or adjacent opposite edges of the sheet of semirigid plastic material (see the first and second straight incisions in annotated Fig. 1 of Gerstle above) and the at least one straight protrusion includes first and second straight protrusions spaced apart from each other (since the blade on the first plate is shaped with first and second protrusions corresponding in shape to the first and second straight incisions) as required by claim 14; that the shaped incision made by the at least one second plate and the second opposing plate is non-linear as required by claim 18 (the shaped incision made by the second plate and the second opposing plate includes the non-linear incision in the annotated Fig. 1 of Gerstle above); and that the at least one shaped incision made by the at least one second incision tool is non-linear (the shaped incision made by the second plate and the second opposing plate includes the non-linear incision in the annotated Fig. 1 of Gerstle above) as required by claim 25. As a final note, the examiner points out that claim 13 does not prohibit the first plate from also including at least one non-linear shaped protrusion, and also does not prohibit the second plate from also including first and second straight protrusions. That is, while the device as disclosed in the present application may include the first and second straight incisions being formed on only a first side of the sheet, with no non-linear incision also formed on the first side of the sheet, and while the device as disclosed in the present application may similarly include the non-linear shaped incision being formed on only a second side of the sheet, with no straight incision being also formed on the second side of the sheet, the present claims permit the first and second straight incisions and the non-linear shaped incision to be formed on both sides of the sheet. Response to Arguments Applicant’s arguments with respect to claim(s) 13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The Gerstle reference is newly cited for the geometries of the protrusions on the first and second plates, along with the shapes of incisions formed by the protrusions. Conclusion 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 EVAN H MACFARLANE whose telephone number is (303)297-4242. The examiner can normally be reached Monday-Friday, 7:30AM to 4:00PM MT. 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, Boyer Ashley can be reached at (571) 272-4502. 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. /EVAN H MACFARLANE/Examiner, Art Unit 3724
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Prosecution Timeline

Aug 12, 2024
Application Filed
Mar 12, 2026
Non-Final Rejection mailed — §103, §112
Jul 13, 2026
Response Filed
Sep 18, 2026
Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
51%
Grant Probability
93%
With Interview (+42.2%)
2y 10m (~8m remaining)
Median Time to Grant
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