Prosecution Insights
Last updated: April 19, 2026
Application No. 18/800,646

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

Non-Final OA §103§112
Filed
Aug 12, 2024
Examiner
MACFARLANE, EVAN H
Art Unit
3724
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
V-SHAPES S.R.L.
OA Round
1 (Non-Final)
50%
Grant Probability
Moderate
1-2
OA Rounds
3y 0m
To Grant
93%
With Interview

Examiner Intelligence

Grants 50% of resolved cases
50%
Career Allow Rate
243 granted / 486 resolved
-20.0% vs TC avg
Strong +43% interview lift
Without
With
+43.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
51 currently pending
Career history
537
Total Applications
across all art units

Statute-Specific Performance

§103
39.5%
-0.5% vs TC avg
§102
18.9%
-21.1% vs TC avg
§112
36.8%
-3.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 486 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 Preliminary Amendment filed 12 August 2024 has been entered. Claims 13-18 are pending. 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. Information Disclosure Statement The Information Disclosure Statement filed 12 August 2024 has been considered. The examiner notes that Non-Patent Literature Document citation number 3 includes an incorrect date for the Brazilian search report. The examiner has annotated the IDS to correct the date of issuance of the Brazilian search report listed as citation number 3 in the Non-Patent Literature Document section. Specification The amendment to the specification filed 12 August 2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: The incorporations by reference of US Pat. Application No. 17/617,145, the international patent application PCT/IT2020/0501430 and of Italian Application No. 102019000009036 are ineffective as they were added on by preliminary amendment on 12 August 2024, which is after the filing date of the instant application. The filing date of this application is the filing date of the associated PCT, in this case 9 June 2020 (see MPEP 1893.03(b)). Therefore, the amendment to the specification of 12 August 2024 to include the incorporations by reference is new matter, per MPEP 608.01(p). To remedy the issue, applicant should delete the sentence, “All applications are incorporated by reference herein,” from the specification. Applicant is required to cancel the new matter in the reply to this Office Action. Claim Objections The claims are objected to because of the following informalities: Claim 13 at line 2 recites, “wherein it comprises”. This recitation should read – wherein the device [[it]] comprises – to make clear that “it” refers to the device rather than the sheet of semirigid plastic material. Claim 13 at lines 2-3 recites, “at least one first plate connected to an incision tool having at least one straight protrusion”. This recitation should read – at least one first plate connected to an incision tool, the incision tool having at least one straight protrusion – to reduce the run-on nature of the recitation and more clearly describe that the incision tool is the structure that has the at least one straight protrusion. Claim 13 at line 5 recites, “and at least one second plate”. This recitation should read – , and the device comprising at least one second plate – in order to more clearly describe that the device is the structure that comprises the at least one second plate. (Alternatively, the applicant can insert line breaks in line 2 following “comprises” and at line 5 following “material and”). Claim 13 at lines 5-6 recites, “at least one second plate connected to at least one incision tool having at least one shaped protrusion”. First, since two incision tools are introduced, the incision tools should be provided with unique names, such as by amending line 4 to read – a first incision tool – and amending line 5 to read – at least one second incision tool –. Second, the recitation at lines 5-6 should be amended to read – at least one second plate connected to at least one second incision tool, the at least one second incision tool having at least one shaped protrusion – to reduce the run-on nature of the recitation and more clearly describe that the at least one second incision tool is the structure that has the at least one shaped protrusion. Claim 15 at line 3 recites, “one following the other”. This recitation should read – one of the incision stations following the other of the incision stations – to make clear that “one” and “the other” refer to the incision stations, rather than the first and second plates. (See claim 16 as evidence that claim 15 at line 3 is referring to the incision stations.) Claim 17 at line 2 recites, “wherein it comprises”. This recitation should read – wherein the device [[it] comprises –. Claim 17 at line 2 introduces, “a plate” that is opposite the first plate, but claim 17 later refers to this plate as “the opposite plate” despite ‘opposite’ not being in the name of the plate as originally introduced. The examiner suggests amending claim 17 at line 2 to introduce – an opposite plate – such that later recitations of “the opposite plate” have a proper antecedent basis. Otherwise, the claim should be amended to avoid adding a new descriptor, “opposite,” into the name of the previously introduced plate. Claim 17 at the final line recites, “without cutting it”. This recitation should read – without cutting the strip [[it]] –. Claim 18 at line 2 recites, “wherein it comprises”. This recitation should read – wherein the device [[it] comprises –. Claim 18 at line 2 introduces, “a plate” that is opposite the first plate, but claim 18 later refers to this plate as “the opposite plate” despite ‘opposite’ not being in the name of the plate as originally introduced. The examiner suggests amending claim 18 at line 2 to introduce – an opposite plate – such that later recitations of “the opposite plate” have a proper antecedent basis. Otherwise, the claim should be amended to avoid adding a new descriptor, “opposite,” into the name of the previously introduced plate. Claim 18 at the final line recites, “without cutting it”. This recitation should read – without cutting the strip [[it]] –. 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. Claim(s) 14 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 14 introduces several features already introduced in claim 13, including “an incision tool”, “at least two straight protrusions” and “a first incision”. Claim 14 is indefinite because the relationship between the “incision tool”, the “at least two straight protrusions”, and the “first incision” as recited in claim 14 with respect to the “incision tool”, “at least one straight protrusion”, and the “first incision” as already introduced in claim 13 is unclear. For example, is claim 14 requiring that there are two first incisions? If not, claim 14 should refer to “the” first incision. If so, claim 14 should use a different name than “first incision” to describe an additional incision given that claim 13 already introduced a first incision. For examination purposes, the examiner interprets claim 14 as if the claim read – wherein the at least one straight protrusion of the incision tool comprises at least two straight protrusions, wherein the at least two straight protrusions are spaced apart from each other for making the first incision and a second incision in the sheet – such that claim 14 is interpreted as further describing the incision tool, members of the at least one straight protrusion, and the first incision already introduced in claim 13. 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 and 15-18 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 Brittini (hereinafter referred to as ‘WO074’). 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), wherein it [the device] comprises an a first incision device having an incision tool for making a 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 incision tool for making a 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 two different incision stations (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), one following the other (see paragraph 3). Regarding claim 16, EP579 discloses that one of the incision stations follows the other incision station (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 incision tool, where the incision tool connected to the at least one first plate has at least one straight protrusion, and at least one second plate connected to the at least one incision tool, the at least one incision tool connected to the second plate having at least one shaped protrusion as required by claim 13. Similarly, EP579 fails to disclose: that the first plate and the second plate are positioned at the two different incision stations as required by claim 15; that the incision station comprising the second plate follows the incision station comprising the first plate as required by claim 16; wherein it [the device] comprises a plate opposite to said first plate, wherein said first plate is movable from a first position far from the opposite plate to a predetermined position near to the opposite plate so as to make a substantially straight incision in a strip of semirigid material placed between the first plate and the opposite plate, thus deforming the strip without cutting it as required by claim 17; and wherein it [the device] comprises a plate opposite to said second plate, wherein said second plate is movable from a first position far from the opposite plate to a predetermined position near to the opposite plate so as to make a shaped incision in a strip of semirigid material placed between the second plate and the opposite plate, thus deforming the strip without cutting it as required by claim 18. 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 a pair of plates 26 (one of the pair of plates 26 can be considered as either of a ‘first’ plate and a ‘second’ plate; the other of the pair of plates 26 can be considered as an ‘opposite plate’ as further discussed below), each of the plates 26 connected to a respective incision tool 27, where the incision tool 27 has at least one straight protrusion (the straight protrusion being defined by the blade of the incision tool 27 that forms the incision 6 per page 14, lines 14-15; see the shape of the incision 6 formed by the blade being straight in Fig. 2 per page 13, lines 17-20 and page 14, lines 6-10; note also that a straight protrusion is a particular type of shaped protrusion, since ‘straight’ is one type of shape – i.e., the shape of the incision 6 shown in Fig. 2 is linear; alternatively, the incision tool 27 is properly considered as having a ‘shaped protrusion’ because the blade of the incision tool 27 forms an incision 6 having a shaped profile as can be seen in any of Figs. 3-5, such that the protrusion is shaped in a direction orthogonal to a surface of the sheet material being processed). [Claim 13] WO074 further teaches that the pair of plates 26 are opposite to each other, where one of the plates 26 is movable from a first position far from the opposite plate 26 to a predetermined position near to the opposite 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) so as to make a substantially straight incision 6 (note that a straight incision is also a ‘shaped’ incision, since a straight line is a particular type of shape; alternatively, the incision 6 is ‘shaped’ due to a profile in a direction orthogonal to the sheet as can be seen in Fig. 3) in a strip of semirigid material placed between the one plate 26 and the opposite plate 26 (see the incision 6 being straight in Fig. 2), thus deforming the strip without cutting it (see the deformation of the sheet 2 in Fig. 2, 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 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 a first one of the incision devices includes a first plate connected to a first incision tool, the first incision tool having a straight protrusion, and a second one of the incision devices includes a second plate connected to a second incision tool, the second incision tool connected to the second plate having a shaped protrusion, 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), since the first and second plates are members of the different incision devices. Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over EP759 as modified by WO074 as applied to claim 13 above, and further in view of US Pat. No. 3,205,750 to Strange, as evidenced by US Pub. No. 2007/0289891 A1 to Davies. Regarding claim 14, EP579, as modified, discloses that the first plate is connected to an incision tool (i.e., each plate 26 of WO074 is connected to an incision tool 27 as explained in the rejection of claim 13 above). EP579, as modified, fails to disclose that the incision tool has at least two straight protrusions spaced apart from each other for making a first and a second incision in the sheet of semirigid plastic material as required by claim 14. Strange, though, teaches an incision tool 12 that includes at least two straight protrusions 14 that are spaced apart from each other for making a first and a second incision 46 in a sheet of material (see Figs. 1 and 6). Further, Davies teaches that a cut 72 in a semi-rigid sheet material can be a series of cuts, or indentations, or perforations (see paragraph 96). Therefore, at least when a user desires to from a series of perforations, it would have been obvious to one of ordinary skill in the art to provide the incision tool of EP579, as modified, which is connected to the first plate, with at least two straight, spaced apart protrusions for making first and second incisions in view of the teachings of Strange. This modification is obvious because it is known in the art, via the teachings of Davies, that one of ordinary skill in the art can select from various types of lines of weakness, including perforations. One of ordinary skill in the art is able to select a blade whose cutting edge shape corresponds to a desired type of line of weakness, including perforations. Citation of Pertinent Prior Art The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Pat. No. 7,506,762 B2 to Nelson discloses a device for processing a sheet of semi-rigid plastic material having two die-cutting stations 1602 and 1604 (see Fig. 17). US Pat. No. 2,308,086 to Landrock and US Pub. No. 2006/0248996 A1 to Valentinis each disclose a device having two guillotine-style cutting stations arranged along a conveyance direction. Conclusion 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
Read full office action

Prosecution Timeline

Aug 12, 2024
Application Filed
Mar 06, 2026
Non-Final Rejection — §103, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
50%
Grant Probability
93%
With Interview (+43.0%)
3y 0m
Median Time to Grant
Low
PTA Risk
Based on 486 resolved cases by this examiner. Grant probability derived from career allow rate.

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