DETAILED ACTION
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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. Therefore, the PET score that does not extend through the PET layer 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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 4-14, 23-28 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.
Applicant provides no support for “wherein the score reduces a thickness of the PET layer without forming a through-opening in the PET layer” in claim 1 and claim 28.
The claims not addressed above are rejected since they depend from a rejected claim.
Claim Rejections - 35 USC § 103
Claim(s) 1, 2, 4, 5, 10, 12, 13, are rejected under 35 U.S.C. 103 as being unpatentable over Leon et al. (US 2020/0391918) in view of Doll et al. (US 2013/0266244).
Regarding claims 1, 2, Leon discloses a child-proof stick pack, fig. 5a-5d, comprising:
a single sheet of film comprising two or more layers, wherein at least one layer, outer “first” layer 1 comprises polyethylene terephthalate and faces an environment exterior to the stick pack [0049-0051], fig. 3,
a laser-scored design (the scores can be formed by laser etching, [0064]) on the film comprising a plurality of scores, wherein each score of the plurality of scores comprises an area in which the polyethylene terephthalate layer is weakened or removed from the film, fig. 1 and 3, wherein the stick pack comprises a bottom seal and a top seal both at reference character 13, fig. 5a, and a rear seal at 6, fig. 5b, extending between the top seal and the bottom seal, and is configured to contain one or more of an active pharmaceutical ingredient, therapeutic agent, or supplement [0004], and
cannot be opened by more than 15% of children under the age of 5 years using only two hands [0074].
Leon does not disclose that the score in the PET layer does not form a through-opening in the PET layer.
Doll is analogous art in regard to stick packs, see fig. 8, and teaches that it is known scoring is known to cause a package to lose structural integrity [0004], [0042], and in one embodiment has scores that do not form through openings in an outer layer, fig. 11.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer layer scores of Leon to be less than the entire thickness of the outer layer as taught by Doll in order to ensure structural integrity of the packaging such that it will not be opened unintentionally [0042] of Doll.
Regarding claim 4, Leon discloses that the plurality of scores extend horizontally across a width of the stick pack and perpendicular to the extending direction of the rear seal, fig. 5a.
Regarding claim 5, Leon discloses fig. 5a, the plurality of scores are located closer to the top seal of the stick pack than the bottom seal.
Regarding claim 10, Leon discloses that the laser-scored design comprises at least two rows of scores, fig. 1 and 3.
Regarding claim 12, Leon discloses that each score has a length L (applicant’s width, see fig. 2) that lies between 50 and 600 microns, that is .05 and .6 mm [0060] and that the package should be easy to open for an adult user [0005]. The upper end of the length, 0.6 microns is within applicant’s claimed range of 0.5-0.7 mm wide. Both Leon and the instant invention are concerned with making the packaging “child-proof.” In addition, applicant doesn’t disclose sufficient specificity for the claimed range, reciting a broad width of 0.3 to 0.9 mm, in paragraph [0078] of the instant application.
With this in mind, Leon’s example of 0.6 microns anticipates claim 12.
Regarding claim 13, Leon further discloses that the ratio between the length to the width (Leon’s width is applicant’s ‘height’) of each score “b”, fig. 1 should be 2:1 [0058], page 4. Leon discloses a maximum length of 600 microns, or .6 mm with a height of .3mm (based on the ratio of 2:1, [0029]; 0.3 mm is within applicant’s claimed range. In addition, applicant doesn’t disclose sufficient specificity for the claimed range, reciting 0.1 to 0.8 mm, in paragraph [0079] of the instant application.
With this in mind, Leon’s disclosed height of 0.3 mm anticipates the limitations of claim 13.
Claim(s) 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Leon and Doll as applied to claim 1 above.
Regarding claim 6, the references applied above teach all of claim 1, as applied above. Leon further discloses a layer of polyethylene PE [0127] (second/middle layer 3), fig. 3, but does not disclose the thickness of the PE. Leon further discloses that material thickness defines tearing properties [0079], in other words the results of the child resistance and ease of opening for adults.
In addition, applicant doesn’t provide sufficient specificity for the claimed range for the thickness of the first layer of polyethylene, [0064] discloses from 10-100 microns.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the thickness of the Polyethylene of Leon to be within the claimed range, 20-40 microns thick, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimal ranges involves only routine skill in the art as claimed in order to arrive at the best tearing properties for ease of tearing by an adult while maintaining child-resistant tearing properties as per the teaching of Leon. In addition, the thickness of other layers fall within the claimed range, for example 23 microns for the PET, and the PET could be substituted with polyethylene, [0051].
Regarding claim 7, Leon discloses a layer of aluminum overlying the layer of polyethylene wherein the laver of aluminum is 6.35 to 30 microns thick [0017] which encompasses applicant’s claimed range of 20-30 microns thick. Leon further discloses that material thickness defines tearing properties [0079]. Both Leon and the instant invention are concerned with providing packaging properties that make the packaging “child-proof.”
In addition, applicant doesn’t provide sufficient specificity for the claimed range of thickness of the aluminum, disclosing a thickness of between 1 and 100 microns in [0065] of the instant application. With this in mind, the upper end of Leon’s disclosed thickness 20-30 microns thick anticipates applicant’s range as the thicknesses disclosed by Leon and provides the claimed child proof properties, as applied above, and further is suitable for increased child-proofing properties since the material is at the thicker end of the range.
Regarding claim 8, Leon further discloses another layer of polyethylene 30 overlying the layer of aluminum 31, [0053], fig. 3 but does not disclose the thickness of the polyethylene.
Leon further discloses that material thickness defines tearing properties [0079] in other words the results of the child resistance and ease of tearing for adults depends on material thicknesses. In addition, applicant discloses a broad range for the thickness of the second layer of polyethylene, [0065], from 1-100 microns.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the thickness of the second layer of polyethylene of Leon to be within the claimed range of 5-30 microns, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimal ranges involves only routine skill in the art as claimed in order to arrive at the best tearing properties for ease of tearing by an adult while maintaining child-resistant tearing properties as per the teaching of Leon.
Regarding claim 9, Leon discloses that the layer of polyethylene terephthalate overlies the all the other layers including a middle layer of polyethylene, polyethylene is the middle layer [0127] wherein the laver of polyethylene terephthalate is between 12 and 23 microns thick, 15-25 microns thick. with specific examples of 19 micrometers or 23 micrometers [0079].
Both Leon and the instant invention are concerned with providing packaging properties that make the packaging “child-proof.”
In addition, applicant doesn’t provide sufficient specificity for the claimed range, reciting a PET thickness of between 5 and 100 microns [0067] of the instant application.
With this in mind, Leon’s disclosed PET thickness examples of 19 and 23 microns, anticipates applicant’s claim 9.
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Leon and Doll as applied to claim 10 above, and further in view of Watanabe (JP 2005289407 A).
Regarding claim 14, the references applied above teach all of claim 10, as applied above. Leon further discloses a score density but no particular distance between vertical scores. Watanabe is analogous art in regard to perforated lines for opening and in fig. 6, shows a series of spaced lines, the lines spaced apart by 0.5mm to a controlled tear opening, see the description of fig. 6 on page 5 of the translation. Applicant discloses a broad range of spacing between rows of perforations [0082] including the spacing taught by Watanabe.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to change the spacing between rows of scores of Leon as a matter of design choice, including 0.5 mm or wider, within the claimed width of 0.6 to 0.9 mm to provide the required amount of deviation from the tear for controlled opening as per the teaching of Watanabe.
Claim(s) 1 and 23-28 are rejected under 35 U.S.C. 103 as being unpatentable over Gruber et al. (US 8889184) in view of Leon and Doll.
Regarding claims 1, 23-28, Gruber discloses that it is known to package particulate pharmaceutical compositions in stick packs, col. 16: 54-end, col. 17: 1-10. The pharmaceutical ingredients include n-SAIDs, including acetylsalicylic acid and naproxen sodium, or antihistamines such as loratadine, nizatidine, col. 6: 50-end, and caffeine, col. 7: 33-40, to name a few.
Gruber does not disclose that the stick-pack be child proof.
Leon teaches a child-proof stick pack, fig. 5a-5d, comprising:
a single sheet of film comprising two or more layers, wherein at least one layer, outer “first” layer 1 comprises polyethylene terephthalate and faces an environment exterior to the stick pack [0049-0051],
a laser-scored design (the scores can be formed by laser etching, [0064]) on the film comprising a plurality of scores, wherein each score of the plurality of scores comprises an area in which the polyethylene terephthalate layer is weakened or removed from the film, fig. 1 and 3, wherein the stick pack comprises a bottom seal and a top seal both at reference character 13, fig. 5a, and a rear seal at 6, fig. 5b, extending between the top seal and the bottom seal, and is configured to contain one or more of an active pharmaceutical ingredient, therapeutic agent, or supplement [0004], and
cannot be opened by more than 15% of children under the age of 5 years using only two hands [0074].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide any of the medications or therapeutic substances disclosed by Gruber to be in a stick pack with child-proof structures as taught by Leon in order to prevent children from inadvertently swallowing medication.
Leon does not disclose that the score in the PET layer does not form a through-opening in the PET layer.
Doll is analogous art in regard to stick packs, see fig. 8, and teaches that it is known scoring is known to cause a package to lose structural integrity [0004], [0042], and in one embodiment has scores that do not form through openings in an outer layer, fig. 11.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer layer scores of Leon to be less than the entire thickness of the outer layer as taught by Doll in order to ensure structural integrity of the packaging such that it will not be opened unintentionally [0042] of Doll.
Response to Arguments
Applicant's arguments filed 30 March 2026 have been fully considered but they are not persuasive.
In response to applicant's argument that the specification discloses the new claimed limitations, examiner disagrees.
Applicant asserts that the specification of the instant application states “the remaining layers of the film stay intact” and that one must construe that in order for the under layers to remain intact, the PET layer cannot have formed a through-opening that would have necessarily damaged the underlying layer.
This argument is not found persuasive since the scores could have been formed in the PET layer prior to combining the layers with no destruction of the other layers. With this in mind, applicant does not have support for the new limitations in claims 1 and 28.
Applicant’s other reference to the instant application supporting the new limitations are not found persuasive since “not all layers of the film are scored” could mean that only the first layer is scored with a through-opening and “the innermost layer remains intact and is not scored” could mean that numerous layers are scored with through openings.
Applicant’s arguments against Leon’s inner layers being intact are not persuasive since Leon discloses that the PET is pierced prior to laminating the layers together [0002].
With this in mind, applicant has not provided any support for the newly claimed subject matter.
In response to applicant's argument that Leon teaches away from the claimed invention, examiner disagrees. There is no explicit teaching that the PET layer must be perforated through and therefore no explicit teaching away. In addition, the limitation in question is taught by Doll, as applied above.
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 MOLLIE L IMPINK whose telephone number is (571)270-1705. The examiner can normally be reached Monday-Friday (7:30-3:30).
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, Anthony Stashick can be reached at (571) 272-4561. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOLLIE IMPINK/Primary Examiner, Art Unit 3799
MOLLIE LLEWELLYN IMPINK
Primary Examiner
Art Unit 3799
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