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 .
Election/Restrictions
Applicant’s election of Invention I (Claims 1-11) in the reply filed on 12/12/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 12-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse.
Specification
The use of the term SULAPAC (Para. 0052, 0054), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 3, 5, and 9 are objected to because of the following informalities:
-Claim 3, line 6, “disposed at recesses” would be better recited as “disposed at the recesses”.
-Claim 5, line 4, “recesses of the second web disposed at recesses of the first web” should instead be “the recesses of the second web disposed at the recesses of the first web”.
-Claim 9, line 2, “web with recesses” should instead be “web with the recesses”.
-Appropriate correction is required.
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.
Claims 1-7 and 10 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Yu (US PGPUB 2016/0221270).
Regarding Claim 1, Yu discloses a method of packaging lateral flow test strips (30; Figures 12 and 14), said method comprising:
providing an elongated first web (lower molding material 2 wound on roll 120; Figures 1, 10; Para. 0053), wherein the elongated first web (2) comprises thermo-formable material (Para. 0056, 0099, 0107, 0109);
thermoforming (via molding unit 300) a plurality of recesses (22, 23) in the elongated first web (2), wherein the recesses (22, 23; Figures 7-9) are at spaced intervals along the elongated first web (2; Para. 0107-0109);
providing a supply of lateral flow test strips (30 at 340; Figures 1, 12; Paras. 0117, 0120);
providing an elongated second web (1 on roll 110; Figures 1-2; Para. 0053);
retaining lateral flow test strips (30) within the recesses (23) of the elongated first web (2) by attaching the second web (1) to the first web (2; see Para. 0015; Para. 0117 discloses placement within the recessed hole 23, Para. 0140 discloses bonding of the webs together); and
cutting the attached together first web (2) and second web (1) to separate the thus retained lateral flow test strips (30) into packages (10, 20; Para. 0150-0154).
Regarding Claim 2, Yu discloses the thermoforming (via 300) a plurality of recesses (22, 23) in the first web (2) comprises forming receptacles (23) for receiving the lateral flow test strips (30; Para. 0107-0109), and wherein the method further comprises placing lateral flow test strips (30) in the recesses (23) of the elongated first web (2) prior to said retaining lateral flow test strips (30) within the recesses (23) of the elongated first web (2 via the bonding unit 400; Para. 0117 discloses placement within the recessed hole 23 before bonding of the webs together per Para. 0140).
Regarding Claim 3, Yu discloses the elongated second web (1) comprises thermo-formable material (1; Para. 0055-0056), and wherein said method further comprises:
thermoforming features (12, 13; Figure 14) in the second web (1) at spaced intervals along the elongated second web (1) wherein the features comprise thermoformed features (12, 13; Para. 0079); and
positioning at least a portion of the second web (1) at the first web (2) such that thermoformed features (12, 13) of the second web (1) are disposed at recesses (22, 23) of the first web (1; see Figure 14; see also Para. 0138 which outlines aligning air tubes 12 and 22).
Regarding Claim 4, Yu discloses cutting sections (at 14, 15) of the second web (1) prior to said positioning at least a portion of the second web (1) at the first web (2; Para. 0081 disclose forming cut sections at punching device 240 which is prior to arranging unit 600), wherein each section of the second web (1) comprises a plurality of thermoformed features (12, 13) for engagement with a plurality of recesses (22, 23; Figure 14).
Regarding Claim 5, Yu discloses the thermoformed features (12, 13) comprise recesses, and wherein the retaining lateral flow test strips (30) within the recesses of the elongated first web (2) by attaching the second web (1) to the first web (2) comprises securing the second web (1) to the first web (2) with recesses (12, 13) of the second web (1) disposed at recesses (22, 23) of the first web (2 as shown in Figure 14; see Paras. 0136-0144 for reference).
Regarding Claim 6, Yu discloses feeding the elongated first web (2) in a feed direction and placing the lateral flow test strips (30) in the recesses (23 at 340) of the elongated first web (2) while the elongated first web (2) is fed in the feed direction (Paras. 0050, 0052, 0058, 0060, 0117).
Regarding Claim 7, Yu discloses the elongated first web (2) is wound on a reel (120) and wherein the method comprises unwinding the reel (120) while feeding the elongated first web (2) in the feed direction (Paras. 0050, 0052, 0058, 0060).
Regarding Claim 10, Yu discloses the individually packaged lateral flow test strips comprise lateral flow test cassettes (formed by 10, 20 shown in Figure 14 as a cassette can be viewed as a casing of the strip).
Claims 1-3, 5-8 and 10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Von Hauswolff (WO 2024/156850 A1- note the WIPO application comprises an effective filing date of 1/27/2023-see MPEP 2154.01(a)).
Regarding Claim 1, Von Hauswolff discloses a method of packaging lateral flow test strips (34; abstract; Figure 2), said method comprising:
providing an elongated first web (10), wherein the elongated first web (10) comprises thermo-formable material (Page 14, lines 1-6);
thermoforming a plurality of recesses (12) in the elongated first web (10), wherein the recesses (12) are at spaced intervals along the elongated first web (10; Page 14, lines 17-26; see also Figures 5-6; Page 21, line 21 through Page 22, line 6);
providing a supply (from reel 36) of lateral flow test strips (34; Page 15, lines 5-23);
providing an elongated second web (60 on reel 62; Page 16, lines 22-30);
retaining lateral flow test strips (34) within the recesses (12) of the elongated first web (10) by attaching the second web (60) to the first web (10; see Page 16, lines 23-34); and
cutting the attached together first web (10) and second web (60) to separate the thus retained lateral flow test strips (34) into packages (Page 17, line 32 through Page 18, line 9).
Regarding Claim 2, Von Hauswolff discloses the thermoforming a plurality of recesses (12) in the first web (10) comprises forming receptacles (12) for receiving the lateral flow test strips (34; Page 14, lines 25-26 ), and wherein the method further comprises placing lateral flow test strips (34) in the recesses (12) of the elongated first web (10) prior to said retaining (via bonding of 60 to 10) lateral flow test strips (34) within the recesses (12) of the elongated first web (10; see Page 15, lines 5-7 and Page 16, lines 23-34).
Regarding Claim 3, Von Hauswolff discloses the elongated second web (60) comprises thermo-formable material (Page 7, lines 11-14), and wherein said method further comprises:
thermoforming features (coupling profile 61) in the second web (60) at spaced intervals along the elongated second web (60; Page 17, lines 19-21) wherein the features comprise thermoformed features (61; Col 17, lines 19-21); and
positioning at least a portion of the second web (60) at the first web (10) such that thermoformed features (61) of the second web (60) are disposed at recesses (at 11) of the first web (10; see Figures 8a-8c; Page 17, lines 7-23).
Regarding Claim 5, Von Hauswolff discloses the thermoformed features (61) comprise recesses (as shown), and wherein the retaining lateral flow test strips (34) within the recesses (12) of the elongated first web (10) by attaching the second web (60) to the first web (10) comprises securing the second web (60) to the first web (10) with recesses (61) of the second web (60) disposed at recesses (11) of the first web (10; Page 17, lines 7-23).
Regarding Claim 6, Von Hauswolff discloses feeding the elongated first web (10) in a feed direction and placing the lateral flow test strips (34) in the recesses (12) of the elongated first web (10) while the elongated first web (10) is fed in the feed direction (Page 15, lines 5-23).
Regarding Claim 7, Von Hauswolff discloses the elongated first web (10) is wound on a reel (15) and wherein the method comprises unwinding the reel (15) while feeding the elongated first web (10) in the feed direction (Page 14, lines 17-18).
Regarding Claim 8, Von Hauswolff discloses said thermoforming the plurality of recesses (12) in the elongated first web occurs prior to winding the elongated first web (10) on the reel (15; Page 14, lines 17-28).
Regarding Claim 10, Von Hauswolff disclose the individually packaged lateral flow test strips comprise lateral flow test cassettes (see 1000A-1000E in Figure 7).
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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Yu (US PGPUB 2016/0221270), in view of Von Hauswolff (WO 2024/156850 A1)
Regarding Claim 8, Yu discloses several features of the claimed invention but does not disclose the thermoforming the plurality of recesses in the elongated first web occurs prior to winding the elongated first web on the reel.
Attention can be brought to Von Hauswolff which teaches a thermoforming step of a plurality of recesses (12; Figure 2) in an elongated first web (10) occurs prior to winding the elongated first web (10) on the reel (15; Page 14, lines 17-28).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have thermoformed the recesses of Yu prior to winding the web onto the reel as taught by Von Hauswolff as such a modification would allow the system/method to be less complex as taught by Von Hauswolff (Page 14, lines 22-24).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Yu (US PGPUB 2016/0221270), in view of Ehrmann (US PGPUB 2017/0021955).
Regarding Claim 9, Yu discloses placing lateral flow test strips (30) on the elongated first web (2) at spaced intervals (within 23; Figure 12; Para. 0120-0127) and placing the second web (1) on the first web (2) with recesses of the first web (2) disposed about the lateral flow test strips (30) on the second web (1; see Figure 14; Para. 0137-0138).
However, Yu does not disclose placing the strips (30) on the second web (1) at spaced intervals and placing the first web on the second web such that the recesses of the first web are disposed about the strips on the second web.
Attention is brought to Ehrmann which outlines another method of packaging objects between a first/top and second/bottom web (6, 10; Figure 1), wherein the method includes forming a recess (9) in the first web (10 at 8) and placing objects (13) on the second web (6) such that the first web (10) and second web (6) are placed on each other in a manner in which the recess (9) is disposed about the object (13) on the second web (6; Para. 0024-0026).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have formed larger recesses of Yu in the top web as taught by Ehrmann such that when the webs are joined, the recess is disposed about the object being packaged. By modifying Yu in this manner, the packaging system can be made in a more compact manner due to lower forming planes as taught by Ehrmann (Para. 0010).
Alternatively, it would have been an obvious matter of design choice to a person of ordinary skill in the art at the time the invention was effectively filed to have formed the recesses on the top web of Yu to be joined with the lower web comprising the strips/objects as taught by Ehrmann because Applicant has not disclosed that such an arrangement provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the arrangement of Yu or Ehrmann because in either instance, the strip would be enclosed and sealed within packaging.
Therefore, it would have been an obvious matter of design choice to modify Yu to obtain the invention as specified in the claim.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Yu (US PGPUB 2016/0221270), in view of Sakurai (US Patent 6,216,419).
Regarding Claim 11, Yu discloses the elongated first web (2) and elongated second web (1) each include lateral edges (edges of the web), but does not disclose the method further comprises forming a plurality of apertures adjacent at least one edge of the first web and/or the second web, wherein the apertures are used for feeding the first web and/or second web.
Attention can be brought to the teachings of Sakurai which discloses another method of packaging including feeding two webs (11, 12; Figure 3) wherein the method includes forming a plurality of apertures (11B) adjacent at least one edge of a first web (11), wherein the apertures (11B) are used for feeding (via sprocket 37; Figure 8) the first web (11) and second web (12 via pulling; see Col 5, lines 32-44).
Utilizing apertures in a carrier tape is a known technique for controlled feeding of webs in the art. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have incorporated apertures into the first web of Yu as taught by Sakurai as such a modification readily allows for the webs to be intermittently pulled/conveyed with a determined pitch as taught by Sakurai (Col 5, lines 38-44).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Von Hauswolff (WO 2024/156850 A1- note the WIPO application comprises an effective filing date of 1/27/2023-see MPEP 2154.01(a)), in view of Ehrmann (US PGPUB 2017/0021955).
Regarding Claim 9, Von Hauswolff discloses several features of the claimed invention but does not outline placing lateral flow test strips (34) on the elongated second web (60) at spaced intervals and placing the first web (10) on the second web (60) with recesses (12) of the first web (10) disposed about the lateral flow test strips (34) on the second web (60). Von Hauswolff instead discloses placing the strips (34) on the first web (10) within the recesses (12) and placing the second web (60) thereon.
Attention is brought to Ehrmann which outlines another method of packaging objects between a first and second web (6, 10; Figure 1), wherein the method includes forming a recess (9) in the first web (10 at 8) and placing objects (13) on the second web (6) such that the first web (10) and second web (6) are placed on each other in a manner in which the recess (9) is disposed about the object (13) on the second web (6; Para. 0024-0026).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have formed larger recesses of Von Hauswolff in the top web as taught by Ehrmann such that when the webs are joined, the recess is disposed about the object being packaged. By modifying Von Hauswolff in this manner, the packaging system can be made in a more compact manner due to lower forming planes as taught by Ehrmann (Para. 0010).
Alternatively, it would have been an obvious matter of design choice to a person of ordinary skill in the art at the time the invention was effectively filed to have formed the recesses on the top web of Von Hauswolff to be joined with the lower web comprising the strips/objects as taught by Ehrmann because Applicant has not disclosed that such an arrangement provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the arrangement of Von Hauswolff or Ehrmann because in either instance, the strip would be enclosed and sealed within packaging.
Therefore, it would have been an obvious matter of design choice to modify Von Hauswolff to obtain the invention as specified in the claim.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Von Hauswolff (WO 2024/156850 A1- note the WIPO application comprises an effective filing date of 1/27/2023-see MPEP 2154.01(a)), in view of Sakurai (US Patent 6,216,419).
Regarding Claim 11, Von Hauswolff discloses the elongated first web and elongated second web each include lateral edges (edges of the web), but does not disclose the method further comprises forming a plurality of apertures adjacent at least one edge of the first web and/or the second web, wherein the apertures are used for feeding the first web and/or second web.
Attention can be brought to the teachings of Sakurai which discloses another method of packaging including feeding two webs (11, 12; Figure 3) wherein the method includes forming a plurality of apertures (11B) adjacent at least one edge of a first web (11), wherein the apertures (11B) are used for feeding (via sprocket 37; Figure 8) the first web (11) and second web (12 via pulling; see Col 5, lines 32-44).
Utilizing apertures in a carrier tape is a known technique for controlled feeding of webs in the art. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have incorporated apertures into the first web of Von Hauswolff as taught by Sakurai as such a modification readily allows for the webs to be intermittently pulled/conveyed with a determined pitch as taught by Sakurai (Col 5, lines 38-44).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. see “Notice of References Cited”.
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/JOSHUA G KOTIS/Examiner, Art Unit 3731 1/21/2026