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 .
Status of the Claims
The amendment filed 12/10/2025 has been entered. Claims 1-8, 10-13 and 15-19 are pending and under consideration. Applicant's amendments and argument to the claims have overcome each and every 112(b) rejection and objection previously set forth in the Non-Final Office Action
Claim Objections
Claims 1 and 13 are objected to because of the following informalities:
Claim 1 line 3 recites “said upper component” which should read “an upper component”
Claim 1 line 5 recite “the usage indicia” which should read “a usage indicia”
Claim 1 line 7 recites “an upper component” which should read “the upper component”
Claim 1 line 9 recites “a usage indicia” which should read “the usage indicia”
Claim 13 line 9 recites “the usage indicia” which should read “a usage indicia”
Claim 13 line 11 recites “a usage indicia” which should read “the usage indicia”
Appropriate correction is required.
Response to Arguments
Applicant's arguments filed 12/10/2025, with respect to rejections under 35 USC 103 have been fully considered but they are not persuasive.
In response to argument section I that cited prior art reference does not teach or suggest an upwardly standing cap-mounted indicator for condition identification, because primary reference Simons (US 20120305177 A1) teaches a flat tag adhered directly to the cap surface using an adhesive backing, Adler (US 7942451 B2) teaches a portion of the card that extends above the cap is used for time-of-day reminders not for condition identification and Adler’s card is offset from the cap and mounted to the container body rather than to the cap itself, and Chapman (US 0576833 A) discloses a neck-mounted shank and disk for time indication, not condition identification. Its upward component is part of a complex timing mechanism rather than a simple visual representation of a medical conditioning.
This is not found persuasive for the following reasons below.
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In the instant case, the prior art rejection relies on Simmons that teaches a removable indica attached to the cap (figure 2 [0015] and [0033], removable tag 130 adhered to a cap comprising indicia describing what medical condition medication is located in the bottle). The cap-mounted indicia is modified by incorporating Adler’s upper component, which extends upwardly and orthogonally from the cap (figure 7 and col 12 lines 15-30, 54 extending from the cap 32) for the purpose of enhancing visibility when the container is positioned at eye level (e.g, on a shelf or in a medicine cabinet), and Chapman supplies the intervening stem structure (figure 1, stem 1 extending between elastic sections 3 and 4 warps around a neck of the container) between the upper component and the base, and the upper component having relatively larger surface compare to the cap, thereby providing additional surface area for useful information while maintaining elevated, two-sided display. Accordingly, the references in combination teach and suggest every element the indicator as claimed. The motivation to combine is taken from the secondary references, and accordingly the rejection is not based on impermissible hindsight reconstruction.
In response to argument II that the prior art above fails to teach a stem disposed between the base and the upper component and extending away from the cap to space the upper component from the cap for allowing the usage indicia to be displayed above the container, because Chapman’s shank is part of a neck clasp assembly, not a cap-mounted stem. Again, the test for obviousness is what the combined teachings would have suggested to a person of ordinary skill, not whether any single references contains every element in the exact claimed arrangement See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The fact that Chapman’s shank is shown attached to a neck clasp does not negate its structural teachings of a stem that spaces an upper indicator above the container opening. One of ordinary skill in the art would have recognized that Chapman’s shank could be mounted on the cap mount base of Simmons and Adler.
In response to argument III regarding the amended claims require the upper component to present a surface area larger than the cap, and the prior art teaches away from providing a large, easily readable surface as Chapman’s disk is small and clutter with tiny numerals and rotating parts, making it difficult to read and mechanically complex, and Adler’s card is narrow and limited not a large display area.
This is not found persuasive. Chapman is cited solely for the structural teaching of the shank + planar disk having relatively larger space area than the cap, and Adler is cited for structural teaching of the upper component extending upwardly and orthogonally from the base. Contrary to applicant’s argument, the clasp support around the neck, and Adler’s visible portion above the cap and magnifying lens are not relevant to the proposed combination.
Applicant’s assertion that the invention solves a long-felt need that is demonstrated by the cited reference that is no one devised a simple, cap-mounted, upwardly standing indicator with a large display area until the present invention. This underscores a long-felt but unloved need.
This is not found persuasive. Applicant’s assertion of long-felt need is a conclusory statement unsupported by objective evidence. To establish a long-felt need, an applicant must provide evidence that the need was a persistent one that was recognized by those of ordinary skill in the art and was not satisfied by the prior art (see MPEP 716.04). No such evidence (e.g., declarations) has been provided to show that the industry recognized the “display area” of the prior art as a problem that needs to be solved. Moreover, the cited prior art already satisfies the very need Applicant identifies. Chapman discloses an upright indicator positioned above the cap that provided improved visibility. Adler expressly teach an upper display portion that “extends beyond cap… visible when the container is stored”. Simmons teaches cap-mounted condition indicia. The cited references collectively supplied upright, elevated, cap mounted labels that improve communication of drug information, then the need was satisfied by others before the effective filing date of the claimed invention contrary to applicant’s assertion.
In response to argument section IV, with regard the first, second and third paragraph, again, the test for obviousness is individual references teaches every limitation of the claim. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Here, Simmons suggest a removable indicia attached to the cap. That cap-mounded indica by incorporating Adler’s upper component, which extends upwardly and orthogonally from the cap, and Chapman supplies the intervening stem structure between the upper component and the base, and the upper component having relatively larger surface compare to the cap, thereby providing additional surface area for useful information while maintaining elevated, two-sided display.
This is not found persuasive. Applicant’s assertion of long-felt need is a conclusory statement unsupported by objective evidence. To establish a long-felt need, an applicant must provide evidence that the need was a persistent one that was recognized by those of ordinary skill in the art and was not satisfied by the prior art (see MPEP 716.04). No such evidence (e.g., declarations) has been provided to show that the industry recognized the “display area” of the prior art as a problem that needs to be solved. Moreover, the cited prior art already satisfies the very need Applicant identifies. Chapman discloses an upright indicator positioned above the cap that provided improved visibility. Adler expressly teach an upper display portion that “extends beyond cap… visible when the container is stored”. Simmons teaches cap-mounted condition indicia. The cited references collectively supplied upright, elevated, cap mounted labels that improve communication of drug information contrary to applicant’s assertion.
Although each individual references does not expressly teach the claimed invention, the combination of references provides a predictable result i.e., positing upright label (Adler) and mounting it on an elevated stem (Chapman) to a known base (Simmons), and without the evidence, the fact that no one made combination earlier does not rebut the prima facie case obviousness.
For the reasons above, applicant’s argument is not found persuasive, and the rejection is mutinied.
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.
Claims 1, 4, 5, 7, 8 12, 13, 15-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Simmons et al (US 20120305177 A1) in view of Adler (US 7942451 B2) and Chapman (US 0576833 A).
Regarding Claim 1, Simmons teaches an indicator (figures 2-3, [0015] and [0033], removably-couplable tag 130 is configured to identify contents in bottle 120 that is closed with a cap 112 and configured to identify medical condition treated with the contents) for identifying a condition to be treated by a medication stored within a medicine container that is closed with a cap, said indicator comprising:
a base (figure 3, body of tab 130 coupled the cap 120) coupled to the cap of the medicine container;
a usage indicia (figure 3 [0015] and [0033], indicia 150 describing what medical condition medication is located in bottle ) comprising a visual representation of a condition to be treated by the medication and supported by one of said first and said second sides of said upper component such that said usage indicia is visible to a user; and
Simmons does not teach the indicator comprising an upper component extending upwardly for said base and orthogonal to the cap and having a first side and a second side;
In the same field of endeavor, namely a medication packaging and labeling system, Adler teaches the indicator (figure 7, information card 48 including an upper portion 54) comprising an upper component (figure 7 col 12 lines 15-30, upper portion 54 extends beyond the cap 40 comprising front and back side) extending upwardly for said base and orthogonal to the cap and having a first side and a second side;
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Simmons to incorporate the teachings of Adler and provides the upper component as claimed for the purpose of enhancing visibility when the container is positioned at eye level, for example when the container stored in a cabinet shelf, as taught by Adler (col 12 lines 15-30).
The combination is still silent as to a stem disposed between said base and said upper component and extending away from the cap to space said upper component from the cap for allowing the usage indica to be displayed above the container for easier viewing;
the upper component joined to the stem; and
wherein said upper component presents a surface area larger than an area of the cap to display said visual representation and said first and said second sides are planar for easier viewing of said visual representation while the container is stored.
In the same field of endeavor, namely a medicine time indicators for bottles, Chapman teaches a stem (figure 1, shank 1 disposed between plate 2 elastic sections 3 and 4 and extending away from the cap) disposed between said base and said upper component and extending away from the cap to space said upper component from the cap for allowing the usage indica to be displayed above the container for easier viewing;
The upper component joined to the stem (figure 1, display 2 joined to shank 1)); and
said upper component (figure 1, plate 2) presents a surface area larger than an area of the cap (see figure 1, the surface area of plate is larger than an arear of cap of bottle) to display said visual representation and said first and said second sides are planar for easier viewing of said visual representation while the container is stored.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Simmons, as modified by Alder, to incorporate the teachings of Chapman and provides the upper component as claimed for the purpose of providing a larger space for useful information for drug and enhanced visibility by providing upright position above the mouth of the bottle as taught by Chapman (col 1 line 44- col 2 line 65).
Regarding Claim 4, Simmons, as modified by Adler and Chapman, teaches the indicator as set forth in claim 1.
The combination further teaches comprising an attachment medium securing said base to the cap (Simmons; [0035] and figure 3, tab 130 includes adhesive backing 134 configured to adhere the tag to the cap )
Regarding Claim 5, Simmons, as modified by Adler and Chapman, teaches the indicator as set forth in claim 4.
The combination further teaches wherein said attachment medium is further defined as a releasable connection such that said indicator can be removed from the cap (Simmons; [0035]-[0036] the adhesive backing 134 is configured to form a temporary bond that can be removed)
Regarding Claim 7, Simmons, as modified by Adler and Chapman, teaches the indicator as set forth in claim 4.
The combination further teaches wherein said attachment medium is further defined as an adhesive disposed between said base and the cap to secure said indicator thereto (Simmons; [0035]-[0036] adhesive backing 134 disposed between the cap and the base).
Regarding Claim 8, Simmons, as modified by Adler and Chapman, teaches the indicator as set forth in claim 1.
The combination does not teach wherein said base is integrally formed with the cap.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Simmons, as modified by Adler and Chapman, teaches such that the said base is integrally formed with the cap as such a modification would have been an obvious matter of design choice involving a making integra. A making integral generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04 V). One of the skill in the art motivated to do so for the purpose of providing secure connection between indicator and cap assembly, and providing simple manufacturing process.
Regarding Claim 12, Simmons, as modified by Adler and Chapman, teaches the indicator as set forth in claim 1.
The combination does not teach wherein said usage indica is removable from said upper component to allow for different identification of conditions;
though the combination teaches the upper component is removable from the cap to allow for different identification of conditions (see claim 5 rejection above);
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Simmons, as modified by Adler and Chapman, such that the usage indica is removable from the upper component instead of the upper component being removable from the cap as such a modification would have been an obvious matter of design choice involving a rearrangement of parts. A rearrangement of parts is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144 VI). One of skill in the art motivated to do so for the purpose of providing secure attachment between the upper compartment and the cap while providing replaceable indicia that informs the drug stored within the container.
Regarding Claim 13, Simmons teaches a cap (figure 3 cap 120 for bottle 120) for a medicine container comprising
a body (figure 3, body of cap 120 comprising an outer surface 114 and inner surface 116) having an upper surface and an underside surface, said underside surface having a connector for mating with an opening of a medicine container for closing the opening ([0030]); and an indicator for identifying a condition to be treated (figures 2-3, [0010] and [0033] removable tag 130), said indicator comprising;
a base (figure 3, body of tag 130) coupled to said cap of the medicine container,
a usage indicia (figure 3 [0015] and [0033] indicia 150 describing what medical condition medication is located in the bottle) comprising a visual representation of a condition to be treated by the medication and supported by one of said first and said second sides of said upper component such that said usage indicia is visible to a user; and
Simmons does not teach the indicator comprising an upper component extending upwardly for said base and orthogonal to said cap and having a first side and a second side,
In the same field of endeavor, namely a medication packaging and labeling system, Adler teaches the indicator (figure 7, information card 48 including an upper portion 54) comprising an upper component (figure 7 col 12 lines 15-30, upper portion 54 extends beyond the cap 40 comprising front and back side) extending upwardly for said base and orthogonal to the cap and having a first side and a second side;
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Simmons to incorporate the teachings of Adler and provides the upper component as claimed for the purpose of enhancing visibility when the container is positioned at eye level in a cabinet shelf, as taught by Adler (col 12 lines 15-30).
The combination is still silent as to a stem disposed between said base and said upper component and extending away from the cap to space said upper component from the cap for allowing the usage indicia to be displayed above the container for easier viewing.
wherein said upper component presents a surface area larger than an area of said cap to display said visual representation and said first and said second sides are planar for easier viewing of said visual representation while the container is stored.
In the same field of endeavor, namely a medicine time indicators for bottles, Chapman teaches
a stem disposed between said base and said upper component and extending away from the cap to space said upper component from the cap for allowing the usage indicia to be displayed above the container for easier viewing (Chapman; figure 1, shank 1 disposed between plate 2 elastic sections 3 and 4 and extending away from the cap);
said upper component (figure 1, plate 2) presents a surface area larger than an area of the cap (see figure 1, the surface area of plate is larger than an arear of cap of bottle) to display said visual representation and said first and said second sides are planar for easier viewing of said visual representation while the container is stored.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Simmons, as modified by Alder, to incorporate the teachings of Chapman and provides the upper component as claimed for the purpose of providing a space for useful information for drug and enhanced visibility.
Regarding Claim 15, Simmons, as modified by Adler and Chapman, teaches the cap as set forth in claim 13.
The combination does not teach wherein said base is integrally formed with the cap.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Simmons, as modified by Adler and Chapman, teaches such that the said base is integrally formed with the cap as such a modification would have been an obvious matter of design choice involving a making integra. A making integral generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04 V). One of the skill in the art motivated to do so for the purpose of providing secure connection between indicator and cap assembly, and providing simple manufacturing process.
Regarding Claim 16, Simmons, as modified by Adler and Chapman, teaches the cap as set forth in claim 13.
The combination further teaches comprising an attachment medium securing said base to the cap (Simmons; [0035] and figure 3, tab 130 includes adhesive backing 134 configured to adhere the tag to the cap )
Regarding Claim 17, Simmons, as modified by Adler and Chapman, teaches the cap as set forth in claim 16.
The combination further teaches wherein said attachment medium is further defined as a releasable connection such that said indicator can be removed from the cap (Simmons; [0035]-[0036] the adhesive backing 134 is configured to form a temporary bond that can be removed)
Regarding Claim 19, Simmons, as modified by Adler and Chapman, teaches the cap as set forth in claim 17.
The combination further teaches wherein said attachment medium is further defined as an adhesive disposed between said base and the cap to secure said indicator thereto (Simmons; [0035]-[0036] adhesive backing 134 disposed between the cap and the base).
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Simmons et al (US 20120305177 A1) in view of Adler (US 7942451 B2) and Chapman (US 0576833 A), and in further view of Herbert et al (US 20140231301 A1).
Regarding Claim 2, Simmons, as modified by Adler and Chapman, teaches the indicator as set forth in claim 1.
The combination does not teach wherein said usage indicia further comprises a dosage indicator indicating an appropriate dose of the medication to be consumed by the user.
In the same field of endeavor, namely a container for medication, Herbert teaches said usage indicia ([0048]-[004] exemplary labels comprises information indicating number of pills to be taken) further comprises a dosage indicator indicating an appropriate dose of the medication to be consumed by the user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Simmons, as modified by Adler and Chapman, to incorporate the teachings of Herbert and provide the usage indica as claimed for the purpose of providing tailored dosage information for individual.
Regarding Claim 3, Simmons, as modified by Adler and Chapman and Herbert, teaches the indicator as set forth in claim 2.
The combination does not teach wherein said usage indicia further comprises a time indicator indicating an approximate time that the medication is to be consumed by the user.
In the same field of endeavor, namely a container for medication, Herbert teaches said usage indicia further comprises a time indicator indicating an approximate time that the medication is to be consumed by the user ([0048] exemplary labels comprises a time indicator).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Simmons, as modified by Adler, Chapman and Herbert, to incorporate the teachings of Herbert and provide the usage indica as claimed for the purpose of providing tailored dosage information for individual.
Claims 6 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Simmons et al (US 20120305177 A1) in view of Adler (US 7942451 B2) and Chapman (US 0576833 A), and in further view of Barker et al (US 5803283 A).
Regarding Claim 6, Simmons, as modified by Adler and Chapman, teaches the indicator as set forth in claim 5.
The combination does not teach wherein said attachment medium is further defined as a hook-and-loop-fastener with a hook portion adhered to one of said base or the cap and a loop portion adhered to the other.
In the same field of endeavor, namely an indicator cap, Barker teaches wherein said attachment medium is further defined as a hook-and-loop-fastener with a hook portion adhered to one of said base or the cap and a loop portion adhered to the other (col 4 lines 30-55, indicator device can be mounted to the cap by Velcro hook and loop fastener).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Simmons, as modified by Adler and Chapman, to incorporate the teachings of Barker and provide the attachment medium as claimed, as the modification would have been a simple substitution of one known element (releasable adhesive of Simmons) with another (hook-and-loop-fastener) as taught by Baker, with a reasonable expectation of success. A substitution of one known element for another to obtain predictable results is generally recognized as being within the level of ordinary skill in the art (see MPEP 2143). One of skill in the art motivated to do so for the purpose of providing releasable connection that is resistant to dirt contamination.
Regarding claim 18, Simmons, as modified by Adler and Chapman, teaches the cap as set forth in claim 17.
The combination does not teach wherein said attachment medium is further defined as a hook-and-loop-fastener with a hook portion adhered to one of said base or the cap and a loop portion adhered to the other.
In the same field of endeavor, namely an indicator cap, Barker teaches wherein said attachment medium is further defined as a hook-and-loop-fastener with a hook portion adhered to one of said base or the cap and a loop portion adhered to the other (col 4 lines 30-55, indicator device can be mounted to the cap by Velcro hook and loop fastener).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Simmons, as modified by Adler and Chapman, to incorporate the teachings of Barker and provide the attachment medium as claimed, as the modification would have been a simple substitution of one known element (releasable adhesive of Simmons) with another (hook-and-loop-fastener) as taught by Baker, with a reasonable expectation of success. A substitution of one known element for another to obtain predictable results is generally recognized as being within the level of ordinary skill in the art (see MPEP 2143). One of skill in the art motivated to do so for the purpose of providing releasable connection that is resistant to dirt contamination.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Simmons et al (US 20120305177 A1) in view of Adler (US 7942451 B2) and Chapman (US 0576833 A), and in further view of Wolpa (US 5992073 A)
Regarding Claim 10, Simmons, as modified by Adler and Chapman, teaches the indicator as set forth in claim 1.
The combination does not teach wherein said upper component is further defined as comprising a frame substantially surrounding and defining an opening for receiving said usage indicia.
In the same field of endeavor, namely a contents identification device, Wolpa teaches wherein said upper component is further defined as comprising a frame (figure 2 col 4 lines 4-15, identification device 10 comprising a window frame 23 and slot opening 34 substantially surrounding label means 40) substantially surrounding and defining an opening for receiving said usage indicia.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Simmons, as modified by Adler and Chapman, to incorporate the teachings of Wolpa and provides the upper component as claimed for the purpose of providing aesthetically replaceable indicator that informs medicine stored within the container
Regarding Claim 11, Simmons, as modified by Adler, Chapman and Wolpa, teaches the indicator as set forth in claim 10.
The combination further teaches wherein said usage indicia is further defined as an insert (Wolpa; Figure 2, col 4 lines 4-15, col 5 lines 40-45, label means 40 can be changed indicating information corresponding to the new contents) configured to be received by said opening of said frame such that said usage indicia can be changed based on the medication in the container.
Conclusion
THIS ACTION IS MADE FINAL. 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 SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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/S.H./Examiner, Art Unit 3781
/JESSICA ARBLE/ Primary Examiner, Art Unit 3781