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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/14/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because:
Fig. 10-12: Decision trees don't show the .
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.
Specification
Regarding “Title of the Invention”:
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested:
'Medication blister pack with contacts to monitor the removal of medication and monitoring of contacts'. (based on the initially filed specification page 4 line 30 to page 5 line 7)
Regarding “Abstract”:
The abstract of the disclosure is objected to because:
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; however, the Abstract does not disclose that the invention is (or is a part of) a medical blister pack.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 1 objected to because of the following informalities:
Claim 1 line 9 states "an evaluation circuit (150) that can be and/or is electrically coupled"; if it is true that 'it is electrically coupled then it is also true that 'it can be electrically coupled'. Examiner recommends (instead of the quoted line with "and/or") using 'an evaluation circuit (150) that can be electrically coupled' or equivalent .
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
1) Claim 1 lines 13-15 : “wherein the evaluation circuit (150) is configured to determine a coupling state of the primary contacts (112, 122) depending on a contact between the first and second test contacts (113, 114, 123, 124)”.
2) Claim 2 lines 1-4: “wherein the evaluation circuit (150) is configured to determine the coupling state as insufficient if no electrical contact is formed between one of the first and one of the second test contacts (113, 114, 123, 124)”
3) Claim 4 lines 2-4: “wherein the evaluation circuit (150) is configured to determine the coupling state of the primary contacts (113, 114, 123, 124) depending on contacting of the first and second test contacts (113, 114, 123, 124) with one another and the further first and second test contacts (116, 117, 126, 127)) to determine the coupling state of the primary contacts (113, 114, 123, 124)”
4) Claim 5 lines 4-7: “wherein the evaluation circuit (150) is configured to determine the coupling state depending on a value of an electrical resistance between the first and the second test contacts (113, 114, 123, 124)”
5) Claim 8 lines 2-4: “in which the evaluation circuit (150) is configured to determine that the contacting is insufficient if at least one of the first test contacts (113, 114) is arranged at a distance from the corresponding second test contact (123, 124)”
6) Claim 9 lines 3-4: “the evaluation circuit (150) is configured to control the removal of medication from the medication blister”
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Three-Prong test for:
Claim 1 lines 13-15 : “wherein the evaluation circuit (150) is configured to determine a coupling state of the primary contacts (112, 122) depending on a contact between the first and second test contacts (113, 114, 123, 124)”
Prong (A) (as above)
Yes;
“the evaluation circuit” is a nonce with no specific structural meaning.
Prong (B) (as above)
Yes;
“configured to” is a linking word or phrase connecting the nonce to functional language.
Prong (C) (as above)
Yes;
It is unclear how to “determine a coupling state of the primary contacts (112, 122) depending on a contact between the first and second test contacts (113, 114, 123, 124)”
Conclusion:
The limitation of:
“the evaluation circuit” for claim 1 and its dependents is interpreted under 35 U.S.C. §112(f).
Claims 2, 4-5, & 8-9 for the same element (i.e. “the evaluation circuit”) are evaluated similarly under 35 U.S.C. §112(f).
Note: the initially filed specifications (11/14/2024) was searched for an interpretation of the functionality of “the evaluation circuit”.
Support for an interpretation was found in page 2 lines 21-28:
“The evaluation circuit is therefore configured, for example, to apply an electrical current and/or an electrical voltage to the test contacts and to determine whether a closed circuit is present. The evaluation circuit is configured to check the test contacts for the presence of an electrical connection. According to at least one further embodiment, the evaluation circuit is configured to determine the coupling state as insufficient if there is no electrical contact between one of the first test contacts and one of the second test contacts.”
For the purposes of examination, “an evaluation circuit” is interpreted as an electrical circuit which tests for electrical continuity between electrical contacts.
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.
Claims 1-15 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.
Regarding “Failure to particularly point out & distinctly claim [indefinite]”:
Claim 1 line 3 states "two first test contacts (113, 114)" and in lines 12-13 states "second primary contacts (113, 114, 123, 124)". Some of the elements (such as the elements 113 and 114) are being referred to by different names or are being referred to by incorrect names.
Claim 1 in lines 14-15 recites the limitation "to determine a coupling state of the primary contacts (112, 122) depending on a contact between the first and second test contacts (113, 114, 123, 124)". It is not clear what the primary contacts are for since the test circuit is described as determining the connectivity of the test contacts but not of the primary contacts. One of ordinary skill would not know why there are primary contacts.
Claim 1 in lines 11-12 recites the limitation "wherein the first contact arrangement (110) and the second contact arrangement (120) are arrangeable on one another". It is not clear what “arrangement” or “arrangeable on one another” means; this could mean that there is one or any number of arrangements in which elements could be combined. For the purposes of examination it is assumed that this is meant to imply that ‘electrical connection(s) can be made’.
Claim 6 in line 3 recites the limitation "are releasably connectable to one another" while Claim 7 in line 3 recites the limitation "releasably fixed". It is not clear what the difference between “releasably connectable” and “releasably fixed” is intended to be (in common vernacular the word ‘fixed’ suggests ‘not releasable’).
Claim 8 in lines 2-4 recites the limitation "in which the evaluation circuit (150) is configured to determine that the contacting is insufficient if at least one of the first contacts (113, 114) is arranged at a distance from the corresponding second test contact (123, 124).". It is not clear from the claim language what would be determined to be “insufficient” or ‘sufficient’; ‘insufficient’ means with regard to some functionality but it isn’t clear what the functionality is which is being determined to be insufficient. For the purposes of examination (and based on claim 2), it is assumed that “insufficient” means that ‘current doesn’t flow through the contacts’.
Claim 9 in line 4 recites the limitation "to control the removal of medication from the medication blister". It is not clear how ‘control’ could be applied to the medication blister. ‘control’ implies being able to stop and start removal of medicine, but this system seems to ‘monitor’ the medication blister.
Claim .
Claim 10 in line 10 recites the limitation "arranging the first and second contact arrangements (110, 120) on top of each other". It is not clear what “arrangements” or “arranging” means; this could mean that there is one or any number of arrangements in which elements could be combined. For the purposes of examination it is assumed that this is meant to imply that ‘electrical connection(s) can be made’.
Claim 10 in lines 15-16 recites the limitation "determining the coupling state of the primary contacts depending on the contacting determined". It is not clear what the primary contacts are for since the test circuit is described as determining the connectivity of the test contacts but not of the primary contacts. One of ordinary skill would not know why there are primary contacts if they are not for carrying some sort of electrical signal.
Regarding “Lack of antecedent basis in the claims”:
Claims 2-9 in line 1 (each claim) recites the limitation "The arrangement according to claim 1". There is insufficient antecedent basis for this limitation in the claim. Claim 1 line 1 states “An arrangement comprising …”, however, then later in the claim also states “a first contact arrangement” & “a second contact arrangement”. Therefore successive references to “arrangement” could refer to either “an arrangement comprising …” (of claim 1 line 1) or the ‘contact arrangements’. The Examiner recommends amending claim 1’s first line to “an arrangement for determining an electrical coupling state comprising …” and for each dependent claim “the arrangement for determining an electrical coupling state of claim 1 comprising …”
Note: the first instance of an element should be in the form “a [unique descriptive terminology]” and successive references to that element should be in the form “the [unique descriptive terminology]” where [unique descriptive terminology] is the same throughout the claims. This is necessary because similarly phrased elements can be patentably distinct.
Regarding ‘rejected for inheriting the rejected limitation(s) of a parent claim without rectifying the issue(s) for which the parent claim(s) were rejected’:
Claims 2-9, & 11-15 are rejected for inheriting the rejected limitations of parent claim 1, & 10 (respectively).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 7489594 B2 (Simon) in view of US 11357700 B2 (Bouthiette).
Regarding claim 1, Simon teaches an arrangement comprising: - a first contact arrangement (110) comprising a first substrate (111) (contacts necessarily imply a substrate), first primary contacts (112) (Fig. 3-9a: contact pads, column 4 lines 7-9: “the printed circuit board 8 has on one side a pattern of individual contact pads 9a to 9g and a common contact pad 10”), … , wherein the first primary contacts (112) and the first test contacts (113, 114) are arranged on the first substrate (111), - a second contact arrangement (120) comprising a second substrate (121), second primary contacts (122) (Fig. 3: the second contact arrangement with second contacts are the parts that complete the electric circuit when the contacts are closed, these necessarily exist if there are contacts and an electric circuit) … , wherein the second primary contacts (122) and the second test contacts (123, 124) are arranged on the second substrate (121) (a circuit with electrical contacts requires that there be second contacts which contact first contacts in order to complete the circuit), - an evaluation circuit (150) (determinations based on electric circuits necessarily imply an “evaluation circuit” ) that can be and/or is electrically coupled to the first test contacts (113, 114) and/or the second two test contacts (123, 124) (column 5 lines 6-11: “where the electronics unit or an electronics module (not represented) contained in the receiving part 23 (or in the holding device) is connected via the individual connect contacts 24a to 24g to the individual connection contact pads 14a to 14g and 15 (cf. FIG. 4) of the blister pack 1”, evaluation circuit/(“electronics unit”)), - wherein the first contact arrangement (110) and the second contact arrangement (120) are arrangeable on one another in order to couple the first and the second primary contacts (113, 114, 123, 124) electrically to one another (Fig. 3: printed circuit, column 3 lines 4-5: “FIG. 3: a printed circuit board with printed conductors and openings for the removal of pills seen from above,”, circuit board requires that a closed contact “contacts electrically to one another” or the circuit wouldn’t be a ‘circuit’ (closed loop)), wherein the evaluation circuit (150) is configured to determine a coupling state of the primary contacts (112, 122) depending on a contact between the first and second test contacts (113, 114, 123, 124) (column 2 lines 36-40: “This coding is, for example, possible by the stamping of slots on the printed circuit board, which interrupts closed contacts of the electronics unit or by printing of conductive contact pads whose different arrangement can be assigned to a corresponding drug contained in the blister.”, to determine/(“coding”) a coupling state/(“closed contacts”)).
Simon does not explicitly teach … and two first test contacts (113, 114) … and two second test contacts (123, 124).
Bouthiette teaches … and two first test contacts (113, 114) (Fig. 10-428: “alignment pin”, column 11 lines 14-18: “The locking and/or alignment pin (428) is shaped, sized and configured so as to be inserted within a respective one of the electronic card apertures (322a, 322b) so as to lock or align the electronic support (302) with or within the electronic card housing (410).”, test contacts/(“alignment pins”) … and two second test contacts (123, 124) (necessarily required by the first test contacts or there wouldn’t be a complete circuit)
It would have been obvious to one of ordinary skill in the relevant art before the effective filing date of the claimed invention to have modified the device taught by Simon with the teachings of Bouthiette. One would have added to the “Blister Pack System” with electrical contacts of Simon the “Wireless Medication Blister Pack System And Blister Pack Attachment” with alignment functionality of Bouthiette. One of ordinary skill in the art could foresee that the alignment functionality could be performed by electrical contacts such as those of Simon. The motivation would have been that incorrect alignment of contacts would result in incorrect signals and determinations of which medications had been taken and in what amounts (see Simon column 2 lines 20-24: “Incorrect recording of signals due to incorrect insertion of the blister pack arrangement into the holding device can be reliably avoided. This is achieved by the fact that the electronics unit is only activated when the blister pack arrangement is in the correct position to contact the plug.”)
Regarding claim 2, Simon in view of Bouthiette teaches the arrangement according to claim 1,
Bouthiette further teaches wherein the evaluation circuit (150) is configured to determine the coupling state as insufficient if no electrical contact is formed between one of the first and one of the second test contacts (113, 114, 123, 124) (Fig. 10-428: “alignment pin”, column 11 lines 14-17: “alignment pin (428) is shaped, sized and configured so as to be inserted within a respective one of the electronic card apertures (322a, 322b) so as to lock or align the electronic support (302)”, poorly aligned circuits would result in an coupling state which is insufficient).
Regarding claim 3, Simon in view of Bouthiette teaches the arrangement according to claim 1,
Simon further teaches in which the first substrate (111) comprises a printed circuit board and/or a foil and/or a housing and the second substrate (121) comprises a printed circuit board and/or a foil and/or a housing (column 1 lines 61-64: “This objective is realized by a connection of a blister pack arrangement with printed conductors and a printed circuit board with a child-safety covering foil with the features described herein.”).
Regarding claim 4, Simon in view of Bouthiette teaches the arrangement according to claim 1,
Simon further teaches wherein the evaluation circuit (150) is configured to determine the coupling state of the primary contacts (113, 114, 123, 124) depending on contacting of the first and second test contacts (113, 114, 123, 124) with one another and the further first and second test contacts (116, 117, 126, 127)) to determine the coupling state of the primary contacts (113, 114, 123, 124), wherein the coupling state comprises information about the positioning of the first contact arrangement (110) and the second contact arrangement (120) relative to one another (determinations based on electric circuits necessarily imply an “evaluation circuit”, if the contacts are touching then the circuit board and the blister pack are aligned (information about the positioning)).
Bouthiette further teaches wherein the first contact arrangement (110) has two further first test contacts (116, 117) and the second contact arrangement (120) has two further second test contacts (126, 127) (Fig. 10-428: “alignment pin”, there are two alignment pins and the line between them is necessary to align the attached components and for electrical contacts there would have to be two pairs of contacts (two pads to complete each circuit)),
Regarding claim 5, Simon in view of Bouthiette teaches the arrangement according to claim 1,
Simon further teaches wherein the evaluation circuit (150) is configured to determine the coupling state depending on a value of an electrical resistance between the first and the second test contacts (113, 114, 123, 124) (column 4 lines 26-30: “FIG. 4, seen from above, shows the state in which the printed circuit board 8 is fastened to the blister pack 1, where the contact pads 5a to 5g of the blister pack 1 (cf. FIG. 2) are then electrically connected to the corresponding contact pads 9a to 9g (cf. FIG. 3, 4) of the printed circuit board 8”).
Regarding claim 6, Simon in view of Bouthiette teaches the arrangement according to claim 1,
Simon further teaches wherein the first contact arrangement (110) and the second contact arrangement (120) are releasably connectable to one another (Fig. 5-2a: “peel back paper off”, column 3 lines 12-13: “FIG. 5: a printed circuit board partially provided with pull-off strips,”, system is designed so that new packets can be connected to the evaluation circuitry which requires that they be releasably connectable).
Regarding claim 7, Simon in view of Bouthiette teaches the arrangement according to claim 1,
Simon further teaches wherein the evaluation circuit (150) is fixed to the second substrate (121), in particular releasably fixed (column 5 lines 4-11: “The present blister pack arrangement is according to FIGS. 4a and b, inserted into a schematically represented receiving part 23 of a holding device not represented in more detail, where the electronics unit or an electronics module (not represented) contained in the receiving part 23 (or in the holding device) is connected via the individual connect contacts 24a to 24g to the individual connection contact pads 14a to 14g and 15 (cf. FIG. 4) of the blister pack 1.”, releasably fixed/(“inserted”) so that the evaluation electronics can be kept while the used blister packs are discarded).
Regarding claim 8, Simon in view of Bouthiette teaches the arrangement according to claim 1,
Bouthiette further teaches in which the evaluation circuit (150) is configured to determine that the contacting is insufficient if at least one of the first test contacts (113, 114) is arranged at a distance from the corresponding second test contact (123, 124) (Fig. 10-428: “alignment pin”, column 11 lines 14-17: “alignment pin (428) is shaped, sized and configured so as to be inserted within a respective one of the electronic card apertures (322a, 322b) so as to lock or align the electronic support (302)”, poorly aligned circuits would result in an coupling state which is insufficient).
Regarding claim 9, Simon in view of Bouthiette teaches the arrangement according to claim 1,
Simon further teaches wherein the first contact arrangement (110) and/or the second contact arrangement (120) is part of a medication blister and the evaluation circuit (150) is configured to control the removal of medication from the medication blister (Fig. 3-2a: “pill basins”, column 3 lines 36-41: “The present blister pack arrangement includes generally a blister pack which can be seen from FIGS. 1 and 2, said blister pack having several pill basins or pockets 2a to 2g which are customary per se and serve to receive medicaments, in particular tablets, pills, or dragees 20, and a printed circuit board 8 (FIGS. 3 and 4)”, Note: the instant application apparently does not mean ‘control’ as in ‘able to start or stop’ but rather ‘to monitor’).
Regarding claim 10, Simon teaches a method for determining a coupling state of a first contact arrangement (110) and a second contact arrangement (120), wherein the first contact arrangement (110) has a first substrate (111) (contacts necessarily imply a substrate), first primary contacts (112) (Fig. 3-9a: contact pads, column 4 lines 7-9: “the printed circuit board 8 has on one side a pattern of individual contact pads 9a to 9g and a common contact pad 10”) … , wherein the first primary contacts (112) and the first test contacts (113, 114) are arranged on the first substrate (111), and wherein the second contact arrangement (120) has a second substrate (121), second primary contacts (122) (Fig. 3: the second contact arrangement with second contacts are the parts that complete the electric circuit when the contacts are closed, these necessarily exist if there are contacts and an electric circuit) … , wherein the second primary contacts (122) and the second test contacts (123, 124) are arranged on the second substrate (121) (a circuit with electrical contacts requires that there be second contacts which contact first contacts in order to complete the circuit), the method comprising: - arranging the first and second contact arrangements (110, 120) on top of each other (Fig. 3 & Fig. 4: column 3 lines 6-12: “FIGS. 4, 4a, and 4b: the printed circuit board of FIG. 3 seen from above with opened blister pack. For explanation: different features of the invention, where FIG. 4a shows the blister pack arrangement before insertion into the receiving part and FIG. 4b shows the blister pack arrangement after insertion into the receiving part”, on top of each other/(after insertion the circuit board and the blister pack are on top of each other)), …
Simon does not explicitly teach … and two first test contacts (113 , 114) … and two second test contacts (123, 124)
Bouthiette teaches … and two first test contacts (113 , 114) (Fig. 10-428: “alignment pin”, column 11 lines 14-18: “The locking and/or alignment pin (428) is shaped, sized and configured so as to be inserted within a respective one of the electronic card apertures (322a, 322b) so as to lock or align the electronic support (302) with or within the electronic card housing (410).”, test contacts/(“alignment pins”) … and two second test contacts (123, 124) (necessarily required by the first test contacts or there wouldn’t be a complete circuit)… - applying a test electrical current to at least one of the first and/or at least one of the second test contacts (113, 114, 123, 124), - detecting a contacting of the first and second test contacts (113, 114, 123, 124) with each other depending on a response to the test current, - determining the coupling state of the primary contacts depending on the contacting determined (test contacts and applying a test signal to those test contacts is about checking the alignment of the blister pack which Bouthiette teaches, the electrical signals is taught by Simon).
It would have been obvious to one of ordinary skill in the relevant art before the effective filing date of the claimed invention to have modified the method taught by Simon with the teachings of Bouthiette. One would have added to the “Blister Pack System” with electrical contacts of Simon the “Wireless Medication Blister Pack System And Blister Pack Attachment” with alignment functionality of Bouthiette. One of ordinary skill in the art could foresee that the alignment functionality could be performed by electrical contacts such as those of Simon. The motivation would have been that incorrect alignment of contacts would result in incorrect signals and determinations of which medications had been taken and in what amounts (see Simon column 2 lines 20-24: “Incorrect recording of signals due to incorrect insertion of the blister pack arrangement into the holding device can be reliably avoided. This is achieved by the fact that the electronics unit is only activated when the blister pack arrangement is in the correct position to contact the plug.”)
Regarding claim 11, Simon in view of Bouthiette teaches the method according to claim 10,
Simon further teaches comprising: - determining the contacting as insufficient if the test current does not flow between one first and one second test contact (113, 114, 123, 124) (Fig. 9-37: “contact springs”, column 6 lines 36-40: “the contact springs 37 according to FIGS. 9a and 9b are fastened to an upper printed circuit board 30 so that their contact areas abut, in the manner of a spring, a contact pad 32 of a lower printed circuit board 31 opposite the upper printed circuit board 30”, if the contacts don’t connect then the current won’t flow indicating that the circuit board and the blister pack are not aligned).
Regarding claim 12, Simon in view of Bouthiette teaches the method according to claim 10,
Simon further teaches the method comprising: - applying a further test current to the further first and/or the further second test contacts (116, 117, 126, 127), - determining the contacting of the further first and second test contacts (116, 117, 126, 127) with one another depending on a response to the further test current, - determining a positioning of the first contact arrangement (110) and the second contact arrangement (120) relative to one another depending on the contacting determined(determinations based on electric circuits necessarily imply an “evaluation circuit”, if the contacts are touching then the circuit board and the blister pack are aligned (information about the positioning)).
Bouthiette further teaches wherein the first contact arrangement (110) comprises two further first test contacts (116, 117) and the second contact arrangement (120) comprises two further second test contacts (126, 127) (Fig. 10-428: “alignment pin”, there are two alignment pins and the line between them is necessary to align the attached components and for electrical contacts there would have to be two pairs of contacts (two pads to complete each circuit)),
Regarding claim 13, Simon in view of Bouthiette teaches the method according to claim 10,
Simon further teaches comprising: - determining a value of an electrical resistance between the first and second test contacts (113, 114, 123, 124), - determining the coupling state depending on the value of the electrical resistance (column 2 lines 36-40: “This coding is, for example, possible by the stamping of slots on the printed circuit board, which interrupts closed contacts of the electronics unit or by printing of conductive contact pads whose different arrangement can be assigned to a corresponding drug contained in the blister.”, to determine/(“coding”) a coupling state/(“closed contacts”)).
Regarding claim 14, Simon in view of Bouthiette teaches the method according to claim 10,
Simon further teaches comprising: - fixing an evaluation circuit (150) to the second substrate (121) so that the evaluation circuit (150) is electrically connected to the second test contacts (123, 124), - removing the evaluation circuit (150) from the second substrate (121) after the coupling state has been determined (column 5 lines 4-11: “The present blister pack arrangement is according to FIGS. 4a and b, inserted into a schematically represented receiving part 23 of a holding device not represented in more detail, where the electronics unit or an electronics module (not represented) contained in the receiving part 23 (or in the holding device) is connected via the individual connect contacts 24a to 24g to the individual connection contact pads 14a to 14g and 15 (cf. FIG. 4) of the blister pack 1.”, releasably fixed/(“inserted”) so that the evaluation electronics can be kept while the used blister packs are discarded).
Regarding claim 15, Simon in view of Bouthiette teaches the method according to claim 10,
Simon further teaches wherein the first contact arrangement (110) and/or the second contact arrangement (120) is part of a medication blister, the method comprising: - detecting a medication removal from the medication blister (Fig. 3-2a: “pill basins”, column 3 lines 36-41: “The present blister pack arrangement includes generally a blister pack which can be seen from FIGS. 1 and 2, said blister pack having several pill basins or pockets 2a to 2g which are customary per se and serve to receive medicaments, in particular tablets, pills, or dragees 20, and a printed circuit board 8 (FIGS. 3 and 4)”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 9904885 B2 "Wireless Medication Compliance Sensing Device, System, And Related Methods" (Sengstaken) is relevant to the Applicant's disclosure, see Fig. 2.
US 9717653 B2 "Conductive Grid Sensor For Smart Packaging" (Harris) is relevant to the Applicant's disclosure, see Fig. 1 & Fig. 3.
US 20230009860 A1 "Evaluation Device for an Electrotonically Readable Blister Pack (Wiedermann) is relevant to the Applicant's disclosure, see Fig. 1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN WALTER BRAUNLICH whose telephone number is (571)272-3178. The examiner can normally be reached Monday-Friday 7:30 am-5:00 pm.
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, Huy Phan can be reached at (571) 272-7924. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN WALTER BRAUNLICH/ Examiner, Art Unit 2858
/HUY Q PHAN/ Supervisory Patent Examiner, Art Unit 2858
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