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 .
Drawings
The drawings are objected to because of the following:
Figs. 2a and 2b each contain reference numeral “150” twice labeling what appears to be two separate structures. The Examiner would like further confirmation and clarity regarding what each of the reference numeral “150” is labeling in Figs. 2a and 2b.
Fig. 2b includes reference numeral “12-.” The Examiner believes this is a typographical error. The Examiner suggests amending this to recite “120” labeling the adhesive patch.
Fig. 3b includes reference numeral 10. The Examiner believes this to be a typographical error and suggests removing or amending this reference numeral because the specification does not include a reference numeral “10.”
Fig. 10a includes reference numeral 182 twice. The Examiner believes the lower reference numeral 182 should be amended to be reference numeral 183 because this label is pointing to the lower movable block 183 based on the disclosure of page 21 of the specification.
Figs. 11b and 11d each include reference numeral 182 twice. The Examiner wants to confirm that that is correct as the reference numeral labels appear to be pointing at two separate structures.
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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
101b as recited in the last paragraph of page 10 of the specification.
211 as recited in the last full paragraph on page 23 of the specification.
322 as recited on the fifth paragraph of page 25 of the specification.
4221 as recited in the third full paragraph of page 26 of the specification.
423 as recited in the last full paragraph of page 26 of the specification.
523 as recited in the last full paragraph of page 27 of the specification.
3107 as recited in the paragraph that starts on page 30 and ends on page 31 of the specification.
4107 as recited in the fourth full paragraph of page 31 of the specification.
1318 as recited in the last paragraph of page 32 of the specification.
1319 as recited in the last paragraph of page 32 of the specification.
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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
201 as shown in Fig. 13a.
202 as shown in Fig. 13a.
211a as shown in Fig. 13b.
211b as shown in Fig. 13b.
212 as shown in Fig. 13b.
215 as shown in Fig. 13b.
216 as shown in Fig. 13b.
217 as shown in Fig. 13b.
218 as shown in Fig. 13b.
219 as shown in Fig. 13b.
220 as shown in Fig. 13b.
221 as shown in Fig. 13b.
301 as shown in Fig. 14b.
323 as shown in Fig. 14b.
S as shown in Fig. 14c.
514 as shown in Fig. 14d.
3122 as shown in Fig. 16.
4122 as shown in Fig. 17b.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because of the following:
reference character “173” has been used to designate both “frame engaging portions” and “card slot.” Both of these references were made on at least page 20 of the Specification.
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. 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
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, requires the specification to be written in “full, clear, concise, and exact terms.” The specification is replete with terms which are not clear, concise and exact. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112. Examples of some unclear, inexact or verbose terms used in the specification are provided below.
The disclosure is objected to because of the following informalities:
The following sentence from page 1, paragraph 4 of the specification is suggested to be amended to recite “According to the blood glucose (BG) level, the artificial pancreas mimics a pancreas to fill the gaps of the required insulin amount via the closed-loop pathway or the semi-closed-loop pathway” to clarify the language within the sentence because how can an artificial pancreas mimic an artificial pancreas.
The following sentence from page 1, paragraph 6 is suggested to be amended to recite “Therefore, in the prior art, there is an urgent need for an integrated skin patch artificial pancreas…” to correct a grammar mistake.
Page 2, paragraph 1 recites the word “durther.” The Examiner suggests amending this to recite the word “further” to correct the misspelling.
The following phrase from page 2, paragraph 1 is suggested to be amended to recite “the control mechanism module controls the infusion mechanism module to infuse a drug” to correct the grammar of the phrase.
Page 2, paragraph 2 recites the word “comtrol.” The Examiner suggests amending this to recite the word “control” to correct the misspelling.
The following sentence from page 5, paragraph 2 is suggested to be amended to recite “FIG.2a is schematic view of an infusion tube…” to provide a space between the words “infusion” and “tube.”
The following sentence from page 5, paragraph 3 is suggested to be amended to recite “FIG.2b is schematic view of an infusion tube…” to provide a space between the words “infusion” and “tube.”
The following sentence from page 6, paragraph 1 is suggested to be amended to recite “Fig. 12a is a schematic view…” to improve the grammar of the sentence.
The following sentence from page 6, paragraph 2 is suggested to be amended to recite “Fig. 12b is a schematic view…” to improve the grammar of the sentence.
The following sentence from page 6, paragraph 3 is suggested to be amended to recite “Fig. 12c is a schematic view…” to improve the grammar of the sentence.
Page 9, paragraph 5 recites “adhesive patch 150.” The Examiner believes this is the incorrect reference numeral for the adhesive patch and suggests amending this to recite “120.”
The following portion of a sentence within page 16, paragraph 1 is suggested to be amended to recite “the elastic member can be flexibly selected according to the requirements of the specific…” to improve the grammar within the sentence.
The following portion of the last paragraph on page 18 is suggested to be amended to recite “the raw material and technological cost.[[.]]” to remove the duplicated punctuation.
The following portion of the first paragraph on page 19 is suggested to be amended to recite “or the two of them can be a sheet metal and then integrated with the third party directly…” to add a space between the words “with” and “the.”
The following portion of the first paragraph on page 21 should be amended to recite “The thread in the movable block 18 does not engage with the screw 135. The screw 135 can be smoothly…the thread in the movable block 18 is engaged with the screw [[rod]] 135” to provide a space between the word “screw” and the reference numeral “135” and refer to reference numeral 135 using the same terminology.
The following portion of the fourth paragraph on page 21 is suggested to be amended to recite “When the artificial pancreas [[110]] 1000…” to correct the reference numeral for this structure.
The following portion of the first paragraph on page 22 is suggested to be amended to recite “on the end face of the driving wheel 161,” to correct the reference numeral for the driving wheel.
Appropriate correction is required.
Claim Objections
Claims 1, 4, 7, and 8 are objected to because of the following informalities:
Claim 1 recites “the output end is electrically connected the infusion mechanism module,” “the control mechanism module controls the infusion mechanism module to infuse drug,” and “wherein the infusion tube is a drug infusion channel , , .” The Examiner suggests the following amendments “the output end is electrically connected to the infusion mechanism module,” “the control mechanism module controls the infusion mechanism module to infuse a drug,” and “wherein the infusion tube is a drug infusion channel[[ , ]], ” to clarify the claim language, provide proper antecedent basis, and remove a duplicate comma and spacing, respectively.
Claim 4 recites “the three- dimensional circuit.” The Examiner suggests amending this to remove the extra space between the word and punctuation “three-“ and the word “dimensional.”
Claim 7 recites “The integrated skin patch artificial pancreas of any claim 1.” The Examiner suggests amending the preamble to remove the word “any” because it creates confusion regarding the dependency of the claim.
Claim 7 recites “the first physical component and the second physical component is operatively electrically connected to generate an in-position detection signal.” The Examiner suggests amending this phrase to recite “the first physical component and the second physical component [[is]] are operatively electrically connected to generate an in-position detection signal” in order to fix the grammatical error within the claim.
Claim 8 recites “The integrated skin patch artificial pancreas of claim1.” The Examiner suggests amending the preamble to provide a space between the word “claim” and the number “1.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1 – 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the control mechanism” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation “the electrically connective regions” in lines 24 – 25. There is insufficient antecedent basis for this limitation in the claim. It cannot be determined if the electrically connective regions” in lines 24 – 25 is referring to the “plurality of electrically connective regions” in lines 15 – 16.
Claim 1 recites “the signal of analyte data in the body fluid” in lines 25 – 26. It cannot be determined if the signal in lines 25 – 26 is referring to the “signals of the analyte data in the body fluid” recited in line 18. Is it one signal of analyte date or multiple signals of analyte data?
Claim 1 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention for the aforementioned ambiguity regarding “the control mechanism,” “the electrically connective regions,” and “the signal of analyte data in the body fluid.”
Claims 2 – 20 are dependent upon Claim 1 and are therefore rejected under 35 U.S.C. 112(b) for the same rationale.
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.
Claim(s) 1 – 3 and 10 – 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yodfat et al. (US 2010/0256593 A1; hereinafter referred to as “Yodfat”).
With regards to claim 1, Yodfat discloses (see Figs. 12a – 12b) an integrated skin patch artificial pancreas (10) (see [0081]), comprising:
a control mechanism module (100) (see [0081]), provided with first electrical contacts (410) (see [0100]) exposed on a surface of the control mechanism (see Fig. 12a) and first engaging portions (see Examiner annotated Fig. 12a below; hereinafter referred to as “Fig. A” wherein the engaging portions are the wall of the control mechanism module 100 that contact the infusion mechanism module 200);
an infusion mechanism module (200) (see [0081]), including a case (see at 200 in Fig. 12a and see [0083] “the disposable part (200) is contained within another separate housing wherein the housing is the case), provided with second electrical contacts (410) (see [0100]) exposed on the case and second engaging portions (see Fig. A below wherein the engaging portions are the wall of the infusion mechanism module 200 that contact the infusion mechanism module 100), wherein when the control mechanism module and the infusion mechanism module are assembled with each other (see Fig. 12a and [0083] “The reusable and disposable parts housings are connected to each other before operation of the patch unit (10).”), the first engaging portions and the second engaging portions are engaged, the first electrical contacts and the second electrical contacts press against each other (see Fig. 12a, [0083], and [0102]), thereby the control mechanism module and the infusion mechanism module are electrically connected to each other (see [0099], [0101], and [0102]), the control mechanism module further comprising an input end (see at 405 in Fig. 12a) and an output end (see at 114 in Fig. 12a), and the input end comprises a plurality of electrically connective regions (405) (see [0099] and [0101]) for receiving signals of analyte data in a body fluid (see [0098] and [0099] “Analyte monitoring and fluid dispensing can be done after connecting and pairing the reusable part (100) to the disposable part (200), connecting connectors (405,405'), and connecting the two paired parts to the cradle unit (20) (not shown) and tip (330).”), the output end is electrically connected the infusion mechanism module (see Fig. 12a which shows the electrical connection between the infusion mechanism module 200 and the output end of the control mechanism module 100 based on the shown wires 2100, 2400 as described within at least [0100] and [0101]), according to the signals of the analyte data in the body fluid, the control mechanism module controls the infusion mechanism module to infuse drug (see [0098] and [0099] “Analyte monitoring and fluid dispensing can be done after connecting and pairing the reusable part (100) to the disposable part (200), connecting connectors (405,405'), and connecting the two paired parts to the cradle unit (20) (not shown) and tip (330).”); and
an infusion tube (330) (see [0101]), provided with electrodes (120, 121, 122) (see [0101]), wherein the infusion tube is a drug infusion channel (see [0091] “In this configuration, the same cannula which is used for fluid delivery serves also as a probe for the analyte monitoring.” and [0092]), when the infusion tube is installed to a working position (see Fig. 12a and [0100] where the working position is when the tip 330 is inserted into the subcutaneous tissue), the infusion tube is connected with the infusion mechanism module (see Fig. 12a), the drug is infused into a body through the infusion tube (see [0091] and [0092]), and the electrodes are electrically connected to the electrically connective regions respectively (see Fig. 12a where the electrodes 120, 121, 122 are electrically connected to the electrically connective regions 405 through the wires 2100 as described within at least [0101]), to input the signal of analyte data in the body fluid to the control mechanism module (see [0099] and [0101]).
PNG
media_image1.png
468
859
media_image1.png
Greyscale
With regards to claim 2, Yodfat discloses the claimed invention of claim 1, and Yodfat further discloses (see Figs. 12a – 12b) wherein an outward extending portion (20) (see [0082]) is provided on the case (see Fig. 12a), and a block (see Fig. A above) is provided on an outside of the outward extending portion (see the location of the annotated block in Fig. A above), the block blocks the control mechanism module (100) (see Fig. 12a where the block blocks the control mechanism module 100 from being inadvertently disconnected).
With regards to claim 3, Yodfat discloses the claimed invention of claim 1, and Yodfat further discloses (see Figs. 12a – 12b) wherein the infusion mechanism module is also provided with a flexible circuit board (130) (see [0095] “The dispensing apparatus (1005) and the monitoring apparatus (1006) are configured to be controlled by a PCB having electronics (130), which may also contain the processor-controller (2200).”), the flexible circuit board is provided with connection ends (see at 130 in Fig. 12a), and the second electrical contacts (410) are electrically connected to the connection ends (see Fig. 12a where the connection ends of the flexible circuit board 130 are electrically connected to the second electrical contacts 410 through the wires 2100 as described within [0099] and [0101]).
With regards to claim 10, Yodfat discloses the claimed invention of claim 1, and Yodfat further discloses (see Figs. 12a – 12b) wherein at least one of the electrodes (120, 121, 122) is arranged on an outer surface of a tube wall of the infusion tube (330) (see [0102] “the electrodes (120, 121, 122) extend along the entire or partial outer periphery of the tip (330).”) or arranged in the tube wall of the infusion tube.
With regards to claim 11, Yodfat discloses the claimed invention of claim 10, and Yodfat further discloses (see Fig. 5) wherein the infusion tube (214, 330) (see [0088]) includes an inner layer (214) and at least an outer layer (330), and the outer layer is disposed outside the inner layer (see Fig. 5 and [0088] “a connecting lumen (214) which is adapted to pierce the rubber septum (320) of the cannula (330)” wherein the connecting lumen is disposed interior to the outer layer 330), and the inner layer is used for drug infusion (see [0088]).
With regards to claim 12, Yodfat discloses the claimed invention of claim 11, and Yodfat further discloses (see Fig. 5) the outer layer is a hose (330) (see [0085] “a soft cannula (330)”), and the inner layer (214) is an infusion steel needle or an infusion hose (see [0088] “a connecting lumen (214) which is adapted to pierce the rubber septum (320) of the cannula (330)” wherein this connecting lumen is an infusion hose).
With regards to claim 13, Yodfat discloses the claimed invention of claim 1, and Yodfat further discloses (see Figs. 12a – 12b) wherein the electrodes (120, 121, 122) constitute a plurality of electrode combinations (see [0101] “the single tip (330) has electrodes (120, 121, 122) longitudinally deployed on its outer surface. One of the electrodes is a working electrode, the other is a counter electrode and the third electrode is a reference electrode.”).
With regards to claim 14, Yodfat discloses the claimed invention of claim 13, and Yodfat further discloses (see Figs. 12a – 12b) wherein there is a common electrode between the electrode combinations (see [0101] wherein the combinations presented allow for one of the electrodes 120, 121, 122 to always be the working electrode, the counter electrode, or the reference electrode).
With regards to claim 15, Yodfat discloses the claimed invention of claim 13, and Yodfat further discloses (see Figs. 12a – 12b) wherein each of the electrode combinations includes a dedicated working electrode and an auxiliary electrode (see [0101] “the single tip (330) has electrodes (120, 121, 122) longitudinally deployed on its outer surface. One of the electrodes is a working electrode, the other is a counter electrode and the third electrode is a reference electrode.” Here, the auxiliary electrode is the reference electrode.).
With regards to claim 16, Yodfat discloses the claimed invention of claim 13, and Yodfat further discloses wherein the control mechanism module (100) (see [0102]) controls the electrode combinations to work interchangeably (see [0101] “One of the electrodes is a working electrode, the other is a counter electrode and the third electrode is a reference electrode” here the electrode combinations are interchangeable because each electrode 120, 121, 122 can be any of the working, counter, or reference electrode).
With regards to claim 17, Yodfat discloses the claimed invention of claim 13, and Yodfat further discloses (see Figs. 12a – 12b) wherein the control mechanism module (100) controls the electrode combinations to work simultaneously (see [0101], [0102], and [0133]).
With regards to claim 18, Yodfat discloses the claimed invention of claim 1, and Yodfat further discloses (see Figs. 12a – 12b) wherein the infusion mechanism module (200) and the control mechanism module (100) are detachable to each other (see [0038], [0083] “The reusable part (100) is contained within one housing and the disposable part (200) is contained within another separate housing.”), and the control mechanism module is reusable (see [0083] “reusable part (100)”).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat and Roesicke (US 2014/0163338 A1).
With regards to claim 4, Yodfat discloses the claimed invention of claim 1, however Yodfat is silent with regards to wherein the infusion mechanism module is also provided with a three-dimensional circuit, the three-dimensional circuit is provided with connection ends, and the second electrical contacts are electrically connected to the connection ends.
Nonetheless Roesicke, which is within the analogous art of analyte sensors (see abstract and title), teaches (see Fig. 1) the infusion mechanism module (112) (see [0086]) is also provided with a three-dimensional circuit (138) (see [0048] “For example, the carrier element may comprise at least one planar circuit carrier…As an alternative or in addition, however, it is also possible to use non-planar circuit carriers, for example, so-called three-dimensional circuit boards” and [0089] “the disposable 112 may for example comprise a base plate 138 or another type of carrier element”), the three-dimensional circuit is provided with connection ends (see [0089] and Fig. 1 where the connection ends are the various locations on the base plate 138 that allows for the connection of the memory element 126 and the battery 124), and the second electrical contacts (see [0089] and Fig. 1 where the battery is connected with the base plate 138) are electrically connected to the connection ends.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the infusion mechanism module of the integrated skin patch artificial pancreas of Yodfat in view of a teaching of Roesicke such that the infusion mechanism module is also provided with a three-dimensional circuit, the three-dimensional circuit is provided with connection ends, and the second electrical contacts are electrically connected to the connection ends. One of ordinary skill in the art would have been motivated to make this modification because three-dimensional circuits enhance performance by reducing the interconnection lengths and increased communication density, lowers power consumption based on the shortened interconnections which mitigate signal degradation and energy loss, and the vertical arrangement of components facilities a smaller footprint making 3D ICs more ideal for devices where minimizing space is sought after. Here, the electronics of the infusion mechanism module of Yodfat would be run through this three-dimensional circuit taught by Roesicke in order to achieve the enhanced performance, lower power consumption, and compact design.
The integrated skin patch artificial pancreas of Yodfat modified in view of Roesicke will hereinafter be referred to as the artificial pancreas of Yodfat and Roesicke.
Claim(s) 5 – 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat and Streit et al. (US 2021/0393871 A1; hereinafter referred to as “Streit”).
With regards to claim 5, Yodfat discloses the claimed invention of claim 3, however, Yodfat is silent with regards to wherein the infusion mechanism module is also provided with elastic conductors, the elastic conductors are electrically connected to the connection ends of the flexible circuit board, the elastic conducts are provided with at least a protrusion.
Nonetheless Streit, which is within the analogous art of wearable drug delivery devices (see abstract), teaches (see Figs. 5 and 8a) the infusion mechanism module (200) (see [0191]) is also provided with elastic conductors (271a – 271d) (see [0209]), the elastic conductors are electrically connected to the connection ends of the flexible circuit board (243) (see [0211] “The first 271a, the second 271b and the third 271c connector member may each include a second end of the contacting arm 272 with a second electrical contact area 272b that may be adapted for electrically contacting the PCB-RU 243 supported by the non-conductive body 290 (see FIGS. 8a, 6a and 6b).”), the elastic conductors are provided with at least a protrusion (272) (see [0211]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the infusion mechanism module of the artificial pancreas of Yodfat in view of a teaching of Streit such that the infusion mechanism module is also provided with elastic conductors, the elastic conductors are electrically connected to the connection ends of the flexible circuit board, the elastic conducts are provided with at least a protrusion. One of ordinary skill in the art would have been motivated to make this modification because Streit teaches that contacting arms are suitable for establishing electrical connection between electrical components (see [0219] of Streit). Using electrical arms to create connections in medical devices is beneficial due to their ability to ensure stable electrical connections, which are essential for preventing interruptions or fluctuations in current. This stability helps maintain the smooth operation of the device and prevents damage to sensitive components. Additionally, electrical arms can reduce energy loss by minimizing resistance, ensuring optimal energy transmission and supporting sustainability initiatives. They also enhance the reliability of the device, withstand mechanical stress, vibration, and thermal fluctuations and improve the safety by handling the electrical currents safely.
With regards to claim 6, Yodfat discloses the claimed invention of claim 1, and Yodfat further discloses (Figs. 12a – 12b) further comprising an adhesive patch (see [0084] “The downwardly facing surface of the cradle unit (20) is covered by a flat sheet with an adhesive layer facing the skin (5).”).
However Yodfat is silent with regards to wherein the adhesive patch comprises a tape and a protective film, an outer edge of the protective film corresponds to an outer edge of the tape, and a rockwell hardness of the protective film is higher than a rockwell hardness of the tape.
Nonetheless Streit, which is within the analogous art of adhesive patches (see [0255]), teaches (see Fig. 26b) the adhesive patch (280) (see [0255]) comprises a tape (280a)(see [0255]) and a protective film (280b) (see [0255]), an outer edge of the protective film corresponds to an outer edge of the tape (see Fig. 26b).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the adhesive patch of Yodfat with the adhesive patch of Streit such that the adhesive patch comprises a tape and a protective film, an outer edge of the protective film corresponds to an outer edge of the tape. One of ordinary skill in the art would have been motivated to make this modification because the adhesive patch of Streit would provide similar results of adhering the device to the user’s skin. Additionally the protective film of Streit prevents the inadvertent adhering of the artificial pancreas to the patient or healthcare professional.
The artificial pancreas of Yodfat modified in view of Streit will hereinafter be referred to as the artificial pancreas of Yodfat and Streit. The combination does not specify a rockwell hardness of the protective film being higher than a rockwell hardness of the tape. It would have been an obvious matter of design choice to a person having an ordinary skill in the art before the effective filing date of the present invention to modify the protective film and tape of the artificial pancreas of Yodfat and Streit such that the rockwell hardness of the protective film is higher than a rockwell hardness of the tape because the applicant has not disclosed that having the rockwell hardness of the protective film higher than the rockwell hardness of the tape solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of a rockwell hardness of the protective film is higher than a rockwell hardness of the tape, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. Furthermore, it has been held that “the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); MPEP 2144.07.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat in view of Yodfat et al. (US 2014/0148756 A1; hereinafter referred to as “Yodfat ‘756”).
With regards to claim 7, Yodfat discloses the claimed invention of claim 1, however, Yodfat is silent with regards to wherein the control mechanism module is provided with a first physical component and the infusion mechanism module is provided with an in-position detection module, wherein the in-position detection module includes a second physical component, the first physical component and the second physical component is operatively electrically connected to generate an in-position detection signal.
Nonetheless Yodfat ‘756, which is within the analogous art of infusion and sensing devices (see abstract and title), teaches (Figs. 2a – 2b) the control mechanism module (100) (see [0111]) is provided with a first physical component (132) (see [0116]) and the infusion mechanism module (200) (see [0116]) is provided with an in-position detection module (270) (see [0116]), wherein the in-position detection module includes a second physical component (see at 270 of Fig. 2b wherein the second physical component is the shape of the plug 270), the first physical component and the second physical component is operatively electrically connected to generate an in-position detection signal (see [0116] “hen the dispensing unit 10 is properly assembled the plug 270 and the socket 132 are connected so as to establish a closed electrical circuit that causes the indicator to be powered and thus to indicate the connection status of the two parts”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the control mechanism module and infusion mechanism module of Yodfat in view of a teaching of Yodfat ‘756 such that the control mechanism module is provided with a first physical component and the infusion mechanism module is provided with an in-position detection module, wherein the in-position detection module includes a second physical component, the first physical component and the second physical component is operatively electrically connected to generate an in-position detection signal. One of ordinary skill in the art would have been motivated to make this modification because Yodfat ‘756 teaches that the proper assembly of these components establishes a closed electrical circuit that causes the indicator to be powered and thus to indicate that connection status (i.e., in position detection signal) of the two parts (see [0116] of Yodfat ‘756).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat and Mounce et al. (US 2008/0077081 A1; hereinafter referred to as “Mounce”).
With regards to claim 8, Yodfat discloses the claimed invention of claim 1, however, Yodfat is silent with regards to the artificial pancreas further comprising a blockage detection module, operably connected to the control mechanism module, wherein the blockage detection module includes a detection circuit and at least one detection element, used to sense and measure physical parameters during a drug filling process or a drug infusion process to confirm whether a blockage has occurred.
Nonetheless Mounce, which is within the analogous art of infusion medium delivery devices (see abstract and title), teaches (see Fig. 42) the artificial pancreas (see [0196] “an infusion delivery device”) further comprising a blockage detection module (516a – 516n, 514, ) (see [0216]), operably connected to the control mechanism module (502) (see [0196]), wherein the blockage detection module includes a detection circuit (514) (see [0216]) and at least one detection element (516a – 516n) (see [0216]), used to sense and measure physical parameters during a drug filling process or a drug infusion process to confirm whether a blockage has occurred (see [0216] “the sensors 516a-516n may include one or more flow detectors, for detecting the occurrence or blockage of a fluid flow path in the infusion device. In such embodiments, the control electronics 514 may be configured to provide a detect signal (to allow operation of the drive device 44) only upon an activation of all (or a predefined number or set of) the magnetically responsive devices 510 and a proper state of sensors 516a-516n.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the artificial pancreas of Yodfat in view of a teaching of Mounce such that the artificial pancreas further comprising a blockage detection module, operably connected to the control mechanism module, wherein the blockage detection module includes a detection circuit and at least one detection element, used to sense and measure physical parameters during a drug filling process or a drug infusion process to confirm whether a blockage has occurred. One of ordinary skill in the art would have been motivated to make this modification because Mounce teaches that the one or more flow detectors detect the occurrence or blockage of a fluid flow path in the infusion device (see [0216]). Here, it would be beneficial to know whether a blockage of the fluid flow path has occurred in order to determine if the medication has been infused.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat and Yodat (US 2012/0277667 A1).
With regards to claim 9, Yodfat discloses the claimed invention of claim 1 however, Yodfat is silent with regards to wherein at least one of the electrodes is a tube wall of the infusion tube.
Nonetheless Yodat, which is within the analogous art of analyte monitoring and lfuid dispensing systems (see abstract and title), teaches wherein at least one of the electrodes is a tube wall of the infusion tube (see [0179] “the one or more electrodes may be embedded within the material of the walls of the cannula 305b, as illustrated in FIG. 9b.” and [0180]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the electrodes of the artificial pancreas of Yodfat in view of a teaching of Yodat such that at least one of the electrodes is a tube wall of the infusion tube. One of ordinary skill in the art would have been motivated to make this modification because doing so would prevent the electrodes from being knocked off of the infusion tube. In other words, when the electrodes are the tube wall of the infusion tube the electrodes would be better secured in place and prevent any inadvertent contact with the electrode.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat in view of Lange et al. (US 2018/0296753 A1; hereinafter referred to as “Lange”).
With regards to claim 19, Yodfat discloses the claimed invention of claim 1, and Yodfat further discloses (see Figs. 12a – 12b) wherein the infusion mechanism module (200) and the control mechanism module (100) are disposed in one housing (20) (see Fig. 12a).
However Yodfat is silent with regards to discarding together after a single-use.
Nonetheless Lange, which is within the analogous art of time controlled periodic infusion (see abstract and title), teaches discarding together after a single-use (see [0080] and [0082]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the artificial pancreas of Yodfat in view of a teaching of Lange such that the infusion mechanism module and the control mechanism module are disposed in one housing wherein they are discarded together after a single-use. One of ordinary skill in the art would have been motivated to make this modification because Lange teaches that it is beneficial to discard the used artificial pancreas after it is fully used (see [0080] and [0082] of Lange). This allows a new artificial pancreas to be positioned on the patient to resume therapy.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat and Roesicke as applied to claim 4 above in further view of Streit.
With regards to claim 20, the artificial pancreas of Yodfat and Roesicke teaches the claimed invention of claim 4, however, Yodfat is silent with regards to the infusion mechanism module is also provided with elastic conductors, the elastic conductors are electrically connected to the connection ends of the three-dimensional circuit, the elastic conductors are provided with at least a protrusion.
Nonetheless Streit, which is within the analogous art of wearable drug delivery devices (see abstract), teaches (see Figs. 5 and 8a) the infusion mechanism module (200) (see [0191]) is also provided with elastic conductors (271a – 271d) (see [0209]), the elastic conductors are electrically connected to the connection ends of the circuit (243) (see [0211] “The first 271a, the second 271b and the third 271c connector member may each include a second end of the contacting arm 272 with a second electrical contact area 272b that may be adapted for electrically contacting the PCB-RU 243 supported by the non-conductive body 290 (see FIGS. 8a, 6a and 6b).”), the elastic conductors are provided with at least a protrusion (272) (see [0211]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the infusion mechanism module of the artificial pancreas of Yodfat and Roesicke in view of a teaching of Streit such that the infusion mechanism module is also provided with elastic conductors, the elastic conductors are electrically connected to the connection ends of the three-dimensional circuit, the elastic conductors are provided with at least a protrusion. One of ordinary skill in the art would have been motivated to make this modification because Streit teaches that contacting arms are suitable for establishing electrical connection between electrical components (see [0219] of Streit). Using electrical arms to create connections in medical devices is beneficial due to their ability to ensure stable electrical connections, which are essential for preventing interruptions or fluctuations in current. This stability helps maintain the smooth operation of the device and prevents damage to sensitive components. Additionally, electrical arms can reduce energy loss by minimizing resistance, ensuring optimal energy transmission and supporting sustainability initiatives. They also enhance the reliability of the device, withstand mechanical stress, vibration, and thermal fluctuations and improve the safety by handling the electrical currents safely.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT F ALLEN whose telephone number is (571)272-6232. The examiner can normally be reached Monday-Friday 8:00 AM - 4:30 PM ET.
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, Chelsea Stinson can be reached at (571)270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 02/18/2026