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.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "23", “230” and "239" have been used to designate “EEPROM”. 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)(4) because reference character “230” has been used to designate both “EEPROM” and “support structure”. 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
The disclosure is objected to because of the following informalities: at paragraph [0055], the specification recites “…designed in the shape of a ruff which is arranged around a neck 51 of the patient 5”. The term “ruff” should apparently read –cuff--
Appropriate correction is required.
Claim Objections
6. Claim 39 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 26. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
7. Claim 43 is objected to because of the following informalities: at line 9, “the second element” should apparently read –the second coupling element--. Appropriate correction is required.
Claim Interpretation
8. 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.
9. 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.
10. 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: “unique identifier member” in claim 24;
“digital data storage” in claim 25 (which is construed as a generic unit for storing digital data for purposes of 112(f));
“the identifier part” in claim 28 (which “…stores unique identifying data representing the individual induction device”), the corresponding structure of which is found to be “EEPROM”;
“control unit” in claims 31, 35 and 37 (which is “configured to control operation of the induction device”), the corresponding structure of which is found to be disclosed at paragraph [0032]; and
“control part” in claim 32 (which is construed as a part for controlling for purposes of 112(f)).
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.
Claim Rejections - 35 USC § 112
11. 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.
12. Claims 24-43 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.
13. Claim 24 at line 5 recites that “the electro-magnetic field generator…comprises a coil design”. It is unclear what constitutes “a coil design” in light of the claims and the specification; for instance, whether “a coil design” implies the shape of a coil; just a coil or coils; or a unit comprising a coil or coils, for instance, or something else.
14. In claim 24, the limitation “unique identifier member” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The description specifies that the “unique identifier member” has an EEPROM and is included in the coil design, and allows the control unit to identify which individual induction device is coupled, however the written description fails to disclose the corresponding structure. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In claim 25, the limitation “digital data storage” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The description specifies that “The EEPROM 23 together with the data storage of the workstation 31 and a data storage of the stimulator 32 establish a digital data storage of the stimulation arrangement,” [0059], however the written description fails to disclose the corresponding structure.
In claim 32, the limitation “control part” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The description specifies that “the data storage of the workstation 31 together with the data storage of the stimulator 32 are a control part of the digital data storage of the stimulation arrangement”; and further how the control part functions ([0035]-[0036]), however the written description fails to disclose the corresponding structure. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
15. Claim 24 at line 14 recites the limitation "the individual induction device". There is insufficient antecedent basis for this limitation in the claim.
16. Regarding claim 25, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(c).
17. Claim 40 at line 3 recites the limitation "the individual target tissue". There is insufficient antecedent basis for this limitation in the claim.
18. Regarding claim 41, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(c). For purposes of examination, the limitations following “preferably” will not be construed as being required by the claim.
19. Claim 43 at line 3 recites the limitation "the identifier part". There is insufficient antecedent basis for this limitation in the claim.
20. Claim 43 at line 4 recites the limitation "the unique identifying data". There is insufficient antecedent basis for this limitation in the claim.
21. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
22. Claim 38 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 38 does not further limit the subject matter of claim 25, from which claim 38 depends, as it appears to recite the same thing. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
23. 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.
24. 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.
25. Claims 24-43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Errico et al. (U.S. Pub. No. 2019/0111255). Regarding claim 24, Errico et al. (hereinafter Errico) teaches a stimulation arrangement for stimulating a target tissue of a patient (Figs. 1C, 6 and 8; [0092]), the stimulation arrangement comprising:
an induction device with an electro-magnetic field generator (magnetic coil 340) and a support structure (Figs. 1C, 3A-3C and 7; [0108]-[0109], [0066], [0164]), wherein
the electro-magnetic field generator (magnetic coil 340) of the induction device comprises a coil design configured to generate a spatial electro-magnetic field having a targeted shape ([0066], [0074], [0108]-[0109], [0114], [0117]),
the coil design of the electro-magnetic field generator of the induction device is coupled to the support structure of the induction device ([0164], Figs. 3A-3C and 7) and
the support structure of the induction device is configured to be positioned at the patient such that the coil design of the electro-magnetic field generator of the induction device is arranged to stimulate the target tissue of the patient by generating the spatial electro-magnetic field (Figs. 6-8; [0108], [0111], [0114], [0117] and [0163]-[0164]), and
the induction device comprises a unique identifier member (construed as a tag/barcode) distinctly identifying the individual induction device (“medical device” 108/208) (see Figs. 12C, 14-15; [0263] and [0303]).
Regarding claims 25 and 38, the stimulation arrangement further comprises a digital data storage, preferably configured to store use data representing a use of the stimulation arrangement in the digital data storage ([0308] – “…program the storage medium…”; also see [0146]-[0147]).
Regarding claims 26 and 39, the stimulation arrangement is configured to store lifetime data representing an operating lifetime of the induction device in the digital data storage ([0313] – “For example, there can be about 10, 31, or 93 (or less or more) days or uses of therapy as prescribed by a medical service provider…; and [0296] – “the processor 104 tracks such use and can take an action when a predetermined threshold is satisfied or not satisfied, such as via the logic stored via the memory 106. For example, the logic tracks a use of the medical device 108 and when a number of uses, as programmed in advance, satisfies or does not satisfy the predetermined threshold, then the processor 104 can take an action”; and [0311] – “the processor 104 instructs the output device of the system 100A to communicate with the storage medium in order to deactivate the storage medium, as disclosed herein, such as via deleting the content from the storage medium, reformatting the card, or others. As per block 508, the processor 104 tracks usage of the medical device 108 in order to be compliant with the content of the storage medium as read by the input device 110. For example, if the content mandates 1 use during 24 hours for 1 week, then the processor 104 track time, data”; also see [0146]-[0147]).
Regarding claim 27, the digital data storage comprises an identifier part (e.g., flash memory) included in the unique identifier member (construed as a tag/barcode) ([0268]-[0269], [0303] and [0305]).
Regarding claim 28, the identifier part of the digital data storage of the unique identifier member stores unique identifying data representing the individual induction device ([0268]-[0269] and [0303]).
Regarding claim 29, the unique identifier member has an electrically erasable programmable read-only memory (flash memory as indicated above with respect to claim 27) comprising the identifier part of the digital data storage.
Regarding claim 30, and in view of its indefinite nature, the “coil design” of the electro-magnetic field generator of the stimulator/“medical device” is shown in Fig. 3B, and Errico further teaches that the unique identifier member (construed as a tag/barcode) is coupled thereto [0303].
Regarding claim 31, the stimulation arrangement further comprises a control unit 330 configured to control operation of the induction device (Fig. 1C; [0108] and [0112]).
Regarding claim 32, the digital data storage comprises a control part included in the control unit (control unit 330 comprises a CPU and computer memories for the storage and retrieval of data [0112]).
Regarding claim 33, the control unit is configured to obtain an identification information from the unique identifier member (construed as a tag/barcode) ([0112] and [0305]).
Regarding claim 34, the stimulation arrangement is configured to assign an identification information of the unique identifier member (construed as a tag/barcode) to an individual therapy (such as prescribing a defined number of doses – [0009], [0140], [0303], [0313] and [0322]).
Regarding claim 35, the stimulation arrangement further comprises a control unit configured to control operation of the induction device (control unit 330 comprises a CPU and computer memories for the storage and retrieval of data [0112]), wherein the control unit is configured to operate the induction device in accordance with the individual therapy assigned to the identification information (such as the defined number of doses - [0009], [0140], [0303], [0313] and [0322]).
Regarding claim 36, the stimulation arrangement is configured to assign an identification information of the unique identifier member (construed as a tag/barcode) to an individual therapy (such as prescribing a defined number of doses – [0009], [0140], [0303], [0313] and [0322]).
Regarding claim 37, the stimulation arrangement further comprises a control unit configured to control operation of the induction device (control unit 330 comprises a CPU and computer memories for the storage and retrieval of data [0112]), wherein the control unit is configured to operate the induction device in accordance with the individual patient assigned to the identification information ([0303]-[0304]).
Regarding claim 40, the support structure of the induction device is configured to be individually adapted to the patient (via tightening of support collar 78 with a strap 79) such that the coil design is arranged to stimulate the individual target tissue of the patient (Fig. 7 and [0163]-[0164]).
Regarding claim 41, the stimulation arrangement is configured to store life time data representing an operating life time of the induction device in the digital data storage (as indicated above with respect to claim 26) and configured to store support structure data representing an individual adaptation of the support structure of the induction device of the individual patient in the digital data storage (the stimulation arrangement is also configured to store various types of data [0268]).
Regarding claim 42, absent any further description of a “blocking configuration,” the support structure of the induction device has a blocking configuration to block the stimulator 30 from touching the patient’s neck (see Fig. 7 and [0164]) when being individually adapted to a child.
Regarding claim 43, the unique identifier member has an electrically erasable programmable read-only memory comprising the identifier part of the digital data storage (see claim 29) and the identification information is the unique identifying data stored in the identifier part of the digital data storage ([0268]-[0269] and [0303]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: U.S. Pub. No. 2019/0198166; U.S. Pub. No. 2017/0095667; and U.S. Patent No. 10,286,222.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE HOPKINS MATTHEWS whose telephone number is (571)272-9058. The examiner can normally be reached Monday - Friday, 7:30 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A Marmor, II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791