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 .
Claim Status
Claims 1-10, 12 and 14-20 as filed on July 10, 2023 are presently pending. Examiner notes that the claim listing does not include claims 11 and 13.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows: The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No.15/885,904, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior filed application fails to provide written description in regards to physiological parameter in relation to constituent in blood in claim 2, a disposable sensor in claims 3 and 16, onset of hypoglycemia or an episode thereof in claims 9, 12 and 17 and treatment to mitigate hypoglycemia in claim 17. If examiner is mistaken, Applicant is respectfully requested to cite specific sections of the prior filed application that provides written description of the subject matter in question. In view of these, claims 2, 3, 9, 12, 15 and 17-20 are not afforded the effective filing date of the prior filed application.
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.75(f) which requires claims to be numbered consecutively. See MPEP § 608.01(i). In the instant case, claim number 11 and 13 are missing on the presented listing of claims to be examined.
Claims 1 and 17 are each objected to because of the following informalities: the word/phrase “control unit” should be preceded by “the” for proper antecedence basis. Appropriate correction is required.
Claims 1 and 17 are each objected to because of the following informalities: the phrase “predict the onset of” should be amended to “predict an onset of” for proper antecedence basis. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: the word/phrase “the sensor” should be amended to “the at least one sensor” for proper antecedence basis. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: the word/phrase “the operation” should be amended to “an operation” for proper antecedence basis. Appropriate correction is required.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
“…level of particular constituent in blood” in claim 2;
“… sensor is disposable” in claim 3 and 16;
“…accepting an input from a user interface to adjust a delay period in causing the appropriate treatment” in claim 8;
“… indicative of the onset of hypoglycemia” in claim 9 and 12; and
“…predict an onset of an episode of hypoglycemia … and cause an appropriate treatment to mitigate hypoglycemia” in claim 17.
Each of the phrases noted above, lack proper antecedence basis and/or counterparts in the specification.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2-3, 8-9, 12, 15 and 17-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention - note, this application is a continuation of 15/885,904 and fails ails to provide adequate written description for a physiological parameter in relation to constituent in blood in claim 2, a disposable sensor in claims 3 and 16, adjusting a delay period in causing the appropriate treatment in claim 8, physiological parameter indicative of onset of hypoglycemia or an episode thereof in claims 9, 12 and 17 and treatment to mitigate hypoglycemia in claim 17.
Claim Rejections - 35 USC § 112
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.
Claims 14 and 16 are 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 14 depend on non-existent claim 11 and claim 16 depends on non-existent claim 13. 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 § 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.
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.
Claims 1, 3, 5-6, 8, 10 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Lamelson US 5738102 A in view of Laitinen et al. US 20040101146 A1 (“Laitinen”).
Regarding claim 1, Lamelson discloses a method comprising: sensing from at least one sensor, a physiological parameter of a subject without requiring compliance by the subject or involvement by a healthcare worker caring for the subject; communicating the physiological parameter to a control unit, monitoring a condition of the subject at control unit by analyzing the physiological parameter to predict the onset of an episode of a physiological event; and causing an appropriate treatment to mitigate the physiological event (e.g. see col. 1, paragraph from line 17 and/or paragraph bridging col. 1-2 and/or col. 2, paragraph from line 35).
Lamelson differs with the claimed invention in regards to wireless communicating the physiological parameter from the sensor to the control unit. However, Laitinen discloses that it was known in the prior art, to connect a processor unit or CPU (control unit) to sensors for monitoring a patient via a sensor interface, either via wired connection or wirelessly ([0046], [0077-0079] and illustration Fig. 6), where the wireless sensors utilize short-range RF technique or a Bluetooth technique([0039]).
In view of these, inasmuch as Laitinen discloses connection of sensors for monitoring a patient to a control unit via wired or wireless connection as art recognized alternatives, it would have been obvious at the time of filing the claimed invention, to one of ordinary skill in the exercise art to substitute one for the other, In re Fout, 675 F.2d 297, 301, 213 USPQ 532, 536 (CCPA 1982), in the instant case, substitute the wired connection of sensors in Lamelson with wireless connection of sensors as taught by Laitinen, to perform the same function.
Regarding claim 3, the recitation, “the sensor is disposable” is directed to intended use or a capability of the sensor, it is well established that a recitation with respect to the manner in which an apparatus is intended to be employed, i.e., a functional limitation, does not impose any structural limitation upon the claimed apparatus which differentiates it from a prior art reference disclosing the structural limitations of the claim. In re Pearson, 494 F.2d 1399, 181 USPQ 641 (CCPA 1974); In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 136 USPQ 458 (CCPA 1963). Where the prior art reference is inherently capable of performing the function described in a functional limitation, such functional limitation does not define the claimed apparatus over such prior art reference, regardless of whether the prior art reference explicitly discusses such capacity for performing the recited function. In the instant case, the sensors of Lamelson in view of Laitinen are capable of being disposed after use in purview of a user.
Regarding claim 5-6 and 10, see Lamelson col. 1, paragraph from line 17 and/or paragraph bridging col. 1-2 and/or col. 2, paragraph from line 35 regarding decision module activating an alarm to alert medical personnel or activating an actuator for administering medical treatment based on an evaluation, the at least one sensor comprises a temperature sensor (Lamelson drawing “temperature sensor 24”).
Regarding claim 8, Lamelson discloses in the drawing, an interface “47” and computer display and keyboard that read on a user interface. Lamelson does not explicitly disclose using the interface to accept an input to adjust a delay period in causing the appropriate treatment. Laitinen teach in [0058] and [0078] rehabilitation staff or rehabilitator retrieving measurement data to evaluate progress and or to give new instructions. In view of these teaching, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the method of Lamelson to include adjust a delay period in causing appropriate treatment via the user interface, to allow the user to evaluate and/or give new instructions for treatment purposes.
Regarding claims 12 and 16, as to claim 12, the sensors of Lamelson have been modified by the teachings of Laitinen for wireless connection via Bluetooth technology, examiner notes that Bluetooth works by pairing devices and hopping frequencies for stable, secure communication and therefore the wireless sensor of modified Lamelson would be selectively paired to the control unit. As to claim 16 (examiner presumes claim 16 depends on claim 12 for examination purposes), see detailed discussion in claim 3 above, the wireless sensors of modified Lamelson are disposable for the same reason.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Lamelson in view of Laitinen as applied to claim 1 above, and further in view of Naruse et al. US 20030214399 A1 (“Naruse”).
Regarding claim 14, Lamelson in view of Laitinen does not explicitly disclose that the at least one sensor is battery powered. However, Naruse discloses analogous wireless sensors ([abstract]) that can be arranged on a bed ([0122]) and further teaches in [0183] that the wireless sensor comprises a coaxial condenser that stores electric charge and works as an equivalent battery. In view of these, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have modified the wireless sensors of Lamelson in view of Laitinen to include a battery, so as to provide power the sensors as a battery was a well known component for providing power to wireless sensor as exemplified by Naruse.
Claims 1-2, 4, 7, 9 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Lange et al. US 20050192508 A1 (“Lange”) in view of Laitinen.
Regarding claim 1, Lange discloses a method [(abstract], [0132], Figs. 1-3) comprising: sensing from at least one sensor, a physiological parameter of a subject without requiring compliance by the subject or involvement by a healthcare worker caring for the subject ([0135-0136], Fig. 2); communicating the physiological parameter to a control unit (Fig. 1, data from data acquisition module is transmitted to pattern analysis module), monitoring a condition of the subject at the control unit by analyzing the physiological parameter to predict an onset of an episode of a physiological event ([0137], [0146]); and causing an appropriate treatment to mitigate the physiological event ([0018], incorporated by reference Lamelson, see col. 1, paragraph from line 17 and/or paragraph bridging col. 1-2 and/or col. 2, paragraph from line 35).
Lamelson differs with the claimed invention in regards to wireless communicating the physiological parameter from the sensor to the control unit. However, Laitinen discloses that it was known in the prior art, to connect a processor unit or CPU (control unit) to sensors for monitoring a patient via a sensor interface, either via wired connection or wirelessly ([0046], [0077-0079] and illustration Fig. 6), where the wireless sensors utilize short-range RF technique or a Bluetooth technique([0039]).
In view of these, inasmuch as Laitinen disclose connection of sensors for monitoring a patient to a control unit via wired or wireless connection as art recognized alternatives, it would have been obvious at the time of filing the claimed invention, to one of ordinary skill in the exercise art to substitute one for the other, In re Fout, 675 F.2d 297, 301, 213 USPQ 532, 536 (CCPA 1982), in the instant case, substitute the wired connection of sensors in Lamelson with wireless connection of sensors as taught by Laitinen, to perform the same function.
Regarding claims 2 and 9, see Lange [0027] hypoglycemia can be deduced from breathing patterns, therefore, the physiological parameter is indicative of an onset of hypoglycemia and hypoglycemia is related to a level of particular constituent (glucose) in blood of the subject.
Regarding claims 4 and 7, see Lange [0157-0158] and illustration Fig. 4, the physiological parameter is a time series of a biological response and analyzing the physiological pattern comprises pattern analysis ([0146]).
Regarding claims 12 and 15, as to claim 12, the sensors of Lamelson have been modified by the teachings of Laitinen for wireless connection via Bluetooth technology, examiner notes that Bluetooth works by pairing devices and hopping frequencies for stable, secure communication and therefore the wireless sensor of modified Lamelson would be selectively paired to the control unit. As to claim 15, see detailed discussion in claim 9 above, hypoglycemia can be deduced from breathing patterns, therefore, the physiological parameter is indicative of an onset of hypoglycemia.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over US Lange, in view of Laitinen and in view of Heller et al. US 6560471 B1 (“Heller”).
Regarding claim 17, Lange in view of Laitinen discloses a method as discussed in claim 1 (discussion and citations in claim 1 are equally applicable here for overlapping subject matter), in regards to analyzing the physiological parameter to predict an onset of an episode of hypoglycemia, Lange discloses in [0027] hypoglycemia can be deduced from breathing patterns and therefore the physiological parameter of the breathing pattern can be analyzed to predict an onset of hypoglycemia.
Lange in view of Laitinen does not disclose causing an appropriate treatment to mitigate hypoglycemia.
Heller, in the same field of endeavor of monitoring for hypoglycemia, discloses monitoring for an onset/impending hypoglycemia to issue an alarm (col. 7: paragraph from line 1), direct the patient to take an action to mitigate the condition e.g. “Eat Sugar” (Col. 57, paragraph from line 31) or administer a drug via a control module (Col. 61, paragraphs from line 35 and line 47).
In view of the teachings of Heller, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to have modified the control unit of Lange, to cause an appropriate treatment to mitigate hypoglycemia, because Lange in incorporated Lamelson teaches appropriate treatment for the detected condition, and Heller discloses causing an appropriate treatment in the case of hypoglycemia, so as to maintain blood sugar above an acceptable level.
Regarding claim 18, the at least one sensor comprises a temperature sensor (see Fig. 1 of Lamelson, “temperature sensor 24”).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lange in view of Laitinen and Heller as applied to claim 18 above, and further in view of Naruse.
Regarding claim 19, Lange in view of Laitinen and Heller does not explicitly disclose that the at least one sensor is battery powered. However, Naruse discloses analogous wireless sensors ([abstract]) that can be arranged on a bed ([0122]) and further teaches in [0183] that the wireless sensor comprises a coaxial condenser that stores electric charge and works as an equivalent battery. In view of these, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have modified the wireless sensors of Lange in view of Laitinen and Heller to include a battery, so as to provide power the sensors as a battery was a well-known component for providing power to wireless sensor as exemplified by Naruse.
Regarding claim 20, the sensors of Lange in view of Laitinen, Heller and Naruse have been modified by the teachings of Laitinen for wireless connection via Bluetooth technology, examiner notes that Bluetooth works by pairing devices and hopping frequencies for stable, secure communication and therefore the wireless sensor of modified Lange would be selectively paired to the control unit.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 9 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5 and 15 of U.S. Patent No. 8,942,779 B2 in view of Laitinen.
Claims 1, 9 and 17 differs with patented claims 1, 5 and 15, in regards to wirelessly communicating the physiological parameter to a control unit. However, this limitation would have been obvious in view of Laitinen for substantially similar rationale as set forth in the prior art rejection of claim 1 or 17 above.
Claims 2-8, 10, 12, 15-16 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5 and 15 of U.S. Patent No. 8,942,779 B2 as applied to claim 1 and 17 above, and further in view of Lange.
Limitations of claims 2-8, 10, 12, 15-16 are disclosed by the combination of Lange and Laitinen as discussed in the rejection section above, examiner notes that Lange incorporates Lamelson, these limitations will therefore be obvious over the patented claims for substantially similar rationale as set forth in the prior art rejection section above.
Claims 14 and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5 and 15 of U.S. Patent No. 8,942,779 B2 as applied to claim 1 and 18 above, and further in view of Naruse.
Limitations of claims 14 and 19-20 are disclosed by the combination of Lange, Laitinen and Naruse as discussed in the rejection section above, these limitations will therefore be obvious over the patented claims for substantially similar rationale as set forth in the prior art rejection section above.
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797