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 INTERPRETATION
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
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 for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that 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. Such claim limitations is/are:
(Claim 1 and 9) “a means to establish fluid communication between the at least one sensor and the sample of interstitial fluid, blood or both”
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
(Claim 1 and 9) “a means to establish fluid communication between the at least one sensor and the sample of interstitial fluid, blood or both”: As identified by the Claims, the following is recognized as the corresponding structure to the means: “wherein the means to establish fluid communication comprises at least one needle.” Or equivalents thereof.
Of note claims 2-4 no longer invoke 112f as the functional language recites definite structure.
If applicant wishes to provide explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9 and 12 and claims dependent thereon 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 pre-AIA the applicant regards as the invention.
Regarding Claim 9, the term “applying a device for measuring one or more analytes from interstitial fluid, blood, or both of the subject;" renders the claim indefinite because it is unclear whether the term “applying” is being used to refer to the action of placing an object on a surface or if the term “applying” is being to refer to the action of making use of something. In this manner, an activation of the device could be considered “applying” the device. Appropriate changes would include -- applying a device for measuring one or more analytes from interstitial fluid, blood, or both of the subject by placing the device partially in-vivo into the skin of the subject;-- and Examiner will be interpreting the claim as such.
Regarding Claim 12, the term “further comprising taking at least one measurement of progesterone by a device containing a sensor for progesterone" renders the claim indefinite because it is unclear if this refers to a second device, separate from the device introduced in claim 9 or if this device is the same device as the device introduced in claim 9. Appropriate changes would include -- further comprising taking at least one measurement of progesterone by a sensor for progesterone contained by the device -- and Examiner will be interpreting the claim as such.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-2, 5-9, 12, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heikenfeld (US 2020/0138347) (“Heikenfeld 347”).
Regarding Claim 1, Heikenfeld 347 teaches a device for measuring one or more analytes in a sample of interstitial fluid, blood or both (Abstract, [0004], [0059]-[0061] various embodiments are understood as descriptions of subcomponents of a single biofluid sample collecting device, with example biofluids being blood and interstitial fluid), comprising:
at least one electrochemical aptamer-based (EAB) sensor comprising one or more attached redox couples that measure at least one of said analytes (Fig. 9 [0078] collection device 900 comprising electrochemical aptamer-based sensors 920 for estrogen and 922 for progesterone, [0089] where electrochemical aptamer-based sensors measure by attached redox couples);
a means to establish fluid communication between the at least one sensor and the sample of interstitial fluid, blood or both (Fig. 17, [0104]-[0105] microneedles 1782 act as means to establish fluid communication between the skin surface / sample of interstitial fluid and the at least one sensor. Further, device 1700 for extracting interstitial fluid to sense one or more analytes utilizing an array of microneedles to penetrate the skin surface and extract fluid can be provided with Fig. 9’s device for collection to jointly teach a particular configuration of the internal components for enabling device 1700 where the opening 1755 corresponds to the opening channel 980, the pump 1730 corresponds to pump 930, the one or more sensors 1720 correspond to sensors 920, 922, and 926, the sample concentrator 1795 corresponds to membrane 995, and the sensors may be electrochemical aptamer-based sensors
);
wherein the one or more analytes are selected from the group consisting of progesterone, luteinizing hormone (LH), estrogen, follicle stimulating hormone (FSH), their metabolites, and combinations thereof ([0078]).
Regarding Claim 2, Heikenfeld 347 teaches the device of claim 1, and Heikenfeld 347 further teaches wherein the means to establish fluid communication comprises at least one needle (See Claim 1 Rejection).
Regarding Claim 5, Heikenfeld 347 teaches the device of claim 1, wherein the device is capable of measurement of one or more analytes for at least 6 hours ([0078] device is worn for 24 hours and is capable of measurement of one or more analytes while worn) and the measurement may be continuous ([0077] continuous measuring achieved by measuring repeatedly, based on when a new fluid sample has entered the collection environment and replaced the previous fluid sample).
Regarding Claim 6, Heikenfeld 347 teaches the device of claim 1, wherein the device is capable of measurement of one or more analytes for at least 24 hours ([0078] device is worn for 24 hours and is capable of measurement of one or more analytes while worn) and the measurement may be continuous ([0077] continuous measuring achieved by measuring repeatedly, based on when a new fluid sample has entered the collection environment and replaced the previous fluid sample).
Regarding Claim 7, Heikenfeld 347 teaches the device of claim 1 wherein the device is capable of taking a single measurement (See Claim 1 Rejection).
Regarding Claim 8, Heikenfeld 347 teaches the device of claim 1, comprising a first EAB sensor and a second EAB sensor ([0078]), wherein the first EAB sensor measures LH and the second EAB sensor measures progesterone ([0078], [0081] where the sensor 926 for luteinizing hormone could also be an electrochemical aptamer-based sensor; EAB sensor 922 for progesterone).
Regarding Claim 9, Heikenfeld 347 teaches a method of predicting and/or confirming ovulation of a subject (Abstract, [0004], [0059]-[0061] various embodiments are understood as descriptions of subcomponents of a single biofluid sample collecting device, with example biofluids being blood and interstitial fluid), comprising:
applying a device for measuring one or more analytes from interstitial fluid, blood or both of the subject (Abstract, [0004], [0059]-[0063]); and
measuring a concentration change of luteinizing hormone (LH), progesterone or both in the subject (Fig. 9, [0078] collection device 900 comprising electrochemical aptamer-based sensors 920 for estrogen and 922 for progesterone for measuring concentration of these analytes, [0079] where estrogen and progesterone concentration changes are measured over time, and may provide the basis for when the luteinizing hormone is measured, rather than a scheduled time);
wherein the one or more analytes are selected from the group consisting of progesterone, luteinizing hormone (LH), estrogen, follicle stimulating hormone (FSH), their metabolites, and combinations thereof ([0078]); and
further, wherein the device comprises:
a) at least one electrochemical aptamer-based (EAB) sensor comprising one or more attached redox couples that measure at least one of said analytes (Fig. 9 [0078], [0089] where electrochemical aptamer-based sensors measure by attached redox couples); and
b) a means to establish fluid communication between the at least one sensor to interstitial fluid, blood or both (Fig. 17, [0104]-[0105] microneedles 1782 act as means to establish fluid communication between the skin surface / sample of interstitial fluid and the at least one sensor. Further, device 1700 for extracting interstitial fluid to sense one or more analytes utilizing an array of microneedles to penetrate the skin surface and extract fluid can be provided with Fig. 9’s device for collection to jointly teach a particular configuration of the internal components for enabling device 1700 where the opening 1755 corresponds to the opening channel 980, the pump 1730 corresponds to pump 930, the one or more sensors 1720 correspond to sensors 920, 922, and 926, the sample concentrator 1795 corresponds to membrane 995, and the sensors may be electrochemical aptamer-based sensors).
Regarding Claim 12, Heikenfeld 347 teaches the method of claim 9, further comprising taking at least one measurement of progesterone by a device containing a sensor for progesterone (See Claim 9 Rejection).
Regarding Claim 14, Heikenfeld 347 teaches the method of claim 9 wherein the device provides data selected from the group consisting of continuous concentration data of at least one of said analytes, a predicted time of ovulation, a predicted time of peak fertility, a confirmation that ovulation has occurred, and combinations thereof ([0078] device is worn for 24 hours and is capable of measurement of one or more analytes of estrogen and progesterone, [0077] continuous measuring achieved by measuring repeatedly, based on when a new fluid sample has entered the collection environment and replaced the previous fluid sample).
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) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld 347 as evidenced by Glazer.
Regarding Claim 3, Heikenfeld 347 teaches the device of claim 2, wherein the at least one needle is hollow and it establishes fluid communication of the sample of interstitial fluid or blood to the at least one sensor (See Claim 2 Rejection) and where fluid communication can be facilitated by diffusion ([0104]-[0105] fluid extracted by microneedles is captured by biofluid collector 1734, [0055] biofluid collection can be facilitated by diffusion coupling).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to facilitate the biofluid collection from the microneedles at 1734 by providing biodfluid collector 1734 with diffusion capability as a way to promote the transport of interstitial fluid from the microneedles.
Regarding Claim 4, Heikenfeld 347 teaches the device of claim 2 wherein the at least one needle is hollow and it establishes fluid communication of the sample of interstitial fluid or blood to the at least one sensor (See Claim 2 Rejection) and where fluid communication can be facilitated by advection ([0104]-[0105] fluid extracted by microneedles is captured by biofluid collector 1734, [0055] biofluid collection can be facilitated by advective coupling).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to facilitate the biofluid collection from the microneedles at 1734 by providing biodfluid collector 1734 with advective capability as a way to promote the transport of interstitial fluid from the microneedles.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld 347 in view of Lakdawala (US 2016/0139156) and further in view of Martinez Hurtado (US 2019/0307432) as noted in Applicant IDS dated 3/18/2024 and further in view of Heikenfeld et al (US 2018/0353748) (“Heikenfeld 748”).
Regarding Claim 10, while Heikenfeld 347 teaches the method of claim 9 wherein said device continuously measures analytes for at least 6 hours ([0077] continuous analyte measurements, [0078] analytes measured during operation for 24 hours), their combined efforts fail to teach the method further comprising the use of at least two urine-based LH test strips to indicate a time for use of the device, and wherein said device continuously measures at least LH for at least 6 hours.
However Lakdawala teaches a fertility monitoring apparatus (Abstract) and teaches that a method for fertility monitoring comprises receiving initial patient fertility data determining a day for a user to perform LH monitoring based on the initial patient fertility data ([0106]) where the LH monitoring comprises urine-based LH strips ([0103], [0105]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to utilize initial monitoring of fertility related data from Heikenfeld 347 to identify the optimal day of LH monitoring as taught by Lakdawala as a means to ensure that the system of Heikenfeld 347 is only utilized at necessary time, saving device battery.
Yet their combined efforts fail to teach the use of at least two urine-based LH test strips to indicate a time for use of the device.
However Martinez Hurtado teaches an estimation of ovulation date (Abstract) and teaches that hormone monitoring strips may be measured multiple times as a confirmation of identified ovulation date ([0025], [0044]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to perform the urinary-based strip testing of Lakdawala twice as taught by Martinez Hurtado to ensure the fertility window of the user is correctly identified, ensuring the best possible chance for a user to get pregnant.
Yet their combined efforts fail to teach wherein said device continuously measures at least LH.
However Heikenfeld 748 teaches a biosensing fluid monitoring (Abstract) comprising measuring luteinizing hormone for fertility monitoring and further teaches that prolonged monitoring of luteinizing hormone may be facilitated at optimal times by applying continuous reverse iontophoresis for a patient intending to get pregnant ([0080]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to enable continuous monitoring of LH in Heikenfeld 347 with the reverse iontophoresis steps of Heikenfeld 748 to ensure that continuous monitoring of LH occurs at an appropriate time, enabling a user to identify their optimal fertility window.
Regarding Claim 11, Heikenfeld 347, Lakdawala, Martinez Hurtado, and Heikenfeld 748 teach the method of claim 10 wherein said device continuously measures analytes for at least 24 hours (See Claim 10 Rejection), their combined efforts fail to teach the continuously monitored analyte is LH.
However Heikenfeld 748 teaches a biosensing fluid monitoring (Abstract) comprising measuring luteinizing hormone for fertility monitoring and further teaches that prolonged monitoring of luteinizing hormone may be facilitated at optimal times by applying continuous reverse iontophoresis for a patient intending to get pregnant ([0080]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to enable continuous monitoring of LH in Heikenfeld 347 with the reverse iontophoresis steps of Heikenfeld 748 to ensure that continuous monitoring of LH occurs at an appropriate time, enabling a user to identify their optimal fertility window.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld 347 in view of Heikenfeld 748.
Regarding Claim 13, while Heikenfeld 347 teaches the method of claim 9 wherein the device contains sensors for both LH and progesterone ([0078]) and measures progesterone continuously for at least 6 hours ([0077] continuous analyte measurements, [0078] analytes measured during operation for 24 hours), their combined efforts fail to teach the continuously monitored analyte is LH.
However Heikenfeld 748 teaches a biosensing fluid monitoring (Abstract) comprising measuring luteinizing hormone for fertility monitoring and further teaches that prolonged monitoring of luteinizing hormone may be facilitated at optimal times by applying continuous reverse iontophoresis for a patient intending to get pregnant ([0080]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to enable continuous monitoring of LH in Heikenfeld 347 with the reverse iontophoresis steps of Heikenfeld 748 to ensure that continuous monitoring of LH occurs at an appropriate time, enabling a user to identify their optimal fertility window.
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 1-14 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 17/822,773 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both comprise an EAB sensor with a redox coupled thereto that measures analytes, a needle that is connected to the EAB and to a device and a method of using the EAB sensor for detecting a hormone.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791