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.
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.
Presently, three claims, claims 1, and 5-6 contain means plus function recitations.
Claim 1 recites “energy means for disrupting or suppressing a contraction wave of the myometrium,” see lines 2-3.
This energy means is interpreted as the “generator 42” in the present written description. For the purposes of providing an examination and search and relevant prior art the examiner interprets the energy means as an (energy/power) generator, source or the like.
Claim 5 recites “monitoring means configured to monitor an affect created on the uterus,” see lines 1-2.
This monitoring means is interpreted as the “sensor 44” in the present written description. For the purposes of providing an examination and search and relevant prior art the examiner interprets the monitoring means as a sensor, detector or the like.
Claim 6 recites “sensing means configured to sense one or more of a condition of the uterus, a fetus or a mother,” see lines 1-2.
This sensing means is ALSO interpreted as the “sensor 44” in the present written description. For the purposes of providing an examination and search and relevant prior art the examiner interprets the sensing means as a sensor, detector or the like.
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.
Claim 1 is rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because the claim purports to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, but fails to recite a combination of elements as required by that statutory provision and thus cannot rely on the specification to provide the structure, material or acts to support the claimed function. As such, the claim recites a function that has no limits and covers every conceivable means for achieving the stated function, while the specification discloses at most only those means known to the inventor. Accordingly, the disclosure is not commensurate with the scope of the claim.
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 1-12, 14-15, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Karsdon et al. (U.S. Patent 11,291,831).
Regarding claim 1, Karsdon et al. disclose a system comprising:
an energy means (“power supply 302, for example a battery or other power source,” see col. 7:56-60 and figure 3, and other alternate/equivalent counterparts in other embodiments) for disrupting or suppressing a contraction wave of the myometrium and rendering the contraction wave ineffective or blocking the contraction wave entirely to thereby delay birth (see abstract, and col. 9:58 through col. 10:5).
Regarding claim 2, Karsdon et al. further disclose one or more electrodes (electrodes 318A and 318B, see col. 9:58 through col. 10:5 and figure 3, and other alternate/equivalent counterparts in other embodiments) configured to be placed adjacent or implanted within the uterus.
Regarding claim 3, Karsdon et al. further disclose the one or more electrodes are configured to deliver a series of electro or mechanical stimulus to disrupt an effectiveness of uterine contractions (electrodes 318A and 318B, see col. 9:58 through col. 10:5 and figure 3, and other alternate/equivalent counterparts in other embodiments) configured to be placed adjacent or implanted within the uterus.
Regarding claim 4, Karsdon et al. further disclose a controller (“wireless controller 706,” see col. 16:3-24 and figure 7, and other alternate/equivalent counterparts in other embodiments) configured to communicate and control operation of the one or more electrodes.
Regarding claim 5, Karsdon et al. further disclose a monitoring means (see A) “controlling uterine contractions is disclosed including receiving data from at least one sensor by a wireless apparatus inserted into the patient's vagina adjacent the cervix,” in the abstract, B) “the controller may be further configured to receive monitoring data from the at least one sensor. The monitoring data may be generated by the at least one sensor based at least in part on a sensed effect of the application of the electrical energy to the patient's uterus via the cervix,” see col. 3:7-14, and C) “receiving, via a wireless communication interface of a wireless apparatus inserted into the patient's vagina adjacent the cervix, data from at least one sensor,” see col. 3:38-57 for example) configured to monitor an affect created on the uterus.
Regarding claim 6, Karsdon et al. further disclose a sensing means (see A) “controlling uterine contractions is disclosed including receiving data from at least one sensor by a wireless apparatus inserted into the patient's vagina adjacent the cervix,” in the abstract, B) “the controller may be further configured to receive monitoring data from the at least one sensor. The monitoring data may be generated by the at least one sensor based at least in part on a sensed effect of the application of the electrical energy to the patient's uterus via the cervix,” see col. 3:7-14, and C) “receiving, via a wireless communication interface of a wireless apparatus inserted into the patient's vagina adjacent the cervix, data from at least one sensor,” see col. 3:38-57 for example) configured to sense one or
more of a condition of the uterus, a fetus or a mother.
Regarding claim 7, Karsdon et al. further disclose an electrical stimulus is provided
to cause depolarization and repolarization of smooth muscles of the uterus (see col. 7:40-49, col. 9:58-col. 10:5, and “the EI uterine pacemaker 100 may apply the electrical energy to the patient's cervix prior to the contraction to control the smooth muscle of the patient's uterus such that when the electrical energy generated by the patient that drives the contraction reaches the controlled smooth muscle, the contraction is inhibited,” in col. 20:22-38, for example). The depolarization and repolarization is just cause for the byproduct contraction and relaxation due to the electrical stimulation of the smooth muscle.
Regarding claim 8, Karsdon et al. further disclose electrical stimulus is automatically responsive to sensed changes in the uterus (see A) “controller may be further configured to cause the generator circuit to adjust the supply of electrical energy to the first and second electrodes based on the monitoring data,” see col. 3:7-14, B) “EI uterine pacemaker 100 may receive the electrical signal from sensor 702, e.g., at one or more of wireless receivers 316, 420, 520, 540, 620, and 640, depending on the configuration, and may activate, disable, or adjust the supply of electrical energy to electrodes 114A-114D based on the received electrical signal,” see col. 15:12-36 for example).
Regarding claim 9, Karsdon et al. further disclose the electrical stimulus is pre-programed based on empirical data collected in advance of a treatment procedure (see the initial impedance measurement to establish baseline impedance measurements for the patient, see col. 13:53 through col. 14:35).
Regarding claim 10, Karsdon et al. further disclose a delivery apparatus (“EI uterine pacemaker 100 also includes electrodes 114, for example, electrodes 114A, 114B, 114C, and 114D,” see col. 5:64 through col. 6:21 and figures 1A-2) configured to contain and deploy the one or more electrodes at a placement site.
Regarding claim 11, Karsdon et al. further disclose the one or more electrodes are spaced to ensure a desired treatment coverage of the uterus (“EI uterine pacemaker 100 also includes electrodes 114, for example, electrodes 114A, 114B, 114C, and 114D,” see col. 5:64 through col. 6:21 and figures 1A-2) configured to contain and deploy the one or more electrodes at a placement site.
Regarding claim 12, Karsdon et al. further disclose the one or more electrodes are placed to have one or more of overlapping effectiveness regions or non-overlapping effectiveness regions. (“EI uterine pacemaker 100 also includes electrodes 114, for example, electrodes 114A, 114B, 114C, and 114D,” see col. 5:64 through col. 6:21 and figures 1A-2) configured to contain and deploy the one or more electrodes at a placement site.
Regarding claim 14, Karsdon et al. further disclose the one or more electrodes are placed in a peritoneal space (“EI uterine pacemaker 100 also includes electrodes 114, for example, electrodes 114A, 114B, 114C, and 114D,” see col. 5:64 through col. 6:21 and figures 1A-2) since the cervix/uterus are in the peritoneal area.
Regarding claim 15, Karsdon et al. further disclose the one or more electrodes are placed on an outer surface of the uterus (“EI uterine pacemaker 100 also includes electrodes 114, for example, electrodes 114A, 114B, 114C, and 114D,” see col. 5:64 through col. 6:21 and figures 1A-2) since the cervix forms the outer lower portion of the uterus.
Regarding claim 20, Karsdon et al. further the energy means is configured to provide long term disruption or suppression of contraction waves of the uterus and render the contraction waves ineffective or block them entirely to thereby delay birth (Applicant’s specification gives no special definition to long term in days, hours, minutes, or seconds and therefore the examiner interpret long term very broadly). Just like Applicant’s disclosure, Karsdon et al. is directed to avoiding pre-term (prior to 37 weeks gestation) birth and since Karsdon et al. disclose a system and method of controlling contractions their system can meet the long term disruption and delay birth.
Claims 1, 13, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Utley et al. (U.S. Patent Application Publication 2009/0318914).
Regarding claim 1, Utley et al. disclose a system comprising:
an energy means (“generator 2,” see [0083] and figure 1, and other alternate/equivalent counterparts in other embodiments).
The recitation of the energy mean is “for disrupting or suppressing a contraction wave of the myometrium and rendering the contraction wave ineffective or blocking the contraction wave entirely to thereby delay birth” is a recitation of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed. A recitation of intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. However, if a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. 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 re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971). In addition, where there is reason to believe that such functional limitation may be an inherent characteristic of the prior art reference, Applicant is required to prove that the subject matter shown in the prior art reference does not possess the characteristic relied upon. In re Spada, 911 F.2d 705, 15 USPQ2d 1655 (Fed. Cir. 1990); In re King, 801 F.2d 1324, 1327, 231 USPQ 136, 138 (Fed. Cir. 1986); In re Ludtke, 441 F.2d at 664, 169 USPQ at 566 (CCPA 1971). A recitation with respect to the manner in which an apparatus is intended to be employed 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 Yanush, 477 F.2d 958, 177 USPQ 705 (CCPA 1973); In re Finsterwalder, 436 F.2d 1028, 168 USPQ 530 (CCPA 1971); In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 136 USPQ 458 (CCPA 1963); Ex parte Masham, 2 USPQ2d 1647 (BdPatApp & Inter 1987).
Regarding claim 13, Utley et al. further disclose structure and functionality to ablate selected sections of the uterus (see abstract, and [0009] for example).
Regarding claim 19, Utley et al. further tissue ablation is performed to alter electromechanical conduction (see abstract, and [0009] for example).
Claims 1, 2, and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garfield et al. (U.S. Patent Application Publication 2016/0235979).
Regarding claim 1, Garfield et al. disclose a system comprising:
an energy means (“source 20 for providing electrical stimulation with varying parameters,” see [0063] and figure 4, and other alternate/equivalent counterparts in other embodiments).
The recitation of the energy mean is “for disrupting or suppressing a contraction wave of the myometrium and rendering the contraction wave ineffective or blocking the contraction wave entirely to thereby delay birth” is a recitation of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed. A recitation of intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. However, if a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. 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 re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971). In addition, where there is reason to believe that such functional limitation may be an inherent characteristic of the prior art reference, Applicant is required to prove that the subject matter shown in the prior art reference does not possess the characteristic relied upon. In re Spada, 911 F.2d 705, 15 USPQ2d 1655 (Fed. Cir. 1990); In re King, 801 F.2d 1324, 1327, 231 USPQ 136, 138 (Fed. Cir. 1986); In re Ludtke, 441 F.2d at 664, 169 USPQ at 566 (CCPA 1971). A recitation with respect to the manner in which an apparatus is intended to be employed 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 Yanush, 477 F.2d 958, 177 USPQ 705 (CCPA 1973); In re Finsterwalder, 436 F.2d 1028, 168 USPQ 530 (CCPA 1971); In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 136 USPQ 458 (CCPA 1963); Ex parte Masham, 2 USPQ2d 1647 (BdPatApp & Inter 1987).
Regarding claims 2, and 16, Garfield et al. disclose the claimed invention including:
A) one or more electrodes (“electrodes 36,” see [0069], [0099]-[0103] and figures 17A-17C) configured to be placed adjacent or implanted within the uterus,
B) the one or more electrodes are placed within a space between an amniotic sac and an internal wall of the uterus,
this recitation is interpreted as an invention capable of placing the one or more electrodes (“electrodes 36,” see [0069], [0099]-[0103] and figures 17A-17C) within a space between an amniotic sac and an internal wall of the uterus.
Regarding claim 17, Garfield et al. disclose the claimed invention including “the one or more electrodes are implanted within the cervix.” This recitation is interpreted by the examiner as the one or more electrodes are configured to be implanted within the cervix – which the examiner further interprets as electrode capable of being inserted into the cervix (“electrodes 36,” see [0069], [0099]-[0103] and figures 17A-17C).
Regarding claim 18, Garfield et al. disclose the claimed invention including “the one or more electrodes are placed within walls of the uterus.” This recitation is interpreted by the examiner as the one or more electrodes are configured to be placed within walls of the uterus – which the examiner further interprets as electrode capable of being inserted into the cervix (“electrodes 36,” see [0069], [0099]-[0103] and figures 17A-17C).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
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/AARON F ROANE/Primary Examiner, Art Unit 3792