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.
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.
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:
“a coupler” in claims 1, 16, 22, 55 and all dependent claims thereof;
“tension coupler” in claim 11, and all dependent claims thereof;
“a retrieval tension member” in claims 50, 52 and 53.
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.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-4, 6-13, 28, 41-45, and 50-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,376, 237. Although the claims at issue are not identical, they are not patentably distinct from each other because both the current application and U.S. Patent No. 10,376,237 are directed to an imager configured to be removably coupled to a probe device, an elongate member, and an elongate retriever coupled to the imager. Furthermore, the independent claim U.S. Patent No. 10,376,237 is narrower than claim 1 of current application.
Claims 16, 18-21, 46-47, 52 and 54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,376,237. Although the claims at issue are not identical, they are not patentably distinct from each other because both the current application and U.S. Patent No. 10,376,237 are directed to an imager configured to be removably coupled to a probe device, a coupler operably attached to the imager and configured to removably couple the imager to a head of a transesophageal prove device, the imager configured to be inserted into an esophagus of a patient, an elongate member coupled to the coupler and entirely circumscribe the transesophageal prove device, and in response to a proximal force applied at a proximal portion of the elongate member, radially expand relative to overcome a friction fit with the head of the transesophageal probe device. Furthermore, the independent claim U.S. Patent No. 10,376,237 is narrower than claim 16 of current application.
Claims 22-26, 48, 49 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,376,237. Although the claims at issue are not identical, they are not patentably distinct from each other because both the current application and U.S. Patent No. 10,376,237 are directed to an imager configured to be removably coupled to a probe device, a coupler operably attached to the imager and configured to removably couple the imager to a head of a transesophageal prove device, the imager configured to be inserted into an esophagus of a patient, an elongate member coupled to the coupler and entirely circumscribe the transesophageal prove device, and in response to a proximal force applied at a proximal portion of the elongate member, radially expand relative to overcome a friction fit with the head of the transesophageal probe device. Furthermore, the independent claim U.S. Patent No. 10,376,237 is narrower than claim 22 of current application.
Claims 55-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,376,237. Although the claims at issue are not identical, they are not patentably distinct from each other because both the current application and U.S. Patent No. 10,376,237 are directed to an imager configured to be removably coupled to a probe device, a coupler operably attached to the imager and configured to removably couple the imager to a head of a transesophageal prove device, the imager configured to be inserted into an esophagus of a patient, an elongate member coupled to the coupler and entirely circumscribe the transesophageal prove device, and in response to a proximal force applied at a proximal portion of the elongate member, radially expand relative to overcome a friction fit with the head of the transesophageal probe device. Furthermore, the independent claim U.S. Patent No. 10,376,237 is narrower than claim 55 of current application.
Claims 1-4, 6-8, 10-13, 28, 43-45, and 50-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,925,576. Although the claims at issue are not identical, they are not patentably distinct from each other because both the current application and U.S. Patent No. 10,925,576 are directed to an imager configured to be removably coupled to a probe device, the imager is releasable from the probe head, and proximally withdrawing the imager from outside the patient from the head of the probe device. Furthermore, the independent claim U.S. Patent No. 10,925,576 is narrower than claim 1 of current application.
Claims 22, 25-26, 48, 49 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,925,576. Although the claims at issue are not identical, they are not patentably distinct from each other because both the current application and U.S. Patent No. 10,925,576 directed to an imager configured to be removably coupled to a probe device, the imager is releasable from the probe head, and proximally withdrawing the imager from outside the patient from the head of the probe device. Furthermore, the independent claim U.S. Patent No. 10,925,576 is narrower than claim 22 of current application.
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.
Claims 1-4, 6, 9, 10, 12, 14, 41-45, and 50-51 are rejected under 35 U.S.C. 103 as being unpatentable over Hadani (US 2008/0255441), in view of Tanakn et al. (US 6,46,304).
Regarding claim 1, Hadani discloses an invasive imaging probe. Hadani shows an apparatus (see fig. 1), comprising: an imager configured to be removably coupled to a head of a transesophageal probe device (see fig. 1; par. [0016], [0018], [0084], [0071], [0101])), and inserted into an esophagus of a patient when removably coupled to the head of the transesophageal probe device (see fig. 1; par. [0016], [0018], [0071], [0101])); a coupler operably attached to the imager and configured to be releasably attach to the imager to the transesophageal probe device (see fig. 1; [0016], [0018], [0071], [0101]); and an elongated member coupled to the imager and configured to extend from the imager through the esophagus and out of the patient when the imager is removable coupled to the transesophageal probe device (see fig. 1; par. [0090], [0091], [0103], [104]), and the transesophageal probe device is disposed withing a target location of the patient (see fig. 1; par. [0016], [0018], [0071], [0084], [0101], [0103], [0104)), the target location including at least one of esophagus or a stomach of the patient (see par. [0071]), a portion of the coupler configured to be transparent to imaging energy (see par. [0076], [0101]).
But, Hadani fails to explicitly state that the portion of the coupler configured to be transparent to ultrasound waves.
Tanaka discloses an ultrasound inspection imaging add on for imaging probe and teaches coupler (see 25 in fig. 2-3) configured to be transparent to ultrasound waves (see abstract; see 27 in fig. 2-3, 643 in fig. 19 and also see fig. 13).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of that the portion of the coupler configured to be transparent to ultrasound waves in the invention of Hadani, to provide an ultrasound inspection imaging add on device which provide cost effective and safe inspection imaging device.
Regarding claim 2, Hadani and Tanaka disclose the invention substantially as described in the 103 rejection above, furthermore, Hadani shows wherein the imager is configured to capture image data withing the esophagus of the patient (see fig. 1; par. [0016], [0018], [0084], [0071], [0101]), the apparatus further comprising: a light source configured to illuminate a portion of the esophagus to improve quality of the image data (see par. [0101]-[0104]).
Regarding claim 3, Hadani and Tanaka disclose the invention substantially as described in the 103 rejection above, furthermore, Hadani shows wherein the image is communicatively coupled to an image data processing device configured to process the image data capture by the imager when the imager is disposed within the esophagus (see par. [0071], [0072], [0075] [0095]), the image processing device being located outside the patient when both imager and the transesophageal probe device are disposed within the target imaging location of the esophagus (see par. [0071], [0072], [0075] [0095]).
Regarding claim 4, Hadani and Tanaka disclose the invention substantially as described in the 103 rejection above, furthermore, Hadani shows a communication line (see par. [0071], [0072], [0075] [0095]), the imager being communicatively coupled to the image data processing device via the line (see par. [0071], [0072], [0075] [0095]).
Regarding claim 6, Hadani and Tanaka disclose the invention substantially as described in the 103 rejection above, furthermore, Hadani shows wherein the coupler is configured to releasably attach the imager to the transesophageal probe device when the coupler is in a first configuration (see par. [0084]), and release the imager from the transesophageal probe device when the coupler is in a second configuration (see par. [0084]).
Regarding claim 9, Hadani and Tanaka disclose the invention substantially as described in the 103 rejection above, furthermore, Hadani shows wherein the imager includes a seal (see fig. 1; par. [0016], [0018], [0071], [0101]). The claim limitation “...to withstand bodily fluid of at least one of the esophagus or a stomach of the patient" are directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Hadani is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Regarding claim 10, Hadani and Tanaka disclose the invention substantially as described in the 103 rejection above, furthermore, Hadani shows wherein the elongate member defines a lumen therethrough (see fig. 1; par. [0090], [0091], [0103], [104]), the apparatus further comprising a communication line extending from the imager through the lumen of the elongate member to outside the patient when both the imager and the probe device are disposed within the target imaging location (see fig. 1; par. [0090], [0091], [0103], [104]).
Regarding claim 12, Hadani and Tanaka disclose the invention substantially as described in the 103 rejection above, furthermore, Hadani shows wherein the imager is configured to entirely circumscribe the probe device (see fig. 1). The claim limitations “...to be detached from the head in response to a force less than 15 Newtons applied by the elongate member" are directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Hadani and Tanaka is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Regarding claim 14, Hadani and Tanaka disclose the invention substantially as described in the 103 rejection above, furthermore, Hadani shows wherein the imager is configured to entirely circumscribe the probe device (see fig. 1). The claim limitations “...slide along the transesophageal probe device in response to a proximal force applied to a proximal portion of the elongate member" are directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Hadani and Tanaka is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Regarding claim 41, Hadani and Tanaka disclose the invention substantially as described in the 103 rejection above, furthermore, Hadani shows wherein the coupler includes a sleeve from of a flexible material (see fig. 2 and 3), the flexible material configured to radially expand relative to the head to release therefrom (see fig. 2 and 3).
Regarding claim 42, Hadani and Tanaka disclose the invention substantially as described in the 103 rejection above, furthermore, Hadani shows wherein the elongate member is coupled to the imager via the coupler (see fig. 1), the coupler including a sleeve configured to circumscribe the prove device (see fig. 1 and 2). The claim limitations “...slide along the transesophageal probe device in response to a proximal force applied at a proximal portion of the elongate member" are directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Hadani and Tanaka is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Regarding claim 43, claim limitations “...configured to extend from the imager through a stomach of the patient and the esophagus and out of the patient when the imager is removably coupled to the transesophageal probe device, and the transesophageal probe device is disposed within the target imaging location of the patient, the target imaging location of the patient being within the stomach" are directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Hadani and Tanaka is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Regarding claims 44-45, claim limitations “wherein the target imaging location is whtin the stomach” and “wherein the target imaging location is withing the esophagus” are directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Hadani and Tanaka is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Regarding claim 50, Hadani and Tanaka disclose the invention substantially as described in the 103 rejection above, furthermore, Hadani shows wherein the elongate member is a retrieval tension member (see fig. 1; par. [0090], [0091], [0103], [104]).
Regarding claim 51, Hadani and Tanaka disclose the invention substantially as described in the 103 rejection above, furthermore, Hadani shows wherein the elongate member defines a lumen configured to receive power line to power the imager (see par. [0072]).
Claims 7-8, 11, 13, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Hadani (US 2008/0255441), in view of Tanakn et al. (US 6,46,304) as applied to clams 1 and 6 above and further in view of in view of Kimmel et al. (US 2007/0175482; hereinafter Kimmel).
Regarding claims 7-8, Hadani and Tanakn disclose the invention substantially as described in the 103 rejection above, furthermore, Hadani shows a controller in operable communication with the coupler when the controller is disposed outside the patient and both the imager and the transesophageal probe device are disposed within the target imaging location (see par. [0071], [0072], [0075] [0095]), but the controller configured to transition the coupler between the first configuration and the second configuration.
Kimmel discloses an apparatus for introducing an instrument. Kimmel teaches a video guided placement of a device in pediatric application under guidance of view images provided by a camera (see abstract; par. [0028], [0063], [0065], [0068], [0076]), state that controller configured to transition the coupler between the first configuration and the second configuration (see par. (see abstract; par. [0028], [0063], [0065], [0068], [0076]; fig. 6A-6C). Kimmel also teaches a mechanical latch (see par. [0058]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have modified the invention of Hadani to incorporate the teaching of controller configured to transition the coupler between the first configuration and the second configuration and mechanical latch in the invention of Hadani and Tanakn, as taught by Kimmel, in order to configure with the distal portion of the probe disposed in a proper position for capturing images of the heart and easily remove the guidance device camera when it is no longer necessary using the mechanical latch.
Regarding claim 11, Hadani and Tanakn disclose the invention substantially as described in the 103 rejection above, furthermore, wherein the elongate member has a medial portion disposed proximal to the imager (see fig. 1), the probe device having a body portion disposed proximal to the head of the probe device (see fig. 1), but, Hadani fails to explicitly state a tension coupler configured to be slidably engage with the body portion of the probe device to limit a maximum distance between the medial portion of the elongate member and the body portion of the probe device.
Kimmel discloses an apparatus for introducing an instrument. Kimmel teaches a tension coupler configured to be slidably engage with the body portion of the probe device to limit a maximum distance between the medial portion of the elongate member and the body portion of the probe device (see par. [0066]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have modified the invention of Hadani Tanakn to incorporate the teaching of tension coupler configured to be slidably engage with the body portion of the probe device to limit a maximum distance between the medial portion of the elongate member and the body portion of the probe device, as taught by Kimmel, in provide a safety feature by limiting further advancement between the elongate member and transesophageal probe.
Regarding claim 13, Hadani and Tanakn disclose the invention substantially as described in the 103 rejection above, furthermore, Hadani shows wherein the imager is configured to circumscribe the image head of the probe device when removable coupled thereto ((see fig. 1; par. [0016], [0018], [0084], [0071], [0101]), but Hadani fails to explicitly state the image configured to be withdrawn along the probe device and removed from at least the esophagus of the patient, leaving the head withing the target imaging location.
Kimmel discloses an apparatus for introducing an instrument. Kimmel teaches a video guided placement of a device in pediatric application under guidance of view images provided by a camera (see abstract; par. [0028], [0063], [0065], [0068], [0076]), state that the image configured to be withdrawn along the probe device and removed from at least the esophagus of the patient, leaving the head withing the target imaging location (see par. (see abstract; par. [0028], [0063], [0065], [0068], [0076]; fig. 6A-6C).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have modified the invention of Hadani and Tanakn to incorporate the teaching of the image configured to be withdrawn along the probe device and removed from at least the esophagus of the patient, leaving the head withing the target imaging location, as taught by Kimmel, in order to configure with the distal portion of the probe disposed in a proper position for capturing images of the heart and remove the guidance device camera when it is no longer necessary.
Regarding claim 28, Hadani and Tanakn disclose the invention substantially as described in the 103 rejection above, furthermore, Hadani shows that the imager is configured to be removable from the head of the transesophageal probe device intra-procedure ((see fig. 1; par. [0016], [0018], [0084], [0071], [0101]), but Hadani fails to explicitly state that the image can withdrawn proximally relative to the head after both the imager and the head have reached the target imaging location, thereby leaving the head in the target imaging location.
Kimmel discloses an apparatus for introducing an instrument. Kimmel teaches a video guided placement of a device in pediatric application under guidance of view images provided by a camera (see abstract; par. [0028], [0063], [0065], [0068], [0076]), state that the image can withdrawn proximally relative to the head after both the imager and the head have reached the target imaging location, thereby leaving the head in the target imaging location (see par. (see abstract; par. [0028], [0063], [0065], [0068], [0076]; fig. 6A-6C).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have modified the invention of Hadani and Tanakn to incorporate the teaching of the image can withdrawn proximally relative to the head after both the imager and the head have reached the target imaging location, thereby leaving the head in the target imaging location, as taught by Kimmel, in order to configure with the distal portion of the probe disposed in a proper position for capturing images of the heart and remove the guidance device camera when it is no longer necessary.
Regarding the limitations of capturing images of the heart is directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Hadani, Tanakn and Kimmel is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Claims 22-23, 25-26, 48-49 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Hadani (US 2008/0255441), in view of Kimmel et al. (US 2007/0175482; hereinafter Kimmel).
Regarding claim 22, Hadani discloses invasive imaging probe. Hadani shows an apparatus (see abstract), comprising: an imager configured to be removably coupled to a head of a transesophageal imaging probe device (see fig. 1; par. [0016], [0018], [0071], [0101]); and inserted into an esophagus of a patient when removably coupled to the head of the transesophageal imaging probe device (see fig. 1; abstract; par. [0016], [0018], [0071], [0101]); a coupler operably attached to the imager and configured to releasably attach the imager to the probe device (see fig. 1; [0016], [0018], [0071], [0101]); an elongate member coupled to the coupler (see fig. 1; par. [0090], [0091], [0103], [104]) and configured to extend from coupler through the esophagus and out of the patient (see fig. 1; par. [0090], [0091]) when the imager is removably coupled intra-procedure to the transesophageal imaging probe device (see fig. 1 and abstract; par. [0016], [0018], [0084], [0071], [0101]), and the transesophageal imaging probe device is disposed within a target imaging location of the patient ((see fig. 1; par. [0016], [0018], [0071], [0101]) and the target location including at least one of esophagus or a stomach of the patient (see par. [0071]).
Hadani fails to explicitly state withdrawing the elongate retriever from outside the patient the imager is withdrawn from the head of the transesophageal probe device after both the imager and the head device have reached the target imaging location, thereby leaving the head in the target imaging location.
Kimmel discloses an apparatus for introducing an instrument. Kimmel teaches a video guided placement of a device in pediatric application under guidance of view images provided by a camera (see abstract; par. [0028], [0063], [0065], [0068], [0076]), wherein elongate retriever can be withdrawn from the device after both the imager and the head probe device have reached the target location, thereby leaving the head device in the target location (see par. (see abstract; par. [0028], [0063], [0065], [0068], [0076]; fig. 6A-6C).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have modified the invention of Hadani to incorporate the teaching of wherein elongate retriever can be withdrawn from the device after both the imager and the head probe device have reached the target location, thereby leaving the device in the target location, as taught by Kimmel, in order to configure with the distal portion of the probe disposed in a proper position for capturing images of the heart and remove the guidance device camera when it is no longer necessary.
Regarding claim 23, Hadani shows wherein the elongate member is coupled to a sleeve of the imager and the sleeve is configured to entirely circumscribe the probe device (see fig. 1). The claim limitations “...slide along the transesophageal imaging probe device in response to a proximal force applied to a proximal portion of the elongate member" are directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Hadani and Kimmel is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Regarding claim 25, Hadani shows a communication line (see par. [0071], [0072], [0075] [0095]), the image being communicatively coupled to an image data processing device via the communication line ((see par. [0071], [0072], [0075] [0095]), wherein the elongate member defines a lumen therethrough (see fig. 1; par. [0090], [0091], [0103], [104]), the communication line configured to extend through the lumen from the imager to the image data processing device when both the imager and the transesophageal imaging probe device are disposed within the esophagus and the image data processing device is located outside the patient (see fig. 1; par. [0090], [0091], [0103], [104]).
Regarding claim 26, Hadani shows wherein the imager is configured to entirely circumscribe the probe device (see fig. 1). The claim limitations “...to be detached from the head in response to a force less than 15 Newtons applied by the elongate member" are directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Hadani and Kimmel is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Regarding claims 48-49, claim limitations “wherein the target imaging location is within the stomach” and “wherein the target imaging location is withing the esophagus” are directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Hadani and Kimmel is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Regarding claim 53, Hadani shows wherein the elongate member is a retrieval tension member ((see fig. 1; par. [0090], [0091], [0103], [104]).
Allowable Subject Matter
Claims 15, 16, 18-21, 24, 27, 46-47, 52, 54-57 are rejected under Double Patenting, but 15, 16, 18-21, 24, 27, 46-47, 52, 54-57 are free of prior art rejection.
Response to Arguments
The previous claim objection to claims 2, 9 and 43 has been withdrawn in view of Applicant’s amendments to the claims.
The examiner has maintained the previous Double Patent rejection since a terminal disclaimer has not been filed.
Applicant’s remarks with respect to independent claims 1 and 22 have been considered but are moot because upon further consideration and in view of Applicant’s amendments to independent claims 1 and 22, a new ground of rejection is made for independent claims 1 and the examiner has maintained the prior art rejection of claim 22 over prior art Hadani. For claim 1, the examiner has provided new prior art Tanaka to address the newly added claim limitation. For claim 22, the examiner maintains that Hadani does show a transesophageal imaging probe device and an imager configured to be removably coupled to a head of a transesophageal imaging probe device (see fig. 1; par. [0016], [0018], [0071], [0101]).
In response to Applicant’s argument on page 13, with respect to claim interpretation under 35 USC (f), the examiner respectfully disagrees. The examiner has maintained the claim interpretation for claim elements “a coupler” in claims 1, 16, 22, 55 and all dependent claims thereof; “tension coupler” in claim 11, and all dependent claims thereof; “a retrieval tension member” in claims 50, 52 and 53 because these claim elements 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. The Applicant argues that the claims does not recite “means for”, however, the MPEP states that a claim element does invoke 35 USC 112 (f) if 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. The examiner notes that the claims include 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:
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M Kozak can be reached at (571)270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAHDEEP MOHAMMED/ Primary Examiner, Art Unit 3797
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