DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “pressure beaching internal lumen” of Claim 20 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 5, 15 and 20-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 5 recites “said at least one fluid delivery port” that lacks proper antecedent basis. Note that in claim 1, line 5, it is “a fluid delivery port” being recited.
Claim 15 recites “said aspiration openings” that lacks proper antecedent basis. Note that in claim 1, line 7, it is “at least one aspiration opening” being recited.
Claim 20 recites “a pressure beaching internal lumen is configured to breach an opening is said sidewall of said retrieval catheter when a threshold pressure is reached within said second internal lumen” that renders the scope of the claim indefinite based on the following considerations: (1) it is unclear what kind of lumen is a pressure beaching internal lumen. It is unclear what it means by “pressure beaching”. Note that this limitation has caused an objection to the drawings. The specification does not provide any further disclosure. (2) the underlined portion of the above limitation is grammatically incorrect. (3) the term “said second internal lumen” lacks proper antecedent basis.
Claim 21 is recited to be dependent to claim 6 that has been canceled. The dependency of claim 21 hence is unclear and redarns the scope of the claim indefinite.
The dependent claims of the above rejected claims are rejected due to their dependency.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 9, 22 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Emery et al., US 5,160,319, hereinafter Emery.
Claims 1, 22 and 25. Emery teaches an oocytes or ovum retrieval device, and a method for retrieval of oocytes or ovum from a subject (Title: Dual-lumen oocyte aspiration needle) comprising:
a retrieval catheter dimensioned for transvaginal insertion into a cervical canal and for advancing distally into a fallopian tube and the ampulla of a female mammal (Col.1, ll.27-30: during an oocyte retrieval procedure, a relatively long aspiration needle is…vaginally…inserted into a patient so that the distal end of the needle is in contact with a patient’s ovary; ll.64-68: each oocyte is located in a fluid-filled sac or follicle. Before an oocyte can be retrieved, a physician needs to be able to accurately puncture each sac prior to retrieval without damaging or losing the oocyte), wherein said retrieval catheter comprises:
(i) one or more fluid delivery lumens having a fluid delivery port for delivering a flushing fluid into said fallopian tube, and (ii) at least one aspiration opening in fluid connection with an internal aspiration lumen of said retrieval catheter (Col.1, ll.58-63: a dual-lumen device has a first fluid path, or lumen, for aspiration and a second fluid path for irrigation. The use of separate paths thereby reduces the possibility of flushing an oocyte out of the aspiration path during an irrigation procedure), wherein
the size of the at least one aspiration opening is determined based on a size of oocytes or ovum (Col.1, ll.30-32: the objective is to puncture an individual follicle on the ovary and withdrawn a single oocyte up through the needle) – since the needle is designed for a single oocyte to pass through for retrieval, the size of the aspiration opening hence is considered being determined based on the size of the oocyte.
Claims 2 and 25. Emery further teaches
an introductory catheter (10, 12) dimensioned for transvaginal insertion into a cervical canal of a female mammal, wherein said retrieval catheter (36) is dimensioned for slidably advancing within a lumen (central channel 18) of said introductory catheter (first hub 12) along a longitudinal axis thereof (FIG.1, arrows connecting 40, 42 and 50) , such that a distal end of said retrieval catheter extends distally of a distal tip of said introductory catheter and into said fallopian tube (Col.1, ll.27-30: during an oocyte retrieval procedure, a relatively long aspiration needle is…vaginally…inserted into a patient so that the distal end of the needle is in contact with a patient’s ovary; Col.3, ll.46-48: the oocyte collection device 10 includes a first hub 12; and Col.4, ll.1-5: FIG.1, the aspiration cannula 36 also extends through the central channel 18 of the first hub 12. Finally, the aspiration cannula 36 extends through substantially the entire length of the outer cannula 30).
Claim 9. Emery further teaches
a vacuum source in fluid connection with said internal aspiration lumen (Col.1, ll.33-37: the proximal end of the needle is connected to flexible tubing which is , in turn, connected to both a test tube and a vacuum source. The vacuum source provides suction through both the tubing and the needle to allow aspiration of the oocyte from the follicle).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Emery in view of Cook et al., US 5,405,321, hereinafter Cook.
Claim 8. Emery teaches all the limitations of claim 1.
Emery does not teach one or more fluid reservoirs in fluid connection with said one or more fluid delivery lumens.
However, in an analogous oocyte retrieval device configuration field of endeavor, Cook teaches
one or more fluid reservoirs (3) in fluid connection with said one or more fluid delivery lumens (Col.1, ll.51058: flushing media can be applied to the follicle to assist in the withdrawal of the ovum, the coupling device comprises an inner chamber and first means for terminating the said second conduit means in the chamber, in that he first conduit means has a lumen therein adapted to be in fluid communication with said inner chamber) – the “inner chamber” is the “one or more fluid reservoirs” as claimed.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the device of Emery employ the feature of “one or more fluid reservoirs in fluid connection with said one or more fluid delivery lumens” as taught in Cook for the advantage of providing a continuous fluid communication within the device, as suggested in Cook, Col.3, ll.25-28.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Emery in view of Payeli et al., US 2022/0031360 A1, hereinafter Payeli.
Claim 10. Emery teaches all the limitations of claim 1.
Emery does not teach that an outer diameter of at least a distal portion of a sidewall of said retrieval catheter is between 1 and 1.4 mm.
However, in an analogous oocyte retrieval device configuration field of endeavor, Payeli teach
an outer diameter of at least a distal portion of a sidewall of said retrieval catheter is between 1 and 1.4 mm ([0022]: the lumen of the needle 202 has a diameter ranging between about 0.6 mm to about 1.6 mm that allow ovum (oocyte cumulus complex) collection from the follicle).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the device of Emery employ the feature of “an outer diameter of at least a distal portion of a sidewall of said retrieval catheter is between 1 and 1.4 mm” as taught in Payeli for the advantage of allowing ovum collection from the follicle, as suggested in Payeli, [0022].
It is noted that, since the function of the retrieval catheter is for retrieving oocytes, the size of the retrieval catheter may be specified based on the overall design of the device. It would be at least reasonably larger than the size of the type of oocytes that it is used to retrieve. To have the size to be between 1 and 1.4 mm is considered among various common practices that normally requires only ordinary skill in the art and hence are considered routine expedients. Such an dimension is considered merely changes in size/proportion, which the court has held normally require only ordinary skill in the art and hence is considered routine expedients. It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to arrive such a configuration through routine experimentation with reasonable expectation of success. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package "of appreciable size and weight requiring handling by a lift truck" were held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) ("mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled." 531 F.2d at 1053, 189 USPQ at 148.). MPEP 2144.04.IV.A.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Emery in view of Seed et al., EP 0131166, hereinafter Seed.
Claim 14. Emery teaches all the limitations of claim 1.
Emery does not teach that a ratio between a cross sectional dimension of said internal aspiration lumen and a cross sectional dimension of said fluid delivery lumen is at least 2 to 1.
However, in an analogous oocyte retrieval device configuration field of endeavor, Seed teaches
a ratio between a cross sectional dimension of said internal aspiration lumen and a cross sectional dimension of said fluid delivery lumen is at least 2 to 1 (p.20. ¶-1: a ratio of diameters of suction lumen to supply lumen of between 5:1 and 15:1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the device of Emery employ the feature of “a ratio between a cross sectional dimension of said internal aspiration lumen and a cross sectional dimension of said fluid delivery lumen is at least 2 to 1” as taught in Seed for the advantage of accomplishing an equalization of supply and recovery, as suggested in Seed, p.20, ¶-1.
It is noted that, since the function of the aspiration lumen (the suction lumen of Seed) and the fluid delivery lumen (the fluid delivery lumen of Seed) is to provide suitable flow supply, the relative size of the aspiration lumen and the fluid delivery lumen may be specified based on the overall design of the device and the requirement of the relative flow through the two lumens. To have the ratio of the cross-section dimension to be at least 2 to 1 is considered among various common practices that normally requires only ordinary skill in the art and hence are considered routine expedients. Such an dimension is considered merely changes in size/proportion, which the court has held normally require only ordinary skill in the art and hence is considered routine expedients. It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to arrive such a configuration through routine experimentation with reasonable expectation of success. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package "of appreciable size and weight requiring handling by a lift truck" were held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) ("mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled." 531 F.2d at 1053, 189 USPQ at 148.). MPEP 2144.04.IV.A.
Claims 15 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Emery in view of Buster et al., US 2014/0378753 A1, hereinafter Buster.
Claim 15. Emery teaches all the limitations of claim 1.
Emery does not teach that said retrieval catheter comprises a plurality of said aspiration openings arranged about an external sidewall of said retrieval catheter.
However, in an analogous oocyte retrieval device configuration field of endeavor, Buster teaches that
said retrieval catheter comprises a plurality of said aspiration openings arranged about an external sidewall of said retrieval catheter ([0067]: referring to FIGS.9A, 9B and 10,…the outer tubular member 62 of the supply/suction line 46 defines a fluid supply line port 86…atraumatic tip 48 defines fluid suction line port 88 that are in fluid communication with outflow lumen through which fluid and entrained blastocysts 20 are recovered from the uterine cavity; and [0126]: referring to FIG.38, a lavage device 10a can include a secondary suction port 88a provided through lumen 78 (FIG.3A)) – the line port 88 is located on a top side external wall, and the secondary suction port 88a is located on a longitudinal side external wall.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the device of Emery employ the feature of “said retrieval catheter comprises a plurality of said aspiration openings arranged about an external sidewall of said retrieval catheter” as taught in Buster for the advantage of providing additional aspiration port to efficient the retrieval process as indicated by the inwards arrows in Buster, FIG.38.
It is noted that, since the function of the aspiration opening is to receive the oocytes to be retrieved, the number of the aspiration opening may be specified based on the overall design of the device and the requirement of the efficiency of the retrieval. To have the a plurality of aspiration openings is considered among various common practices that normally requires only ordinary skill in the art and hence are considered routine expedients. Such an dimension is considered merely duplication of parts, which the court has held normally require only ordinary skill in the art and hence is considered routine expedients. It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to arrive such a configuration through routine experimentation with reasonable expectation of success. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.). MPEP 2144.04.VI.B.
Further, since the function of the aspiration opening is to receive the oocytes to be retrieved, the location of the opening may be specified based on the overall design of the device in order for the retrieval to be executed properly. To have the external wall to be a particular sidewall is considered among various common practices that normally requires only ordinary skill in the art and hence are considered routine expedients. Such an dimension is considered merely rearrangement of parts, which the court has held normally require only ordinary skill in the art and hence is considered routine expedients. It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to arrive such a configuration through routine experimentation with reasonable expectation of success. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). MPEP 2144.04.VI.C.
Claim 35. Emery teaches all the limitations of claim 25.
Emery does not teach that the retrieval catheter further comprising a conduit allowing flushing liquid to flow in the fallopian tube toward the uterus.
However, in an analogous oocyte retrieval device configuration field of endeavor, Buster teaches that
the retrieval catheter further comprising a conduit allowing flushing liquid to flow in the fallopian tube toward the uterus (Abstract: the device defines a distal suction port for aspirating fluid and entrained blastocysts from the uterus. The distal fluid delivery port and the distal suction port are arranged such that, in use, fluid delivered from the distal fluid delivery port travels through the distal suction port to the uterus).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the device of Emery employ the feature of “the retrieval catheter further comprising a conduit allowing flushing liquid to flow in the fallopian tube toward the uterus” as taught in Buster for the advantage of ensuring a proper fluid flow direction, as suggested in Buster, Abstract.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Emery in view of Addis et al., US 2020/0008840 A1, hereinafter Addis.
Claim 20. Emery teaches all the limitation of claim 1.
Emery does not teach that said retrieval catheter comprises a pressure beaching internal lumen, and wherein said pressure beaching internal lumen is configured to breach an opening is said sidewall of said retrieval catheter when a threshold pressure is reached within said second internal lumen.
However, in an analogous oocyte retrieval device configuration field of endeavor, Addis teaches that
said retrieval catheter comprises a pressure beaching internal lumen, and wherein said pressure beaching internal lumen is configured to breach an opening is said sidewall of said retrieval catheter when a threshold pressure is reached within said second internal lumen ([0149]: the nozzle control module sets a pressure threshold and instructs the lavage controller to calculate a difference between a measured pressure from the proximity sensor and the pressure threshold. In some embodiments, the nozzle control module instructs the lavage controller to actuate the translator to adjust position of nozzle 207 based on calculated difference in pressure).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the device of Emery employ the feature of “said retrieval catheter comprises a pressure beaching internal lumen, and wherein said pressure beaching internal lumen is configured to breach an opening is said sidewall of said retrieval catheter when a threshold pressure is reached within said second internal lumen” as taught in Addis for the advantage of controlling the pressure at the nozzle to ensure that the pressure does not over the pre-set threshold, as suggested in Addis, [0149].
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Emery in view of Bicich et al., US 2015/0133737 A1, hereinafter Bicich.
Claim 21. Emery teaches all the limitations of claim 1.
Emery does not teach that said fluid delivery lumen comprises an internal unidirectional valve to prevent passage of fluid in one direction of said fluid delivery lumen.
However, in an analogous biological material retrieval arrangement field of endeavor, Bicich teaches
said fluid delivery lumen comprises an internal unidirectional valve to prevent passage of fluid in one direction of said fluid delivery lumen ([0091]: the proximal check valve 54 can prevent or minimize the fluid media from leaking to bleeding in the proximal direction and out of the inlet port).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the device of Emery employ the feature of “said fluid delivery lumen comprises an internal unidirectional valve to prevent passage of fluid in one direction of said fluid delivery lumen” as taught in Bicich for the advantage of preventing or minimizing the fluid media from leaking to an undesired direction, as suggested in Bicich, [0091].
Allowable Subject Matter
Claims 4, 18-19, 23, 26 and 28-29 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 5 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The limitations recited in claims 4 and 28 in regard to the features of “a first occluding element for deployment at an occlusion point, wherein said first occlusion element is configured to prevent passage of said fluid distally of said occlusion point in the fallopian tube", in combination with the other claimed elements, are not taught or disclosed in the prior arts.
The limitations recited in claim 5 in regard to the features of “a second occluding element for deployment at a second occlusion point proximally of said at least one fluid delivery port, wherein said occlusion element is configured to prevent passage of said fluid proximally of said second occlusion point in the fallopian tube", in combination with the other claimed elements, are not taught or disclosed in the prior arts.
The limitations recited in claim 23 in regard to the features of “occluding a passage of said fluid, distally from said fluid delivery port, by inserting a first occluding element, included in the device, for deployment of a first occlusion point in the fallopian tube”, in combination with the other claimed elements, are not taught or disclosed in the prior arts.
The limitation recited in claim 26 in regard to the features of “the retrieval catheter is inserted in the aspiration catheter lumen”, in combination with the other claimed elements, is not taught or disclosed in the prior arts.
Dependent claims 18-19 and 29 are allowed at least by virtue of their respective dependency upon an allowable claim.
Conclusion
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798