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 .
Response to Amendment
The amendment filed 07/09/2024 has been entered. Claims 1-12 are pending in the application.
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 1-12 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “a hardness of the front end portion is 0.15 N or more and 0.30 N or less, and a hardness of a center of the needle tube is 0.80 N or more and 1.50 N or less” in lines 14-15. It is unclear what the units are as Newtons (which is typically indicated by N) is not a known measure of hardness. Thus, the Examiner is unable to ascertain the levels of harness of the needle tube. For the sake of examination, the limitation will be interpreted “the front end portion is more flexible than the center of the needle tube”.
Claim 2 recites the limitation “the hardness of the front end portion is 0.20 N or more and 0.30 N or less.” It is unclear what the units are as Newtons (which is typically indicated by N) is not a known measure of hardness. Thus, the Examiner is unable to ascertain the levels of harness of the needle tube. For the sake of examination, the limitation will be interpreted “the front end portion is flexible”.
Claims 3-12 are rejected as depending from rejected claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 4-6, 8, 12 are rejected under 35 U.S.C. 103 as being unpatentable over Xiong (CN 213910844) in view of Andino (US 2023/0363941) and further in view of Bley (US 2020/0261266). *Citations to Xiong are directed to the machine translation attached
Regarding Claim 1, Xiong discloses a tissue transplantation resin tip to be used for transplanting a tissue under a retina in an eyeball (See Abstract), the tissue transplantation resin tip comprising: a needle tube (101, Fig 3) to be inserted into an eyeball, wherein the needle tube includes a main body portion (Straight portion of needle tube 101, Fig 3) that extends linearly, and a front end portion (Curved portion of needle tube 101, Fig 3) that is bent with respect to the main body portion and extends linearly, and that discharges the tissue from a front end, a length of the needle tube is 25 mm or more and 50 mm or less (Page 7, paragraph 3, “35mm”), a cross-sectional external shape of the front end portion is an oval shape (Page 7, paragraph 1, “the cross section shape of the head end of the central through hole of the inner pipe is elliptic”) having a major axis of 0.8 mm or more and 1.5 mm or less, and a minor axis of 0.5 mm or more and 1.0 mm or less (Page 7, paragraph 2, “the elliptical diameter ratio is 1:2 to 1:3, the outer diameter of the head end of the inner tube is 1-3mm”; If the diameter of the long axis can be 1mm, the short axis can be 0.5mm given the ratio is 1:2),
Xiong is silent regarding the front end of the front end portion is a bevel surface that extends in a direction substantially perpendicular to the main body portion, and that has a bevel angle of 50° or more and 85° or less, and the front end portion is more flexible than the center of the needle tube.
Andino teaches an analogous needle tube having a bevel surface that extends in a direction substantially perpendicular to the main body portion, and that has a bevel angle of 50° or more and 85° or less (Para 0109).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle tube to have a bevel as taught by Andino in order to have a needle that can more easily penetrate the sclera without causing additional deformation to the sclera (Para 0109).
The modified invention of Xiong and Andino disclose all of the elements of the invention as discussed above, however, silent regarding the front end portion is more flexible than the center of the needle tube.
Bley teaches an analogous needle tube wherein the front end portion is more flexible than the center of the needle tube (Para 0013).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the front end needle tube to be more flexible than the proximal portion of the needle tube as taught by Bley in order to have an atraumatic tip (Para 0089).
Regarding Claim 2, the modified invention of Xiong, Andino, and Bley discloses the front end portion is flexible (Para 0089 -Bley).
Regarding Claim 4, the modified invention of Xiong, Andino, and Bley discloses the front end portion is bent so as to form an angle of 120° or more and 160° or less with respect to the main body portion (Page 6, paragraph 5, “the central line of the arc tube section and the central line of the linear pipeline form an included angle of 105 degrees to 140 degrees” -Xiong).
Regarding Claim 5, the modified invention of Xiong, Andino, and Bley discloses an outer diameter of the center of the needle tube is 1.5 mm or more and 3.5 mm or less (Page 7, paragraph 2, “the diameter of the round of the tail end of the central through hole of the inner tube is 2-3 mm” -Xiong).
Regarding Claim 6, the modified invention of Xiong, Andino, and Bley discloses the needle tube has transparency that allows the tissue moving inside the needle tube to be visually recognized from an outside (Page 7, Paragraph 3, “the outer tube and the inner tube are made of transparent material, convenient for observing the pushing process of the transplanting sheet layer” -Xiong).
Regarding Claim 8, the modified invention of Xiong, Andino, and Bley discloses a stopper (2041, Fig 6 -Xiong) that prevents movement of the tissue toward a rear end of the needle tube in the main body portion (Page 9, Paragraph 2, “the elastic section 2041 of the front part has elasticity, on the one hand, it can be with the cell bracket planting sheet safety contact On the other hand, when the push rod 204 reaches the arc tube section of the inner tube, because the elastic section 2041 has elasticity, it can conform to the radian of the inner tube of the cell bracket implant into the lower cavity of the retina. the length of the elastic section 2041 is slightly greater than the length of the arc tube section on the inner tube; it can ensure the elastic section 2041 the planting sheet from the front end of the arc tube section” -Xiong).
Regarding Claim 12, the modified invention of Xiong, Andino, and Bley discloses A retina tissue transplantation kit, comprising: a retina tissue (“transplanted retina cell layer”, Page 11, Claim 1); and the tissue transplantation resin tip according to claim 1 (See rejection of Claim 1 above).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Xiong (CN 213910844) in view of Andino (US 2023/0363941) and further in view of Bley (US 2020/0261266) and further in view of Charles (US 2015/0173947).
Regarding Claim 3, the modified invention of Xiong, Andino, and Bley discloses all of the elements of the invention as discussed above, however, is silent regarding a length of the front end portion is 2 mm or more and less than 6 mm.
Charles teaches an analogous needle tube (205, Fig 3) having a front end portion (150, Fig 3) that is 2 mm or more and less than 6 mm (Para 0038).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the front end portion of the needle tube to be 2mm-6mm as taught by Charles in order to have a needle tube that is dimensioned to access an average patient’s retina (Para 0038).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Xiong (CN 213910844) in view of Andino (US 2023/0363941) and further in view of Bley (US 2020/0261266) and further in view of Schaller (US 2020/0397477).
Regarding Claim 7, the modified invention of Xiong, Andino, and Bley discloses all of the elements of the invention as discussed above, however, is silent regarding the tissue transplantation resin tip is formed from at least one type of resin of polyolefin resin, cycloolefin resin, polyester resin, fluorine resin, polycarbonate, and polyimide
Schaller teaches an analogous needle tube (110, Fig 2) formed from polyimides (Para 0035).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tissue transplantation resin tip to be formed of polyimides as taught by Schaller in order to be made of a medically compatible soft polymer that can provide a cushioning and/or non-abrasive engagement with delicate tissues (Para 0035).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Xiong (CN 213910844) in view of Andino (US 2023/0363941) and further in view of Bley (US 2020/0261266) and further in view of Hughes (US 6,514,238).
Regarding Claim 9, the modified invention of Xiong, Andino, and Bley discloses the tissue is a retina tissue (“transplanted retina cell layer”, Page 11, Claim 1), and the retina tissue having a minor axis of 400 m or more and 800 pm or less, and a thickness of 400 pm or more and 600 pm or less can move inside the needle tube.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the retina tissue minor axis and thickness to include be 400-800µm and 400-600µm, respectively, since Hughes teaches that size of the retina tissue is chosen based on the inner diameter of the needle. Further, the instant specification in para 0026 does not provide any criticality to the dimensions of the retinal tissue and states a similar point that the tissue size is limited only by the inner diameter of the needle tube. It has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Xiong (CN 213910844) in view of Andino (US 2023/0363941) and further in view of Bley (US 2020/0261266) and further in view of Li (CN 200994858). *Citations to Li are directed to the machine translation attached
Regarding Claim 10, the modified invention of Xiong, Andino, and Bley a tissue transplantation device, comprising: the tissue transplantation resin tip according to claim 1 (See the rejection of claim 1 above), however, is silent regarding a stopcock, wherein the tissue transplantation resin tip configured to be connected to a port of the stopcock; and a syringe configured to be connected to another port of the stopcock
Li teaches a tissue transplantation device, comprising: an analogous tissue transplantation tip (7, Fig 1); a stopcock (See annotated Fig 7), wherein the tissue transplantation resin tip configured to be connected to a port of the stopcock (they are connected through hydraulic pipe 8 and connector 11); and a syringe (See annotated Fig 7) configured to be connected to another port of the stopcock (Page 3, “As shown in Figure 7: When the utility model is used, it is first connected to the power device through the connector, and the power device is composed of a connecting pipe, a piston, a steering switch, a digital display screen, a motor and a pedal device. Then all the pipes are filled with liquid. After checking the airtightness, the operator adjusts the power part to the retraction mode through the pedal device, and smoothly sucks the retinal transplant into the transplant head to the fixed tube, and quickly adjusts it to the fixed mode. The operator holds the operating handle, puts the transplant head into the desired transplant position, adjusts it to the push mode through the pedal and sets the corresponding thrust, and then pushes the transplant out.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the manual tissue transplantation device disclosed by Xiong with the powered device seen in Fig 7 and described on Page 3 of Li in order to have a device that can conveniently and accurately control the direction and speed of transplantation, which significantly reduces the difficulty of transplantation and significantly improves the transplantation effect (Page 1, paragraph 4).
Regarding Claim 11, the modified invention of Xiong, Andino, Bley, and Li discloses a retina tissue transplantation method of transplanting a retina tissue under a retina in an eyeball of a patient who suffers from a disease based on a disorder of or a damage to the retina tissue, the retina tissue transplantation method comprising: a step of sucking the retina tissue inside the needle tube of the tissue transplantation resin tip by pulling the syringe using the tissue transplantation device according to claim 10; a step of inserting the needle tube that has sucked the retina tissue into a space under the retina in the eyeball of the patient; and a step of discharging the retina tissue to the space under the retina from inside the needle tube (Page 3, “As shown in Figure 7: When the utility model is used, it is first connected to the power device through the connector, and the power device is composed of a connecting pipe, a piston, a steering switch, a digital display screen, a motor and a pedal device. Then all the pipes are filled with liquid. After checking the airtightness, the operator adjusts the power part to the retraction mode through the pedal device, and smoothly sucks the retinal transplant into the transplant head to the fixed tube, and quickly adjusts it to the fixed mode. The operator holds the operating handle, puts the transplant head into the desired transplant position, adjusts it to the push mode through the pedal and sets the corresponding thrust, and then pushes the transplant out.” -Li).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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