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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/30/2024 is being considered by the examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Suyeoka (3,595,230) in view of Ouyang et al (10,874,287).
As to claim 1, Suyeoka discloses a medical package system (Figure 1) comprises an medical device (6), the medical device comprises a interface (10) and an insertion cord (6), the insert insertion cord configured to be inserted into a patient’s body (intravenous catheter is use to insert into patients vein) and comprising a bending section (the body of the catheter 6 is made of polyvinyl chloride and flexible, column 2, line 74) and a distal tip (24), the bending section comprising bending segments made from a polymer material (extruded plasticized polyvinyl chloride , column 4, lines 65-66), a protective sheath part (4, Figure 4) configured to accommodate at least the distal tip and the bending section of the insertion cord and to keep the bending section straight during storage and transport (Figure 1 shows a portion of the tip and bending section, i.e., the entire catheter can be bend, and the sheath part 4 can protect both the tip and the bending section); and a protection pipe (2) configured to receive and accommodate the insertion cord and the protective sheath part (as shown in Figure 1, the protective sheath part is insert into the protection pipe end and the pipe also accommodate the insert cord 6). However, Suyeoka does not specifically disclose an endoscope including an endoscope handle or interface and an insertion cord, the insertion cord configured to be inserted into a patient’s body cavity and comprising a bending section and a distal tip, the bending section comprising bending segments made from a polymer material
Nevertheless, Ouyang discloses an handheld surgical endoscope including an endoscope handle (140) or interface and an insertion cord (120), the insertion cord configured to be inserted into a patient’s body cavity and comprising a bending section (122) and a distal tip (110), the bending section comprising bending segments made from a polymer material (the cannula 120 comprises nylon material and nylon is a type of polymer).
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 packaging of Suyeoka that holds catheter with the same protection to use to protect the endoscope of Ouyang in order to provide a protection shield and stabilize the distal tip of the endoscope.
As to claim 2, Suyeoka as modified further discloses the bending section has an outer circumference and the protective sheath part has an inner circumference configured in size and shape to the outer circumference of the bending section so that the bending section is kept straight when accommodated in the protective sheath part (as shown in Suyeoka, Figure 2, the distal tip and part of the catheter are inside the protection sheath, the channel inside the protection sheath is straight and keeps the catheter straight, the catheter further have outer circumferences that matches with the inner circumference of the protective sheave).
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Macalalad (3,709,233) in view of Ouyang et al (10,874,287).
As to claim 1, Macalalad discloses a medical package system (Figure 1) comprises an medical device 10), the medical device comprises a interface (21) and an insertion cord (20), the insert insertion cord configured to be inserted into a patient’s body (intravenous catheter is use to insert into patients vein) and comprising a bending section (the body of the catheter tubing 17 is made of flexible material which can be bend) and a distal tip, a protective sheath part (rigid tubular cannula 12 and protective hood and hub are all considered as a protective sheath part Figure 2) configured to accommodate at least the distal tip and the bending section of the insertion cord and to keep the bending section straight during storage and transport (Figure 2 shows a portion of the tip and bending section, i.e., the entire catheter can be bend, and the sheath part can protect both the tip and the bending section); and a protection pipe (1) configured to receive and accommodate the insertion cord and the protective sheath part (as shown in Figure 1, the protective sheath part is inside the protection pipe and the pipe also accommodate the insert cord 17). However, Macalalad does not specifically disclose an endoscope including an endoscope handle or interface and an insertion cord, the insertion cord configured to be inserted into a patient’s body cavity and comprising a bending section and a distal tip, the bending section comprising bending segments made from a polymer material
Nevertheless, Ouyang discloses an handheld surgical endoscope including an endoscope handle (140) or interface and an insertion cord (120), the insertion cord configured to be inserted into a patient’s body cavity and comprising a bending section (122) and a distal tip (110), the bending section comprising bending segments made from a polymer material (the cannula 120 comprises nylon material and nylon is a type of polymer).
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 packaging of Macalalad that holds catheter with the same protection to use to protect the endoscope of Ouyang in order to provide a protection shield and stabilize the distal tip of the endoscope.
As to claim 2, Macalalad as modified further discloses the bending section has an outer circumference and the protective sheath part has an inner circumference configured in size and shape to the outer circumference of the bending section so that the bending section is kept straight when accommodated in the protective sheath part (as shown in Macalalad, Figure 2, the distal tip and part of the catheter are inside the protection sheath, the channel inside the protection sheath is straight and keeps the catheter straight, the catheter further have outer circumferences that matches with the inner circumference of the protective sheave).
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As to claim 3, Macalalad as modified further discloses the protective sheath part (rigid tubular cannula 12 and protective hood and hub are all considered as a protective sheath part Figure 2) comprises a proximal end and a distal end, the proximal end comprising a hole or channel for insertion of the distal tip and the bending section, and the distal end comprising a distal guide portion, a flange, a stop, and a hole, the stop configured to prevent further insertion of the distal tip and the bending section when the distal tip reaches the stop, the distal guide portion configured to contact an inner surface of the protection pipe to prevent radial movement of the distal guide portion relative to a distal end of the protection pipe, the flange extending radially outwardly from the distal guide portion and having a circumference greater than an inner radial periphery of the protection pipe, and the hole establishing fluid communication a volume outside the protection pipe and a volume inside the protection pipe (as shown in Figure 2, examiner annotate the figure with proper annotation to show the hole, stop and flange structure of the protective sheath).
As to claims 4-5, Macalalad as modified further discloses the protective sheath part comprises: a distal stopper portion (end of 13), a proximal insertion portion (internal bore or recess 15), and an intermediate tube portion or element between the distal stopper portion or element and the proximal insertion portion or element, the proximal insertion portion is cone-shaped or funnel-shaped (as shown in Figure above, the insertion portion is a funnel shaped) for guiding the distal tip and the bending section into the protective sheath part (Figure 2 shows the insertion of the medical device into the protective sheath).
As to claim 6, Macalalad as modified further discloses the protective sheath part comprises, at the distal stopper portion, a press fit portion providing a press fit engagement between the protective sheath part and the protection pipe (as shown in Figure 2 above, at the distal stopper portion, end of the hood portion, comprises a press fit portion which is considered as the interface between the pipe 2 and the sheath 22, a ring shape object with reference 23 forming a press fit engagement to the sheath part and the pipe 1).
As to claim 7-8, Macalalad as modified further discloses a hole or channel for insertion of the distal tip and the bending section (bore or recess 15 forming a hole or channel for insertion of the distal top and the bending section), protective sheath part comprises a stop (the end pf protection hood) configured to prevent further insertion of the distal tip and the bending section when the distal tip reaches the stop (Figure 2).
As to claim 9, Macalalad as modified further discloses the catheter being the flexible structure which can be bended and the protective sheath part is covering the distal tip and the partial bend portion. Ouyang discloses the endoscope having the top and the bend portion form near the distal tip of the endoscope medical device. But does not specifically disclose the distal tip and the bending section together have an axial length in an axial direction of the insertion cord, wherein the protective sheath part has an axial length, and wherein the axial length of the protective sheath part is longer than or as long as the axial length of the distal tip and the bending section, and is shorter than an axial length of the insertion cord. 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 length of the protective sheath part only be longer than the protect the distal end of the endoscope and flexible bend part in order to protect and maintain the structure of the distal tip and not the entire insertion cord to reduce the excessive material use to achieve the purpose of protecting the distal tip and the bend portion.
As to claim 10, Macalalad as modified further discloses the protective sheath part is arranged radially between the insertion cord and the protection pipe.
As to claim 11, Macalalad as modified further discloses the protective sheath part comprises, at the distal stopper portion, a press fit portion providing a press fit engagement between the protective sheath part and the protection pipe (as shown in Figure 2 above, at the distal stopper portion, end of the hood portion, comprises a press fit portion which is considered as the interface between the pipe 2 and the sheath 22, a ring shape object with reference 23 forming a press fit engagement to the sheath part and the pipe 1).
As to claim 12, Macalalad as modified further discloses the protective sheath part comprises a guide portion configured to guide the protective sheath part into the protection pipe (the lip 5 can be considered as the guide portion).
As to claim 13-14, Macalalad further discloses the protective sheath part is an integral one-piece part comprising a distal stopper portion, a proximal insertion portion, and an intermediate tube portion between the distal stopper portion and the proximal insertion portion (as shown in Figure 1, the distal stopper portion, a proximal insertion portion, and an intermediate tube portion are all attached together and form an integral one piece structure), the protective sheath part comprises a distal stopper element, a proximal insertion element, and an intermediate tube element, wherein the distal stopper element and the proximal insertion element are both attached to the intermediate tube element (all of the structure are attached to each other).
As to claim 15, Macalalad as modified further discloses the distal stopper, proximal insertion element and attached all together with the intermediate tube element. With regarding to the specific process of forming the distal stopper, proximal insertion element and intermediate tube element into the protective sheath, applicant is claiming a product by process claim, the determination of patentability in a product-by-process claim is based on the product itself, even though the claim may be limited and defined by the process. That is, the product in such a claim is unpatentable if it is the same as or obvious from the product of the prior art, even if the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 697, 227 USPQ 964, 966 (Fed. Cir. 1985). A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. (Same cite as above).
Conclusion
Examiner has cited particular paragraphs and/or columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested of the applicant, in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or prior art(s) disclosed by the Examiner (in the attached PTO-892 form).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHUN HOI CHEUNG whose telephone number is (571)270-5702. The examiner can normally be reached Monday to Friday 9AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Orlando E Aviles can be reached at (571)270-5531. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHUN HOI CHEUNG/Primary Examiner, Art Unit 3736