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 .
Status of Claims
Claims 1-14 are pending and currently under consideration for patentability under 37 CFR 1.104.
Foreign Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copies have been received.
Claim Objections
Claims 1-14 are objected to because of the following informalities:
The preamble of claims 2, 3, 5, 6, 7, and 8 are different from the “External endoluminal fixator device” as recited in the preamble of claim 1. All of the preambles should recites the same language.
Claim 1 states “a head configured at distal end”. The examiner believes “a head configured at a distal end” are the correct words to use here.
Claim 3 recites “the head is configured with a detachable wheel”. The examiner believes “the handle is configured with a detachable wheel” are the correct words to use here.
Claim 8 recites “introducing a head of endoluminal fixator device”. The examiner believes “introducing a head of the endoluminal fixator device” are the correct words to use here.
Appropriate correction is required.
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.
Claim 5 is 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 5 recites the limitation "the optical cable”. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1, 3-8 and 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2014/0275763 to King et al. (hereinafter “King”) in view of U.S. Publication No. 2018/0206708 to Miller.
Regarding claim 1, King discloses an external endoluminal fixator device to fix rectal prolapse and/or vaginal and/or uterine and/or urinary bladder prolapse by passing intraluminally through rectum and vagina respectively, wherein the external endoluminal fixating device is characterized by: a head (106, Fig. 4, [0055]) configured at distal end of the external endoluminal fixator device (Fig. 4) such that the head passes through an anorectum or a vagina of a human body (18, Fig. 18, [0057], [0136]), a hollow shaft (104, Fig. 4, [0055]) connected with the head (Fig. 4) which is in an angulation corresponding to usage in the anorectum or a sacral hollow or the vagina of the human body (Fig. 4), so as to enable entry of one or more endoluminal instruments (192, Fig. 4, [0061]), wherein the hollow shaft is configured with an endoluminal forceps or a grasper to hold one or more percutaneous suture needles ([0155]); or allow passage of an external flexible endoscope (“and/or” denotes an optionally recited limitation and optionally recited limitations are not guaranteed to take place and are therefore not required to be taught, see MPEP § 2103 Section 1(C)) and an endoluminal fixator device handle (102, Fig. 4, [0055]) connected with the hollow shaft at proximal end of the external endoluminal fixator device (Fig. 4), configured to remain outside (Fig. 4) anus or vagina to have a sturdy grip so as to push up the head of the endoluminal fixator device placed either trans-anally or vaginally so as to push the prolapsed anorectum or the vagina and/or cervix up and against undersurface of the anterior abdominal wall (Fig. 4), wherein, the endoluminal fixator device handle is made hollow to allow passage to the one or more endoluminal instruments or an external flexible endoscope (192, Fig. 4, [0155]).
King fails to expressly teach wherein the head is made of transparent silicone gel so as to allow light of an endovision system to pass-through, creating trans-illumination in an anterior abdominal wall.
However, Miller teaches of a device wherein the head (Miller: 10, Fig. 1A, [0055]) is made of transparent silicone gel (Miller: [0056]) so as to allow light of an endovision system to pass-through (Miller: [0056]), creating trans-illumination in an anterior abdominal wall (Miller: [0056]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of King to utilize transparent silicone gel, as taught by Miller. It would have been advantageous to make the combination for the purpose of preventing the adherence or colonization of bacteria on the scope ([0056] of Miller).
Regarding claim 3, King, in view of Miller, teaches the head as claimed in claim 1, and King further discloses wherein, the head is configured with a de- attachable wheel connected at a bending section of the head /shaft using a pulley (King: 140, Fig. 9, [0086]), so that if attached can enable the head to move up and down (King: [0086]), or else the head remains fixed at a position (King: [0086]).
Regarding claim 4, King, in view of Miller, teaches the external endoluminal fixator device as claimed in claim 1, and King further discloses wherein the system comprises an endovision channel (King: 110, Fig. 4, [0063]) having a CMOS camera chip at a base of the head (King: 198, Fig. 4, [0063]) for wireless transmission of intraluminal images so as to achieve an independent endovision system without a requirement of insertion of an external flexible endoscope and also to get more space inside lumen of the hollow shaft to introduce one or more instruments for intervention (King: [0063]).
Regarding claim 5, King, in view of Miller, teaches the optical cable as claimed in claim 4, and King further discloses wherein the optical cable is configured with a CCD camera as distal end for vision (King: 198, Fig. 4, [0063]) and a user interface at proximal end of the optical cable for viewing or monitoring so as to get more space inside lumen of the hollow shaft to introduce one or more instruments for intervention (King: [0125]).
Regarding claim 6, King, in view of Miller, teaches the head as claimed in claim 1.
King, in view of Miller, fails to expressly teach wherein the silicone gel is configured with a thin rim so as to allow the one or more percutaneous suture needles to pass through a lumen of the endoluminal fixator device placed inside the rectum or the vagina to outside of the anterior abdominal wall from inside.
However, Miller further teaches wherein the silicone gel is configured with a thin rim so as to allow the one or more percutaneous suture needles to pass through a lumen of the endoluminal fixator device placed inside the rectum or the vagina to outside of the anterior abdominal wall from inside (Miller: [0056]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of King, in view of Miller, to utilize silicon gel, as taught by Miller. It would have been advantageous to make the combination for the purpose of preventing the adherence or colonization of bacteria on the scope ([0056] of Miller).
Regarding claim 7, King, in view of Miller, teaches the hollow shaft as claimed in claim 1, and King further discloses wherein the hollow shaft can be made either of an opaque or translucent biopolymer so as to make the hollow shaft disposable or of stainless steel so as to make the hollow shaft reusable (King: [0059], [0088], [0160]).
Regarding claim 8, King discloses a method to fix rectal prolapse and vaginal prolapse by passing through rectum and/or vaginal and/or uterine and/or urinary bladder respectively with an external endoluminal fixator device (100, Fig. 4, [0055]), wherein the method comprises steps of: introducing a head (106, Fig. 4, [0055]) of endoluminal fixator device at the apex of the rectum or vagina (184, Fig. 18, [0154]), wherein the head is configured at distal end of the external endoluminal fixator device such that the head passes through the anorectum or a vagina of the body (Fig. 4); lifting and pushing the prolapsed rectum or the /cervix to an under (posterior) surface of the anterior abdominal wall by help of a hollow shaft (104, Fig. 4, [0055]) connected in an angulation corresponding to usage in the anorectum or a sacral hollow or the vagina of the body (104, Fig. 4, [0055]), so as to enable entry of one or more endoluminal instruments (192, Fig. 4, [0061]), wherein the hollow shaft is configured with endoluminal forceps ([0155]) or a grasper to hold one or more percutaneous suture needles (“and/or” denotes an optionally recited limitation and optionally recited limitations are not guaranteed to take place and are therefore not required to be taught, see MPEP § 2103 Section 1(C)); and fixing the rectum or the vagina/ uterine cervix to the undersurface of the anterior abdominal wall by one or more percutaneous suture needles with the help of an endoluminal fixator device handle (102, Fig. 4, [0055]) connected with the hollow shaft at proximal end of the external endoluminal fixator device (Fig. 4), configured to remain outside of anus or vagina to have a sturdy grip so as to push up the head of the endoluminal fixator device either trans-anally or vaginally with the anorectum or the vagina and/or cervix against undersurface of the anterior abdominal wall (Fig. 4), wherein, the endoluminal fixator device handle is made hollow to allow passage to the one or more endoluminal instruments or a flexible endoscope for independent vision (192, Fig. 4, [0155]).
King fails to expressly teach said head is made of transparent silicone gel so as to allow light of an endovision system to pass-through, creating trans-illumination in an anterior abdominal wall.
However, Miller teaches of an analogous method wherein, said head (Miller: 10, Fig. 1A, [0055]) is made of transparent silicone gel (Miller: [0056]) so as to allow light of an endovision system to pass-through, creating trans-illumination in an anterior abdominal wall (Miller: [0056]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of King, to utilize a transparent silicone gel, as taught by Miller. It would have been advantageous to make the combination for the purpose of preventing the adherence or colonization of bacteria on the scope ([0056] of Miller).
Regarding claim 10, King, in view of Miller, teaches the method as claimed in claim 8, and King further discloses wherein, the method comprises steps of making the head flexible with a de-attachable wheel connected at a bending section of the head- shaft using a pulley (King: 140, Fig. 9, [0086]), so that if attached can enable the head to move up and down (King: [0086]), else the head remains fixed at a position (King: [0086]).
Regarding claim 11, King, in view of Miller, teaches the method as claimed in claim 8, and King further teaches wherein the method comprises steps of fixing a camera chip at a base of the head (King: 198, Fig. 4, [0063]) so as to create an endovision channel (King: 110, Fig. 4, [0063]), wherein the camera chip can be CMOS channel (King: 198, Fig. 4, [0063]) to make a wireless transmission of intraluminal images (King :or connected with an optical cable configures with the walls of the hollow shaft so as to keep hollow space of the hollow shaft available for introduction of one or more endoluminal instruments.
Regarding claim 12, King, in view of Miller, teaches the method as claimed in claim 11, and King further teaches wherein the method comprises steps of configuring the optical cable with a CCD camera at distal end for vision (King: 198, Fig. 4, [0063]) and a user interface at proximal end of the optical cable for viewing or monitoring so as to get more space inside lumen of the hollow shaft to introduce one or more instrument for intervention (King: [0125]).
Regarding claim 13, King, in view of Miller, teaches the method as claimed in claim 8.
King, in view of Miller, fails to expressly teach wherein the method comprises steps of configuring the silicone gel with a thin rim so as to allow the one or more percutaneous suture needles to pass through a lumen of the endoluminal fixator device placed inside the rectum or the vagina to outside of the anterior abdominal wall.
However, Miller further teaches wherein the method comprises steps of configuring the silicone gel with a thin rim so as to allow the one or more percutaneous suture needles to pass through a lumen of the endoluminal fixator device placed inside the rectum or the vagina to outside of the anterior abdominal wall (Miller: [0056]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of King, in view of Miller, to utilize a silicone gel, as taught by Miller. It would have been advantageous to make the combination for the purpose of preventing the adherence or colonization of bacteria on the scope ([0056] of Miller).
Regarding claim 14, King, in view of Miller, teaches the method as claimed in claim 8, and King further teaches wherein the hollow shaft can be made either of an opaque or translucent biopolymer so as to make the hollow shaft disposable or of stainless steel so as to make the hollow shaft reusable (King: [0059], [0088], [0160]).
Claim(s) 2 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over King in view of Miller and further in view of U.S. Publication No. 2019/0183507 to Baillargeon.
Regarding claim 2, King, in view of Miller, teaches the head as claimed in claim 1, and King further discloses wherein the interior wall of the head is configured with non-magnetic - metallic lining in case one or more percutaneous suture needles are introduced through the hollow of endoluminal fixator device handle/shaft / to its head and then through the anterior walls of either Rectum or vagina/cervix into the anterior abdominal wall, by endoluminal instruments passed through the hollow of the shaft (King: 106, Fig. 4, [0055], [0059], [0088], [0160]).
King, in view of Miller, fails to expressly teach wherein the interior wall of the head is configured with magnetic metallic lining to attract and pull one or more percutaneous suture needles which are introduced from outside through the anterior abdominal wall into the head of the endoluminal fixator device placed inside the reduced rectum or vagina/cervix pushing them up and against the undersurface of anterior abdominal wall.
However, Baillargeon teaches of an analogous device wherein the interior wall of the head is configured with magnetic metallic lining to attract and pull one or more percutaneous suture needles which are introduced from outside through the anterior abdominal wall into the head of the endoluminal fixator device placed inside the reduced rectum or vagina/cervix pushing them up and against the undersurface of anterior abdominal wall (Baillargeon: [0056]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of King, in view of Miller, to utilize a magnetic metallic lining, as taught by Baillargeon. It would have been advantageous to make the combination for the purpose of easily manipulating the tool ([0056] of Baillargeon).
Regarding claim 9, King, in view of Miller, teaches the method as claimed in claim 8.
King, in view of Miller, fails to expressly teach wherein the method comprises steps of attracting and pulling one or more percutaneous suture needles by magnetic metallic lining so as to create a magnetic effect while the one or more percutaneous suture needles are inserted through abdominal wall into the silicone gel head to the endoluminal fixator device, placed inside the lumen of the reduced Rectum or vagina/cervix.
However, Baillargeon teaches of an analogous method wherein the method comprises steps of attracting and pulling one or more percutaneous suture needles by magnetic metallic lining so as to create a magnetic effect while the one or more percutaneous suture needles are inserted through abdominal wall into the silicone gel head to the endoluminal fixator device, placed inside the lumen of the reduced Rectum or vagina/cervix (Baillargeon: [0056]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of King, in view of Miller, to utilize a magnetic metallic lining, as taught by Baillargeon. It would have been advantageous to make the combination for the purpose of easily manipulating the tool ([0056] of Baillargeon).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTEN A. SHARPLESS whose telephone number is (571)272-2387. The examiner can normally be reached Monday-Tuesday 6:00 AM - 2:00 PM, and Friday 6:00 AM - 10:00 AM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.A.S./Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795