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 Objections
Claims 1, 7, and 9 are objected to because of the following informalities:
Claim 1, lines 12-13: “first and second branches of said structure a first circulation circuit” should read “first and second branches of said structure comprising a first circulation circuit”;
Claim 1, lines 16-17: “second branch of said structure a second circulation” should read “second branch of said structure comprising a second circulation”;
Claim 7, line 1: “The fat preparation device claim 1” should read “The fat preparation device according to claim 1”;
Claim 9, line 4: “said structure said first circulation circuit” should read “said structure comprising said first circulation circuit”;
Claim 9, line 8: “said structure said second circulation circuit” should read “said structure comprising said second circulation circuit”. 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 12 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 12 recites the limitation "the first angle" and “the second angle” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the first angle” and “the second angle” is interpreted to be the angles of the first and second branch to the connecting element, as discussed in page 27, line 23 and page 28, line 4 of the specification.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Goisis (Publication No. WO 2020/230045 A1) in view of Melsheimer et al. (Publication No. US 2009/027985 A1).
Regarding claim 1, Goisis teaches a fat preparation device for preparation of fat harvested from a first area of a patient’s body for reinjection into a second area of the patient’s body (device 100 collects fat from a first site from the patient’s body and for reinjection to a second area of the patient’s body for nanofat grafting; Abstract; Column 1, line 26 to Column 2, line 1; Column 2, lines 20-22 and Column 6, lines 21-26), said fat preparation device comprising:
a structure comprising a first and a second branch to which a first syringe and a second syringe are connected respectively (first end region of duct 105 comprising first connector 101 and safety valve 119 to which first syringe 102 and collection container 122 are connected; Figure 1; Column 11, line 21 to Column 12, line 2); and
a connecting element of said first and second branches (middle region of duct 105 comprising filter 108 and third connector 109 and is connected to first and second branches; Figure 1; Abstract; Claim 1), said connecting element fitting into said structure and comprising a membrane for filtering said fat (middle region of duct 105 is connected to first end region through the connection with filter 108 for filtering fat; Figure 1; Abstract; Claim 1), and said connecting element being connected to a third syringe (middle region of duct 105 has a third connector 109 that is connected to receiving member 110; Abstract; Figure 1). Goisis does not teach the connecting element configured to assume at least two positions: an emulsification position in which said connecting element forms with said first and second branches of said structure a first circulation circuit for the fat between the first syringe and the second syringe, and a transfer position in which said connecting element forms with said first or second branch of said structure a second circulation circuit for the fat between the first or the second syringe and a third syringe.
However, Melsheimer teaches the connecting element configured to assume at least two positions: an emulsification position in which said connecting element forms with said first and second branches of said structure a first circulation circuit for the fat between the first syringe and the second syringe (valve 20 is in position D which allows for the agitation of the liquid between syringe 14 and syringe 16; Paragraph 0036; Figure 1A), and a transfer position in which said connecting element forms with said first or second branch of said structure a second circulation circuit for the fat between the first or the second syringe and a third syringe (valve is in position C to allow for transferring of liquid from syringe 14 or syringe 16 into syringe 12; Figure 1B; Paragraph 0035).
Goisis and Melsheimer are both considered to be analogous to the claimed invention because they are in the field of devices for processing fluid and delivery. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the effective filing date of the claimed invention to have modified Goisis to incorporate the teachings of Melsheimer and have the valve of Melsheimer in the middle region of the duct between the filter and the third connector of Goisis. This allows for the user to control and select the mixing and delivery of the fluid between the syringes of the device (Melsheimer; Paragraph 0014 and 0016).
Regarding claim 2, Goisis in view of Melsheimer teaches the device of claim 1. Goisis further teaches wherein said first and second branches of said structure are positioned relative to one another in the form of a V (ports 101 and 119 of the first end region of duct 105 are positioned to each other in the form of a V; Figure 1).
Regarding claim 3, Goisis in view of Melsheimer teaches the device of claim 2. Goisis further teaches wherein said first and second branches of said structure are positioned relative to one another at an angle between 45° and 135° (ports 101 and 119 are 90° from each other; Figure 1).
Regarding claim 4, Goisis in view of Melsheimer teaches the device of claim 2. Goisis further teaches wherein said first and second branches of said structure form a Y shape with said connecting element (ports 101 and 119 and first end region of duct 105 forms a letter Y shape, with the ports 101 and 109 is the top part of the Y and the first end region of the duct 105 being the stem of the Y; Figure 1).
Regarding claim 5, Goisis in view of Melsheimer teaches the device of claim 4. The combination of Goisis in view of Melsheimer does not expressly teach wherein said first branch forms a first angle with said connecting element of approximately 112.5°-157.5°, and said second branch forms a second angle with said connecting element of approximately 112.5°-157.5°.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the first angle and the second angle to be approximately 112.5°-157.5° since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the first and second branches would not operate differently with the first and second angles since the device is constructed with similar components and structure and is intended to collect fluid from the user and process it for delivery. Further, it appears that the applicant places no criticality on the range claimed, mentioning that the first and second angles are “approximately” the given ranges (claim 5; page 27, line 24 to page 28, line 4 of specification of instant application).
Regarding claim 10, Goisis teaches a method for preparation of fat harvested from a first area of a patient’s body for reinjection into a second area of said patient’s body (device 100 collects fat from a first site from the patient’s body and for reinjection to a second area of the patient’s body for nanofat grafting; Abstract; Column 1, line 26 to Column 2, line 1; Column 2, lines 20-22 and Column 6, lines 21-26), wherein the method comprises:
using a fat preparation device to prepare the fat (device 100; Abstract; Column 1, line 26 to Column 2, line 1; Column 2, lines 20-22 and Column 6, lines 21-26), the device comprising:
a structure comprising a first and a second branch to which a first syringe and a second syringe are connected respectively (first end region of duct 105 comprising first connector 101 and safety valve 119 to which first syringe 102 and collection container 122 are connected; Figure 1; Column 11, line 21 to Column 12, line 2); and
a connecting element of said first and second branches (middle region of duct 105 comprising filter 108 and third connector 109 and is connected to first and second branches; Figure 1; Abstract; Claim 1), said connecting element fitting into said structure and comprising a membrane for filtering said fat (middle region of duct 105 is connected to first end region through the connection with filter 108 for filtering fat; Figure 1; Abstract; Claim 1), and said connecting element being connected to a third syringe (middle region of duct 105 has a third connector 109 that is connected to receiving member 110; Abstract; Figure 1). Goisis does not teach the connecting element configured to assume at least two positions:
an emulsification position in which said connecting element forms with said first and second branches of said structure a first circulation circuit for the fat between the first syringe and the second syringe, and
a transfer position in which said connecting element forms with said first or second branch of said structure a second circulation circuit for the fat between the first or the second syringe and a third syringe.
However, Melsheimer teaches the connecting element configured to assume at least two positions:
an emulsification position in which said connecting element forms with said first and second branches of said structure a first circulation circuit for the fat between the first syringe and the second syringe (valve 20 is in position D which allows for the agitation of the liquid between syringe 14 and syringe 16; Paragraph 0036; Figure 1A), and
a transfer position in which said connecting element forms with said first or second branch of said structure a second circulation circuit for the fat between the first or the second syringe and a third syringe (valve is in position C to allow for transferring of liquid from syringe 14 or syringe 16 into syringe 12; Figure 1B; Paragraph 0035).
Goisis and Melsheimer are both considered to be analogous to the claimed invention because they are in the field of devices for processing fluid and delivery. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the effective filing date of the claimed invention to have modified Goisis to incorporate the teachings of Melsheimer and have the valve of Melsheimer in the middle region of the duct between the filter and the third connector of Goisis. This allows for the user to control and select the mixing and delivery of the fluid between the syringes of the device (Melsheimer; Paragraph 0014 and 0016).
The combination of Goisis in view of Melsheimer further teaches positioning the connecting element in said emulsification position (Melsheimer; valve 20 is in position D which allows for the agitation of the liquid between syringe 14 and syringe 16; Paragraph 0036; Figure 1A);
emulsifying said harvested fat by successive and repeated pressing movements by an operator on said first and second syringes, said pressing movements causing said fat to circulate in said first circuit from said first syringe to said second syringe and vice- versa (position D of the valve 20 of Melsheimer with the pressing of the first and second syringe of Goisis will allow for mixing/agitating of fat between first and second syringes; Melsheimer; Paragraph 0036; Figure 1A; Goisis; Column 3, line 30 to Column 4, line 6 and Column 10, lines 16-19);
positioning said connecting element in said transfer position by changing the position of said connecting element relative to said structure (Melsheimer; valve is in position C to allow for transferring of liquid from syringe 14 or syringe 16 into syringe 12; Figure 1B; Paragraph 0035);
filtering and transferring said fat emulsified by the operator pressing on one of the first or second syringes, said pressing movement causing said harvested fat to flow in said second circuit through said filtering membrane into said third syringe (position C of the valve 20 of Melsheimer with the pressing of the first and second syringe of Goisis will allow for delivery of fat between first or second syringe to third syringe; Melsheimer; Paragraph 0035; Figure 1A).
Regarding claim 11, Goisis in view of Melsheimer teaches the device of claim 2. Goisis further teaches wherein said first and second branches of said structure are positioned relative to one another at an angle of 90° (ports 101 and 119 are 90° from each other; Figure 1).
Regarding claim 12, Goisis in view of Melsheimer teaches the device of claim 4. The combination of Goisis in view of Melsheimer does not expressly teach wherein the first angle and the second angle are 135°.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the first angle and the second angle to be 135° since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the first and second branches would not operate differently with the first and second angles since the device is constructed with similar components and structure and is intended to collect fluid from the user and process it for delivery. Further, it appears that the applicant places no criticality on the range claimed (page 27, line 24 to page 28, line 4 of specification of instant application).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Goisis (Publication No. WO 2020/230045 A1) in view of Melsheimer et al. (Publication No. US 2009/027985 A1), as applied to claim 1 above, and further in view of Howard et al. (Publication No. US 2008/0243028 A1).
Regarding claim 6, Goisis in view of Melsheimer teaches the device of claim 1. The combination of Goisis in view of Melsheimer does not teach wherein said filtering membrane is held in said connecting element by a cover fixed to said connecting element, said cover comprising a connecting port with said third syringe.
However, Howard teaches wherein said filtering membrane is held in said connecting element by a cover fixed to said connecting element (membrane 48 is within the housing 42 of device; Figure 4C; Paragraph 0039)), said cover comprising a connecting port with said third syringe (housing 42 has port 45 to connect with receiving syringe 70; Figure 4C; Paragraph 0039 and 0041).
Goisis in view of Melsheimer and Howard are both considered to be analogous to the claimed invention because they are in the field of devices for processing fluid and delivery. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the effective filing date of the claimed invention to have modified Goisis in view of Melsheimer to incorporate the teachings of Howard and have the housing/cover with the connecting port of Howard over the filtering membrane and fixed to the connecting element of Goisis in view of Melsheimer. This allows for an interior space to be formed so that the fluid can be filtered and held for further processing/delivery (Howard; Paragraph 0039 and 0041).
Claim(s) 7-9 is rejected under 35 U.S.C. 103 as being unpatentable over Goisis (Publication No. WO 2020/230045 A1) in view of Melsheimer et al. (Publication No. US 2009/027985 A1), as applied to claim 1 above, and further in view of Murphy (Patent No. US 1,081,322 A).
Regarding claim 7, Goisis in view of Melsheimer teaches the device of claim 1. The combination of Goisis in view of Melsheimer teaches wherein said structure comprises at least one track comprising a first end for engaging the emulsification position and a second end for engaging the transfer position (Melsheimer; valve 20 has a valve member 190 that is rotatable along a track to orient the valve from position D at the first end position of the rotation, emulsification, to position C at the second end position of the rotation, transferring position; Figures 1A-1B and 4; Paragraph 0035-0036 and 0047). The combination of Goisis in view of Melsheimer does not teach said connecting element comprises a base with at least one fixing stud, said at least one fixing stud locks into either of the first and second ends, when the connecting element is placed in the corresponding position.
However, Murphy teaches said connecting element comprises a base with at least one fixing stud (cover 4 has lugs 16 and 17 to hold the handle 15 in a fixed position after rotation; Figure 1; Lines 63-85), said at least one fixing stud locks into either of the first and second ends, when the connecting element is placed in the corresponding position (lugs 16 and 17 holds handle at the valve positions; Figure 1; Lines 63-85).
Goisis in view of Melsheimer and Murphy are both considered to be analogous to the claimed invention because the inventor of Murphy is reasonably pertinent to the problem faced by the inventor, more specifically, the fixing of the valve in the different valve positions to prevent unwanted movement from applied unwanted external forces on the handle (Murphy; Lines 81-85). Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the effective filing date of the claimed invention to have modified Goisis in view of Melsheimer to incorporate the teachings of Murphy and have the base and the lugs/fixing studs of Murphy on the connecting element of Goisis in view of Melsheimer. This allows for the valve position to be held in place and prevents movement of valve due to unwanted external forces on the handle (Murphy; Lines 81-85).
Regarding claim 8, Goisis in view of Melsheimer and Murphy teaches the device of claim 7. The combination of Goisis in view of Melsheimer and Murphy further teaches wherein said connecting element comprises a central stud fixed to said base and oriented in a longitudinal axis of said structure (valve of Figures 1A-1B and 4 of Melsheimer has a central stud comprising valve members 82 and 88, see annotated Figure 4 below and Figures 1B-1C, that is fixed to base of Murphy and rotates the bores to control the positioning of the valve and the flow of fluid through the device, Figures 1b-1c and 4 and Paragraphs 0029-0032 of Melsheimer; obvious that device can be oriented so that central stud is aligned to the longitudinal axis of device), said central stud comprising at least two movement transformation interfaces into which at least one follower of said first branch and at least one follower of said second branch of said structure slide to transform a rotational movement of said connecting element relative to said structure, by an effect of a rotational action of said connecting element exerted by a practitioner on said base about said longitudinal axis, into a translational movement of said connecting element in said longitudinal axis (Melsheimer; central stud has movement between position D and position C by applying a rotational force onto central stud, fixed on the base of Murphy, through the rotation of the valve member 22, where the bores 88/followers of the first and the second branch are protruding through the valve body connected to the central stud and slides rotationally based on movement of central stud; see Figure 1B-1C and annotated Figure 4 below; Paragraphs 0029-0032).
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Annotated Figure 4
Regarding claim 9, Goisis in view of Melsheimer and Murphy teaches the device of claim 8. The combination of Goisis in view of Melsheimer and Murphy further teaches wherein said central stud further comprises:
a first fat emulsification channel which forms with said first and second branches of said structure said first circulation circuit of said fat between said first syringe and said second syringe, when said connecting element is placed in said emulsification position (Melsheimer; position D, Figure 1C, has a first channel between syringe 16 and 14 through the valve member 88 of central stud to allow for the first circulation of fluid between the two syringes; Figure 1C; Paragraph 0032),
a second fat transfer channel which forms with said first or second branch of said structure said second circulation circuit of fat between the first or second syringe and said third syringe, when said connecting element is placed in said transfer position (Melsheimer; position C, Figure 1B, has a second channel between syringe 16, 14 and syringe 12 through the valve member 88 of central stud to allow for the second circulation of fluid between the two syringes with the syringe 12; Figure 1C; Paragraph 0032).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781