DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Claim Objections
Claim 27 is objected to because of the following informalities: line 3 should be amended to - retrograde depositing the dermal filler as the needle is being at least partially-. Appropriate correction is required.
Claim 29 is objected to because of the following informalities: line 3 should be amended to - injecting a bolus deposit of the dermal filler whilst the needle is static-. 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.
Claims 1-11, 14, 17, 19, 21, 23-25, 27 and 29 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.
Regarding claim 1:
The claim recites the limitation "the dermis" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-11, 14, 17, 19, 21, 23-25, 27 and 29 are rejected due to their dependence on claim 1.
Regarding claim 23:
The limitation “wherein the needle is packaged in a blister pack” in line 2 is unclear. Its unclear what structure this limitation requires since the blister pack is not positively claimed and since it is beyond the scope of the claim which is a needle. For the sake of examination, the office has interpreted this limitation to be intended use and the structure of the blister pack is not required structure.
Claim Rejections - 35 USC § 102
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.
Claims 1-8, 10, 17, 19, 23-25 and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20010037092 A1 to Amar.
Amar discloses:
Regarding claim 1:
A needle (80 in figure 10 or 100 in figure 12 or 50 in figure 7) for injecting dermal filler (“tissue injection”, ¶0006) into the dermis (as shown in figures 1-4), the needle (80/100) comprising:
a proximal end (see end B in figure 1 below) for connection to a syringe (hub 81/42 connects to the syringe as indicated in ¶0029); and
a distal end (see the distal end A in figure 1 below) comprising a sharpened tip (see the spatula tip of 88/106),
wherein the needle (80/100/50) comprises a curved region (84/104/54) between the proximal end (B in figure 1 below) and the distal end (A in figure 1 below).
PNG
media_image1.png
369
776
media_image1.png
Greyscale
Figure 1 – figure 10 of Amar, annotated by the examiner
Regarding claim 2:
The needle according to claim 1, a vertex angle of the curved region being between 130º and 179º (¶0034 indicates the arc is 20 º and therefore the vertex angle is 160º as shown in figure 2 below).
PNG
media_image2.png
438
828
media_image2.png
Greyscale
Figure 2 – figure 10 of Amar, annotated by the examiner
Regarding claim 3:
The needle (100) according to claim l, further comprising a first straight region (102) extending from the proximal end (extends to the proximal end corresponding to B in figure 12) to the curved region (104).
Regarding claim 4:
The needle according to claim 3, wherein the first straight region comprises a length of between 4mm and 18mm (see ¶0036 which indicates 102 can have a length of 5mm).
Regarding claim 5:
The needle (100/50) according to claim l, wherein the curved region (104/54) terminates at the distal end (see figures 12 or 7 where the curve 104/54 extends to the distal end).
Regarding claim 6:
The needle according to claim 5, wherein the vertex angle of the curved region is between 160º and 179º (see below where the vertex angle is 174º since the corresponding angle is 6º as mentioned in ¶0031).
PNG
media_image3.png
392
764
media_image3.png
Greyscale
Figure 3 – figure
Regarding claim 7:
The needle according to claim 5, wherein the curved region (54) comprises an arc length of between 8mm and 18mm (curve 54 is 15mm as indicated in ¶0031).
Regarding claim 8:
The needle (80) according to claim 3, further comprising a second straight region (86) extending from the curved region (84) to the distal end (A in figure 1 above).
Regarding claim 10:
The needle according to claim 8, wherein a vertex angle of the curved region is between 140º and 160º (¶0034 indicates the arc is 20 º and therefore the vertex angle is 160º as shown in figure 2 above).
Regarding claim 17:
The needle (80) according to claim l, wherein a wall thickness of the needle (80) tapers (see the spatula tip mentioned in ¶0035) toward the distal end (A in figure 1 above) along at least a portion of a length of the needle (80).
Regarding claim 19:
The needle (80) according to claim 18, wherein the material of the needle (80) is selected from the group consisting of stainless steel (“stainless steel”, ¶0027), titanium, cobalt chrome, and platinum, and combinations thereof.
Regarding claim 23 (as best understood by the examiner, see the 35 USC 112(b) rejection above for the claim interpretation):
The needle (80) according to claim l, wherein the needle (80) is packaged in a blister pack (interpreted as intended use as indicated in the 35 USC 112(b) rejection above and this needle as shown in figure 10 can be packaged in a blister pack).
Regarding claim 24:
A method of injecting dermal filler into the dermis, the method comprising:
injecting the dermal filler (“fat micro injection” as mentioned in ¶0004 and is a lip injection device as indicated in ¶0008) via the needle (80) of claim 1.
Regarding claim 25:
The method according to claim 24, and further comprising:
injecting the dermal filler into a lip (¶0008 indicates that the injections can be in the “lip philtrum”) or perioral area of a face.
Regarding claim 29:
The method according to claim 24, the method further comprising:
injecting a bolus deposit of dermal filler whilst the needle is static (see the micro injections mentioned in ¶0026 and ¶0004 indicating small deposits are made at different locations).
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.
Claim(s) 9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20010037092 A1 to Amar as applied to claim 8 above.
Regarding claim 9:
Amar fails to disclose:
The needle according to claim 8, wherein the second straight region comprises a length of between 7mm and 12 mm.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Amar to have a second straight region length between 7mm to 12mm. Amar teaches throughout the specification that you can have needles of varying shapes and sizes (¶0030 and figures 7-12) in order to reach different locations on the face (see ¶0031-0037 which show different lengths and angles in order to reach different parts of the face). This teaches that the length and angle of the straight regions and curved regions are results effective variables dependent on the location of the face that the surgeon intends to reach. For this reason, the length of 7mm and 12 mm for the second straight region would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to reach particular locations on the face.
Regarding claim 11:
Amar fails to disclose:
The needle according to claim 8, wherein the curved region comprises an arc length of between 2mm and 5mm.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Amar to have the curved region length between 2mm and 5mm. Amar teaches throughout the specification that you can have needles of varying shapes and sizes (¶0030 and figures 7-12) in order to reach different locations on the face (see ¶0031-0037 which show different lengths and angles in order to reach different parts of the face). This teaches that the length and angle of the straight regions and curved regions are results effective variables dependent on the location of the face that the surgeon intends to reach. For this reason, the length of 2mm and 5mm mm for the curved region would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to reach particular locations on the face.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20010037092 A1 to Amar as applied to claim 1 above, and further in view of US 20040078008 A1 to Ueda et al. (Ueda).
Regarding claim 14:
Amar fails to disclose:
The needle according to claim l, comprising an outer diameter of between 0.235mm and 0.362mm.
Ueda teaches:
A needle for liquid injections (2 as shown in figure 5) that includes a diameter ranging between 0.1 and 0.25 mm (abstract; ¶0018).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Amar to have a diameter of 0.25mm as taught by Ueda in order to reduce sticking resistance (Ueda, ¶0058).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20010037092 A1 to Amar as applied to claim 1 above, and further in view of US 20170100542 A1 to Norton et al. (Norton).
Regarding claim 21:
Amar fails to disclose:
The needle according to claim l, wherein the needle is between approximately 25-gauge and approximately 32-gauge.
Norton teaches:
A needle (754) that is between 25-30 gauge (¶0264).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Amar to make the needle between the 25-30 gauge as taught by Norton for intramuscular injection (Norton, ¶0121).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20010037092 A1 to Amar as applied to claim 1 above, and further in view of US 20100256553 A1 to Fletcher.
Regarding claim 27:
Amar fails to disclose:
The method according to claim 24, the method further comprising:
retrograde depositing dermal filler as the needle is being at least partially withdrawn from the dermis.
Fletcher teaches:
A curved needle (504) that is used to inject filler (¶0010). Further, the reference teaches injecting filler into the dermal as the needle is withdrawn form the dermis to raise facial depressions, winkles or folds (¶0010 and ¶0013).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Amar to inject filler into the facial dermis as the needle is withdrawn as taught by Fletcher to raise depressions, windles or folds (Fletcher, ¶0010 and ¶0013).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-4383530-A
Bruno
See the curved region 40
US-1728259-A
CRESSLER
See the curved region 9
US-20210060264-A1
Martini
See the curved region 314
US-2899958-A
Son
See the curved region 8
US-5456675-A
Wolbring
See the curved region 22
US-20210316083-A1
Washington
See the curved region 120
US-20080269763-A1
Bonde
See the curved region 62
CN-211536005-U
ZHOU
See the curved region 20
KR-20160124015-A
LEE
See the curved region 13
CN-110624167-A
BI
See the curved region 1
WO-2017118972-A1
AMIR
See the curved region 3
JP-2008228993-A
FUKUOKA
See the curved region 10
WO-0197721-A2
BOUCHER
See the injection as the needle is removed in figures 9b-9c
EP-3539597-A1
PARTENHAUSER
See the curved region 50
CN-209301254-U
GUO
See the curved region 12
WO-2009146930-A1
KERSBERGEN
See the curved region 25b
WO-2014081780-A1
RING
See the curved region 124
CN-102695460-A
MAURER
See the curved region 10
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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, Michael Tsai can be reached on (571) 270-5246. 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.
/WESLEY G HARRIS/Examiner, Art Unit 3783
Prosecution Insights