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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 15, 2026 has been entered.
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.
Claims 1, 2, 4, 5, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2018/0263614 A1) in view of Whitehead et al. (US Pat. No. 5,921,991).
Regarding claim 1, Lee discloses a medical clip 22 comprising two clamping arms 61b and a spring 60b, wherein in each one of the two clamping arms is arranged or formed on a respective free end of the spring (para. [0100]; Fig. 2A), and wherein the two clamping arms in a basic position abut against one another (para. [0100]) and are movable away from one another against the action of the spring into an open position (para. [0101]), wherein at least part of a surface of the clip is of colored configuration (i.e., via 66, see para. [0108]), wherein the clip defines at least three clip regions that are spatially separate from one another (Fig. 2A;para. [0108]). Lee also discloses that a first clip region of the at least three clip regions comprises free ends of the two clamping arms (Fig. 2A), wherein a second clip region of the at least three clip regions comprises the spring or part thereof (Fig. 2A), and wherein at least one third clip region of the at least three clip regions is arranged or formed between the first clip region and the second clip region (Fig. 2A). However, Lee does not disclose that adjacent clip regions of the at least three clip regions (as further defined above) are of differently colored configuration.
In the same field of endeavor of multi-colored umbilical cord clamp, Whitehead discloses a similar device including three regions comprising a spring region 13, a clamp region 23, 18 and a region disposed between the two regions 16/11. Whitefield also discloses that adjacent clip regions are of differently colored configuration (under BRI at least 23 and 16/11 are different colors; see Col. 3 line 59-Col. 4 line 16 and 16/11 are different colors than 13 or 23 by way of 16 being a transparent color different than 23 or 13 see Col. 3 lines 12-24 and 36-58 i.e., at least since the transparent cap is one color (i.e., clear blue), and the arm would be a second color (i.e., yellow) such it would appear as green).
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 device of Lee such that it has separate colors in adjacent regions for purposes of providing the user with visible assurance of complete closure such that it decreases the likelihood that the clamp will slip off because it was not completely closed (Col. 3 lines 51-54).
Regarding claim 2, Lee and Whitehead disclose the medical clip according to claim 1. Whitehead also discloses wherein at least two of the at least three clip regions are of identically colored configuration and wherein these at least two clip regions do not directly adjoin one another (i.e., 13 and 18 of Fig. 1).
Regarding claim 4, Lee and Whitehead disclose the medical clip according to claim 1. Whitehead also discloses at least one of the at least clip regions is colored in one of the colors green (Col. 3 lines 35-54), blue (Col. 3 lines 35-54), violet, yellow (Col. 3 lines 35-54), or golden.
Regarding claim 5, Lee and Whitehead disclose the medical clip according to claim 1. Whitehead also discloses two adjoining clip regions of the at least three clip regions define a colored transition region (i.e., 16 of Fig. 1) of the surface and wherein the colored transition region is arranged or formed on a geometrically defined region of the clip (i.e., along the longitudinal section of 11), the cross section of the geometrically defined region being constant (Fig. 1) or conically tapers or widens on a region length, which corresponds to at least about 5% of a total length of the clip (i.e., see Fig. 1 such that the region 11 corresponds to at least 5% of the total length of the clip).
Regarding claim 20, Lee discloses a method for producing a medical implant 22 having an implant surface 62b with a colored configuration and at least three implant regions that are spatially separate from one another (i.e., at least one of the markers 66 and the space on either side), the at least three implant regions comprising adjacent implant regions that are of differently colored configuration (para. [0108] discloses alternating light and dark stripes and as such, adjacent clip regions are different colored but the third stripe would be the same color; i.e., light, dark, light, additionally a single marker would have the same color (i.e., the color of the device) on either side of the marker), the method comprising the steps of: producing two clamping arms 61b and a spring 60b, each of the two clamping arms being arranged or formed on a free end of the spring (para. [0100]; Fig. 2A), wherein the two clamping arms abut against one another in a basic position and are movable away from one another against the action of the spring into an open position (para. [0101]), wherein the implant is configured in the form of a medical clip (Fig. 2A), wherein at least part of a surface of the medical clip is of colored configuration (i.e., via 66, see para. [0108]), wherein the medical clip defines at least three clip regions that are spatially separate from one another (Fig. 2A;para. [0108]) and wherein adjacent clip regions of the at least three clip regions are of differently colored configuration (i.e., para. [0108] for example discloses alternating light and dark stripes and as such, adjacent clip regions are of differently colored configuration. Para. [0108] also discloses the reference markers may include a variety of colors; alternatively, between lines 66 are uncolored such that they would be differently colored than markers 66).
Lee also discloses that a first clip region of the at least three clip regions comprises free ends of the two clamping arms (Fig. 2A), wherein a second clip region of the at least three clip regions comprises the spring or part thereof (Fig. 2A), and wherein at least one third clip region of the at least three clip regions is arranged or formed between the first clip region and the second clip region (Fig. 2A). However, Lee does not disclose that adjacent clip regions of the at least three clip regions (as further defined above) are of differently colored configuration.
In the same field of endeavor of multi-colored umbilical cord clamp, Whitehead discloses a similar device including three regions comprising a spring region 13, a clamp region 23, 18 and a region disposed between the two regions 16/11. Whitefield also discloses that adjacent clip regions are of differently colored configuration (under BRI at least 23 and 16/11 are different colors; see Col. 3 line 59-Col. 4 line 16 and 16/11 are different colors than 13 or 23 by way of 16 being a transparent color different than 23 or 13 see Col. 3 lines 12-24 and 36-58).
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 device of Lee such that it has separate colors in adjacent regions for purposes of providing the user with visible assurance of complete closure such that it decreases the likelihood that the clamp will slip off because it was not completely closed (Col. 3 lines 51-54).
Claims 6-7, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Lee and Whitehead in view of Shelton, IV et al. (US 20190125459 A1).
Regarding claims 6 and 7, Lee and Whitehead disclose the medical clip according to claim 1. Lee and Whitehead don’t directly disclose at least one clip region of the at least three clip regions is of colored configuration by way of a coating;
at least one of: a) a layer thickness of the coating is in a range of about 10 nm to about 500 nm; and b) the coating is configured as an oxide layer (102, 104, 106) formed by anodic oxidation; and c) clip regions with surfaces of identically colored configuration are provided with an identical coating; and d) the coating contains gold or consists of gold.
However, in the same field of endeavor of surgical suturing instrument, Shelton IV discloses various methods of having visual markers placed on surgical suturing devices (i.e., staples), including coatings (para. [0851]);
at least one of: a) a layer thickness of the coating is in a range of about 10 nm to about 500 nm; and b) the coating is configured as an oxide layer (102, 104, 106) formed by anodic oxidation (para. [0851]); and c) clip regions with surfaces of identically colored configuration are provided with an identical coating; and d) the coating contains gold or consists of gold.
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 device of Lee and Whitehead to utilize coatings to place markers on the device since coatings are commonly used for purposes of distinguishing various parts of the device (para. [0851]).
Regarding claim 8, Lee and Whitehead disclose the medical clip according to claim 1. Lee in view of Whitehead and Shelton also disclose at least one of: a) at least one clip region of the at least three clip regions is uncoated (i.e., at least since the coating only needs to be applied to the markers 66 so between the markers 66 are uncoated); and b) the clip is made of a biocompatible metal (para. [0159]).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable by Trivisani (US 2014/0276917 A1) in view of Yoon (US Pat. No. 5695505) and Stokes (US 20190046200 A1).
Regarding claim 9, Trivisani discloses a medical clip system (para. [0022]) comprising at least two clips 10, 20, a first clip 20 of the at least two clips configured as a permanent clip (para. [0027]), the surface of which is of colored configuration (para. [0027]), and wherein a second clip 10 of the at least two clips, which corresponds at least one of in shape and size with the permanent clip (Fig. 1), is configured as a temporary clip (para. [0026]), the surface of which is configured at least partially corresponding in color to the permanent clip and at least partially colored for coding as the temporary clip (para. [0026] discloses marking which would include at least two colors such that the marking is one color and the clip is a second color, one of which may correspond to the temporary clip and one corresponding in color to the permanent clip; i.e., note: that although a different color is preferred, its not required), wherein the temporary clip is configured in the form of a medical clip (Fig 1), which comprises two clamping arms and a spring (Figs. 1-2; i.e., the base of the clips corresponds in function to the spring as discussed above with regard to 112f), wherein each of the two clamping arms is arranged or formed on a respective free end of the spring (Figs. 1-2), wherein at least part of a surface of the temporary clip is of colored configuration (para. [0026]), wherein the temporary clip defines at least three clip regions that are spatially separate from one another (i.e., distal region with lock, clip arm region including number indicated as 25, and connecting/biasing member at proximal end as shown in Fig. 1).
Trivisani doesn’t directly disclose:
the two clamping arms in a basic position abut against one another and are movable away from one another against the action of the spring into an open position;
adjacent clip regions of the at least three clip regions are of differently colored configuration.
Regarding (i):
In the same field of endeavor of spring clips, Yoon discloses a similar clip mechanism to Trivisani including a clip 10 with grasping surfaces 18, 20 and a spring that biases the clip in the closed position (Col. 6 line 53-Col. 7 line 5). Yoon also discloses the two clamping arms in a basic position abut against one another and are movable away from one another against the action of the spring into an open position (Col. 6 line 53-Col. 7 line 5).
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 device of Trivisani to be in a basic position abut against one another and are movable away from one another against the action of the spring into an open position for purposes of tightly gripping tissue between the opposed surfaces in a closed position (Col. 6 line 53-Col. 7 line 17).
Regarding (ii):
In the same field of endeavor of clip appliers, Stokes discloses incorporating visual markers (i.e., colors) into the clip for the purpose of visualizing the clip arm. Stokes specifically discloses using a first color of a jaw member with a second extended tip portion color, a third color for the clip engaging portion, and a marking which may be a fourth color (para. [0050]). Stokes therefore also teaches incorporating coloring of a clip in lieu of a clip applier such that adjacent clip regions (i.e., tip, base, and marking) of the at least three clip regions are of differently colored configuration (para. [0050]).
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 clip device of Trivisani as modified by Yoon such that the clip has a single color exterior with a separate colored tip and an additional colored marking that teaches that adjacent regions of the at least three clip regions are of differently colored configuration for purposes of proper positioning of the clip (para. [0050] of Stokes) since Trivisani discloses a need for proper positioning of the clip (see para. [0025] of Trivisani).
Regarding claim 10, Trivisani, Yoon, and Stokes disclose the medical clip system according to claim 9. Trivisani also discloses at least one of: a) the color of the surface of the permanent clip forms a coding for at least one of the shape and size of the permanent clip (para. [0026]); and b) each of the at least two medical clips comprises two clamping arms and a spring, wherein in each case a clamping arm is arranged or formed on a free end of the spring, and wherein the two clamping arms in a basic position abut against one another and are movable away from one another against the action of the spring into an open position and c) the permanent clip and the temporary clip are of identical configuration except for the coloring and (para. [0026]) d) the clip system comprises at least two permanent clips differing in at least one of size and shape (para. [0026]).
Response to Arguments
Applicant's arguments filed March 19, 2026 have been fully considered but they are not persuasive.
Regarding Applicant’s first argument that neither Lee nor Whitehead teaches or suggest an aneurism clip, Applicant’s arguments rely on language solely recited in preamble recitations in claim(s) 1 and 9. When reading the preamble in the context of the entire claim, the recitation “in the form of an aneurism clip” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Further, regarding claim 20, a medical clip that holds tissue as disclosed in Lee and an umbilical clip as disclosed in Whitehead is in the same field of endeavor as aneurism clips. The fact that the clip is used as an aneurism clip is simply a recitation of the intended use of the claimed invention which must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As such, since both clips of Lee and Whitehead are medical clips capable of clamping with enough force to prevent bloodflow (i.e., at least in Whitehead which is the purpose of umbilical clips), the prior art structure is capable of performing the intended us of being an aneurism clip.
Regarding Applicant’s argument that Whithead does not provide teachings to arrive at the claimed invention, Examiner disagrees. Firstly, Applicant incorrectly argues that Whitehead is required to teach THREE separate colors. Applicant specifically argues “claim 1 requires one color on the arms, another color on the spring, and a third color between the arms and spring.” Claim 1 has no such language. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Examiner notes that the claim only reads that adjacent clip regions are different colors. So, under BRI, if a middle portion of the clip is a separate color, then each adjacent region would be a different color than the middle region (i.e., green, red, green). Therefore, Applicant’s argument that “all of the clip except for the window 23 is the same color as the colored head 42” would be correct and read on the claim since the colored window is the “middle portion” and adjacent portions would be different in color to the window.
Regarding Applicant’s third argument that there is no proper motivation to combine Lee with Whitehead, Examiner disagrees. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Examiner has provided a teaching, suggestion, and motivation to modify Lee to have the colors of the clip as disclosed by Whitehead in Col. 3 lines 51-54 for the purposes of providing the user with visible assurance of complete closure such that it decreases the likelihood that the clamp will slip off because it was not completely closed (i.e., this motivation does not require a lock; it is common knowledge in the art that the clip must stop blood flow and as such much be clamped fully in order to completely stop blood flow through the vessel).
Regarding Applicant’s fourth argument that Whitehead is not proper analogous art, Examiner disagrees. It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Applicant discloses a medical clip which is analogous art. Medical clips may include aneurism clips, umbilical clips, ligation clips, endoscopic clips, etc. are all in the same field of endeavor.
Regarding claim 9, Applicant also argues that the spring would make Trivisani’s umbilical clamp impossible to use. Examiner disagrees. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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