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 .
Response to Amendment
Applicant’s amendments to claims 14 and 16 filed 06/30/2026 is acknowledged by the examiner.
Claims 1-20 are currently pending and are under examination.
Response to Arguments
Applicant's arguments filed 06/30/2026 have been fully considered but they are not persuasive.
Applicant’s argument: Applicant submits that’s a person of ordinary skill in the art would not be motivated to modify the plug (IMP) of Fig. 3 of Herrick with the devices shown in Felder. The Herrick plug is directed to a “method of performing temporary and permanent horizontal canalicular blockade.” Col. 2 lines 33-35 of Herrick. For Example, Herrick states “it is preferred that the implant Imp be placed in the horizontal portion of the canaliculus” and “the implant Imp is advanced through the punctum into the vertical portion of the canaliculus until it is advanced within the horizontal canaliculus, wherein it will reside.” Herrick Col. 4 lines 42-44, Col. 5 lines 4-7. Herrick also explains why the plug is advanced into the horizontal canaliculus and does not reside in the vertical canaliculus. Thus, shortening the plug (IMP) of Herrick so that the plug (IMP) never reaches the horizontal canaliculus would defeat the very placement Herrick identifies as preferred and which is identified as the location where the implant “will reside.” Felder, in contrast to the device of Herrick is not an occlusive plug and fails to provide the missing reason to make the redesign alleged in the Office Action. Therefore, when taking both references as a whole, one of skill in the art would not look to modify the plug (IMP) of Herrick with that of Felder since the modification of the Herrick plug as proposed would render the Herrick plug unsatisfactory for its intended purpose, which is clearly described in Herrick as performing temporary and permanent horizontal canalicular blockade and which is achieved by positioning the Herrick plug in horizontal canaliculus. Further, when taking both references as a whole, the combination of references would lead away from a plug configured for occluding a horizontal canaliculus of a lacrimal drainage system. The asserted combination depends on picking the length of the device of Felder while rejecting what Felder focuses on, namely permitting tear fluid to flow through the plug in order to “analyze the amount of glucose present in the tear fluid.” Felder, Col. 6 line 62. “It is impermissible within the framework of section 103 to pick and choose from any one reference only so much of it as will support a given position, to the exclusion of other parts necessary to the full appreciation of what such reference fairly suggests to one of ordinary skill in the art.” In re Wesslau, 353 F.2d 238 (CCPA 1965). The examiner cannot “stitch together an obviousness finding from discrete portions of prior art references without considering the references as a whole.” In re Enhanced Security Research, LLC, 739 F.3d 1347, 1355 (Fed. Cir. 2014). Nor can the examiner take a single aspect of a reference out of context and use it with hindsight to find obviousness. The Office Action improperly concludes the existence of various purported benefits of modifying Herrick in light of Felder. The Office Action fails to provide any evidence or articulated reasoning to show that such a modification would result in the purported reduced chance of irritation. Further, the Office Action fails to provide any evidence or any articulated reasoning that modifying the length of the plug of Herrick would have any effect manufacturing costs. These assertions of benefit in the Office Action are entirely conclusory. Here, there is no rational underpinning that supports the conclusory statement that modifying the overall length of plug (IMP) of Herrick as allegedly taught by Felder would reduce the chance of irritation. There is no discussion in the Office Action regarding any facts that support that the Herrick plug causes irritation, much less that modifying the overall length of the Herrick plug would reduce any such irritation. Similarly, there is no rational underpinning that supports the conclusory statement that modifying the overall length of plug of Herrick as allegedly taught by Felder would lower the cost to manufacture the plug disclosed in Herrick. There is no discussion in the Office Action regarding any facts that support that the Herrick plug would be lower in cost to manufacture if modified by what is disclosed in Felder. Further, Felder is not merely a simplified or lower-cost version of Herrick’s plug; rather, a person having ordinary skill in the art would recognize Felder as a sophisticated and likely costly to manufacture device. Examiner is reminded that it is impermissible to cherry pick certain aspects of any reference, including the Felder reference, and that the entirety of the disclosure must be considered. Further, Herrick II states that “by selecting a punctum plug of an appropriate length, the above elements are effective to hold the plug in place and to prevent inadvertent removal or any possible migration of the plug while implanted within the eye.” Herrick II, Column 21 lines 27-30. Therefore, shortening the plug of Herrick II so that the plug never reaches the horizontal canaliculus after complete implantation would defeat the very placement Herrick II identifies as preferred to prevent “inadvertent removal.”
Examiner’s response: Herrick states “it is preferred that the implant Imp be placed in the horizontal portion of the canaliclus,” and therefore, the Herrick reference is still open to modification, as the reference does not explicitly state that the implant Imp must be placed in the horizontal portion of the canaliculus or that the implant Imp cannot be placed in the vertical portion of the canaliculus. Further Herrick states “the implant Imp, however, may¸ have lengths that fall within the range of 5 to 8 millimeters…,” and therefore, the Herrick reference is still open to modification, as the references does not explicitly state that implant Imp must be 5 to 8 millimeters in length or criticizes/discredits the implant Imp being less than 5 to 8 millimeters in length. Similarly, with regards to the arguments regarding the Herrick II reference, Herrick II states that “the overall length could be in the order of about 2.5 mm to 8mm” (Col. 17 lines 61-62 of Herrick II), therefore the Herrick II references is also still open to modification. Furthermore, "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See also UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 692, 2023 USPQ2d 448 (Fed. Cir. 2023) ("a reference does not teach away if it merely expresses a general preference for an alternative invention but does not criticize, discredit or otherwise discourage investigation into the invention claimed.") (internal quotations omitted) (quoting DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009)); and Schwendimann v. Neenah, Inc., 82 F.4th 1371, 1381, 2023 USPQ2d 1173 (Fed. Cir. 2023) ("Although Oez [the prior art] used a white pigment with a cross-linking polymer, it does not discourage a skilled artisan from using the white pigment without a cross-linking polymer or lead the skilled artisan in a direction divergent from the path taken in the Appealed Patents. Thus, Oez's disclosure is substantial evidence that supports the Board's finding that Oez does not teach away from the proposed combination. Further, 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, modifying the Herrick plug Imp to be shorter in length would cost less to manufacture as there is less material needed to create the Herrick plug Imp, and thus is knowledge generally available to one of ordinary skill in the art. Similarly, modifying the Herrick plug Imp to be shorter in length would also reduce chance of irritation as it reduces the chances of contacting with deeper tissues in the eyes and potentially causing irritation/harming a user’s eye tissues, and also reduces chance of irritation by have less material having to navigate through the punctum overall, which is also knowledge generally available to one of ordinary skill in the art. Further, 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 suggest in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggest to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant also cites Col. 21 lines 27-30 of Herrick II in relation to plug 498 of Herrick II, however, this portion of specification is directed to the punctum plug with the collapsible flared section and therefore, is not the same embodiment that is being disclosed in the Office Action, see Col. 21 lines 21-27 of Herrick II.
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) 1-2, 5-6, 8-10, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herrick et al. (referred to as “Herrick”) (US 5,049,142) in view of Felder (US 8,090,426 B2).
Regarding claim 1, Herrick discloses a plug (IMP) configured for occluding a vertical canaliculus of a lacrimal drainage system (see Fig. 3 and Col. 5 lines 4-5 which discusses how the implant IMP is advanced through the punctum and into the vertical portion of the canaliculus, of a lacrimal drainage system, and thus occluding a vertical canaliculus), comprising:
a body portion having a first end and a second end (see Annotated Fig. 3 of Herrick which has a body portion labeled with a first end and a second end), wherein the first end of the body portion is coincident with a terminal end of the plug (IMP) (see Annotated Fig. 3 of Herrick, which has the first end of the body portion labeled as well as a terminal end of the plug, which is coincident with the first end), the body portion having a continuous cylindrical shape from the first end to the second end (see Annotated Fig. 3 of Herrick; the body portion has a continuous cylindrical shape from the first end to the second end, also see Col. 2 lines 67-68); and
a tapered portion having a distal tip (N) and a proximal end (see Annotated Fig. 3 of Herrick which has a tapered portion labeled, also see Col. 3 lines 2-4 and Col. 5 lines 12-14, and this tapered portion has a distal tip which is snub nose N, and a proximal end which is also labeled in Annotated Fig. 3), wherein the proximal end extends from the second end of the body portion (see Annotated Fig. 3 of Herrick; the proximal end extends from the second end of the body portion), wherein the tapered portion has a conical shape along a length extending from the proximal end and to the distal tip (N) (see Annotated Fig. 3 of Herrick; the tapered portion has a conical shape along a length extending from the proximal end to the snub nose N, as the tapered portion tapers from a circular base, as the body portion is a cylinder shape, see Col. 2 lines 67-68 et seq. Col. 3 lines 2-4, Col. 4 lines 12-14);
wherein:
the plug (IMP) is solid from the first end to the distal tip (N) (see Annotated Fig. 3 of Herrick and Col. 3 lines 67-68, and Col. 4 lines 45-46; the implant IMP is constructed of a solid element, and can totally block the canaliculus from the first end to the snub nose N);
the second end of the body portion and the proximal end of the tapered portion having a same outer diameter (see Annotated Fig. 3 of Herrick; the second end of the body portion and the proximal end of the tapered portion have the same outer diameter);
the plug (IMP) is configured to be, after complete implantation into the lacrimal drainage system, positioned within the vertical canaliculus of the lacrimal drainage system (see Col. 5 lines 4-5 which discusses how the implant IMP is advanced through the punctum and into the vertical portion of the canaliculus of a lacrimal drainage system, and thus implant IMP is configured to be positioned within the vertical canaliculus after complete implantation into the lacrimal drainage system);
the plug (IMP) is configured to, after complete implantation into the lacrimal drainage system, occlude a flow of fluid through the lacrimal drainage system (see Figs. 1 and 3, and Col. 4 lines 45-46, and Col. 4 lines 49-50; the implant IMP is configured to occlude or block a flow of fluid through the lacrimal drainage system, after complete implantation into the lacrimal drainage system).
Herrick is silent on the plug is configured to be, after complete implantation into the lacrimal drainage system, completely positioned within the vertical canaliculus of the lacrimal drainage system such that no portion is external to a punctal opening; the plug is configured to be, after complete implantation into the lacrimal drainage system, external to a horizontal canaliculus of the lacrimal drainage system.
However, Felder teaches an analogous plug (30) (see Fig. 4 and Fig. 11), and the plug (30) is configured to be, after complete implantation into the lacrimal drainage system, completely positioned within the vertical canaliculus of the lacrimal drainage system such that no portion is external to a punctal opening (see Figs. 4 and 11; plug 30 is configured to be, after complete implantation into the lacrimal drainage system, completely positioned within the vertical canaliculus 16 of the lacrimal drainage system such that no portion is external to a punctal opening 12, 14, as the plug 30 has a length of 1.5 mm to 2.0 mm, see Col. 5 lines 2-9, and see Fig. 11 and Fig. 2 which shows the dimension of the vertical canaliculi 16 to be 2 mm, and thus plug 30 having a length of 1.5 mm when completely positioned within the vertical canaliculus would have no portion external to the punctal opening 12,14); and the plug (30) is configured to be, after complete implantation into the lacrimal drainage system, external to a horizonal canaliculus of the lacrimal drainage system (see Figs. 2, 4, and 11, and Col. 5 lines 2-9; the plug 30 has a length of 1.5 mm to 2.0 mm, see Col. 5 lines 2-9, and the length of the vertical canaliculi 16 is 2 mm as shown in Fig. 2, and thus the plug 30 can be 1.5 mm which is less than 2 mm, and thus after complete implantation into the vertical canaliculi 16, the plug 30 would be external to a horizontal canaliculus, also see Fig. 11 which shows plug 30 external to the horizontal canaliculus), providing a plug that reduces the chance of irritation while being lower in cost to manufacture.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified an overall length of plug (IMP) of Herrick such that the plug is configured to be, after complete implantation into the lacrimal drainage system, completely positioned within the vertical canaliculus of the lacrimal drainage system such that no portion is external to a punctal opening, and such that the plug is configured to be, after complete implantation into the lacrimal drainage system, external to a horizontal canaliculus of the lacrimal drainage system as taught by Felder to have provided an improved plug that reduces the chance of irritation while being lower in cost to manufacture.
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Annotated Fig. 3 of Herrick.
Regarding claim 2, Herrick in view of Felder discloses the invention as discussed in claim 1. Herrick in view of Felder further discloses wherein the first end of the plug (IMP of Herrick) is planar and is orthogonal to a longitudinal axis of the plug (IMP of Herrick) (see Annotated Fig. 3 of Herrick; the first end of the implant IMP of Herrick is planar or flat, and is orthogonal to a longitudinal axis of the implant IMP of Herrick, as the longitudinal axis is the dotted horizontal line in Annotated Fig. 3 of Herrick, and the first end of implant IMP of Herrick is flat also indicated by the vertical solid line and thus forming a right angle with the longitudinal axis).
Regarding claim 5, Herrick in view of Felder discloses the invention as discussed in claim 1. Herrick in view of Felder further discloses wherein the plug (IMP of Herrick) is configured to be inserted through the punctal opening having a diameter ranging from 0.2 mm to 1.0 mm (see Figs. 1 and 3 of Herrick, and see Col. 3 lines 61-63 of Herrick which discusses how the punctal opening or punctum has a diameter of 0.3 mm which implant IMP of Herrick is configured to be inserted through).
Regarding claim 6, Herrick in view of Felder discloses the invention as discussed in claim 1.
Felder further teaches wherein the analogous plug (30) has an overall length from 1.5 mm to 3.0 mm (see Col. 5 lines 7-9 which discusses the overall length of plug 30 being 1.5 mm to 2.0 mm, which is within the claimed range), providing a plug that reduces the chance of irritation while being lower in cost to manufacture.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified an overall length of the plug (IMP of Herrick) in the device of Herrick in view of Felder to have an overall length of 1.5 mm to 2.0 mm as taught by Felder to have provided an improved plug that reduces the chance of irritation while being lower in cost to manufacture.
Regarding claim 8, Herrick in view of Felder discloses the invention as discussed in claim 1. Herrick in view of Felder further discloses wherein the body portion of the plug (IMP of Herrick) has a diameter of from approximately 0.3 mm to approximately 0.9 mm (see Col. 4 lines 57-58 of Herrick which discusses the body portion of the implant IMP of Herrick having a diameter of 0.5 mm, which is within the claimed range).
Regarding claim 9, Herrick in view of Felder discloses the invention as discussed in claim 1. Herrick in view of Felder further discloses wherein the tapered portion is tapered at a constant angle (see Annotated Fig. 3 of Herrick and Col. 4 lines 62-65 of Herrick which discusses how the tapered portion is tapered at a constant angle).
Regarding claim 10, Herrick in view of Felder discloses the invention as discussed in claim 1. Herrick in view of Felder further discloses wherein the tapered portion of the plug (IMP of Herrick) is tapered at an angle that is from 6 degrees to 30 degrees relative to a longitudinal axis of the plug (IMP of Herrick) (see Annotated Fig. 3 of Herrick and Col. 4 lines 62-67 of Herrick which discusses how the tapered portion of implant IMP of Herrick is tapered at an angle of 8 degrees relative to a longitudinal axis of the plug, which is within the claimed range).
Regarding claim 13, Herrick in view of Felder discloses the invention as discussed in claim 1. Herrick in view of Felder further discloses wherein the tapered portion is configured to facilitate insertion of the plug (IMP of Herrick) through the punctal opening (see Annotated Fig. 3 of Herrick, and see Col. 5 lines 12-14 of Herrick which discusses how the tapered portion is configured to facilitate insertion of the implant IMP of Herrick).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herrick in view of Felder further in view of Webb (US 6,082,362).
Regarding claim 4, Herrick in view of Felder discloses the invention as discussed in claim 1.
Herrick in view of Felder is silent on wherein the distal tip is rounded.
However, Webb teaches an analogous distal tip (320a) that is rounded (see Fig. 10 and Col. 4 lines 55-57 which discusses the distal end 320a of plug 300a being rounded), providing to prevent any damage to the user’s eye and any surrounding tissues during insertion of the plug.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal tip (N of Herrick) in the device of Herrick in view of Felder to be rounded as taught by Webb to have provided an improved plug that prevents any damage to the user’s eye and any surrounding tissues during insertion of the plug.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herrick in view of Felder further in view of Murray (US 7,862,532 B2).
Regarding claim 7, Herrick in view of Felder discloses the invention as discussed in claim 1.
Herrick in view of Felder is silent on wherein the length of the tapered portion of the plug is 0.7 mm to 1.3 mm.
However, Murray teaches an analogous plug (40) (see Figs. 2-4), and wherein the length of the analogous tapered portion (48) of the plug (40) is 0.7 mm to 1.3 mm (see Col. 10 lines 3-5 and Figs. 2-4; distal tip 42 which makes up the tapered portion which is shown by main section 48, has a length of 0.0280 inches, which is equivalent to 0.711 mm, which is within the claimed range), providing a length that is sufficient enough to help the insertion of the plug into the punctal opening, and providing a plug that better adapts to the anatomical characteristics of the punctal opening/tissue in the eyes, as the tapered portion helps to ease the plug into the opening.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the length of the tapered portion in the device of Herrick in view of Felder to be 0.7 mm as taught by Murray to have provided an improved plug that is of sufficient length to help the insertion of the plug into the punctal opening, and better adapt to the anatomical characteristics of the punctal opening/tissue in the eyes, as the tapered portion helps to ease the plug into the opening.
Claim(s) 1, 3, 11-12, 16, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herrick, II (referred to as “Herrick II”) (US 7,404,825 B2) in view of Felder.
Regarding claim 1, Herrick II discloses a plug (498) (see Fig. 28) configured for occluding a vertical canaliculus of a lacrimal drainage system (see Fig. 28 and Col. 19 line 54; implant 498 is a plug that is configured for occluding a canaliculus of a lacrimal drainage system), comprising:
a body portion (502) having a first end and a second end, wherein the first end of the body portion (502) is coincident with a terminal end of the plug (498) (see Annotated Fig. 28 of Herrick II; central body 502 is a body portion having a first end and a second end labeled in Annotated Fig. 28, and the first end is coincident with a terminal end of implant 498, which is also labeled in Annotated Fig. 28), the body portion (502) having a continuous cylindrical shape from the first end to the second end (see Annotated Fig. 28 of Herrick II and Col. 19 lines 54-60; the central body 502 has a continuous cylindrical shape from the first end to the second end); and
a tapered portion having a distal tip (504) and a proximal end (see Annotated Fig. 28 of Herrick II and Col. 19 lines 57-58; the tapered portion of implant 498 is labeled in Annotated Fig. 28 and has a distal end section 504 which is the distal tip and a proximal end, which is also labeled in Annotated Fig. 28), wherein the proximal end extends from the second end of the body portion (502) (see Annotated Fig. 28 of Herrick II; the proximal end of the tapered portion extends from the second end of the central body 502), wherein the tapered portion has a conical shape along a length extending from the proximal end to the distal tip (504) (see Annotated Fig. 28 of Herrick II; the tapered portion is a conical or cone shape along a length extending from the proximal end to the distal end section 504 as this portion tapers from a cylindrical base of central body 502);
wherein:
the plug is solid from the first end to the distal tip (504) (see Annotated Fig. 28 of Herrick II; the implant 298 is solid from the first end to the distal end section 504, also see Fig. 29);
the second end of the body portion (502) and the proximal end of the tapered portion have a same outer diameter (see Annotated Fig. 28 of Herrick II; the second end of central body 502 has an outer diameter that is the same as the outer diameter of the proximal end of the tapered portion as seen in the figure 28);
the plug (498) is configured to be, after complete implantation into the lacrimal drainage system, positioned within the vertical canaliculus of the lacrimal drainage system (see Fig. 28; the implant 498 is a lacrimal implant or plug and thus is configured to be or is capable of being, after complete implantation into the lacrimal drainage system, positioned within the vertical canaliculus of the lacrimal drainage system); and
the plug (498) is configured to be, after complete implantation into the lacrimal drainage system, occlude a flow of fluid through the lacrimal drainage system (see Fig. 28-29; the implant 498 is configured to be or is capable of being able to occlude a flow of fluid through the lacrimal drainage system, after complete implantation into the lacrimal drainage system, as the implant 498 is solid, also see Col. 8 lines 49-52).
Herrick II is silent on wherein the plug is configured to be, after complete implantation into the lacrimal drainage system, completely positioned within the vertical canaliculus of the lacrimal drainage system such that no portion is external to a punctal opening; and the plug is configured to be, after complete implantation into the lacrimal drainage system, external to a horizontal canaliculus of the lacrimal drainage system.
However, Felder teaches an analogous plug (30) (see Fig. 4 and Fig. 11), and the plug (30) is configured to be, after complete implantation into the lacrimal drainage system, completely positioned within the vertical canaliculus of the lacrimal drainage system such that no portion is external to a punctal opening (see Figs. 4 and 11; plug 30 is configured to be, after complete implantation into the lacrimal drainage system, completely positioned within the vertical canaliculus 16 of the lacrimal drainage system such that no portion is external to a punctal opening 12, 14, as the plug 30 has a length of 1.5 mm to 2.0 mm, see Col. 5 lines 2-9, and see Fig. 11 and Fig. 2 which shows the dimension of the vertical canaliculi 16 to be 2 mm, and thus plug 30 having a length of 1.5 mm when completely positioned within the vertical canaliculus would have no portion external to the punctal opening 12,14); and the plug (30) is configured to be, after complete implantation into the lacrimal drainage system, external to a horizonal canaliculus of the lacrimal drainage system (see Figs. 2, 4, and 11, and Col. 5 lines 2-9; the plug 30 has a length of 1.5 mm to 2.0 mm, see Col. 5 lines 2-9, and the length of the vertical canaliculi 16 is 2 mm as shown in Fig. 2, and thus the plug 30 can be 1.5 mm which is less than 2 mm, and thus after complete implantation into the vertical canaliculi 16, the plug 30 would be external to a horizontal canaliculus, also see Fig. 11 which shows plug 30 external to the horizontal canaliculus), providing a plug that reduces the chance of irritation while being lower in cost to manufacture.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified an overall length of plug (498) of Herrick II such that the plug is configured to be, after complete implantation into the lacrimal drainage system, completely positioned within the vertical canaliculus of the lacrimal drainage system such that no portion is external to a punctal opening, and such that the plug is configured to be, after complete implantation into the lacrimal drainage system, external to a horizontal canaliculus of the lacrimal drainage system as taught by Felder to have provided an improved plug that reduces the chance of irritation while being lower in cost to manufacture.
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Annotated Fig. 28 of Herrick II.
Regarding claim 3, Herrick II in view of Felder discloses the invention as discussed in claim 1. Herrick II in view of Felder further discloses wherein the plug is bioabsorbable (see Col. 21 lines 40-43 and Col. 17 lines 24-37 of Herrick II which discusses how the plug may be absorbable in the body, or bioabsorbable).
Regarding claim 11, Herrick II in view of Felder discloses the invention as discussed in claim 1. Herrick II in view of Felder further discloses wherein the plug is dissolvable (see Col. 21 lines 40-43 of Herrick II which discusses how the plug may be dissolvable).
Regarding claim 12, Herrick II in view of Felder discloses the invention as discussed in claim 1.
Herrick II further teaches wherein an analogous plug (178) is made from a polymer or copolymer of glycolide, lactide, dioxanone, caprolactone, or trimethylene carbonate (see Col. 17 lines 24-34 of Herrick II which discusses how in another embodiment, plug 178 may be made in whole from polyglycolic acid, which is a polymer of glycolide), providing a material that is biocompatible so that it does not harm a user when bioabsored.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material of the plug (498 of Herrick II) in the device of Herrick II in view of Felder to be made from a polymer of glycolide as taught by another embodiment of Herrick II to have provided an improved plug that provides a material that is biocompatible so that it does not harm a user when bioabsorbed.
Regarding claim 16, Herrick II discloses a method of occluding a vertical canaliculus of a lacrimal drainage system (see Fig. 28 and Col. 19 line 54 and Abstract; implant 498 is a plug that is configured for occluding a vertical canaliculus of a lacrimal drainage system), comprising:
advancing a plug (498) through a punctal opening of the lacrimal drainage system (see Abstract and Col. 19 lines 54-56; lacrimal implant 498 is advanced through a punctum or punctal opening and into the canaliculus), the plug (498) having:
a body portion (502) having a first end and a second end, wherein the first end of the body portion (502) is coincident with a terminal end of the plug (498) (see Annotated Fig. 28 of Herrick II; central body 502 is a body portion having a first end and a second end labeled in Annotated Fig. 28, and the first end is coincident with a terminal end of implant 498, which is also labeled in Annotated Fig. 28), the body portion (502) having a continuous cylindrical shape from the first end to the second end (see Annotated Fig. 28 of Herrick II and Col. 19 lines 54-60; the central body 502 has a continuous cylindrical shape from the first end to the second end); and
a tapered portion having a distal tip (504) and a proximal end (see Annotated Fig. 28 of Herrick II and Col. 19 lines 57-58; the tapered portion of implant 498 is labeled in Annotated Fig. 28 and has a distal end section 504 which is the distal tip and a proximal end, which is also labeled in Annotated Fig. 28), wherein the proximal end extends from the second end of the body portion (502) (see Annotated Fig. 28 of Herrick II; the proximal end of the tapered portion extends from the second end of the central body 502), wherein the tapered portion has a conical shape along a length extending from the proximal end to the distal tip (504) (see Annotated Fig. 28 of Herrick II; the tapered portion is a conical or cone shape along a length extending from the proximal end to the distal end section 504 as this portion tapers from a cylindrical base of central body 502), wherein a diameter of the tapered portion at the proximal end is equal to an outer diameter of the body portion (502) (see Annotated Fig. 28 of Herrick II; a diameter of the tapered portion at the proximal end is equal to an outer diameter of the central body 502).
Herrick II is silent on advancing the plug into the vertical canaliculus of the lacrimal drainage system without advancing any portion of the plug into a horizontal canaliculus of the lacrimal drainage system; and retaining the plug within the vertical canaliculus.
However, Felder teaches an analogous plug (30) (see Fig. 4 and 11), and advancing the plug (30) into the vertical canaliculus of the lacrimal drainage system without advancing any portion of the plug into a horizontal canaliculus of the lacrimal drainage system (see Figs. 4 and 11, and Col. 4 lines 65-67 et seq. Col. 5 lines 2-9; plug 30 is advanced into the vertical canaliculus through one of the punctum without advancing any portion of plug 30 into a horizontal canaliculus of the lacrimal drainage system, as plug 30 can have a length of 1.5 mm and the length of the vertical canaliculi 16 is 2 mm as shown in Fig. 2, and thus once plug 30 is advanced into the vertical canaliculus, the length of the plug makes it so that no portion of plug 30 is advanced into a horizontal canaliculus); and retaining the plug (30) within the vertical canaliculus (see Figs. 4 and 11, and Col. 4 lines 65-67 et seq. Col. 5 lines 2-9; plug 30 is sized and shaped for insertion into one of the punctum, and plug 30 ultimately can remain within the vertical canaliculi 16, as seen in Fig. 11), providing a plug that reduces the chance of irritation while being lower in cost to manufacture.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Herrick II to include advancing the plug into the vertical canaliculus of the lacrimal drainage system without advancing any portion of the plug into a horizontal canaliculus of the lacrimal drainage system and retaining the plug within the vertical canaliculus as taught by Felder to have provided an improved method that reduces the chance of irritation while being lower in cost to manufacture.
Regarding claim 18, Herrick II in view of Felder discloses the invention as discussed in claim 16. Herrick II in view of Felder further discloses completely occluding the vertical canaliculus with the plug (498 of Herrick II) (see claim 16; as previously modified above, the lacrimal implant 498 of Herrick II completely occludes the vertical canaliculus).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herrick in view of LUST et al. (referred to as “LUST”) (US 2011/0196317 A1) further in view of Witham et al. (referred to as “Witham”) (US 2018/0201426 A1).
Regarding claim 14, Herrick discloses a kit for occluding a first vertical canaliculus and a second vertical canaliculus of a lacrimal drainage system (see Fig. 3 and Col. 5 lines 4-5 which discusses how the implant IMP is advanced through the punctum and into the vertical portion of the canaliculus of a lacrimal drainage system, and thus is capable of occluding a first and second vertical canaliculus of a lacrimal drainage system), comprising:
a first plug (IMP) configured to be positioned in the first vertical canaliculus (see Fig. 3 and Col. 5 lines 4-5 which discusses how the implant IMP is advanced through the punctum and into the vertical portion of the canaliculus of a lacrimal drainage system, and thus is configured to be positioned in the first vertical canaliculus, as there are two vertical canaliculi per eye, see Fig. 1 which shows the lower punctum 13 and upper punctum 14 which both have a vertical canaliculus), comprising:
a first body portion having a continuous cylindrical outer surface between a first end and a second end of the first body portion (see Annotated Fig. 3 of Herrick which has a body portion labeled with a first end and a second end, and the body portion has a continuous cylindrical outer surface between the first end and second end, see Col. 2 lines 67-68), wherein the first end is a terminal end of the first plug (IMP) (see Annotated Fig. 3 of Herrick, which has the first end of the body portion labeled as well as a terminal end of the implant IMP, which are the same), wherein the continuous cylindrical outer surface of the first body portion has a first outer diameter (see Annotated Fig. 3 of Herrick; the continuous cylindrical outer surface of the first body portion has a first outer diameter); and
a tapered portion having a distal tip (N) and a proximal end (see Annotated Fig. 3 of Herrick which has a tapered portion labeled, also see Col. 3 lines 2-4 and Col. 5 lines 12-14, and this tapered portion has a distal tip which is snub nose N, and a proximal end which is also labeled in Annotated Fig. 3), wherein the proximal end extends from the second end of the body portion (see Annotated Fig. 3 of Herrick; the proximal end extends from the second end of the body portion), wherein the tapered portion has a conical shape along a length extending from the proximal end and to the distal tip (N) (see Annotated Fig. 3 of Herrick; the tapered portion has a conical shape along a length extending from the proximal end to the snub nose N, as the tapered portion tapers from a circular base, as the body portion is a cylinder shape, see Col. 2 lines 67-68 et seq. Col. 3 lines 2-4, Col. 4 lines 12-14);
wherein: the first plug (IMP) is solid (see Annotated Fig. 3 of Herrick and Col. 3 lines 67-68, and Col. 4 lines 45-46; the implant IMP is constructed of a solid element, and can totally block the canaliculus from the first end to the snub nose N);
the first plug (IMP) is configured to be, after complete implantation into the lacrimal drainage system, positioned within the first vertical canaliculus of the lacrimal drainage system to occlude a flow through the first vertical canaliculus (see Col. 5 lines 4-5 which discusses how the implant IMP is advanced through the punctum and into the vertical portion of the canaliculus of a lacrimal drainage system, and thus implant IMP is configured to be positioned within the first vertical canaliculus after complete implantation into the lacrimal drainage system to occlude a flow through the first vertical canaliculus, as the implant IMP is configured to occlude or blow flow of fluid, see Col. 4 lines 45-46 and Col. 4 lines 49-50).
Herrick is silent on a kit for occluding a first vertical canaliculus and a second vertical canaliculus, a second plug configured to be positioned in the second vertical canaliculus, comprising: a second body portion having a second continuous cylindrical outer surface between a first end and a second end of the second body portion, wherein the first end is a terminal end of the second plug, wherein the continuous cylindrical outer surface of the second plug has a second outer diameter; and a tapered portion having a distal tip and a proximal end, wherein the proximal end extends from the second end of the second body portion, wherein the tapered portion has a conical shape along a length extending from the proximal end and to the distal tip; wherein: the second outer diameter is less than the first outer diameter; the second is solid; the first plug is configured to be, after complete implantation into a lacrimal drainage system, completely and entirely positioned within the first vertical canaliculus of the lacrimal drainage system to occlude a flow through the first vertical canaliculus without advancing any portion of the first body portion of the first plug into a first horizontal canaliculus of the lacrimal drainage system; and the second plug is configured to be, after complete implantation into the lacrimal drainage system, completely and entirely positioned within the second vertical canaliculus of the lacrimal drainage system to occlude a flow through the lacrimal drainage system without advancing any portion of the second body portion of the second plug into a second horizontal canaliculus of the lacrimal drainage system.
However, LUST teaches an analogous plug (180), and an analogous kit for occluding a first vertical canaliculus and a second vertical canaliculus (see Figs. 1D and 7, and [0044], and [0025] which discusses how the punctal plug 180 is a device for insertion into the inferior or superior lacrimal canaliculus through the inferior or superior punctum, and Fig. 7 discloses a kit 700 that has multiple plugs 180 mounted to caps 150, and thus is a kit for occluding a first vertical canaliculus and a second vertical canaliculus); and the second outer diameter is less than the first outer diameter (see Fig. 7 and [0044] which discusses how kit 700 has multiple different sized plugs 180, e.g. 0.7 mm sized plug and a 0.3 mm sized plug, and thus the diameter of the 0.3 mm sized plug is less than the diameter of the 0.7 mm sized plug), providing a kit that has a plurality of plugs so that a user can pick and choose between differing sizes, while also being able to occlude an upper and lower punctum simultaneously if necessary.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the plug (IMP) of Herrick with a second plug with a second outer diameter that is less than the first outer diameter to occlude a first vertical canaliculus and a second vertical canaliculus as taught by LUST to have provided an improved kit that provides a plurality of plugs so that a user can pick and choose between differing sizes, while also being able to occlude an upper and lower punctum simultaneously if necessary. Therefore, the combination of Herrick in view of LUST results in a second plug (IMP of Herrick) configured to be positioned in the second vertical canaliculus (see Fig. 3 and Col. 5 lines 4-5 of Herrick which discusses how the implant IMP of Herrick is advanced through the punctum and into the vertical portion of the canaliculus of a lacrimal drainage system, and thus is configured to be positioned in the second vertical canaliculus, as previously modified above via LUST), comprising: a second body portion having a second continuous cylindrical outer surface between a first end and a second end of the second body portion (see Annotated Fig. 3 of Herrick which has a body portion labeled with a first end and a second end, and the body portion has a continuous cylindrical outer surface between the first end and second end, see Col. 2 lines 67-68 of Herrick), wherein the first end is a terminal end of the second plug (IMP of Herrick) (see Annotated Fig. 3 of Herrick, which has the first end of the body portion labeled as well as a terminal end of the implant IMP, which are the same), wherein the continuous cylindrical outer surface of the second plug has a second outer diameter (see Annotated Fig. 3 of Herrick; the continuous cylindrical outer surface of the second plug IMP of Herrick has a second outer diameter); and a tapered portion having a distal tip (N of Herrick) and a proximal end (see Annotated Fig. 3 of Herrick which has a tapered portion labeled, also see Col. 3 lines 2-4 and Col. 5 lines 12-14 of Herrick, and this tapered portion has a distal tip which is snub nose N, and a proximal end which is also labeled in Annotated Fig. 3 of Herrick), wherein the proximal end extends from the second end of the second body portion (see Annotated Fig. 3 of Herrick; the proximal end extends from the second end of the second body portion), wherein the tapered portion has a conical shape along a length extending from the proximal end and to the distal tip (N) (see Annotated Fig. 3 of Herrick; the tapered portion has a conical shape along a length extending from the proximal end to the snub nose N, as the tapered portion tapers from a circular base, as the body portion is a cylinder shape, see Col. 2 lines 67-68 et seq. Col. 3 lines 2-4, Col. 4 lines 12-14); wherein: the second plug (IMP of Herrick) is solid (see Annotated Fig. 3 of Herrick and Col. 3 lines 67-68, and Col. 4 lines 45-46 of Herrick; the implant IMP of Herrick is constructed of a solid element, and can totally block the canaliculus from the first end to the snub nose N of Herrick); and the second plug (IMP of Herrick) is configured to be, after complete implantation into the lacrimal drainage system, positioned within the second vertical canaliculus of the lacrimal drainage system to occlude a flow through the second vertical canaliculus (see Col. 5 lines 4-5 of Herrick which discusses how the implant IMP of Herrick is advanced through the punctum and into the vertical portion of the canaliculus of a lacrimal drainage system, and thus implant IMP of Herrick is configured to be positioned within the second vertical canaliculus, as previously modified above by LUST teaching a kit of multiple plugs, after complete implantation into the lacrimal drainage system to occlude a flow through the second vertical canaliculus, as the implant IMP of Herrick is configured to occlude or blow flow of fluid, see Col. 4 lines 45-46 and Col. 4 lines 49-50 of Herrick).
Herrick in view of LUST discloses the invention as discussed above.
Herrick in view of LUST is silent on the first plug is configured to be, after complete implantation into a lacrimal drainage system, completely and entirely positioned within the first vertical canaliculus of the lacrimal drainage system to occlude a flow through the first vertical canaliculus without advancing any portion of the first body portion of the first plug into a first horizontal canaliculus of the lacrimal drainage system; and the second plug is configured to be, after complete implantation into the lacrimal drainage system, completely and entirely positioned within the second vertical canaliculus of the lacrimal drainage system to occlude a flow through the lacrimal drainage system without advancing any portion of the second body portion of the second plug into a second horizontal canaliculus of the lacrimal drainage system.
However, Witham teaches an analogous first plug and second plug (17, 17) (see Figs. 3-4 and [0043]-[0044]; two plugs 17 are packaged together, forming an analogous kit), and the first plug (17) is configured to be, after complete implantation into a lacrimal drainage system, completely and entirely positioned within the first vertical canaliculus of the lacrimal drainage system to occlude a flow through the first vertical canaliculus without advancing any portion of the first body portion of the first plug into a first horizontal canaliculus of the lacrimal drainage system (see Figs. 3-4 and [0043]-[0044]; there are two plugs 17 in Fig. 3, and thus the top plug 17 is the first plug which has a first body portion which is the entire plug as seen in Fig. 4, and the top plug 17 is configured to be, after complete implantation into a lacrimal drainage system, completely and entirely positioned within the first vertical canaliculus of the lacrimal drainage system to occlude a flow through the first vertical canaliculus without advancing any portion of the first body portion of the top plug 17 into a horizontal canaliculus of the lacrimal drainage system, as the plugs 17 are 1.75 mm long, and as evidenced by Herrick US 5,049142, the vertical canaliculus runs vertically for about 2 mm, see Col. 3 lines 63-65 of Herrick, and thus when plug 17 is inserted through the punctal opening into the canaliculus in order to block tear drainage through the lacrimal drainage system, due to the size of plug 17 being 1.75 mm, the first body portion of the top plug 17 will not be advanced into a first horizontal canaliculus); and the second plug (17) is configured to be, after complete implantation into the lacrimal drainage system, completely and entirely positioned within the second vertical canaliculus of the lacrimal drainage system to occlude a flow through the lacrimal drainage system without advancing any portion of the second body portion of the second plug (17) into a second horizontal canaliculus of the lacrimal drainage system (see Figs. 3-4 and [0043]-[0044]; there are two plugs 17 in Fig. 3, and thus the bottom plug 17 is the second plug which has a second body portion which is the entire plug as seen in Fig. 4, and the bottom plug 17 is configured to be, after complete implantation into a lacrimal drainage system, completely and entirely positioned within the second vertical canaliculus of the lacrimal drainage system to occlude a flow through the second vertical canaliculus without advancing any portion of the second body portion of the bottom plug 17 into a second horizontal canaliculus of the lacrimal drainage system, as the plugs 17 are 1.75 mm long, and as evidenced by Herrick US 5,049142, the vertical canaliculus runs vertically for about 2 mm, see Col. 3 lines 63-65 of Herrick, and thus when plug 17 is inserted through the punctal opening into the canaliculus in order to block tear drainage through the lacrimal drainage system, due to the size of plug 17 being 1.75 mm, the second body portion of the bottom plug 17 the bottom plug 17 will not be advanced into a second horizontal canaliculus), providing plugs that reduces the chance of irritation while being lower in cost to manufacture.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified an overall length of the first and second plugs (IMP of Herrick) as taught by Herrick in view of LUST such that the first plug is configured to be, after complete implantation into a lacrimal drainage system, completely and entirely positioned within the first vertical canaliculus of the lacrimal drainage system to occlude a flow through the first vertical canaliculus without advancing any portion of the first body portion of the first plug into a first horizontal canaliculus of the lacrimal drainage system, and such that the second plug is configured to be, after complete implantation into the lacrimal drainage system, completely and entirely positioned within the second vertical canaliculus of the lacrimal drainage system to occlude a flow through the lacrimal drainage system without advancing any portion of the second body portion of the second plug into a second horizontal canaliculus of the lacrimal drainage system as taught by Witham to have provided an improved kit that provides plugs that reduces the chance of irritation while being lower in cost to manufacture.
Regarding claim 15, Herrick in view of LUST further in view of Witham discloses the invention as discussed in claim 14.
LUST further teaches an analogous kit (700) (see [0044]; kit 700 includes multiple punctal plugs 180), and wherein the first plug (180) is removably coupled with a first insertion device (100, 150) and the second plug (180) is removably coupled with a second insertion device (100, 150) (see Figs. 1A-1D and 7, and [0044], [0046]; kit 700 comprises additional caps 150 with additional plugs 180 mounted on the caps 150, and thus there is at least a first plug 180 and a second plug 180, and the first plug 180 is removably coupled to the first cap 150 and instrument 100 for insertion into the punctal opening, and the second plug 180 is removably coupled to a second cap 150 which is a second insertion device and instrument 100), providing physicians, healthcare providers, or any other user with all the necessary equipment to properly be able to use the punctal plugs.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the kit in the device of Herrick in view of LUST further in view of Witham with a first insertion device removably coupled to the first plug and a second insertion device removably coupled with the second plug as taught by LUST to have provided an improved kit that provides physicians, healthcare providers, or any other users with all the necessary equipment to properly be able to use the punctal plugs.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Felder in view of Herrick.
Regarding claim 16, Felder discloses a method of occluding a vertical canaliculus of a lacrimal drainage system (see Figs. 4 and 11, and Col. 4 lines 65-67 et seq. Col. 5 lines 1-3 which discusses how the plug 30 is designed for insertion into one of the vertical canaliculi 16 and thus occludes a portion of the vertical canaliculus), comprising:
advancing a plug (30) through a punctal opening of the lacrimal drainage system (see Figs. 4 and 11, and Col. 4 lines 65-67 et seq. Col. 5 lines 1-2; plug 30 is advanced through a punctum or punctal opening of the lacrimal drainage system), the plug (30) having:
a body portion (32) having a first end and a second end (see Annotated Fig. 4 of Felder which has the first end and second end of body 32 labeled), wherein the first end of the body portion (32) is coincident with a terminal end of the plug (30) (see Annotated Fig. 4 of Felder which has the terminal end and first end of body 32 labeled, and are coincident), the body portion (32) having a continuous cylindrical shape from the first end to the second end (see Annotated Fig. 4 of Felder; the body 32 is an “elongate cylindrical body” and thus has a continuous cylindrical shape from the first end to the second end, also see Col. 4 line 60);
advancing the plug (30) into the vertical canaliculus of the lacrimal drainage system without advancing any portion of the plug into a horizontal canaliculus of the lacrimal drainage system (see Figs. 4 and 11, and Col. 4 lines 65-67 et seq. Col. 5 lines 2-9; plug 30 is advanced into the vertical canaliculus through one of the punctum without advancing any portion of plug 30 into a horizontal canaliculus of the lacrimal drainage system, as plug 30 can have a length of 1.5 mm and the length of the vertical canaliculi 16 is 2 mm as shown in Fig. 2, and thus once plug 30 is advanced into the vertical canaliculus, the length of the plug makes it so that no portion of plug 30 is advanced into a horizontal canaliculus); and
retaining the plug (30) within the vertical canaliculus (see Figs. 4 and 11, and Col. 4 lines 65-67 et seq. Col. 5 lines 2-9; plug 30 is sized and shaped for insertion into one of the punctum, and plug 30 ultimately can remain within the vertical canaliculi 16, as seen in Fig. 11).
Felder is silent on a tapered portion having a distal tip and proximal end, wherein the proximal end extends from the second end of the body portion, wherein the tapered portion has a conical shape along a length extending from the proximal end to the distal tip, wherein a diameter of the tapered portion at the proximal end is equal to an outer diameter of the body portion.
However, Herrick teaches an analogous plug (IMP) with an analogous body portion (see Annotated Fig. 3 of Herrick which has the body portion labeled), and a tapered portion having a distal tip (N) and a proximal end (see Annotated Fig. 3 of Herrick which has a tapered portion labeled, also see Col. 3 lines 2-4 and Col. 5 lines 12-14, and this tapered portion has a distal tip which is snub nose N, and a proximal end which is also labeled in Annotated Fig. 3), wherein the proximal end extends from the second end of the body portion (see Annotated Fig. 3 of Herrick; the proximal end extends from the second end of the body portion), wherein the tapered portion has a conical shape along a length extending from the proximal end and to the distal tip (N) (see Annotated Fig. 3 of Herrick; the tapered portion has a conical shape along a length extending from the proximal end to the snub nose N, as the tapered portion tapers from a circular base, as the body portion is a cylinder shape, see Col. 2 lines 67-68 et seq. Col. 3 lines 2-4, Col. 4 lines 12-14), wherein a diameter of the tapered portion at the proximal end is equal to an outer diameter of the body portion (see Annotated Fig. 3 of Herrick; the second end of the body portion and the proximal end of the tapered portion have the same outer diameter), providing to facilitate implantation and removal of the plug (see Col. 5 lines 12-14).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plug (30) and method of Felder to have a tapered portion having a distal tip and proximal end, wherein the proximal end extends from the second end of the body portion, wherein the tapered portion has a conical shape along a length extending from the proximal end to the distal tip, wherein a diameter of the tapered portion at the proximal end is equal to an outer diameter of the body portion as taught by Herrick to have provided an improved method of occluding a vertical canaliculus that provides to facilitate implantation and removal of the plug.
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Annotated Fig. 4 of Felder.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Felder in view of Herrick further in view of Freeman (US 3,949,750).
Regarding claim 17, Felder in view of Herrick discloses the invention as discussed in claim 16.
Felder in view of Herrick is silent on dilating the punctal opening with the tapered portion when advancing the plug into the vertical canaliculus.
However, Freeman teaches an analogous tapered portion (22 or 22’) (see Figs. 2A-2B), dilating the punctal opening with the tapered portion (22 or 22’) when advancing the analogous plug (20 or 20’) into the vertical canaliculus (see Figs. 1-3A and Col. 4 lines 56-67 which discusses how the tip or barb portion 22, 22’ of the punctum plug 20, 20’ is designed with a tapered or semi-tapered tip for further dilation into the punctal opening and eventually into the vertical canaliculus), providing to facilitate ease of insertion of the plug into the punctal opening (see Col. 4 lines 56-60).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Felder in view of Herrick to include dilating the punctal opening with the tapered portion when advancing the plug into the vertical canaliculus as taught by Freeman to have provided an improved method that facilitates ease of insertion of the plug into the punctal opening (see Col. 4 lines 56-60).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herrick II in view of Felder further in view of Herrick (referred to as “Herrick ‘684”) (US 6,290,684 B1).
Regarding claim 19, Herrick II in view of Felder discloses the invention as discussed in claim 16.
Herrick II in view of Felder is silent on completely dissolving the plug in the vertical canaliculus over a period of time.
However, Herrick ‘684 teaches an analogous plug (232) and completely dissolving the plug (232) in the vertical canaliculus over a period of time (see Col. 14 lines 3-15 and Col. 1 lines 50-57; punctum plug 232 completely dissolves in the vertical canaliculus over a period of time, as the punctum plug 232 made of dissolvable material and placed in the vertical canaliculus), providing a temporary blockage to determine if any improvement in the eye condition has been achieved (see Col. 1 lines 45-48).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Herrick II in view of Felder to include completely dissolved the plug in the vertical canaliculus over a period of time as taught by Herrick ‘684 to provide temporary blockage to determine if any improvement in the eye condition has been achieved (see Col. 1 lines 45-48).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Felder in view of Herrick further in view of Witham.
Regarding claim 20, Felder in view of Herrick discloses the invention as discussed in claim 16.
Felder in view of Herrick is silent on advancing a second plug into a second vertical canaliculus of the lacrimal drainage system.
However, Witham teaches an analogous plug (17) (see Figs. 3-4), and advancing a second plug (17) into a second canaliculus of the lacrimal drainage system (see Figs. 3-4 and [0043]-[0044]; there are two plugs 17 packaged together so that a plug can be placed in each canaliculus, and thus advancing a second plug into a second vertical canaliculus of the lacrimal drainage system), providing to occlude each of the canaliculi simultaneously if necessary.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Felder in view of Herrick to include advancing a second plug into a second vertical canaliculus of the lacrimal drainage system as taught by Witham to have provided an improved method that occludes each of the canaliculi simultaneously if necessary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,396,734 B1.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of patent ‘734 recites the limitations of a plug configured for occluding a vertical canaliculus of a lacrimal drainage system, comprising: a body portiong having a first end and a second end, wherein the first end of the body portion is coincident with a terminal end of the plug, the body portion having a continuous cylindrical shape from the first end to the second end; and a tapered portion having a distal tip and a proximal end, wherein the proximal end extends from the second end of the body portion, wherein the tapered portion has a conical shape along a length extending from the proximal end and to the distal tip; wherein: the plug is solid from the first end to the distal tip; the second end of the body portion and the proximal end of the tapered portion have a same outer diameter; the plug is configured to be, after complete implantation into the lacrimal drainage system, completely positioned within the vertical canaliculus of the lacrimal drainage system such that no portion is external to a punctal opening; the plug is configured to be, after complete implantation into the lacrimal drainage system, external to a horizontal canaliculus of the lacrimal drainage system; and the plug is configured to, after complete implantation into the lacrimal drainage system, occlude a flow of fluid through the lacrimal drainage system.
With respect to claim 2 of the instant application, all of the limitations are found in claim 2 of patent ‘734.
With respect to claim 3 of the instant application, all of the limitations are found in claim 1 of patent ‘734.
With respect to claim 4 of the instant application, all of the limitations are found in claim 3 of patent ‘734.
With respect to claim 5 of the instant application, all of the limitations are found in claim 4 of patent ‘734.
With respect to claim 6 of the instant application, all of the limitations are found in claim 1 of patent ‘734.
With respect to claim 7 of the instant application, all of the limitations are found in claim 5 of patent ‘734.
With respect to claim 8 of the instant application, all of the limitations are found in claim 6 of patent ‘734.
With respect to claim 9 of the instant application, all of the limitations are found in claim 7 of patent ‘734.
With respect to claim 10 of the instant application, all of the limitations are found in claim 8 of patent ‘734.
With respect to claim 11 of the instant application, all of the limitations are found in claim 1 of patent ‘734.
With respect to claim 12 of the instant application, all of the limitations are found in claim 1 of patent ‘734.
Claim 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,396,734 B1 in view of Herrick.
With respect to claim 13 of the instant application, all of the limitations are found in claim 1 of patent ‘734.
The patent ‘734 fails to recite wherein the tapered portion is configured to facilitate insertion of the plug through the punctal opening.
However, Herrick teaches an analogous tapered portion (see Annotated Fig. 3 of Herrick above), wherein the tapered portion is configured to facilitate insertion of the plug (IMP of Herrick) through the punctal opening (see Annotated Fig. 3 of Herrick, and see Col. 5 lines 12-14 of Herrick which discusses how the tapered portion is configured to facilitate insertion of the implant IMP of Herrick), providing to facilitate insertion of the plug (see Col. 5 lines 12-14) for better safety and comfort.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tapered portion of patent ‘734 to facilitate insertion of the plug through the punctal opening as taught by Herrick to have provided an improved plug that facilitates insertion of the plug (see Col. 5 lines 12-14) for better safety and comfort.
Claims 14-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-17 of U.S. Patent No. 12,396,734 B1.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 16 of patent ‘734 recites the limitations of a kit for occluding a first vertical canaliculus and a second vertical canaliculus of a lacrimal drainage system, comprising: a first plug configured to be positioned in the first vertical canaliculus, comprising: a first body portion having a continuous cylindrical outer surface between a first end and a second end of the first body portion, wherein the first end is a terminal end of the first plug, wherein the continuous cylindrical outer surface of the first body portion has a first outer diameter; and a tapered portion having a distal tip and a proximal end, wherein the proximal end extends from the second end of the first body portion; a second plug configured to be positioned in the second vertical canaliculus, comprising: a second body portion having a continuous cylindrical outer surface between a first end and a second end of the second body portion, wherein the first end is a terminal end of the second plug, wherein the continuous cylindrical outer surface of the second plug has a second outer diameter; and a tapered portion having a distal tip and a proximal end, wherein the proximal end extends from the second end of the second body portion; wherein: the second outer diameter is less than the first outer diameter; the first plug and the second plug are solid; the first plug is configured to be, after complete implantation into a lacrimal drainage system, completely and entirely positioned within the first vertical canaliculus without advancing any portion of the first body portion of the first plug into a first horizontal canaliculus of the lacrimal drainage system and the second plug is configured to be, after complete implantation into the lacrimal drainage system, completely and entirely positioned within the second vertical canaliculus of the lacrimal drainage system to occlude a flow through the lacrimal drainage system without advancing any portion of the second body portion of the second plug into a second horizontal canaliculus of the lacrimal drainage system.
With respect to claim 15 of the instant application, all of the limitations are found in claim 17 of patent ‘734.
Claims 16 and 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-15 of U.S. Patent No. 12,396,734 B1.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 11 of patent ‘734 recites the limitations of a method of occluding a vertical canaliculus of a lacrimal drainage system, comprising: advancing a plug through a punctal opening of the lacrimal drainage system, the plug having: a body portion having a first end and a second end, wherein the first end of the body portion is coincident with a terminal end of the plug, the body portion having a continuous cylindrical shape from the first end to the second end; and a tapered portion having a distal tip and a proximal end, wherein the proximal end extends from the second end of the body portion, wherein the tapered portion has a conical shape along a length extending from the proximal end to the distal tip, wherein a diameter of the tapered portion at the proximal end is equal to an outer diameter of the body portion; advancing the plug into the vertical canaliculus of the lacrimal drainage system without advancing any portion of the plug into a horizontal canaliculus of the lacrimal drainage system; and retaining the plug within the vertical canaliculus.
With respect to claim 18 of the instant application, all of the limitations are found in claim 11 of patent ‘734.
With respect to claim 19 of the instant application, all of the limitations are found in claim 11 of patent ‘734.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 12,396,734 B1 in view of Freeman.
With respect to claim 17 of the instant application, all of the limitations are found in claim 11 of patent ‘734.
The patent ‘734 fails to recite dilating the punctal opening with the tapered portion when advancing the plug into the vertical canaliculus.
However, Freeman teaches an analogous tapered portion (22 or 22’) (see Figs. 2A-2B), dilating the punctal opening with the tapered portion (22 or 22’) when advancing the analogous plug (20 or 20’) into the vertical canaliculus (see Figs. 1-3A and Col. 4 lines 56-67 which discusses how the tip or barb portion 22, 22’ of the punctum plug 20, 20’ is designed with a tapered or semi-tapered tip for further dilation into the punctal opening and eventually into the vertical canaliculus), providing to facilitate ease of insertion of the plug into the punctal opening (see Col. 4 lines 56-60).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of patent ‘734 to include dilating the punctal opening with the tapered portion when advancing the plug into the vertical canaliculus as taught by Freeman to have provided an improved method that facilitates ease of insertion of the plug into the punctal opening (see Col. 4 lines 56-60).
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 12,396,734 B1 in view of Witham.
With respect to claim 20 of the instant application, all of the limitations are found in claim 11 of patent ‘734.
The patent ‘734 fails to recite advancing a second plug into a second vertical canaliculus of the lacrimal drainage system.
However, Witham teaches an analogous plug (17) (see Figs. 3-4), and advancing a second plug (17) into a second canaliculus of the lacrimal drainage system (see Figs. 3-4 and [0043]-[0044]; there are two plugs 17 packaged together so that a plug can be placed in each canaliculus, and thus advancing a second plug into a second vertical canaliculus of the lacrimal drainage system), providing to occlude each of the canaliculi simultaneously if necessary.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of patent ‘734 to include advancing a second plug into a second vertical canaliculus of the lacrimal drainage system as taught by Witham to have provided an improved method that occludes each of the canaliculi simultaneously if necessary.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ROBIN HAN/Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786
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