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 .
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-13, drawn to a surgical kit for treating glaucoma.
Group II, claim(s) 14-16, drawn to a surgical method of treating glaucoma.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a surgical kit, cutting blade, and shunt comprising an elongate duct and fixation body, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Pinchuk et al. (US 2018/0344525 A1).
Pinchuk teaches a surgical kit for treating glaucoma in a patient (Figs. 3 and 6-7; Abstract), the surgical kit comprising:
a cutting blade (¶ 77; instrument 342 in Figs. 18B-C; ¶ 72 also indicates a knife), and
a (drainage device 201 in Figs. 3 and 6-7; ¶s 48-49), the shunt comprising a deformable elongate duct (¶s 61-62 indicate the drainage device is elastomeric and thus is deformable) which is locatable in the scleral passageway (¶s 12 and 70-72; Fig. 15) and which defines a distal end of the elongate duct (distal end 209) and a fixation body located on the elongate duct intermediate the ends of the elongate duct (tabs 213 and walls 223).
During a telephone conversation with Matthew Sutch on 6/18, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-13. Affirmation of this election must be made by applicant in replying to this Office action. Claims 14-16 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Response to Amendment
The amendment filed 7/12/2024 has been entered: Claims 1-16 remain pending in the present application. Claims 2-16 have been amended. Claims 14-16 are withdrawn from consideration. Claims 1-13 are examined on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5 and 7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “relatively” in claim 5 is a relative term which renders the claim indefinite. The term “relatively” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In an effort to promote compact prosecution, a lumen with a smaller internal diameter is interpreted as meeting the claim limitations.
Claim 5 recites the phrase “sufficient to prevent hypertony”. This limitation is indefinite a one or ordinary skilled in the art could not determine specific values for the amount (i.e. the relative internal diameter of the proximal lumen) based on the disclosure. See MPEP 2173.05(c).
The terms “sufficient” and “moderate” in claim 7 are relative terms which renders the claim indefinite. The terms “sufficient” and “moderate” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In an effort to promote compact prosecution, a fixation body frictionally located on the elongate duct is interpreted as meeting the limitations of the claim.
Appropriate correction is required.
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 1-4, 10-11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Pinchuk (US 2018/0344525 A1).
Regarding claim 1, Pinchuk teaches a surgical kit for treating glaucoma in a patient (Figs. 3 and 6-7; Abstract), the surgical kit comprising:
a surgical instrument having a flat cutting blade for creating a passageway through scleral tissue (¶ 77; instrument 342 in Figs. 18B-C; ¶ 72 also indicates a knife), the flat blade having a first maximal cross-sectional dimension (inherent to the shape of the blade; also see ¶S 76 and 53; Fig. 18b shows dimension “b”); and
a shunt for diverting aqueous humor from a chamber of the eye of the patient(drainage device 201 in Figs. 3 and 6-7; ¶s 48-49), the shunt comprising a deformable elongate duct (¶s 61-62 indicate the drainage device is elastomeric and thus is deformable) which is locatable in the scleral passageway (¶s 12 and 70-72; Fig. 15) and which defines a distal end of the elongate duct (distal end 209) and a fixation body located on the elongate duct intermediate the ends of the elongate duct (tabs 213 and walls 223), the distal portion of the elongate duct of the shunt having a second maximal cross-sectional dimension (inherent to the 3-dimensional shape of the distal portion of the duct; also see ¶ 49); and the fixation body having a third maximal cross-sectional dimension that is greater than the second maximal cross-sectional dimension (inherent to the 3-dimensional shape of the fixation body).
Pinchuk does not explicitly teach that the second maximal cross-sectional dimension is less than the first maximal cross-sectional dimension, and the third maximal cross-sectional dimension is less than the first maximal cross-sectional dimension.
However, Pinchuk teaches that knives of different diameters would be used to correspond to different size elements of the kit and to affect the stab incision (¶s 53) and as such the knife maximal cross-sectional dimension is disclosed to be a result effective variable in that the size of the knife affects the incision size which (in turn would affect the parameters of surgery). 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 knife of Pinchuk such that the second maximal cross-sectional dimension is less than the first maximal cross-sectional dimension, and the third maximal cross-sectional dimension is less than the first maximal cross-sectional dimension. as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 2, Pinchuk further teaches the cutting blade of the surgical instrument as beveled cutting surfaces at opposite sides of the cutting blade at a tip region of the cutting blade (Fig. 18B shows beveled edges corresponding to dimension “b”).
Regarding claim 3, Pinchuk does not explicitly teach the beveled cutting tip has a length of approximately 2 mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Pinchuk to have the beveled cutting tip length be approximately 2 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Pinchuk would not operate differently with the claimed (¶ 53 of Pinchuk already acknowledges different than mentioned cutting implements are suitable). Further, applicant places no criticality on the range claimed (Applicant only states that the cutting tip “may have” a length of approximately 2 mm on Page 5, lines 25-26).
Regarding claim 4, Pinchuk further teaches the chamber of the eye in which the shunt is implanted may be the anterior chamber of the eye (Abstract).
Regarding claim 10, Pinchuk further teaches the fixation body has a pair of laterally-extending flange’s which project outwardly from opposite sides thereof (fins 213).
Regarding claim 11, Pinchuk further teaches the fixation body has a convexly rounded lower surface and a substantially flat upper surface (¶ 67 describes how the device is made of flexible materials that conform to the surface of the eye which is convex the rounded; ¶s 49 and 57 describe flat features of the fixation body).
Regarding claim 13, Pinchuk further teaches fixation body defines a curved internal passage within the elongate duct is received (¶ 67 describes how the device is made of flexible materials that conform to the surface of the eye which would result in the fixation body and elongate duct being curved together; ¶ 68 describes how the tabs and tube can be made of different polymeric materials, which would result in the tabs creating a passage within which the elongate duct is received).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Pinchuk as applied to claim 1 above, and further in view of Horvath et al. (US 2019/0133826 A1).
Regarding claim 5, Pinchuk further teaches the elongate duct of the shunt has a proximal portion defining a proximal end of the elongate duct (proximal end 207), the proximal portion being locatable externally of the scleral passage and having a proximal capillary lumen which is in fluid flow communication with the distal lumen (Fig. 15),
Pinchuk does not explicitly teach the proximal lumen having an internal diameter which is relatively smaller than an internal diameter of the distal lumen so as to reduce a flow rate of the aqueous humor and regulate pressure along the proximal capillary lumen sufficient to prevent hypotony.
However, Horvath teaches an intraocular flow shunt (Figs. 2 and 6-9; Abstract), thus being in the same field of endeavor, comprising an proximal shunt portion (outflow end 108) having an internal diameter which is relatively smaller than an internal diameter of the distal lumen (by way of occluding components 150, 152 in Fig. 7 and restrictive sections 252, 254 in Fig. 9) so as to reduce a flow rate of the aqueous humor and regulate pressure along the proximal capillary lumen sufficient to prevent hypotony (¶s 29-30 and 113).
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 device of Pinchuk to comprise a proximal shunt portion having an internal diameter which is relatively smaller than an internal diameter of the distal lumen. Doing so would reduce a flow rate of the aqueous humor and regulate pressure along the proximal capillary lumen sufficient to prevent hypotony. Doing so would be advantageous to avoid early low post-op intraocular pressures and to enable control over outflow resistance (¶ 30 of Horvath).
Claims 6-7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Pinchuk as applied to claim 1 above, and further in view of Silvestrini et al. (US 2009/0182421 A1).
Regarding claim 6, Pinchuk further teaches the fixation body is located on the distal portion of the elongate duct (tabs 213 and walls 223; the tabs and walls are interpreted as denoting the transition from the proximal portion to the distal portion).
Pinchuk does not explicitly teach the fixation body of the shunt is slidably located as Pinchuk teaches the device is molded (¶ 68).
However, Silvestrini teaches an ocular drainage device (Figs. 1 and 72-73; Abstract), thus being in the same field of endeavor, comprising a fixation body which is attached by a friction fit or created through molding with the rest of the implant (¶ 111). Thus, Silvestrini shows that having a friction fit is an equivalent structure known in the art. Therefore, because these various attachment means were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute the frictional fit of Silvestrini for the molded form of Pinchuk.
The limitations of the fixation body of the shunt being “slidably located… For fixing the distal portion of the duct within the scleral channel at a desired position” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the fixation body of Pinchuk and Silvestrini has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (the frictional fit would allow for repositioning of the fixation body, including to be on the distal portion of the elongate duct for fixing the distal portion of the docs within the scleral channel at a desired position).
Regarding claim 7, the combination of Pinchuk and Silvestrini substantially disclose the invention of claim 6.
The limitations of the fixation body of the shunt being “frictionally located on the distal portion of the elongate duct in an arrangement wherein a coefficient of friction acting between the fixation body and the elongate duct is sufficient to adequately resist movement of the fixation body relative to the elongate duct when the elongate duct is implanted in the scleral passageway of the patient yet permit sliding displacement of the fixation body relative to the elongate duct when a moderate force is applied to the fixation body by a surgeon ” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the fixation body of Pinchuk and Silvestrini has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (the frictional fit would allow for resisting movement while also allowing for sliding depending on the force applied to the fixation body as claimed).
Regarding claim 12, Pinchuk does not explicitly teach that the fixation body is flexible or rigid (¶ 108).
However, Silvestrini shows that having a rigid fixation body is an equivalent structure known in the art. Therefore, because these fixation body configurations were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute the rigid construction fixation body of Silvestrini for the flexible configuration of Pinchuk.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Pinchuk as applied to claim 1 above, and further in view of Chew et al. (US 2009/0182421 A1).
Regarding claims 8-9, Pinchuk does not explicitly teach (Claim 8) wherein the fixation body defines an internal passage within the elongate duct is received, or (Claim 9) wherein the fixation body is located on the elongate duct in an interference fit wherein an internal diameter of the fixation body is slightly less than an external diameter of the distal portion of the elongate duct.
However, Chew teaches an ocular drainage device (Fig. 1A-1B, Abstract), thus being in the same field of endeavor, comprising a fixation body (cuff 18) which defines an internal passage within which the elongate duct is received (¶ 66) and the fixation body is located on the elongate duct in an interference fit wherein an internal diameter of the fixation body slightly less than an external diameter of the distal portion of the elongate duct (¶ 71 describes how the cuff reduces the diameter of tube 6; also ¶s 76-78).
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 device of Pinchuk to comprise the fixation body of Chew. Doing so comprise (Claim 8) wherein the fixation body defines an internal passage within the elongate duct is received, or (Claim 9) wherein the fixation body is located on the elongate duct in an interference fit wherein an internal diameter of the fixation body is slightly less than an external diameter of the distal portion of the elongate duct. Doing so would be advantageous in providing a flow control system to prevent treatment complications (¶ 12 of Chew).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALESSANDRO R DEL PRIORE/ Examiner, Art Unit 3781
/GUY K TOWNSEND/ Primary Examiner, Art Unit 3781
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