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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “the pair of oppositely facing, relatively abrasive, surfaces located on either side of the central axis” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
(Examiner’s note: the phrase “either side” is defined as “on one side or the other”, so the claim limitations reads wherein the pair of surfaces (together) are “on one side or the other” of the central axis. If Applicant is intending for the claim to mean that there is one surface of the pair of surfaces on one side of the central axis and the other surface of the pair of surfaces is on an opposite surface of the central axis, then the Examiner suggests the claims (12 and 16) be amended to read as such).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 2, 4 – 15, 19 – 21, and 24 are objected to because of the following informalities:
Claims 1 and 21 recite “the trabecular meshwork” and “the eye” in lines 1, although the lines are understood by the Examiner to mean “a trabecular meshwork” and “an eye” as neither term was previously defined, the Examiner suggests the lines be amended to read “a trabecular meshwork” and “an eye” for the purpose of having proper antecedent basis for the claimed terms;
Claims 1 and 21 recite “, having proximal and distal ends” in lines 3, although the line is understood by the Examiner to mean “, the hand grip portion having proximal and distal ends” as it is clear that the proximal and distal ends belong to the hand grip portion, based on Applicant’s disclosure, the Examiner suggests the lines be amended to read “, the hand grip portion having proximal and distal ends” for the purpose of maintaining consistent language throughout the claims;
Claims 1, 2, 4, 5, 6, 7, 12, 14, 15, 19, 21, and 24 recite “the free end” in at least one line, although the line is understood by the Examiner to mean “the tapered free end” as previously defined and repeated in claim 20, the Examiner suggests every instance of “the free end” be amended to read “the tapered free end” for the purpose of maintaining consistent language throughout the claims;
Claims 1 (line 2), 9, 10, 11, and 21, recite “the instrument” in at least one line, although the line(s) is/are understood by the Examiner to mean “the surgical instrument” as previously defined and repeated in claim 20, the Examiner suggests the lines be amended to read “the surgical instrument” for the purpose of maintaining consistent language throughout the claims;
Claim 6 recites “said relatively abrasive surface” in line 2, although the line is understood by the Examiner to mean “said at least one relatively abrasive surface” as previously defined, the Examiner suggests the line be amended to read “said at least one relatively abrasive surface” for the purpose of maintaining consistent language throughout the claims;
Claims 11 and 20 recite “an irrigation fluid” in lines 2 and 3 and 7, respectively, although the lines are understood by the Examiner to mean “the irrigation fluid” as the “irrigation fluid” was previously defined in claim 1, the Examiner suggests the lines be amended to read “the irrigation fluid” for the purpose of maintaining consistent language throughout the claims;
Claim 13 recites “said hand grip portion distal end” in line 2, although the line is understood by the Examiner to mean “the distal end of said hand grip portion” as previously recited / defined in claim 1, the Examiner suggests the line be amended to read “the distal end of said hand grip portion” for the purpose of maintaining consistent language throughout the claims;
Claim 20 recites “improvement of the drainage of fluid of the eye” in line 1, although the line is understood by the Examiner to mean “improvement of drainage of fluid of an eye” as the “drainage” and the “eye” were not previously defined, the Examiner suggests the line be amended to read “improvement of drainage of fluid of an eye” for the purpose of having proper antecedent basis for each claimed term;
Claim 20 recites “the meshwork” in line 6, although the line is understood by the Examiner to mean “the trabecular meshwork” as previously defined and repeated in claims 1 and 20, the Examiner suggests the line be amended to read “the trabecular meshwork” for the purpose of maintaining consistent language throughout the claims;
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. See claim 11.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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, 4 – 11, 20, 21, 22, and 24 – 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 – 7, 12, and 16 of copending Application No. 18/767,055.
Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims would have been obvious over the claims of copending Application No. 18/767,055.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 1 of the Instant Application, claim 1 of copending Application No. 18/767,055 also claims a surgical instrument for massaging the trabecular meshwork of the eye, the instrument comprising:
a hand grip portion having an elongated configuration, having proximal and distal ends (claim 1); and
a tip portion extending from the distal end of said hand grip portion, said tip portion comprising an elastomeric element having a base secured to said distal end of said hand grip portion (claim 1), and
a tapered free end extending from said base, said free end configured to massage the trabecular meshwork of the eye, and at least one irrigation passage extending through said tip portion for directing an irrigation fluid proximate to the trabecular meshwork of the eye (claim 1).
Regarding claim 4 of the Instant Application, claim 12 of copending Application No. 18/767,055 also claims wherein said free end includes at least one relatively abrasive surface (claim 12).
Regarding claims 5 and 6 of the Instant Application, claim 12 of copending Application No. 18/767,055 also makes obvious wherein said at least one relatively abrasive surface of said free end comprises an impregnated abrasive composition or comprises surface-roughening (Examiner’s note: as stated in claim 12 of the copending Application No. 18/767,055, the surface is abrasive; and the Examiner contends it would be obvious to form the abrasive surface via impregnating the surface or roughening the surface, as both methods are known methods for forming an abrasive surface, and one of ordinary skill in the art would have a reasonable expectation of success in making the abrasive surface via impregnating the surface or surface roughening, and the results would be predictable and resulted in the abrasive surface being able to operate as intended).
Regarding claim 7 of the Instant Application, claim 6 of copending Application No. 18/767,055 also claims combination with a handpiece connected to said hand grip portion configured to vibrate said free end (claim 6).
Regarding claim 8 of the Instant Application, claim 7 of copending Application No. 18/767,055 also claims wherein said handpiece is one of: a longitudinally-vibrating phacoemulsification handpiece; a torsionally-vibrating phacoemulsification handpiece, an elliptically-vibrating phacoemulsification handpiece, a phacoemulsification handpiece configured for vibratory movement in three dimensions, a vitrectomy handpiece, a piezo electric handpiece, a solenoid valve handpiece, or a battery powered handpiece (claim 7).
Regarding claim 9 of the Instant Application, claim 4 of copending Application No. 18/767,055 also claims in combination with an irrigation supply source to provide an irrigation fluid (i) through said at least one irrigation passage of said instrument (claim 4).
Regarding claim 10 of the Instant Application, claim 5 of copending Application No. 18/767,055 also claims with a vacuum to provide aspiration through said instrument, or around said instrument (claim 5).
Regarding claim 11 of the Instant Application, claim 4 of copending Application No. 18/767,055 makes obvious wherein said hand grip portion includes a reservoir for containing an irrigation fluid and a means to selectively provide an irrigation fluid through said at least one irrigation passage of said instrument (Examiner’s note: it would be obvious to one of ordinary skill in the art to for the hand grip portion to include a reservoir and a means to provide the irrigation fluid through the passage for the purpose of applying the irrigation fluid to the eye during the massaging).
Regarding claim 20 of the Instant Application, claim 16 of copending Application No. 18/767,055 also claims a method for improvement of the drainage of fluid of the eye, wherein the method comprises the steps of:
obtaining the surgical instrument in accordance with claim 1 (claim 16);
contacting the trabecular meshwork of the eye with said tapered free end of said elastomeric element to massage the trabecular meshwork to dislodge deposits within the meshwork (claim 16); and
directing an irrigating fluid through said surgical instrument to direct flow of the irrigating fluid from said at least one irrigation passage to the trabecular meshwork (claim 16).
Regarding claim 21 of the Instant Application, claim 1 of copending Application No. 18/767,055 also claims a surgical instrument for massaging the trabecular meshwork of the eye, the instrument comprising:
a hand grip portion having an elongated configuration, having proximal and distal ends (claim 1); and
a tip portion extending from the distal end of said hand grip portion, said tip portion comprising an elastomeric element having a base secured to said distal end of said hand grip portion (claim 1), and
a tapered free end extending from said base (claim 1), said free end configured to mechanically stretch the trabecular meshwork of the eye (Examiner’s note: the free end of the copending Application is capable of functioning as claimed).
Regarding claim 22 of the Instant Application, claim 12 of copending Application No. 18/767,055 also claims wherein said tip portion defines a central axis and said elastomeric element includes at least one roughened surface (claim 12).
Regarding claim 24 of the Instant Application, claim 6 of copending Application No. 18/767,055 also claims in combination with a handpiece connected to said hand grip portion configured to vibrate said free end (claim 6).
Regarding claim 25 of the Instant Application, claim 7 of copending Application No. 18/767,055 also claims wherein said handpiece is one of: a longitudinally-vibrating phacoemulsification handpiece; a torsionally-vibrating phacoemulsification handpiece, an elliptically-vibrating phacoemulsification handpiece, a phacoemulsification handpiece configured for vibratory movement in three dimensions, a vitrectomy handpiece, a piezo electric handpiece, a solenoid valve handpiece, or a battery powered handpiece (claim 7).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4 – 13, and 16 – 25 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Nallakrishnan et al (US 2021/0000648 A1).
Regarding claims 1, 4 – 13, and 16 – 19, Nallakrishnan discloses a surgical instrument (instrument 10B) for massaging the trabecular meshwork of the eye (abstract, paragraphs [0073 – 0076], and Figs. 1, 4), the instrument comprising:
a hand grip portion (handle 12B) having an elongated configuration, having proximal and distal ends (paragraphs [0054], [0059], and Fig. 4); and
a tip portion (14B) extending from the distal end of said hand grip portion (paragraph [0073] and Figs. 1,4), said tip portion comprising an elastomeric element (elastomeric element 16B) having a base (base 20B) secured to said distal end of said hand grip portion (handle 12B) (paragraph [0073] and Figs. 1,4) and a tapered free end (free end 18B) extending from said base (paragraphs [0073 – 0074] and Figs. 1,4),
said free end configured to massage the trabecular meshwork of the eye (paragraphs [0073 – 0074] and Figs. 1,4), and at least one irrigation passage extending through said tip portion for directing an irrigation fluid proximate to the trabecular meshwork of the eye (Examiner’s note: as stated in paragraphs [0016] and [0111] the device comprises an irrigation source to provide an irrigation fluid through said instrument by way of one or more cannulas; therefore, Nallakrishnan discloses an irrigation passage (i.e., the cannula that extends through the system) for directing fluid proximate the meshwork of the eye);
[claim 4] wherein said free end (free end 18B) includes at least one relatively abrasive surface (paragraphs [0073 – 0074] and Figs. 1,4);
[claims 5 and 6] wherein said at least one relatively abrasive surface of said free end comprises an impregnated abrasive composition or comprises surface-roughening (paragraph [0009]);
[claims 7 and 8] a longitudinally-vibrating phacoemulsification handpiece hand piece (hand piece 100) connected to said hand grip portion configured to vibrate said free end (paragraph [0108]);
[claims 9 and 11] with an irrigation supply source (irrigation supply) to provide an irrigation fluid through said at least one irrigation passage of said instrument and said hand grip portion includes a reservoir for containing an irrigation fluid and a means to selectively provide an irrigation fluid through said at least one irrigation passage of said instrument (paragraphs [0016], [0111]);
[claim 10] a vacuum (vacuum generator) to provide aspiration through said instrument, or around said instrument (paragraph [0111]);
[claim 12] wherein the tip portion (14B) defines a central axis (longitudinal axis of tip 14B) and said free end (18B) is substantially flat and transverse to said central axis (Examiner’s note: the term “substantially” is a broad term and the distal most face of the free end 18B, as shown in Fig. 4, is “substantially” flat, in that it does not form a point and extends along a plane that is transverse to the central, longitudinal, axis of the tip portion 14B), said tip portion further includes a pair of oppositely facing relatively abrasive surfaces (regions 60B) located on either side of said central axis (paragraph [0074]);
[claim 13] wherein said tip portion (tip portion 14B) overlies a length of said hand grip portion distal end (Examiner’s note: as discussed in paragraph [0073] the instrument 10B is similar to the instrument 10A, wherein the tip portion 14B extends from the distal end of the handle grip portion 14B; additionally, paragraph [0063] states wherein the tip portion 14A is overmolding the elastomeric element to the handle grip portion 12A. Therefore, the tip portion 14B is also overmolded on the handle grip portion 12B, such that the tip portion 14B will overlay a length (a portion) of the handle grip portion 12B) .
[claims 16, 17, and 18] said tip portion (14B) defines a central axis and includes a pair of oppositely facing, substantially elliptical, relatively abrasive surfaces (regions 60B) located on either side of said central axis extending along more than half of a length of said tip portion in the direction of said central axis (paragraph [0074] and Fig. 4), each one of said pair of oppositely facing relatively abrasive surfaces is concave (paragraph [0074] and Fig. 4);
[claim 19] wherein said free end (18B) has a pair of relatively smooth, non-abrasive top and bottom surfaces and a pair of relatively abrasive, opposite lateral surfaces (surfaces 60B) (paragraph [0074] and Fig. 4);
Regarding claim 20, Nallakrishnan discloses a method for improvement of the drainage of fluid of the eye, wherein the method comprises the steps of:
obtaining the surgical instrument (instrument 10B) in accordance with claim 1 (paragraphs [0072 – 0075] and Fig. 4);
contacting the trabecular meshwork of the eye with said tapered free end of said elastomeric element to massage the trabecular meshwork to dislodge deposits within the meshwork (claim 23); and
directing an irrigating fluid through said surgical instrument to direct flow of the irrigating fluid from said at least one irrigation passage to the trabecular meshwork (paragraph [0111]).
Regarding claims 21 – 25, Nallakrishnan discloses a surgical instrument (instrument 10B) for massaging the trabecular meshwork of the eye (abstract, paragraphs [0073 – 0076], and Figs. 1, 4), the instrument comprising:
a hand grip portion (handle 12J) having an elongated configuration, having proximal and distal ends (paragraphs [0054], [0059], and Fig. 4); and
a tip portion (14B) extending from the distal end of said hand grip portion (paragraph [0073] and Figs. 1,4), said tip portion comprising an elastomeric element (elastomeric element 16B) having a base (base 20B) secured to said distal end of said hand grip portion (handle 12B) (paragraph [0073] and Figs. 1,4) and a tapered free end (free end 18B) extending from said base (paragraphs [0073 – 0074] and Figs. 1,4),
said free end configured to mechanically stretch the trabecular meshwork of the eye (Examiner’s note: it should be understood that the preceding limitation is an intended use limitation, which requires only that the structure of the prior art be capable of functioning in the manner claimed. With that said, with the right amount of pressure from the user, the free end 18B can massage / stretch the meshwork of the eye as claimed);
[claims 22 and 23] wherein said tip portion defines a central axis and said elastomeric element includes at least one roughened surface which includes a pair of semi-elliptical roughened surfaces (left and right surfaces) located on opposite sides of said central axis and a substantially rectangular roughened surface (distal most surface) located between said pair of semi-elliptical roughened surfaces (Examiner’s note: as shown in Figs. 3 and 4 the side surfaces are convex and have a semi-elliptical shape; and the distal most surface is substantially rectangular);
[claims 24 – 25] a longitudinally-vibrating phacoemulsification handpiece hand piece (hand piece 100) connected to said hand grip portion configured to vibrate said free end (paragraph [0108]).
Claims 21 – 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yokoyama (US 2022/0087864 A1) (filed on 07/13/2021).
Regarding claims 21 – 23, Yokoyama discloses a surgical instrument (instrument 10B) capable of massaging the trabecular meshwork of the eye (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d150,152,88. With that said the surgical device of Yokoyama is capable of massaging the trabecular meshwork of the eye as in the manner as claimed as it includes all of the required structured to do so) (abstract, paragraphs [0044 – 0048], and Figs. 1, 3, 4), the instrument comprising:
a hand grip portion (handle 12B) having an elongated configuration, having proximal and distal ends (paragraph [0044] and Figs. 4); and
a tip portion (14B) extending from the distal end of said hand grip portion (paragraph [0044] and Figs. 3 and 4), said tip portion comprising an elastomeric element (elastomeric element 16B) having a base (base 20B) secured to said distal end of said hand grip portion (handle 12B) (paragraph [0044] and Figs. 3 and 4) and a tapered free end (free end 18B) extending from said base (paragraph [0044] and Figs. 3 and 4),
said free end configured to mechanically stretch the trabecular meshwork of the eye (Examiner’s note: it should be understood that the preceding limitation is an intended use limitation, which requires only that the structure of the prior art be capable of functioning in the manner claimed. With that said, with the right amount of pressure from the user, the free end 18B can massage / stretch the meshwork of the eye as claimed);
[claims 22 and 23] wherein said tip portion defines a central axis and said elastomeric element includes at least one roughened surface which includes a pair of semi-elliptical roughened surfaces (left and right surfaces) located on opposite sides of said central axis and a substantially rectangular roughened surface (flat distal most face) located between said pair of semi-elliptical roughened surfaces (Examiner’s note: as shown in Figs. 3 and 4 the side surfaces are convex and have a semi-elliptical shape; and the distal most face is substantially rectangular).
Claims 1, 2, 4 – 7, 9, 10, 13, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walter (US 2015/0005753 A1).
Regarding claim 1, Walter discloses a surgical instrument (surgical device 20) (abstract, paragraphs [0131], [0133], [0166 – 0169], [0188], and Figs. 1 – 9, 19B, 20A – E) capable of massaging the trabecular meshwork of the eye (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d150,152,88. With that said the surgical device of Walter is capable of massaging the trabecular meshwork of the eye as in the manner as claimed as it includes all of the required structured to do so. Additionally, as discussed in paragraph [0188] the tip 10” of the embodiment of Fig. 19B is used with same surgical device 20 as that of the tip 10 shown in Figs. 1 – 9), the instrument comprising:
a hand grip portion (hub 16 and cannula 12) having an elongated configuration, having proximal and distal ends (paragraphs [0131 – 0137] and Figs. 1 – 9); and
a tip portion (tip 10’’) extending from the distal end of said hand grip portion (paragraph [0038], [0188], and Figs. 1, 19B and 20A – 20E), said tip portion comprising an elastomeric element (Examiner’s note: as stated in paragraph [0188] the tip 10’’ can comprise the same polymer as the tip 10, and as stated in paragraph [0130] the tip 10’’ is comprised of an elastomer. Therefore, Walter encompasses wherein the tip 10’’ comprises an elastomer) having a base (proximal most end; end that attaches to the cannula 12 – shown in Fig. 6 as tip 10) secured to said distal end of said hand grip portion (hub 16 and cannula 12) (paragraph [0188] and Fig. 6), and a tapered free end (end shown in Fig. 19B) extending from said base,
said free end configured to massage the trabecular meshwork of the eye (Examiner’s note: it should be understood that the preceding limitation is an intended use limitation, which requires only that the structure of the prior art be capable of functioning in the manner claimed. With that said, with the right amount of pressure from the user, the surgical device 10 / the free end of the tip 10’’ can be used to massage the trabecular meshwork of the eye as claimed), and at least one irrigation passage (flow channel 130) extending through said tip portion (tip 10’’) for directing an irrigation fluid proximate to the trabecular meshwork of the eye (paragraphs [0133], [0166 – 0169], and Figs. 4 – 9 and 19B);
[claim 4] wherein said free end includes at least one relatively abrasive surface (textured surface 10t) (paragraphs [0145], [0196 – 0197], and Fig. 19B);
[claim 7] a hand piece (hand piece 100h) connected to said hand grip portion configured to vibrate said free end (Examiner’s note: it should be understood that the preceding limitation is an intended use limitation and requires only that the structure of the prior art be capable of functioning in the manner claimed; with that said, the hand piece 100h can be manually vibrated to vibrate the tip 10, therefore the structure of Walter is capable of functioning as claimed);
[claim 9] with an irrigation supply source (irrigation system 110) to provide an irrigation fluid through said at least one irrigation passage of said instrument (paragraph [0134] and Fig. 4);
[claim 10] a vacuum (aspiration source 100) to provide aspiration through said instrument, or around said instrument (paragraph [0134] and Fig. 4).
Regarding claim 5, Walter discloses wherein said at least one relatively abrasive surface (textured surface 10t) of said free end comprises an impregnated abrasive composition (Examiner’s note: as stated in paragraph [0145] the textured surface has a coating with particulates).
Regarding claim 6, Walter discloses wherein said at least one relatively abrasive surface (textured surface 10t) of said free end comprises surface-roughening (Examiner’s note: as stated in paragraph [0145] the textured surface is roughened texture via sandblasting or pinging).
Regarding claim 1, (alternate embodiment – changes italicized) Walter discloses a surgical instrument (surgical device 20) (abstract, paragraphs [0125 – 0136], and Figs. 1 – 6) capable of massaging the trabecular meshwork of the eye (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d150,152,88. With that said the surgical device of Walter is capable of massaging the trabecular meshwork of the eye as in the manner as claimed as it includes all of the required structured to do so), the instrument comprising:
a hand grip portion (hub 16 and cannula 12) having an elongated configuration, having proximal and distal ends (paragraphs [0131 – 0137] and Figs. 1 – 9); and
a tip portion (tip 10) extending from the distal end of said hand grip portion (paragraph [0038], [0132], and Figs. 1 – 6), said tip portion comprising an elastomeric element (tip 10) (Examiner’s note: as stated in paragraph [0130] the tip 10 is comprised of an elastomeric element) having a base (proximal most end; end that attaches to the cannula 12 – shown in Fig. 6 as tip 10) secured to said distal end of said hand grip portion (hub 16 and cannula 12) (paragraph [0133] and Fig. 6), and a tapered free end (distal most end of tip 10) extending from said base (Figs. 5, 6),
said free end configured to massage the trabecular meshwork of the eye (Examiner’s note: it should be understood that the preceding limitation is an intended use limitation, which requires only that the structure of the prior art be capable of functioning in the manner claimed. With that said, with the right amount of pressure from the user, the surgical device 10 / the free end of the tip 10 can be used to massage the trabecular meshwork of the eye as claimed), and at least one irrigation passage (passage that leads to irrigation port 30) extending through said tip portion (tip 10) for directing an irrigation fluid proximate to the trabecular meshwork of the eye (paragraph [0136]);
[claim 4] wherein said free end includes at least one relatively abrasive surface (textured surface 10t) (paragraphs [0133], [0136], [0140], and Figs. 1 – 6);
[claim 7] a hand piece (hand piece 100h) connected to said hand grip portion configured to vibrate said free end (paragraph [0134]) (Examiner’s note: it should be understood that the preceding limitation is an intended use limitation and requires only that the structure of the prior art be capable of functioning in the manner claimed; with that said, the hand piece 100h can be manually vibrated to vibrate the tip 10, therefore the structure of Walter is capable of functioning as claimed);
[claim 9] with an irrigation supply source (irrigation system 110) to provide an irrigation fluid through said at least one irrigation passage of said instrument (paragraph [0134] and Fig. 4);
[claim 10] a vacuum (aspiration source 100) to provide aspiration through said instrument, or around said instrument (paragraph [0134] and Fig. 4).
Regarding claim 2, (alternate embodiment) Walter discloses wherein said at least one irrigation passage (passage that leads to irrigation port 30) terminates in a single aperture (port 30) in said free end (Examiner’s note: as shown in Figs. 5 and 6 and discussed in paragraph [0134] the embodiment of Figs. 4 – 6 comprise a singular irrigation portion 30).
Regarding claim 5, (alternate embodiment) Walter discloses wherein said at least one relatively abrasive surface (textured surface 10t) of said free end comprises an impregnated abrasive composition (Examiner’s note: as stated in paragraph [0145] the textured surface has a coating with particulates).
Regarding claim 6, (alternate embodiment) Walter discloses wherein said at least one relatively abrasive surface (textured surface 10t) of said free end comprises surface-roughening (Examiner’s note: as stated in paragraph [0145] the textured surface is roughened texture via sandblasting or pinging).
Regarding claim 13, (alternate embodiment) Walter discloses wherein said tip portion (tip 10) overlies a length of said hand grip portion distal end (distal end of cannula 12) (Figs. 5 – 6).
Regarding claim 21, (alternate embodiment) Walter discloses a surgical instrument (surgical device 20) (abstract, paragraphs [0125 – 0136], and Figs. 1 – 6) capable of massaging the trabecular meshwork of the eye (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d150,152,88. With that said the surgical device of Walter is capable of massaging the trabecular meshwork of the eye as in the manner as claimed as it includes all of the required structured to do so), the instrument comprising:
a hand grip portion (hub 16 and cannula 12) having an elongated configuration, having proximal and distal ends (paragraphs [0131 – 0137] and Figs. 1 – 9); and
a tip portion (tip 10) extending from the distal end of said hand grip portion (paragraph [0038], [0132], and Figs. 1 – 6), said tip portion comprising an elastomeric element (tip 10) (Examiner’s note: as stated in paragraph [0130] the tip 10 is comprised of an elastomeric element) having a base (proximal most end; end that attaches to the cannula 12 – shown in Fig. 6 as tip 10) secured to said distal end of said hand grip portion (hub 16 and cannula 12) (paragraph [0133] and Fig. 6), and a tapered free end (distal most end of tip 10) extending from said base (Figs. 5, 6),
said free end configured to mechanically stretch the trabecular meshwork of the eye (Examiner’s note: it should be understood that the preceding limitation is an intended use limitation, which requires only that the structure of the prior art be capable of functioning in the manner claimed. With that said, with the right amount of pressure from the user, the surgical device 10 / the free end of the tip 10 can be used to massage / stretch the trabecular meshwork of the eye as claimed).
Regarding claim 22, (alternate embodiment) Walter discloses wherein said tip portion (tip 10) defines a central axis and said elastomeric element includes at least one roughened surface (textured surface 10t) (paragraphs [0130 – 0133] and Figs. 4 – 6).
Regarding claim 24, (alternate embodiment) Walter discloses a hand piece (hand piece 100h) connected to said hand grip portion configured to vibrate said free end (paragraph [0134]) (Examiner’s note: it should be understood that the preceding limitation is an intended use limitation and requires only that the structure of the prior art be capable of functioning in the manner claimed; with that said, the hand piece 100h can be manually vibrated to vibrate the tip 10, therefore the structure of Walter is capable of functioning as claimed)
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 3, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Nallakrishnan et al (US 2021/0000648 A1) in view of Kasani et al (US 2015/0164687 A1).
Regarding claims 2, 3, 14, and 15, as discussed above, Nallakrishnan discloses the device of claim 1. Additionally, Nallakrishnan discloses a portion of [claims 14 and 15] wherein said free end (18B) terminates in an annular surface (Examiner’s note: as shown in Fig. 4 the free end curves around the tip), said surface having a pair of opposite arcuate sides (regions 60B) and a pair of opposite flat sides (top and bottom sides) (paragraph [0074] and Fig. 4).
However, Nallakrishnan is silent to the location of the terminal end of the at least one irrigation passage, (i) [claims 2 and 3] said at least one irrigation passage terminates in a single aperture in said free end aligned with a central axis of said tip portion and (ii) [claims 14 and 15] wherein the free end surrounds the at least one irrigation passage. With respect to both (i) and (ii), Nallakrishnan discloses in paragraph [0016] an irrigation source providing irrigation fluid through the instrument.
As to the above, Kashini teaches a retinal treatment system for delivering irrigation to the eye, wherein the system (delivery device 400) comprises a tip portion (tip structure 412) and an irrigation passage (lumen of needle 404) terminating in a single aperture aligned with the central axis of the tip portion (tip structure 412) (abstract, paragraphs [0031- 0032], and Fig. 4).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the location of the irrigation port to be aligned with the central axis, as taught by Kashini, as the location is a known location for the placement of an irrigation port, and one of ordinary skill in the art would have a reasonable expectation of success in having the irrigation lumen / port of Nallakrishnan be centrally aligned, and the modification would result in the system of Nallakrishnan being able to function as intended to irrigate the trabecular meshwork. With respect to (ii), it should be understood that because the irrigation port is modified to be at the end of the distal most surface of the free end and aligned with the central axis, the free end surrounds said irrigation passage in the tip portion as claimed.
Claims 1 – 6, 9 – 14, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Yokoyama (US 2022/0087864 A1) (filed on 07/13/2021) in view of Kashani et al (US 2015/0164687 A1).
Regarding claims 1 – 3, Yokoyama discloses a surgical instrument (instrument 10C) capable of massaging the trabecular meshwork of the eye (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d150,152,88. With that said the surgical device of Yokoyama is capable of massaging the trabecular meshwork of the eye as in the manner as claimed as it includes all of the required structured to do so) (abstract, paragraphs [0049 – 0053], and Figs. 1, 5, and 8), the instrument comprising:
a hand grip portion (handle 12C) having an elongated configuration, having proximal and distal ends (paragraph [0050] and Figs. 5 and 8); and
a tip portion (14C) extending from the distal end of said hand grip portion (paragraph [0050] and Figs. 5 and 8), said tip portion comprising an elastomeric element (elastomeric element 16C) having a base (base 20C) secured to said distal end of said hand grip portion (handle 12C) (paragraph [0050] and Figs. 5 and 8) and a tapered free end (free end 18C) extending from said base (paragraph [0050] and Figs. 5 and 8),
said free end configured to massage the trabecular meshwork of the eye (Examiner’s note: it should be understood that the preceding limitation is an intended use limitation, which requires only that the structure of the prior art be capable of functioning in the manner claimed. With that said, with the right amount of pressure from the user, the free end 18C can massage the meshwork of the eye as claimed).
However, Yokoyama is silent regarding (i) at least one irrigation passage extending through said tip portion for directing an irrigation fluid proximate to the trabecular meshwork of the eye and (ii) [claims 2 and 3] said at least one irrigation passage terminates in a single aperture in said free end aligned with a central axis of said tip portion. With respect to (i), Yokoyama discloses in paragraph [0054] wherein it may further be advantageous to combine any one of the instruments disclosed herein with an irrigation system and an aspiration system. For example, the instruments may be incorporated into an aspiration/irrigation handpiece to supply irrigating liquids to the eye in order to aid in flushing and aspirating dislodged particles in the eye during the use of the instruments. Additionally, in paragraph [0042] Yokoyama discloses delivering an irrigation fluid and aspiration to the eye during the procedure.
As to the above, Kashani teaches a retinal treatment system for delivering irrigation to the eye, wherein the system (delivery device 400) comprises a tip portion (tip structure 412) and an irrigation passage (lumen of needle 404) terminating in a single aperture aligned with the central axis of the tip portion (tip structure 412) (abstract, paragraphs [0031- 0032], and Fig. 4).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system to have the irrigation passage run therethrough, based on the teachings of Yokoyama, for the purpose of supply irrigating liquids to the eye in order to aid in flushing particles in the eye during the use of the instruments. Additionally, it would be obvious for the irrigation passage run therethrough and terminate at an irrigation port at the free end, that is aligned with the central axis, as taught by Kashani, as the placement and location of the lumen and part are known locations for the placement of an irrigation lumen and port, and one of ordinary skill in the art would have a reasonable expectation of success in having the irrigation lumen / port of Yokoyama be within the system and centrally aligned and the free end, and the modification would result in the system of Yokoyama being able to function as intended to irrigate the trabecular me