DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 08/23/2021, has been considered by the examiner.
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 2-20 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.
[Claims 2 and 16] The claims recite the limitation of a hub/proximal end “portion configured to connect, in a watertight fit, to an ophthalmic instrument having an irrigation channel and an aspiration port.” The examiner is unable to determine the metes and bounds of the claims. Specifically, it is unclear if the “irrigation channel” and “aspiration port” are intended as structure for the positively recited hub/proximal end “portion,” or if they are considered part of the functionally recited “ophthalmic instrument.” For purposes of examination, it is interpreted that the “irrigation channel” and “aspiration port” are associated with the functionally recited “ophthalmic instrument.”
[Claims 3-15 and 17-20] The claims are rejected based upon their dependency from independent claims 2 and 16.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 2, 6, 7, 9, 10, 12, 14-16, 19, and 20, are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Dimalanta et al. (PGPub 2010/0160851).
[Claims 2 and 16] Dimalanta teaches a tip (figure 1, item 100/110) for an ophthalmic instrument (“phacoemulsification handpiece”) (paragraph [0031]), the tip comprising:
a tip component (figure 2, item 110) comprising:
a proximal end portion (figure 1, item 112) configured to connect, in a watertight fit (via item 114), to a distal end of an ophthalmic instrument having an irrigation channel and an aspiration channel (see 112, 2nd interpretation above) (paragraph [0031]),
a cannula portion (figure 2, items 116/110) projecting distally from the proximal end portion (figure 1, item 112), the cannula portion (figure 2, items 116/110) comprising a first aspiration port (distal opening of needle 110) at or adjacent to a distal end of the cannula portion (paragraph [0031]), and
a channel (aspiration lumen of item 110) extending through the proximal end portion (figure 1, item 112) and the cannula portion (figure 2, items 116/110), wherein the channel is configured to be in fluid communication with the first aspiration port (distal opening of needle 110) of the cannula portion (figure 2, items 116/110) and the aspiration channel of the ophthalmic instrument (paragraph [0031]); and
a sleeve (figure 2, item 100) comprising:
a hub portion (figure 2, item 104) configured to connect, in a watertight fit (“internal threads”), to the distal end of the ophthalmic instrument (paragraph [0031]);
an intermediate portion (figure 2, item 102) projecting from the hub portion (figure 2, item 104);
a distal portion (see annotated figure below) projecting from the intermediate portion (figure 2, item 102) and having an irrigation port (figure 6, item 150) (paragraphs [0032], [0036]); and
a distal end portion (see annotated figure below) projecting from the distal portion and having a second aspiration port (see annotated figure below), wherein the second aspiration port of the distal end portion is configured to be in fluid communication (figures 1 and 6) with the first aspiration port (distal opening of needle 110) of the cannula portion (figure 2, items 116/110) of the tip component (figure 2, item 110);
wherein the intermediate portion (figure 2, item 102) and the distal portion form an annular channel (figure 2, as shown by arrows 130) that surrounds at least a part of the tip component (figure 2, item 110) and is configured to be in fluid communication with the irrigation port (figure 6, item 150) of the distal portion of the sleeve (figure 2, item 100) and the irrigation channel of the ophthalmic instrument (figure 2; paragraph [0031]).
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[Claim 6] Dimalanta teaches the limitations of claim 2, upon which claim 6 depends. In addition, Dimalanta discloses an aspiration cavity (see annotated figure below) configured to be in fluid communication with and disposed between the aspiration port of the distal end portion of the sleeve (figure 6; see annotated figure above) and the aspiration port of the ophthalmic instrument (figure 2; paragraph [0031]).
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[Claim 7] Dimalanta teaches the limitations of claim 6, upon which claim 7 depends. Dimalanta also teaches the distal end portion of the sleeve (see annotated figure above) comprises an annular shoulder (see annotated figure below) configured to fluidly seal the aspiration cavity to the aspiration port of the ophthalmic instrument (figure 2; paragraph [0031]).
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[Claim 9] Dimalanta teaches the limitations of claim 2, upon which claim 9 depends. Dimalanta further discloses the hub portion (figure 2, item 104) of the sleeve (figure 2, item 100) comprises a wall thickness greater than a wall thickness (the examiner notes the claim doesn’t require a total wall thickness; as such, a “wall thickness” can be considered to be a portion of a total wall thickness; given this, there exists a “wall thickness” of the hub portion that is greater than a “wall thickness” of the intermediate and distal portions) of the intermediate portion (figure 2, item 102) of the sleeve (figure 2, item 100) and the distal portion (see annotated figure above) of the sleeve (figure 2, item 100).
[Claim 10] Dimalanta teaches the limitations of claim 2, upon which claim 10 depends. Dimalanta also discloses an internal face (see annotated figure below) of a proximal end of the hub portion (figure 2, item 104) of the sleeve (figure 2, item 100) is tapered.
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[Claim 12] Dimalanta teaches the limitations of claim 2, upon which claim 12 depends. In addition, Dimalanta teaches a diameter of the intermediate portion of the sleeve (figure 2, item 100) decreases towards the distal portion of the sleeve (figure 2, item 100) (see annotated figure below).
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[Claim 14] Dimalanta teaches the limitations of claim 2, upon which claim 14 depends. Dimalanta further discloses a mark (figure 2, item 114) for aligning the sleeve with the ophthalmic instrument (the examiner notes that, lacking any further description or limitations, a “mark” could be considered any structure on the sleeve).
[Claim 15] Dimalanta teaches the limitations of claim 2, upon which claim 15 depends. Dimalanta also teaches the hub portion (figure 2, item 104) of the sleeve (figure 2, item 100) comprises a non-cylindrical shape (see annotated figure above).
[Claim 19] Dimalanta teaches the limitations of claim 16, upon which claim 19 depends. In addition, Dimalanta discloses the irrigation port (figure 6, item 150) of the distal portion (see annotated figure above) of the sleeve (figure 2, item 100) is disposed along a sidewall of the distal portion (see annotated figure above) of the sleeve (figure 2, item 100) and lateral to the second aspiration port (see annotated figure above) (figure 6).
[Claim 20] Dimalanta teaches the limitations of claim 16, upon which claim 20 depends. Dimalanta also teaches the sleeve (figure 2, item 100) covers the tip component (figure 2, item 110) (figure 2).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 3, 5, and 8, are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dimalanta et al. (PGPub 2010/0160851), in view of Akahoshi (PGPub 2011/0015562).
[Claims 3 and 5] Dimalanta teaches the limitations of claim 2, upon which claim 3 depends. Dimalanta does not specifically disclose a bend in the distal portion of the sleeve disposed between the intermediate portion of the sleeve and the distal end portion of the sleeve.
However, Akahoski teaches a sleeve (figure 4, item 66) for an ophthalmic instrument (paragraph [0057]) which comprises a bend (see annotated figure below) in a distal portion (see annotated figure below) between an intermediate (see annotated figure below) and distal end portion (see annotated figure below), which is configured to be disposed adjacent to or overlapping with an edge of an irrigation port (figure 6, item 82) of the distal portion (see annotated figure below) of the sleeve (figure 4, item 66).
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It would have been obvious to one of ordinary skill in the art, at the time of the invention, to have modified the sleeve taught by Dimalanta, to have included a bend disposed between the intermediate portion and distal end portion, as taught by Akahoski, in order to provide increased functionality and versatility, by allowing for an improved range of maneuverability for irrigation and aspiration.
[Claim 8] Dimalanta teaches the limitations of claim 2, upon which claim 8 depends. Dimalanta does not specifically disclose the aspiration port of the distal end portion of the sleeve is disposed along a sidewall of the distal end portion of the sleeve.
However, Akahoski teaches a sleeve (figure 4, item 66) for an ophthalmic instrument (paragraph [0057]) which comprises an aspiration port (figure 6, item 82) in the distal end portion (see annotated figure above) of the sleeve (figure 4, item 66) which is disposed along a sidewall of the distal end portion (see annotated figure above) of the sleeve (figure 4, item 66).
It would have been obvious to one of ordinary skill in the art, at the time of the invention, to have modified the sleeve taught by Dimalanta, to have positioned the aspiration port along a sidewall of the distal end portion of the sleeve, as taught by Akahoski, in order to provide increased functionality and versatility, by allowing for an improved range of maneuverability for irrigation and/or aspiration.
Claim 13 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dimalanta et al. (PGPub 2010/0160851), in view of Akahoshi (PGPub 2011/0015562), in further view of Kutner (USPN 4,204,328).
[Claim 13] Dimalanta and Akahoshi teach the limitations of claim 3, upon which claim 13 depends. Dimalanta and Akahoshi do not specifically disclose a diameter of the distal portion of the sleeve decreases from the bend towards the distal end portion of the sleeve.
However, Kutner teaches a sleeve (figure 1, items 21/27) for an ophthalmic instrument (column 3, lines 14-21) wherein a diameter of a distal portion of the sleeve (figure 1, items 21/27) decreases (as best shown in figure 3) from a bend (figure 3, at item 21B) towards a distal end portion (figure 3, at item 28) of the sleeve (figure 1, items 21/27).
It would have been obvious to one of ordinary skill in the art, at the time of the invention, to have modified the sleeve taught by Dimalanta and Akahoshi, to have utilized a decreased distal diameter in the sleeve, as taught by Kutner, in order to provide increased functionality and versatility, by allowing for improved accuracy and precision during aspiration and/or irrigation procedures.
Claim 11 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dimalanta et al. (PGPub 2010/0160851), in view of Steppe et al. (USPN 4,983,160).
[Claim 11] Dimalanta teaches the limitations of claim 2, upon which claim 11 depends. Dimalanta does not specifically disclose the hub portion of the sleeve comprises a rib configured to form the watertight fit with the ophthalmic instrument.
However, Steppe teaches a sleeve (figure 5, item 130) for an ophthalmic instrument (column 3, lines 33-36), having a hub portion comprising a rib (figure 5, item 142) configured to form a watertight fit with the ophthalmic instrument (column 5, lines 6-15).
It would have been obvious to one of ordinary skill in the art, at the time of the invention, to have modified the sleeve taught by Dimalanta, to have included a rib in the hub portion of the sleeve, as taught by Steppe, in order to provide additional functionality and control, by allowing for improved sealing between the sleeve and an ophthalmic instrument.
Allowable Subject Matter
Claims 4, 17, and 18, would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nathan Price can be reached on 571-270-5421. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 04/12/2024
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