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 .
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 7-11 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.
Claim 7 recites “a flange that has a first flange portion… and a second flange portion that protrudes in an A’ direction… is moveable in the axial direction relative to the hollow body and is configured to receive fingers…. Due to the manner in which the claim is currently written, it is unclear whether Applicant is attempting to recite that the entire flange is moveable or only the second flange portion is moveable. Claims 8-11 depend from claim 7 and are indefinite for the same reasons.
Claim 8 recites the limitation "the first flange” and “the second flange" in line 1. Since claim 1 recites a flange, and then a first flange portion and a second flange portion, it is unclear what elements are being referred to here.
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 7-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7, 8 of U.S. Patent No. 12,076,231. Although the claims at issue are not identical, they are not patentably distinct from each other because all the limitations of claim 1 of this application are anticipated by claim 7 of the ‘231 patent. Claim 7 of the ‘231 patent recites a first flange and a second flange, which correspond with the first flange portion and second flange portion of this application. Claim 7 of the ‘231 patent recites that both flanges are moveable, which corresponds with the limitation “movable in the axial direction” in claim 1 of this application. The ‘231 patent also recites additional limitations, wherein it is considered obvious to broaden the scope of a claim by removing claim limitations.
Claims 8-10 are anticipated by claims 8-10 of the ‘231 patent.
Claim Rejections - 35 USC § 102
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.
Claim(s) 7, 9 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by USPAP 2013/0006259 (Sanger).
Sanger discloses an intraocular lens injector comprising a hollow body (1A) that defines a tip end (4A), an outer surface and an axial direction and that includes a lens setting portion configured to support an intraocular lens (see area supporting lens 2 in Figure 1); a plunger (21) that is movable relative to the hollow body in the axial direction; a pushing member (20) that moves with the plunger and is configured to push the intraocular lens through the tip end of the hollow body (Figure 2); and a flange (11) that has a first flange portion that protrudes in an A direction from the hollow body outer surface and a second flange portion that protrudes in an A' direction, which is opposite the A direction, from the hollow body outer surface (see two portions of slider 11 extending in opposite directions from the hollow body in figure 2), is movable in the axial direction relative to the hollow body [0038; 0050], and is configured to receive fingers on tip end sides of the first and second flange portions (the flange portions 11 are configured for engagement by an operator’s fingers).
In regards to claim 9, since the hollow tubular body surrounds the lens setting portion and the lens (2) (see Figure 1), the device can be described such that the lens setting portion “faces” the A direction (the direction in which one flanges of the slider 11 extends).
Regarding claim 10, the hollow body (1B) has indexes 16A and 12A (see description of indicia ([0041]; [0055]) that correspond with the flange (11), wherein the phrase ‘corresponding to flange location” is given its broadest reasonable interpretation to encompass the indicia being after the flanges/slider (11) have been moved to fold the IOL [0052].
Claim Rejections - 35 USC § 103
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) 8 are rejected under 35 U.S.C. 103 as being unpatentable over Sanger in view of USPAP 2014/0135784 (Maroscheck). Sanger is silent with respect to the dimensions of the injector but Maroscheck teaches the general diameter of an IOL injector is in the range of 8-16 mm. The claim does not specify the direction in which the dimension of “protrude” is measured. Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it to be an obvious matter of design choice configure flanges of the Sanger device to extend 10 mm or more in the axial direction and/or a radial direction, as such a modification would have involved a mere change in size of a component, which is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Allowable Subject Matter
Claims 12-19 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: Prior art discloses various IOL injectors with different arrangements of flanges and moveable sliders having flanges for engaging a user’s fingers, such as:
USPAP 2015/0045805 – see lock 4 in Figure 4 [0049]
USPAP 2013/0226193 comprises a moveable flange and indicia (12c) [0066]
In regards to claim 12: Prior art fails to disclose an IOL injector having a flange that protrudes from the hollow body outer surface, is movable in the axial direction relative to the hollow body, and is configured to receive fingers on tip end sides of the first and second flange portions; and an index including indicia at a plurality of axially spaced locations that are indicative of respective glove sizes when the flange is located at the axially spaced locations; wherein the flange and the index are configured to draw attention to the indicia at the location at which the flange is located.
In regards to claim 18, prior art fails to disclose a method for use with an intraocular lens comprising the step of identifying locations of a flange that slides relative to the hollow body of the injector that correspond to particular glove sizes with indicia on the hollow body outer surface.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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