DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed 03/17/26 has been entered. Claims 1-20 are addressed in the following office action.
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.
Claims 1-3 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Springer et al. (US 2019/0224002) in view of Davis (US 5,388,589), both cited in previous office action.
Regarding claim 1, an invention relating an IOL injector, Springer discloses (Figs. 1B, 2B, 3B, 5B, 9) an apparatus for delivery of an intraocular lens (Abstract), comprising: a handpiece (150) configured to removably attach to an IOL cartridge [Note, the IOL cartridge is not positively recited, hence it is not considered part of the claimed invention] at a distal end of the handpiece (Par. 0059), the handpiece comprising: a housing, comprising: a rigid tubular member (172; Par. 0094); at least one slot (see annotated figure below) disposed through the rigid tubular member and configured to engage with a member (212 & 214) of the IOL cartridge to secure the IOL cartridge to the handpiece (Par. 0060); a push rod (180) movably disposed within the rigid tubular member (Fig. 5B); and at least one internal projection (930) extending from an inner wall (see annotated figure below) of the rigid tubular member and configured to engage with a plunger (510) of the IOL cartridge to secure the push rod to the plunger (Par. 0069 & 0073). Also, Springer discloses although in the examples provided above a system of hooks and latches is used to affix the delivery unit to one of the handpieces, the present disclosure is not limited to this type of arrangement. In this regard, it will be understood that any other suitable interface for affixing the delivery unit to the first and second handpieces may be used instead. Similarly, it will be understood that any other suitable receiving interface for affixing the delivery unit to the first and second handpieces may be used, as well. (Par. 0093). However, Springer fails to disclose at least one slot disposed through the rigid tubular member and configured to engage with a flexible member of the IOL cartridge to secure the IOL cartridge to the handpiece; at least one flexible clip disposed adjacent to the at least one slot on the rigid tubular member and configured to abut the flexible member when the IOL cartridge is attached to the handpiece, wherein inward depression of the at least one flexible clip facilitates release of IOL cartridge from the handpiece.
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In the analogous art of medical means of assembly, Davis teaches (Figs. 1-3) at least one slot (50) disposed through a rigid tubular member (40) and configured to engage with a flexible member (74) of a cartridge (60) to secure the cartridge to a handpiece (30); at least one flexible clip (46) disposed adjacent to the at least one slot on the rigid tubular member and configured to abut the flexible member when the IOL cartridge is attached to the handpiece, wherein inward depression of the at least one flexible clip facilitates release of IOL cartridge from the handpiece (Col. 2, lines 51-57 & Col. 3, lines 16-29).
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 substituted the latches of Springer that secures the cartridge to the handpiece, for the snap-fit means of assembly of Davis since these mechanisms perform the same function of securing the cartridge to the handpiece. Simply substituting one means of securing for another would yield the predicable result of an assembled device [i.e. assembling of the cartridge and handpiece]. See MPEP 2143.
Regarding claim 2, Springer, as modified by Davis, further discloses wherein the at least one slot comprises a pair of slots on opposing sides of the rigid tubular member [i.e. openings (50) see Davis figure 3].
Regarding claim 3, Springer, as modified by Davis, further discloses wherein the at least one flexible clip comprises a pair of flexible clips on opposing sides of the rigid tubular member [i.e. flexible wings (46) see Davis figure 1].
Regarding claim 7, Springer, as modified by Davis, discloses the apparatus of claim 1. Springer further discloses (Fig. 1B) wherein the push rod is coupled to a rotatable dial (184) adjacent a proximal end of the handpiece to facilitate manual actuation of the push rod (Par. 0058 & 0074-0075).
Regarding claim 8, Springer, as modified by Davis, discloses the apparatus of claim 1. Springer further discloses (Fig. 2B) comprising the IOL cartridge (220) coupled to the apparatus (Par. 0060).
Claims 1-3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Meyer (US 2013/0060257) in view of Davis (US 5,388,589), both cited in previous office action.
Regarding claim 1, an invention relating an IOL injector, Meyer discloses (Figs. 1, 7, 11) an apparatus for delivery of an intraocular lens (Abstract), comprising: a handpiece (10, 20, 30) configured to removably attach to an IOL cartridge [Note, the IOL cartridge is not positively recited, hence it is not considered part of the claimed invention] at a distal end of the handpiece (Par. 0050), the handpiece comprising: a housing, comprising: a rigid tubular member (20 & 30; Par. 0057); at least one slot (13) disposed through the rigid tubular member and configured to engage with a member [i.e. part that engages slot] of the IOL cartridge to secure the IOL cartridge to the handpiece (Par. 0050 & 0061); a push rod (80) movably disposed within the rigid tubular member (Fig. 11); and at least one internal projection (40) extending from an inner wall (see annotated figure below) of the rigid tubular member and configured to engage with a plunger (50) of the IOL cartridge to secure the push rod to the plunger (Par. 0058 & 0060). Also, Springer discloses although in the examples provided above a system of hooks and latches is used to affix the delivery unit to one of the handpieces, the present disclosure is not limited to this type of arrangement. In this regard, it will be understood that any other suitable interface for affixing the delivery unit to the first and second handpieces may be used instead. Similarly, it will be understood that any other suitable receiving interface for affixing the delivery unit to the first and second handpieces may be used, as well. (Par. 0093). However, Springer fails to disclose at least one slot disposed through the rigid tubular member and configured to engage with a flexible member of the IOL cartridge to secure the IOL cartridge to the handpiece; at least one flexible clip disposed adjacent to the at least one slot on the rigid tubular member and configured to abut the flexible member when the IOL cartridge is attached to the handpiece, wherein inward depression of the at least one flexible clip facilitates release of IOL cartridge from the handpiece.
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In the analogous art of medical means of assembly, Davis teaches (Figs. 1-3) at least one slot (50) disposed through a rigid tubular member (40) and configured to engage with a flexible member (74) of a cartridge (60) to secure the cartridge to a handpiece (30); at least one flexible clip (46) disposed adjacent to the at least one slot on the rigid tubular member and configured to abut the flexible member when the IOL cartridge is attached to the handpiece, wherein inward depression of the at least one flexible clip facilitates release of IOL cartridge from the handpiece (Col. 2, lines 51-57 & Col. 3, lines 16-29).
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 substituted the hooks of Meyer that secures the cartridge to the handpiece, for the snap-fit means of assembly of Davis since these mechanisms perform the same function of securing the cartridge to the handpiece. Simply substituting one means of securing for another would yield the predicable result of an assembled device [i.e. assembling of the cartridge and handpiece]. See MPEP 2143.
Regarding claim 2, Meyer, as modified by Davis, further discloses wherein the at least one slot comprises a pair of slots on opposing sides of the rigid tubular member [i.e. openings (50) see Davis figure 3].
Regarding claim 3, Meyer, as modified by Davis, further discloses wherein the at least one flexible clip comprises a pair of flexible clips on opposing sides of the rigid tubular member [i.e. flexible wings (46) see Davis figure 1].
Regarding claim 8, Meyer, as modified by Davis, discloses the apparatus of claim 1. Meyer further discloses comprising the IOL cartridge coupled to the apparatus (Par. 0050 & 0061).
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 1-3, 8-9, and 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 6-8 of U.S. Patent No. 11,903,822. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are fully contained within the claim of the patent application.
Claims 18/415,363
1
2
3
8
9
12
13
14
15
16
17
18
19
20
Claims Patent
11,903,822
1, 2, 6
1, 6
6
1, 2, 6
6
6
6 & 8
1, 2, 6
6
6
7
8
6
6
Claims 7 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2 and 6 of U.S. Patent No. 11,903,822 in view of Springer et al. (US 2019/0224002).
Springer further discloses (Fig. 1B) wherein the push rod is coupled to a rotatable dial (184) adjacent a proximal end of the handpiece to facilitate manual actuation of the push rod (Par. 0058 & 0074-0075).
Allowable Subject Matter
Claims 4-6 and 10 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Modifying the prior art to include the missing limitations wouldn’t have been obvious because modification would only be motivated by hindsight and would possibly render the device inoperable. Furthermore, a teaching reference with this missing structure could not be found.
Response to Arguments
Applicant's arguments filed 03/17/26 have been fully considered but they are not persuasive. Applicant argues that previously cited prior art references Springer in view of Davis, and Meyer in view of Davis, alone or in combination, fail to teach or suggest each and every element of pending independent claim 1, either explicitly or inherently. Specifically, the cited combinations fail to teach or suggest, at least, "at least one slot disposed through the rigid tubular member and configured to engage with a flexible member of the IOL cartridge to secure the IOL cartridge to the handpiece; [and] at least one flexible clip disposed adjacent to the at least one slot on the rigid tubular member and configured to abut the flexible member when the IOL cartridge is attached to the handpiece, wherein inward depression of the at least one flexible clip facilitates release of IOL cartridge from the handpiece", as recited in claim 1. Concerning the detailed limitation, applicant argues that a person of ordinary skill in the art of ophthalmic surgical devices would no reasonably look to a biopsy instrument to modify the cartridge interface of an IOL injector because they are not from analogous arts, hence the proposed combinations of previously cited prior art would be improper. Also, applicant argues the combination of prior art references would be improper because the modification would require relocating and reconfiguring the attachment mechanism which would change the mode of operation; hence the modification would not be considered simple substitution. Examiner respectfully disagrees.
Previously cited prior art reference Davis is only relied upon to teach an attachment mechanism that is functionally equivalent to the attachment mechanisms disclosed by previously cited primary references Davis and Meyer. Davis’s snap-fit attachment mechanism performs the intended function of securing two parts of an assembled medical device together as desired by the primary references and the claimed invention. Also, applicant fails to positively recite the “IOL cartridge” as part of the claimed invention, hence the recitations detailing the IOL cartridge are considered functional. So, structure divulged by the combination of references are considered adequate in functioning with a IOL cartridge as functionally claimed. Furthermore, applicant has not shown that the detailed modifications would destroy the devices of Springer or Meyer and/or prevent the devices from functioning as intended.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 May 15, 2026
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