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 .
1.Claims 7 and 8 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, line 2, it is unclear what “fluid” is being referred to and such should clearly be set forth. As it stands, any fluid that would be within the lenticule will be considered to be encompassed by the claim. Also, in claim 7, line 3, “the controller” lacks antecedent basis. Claim 8, line 3, “the hydrating fluid” also lacks antecedent basis.
2.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) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mueller 2014/0264980 (see paragraphs 0046-0053; Figs. 8 and 16C).
Mueller discloses the basic claimed system for forming a corneal implant including a receptacle (64 in Fig. 16C) configured to receive a lenticule (52) formed from corneal tissue and a cutting apparatus including a laser to cut the lenticule, the applied reference essentially failing to disclose one or more optical elements to direct the laser. It is nothing but conventional in the art to employ such optics—Official Notice is hereby taken of this—and such would have been an obvious modification to the system of Mueller to facilitate the cutting as desired. Concerning maintaining the state of the lenticule, paragraph 0052, line 3 teaches a “controlled environment” in which all operations are performed and such would have clearly been used in the cutting and for the receptacle of Fig. 16C. Paragraph 0052, line 4 discloses “same state of hydration”, thereby meeting instant claim 2. Employing a temperature element or humidifier is nothing but conventional in the art—Official Notice is hereby taken of this—to maintain a state of a material to be processed and including such as part of the receptacle would have been obvious to ensure that the state of the lenticule is maintained. Given that the state of the lenticule is to be maintained, then a sealed enclosure as recited in instant claims 4 and 5 would obviously have been useful to facilitate the maintenance. Further, it is submitted that sealed enclosures to process biological substrates are well known in the art—Official Notice is also hereby taken of this—and such would have been an obvious modification to the system of Mueller to facilitate the “conduction in a controlled environment” so that the lenticule is “maintained in the same state of hydration” as taught by Mueller. Obviously, if the lenticule is contained within an enclosure, and is to be cut with a laser, there would beneficially be a laser transparent window in or on the enclosure. It is submitted that such windows are conventional in the art—Official Notice is also taken of this—and such would have been an obvious feature in the system of the applied reference to allow the laser beam to pass through and perform the ablation of the lenticule.
3.Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mueller 2014/02649809 in view of Swinger 5,647,865 (see Fig. 3 and col. 5, lines 1-17).
Mueller discloses the basic claimed system as set forth in paragraph 2, supra, including a receptacle (64 in Fig. 16C) with one or more evacuation mechanisms (86 in Fig. 16C) that are connected to a vacuum source (paragraph 0066) to hold the lenticule in place and to draw any fluid therefrom (paragraph 0079), the primary reference essentially lacking the aspect of the receptacle including a recess to receive the lenticule and fluid. Swinger shows a similar receptacle that has a recess configured to receive a lenticule and such would have been an obvious modification to the receptacle of Mueller to facilitate the accurate placement and cutting of the lenticule. Mueller (see paragraphs 0073 and 0083) discloses that the steps of the process are automated under the control of a controller, and clearly the laser cutting would have been under such control.
4.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.
5.Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,449,090. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the previously issued patent recite substantially the same or similar system with additional features that are not recited in the instant claims. It is always within the skill level of the art to eliminate features that are not needed.
6.Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,952,900. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the previously issued patent recite substantially the same or similar system with additional features that are not recited in the instant claims. It is always within the skill level of the art to eliminate features that are not needed.
7.Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,070,422. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the previously issued patent recite substantially the same or similar system with additional features that are not recited in the instant claims. It is always within the skill level of the art to eliminate features that are not needed.
8.Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATHIEU D VARGOT whose telephone number is (571)272-1211. The examiner can normally be reached on Mon-Fri from 9 to 6.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christina A Johnson, can be reached at telephone number 571 272-1176. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATHIEU D VARGOT/Primary Examiner, Art Unit 1742
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