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 implant “core” (claim 12, line 2; page 22, line 2, of specification) must be shown or the feature canceled from the claim. No new matter should be entered.
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, 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.
Specification
The disclosure is objected to because of the following informalities: Reference characters 130a and 130b (Figure 3) are not believed to be mentioned in the specification. On page 5, line 1, “inward the cannula” lacks proper grammatical syntax. In the Brief Description of the Drawings on pages 6-7 of the specification, reference should be made to each drawing, namely Figures 2(a)-2(b), 4(a)-4(e), 5(a)-5(i), and 8(a)-8(b); attention is directed to MPEP § 608.01(f). On page 12, the sentence beginning on line 15 should start with a capitalized word. On page 17, the second to last line is lacking a closed parenthesis. On page 22, line 2, “core 330” is not indicated in the drawings. On page 23, line 15, “12” is not shown in the drawings or is erroneous. On page 24, line 15, --be-- should apparently be inserted after “to”. Appropriate correction is required.
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, 10, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of copending Application No. 19/054,936 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because all of the limitations of instant claims 1, 10, and 13 are clearly set forth in copending claims 1-4. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Nazzaro, US 2022/0168141 A1, which discloses an apparatus 100 for injecting an implant 112 for eye disease (abstract; Figures 1B-1C; paragraphs 0003, 0017, 0020-0021, 0030, 0032), the apparatus comprising a cannula needle 104 having an internal space 104a and at least first, second, and third integrally connected segments, the latter including a side opening 116 for retaining implant 112 (Figures 3A-3C, 4A, 4C, 6A-6B; paragraphs 0005, 0016, 0018-0021, 0028-0032). Regarding claims 2-3, the distance d (Figure 3A) represents the sum of lengths of first segment or beveled distal end 105 and the second segment, which extends from first segment 105 to third segment at side opening 116, and distance d may be 5mm or 10mm such that the length of the second segment is larger than 1mm (paragraph 0028).
Regarding claims 4-7, heights of each open end may, for example, be measured from distal end 105, and a continuum of inclinations and lateral heights are innate from the curvatures associated with cutout 116 into the circular or rounded cross-section of cannula needle 104 (Figure 4A, bottom middle drawing; paragraph 0028); heights could also be measured relative to flexible arm 114 and hook 115 at positions depicted in Figures 3A-3C. Regarding claim 8, cannula needle 104 is open at beveled distal end 105 [Figures 3C, 4A (topmost drawing); paragraphs 0005, 0025, 0032]. Regarding claim 9, needle stop 106 defines a second segment protrusion disposed adjacent to side opening 116 (Figures 2A, 5A-5C, 6A-6B; paragraphs 0035-0036).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Nazzaro, US 2022/0168141 A1, in view of Camras et al., US 2016/0058615 A1. Regarding claim 10, implant 112 being tubular would have been obvious to one of ordinary skill in the art at the effective filing date of the present application in view of the drawings of Camras et al., who teach that implant passages are useful “for draining aqueous humor from an eye for reducing intraocular pressure” [abstract, first sentence; paragraphs 0001-0003, 0007, 0040-0041, 0078 (trocar; “a multitude of instruments familiar to ophthalmologic practitioners may be used… to make a stab incision through the sclera into the anterior chamber”), 0084 (“minimal invasiveness”)], with further motivation (to combine) provided by the implant materials and purposes discussed by Nazzaro (paragraphs 0003, 0021, 0033) and Camras et al. similarly being directed to various agents for treating an eye and facilitating implantation (paragraphs 0073-0075, 0084); the tubular variant 112 would then be disposed in the second segment during the insertion process (Figure 3B of Nazzaro).
Regarding claim 11, implant 112 is inserted into cannula 104 toward first segment 105 through opening 116 accommodating hook 115 forced outwardly (Nazzaro: Figures 3A-3C; paragraphs 0029-0030); moreover, implant 112 is capable (MPEP § 2114) of extending or passing through opening 116 (by pulling flexible arm 114 and hook 115 further outwardly) even though such was not the intended purpose, and Applicant’s claim 11 could also be interpreted as a product-by-process assembly (MPEP § 2113). Regarding claims 12-15, Camras et al. include various cores [such as filters and inner structures: Figures 3, 7-8, 11-12, 16, 19-20, 25, 28; paragraphs 0040, 0047 (“filter 40 functions to prevent bacterial migration and may be used to regulate intraocular pressure”), 0049, 0069], wings [Figures 1-2, 4, 6-7, 9-11, 13-15, 18-19, 22, 24-27, 29; paragraphs 0007 (“tabs are adapted to be disposed subconjunctivally for securing the drainage apparatus relative to the eyeball”), 0046 (“prevent extrusion or pultrusion”), 0064 (“suture wings 202”)], and matrix covers impregnated with a solution for eye disease [paragraphs 0073-0075 (“growth factors”; “heparin”; “drug eluting coating”)], and these features would have been obvious from the respective advantages, as explained in the cited passages.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David H. Willse, whose telephone number is 571-272-4762. The examiner can normally be reached on Monday through Thursday. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Thomas Barrett can be reached at telephone number 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID H WILLSE/ Primary Examiner, Art Unit 3774