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 .
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-8, drawn to apparatus, classified in A61F9/00754.
II. Claims 9-17, drawn to method, classified in Y10T29/49.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product made and process of making. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the process as claimed can be used to make another and materially different product. Specifically, a biopsy device to cut/sample tissue from non-ocular tissue.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
An extensive search of multiple classifications would have to be conducted and applicable art for the two inventions would not necessarily be applicable to one another.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Joseph Felber on 08/13/16 a provisional election was made without traverse to prosecute the invention of elected group I, claims 1-8. Affirmation of this election must be made by applicant in replying to this Office action. Claims 9-17 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claims 2-3 and 5-6 objected to because of the following informalities:
In claim 2, line 2: “all spoke members” should read “the plurality of spoke members”.
In claim 3, line 1: “each spoke member” should read “each spoke member of the plurality of spoke members”.
In claim 5, line 2: “its circumference” should read “a circumference of the circular body”.
In claim 6, line 2: “its circumference” should read “a circumference of the circular body”.
Appropriate correction is required.
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 3-4 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.
Regarding claim 3, the phrase "possibly" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the limitation will be interpreted as not part of the claimed invention. Claim 4 is rejected for the same reasons as claim 3 by virtue of dependency on claim 3.
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, 5, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Keller (US 2014/0350554).
Regarding claim 1, an invention relating to capsulotomy, Keller discloses (Figs. 21-24) a cutting blade [i.e. bottom portion comprising the circular electrode and a top portion comprising the discrete tabs] for a capsulotomy device having a unitary one-piece construction [i.e. a continuous structure], the cutting blade comprising a circular body [i.e. bottom portion of support structure making up the circular electrode] and a plurality of spoke members [i.e. discrete tabs (75) cut out from the top portion of the support structure] integral with the body [i.e. one continuous piece] and extending each away from different circumferential locations about the body to meet at a central region of the cutting blade [i.e. the central region is a circular area with a diameter less than the diameter of the circular body, and the circular area encompasses a distal portion of the discrete tabs. The discrete tabs are pointed radially into the center of the elastomeric structure from where the top portion meets the bottom portion of the support structure, and the discrete tabs can be longer than depicted] (Fig. 22; Abstract; Par. 0066, 0070-0071, 0129).
Regarding claim 5, Keller discloses the cutting blade of claim 1. Keller further discloses wherein the circular body comprises a circular cutting edge along its circumference (Par. 0068).
Regarding claim 7, Keller discloses the cutting blade of claim 1. Keller further discloses wherein the entire cutting blade is formed of the same material (Par. 0066, 0071, 0129, 0143).
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 1-2 and 5-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,310,889 in view of Keller (US 2014/0350554).
Claims
19/186,085
1
2
5
6
7
8
Claims
US Patent No
12,310,889
1
1
1
1
1
1
Claim 1 of Patent No. 12,310,889 fails to claim the cutting blade … has a unitary one-piece construction [in Claim 1 of application 19/186,085], wherein the entire cutting blade is formed of the same material [in Claims 7 & 8 of application 19/186,085].
In the same field of endeavor, which is capsulotomy, Keller teaches (Figs. 21-24) a cutting blade [i.e. bottom portion comprising the circular electrode and a top portion comprising the discrete tabs] for a capsulotomy device having a unitary one-piece construction [i.e. a continuous structure], wherein the entire cutting blade is formed of the same material (Fig. 22; Abstract; Par. 0066, 0070-0071, 0129, 0143).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified Patent No. 12,310,889 to have a cutting blade for a capsulotomy device having a unitary one-piece construction, as taught by Keller, instead of a plurality of parts, since it has been held that the use of a one piece construction instead of a plurality of separable parts would be merely a matter of obvious engineering choice. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). Also, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified Patent No. 12,310,889 to have wherein the entire cutting blade is formed of the same material, as taught by Keller. It has been held to be within the general skill of a worker, in the art, to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Allowable Subject Matter
Claim 2 would be allowable if a timely filing of a terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) is made to overcome the nonstatutory double patenting rejection, set forth in this Office action, and if rewritten to include all of the limitations of the base claim and any intervening claims.
Claim 3 would be allowable if rewritten to overcome the rejection 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. Prior art of record above fails to disclose wherein each spoke member is formed with at least one twist region.
Conclusion
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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/CHIMA U IGBOKO/ Examiner, Art Unit 3771
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