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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2/11/25 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: in lines 6-7, the Examiner suggests inserting --and-- between “tissue;” and “a handle”. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: in line 1, the Examiner suggests inserting --grip-- between “elongate” and “includes”. 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, and 12-15 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 3 recites the limitation "the elongate housing" in line 6. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 4 recites the limitation "the truncate stub" in line 3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 12 recites the limitation "the elongate housing" in line 4. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claims 13-15 are dependent on rejected claim 12, thus are also rendered indefinite.
Claim 14 recites the limitation "the housing" in line 2. There is insufficient antecedent basis for this limitation in the claim. 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 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12,239,339 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, US 12,239,339 B2 discloses a medical device for tissue removal (claim 1), the medical device comprising: a housing (claim 1); a shaft extending at least partially through the housing and extending distally out of the housing, the shaft including a cutter configured to be driven by an actuator or driver to cut tissue (claim 1); a handle comprising an elongate grip pivotably coupled to the housing (claim 1).
Regarding claim 2, US 12,239,339 B2 discloses that the elongate grip is translatable along the housing (claim 1).
Regarding claim 3, US 12,239,339 B2 discloses that the elongate grip is configured to pivotable to move between: a collapsed position wherein the elongate grip is at least partially located in a cavity in the housing (claim 2); and a deployed position wherein the elongate grip extends distally and laterally outward from the elongate housing (claim 2).
Regarding claim 4, US 12,239,339 B2 discloses that the elongate grip includes at least one longitudinal groove, at least a portion of the handle located at least partially within the longitudinal groove such that the truncate stub is translatable relative to the housing along the longitudinal groove (claim 3).
Regarding claim 5, US 12,239,339 B2 discloses that the shaft includes a lumen connectable to a vacuum port to receive remote suction in the lumen (claim 4).
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, 3, and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller et al. (US 2008/0221580 A1) (“Miller”).
Regarding claim 1, Miller discloses (Figures 4A-5D) a medical device for tissue removal, the medical device comprising: a housing (330a); a shaft (352) extending at least partially through the housing and extending distally out of the housing, the shaft including a cutter (attaches to penetrator 220 with cutting surface 222; paragraph 0075) configured to be driven by an actuator or driver (motor) to cut tissue; a handle comprising an elongate grip (390b) pivotably coupled to the housing.
Regarding claim 3, Miller discloses that the elongate grip (390b) is configured to pivotable to move between: a collapsed position wherein the elongate grip is at least partially located in a cavity in the housing (Figure 5A); and a deployed position wherein the elongate grip extends distally and laterally outward from the elongate housing (Figure 5D).
Regarding claim 12, Miller discloses a method of using a medical device with a collapsible handle, the method comprising: turning an elongate grip (390b) about a pivot (392) on a truncate stub (see Figure 5A annotated below); positioning a cutter (222) at a distal end of a shaft (352), the shaft extending through the elongate housing and distally therefrom (Figure 5A); and severing tissue with the cutter (paragraphs 0065, 0073).
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Regarding claim 13, Miller discloses (Figure 5A) turning further comprises closing the elongate grip aft about the pivot (392) and at least partially disposing the grip in a cavity (within 390a) in the elongate housing (paragraphs 0077-0078).
Regarding claim 14, Miller discloses (Figure 5D) opening the elongate grip fore and extending the grip distally from the housing (paragraph 0078).
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vij et al. (US 2015/0272596 A1) (“Vij”).
Regarding claim 1, Vij discloses (Figures 1-2B) a medical device for tissue removal, the medical device comprising: a housing (10h); a shaft (11s) extending at least partially through the housing and extending distally out of the housing, the shaft including a cutter (held by 11c) configured to be driven by an actuator or driver (M) to cut tissue (paragraph 0092); a handle comprising an elongate grip (12) pivotably coupled to the housing (via 12p, paragraph 0067).
Regarding claim 2, Vij discloses (Figures 1-2B) the elongate grip is translatable along the housing (at 12s).
Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mark et al. (US 2011/0190801 A1) (“Mark”).
Regarding claim 1, Mark discloses (Figures 5A-5D) a medical device for tissue removal, the medical device comprising: a housing (408, 436); a shaft (402) extending at least partially through the housing (at 406) and extending distally out of the housing (at 404), the shaft including a cutter (416) configured to be driven by an actuator or driver (444; paragraphs 0081, 0092) to cut tissue (paragraph 0092); a handle comprising an elongate grip (434) pivotably coupled to the housing (paragraphs 0082-0083).
Regarding claim 5, Mark discloses (Figures 5A-5D) that the shaft (402) includes a lumen connectable to a vacuum port (426) to receive remote suction in the lumen (paragraph 0093).
Claims 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (US 5,645,519) (“Lee”).
Regarding claim 6, Lee discloses (Figures 1 and 2) a collapsible handle for use with a medical instrument (NOTE: the medical instrument is not positively recited in the claim), the handle comprising: a truncate stub (116) capable of coupling to a medical instrument; and an elongate grip (114) pivotably connected to the truncate stub (at 69), the elongate grip capable of pivotably alternating between: a collapsed position wherein the elongate grip is closed aft and at least partially disposed in a cavity in an elongate housing of the medical instrument (NOTE: the cavity and the elongate housing are part of the medical instrument, which is not positively recited the claim); and a deployed position wherein the elongate grip opens fore and extends distally from the housing (Column 9, lines 28-49 and Column 11, line 65 – Column 12, line 2).
Regarding claim 7, the truncate stub (116) disclosed by Lee is capable of slidably coupling to the elongate housing (Column 11, lines 32-44). NOTE: as stated above, the elongate housing is not positively recited.
Regarding claim 8, the truncate stub disclosed by Lee is capable of slidably coupling to the elongate housing in at least one longitudinal groove of the elongate housing (Column 11, lines 32-44). NOTE: as stated above, the elongate housing (and thus the at least one longitudinal groove) is not positively recited.
Allowable Subject Matter
Claims 9-11 are 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.
Claims 4 and 15 would be allowable if rewritten to overcome the rejection(s) 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.
The following is a statement of reasons for the indication of allowable subject matter: claim 4 recites that the elongate grip includes at least one longitudinal groove, at least a portion of the handle located at least partially within the longitudinal groove such that the truncate stub is translatable relative to the housing along the longitudinal grip. These limitations (if rewritten to overcome the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph above), in combination with the limitations of claim 1 and intervening claim 3, are not disclosed or suggested in the prior art of record.
claim 9 recites that the elongate grip is pivotably coupled to the truncate stub at a first end of the elongate grip, the first end of the elongate grip including an eccentric locking cam configured to engage on the elongate housing when the elongate grip is in the deployed position. The prior art of record fails to disclose or suggest these limitations, in combination with the limitations of independent claim 6 and intervening claims 7 and 8. Lee discloses that the elongate grip (54) is pivotably coupled to the truncate stub at a first end of the elongate grip. However, Lee fails to disclose or suggest the first end of the elongate grip including an eccentric locking cam configured to engage on the elongate housing when the elongate grip is in the deployed position. Claims 10 and 11 are dependent on claim 9, thus would also be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 15 recites that the method further comprises sliding the truncate stub along at least one longitudinal groove in the elongate housing. The prior art of record fails to disclose or suggest this limitation in combination with the limitations of claim 12.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Christoudias (US 5,565,004) discloses (Figures 4-6) a medical device (twin forceps approximator 10) with an adjustable/pivotable handle/grip (25) similar to that of the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN D KNAUSS whose telephone number is (571)272-8641. The examiner can normally be reached M-F 12:30-8:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771
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