Notice of 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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “a tip means for atraumatically enabling tissue” in claim 16.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,446,876. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of the instant application are encompassed by that of USPN 12,446,876.
Instant application claim 1
USPN 12,446,876 Claim 1
1. An apparatus comprising:
(a) a first jaw configured to receive a staple cartridge having a distal end which
extends beyond a distal end of the first jaw when seated therein;
(b) a second jaw having a plurality of staple forming pockets and configured to
cooperate with the first jaw to at least clamp tissue; and
(c) a tip coupled with the second jaw such that a proximal end of the tip is longitudinally constrained relative to the second jaw, wherein the tip is configured to transition relative to the second jaw between first and second configurations,
wherein in the first configuration a distal portion of the tip extends non-parallel to a longitudinal axis of the second jaw such that, when the first and second jaws are closed without tissue present therebetween, substantial deflection of the distal portion of the tip toward a distal end of the first jaw is prevented by the distal end of the staple cartridge when seated therein,
and wherein in the second configuration the
distal portion of the tip is deflected away from the distal end of the staple cartridge, wherein the tip is configured to transition from the first configuration to the second configuration at least when the first and second jaws are closed onto tissue extending distally from between the first and second jaws,
wherein the distal end of the tip does not extend distally beyond the distal end of the staple cartridge when seated in the first jaw in at least the first configuration.
1. An apparatus comprising:
(a) a first jaw configured to receive a staple cartridge seated therein and having a plurality of staple apertures that house a plurality of staples, the staple cartridge having a distal end which extends beyond a distal end of the first jaw when seated therein;
(b) a second jaw having a plurality of staple forming pockets configured to form the staples, wherein the first and second jaws are configured to cooperate to clamp and staple tissue with the staples; and
(c) a tip member, wherein the tip member is coupled with the second jaw such that a proximal end of the tip member is longitudinally constrained relative to the second jaw, wherein the tip member is configured to extend along a portion of the first jaw defined by the second jaw, wherein the tip member is configured to transition relative to the second jaw between a first configuration and a second configuration,
wherein in the first configuration a distal portion of the tip member extends non-parallel to a longitudinal axis of the second jaw such that substantial deflection of the distal end toward a distal end of the first jaw is prevented by the distal end of the staple cartridge when seated therein when the first and second jaws are closed without tissue present therebetween,
wherein a distal end of the tip member is configured to not extend distally beyond the distal end of the staple cartridge when seated in the first jaw in at least one of the first configuration or the second configuration, wherein the tip member is configured to transition from the first configuration to the second configuration,
wherein the distal end of the tip is deflected away from the distal end of the staple cartridge, when seated in the first jaw, in response to closure of the first and second jaws onto tissue extending from the first and second jaws.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 12,446,876. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of the instant application are encompassed by that of USPN 12,446,876 such as “the tip” is equivalent to “the tip member”.
Instant application claim 2
USPN 12,446,876 Claim 3
2. The apparatus of claim 1,
wherein in the first configuration the distal end of the tip is positioned at a first distance from a distal end of the staple cartridge, when seated in the first jaw, wherein in the second configuration the distal end of the tip is positioned
at a second distance from the distal end of the staple cartridge, when seated in the first
jaw.
3. The apparatus of claim 1,
wherein in the first configuration the distal end of the tip member is positioned at a first distance from a distal end of the staple cartridge, when seated in the first jaw, wherein in the second configuration the distal of the tip member is positioned at a second distance from the distal end of the staple cartridge, when seated in the first jaw.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 12,446,876. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of the instant application are encompassed by that of USPN 12,446,876.
Instant application claim 3
USPN 12,446,876 Claim 4
3. The apparatus of claim 1, wherein the tip elastically deforms from the first
configuration to the second configuration.
4. The apparatus of claim 1, wherein the tip member is configured to elastically deform to transition from the first configuration to the second configuration.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 6 of U.S. Patent No. 12,446,876. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of the instant application are encompassed by that of USPN 12,446,876.
Instant application claim 4
USPN 12,446,876 Claims 5 and 6
4. The apparatus of claim 1, wherein the distal portion of the tip is one of linear and is
configured to extend angularly relative to the longitudinal axis in the first configuration or curved and is configured to extend along an arcuate path in the first
configuration.
5. The apparatus of claim 1, wherein the distal portion of the tip member is linear and is configured to extend angularly relative to the longitudinal axis when the tip member is in the first configuration.
6. The apparatus of claim 1, wherein the distal portion of the tip member is curved and is configured to extend along an arcuate path when the tip member is in the first configuration.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 of U.S. Patent No. 12,446,876. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of the instant application are encompassed by that of USPN 12,446,876.
Instant application claim 5
USPN 12,446,876 Claim 7
5. The apparatus of claim 1, wherein the tip comprises an underside surface and the
distal end of the staple cartridge includes a distal nose having an angled nose surface,
wherein the underside surface remains spaced apart from the angled nose surface in
the first configuration.
7. The apparatus of claim 1, wherein the tip member includes an underside surface and the distal end of the staple cartridge includes a distal nose having an angled nose surface, wherein the underside surface is configured to remain spaced apart from the angled nose surface in each of the first configuration and the second configuration when the first and second jaws are closed.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10 of U.S. Patent No. 12,446,876. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of the instant application are encompassed by that of USPN 12,446,876.
Instant application claim 7
USPN 12,446,876 Claim 10
7. The apparatus of claim 1, wherein the first and second jaws are pivotable relative to one another between an open state for receiving tissue and a closed state for clamping tissue.
10. The apparatus of claim 1, wherein the first and second jaws are pivotable relative to one another between an open state for receiving tissue and a closed state for clamping tissue.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11 of U.S. Patent No. 12,446,876. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of the instant application are encompassed by that of USPN 12,446,876.
Instant application claim 8
USPN 12,446,876 Claim 11
8. The apparatus of claim 1, wherein the tip comprises a rigid portion and an elastically
deflectable portion.
11. The apparatus of claim 1, wherein the tip member comprises a rigid portion and an elastically deflectable portion.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 12,446,876. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of the instant application are encompassed by that of USPN 12,446,876.
Instant application claim 10
USPN 12,446,876 Claim 1
10. The apparatus of claim 1, wherein the distal portion of the tip deflects away from the
distal end of the first jaw when at least when the first and second jaws are closed
without tissue extending therefrom.
11. “wherein the distal end of the tip is deflected away from the distal end of the staple cartridge, when seated in the first jaw, in response to closure of the first and second jaws”.
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 12,446,876. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of the instant application are encompassed by that of USPN 12,446,876.
Instant application claim 18
USPN 12,446,876 Claims 1-2
18. An apparatus comprising:
(a) a first jaw configured to receive a staple cartridge having a distal end which extends beyond a distal end of the first jaw when seated therein;
(b) a second jaw having a plurality of staple forming pockets and configured to
cooperate with the first jaw to at least clamp tissue; and
(c) a tip affixed to a distal end of the second jaw and resiliently biased to assume an orientation toward the distal end of the staple cartridge when seated therein
such that substantial further deflection toward the distal end of the staple cartridge is prevented and deflect away therefrom in response to a force external to the tip applied thereto,
wherein the distal end of the tip does not extend distally beyond the distal end of the staple cartridge when seated in the first jaw when at least in the orientation.
1. An apparatus comprising:
(a) a first jaw configured to receive a staple cartridge seated therein and having a plurality of staple apertures that house a plurality of staples, the staple cartridge having a distal end which extends beyond a distal end of the first jaw when seated therein;
(b) a second jaw having a plurality of staple forming pockets configured to form the staples, wherein the first and second jaws are configured to cooperate to clamp and staple tissue with the staples; and
(c) a tip member, wherein the tip member is coupled with the second jaw such that a proximal end of the tip member is longitudinally constrained relative to the second jaw, wherein the tip member is configured to extend along a portion of the first jaw defined by the second jaw, wherein the tip member is configured to transition relative to the second jaw between a first configuration and a second configuration,
wherein in the first configuration a distal portion of the tip member extends non-parallel to a longitudinal axis of the second jaw such that substantial deflection of the distal end toward a distal end of the first jaw is prevented by the distal end of the staple cartridge when seated therein when the first and second jaws are closed without tissue present therebetween,
wherein a distal end of the tip member is configured to not extend distally beyond the distal end of the staple cartridge when seated in the first jaw in at least one of the first configuration or the second configuration, wherein the tip member is configured to transition from the first configuration to the second configuration,
wherein the distal end of the tip is deflected away from the distal end of the staple cartridge, when seated in the first jaw, in response to closure of the first and second jaws onto tissue extending from the first and second jaws.
2. The apparatus of claim 1, wherein the second jaw includes a jaw body, wherein the proximal end of the tip member is affixed to a distal end of the jaw body.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11 of U.S. Patent No. 12,446,876. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of the instant application are encompassed by that of USPN 12,446,876.
Instant application claim 20
USPN 12,446,876 Claim 11
20. The apparatus of claim 18, wherein the tip comprises a rigid portion and an elastically
deflectable portion.
11. The apparatus of claim 1, wherein the tip member comprises a rigid portion and an elastically deflectable portion.
Allowable Subject Matter
Claims 16-17 are allowed.
Claims 6,9,11-15,and 19 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 1-5,7-8,10,18, and 20 are rejected under nonstatutory double patenting, these claims would also be allowable if a terminal disclaimer is filed, or independent claims 1 and 18 are amended to overcome the double patenting rejection.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Demmy et al. US 2004/0243151 and Smith US 2019/0076143, both references disclose a surgical stapling apparatus with an introducer tip to resiliently guide a surgical stapler through tissue (See Final rejection dated 3/25/2025 of parent application 17/666,807 for detailed explanation of both of these references related to the limitations of the instant application.
See notice of allowance dated 6/24/2025 of parent application 17/666,807 for reasons of allowance, specifically,
Regarding independent claims 1,16 and 18 none of the prior art references, alone or in proper
combination, anticipate or render obvious the claimed invention, the prior art references of Smith and Demmy in combination disclose or render obvious several features of the claimed invention.
However Smith and Demmy fail to teach an apparatus comprising a first jaw configured to receive a staple cartridge having a distal end which extends beyond a distal end of the first jaw when seated therein, and a second jaw configured to form staples, and a tip that is longitudinally constrained relative to the second jaw and extends along a portion of the first jaw defined by the second jaw, wherein the tip is configured to transition between a first position and a second position such that substantial deflection of the distal end toward the distal end of the first jaw is prevented by the distal end of the staple cartridge when seated therein, such that a distal end of the tip member does not extend beyond a distal end of the opposed jaw, along with all the remaining limitations in the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY C HIBBERT-COPELAND whose telephone number is (571)270-0601. The examiner can normally be reached M-TH 9am -5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anna Kinsaul can be reached at 5712701926. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY C HIBBERT-COPELAND/Examiner, Art Unit 3731
/VERONICA MARTIN/Primary Examiner, Art Unit 3731
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