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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. 14/924,087; 13/328,003; and 12/485,576 as well as Provisional Application Nos. 61/459,970; 61/483,679; 61/162,249; and 61/073,340, each fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. None of the cited priority documents discloses a suture anchor and/or an anchor and suture assembly wherein the anchor comprises a tubular anchor body and a blunt tip portion at a distal end of the tubular body. Accordingly, claims 1-10 and 14-20 have a priority date of June 28, 2019 (i.e., the filing date of 16/456,692 having support for such “a blunt tip portion”).
Specification
The disclosure is objected to because of the following informalities:
In at least paragraphs [0267] and [0279], reference numeral “286” is improperly used to designate both a second portion and a third portion.
Appropriate correction is required.
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 do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a retaining structure” in claims 4 and 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend 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 avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-4 and 6-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Larsen et al. (US 5,948,000).
Larsen discloses (see Figs. 1-8 and 23-24) an anchor and suture assembly comprising the following claim limitations:
(claim 1) A suture anchor comprising: a tubular body (12, Fig. 1) defining a lumen (i.e., see interior ghost lines in Fig. 1, with suture 30 disposed therein) therethrough with a proximal open end (at 14, Fig. 1) configured and dimensioned to be (i.e., capable of) removably mounted on an anchor holder arm (as expressly shown in Figs. 6-8); and a blunt tip portion (20, Fig. 1) at a distal end of said tubular body (12) (as expressly shown in Figs. 1-3 and 23-24);
(claim 2) wherein a suture hole (i.e., plurality of holes depicted between adjacent legs 15) is defined in said tubular body (12) between the proximal open end (at 14, Fig. 1) and the distal end (13, Fig. 1) (as expressly shown in Figs. 6-7);
(claim 3) wherein the proximal open end (at 14, Fig. 1) of said tubular body (12) is configured to (i.e., capable of) removably receive the anchor holder arm (261, Figs. 6-8) to removably retain said suture anchor on the anchor holder arm (261) (col.5, lines 4-9; removable anchor retention expressly disclosed);
(claim 4) wherein said tubular body (12) includes a retaining structure (i.e., proximal end portions of legs 15) configured to (i.e., capable of) engage the anchor holder arm (261) (as shown in Figs. 6-8; col. 5, lines 4-9);
(claim 6) wherein said blunt tip portion (20) is received in a distal open end (at 13, Fig. 1) of said tubular body (12) to extend into the lumen defined through said tubular body (12) (as expressly shown in Fig. 1);
(claim 7) wherein said tubular body (12) includes one or more tip tabs (17, Fig. 1; i.e., inner inclined tab portions) extending radially inwardly toward the lumen defined through said tubular body (12) to engage a portion of said blunt tip portion (20) received in the lumen defined in said tubular body (12) (as expressly shown in Figs. 1-3 and 23-24);
(claim 8) wherein said blunt tip portion (20) defines a tab groove portion (24, Fig. 1) configured and positioned to be (i.e., capable of) engaged with said tip tabs (17) of said tubular body (12) to retain said blunt tip portion (20) with respect to said tubular body (12) (as expressly shown in Figs. 1-3 and 23-24; inclined tabs 17 positioned to engage shaft 22 and grooves 24 when tip 20 is retained in tubular body 12);
(claim 9) wherein said blunt tip portion (20) further defines a capture groove (21, Fig. 1) configured to be (i.e., capable of) engaged by a capture device configured to (i.e., capable of) remove said blunt tip portion (20) from engagement with said tubular body (12) (as shown in Fig. 1, transverse aperture 21 is fully capable of receiving another suture (or any other capture device) to pull tip portion 20 from tubular body 12);
(claim 10) wherein the capture groove (21) is positioned between a distalmost blunt tip (i.e., flat/truncated frustoconical end wall of tip 20; distally disposed relative to capture groove 21) of said blunt tip portion (20) and the tab groove portion (24; proximally disposed relative to capture groove 21) of said blunt tip portion (20);
(claim 11) An anchor and suture assembly comprising: a suture anchor (10, Fig. 1) including a tubular anchor body (11, Fig. 1) having a tubular wall (12, Fig. 1) with a suture hole (i.e., plurality of holes depicted between adjacent legs 15) extending radially through said tubular wall (12) (as shown in Figs. 1-3); and a suture (30, Fig. 1) having a first end (i.e., distal end) secured within the tubular anchor body (11) (as shown in Figs. 1-3 and 23-24; distal end of suture secured within aperture 21), said suture (30) extending out of said tubular anchor body (11) through the suture hole and to a second end (i.e., proximally extending suture end) outside said suture anchor (10) (as expressly shown in Fig. 6-8);
(claim 12) wherein said tubular body (11) includes a retaining structure (17, Fig. 1; i.e., inner inclined tab portions) configured to (i.e., capable of) engage said suture (30) (as expressly shown in Figs. 1-3 and 23);
(claim 13) wherein said retaining structure (17) includes one or more suture tabs (i.e., inner inclined tab portions of element 17) extending radially inwardly toward the lumen of said tubular body (11) to engage said suture (30) (as shown in Figs. 1-3 and 23); and
(claim 14) further comprising a blunt tip portion (20, Fig. 1) at an end of said tubular body (11) (as shown in Figs. 1-3 and 23-24).
Claim(s) 1, 3-5, 15-17 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Modesitt et al. (US 6,136,010).
Modesitt discloses (see Figs. 4-5) a suturing system comprising the following claim limitations:
(claim 1) A suture anchor comprising: a tubular body (40, Figs. 4-4A) defining a lumen (46, Figs. 4-4A) therethrough with a proximal open end (i.e., right end adjacent 48 in Figs. 4-4A) configured and dimensioned to (i.e., capable of) be removably mounted on an anchor holder arm (38, Figs. 4-4A); and a blunt tip portion (i.e., flat/blunt left end adjacent 50 in Figs. 4-4A) at a distal end (i.e., left end adjacent 50 in Figs. 4-4A) of said tubular body (40);
(claim 3) wherein the proximal open end (i.e., right end) of said tubular body (40) is configured to (i.e., capable of) removably receive the anchor holder arm (38) to removably retain said suture anchor on the anchor holder arm (38) (as expressly shown in Fig. 5);
(claim 4) wherein said tubular body (40) includes a retaining structure (48, Figs. 4-4A) configured to (i.e., capable of) engage the anchor holder arm (38) (see Fig. 4; col. 7, lines 28-39; col. 8, lines 13-16);
(claim 5) wherein said retaining structure (48) includes one or more needle holder tabs extending radially inwardly from said tubular body (40) toward the lumen (46) defined through said tubular body (40) to engage the anchor holder arm (38) received therein (as shown in Figs. 4-5; col. 7, lines 28-39; col. 8, lines 13-16);
(claim 15) An anchor and suture assembly for use in association with a suturing device having a movable anchor holder arm (38, Figs. 4-5), said assembly comprising: an anchor having a tubular body (40, Figs. 4-4A) with a first end (i.e., left end adjacent 50 in Figs. 4-4A) and a second end (i.e., right end adjacent 48 in Figs. 4-4A) and defining a lumen (46, Figs. 4-4A) extending therethrough between the first end and the second end (as shown in Figs. 4-4A), a blunt anchor tip (i.e., flat/blunt left end adjacent 50 in Figs. 4-4A) at the first end of said tubular body (40) (as shown in Figs. 4-4A), and an opening at the second end of said tubular body (40) communicating with the lumen (46) through said tubular body (40) and configured to (i.e., capable of) receive an end (42, Fig. 4) of the anchor holder arm (38) (as shown in Figs. 4-5; col. 7, lines 30-39); and a suture (34, Figs. 4-5) extending through a suture opening (i.e., lumen opening adjacent 50 in Figs. 4-4A) defined in said tubular body (40) of said anchor and fixed within the lumen (46) of said tubular body (40) (as shown in Fig. 4; col. 7, lines 40-46);
(claim 16) wherein said tubular body (40) includes one or more needle holder tabs (48, Figs. 4-4A) extending radially inwardly toward the lumen (46) defined through said tubular body (40) for releasably retaining said tubular body (40) relative to the needle holder arm (38) (as shown in Figs. 4-5; col. 7, lines 28-39; col. 8, lines 13-16);
(claim 17) wherein said needle holder tabs (48) are elastically deformable to allow said tubular body (40) to be released from the needle holder arm (38) upon application of force therebetween (col. 7, lines 28-39; col. 8, lines 13-16; resiliently displaceable tabs 48 expressly disclosed); and
(claim 19) wherein said tubular body (40) includes one or more suture tabs (50, Figs. 4-4A) extending radially inwardly toward the lumen (46) defined through said tubular body (40) (col. 7, lines 40-46; tab/collar 50 expressly compressed radially inward to secure suture 34), said suture (34) extending through the suture opening and engaged by said one or more suture tabs (50) to be retained within said tubular body (40) (as expressly shown in Fig. 4).
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,812,951. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader variants of the claims of the patent and this anticipate the claims of the patent, as set forth below. See MPEP 2131.02(I).
Present Invention
U.S. Pat. No. 11,812,951
1
1-11
2
4,8-11
3
1-11
4
1-11
5
1-7
6
1-11
7
1-11
8
1-11
9
1-11
10
1-7
11
4,8-11
12
4,8-11
13
4,11
14
4,8-11
15
4,8-11
16
4
17
4
18
4,8-11
19
4,11
20
4,11
Allowable Subject Matter
Claims 18 and 20 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. It is noted that claims 18 and 20 remain subject to double patenting rejections as set forth above, that must be resolved before either claim can be rewritten into proper condition for allowance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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