DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The disclosure is objected to because of the following informalities: in [0084], “racks 66, 68” should recite - - racks 64, 66 - - to keep the reference numbers consistent.
Appropriate correction is required.
Drawings
The drawings are objected to because reference number 264, which is in reference to the first rack in the specification ([0117], [0118]), is not correctly pointing to the first rack in Figs. 8A-8C. Instead, reference number 264 is pointed at the same structure as housing 223.
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, the 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.
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 4, 5, 8 and 16 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 4 recites the limitation "a second rack". There is insufficient antecedent basis for this limitation in the claim. The term “second” would imply there is a first rack. However, no such rack has been introduced in claim 1 nor claim 4. Therefore, the scope of claim 4 is indefinite and it is not clear how many racks are required by the claim.
Claim(s) 5 is/are rejected as being dependent on, and failing to cure the deficiencies of, their rejected respective parent claims.
Claim 8 recites the limitation "the second rack". There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the corresponding actuation features of the first rack and the second rack".
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 retraction mechanism” (generic placeholder) coupled with the functional language of “configured to retract the expandable member through the sealant” without further structural modifiers (claims 9 and 18).
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
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-3 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Terwey (US 2010/0286727).
Terwey discloses the following limitations:
Claim 1. A closure system (Figs. 5A-5I) for closing a puncture (218) in a vessel wall (228), the closure system comprising:
a tubular member (216) ([0038]);
a positioning member (204) extending through the tubular member and having an expandable member (208; wherein anchor 208 is considered expandable in the radial dimension when transitioning from its low profile in Fig. 5A to its expanded profile in Figs. 5B-5I. This transition results in the radial dimension, orthogonal to the longitudinal axis of the system, expanding in Figs. 5B-5I)) at a distal end thereof;
a sealant (210) positioned in a distal end of the tubular member (Fig. 5A; [0042]);
a support member (212) proximal to the sealant ([0044], [0045]); and
a handle portion (see annotated solid box below, the region enclosed by the box is interpreted as the ‘handle portion’ since any portion therein can be handled by the user) at a proximal end of the tubular member, the handle portion comprising an actuator (see region enclosed by the annotated dashed box below) configured to both deploy the sealant within the puncture and to tamp the sealant against the vessel wall ([0061]).
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Claim 2. The closure system of claim 1, wherein the actuator is actuatable to move the tubular member (216) proximally ([0056]).
Claim 3. The closure system of claim 1, wherein the actuator is actuatable to move the support member (212) distally ([0061]).
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 11-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of copending Application No. 18/929,373 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the elements of claims 11-20 of the instant application are to be found in claim 5 of the reference application. Thus the difference between claims 11-20 of the instant application and claim 5 of the reference application lies in the fact that the reference application claim includes many more elements and is thus much more specific. Thus, the invention of claim 5 of the reference application is in effect a “species” of the “generic” invention of claims 11-20 of the instant application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claims 11-20 are anticipated by claim 5 of the reference application, it is not patentably distinct from claim 5 of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 6-10 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 11-20 are allowable if the double patenting rejection and 35 U.S.C. 112 rejections are obviated.
The following is an examiner’s statement of reasons for indicating allowable subject matter:
In regards to claims 6 and 9, the closest prior art of record, Terwey, discloses the invention substantially as claimed above.
Specifically, in regards to claim 6, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed closure system comprising, inter alia, handle portion further includes a first rack configured to engage with the actuator, the first rack being connected to the tubular member. Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Specifically, in regards to claim 9, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed closure system comprising, inter alia, a retraction mechanism configured to retract the expandable member through the sealant. Instead, the cited expandable member of Terwey is intended to bio-reabsorb into the body ([0041]) and therefore does not require a need for retraction. Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
In regards to claim 11, the closest prior arts of record include Forsberg (US 2006/0229674) and Weldon et al (US 2003/0191516).
Forsberg discloses a system (200) for closing a puncture in a vessel wall ([0040]; Figs. 5-8), comprising: a housing (252); a tubular member (202) comprising a lumen; a support member (212), wherein at least a portion of the support member is positioned within the tubular member lumen ([0044]-[0046]); a sealant (210) positioned in a distal end of the tubular member lumen, wherein a distal end of the support member is positioned adjacent to a proximal end of the sealant ([0043]; elongate member 204 is threaded through perforations of sealant 210)(Fig. 5; [0044]).
Weldon et al discloses a system (Figs. 2-3) for delivering a device (10) into a blood vessel, the device comprising: a first rack member (34); a tubular member (28) coupled to a distal end of the first rack member and movable with the first rack member (Figs. 2A-2C; [0035], [0037]), wherein the tubular member further comprises a lumen; a second rack member (36); a support member (27) coupled to a distal end of the second rack member and movable with the second rack member ([0035], [0037]), and wherein at least a portion of the support member is positioned within the tubular member lumen (Figs. 2A-2C); a device (10) positioned in a distal end of the tubular member lumen, and wherein a distal end of the support member is positioned adjacent a proximal end of the device; and a deployment actuator (48 or 49) configured to both: engage the first rack member to actuate the first rack member in a first direction; engage the second rack member to actuate the second rack member in a second direction opposite the first direction (Figs. 3A, 3B; [0039]).
It would not have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Forsberg with the racks and deployment actuator of Weldon et al as this would destroy the intended purpose of the mechanism of Forsberg. Forsberg discloses the importance of its automatic variable gear ratio transmission (240) to perform automatic driving of the tubular member (212). A scroll gearset (244) of the automatic variable gear ratio transmission is drive by a spool (248) the elongate member (204) is wound upon. It would require undue experimentation by one of ordinary skill in the art to combine the deployment actuation and racks of Weldon et al into the deployment mechanism of Forsberg without destroying or altering the automatic driving of the tubular member (212). Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/KATHERINE M SHI/ Primary Examiner, Art Unit 3771
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