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 .
Examiner’s Note
The Examiner reached out to, and left a detailed voicemail for, Applicant’s representative on 06/09/2026 for the purpose of suggesting an Examiner’s amendment to the claims in order to put the Application in condition for allowance and to suggest the filing of an eTD in order to over come the Non-Statutory Double Patenting and amend claim 14 to overcome the Statutory Double Patenting. However, no response was received, therefore, the Examiner has chosen to send out a Non-Final rejection.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “third securement band…fixedly coupled to the body circumferentially between the first coupling tab and the third coupling tab” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. (Examiner’s note: as shown in Fig. 4 it appears that the third securement tab is fixedly coupled to the body between the second coupling tab and the third coupling tab. Also see claim 10 of the Parent Application Allowability Notice where the same issue was corrected via an Examiner’s Amendment)
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 Objections
Claims 14, 16, 26, and 28 are objected to because of the following informalities:
Claim 14 recites “a vascular access puncture site” and “a compressive force” in lines 3 and 14, respectively, although the lines are understood by the Examiner to mean “the vascular access puncture site” and “the compressive force” as both were previously defined prior to their respective lines, the Examiner suggests the lines be amended to read “the vascular access puncture site” and “the compressive force” for the purpose of maintaining consistent language throughout the claims;
Claim 16 recites “the third tab” in line 12, although the line is understood by the Examiner to mean “the third coupling tab” as previously defined and repeated in following limitations, the Examiner suggests the line be amended to read “the third coupling tab” for the purpose of maintaining consistent language throughout the claims;
Claim 16 recites “the patient’s toe” in line 13, although the line is understood by the Examiner to mean “a toe of the patient” as the “toe” was not previously defined, the Examiner suggests the line be amended to read “a toe of the patient” for the purpose of providing proper antecedent basis to the claimed terms;
Claims 26 and 28 recite “the puncture site” and “the vascular access puncture site”, respectively, although the lines are understood by the Examiner to mean “the vascular puncture site” as previously defined and repeated, the Examiner suggests the lines be amended to read “the vascular puncture site” for the purpose of maintaining consistent language throughout the claims;
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 26 and 27 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.
Claims 26 and 27 recite the limitation "the inflatable bladder" in line 1. There is insufficient antecedent basis for this limitation in the claim. Furthermore, the line renders the claims indefinite because it is unclear if Applicant is intending for claims 26 and 27 to be dependent on claim 19 which provides antecedent basis for the “inflatable bladder” or if Applicant is intending for claims 26 and 27 to provide the antecedent basis for the “inflatable bladder”. For the purpose of examination, the Examiner will read the claimed phrase as “an inflatable bladder of the compression member” thereby providing antecedent basis within the respective claims.
Double Patenting
Statutory
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 14 and 15 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 17 and 18 of prior U.S. Patent No. 12,426,864 B2. This is a statutory double patenting rejection.
Non-Statutory
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 16, 17, 19, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 10, and 13 – 16 of U.S. Patent No. 12,426,864 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims would have been obvious over the claims of U.S. Patent No. 12,426,864 B2.
Regarding Instant Claim 16, claim 10 of U.S. Patent No. 12,426,864 B2 also claims compression hemostasis device (claim 1), comprising:
a body (claim 1) comprising:
a first coupling tab (claim 1);
a second coupling tab (claim 1);
a third coupling tab (claim 1);
a fourth coupling tab circumferentially disposed between the first coupling tab and the third coupling tab (claim 7); and
a compression member configured to compress a vascular puncture site (claim 1);
a plurality of securement bands (claim 1), comprising:
a first securement band releasably coupled to the first and second coupling tabs and configured to wrap around an ankle of a patient (claim 1);
a second securement band releasably coupled to the third tab and configured to wrap around the patient's toe or extend between adjacent toes of the patient (claim 1); and
a third securement band releasably coupled to the fourth coupling tab and fixedly coupled to the body circumferentially between the first coupling tab and the third coupling tab (claim 10), wherein the third securement band is configured to wrap around a foot of the patient (claim 10).
Regarding Instant Claim 16, (alternate rejection) claim 13 of U.S. Patent No. 12,426,864 B2 also claims compression hemostasis device (claim 1), comprising:
a body (claim 1) comprising:
a first coupling tab (claim 1);
a second coupling tab (claim 1);
a third coupling tab (claim 1);
a fourth coupling tab circumferentially disposed between the first coupling tab and the third coupling tab (claim 13); and
a compression member configured to compress a vascular puncture site (claim 1);
a plurality of securement bands (claim 1), comprising:
a first securement band releasably coupled to the first and second coupling tabs and configured to wrap around an ankle of a patient (claim 1);
a second securement band releasably coupled to the third tab and configured to wrap around the patient's toe or extend between adjacent toes of the patient (claim 1); and
a third securement band releasably coupled to the fourth coupling tab and fixedly coupled to the body circumferentially between the first coupling tab and the third coupling tab (claim 13), wherein the third securement band is configured to wrap around a foot of the patient (claim 13).
Regarding Instant Claim 17, claim 14 of U.S. Patent No. 12,426,864 B2 also claims
wherein an angle between the first coupling tab and the second coupling tab ranges from 60 degrees to 120 degrees (claim 14);
wherein an angle between the first coupling tab and the third coupling tab ranges from 90 degrees to 150 degrees (claim 14); and
wherein an angle between the first coupling tab and the fourth coupling tab ranges from 30 degrees to 90 degrees (claim 14).
Regarding Instant Claim 19, claim 15 of U.S. Patent No. 12,426,864 B2 also claims wherein the compression member comprises:
a top plate (claim 15);
an inflatable bladder coupled to a bottom surface of the top plate (claim 15); and
an inflation port in fluid communication with the inflatable bladder (claim 15).
Regarding Instant Claim 20, claim 16 of U.S. Patent No. 12,426,864 B2 also claims wherein the inflation port comprises a self- closing valve member coupled to the top plate (claim 20).
Allowable Subject Matter
Claims 14 – 30 are allowed over the prior art. It should be understood that claims 14 and 15 are rejected under Statutory Double Patenting, which can NOT be overcome via a Terminal Disclaimer; and claims 16, 17, 19, and 20 are rejected under Non-Statutory Double Patenting which can be overcome via a Terminal Disclaimer.
Claims 26 and 27 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.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Daneshvar (US 5,779,657 A) teaches a compression hemostasis device.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached 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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/Andrew Restaino/Primary Examiner, Art Unit 3771
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