DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
The instant application filed 01/08/2025 is a Continuation of 18230008, filed 08/03/2023;
18230008 is a Divisional of 16993883, filed 08/14/2020;
16993883 is a Continuation of 16722567, filed 12/20/2019;
16722567 is a Continuation of 16409691, filed 05/10/2019;
16409691 is a Continuation of 15237493, filed 08/15/2016;
15237493 is a Continuation of 14542066, filed 11/14/2014;
14542066 is a Continuation of 13452656, filed 04/20/2012;
13452656 is a Continuation in Part of 12492779, filed 06/26/2009; and
12492779 claims priority from Provisional Application 61077104, filed 06/30/2008.
However, claims 1-14 are directed to subject matter that was introduced for the first time in U.S. Application 12/492,779, filed 6/26/2009. For example, the claim subject matter of an inner sheath (152) disposed between the hemostatic implant and the outer sleeve in the first position (Fig. 9) of the instant application was introduced for the first time in U.S. Application 12/492,779. The earlier filed provisional application does not disclose such an inner sheath.
Thus the effective filing date for the subject matter of claims 1-14 is 6/26/2009.
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 6 and 12 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 6 and 12 recite the limitation "the release sheath". There is insufficient antecedent basis for this limitation in the claim. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret the phrase as - - the inner sheath - -.
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 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) 1-5, 7, 9, 10, 11, 13 and 14 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Khosravi et al (US 2008/0082122).
Khosravi et al discloses the following limitations:
Claim 1. An apparatus for sealing a blood vessel (94) penetration disposed at the end of a tissue tract (90) ([0007], [0045]), the apparatus comprising:
a shaft (elongate member of 140) having an axis (central axis), a proximal end (142), a distal end (144), and an exterior surface (Figs. 4A-4C; [0057]);
an occlusion element (146) located at the distal end of the shaft, the occlusion element having a collapsed configuration (Fig. 4A) and an expanded configuration (Fig. 4C);
a hemostatic implant (102) disposed over the exterior surface of the shaft near the occlusion element at the distal end of the shaft ()[0034], [0057]);
an outer sleeve (120) slidably disposed, in a first position (Fig. 4A), over the hemostatic implant and, when actuated, is retracted proximally away from the occlusion element towards a second position (Fig. 4C; [0058]-[0067], [0070]); and
an inner sheath (170) disposed between the hemostatic implant and the outer sleeve in the first position ([0059]-[0061], [0065], [0070]).
Claim 2. An apparatus according to claim 1, wherein the hemostatic implant (102) is configured to remain stationary on the shaft while the outer sleeve is being retracted ([0083]).
Claim 3. An apparatus according to claim 2, wherein the inner sheath (170) is exposed to the tissue tract when the outer sleeve is retracted proximally (Figs. 4B, 4C; [0061]).
Claim 4. An apparatus according to claim 3, wherein the outer sleeve (120) is configured to couple to and retract the inner sheath (170) to expose the hemostatic implant (102) to the tissue tract as the outer sleeve is retracted ([0074]; “Thus, these feature(s) may…synchronize subsequent movement of the outer tubular member 120 to movement of the housing 180 and/or inner tubular member 170”).
Claim 5. An apparatus according to claim 4, wherein the outer sleeve (120) is configured to be retracted proximally while the occlusion element (146) is in the expanded configuration (once outer sleeve 120 is retracted to partially expose occlusion element 146, the occlusion element may begin to partially expand now that it is not fully constrained within outer sleeve. The outer sleeve may then continue to retract until it is fully retracted).
Claim 7. An apparatus according to claim 5, wherein the hemostatic implant (102) comprises a cylindrical body which circumscribes (140) the shaft and having at least one axial split along its length (Fig. 2; [0033], [0034], wherein in application Ser. No. 11/465,791 incorporated by reference, paragraph [0072] of the publication US 2007/0231366, discloses the side edges of the implant sheet butted to one another, thus allowing the implant to split open).
Claim 9. An apparatus according to claim 5, wherein the hemostatic implant (102) comprises a wrapped sheet which is axially split and which partially or fully circumscribes the shaft (140) ([0034], wherein in application Ser. No. 11/465,791 incorporated by reference, paragraph [0072] of the publication US 2007/0231366, discloses the side edges of the implant sheet butted to one another, thus allowing the implant to split open).
Claim 10. An apparatus according to claim 5, wherein the inner sheath (170) inhibits sticking between the outer sleeve (120) and the hemostatic implant (102) as the outer sleeve is retracted (it is inherent to Khosravi’s disclosure the inner sheath inhibits sticking between the outer sleeve and the implant since the inner sheath is positioned between the outer sleeve and the implant as seen in Fig. 4A. Thus, the inner sheath acts as a barrier between the outer sleeve and implant and prevents the implant from sticking onto the outer sleeve).
Claim 11. An apparatus according to claim 2, wherein the outer sleeve (120) is configured to couple to and retract the inner sheath (170) to expose and release the hemostatic implant as the outer sleeve is retraced ([0074]; “Thus, these feature(s) may…synchronize subsequent movement of the outer tubular member 120 to movement of the housing 180 and/or inner tubular member 170”).
Claim 13. An apparatus according to claim 2, further comprising a back stop (130) on the shaft (140), wherein the back stop engages the hemostatic implant (102) to immobilize the implant while the outer sleeve (120) is being proximally retracted ([0083]).
Claim 14. An apparatus according to claim 2, wherein the hemostatic implant (102) comprises a swellable, biodegradable polymer, wherein the polymer is not fully hydrated when covered by the outer sleeve (120) and inner sheath (170), and hydrates when exposed by retracting the outer sleeve and inner sheath ([0034], [0056]).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 6 and 12 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Khosravi et al in view of Austin (US 2006/0184226).
Claims 6 and 12. Kshoravi et al discloses the invention substantially as claimed above but fails to disclose the inner sheath is split so that the inner sheath opens over the hemostatic implant as the outer sleeve is retracted.
However, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, namely an apparatus for deployment of an implant using elements that retract to thereby expose the implant, Austin discloses an apparatus for deploying an implant (12), wherein the inner sheath (16) is split so that it opens over the implant as the outer sleeve (13) is retracted (Figs. 1 and 2; [0065]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Khosravi et al to have the inner sheath split so that it opens over the implant as the outer sleeve is retracted based upon the teachings of Austin, to prevent damage to the implant during deployment ([0065]).
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 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-5 of U.S. Patent No. 9439637.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11717278.
Although the claims at issue are not identical, they are not patentably distinct from each other because the elements of the claims of the instant application are to be found in the claims of the patents. Thus the difference between the claims of the instant application and the claims of the patents lies in the fact that the patent claims include many more elements and is thus much more specific. Thus, the inventions of the claims of the patents are in effect a “species” of the “generic” invention of the claims 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 the claims are anticipated by the claims of the patents, they are not patentably distinct from the claims of the patents.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-5 of U.S. Patent No. 9439637 in view of Khosravi et al.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-5 of U.S. Patent No. 11717278 in view of Khosravi et al.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the application claims merely add an obvious feature absent from the patent claims.
Claim 14 recites the additional feature of the hemostatic implant comprises a swellable, biodegradable polymer, wherein the polymer is not fully hydrated when covered by the outer sleeve and inner sheath, and hydrates when exposed by retracting the outer sleeve and inner sheath absent from the patent claims. However, Khosravi et al teaches an apparatus for sealing a blood vessel (94) penetration disposed at the end of a tissue tract (90), wherein a hemostatic implant (102) comprises a swellable, biodegradable polymer, wherein the polymer is not fully hydrated when covered by the outer sleeve (120) and inner sheath (170), and hydrates when exposed by retracting the outer sleeve and inner sheath ([0034], [0056]). Therefore, it would have been obvious to one of ordinary skill in the art before at the time of the invention to modify the patent claims to include the features regarding the swellable, biodegradable polymer, to provide an implant made of a material that will reabsorb back into the body when healing is complete and not require further intervention by the surgeon.
Allowable Subject Matter
Claim 8 is 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 and if the above double patenting rejections are obviated.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Khosravi et al discloses the invention substantially as claimed above. The prior art of record does not disclose or fairly suggest either singly or in combination the claimed apparatus comprising, inter alia, the hemostatic implant has a crescent-shaped cross-section. Khosravi et la instead discloses a concentrically mounted cylindrical hemostatic implant on the shaft. Applicant discloses the advantage of such an implant in [0050] of the instant specification, specifically stating the crescent shape allows for lateral displacement of the outer tube 71 and inner rod 76 within the protective sleeve 123. This allows for the volume of the hemostatic implant 121 to be generally the same as a concentric implant. By disposing the outer tube 71 and collapsed occlusive element 90 to one side of the implant, it is much easier to withdraw the apparatus and collapsed occlusion member past the implant without dislodging the implant within the tissue track.
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.
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.
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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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/KATHERINE M SHI/ Primary Examiner, Art Unit 3771
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