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 .
Response to Amendment
In response to the amendment filed on 10/01/2024, Claims 1 has been cancelled, and newly added Claims 2-20 are pending.
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.
Claim 15 is 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 15 recites the limitation "the transparent window" in Line 1. There is insufficient antecedent basis for this limitation in the claim. It is noted that Claim 15 currently depends on Claim 13, however “a transparent window” is first recited in Claim 14.
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 2, 9 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 12,102,307. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding Present Claim 2, Claim 18 (which includes the language of Claim 1, 16 and 17 by dependency) of Pat ’307 discloses a customizable surgical delivery device to provide one or more flexible sleeves for delivery of one or more silicone implants (Claim 1; Column 15, Lines 8-10; the examiner notes that the term customizable is an intended use in the preamble and does not obviate the double patenting rejection, furthermore Claim 1, Column 15, Line 11 discloses that the flexible main body is adjustable and thus is customizable), comprising:
a flexible main body that is flat and adjustable to an expanded condition to provide an interior cavity sized to receive a silicone implant (Claim 1; Column 15, Lines 11-13), the flexible main body comprising an intermediate section, a first tapered section adjacent to the intermediate section and offset from a central lateral axis of the intermediate section (Claim 1; Column 15, Lines 13-16), and a second tapered section adjacent to the intermediate section and offset from the central lateral axis of the intermediate section opposite from the first tapered section so that at least one of the first and second tapered sections is separable from a portion of the intermediate section for expansion to a tapered implant guide sleeve (Claim 1; Column 15, Lines 17-23), wherein the first tapered section extends away from the intermediate section to a first end that extends parallel to the central lateral axis (Claim 1; Column 15, Lines 23-25), and the second tapered extends away from the intermediate section to a second end that extends parallel to the central lateral axis and the first end (Claim 1; Column 15, Lines 25-28),
wherein the intermediate section comprises a first side edge and a second side edge opposite from the first side edge, the first and second side edges extending parallel to a central longitudinal axis of the intermediate section (Claim 16; wherein the first/second side edge of present Claim 1 is the same as the first tapered edge in Claim 16),
wherein the first tapered section comprises a first tapered edge extending from one of the first and second side edges of the intermediate section toward the first end at a first taper angle (Claim 17, wherein the taper angle is 150 degrees), and a first straight edge collinear with another of the first and second side edges of the intermediate section and extending toward the first end (Claim 18), and
wherein the second tapered section comprises a second tapered edge extending from one of the first and second side edges of the intermediate section toward the second end at a second taper angle equal to the first taper angle (Claim 17, wherein the taper angle is 150 degrees and is equal to the first taper angle which is 150 degrees), and a second straight edge collinear with another of the first and second side edges of the intermediate section and extending toward the second end equally sized with the first end (Claim 18).
Regarding Present Claim 9, Claim 18 of Pat ’307 discloses the device of claim 2, further comprising first and second exterior handles attached to opposing major surfaces of the flexible main body at a location proximate to a first cut line formed on the flexible main body to provide grasping locations when expanding at least one of said first and second tapered sections into said tapered implant guide sleeve (Claim 1; Column 15, Lines 29-34);.
Regarding Present Claim 19, Claim 18 of Pat ’307 discloses the surgical implant delivery device of claim 2, wherein the first taper angle of the first tapered section is about 150-degrees, and the second taper angle of the second tapered section is about 150-degrees (Claim 17).
Claim 2, 14, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16, 18, 19 of U.S. Patent No. 11,350,917. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding Present Claim 2, Claim 16 (which includes the limitation of Claim 1) of Pat ‘917 discloses a customizable surgical delivery device to provide one or more flexible sleeves for delivery of one or more silicone implants (Claim 1, Column 15, Lines 7-9), comprising:
a flexible main body that is flat and adjustable to an expanded condition to provide an interior cavity sized to receive a silicone implant (Claim 16), the flexible main body comprising an intermediate section, a first tapered section adjacent to the intermediate section and offset from a central lateral axis of the intermediate section, and a second tapered section adjacent to the intermediate section and offset from the central lateral axis of the intermediate section opposite from the first tapered section so that at least one of the first and second tapered sections is separable from a portion of the intermediate section for expansion to a tapered implant guide sleeve (Claim 1, Column 15, Lines 10-18),
wherein the intermediate section comprises a first side edge and a second side edge opposite from the first side edge, the first and second side edges extending parallel to a central longitudinal axis of the intermediate section (Claim 1, Column 15, Lines 19-23),
wherein the first tapered section comprises a first tapered edge extending from one of the first and second side edges of the intermediate section toward the first end at a first taper angle and a first straight edge collinear with another of the first and second side edges of the intermediate section and extending toward the first end (Claim 1, Column 15, Lines 24-28), and
wherein the second tapered section comprises a second tapered edge extending from one of the first and second side edges of the intermediate section toward the second end at a second taper angle equal to the first taper angle, and a second straight edge collinear with another of the first and second side edges of the intermediate section and extending toward the second end equally sized with the first end (Claim 1, Column 15, Lines 29-34).
Claim 16 of Pat ‘917 fails to disclose:
a first tapered section offset from a central lateral axis of the intermediate section
a second tapered section offset from the central lateral axis of the intermediate section
wherein the first tapered section extends away from the intermediate section to a first end that extends parallel to the central lateral axis, and the second tapered extends away from the intermediate section to a second end that extends parallel to the central lateral axis and the first end.
Gellman teaches an surgical device (Figure 100 and Figure 102A; Paragraph 0499-0500) which comprises a flexible main body (Figure 100) having an intermediate section (12B) and a first tapered section (14B) and a second tapered section (16B) (see Figure 100 and Paragraph 0499) in which:
the first tapered section (14B) offset from a central lateral axis (between lines 20B in Figure 100) of the intermediate section (12B) (Figure 100)
the second tapered section (16B) offset from the central lateral axis (between lines 20B) of the intermediate section (12B) (Figure 100)
wherein the first tapered section (14B) extends away from the intermediate section (12B) to a first end (flat left-most side of 14B) that extends parallel to the central lateral axis (Figure 100 and Figure 102A), and the second tapered (16B) extends away from the intermediate section (12B) to a second end (flat right-most side of 16B) that extends parallel to the central lateral axis and the first end (Figure 100 and Figure 102A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the claim 16 of the parent application with the teachings of Gellman for the advantage of providing collinear ends on the tapered sections that can be rolled over the intermediate portion to be secured in a central manner.
Furthermore/Alternatively, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the tapered sections of Claim 16 with the tapered section teachings of Gellman since it has been held that the variations in shape were a matter of choice and only involves routine skill in the art. See In re Dailey, 357 F.2d 669, 149 USPQ (CCPA 1966). (See MPEP 2144.04).
Regarding Present Claim 14, the modified Claim 18 (which depends on Claim 16) of Pat ‘917 discloses the surgical implant delivery device of claim 2, wherein the flexible main body comprises a transparent window positioned between opaque wall regions such that the interior cavity of the main body is viewable through the transparent window.
Regarding Present Claim 16, the modified Claim 19 (of which depends on Claim 16) of Pat ‘917 discloses the surgical implant delivery device of claim 2, further comprising an antimicrobial material positioned in the interior cavity of the flexible main body.
Allowable Subject Matter
Claims 3-8, 10-13, 17, 18, 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.
Claim 15 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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Winn (US PGPub 2019/0117375).
Chu (US PGPub 2011/0144422).
Preissman (US PGPub 2010/0280610)
Gellman (US PGPub 2008/0221386).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MOHAMED GAMIL GABR
Primary Examiner
Art Unit 3771
/MOHAMED G GABR/Primary Examiner, Art Unit 3771