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 .
Election/Restrictions
Applicant’s election without traverse of Species A and Species G in the reply filed on 28 May 2026 is acknowledged.
Claims 11 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Species B-D and Species C, respectively, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 28 May 2026.
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. 119(e) 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 No. 62/717,338, 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. Application No. 62/717,338 fails to provide adequate support or enablement for a speculum comprising an outer balloon layer, an inner balloon layer, and a shape memory alloy layer within the outer balloon layer configured to transition to a first shape when heated above a transition temperature, as required by Claim 1. ‘338 appears to disclose an outer balloon layer (outer lumen) and an inner balloon layer (inner lumen) which can be a balloon or nitinol, but does not disclose a separate layer comprising the shape memory alloy layer in addition to the outer and inner balloon layers. Accordingly, the claims are not entitled to the benefit of prior-filed application ‘338 and will receive a priority date of 12 August 2019.
Claim Objections
Claims 7 and 8 are objected to because of the following informalities: improper antecedence. Appropriate correction is required. The following amendments are suggested:
Claim 7 / lines 1-2: “the outer balloon layer”
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4-6, 10, 12, 13, 15, and 16 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. US 8,690,817 to Assaf et al. (hereinafter, “Assaf”).
As to claim 1, Assaf discloses a speculum (12), FIG. 2C, comprising: an outer balloon layer (outer facing wall or layer of balloons 26) configured to expand circumferentially (interpreted as language of intended use; fully capable of expanding circumferentially since it is part of an inflatable/circumferentially expanding balloon, col. 7 / lines 39-44, and has radial compliance, col. 10 / lines 19-20; col. 11 / lines 53-56); an inner balloon layer (inner facing wall or layer of balloons 26, i.e. inner wall of 16) configured to expand circumferentially (interpreted as language of intended use; fully capable of expanding circumferentially since it is part of an inflatable/circumferentially expanding balloon and has radial compliance, col. 10 / lines 19-20; col. 11 / lines 53-56), the inner balloon layer formed within the outer balloon layer, FIG. 2C, the outer balloon layer and the inner balloon layer forming a sealed cavity configured to hold a liquid (interpreted as language of intended use without positive recitation of a liquid; col. 9 / lines 55-60); an access tube (28) for injecting the liquid into the cavity (col. 9 / lines 55-60), FIG. 1A; and a shape memory alloy layer (29, fabricated from the shape memory alloy Nitinol, col. 10 / lines 27-28; the commonly understood definition of the term “layer” being a thickness of material that is laid on or covers a surface) within the outer balloon layer (since the shape memory alloy layer is within the inner balloon layer, col. 10 / lines 23-26, and the inner balloon layer is within the outer balloon layer) configured to transition to a first shape when heated above a transition temperature (a transition temperature is a characteristic of Nitinol).
As to claim 2, Assaf discloses the speculum of claim 1, wherein the liquid emits light (interpreted as language of intended use without positive recitation of the liquid; the sealed cavity is fully capable of holding a liquid that emits light).
As to claim 4, Assaf discloses the speculum of claim 1, wherein the shape memory alloy comprises nitinol (col. 10 / lines 27-28).
As to claim 5, Assaf discloses the speculum of claim 1, wherein the inner balloon layer has a more rigid structure than the outer balloon layer (since the stiffening struts 29 are attached to the inner balloon layer, col. 10 / lines 23-26).
As to claim 6, Assaf discloses the speculum of claim 1, wherein the outer balloon layer comprises latex, rubber, silicon (col. 6 / line 44 – col. 7 / line 10, col. 9 / lines 25-30), or a flexible plastic.
As to claim 10, Assaf discloses the speculum of claim 1, wherein the shape memory alloy layer abuts the inner balloon layer (col. 10 / lines 23-25), FIG. 2C.
As to claim 12, Assaf discloses the speculum of claim 10, wherein the inner balloon layer surrounds the shape memory alloy layer, FIG. 2C.
As to claim 13, Assaf discloses the speculum of claim 1, wherein the outer balloon layer surrounds the shape memory alloy layer (since the outer balloon layer surrounds the inner balloon layer which in turn surrounds the shape memory alloy layer).
As to claim 15, Assaf discloses the speculum of claim 1, further comprising an applicator (38) configured to insert the speculum into a vaginal canal (interpreted as language of intended use; fully capable of insertion into a vaginal canal).
As to claim 16, Assaf discloses the speculum of claim 1, further comprising a valve (valve at filling port 30) to regulate a flow of fluid from a syringe (interpreted as language of intended use without positive recitation of a syringe) into the access tube (col. 9 / lines 55-60).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Assaf.
As to claims 7 and 8, Assaf is silent as to further comprising rods incorporated into the outer balloon wall in a longitudinal direction, the rods being flexible (claim 7); wherein the rods comprise silicon (claim 8).
Assaf discloses that the distal portion of the device is longitudinally stiffened while maintaining radial compliance by the provision of struts (29, fabricated from Nitinol) attached to the inner balloon layer. Assaf also contemplates that the struts may comprise silicon (col. 10 / lines 27-28), and that the struts may be co-molded with the balloon wall (col. 10 / lines 25-26).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide struts on the outer balloon layer as well as the inner balloon layer, to provide increased longitudinal stiffness on the distal portion of the device, where both the inner and outer balloon layers are disposed, and since the mere duplication of the essential working parts of a device involves only routine skill in the art. The struts on the inner balloon layer would remain as disclosed above, with additional rods/struts of flexible silicon incorporated into the outer balloon wall in a longitudinal direction, in view of Assaf’s teaching that the struts may comprise silicon and may be co-molded with the balloon wall. It is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
As to claim 9, Assaf is silent as to wherein the shape memory alloy layer comprises a mesh.
Assaf contemplates effecting stiffening using a stent-like structure cut from a tube or braided from wire (col. 10 / lines 31-32).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the shape memory alloy layer as a stent-like structure cut from a tube or braided from wire, presenting a mesh, instead of the struts shape as shown in FIG. 2C, since Assaf contemplates such a mesh configuration is effective for stiffening. The shape memory alloy layer would remain fabricated from Nitinol as also disclosed by Assaf, therefore combining the material composition and particular structure into an effective stiffening region.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Assaf in view of U.S. Patent No. US 9,066,653 to Mihaljevic et al. (hereinafter, “Mihaljevic”).
As to claim 3, Assaf discloses at least a portion of the inner balloon layer comprises silicon (col. 6 / line 44 – col. 7 / line 10, col. 9 / lines 25-30), but is silent as to wherein at least a portion of the inner balloon layer is translucent.
Mihaljevic teaches that a pliable balloon-type structure can be constructed with silicon, and may be translucent (col. 8 / lines 8-13), indicating that silicon may be translucent.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to comprise at least a portion of the inner balloon layer of silicon that is translucent, since Mihaljevic teaches that silicon may be translucent, and Assaf discloses the inner balloon layer comprises silicon. The translucency would allow for better viewing through the speculum.
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 1-9, 13, 15, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8, and 9 of U.S. Patent No. US 11,445,901. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus more specific. Thus the invention of the patent claims are in effect a “species” of the “generic” invention of the application claims. 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 application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Application claims 18/887,559
Patent claims 11,445,901
1-3, 9, and 13
1
4
2
5
3
6
4
7
5
8
6
15
8
16
9
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
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