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 Invention I (Claims 1-18) in the reply filed on 3/3/2026 is acknowledged.
Claims 19-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/3/2026.
Applicant's election with traverse of Species 1C (Fig. 3) and Subspecies 2A (Fig. 7A) in the reply filed on 3/3/2026 is acknowledged.
The restriction of Species and SubSpecies is withdrawn, Applicant’s arguments are found persuasive.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-2, 4-11 and 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abbott (US 20130123716 A1). Regarding claim 1, Abbott discloses a non-hormonal contraceptive 10 (Fig. 1-2, vaginal therapeutic 10 [0017], invention uses copper to kill microbials in the vaginal canal [0006], would also implicitly kill off any sperm within the vaginal canal, thus being capable of being a contraceptive as noted in [0027]) comprising:
a body 12 formed of one or more non-porous, biocompatible materials (plastic [0022], inner material of the body may be formed of plastic being implicitly a nonporous and biocompatible material in the art, placed into the body thus being an implicitly biocompatible material),
wherein the body 12 has a length in a range from 1 centimeter to 31 centimeters ([0025] length of 3.125 inches to 3.25 inches, or 7.9375 to 8.255 cm), and wherein the body 12 has a width in a range from 0.5 centimeters to 10 centimeters ([0025] 0.375 inches to 0.5 inches, or 0.95 cm to 1.27 cm); and
a copper inlay 13 on the body 12 ([0022] exterior surface is copper on the body 12).
Abbott does not explicitly disclose the copper inlay 13 having an exposed surface area in a range from 200 square millimeters to 1000 square millimeters.
However, Abbott provides for the copper being the entire outer body ([0017]), wherein as seen in the Fig. 1-2 the copper has an exposed surface area implicitly and considering it has a maximum diameter of 0.5 inches/12.3 mm and a maximum height/length of 3.25 inches/82.55 mm, then assuming for calculation a cylinder as the surface area the copper would have about a 249 square mm exposed area.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have known that the claimed exposed surface area in a range from 200 square millimeters to 1000 square millimeters for the copper would be implicitly found within the invention of Abbott herein given the dimensions. Also furthermore, the present application lacks any criticality of the specific exposed surface area thus the claimed range of exposed surface may have been found obvious as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05.
Regarding claim 2, Abbott discloses the invention of claim 1.
Abbott further discloses wherein at least a portion of the body 12 is spherical or spherocylindrical (Fig. 1-2 body has spherical and cylindrical shapes).
Regarding claim 4, Abbott discloses the invention of claim 1.
Abbott further discloses wherein the body 12 comprises an applicator end 12 and a manipulator end 24/22 opposite the applicator end 12 (Fig. 1-2).
Regarding claim 5, Abbott discloses the invention of claim 4.
Abbott further discloses wherein the copper inlay 13 is on the applicator end 12 of the body 12 (see [0017, 0022]).
Regarding claim 6, Abbott discloses the invention of claim 4.
Abbott further discloses wherein the manipulator end 24/22 of the body comprises one or more of a string, a cord, or a handle (Fig. 1-2, ring 26 [0018] is a handle).
Regarding claim 7, Abbott discloses the invention of claim 4.
Abbott further discloses wherein the manipulator end 24/22 and the applicator end 12 are comprised of a same material ([0018] both may comprise copper).
Regarding claim 8, Abbott discloses the invention of claim 4.
Abbott further discloses wherein the manipulator end 24/22 and the applicator end 12 are comprised of different materials ([0018] “the stem 24 and/or the ring 26 may be made of a material different from the material of the body 12”).
Regarding claim 9, Abbott discloses the invention of claim 4.
Abbott further discloses wherein the manipulator end 24/22 is spherical or spherocylindrical (Fig. 1-2, stem 24 of the manipulator end is spherocylindrical).
Regarding claim 10, Abbott discloses the invention of claim 4.
Abbott further discloses wherein the applicator end 12 is cylindrical (Fig. 1-2, there are cylinders 30).
Regarding claim 11, Abbott discloses the invention of claim 4.
Abbott further discloses wherein the body 12 is comprised of one or more of a synthetic material ([0022] may comprise plastic being a synthetic material) and a natural material (further comprises the copper, which is a natural material).
Regarding claim 14, Abbott discloses the invention of claim 1.
Abbott further discloses wherein the copper inlay has a width in a range from 0.07 millimeters to 23 millimeters (Fig. 1-2, the exterior surface 13 being the copper of the body 12, wherein as shown the width the of the body also being the width of the copper, wherein the width is [0025] 0.375 inches to 0.5 inches, or 9.525 mm to 12.7 mm).
Regarding claim 15, Abbott discloses the invention of claim 1.
Abbott further discloses wherein the copper inlay 13 has a uniform width or a non-uniform width (Fig. 1-2, the exterior surface 13 being the copper of the body 12, wherein as shown the width the of the body also being the width of the copper is non-uniform across the length of the device).
Regarding claim 16, Abbott discloses the invention of claim 1.
Abbott further discloses wherein the copper inlay 13 comprises two or more sections not connected to each other (Fig. 1-2 and [0019], the proximal end 16 and the distal end 14 copper surfaces are not directly connected to each other, being two sections therein).
Regarding claim 17, Abbott discloses the invention of claim 1.
Abbott further discloses wherein at least a portion of an outer surface of the copper inlay is flush with an outer surface of the body, raised above the outer surface of the body, or sunk below the outer surface of the body ([0022] the copper surface is raised above/on top of the outer surface of the body 12 being the flexible inner material).
Regarding claim 18, Abbott discloses the invention of claim 1.
Abbott further discloses wherein the copper inlay is attached to the body by one or more of a biocompatible adhesive, tension fitting, machine pressing, solder, and heat bonding ([0023] the copper sheets are formed by machine pressing, thus being attached to the inner part [0022] by machine pressing; furthermore, this is product-by-process and as [0022] provides the body 12 and exterior surface 13 being attached the claim is anticipated).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abbott (US 20130123716 A1) in view of Paz (US 20260014373 A1).
Regarding claim 3, Abbott discloses the invention of claim 2.
Abbott does not disclose wherein the body is egg-shaped.
However, Paz teaches an analogous intravaginal device (abstract), wherein the analogous body of the device may be egg shaped (see [0089]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have changed the body 12 of Abbott to be egg shaped as taught by Paz as changes in shape have been held to be a matter of design choice absent persuasive evidence that the particular configuration of the claimed shape was significant. See MPEP 2144(IV)(B) and In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abbott (US 20130123716 A1) in view of Lerner (US 3786808 A).
Regarding claim 3, Abbott discloses the invention of claim 11.
Abbott does not disclose wherein the synthetic material comprises one or more of silicone, glass, and stainless steel.
However, Lerner provides for an analogous contraceptive (title) providing analogously that the body may be formed of a light and flexible plastic wherein a known alternative material is silicone rubber (Col. 8 line 63 – Col. 9 line 22).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted the plastic of the body 12 of Abbott to be instead silicone as taught by Lerner as a known flexible lightweight alternative to plastic in the field of invention of contraceptives, wherein silicone further provides likely improved cushioning/comfort and known bio-inert properties (Lerner Col. 8 line 63 – Col. 9 line 22).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abbott (US 20130123716 A1) in view of シュミット (JP 2022525619 A) (see attached translation).
Regarding claim 13, Abbott discloses the invention of claim 11.
Abbott does not disclose wherein the natural material comprises one or more of stone or crystal.
However, シュミット teaches in the field of medical devices ([0013-0015]) an analogous plastic in the form of polyethylene polymer ([0012]), wherein the polymer may have reinforming filler in the form of types of stone (see [0039]) in order to provide improved mechanical strength therein.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided stone to the body 12 as taught by シュミットin order to provide an improved material with higher mechanical strength therein ([0039] of シュミット ).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN S ALBERS whose telephone number is (571)272-0139. The examiner can normally be reached Monday-Friday 7:30 am to 5:00 pm.
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/KEVIN S ALBERS/Patent Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786