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/Restriction
Applicant's election without traverse of Group l: Claims 1-8 and 10-12 in the reply filed on 3/13/2026 is acknowledged.
Claim 9 drawn to the non-elected group is withdrawn.
IDS
The IDS entered 09/24/2024 has been considered by the examiner.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 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 1-3 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thiyagarajan of record (US 20210189106 A1).
Regarding claim 1, Thiyagarajan teaches compounding one or more compositions comprising natural rubber latex to make a first batch of compounded latex (P0005-6, P0020); compounding one or more compositions comprising natural rubber latex to make a second batch of compounded latex (P0020); dipping a plurality of formers into the first batch of compounded latex to form a plurality of condoms and then dipping said plurality of formers into the second batch of compounded latex to form a plurality of condoms (P0056); wherein each of the one or more compositions comprising natural rubber latex, which are used to make the first and second batch of compounded latex, has a zinc content less than 60 ppm (Tables 3-6, batches contain no zinc and 0% is within the range of 0-60 ppm, P0067).
Regarding claim 2, Thiyagarajan teaches each of the one or more compositions comprising natural rubber latex has a zinc content less than 50 ppm (Tables 3-6, batches contain no zinc and 0% is within the range of 0-50 ppm, P0067).
Regarding claim 3, Thiyagarajan teaches each of the one or more compositions comprising natural rubber latex is preserved with a preservative comprising zinc before compounding (P0042, P0044, P0067, “ zinc dibutyldithiocarbamate (ZDBC), zinc diethydithiocarbamate (ZDEC), zinc dimethyldithiocarbamate (ZDMC), zinc dibenzyl dithiocarbamate (ZBED), sodium diethyl dithiocarbamate (SDEC), and sodium dibutyldithiocarbamate (SDBC)”).
Regarding claim 10, Thiyagarajan teaches each of the one or more compositions comprising natural rubber latex has a zinc content less than 30 ppm (Tables 3-6, batches contain no zinc and 0% is within the range of 0-30 ppm, P0067).
Regarding claim 11, Thiyagarajan teaches each of the one or more compositions comprising natural rubber latex has a zinc content less than 20 ppm (Tables 3-6, batches contain no zinc and 0% is within the range of 0-20 ppm, P0067).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Thiyagarajan of record (US 20210189106 A1) as applied to claim 1.
Regarding claim 7, Thiyagarajan teaches each of the plurality of condoms has a thickness of 0.1mm or less which overlaps the claimed range of from 35 to 55 μm.
Overlapping ranges are prima facie evidence of obviousness. It would have been obvious to one having ordinary skill in the art to have selected the portion of Thiyagarajan 's thickness range that corresponds to the claimed range. In re Malagari, 184 USPQ 549 (CCPA 1974).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Thiyagarajan of record (US 20210189106 A1) as applied to claim 1 further in view of De Jong (US 20210394404 A1).
Regarding claim 4, Thiyagarajan teaches compositions comprising natural rubber latex but is silent to the presence of ammonia.
De Jong, in the same field of endeavor, condom production (P0045), discloses each of the one or more compositions has an ammonia content of 0.3 to 1.5 wt % (P0026) which overlaps the claimed range of from 0.65 to 1.5 wt %.
Overlapping ranges are prima facie evidence of obviousness. It would have been obvious to one having ordinary skill in the art to have selected the portion of De Jong 's ammonia range that corresponds to the claimed range. In re Malagari, 184 USPQ 549 (CCPA 1974). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have ammonia in this range for the purpose of adjusting the pH as taught by De Jong (P0026).
Claims 5-6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Thiyagarajan of record (US 20210189106 A1) as applied to claim 1 further in view of Kodama (US 20090105424 A1).
Regarding claims 5 and 12, Thiyagarajan teaches each of the one or more compositions comprising natural rubber latex is stored for a storage period of 2 days (48 hours, P0025) but is silent to a storage period of at least 30 days before compounding or a storage period of at least 42 days before compounding.
Kodama, in the same field of endeavor, latex article production (ABS), discloses a storage period of 6 months (P0156) which is fully within the claimed ranges of 30 days or more or 42 days or more.
Regarding claim 6, Thiyagarajan teaches the zinc content of each of the one or more compositions comprising natural rubber latex is maintained at a level less than 60 ppm throughout said storage period (Tables 3-6, batches contain no zinc and 0% is within the range of 0-50 ppm, P0067).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Thiyagarajan of record (US 20210189106 A1) as applied to claim 1 further in view of Arnold (US 20140326250 A1).
Regarding claim 8, Thiyagarajan teaches electronic testing of each of the plurality of condoms (P0068-70), but is silent to wherein at least 90% of the condoms of the plurality of condoms obtained by the method pass the electronic testing and all those condoms which do not pass the electronic testing are discarded.
Arnold, in the same field of endeavor, condom production teaches electronic testing of each of the plurality of condoms wherein all those condoms which do not pass the electronic testing are discarded (P0049).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have tested the condoms and discarded the articles that do not pass the testing as part of standard quality control procedure as taught by Arnold (P0049).
While Arnold is not specific to 90% of the condoms passing the testing, it would be obvious to optimize this value so that as few condoms as possible are discarded. 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. It would have been obvious to one having ordinary skill in the art to have determined the optimum values of the relevant process parameters through routine experimentation in the absence of a showing of criticality. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA H FUNK whose telephone number is (571)272-3785. The examiner can normally be reached Monday-Friday 8:00-5:00pm ET.
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/ERICA HARTSELL FUNK/Examiner, Art Unit 1741