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 .
Any References cited but not appearing in any current Form 892 may be found in previous Form 892’s or IDS’s.
Specification
The substitute specification filed 04/21/2026 is acknowledged. The amendment to the specification overcomes the objection to the specification.
Response to Amendment
The amendment to the claims filed on 04/21/2026 is acknowledged. In the amendment, claims 1 and 6 are amended. Claims 1-6 are currently pending.
The amendment to claim 6 overcomes the 112b rejection with regard to that claim.
Response to Arguments
Applicant's arguments filed 04/21/2025 have been fully considered but they are not persuasive. Applicant argues the following at page 5 of the arguments:
The Office Action states that the claimed subject matter is unpatentable based on a
product-by-process rationale. However, the patentability of a product-by-process claim is
based on the product itself. (See MPEP § 2113(I)). In chemical cases, a compound and all
of its properties are inseparable; therefore, if the prior art teaches a different chemical
structure, then the properties should also be different. (See MPEP § 2112.01(II)).
In the present case, the claimed product is formed from synthetic polyisoprene, a
hydrocarbon-based polymer that is structurally and chemically distinct from the nitrile
rubber compositions of Ozawa. Unlike nitrile systems, synthetic polyisoprene does not
include nitrile groups and exhibits different polarity, polymerization behavior, and curing
characteristics.
Because the claimed product is based on a materially different chemical structure,
it is not the same product as that disclosed in Ozawa. The present claims are not directed
merely to a different process yielding the same product, but instead to a different material
system that results in a different chemical structure and therefore a different product.
Ozawa teaches nitrile rubber latex systems used to form dip-molded rubber
articles. As described on page 5 of the Office Action, Ozawa uses a vulcanizable latex
composition based on nitrile rubber, which includes nitrogen-containing structures and
nitrogen-containing accelerators. Therefore, nitrosamine formation is managed and
reduced by accelerators and curing conditions.
In contrast, the Applicant's independent claim 1 recites a condom comprising a
"latex synthesized from a latex emulsion" comprising "synthetic polyisoprene latex".
Synthetic polyisoprene is a hydrocarbon-based polymer that is structurally and chemically
distinct from nitrile rubber. Unlike nitrile systems, synthetic polyisoprene does not
include nitrile groups and exhibits different polarity, polymerization behavior, and curing
characteristics.
Examiner respectfully submits that the arguments are not persuasive. The claimed product is, per claim 1, a condom comprising a latex, where the condom releases less than 10 ppb (parts per billion) of nitrosamine. As indicated in the Non-Final rejection dated 02/20/2026, pages 3-5, Ozawa discloses a rubber dip-formed article (which in the combination with Chen is taught to be a condom) comprising a latex (vulcanizable dip-forming rubber latex composition, Ozawa, col. lines 20-62) and wherein the rubber article dip-formed releases less than 10 ppb of nitrosamine (Ozawa, col. 6, lines 10-23, the content of the nitrosamines in a rubber article-dip formed can be controlled to zero or a negligible amount) and the condom contains nitrogen. Thus Ozawa’s article composition is based on nitrile rubber and the end product result is the same as the product claimed i.e. a product (which is a condom in the combination with Chen) that is comprising latex and that has less than 10 ppb of nitrosamine and the condom contains nitrogen (see Non-Final rejection pages 4-5 indicating how Ozawa discloses this). Thus the combination of references discloses the product as claimed.
The limitations pertaining to the emulsion used in the synthesizing process of the latex condom are product-by-process limitations. As indicated in the Non-Final rejection at page 4, when a claim is directed to a device, the process steps are not germane to the issues of patentability and product by process claims are not limited to the manipulation recited in the steps, only the structure implied by the steps. Applicant has not shown an unobvious difference in the product as claimed. Accordingly, the arguments are not persuasive.
Applicant also argues at pages 5-6:
This distinction is significant. The Office Action relies on the position that the
product of the claimed process is the same as or obvious over the product of Ozawa.
However, Ozawa's teachings are specific to nitrile rubber systems and how nitrosamine
levels are controlled within such systems. A person of ordinary skill in the art would not
reasonably expect that completely switching from nitrile rubber to synthetic polyisoprene
would give the same results, because the underlying chemistry and reaction behavior are
different. This is not simply a different process, but also a different material system
(synthetic polyisoprene versus nitrile rubber), resulting in a different product.
Even though both systems may use nitrogen-containing accelerators, those
accelerators do not behave the same way in different polymer systems. Nitrile rubber is
more polar and influenced by its nitrile groups, while synthetic polyisoprene is a nonpolar
hydrocarbon. Because of this, the curing process and the formation or reduction of
byproducts, including nitrosamines, are not the same.
Examiner respectfully submits that the arguments are not persuasive. The end product as claimed in the present application is the same as the end product as disclosed by the combination of Ozawa and Chen. As explained above, the final product is a condom comprising a latex, wherein the condom releases less than 10 ppb of nitrosamine and the condom contains nitrogen. With regard to the argument that the accelerators do not behave the same way in different polymer systems and the curing process and formation or reduction of byproducts is not the same, Examiner submits that these process/synthesizing steps are produce-by-process limitations as it is the claimed product and not the process itself that is claimed. Accordingly, the arguments are not persuasive.
Applicant also argues at page 7:
In addition, claim 1 recites a limitation that the condom releases less than 10 ppb
(parts per billion) of nitrosamine. While Ozawa describes reducing nitrosamine levels
within a nitrile system, it does so within the context of that specific material system. The
Applicant's claimed product achieves low nitrosamine levels in a chemically distinct
polyisoprene system, which would not have been a predictable result based on the
teachings of Ozawa. The other cited references do not cure the deficiencies of Ozawa.
Examiner respectfully submits that the arguments are not persuasive. As explained in the Non-Final Rejection (pages 4-5), in Ozawa, the content of the nitrosamines can be controlled to zero or a negligible amount (Ozawa, col. 6, lines 10-23, the content of the nitrosamines in a rubber article-dip formed can be controlled to zero or a negligible amount) and the rubber article dip-formed contains nitrogen (Non-Final Rejection, pages 4-5) (Ozawa, col. 2, lines 1063, col. 3, lines 1-33). Applicant is arguing that the process/system for synthesizing the product are chemically distinct. However, the process is not being claimed, the product is. Accordingly, the arguments are not persuasive.
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.
Claim(s) 1 and 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ozawa (US 6187857) in view of Chen (US 2019/0177496).
Regarding claim 1, Ozawa discloses a rubber article dip-formed (used in medical articles that come in contact with the human body, col. 1, lines 25-34, col. 2, lines 59-62) comprising: a. a latex (vulcanizable dip-forming rubber latex composition, col. 2, lines 20-62, a rubber article dip-formed from vulcanizable dip-forming rubber latex composition) synthesized from a latex emulsion, comprising: i. synthetic polyisoprene latex having; ii. accelerators, each containing nitrogen, including: 1. zinc diethydithicarbamate; 2. zinc dibenzyldithiocarbamate; 3. zinc dibutyldithiocarbamate; (As to claim 1, the limitation, “a. a latex synthesized from a latex emulsion, comprising: i. synthetic polyisoprene latex having; ii. accelerators, each containing nitrogen, including: 1. zinc diethydithicarbamate; 2. zinc dibenzyldithiocarbamate; 3. zinc dibutyldithiocarbamate” is drawn to an article of manufacture, and therefore the limitation is considered to be a product-by-process limitation that is given patentable weight only for the structural limitations imparted to the final product by the process. When a claim is directed to a device, the process steps are not germane to the issue of patentability. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Here, a synthesizing process includes synthesized from a particular mixture in the process steps but as the product in the product-by-process claim [rubber article dip-formed] is the same as or obvious from Ozawa, the process limitations are met), and wherein the rubber article dip-formed releases less than 10 ppb (parts per billion) of nitrosamine (col. 6, lines 10-23, the content of the nitrosamines in a rubber article-dip formed can be controlled to zero or a negligible amount. The amount of the nitrosamine extracted from the rubber article dip-formed therefrom is generally not larger than 1ppm; NOTE: zero is less than 10 ppb and additionally 1 ppm is equal to 0.01 ppb which is less than 10 ppb) and the rubber article dip-formed contains nitrogen (col. 2, lines 1-63, col. 3, lines 1-33, a vulcanizable dip-forming rubber latex composition characterized as comprising an unsaturated nitrile conjugated diene copolymer rubber latex, a sulfur containing vulcanizer, at least one vulcanization accelerator selected from dithiocarbamic acid compounds represented by the formula (1); NOTE: it is inherent that a nitrile contains nitrogen and thus the vulcanizable dip-forming rubber latex composition contains nitrogen as it contains a nitrile conjugated diene copolymer rubber latex thus so does the rubber article-dip formed from the vulcanizable dip-forming rubber latex composition contain the rubber latex and the nitrile; ALSO NOTE: as seen in the formula (1), col. 2, lines 35-45, the chemical structure of dithiocarbamic acids have nitrogen in the structure, and as the vulcanizable dip-forming rubber latex composition comprises dithiocarbamic acid which has nitrogen it is implied the rubber article dip-formed with the dip-forming rubber latex composition contains nitrogen via the dithiocarbamic acid in the vulcanizable dip-forming rubber latex composition).
Ozawa does not disclose that the rubber article dip-formed is a condom.
Chen teaches an analogous latex ([0039], latex formulation) and an analogous rubber articled dip-formed ([0008], elastomeric articles are generally manufactured using a latex dipping process, the molds are dipped into a compounded latex such that a film of coagulated rubber particles is dissolved thereon) that is a condom ([0008]; [0039], the latex formation may be used to form elastomeric articles that may include condoms).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the rubber article dip-formed of Ozawa, is a condom, as taught by Chen, in order to provide an improved invention that facilitates formation of a specific type of desired elastomeric article (Chen, [0039]).
Ozawa in view of Chen discloses the invention as described above and the combination further discloses wherein the condom releases less than 10 ppb (ppm) of nitrosamine and the condom contains nitrogen (as described above the with regard to Ozawa, the rubber article dip-formed releases less than 10 ppb of nitrosamine and in the combination the rubber article dip-formed is a condom and thus it would follow that the condom releases less than 10 ppb of nitrosamine as does the material with which it is made) and the condom contains nitrogen (as described above the vulcanizable dip-forming rubber latex composition that contains nitrogen is used to make the rubber article dip-formed per the disclosure of Ozawa and thus the article contains nitrogen and in the combination Chen teaches the rubber article dip-formed is a condom thus in the combination the condom contains nitrogen).
Regarding claim 4, Ozawa in view of Chen discloses the invention as described above.
The combination further discloses wherein the latex is cured at a temperature from 90°C and 120°C for a period of 5 to 20 minutes (The limitation of curing the latex is a produce-by-process limitation. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the claim was made by a different process.” In re Thorpe, 111 F. 2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).; NOTE: the product [condom] in the product-by-process claim is the same as or obvious from the product of Ozawa in view of Chen, thus the process limitations are met).
Regarding claim 5, Ozawa in view of Chen discloses the invention as described above with regard to claim 1.
The combination further discloses wherein the condom releases less than 1 ppb of nitrosamine (Ozawa, col. 6, lines 10-23, the content of the nitrosamines in a rubber article-dip formed can be controlled to zero or a negligible amount. The amount of the nitrosamine extracted from the rubber article dip-formed therefrom is generally not larger than 1 ppm; NOTE: zero is less than 10 ppb and 1 ppm is equal to 0.01 ppb which is less than 10 ppb; in the combination, Chen teaches the rubber dip-formed article is a condom and thus the condom releases less than 1 ppb of nitrosamine in the combination).
Regarding claim 6, Ozawa in view of Chen discloses the invention as described above with regard to claim 1.
The combination further discloses wherein the synthetic polyisoprene latex is pre-vulcanized has a swelling index of 130% (The latex emulsion from which the condom is synthesized comprises pre-vulcanized synthetic polyisoprene latex that has a swelling index of 130%, which limitation is a product-by-process-limitation. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the claim was made by a different process.” In re Thorpe, 111 F. 2d 695, 698, 227 USPQ 964, 966 [Fed. Cir. 1985] [citations omitted].; NOTE: the product [condom] in the product-by-process claim is the same as or obvious from the product of Ozawa in view of Chen, thus the process limitations pertaining to a swelling index of the pre-vulcanized synthetic polyisoprene latex in the emulsion used to make the condom are met).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ozawa (US 6187857) in view of Chen (US 2019/0177496), as applied to claim 1 above and further in view of Chiaokun (US 2017/0049608).
Regarding claim 2, Ozawa in view of Chen discloses the invention as described above with regard to claim 1.
Ozawa in view of Chen does not disclose wherein the condom has a width of 49 mm to 60 mm and a length of minimum 160 mm with a thickness of 0.045 mm to 0.090 mm.
Chiaokun teaches an analogous condom ([0002]) wherein the condom has a width of 49 mm to 60 mm (Condoms can be formed with…a nominal width or diameter at a midpoint of the condom in a non-stressed condition of between 49-58 mm, [0002]; NOTE: values of this range fall within the claimed range) and a length of minimum 160mm (Condoms can be formed with a length of greater than 180 mm, [0002]; NOTE: values greater than 180 fall within the claimed range) with a thickness of 0.045 mm to 0.090 mm (Condoms can be formed in various thicknesses ranging between 0.03-0.09 mm, [0002]); NOTE: values within this range fall within the claimed ranged).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the condom of Ozawa in view of Chen has a width of 49 mm to 60 mm and a length of minimum 160 mm with a thickness of 0.045 mm to 0.090 mm, as taught by Chiaokun, in order to provide an improved synthetic polyisoprene latex condom article that facilitates providing a condom which is a thin sheath worn on a man’s penis during intercourse (Chiaokun, [0001]; [0002]).
Further It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the condom of Ozawa in view of Chen and in further view of Chiaokun has a width of 49 mm to 60 mm and a length of minimum 160 mm with a thickness of 0.045 mm to 0.090 mm, as Applicant has appeared to place no criticality on the claimed range (Applicant’s specification recites “typically making the total thickness 45 to 80 microns, [0056]; NOTE: typical infers that it is not critical; Further, Applicant’s specification appears to be silent with regard to length and width evidencing non criticality) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges as disclosed by the prior art, a prima face case of obviousness exists.” In re Wertheim, 541 F. 2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ozawa (US 6187857) in view of Chen (US 2019/0177496), as applied to claim 1 above and further in view of Lucas (US 2009/0272384).
Regarding claim 3, Ozawa in view of Chen discloses the invention as described above.
Ozawa in view of Chen does not disclose wherein the condom has a burst volume greater than 22 liters, and burst pressure of greater than 1 kPa.
Lucas teaches an analogous condom ([0058]) that has a burst volume greater than 22 liters, and burst pressure of greater than 1kPa (See Table 6A entitled Burst Unage [200 pieces tested] showing for example that the first batch of synthetic PI has a MV [mean volume] of 53.20 (L) and an MP [mean pressure of 1.70 (kPa) which values fall within the claimed range of a burst volume greater than 22 liters and burst pressure of greater than 1kPa).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the condom of Ozawa in view of Chen has a burst volume greater than 22 liters, and burst pressure of greater than 1kPa, as taught by Lucas, in order to provide an improved synthetic polyisoprene latex condom article that facilitates desired condom performance (Lucas, [0042] and is comparable to that of natural rubber and has adequate mechanical properties (Lucas, [0057]).
Further, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the condom article of Ozawa in view of Chen and in further view of Lucas, has a burst volume greater than 22 liters, and burst pressure of greater than 1kPa as Applicant has appeared to place no criticality on the claimed ranges (Applicant’s specification appears silent with regard to burst volume and burst pressure thereby evidencing no criticality) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges as disclosed by the prior art, a prima face case of obviousness exists.” In re Wertheim, 541 F. 2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
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 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12,409,255 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are a broader recitation than that of the patent.
Claim 1 of the instant application recites: A condom comprising: a. a latex synthesized from a latex emulsion, comprising: i. synthetic polyisoprene latex having; ii. accelerators, each containing nitrogen, including:1. zinc diethydithicarbamate;2. zinc dibenzyldithiocarbamate;3. zinc dibutyldithiocarbamate; and wherein the condom releases less than 10 ppb (parts per billion) of nitrosamine and the condom contains nitrogen.
Claim 1 of the reference patent recites: A condom comprising: a. a latex synthesized from a pre-vulcanized latex emulsion, comprising: i. pre-vulcanized synthetic polyisoprene latex having a swelling index from 100% to 130%; ii. accelerators, each containing nitrogen, including: 1. zinc diethyldithiocarbamate; 2. zinc dibenzyldithiocarbamate; 3. zinc dibutyldithiocarbamate; and iii. an anionic surfactant wherein the anionic surfactant is sodium C14-17 alkyl sec sulfonate selected from the group consisting of alkyl sulphonates, alkyl aryl sulphonates, olefin sulphonates, and alcohol sulphates; and iv. water, wherein said condom has strength, is highly stretchable up to and about 900%, and wherein the condom releases less than 10 ppb (parts per billion) of nitrosamine and the condom contains nitrogen.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between claim 1 of the current application and claim 1 of the reference patent lies in the fact that the reference patent claim includes many more elements and is thus much more specific. Thus, the invention of claim 1 of the reference patent is in effect a “species” of the “generic” invention of current application claim 1. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the current application is anticipated by claim 1 of the reference patent, it is not patentably distinct from claim 1 of the reference patent.
Regarding claim 2, the limitations therein are substantially recited in claim 2 of the reference patent.
Regarding claim 3, the limitations therein are substantially recited in claim 3 of the reference patent.
Regarding claim 4, the limitations therein are substantially recited in claim 4 of the reference patent.
Regarding claim 5, the limitations therein are substantially recited in claim 5 of the reference patent.
Regarding claim 6, the limitations therein are substantially recited in claim 6 of the reference patent.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/G.M./Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786
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