The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 30, 2025 has been entered.
The disclosure is objected to because of the following informalities: the status of the parent application needs to be updated.
Appropriate correction is required.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-3 and 5-18 are rejected under 35 U.S.C. 112(a), as failing to comply with the enablement requirement and/or as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention and/or the claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention. Claim 1 is directed to determining the presence of residual carbamate compounds on an elastomeric article. Claim 1 has language directed toward determining the carbamate concentration in an extract formed by contacting the elastomeric article with an extractant solvent (see claims 1 and 9) and contacting the extractant solution with a copper acetate/acetone solution. Claim 1 also has an alternative method in which the elastomeric article is directly contacted with the copper acetate/acetone solution. In claim 1, the concentration of carbamate measured in the extract is then used to decide the propensity of the elastomeric article to stain (with a carbamate concentration of greater than about 0.5 ppm being considered a positive test for staining – see cancelled claim 19 and/or the first full paragraph on page 8 of the instant specification). It is not clear from the description whether the presence of a residual carbamate or a carbamate concentration of greater than 0.5 ppm in the extract actually corresponds to a positive test for staining for the following reason. First, the test is run on an extract of the elastomeric article and there is no corresponding data to show at what point the concentration measured in the extract corresponds to visible staining on the article if the reagent were applied directly to the article (thus there is no evidence of record that that determining that the carbamate is present and/or at a concentration of 0.5 ppm would correspond to visible staining on the elastomeric article). In other words, the presence of and/or a concentration value of 0.5 ppm of carbamate in the extract as a positive test for staining appears to be an arbitrary number that is not based on actual staining. Since there is this question with respect to the correspondence between the measured level of carbamate in the extract and the propensity to indicate staining, the extractant alternative of claim 1 is not enabled and/or sufficiently described at the scope of claim 1.
Additional issues are related to what constitutes a positive test for staining which is claimed and described in the instant specification as greater than a certain concentration of carbamate (greater than about 0.5 ppm) in the extract. In this regard, examiner first points out that in instant figures 1-3, the intensity of the signal is related to the concentration of the carbamate in the extraction solution. Examiner next points out that that an elastomeric article such as a glove might have a larger surface area and/or weigh more than and elastomeric article such as a balloon, condom or elastic seal. It appears that solutions used to prepare these elastic articles are made in such a manner that the incorporation of carbamates into the solution is as homogeneous/uniform as possible (see example 1 in the cited Knight patent, US 4,062,906, in which zinc N,N-diethyldithiocarbamate is added with stirring until it has been well dispersed). If this is the case, one of ordinary skill in the art would have expected the carbamate that is extracted to be rather uniformly distributed on or near the surface of the article. Thus the amount extracted from an elastomeric article into the extractant would be expected by those of ordinary skill in the art to depend on factors such as the surface area in contact with the extractant, the ability of the extractant to extract the carbamate from the surface of the article and/or the solubility of the carbamate in the extractant. For an extractant that has good solubility for carbamates, the concentration of the carbamate would also be expected by those of ordinary skill in the art to be dependent on the amount of extractant used to extract the carbamate. For example, if three different sizes of gloves were made by the same process from the same carbamate containing solution, the amount of extractable carbamate would be expected to vary based on the different surface areas of the gloves in contact with the extractant. Additionally, the concentration of carbamate in the extractant would be expected to be a function of the amount of extractant used. The instant description teaches using an equivalent amount of extractant for each extraction so that the concentration of carbamate in the extractant would not be expected to vary based on the amount of extractant. Since the same solution and proves were used to make the different sized gloves, the amount of carbamate that is at or near the surface of the article would be expected to be similar so that the amount of extractable carbamate per area in contact with the extractant is similar. Thus the main factor controlling the concentration of carbamate in the extractant would be related to the surface area of the gloves in contact with the extractant. By way of example, examiner will treat the largest glove as having twice the surface area as the smallest glove so that the amount of carbamate in the extractant for the largest glove would have been twice the amount extracted from the smallest glove and the concentration of carbamate in the extractant from the largest glove would have been expected to be twice the concentration of carbamate extracted from the smallest glove (e.g. a concentration of about 0.70 ppm in the extractant of the largest glove would have been expected to result in a concentration of about 0.35 in the extractant of the smallest glove). The propensity of the two gloves to stain would have been expected by those of ordinary skill in the art to be similar and/or equivalent based on using the same starting solution and the same process to produce the two gloves. However, in the above case, the concentration of carbamate in the extract from the largest glove would have resulted in a positive staining test determination while the concentration of carbamate in the extract from the smallest glove would not have resulted in a positive staining test determination. In other words, two elastomeric articles that would have been expected to have resulted in a similar and/or equivalent test result for staining would have received different results. Thus the instant description is not enabled and/or sufficient to show that applicant was in possession of the clamed invention.
Additionally, the definition of ppm in the preparation of reagents section (page 9, lines 10-18) appears to be based on mass of the carbamate in the extract relative to volume of extraction solvent. That is not a conventional definition. A more conventional definition would be the mass of carbamate compared to the mass of the extraction solution. Examiner notes that the two definitions are equivalent if the density of the extraction solvent 1 gram/mL so that 1 g of carbamate in 1 mL of extractant is one part per million on a mass/mass basis. However, if the extractant is acetone, its density is less than 1 gram/mL (0.790 g/cm3, see the cited table of solvent properties). Since the extraction ability of different extractants is known to be different as shown by the Knudsen paper described above, a 0.5 ppm concentration using acetone as the extractant is different from a 0.5 ppm concentration using water and/or an aqueous solution such as Knudsen’s phosphate buffer. Here again, depending on the ability of the reagent being applied directly to the elastomeric article to produce a visible stain on the article and the ability of the extractant to remove the carbamate from the elastomeric article, a concentration of 0.5 ppm in the extractant may or may not correspond to visible stains appearing on an elastomeric article. Thus the instant claims are not enabled and or the instant disclosure is not sufficient.
One final issue is related to the use of the term carbamate in the claims. Claims 1 and 21 require a copper acetate solution as the agent/reagent either applied to the elastomeric article or mixed with the extract. Page 5, lines 27-31 and other places throughout the instant specification teach that accelerators that can be used to produce the elastomeric articles include various carbamates. For instance, metal dialkyldithiocarbamates are commonly used as accelerators in producing nitrile elastomeric products. Such accelerators include zinc diethyldithiocarbamate, zinc dibutyldithiocarbamate, and mixtures thereof. It is also clear that the interaction responsible for the staining and/or color measured in the extract is an interaction between copper and the sulfurs of the dialkyldithiocarbamates. However, the term carbamate has a much broader scope than the metal dialkyldithiocarbamates that are clearly described as the target carbamates to determine the propensity of the elastomeric article to stain. For example the previously cited Riahi paper (International Journal of Polymeric Materials, 2004) teaches the use of hexamethylene-N,N'-bis-(tert-butylperoxy carbamate) (HBTP) as the accelerator being tested/used in the process of producing the elastomer. Since this is clearly a carbamate, it would fall under the scope of the term “carbamate” found in the instant claims. However, in the best situation, since this carbamate does not have the sulfurs of a dialkyldithiocarbamate, it is at least not clear if the copper acetate reagent would be capable of determining a residual of this carbamate in any elastomeric article produced through its use. At worst, those of ordinary skill in the art would not expect this carbamate to interact with the copper acetate reagent to produce a detectable/measurable stain or color change. Thus the instant claims are not enabled and or the instant disclosure is not sufficient.
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.
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 1-3, 5-18 and 21-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,988,601. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are of a scope that the entirely encompass the patented claims such that one cannot reasonably practice the patented claims without also practicing the instant claims.
Applicant's arguments filed December 30, 2025 have been fully considered but they are not persuasive. In response to the changes the rejection under 35 U.S.C. 112(b) has been withdrawn and the rejection under 35 U.S.C. 112(a) and obviousness-type double-patenting rejection have modified to account for the changes. Some aspects have been clarified and others were modified to adjust for claim amendments and/or new claims. The arguments are moot with respect to the withdrawn rejection.
With respect to the rejection under 35 U.S.C. 112(a), examiner notes that the extract alternative of claim 1 has two requirements: contacting an extract obtained from the elastomeric article (by contacting the elastomeric article with an acetone solution) with a defined copper acetate/acetone solution and testing the mixture of the extract and copper acetate/acetone solution for the propensity of the article to stain. Within the scope of this claim is a myriad of potential extractant compositions for use in forming the extract if one looks at the “an acetone solution” language as possibly including other components/solvents. The instant disclosure also fails to describe any correlation between the presence and/or concentration of the carbamate in the extract determined from the test of the mixture of the extract and the copper acetate/acetone solution and an actual propensity of the article to stain. When the copper acetate/acetone solution is applied directly to the elastomeric article, the propensity to stain is clearly evident by the formation of a stain. It is true that page 7, lines 7-9 teach that the ”present disclosure is also directed to a test for determining not only the presence of residual accelerators on the elastomeric article but also for determining the concentration of the residual accelerators or carbamates.” However, to determine whether there is a propensity to stain, as required by claim 1, from measurements on the acetone extract requires knowledge of whether the presence of residual accelerators or carbamates at any concentration or above a certain threshold concentration/level in the extract will result in staining if the reagent had been directly applied to the article. Examiner recognizes that this may also be dependent on how the residual accelerators or carbamates are distributed on the surface of the elastomeric article. In other words examiner recognizes that an average concentration of residual accelerators or carbamates in the extract may not point to a propensity to stain when the residual accelerators or carbamates were not evenly distributed on the surface of the elastomeric article. However, the instant disclosure makes no attempt to even address whether a simple presence of residual accelerators or carbamates is considered indicative of a propensity for the elastomeric article to stain or if the concentration in the extract needs to be above a certain threshold for there to be a propensity to stain. In other words, there does not appear to be a clear correlation between a propensity of an elastomeric article to stain and any particular concentration of residual accelerators or carbamates in the extract. Thus examiner has said that there appears to be two distinct methods rather than a single generic method. The first method is a method of measuring the propensity to stain by the formation of a stain on an article that has been contacted with the copper acetate/acetone reagent. A concentration of the residual accelerators or carbamates does not need to be known because a stain is formed. The second method is determining the presence and/or concentration of residual accelerators or carbamates in an acetone extract of the article. In this method, the disclosure needs to be clear on what applicant considers to constitute a propensity to stain: the mere presence of residual accelerators or carbamates in the extract or a concentration of residual accelerators or carbamates above some level or threshold in the extract. The instant disclosure fails to clearly define what constitutes a propensity to stain based on the determination of residual accelerators or carbamates in the extract. Examiner points out that there is no art rejection at this point for either of these methods. With respect to the claimed extract method, applicant’s disclosure describes a single extractant and fails to show what concentration of carbamate in the extract actually correlates to the formation of a stain if the copper acetate/acetone solution were directly applied to the article from which the extract was obtained. Thus the argument is not persuasive.
With respect to the obviousness-type double-patenting rejection, there are at least three possible situations. The first situation is one in which the patented claims and the application’s claims have a scope that does not completely overlap. In this case there is a need to show the obviousness of the difference(s) between the claims. The second situation is one in which the patented claims are of a scope that encompasses the narrower claims of the application. In this situation there is a need to show that the narrower limitations of the application’s claims would have been an obvious modification of the broader claims of the patent. The third situation is one in which the application’s claims are of a scope that completely encompasses the narrower patented claims. The instant situation is the third situation. In the third situation, one cannot practice the patented claims without also practicing the application’s claims. In this situation the application’s claims are simply a broadening of the scope of the patented claims. The fact that the scope of protection is different would not be grounds for a restriction between the claims if they were presented in the same application. In the instant case, claim 1 is of a scope that encompasses both patented claims 1 and 6 and instant claim 21 is of a scope that completely encompasses patented claim 6. Thus the arguments are not persuasive.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The additionally cited art relates to measurement of sulfur and other compounds in elastomeric articles. In particular the Nakayama publication (US 2012/0065325) teaches solvent extraction of rubber for vulcanizing agent using acetone (see at least paragraphs [0062]-[0064]). The Hudson patent(US 5,075,028) also teaches the extraction of organic sulfur vulcanizing agents with a certain solvent for analysis of the accelerators (see at least the paragraph bridging columns 2-3).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Arlen Soderquist whose telephone number is (571)272-1265. The examiner can normally be reached 1st week Monday-Thursday, 2nd week Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached on (571)272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARLEN SODERQUIST/ Primary Examiner, Art Unit 1797