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
Claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected kit, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/1/2026. Although untraversed, the Applicant contends that there is no examination burden. Since the claims were filed under 35 USC 371, the test for different inventions is whether there is unity of invention. See MPEP 823. Since the Restriction Requirement broke unity of invention, because the novelty of the invention was already taught by the prior art, the requirement was proper. See MPEP 1893.03(d). However, if allowable material is found in the pending claims, a rejoinder would be considered for the withdrawn claims, assuming they are consistent with any allowable material.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 contains the trademark/trade name Teflon. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe polytetrafluoroethylene and, accordingly, the identification/description is indefinite.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “is equal to or more than 65°,” and the claim also recites “equal to or more than 77°,” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102/103
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 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.
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 1-3, 6 and 7 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Wang (CN1570648A [Machine translation is attached to the submitted reference]). Prior to discussing the prior art, elements of claim interpretation must be discussed. The claims include some limitations that describe uses, and diagnostic means, but it is unclear how to consider these in terms of the structure and compositional elements of the claimed reagent. First, the claim states that the first reagent is used in a method of quantifying sdLDL-c; however, there is nothing in this limitation that provides any clear direction as to how this affects the structure or the ingredients of the claimed composition. As such, this limitation cannot provide any clear patentable weight when considering the ingredients of the claimed composition. Similarly, claims 1, 6, and 7 recite diagnostic means for determining specific physical properties of the claimed composition. Since the composition is only described by its ingredients, and not how it is made (see MPEP 2113 for product-by-process limitations), if the prior art does not explicitly describe these physical properties, there is no manner for the Office to reasonable ascertain if these elements are present in the prior art reference. As such, if all of the compositional elements are present, it must be assumed that the prior art composition possesses the same physical characteristics; if the claimed composition possesses the same ingredients, but possesses different physical characteristics that would only arise based upon manufacturing methods, the claims should also be disclosed in terms of these manufacturing methods. For the sake of examining the claims on their merit, if the prior art discloses the claimed ingredients, it must be assumed that the cited prior art also discloses the same physical properties. It is the Applicant’s burden to show that the claimed composition is different. See MPEP 2112.
Wang teaches a composition that comprises an anionic surfactant, cholesterol esterase, cholesterol oxidase, and peroxidase. See claim 2. As such, Wang explicitly teaches all of the claimed ingredients. Wang, does not teach any physical properties of the composition. Since Wang teaches all of the compositional elements, it would appear as though Wang must anticipate the claimed composition; however, if it can be shown that Wang’s composition provides for physical characteristics that are different than those claimed, the ordinary artisan would be well-within their knowledge-base to modify the amount of surfactant to modify the composition’s contact angle to a preferred value.
With respect to claim 1, Wang teaches all of the explicitly described ingredients, thereby anticipating the contents of the composition. Since Wang does not teach contact angle, or methods of deriving the contact angle, there is no reasonable manner to compare the angle of Wang with that claimed. However, there is nothing non-obvious about tuning an aqueous solution’s contact angle to a somewhat hydrophilic level.
With respect to claim 2, Wang teaches the inclusion of ascorbic acid oxidase. See claim 2.
With respect to claim 3, Wang does not appear to include any enzymes with sphingomyelinase activity. As such, Wang’s composition must be consistent with the claimed composition.
With respect to claims 6 and 7, Wang teaches all of the explicitly described ingredients, thereby anticipating the contents of the composition. Since Wang does not teach viscosity, there is no reasonable manner to compare the viscosity of Wang with that claimed. However, there is nothing non-obvious about tuning an aqueous solution’s viscosity to a level would be useful for a particular method.
Claim Rejections - 35 USC § 103
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (CN1570648A [Machine translation is attached to the submitted reference]) and Itoh (US Pat. 8,030,081 [IDS Reference]). Although Wang does teach anionic surfactants, Wang does not explicitly describe those with a sulfuric acid ester salt.
Itoh teaches a composition, and method of using the composition, that overlaps with that of Wang; specifically, Itoh teaches composition for determining sdLDL-C that comprises a surfactant, cholesterol oxidase, cholesterol esterase, and catalase. See column 2, lines 25-55. In the cited passage, Itoh teaches anionic surfactants that include those that are sulfuric acid ester salts. Since the ordinary artisan understands the nuances of different anionic surfactants, and the fact that the only difference between the surfactants taught in Wang and Itoh is the fact that Itoh teaches the sulfate salt form of the surfactants taught, would suggest that these types of surfactants can be used as obvious variants with predictable outcomes. Predictability is underscored by the fact that both Wang and Itoh are intent on performing the same analytical methods using the same active ingredients. That is to say, Itoh and Wang teach all of the same enzymes for the same analytical purpose; the ordinary artisan would predictably modify Wang, with Itoh, and provide for the same analytical methods of determining sdLDL-C.
With respect to claim 4, as stated the surfactants described in Wang and Itoh are obvious variants of each other, wherein they provide the ordinary artisan with predictable behaviors.
With respect to claim 5, Itoh teaches the inclusion of hydrogen donors. See column 8, line 3. It would be obvious to include hydrogen donors in the composition of Wang because both Wang and Itoh are concerned with the same analytical method, wherein Itoh provides ample rationale to include the hydrogen donor into a composition described by Wang.
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 and 3-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4 and5 of U.S. Patent No. 8,030,081. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent provides for limitations that would anticipate the instant claims.
The patent provides for a method of determining sdLDL in a sample by providing a surfactant, cholesterol esterase, cholesterol oxidase, and catalase. These are the four explicitly claimed ingredients provided in the instant claim-set. Since there is no bar on double patenting rejections across statutory categories, and since the cited claims of the patent anticipate the instant composition, the claims are considered non-statutory double patenting with the cited claims of the patent.
Claims 1 and 4-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 8,440,419. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent provides for limitations that would anticipate the instant claims.
The patent provides for a method of determining sdLDL in a sample by providing a surfactant, cholesterol esterase, cholesterol oxidase, and catalase. These are the four explicitly claimed ingredients provided in the instant claim-set. Since there is no bar on double patenting rejections across statutory categories, and since the cited claims of the patent anticipate the instant composition, the claims are considered non-statutory double patenting with the cited claims of the patent.
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Matje, et al (US Pat. 9,051,599).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651
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