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Claims 11-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/8/26. The examiner notes that claims 11-21 were not listed as withdrawn in the 7/8/26 claim set however the applicant points out “Applicant hereby elects Species C (FIG. 5) for continued examination without traverse. As the Examiner indicates in the Office Action, the claims believed to encompass the elected species are claims 1-10”. Therefore, claims 11-21 are considered withdrawn.
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 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 2 of U.S. Patent No. 11,918,795. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both drawn to the similar subject matter of a puncturing device configured to differentiate between a venipuncture and ana arterial puncture, comprising a needle including a shaft, a hub over a proximal-end portion of the shaft, a blood-flashback chamber, an oxygen sensor, and a comparator. The difference between instant claim 1 and claim 2 of the patent is that instant claim 1 is broader in that it does not require the specifics of a lumen defined by an inner portion of the shaft, and the blood-flashback chamber in fluid communication with the lumen. However, it could be discerned by one of ordinary skill in the art that since the needle is intended to puncture a vein or artery, the blood-flashback chamber would necessarily be in communication with the lumen. Additionally, similar limitations are found in instant claim 2. The instant claim 1 is also silent to wherein the oxygen sensor includes a chemical formulation having an alkaline buffer and indigo carmine as a color agent disposed in the blood-flashback chamber. The examiner notes however that these limitations are found in instant claims 3 and 4.
Claims 6-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 5 of U.S. Patent No. 11,918,795. Although the claims are not identical they are not patentably distinct from each other because they are both drawn to a method for differentiating between a venipuncture and an arterial puncture, comprising: accessing a vein or an artery of a patient by way of a puncture with a puncturing device, the puncturing device including a needle including a shaft, a hub disposed over a proximal-end portion, a blood-flashback chamber and an oxygen sensor, and further steps of consulting the oxygen sensor, comparing the concentration of the oxygen in the captured blood colorimetrically indicated by the chemical formulation against a comparator on the hub, and colorimetrically determining whether the concentration of the oxygen in the captured blood is consistent with venous blood or arterial blood. The difference between instant claim 6 and claim 5 of the patent is that there are minor wording differences and variation in the order things are introduced but these do not amount to any non-obvious difference between the two claims. The limitations of instant claim 7-9 are found within claim 5 of the patent.
Allowable Subject Matter
Claims 5 and 10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claim 5 depends from claim 1 and claim 10 depends from claim 6. The only rejections being given for claim 1 and claim 6, respectively, are the double patenting rejections above. Claims 5 and 10 are being objected to as the claims in the reference patent (#11,918,795) do not mention the comparator being printed on the hub.
In terms of prior art, the closest of record appears to be Hulvershorn et al. (US 2011/0060229 A1, hereafter “Hulvershorn”). Hulvershorn discloses a puncturing device (Fig. 6A) configured to differentiate between a venipuncture and an arterial puncture (see para 0055), comprising: a needle (520) including a shaft (520), and a hub (510) over a proximal-end portion of the shaft (see Fig. 6A), the hub including: a blood-flashback chamber configured to capture an aliquot of blood at a time of accessing a vein or an artery of a patient by way of a puncture with the needle (see para 0064, 0066, 0114, 0115 and Figs. 1A-1B showing passage 132 of AECD 100; similar to passage 532 of AECD portion 510; which includes a blood-flashback chamber 130); an oxygen sensor (para 0070, 0076). However, Hulvershorn does not expressly recite the oxygen sensor including a buffered chemical formulation disposed in the blood-flashback chamber, the chemical formulation including a color agent for providing a colorimetric indication of a concentration of oxygen in the aliquot of blood; and a comparator on the hub for colorimetrically determining from the colorimetric indication whether the concentration of oxygen in the aliquot of blood is consistent with venous blood or arterial blood. Other references like Saitou et al. (US 2011/0077461 A1) disclose displaying a color bar 74a showing hues from cyan to red (para 0149) but this does not appear close enough to the limitations mentioned above to form a prior art rejection for claim 1 or claim 6.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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/James D Ponton/Primary Examiner, Art Unit 3783
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