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 .
Amendments Entered
The preliminary amendment filed on September 19, 2023 is entered. Claims 2-26 are canceled and claim 1 is pending.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
First Action Final
This is a continuation of applicant's earlier Application Nos. 14/995652 and 15/786746. All claims are drawn to the same invention claimed in the earlier application and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b).
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 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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 7,291,159 to Schmelzeisen-Redeker et al (hereinafter “SR”; cited by Applicant). SR discloses a lancet device comprising: (a) a base (20) that includes a support surface (Fig. 1A, 1B); (b) a lancet (60) supported by the base and extending away from the support surface at an angle of approximately 90 (Fig. 5); (c) a cover that includes (i) a peripheral edge along which the cover is connected to the base (Figs. 1A,.1B, 5), (ii) a cover region configured to cover the lancet when the cover is in an un-depressed position (Figs. 1A, 1B), the cover region having a cover region geometry, (iii) a lancet aperture (12, Fig. 1A) through which the lancet is configured to protrude when the cover is in a depressed position, and (iv) a peripheral hinge near the peripheral edge (thinnest portion of 14 shown in Figs. 2B, 5), the peripheral hinge having a peripheral hinge geometry that differs from the cover region geometry to facilitate controlled movement of the cover from the un-depressed position to the depressed position upon application of a predetermined depression force (col 6, In 33-41).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2006/0184189 to Olson et al (hereinafter “Olson”; cited by Applicant). Olson discloses a lancet device comprising: (a) a base (106, 107, 108) that includes a support surface; (b) a lancet supported by the base and extending away from the support surface at an angle of approximately 90 (fig. 9a); (c) a cover (114) that includes (i) a peripheral edge (117) along which the cover is connected to the base (para [0073]), (ii) a cover region configured to cover the lancet when the cover is in an un-depressed position, the cover region having a cover region geometry (para [0070]), (iii) a lancet aperture (112a, b) through which the lancet is configured to protrude when the cover is in a depressed position, and (iv) a peripheral hinge near the peripheral edge, the peripheral hinge having a peripheral hinge geometry that differs from the cover region geometry to facilitate controlled movement of the cover from the un-depressed position to the depressed position upon application of a predetermined depression force (thinner portion shown bending in Fig. 9B; para [0073]).
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1 is rejected under 35 U.S.C. 103 as being unpatentable over US 2012/0203083 to Christensen et al (hereinafter “Christensen”; cited by Applicant) in view of SR. Christensen teaches a lancet device comprising:
(a) a base that includes a support surface (17, Fig. 6);
(b) a lancet (3) supported by the base and extending away from the support surface at an angle of approximately 90 (para [0031], Fig. 6);
(c) a cover (7) that includes (i) a peripheral edge along which the cover is connected to the base, (ii) a cover region configured to cover the lancet when the cover is in an un-depressed position, the cover region having a cover region geometry, (iii) a lancet aperture (“hole” para [0028]) through which the lancet is configured to protrude when the cover is in a depressed position (para [0024], [0028]).
Christensen does not teach a peripheral hinge near the peripheral edge, the peripheral hinge having a peripheral hinge geometry that differs from the cover region geometry to facilitate controlled movement of the cover from the un-depressed position to the depressed position upon application of a predetermined depression force. SR teaches a peripheral hinge near the peripheral edge (thinnest portion of 14 shown in Figs. 2B, 5), the peripheral hinge having a peripheral hinge geometry that differs from the cover region geometry to facilitate controlled movement of the cover from the un-depressed position to the depressed position upon application of a predetermined depression force (col 6, In 33-41). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the peripheral hinge of SR with the cover of Christensen to enable "the partial collapse of the compression unit which occurs when pressure is applied to the compression unit, to be clearly felt by the user.” SR, col 6, In 33-36.
The Federal Circuit has held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” MPEP 2144.04 IV. A. citing Gardner v. TEC Syst., Inc. 220 USPQ 777 (Fed. Cir. 1984), cert, denied, 469 U.S. 830, 225 USPQ 232 (1984). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the claimed dimension to ensure the collapse of the cover when the pressure is applied and allow the user to feel the collapse.
One skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combinations would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of the invention. In addition, it would have been obvious to one of ordinary skill in the art at the time of the invention that with routine experimentation, the geometry of the wall would be optimized to facilitate movement from first and second positions. See MPEP 2144.04 IV. A.; In re Rose, 105 USPQ 237 (CCPA 1955) (limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art).
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 9,380,970. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,237,866. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 8,647,357. Although the claims at issue are not identical, they are not patentably distinct from each other.
Conclusion
This is a continuation of applicant's earlier Application No. 16/998,157. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Messersmith whose telephone number is (571)270-7081. The examiner can normally be reached M-F, 830am-5pm.
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/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791