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 .
Response to Amendment
This action is in response to the preliminary amendment filed on 10/22/2024. In the amendment, claims 1-3 & 5-11 have been amended.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: ‘lancet retaining features’ in claims 1, 2, 6, & 8-11.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1, 9 & 10 are objected to because of the following informalities: line 14 (claim 1), line 2 (claim 9), & line 4 (claim 10) - examiner suggests amending ‘member’ to read --resiliently deformable member-- to clarify the exact element being referred to be the generic term ‘member’ in the claim. Appropriate correction is required.
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of copending Application No. 18/849247 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 10 of 18/849247 discloses a lancing device (same as claim 1 of the present application) comprising :a housing (same as claim 1 of the present application); a lancet comprising a needle (same as claim 1 of the present application), the lancet being configured to be movable rearwardly within the housing from an initial operational position to a retracted position; a shroud coupled movably to the housing (same as claim 1 of the present application) and at least partially covering and extending forwards beyond a forward end of the needle before use of the lancing device; and a biasing member (‘resiliently deformable member’ of claim 1 of present application) coupled between the lancet and the shroud (same as claim 1 of the present application), wherein the shroud is configured to, when pressed against skin around a sampling site, move rearwards relative to the housing and, at a first point of the rearward movement, allow the needle to contact the sampling site and subsequently, at a second point of the rearward movement, release energy stored in the biasing member to drive the lancet from the operational position to the retracted position (italicized functionality drawn to the same function as worded in claim 1 of the present application), and wherein the housing comprises lancet retaining features comprising one or more deflectable legs configured to retain the lancet in the operational position until the shroud reaches the second point of the rearward movement.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 (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.
Claims 1 & 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dicesare et al. (WO 2005/110226 A1).
Regarding claim 1, Dicesare et al. disclose a lancing device (Figs. 6-9) for use in producing a sample of blood on a subject's skin, the device comprising: a housing 28 (Figs. 6-9); a lancet comprising a needle 54 (Figs. 6-9) having a needle tip; lancet retaining features 62 (Figs. 6-9) for releasably retaining the lancet 54 in a forward position prior to use; a shroud 42 (Figs. 6-9) coupled movably to the housing 28 (arrow 90 - Fig. 6 to Fig. 7) and configured to cover the needle tip 54 when the lancet is in the forward position; and a resiliently deformable member 72 (Figs. 6-9) coupled between the shroud 42 and the lancet 54, wherein the shroud 42 is configured to, when pressed against the subject's skin, move rearwards relative to the housing whilst compressing the resiliently deformable member 72 (Fig. 8 shows the shroud 42 retracted relative to the housing and the resiliently deformable member 72 compressed), and the lancet retaining features 62 are configured to, at a point of the rearward movement of the shroud, release the lancet allowing said member 72 to expand and exert a rearward force to retract the lancet into the housing 28 (Fig. 9).
Regarding claim 9, Dicesare et al. further disclose wherein the member 72 is tubular and surrounds a portion of the lancet 54 (springs are tubular - seen surrounding the lancet in Figs. 8 & 9).
Regarding claim 10, Dicesare et al. further disclose wherein the shroud 42 is configured to directly contact the lancet 54 (via tab members 62 which rest on the proximal end of the shroud 42 until rotated to align with channels 64 for deployment) prior to said point of the rearward movement of the shroud 42 so as to exert a rearward force on the lancet 42 in addition to the rearward force exerted by the member 72.
Regarding claim 11, Dicesare et al. further disclose the shroud 42 being slidably received within the housing 28 and being held in an extended position by cooperating features of the shroud 42 and the housing 28 (proximal end of shroud interacts with the lancet holder which interacts with the housing via resistance force of spring member 70 - Figs. 6-7), the cooperating features providing a resistance force (via spring 70) when the shroud 42 is pressed against the skin that must be overcome before the shroud 42 can be moved into the housing from the forward position.
Claim Rejections - 35 USC § 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 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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Dicesare et al. (WO 2005/110226 A1) in view of Brancazio (US Pub. No. 2012/0123297 A1).
Regarding claim 2, Dicesare et al. fail to further disclose wherein the resiliently deformable member comprises a closed-cell or open-cell foam.
However, Brancazio teaches a similar lancing device wherein the device comprises a retraction component 1126 (Fig. 12) that is used to retract the needle element back inside the housing, wherein the retraction component is said to be any of a known deployment actuator such as a coil spring or foam (paragraph [0079]).
Therefore, because these two retraction/resiliently deformable members were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute a retraction foam for a coil retraction spring.
Allowable Subject Matter
Claims 3-8 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: the prior art fails to further, disclose, teach, or suggest wherein the lancet retaining features comprise one or more deflectable fingers extending from an inner surface of the housing, and wherein one or more shoulders provided on the lancet are configured to engage with the or each deflectable finger to restrict a rearward movement of the lancet until a force exerted by the shroud causes sufficient deflection of the or each finger [claim 3]; wherein the lancet retaining features are configured, upon release of the lancet, to further urge the lancet in a rearward direction [claim 6]; wherein, prior to use, said member is held in a partially compressed state so as to bias the lancet rearward and thereby engage the lancet retaining features [claim 8].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 June 11, 2026
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