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 .
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.
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: “the first flow directing attachment portion … for controlling the flow of blood from a skin surface to a portion of the housing” (lines 1-3) in claim 2;
Regarding “the first flow directing attachment portion … for controlling the flow of blood from a skin surface to a portion of the housing,” attachment is a non-structure term as a modifier to a generic placeholder “portion”, furthermore, a functional limitation “controlling the flow from a skin surface to a portion of the housing” is used, there is no additional claim limitation that provides a sufficient structure, material, or act to perform the entire claimed language of transmitting the temperature measurement values. Thus, it meets the 3 prongs test and involved 112 (f), despite of absence of “means”. Specification discloses “the first flow directing attachment portion may include a variety of designs and structure as shown in Figs. 3-6, that may include hydrophilic surface property to attract the blood and establish a flow path to second capillary section” (see at least [0070] and Figs. 3-6), thus provides a sufficient structure explicitly, so A PHOSITA can perform the entire claimed function.
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 Rejections - 35 USC § 102
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(s) 1-10 and 13-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bartfeld et al. (US 2009/0259145).
Regarding claim 1, Bartfeld teaches a device for the attached flow of blood (device 2 for collecting a fluid sample, such as a blood sample; Figure 1), the device comprising:
a housing (collector 130) defining a centerline (centerline of collector 130, approximately along line of cannula 160, Figures 3 and 19) and having a first end (a first end 134; Figure 18), a second end (second end 136), a hollow needle (needle cannula 160), and a flow channel having an inlet (collection area 148) and an outlet (distal end 164 of channel 170), a portion of the flow channel offset from the centerline of the housing (Figure 19; the channel 170/172 is offset from centerline of housing 130), the flow channel having a flow directing attachment portion (top portion of the collector 130 to induce the blood flow, including channel member 150 in annotated Figure 18) adjacent the outlet (164), and the hollow needle between the first end of the housing and the flow channel (annotated Figure 18); and
a container (container assembly 10, Figure 1) removably connectable to the housing (Paragraph 0068; ‘collector 130 may be removed from container assembly 10’), the container defining a collection cavity (central bore 36) and having an interior wall (inner surface 38),
wherein, with the container connected to the housing (Figure 3), the outlet (164) of the flow channel is in fluid communication with the collection cavity (36) of the container (10) and the outlet of the flow channel is adjacent the interior wall of the container (Figure 3, the end of channel 170 is adjacent the inner surface 38).
Regarding claim 2, Bartfeld teaches wherein the flow directing attachment portion provides a fluid attachment point for blood to attach to for controlling the flow of blood from a portion of the housing to the collection cavity of the container (collector body 132; Figures 2-3; Channel members 150 and, more particularly, intervening capillary channels 152 form capillary flow channels to guide a fluid sample downward into central bore 142 defined by sidewall 138 of collector body 132 under capillary action. Thus, capillary channels 152 operate generally as fluid guides to guide a desired fluid sample into central bore 142 in collector body 132; Paragraph 0063).
Regarding claim 3, Bartfeld teaches wherein, with the first end (134) of the housing in communication with a source of blood, the hollow needle, the flow channel (through channel 170), the flow directing attachment portion, and the interior wall of the container provide attachment portions to establish attached blood flow, for a first drop of blood and subsequent blood to follow, from the first end of the housing to the collection cavity of the container (Figure 3, when finger is in contact with channel chambers 150, channels 152 guides the blood to flow into collector body 132, then the blood flows into channels 170, after passing the distal end 168 of the channel 170, the blood flows into capillary channel 40 on the internal surface 38 of the inner member 20; Paragraphs 0052, 0063-0064), for a first drop of blood and subsequent blood to follow, from the first end (134) of the housing (130) to the collection cavity (36) of the container (10).
Regarding claim 4, Bartfeld teaches wherein, with the inlet of the flow channel in communication with a source of blood, the blood fluidly attaches to a portion of the hollow needle and flows through the hollow needle to the flow channel (collector body 132 and channel 170, Figure 3) (Paragraph 0063 ‘capillary channels 152 operate generally as fluid guides to guide a desired fluid sample into central bore 142 in collector body 132’).
Regarding claim 5, Bartfeld teaches wherein the blood is subsequently pulled through the flow channel to the flow directing attachment portion via capillary action (Abstract; Paragraph 0064).
Regarding claim 6, Bartfeld teaches wherein, the blood fluidly attaches to the flow directing attachment portion and the interior wall of the container to flow from the flow channel into the collection cavity of the container (Figure 3, blood flows from distal end 168 of channel 170 into bore 36 of inner member 20; Paragraph 0064 ‘collector 130 is the provision of an accessing needle cannula 160 at the distal end 1 36 of collector body 132 used to pierce or puncture closure body 72 to gain access to the interior of container assembly 10 and, particularly, fluid sample collection chamber 116).
Regarding claim 7, Bartfeld teaches wherein the housing includes a sloped wall surface between the hollow needle and the flow channel, and the sloped wall surface defines a flow channel entry (inner surface 146; Figure 3A; Paragraph 0061, ‘[A]n inner surface 146 of rim portion 140 has a generally curved or arcuate shape’; Examiner further notes any wall can be considered sloped depending on the perspective as the claim does not define what the wall is sloped relative to)
Regarding claim 8, Bartfeld teaches wherein the flow directing attachment portion is an attachment lip (Figure 4).
Regarding claim 9, Bartfeld teaches wherein the flow directing attachment portion is an extended capillary tube portion (Paragraph 0062)
Regarding claim 10, Bartfeld teaches wherein the flow directing attachment portion is an inward curved lip (Figure 4).
Regarding claim 13, Bartfeld teaches wherein the outlet of the flow channel extends beyond the second end of the housing (it is shown clearly that distal end 164 of channel 170 extends beyond the distal end 136 of the housing 130).
Regarding claim 14, Bartfeld teaches further comprising a flow directing ring around the hollow needle (40; Figure 3).
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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 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.
Claim(s) 11, 15, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bartfeld et al. (US 2009/0259145) in view of Sanz (US Patent No. 3623475).
Regarding claim 11, Bartfeld is silent on the flow directing attachment portion being a planar cut lip. Sanz teaches wherein the flow directing attachment portion is a planar cut lip (Figures 1-2 and 4-5). It would have been obvious to one of ordinary skill in the art to have modified Bartfeld with Sanz because the changes in shape claimed represent a design choice, and so a person of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996).
Regarding claim 15, Bartfeld is silent on the hollow needle including a lancing blade. Sanz teaches wherein the hollow needle (8a, 8b, and 6 combined) includes a lancing blade (lancet being 8a, 8b). It would have been obvious to one of ordinary skill in the art to have modified Bartfeld with Sanz because Bartfeld teaches the use of a lancet (Paragraph 0061) and thus combining the elements into one integrated unit would only require routine experimentation and engineering skills and since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. MPEP 2144.04 V. (B)
Regarding claim 16, Bartfeld is silent on the hollow needle including a lancing blade. Sanz teaches wherein, with the first end of the housing in communication with a source of blood, a first drop of blood attaches to the lancing blade and flows through the hollow needle to the flow channel (Figure 2). It would have been obvious to one of ordinary skill in the art to have modified Bartfeld with Sanz because Bartfeld teaches the use of a lancet (Paragraph 0061) and thus combining the elements into one integrated unit would only require routine experimentation and engineering skills and since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. MPEP 2144.04 V. (B)
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bartfeld et al. (US 2009/0259145) in view of Rostaing (US 2011/0124984).
Regarding claim 12, Bartfeld is silent on the extended pillar structure. Rostaing teaches wherein the flow directing attachment portion is an extended pillar structure (Paragraph 0035). It would have been obvious to one of ordinary skill in the art to have modified Bartfeld with Rostaing because Rostaing teaches the pillars assist in locally massaging the finger and thus facilitating the flow of blood from the finger into the device (Paragraph 0035 of Rostaing).
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 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11771352 in view of Bartfeld et al. (US 2009/0259145).
Instant Application 18/237,670
US Patent No. 11771352
1. A device for the attached flow of blood, the device comprising:
a housing defining a centerline and having a first end, a second end, a hollow needle, and a flow channel having an inlet and an outlet, a portion of the flow channel offset from the centerline of the housing, the flow channel having a flow directing attachment portion adjacent the outlet, and the hollow needle between the first end of the housing and the flow channel; and
a container removably connectable to the housing, the container defining a collection cavity and having an interior wall,
wherein, with the container connected to the housing, the outlet of the flow channel is in fluid communication with the collection cavity of the container and the outlet of the flow channel is adjacent the interior wall of the container.
1. A device for attached flow of blood, the device comprising:
a housing defining a centerline and having a first end, a second end, and a flow channel having an inlet and an outlet, a portion of the flow channel offset from the centerline of the housing, and the flow channel having a first flow directing attachment portion adjacent to the inlet and a second flow directing attachment portion adjacent to the outlet, the first flow directing attachment portion provides a first fluid attachment point for controlling the flow of blood that attaches thereto from a skin surface to a portion of the housing; and
a container removably connectable to the housing, the container having an interior wall defining a collection cavity,
wherein, with the container connected to the housing, the outlet of the flow channel is in fluid communication with the collection cavity of the container and the outlet of the flow channel is adjacent to the interior wall of the container, the outlet of the flow channel and the second flow directing attachment portion are configured to provide a second fluid attachment point for attached flow of blood directly from the flow channel to the interior wall of the container,
wherein the first end of the housing includes a sloped wall surface, and
wherein the first flow directing attachment portion is an attachment pillar and extends entirely from the sloped wall surface along the centerline.
The only differences between the instant application and the Patent are that the instant application has a hollow needle and that the flow directing attachment portion is claimed adjacent the outlet versus adjacent the inlet. The adjacent the outlet vs inlet is still taught by the patent give the entire device is one unit and any part of the structure would be considered adjacent any other portion and further it has been held that rearranging parts of an invention involves only routine skill in the art MPEP 2144.04 VI. (C). The hollow needle of the instant application is merely a more specific second flow directing attachment portion as recited in the patent. This is taught by Bartfeld as noted in the 102 rejection above. And it would have been obvious to one of ordinary skill in the art to have modified the patent with Bartfeld because it would only require the routine skill of simple substitution of one known element for another to obtain predictable results (MPEP 2143 I. B.) in this case the flow directing attachment portion of the patent with it being a hollow needle as taught by Bartfeld. The dependent claims of the instant application are all either verbatim recited in the patent or only involve minor modifications that would be done through routine experimentation which would yield predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK FERNANDES whose telephone number is (571)272-7706. The examiner can normally be reached Monday-Thursday 9AM-3PM EST.
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791