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 .
DETAILED ACTION
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claim 1-15, drawn to a sampling device, classified in A61F9/0008.
II. Claim 16-21, drawn to an adapter for a syringe, classified in A61M5/345.
The inventions are independent or distinct, each from the other because:
Inventions I and II are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed the invention of Group I relates to system used for sampling a biological fluid and delivering a medication. The Group relates to a specific container for containing the sample of biological fluid including specific septums and layers for sealing the container not require by the device of Group II. Group II relates to an adapter for a syringe having a septum at an end, a window and specific dimensions not required by Group I. While the invention of Group I uses an adapter, the adapter of Group II can be used in a materially different system than the one in Group I. Further a materially different adapter, other than the one claimed in Group II can be used in the system of Group I because the adapter claimed in Group I does not require all the claimed features of that of Group II. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions require a different field of search (e.g. searching different classes/subclasses or electronic resources, or employing different search queries); and/or the prior art applicable to one group would not likely be applicable to another group; and/or the groups are likely to raise different non-prior art related issues under 35 U.S.C. 101 and/or 35 U.S.C. 112(a).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Clink Wilkins and Dirk Bernhardt on 9/25/25 a provisional election was made with traverse to prosecute the invention of Group I, claims 1-15. Affirmation of this election must be made by applicant in replying to this Office action. Claims 16-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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.
Claim(s) 1-3, 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dastane et al. (US 2005/0059163 A1) in view of Shepard et al. (US 5,511,558).
With regard to claim 1, Dastane discloses A sampling device (Fig. 1-4), comprising: a container (17) comprising a body (17) defining a chamber (at 32) and an opening to the chamber (where 18 is pointing); and a septum (22) bonded to the container to cover the opening and hermetically seal the chamber ([0093]) the septum comprising an elastomeric layer ([0093], elastomeric plug) .
However, Dastane does not disclose an adherent layer or a metallic foil layer.
Shepard teaches a sampling device (Fig. 1 and 3) comprising a container (Fig. 3, element 42) that includes a septum (51) comprising an adherent layer (glue layer that adheres the foil onto the barrel of the container, Col 3, lines 49-59) having a first thickness (inherent) and comprising a material configured to adhere to a rim of the container to provide a hermetic seal with the container (col 3, lines 49-59, the glue adheres to the rim of the barrel); a metallic foil layer (col 3, lines 49-59; metal foil affixed to the barrel) having a second thickness (inherent) and being coupled to the adherent layer (Col 3, lines 49-59). The foil and adherent layers can be added to the elastomeric layer of Dastane to provide a water impermeable barrier that is still puncturable by a needle (Col 3, lines 49-59). Wherein the third thickness of the elastomeric layer is greater than the sum of the first thickness and the second thickness (as shown in Dastane the elastomeric layer is shown as having a relatively larger thickness than the foil layers of Dastane which are described as being only 0.02 to 0.08mm each).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Dastane with the foil and adherent layers as taught by Shepard for the purpose of providing a water impermeable barrier that is still puncturable by a needle (Col 3, lines 49-59).
With regard to claim 2, Dastane discloses wherein the opening of the container is a distal opening (Dastane teaches having an opening at each end so one end can be considered the distal and the other end is the proximal, see Fig. 1-4), wherein the container further includes a proximal opening (other of the openings 18/22) opposite and aligned with the distal opening (see Fig. 1-4), and wherein the sampling device further comprises a proximal septum (other of 22) bonded to the container to cover the proximal opening, the proximal septum comprising: an elastomeric layer ([0093])
However, Dastane does not disclose an adherent layer or a metallic foil layer.
Shepard teaches a sampling device (Fig. 1 and 3) comprising a container (Fig. 3, element 42) that includes a septum (51) comprising an adherent layer (glue layer that adheres the foil onto the barrel of the container, Col 3, lines 49-59) having a first thickness (inherent) and comprising a material configured to adhere to a rim of the container to provide a hermetic seal with the container (col 3, lines 49-59, the glue adheres to the rim of the barrel); a metallic foil layer (col 3, lines 49-59; metal foil affixed to the barrel) having a second thickness (inherent) and being coupled to the adherent layer (Col 3, lines 49-59). The foil and adherent layers can be added to the elastomeric layer of Dastane to provide a water impermeable barrier that is still puncturable by a needle (Col 3, lines 49-59). Wherein the third thickness of the elastomeric layer is greater than the sum of the first thickness and the second thickness (as shown in Dastane the elastomeric layer is shown as having a relatively larger thickness than the foil layers of Dastane which are described as being only 0.02 to 0.08mm each).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Dastane with the foil and adherent layers as taught by Shepard for the purpose of providing a water impermeable barrier that is still puncturable by a needle (Col 3, lines 49-59).
With regard to claim 3, Dastane discloses an elastomeric layer having a sixth thickness (inherent).
However, Dastane does not disclose an adherent layer or a metallic foil layer.
Shepard teaches a sampling device (Fig. 1 and 3) comprising a container (Fig. 3, element 42) that includes a septum (51) comprising an adherent layer (glue layer that adheres the foil onto the barrel of the container, Col 3, lines 49-59) having a first thickness (inherent) and comprising a material configured to adhere to a rim of the container to provide a hermetic seal with the container (col 3, lines 49-59, the glue adheres to the rim of the barrel); a metallic foil layer (col 3, lines 49-59; metal foil affixed to the barrel) having a second thickness (inherent) and being coupled to the adherent layer (Col 3, lines 49-59). The foil and adherent layers can be added to the elastomeric layer of Dastane to provide a water impermeable barrier that is still puncturable by a needle (Col 3, lines 49-59). Wherein the sixth thickness of the elastomeric layer is greater than the sum of the fourth thickness and the fifth thickness (as shown in Dastane the elastomeric layer is shown as having a relatively larger thickness than the foil layers of Dastane which are described as being only 0.02 to 0.08mm each).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Dastane with the foil and adherent layers as taught by Shepard for the purpose of providing a water impermeable barrier that is still puncturable by a needle (Col 3, lines 49-59).
With regard to claim 5, Dastane discloses the claimed invention except for an adherent layer.
Shepard teaches wherein the adherent layer comprises an adhesive (glue, Col 3, lines 49-59).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Dastane with the foil and adherent layers as taught by Shepard for the purpose of providing a water impermeable barrier that is still puncturable by a needle (Col 3, lines 49-59).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dastane et al. (US 2005/0059163 A1) in view of Shepard et al. (US 5,511,558) in further view of Baretta et al. (US 2002/0169408 A1).
With regard to claim 4, Dastane/Shepard teach the claimed invention except for bonding with heat.
Baretta teaches sampling containers (test tubes, [0040]) that area sealed by heat-sealing to bond with the rim of the container ([0040]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Dastane/Shepard with the heat sealing as taught by Baretta for the purpose of ensuring a perfect air-tightness ([0040]).
Claim(s) 6-7, 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lockhart (US 2,693,184) in view of Watson (US 2,567,001).
With regard to claim 6, Lockhart discloses A system (Fig. 1, 3-6) for use with a syringe (this is functional language, therefore the syringe itself is not required to be taught by the prior art as long as the system is capable of being used with a syringe) for obtaining a biological sample and delivering a pharmaceutical agent to a patient, the system comprising: a barrel (Fig 1, element 10 and 12) comprising a hollow body (10 and 12) defining an interior region; an adapter (12) positioned within the interior region and having a proximal connecter (25) configured to couple the adapter to a distal end of the syringe (without further definition of how the adapter is “coupled” the connector 25 is considered to be capable of being connected with a syringe), a first septum (fig. 6, element 221) being disposed at a distal end of the adapter; and an evacuated container (222) slidably received within the interior region distally from the adapter (plugs 221 are considered to be slidably received as it is pushed into the tubing 12 to be placed into position) and having a body defining a chamber (formed by 222) configured to contain the biological sample (contains blood, Col 3, lines 31-62; Col 3, lines 63-Col 4, line 13) and an opening extending to the chamber (closed by septum 38), wherein a second septum (38) covers the opening; and a two-sided needle (11) having a proximal end disposed within the barrel distally from the evacuated container (see Fig. 6) and a distal end positioned for insertion into the patient (see Fig. 1), wherein the evacuated chamber is movable within the barrel to a first position placing the proximal end of the needle within the chamber to draw the biological sample from the patient into the chamber (see Fig. 3 showing blood going into the chamber 122 which equivalent to the chamber 222 in Fig. 6).
However, Lockhart does not disclose a second position where the needle passes through the chamber.
Watson teaches a similar device (Fig. 1-3) having an evacuated chamber (25 in Fig. 1 and 2) closed by a septum (23) and a proximal septum (24) positioned in a first position (Fig. 2, where the double-sided needle is placed inside the chamber and to a second position (Fig. 3) in which the proximal end of the needle passes entirely through the evacuated chamber (see Fig. 3) and through the first septum (24) to deliver the pharmaceutical agent from the syringe to the patient.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Lockhart with the needle passing through the container as taught by Watson for the purpose of allowing the liquid drug to be expelled (Col 4, lines 16-43).
With regard to claim 7, Lockhart discloses wherein the evacuated container (122) is movable in the same direction relative to the barrel to reach both the first and second positions (see Fig. 3).
With regard to claim 12 and 13, Lockhart discloses the claimed invention except for the o-ring.
Watson teaches the use of an o-ring (Fig. 3, element 36) with a concave seat 34 for holding the o-ring that can be used to further seal two components of the device. This o-ring can be added the adapter of Lockhart for the purpose of sealing it to the container.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Lockhart with the o-ring as taught by Watson for the purpose of sealing the two components together (Col 3, lines 42-59).
With regard to claim 14, Lockhart discloses wherein the proximal end of the two-sided needle comprises a beveled opening (at 15).
Related Prior Art
Ang et al. (US 2019/0159930 A1) – Teaches a sampling and injection device for the eye (see Fig. 2a-2c, as well as Fig. 3a and 3b). Chamber 500 is designed to receive biological fluid after which fluid can be injected via syringe plunger 410. However, Ang does not teach the claim limitation “wherein the evacuated chamber is movable within the barrel to a first position placing the proximal end of the needle within the chamber to draw the biological sample from the patient into the chamber and to a second position in which the proximal end of the needle passes entirely through the evacuated chamber and through the first septum to deliver the pharmaceutical agent from the syringe to the patient”.
Allowable Subject Matter
Claims 8-11, 15 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 details regarding the evacuated chamber are allowable over the prior art as there is no combination of prior art or motivation to combine these claim limitations with the claimed system in claim 6.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Lauren P Farrar/Primary Examiner, Art Unit 3783
Prosecution Insights