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 .
This office action is in response to applicant’s communication of 6/12/2024. Currently claims 1-11 are pending and rejected below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/04/2024 is being considered by the examiner.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 5-8, 11 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Choi (US 2010/0286618 A1).
Choi discloses a fluid injection device (as in figures 2-9 for examples) for filling a tissue expander comprising: a plurality of needles (310), each being in fluid communication with a respective needle base (220); a hub (200) having a first end portion and a second end portion, the plurality of needles projecting from the first end portion of the hub; and a tubing (211) extending from the hub and configured to attach the hub to a fluid source (for example in figure 4 and source 110), wherein the plurality of needles comprises four or more needles (see multiple 310) axially aligned such that each of the needles can be inserted into an injection port of a tissue expander simultaneously, and wherein the needles are sized and spaced to allow an increased flow rate compared to a single needle without causing leakage from the injection port (see para [0046]).
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Concerning claim 2 and the plurality needles comprises four needles (note at least 4 needles 310 as in figure 7).
Concerning claim 5 and the fluid source comprises a syringe (see 101/110 element).
Concerning claim 6 and the hub includes handles extending therefrom for enabling easier insertion of the needles into an injection port (note portion of hub near 210 which examiner is of a position that this is a handle as this is the portion grasped by a user during operation of the device).
Concerning claim 7 and each of the plurality of needles comprises an ultra-thin wall needle (examiner is of the position that the walls of needles 310 would be considered ultra thin wall needles as they have thin walls for penetration of the dermis for some embodiments).
Concerning claim 8 and the plurality of the needles comprises a longitudinal length from the hub to a tip of the needle, the longitudinal length of each of the plurality of needles being approximately equal (see figure 5 and note equal length of 310).
Concerning claim 11 and the plurality of needles are hypodermic needles (examiner is of the position that that Choi needles 310 would be considered hypodermic needles as their intended usage is to transfer fluids and penetrate skin).
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) 3-4, 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi (US 2010/0286618 A1).
Concerning claim 3 and the needles being 21 gauge needles it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the needles 21 gauge since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Further needles for injection are known to be in the 21 gauge size to a PHOSITA in order to penetrate a certain thickness of skin while providing a certain volume of flow therethrough.
Concerning claim 4 note Choi show hub has a diameter of 3 cm or less or it would have been obvious to one having ordinary skill in the art at the time the invention was made to size a hub that has a diameter of 3 cm or less since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Here the small size would allow for a connection to conventional syringe tips and nozzles well known to PHOSITAs to construct medical devices and needle hubs from.
Concerning claim 9 note Choi show needles spaced no more than 5 mm or it would have been obvious to one having ordinary skill in the art at the time the invention was made to space them less than 5 mm apart, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Here the close spacing would allow for a tight concentrated delivery to a small area anatomical structure.
Concerning claim 10 it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the hub diameter in the range of .25 cm to 3cm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). This range is the general size range for medical devices and injection needle arrays and a PHOSITA would know to size the hub in this range in order to be portable for patient delivery and use while large enough to transfer fluids through.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
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, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
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