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 4/09/2026. Currently claims 1-5, 7-8, 10-14, 16-20 are pending and subject to the rejections below.
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.
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(s) 1-5, 7-8, 10-14, 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eaton et al. (US 2014/0221970 A1) in view of Assaf (US 2004/0260269 A1).
Eaton discloses a medication delivery device (as shown in figures 1-18 comprising:
a dispensing mechanism (112) connected to a reservoir (106/105) configured for containing a medication; and a stainless steel needle (104 connected to said dispensing mechanism for delivering the medication, said stainless steel needle having an outer surface configured for contacting the patient (as in figure 1-2 for example), said stainless steel needle having protective layer of a non-allergenic material over at least a portion of said stainless steel needle (para [0039]) to prevent direct contact of the stainless steel needle with the patient (see para [0051] disclosure of coatings).
Eaton discloses the claimed invention except for the protective layer is formed only on one of the distal end or the intermediate surface. Assaf teaches that it is known to use protective layer is formed only on one of the distal end or the intermediate surface as set forth in figure 1 and area 4 to provide an improved visualization of the needle during a medical procedure or imaging. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Eaton with the protective layer is formed only on one of the distal end or the intermediate surface as taught by Assaf, since such a modification would provide the system with the protective layer is formed only on one of the distal end or the intermediate surface for providing an improved visualization of the needle during a medical procedure or imaging.
Concerning claim 2 and said protective layer is a metal coating of an anodized (see para [0077] disclosure of coatings to steel needle may be anodized markings).
Concerning claim 3 and said protective layer is a metal coating formed directly on said outer surface of said needle, and where said metal coating is selected from the group consisting of gold, platinum, iridium, silver, rhenium, ruthenium, rhodium, palladium, iridium, and osmium (see para [0051] disclosure of coatings to steel needle may be gold or silver).
Concerning claim 4 and said protective layer is a gold coating formed directly on said stainless steel needle (again see para [0051] disclosure of coatings to steel needle may be gold).
Concerning claim 5 and said gold coating is formed on a distal tip of said needle (note needle 104 may be coated of gold as in figure 1 for example).
Concerning the stainless steel needle has a distal end, a proximal end, and an intermediate surface oriented between said distal end and said proximal end (note needle 104 as in figures 1-2 for examples).
Concerning claim 7 and the protective layer is a gold coating formed on said distal end and is spaced distally from said intermediate surface and said spaced from said proximal end. (see para [0051] disclosure of coatings to steel needle may be gold and formed on portions of the needle (note para [0052 discusses covering at least partially before and during injections).
Concerning claim 8 and said protective layer is a gold coating provided on said intermediate surface and spaced from said distal end and said proximal end examiner is of the position that if not inherent in the disclosure of Eaton then it would have been an obvious modification to a PHOSITA to have the gold protective layer on the intermediate portion. It has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70 (CCPA 1950).
Examiner if of the position that a PHOSITA would know to place a protective gold coating wherever the PHOSITA wishes to prevent contamination or infections (Eaton para [0051]), and a PHOSITA would know that the intermediate portion would contact skin or be placed against the skin and therefore would want to prevent contamination/infection with the skin and provide the gold coating on that portion (the intermediate or middle part of the needle). Therefore it is examiner position that a PHOSITA would know and appreciate that they may place a gold protective coating on the portions of the needle that they wish were protecting from contamination/infection such as the middle, proximal, distal, entire lengths or certain portions thereof to prevent contamination/infections during injections or fillings.
Concerning claim 10 and the delivery device comprises a catheter (as in figure 10 and para [0003]) and said stainless steel is an introducer needle positioned in a lumen of said catheter (see figure 10) with a distal end of said stainless steel needle extending from said catheter, and where said distal end of said introducer needle is covered by said protective layer to prevent direct contact of said stainless steel needle with the patient (para [0040] devices disclosure and [0051] coating of gold disclosure).
Concerning claim 11 and the delivery device is a pen needle having a needle hub with a proximal end configured for connecting to a delivery pen, and a distal end supporting said needle (para [0040] devices disclosure which examiner is of the position is a delivery pen and para [0051] coating of gold disclosure).
Concerning claim 12 and a medication delivery device (see figure 1 for example) comprising:
a syringe 100) having a syringe barrel (106) with a proximal end, a distal end, a lumen extending between said proximal end and said distal end, and a stainless steel needle (104) extending from said distal end; said stainless steel needle (104) having length for injecting a medication into a subject and an outer surface covered by a protective layer of a non-allergenic coating material to prevent contact of an outer surface of the stainless steel needle directly with a tissue of the subject and prevent an allergic reaction in the subject by contact with the stainless steel needle (see para [0051] disclosure of coatings).
Eaton discloses the claimed invention except for the protective layer is formed only on one of the distal end or the intermediate surface. Assaf teaches that it is known to use protective layer is formed only on one of the distal end or the intermediate surface as set forth in figure 1 and area 4 to provide an improved visualization of the needle during a medical procedure or imaging. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Eaton with the protective layer is formed only on one of the distal end or the intermediate surface as taught by Assaf, since such a modification would provide the system with the protective layer is formed only on one of the distal end or the intermediate surface for providing an improved visualization of the needle during a medical procedure or imaging.
Concerning claim 13 and the protective layer is anodized (see para [0077] disclosure of coatings to steel needle may be anodized markings).
Concerning claim 14 and the protective layer is a metal coating selected from the group consisting of gold, platinum, iridium, silver, rhenium, ruthenium, rhodium, palladium, iridium, and osmium (see para [0051] disclosure of coatings to steel needle may be gold or silver).
Concerning claim 16 and a method for injecting a medication to a subject and inhibiting an allergic reaction at a delivery site, comprising providing a delivery device (as in figure 1 for example) including a medication reservoir (106/105), a dispensing mechanism (112) connected to said reservoir, and a stainless steel needle (104) having lumen, a distal end, a proximal end, and an intermediate surface between said distal end and said proximal end, said stainless steel needle having an outer protective layer to prevent direct contact with tissue of a patient (para [0051] coating of gold disclosure).; and contacting said stainless steel needle with the patient and delivering the medication to the patient, said outer protective layer preventing contact of the stainless steel needle with the patient and preventing or inhibiting allergic reactions by the patient from nickel in the stainless steel needle (see para [0051] to prevent contamination or infection for examples).
Eaton discloses the claimed invention except for the protective layer is formed only on one of the distal end or the intermediate surface. Assaf teaches that it is known to use protective layer is formed only on one of the distal end or the intermediate surface as set forth in figure 1 and area 4 to provide an improved visualization of the needle during a medical procedure or imaging. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Eaton with the protective layer is formed only on one of the distal end or the intermediate surface as taught by Assaf, since such a modification would provide the system with the protective layer is formed only on one of the distal end or the intermediate surface for providing an improved visualization of the needle during a medical procedure or imaging.
Concerning claim 17 and the protective layer is anodized (see para [0077] disclosure of coatings to steel needle may be anodized markings).Concerning claim 18 and the outer protective layer is gold. (again see para [0051] disclosure of coatings to steel needle may be gold).
Concerning claim 19 and the outer protective layer is provided on said distal end of said needle and spaced from said intermediate surface, and where said intermediate surface of said needle is spaced from a surface of said patient when said needle is inserted. (again see para [0051] disclosure of coatings to steel needle may be gold and formed on portions of the needle and note para [0052 discusses covering at least partially before and during injections).
Concerning claim 20 and the outer protective layer is formed on said intermediate surface, and where said needle is inserted into a lumen where said distal end is oriented in the lumen and the protective layer on the intermediate surface contacts a surface of the patient; Examiner is of the position that if not inherent in the disclosure of Eaton then it would have been an obvious modification to a PHOSITA to have the gold protective layer on the intermediate portion. It has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70 (CCPA 1950).
Examiner if of the position that a PHOSITA would know to place a protective gold coating wherever the PHOSITA wishes to prevent contamination or infections (Eaton para [0051]), and a PHOSITA would know that the intermediate portion would contact skin or be placed against the skin and therefore would want to prevent contamination/infection with the skin and provide the gold coating on that portion (the intermediate or middle part of the needle). Therefore it is examiner position that a PHOSITA would know and appreciate that they may place a gold protective coating on the portions of the needle that they wish were protecting from contamination/infection such as the middle, proximal, distal, entire lengths or certain portions thereof to prevent contamination/infections during injections or fillings.
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Response to Arguments
Applicant's arguments filed 4/9/2026 have been fully considered but they are not persuasive. Examiner is of the positon that the amended claims are taught in the 103 rejection above of Eaton in view of Assaf.
As stated in the rejection above Eaton discloses the claimed invention except for the protective layer is formed only on one of the distal end or the intermediate surface. Assaf teaches that it is known to use protective layer is formed only on one of the distal end or the intermediate surface as set forth in figure 1 and area 4 to provide an improved visualization of the needle during a medical procedure or imaging. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Eaton with the protective layer is formed only on one of the distal end or the intermediate surface as taught by Assaf, since such a modification would provide the system with the protective layer is formed only on one of the distal end or the intermediate surface for providing an improved visualization of the needle during a medical procedure or imaging. Examiner is of the position that all positively claimed structures are taught in the combination and obviousness rejection of Eaton in view of Assaf.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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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