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 .
Election/Restrictions
Applicant’s election without traverse of group I ( CLAIMS 1-3, 27, 28, 37, 38, 55, 59, 61) in the reply filed on 11/13/2025 is acknowledged.
Claims 11-13, 21-22, 25, 39-40, 53-54, 56-58, 60-62 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/13/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 27-28, 37-38, 55, 59, 61 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the subject’s skin" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "wherein the at least two consecutive transverse walls or projections form a gap therebetween" in lines 11-12. It is unclear that it means both of the at least two consecutive transverse walls or projections of the first housing portion and second housing portion are forming a gap therebetween or wherein the at least two consecutive transverse walls or projections of at least one of the first housing portion and second housing portion form a gap therebetween. Note: for the purpose of examination, the examiner will interpret the limitation such as “wherein the at least two consecutive transverse walls or projections of each of the first housing and second housing form a gap therebetween ” (similar to claim 2).
Claim 3 recites the limitation "optionally..etc." in line 11. It is unclear if the limitation after the term “optionally” is positively recited or not. Note: for the purpose of examination, the examiner will interpret the limitation after the term “optionally” as not positively recited and can be negated.
Claim 27 recites the limitation "optionally..etc." in line 4. It is unclear if the limitation after the term “optionally” is positively recited or not. Note: for the purpose of examination, the examiner will interpret the limitation after the term “optionally” as not positively recited and can be negated.
Claim 27 recites the limitation "the gap formed between the at least two consecutive transverse walls or projections " in line 8. It is unclear if it means that both gaps formed between the at least two consecutive transverse walls or projections of the first housing portion and the second housing portion or one gap formed between the at least two consecutive transverse walls or projections of at least one of the first housing portion and second housing portion. Note: for the purpose of examination, the examiner will interpret the limitation such as “the gaps formed the at least two consecutive transverse walls or projections of each of the first housing and second housing” .
Claim 28 recites the limitation "optionally..etc." in line 7. It is unclear if the limitation after the term “optionally” is positively recited or not. Note: for the purpose of examination, the examiner will interpret the limitation after the term “optionally” as not positively recited and can be negated.
Claim 28 recites the limitation "the gap formed between the at least two consecutive transverse walls or projections …" in the last 3 lines. It is unclear if it means that both gaps formed between the at least two consecutive transverse walls or projections of the first housing portion and the second housing portion or one gap formed between the at least two consecutive transverse walls or projections of at least one of the first housing portion and second housing portion. Note: for the purpose of examination, the examiner will interpret the limitation such as “the gaps formed the at least two consecutive transverse walls or projections of each of the first housing and second housing” .
Claim 37 recites the limitation "optionally..etc." in line 5. It is unclear if the limitation after the term “optionally” is positively recited or not. Note: for the purpose of examination, the examiner will interpret the limitation after the term “optionally” as not positively recited and can be negated.
Claim 38 recites the limitation "optionally..etc." in line 5. It is unclear if the limitation after the term “optionally” is positively recited or not. Note: for the purpose of examination, the examiner will interpret the limitation after the term “optionally” as not positively recited and can be negated.
Claim 55 recites the limitation "optionally..etc." in last 3 lines. It is unclear if the limitation after the term “optionally” is positively recited or not. Note: for the purpose of examination, the examiner will interpret the limitation after the term “optionally” as not positively recited and can be negated.
Claim 59 recites the limitation "optionally..etc." in line 6 and repeated in line 7, 10 and last line. It is unclear if the limitation after the term “optionally” is positively recited or not. Note: for the purpose of examination, the examiner will interpret the limitation after the term “optionally” as not positively recited and can be negated.
Claim 61 recites the limitation "optionally..etc." in line 4. It is unclear if the limitation after the term “optionally” is positively recited or not. Note: for the purpose of examination, the examiner will interpret the limitation after the term “optionally” as not positively recited and can be negated.
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, 55, 59, 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alchas et al. (US. 20030199822A1) (“Alchas”) in view of Iwase et al. (US. 20160022924 A1) (“Iwase”).
Re Claim 1, Alchas discloses a needle adaptor (10, Fig. 1a-6) for forming an injection device (20 and 10, Fig. 2) for administering a fluid to a subject (¶0003) comprising: a housing (12) formed from a first housing portion (right half portion) and a second housing portion ( left half portion), the housing having a proximal end (top end of 12 , Fig. 3) and a distal end ( close to 46 end); a needle unit (36 and 14) fixedly mounted within the housing (¶0035, Fig. 3), wherein the needle unit comprises: a needle shaft (36) comprising a first end for penetrating the subject's skin (end 42, ¶0037) and a second end connected to a needle hub (top end 38 is connected to 14, 34), the needle hub comprising a distal end connected to the second end of the needle shaft (34) and a proximal end (top end) comprising a pair of radially extending diametrically opposing flanges (left half and right half of flange 26, ¶0035); wherein each of the first housing portion and the second housing portion comprises at least two consecutive transverse walls or projections extending from an inner surface thereof (24, lower ridge under 26 and/or 30, ¶0035), wherein the at least two consecutive transverse walls or projections form a gap therebetween for receiving at least a portion of one or both of the pair of radially extending diametrically opposing flanges of the needle unit (space between 24 and ridge under 26 or 30, Fig. 3, ¶0035) to fixedly mount the needle unit within the housing (¶0035, Fig. 3); wherein the proximal end of the housing together with the at least two consecutive transverse walls or projections of each of the first housing portion and the second housing portion define a channel for receiving a syringe tip for engagement with the needle hub (space 23, 18, ¶0033, Figs. 2-3); wherein the distal end of the housing comprises a first contact surface (46) adapted to be placed on a skin of the subject (¶0038) and wherein the first end of the needle shaft extends out of the a needle opening by a predefined distance for limiting a penetration depth of the needle shaft (¶0038, ¶0040), but it fails to disclose a second contact surface, wherein the first end of the needle shaft extends out of the second contact surface by a predefined distance for limiting a penetration depth of the needle shaft.
However, Iwase discloses a needle adapter ( Fig. 1-9), and wherein comprises a first contact surface (lower surface of 44) and a second contact surface (lower surface of 42), wherein the first end of the needle shaft (11) extends out of the second contact surface by a predefined distance for limiting a penetration depth of the needle shaft (Fig, 2, ¶0057).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify proximal end of adapter of Alchas so that the adapter comprises a second contact surface, wherein the first end of the needle shaft extends out of the second contact surface by a predefined distance for limiting a penetration depth of the needle shaft as taught by Koiwai for the purpose of guiding the needle and stabilizing the needle during the injection (Iwase, ¶0057).
Re Claim 3, the modified Alchas discloses the needle adapter further comprising one or more of the following characteristics:(a )wherein the at least a portion of one or both of the pair of radially extending diametrically opposing flanges of the needle unit has a frictional engagement with opposing surfaces of the at least two consecutive transverse walls or projections of each of the first housing portion and the second housing portion when received in the gap therebetween ( Alchas, snap friction, ¶0035); (b) the first housing portion and the second housing portion are configured for snap-fit engagement with one another to form the housing;(c) each of the first housing portion and the second housing portion further comprises a plurality of projections extending from the inner surface of a distal end thereof to form a needle guide configured to hold the needle shaft in place; optionally, wherein the plurality of projections comprises at least two needle- stabilizing projections disposed on either side of the needle shaft and offset from one another along a longitudinal axis of the needle shaft, each of the at least two needle-stabilizing projections having a sloped surface abutting the needle shaft;(d) the first contact surface is disposed along the perimeter of the distal end of the housing, and the second contact surface is substantially centrally disposed at the distal end of the housing (the combined surface see Fig. 2 of Iwase);(e) the first housing portion and the second housing portion are of at least substantially similar or identical construction (Fig. 3 of Alchas) ;(f) the housing is generally cylindrical in shape (Fig. 2, Alchas); and(g) each of the first housing portion and the second housing portion is generally semi-cylindrical in shape (Fig. 2, Alchas).
Re Claim 55, the modified Alchas discloses a method of administering a fluid to a subject via injection, the method comprising: (a) obtaining the needle adaptor of claim1 (see the rejection of claim 1); (b) obtaining a syringe or other dosing device (20, ¶0036, Fig. 2 of Alchas), wherein the other dosing device comprises a dispensing tip that is similar in size and shape to a syringe tip (20, ¶0036, Fig. 2 of Alchas), wherein the syringe or the other dosing device is loaded with the fluid to be administered to the subject (¶0036, Fig. 2 of Alchas); (c) inserting the tip of the syringe or the other dosing device into the channel disposed at the proximal end of the housing so as to engage the tip with the needle hub (23, 18, Fig. 2-3, ¶0036 of Alchas); (d) engaging the first contact surface with the skin of the subject (¶0038 of Alchas); (e) pushing the housing against the skin to allow the first end of the needle shaft to penetrate the skin (¶0038 of Alchas); (f) expelling the fluid from the syringe or the other dosing device through the needle shaft into the subject (¶0038 of Alchas); and (g) optionally, engaging the needle adaptor with a safety holder (16, ¶0047 of Alchas), wherein the safety holder has an open end for receiving at least the distal end of the needle adaptor housing (top end of 16, Fig. 3, ¶0047 of Alchas) and a closed end ( lower end of 16 of Alchas), the closed end comprising opposed wings for stabilizing the safety holder on a horizontal surface (protrusion between 16 and 12 near 50 of Alchas).
Re Claim 59, the modified Alchas discloses a kit comprising: the needle adaptor of claim1 (see rejection of claim 1); a syringe or other dosing device (20, Alchas), wherein the other dosing device comprises a dispensing tip that is similar in size and shape to a syringe tip (¶0043 of Alchas), wherein the syringe or the other dosing device is optionally loaded with the fluid to be administered to the subject (¶0043 of Alchas); optionally, a vial containing the fluid to be administered to the subject (¶0043 of Alchas); optionally, a removable needle unit or other means for extracting the fluid from the optional vial into the syringe or the other dosing device, the removable needle unit being removable for allowing the tip of the syringe or the other dosing device to be inserted into the channel of the housing; optionally, wherein the safety holder has an open end for receiving at least the distal end of the needle adaptor housing (top end of 16, Fig. 3, ¶0047 of Alchas) and a closed end ( lower end of 16 of Alchas), the closed end comprising opposed wings for stabilizing the safety holder on a horizontal surface (protrusion between 16 and 12 near 50 of Alchas); and optionally, instructions for use.
Re Claim 61, the modified Alchas discloses an injection device comprising: the needle adaptor of any one of claim 1 (see the rejection of claim 1); and a syringe or other dosing device, wherein the other dosing device comprises a dispensing tip that is similar in size and shape to a syringe tip (20, ¶0043 of Alchas ), wherein the syringe or the other dosing device is optionally loaded with a fluid to be administered to a subject (20, ¶0043 of Alchas ).
Claim(s) 2, 28, 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alchas in view of Iwase and further in view of Choi (US. 20090259180A1).
Re Claim 2, Alchas discloses wherein the gap formed by the at least two consecutive transverse walls or projections of each of the first housing portion and the second housing portion is configured to receive the at least a portion of one or both of the pair of radially extending diametrically opposing flanges of the needle unit in one of a first orientation (Fig. 3 of Alchas is considered a first orientation) wherein: the predefined distance by which the first end of the needle shaft extends out of the second contact surface is a first predefined distance when the needle unit is mounted in the first orientation (Fig. 3), but it fails to disclose a second orientation of mounting of the needle unit, and the predefined distance by which the first end of the needle shaft extends out of the second contact surface is a second predefined distance when the needle unit is mounted in the second orientation, wherein the first predefined distance is different from the second predefined distance.
However, Choi discloses a needle adapter (140, Fig. 1-7), and wherein comprises a needle unit (130) and flanges (130a) and the at least two consecutive transverse walls or projections (131) and wherein a first orientation (Fig, 7) has a first predefined distance (as the depth is close to 0 ) and a second orientation of mounting of the needle unit ( Fig. 7, the needle exposed longer due to adjusting the longer depth than the first predefined distance, ¶0028, ¶0031) , and the predefined distance by which the first end of the needle shaft extends out of the second contact surface is a second predefined distance when the needle unit is mounted in the second orientation, wherein the first predefined distance is different from the second predefined distance (¶0031, the length can be adjusted to have longer than the first predefined distance).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify at least two consecutive transverse walls or projections of Alchas so that a second orientation of mounting of the needle unit, and the predefined distance by which the first end of the needle shaft extends out of the second contact surface is a second predefined distance when the needle unit is mounted in the second orientation, wherein the first predefined distance is different from the second predefined distance as taught by Choi for the purpose of adjusting the depth of the needled to a desired length (Choi, ¶0031, wherein at least two consecutive transverse walls or projections is threadedly connected to the flanges).
Claim(s) 27, 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alchas in view of Iwase further in view Ben (WO 2018034660).
Re Claim 27, the modified Alchas discloses a method for assembling the needle adaptor of claim 1 (see the rejection of claim 1), the method comprising: obtaining the first housing portion and the second housing portion (Fig. 2 of Alchas); obtaining the needle unit (14, 36, Alchas); optionally, measuring a length of the needle shaft, and removing a preselected portion of a distal end of each of the first housing portion and the second housing portion based on the length of the needle shaft; mounting the needle unit in one of the first housing portion and the second housing portion by inserting the at least a portion of one or both of the pair of radially extending diametrically opposing flanges of the needle unit into the gap formed between the at least two consecutive transverse walls or projections (Fig. 3 of Alchas); but it fails to disclose engaging the first housing portion and the second housing portion with one another to form the housing.
However, Ben discloses a needle adapter (Fig. 1-9) and wherein the housing has a first housing portion (32) and a second housing portion ( 36) and a needle unit (28) in placed in the first housing portion (Fig. 8) and the engaging the first housing portion and the second housing portion with one another to form the housing (Fig. 9, ¶0033).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the method of Alchas to include that the first housing portion is separated from the second housing portion so that engaging the first housing portion and the second housing portion with one another to form the housing as taught by Ben for the purpose of providing a housing the easily disengaged/engaged to provide an access to the cavity and adjusted the needle (Ben , ¶0033-¶0034).
Re Claim 37, the modified Alchas discloses further comprising one or more of the following characteristics:(a)wherein removing the preselected portion of the distal end of each of the first housing portion and the second housing portion comprising cutting the preselected portion of the distal end of each of the first housing portion and the second housing portion, optionally by laser cutting (Fig. 3 of Alchas, the distal end of the housings portions are cut during the manufacturing); and(b) the method is automated.
Claim(s28, 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alchas in view of Iwase and Choi and further in view Ben (WO 2018034660)..
Re Claim 28, the modified Alchas discloses a method for assembling the needle adaptor of claim 2 ( see the rejection of claim 2), the method comprising: obtaining the first housing portion and the second housing portion (the housing 12 of Alchas); obtaining the needle unit (14, 36 of Alchas); measuring a length of the needle shaft; determining whether the needle unit is to be mounted in the first orientation or the second orientation based on the length of the needle shaft (¶0005, ¶0030 of Alchas); optionally, removing a preselected portion of a distal end of each of the first housing portion and the second housing portion based on the length of the needle shaft and based on whether the needle unit is to be mounted in the first orientation or the second orientation (remove 52, Alchas); mounting the needle unit in one of the first housing portion and the second housing portion in the first orientation or the second orientation by inserting the at least a portion of one or both of the pair of radially extending diametrically opposing flanges of the needle unit into the gap formed between the at least two consecutive transverse walls or projections (the housing 12 of Alchas), but it fails to disclose engaging the first housing portion and the second housing portion with one another to form the housing.
However, Ben discloses a needle adapter (Fig. 1-9) and wherein the housing has a first housing portion (32) and a second housing portion ( 36) and a needle unit (28) in placed in the first housing portion (Fig. 8) and the engaging the first housing portion and the second housing portion with one another to form the housing (Fig. 9, ¶0033).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the method of Alchas to include that the first housing portion is separated from the second housing portion so that engaging the first housing portion and the second housing portion with one another to form the housing as taught by Ben for the purpose of providing a housing the easily disengaged/engaged to provide an access to the cavity and adjusted the needle (Ben , ¶0033-¶0034).
Re Claim 38, the modified Alchas discloses further comprising one or more of the following characteristics:(a) removing the preselected portion of the distal end of each of the first housing portion and the second housing portion comprising cutting the preselected portion of the distal end of each of the first housing portion and the second housing portion (removing 52, Fig. 3 of Alchas, the distal end of the housings portions are cut during the manufacturing), optionally by laser cutting; and wherein the method is automated.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783