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 .
Acknowledgment
Claims 1, 3, 28, 38, 55, 59, 61 are amended and field on 6/16/2026.
Claims 2, 227, 37 are canceled.
Note: the examiner try to resolve the issue by examiner amendment with the applicant, but it seems that the attorney was not able to get an approval from the inventor.
Claim Objections
Claims 1, 55, 59, 61 are objected to because of the following informalities:
Claim 1 recites the limitation “ a needle adaptor for forming an injection device” in line 1.
It is unclear if the claim is device claim or a method of making. The applicant is advised to amend the claims such as “ a needle adaptor to be engaged with an injection device”.
Claim 1 recites the limitation “ a syringe tip” in line 18. It is unclear if it should read as “ a tip of injection device” or should read as “a syringe tip within the injection device” The applicant is advised to amend the claims such as “a of injection device”.
Claim 55 recites the limitation “ a syringe or other dosing deice…a dispensing tip …a syringe tip ” in line 4. It is unclear if it is referring to “injection device in claim 1 or it is new device . The applicant is advised to amend the claim such as “ the injection device which is a syringe or .. and wherein the tip is …a syringe tip”.
Claim 59 recites the limitation “ a syringe or other dosing deice…a dispensing tip …a syringe tip ” in lines 34. It is unclear if it is referring to “injection device in claim 1 or it is new device . The applicant is advised to amend the claim such as “ the injection device which is a syringe or .. and wherein the
Claim 61 recites the limitation “ a syringe or other dosing deice…a dispensing tip …a syringe tip ” in lines 34. It is unclear if it is referring to “injection device in claim 1 or it is new device . The applicant is advised to amend the claim such as “ the injection device which is a syringe or .. and wherein the . Appropriate correction is required.
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.
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: other means for extracting in claim 64 see ¶0088 of the current application wherein it is unclear what it the means for extracting.
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 § 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, 28, 38, 55, 59, 61, 63-65 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 “ a syringe tip” in line 18 ( in view of new claim 65). It is unclear if it should read as “ a tip of injection device” or should read as “a syringe tip within the injection device” The applicant is advised to amend the claims such as “a of injection device”.
Claim 64 recites the limitation “ the syringe or the other dosing device” in line 3. It is unclear if it is referring to “injection device in claim 1 or it is new device . The applicant is advised to amend the claim such as “ the injection device which is the syringe or
Claim 64 recites the limitation “ a vial containing ” in line 5. It is unclear if it is referring to limitation in line 4 of claim 64 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to the line 4 of claim 64.
Claim 64 recites the limitation “ other means for extracting” in line 6. It is unclear if it is what other means is referring to.
Claim 64 recites the limitation “ a fluid ..a subject ” in line 3. It is unclear if it is referring to limitation in lines 1-2 of claim 1 or it is referring to new limitation . For the purpose of examination, the examiner will interpret the limitation as it is referring to the lines 1-2 of claim 1.
Allowable Subject Matter
Claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claim 3, 28, 38, 55, 59, 61, 63-65 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the closest art which was Alchas et al. (US20030199822A1) comprises: a needle adaptor (100, Fig. 1-5) for forming an injection device for administering a fluid to a subject comprising: a housing formed from a first housing portion (right portion of 12 ) and a second housing portion (left portion of 12); a needle unit (36, 14) fixedly mounted within the housing, a needle hub (36) comprising a pair of radially extending diametrically opposing flanges (left and right 26);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 and 26), But it fails to disclose 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 and a second orientation of mounting of the needle unit, 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, 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, and wherein the first predefined distance is different from the second predefined distance.
Conclusion
THIS ACTION IS MADE FINAL. 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 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
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