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 .
Response to Amendment
This office action is responsive to the amendment filed on 20 March 2026. As directed by the amendment: claims 1-2 have been amended; no claims have been canceled or added. Thus, claims 1-3 are presently pending in this application with claim 3 withdrawn from consideration.
Response to Arguments
Applicant's arguments filed 20 March 2026 have been fully considered but they are not persuasive. Applicant argues that, in the invention of Caizza, (a) the interpreted flange does not disclose a recess portion, (b) the interpreted weld line is a ramp when a weld line by definition is a defect where two flow fronts meet, and (c) the limitations of claim 2 describe a specific structural relationship between a gate rest and a recess portion that isn’t taught by Caizza. However, applicant is pulling limitations from the specification into the claim interpretation that are not disclosed in the claims. Regarding (a), a recess is known in the art to be an open space within a structure, not exclusively a structure carved out of a solid piece. As such, the gap formed by the flange is properly interpreted as recess based on the broadest reasonable interpretation of the claims. Regarding (b), a “weld line” is not given a special definition and is not a well-known term in the art and has therefore been given its broadest reasonable interpretation in the art of medical syringe barrels, namely that a “weld line” is a line akin to a joint between two structures. In Caizza, the structure of ramp 427 is a joint that limits movement of a plunger within the syringe barrel and as such can be interpreted as a weld line, independent of the manufacturing steps that are implied by applicant’s definition of a weld line. Regarding (c), the interpreted product by process claims rely on functionally claimed structures of a gate rest and the recess portion. Because the structure of a gate rest is not positively claimed and is not part of the claimed medical syringe barrel, any syringe barrel with a recess portion can be interpreted as meeting this limitation. As such, the rejections are maintained as detailed below.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 1 is rejected under 35 U.S.C. 102(A)(1) as being anticipated by Caizza et al (US 2011/0092903).
Regarding claim 1, Caizza discloses:
A medical syringe barrel (420; Fig. 28) comprising a tubular barrel section (429) for accommodating an internal-use solution (¶0005) in the interior thereof, an injection nozzle section (422; Fig. 29) formed at one end of the barrel section (429), and a flange section (424) formed at an opening section (¶0118 – opening through which plunger 440 moves) on the other end of the barrel section (429) to project radially outward (Fig. 29), wherein the barrel section (429) includes an internal-use solution filled section (426) which is set to be filled with the internal-use solution (¶0120) and an internal-use solution unfilled section (425) which is set not to be filled with the internal-use solution (¶0119) when the internal-use solution is poured into the syringe barrel (429) from the opening section; the surface of the flange section (424) has a recess portion (see Image 1 below); and a weld line (427; Fig. 30) is not formed in the internal-use solution filled section (426).
Image 1. Annotated portion of Fig. 30
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Claim Rejections - 35 USC § 102 / 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 2 is rejected under 35 U.S.C. 102(A)(1) / 103 as being anticipated by Caizza.
Regarding claim 2, Caizza discloses a medical syringe barrel according to claim 1. The limitation “the height of a gate rest by injection molding is smaller than the depth of the recess portion in the flange section, and the gate rest fits in the interior of the recess portion” is a product-by-process limitation. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a recess portion with any depth. Manufacturing steps such as using a gate rest or injection molding are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.
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 TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571)272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783