DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/19/26 has been entered.
Product by Process Limitations
Initially, and with respect to claim(s) 1, note that a "product by process" claim is directed to the product per se, no matter how actually made. See In re Thorpe et ah, 227 USPQ 964 (CAFC, 1985) and the related case law cited therein which makes it clear that it is the final product per se which must be determined in a "product by process" claim, and not the patentability of the process, and that, as here, an old or obvious product produced by a new method is not patentable as a product, whether claimed in "product by process" claims or not. As stated in Thorpe, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972); In re Pilkington, 411 F.2d 1345, 1348, 162 USPQ 145, 147 (CCPA 1969); Buono v. Yankee Maid Dress Corp., 77 F.2d 274, 279, 26 USPQ 57, 61 (2d. Cir. 1935).
Note that Applicant has burden of proof in such cases as the above case law makes clear.
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 and 4 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.
Regarding claim 1:
The claim limitation “an upper section” in line 19 is unclear. The limitation is unclear because of the earlier recitation of the limitation “an upper section” in line 9 of the claim which raises a question of if two of upper sections are required by the claim or only one. For the sake of examination, the office has assumed that only one upper section is required by the claim.
Claim 4 is rejected due to its dependence on claim 1.
Regarding claim 4:
The claim recites the limitation "the coupling" in line 4. There is insufficient antecedent basis for this limitation in the claim.
The claim recites the limitation "the passage" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over GB 2202148 A to Hymanson in view of US 4568336 A to Cooper.
Regarding claim 1:
Hymanson discloses:
A device (figures 3, 4 and 5) for injecting a liquid drug (page 2, lines 15-20) with a syringe (see figure 5) comprising:
a tube (22) containing the liquid drug to be injected;
a needle holder piece (15) partially coupled to the tube (22) up to a first position and (position as shown in figure 2 where the needle is outside the plug 38 and prior to assembly with the tube 22 indicating that this “first position” is inherent; further, this limitation is considered a product by process limitation since it details the assembly of the device and since the ultimate assembly/product is the product outlined in the reference; further, the structure in Hymanson is capable of this function/step since it includes all of the structure required by the claim) an inlet end (18) of a needle (11) located inside the needle holder piece (15) remains near a plug (38),
a unidirectional male coupling (see male coupling A in figure 1 below) and female coupling (see female coupling B in figure 1 below) the unidirectional male coupling (A in figure 1 below) and the female coupling (B in figure 1 below) connect the tube (22) to the needle holder piece (15)(as shown in figure 5 which shows 22 and 15 connected), the male coupling (A in figure 1 below) is located at a distal end (see the distal end adjacent to 38) of the tube (22) and the female coupling (B in figure 1 below) is located at a cavity (30) defined by an upper section (see the top portion of 15 as shown in figure 1 below) of the needle holder piece (15) and is tightly fixed (as shown in figure 5) by a lower portion of the needle holder piece (15);
a cap (13) to push (the cap in this structure is capable of this function) the female coupling (B as shown in figure 1 below) for the needle holder piece (15) into the tube (22);
a plunger (37) located at a proximal section (can be located on both ends of the tube 22 depending on the application of force to the stem) of the tube (22), the plunger (37) is moved by (column 5, lines 10-15) a stem (21),
the plug (38) is located the distal end (see the distal end adjacent to 38) of the tube (22), the plug (38) is pierced by the inlet end (18) of the needle (11) in a second position (as shown in figure 5);
wherein an external face (A in figure 1 below) of the distal end (see the distal end adjacent to 38) of the tube (22) and an internal face (B in figure 1 below) of an upper section (see the top portion of 15 as shown in figure 1 below) of the needle holder piece (15) include respective complementary projections (31 and 32) which determine an irreversible unidirectional coupling (inherent function due to the saw tooth shape of the projections 31 and 32) between said tube (22) and said needle holder piece (15);
wherein said complementary projections (31 and 32) have a shape of a sawtooth (page 6, lines 1-10 which described the projections 31 and 32 are saw-tooth),
wherein the second position (as shown in figure 5), the cap (13) is pressed against (the structure of the cap is capable of this function) the needle holder piece (15) piercing the plug (38) with the inlet end (18) of the needle (11) inserting the needle (11) into the tube (22)(as shown in figure 5), and the complementary projections (31 and 32) of the male coupling (A in figure 1 below) are forced to move (with the final position shown in figure 5 the projections of B move over the projections of A of figure 1 below) facing the corresponding complementary projections (31 and 32) of the female coupling (B in figure 1 below) defining the irreversible coupling by blocking a backward movement (inherent function of the male or female coupling/projections and the sawtooth shape which allows the needle holder piece 15 to slide over the end of tube 22 but make dislodging of the components from one another harder) of the needle holder piece (15).
Hymanson fails to disclose:
The plug is made of an elastomeric material.
Cooper teaches:
A syringe (see figure 1) with a tube (11), needle holder piece (34), a needle (35) and a plug (22). As shown in figure 5, the needle pierces the plug and the reference further indicates the plug is made from an elastomeric material (column 3, lines 30-35).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hymanson to make the plug of an elastomeric material as taught by Cooper to allow the needle to pierce the plug. Further, this is a simple substitution of one known element (the material of the plug in Hymanson) for another (the elastomeric material of the plug in Cooper) to obtain predictable results (to seal the needle 30 with the tube 22).
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Figure 1 – figure 4 of Hymanson, annotated by the examiner
Regarding claim 4:
Hymanson discloses:
The device according to claim 1, wherein between a front section (see the section D in figure 1 above) and a rear section (see the section E in figure 1 above) of the needle holder piece (15) includes a perimeter step (see the step C in figure 1 above) that defines a circumferential stop (see the stop shape of C as shown in figure 1 above) for pushing (due to the shape of the needle holder piece 15 the structure is capable of this function) the needle holder piece (15) against the distal end (see the distal end adjacent to 38) of the tube (22) by the cap (13) covering the needle (11) for the coupling and piercing (as shown in figure 5) of the plug (38) and the passage (as shown in figure 5) of the inlet end (18) of the needle into the tube (22).
Response to Arguments
Applicant's arguments filed 1/20/26 have been fully considered but they are not persuasive.
Regarding the 35 USC 102 rejection of claim 1:
The applicant makes several arguments as to why the above rejection is improper however the office is not persuaded. The applicant argues that limitations “a needle holder piece (3) partially coupled to the tube (1) up to a first position and an inlet end of a needle (2) located inside the needle holder piece (3) remains near a plug (8)” and “in the second position, the cap (4) is pressed against the needle holder piece (3) piercing the plug (8) with the inlet end of the needle (2) inserting the needle (2) into the tube (1)” are not taught by the Hymanson reference (see page 6 of the remarks). However, the office disagrees with this argument for several reasons. First, the limitation is a product by process limitation (see the pre-assembled arguments on page 8 of the remarks) since the first position described is an intermediate step to the final assembly/product of the claim where the cap is located in the tube and the needle is through the plug which is taught by the Hymanson reference and for this reason reads on the claim. Second, the argument is not persuasive since the first position is an intermediate step that the Hymanson reference must inherently perform during assembly of the needle holder piece and needle to the tube and plug. The needle holder piece 15 and the needle 11 are attached together as shown in figure 2 and then the two parts (needle holder piece and the needle) are assembled to the tube 22. During the assembly process there is a period of time or first position where the needle holder piece and the needle are on the inlet 25 of the tube but the needle has not pierced the plug. While the applicant is correct in indicating that the cap 14 covers the needle holder piece 15 and needle 11/18 for a time (see page 9 of the remarks), it’s also true that there is a period of time where the cap 14 is removed and the needle and holder piece are attached to 25 before the needle pierces the plug. Further, the applicant argues that there is a first position where the needle holder piece is attached to the tube but the needle does not pierce the plug (see page 10 of the remarks) however this is not claimed. The claim only indicates that in the first position the needle is near the plug but fails to mention whether it is pierced or not. For this reason, even if the reference teaches the needle pierces the plug it would still read on the limitation since it is near the plug. For this reason, the limitation is inherently taught by the reference. Third, since the Hymanson reference teaches all of the structure required by the claim, it is capable of the function outlined by the claim. Since it is capable of the function and includes all of the structure required by the claim the reference still reads on the claim.
Further, if the applicant intends to claim specifically that the needle does not pierce the plug in the first position and argue that this is not the case in the Hymanson reference then they should consider references such as US 2841143 A to Bertram, US 3158155 A to SIMON et al. and US 5611786 A to Kirchhofer et al. which show this function as well.
For these reasons, the above rejection of the claim is maintained.
Regarding the 35 USC 112(b) claim rejections:
The applicant’s amendments to the claims are persuasive and for this reason the previous rejections are withdrawn. However, a new set of rejections have been made based on the amendments to the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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/WESLEY G HARRIS/Examiner, Art Unit 3783