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 .
It appears the inventor(s) filed the current application pro se (i.e., without the benefit of representation by a registered patent practitioner). While inventors named as applicants in a patent application may prosecute the application pro se, lack of familiarity with patent examination practice and procedure may result in missed opportunities in obtaining optimal protection for the invention disclosed. The inventor(s) may wish to secure the services of a registered patent practitioner to prosecute the application, because the value of a patent is largely dependent upon skilled preparation and prosecution. The Office cannot aid in selecting a patent practitioner.
A listing of registered patent practitioners is available at https://oedci.uspto.gov/OEDCI/. Applicants may also obtain a list of registered patent practitioners located in their area by writing to Mail Stop OED, Director of the U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.
Election/Restrictions
Applicant’s election of Species I(A) and Species II(A) in the reply filed on 01/29/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 17 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/29/2026.
Claim 17 is are withdrawn since the claim describes a concave portion 119 on the main body. The concave portion is only shown in instant application Figure 12, which is a reflection of unelected Species II(C). As such, the concave portion is unique to an unelected species, so Claim 17 is withdrawn.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1, 5 & 19 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of Claims 1 & 4 of prior U.S. Patent No. 12,521,496 (referred to as ‘496). This is a statutory double patenting rejection.
Patent ‘496 Claim 1 teaches instant application Claim 1; An injection needle apparatus with safe-protection function, comprising: (‘496 Claim 1, Line 34)
an injection module (1) including an injection cylinder and a pullable piston rod installed within the injection cylinder; the injection cylinder including a main body, a head portion and a handhold portion; the head portion and the handhold portion being at two ends of the main body, respectively; (‘496 Claim 1, Lines 35-40)
a needle module (2) including a needle seat and an injection needle; the needle seat having a seat body and a buckle; in installation state, the seat body covering the head portion and holding the injection needle; the buckle being integrally connected to the seat body at an end near the main body and around the seat body; (‘496 Claim 1, Lines 41-46)
a safety sleeve (3) covering movably around the injection cylinder (11) between an installation position and a protection position; the safety sleeve having a sleeve body, a first end portion, and a second end portion; the first end portion and the second end portion being at two opposite ends of the sleeve body; wherein in the installing position, the first end portion is near the buckle and the second end portion is near the handhold portion; while in the protection position, the first end portion is protruded from the injection cylinder for covering the injection needle and the second end portion is near the head portion; and (‘496 Claim 1, Lines 47-58)
an inner side of the sleeve body (31) near the second end portion being formed with a buckling portion; the buckling portion being used to buckle with the buckle (212) so that the safety sleeve (3) and the needle seat (21) are fixed together for separating from the injection cylinder and after separation, the safety sleeve covers the needle seat (‘496 Claim 1, Lines 59-67).
Patent ‘496 Claim 1 teaches instant application Claim 5; The injection needle apparatus with safe-protection function as claimed in claim 1, wherein the buckling portion includes a first annular flange (311) and a second annular flange (312); an annular groove (313) being formed between the first annular flange and the annular second flange; the annular groove being used to confine the buckle. (‘496 Claim 1, Lines 60-64).
Patent ‘496 Claim 4 teaches instant application Claim 19; The injection needle apparatus with safe-protection function as claimed in claim 1, wherein the buckle is extended with a plurality of buckling blocks and a plurality of thin portions around an outer periphery thereof, the plurality of buckling blocks and the thin portions are alternatively arranged.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 & 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-3 & 5 of copending Application No. 18/381,633 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following.
Reference Application ‘633 Claim 1 teaches instant application Claim 1.
Reference Application ‘633 Claim 2 teaches instant application Claim 2.
Reference Application ‘633 Claim 3 teaches instant application Claim 3.
Reference Application ‘633 Claim 5 teaches instant application Claim 5.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Objections
Claims 1-8 & 19-20 are objected to because of the following informalities.
Although element numbers may be presented in parenthesis, for consistency Applicant should maintain the element numbers throughout each of the claims and limitations, as well as include the element numbers for each claimed structure; Applicant may also delete all element numbers in the claims
Claim 5 should read --The injection needle apparatus with safe-protection function as claimed in claim 1, wherein the buckling portion includes a first annular flange (311) and a second annular flange (312); an annular groove (313) being formed between the first annular flange and the annular flange; the annular groove being used to confine the buckle.—
Claim 6 should read --The injection needle apparatus with safe-protection function as claimed in claim 4, wherein the buckling portion includes a first annular flange (311) and a second annular flange (312); an annular groove (313) being formed between the first annular flange and the annular flange; the annular groove being used to confine the buckle.—
Claim 19 should read --The injection needle apparatus with safe-protection function as claimed in claim 1, wherein the buckle is extended with a plurality of buckling blocks and a plurality of thin portions around an outer periphery thereof, the plurality of buckling blocks and the plurality of thin portions are alternately arranged.—
Claim 20 should read --The injection needle apparatus with safe-protection function as claimed in claim 19, wherein each buckling block of the plurality of buckling blocks is formed with at least one recess.--
Appropriate correction is required.
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 1-8 & 19-20 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.
As to Claim 1, the limitation “the head portion and the handhold portion being at two ends of the main body, respectively”, in Lines 5-7, is indefinite. The limitation may be interpreted as though the head portion is located at both ends, and the handheld portion is located at both ends. However, instant application Figure 2, shows the head portion being located only at a first end of the main body, and the handheld portion located only at a second end of the main body. As such, the limitation conflicts with disclosed invention, rendering the claim indefinite. For the purpose of examination, the limitation will be interpreted in line with instant application Figure 2, where the head portion being located at a first end of the main body, and the handheld portion located at a second end of the main body.
The limitation “in installation state, the seat body covering the head portion and holding the injection needle; the buckle being integrally connected to the seat body at an end near the main body and around the seat body”, in Lines 9-12, is indefinite. The limitation is grammatically confusing, since the limitation uses multiple tenses. Additionally, the term “an end” requires a reference structure which was not provided. As such, it is not clear which structure the end belongs to, or if the end is one of the two ends defined in Line 6.
For the purpose of examination, the limitation will be interpreted as in an installation state, the seat bodycovers the head portion and holds the injection needle; the buckle is integrally connected around the seat body to an end of the seat body located near the main body
The limitation “the first end portion and the second end portion being at two opposite ends of the sleeve body”, in Lines 15-17, is indefinite. The limitation may be interpreted as though the first end portion is located at both ends, and the second end portion is located at both ends. However, instant application Figure 6, shows the first end portion being located only at one end of the sleeve body, and the second end portion located only at one end of the sleeve body. As such, the limitation conflicts with disclosed invention, rendering the claim indefinite. For the purpose of examination, the limitation will be interpreted as the first end portion is located at a first end of the sleeve body, and the second end portion is located at a second end of the sleeve body, the second end of the sleeve body located at an opposite end of the sleeve body from the first end of the sleeve body.
The term “the installing position”, in Line 17, should read –the installation position.
As to Claim 2, the limitation “a fixing structure is formed at a lower end of the injection cylinder near the handhold portion and a rear end of the safety sleeve so that when the safety sleeve retracts backwards to be near the handhold portion of the injection cylinder, the safety sleeve can be fixed as the position to prevent the safety sleeve from moving with the injection needle”, is indefinite. Instant application Figure 2 shows the fixing structure 50 as part of the injection cylinder. However, the only structure which may be interpreted as a fixing structure on the safety sleeve is the buckling portion 34. A buckling portion was already defined in Claim 1. As such, it is not clear what structure constitutes the claimed fixing structure on the safety sleeve in Claim 2, rendering the claim indefinite.
It is not clear if the “rear end of the safety sleeve” is one of the “two opposite ends of the sleeve body” defined in Claim 1, or if a new end is being defined in Claim 2. If the rear end is one of the two opposite ends, this must be clarified. If the rear end is not one of the two opposite ends, it is not clear where the rear end would be placed on the safety sleeve.
It is not clear if “when the safety sleeve retracts backward to be near the handheld portion of the injection cylinder” is the same position as the “installation position” defined in Claim 1, or if the two positions are different positions. The two positions appear to have an identical structural relationship. If the two positions are different, it is not clear how the two positions are different. If the two positions are the same, it is not clear why new terminology is being used for the same structural position previously defined.
It is not clear what position “the position” refers to, since multiple positions have previously been defined.
For the purpose of examination, the limitation will be interpreted as a fixing structure is formed at a lower end of the injection cylinder near the handhold portion, and when the safety sleeve is in the protection position, the fixing structure is engaged with the buckling portion to prevent the safety sleeve from moving with the injection needle.
As to Claim 3, the phrase “a rear end of the seat body”, is indefinite. An end of the seat body, near the main body, was defined in Claim 1. As such, it is not clear if the rear end in Claim 3 is the same end as the end in Claim 1, or if the ends are different. For the purpose of examination, the two ends will be interpreted as the same end.
The limitation “therefore, the seat body (211) of the needle seat (21) can be tightly fixed to the head portion (112) of the needle seat (21) to prevent the needle seat (21) from separating with the head portion (112) of the injection cylinder (11)” should read –soinjection cylinder to prevent the needle seat (21) from
As to Claim 4, the phrase “a rear end of the seat body”, is indefinite. An end of the seat body, near the main body, was defined in Claim 1. As such, it is not clear if the rear end in Claim 4 is the same end as the end in Claim 1, or if the ends are different. For the purpose of examination, the two ends will be interpreted as the same end.
The limitation “therefore, the seat body (211) of the needle seat (21) can be tightly fixed to the head portion (112) of the needle seat (21) to prevent the needle seat (21) from separating with the head portion (112) of the injection cylinder (11)” should read –soinjection cylinder to prevent the needle seat (21) from
As to Claim 7, the limitation “a cross sections in radial direction of the tapered portion becomes larger and larger from a distal end to an end near the extended handhold portion” is indefinite.
The phrase “a cross sections” should read –[[a]] cross sections.
The phrase “in radial direction” should read –in a radial direction.
It is not clear how to interpret the phrase “becomes larger and larger”, since it is not clear how the second iteration of the term “larger” contributes to the phrase.
Instant application Figure 14 shows the tapered portion 521 of the head portion 112 only extending to the left end of the main body 111. Whereas the claimed extended handhold portion 113 is at the right end of the main body 111. As such, it is not clear how the cross sections of the tapered portion are capable of becoming larger all the way to the claimed extended handhold portion, rendering the claim indefinite. Additionally, the term “the extended handhold portion” should read –the
The limitation “a maximum radial length in the cross sections of the tapered portion is larger than a maximum radial length of an opening of the seat body so that when the needle seat is assembled to the head portion, the seat body buckles the tapered portion of the head portion with the movement of the tapered portion into the opening so that the needle seat is tightly buckled with the head portion and not pulled out easily”, is indefinite.
The limitation appears to be defining the claimed invention by the dimensions of the respective structures before assembly of the claimed invention. As such, the scope of the claim is not clear, since it is not clear if the claimed invention is claiming the apparatus as a kit, or if the claimed invention is claiming the apparatus after assembly. Since the preamble only states “an injection needle apparatus…”, and not a kit, the claimed invention will be interpreted as an assembled apparatus. As such, the respective maximum radial lengths will be interpreted as product-by-process, where the result of assembling the tapered portion to the head portion is an interference fit. See MPEP 2113.
The phrase “not pulled out easily” is a relative term which renders the claim indefinite. The term “easily” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, it is not clear how to interpret the phrase.
As to Claim 8, the limitation “a cross sections in radial direction of the tapered portion becomes larger and larger from a distal end to an end near the extended handhold portion” is indefinite.
The phrase “a cross sections” should read –[[a]] cross sections.
The phrase “in radial direction” should read –in a radial direction.
It is not clear how to interpret the phrase “becomes larger and larger”, since it is not clear how the second iteration of the term “larger” contributes to the phrase.
Instant application Figure 14 shows the tapered portion 521 of the head portion 112 only extending to the left end of the main body 111. Whereas the claimed extended handhold portion 113 is at the right end of the main body 111. As such, it is not clear how the cross sections of the tapered portion are capable of becoming larger all the way to the claimed extended handhold portion, rendering the claim indefinite. Additionally, the term “the extended handhold portion” should read –the
The limitation “a maximum radial length in the cross sections of the tapered portion is larger than a maximum radial length of an opening of the seat body so that when the needle seat is assembled to the head portion, the seat body buckles the tapered portion of the head portion with the movement of the tapered portion into the opening so that the needle seat is tightly buckled with the head portion and not pulled out easily”, is indefinite.
The limitation appears to be defining the claimed invention by the dimensions of the respective structures before assembly of the claimed invention. As such, the scope of the claim is not clear, since it is not clear if the claimed invention is claiming the apparatus as a kit, or if the claimed invention is claiming the apparatus after assembly. Since the preamble only states “an injection needle apparatus…”, and not a kit, the claimed invention will be interpreted as an assembled apparatus. As such, the respective maximum radial lengths will be interpreted as product-by-process, where the result of assembling the tapered portion to the head portion is an interference fit. See MPEP 2113.
The phrase “not pulled out easily” is a relative term which renders the claim indefinite. The term “easily” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, it is not clear how to interpret the phrase.
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.
Claims 1-6 & 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hung (U.S. PGPub 2023/0138069).
As to Claim 1, Hung teaches an injection needle apparatus (10) with safe-protection function (Abstract), comprising:
an injection module including an injection cylinder (40) and a pullable piston rod (45) installed within (as shown in Figure 1) the injection cylinder (40); the injection cylinder (40) including a main body (41), a head portion (42) and a handhold portion (43); the head portion (42) and the handhold portion (43) being at two ends (the head portion 42 is located at the top end of main body 41, as viewed in Figure 2, and the handheld portion 43 is located at the bottom end of main body 41, as viewed in Figure 2) of the main body (41), respectively (as shown in Figure 2);
a needle module (12/20/24/30) including a needle seat (30) and an injection needle (12/20/24); the needle seat (30) having a seat body (32) and a buckle (31/34/35); in installation state (Figure 1), the seat body (32) covering (as shown in Figure 1) the head portion (42) and holding (as shown in Figure 1) the injection needle (12/20/24); the buckle (31/34/35) being integrally connected to (as shown in Figures 3/4) the seat body (32) at an end (the bottom end of seat body 32, as viewed in Figure 1) near the main body (41) and around (as shown in Figure 4) the seat body (32);
a safety sleeve (50) covering (as shown in Figures 1/5) movably around (as shown in Figures 1/5) the injection cylinder (40) between an installation position (Figure 1) and a protection position (Figure 5); the safety sleeve (50) having a sleeve body (50), a first end portion (the top of 50, as viewed in Figure 2), and a second end portion (the bottom of 50, as viewed in Figure 2); the first end portion (the top of 50, as viewed in Figure 2) and the second end portion (the bottom of 50, as viewed in Figure 2) being at two opposite ends (as shown in Figure 2) of the sleeve body (50); wherein in the installing position (Figure 1), the first end portion (the top of 50, as viewed in Figure 2) is near (as shown in Figure 1) the buckle (31/34/35) and the second end portion (the bottom of 50, as viewed in Figure 2) is near (as shown in Figure 1) the handhold portion (43); while in the protection position (Figure 5), the first end portion (the top of 50, as viewed in Figure 2) is protruded from (as shown in Figure 5) the injection cylinder (40) for covering (as shown in Figure 5) the injection needle (12/20/24) and the second end portion (the bottom of 50, as viewed in Figure 2) is near (as shown in Figure 5) the head portion (42); and
an inner side (the inner circumferential surface of 50, as viewed in Figure 2) of the sleeve body (50) near the second end portion (the bottom of 50, as viewed in Figure 2) being formed with (as shown in Figure 5) a buckling portion (54/55); the buckling portion (54/55) being used to buckle with (as shown in Figure 5) the buckle (31/34/35) so that the safety sleeve (50) and the needle seat (30) are fixed together (as shown in Figure 5) for separating from (as shown in Figure 6) the injection cylinder (40) and after separation (as shown in Figure 6), the safety sleeve (50) covers (as shown in Figure 6) the needle seat (30).
As to Claim 2, Hung teaches all the limitations of Claim 1, and continues to teach a fixing structure (44) is formed at (as shown in Figure 2) a lower end (the bottom of 40, as viewed in Figure 2) of the injection cylinder (40) near (as shown in Figure 2) the handhold portion (43) and a rear end of the safety sleeve (3) so that when the safety sleeve (50) retracts backwards to be near (Figure 1) the handhold portion (113) of the injection cylinder (11), the safety sleeve (50) can be fixed (as shown in Figure 1) as the position (Figure 1) to prevent (Paragraph 0026) the safety sleeve (50) from moving with (Paragraph 0026) the injection needle (12/20/24).
As to Claim 3, Hung teaches all the limitations of Claim 1, and continues to teach a tight buckling structure (the outer surface of head portion 42, and baffle 36 of seat body 32; since the outer surface of head portion 42 is in contact with the inner surface of seat body 32, one of ordinary skill in the art would broadly conclude the structure is “tight”) is formed (as shown in Figure 1) at the head portion (42) of the injection cylinder (40) and a rear end (the bottom end of 32, as viewed in Figure 1) of the seat body (32) of the needle seat (30); therefore, the seat body (32) of the needle seat (30) can be tightly fixed to (as shown in Figure 1) the head portion (42) of the injection cylinder (40) to prevent the needle seat (30) from separating with (as shown between Figures 1/5) the head portion (42) of the injection cylinder (40).
As to Claim 4, Hung teaches all the limitations of Claims 1-2, and continues to teach a tight buckling structure (the outer surface of head portion 42, and baffle 36 of seat body 32; since the outer surface of head portion 42 is in contact with the inner surface of seat body 32, one of ordinary skill in the art would broadly conclude the structure is “tight”) is formed (as shown in Figure 1) at the head portion (42) of the injection cylinder (40) and a rear end (the bottom end of 32, as viewed in Figure 1) of the seat body (32) of the needle seat (30); therefore, the seat body (32) of the needle seat (30) can be tightly fixed to (as shown in Figure 1) the head portion (42) of the injection cylinder (40) to prevent the needle seat (30) from separating with (as shown between Figures 1/5) the head portion (42) of the injection cylinder (40).
As to Claim 5, Hung teaches all the limitations of Claim 1, and continues to teach the buckling portion (54/55) includes a first annular flange (54) and a second annular flange (55); an annular groove (the groove between 54/55, as viewed in Figure 2) being formed between (as shown in Figure 2) the first annular flange (54) and the annular second flange (55); the annular groove (the groove between 54/55, as viewed in Figure 2) being used to confine (as shown in Figure 5) the buckle (31/34/35).
As to Claim 6, Hung teaches all the limitations of Claims 1-2 & 4, and continues to teach the buckling portion (54/55) includes a first annular flange (54) and a second annular flange (55); an annular groove (the groove between 54/55, as viewed in Figure 2) being formed between (as shown in Figure 2) the first annular flange (54) and the annular second flange (55); the annular groove (the groove between 54/55, as viewed in Figure 2) being used to confine (as shown in Figure 5) the buckle (31/34/35).
As to Claim 19, Hung teaches all the limitations of Claim 1, and continues to teach the buckle (31/34/35) is extended with a plurality of buckling blocks (34/35) and a plurality of thin portions (see Figure 3 below) around an outer periphery (see Figure 3 below) thereof, the plurality of buckling blocks (34/35) and the thin portions (see Figure 3 below) are alternatively arranged (as shown in Figure 3).
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Hung Figure 3, Modified by Examiner
As to Claim 20, Hung teaches all the limitations of Claims 1 & 19, and continues to teach each buckling block (34/35) is formed with (as shown in Figure 3) at least one recess (34).
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.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hung, in view of Mide (U.S. PGPub 2016/0262980).
As to Claim 7, Hung teaches all the limitations of Claim 1, and continues to teach the head portion (42) of the injection cylinder (40) is formed as a tapered portion (see Figure 2 below; the parallel dashed lines show the top of head portion 42 is smaller than the bottom of head portion 42, which one of ordinary skill in the art would interpret as tapered); a cross sections (the solid lines shown in Figure 2 below) in radial direction (left and right, as viewed in Figure 2) of the tapered portion (see Figure 2 below) becomes larger and larger (as shown in Figure 2 below) from a distal end (the top end of 42, as viewed in Figure 2) to an end (the bottom end of 42, as viewed in Figure 2) near (as shown in Figure 2) the extended handhold portion (43).
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Hung Figure 2, Modified by Examiner
Hung is silent on the fit between the head portion and the seat body, so does not explicitly teach a maximum radial length in the cross sections of the tapered portion (521) is larger than a maximum radial length of an opening (215) of the seat body (211) so that when the needle seat (21) is assembled to the head portion (112), the seat body (211) buckles the tapered portion (521) of the head portion with the movement of the tapered portion (521) into the opening (215) so that the needle seat is tightly buckled with the head portion and not pulled out easily.
Mide describes a syringe with a similar head portion and a connector to the head portion, and teaches the connector is fit onto the head portion via an interference fit (Paragraph 0070).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to connect the seat body to the head portion, as taught by Hung, via interference fit, as taught by Mide, since interference fits are well-known connection means which yield predictable results, i.e., provide reliable connections which are easily adjusted/removed/fixed.
Modifying Mide into Hung results in a maximum radial length in the cross sections (the solid lines shown in Hung Figure 2 above) of the tapered portion (see Hung Figure 2 above) is larger than a maximum radial length of an opening of the seat body (Hung 32) so that when the needle seat (Hung 30) is assembled to (as shown in Hung Figure 1) the head portion (Hung 42), the seat body (Hung 32) buckles (see end of paragraph for clarification) the tapered portion (see Hung Figure 2 above) of the head portion (Hung 42) with the movement of the tapered portion (see Hung Figure 2 above) into the opening so that the needle seat (Hung 30) is tightly buckled with the head portion (Hung 42) and not pulled out easily.
As described in the 112(b) rejection above, this limitation is considered a product-by-process, and "[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." Since Hung, as modified, already meets the structural limitations of the claim, i.e., the tapered portion and the seat body are connected via interference fit, the limitation is considered to be taught by Hung, as modified. See MPEP 2113.
As to Claim 8, Hung teaches all the limitations of Claims 1-2 & 4, and continues to teach the head portion (42) of the injection cylinder (40) is formed as a tapered portion (see Figure 2 in the Claim 7 rejection above; the parallel dashed lines show the top of head portion 42 is smaller than the bottom of head portion 42, which one of ordinary skill in the art would interpret as tapered); a cross sections (the solid lines shown in Figure 2 in the Claim 7 rejection above) in radial direction (left and right, as viewed in Figure 2) of the tapered portion (see Figure 2 in the Claim 7 rejection above) becomes larger and larger (as shown in Figure 2 in the Claim 7 rejection above) from a distal end (the top end of 42, as viewed in Figure 2) to an end (the bottom end of 42, as viewed in Figure 2) near (as shown in Figure 2) the extended handhold portion (43).
Hung is silent on the fit between the head portion and the seat body, so does not explicitly teach a maximum radial length in the cross sections of the tapered portion (521) is larger than a maximum radial length of an opening (215) of the seat body (211) so that when the needle seat (21) is assembled to the head portion (112), the seat body (211) buckles the tapered portion (521) of the head portion with the movement of the tapered portion (521) into the opening (215) so that the needle seat is tightly buckled with the head portion and not pulled out easily.
Mide describes a syringe with a similar head portion and a connector to the head portion, and teaches the connector is fit onto the head portion via an interference fit (Paragraph 0070).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to connect the seat body to the head portion, as taught by Hung, via interference fit, as taught by Mide, since interference fits are well-known connection means which yield predictable results, i.e., provide reliable connections which are easily adjusted/removed/fixed.
Modifying Mide into Hung results in a maximum radial length in the cross sections (the solid lines shown in Hung Figure 2 in the Claim 7 rejection above) of the tapered portion (see Hung Figure 2 in the Claim 7 rejection above) is larger than a maximum radial length of an opening of the seat body (Hung 32) so that when the needle seat (Hung 30) is assembled to (as shown in Hung Figure 1) the head portion (Hung 42), the seat body (Hung 32) buckles (see end of paragraph for clarification) the tapered portion (see Hung Figure 2 in the Claim 7 rejection above) of the head portion (Hung 42) with the movement of the tapered portion (see Hung Figure 2 in the Claim 7 rejection above) into the opening so that the needle seat (Hung 30) is tightly buckled with the head portion (Hung 42) and not pulled out easily.
As described in the 112(b) rejection above, this limitation is considered a product-by-process, and "[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." Since Hung, as modified, already meets the structural limitations of the claim, i.e., the tapered portion and the seat body are connected via interference fit, the limitation is considered to be taught by Hung, as modified. See MPEP 2113.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Vetter (2002/0002354) and Mitchell (4,631,057) describe similar apparatuses.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783
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