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 .
Claim Objections
Claims 6 & 10 are objected to because of the following informalities.
Claim 6 should read --The safe puncture needle according to claim 1, wherein the base (2) further comprises a skin-friendly member (26) provided on an outer surface of the lower end of the base body (21).--; this is the first use of the term outer surface of the lower end of the base body
Claim 10 should read --The safe puncture needle according to claim 1, wherein the third through-hole (221) corresponds to a position of the second through-hole (2121) and that the needle tubing tip (32) is adapted to be retracted into the third through-hole (221).--; this is the first use of the term position for the second through-hole
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 as follows,
“skin-friendly member” in Claim 6, where the generic placeholder is “member”, the functional language is “skin-friendly”, and sufficient modifying structure is not provided; instant application Paragraphs 0044/0045 describe the member as being skin-friendly when the member is made of a material which “may directly contact the patient's skin to enhance the patient' s experience when performing a puncture infusion or the like on the patient”, providing sufficient modifying structure
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 1-10 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 other end is connected to the needle tubing tip and is used for passing through the third through-hole”, in Lines 9-10, is indefinite.
The term “the other end”, in Line 9, lacks antecedent basis. Additionally, it is not clear what structure “the other end” is part of, rendering the claim indefinite. For the purpose of examination, the other end will be interpreted as part of the needle tubing body.
Additionally, the phrase “is used for passing through the third through-hole” is grammatically confusing. It is not clear what is “passing through the third through-hole”. For example, the phrase may be interpreted as the other end is used for passing fluid through the third through-hole, or the other end passes through the third through-hole.
For the purpose of examination, the limitation will be interpreted as an other end of the needle tubing body is connected to the needle tubing tip and is used for passing through the third through-hole and extends through the third through-hole.
The limitation “the needle tubing tip is used for retracting from the second through-hole”, in Line 12, is indefinite. The limitation is grammatically confusing. For the purpose of examination, the limitation will be interpreted as the needle tubing tip is configured to retract through the second through-hole.
As to Claim 2, the term “the other end” is indefinite. The term lacks antecedent basis. Additionally, Claim 2 includes all of the structure of Claim 1, so the term could be applied to any of the structure in Claims 1 & 2. As such, it is not clear which structure is being referred to by the term. For the purpose of examination, the term will be interpreted as an other end of the elastic body.
As to Claim 5, the term “the other” is indefinite. The term lacks antecedent basis. Additionally, Claim 5 includes all of the structure of Claims 1 & 4, so the term could be applied to any of the structure in Claims 1, 4 & 5. As such, it is not clear which structure is being referred to by the term. For the purpose of examination, the term will be interpreted as an other end of the lower base.
As to Claim 7, the limitation “the forward projection of the needle tubing tip (32) on the end face of the flanging portion (41) facing away from the main body portion (42) is located at least partially outside the fourth through-hole (43)”, in Lines 6-8, is indefinite.
The limitation is grammatically confusing.
The term “the forward projection of the needle tubing tip” lacks antecedent basis.
The term “the end face” lacks antecedent basis.
Additionally, the term “the forward projection” is claimed as being part of the needle tubing tip and the flanging portion, which is part of the rivet member. The needle tubing tip and the rivet member are two separate components, so it is not clear how the forward projection can be part of both components, rendering the limitation indefinite.
For the purpose of examination, the limitation will be interpreted as the needle tubing tip projects through an end face of the flanging portion facing away from the main body portion, and the needle tubing tip is located at least partially outside the fourth through-hole.
The limitation “the forward projection of the flanging portion (41) on the upper end face of the base body (21) is located at least partially outside the first through-hole (2111)”, in Lines 8-10, is indefinite.
The limitation is grammatically confusing.
The term “the forward projection of the flanging portion” lacks antecedent basis.
The term “the upper end face” lacks antecedent basis.
Additionally, the term “the forward projection” is claimed as being part of the flanging portion and the base body. The flanging portion and the base body are two separate components, so it is not clear how the forward projection can be part of both components, rendering the limitation indefinite.
For the purpose of examination, the limitation will be interpreted as the flanging portion projects through an upper end face of the base body, and the flanging portion is located at least partially outside the first through-hole.
As to Claim 8, the term “the other” is indefinite. The term lacks antecedent basis. Additionally, Claim 8 includes all of the structure of Claim 1, so the term could be applied to any of the structure in Claims 1 & 8. As such, it is not clear which structure is being referred to by the term. For the purpose of examination, the term will be interpreted to be applied to the base body.
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, 4-5, 8 & 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang (CN111643764A – see attached translation).
As to Claim 1, Zhang teaches a safe puncture needle (Figure 5), comprising a needle holder (1), a base (2/3/7) and a needle tubing (4), wherein the needle tubing (4) comprises a needle tubing body (401) and a needle tubing tip (402) having a bent structure (as shown in Figure 5), the base (2/3/7) comprises a base body (2/3) and a guide block (7), the base body (2/3) is provided with a second inner space (the volume within 2/3/8, as viewed in Figure 5), an upper end (the lower portion of 3, as viewed in Figure 5) and a lower end (the upper portion of 2, as viewed in Figure 5) of the base body (2/3) are respectively provided with (as shown in Figure 5) a first through-hole (see Figure 5 below) and a second through-hole (see Figure 5 below) communicating with (as shown in Figure 5) the second inner space (the volume within 2/3/8, as viewed in Figure 5), the guide block (7) is provided with (as shown in Figure 5) a third through-hole (see Figure 5 below) and is connected to (as shown in Figure 5) the base body (2/3) in (as shown in Figure 5) the second inner space (the volume within 2/3/8, as viewed in Figure 5), one end (the bottom end of 401, as viewed in Figure 5) of the needle tubing body (401) passes through (as shown in Figure 5) the first through-hole (see Figure 5 below) and is connected to (as shown in Figure 5) the needle holder (1), the other end (the top end of 401, as viewed in Figure 5) is connected to (as shown in Figure 5) the needle tubing tip (402) and extends though (as shown in Figure 5) through the third through-hole (221), and the needle tubing body (401) is slidably connected to (as shown between Figures 5 and 10) the guide block (7) at (as shown in Figures 5 & 10) the third through-hole (see Figure 5 below), and the needle tubing tip (402) is used for retracting from (as shown between Figures 5 and 10) the second through-hole (see Figure 5 below). See 112(b) rejection above for interpretation clarification.
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Zhang Figure 5, Modified by Examiner
As to Claim 4, Zhang teaches all the limitations of Claim 1, and continues to teach the base body (2/3) comprises an upper base (2) and a lower base (3), the upper base (2) is sealingly connected to (instant application Paragraph 0038 describes the term “sealingly” as sheathing a side wall structure of the upper base onto the lower base; this sheathing feature is shown in Zhang Figure 5, where the side wall structure of upper base 2 is shown radially outside lower base 3) the lower base (3) to form (as shown in Figure 5) the second inner space (the volume within 2/3/8, as viewed in Figure 5), the first through-hole (see Figure 5 in the Claim 1 rejection above) is provided at (as shown in Figure 5) the upper base (2), and the second through-hole (see Figure 5 in the Claim 1 rejection above) is provided at the lower base (3).
As to Claim 5, Zhang teaches all the limitations of Claims 1 & 4, and continues to teach one (2) of the upper base (2) and the lower base (3) is provided with (as shown in Figure 2) a positioning hole (see Figure 2 below), and the other (3) is provided with (as shown in Figure 2) a positioning post (see Figure 2 below), and the positioning post (see Figure 2 below) is inserted into (one of ordinary skill in the art would conclude, based on the location of the respective positioning posts and holes, and how the upper and lower bases fit together in Figure 5, the positioning posts must be inserted into the positioning holes in order for the lower base to lay flat against the upper base, as shown in Figure 5) the positioning hole (see Figure 2 below).
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Zhang Figure 2, Modified by Examiner
As to Claim 8, Zhang teaches all the limitations of Claim 1, and continues to teach one (2/3) of the base body (2/3) and the needle holder (1) is provided with (as shown in Figure 3) a guide insert (8) and the other (1) with a guide groove (see Figure 3 below), and the guide insert (8) is slidably connected to (as shown in Figure 3) the guide groove (see Figure 3 below).
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Zhang Figure 3, Modified by Examiner
As to Claim 10, Zhang teaches all the limitations of Claim 1, and continues to teach the third through-hole (see Figure 5 in the Claim 1 rejection above) corresponds to (the phrase “corresponds to” is a very broad phrase; since Figure 5 shows the third and second through-holes axially aligned, one of ordinary skill in the art would conclude the third and second through-holes broadly correspond to each other) a position (the position of the second through-hole shown in Figure 5) of the second through-hole (see Figure 5 in the Claim 1 rejection above) and that the needle tubing tip (402) is adapted to be retracted into (as shown in Figure 10) the third through-hole (see Figure 5 in the Claim 1 rejection above).
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 2-3, 7 & 9 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang, in view of Erskine (U.S. PGPub 2012/0123332).
As to Claim 2, Zhang teaches all the limitations of Claim 1, and continues to teach the base (2/3/7) further comprises an actuating member (6) and a shield (5), the actuating member (6) is located in (as shown in Figure 2) the second inner space (the volume within 2/3/8, as viewed in Figure 5) and has one end connected to (the right end of 6, as viewed in Figure 2) the base body (2/3) and the other end (the left end of 6, as viewed in Figure 2) connected to (Elements 5 and 6 are magnetically connected, as described in Paragraph 0027) the shield (5) for shielding (Paragraph 0027) the needle tubing tip (402) when the needle tubing tip (402) is retracted (as shown in Figure 10).
Zhang does not teach the actuating member as an elastic member.
Erskine describes a similar safe puncture needle with multiple means to actuate the shield 122, and teaches the actuating member (131; Figure 7A) as an elastic member (Paragraph 0033 describes Element 131 as an O-ring “that expands”, which one of ordinary skill in the art would conclude is “elastic”).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use the actuating member, as taught by Erskine, in place of the actuating member, as taught by Zhang. The use of actuating members to move shields is a known method which yields predictable results --i.e., moves the shield over the needle tubing tip. The use of the Erskine actuating member in place of the Zhang actuating member is considered a simple substitution of one known actuating member for another known actuating member. Where a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement", the claim is unpatentable under 35 U.S.C. 103. Ex Parte Smith, 83 USPQ.2d 1509, 1518-19 (BPAI, 2007) (citing KSA v. Teleflex, 127 S.Ct. 1727, 1740, 82 USPQ2d 1385, 1396 (2007))."
As to Claim 3, Zhang, as modified, teaches all the limitations of Claims 1-2, and continues to teach the shield (Zhang 5) is provided with a slide (see Zhang Figure 3 in the Claim 8 rejection above) and the base body (Zhang 2/3) is provided with (as shown in Figure 3) a first slide groove (Zhang 202), and the slide (see Zhang Figure 3 in the Claim 8 rejection above) is slidably connected to (Zhang Paragraph 0030) the base body (Zhang 2/3) at the first slide groove (Zhang 202).
As to Claim 7, Zhang teaches all the limitations of Claim 1, but does not teach a rivet member (4) comprising a flanging portion (41) and a main body portion (42) connected to each other, the rivet member (4) being provided with a fourth through-hole (43) passing through the flanging portion (41) and the main body portion (42), the main body portion (42) being slidably connected to the base body (21) at the first through-hole (2111), the needle tubing body (31) passing through the fourth through-hole (43), the forward projection of the needle tubing tip (32) on the end face of the flanging portion (41) facing away from the main body portion (42) is located at least partially outside the fourth through-hole (43), and the forward projection of the flanging portion (41) on the upper end face of the base body (21) is located at least partially outside the first through-hole (2111).
Erskine describes a similar safe puncture needle, and teaches a rivet member (120) comprising a flanging portion (180) and a main body portion (see Figure 4 below) connected to each other (as shown in Figure 4), the rivet member (120) being provided with (as shown in Figures 4/6) a fourth through-hole (172) passing through (as shown in Figure 4) the flanging portion (41) and the main body portion (see Figure 4 below), the main body portion (see Figure 4 below) being slidably connected to (Paragraph 0038) the base body (124/148; Paragraph 0036) at the first through-hole (2111), the needle tubing body (102) passing through (as shown in Figure 4) the fourth through-hole (172), the needle tubing tip (107/108) projects through (as shown in Figures 2/4) an end face (see Figure 4 below) of the flanging portion (180) facing away from (down, as viewed in Figure 4) the main body portion (see Figure 4 below), and the needle tubing tip (107/108) is located at least partially outside (as shown in Figures 2/4) the fourth through-hole (172), and the flanging portion (180) projects through (as shown in Figure 4) an upper end face (see Figure 4 below) of the base body (124/148), and the flanging portion (180) is located at least partially outside (as shown in Figure 4) the first through-hole (126).
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Erskine Figure 4, Modified by Examiner
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use the rivet member, as taught by Erskine, in the base body, as taught by Zhang, to hold the shield in place (Paragraph 0038).
As to Claim 9, Zhang, as modified, teaches all the limitations of Claims 1-2, and continues to teach the lower end (the upper portion of Zhang 2, as viewed in Zhang Figure 5) of the base body (Zhang 2/3) is provided with a fifth through-hole (see Zhang Figure 5 in the Claim 1 rejection above; instant application Figure 1 shows the second through-hole 2121 and the fifth through-hole 2122 as two through-hole components forming a larger through-hole; in light of instant application Figure 1, one of ordinary skill in the art could broadly divide the Zhang through-hole in Zhang Figure 5 –showing the second and fifth through-holes in the Claim 1 rejection above—in half, where a first side is the second through-hole and a second side is the fifth through-hole) communicating with (as shown in Zhang Figure 5) the second inner space (the volume within Zhang 2/3/8, as viewed in Zhang Figure 5), and the fifth through-hole (see Zhang Figure 5 in the Claim 1 rejection above) is located on a side (the left side of Erskine 122, as viewed in Erskine Figure 7A, which is the equivalent of the left side of Zhang shield 5, as viewed in Zhang Figure 2) of the shield (Zhang 5) facing away from (as shown in Erskine Figure 7A) the elastic member (Erskine 131).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang, in view of Howell (U.S. PGPub 2015/0297867).
As to Claim 6, Zhang teaches all the limitations of Claim 1, and continues to teach the base (2/3/7) is comprised of a member which one of ordinary skill in the art would conclude is intended to be in contact with skin –in view of Paragraph 0004 and Figure 5-- during operation of the safe puncture needle, the member (see “skin contact member” in Figure 5 in the Claim 1 rejection above) provided on an outer surface (see Figure 5 in the Claim 1 rejection above) of the lower end (the upper portion of 2, as viewed in Figure 5) of the base body (2/3).
Zhang is silent on the material or function of the member, so does not explicitly teach the member is a skin-friendly member (26).
Howell describes a similar safe puncture needle, and teaches the member (500/502B) is a skin-friendly member (Paragraph 0087, where one of ordinary skill in the art would conclude “increasing patient comfort” would “enhance the patient’s experience” as defined in instant application Paragraph 0045).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use the material and textures, as taught by Howell, for the skin contacting member, as taught by Zhang, “for increasing patient comfort while the needle assembly is disposed on the skin of the patient (Paragraph 0087).”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Baid (2008/0171986) and Terndrup (4,917,672) describe similar shield features as claimed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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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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/DAVID N BRANDT/Primary Examiner, Art Unit 3783