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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 06/22/2026 is acknowledged.
Applicant’s election of Species I in the reply filed on 06/22/2026 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)).
Claims 8 & 12-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/22/2026.
Claim Objections
Claims 3-6 & 10-11 are objected to because of the following informalities.
Claim 3 should read --The aid according to claim 1 further comprising:
a positioning portion that is provided on the pinching surface of at least one of the first pinching piece or the second pinching piece and is configured to position being configured to abut
Claim 4 should read -- The aid according to claim 1, wherein the reception portion is configured to position top part vicinity region by being configured to engage
Claim 10 should read --The aid according to claim 9, wherein the first extension part is configured
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 1-7 & 9-11 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 terms “an injection port” and “a nozzle portion”, in the preamble, are incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: what structure the injection port and nozzle portion are part of. It is not clear if the injection port or nozzle portion are part of the aid or the jet injector. For the purpose of examination, the injection port and nozzle portion will be interpreted as part of the jet injector.
The limitation “a first pinching piece and a second pinching piece that face each other, and pinch a skin in a state of holding the skin with pinching surfaces facing each other and thus form a fold shape part where the skin is raised in a fold shape”, in Lines 4-6, is indefinite. The limitation positively claims skin as part of the claimed invention. However, the preamble only claims the aid as part of the claimed invention. In light of the specification, one of ordinary skill in the art would conclude skin is not part of the aid. As such, the scope of the invention is not clear, since the bounds of the claimed aid are not clear.
The term “fold shape part” is incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: what structure the fold shape part is part of. It is not clear if the fold shape part is part of the pinching pieces or the skin. For the purpose of examination, the fold shape part will be interpreted as part of the skin.
The term “pinching surfaces” is incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: what structure the pinching surfaces are part of. It is not clear if the pinching surfaces are part of the pinching pieces or separate structure. For the purpose of examination, the pinching surfaces will be interpreted as part of the respective pinching pieces.
As to Claim 2, the limitation “the fold top part vicinity region is a region positioned in a range within 3 mm from the fold top part to a fold root part side in the fold shape part” is indefinite. The fold top part vicinity region, the fold top part, the fold root part side, and the fold shape part are all defined as being part of the skin. As such, the limitation positively claims the placement of the fold top part vicinity region as being based on the placement of the skin within the aid, resulting in the skin claimed as part of the claimed invention. However, the preamble only claims the aid as part of the claimed invention. In light of the specification, one of ordinary skill in the art would conclude skin is not part of the aid. As such, the scope of the invention is not clear, since the bounds of the claimed aid are not clear.
Additionally, it is not clear how the 3 mm range is being defined. For example, it is not clear if the range is defined from the fold top part up to 3 mm; if the range is defined from the fold root part side; if the fold top part vicinity region is positioned within the 3 mm range, or if the range begins 3 mm from either the fold top part or the fold root part side.
The indefiniteness of the claim results in “there [being] a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim". Therefore, " it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims.”
As to Claim 5, the limitation “wherein the reception portion positions the injection port by being engaged with the nozzle portion of the jet injector and…” should read --wherein the reception portion is configured to position configured to engage , and.
The limitation “the injection port is positioned within 3 mm from the fold top part to the fold root part side in the fold shape part”, is indefinite. The limitation is grammatically confusing. It is not clear where the injection port should be positioned. For example, it is not clear if the injection port should be positioned 3 mm from the fold top part, 3 mm from the fold root part side, within a 3 mm range between the fold top part and the fold root part side, or somewhere else. If the injection port should be placed within a 3 mm range between the fold top part and the fold root part side, it is not clear where the range begins or ends.
Additionally, the term “the fold root part side” lacks antecedent basis.
The indefiniteness of the claim results in “there [being] a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim". Therefore, " it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims.”
As to Claim 6, the limitation “wherein the reception portion positions the injection port by being engaged with the nozzle portion of the jet injector and…” should read --wherein the reception portion is configured to position configured to engage , and.
The limitation “the injection port is positioned within 1.5 mm from the fold top part to the fold root part side in the fold shape part”, is indefinite. The limitation is grammatically confusing. It is not clear where the injection port should be positioned. For example, it is not clear if the injection port should be positioned 1.5 mm from the fold top part, 1.5 mm from the fold root part side, within a 1.5 mm range between the fold top part and the fold root part side, or somewhere else. If the injection port should be placed within a 1.5 mm range between the fold top part and the fold root part side, it is not clear where the range begins or ends.
Additionally, the term “the fold root part side” lacks antecedent basis.
The indefiniteness of the claim results in “there [being] a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim". Therefore, " it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims.”
As to Claim 11, the limitation “the first extension part extends from the first pinching piece and the first pinching piece and the first extension part form a straight line shape” is indefinite in light of the specification. Instant application Paragraph 0049 states this feature is shown in instant application Figure 8. However, instant application Figure 8 does not show first extension part 12 forming a straight line with first pinching piece 11. Rather a shape with five different line segments and four angle changes is shown. As such, it is not clear what is meant by the term “straight line shape”, since the shape shown in Figure 8 is not a straight line. For the purpose of examination, any shape with a straight line will be interpreted to meet the limitation.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-7 & 9-11 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
As to Claim 1, the claim positively claims skin as part of the claimed invention, thereby requiring the human body as part of the claim. It is recommended to amend the claim language to recite the pinching pieces are configured to pinch a skin resulting in the skin forming a fold shape, and the reception portion is configured to expose the fold top part.
As to Claims 2-6 & 9-11, similar limitations have the same problem. Applicant may overcome most of the rejections using similar terminology where the limitation claims structure is configured to perform a function.
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, 3-4, 7 & 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Imai (JP2008295590A – see previously attached translation).
As to Claim 1, Imai teaches an aid (1) to be applied to a jet injector (intended use; see end of paragraph for clarification) that intradermally injects an injection objective substance (the liquid described in Paragraph 0050) by injecting the injection objective substance (the liquid described in Paragraph 0050) from an injection port formed in a nozzle portion (the tip of the syringe or catheter, as described in Paragraph 0028), the aid (1) comprising:
a first pinching piece (21) and a second pinching piece (31) that face each other (as shown in Figure 5), and pinch (as shown in Figure 5) a skin (E/F) in a state of holding (as shown in Figure 5) the skin (E/F) with pinching surfaces (25/35) facing each other (as shown in Figure 5) and thus form (as shown in Figure 5) a fold shape part (the portion of skin E/F shown between pinching pieces 21/31, as viewed in Figure 5) where the skin (E/F) is raised in a fold shape (as shown in Figure 5); and
a reception portion (29/29a) that is provided in (as shown in Figure 5) the first pinching piece (21), exposes (as shown in Figure 5) a fold top part vicinity region (see Figure 5 below), which is a region in a vicinity of (as shown in Figure 5) a fold top part (see Figure 5 below), in the fold shape part (the portion of skin E/F shown between pinching pieces 21/31, as viewed in Figure 5), and can receive (Paragraph 0028) the nozzle portion (the tip of the syringe or catheter, as described in Paragraph 0028).
The intention to use the aid with a jet injector is not a patentable limitation, as a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Ex parte Masham, 2 USPQ2d 1647; MPEP 2114(II). Also see MPEP 2115. Additionally, one of ordinary skill in the art would conclude the Imai aid may be used with a jet injector via connecting part 29, in light of Imai Paragraph 0028.
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Imai Figure 5, Modified by Examiner
As to Claim 3, Imai teaches all the limitations of Claim 1, and continues to teach a positioning portion (27/37) that is provided on (as shown in Figures 1/2) the pinching surface (25/35) of at least one of the first pinching piece (21) or the second pinching piece (31) and positions (as shown in Figure 5) the fold top part (see Figure 5 in the Claim 1 rejection above) by abutting on (as shown in Figure 5) the fold top part (see Figure 5 in the Claim 1 rejection above) of the fold shape part (the portion of skin E/F shown between pinching pieces 21/31, as viewed in Figure 5).
As to Claim 4, Imai teaches all the limitations of Claim 1, and continues to teach the reception portion (29/29a) positions (as shown in Figure 5) the injection port (the tip of the syringe or catheter, as described in Paragraph 0028) with respect to (as shown in Figure 5) the fold top part vicinity region (see Figure 5 in the Claim 1 rejection above) by being engaged with (Paragraph 0028) the nozzle portion (the tip of the syringe or catheter, as described in Paragraph 0028) of the jet injector (the syringe or catheter, as described in Paragraph 0028).
As to Claim 7, Imai teaches all the limitations of Claim 1, and continues to teach the pinching surface (35) of the second pinching piece (31) is formed as a flat surface (as shown in Figure 5).
As to Claim 9, Imai teaches all the limitations of Claim 1, and continues to teach a first extension part (22) extending from (as shown in Figure 2) one end (the top end of 21, as viewed in Figure 2) of the first pinching piece (21) and provided with (as shown in Figure 2) a first grasping part (22) at least in a part (as shown in Figure 2) of the first extension part (22), a second extension part (32) extending from (as shown in Figure 2) one end (the top end of 31, as viewed in Figure 2) of the second pinching piece (31) and provided with (as shown in Figure 2) a second grasping part (32) at least in a part (as shown in Figure 2) of the second extension part (32), and a coupling portion (6/23) coupling (as shown in Figure 2) the first extension part (22) and the second extension part (32) such that the first pinching piece (21) and the second pinching piece (31) open and close (via spring 4) by an operation (pushing 22 and 32 together and releasing 22 and 32 to allow the 22 and 32 to move away from each other due to spring 4) of the first grasping part (22) and the second grasping part (32).
As to Claim 10, Imai teaches all the limitations of Claim 1, and continues to teach the first extension part (22) extends (as shown in Figure 2) such that the nozzle portion (the tip of the syringe or catheter, as described in Paragraph 0028) does not interfere with the first extension part (22) when the nozzle portion (the tip of the syringe or catheter, as described in Paragraph 0028) is received in the reception portion (29/29a). When viewing Figure 3, one of ordinary skill in the art would conclude the nozzle portion would not interfere with the first extension part, since the reception portion is substantially spaced from the first extension part.
As to Claim 11, Imai teaches all the limitations of Claims 1 & 10, and continues to teach the first extension part (22) extends from (as shown in Figure 2) the first pinching piece (21) and the first pinching piece (21) and the first extension part (22) form (as shown in Figure 3) a straight line shape (where Figure 3 shows two straight line shapes –i.e., 21 and 22), and
the second extension part (32) extends from (as shown in Figure 2) the second pinching piece (31) and the second pinching piece (31) and the second extension part (32) form (as shown in Figure 3) a V shape (where Figure 3 shows 31 and 32 angled with respect to each other to form a V shape).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gubich (5,147,306 – see Figures 1-4) and Imai (2016/0331910 – see Figures 15-16) describe similar aids 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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