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 .
Acknowledgments
In the reply, filed on May 25, 2023, Applicant cancelled claims 1-25.
Applicant added new claims 26-50.
Currently, claims 26-50 are under examination.
Specification
The abstract of the disclosure is objected to because:
In line 1, “the same” should be changed to “the needle”
In line 1, “the present disclosure” should be changed to “a present disclosure”
In line 2, “a needle” should be changed to “the needle”
In line 3, “the longitudinal direction” should be changed to “a longitudinal direction”
In line 6, “the lower portion” should be changed to “a lower portion”
In line 11, “a syringe” should be changed to “the syringe”
In line 2, “such needle” should be changed to “the needle”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 26, 30, and 40-41 are objected to because of the following informalities:
In regards to claim 26, line 3, “the longitudinal direction” should be changed to “a longitudinal direction”.
In regards to claim 26, line 6, “the lower portion” should be changed to “a lower portion”.
In regards to claim 30, line 1, “the first holes” should be changed to “the plurality of first holes”.
In regards to claim 40, line 2, “a needle” should be changed to “the needle”.
In regards to claim 41, line 2, “the skin layer” should be changed to “a skin layer”.
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 26-50 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.
In regards to claim 26, lines 7-10 recite: wherein the outlets are formed in a first section between the second end and “a location corresponding to a tendon membrane” located inside the skin tissue when the needle is in a state of penetrating the skin layer, and in a second section between “the location corresponding to the tendon membrane” and the first end. It is unclear how to interpret the term “a location corresponding to a tendon membrane” of the needle, especially with respect to the prior art. For example, it is unclear which structural characteristics or measurements the needle must require in order to be understood as “a location corresponding to a tendon membrane”. Claims 27-50 are rejected by virtue of being dependent upon claim 26.
In regards to claim 29, line 1 recites “a plurality of first holes”. Claim 29 depends upon claim 27. Claim 27, line 1 recites “a first hole”. It is unclear whether the two terms are the same or different. Claim 30 is rejected by virtue of being dependent upon claim 29. Claim 30, line 1 also recites the unclear term “the first holes”.
In regards to claim 32, lines 1-2 recite: “the second section is between 6.5 mm and 16.5 mm”. It is unclear what said limitation is a measurement of. Claims 33-34 are rejected by virtue of being dependent upon claim 32.
In regards to claim 35, lines 1-2 recite: “the second section is between 6.5 mm and 21.5 mm”. It is unclear what said limitation is a measurement of. Claims 36-37 are rejected by virtue of being dependent upon claim 35.
In regards to claim 38, line 3 and line 4 recite: “the outlet”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 38 depends upon claim 26. Claim 26, line 3 recites “outlets”. It is unclear whether the two terms are the same or different. Claim 39 is rejected by virtue of being dependent upon claim 38.
In regards to claim 38, line 4 recites: “the first direction”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 38, line 2 recites “a first axis”. It is unclear whether the two terms are the same or different. Claim 39 is rejected by virtue of being dependent upon claim 38.
In regards to claim 38, line 4 recites: “the second direction”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 38, line 3 recites “a second axis”. It is unclear whether the two terms are the same or different. Claim 39 is rejected by virtue of being dependent upon claim 38.
In regards to claim 39, line 1 recites: “different angles”. Claim 39 depends upon claim 38. Claim 38, lines 4-5 recite “a predetermined angle”. It is unclear whether the two terms are the same or different.
In regards to claim 41, line 2 recites: “the outlet”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 41 depends upon claim 40, which depends upon claim 26. Claim 26, line 3 recites “outlets”. It is unclear whether the two terms are the same or different.
In regards to claim 45, lines 1-2 recite: “the second section is between 6.5 mm and 16.5 mm”. It is unclear what said limitation is a measurement of. Claims 46-47 are rejected by virtue of being dependent upon claim 45.
In regards to claim 48, lines 1-2 recite: “the second section is between 6.5 mm and 21.5 mm”. It is unclear what said limitation is a measurement of. Claims 49-50 are rejected by virtue of being dependent upon claim 48.
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 26, 38, and 40-41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shin et al (US 2018/0028763).
In regards to claim 26, Shin et al teaches a needle (Figures 1a-2b, needle for drug injection 10) provided in a device for injecting a medicinal liquid through a skin layer (Figures 1a-1b), the needle comprising:
outlets (221, 222, 223, 224, 225) formed along the longitudinal direction of the needle between a first end (paragraph [0061]: other end) of the needle connected to an accommodating part of the device containing the medicinal liquid and a second end (215) of the needle configured to penetrate the skin layer, so that the medicinal liquid can be evenly injected into a skin tissue in the lower portion of the skin layer (Figure 7)
wherein the outlets are formed in a first section (labeled in Figure 7 below) between the second end and a location (labeled in Figure 7 below) corresponding to a tendon membrane located inside the skin tissue when the needle is in a state of penetrating the skin layer, and in a second section (labeled in Figure 7 below) between the location corresponding to the tendon membrane and the first end, respectively, so that the medicinal liquid is evenly injected around the tendon membrane (Figure 7)(paragraph [0085]: the needle for drug injection (10) can be used for Achilles tendinitis. Achilles tendinitis occurs in the inferior area (710) that faces the bone, not the outside)
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In regards to claim 38, Shin et al teaches wherein when an axis through which the second end is configured to be inserted to penetrate the skin layer is defined as a first axis, and a central axis of the outlet through which the medicinal liquid is configured to move is defined as a second axis, the outlet is formed such that the first direction and the second direction form a predetermined angle (Figure 2b).
In regards to claim 40, Shin et al teaches a syringe (Figures 1a, 2a-2b, drug injection apparatus 1) comprising:
a needle (10) according to claim 26
a cylinder (22) in which a medicinal liquid to be moved through the needle can be accommodated
In regards to claim 41, Shin et al teaches wherein the second end of the needle is closed (Figures 2a-2b), so that the medicinal liquid can be evenly injected into the skin layer through the outlet of the needle (Figures 2a-2b).
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 27-28, 31-37, and 42-50 are rejected under 35 U.S.C. 103 as being unpatentable over Shin et al, as applied to claims 26 and 40 above.
In regards to claim 27, Shin et al teaches wherein the outlets are provided with a first hole (221) formed in the first section; however, Shin et al is silent about wherein the first hole is formed in the first section of between 1.9% and 18.5% from the second end toward the first end. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first hole formed in the first section, of the needle of Shin et al, to be of between 1.9% and 18.5% from the second end toward the first end, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the needle of Shin et al would not operate differently with the claimed location of the first hole. Further, Applicant places no criticality on the range claimed for the location of the first hole.
In regards to claim 28, in the modified needle of Shin et al, Shin et al is silent about wherein the first hole is formed at a location between 0.5 mm and 3.5 mm from the second end. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first hole, of the modified needle of Shin et al, to be formed at a location between 0.5 mm and 3.5 mm from the second end, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified needle of Shin et al would not operate differently with the claimed location of the first hole. Further, Applicant places no criticality on the range claimed for the location of the first hole.
In regards to claim 31, Shin et al teaches wherein the outlets are provided with a second hole (224) and a third hole (225) formed in the second section; however, Shin et al is silent about wherein the second hole and the third hole are formed in the second section of between 25.6% and 86.8% from the second end toward the first end. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the second hole and the third hole formed in the second section, of the needle of Shin et al, to be of between 25.6% and 86.8% from the second end toward the first end, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the needle of Shin et al would not operate differently with the claimed location of the second hole and the third hole. Further, Applicant places no criticality on the range claimed for the location of the second hole and the third hole.
In regards to claim 32, in the modified needle of Shin et al, Shin et al is silent about wherein when the needle used has a length of 19 mm, the second section is between 6.5 mm and 16.5 mm. Shin et al only teaches the needle used has a length of 1 to 10 cm (paragraph [0059]). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the modified needle, of Shin et al, to have a length of 19 mm, as Applicant has not disclosed that such a length of the needle provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art furthermore would have expected Applicant’s invention to perform equally well with the needle having a length of 1 to 10 cm, as taught by Shin et al, as a person having ordinary skill in the art would have known how to select the length of the needle in order to be able to access a specific target of interest. And it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify wherein when the needle used has a length of 19 mm, of the modified needle of Shin et al, to have the second section be between 6.5 mm and 16.5 mm, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified needle of Shin et al would not operate differently with the claimed length of the second section. Further, Applicant places no criticality on the range claimed for the length of the second section.
In regards to claim 33, in the modified needle of Shin et al, Shin et al is silent about wherein the second hole is formed at a location between 6.5 mm and 11 mm from the second end. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the second hole, of the modified needle of Shin et al, to be formed at a location between 6.5 mm and 11 mm from the second end, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified needle of Shin et al would not operate differently with the claimed location of the second hole. Further, Applicant places no criticality on the range claimed for the location of the second hole.
In regards to claim 34, in the modified needle of Shin et al, Shin et al is silent about wherein the third hole is formed at a location between 12 mm and 16.5 mm from the second end. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the third hole, of the modified needle of Shin et al, to be formed at a location between 12 mm and 16.5 mm from the second end, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified needle of Shin et al would not operate differently with the claimed location of the third hole. Further, Applicant places no criticality on the range claimed for the location of the third hole.
In regards to claim 35, in the modified needle of Shin et al, Shin et al is silent about wherein when the needle used has a length of 25.4 mm, the second section is between 6.5 mm and 21.5 mm. Shin et al only teaches the needle used has a length of 1 to 10 cm (paragraph [0059]). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the modified needle, of Shin et al, to have a length of 25.4 mm, as Applicant has not disclosed that such a length of the needle provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art furthermore would have expected Applicant’s invention to perform equally well with the needle having a length of 1 to 10 cm, as taught by Shin et al, as a person having ordinary skill in the art would have known how to select the length of the needle in order to be able to access a specific target of interest. And it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify wherein when the needle used has a length of 25.4 mm, of the modified needle of Shin et al, to have the second section be between 6.5 mm and 21.5 mm, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified needle of Shin et al would not operate differently with the claimed length of the second section. Further, Applicant places no criticality on the range claimed for the length of the second section.
In regards to claim 36, in the modified needle of Shin et al, Shin et al is silent about wherein the second hole is formed at a location between 6.5 mm and 13.5 mm from the second end. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the second hole, of the modified needle of Shin et al, to be formed at a location between 6.5 mm and 13.5 mm from the second end, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified needle of Shin et al would not operate differently with the claimed location of the second hole. Further, Applicant places no criticality on the range claimed for the location of the second hole.
In regards to claim 37, in the modified needle of Shin et al, Shin et al is silent about wherein the third hole is formed at a location between 14.5 mm and 21.5 mm from the second end. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the third hole, of the modified needle of Shin et al, to be formed at a location between 14.5 mm and 21.5 mm from the second end, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified needle of Shin et al would not operate differently with the claimed location of the third hole. Further, Applicant places no criticality on the range claimed for the location of the third hole.
In regards to claim 42, Shin et al teaches wherein the outlets are provided with a first hole (221) formed in the first section; however, Shin et al is silent about wherein the first hole is formed in the first section of between 1.9% and 18.5% from the second end toward the first end. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first hole formed in the first section, of the syringe of Shin et al, to be of between 1.9% and 18.5% from the second end toward the first end, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the syringe of Shin et al would not operate differently with the claimed location of the first hole. Further, Applicant places no criticality on the range claimed for the location of the first hole.
In regards to claim 43, in the modified syringe of Shin et al, Shin et al is silent about wherein the first hole is formed at a location between 0.5 mm and 3.5 mm from the second end. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first hole, of the modified syringe of Shin et al, to be formed at a location between 0.5 mm and 3.5 mm from the second end, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified syringe of Shin et al would not operate differently with the claimed location of the first hole. Further, Applicant places no criticality on the range claimed for the location of the first hole.
In regards to claim 44, Shin et al teaches wherein the outlets are provided with a second hole (224) and a third hole (225) formed in the second section; however, Shin et al is silent about wherein the second hole and the third hole are formed in the second section of between 25.6% and 86.8% from the second end toward the first end. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the second hole and the third hole formed in the second section, of the syringe of Shin et al, to be of between 25.6% and 86.8% from the second end toward the first end, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the syringe of Shin et al would not operate differently with the claimed location of the second hole and the third hole. Further, Applicant places no criticality on the range claimed for the location of the second hole and the third hole.
In regards to claim 45, in the modified syringe of Shin et al, Shin et al is silent about wherein when the needle used has a length of 19 mm, the second section is between 6.5 mm and 16.5 mm. Shin et al only teaches the needle used has a length of 1 to 10 cm (paragraph [0059]). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the needle, of the modified syringe of Shin et al, to have a length of 19 mm, as Applicant has not disclosed that such a length of the needle provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art furthermore would have expected Applicant’s invention to perform equally well with the needle having a length of 1 to 10 cm, as taught by Shin et al, as a person having ordinary skill in the art would have known how to select the length of the needle in order to be able to access a specific target of interest. And it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify wherein when the needle used has a length of 19 mm, of the modified syringe of Shin et al, to have the second section be between 6.5 mm and 16.5 mm, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified syringe of Shin et al would not operate differently with the claimed length of the second section. Further, Applicant places no criticality on the range claimed for the length of the second section.
In regards to claim 46, in the modified syringe of Shin et al, Shin et al is silent about wherein the second hole is formed at a location between 6.5 mm and 11 mm from the second end. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the second hole, of the modified syringe of Shin et al, to be formed at a location between 6.5 mm and 11 mm from the second end, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified syringe of Shin et al would not operate differently with the claimed location of the second hole. Further, Applicant places no criticality on the range claimed for the location of the second hole.
In regards to claim 47, in the modified syringe of Shin et al, Shin et al is silent about wherein the third hole is formed at a location between 12 mm and 16.5 mm from the second end. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the third hole, of the modified syringe of Shin et al, to be formed at a location between 12 mm and 16.5 mm from the second end, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified syringe of Shin et al would not operate differently with the claimed location of the third hole. Further, Applicant places no criticality on the range claimed for the location of the third hole.
In regards to claim 48, in the modified syringe of Shin et al, Shin et al is silent about wherein when the needle used has a length of 25.4 mm, the second section is between 6.5 mm and 21.5 mm. Shin et al only teaches the needle used has a length of 1 to 10 cm (paragraph [0059]). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the needle, of the modified syringe of Shin et al, to have a length of 25.4 mm, as Applicant has not disclosed that such a length of the needle provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art furthermore would have expected Applicant’s invention to perform equally well with the needle having a length of 1 to 10 cm, as taught by Shin et al, as a person having ordinary skill in the art would have known how to select the length of the needle in order to be able to access a specific target of interest. And it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify wherein when the needle used has a length of 25.4 mm, of the modified syringe of Shin et al, to have the second section be between 6.5 mm and 21.5 mm, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified syringe of Shin et al would not operate differently with the claimed length of the second section. Further, Applicant places no criticality on the range claimed for the length of the second section.
In regards to claim 49, in the modified syringe of Shin et al, Shin et al is silent about wherein the second hole is formed at a location between 6.5 mm and 13.5 mm from the second end. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the second hole, of the modified syringe of Shin et al, to be formed at a location between 6.5 mm and 13.5 mm from the second end, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified syringe of Shin et al would not operate differently with the claimed location of the second hole. Further, Applicant places no criticality on the range claimed for the location of the second hole.
In regards to claim 50, in the modified syringe of Shin et al, Shin et al is silent about wherein the third hole is formed at a location between 14.5 mm and 21.5 mm from the second end. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the third hole, of the modified syringe of Shin et al, to be formed at a location between 14.5 mm and 21.5 mm from the second end, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified syringe of Shin et al would not operate differently with the claimed location of the third hole. Further, Applicant places no criticality on the range claimed for the location of the third hole.
Claims 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Shin et al, as applied to claim 27 above, and further in view of Schwartz et al (US 6,969,373).
In regards to claim 29, in the modified needle of Shin et al, Shin et al does not teach wherein there are a plurality of first holes formed at locations spaced apart by the same length with respect to the second end. Schwartz et al teaches a needle (Figure 22) wherein there are a plurality of first holes formed at locations spaced apart by the same length with respect to a second end (Figure 22). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified needle, of Shin et al, wherein there are a plurality of first holes formed at locations spaced apart by the same length with respect to the second end, as taught by Schwartz et al, as such will create a desired injectate cloud pattern (Abstract) in tissue, having a predetermined shape, size and concentration (column 3, lines 23-26) such as in the shape of a disk (column 9, lines 44-46) in order to target a specifically shaped tumor or other spatial pattern, or provide a relatively uniform area of delivery of such injectates as steroids or local anesthetics (column 15, lines 30-34)(Figure 22).
In regards to claim 30, in the modified needle of Shin et al and Schwartz et al, Shin et al does not teach wherein the first holes form the same angle with each other at the locations spaced apart by the same length with respect to the second end. Schwartz et al teaches wherein the first holes form the same angle with each other at the locations spaced apart by the same length with respect to the second end (Figure 22). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first holes, of the modified needle of Shin et al and Schwartz et al, to form the same angle with each other at the locations spaced apart by the same length with respect to the second end, as taught by Schwartz et al, as such will create a desired injectate cloud pattern (Abstract) in tissue, having a predetermined shape, size and concentration (column 3, lines 23-26) such as in the shape of a disk (column 9, lines 44-46) in order to target a specifically shaped tumor or other spatial pattern, or provide a relatively uniform area of delivery of such injectates as steroids or local anesthetics (column 15, lines 30-34)(Figure 22).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Shin et al, as applied to claim 38 above, and further in view of Schwartz et al.
In regards to claim 39, Shin et al does not teach wherein the outlets are inclined at different angles, as Shin et al instead teaches wherein the outlets are inclined at the same angle (Figure 2b). Schwartz et al teaches a needle (Figure 10) wherein outlets (66a, 66b, 66c) are inclined at different angles (Figure 10). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the outlets, of the needle of Shin et al, to be inclined at different angles, as taught by Schwartz et al, as such will create a desired injectate cloud pattern (Abstract) in tissue, having a predetermined shape, size and concentration (column 3, lines 23-26) such as a large cloud (column 16, lines 40-47) in order to target a specifically shaped tumor or other spatial pattern, or provide a relatively uniform area of delivery of such injectates as steroids or local anesthetics (column 15, lines 30-34)(Figure 10).
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783