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 April 9, 2026, Applicant amended claims 26, 28-30, 32, 35, 38-41, 43, 45, and 47.
Applicant cancelled claims 27, 31, 42, and 44.
Applicant added new claims 51-54.
In the non-final rejection of January 9, 2026, Examiner objected to the Abstract. Applicant amended the Abstract. Objection is withdrawn.
Examiner objected to claims 26, 30, and 40-41. Applicant amended claims 26, 30, and 40-41; however, Applicant did not address all of the objections. Objection is maintained.
Examiner rejected claims 26-50 under 35 U.S.C. 112(b). Applicant amended claims 26, 32, 35, 38-39, 45; however, Applicant did not address all of the rejections. Rejection is maintained.
Claim Objections
Claims 26, 28, 38-39, 47, 52, and 54 are objected to because of the following informalities:
In regards to claim 26, line 6, “the lower portion” should be changed to “a lower portion”.
In regards to claim 26, line 14, “each first hole” should be changed to “each first hole of the at least one first hole”.
In regards to claim 28, line 1, “the first hole” should be changed to “the at least one first hole”.
In regards to claim 38, line 5, “the skin” should be changed to “the skin layer”.
In regards to claim 39, line 2, “the respective outlets” should be changed to “respective outlets”.
In regards to claim 47, line 2, “spans” should be changed to “spanning”.
In regards to claim 52, line 6, “the lower portion” should be changed to “a lower portion”.
In regards to claim 52, line 8, “each first hole” should be changed to “each first hole of the at least one first hole”.
In regards to claim 54, line 3, “a device” should be changed to “the device”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 32-37, 45-47, and 52-54 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regards to claim 32, lines 2-3 recite: the second section spans between 6.5 mm and 16.5 mm in distance “from the second end”; however, such is new matter not described in the Specification. Claims 33-34 are rejected by virtue of being dependent upon claim 32.
In regards to claim 35, lines 2-3 recite: the second section spans between 6.5 mm and 21.5 mm in distance “from the second end”; however, such is new matter not described in the Specification. Claims 36-37 are rejected by virtue of being dependent upon claim 35.
In regards to claim 45, line 2 recites: the second section spans between 6.5 mm and 16.5 mm in distance “from the second end”; however, such is new matter not described in the Specification. Claims 46-47 are rejected by virtue of being dependent upon claim 45.
In regards to claim 47, lines 1-2 recite: wherein the third hole is formed at a location spans “between 6.5 mm and 21.5 mm in distance from the second end”; however, such is new matter not described in the Specification.
In regards to claim 52, lines 11-12 recite: a second hole formed in the needle at a position “between 6.5 mm and 21.5 mm” from the second end of the needle; however, such is new matter not described in the Specification. Claims 53-54 are rejected by virtue of being dependent upon claim 52.
In regards to claim 52, lines 13-14 recite: a third hole formed in the needle at a position “between 6.5 mm and 21.5 mm” from the second end of the needle; however, such is new matter not described in the Specification. Claims 53-54 are rejected by virtue of being dependent upon claim 52.
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 28-30, 32-41, 43, 45-50, and 52-54 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 28, line 1 recites: “The needle of claim 26”. Claim 28 depends upon claim 26. Claim 26, line 1 recites “A device configured with a needle”. Thus, it is unclear why the preamble of claim 28 is not “The device of claim 26”.
In regards to claim 29, line 1 recites: “The needle of claim 26”. Claim 29 depends upon claim 26. Claim 26, line 1 recites “A device configured with a needle”. Thus, it is unclear why the preamble of claim 29 is not “The device of claim 26”. Claim 30 is rejected by virtue of being dependent upon claim 29.
In regards to claim 29, line 1 recites “a plurality of first holes”. Claim 29 depends upon claim 26. Claim 26, line 14 recites “at least one 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 plurality of first holes”.
In regards to claim 30, line 1 recites: “The needle of claim 29”. Claim 30 depends upon claim 29, which depends upon claim 26. Claim 26, line 1 recites “A device configured with a needle”. Thus, it is unclear why the preamble of claim 30 is not “The device of claim 29”.
In regards to claim 32, line 1 recites: “The needle of claim 26”. Claim 32 depends upon claim 26. Claim 26, line 1 recites “A device configured with a needle”. Thus, it is unclear why the preamble of claim 32 is not “The device of claim 26”. Claims 33-34 are rejected by virtue of being dependent upon claim 32.
In regards to claim 32, line 2 recites: “the second section”. There is insufficient antecedent basis for this limitation in the claim. Claims 33-34 are rejected by virtue of being dependent upon claim 32.
In regards to claim 33, line 1 recites: “The needle of claim 32”. Claim 33 depends upon claim 32, which depends upon claim 26. Claim 26, line 1 recites “A device configured with a needle”. Thus, it is unclear why the preamble of claim 33 is not “The device of claim 32”.
In regards to claim 34, line 1 recites: “The needle of claim 32”. Claim 34 depends upon claim 32, which depends upon claim 26. Claim 26, line 1 recites “A device configured with a needle”. Thus, it is unclear why the preamble of claim 34 is not “The device of claim 32”.
In regards to claim 35, line 1 recites: “The needle of claim 26”. Claim 35 depends upon claim 26. Claim 26, line 1 recites “A device configured with a needle”. Thus, it is unclear why the preamble of claim 35 is not “The device of claim 26”. Claims 36-37 are rejected by virtue of being dependent upon claim 35.
In regards to claim 35, line 2 recites: “the second section”. There is insufficient antecedent basis for this limitation in the claim. Claims 36-37 are rejected by virtue of being dependent upon claim 35.
In regards to claim 36, line 1 recites: “The needle of claim 35”. Claim 36 depends upon claim 35, which depends upon claim 26. Claim 26, line 1 recites “A device configured with a needle”. Thus, it is unclear why the preamble of claim 36 is not “The device of claim 35”.
In regards to claim 37, line 1 recites: “The needle of claim 35”. Claim 37 depends upon claim 35, which depends upon claim 26. Claim 26, line 1 recites “A device configured with a needle”. Thus, it is unclear why the preamble of claim 37 is not “The device of claim 35”.
In regards to claim 38, line 1 recites: “The needle of claim 26”. Claim 38 depends upon claim 26. Claim 26, line 1 recites “A device configured with a needle”. Thus, it is unclear why the preamble of claim 38 is not “The device of claim 26”. Claim 39 is rejected by virtue of being dependent upon claim 38.
In regards to claim 38, lines 3-4 recite “axis, the”. It is unclear what is meant by the recitation. Claim 39 is rejected by virtue of being dependent upon claim 38.
In regards to claim 38, line 6 recites “at least one outlet”. 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 38, line 7 also recites the unclear term “the at least one outlet”. Claim 39 is rejected by virtue of being dependent upon claim 38.
In regards to claim 39, line 1 recites: “The needle of claim 38”. Claim 39 depends upon claim 38, which depends upon claim 26. Claim 26, line 1 recites “A device configured with a needle”. Thus, it is unclear why the preamble of claim 39 is not “The device of claim 38”.
In regards to claim 39, line 1 recites “a plurality of outlets”. Claim 39 depends upon claim 38, which depends upon claim 26. Claim 26, line 3 recites “outlets”. It is unclear whether the two terms are the same or different. Claim 38, line 2 also recites the unclear term “the respective outlets among the plurality of outlets”. Claim 39 is rejected by virtue of being dependent upon claim 38.
In regards to claim 39, lines 1-2 recite: “the predetermined angles”. There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 40, line 2 recites: “the needle according to claim 26”. Claim 40 depends upon claim 26. Claim 26, line 1 recites “A device configured with a needle”. Thus, it is unclear why said limitation of claim 40 is not “the device according to claim 26”. Claims 41, 43, and 45-50 are rejected by virtue of being dependent upon claim 40.
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, line 1 recites: The syringe of “claim 44”. However, claim 44 is a cancelled claim. Thus, the dependency of claim 45 is unclear. For the purposes of examination, claim 45 is being examined as if dependent upon claim 40. Claims 46-47 are rejected by virtue of being dependent upon claim 45.
In regards to claim 45, line 2 recites: “the second section”. There is insufficient antecedent basis for this limitation in the claim. Claims 46-47 are rejected by virtue of being dependent upon claim 45.
In regards to claim 48, line 1 recites: The syringe of “claim 44”. However, claim 44 is a cancelled claim. Thus, the dependency of claim 48 is unclear. For the purposes of examination, claim 48 is being examined as if dependent upon claim 40. Claims 49-50 are rejected by virtue of being dependent upon claim 48.
In regards to claim 48, line 2 recites: “the second section”. There is insufficient antecedent basis for this limitation in the claim. Claims 49-50 are rejected by virtue of being dependent upon claim 48.
In regards to claim 48, line 2 recited: “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.
In regards to claim 52, line 8 recites: “the first section”. There is insufficient antecedent basis for this limitation in the claim. Claims 53-54 are rejected by virtue of being dependent upon claim 52.
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 26, 28, 32-38, 40-41, 43, and 45-54 are rejected under 35 U.S.C. 103 as being unpatentable over Shin et al (US 2018/0028763).
In regards to claim 26, Shin et al teaches a device (Figures 1a-2b) configured with a needle (10) for injecting a medicinal liquid through a skin layer, the needle comprising:
outlets (221, 222, 223, 224, 225) formed along a 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 comprise:
at least one first hole (221) formed in the needle
a second hole (224) formed in the needle
a third hole (225) formed in the needle
Shin et al is silent about each first hole being formed at a position 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 each first hole, of the device of Shin et al, to be formed at a position 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 device of Shin et al would not operate differently with the claimed location of each first hole. Further, Applicant places no criticality on the range claimed for the location of each first hole.
Further, Shin et al is silent about the second hole formed in the needle at a position 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, of the modified device of Shin et al, to be formed in the needle at a position 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 modified device 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.
Further, Shin et al is silent about the third hole formed in the needle at a position 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 third hole, of the modified device of Shin et al, to be formed in the needle at a position 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 modified device 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 28, in the modified device 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 device 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 device 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 32, in the modified device of Shin et al, Shin et al is silent about wherein when the needle used has a length of 19 mm, the second section spans between 6.5 mm and 16.5 mm in distance from the second end. 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 device 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 device of Shin et al, to have the second section span between 6.5 mm and 16.5 mm in distance 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 device of Shin et al would not operate differently with the claimed distance of the second section. Further, Applicant places no criticality on the range claimed for the distance of the second section.
In regards to claim 33, in the modified device 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 device 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 device 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 device 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 device 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 device 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 device 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 spans between 6.5 mm and 21.5 mm in distance from the second end. 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 device 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 device of Shin et al, to have the second section span between 6.5 mm and 21.5 mm in distance 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 device of Shin et al would not operate differently with the claimed distance of the second section. Further, Applicant places no criticality on the range claimed for the distance of the second section.
In regards to claim 36, in the modified device 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 device 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 device 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 device 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 device 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 device 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 38, in the modified device of Shin et al, Shin et al teaches wherein axis, the a first axis is defined by a direction in which the second end is configured to penetrate the skin, and a second axis is defined by a central axis of at least one outlet through which the medicinal liquid is configured to move, and wherein the at least one outlet is formed such that the first axis and the second axis 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:
the needle, of the modified device of Shin et al, according to claim 26
a cylinder (22) configured to accommodate a medicinal liquid to be moved through the needle
In regards to claim 41, in the modified syringe of Shin et al, 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 a skin layer through the outlet of the needle (Figures 2a-2b).
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 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 spans between 6.5 mm and 16.5 mm in distance from the second end. 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 span between 6.5 mm and 16.5 mm in distance 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 distance of the second section. Further, Applicant places no criticality on the range claimed for the distance 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 spans between 6.5 mm and 21.5 mm in distance 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 spans between 6.5 mm and 21.5 mm in distance 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.
In regards to claim 51, Shin et al teaches a method for injecting a medicinal liquid through a skin layer and into a skin tissue (Figure 7), the method comprising:
providing a device (Figures 1a-2b) containing the medicinal liquid and a needle (10) having a first end (paragraph [0061]: other end) connected to an accommodating part of the device and a second end (215) configured to penetrate the skin layer
penetrating the skin layer with the needle (Figure 7)
positioning the needle adjacent a tendon membrane inside the skin tissue (Figure 7)
injecting the medicinal liquid through the needle around the tendon membrane (Figure 7)(paragraph [0086])
wherein the needle comprises outlets (221, 222, 223, 224, 225) formed along a longitudinal direction of the needle between the first end of the needle and the second end of the needle, the outlets comprising:
at least one first hole (221) formed in the needle
a second hole (224) formed in the needle
a third hole (225) formed in the needle
Shin et al is silent about the at least one first hole formed in the needle at a position 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 at least one first hole, of the method of Shin et al, to be formed in the needle at a position 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 method of Shin et al would not operate differently with the claimed location of the at least one first hole. Further, Applicant places no criticality on the range claimed for the location of the at least one first hole.
Further, Shin et al is silent about the second hole formed in the needle at a position 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, of the modified method of Shin et al, to be formed in the needle at a position 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 modified method 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.
Further, Shin et al is silent about the third hole formed in the needle at a position 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 third hole, of the modified method of Shin et al, to be formed in the needle at a position 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 modified method 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 52, Shin et al teaches a device (Figures 1a-2b) configured with a needle (10) for injecting a medicinal liquid through a skin layer, the needle comprising:
outlets (221, 222, 223, 224, 225) formed along a 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 comprise:
at least one first hole (221) formed in the first section
a second hole (224) formed in the needle
a third hole (225) formed in the needle
Shin et al is silent about each first hole being independently formed at a location between 0.5 mm and 3.5 mm from the second end of the needle. 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 each first hole, of the device of Shin et al, to be independently formed at a location between 0.5 mm and 3.5 mm from the second end of the needle, 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 device of Shin et al would not operate differently with the claimed location of the at least one first hole. Further, Applicant places no criticality on the range claimed for the location of the at least one first hole.
Further, Shin et al is silent about the second hole formed in the needle at a position between 6.5 mm and 21.5 mm from the second end of the needle. 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 device of Shin et al, to be formed in the needle at a position between 6.5 mm and 21.5 mm from the second end of the needle, 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 device 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.
Further, Shin et al is silent about the third hole formed in the needle at a position between 6.5 mm and 21.5 mm from the second end of the needle. 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 device of Shin et al, to be formed in the needle at a position between 6.5 mm and 21.5 mm from the second end of the needle, 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 device 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 53, in the modified device 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, and 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 second hole, of the modified device 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 device 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. 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 the third hole, of the modified device 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 device 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 54, Shin et al teaches a method for injecting a medicinal liquid through a skin layer and into a skin tissue (Figure 7), the method comprising:
providing a modified device of Shin et al of claim 52
penetrating the skin layer with the needle (Figure 7)
positioning the needle adjacent a tendon membrane inside the skin tissue (Figure 7)
injecting the medicinal liquid through the needle around the tendon membrane (Figure 7)(paragraph [0086])
Claims 29-30 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Shin et al, as applied to claims 26 and 38 above, and further in view of Schwartz et al (US 6,969,373).
In regards to claim 29, in the modified device 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 device (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 device, 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 device of Shin et al and Schwartz et al, Shin et al does not teach wherein the plurality of 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 plurality of 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 plurality of first holes, of the modified device 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).
In regards to claim 39, in the modified device of Shin et al, Shin et al teaches a plurality of outlets (221, 222, 223, 224, 225); however Shin et al does not teach wherein the predetermined angles of the respective outlets among the plurality of outlets differ from each other, as Shin et al instead teaches wherein the predetermined angles of the respective outlets among the plurality of outlets are the same (Figure 2b). Schwartz et al teaches a device (Figure 10) wherein predetermined angles of respective outlets among a plurality of outlets (66a, 66b, 66c) differ from each other (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 predetermined angles of the respective outlets among the plurality of outlets, of the modified device of Shin et al, to differ from each other, 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).
Response to Arguments
Applicant's arguments filed April 9, 2026, have been fully considered but they are not persuasive:
In regards to claim 26, Applicant argued: The amendment to claim 26 also leads to a consequential absence of holes in the zone between 18.5% to 25.6% from the second end of the needle which corresponds with the tendon membrane (Remarks, page 14). Examiner disagrees. The claim does not require “a consequential absence of holes in the zone between 18.5% to 25.6% from the second end of the needle which corresponds with the tendon membrane”, as argued by Applicant.
In regards to claim 26, Applicant argued: Applicant disagrees that the amended claims are anticipated by Shin because it fails to disclose the specific arrangement of outlets required by the amended claims. Shin discloses a needle "for drug injection to deliver a large amount of drug to a lesion accurately with minimizing tissue damage, and a drug injection apparatus comprising the same." Shin at p.1, [0014]. While the needle disclosed by Shin has at least one outlet for drug distribution, it does not disclose the particularized arrangement of outlets as required by the amended claims (Remarks, pages 14-15). Examiner disagrees. Shin et al teaches wherein the outlets comprise: at least one first hole (221) formed in the needle (10), a second hole (224) formed in the needle, and a third hole (225) formed in the needle.
In regards to claim 26, Applicant argued: Shin does not teach or suggest the specific arrangement of outlets required by amended claim 26 and claims dependent therefrom. There is no indication of the specifically claimed discontinuous pattern of outlets where there is a specific "dead zone" of outlets that corresponds with the tendon membrane (Remarks, page 15). Examiner disagrees. First, Shin et al teaches wherein the outlets comprise: at least one first hole (221) formed in the needle (10), a second hole (224) formed in the needle, and a third hole (225) formed in the needle. Second, the claim does not require “discontinuous pattern of outlets where there is a specific "dead zone" of outlets that corresponds with the tendon membrane”, as argued by Applicant.
In regards to claim 26, Applicant argued: The Office's reliance on Gardner v. TEC Sys., Inc. to dismiss the claimed numerical ranges as mere relative dimensions is misplaced because the claimed ranges solve the specific clinical problem of the clinical risk of damaging the tendon membrane during medicinal injections. [S]ince the most stable medical procedure is possible only when the medicinal liquid is evenly supplied to the surrounding portions of the tendon membrane, there is a difficulty in that an operator needs to meticulously adjust this. In order to overcome such drawbacks, a means for injecting a medicinal liquid capable of evenly supplying the medicinal liquid to each layer of the skin has been actively devised, and a method capable of solving these problems is required. Specification at [8]-[9]. More specifically, if the needle outlets are positioned directly at the location of the tendon membrane, the medicinal liquid will be injected directly into the membrane and potentially damage the tendon tissue and cause adverse side effects. The inventors of the amended claims discovered through clinical investigation that the tendon membrane of various patients is located within a zone of approximately 18.5% to 25.6% of the needle length from the penetrating tip. As seen in FIG. 19, reproduced below, and as described in the specification at [144]: Meanwhile, as shown in FIG. 19, it can be confirmed that the first hole H1, the second hole H2, and the third hole H3 have different locations as b, c, and d of the tendon membrane T, respectively, and therefore, the section between 18.5% and 25.6% spaced apart from the other end of the needle 100, which is excluded from the first section S1 and the second section S2, may be a location corresponding to the tendon membrane T based on the predetermined distances in the range of the location of the tendon membrane T. The needle of the amended claims ensures that medicinal liquid is delivered only to surrounding tissues rather than directly into sensitive membrane. Shin does not identify this particular clinical problem, nor the specific clinical significance of the claimed dimensions. The amended claims encompass a needle that performs differently than the needle disclosed by Shin. C nsequently, the claimed ranges are not arbitrary dimension choices but correspond to m aningful anatomical features that render the needle patentably distinct from Shin (Remarks, pages 17-18). Examiner disagrees. The claimed numerical ranges are not linked to disclosed advantages or criticality in the Specification. Thus, the rejections of the claimed numerical ranges under Gardner v. TEC Syst., Inc. are maintained.
In regards to claim 26, Applicant argued: As previously mentioned, the needle of Shin is disclosed "for drug injection to deliver a large amount of drug to a lesion accurately with minimizing tissue damage, and a drug injection apparatus comprising the same." Shin at p.1, [0014]. However, Shin does not recognize the specific clinical problem of avoiding direct injection into a tendon membrane. Shin does not recognize the clinical importance of omitting outlets in the claimed range to avoid tendon membrane injury. While Shin discusses treating Achilles tendonitis, it describes "the needle for drug injection (10) of the present invention is inserted from the side of the Achilles tendon and discharges the drug sideway toward the inside of the Achilles tendon , by which the needle for drug injection (10) of the invention can discharge the drug accurately to the damaged area." Shin at p. 4, [0086]. Shin provides no teaching regarding percentage-based positioning or a discontinuous hole distribution designed to protect the membrane. Schwartz focuses on creating injectate cloud patterns for tumors or anesthetics through equidistant hole spacing and varying angles. Schwartz at p. 1, Abstract. Similarly to Shin, Schwartz does not address the anatomical constraints of the tendon membrane, the clinical problem of direct membrane injection, nor the corresponding hole-free zone of the amended claims. Schwartz's teaching is directed to a completely different objective and provides no motivation to define hole placement based on tendon membrane location… Based on the teachings of both Shin, a person of ordinary skill in the art would have had no motivation to modify Shin to arrive at the specific hole placement ranges of the amended claims. Furthermore, Schwartz does not cure the defects of Shin. Furthermore, one of skill in the art would not have been motivated to combine Shin with Schwartz to reach the needle of the amended claims. Therefore, Applicant requests withdrawal of the rejections of the claims under 35 U.S.C. § 103 (Remarks, page 19). Examiner disagrees. First, the claim does not require “avoiding direct injection into a tendon membrane” and “omitting outlets in the claimed range to avoid tendon membrane injury”, as argued by Applicant. Second, the claimed numerical ranges are not linked to disclosed advantages or criticality in the Specification. Thus, the rejections of the claimed numerical ranges under Gardner v. TEC Syst., Inc. are maintained. Third, the claim does not require “a discontinuous hole distribution designed to protect the membrane”, “address the anatomical constraints of the tendon membrane, the clinical problem of direct membrane injection, nor the corresponding hole-free zone” and “to define hole placement based on tendon membrane location”, as argued by Applicant.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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