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 .
Specification
The disclosure is objected to because of the following informalities:
The reference character “10” has been used to refer to “internal threads” on page 6, line 5 and “internal proximal needle portion” on page 6, line 9.
Appropriate correction is required.
Claim Objections
Claims 3, 5, 6 and 10 are objected to because of the following informalities:
Claim 3 recites the limitation “the fluid” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation “the fluid” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation “the proximal end” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation “the exit end” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 10, line 13, the recitation “the exit passageway” appears to be amended to recite “the passageway” in order to refer to “a passageway” recited in claim 10, line 5.
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 5-7 and 9-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitation “the exit passageway” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 5 appears to overcome the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph if claim 5 is amended to recite “the passageway” in order to refer to “a passageway” recited in claim 1, line 5. For examination purposes, examiner construes “the exit passageway” same as “a passageway” recited in claim 1, line 5.
Claims 6 and 7 being dependent on claim 5 are also rejected.
Regarding claim 6, the recitation “of the is capable of” renders the claim indefinite because the claim is unclear regarding “the needle” of which feature is being referred. Is the claim referring to the needle of a syringe assembly recited in claim 1 or different. For examination purposes, examiner construes that “the needle” in claim 6 refers to the needle of a syringe assembly.
Regarding claims 9 and 10, the recitation of “exceeding at least a length of the injection needle” appears to render the claim indefinite because original disclosure shows in figure 4 where spring exceeds one end of the injection needle but do not show whether spring exceeds other end of the needle as well in order to construe “exceeding at least a length of the injection needle”. The spring could have same length as length of the injection needle and could be exceeding one end of the needle due to staggered placement of the spring with respect to the needle. For examination purposes, examiner construes that the spring exceeding from at least one end of the needle is construed as meeting the claimed limitation.
Claim 11 being dependent on claim 10 is also rejected.
Regarding claim 11, line 4, the recitation “a receiving person” renders the claim indefinite because the claim is unclear if “a receiving person” is same as “a user” recited in claim 10, line 14 or different. For examination purposes, examiner construes that “a receiving person” is same as “a user”. Claim 11 appears to overcome the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph if claim 11 is amended to recite “the user” instead of “a receiving person”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-6 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pierre-Jean (FR 832493 A, English translation is used for referring to the specification, due to machine translation, English translation is not accurate but clear enough to understand the invention therefore examiner has tried best to understand the invention with the available machine translation).
Regarding claim 1, Pierre-Jean teaches a syringe assembly (figure 3) comprising:
a flexible reservoir (see “B” in figure 3 below, page 1, lines 23-25) at a proximal end (end where “B” is located) of the syringe assembly (figure 3);
a needle-holding section (see “H” in figure 3 below) at a distal end (end where element “H” is present) of the syringe assembly having an injection needle (see “N” in figure 3 below) extending therefrom; and
a passageway (see “P” in figure 3 below) at an exit end (see “E” in figure 3 below) of the reservoir (see “B” in figure 3 below) connecting the reservoir (see “B” in figure 3 below) to the needle-holding section (see “H” in figure 3 below).
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Regarding claim 2, Pierre-Jean teaches wherein the reservoir (see “B” in figure 3 above) is prefilled with fluid (see page 1, line 25).
Regarding claim 3, Pierre-Jean taches wherein the passageway (see “P” in figure 3 above) further comprises: a seal (page 1, lines 27-29, “perforate the bulb” is construed that there has to be a seal present otherwise perforation is not required in order to place fluid in communication with the needle, additionally, the invention focuses on maintaining sterility by describing needle sterility on page 1, lines 29-31 and therefore, the seal has to protect the fluid from exposure to air and contamination in order to maintain drug sterility) at the exit end (see “E” in figure 3 above) of the reservoir (see “B” in figure 3 above) to protect the fluid from exposure to air and contamination.
Regarding claim 4, Pierre-Jean teaches wherein the needle-holding section (see “H” in figure 3 above) is threadably (page 1, lines 27-29, “screw socket” is construed to have thread therefore, the needle-holding section has to be connected via threaded connection to the passageway. Furthermore, figure 3 shows threaded connection between the needle-holding section and the reservoir) connected to the passageway (see “P” in figure 3 above).
Regarding claim 5, Pierre-Jean teaches wherein the needle (see “N” in figure 3 above) in the needle-holding section (see “H” in figure 3 above) has an interior proximal portion (see “NI”, page 1, lines 27-29, in order for fluid communication establishment, a portion indicated by “NI” in figure 3 above has to extend into the exit passageway) that extends into the exit passageway (see “P” in figure 3 above) of the reservoir (see “B” in figure 3 above) and an exterior distal portion (see “NE” in figure 3 above) for injecting the fluid into a user.
Regarding claim 6, Pierre-Jean teaches wherein the proximal end of the needle (see “N” in figure 3 above) is capable of piercing (page 1, lines 27-29) the seal when the needle-holding section is rotated inward toward the reservoir (see “B” in figure 3 above).
Regarding claim 8, Pierre-Jean teaches wherein the flexible reservoir (see “B” in figure 3 above) is bulb shaped (figure 3).
Claim(s) 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anthony (US 1,676,881).
Regarding claim 1, Anthony teaches a syringe assembly (figure 1) comprising:
a flexible reservoir 2 (page 1, lines 99-107) at a proximal end (end where element 2 is present) of the syringe assembly;
a needle-holding section 8 at a distal end (end where element 8 is present) of the syringe assembly (figure 1) having an injection needle 9 extending therefrom; and
a passageway (hollow portion inside element 2 at element 4, hereinafter referred by reference element “4”) at an exit end (end where element 4 is present) of the reservoir 2 connecting the reservoir 2 to the needle-holding section 8.
Regarding claim 2, Anthony teaches wherein the reservoir 2 is prefilled with fluid (see figure 1 where element 2 is prefilled, page 1, lines 104-107).
Regarding claim 3, Anthony teaches wherein the passageway further comprises a seal 6 at the exit end of the reservoir to protect the fluid from exposure to air and contamination (page 1, lines 104-107).
Regarding claim 4, Anthony teaches wherein the needle-holding section 8 is threadably (page 2, lines 10-13) connected to the passageway 4.
Regarding claim 5, Anthony teaches wherein the needle 9 in the needle-holding section 8 has an interior proximal portion (portion of element 9 that extends inside element 4) that extends into the exit passageway 4 of the reservoir 2 and an exterior distal portion (portion of element 9 that extends outside element 4) for injecting the fluid into a user.
Regarding claim 6, Anthony teaches wherein the proximal end of the needle 9 is capable of piercing the seal 6 when the needle-holding section 8 is rotated inward toward the reservoir 2 (page 2, lines 10-24).
Regarding claim 7, Anthony teaches further comprising: a cover 16 (figure 3) over the exit end of the needle 9.
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.
Claim(s) 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Pierre-Jean (FR 832493 A) in view of Patrick (FR 2746319 A1, English translation is used to refer to the specification).
Regarding claim 9, Pierre-Jean discloses the claimed invention substantially as claimed, as set forth above in claim 1. Pierre-Jean is silent regarding further comprising: a spring secured to the needle-holding section, said spring surrounding and exceeding at least a length of the injection needle to act as a cover to prevent inadvertent needle pricks.
However, Patrick teaches a design of a needle guard comprising: a spring (entire structure shown in figure 1 except for elements 6 and 4) secured to the needle-holding section 6, said spring surrounding and exceeding at least a length of the injection needle 4 to act as a cover to prevent inadvertent needle pricks (page 3, lines 5-8) for the purpose of covering the end of the needle to prevent inadvertent pricks (page 3, lines 5-8).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the syringe assembly of Pierre-Jean to incorporate a spring secured to the needle-holding section, said spring surrounding and exceeding at least a length of the injection needle to act as a cover to prevent inadvertent needle pricks as taught by Patrick for the purpose of covering the end of the needle to prevent inadvertent pricks (page 3, lines 5-8).
Regarding claim 10, Pierre-Jean discloses a syringe assembly (figure 3) comprising:
a flexible reservoir (see “B” in figure 3 above, page 1, lines 23-25) at a proximal end (end where “B” is located) of the syringe assembly (figure 3);
a needle-holding section (see “H” in figure 3 above) at a distal end (end where element “H” is present) of the syringe assembly having an injection needle (see “N” in figure 3 above) extending therefrom; and
a passageway (see “P” in figure 3 above) at an exit end (see “E” in figure 3 above) of the reservoir (see “B” in figure 3 above) connecting the reservoir (see “B” in figure 3 above) to the needle-holding section (see “H” in figure 3 below);
wherein the reservoir (see “B” in figure 3 above) is prefilled with fluid (see page 1, line 25);
wherein the passageway further comprises a seal 6 at the exit end of the reservoir to protect the fluid from exposure to air and contamination (page 1, lines 104-107);
wherein the needle-holding section 8 is threadably (page 2, lines 10-13) connected to the passageway 4 of the reservoir;
wherein the needle 9 in the needle-holding section 8 has an interior proximal portion (portion of element 9 that extends inside element 4) that extends into the exit passageway 4 of the reservoir 2 and an exterior distal portion (portion of element 9 that extends outside element 4) for injecting the fluid into a user.
Pierre-Jean is silent regarding further comprising: a spring secured to the needle-holding section, said spring surrounding and exceeding at least a length of the injection needle to act as a cover to prevent inadvertent needle pricks.
However, Patrick teaches a design of a needle guard comprising: a spring (entire structure shown in figure 1 except for elements 6 and 4) secured to the needle-holding section 6, said spring surrounding and exceeding at least a length of the injection needle 4 to act as a cover to prevent inadvertent needle pricks (page 3, lines 5-8) for the purpose of covering the end of the needle to prevent inadvertent pricks (page 3, lines 5-8).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the syringe assembly of Pierre-Jean to incorporate a spring secured to the needle-holding section, said spring surrounding and exceeding at least a length of the injection needle to act as a cover to prevent inadvertent needle pricks as taught by Patrick for the purpose of covering the end of the needle to prevent inadvertent pricks (page 3, lines 5-8).
Regarding claim 11, Pierre-Jean discloses a method of using the syringe assembly comprising the steps of: rotating the needle-holding section (see “H” in figure 3 above) inward toward the flexible reservoir (see “B” in figure 3 above) until the proximal portion of the needle pierces the seal (page 1, lines 27-29, “perforate the bulb”); squeezing the flexible reservoir (page 2, lines 1-7) to cause the fluid in the reservoir to be expelled from the reservoir through the needle and into the user’s body but is silent regarding pressing the spring against a skin of a receiving person, thereby depressing the spring and inserting the distal portion of the needle into a user’s body; and removing the needle from the user’s body while allowing the spring to extending around the needle to act as a cover to prevent accidental needle pricks.
However, Patrick teaches pressing the spring (page 2, last line-page 3, line 5, “A tension applied … to compress the remainder”) against a skin of a receiving person, thereby depressing the spring and inserting the distal portion of the needle into a user’s body; and removing (page 3, lines 5-8) the needle from the user’s body while allowing the spring to extending around the needle to act as a cover to prevent accidental needle pricks for the purpose of securely delivering the fluid while minimizing the risk of inadvertent pricks by covering the needle when not in use or at the end of the use (page 3, lines 5-8).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the method of Pierre-Jean to incorporate the spring against a skin of a receiving person, thereby depressing the spring and inserting the distal portion of the needle into a user’s body; and removing the needle from the user’s body while allowing the spring to extending around the needle to act as a cover to prevent accidental needle pricks as taught by Patrick for the purpose of securely delivering the fluid while minimizing the risk of inadvertent pricks by covering the needle when not in use or at the end of the use (page 3, lines 5-8).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783