DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 5-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/29/26.
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 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.
Claim 3 and 12-17 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 3 states “wherein the silicone layer is a spray-on silicone layer that has been treated to reduce its thickness”. It is unclear if this means treatment has occurred before or after the thickness mentioned in claim 1 – i.e. if treatment makes that thickness less than the range claimed in claim 1 or if the treatment is what makes the thickness be within the range of claim 1.
Claims 12, 13, 16 and 17 each use the term “optionally”. This implies the limitations that follow are not required. It is unclear however if the applicant intends for this to be the case. The examiner suggests removal of the term “optionally”. For the sake of compact prosecution, the examiner will assume that the limitations are required.
Regarding claim 12, the phrases “in particular” and “more particularly” are similar to "for example", and render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 14 recites “A syringe of claim 12 for use in a therapeutic method”. It is not clear how “for use in a therapeutic method” is intended to further limit the syringe of claim 12 as presumably the syringe would already be configured for use in a therapeutic method.
Claims 14-15 are rejected as they depend from/require all the limitations of a rejected claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 14 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
As to claim 14, the recitation of “for use in a therapeutic method” does not appear to further limit the subject matter of claim 12 as the syringe of claim 12 is presumably already configured to be used in a therapeutic method. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gibson et al. (US 2020/0093992), cited previously and hereafter “Gibson”.
As to claim 1, Gibson discloses a syringe barrel (151) having a proximal end (153), a distal end (152) and a sidewall extending therebetween, the sidewall having a cylindrical interior surface (156; see para 0051, Fig. 1) defining at least a portion of a chamber for receiving an aqueous formulation, wherein the cylindrical interior surface is coated with a silicone layer ("lubrication 159"; para 0016, 0060 teaching silicone) having a thickness of about 5 nm to about 100 nm (see para 0062 teaching "the lubrication layer 159 may have a thickness between about 0.1 µm…”; 0.1 µm being equal to 100nm).
As to claim 2, Gibson discloses the syringe barrel of claim 1, wherein the silicone layer has a thickness of about 40 nm to about 100 nm (see para 0062 teaching "the lubrication layer 159 may have a thickness between about 0.1 µm…”; 0.1 µm being equal to 100nm).
As to claim 4, Gibson discloses the syringe barrel of claim 1, wherein the syringe barrel is made of glass (para 0016, 0050), or wherein the distal end of the syringe barrel includes a tip (161) having a passage extending therethrough (passage where needle 155 extends through; see Fig. 1) and/or the proximal end of the syringe barrel includes an outwardly extending flange (see Fig. 1).
Regarding claim 11, the examiner notes that claim 11 is a product-by-process claim - MPEP 2113 states “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”. In this instance, the product is a syringe barrel having a proximal end, a distal end and a sidewall extending therebetween, the sidewall having a cylindrical interior surface defining at least a portion of a chamber for receiving an aqueous formulation, wherein the cylindrical interior surface is coated with a silicone layer having a thickness of between about 5 nm to about 100 nm or between about 30 nm and about 100. Gibson discloses a syringe barrel (151) having a proximal end (153), a distal end (152) and a sidewall extending therebetween, the sidewall having a cylindrical interior surface (156; see para 0051, Fig. 1) defining at least a portion of a chamber for receiving an aqueous formulation, wherein the cylindrical interior surface is coated with a silicone layer ("lubrication 159"; para 0016, 0060 teaching silicone) having a thickness of between about 5 nm to about 100 nm or between about 30 nm and about 100 nm (see para 0062 teaching "the lubrication layer 159 may have a thickness between about 0.1 µm…”; 0.1 µm being equal to 100nm).
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 of this title, 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) 3 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Gibson, or, in the alternative, under 35 U.S.C. 103 as obvious over Gibson in view of Janvier et al. (US 2014/0221934 A1), hereafter “Janvier”.
As to claim 3, Gibson discloses the syringe barrel of claim 1 as described above. Claim 3 appears to be a product-by-process claim. MPEP 2113 states “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”. In this instance, the process of spray-on the silicone layer and treating it to reduce its thickness amounts to a process that does not appear to result in any difference in the product made by other methods. Since Gibson satisfies the structure for the syringe barrel as required in claim 1, it is assumed that Gibson satisfies claim 3. However, the examiner does note the lack of clarity surrounding claim 3 (see above rejection under 35 U.S.C. 112(b)).
In the even that “wherein the silicone layer is a spray-on silicone layer that has been treated to reduce its thickness” means there is a particular structural difference in the syringe barrel as compared to claim 1 and/or comparable methods, Janvier teaches application of silicone layers onto syringes by spraying silicone (see para 0121, 0122, 0222). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the silicone layer of Gibson as a spray-on silicone layer as taught by Janvier, which teaches spraying on as a known method of applying silicone layers (see para 0121, 0122, 0222 of Janvier). Further, regarding the limitation of “treated to reduce its thickness”, the instant specification states “reducing the initial thickness of the silicone layer … by subjecting the cylindrical interior surface of the syringe barrel to mechanical treatment (e.g., mechanical contact treatment resulting in friction and wear)”. It is assumed that the abrasive effect of a standard plunger on the silicone coating of the inner surface of a syringe barrel is in fact present in any standard syringe with a standard silicone coating (or in this case, the syringe of Gibson). In turn, this means that any reusable syringe is novelty destroying as it is safe to assume that such a syringe will have been used multiple times, thereby reducing said coating up until the coating is gone or has deteriorated such that its lubricating function is not sufficiently present anymore. Such a syringe/coating will have satisfied the limitation of being “treated to reduce its thickness”.
Claim(s) 12 and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gibson in view of Thibault et al. (US 5,607,400), hereafter “Thibault” and further in view of Vogt (US 2017/0340823).
As to claim 12, Gibson discloses a syringe comprising the syringe barrel of claim 1, optionally (use of the word “optionally” implies the following limitations are not required and therefore Gibson satisfies this part of claim 12 already without continuing on, however, see following mapping of claim 12) further comprising - a plunger stopper (157) slidably positioned inside the syringe barrel and providing a fluid- tight seal of the proximal end of the syringe barrel (para 0051-0053).
Gibson is silent to a closure device attached to the distal end of the syringe barrel, the closure device having an outlet engaging portion sealingly engaging and closing a distal open outlet end of the syringe to prevent leakage. Thibault discloses a closure device (cap 30) attached to the distal end of the syringe barrel (12), the closure device having an outlet engaging portion sealingly engaging and closing a distal open outlet end of the syringe to prevent leakage (see Figs. 1-6, para beginning line 33 col. 2, para beginning line 32 col. 4). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Gibson to include a closure device attached to the distal end of the syringe barrel, the closure device having an outlet engaging portion sealingly engaging and closing a distal open outlet end of the syringe to prevent leakage. One would have been motivated to do so based off of Thibault, to provide a means of preventing leakage of a substance in the syringe (see Figs. 1-6, para beginning line 33 col. 2, para beginning line 32 col. 4 of Tibault).
Gibson is further silent to optionally - an aqueous formulation, particularly an aqueous protein formulation and more particularly an aqueous botulinum toxin formulation. Vogt discloses a syringe containing an aqueous botulinum toxin formulation (see para 0059, 0086, 0114). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have used the known syringe of Gibson (as already modified above) to inject the known substance of aqueous botulinum toxin (from Vogt) to provide therapeutic and cosmetic applications to a patient (see para 0001, 0017, 0019 of Vogt).
As to claim 14, Gibson in view of Thibault and Vogt teaches the syringe of claim 12 as described above, for use in a therapeutic method (see para 0046 of Gibson mentioning presence of a therapeutic fluid).
As to claim 15, Gibson in view of Thibault and Vogt teaches use of a syringe of claim 12 in cosmetic applications (see para 0001, 0017, 0019 of Vogt, which was used to add botulinum toxin which can be used in cosmetic applications).
As to claim 16, Gibson discloses a syringe comprising the syringe barrel of claim 11, optionally (use of the word “optionally” implies the following limitations are not required and therefore Gibson satisfies this part of claim 16 already without continuing on, however, see following mapping of claim 16) further comprising a plunger stopper (157) slidably positioned inside the syringe barrel and providing a fluid- tight seal of the proximal end of the syringe barrel (para 0051-0053).
Gibson is silent to a closure device attached to the distal end of the syringe barrel, the closure device having an outlet engaging portion sealingly engaging and closing a distal open outlet end of the syringe to prevent leakage. Thibault discloses a closure device (cap 30) attached to the distal end of the syringe barrel (12), the closure device having an outlet engaging portion sealingly engaging and closing a distal open outlet end of the syringe to prevent leakage (see Figs. 1-6, para beginning line 33 col. 2, para beginning line 32 col. 4). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Gibson to include a closure device attached to the distal end of the syringe barrel, the closure device having an outlet engaging portion sealingly engaging and closing a distal open outlet end of the syringe to prevent leakage. One would have been motivated to do so based off of Thibault, to provide a means of preventing leakage of a substance in the syringe (see Figs. 1-6, para beginning line 33 col. 2, para beginning line 32 col. 4 of Tibault).
Gibson is also silent to optionally an aqueous formulation, particularly an aqueous protein formulation and more particularly an aqueous botulinum toxin formulation. Vogt discloses a syringe containing an aqueous botulinum toxin formulation (see para 0059, 0086, 0114). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have used the known syringe of Gibson (as already modified above) to inject the known substance of aqueous botulinum toxin (from Vogt) to provide therapeutic and cosmetic applications to a patient (see para 0001, 0017, 0019 of Vogt).
Claim(s) 13 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gibson in view of Klenk et al. (US 2013/0245492 A1), hereafter “Klenk”, and further in view of Vogt.
As to claim 13, Gibson discloses a pre-filled syringe that comprises a syringe barrel of claim 1 (see rejection of claim 1 above).
Gibson is silent to the pre-filled syringe being part of a kit comprising instructions for use of said pre-filled syringe. Klenk discloses a pre-filled syringe being part of a kit comprising instructions for use of said pre-filled syringe (see para 0032, 0062). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included the pre-filled syringe as part of a kit comprising instructions for use of said pre-filled syringe. One would have been motivated to do so as a way of providing instructions to user along with the syringe (see para 0032, 0062 of Klenk).
Gibson is silent to the pre-filled syringe being preferably filled with an aqueous formulation, particularly an aqueous protein formulation and more particularly an aqueous botulinum toxin formulation. Vogt discloses a syringe containing an aqueous botulinum toxin formulation (see para 0059, 0086, 0114). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have used the known syringe of Gibson (as already modified above) to inject the known substance of aqueous botulinum toxin (from Vogt) to provide therapeutic and cosmetic applications to a patient (see para 0001, 0017, 0019 of Vogt).
As to claim 17, Gibson discloses a kit comprising a pre-filled syringe that comprises a syringe barrel of claim 1 (see rejection of claim 1 above)
Gibson is silent to the pre-filled syringe being part of a kit comprising optionally instructions for use of said pre-filled syringe. Klenk discloses a pre-filled syringe being part of a kit comprising instructions for use of said pre-filled syringe (see para 0032, 0062). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included the pre-filled syringe as part of a kit comprising instructions for use of said pre-filled syringe. One would have been motivated to do so as a way of providing instructions to user along with the syringe (see para 0032, 0062 of Klenk).
Gibson is also silent to the pre-filled syringe being preferably filled with an aqueous formulation, particularly an aqueous protein formulation and more particularly an aqueous botulinum toxin formulation. Vogt discloses a syringe containing an aqueous botulinum toxin formulation (see para 0059, 0086, 0114). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have used the known syringe of Gibson (as already modified above) to inject the known substance of aqueous botulinum toxin (from Vogt) to provide therapeutic and cosmetic applications to a patient (see para 0001, 0017, 0019 of Vogt).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/James D Ponton/Primary Examiner, Art Unit 3783
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