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 .
Claims 1-20 are pending in the instant application and are examined on the merits herein.
Priority
The instant application claims priority to 18/078,440 filed on 12/09/2022.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 112(a) as follows:
Applicant states that this application is a continuation or divisional application of the prior-filed application. A continuation or divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this application contains the following matter not disclosed in the prior-filed application: Fig. 6-12 and all accompanying description.
Claims 1-20 receive the filing date of the instant application, filed on 11/01/2023.
Specification
The abstract of the disclosure is objected to because the abstract comprises phrases which can be implied. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
The needle is referred to by an incorrect reference number (para. 0074).
The delivery end is referred to by an incorrect reference number (para. 0080).
The connector end is referred to by an incorrect reference number (para. 0083).
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.
Claim 12 is 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 12 recites the limitation “wherein the ejector, once depressed within the hollow portion to physically move at least one portion of the one or more topical compounds through the tip portion, cannot be moved in a direction opposite to the physical movement” in ln. 1-3. This limitation is indefinite in that it is unclear how depressed the ejector should be before it cannot be moved in a direction opposite to the physical movement. For the sake of compact prosecution, the examiner is treating the claim as though the ejector must be depressed until it reaches some physical structure that does not allow for movement in a second direction.
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.
Claims 1 and 3-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent no. 7,077,826 B1 to Gray.
Regarding claim 1, Gray discloses a device (Fig. 14A-14B, syringe 700) for delivering one or more topical compounds to a surface of mammalian tissue (col. 26 ln. 64-67 and col. 27 ln. 1-3; col. 35 ln. 54-60; col. 62 ln. 49-67, col. 63, and col. 64 ln. 1-19), the device comprising:
a hollow portion (Fig. 14A-14B, syringe barrel 701) comprising one or more marked gradations (col. 61 ln. 12-67);
an ejector (Fig. 14A-14B, ejector comprised of plunger shaft 703, piston 704p, and sheath 707); and
a tip portion (Fig. 14A-14B, tip portion comprised of reduced diameter neck 701RDN comprising entrance/exit port 701 EP),
wherein the hollow portion is configured to hold the one or more topical compounds to be delivered to the surface of mammalian tissue (col. 26 ln. 64-67 and col. 27 ln. 1-3; col. 35 ln. 54-60; col. 62 ln. 49-67, col. 63, and col. 64 ln. 1-19),
wherein the ejector is configured to be physically placed at least partially within the hollow portion (Fig. 14A-14B), and
wherein the physically placed ejector is depressible within the hollow portion to physically move at least one portion of the one or more topical compounds through the tip portion (col. 35 ln. 54-60).
Regarding claim 3, Gray discloses the invention of claim 1. Grey further discloses wherein the hollow portion is made of one or more types of plastic, and wherein the one or more types of plastic comprises polyethylene (col. 62 ln. 10-39).
Regarding claim 4, Gray discloses the invention of claim 1. Grey further discloses wherein the hollow portion is made of one or more types of autoclavable material, and wherein the one or more types of autoclavable material comprises glass (col. 62 ln. 10-39).
Regarding claim 5, Gray discloses the invention of claim 1. Grey further discloses wherein the hollow portion is clear and/or completely transparent such that a user can see the one or more topical compounds displaced within the hollow portion (col. 24 ln. 44-51; col. 61 ln. 12-67, a part of the hollow portion may be clear).
Regarding claim 6, Gray discloses the invention of claim 1. Grey further discloses wherein the hollow portion is colored with a color selected from the group consisting of: blue, brown, green, red, orange, ivory, purple, gold, black, white, and combinations thereof (col. 61 ln. 12-67; understanding the claim to read that the hollow portion can be any color as all colors can be created from combinations of the colors claimed).
Regarding claim 7, Gray discloses the invention of claim 6. Grey further discloses wherein the color matches a color of the tip portion (col. 61 ln. 12-67).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Gray as applied above, and further in view of US/2020/0254186 A1 to Hernandez.
Regarding claim 2, Gray discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the one or more marked gradations comprise a number of uses and/or administrations of the one or more topical compounds.
Hernandez teaches a syringe wherein one or more marked gradations comprise a number of uses and/or administrations of one or more compounds for use when sequential doses of medicine need to be provided to a patient (para. 0082-0083; Fig. 11, syringe 1100 comprising 1110a-d marked gradations showing doses).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the marked gradations of Gray to comprise the number of uses and/or administrations as taught by Hernandez, because Hernandez teaches that this provides particular utility in situations in which the practice of medicine requires that sequential doses of the same medicine be provided to a patient and that when conventional dosing instruments are utilized in emergency scenarios, critical time can be lost in calculating/measuring medicine dose (para. 0083).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Gray as applied above, and further in view of US/2004/0210183 A1 to Schulz.
Regarding claim 8, Gray discloses the invention of claim 1. Gray further discloses wherein the hollow portion is colored, and wherein the one or more topical compounds are light-sensitive (col. 61 ln. 12-67); however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the hollow portion is colored amber.
Schulz teaches a syringe wherein the hollow portion is colored amber to protect compounds from detrimental UV radiation (Fig. 1, syringe barrel 5; para. 0007-0008; para. 0025), and wherein the one or more compounds are light-sensitive (para. 0007-0008).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the hollow portion of Gray to be made from an amber-colored polymer as taught by Schulz, because Schulz teaches that an amber colored syringe barrel of their invention advantageously has spectrally selective absorbing properties for detrimental UV radiation and transmits visible radiation to allow a user to determine how much liquid has been discharged (para. 0007-0008).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Gray as applied above, and further in view of US/2023/0226280 A1 to Lerner.
Regarding claims 9-10, Gray discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose
(Claim 9) one or more filters disposed in an interior of the hollow portion; and
(Claim 10) wherein the one or more filters comprises a 5 micron filter.
Lerner teaches a syringe comprising a 0.1-10 micron filter disposed in an interior of a hollow portion to enable filtration-sterilization of pathogens such as bacteria from a therapeutic agent solution and control the force and travel distance of injected fluid (Fig. 1, syringe 1; para. 0103-0106).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the hollow portion of Gray to comprise a filter as taught by Lerner, because Lerner teaches that a filter can remove infectious agents and/or impurities from reservoir contents and act as a jet control mechanism (para. 0103-0106).
Further, It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the size of the pores in the filter of Gray and Lerner from between 0.1-10 microns to 5 microns since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed value (see pp. [0122] indicating that the filter may have any suitable pore size).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Gray as applied above, and further in view of US/2018/0236183 A1 to Chang.
Regarding claim 11, Gray discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose one or more retaining rings physically connected to the ejector.
Chang teaches a syringe comprising one or more retaining rings physically connected to the ejector and a retaining structure to avoid re-use of the syringe (Fig. 1, syringe comprising retaining rings 500 connected to plunger 400 and retaining structure 300; para. 0002-0005; para. 0032-0040).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the ejector and hollow portion of the syringe of Gray to comprise the retaining structures of Chang, because Chang teaches that these structures in conjunction provide actual countermeasures to avoid re-use of syringes that may be re-used in poor countries or by unscrupulous medical care providers (para. 0002-0005).
Regarding claim 12, Gray discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to discloses wherein the ejector, once depressed within the hollow portion to physically move at least one portion of the one or more topical compounds through the tip portion, cannot be moved in a direction opposite to the physical movement.
Chang teaches a syringe wherein the ejector, once depressed within the hollow portion to physically move at least one portion of the one or more topical compounds through the tip portion, cannot be moved in a direction opposite to the physical movement to avoid re-use of the syringe (para. 0002-0005; para. 0032-0040; Fig. 6, syringe comprising plunger 400 depressed within hollow portion 100 such that retaining rings 500 are pushed through unidirectional entry portion 300).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the ejector and hollow portion of the syringe of Gray to comprise the retaining structures of Chang, because Chang teaches that these structures in conjunction provide actual countermeasures to avoid re-use of syringes that may be re-used in poor countries or by unscrupulous medical care providers (para. 0002-0005).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Gray as applied above, and further in view of US/2018/0043102 A1 to Cojocariu.
Regarding claim 13, Gray discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the ejector is lubricated with one or more silicone lubricants.
Cojocariu teaches a syringe comprising a plunger head that is lubricated with silicone oil lubricant (Fig. 5A, syringe 112 comprising plunger head 10; para. 0054).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the ejector of Gray to be lubricated with a silicone lubricant as taught by Cojocariu, because Cojocariu teaches that lubricating a plunger head of a plunger ensures that break-loose and break-out forces are not too high during operation of the syringe (para. 0004).
Claims 14-15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Grey as applied above, and further in view of WO/2021/263084 A1 to Suh.
Regarding claims 14-15, Gray discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose
(Claim 14) further comprising one or more textured areas; and
(Claim 15) wherein a first area in the one or more textured areas is disposed on an end of the ejector.
Suh teaches a syringe comprising one or more textured areas and wherein a first area is disposed on an end of an ejector to provide easier push and pull of the plunger (Fig. 2, syringe 100 comprising textured areas 124/126 on syringe plunger 104 and textured area 126 on syringe plunger end 122; para. 0041).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the ejector of Gray to comprise a textured area on an end thereof as taught by Suh, because Suh teaches that providing texturing on the plunger provides an easier to grip surface that can be pushed or pulled more easily than a smooth surface (para. 0041).
Regarding claim 20, Gray discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose a tab and/or lever disposed on the hollow portion such that movement of the tab and/or lever results in movement of the ejector.
Suh teaches a syringe comprising a tab disposed on a hollow portion such that movement of the lever results in movement of the ejector to provide increased usability of the syringe (Fig. 1, syringe 100 comprising plunger arm 110 attached to guide 140 on syringe barrel 102; para. 0030; para. 0038).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the syringe of Gray to comprise a tab disposed on the hollow portion as taught by Suh, because Suh teaches that syringes are often employed in procedures where it may be necessary to position or orient the syringe in a manner that makes it difficult to apply a force to the base of the plunger in order to dispense fluid and that providing the tab of their invention allows for a user to actuate a plunger from the base of the plunger or from a distal end of an external portion of a plunger near the tip of the syringe (para. 0030).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Grey and Suh as applied above, and further in view of US/2002/0099336 A1 to Wang.
Regarding claim 16, the cited prior art suggests the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein a second area in the one or more textured areas is disposed on a portion of an exterior surface of the hollow portion, and wherein a third area in the one or more textured areas is disposed on another portion of the exterior surface of the hollow portion.
Wang teaches a syringe comprising textured areas on first and second separate portions of an exterior surface of a barrel to provide increased grip (Fig. 2-3, syringe comprising three slip-proof straps 11 on syringe barrel 1; para. 0015).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the hollow portion of Gray to comprise the textured areas of Wang, because Wang teaches that providing slip-proof straps on the barrel of the syringe provides to a user a firm grip on the barrel (para. 0015).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Grey as applied above, and further in view of US/2024/0139424 A1 to Kumar.
Regarding claims 17-18, Gray discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose
(Claim 17) a cover physically connected to the device, wherein the cover is moveable to be placed on the tip portion; and
(Claim 18) an arm having a first end and a second end, wherein the first end is physically connected to the hollow portion, and wherein the second end is physically connected to the tip portion.
Kumar teaches a syringe comprising a physically connected cover that is moveable and placed on a tip portion to cover a tip portion (Fig. 2A, syringe 10 comprising tip cap 24 placed on distal tip 18; para. 0076; para. 0083). Kumar further teaches an arm, wherein a first end is physically connected to a syringe barrel and a second end is physically indirectly connected to the tip portion to tether a tip cap (Fig. 2A, arm 88 comprising first end 70 connected to syringe barrel 12 and second end 72 directly connected to tip cap 24 which is further directly connected to distal tip 18; para. 0077; para. 0092).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of Gray to comprise a cover and an arm as taught by Kumar, because Kumar teaches that providing a tip cap on a syringe reduces contamination risks and tethering said tip cap ensures that said tip cap does not become a hazard or obstruction preventing a practitioner from using a syringe in an expected manner (para. 0076-0077).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Grey as applied above, and further in view of U.S. Patent 11,259,959 to Dewoolfson.
Regarding claim 19, Gray discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose a guide disposed on an exterior surface of the hollow portion such that a distance between the guide and the tip portion is constant.
Dewoolfson teaches a syringe comprising a guide disposed on an exterior surface of a syringe barrel such that a distance between the guide and a tip portion is constant (Fig. 3, guide 110 disposed on an exterior surface of syringe barrel 102 and distanced from tip portion 106; col. 7 ln. 33-35 and 41-53).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the hollow portion of Gray to further comprise the base and guide of Dewoolfson, because Gray teaches that the syringe of their invention may be used with an ophthalmic composition (col. 62 ln. 49-67, col. 63, and col. 64 ln. 1-19) and Dewoolfson teaches that the guide of their invention may contact a subject’s eye and form a space to hold an ophthalmic composition in contact with an eye for a sufficient amount of time (col. 9 ln. 46-53; col. 10 ln. 65-67 and col. 11 ln. 1-16).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US/2002/0088131 A1 to Baxa discloses a syringe comprising marked dose gradations. WO/2020/204992 A1 to Shaw discloses a syringe comprising an indicia display connected to a cap and comprising textured surfaces.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781