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:
Page 10, line 26 recites the word “transvers.” The Examiner believes this is a spelling error for the word “transverse.”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The following Claim limitations use the word “means” are being interpreted under 35 U.S.C. § 112(f):
“a rod with visual means for marking an unlock position” in Claim 16.
According to page 11, lines 23 – 31, “visual means” is interpreted to be colored indicators, literal indicators, pictograms, or other similar structures.
“said locking ring has means for blocking the plunger stroke in a locked position” in Claim 16.
According to page 4, lines 1 – 10, “means for blocking” is interpreted to be at least one tab or similar structure.
“an adapter…comprising means for receiving the locking ring” in Claim 17.
According to page 3, lines 10 – 13, “means for receiving the locking ring” is interpreted to be at least one groove or similar structure.
“wherein the plunger and the locking ring are connected together so that means for blocking the plunger stroke in a locked position, are not visible from the operator” in Claim 25.
According to page 4, lines 1 – 10, “means for blocking” is interpreted to be at least one tab or similar structure.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
“means for receiving the locking ring comprise at least one groove” in claim 19.
“means for blocking the plunger stroke in a lock position comprise at least one tab” in claim 22.
“means for blocking the plunger stroke in a lock position comprise at least one tab” in claim 23.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 16 – 31 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 16 recites the limitation “the plunger stroke.” There is insufficient antecedent basis for this limitation in the claim. The Examiner suggests amending this to recite “[[the]] a plunger stroke.”
Claims 22, 23, 25, and 31 each recite “the plunger stroke.” There is also insufficient antecedent basis for these limitation in these claims. However, amending Claim 16 to provide antecedent basis for “the plunger stroke” would provide antecedent basis for the subsequent recitations of “the plunger stroke” in Claims 22, 23, 25, and 31.
Claims 17 – 31 are dependent upon Claim 16 and are rejected under 35 U.S.C. § 112(b) for the same rationale.
Claim 17 recites “wherein the locking mechanism further comprises an adapter configured to be attached to the proximal end of the syringe body and comprising means for receiving the locking ring.” It is unclear if the “comprising means for receiving the locking ring” is further narrowing the structure to the “locking mechanism” or the “adapter.” The Examiner suggests amending Claim 17 such that there is no confusion with regards to which structure comprises the means for receiving the locking ring.
Claim 18 and 20 are dependent upon Claim 17 and are rejected under 112(b) for the same rationale.
Claim 19 recites “[t]he lockable syringe according to claim 16, wherein means for receiving the locking ring comprise at least one groove.” It is unclear how the means for receiving the locking ring interacts with the claim limitations of Claim 16. Which component of Claim 16 further comprises the means for receiving the locking ring? Is the means for receiving the locking ring a separate structure from all the recited components of Claim 16? Based on the Specification the means for receiving the locking ring is the adapter but this structure has not been recited in either Claim 16 or 19. The Examiner suggests amending Claim 19 such that there is no confusion with regards to how the means for receiving the locking ring is incorporated into the claimed invention of claim 16.
Claim 20 recites the limitation “the flanges of the syringe body” There is insufficient antecedent basis for this limitation in the claim. The Examiner suggests amending this to recite “[[the]] flanges of the syringe body” to provide the antecedent basis for the claim limitation.
Claim 21 recites “wherein the locking ring comprises at least two visual indicators.” It is unclear if the “at least two visual indicators” referring to the “at least one visual indicator” in Claim 16? Claim 21 is indefinite because the Examiner cannot determine whether the claim limitation “at least two visual indicators” of Claim 21 is referring to the “at least one visual indicator” of Claim 16. The Examiner suggests amending Claim 21 to clarify the antecedent basis for the at least two visual indicators recited in Claim 21.
Claim 21 recites “wherein the locking ring comprises at least two visual indicators which may be of the same or different nature.” The claim limitation of “the same or different nature” is indefinite because it cannot be determined what “nature” is referring to. Does nature mean the same material, color, design, functionality, mechanism of providing visual indication, or something different altogether?
Claim 22 recite “wherein means for blocking the plunger stroke.” It is unclear if the “means for blocking the plunger stroke” of Claim 22 is the same “means for blocking the plunger stroke” of Claim 16. The Examiner suggests amending Claim 22 such that there is no confusion as to if the “means for blocking the plunger” of Claim 22 is the same as the “means for blocking the plunger” of Claim 16. The Examiner suggests amending Claim 22 to recite “wherein the means for blocking the plunger stroke” such that proper antecedent basis is provided for this claim limitation.
Claim 22 recites “a lock position.” It is unclear if the “lock position” recited in Claim 22 is the same “locked position” recited in Claim 16. Claim 22 is indefinite because the Examiner cannot determine whether the “lock position” of Claim 22 is referring to the “locked position” of Claim 16. The Examiner suggests amending “a lock position” in Claim 22 to recite “[[a]] the locked position.”
Claim 26 is dependent upon Claim 22 and is therefore rejected for the same aforementioned rationale as to why Claim 22 is rejected under 35 U.S.C. § 112(b).
Claim 23 recite “wherein when means for blocking the plunger stroke.” It is unclear if the “means for blocking the plunger stroke” of Claim 23 is the same “means for blocking the plunger stroke” of Claim 16. The Examiner suggests amending Claim 23 such that there is no confusion as to if the “means for blocking the plunger” of Claim 23 is the same as the “means for blocking the plunger” of Claim 16. The Examiner suggests amending Claim 23 to recite “wherein when the means for blocking the plunger stroke” such that proper antecedent basis is provided for this claim limitation.
Claim 23 recites “a lock position.” It is unclear if the “lock position” recited in Claim 23 is the same “locked position” recited in Claim 16. Claim 22 is indefinite because the Examiner cannot determine whether the “lock position” of Claim 22 is referring to the “locked position” of Claim 16. The Examiner suggests amending “a lock position” in Claim 23 to recite “[[a]] the locked position.”
Claim 23 recites “said tab.” It is unclear if the “said tab” is referring to the “at least one tab” as recited earlier within Claim 23. Claim 23 is indefinite because the proper antecedent basis has not been provided for the limitation of “said tab.” The Examiner suggests amending the limitation “said tab” to recite “said at least one tab” to provide proper antecedent basis for the claim limitation.
Claim 23 recites “an unlock position.” It is unclear if the “unlock position” of Claim 23 is referring to the “unlock position” of Claim 16. Claim 23 is indefinite because the Examiner cannot determine if the unlock position of Claim 23 is the same unlock position of Claim 16. The Examiner suggests amending “an unlock position” of Claim 23 to recite “the [[an]] unlock position” to provide the proper antecedent basis for the claim limitation.
Claim 23 recites “the distal plate.” It is unclear if “the distal plate” of Claim 23 is referring to the same “at least one distal plate” recited in Claim 16. Claim 23 is indefinite because it cannot be determined whether “the distal plate” of Claim 23 is referring to the “at least one distal plate” of Claim 16. The Examiner suggests amending Claim 23 to recite “the at least one distal plate” to provide proper antecedent basis for the claim limitation.
Claim 24 is dependent upon Claim 23 and is therefore rejected for the same aforementioned rationale as to why Claim 23 is rejected under 35 U.S.C. § 112(b).
Claim 24 recites “[t]he lockable syringe according to claim 23, wherein the notch.” It is unclear if “the notch” of Claim 23 is referring to the “at least one notch” recited in Claim 23. Claim 24 is indefinite because the Examiner cannot determine if “the notch” of Claim 24 is one of the “at least one notch” of Claim 23. The Examiner suggests amending “the notch” of Claim 23 to recite “the at least one notch” to provide the proper antecedent basis for the claim limitation.
Claim 24 recites “a visual indicator on the rod of the plunger.” It is unclear the “visual indicator” of Claim 24 is referring to the “visual means” of the rod of the plunger of Claim 16. Claim 24 is indefinite because the Examiner cannot determine whether the “visual indicator” of Claim 24 is the “visual means” of Claim 16.
Claim 25 recite “wherein means for blocking the plunger stroke.” It is unclear if the “means for blocking the plunger stroke” of Claim 25 is the same “means for blocking the plunger stroke” of Claim 16. The Examiner suggests amending Claim 25 such that there is no confusion as to if the “means for blocking the plunger” of Claim 25 is the same as the “means for blocking the plunger” of Claim 16. The Examiner suggests amending Claim 25 to recite “wherein the means for blocking the plunger stroke” such that proper antecedent basis is provided for this claim limitation.
Claim 25 recites “a locked position.” It is unclear if the “locked position” recited in Claim 25 is the same “locked position” recited in Claim 16. Claim 25 is indefinite because the Examiner cannot determine whether the “locked position” of Claim 25 is referring to the “locked position” of Claim 16. The Examiner suggests amending “a locked position” in Claim 25 to recite “[[a]] the locked position.”
Claim 25 recites the limitation “the operator.” There is insufficient antecedent basis for this limitation in the claim. The Examiner suggests amending this to recite “[[the]] an operator” to provide the proper antecedent basis for the claim limitation.
Claim 26 recites “one visual indicator present on the outer surface of the locking ring.” It is unclear if the “one visual indicator” of Claim 26 is referring to the same “at least one visual indicator” of Claim 16. Claim 26 is indefinite because the Examiner cannot determine whether the “one visual indicator” of Claim 26 is the same “at least one visual indicator” of Claim 16. The Examiner suggests amending Claim 26 to clarify if the one visual indicator recited in Claim 26 is the same at least one visual indicator recited in Claim 16.
Claim 31 recites “the plunger comprises a colored indicator in its rod.” It is unclear if the “colored indicator” of Claim 31 is one of the “visual means” of Claim 16. Claim 31 is indefinite because the Examiner cannot determine whether the “colored indicator” of Claim 31 is the visual means of the plunger recited in Claim 16. The Examiner suggests amending Claim 31 to clarify whether the “colored indicator” of Claim 31 is the “visual means” recited in Claim 16.
Claim 31 recites “the locking ring comprises on its outer surface, from 4 to 8 different visual indicators.” It is unclear if these “4 to 8 different visual indicators” of Claim 31 are “the at least one visual indicator” recited in Claim 16. Claim 31 is indefinite because it cannot be determined whether the 4 to 8 different visual indicators of Claim 31 are further narrowing the at least one visual indicator recited in Claim 16. The Examiner suggests amending Claim 31 to clarify whether the “4 to 8 different visual indicators” are referring to the “at least one visual indicator” recited in Claim 16.
Claim 31 recites “the locking ring…has one tag in its inner surface, for blocking the plunger stroke in a locked position.” It is unclear if the “tag” recited in Claim 31 is the “means for blocking the plunger stroke” recited in Claim 16. Claim 31 is indefinite because the Examiner cannot determine whether the tag recited in Claim 31 is the means for blocking the plunger stroke in Claim 16. The Examiner suggests amending Claim 31 to clarify if the tag of Claim 31 is the means for blocking the plunger stroke in Claim 16.
Claim 31 recites “a locked position.” It is unclear if the “locked position” recited in Claim 31 is the same “locked position” recited in Claim 16. Claim 31 is indefinite because the Examiner cannot determine whether the “locked position” of Claim 31 is referring to the “locked position” of Claim 16. The Examiner suggests amending “a locked position” in Claim 31 to recite “[[a]] the locked position.”
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 16, 17, and 19 – 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raghuveer et al. (US 2017/0274147 A1 hereinafter referred to as “Raghuveer”).
Raghuveer is cited in the IDS dated 17 March 2023.
With regards to claim 16, Raghuveer discloses (Figs. 1 – 7E) a lockable syringe (1) (see [0061]) for dispensing a drug (see [0002] and [0061]), comprising:
a syringe body (2, 4) (see [0061]) having a longitudinal axis and comprising a distal end and a proximal end (see Fig. 2 where the distal end is the lefthand side and the proximal end is the righthand side); and
a locking mechanism (3, 5, 6, 7);
wherein:
said locking mechanism is configured to be attached to the proximal end of the syringe body (see [0061] and Fig. 2), and said locking mechanism comprises:
a plunger (3) (see [0061]) having at least one distal plate (see Examiner annotated Fig. 6 below hereinafter referred to as “Fig. A”), and a rod (see Fig. A below) with visual means (13) (see [0066] and see Fig. 6 where these dosage indicia 13 align with the grooves 8 and therefore the unlock position) for marking an unlock position; and
a locking ring (5) (see [0061]) which is free in its rotation about the longitudinal axis of the syringe body (see [0068] “The ring 5 may be rotated clockwise or anticlockwise for selection of the required dose.”) said locking ring has at least one visual indicator (10, 11) (see [0064]) on its outer surface, and said locking ring has means for blocking the plunger stroke in a locked position (7) (see [0062] and [0065]) “The stopper 7 may limit the vertical motion of the plunger 3 by engaging with a selected plunger groove 8.” Wherein the means for blocking is the tip of the stopper 7 that interacts with the plunger groove 8).
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With regards to claim 17, Raghuveer discloses the claimed invention of Claim 16, and Raghuveer further discloses (Figs. 1 – 7E) wherein the locking mechanism (3, 5, 6, 7) further comprises an adapter (6) (see [0061]) configured to be attached to the proximal end of the syringe body (see Fig. 2 and [0061]) and comprising means for receiving the locking ring (see Examiner annotated Fig. 3 below hereinafter referred to as “Fig. B” at the annotated “at least one groove” and [0061]).
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With regards to claim 19, Raghuveer discloses the claimed invention of Claim 16, and Raghuveer further discloses (Figs. 1 – 7E) wherein means for receiving (see “Fig. B” at the annotated “at least one groove” and [0061]) the locking ring (5) (see [0061]) comprise at least one groove (see Fig. B above).
With regards to claim 20, Raghuveer discloses the claimed invention of Claim 17, and Raghuveer further discloses (Figs. 1 – 7E) wherein the adapter (6) (see [0061]) is located on the flanges (see Examiner annotated Fig. 2 below hereinafter referred to as “Fig. C” where the flanges are on either side of the plunger 3) of the syringe body (2, 4) (see [0061]).
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With regards to claim 21, Raghuveer discloses the claimed invention of Claim 16, and Raghuveer further discloses (Figs. 1 – 7E) wherein the locking ring (5) (see [0061]) comprises at least two visual indicators (10, 11) (see [0064] and Fig. 4) which may be of the same or different nature (see Fig. 4 where the visual indicators are of different natures as described within [0064]).
With regards to claim 22, Raghuveer discloses the claimed invention of Claim 16, and Raghuveer further discloses (Figs. 1 – 7E) wherein means for blocking the plunger stroke in a lock position comprise at least one tab (7) (see [0062], [0065] “The stopper 7 may limit the vertical motion of the plunger 3 by engaging with a selected plunger groove 8.” Wherein the means for blocking is the tip of the stopper 7 that interacts with the plunger groove 8, [0070], and Fig. 7C).
With regards to claim 23, Raghuveer discloses the claimed invention of Claim 16, and Raghuveer further discloses (Figs. 1 – 7E) wherein when means for blocking the plunger stroke in a lock position comprise at least one tab (7) (see [0062], [0065] “The stopper 7 may limit the vertical motion of the plunger 3 by engaging with a selected plunger groove 8.” Wherein the means for blocking is the tip of the stopper 7 that interacts with the plunger groove 8, [0070], [0072] and Fig. 7C), the plunger (3) (see [0061]) comprises at least one notch (8) (see [0061]) on the distal plate (see Fig. A above) configured for receiving said tab and providing an unlock position (see [0061] – [0062], [0067], [0070], [0072]).
With regards to claim 24, Raghuveer discloses the claimed invention of Claim 23, and Raghuveer further discloses (Figs. 1 – 7E) wherein the notch (8) (see [0061]) is marked by a visual indicator (13) (see [0063] and [0066]) on the rod (see Fig. A above) of the plunger (3) (see [0061] and Fig. 6).
With regards to claim 25, Raghuveer discloses the claimed invention of Claim 16, and Raghuveer further discloses (Figs. 1 – 7E) wherein the plunger (3) (see [0061]) and the locking ring (5) (see [0061]) are connected together (see Fig. 7c) so that means for blocking the plunger stroke in a locked position (7) (see [0062] and [0065]) “The stopper 7 may limit the vertical motion of the plunger 3 by engaging with a selected plunger groove 8.” Wherein the means for blocking is the tip of the stopper 7 that interacts with the plunger groove 8), are not visible from the operator (see Figs. 7c and 7e where the tip of the stopper 7 that interacts with the plunger groove 8 is not visible from the operator).
With regards to claim 26, Raghuveer discloses the claimed invention of Claim 22, and Raghuveer further discloses (Figs. 1 – 7E) wherein the at least one tab (7) (see [0062], [0065], [0070], [0072] and Fig. 7C) is aligned on one visual indicator (10) (see [0064] and see Figs. 4 and 7a) present on the outer surface of the locking ring (5) (see [0061]).
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(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raghuveer in view of Heinsbergen et al. (US 2017/0182254 A1 hereinafter referred to as “Heinsbergen”).
With regards to claim 18, Raghuveer discloses the claimed invention of claim 17, and Raghuveer discloses that the ring 6 is fixedly attached to the barrel 2 of the syringe (see [0061]). However, Raghuveer is silent with regards to the adapter being molded with the syringe body.
Nonetheless Heinsbergen, which is within the analogous art of syringes (see abstract), teaches the adapter (58) (see [0030]) is molded with the syringe body (52) (see [0030] “the collar 58 may be formed integrally with the barrel (e.g., by molding)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the adapter of the lockable syringe of Raghuveer in view of a teaching of Heinsbergen such that the adapter being molded with the syringe body. One of ordinary skill in the art would have been motivated to make this modification because Heinsbergen teaches that it is common for an adapter to be integrally connected to the syringe body via molding. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to fixedly attach the ring 6 to the barrel 2 of the syringe of Raghuveer in view of a teaching of Heinsbergen because it has been held that forming in one piece an article which was formerly formed of two pieces to be routine skill in the art. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965); MPEP 2144.04(V)(B).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raghuveer in view of Tretinyak et al. (US 4,386,606 A).
With regards to claim 27, Raghuveer discloses the claimed invention of claim 16, however, Raghuveer is silent with regards to wherein the locking mechanism is made of plastic.
Nonetheless Tretinyak, which is within the analogous art of syringe locks (see abstract), teaches the locking mechanism is made of plastic (see Col. 7, lines 51 – 57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the material of the locking mechanism of the lockable syringe of Raghuveer in view of a teaching of Tretinyak such that the locking mechanism is made of plastic. One of ordinary skill in the art would have been motivated to make this modification because Tretinyak teaches that locking mechanisms may be made from plastic such as polyethylene or polypropylene or the like for puposes of high volume, low unit cost production (see Col. 7, lines 51 – 57 of Tretinyak).
Claim(s) 28 – 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raghuveer in view of Rafaat (US 9,302,052 B1).
With regards to claim 28, Raghuveer discloses the claimed invention of claim 16, however, Raghuveer is silent with regards to wherein the lockable syringe is a pre-filled syringe.
Nonetheless Rafaat, which is within the analogous art of pre-loaded syringes (see abstract), teaches the lockable syringe is a pre-filled syringe (see Col. 4, lines 63 – 67).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the lockable syringe of Raghuveer in view of a teaching of Rafaat such that the lockable syringe is a pre-filled syringe. One of ordinary skill in the art would have been motivated to make this modification because a preloaded or prefilled syringe enhances patient safety by minimizing the risk of dosage errors and contamination during filling of the syringe. Further, a preloaded or prefilled syringe improves efficiency of healthcare providers and patients because the syringe is ready-to-administer as soon as the syringe is picked up by the healthcare provider and patient. Here, Rafaat teaches that preloaded or prefilled syringes are well known in the art for these reasons (see Col. 3, lines 39 – 67 of Rafaat).
The lockable syringe of Raghuveer modified in view of a teaching of Rafaat will hereinafter be referred to as the lockable syringe of Rahuveer and Rafaat.
With regards to claim 29, the lockable syringe of Rahuveer and Rafaat teaches the claimed invention of claim 28, however, Rahuveer is silent with regards to wherein the syringe is pre-filled with a drug.
Nonetheless Rafaat, which is within the analogous art of pre-loaded syringes (see abstract), teaches wherein the syringe is pre-filled with a drug (see Col. 4, lines 5 – 20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the syringe of Rahuveer and Rafaat in view of a further teaching of Rafaat such that the syringe is pre-filled with a drug. One of ordinary skill in the art would have been motivated to make this modification because a preloaded or prefilled syringe enhances patient safety by minimizing the risk of dosage errors and contamination during filling of the syringe. Further, a preloaded or prefilled syringe improves efficiency of healthcare providers and patients because the syringe is ready-to-administer as soon as the syringe is picked up by the healthcare provider and patient. Here, Rafaat teaches that syringes being preloaded or prefilled with ephedrine, atropine and other vaiorus drugs is well known for the aforementioned benefits (see Col. 3, lines 39 – 67, Col. 4, lines 5 – 20 of Rafaat).
With regards to claim 30, the lockable syringe of Rahuveer and Rafaat teaches the claimed invention of claim 29, however, Rahuveer is silent with regards to wherein the drug is selected from the following drugs or acceptable salts thereof: midazolam, ropivacaine, lidocaine, mepivacaine, bupivacaine, levobupivacaine, lidocaine epinephrine, naloxone, urapidil, dexamethasone, ondansetron, fentanyl, sufentail, glucose, oxycodone, atracurium, cisatracurium, hydromorphone, alfentanil, prilocaine, chloroprocaine, nicardipine, norepinephrine, propofol, dexmedetomidine, morphine, calcium chloride, calcium gluconate, sodium bicarbonate, furosemide, magnesium sulfate, glycopyrronium, neostigmine, neostigmine/glycopyrronium, rocuronium, sugammadex, ketamine, adenosine, vecuronium, tranexamic acid, amiodarone, diazepam, droperidol, atropine, phenylephrine, ephedrine, suxamethonium, atosiban, baclofen, dobutamine and dopamine.
Nonetheless Rafaat, which is within the analogous art of pre-loaded syringes (see abstract), teaches wherein the drug is selected from the following drugs or acceptable salts thereof: midazolam, ropivacaine, lidocaine, mepivacaine, bupivacaine, levobupivacaine, lidocaine epinephrine, naloxone, urapidil, dexamethasone, ondansetron, fentanyl, sufentail, glucose, oxycodone, atracurium, cisatracurium, hydromorphone, alfentanil, prilocaine, chloroprocaine, nicardipine, norepinephrine, propofol, dexmedetomidine, morphine, calcium chloride, calcium gluconate, sodium bicarbonate, furosemide, magnesium sulfate, glycopyrronium, neostigmine, neostigmine/glycopyrronium, rocuronium, sugammadex, ketamine, adenosine, vecuronium, tranexamic acid, amiodarone, diazepam, droperidol, atropine, phenylephrine, ephedrine, suxamethonium, atosiban, baclofen, dobutamine and dopamine (see Col. 4, lines 5 – 20 “ephedrine…atropine”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the drug within the prefilled syringe of Rahuveer and Rafaat in view of a further teaching of Rafaat such that the drug is selected from the following drugs or acceptable salts thereof: midazolam, ropivacaine, lidocaine, mepivacaine, bupivacaine, levobupivacaine, lidocaine epinephrine, naloxone, urapidil, dexamethasone, ondansetron, fentanyl, sufentail, glucose, oxycodone, atracurium, cisatracurium, hydromorphone, alfentanil, prilocaine, chloroprocaine, nicardipine, norepinephrine, propofol, dexmedetomidine, morphine, calcium chloride, calcium gluconate, sodium bicarbonate, furosemide, magnesium sulfate, glycopyrronium, neostigmine, neostigmine/glycopyrronium, rocuronium, sugammadex, ketamine, adenosine, vecuronium, tranexamic acid, amiodarone, diazepam, droperidol, atropine, phenylephrine, ephedrine, suxamethonium, atosiban, baclofen, dobutamine and dopamine.
One of ordinary skill in the art would have been motivated to make this modification because a preloaded or prefilled syringe enhances patient safety by minimizing the risk of dosage errors and contamination during filling of the syringe. Further, a preloaded or prefilled syringe improves efficiency of healthcare providers and patients because the syringe is ready-to-administer as soon as the syringe is picked up by the healthcare provider and patient. Here, Rafaat teaches that syringes being preloaded or prefilled with ephedrine and atropine is well known for the aforementioned benefits (see Col. 3, lines 39 – 67, Col. 4, lines 5 – 20 of Rafaat).
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raghuveer in view of Jones (US 9,566,388 B1) and Saied (US 2003/0014019 A1).
With regards to claim 31, Raghuveer discloses the claimed invention of claim 16, and Raghuveer discloses the locking ring (5) (see [0061]) has one tag (7) in its inner surface (see Fig. 7a), for blocking the plunger stroke in a locked position (see [0062], [0064], [0065], and [0070])
Raghuveer is silent with regards to wherein:
the plunger comprises a colored indicator on its rod, for marking the unlock position of the locking mechanism; and
the locking ring comprises on its outer surface, from 4 to 8 different visual indicators.
Nonetheless Jones, which is within the analogous art of syringe measurement markings (see abstract), teaches the plunger comprises a colored indicator on its rod (see Col. 1, lines 35 – 57). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the indicator on the rod of the lockable syringe of Raghuveer in view of a teaching of Jones such that the plunger comprises a colored indicator on its rod. One of ordinary skill in the art would have been motivated to make this modification because Jones teaches that numerical measuring indicia may be color-coded for ease of reference (see Col. 1, lines 35 – 57 of Jones). Additionally, a person having ordinary skill in the art would recognize that contrasting the color of the indicator on the rod with the color of the rod itself would make it easier for a healthcare provider to determine which dosage has been chosen.
The lockable syringe of Raghuveer modified in view of a teaching of Jones will hereinafter be referred to as the lockable syringe of Raghuveer and Jones.
Here, the lockable syringe of Raghuveer and Jones reads upon the limitation “the plunger comprises a colored indicator on its rod, for marking the unlock position of the locking mechanism” because the dosage indicia 13 of Raghuveer modified to be colored in view of Jones marks the unlocked position of the locking mechanism.
However, neither Raghuveer nor Jones teaches the locking ring comprises on its outer surface, from 4 to 8 different visual indicators.
Nonetheless Saied, which is within the analogous art of medical devices (see abstract), teaches the locking ring comprises on its outer surface, from 4 to 8 different visual indicators (see [0025] and Figures 2A – 2E).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the locking ring of the lockable syringe of Raghuveer and Jones in view of a teaching of Saied such that the locking ring comprises on its outer surface, from 4 to 8 different visual indicators. One of ordinary skill in the art would have been motivated to make this modification because Saied teaches that colored markings and/or indentations may be made on the locking ring to allow the user to continue rotation until the markings are in alignment (see [0025] of Saied). Here, a person of ordinary skill in the art would recognize that including visual indicators along the locking ring would be beneficial because the visual indicators would assist a healthcare professional with administering the proper dose by aligning the components of the one or more grooves 7 of the plunger 3 with the stopper 7 of Raghuveer.
Conclusion
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
12/08/2025