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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Amendment
This office action is responsive to the preliminary amendment filed on 6/7/2023 . As directed by the amendment: claim(s) 1-7 have been amended. Thus, claims 1-7 are presently pending in this application.
Claim Rejections - 35 USC § 112
Claims 1-7 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.
Regarding claim 1
Claim 1 recites "which has on its inside an inner channel for connection to a needle holder", however this claim language is indefinite because it is not clear what element is in possession of the claimed inner channel, for instance the connecting element, distal end of the hollow body, or simply the hollow body itself. For examination purposes to be interpreted as "wherein the connecting element has on its inside an inner channel" in view of paragraph 7 of applicant's disclosure.
Claim 1 further recites "which is provided on its outside with means for mechanical fastening ", however this claim language is indefinite because it is not clear what element is in possession of the claimed means for mechanical fastening, for instance the inner channel, the connecting element, or other elements of the invention. For examination purposes to be interpreted as "wherein means for mechanical fastening of the needle holder are provided on an outside of the connecting element." in view of paragraph 33 of applicant's disclosure.
Claim 1 further recites “A hollow body for use as a syringe housing intended to receive a medical active substance, wherein …” which has a distinct lack of a transitional phrase (e.g. comprising, consisting of, etc.) which renders the scope of the claim unclear as to whether the following limitations are presented in an open or closed format, see MPEP 2111.03. For examination purposes the claim is to be interpreted as presenting its claim limitations in an open format in view of paragraph 30 of applicant’s disclosure.
Regarding claim 2
The term “about” in claim 2 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Accordingly, it is not clear whether applicant is claiming an internal channel with a cone with a cone angle of two degrees, or merely proximate two degrees, for instance zero degree, one degree, ten degrees, twenty degrees, etc. Considering applicant’s disclosure similarly recites in paragraph 34 that the cone angle may be about or approximately 2 degrees, for examination purposes the claim will be interpreted that the angle of the cone be proximate or near two degrees but not necessarily precisely two degrees.
Regarding claim 4
Claim 4 recites "which has on its outside a conically designed contact surface adapted in its dimensioning", however this claim language is indefinite because it is not clear what element has a conically designed contact surface on its outside, for instance the needle holder, hollow needle, bearing sleeve, or other elements of the invention. For examination purposes to be interpreted as "wherein an outside of the bearing sleeve has a conically designed…" in view of paragraph 35 and fig 3 of applicant's disclosure.
Claim 4 further recites “A medical syringe with a hollow body according to claim 1, which forms …” which has a distinct lack of a transitional phrase (e.g. comprising, consisting of, etc.) which renders the scope of the claim unclear as to whether the following limitations are presented in an open or closed format, see MPEP 2111.03. For examination purposes the claim is to be interpreted as presenting its claim limitations in an open format in view of paragraph 30 of applicant’s disclosure.
Claim 4 simultaneously recites that the claimed invention contains a hollow body according to claim 1, and then goes on to recite subsequent elements related to the hollow body (e.g. forming a syringe housing, being provided with a needle holder, etc.) which were already recited as elements of the hollow body according to claim 1. Thus the claim is unclear as to whether the recited elements are the same as that recited in claim 1, or are duplicative of/different from those previously recited. For examination purposes the claim is to be interpreted as referring to the same elements which were recited in the preceding claim 1, in view of paragraph 30-39 of applicant’s disclosure.
Regarding claim 5
Claim 5 recites "having a hollow body which forms the syringe housing and is provided for accommodating a medical active ingredient ", however the antecedent basis of the claim elements render the claim indefinite as a hollow body forming the syringe housing and containing a medically active ingredient/substance had already been recited in the preceding claim 4, making the claim unclear as to whether it disposing a grip plate on the precedingly recited hollow body forming the syringe housing, or instead on a whole new hollow body forming the syringe housing. For examination purposes to be interpreted as referring to the same previously recited hollow body, in light of paragraph 9 of applicant's disclosure.
Claim 4 further recites the following exemplary claim language "in particular with regard to ", accordingly the intended scope of the claim is unclear regarding, whether the adaptations to the dimensioning of the conically designed contact surface are limited to group of cross-sectional area, diameter, and cone angle of the surface, or if other types of dimensioning are in scope of the claim. For examination purposes to be interpreted as being limited to the listed features in light of paragraph 35 of applicant’s disclosure.
Claim 5 simultaneously recites that the claimed invention contains “the medical syringe of claim 4, having a hollow body…” and then goes on to recite subsequent elements related to the hollow body (e.g. forming a syringe housing, being provided for accommodating medicament, etc.) which were already recited as elements of the hollow body and thus its medical syringe according to claim 4. Thus the claim is unclear as to whether the recited elements are the same as that recited in claim 4, or are duplicative of/different from those previously recited. For examination purposes the claim is to be interpreted as referring to the same elements which were recited in the preceding claim 4, in view of paragraph 30-39+54 of applicant’s disclosure.
Regarding claim 6
Claim 6 recites "having a hollow body which forms the syringe housing and is provided for receiving a medical active ingredient ", however the antecedent basis of the claim elements render the claim indefinite as a hollow body forming the syringe housing and containing a medically active ingredient/substance had already been recited in the preceding claim 4, making the claim unclear as to whether it disposing a grip plate on the precedingly recited hollow body forming the syringe housing, or instead on a whole new hollow body forming the syringe housing. For examination purposes to be interpreted as referring to the same previously recited hollow body, in light of paragraph 9 of applicant's disclosure.
Claim 6 simultaneously recites that the claimed invention contains “the medical syringe of claim 4, …. having a hollow body which forms the syringe housing and is provided for receiving a medical active ingredient…” which were already recited as elements of the hollow body and thus its medical syringe according to claim 4. Thus the claim is unclear as to whether the recited elements are the same as that recited in claim 4, or are duplicative of/different from those previously recited. For examination purposes the claim is to be interpreted as referring to the same elements which were recited in the preceding claim 4, in view of paragraph 30-39+54 of applicant’s disclosure.
Regarding claim 3 and 7,
The above claims are at least rejected for being dependent upon the rejected independent claim 1.
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.
Regarding claim 1
The claim recites “means for mechanical fastening of the needle holder” uses the term “means” and does not recite the structure which performs the mechanical fastening of the needle holder to the connecting element. Based on applicant’s disclosure, particularly paragraph 33-35 and fig 2-3, such means for mechanical fastening may comprise threaded mating mechanisms, internally/externally matched contours, and the structural equivalents thereof.
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.
(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 6-7 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by US 5584817 A, henceforth written as APIS.
Regarding claim 1, APIS discloses:
A hollow body for use as a syringe housing intended to receive a medical active substance,
(container 1 retaining liquid 2 to be injected into a patient, therein a medically active substance, via the syringe (not enumerated) of fig 1-5)
wherein a connecting element is integrally formed at a distal end of the hollow body,
(outflow opening 10; fig 1-5, demonstrating the distal disposition of opening 10 on container 1)
which has on its inside an inner channel for connection to
(the claimed inner channel is considered the internal opening defined by inner wall 15 of outflow opening 10; fig 1-5)
a needle holder for a hollow needle provided for injection of the medical active substance,
(injection needle assembly 20 retains injection needle 21; fig 1-5)
which inner channel has an inner cross-section which widens continuously towards the distal end, and
(fig 2 best illustrates that internal opening defined by inner wall 15 of outflow opening 10 widens continuous toward its injection needle assembly 20 mating end)
which is provided on its outside with means for mechanical fastening of the needle holder.
(the mounting snap lugs 25 of injection needle assembly 20 slide/slip over the circumferential collar 26 on the outer wall (not enumerated) of outflow opening 10 to mechanically fasten the elements together; fig 1-5; examiner notes that the mating lugs 25 and collar 26 of APIS may considered means for mechanical fastening according to the 112(f) claim interpretation provided above in the manner by which the surface contours of the elements mate to form a sealing connection therebetween)
Regarding claim 2, APIS discloses:
The hollow body of claim 1, wherein the inner channel is configured in the manner of a cone widening toward the distal end.
(fig 2 best illustrates the conical nature of the inner wall 15 of outflow opening 10, widening in a distal direction)
Regarding claim 4, APIS discloses:
A medical syringe
(syringe (not enumerated) of fig 1-5)
with a hollow body according to claim 1,which forms a syringe housing and is provided for receiving the medical active substance, and
(container 1 forms the outer housing of the syringe (not enumerated) of fig 1-5, and contains liquid 2 for injection into a patient, therein a medically active substance)
with a needle holder with a hollow needle provided for injecting the medical active substance,
(injection needle assembly 20 retains injection needle 21; fig 1-5)
wherein the needle holder has a bearing sleeve for the hollow needle,
(cap 23 retains needle 21 in its opening 28; fig 1-5)
which has on its outside a conically designed contact surface adapted in its dimensioning, in particular with regard to its cross-sectional area, its diameter and/or its cone angle, to the inner channel of the connecting element and insertable therein.
(fig 1-5, and fig 2 and col 3 line 61-63 which provides greater detail, demonstrate that the portion 27, therein the conically designed contact surface of the claimed bearing sleeve, on cap 23 has a cross-sectional area, diameter, and angle which permit sealing insertion of portion 27 within the internal opening of the outflow opening 10 defined by the inner wall 15)
Regarding claim 6, APIS discloses:
The medical syringe of claim 5, having an actuating plunger and
(piston 3; fig 1-5)
having a hollow body which forms the syringe housing and is provided for receiving a medical active ingredient,
(container 1; fig 1-5)
a number of stop and latching elements being arranged on a shaft of the actuating plunger.
(recess 7 and inwardly directed collar 8, the claimed number of stop and latching elements, are disposed at a distal end of piston head 4, therein shaft, of piston 3; fig 1-5)
Regarding claim 7, APIS discloses:
The medical syringe of claim 6, the latching elements of which are designed as adjusting rings running around the shaft.
(col 4 line 1-17; inwardly directed collar 8 is cylindrical in shape, and thus can be considered a ring running around the claimed shaft, and can be considered adjusting/adjustable in the manner by which the collar 8 is depressed/flexed to permit claws 31 snapping into recess 7 and subsequently collar 8 sealing to lips 30; fig 2-4)
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over PPPPP, as applied to claim 2 above, in view of US 20190083716 A1, henceforth written as Saxe.
Regarding Claim 3,
APIS discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, APIS is silent regarding:
The hollow body of claim 2, wherein the cone formed by the internal channel has a cone angle of about 2°.
However, Saxe teaches a coaxially sliding needle assembly wherein the connection between two coaxially sliding elements, shield 60 and portion 40, is optimized for forming a pressure fitted connection between the two elements by selecting a draft angle, for instance between 0.2 and 5 degrees, for each mating surface of the sliding elements, see paragraph 39+88+104 of Saxe. Further as noted in paragraph 23+39+88, this draft angle permits an ease of release of a mould which is used to fabricate the sliding elements.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement Saxe’s teachings of optimizing the cone angle of two coaxially sliding/mating surfaces to the inner channel and bearing sleeve disclosed by APIS, therein arriving at the claimed angle of the internal channel, in order to advantageously arrive at an invention with an optimized pressure fitting connection improving the sealability of the interfacing elements, see paragraph 104 of Saxe, reducing leakage risk, and further improve the ease by which some elements are manufactured by permitting an easy removal of a mold used to fabricate each element.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over APIS, as applied to claim 4 above, in view of US 20080033368 A1, henceforth written as Fago.
Regarding Claim 5,
APIS discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The medical syringe of claim 4, having a hollow body which forms the syringe housing and is provided for accommodating a medical active ingredient
(container 1; fig 1-5)
However, APIS is silent regarding:
and at whose proximal end a grip plate is integrally formed, on which an RFID chip is arranged.
However, Fago teaches a system for tracking information on syringe comprising:
A syringe at whose proximal end a grip plate is integrally formed,
(paragraph 103; syringe 20 has flange 56; fig 2)
on which an RFID chip is arranged
(paragraph 103-121; RFID tag 60 containing information about syringe 20; fig 2)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to dispose Fago’s teaching of an integral syringe flange on the syringe disclosed by APIS, in order to advantageously arrive at an invention which provides a surface for a user to improve the leverage their digits have to bias the syringe plunger forward and deliver medicament.
It would be similarly obvious to implement Fago’s teachings of an RGID tag disposed on a flange of a medical device to the invention disclosed by APIS, in order to advantageously arrive at an invention which provides valuable information to a user such as a manufacturing date of the medicament contained therein, see paragraph 112 of Fago, therein ensuring that risks associated with administering expired medicament, such as worsening illness and death, are minimized.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure, particularly the independent claims:
US 20210085891 A1
US 20040153036 A1
US 5820605 A
US 20100100053 A1
US 5395346 A
US 5538507 A
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FORREST BLAKE DIPERT/ Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783