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 .
Response to Amendment
The Amendment filed 04/13/2026 has been entered. Claims 1-17 and 21-22 are pending in the application. Claim 17 is withdrawn. Claims 1-16 and 21-22 are being examined herein.
Status of Objections and Rejections
All objections/rejections of claims 18-20 are obviated by Applicant’s cancellation.
The nonstatutory double patenting rejections are being withdrawn in view of Applicant’s amendment.
The claim objections are being withdrawn in view of Applicant’s amendment.
The rejection under 35 U.S.C 112(b) are being withdrawn.
New grounds for rejection under 35 U.S.C. 112(a) and 35 U.S.C. 112(b) are necessitated by Applicant’s amendments.
The rejections under 35 U.S.C. 102 and 35 U.S.C. 103 are being withdrawn in view of Applicant’s amendment.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/13/2026 and 06/30/2026 are being considered by the examiner.
Claim Objections
Claims 1 and 2 objected to because of the following informalities:
Claim 1, line 12, “latch” should read “latch member”;
Claim 11, lines 1-2 “…wherein the retaining mechanism temporarily interrupts the operation of a drive means…” should read “the device further comprises a drive means, wherein the retaining mechanism temporarily interrupts the operation of the drive means…”to be consistent with what the Applicant intends to claim (Remarks of 04/13/2026, p. 7, 2nd para.) and for clarity;
Claim 21, line 2, “latch” should read “latch member” to be consistent.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
"biasing means" in claim 10, line 3
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend 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 avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
In this instant application, the corresponding structure for:
"biasing means" is being interpreted as a spring or a gas spring (p. 3, lines 12-13) and equivalents thereof.
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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-16 and 21-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is amended to recite the limitation “wherein one motion of the latch member between said positions causes the latch member to engage with the fusible retaining member and stop said motion … the one motion of the latch further causing activation of the heating member to affect at least a portion of the fusible retaining member … ” in lines 9-15. The original disclosure (p. 5, lines 22-23 and claim 1 of 02/13/2023) discloses “wherein one motion of the latch member between said positions causes [the latch member] to engage with the fusible retaining member and stop said motion, and activation of the heating member affects at least a portion of the fusible retaining member…“, which does not disclose the “activation of the heating member” being caused by the “one motion of the latch member” or the “latch member.” The examiner notes that the term “latch member” is not identified with any element in the Drawings or used in the portion of the Specification that discussed the Drawings. Since the “latch member” being a crucial part of the invention has to be in the Drawings, the examiner deduces and interprets that the “rotary member” (54) is the “latch member”. The reason being the Specification discloses that the latch member can be a rotary latch member (p. 5, line 39, p. 6, line 16 and claim 17) and the function of the rotary member appears to be of the function of the latch member (e.g., p. 26, lns. 16-20 and claim 17). However, even with this interpretation, the original disclosure still does not disclose the activation of the heating member is caused by the rotary member or its motion of engaging the fusible retaining member. The original disclosure discloses that “the device” activates the heating element (heating element 1301) (p. 26, lines 17-18), but not specifically which parts of “the device.” Therefore, this amended limitation contains subject matter which was not described in the specification in such a way as to reasonably convey at the time the application was filed, had possession of the claimed invention. It is suggested that “…, the one motion of the latch further causing activation of the heating member to affect at least a portion of the fusible retaining member …” in lines 11-13 to be amended back to “…, and activation of the heating member affects at least a portion of the fusible retaining member…” to overcome this new matter rejection.
Claims 2-16 and 21-22 are rejected because of their dependence on claim 1.
Claim 11 is amended to recite the limitation “… a drive means comprising a biasing means and a rotary member” in lines 2-3. It is first noted that Applicant intends for the drive means to be positively recited as states in the Remarks of 04/13/2026. See also claim objection above. The Specification disclose the drive means comprises a spring (p. 3, line 11) and a rotary member (p. 3, line 27). However, the rotary member is the latch member of claim 1 as discussed above in the rejection of claim 1. Since the latch member is already positively recited in claim 1, the rotary member in this claim is considered be new matter because in the original disclosure, the invention has only one latch member/rotary member.
Claim 12 is rejected because of its dependence on claim 11.
Claim 21, a new claim, recites the limitation “a rotary member operatively coupled to the resiliently biased latch [member]…” in lines 1-2. There is a lack of support in the original disclosure for this limitation. There is no discussion of any relationship between the “latch member” and the “rotary member” in the original disclosure. In fact, the rotary member is the latch member of claim 1 based on the reason discussed above in the rejection of claim 1.
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 1-16 and 21-22 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 1 recites the preamble “[a] device containing a retaining mechanism comprising: ” in line 1. It is unclear whether the “comprising” in the preamble is referring to the “device” or “the retaining mechanism.” The Applicant appears to have the intention for “comprising” to be referring to the “retaining mechanism” as p. 6 of Remarks of 04/13/2026 states “retaining mechanism further comprises a heating member and a vertical boss, as recited instant claim 1.” However, the Applicant also intends for the “drive means” in claim 11 to be positively recited (p. 7 of Remarks of 04/13/2026) which necessitates “comprising” in the preamble to be referring to the device and not the retaining mechanism. The reason being if the “drive means” is a part of “retaining mechanism” (which would be the case if “comprising” in the preamble is referring to the “retaining mechanism”), then it would not make sense for “the retaining mechanism” to interrupt the “drive means”. Clarification is requested. Claims 2-16 and 21-22 are indefinite because of their dependence on claim 1.
Claim 1 is amended to recite the limitation “wherein one motion of the latch member between said positions causes the latch member to engage with the fusible retaining member and stop said motion… the one motion of the latch further causing activation of the heating member to affect at least a portion of the fusible retaining member … ” in lines 9-15. This limitation is indefinite in light of the specification. The specification does not disclose a latch member with a motion that can achieve the recited functions in the limitation, and thus it is unclear whether the claim intends to compass what is disclosed or whether it intends to recite a separate structure. Clarification is requested.
Claims 2-16 and 21-22 are indefinite because of their dependence on claim 1.
Claim 11 is amended to recite the limitation “… a drive means comprising a biasing means and a rotary member” in lines 2-3. It is first noted that Applicant intends for the drive means to be positively recited as states in Remarks of 04/13/2026. See also claim objection above. The Specification disclose the drive means comprises a spring (p. 3, line 11) and a rotary member (p. 3, line 27); and the rotary member is interpreted as the latch member of claim 1 as discussed above in the rejection of claim 1 under 112(a). Since the latch member is already positively recited in claim 1 and the specification only just one latch member/rotary member, it is unclear how this additional rotary member related to the rest of the components of the device. Clarification is requested.
Claim 12 is indefinite because of its dependence on claim 11.
Claim 21, a new claim, recites the limitation “a rotary member operatively coupled to the resiliently biased latch [member]…” in lines 1-2. The disclosure does not discuss any relationship between the “latch member” and the “rotary member”; the rotary member is being interpreted the latch member of claim 1 based on the reason discussed above in the rejection of claim 1. Since the latch member is already positively recited in claim 1 and the specification only just one latch member/rotary member, it is unclear how this additional rotary member related to the rest of the components of the device, and it is also unclear whether the claim intends to compass what is disclosed or whether it intends to recite a separate structure. Clarification is requested.
Prior Art
Claims 1-16 and 21-22 are free of the prior art since the prior art neither teaches nor renders obvious the limitation "wherein one motion of the latch member between said positions causes the latch member to engage with the fusible retaining member and stop said motion … the one motion of the latch further causing activation of the heating member to affect at least a portion of the fusible retaining member …” in lines 9-15 of claim 1 in combination with the other recited elements.
However, should Applicant amend as examiner has suggested above to overcome the 35 U.S.C. 112(a) rejection, rejections for the claims would be put forth in view of the teachings of Streit et al. (EP 3636298 A1) (Reference herein made with respect to English equivalent found at US 20210228799 A1) and Waters (US 4518223). Streit teaches a device containing a retaining mechanism (Figs. 1, 4 and 13-15) comprising: a resiliently biased latch member (cannula unit comprises 20, 25a, 25b, 23, 22 and 24) adapted for motion between at least three positions (the cannula unit is structurally capable of being in motion between at least three position, including the position immediately before latch member is secured by 260, and Figs. 5-10 and paras. 0063, 0065 and 0067, secured position, piercing position and retracted position); a fusible retaining member (250 and 260) configured to act as a stop to motion of the latch member between two of said positions (para. 0089); and a heating member (41) positioned adjacent to the retaining member (para. 0096); and a vertical boss (235), activation of the heating member affects at least a portion of the fusible retaining member causing the fusible retaining member to soften, melt, weaken or break allowing the latch member to move so as to release the latch member for a further motion between said positions (Fig. 5 and paras. 0089 and 0097).
Streit further teaches the ring part of securing member 250 (Figs. 13-15) is coupled to the pin 235 in order for securing member 25 to be held to the base of the device (para. 0108). Streit teaches the ring part of 250 has a hollow center, where the pin 235 can inserted into to achieve coupling. Waters teaches coupling of a first part with a hollow center (coupler 90 and two protruding pins 100, Fig. 3) to a second part (shaft 50) that can be inserted into the hollow center of the first part (Fig. 3). Waters teaches the first part (coupler 90 and two protruding pins 100) comprising two axial fingers (pins 100) and the second part (shaft 50) comprising a cylindrical opening comprising diametrically opposed apertures (slots 92). Waters teaches the first and second parts can be coupled together by inserting the second part into the first part and then securing the two parts with pins protruding 100 of the first part being inserted into the slots 92 of the second part. In view of Waters’ teachings, it is within the ambit of a POSTIA to achieve coupling with modified the ring part of 250 and pin 235 taught by Streit. In particular, the ring part of 250 can be modified to comprise two axial fingers, and the pin 235 can be modified to comprise a cylindrical opening comprising two diametrically opposed apertures, and wherein the modified parts can be coupled by engaging the two axial fingers with the diametrically opposed apertures. The teachings of modified Streit would yield wherein one motion of the latch member between said positions causes the latch member to engage with the fusible retaining member and stop said motion by causing the two axial fingers to be engaged with the diametrically opposed apertures.
Response to Arguments
Applicant's arguments, see p. 5, filed 04/13/2026, with respect to no new matter has been added to the amendment and new claims have been fully considered but they are not persuasive. The Applicant cited that support “can be found throughout the Specification and claims, including, for example, at claims 18-20, pg. 13, lines 38-45, and pg. 14 lines 1-2, and 12-20”; however support for amended limitations in lines 9-15 of claim 1, lines 2-3 of claim 11, and the new limitation in lines 1-2 of new claim 21 is not found in the original disclosure as explained above in the 35 U.S.C. 112(a) section. Therefore this argument is unpersuasive.
Applicant’s arguments, see p. 5, filed 04/13/2026, with respect to the nonstatutory double patenting rejection have been fully considered and are persuasive. The rejection of 01/13/2026 has been withdrawn.
Applicant’s arguments, see p. 5, filed 04/13/2026, with respect to claim objections have been fully considered and are persuasive. The rejection of 01/13/2026 has been withdrawn.
Applicant’s arguments, see p. 6, filed 04/23/2026, with respect to the claim interpretation of 35 U.S.C. 112(f) have been fully considered. The 35 U.S.C. 112(f) interpretation of “retaining mechanism” has been removed based on Applicant’s remarks. However, the remarks raise a questions regarding the preamble. Please see the 35 U.S.C. 112(b) section above.
Applicant’s arguments, see pp. 6-7, filed 04/23/2026, with respect to the rejection of claim 16 under 35 U.S.C. 112(b) have been fully considered and are persuasive. With respect to the rejection of claim 11, the Applicant states the intention to positively recite a “drive means”; however, the claim language still does not reflect that the “drive means” is positively recited. For this reason, the rejection has been withdrawn, but the claim is objected because the language is unclear. See the “Claim Objections” section above.
Applicant’s arguments, see p. 7-9, filed 04/13/2026, with respect to the rejection(s) under 35 U.S.C. 102 and 35 U.S.C. 103 have been fully considered and are persuasive. The rejection of 01/13/2026 has been withdrawn. However, as stated in the “Prior Art” section, it is within the ambits of a POSITA, in view of the Waters’ teachings, to modified the ring part of 250 and pin 235 of Streit to comprising the two axial fingers and diametrically opposed apertures to achieve coupling. The examiner notes that in the OA of 1/13/2025, claims 18 and 19 (of claim set 11/06/2025) require additional structures for the retaining member and the boss as compared to the amended claim 1 of the current claim set (4/13/2026), and thus necessitates different mappings. Consequently, the reasoning for indicating as allowable subject matter in the OA of 01/32/206 due to the boss comprising diametrically opposed apertures in claim 19 of 11/06/2025 does not apply to the amended claim 1 of the current claim set.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.L.C./ Examiner, Art Unit 1758
/MARIS R KESSEL/ Supervisory Patent Examiner, Art Unit 1758
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