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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 19 and 24-36 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12110995. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent encompasses the subject matter of the instant claims.
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 19 and 24-37 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 19 recites, “the second latch member pivotably coupled to the first latch member and configured to form- a contained engagement with the first closure region of the first clamp member in the closed configuration of the tube clamp.” The original disclosure does not contain “contained engagement”, and the only appearances of “engagement” in original disclosure are:
In some embodiments, each prong may include a plurality of protrusions projecting off of an engagement surface.
In some embodiments, the first and second clamp members may move relative to one another to form an open configuration and a closed configuration and in the closed configuration the engagement surface of the first clamp member comes into physical contact with an engagement surface of the second clamp member.
In some embodiments, each prong 502 may include a plurality of protrusion 514 projecting off of an engagement surface 512.
In some embodiments, the engagement surface 510 of the first clamp member 102 may come into physical contact with the engagement surface 512 of the second clamp member 114. In some embodiments, the engagement surfaces 510, 512 physically interact through the plurality of protrusions 514.
The original disclosure does not support a contained engagement with the first closure region of the first clamp member in the closed configuration of the tube clamp. Therefore, the Examiner must conclude 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. The pending claim will be given its broadest reasonable interpretation consistent with the specification.
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 37 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 37 recites, “the latch assembly has no protrusions projecting beyond the latch assembly in the closed configuration of the tube clamp.” However, it is not clear to the Examiner exactly what this means. Exactly what is concerned a projection? The original disclosure does not offer any explanation of what the claim language means. The Examiner is unable to determine the metes and bounds of the claim. The pending claim will be given its broadest reasonable interpretation consistent with the specification.
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) 19, 24-27 and 30-37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipate by US 1162362, Hyland.
In regards to claim 19, in Figures 1-5 and paragraphs detailing said figures, Hyland discloses a tube clamp for bioprocessing, comprising: a first clamp member (A) having a first closure region joined to a first end (near H) of the first clamp member; and a first attachment region (near E) joined to a second end of the first clamp member; a second clamp member having a second closure region joined to a first end (near I) of the second clamp member; and a second attachment region (near E) joined to a second end of the second clamp member; and a latch assembly coupled to the second clamp member and configured to allow the first and second clamp members to move between an open configuration and a closed configuration of the tube clamp, wherein the latch assembly comprises a first latch member (F) and a second latch member (G), the second latch member pivotably coupled to the first latch member and configured to form a contained engagement with the first closure region of the first clamp member in the closed configuration of the tube clamp.
In regards to claim 24, in Figures 1-5 and paragraphs detailing said figures, Hyland discloses the first attachment region has a first base with an opening and the second attachment region has a second base with a projection (see Fig. 2 below) configured to extend into the opening to allow the first and second clamp members to move between open and closed configurations.
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In regards to claim 25, in Figures 1-5 and paragraphs detailing said figures, Hyland discloses the first clamp member has a first body having a crescent shape and the second clamp member has a second body having a crescent shape.
In regards to claim 26, in Figures 1-5 and paragraphs detailing said figures, Hyland discloses the first body has a first interior having a first lower surface joined to a first interior sidewall and a first top surface joined to the first interior sidewall by a first tapered surface.
In regards to claim 27, in Figures 1-5 and paragraphs detailing said figures, Hyland discloses the second body has a second interior having a second lower surface joined to a second interior sidewall and a second top surface joined to the second interior sidewall by a second tapered surface.
In regards to claim 30, in Figures 1-5 and paragraphs detailing said figures, Hyland discloses the second latch member is configured to couple to the first closure region of the first clamp member.
In regards to claim 31, in Figures 1-5 and paragraphs detailing said figures, Hyland discloses the first latch member has a first end and a second end, and the second latch member has a first end and a second end, the second end of the second latch member being coupled to the first latch member.
In regards to claim 32, in Figures 1-5 and paragraphs detailing said figures, Hyland discloses the first end of the second latch member is configured to couple to the first closure region of the first clamp member.
In regards to claim 33, in Figures 1-5 and paragraphs detailing said figures, Hyland discloses actuating the first end of the second latch member causes the second latch member to pivot relative to the first latch member.
In regards to claim 34, in Figures 1-5 and paragraphs detailing said figures, Hyland discloses the first latch member has a curved body.
In regards to claim 35, in Figures 1-5 and paragraphs detailing said figures, Hyland discloses the second latch member has a curved body.
In regards to claim 36, in Figures 1-5 and paragraphs detailing said figures, Hyland discloses the second latch member is not coupled to the first clamp member in the open configuration of the tube clamp.
In regards to claim 37, in Figures 1-5 and paragraphs detailing said figures, Hyland discloses the latch assembly has no protrusions projecting beyond the latch assembly in the closed configuration of the tube clamp.
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.
Claim(s) 28 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hyland.
In regards to claims 28 and 29, Hyland discloses the claimed invention except for the first exterior having a first exterior top surface joined to a first exterior sidewall by a first exterior taper, and the second exterior having a second exterior top surface joined to a second exterior sidewall by a second exterior taper. Applicant has not provided any criticality for the first exterior having a first exterior top surface joined to a first exterior sidewall by a first exterior taper, and the second exterior having a second exterior top surface joined to a second exterior sidewall by a second exterior taper. The Hyland invention is clearly capable of being modified to have the first exterior having a first exterior top surface joined to a first exterior sidewall by a first exterior taper, and the second exterior having a second exterior top surface joined to a second exterior sidewall by a second exterior taper. Therefore, it 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 modify the first and second sidewalls with a taper, since a change in the shape of a prior art device is a design consideration within the level of skill of one skilled in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Response to Arguments
Applicant's arguments filed 1/27/2026 have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the outer surfaces of the first and second clamp members created a smooth, continuous profile that is substantially free of any sharp or irregular protrusions that project beyond the main body of the latch assembly) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues that Hyland does not disclose the claimed subject matter (i.e., using the same terms or in haec verba) as recited in the claims. The Examiner disagrees. The pending claim will be given its broadest reasonable interpretation, and prior art may not use the same terms, or in haec verba, but the prior art reads on the claim.
Applicant “requests that the non-statutory double patenting rejections be held in abeyance until a determination of allowable subject matter has been finally made in the instant application”. The Examiner disagrees. No rejection will be held in abeyance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON M DUNWOODY whose telephone number is (571)272-7080. The examiner can normally be reached Monday - Friday 9:00 am - 6:00 pm.
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/AARON M DUNWOODY/Primary Examiner, Art Unit 3679