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
Acknowledgement is made of applicant’s claim for foreign priority under 35 U.S.C. 119. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Preliminary Amendment
Receipt is acknowledged of a preliminary amendment, filed 01 August 2025, which has been placed of record and entered in the file.
Status of the claims:
Claims 15-47 are pending.
Claims 15-47 are new.
Claims 1-14 are canceled.
Specification and Drawings:
Amendments to the specification have been submitted in the amendment filed 01 August 2025. Receipt is acknowledged of the marked-up copy of the substitute specification, the clean copy of the substitute specification.
Amendments to the drawings have not been submitted in the amendment filed 01 August 2025.
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 17, 24-29, 37 and 46 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.
In claims 17, 24, 25, 26, and 27, the phrase “flange-like” is ambiguous. The addition of the word “like” to an otherwise definite expression (flange) extends the scope of the expression so as to render it indefinite. MPEP 2173.05(b) III. E.
Claims 28-29 depend from claim 27, and are likewise rejected.
Claim 37 is ambiguous as the phrase “is designed” fails to give meaning to the structure of the device. It is not clear what “is designed” includes.
Claim 46 recites the limitation "the factory" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 15-17, 35, 43-44, and 46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by de la Poype (US Patent No. 4,603,536).
With respect to claim 15, de la Poype discloses a method for producing a bag for receiving at least one of a medical product or a dry medical concentrate (pharmaceuticals, col. 1, l. 14-22), the method comprising: providing a flat film with two outer edges (providing flat film 12, fig. 2); fixing at least one connection to the flat film using butt welding (fitment 14 is butt welded to film 12 at station 36, fig. 2, col. 3, l. 1-13); producing a film tube out of the flat film using a forming shoulder and by sealing the outer edges of the flat film together (forming film 12 on shoulder 20 and sealing edges with sealer 40, fig. 2); producing a sealing seam that extends perpendicular to at least one of a longitudinal direction or extending direction of the film tube, whereby a receiving pocket is produced in the film tube (forming transverse seals 39, 41 with sealer 42, fig. 2); filling the receiving pocket along at least one of the longitudinal direction or the extending direction of the film tube with at least one of liquid or solid contents (filling the tube with a fill tube, col. 3, l. 28-39); and closing the receiving pocket by producing an additional sealing seam that extends perpendicular to at least one of the longitudinal direction or the extending direction of the film tube (sealer 42 produces cross-wise seals 39, 41, figs. 2, 3), whereby the receiving pocket is closed, and a completely closed chamber is formed (formed bag 32, fig. 3).
With respect to claim 16, de la Poype discloses filling the receiving pocked comprises filling the receiving pocket in the vertical direction from above (device includes a fill tube that fills the web after one of the transverse seals has been created, i.e., the filling opening is positioned for filling from above, fig. 2, col. 3, l. 28-39).
With respect to claim 17, de la Poype discloses fixing the at least one connection to the flat film by butt welding comprises at least one of the following: providing a cylindrical tube section (fitment 14 includes a cylindrical tube section, fig. 3); preforming a connection section of the tube section by locally expanding the tube, whereby a flange-like connection section is formed by means of pressure and heat; placing the connection section on the flat film so that the flat film is interposed between the connection section and a pressure plate; or welding the connection section to the flat film by pressing on the connection section while exerting a counter-pressure by means of the pressure plate, whereby the connection section is connected to the flat film and forms a connection.
With respect to claim 35, de la Poype discloses completely closed chambers are produced continuously along a continuous film tube and are connected to each other by the sealing seam (fig. 2), and the completely closed chambers are separated from each other by separation along a sealing seam extending perpendicular to at least one of the longitudinal direction or extending direction of the film tube, whereby separate bags are produced, each having one or more chambers (transverse sealing station 42 includes severing means for separating between the transverse seals and creating individual containers 32, figs. 2, 3, col. 3, l. 28-39).
With respect to claim 43, de la Poype discloses a bag (flexible container 32, fig. 3) which has at least one side formed by a folded-over film (bottom of flexible container 32 is formed by folded film 12, figs. 2, 3) to which at least one connection is non-detachably arranged using butt welding (fitment 14 butt welded to fold of film 12, fig. 3), wherein the bag is produced by a method comprising: providing a flat film with two outer edges (providing flat film 12, fig. 2); fixing at least one connection to the flat film using butt welding (fitment 14 is butt welded to film 12 at station 36, fig. 2, col. 3, l. 1-13); producing a film tube out of the flat film using a forming shoulder and by sealing the outer edges of the flat film together (forming film 12 on shoulder 20 and sealing edges with sealer 40, fig. 2); producing a sealing seam that extends perpendicular to at least one of a longitudinal direction or extending direction of the film tube, whereby a receiving pocket is produced in the film tube (forming transverse seals 39, 41 with sealer 42, fig. 2); filling the receiving pocket along at least one of the longitudinal direction or the extending direction of the film tube with at least one of liquid or solid contents (filling the tube with a fill tube, col. 3, l. 28-39); and closing the receiving pocket by producing an additional sealing seam that extends perpendicular to at least one of the longitudinal direction or the extending direction of the film tube (sealer 42 produces cross-wise seals 39, 41, figs. 2, 3), whereby the receiving pocket is closed, and a completely closed chamber is formed (formed bag 32, fig. 3).
With respect to claim 44, de la Poype discloses the at least one connection comprises a tube section (fitment 14 includes two tubes, fig. 3).
With respect to claim 46, de la Poype discloses the bag does not have, in addition to the at least one connection arranged on the bag by butt welding, a filling port designed to fill the bag or at least one chamber thereof with a desired content at the factory (flexible container 32 includes no filling port, fig. 3).
Claims 43-44 and 46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Merkus (US Patent No. 4,709,528).
With respect to claim 43, Merkus discloses a bag (individual bag 4, fig. 1) which has at least one side formed by a folded-over film (bag side includes folded film 1, fig. 1) to which at least one connection is non-detachably arranged using butt welding (fitment 5 is butt welded to film 1, fig. 2), wherein the bag is produced by a method comprising: providing a flat film with two outer edges (film 1, fig. 1); fixing at least one connection to the flat film by butt welding (fitment 5 is heat sealed by butt welding to film 1, fig. 2); producing a film tube out of the flat film by a forming shoulder and by sealing the outer edges of the flat film together (film 1 is formed by forming shoulder 10 and longitudinal edges are sealed by jaws 12, fig. 1); producing a sealing seam that extends perpendicular to at least one of a longitudinal direction or extending direction of the film tube (cross-wise seals are produced by jaws 13, fig. 1), whereby a receiving pocket is produced in the film tube (pocket above heat sealed cross-wise seal, fig. 1); filling the receiving pocket along the longitudinal direction of the film tube with at least one of liquid or solid contents (pocket is filled through filling tube 40, fig. 2); and closing the receiving pocket by producing an additional sealing seam that extends perpendicular to the longitudinal direction of the film tube, whereby the receiving pocket is closed (jaws 13 seal and cut cross-wise, fig. 1), and a completely closed chamber is formed (individual packages 4 are formed, fig. 1).
With respect to claim 44, Merkus discloses the at least one connection comprises a tube section (tubes 7, fig. 2).
With respect to claim 46, Merkus discloses the bag does not have, in addition to the at least one connection arranged on the bag by butt welding, a filling port designed to fill the bag or at least one chamber thereof with a desired content at the factory (bag 4 includes no additional filling port, fig. 1).
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.
Claims 18-34 are rejected under 35 U.S.C. 103 as being unpatentable over de la Poype (US Patent No. 4,603,536) in view of Hurst et al. (US Patent Publ. No. 2005/0186377).
With respect to claim 18, de la Poype fails to disclose the at least one connection is preformed at a temperature between 80°C and 300°C.
Hurst et al. disclose a method of bonding medical devices and container components with heating, including providing a container and component having a melting temperature of about 130-150 degrees Celsius.
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 to modify the de la Poype method to substitute a connection preformed at a temperature between 80°C and 300°C, as suggested by Hurst et al., as a matter of optimization through routine experimentation, in the absence of any unexpected results of particular preforming temperature. A person of ordinary skill in the art would have good reason to pursue the particular preforming temperature of the connection. MPEP 2144.05 II. A. and B.
With respect to claim 19, de la Poype fails to disclose the at least one connection is preformed at a temperature between 220°C and 280°C.
Hurst et al. disclose a method of bonding medical devices and container components with heating, including providing a container and component having a melting temperature of about 130-150 degrees Celsius.
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 to modify the de la Poype method to substitute a connection preformed at a temperature between 220-280 degrees Celsius, as suggested by Hurst et al., as a matter of optimization through routine experimentation, in the absence of any unexpected results of particular preforming temperature. A person of ordinary skill in the art would have good reason to pursue the particular preforming temperature of the connection. MPEP 2144.05 II. A. and B. The preforming temperature of Hurst et al. and the claimed preforming temperature are so close that prima facie one skilled in the art would have expected them to have the same properties. MPEP 2144.05 I.
With respect to claim 20, de la Poype fail to disclose the at least one connection is preformed in a period of time of 0.1 s to 4 s.
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 to modify the de la Poype method to include preforming the connection in a period of time of 0.1 s to 4s, as a matter of optimization through routine experimentation, in the absence of any unexpected results of the particular time of preforming. MEP 2144.05 II. A. and B. The particular time of preforming does not patentably distinguish Applicant’s claimed method form the prior art where the only difference between the prior art and the claims is a recitation of the preforming time, and a preform having the claimed preforming time would not perform differently than the prior art connection. MPEP 2144.04 IV. A.
With respect to claim 21, de la Poype fail to disclose the at least one connection is preformed in a period of time of 1.5 s to 3.5 s.
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 to modify the de la Poype method to include preforming the connection in a period of time of 1.5s to 3.5, as a matter of optimization through routine experimentation, in the absence of any unexpected results of the particular time of preforming. MEP 2144.05 II. A. and B. The particular time of preforming does not patentably distinguish Applicant’s claimed method form the prior art where the only difference between the prior art and the claims is a recitation of the preforming time, and a preform having the claimed preforming time would not perform differently than the prior art connection. MPEP 2144.04 IV. A.
With respect to claim 22, de la Poype fail to disclose the at least one connection is preformed at a pressure of 0.1 N/mm2 to 2 N/mm2.
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 to modify the de la Poype method to include preforming the connection at a pressure of 0.1 N/mm2 to 2 N/mm2, as a matter of optimization through routine experimentation, in the absence of any unexpected results of the particular pressure of preforming. MEP 2144.05 II. A. and B. The particular pressure of preforming does not patentably distinguish Applicant’s claimed method from the prior art where the only difference between the prior art and the claims is a recitation of the preforming pressure, and a preform having the claimed preforming pressure would not perform differently than the prior art connection. MPEP 2144.04 IV. A.
With respect to claim 23, de la Poype fail to disclose the at least one connection is preformed at a pressure of 0.3 N/mm2 to 0.5 N/mm2.
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 to modify the de la Poype method to include preforming the connection at a pressure of 0.3 N/mm2 to 0.5 N/mm2, as a matter of optimization through routine experimentation, in the absence of any unexpected results of the particular pressure of preforming. MEP 2144.05 II. A. and B. The particular pressure of preforming does not patentably distinguish Applicant’s claimed method from the prior art where the only difference between the prior art and the claims is a recitation of the preforming pressure, and a preform having the claimed preforming pressure would not perform differently than the prior art connection. MPEP 2144.04 IV. A.
With respect to claim 24, de la Poype disclose fixing the at least one connection comprises preforming the at least one connection (the fitment is preformed, fig. 1), wherein a flange-like connection section of a tube section is formed during preforming (fig. 3).
De la Poype fails to disclose a thickness of the flange-like connection section in the longitudinal direction of the tube section is between 0.1 mm and 2 mm.
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 to modify the de la Poype method to include the flange having a thickness between 0.1 mm and 2 mm, as a matter of optimization through routine experimentation, in the absence of any unexpected results of the particular dimensions of the flange. MEP 2144.05 II. A. and B. The particular dimension of the flange does not patentably distinguish Applicant’s claimed method from the prior art where the only difference between the prior art and the claims is a recitation of the flange dimensions, and a preform having the claimed flange dimension would not perform differently than the prior art connection. MPEP 2144.04 IV. A.
With respect to claim 25, de la Poype fails to disclose a thickness of the flange-like connection is between 0.3 mm and 0.5 mm.
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 to modify the de la Poype method to include the flange having a thickness between 0.3 mm and 0.5 mm, as a matter of optimization through routine experimentation, in the absence of any unexpected results of the particular dimensions of the flange. MEP 2144.05 II. A. and B. The particular dimension of the flange does not patentably distinguish Applicant’s claimed method from the prior art where the only difference between the prior art and the claims is a recitation of the flange dimensions, and a preform having the claimed flange dimension would not perform differently than the prior art connection. MPEP 2144.04 IV. A.
With respect to claim 26, de la Poype fails to disclose a thickness of the flange-like connection is approximately 0.4 mm.
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 to modify the de la Poype method to include the flange having a thickness of approximately 0.4 mm, as a matter of optimization through routine experimentation, in the absence of any unexpected results of the particular dimensions of the flange. MEP 2144.05 II. A. and B. The particular dimension of the flange does not patentably distinguish Applicant’s claimed method from the prior art where the only difference between the prior art and the claims is a recitation of the flange dimensions, and a preform having the claimed flange dimension would not perform differently than the prior art connection. MPEP 2144.04 IV. A.
With respect to claim 27, de la Poype fails to disclose a diameter of an end face of the flange-like connection is between 5 mm and 25 mm.
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 to modify the de la Poype method to include diameter of an end face of the flange of between 5 mm and 25 mm, as a matter of optimization through routine experimentation, in the absence of any unexpected results of the particular dimensions of the flange. MEP 2144.05 II. A. and B. The particular dimension of the flange does not patentably distinguish Applicant’s claimed method from the prior art where the only difference between the prior art and the claims is a recitation of the flange dimensions, and a preform having the claimed flange dimension would not perform differently than the prior art connection. MPEP 2144.04 IV. A.
With respect to claim 28, de la Poype fails to disclose a diameter between 10 mm and 14 mm.
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 to modify the de la Poype method to include diameter of an end face of the flange of between 10 mm and 14 mm, as a matter of optimization through routine experimentation, in the absence of any unexpected results of the particular dimensions of the flange. MEP 2144.05 II. A. and B. The particular dimension of the flange does not patentably distinguish Applicant’s claimed method from the prior art where the only difference between the prior art and the claims is a recitation of the flange dimensions, and a preform having the claimed flange dimension would not perform differently than the prior art connection. MPEP 2144.04 IV. A.
With respect to claim 29, de la Poype fails to disclose a diameter of 12 mm.
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 to modify the de la Poype method to include diameter of an end face of the flange of 12 mm, as a matter of optimization through routine experimentation, in the absence of any unexpected results of the particular dimensions of the flange. MEP 2144.05 II. A. and B. The particular dimension of the flange does not patentably distinguish Applicant’s claimed method from the prior art where the only difference between the prior art and the claims is a recitation of the flange dimensions, and a preform having the claimed flange dimension would not perform differently than the prior art connection. MPEP 2144.04 IV. A.
With respect to claim 30, de la Poype discloses fixing the at least one connection comprises placing a connection section on the flat film (fig. 1), but fails to disclose wherein a temperature of the connection section is at least partially between 200°C and 280°C.
Hurst et al. disclose a method of bonding medical devices and container components with heating, including providing a container and component having a melting temperature of about 130-150 degrees Celsius.
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 to modify the de la Poype method to substitute a temperature between 220-280 degrees Celsius, as suggested by Hurst et al., as a matter of optimization through routine experimentation, in the absence of any unexpected results of particular bonding temperature. A person of ordinary skill in the art would have good reason to pursue the particular bonding temperature of the connection. MPEP 2144.05 II. A. and B. The bonding temperature of Hurst et al. and the claimed bonding temperature are so close that prima facie one skilled in the art would have expected them to have the same properties. MPEP 2144.05 I.
With respect to claim 31, de la Poype fails to disclose welding the connection section to the flat film is carried out at a temperature of a pressure plate of 80°C to 150°C.
Hurst et al. disclose a method of bonding medical devices and container components with heating, including providing a container and component having a melting temperature of about 130-150 degrees Celsius.
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 to modify the de la Poype method to substitute a temperature between 80-150 degrees Celsius, as suggested by Hurst et al., as a matter of optimization through routine experimentation, in the absence of any unexpected results of particular bonding temperature. A person of ordinary skill in the art would have good reason to pursue the particular bonding temperature of the connection. MPEP 2144.05 II. A. and B. The bonding temperature of Hurst et al. and the claimed bonding temperature are so close that prima facie one skilled in the art would have expected them to have the same properties. MPEP 2144.05 I.
With respect to claim 32, de la Poype fails to disclose welding the connection section to the flat film is carried out at a temperature of a pressure plate of 90°C to 110°C for a time period of 0.1 s to 4s.
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 to modify the de la Poype method to substitute a temperature between 90-110 degrees Celsius, as suggested by Hurst et al., as a matter of optimization through routine experimentation, in the absence of any unexpected results of the particular bonding temperature. A person of ordinary skill in the art would have good reason to pursue the particular bonding temperature of the connection. MPEP 2144.05 II. A. and B. The bonding temperature of Hurst et al. and the claimed bonding temperature are so close that prima facie one skilled in the art would have expected them to have the same properties. MPEP 2144.05 I.
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 to modify the de la Poype method to include preforming the connection in a period of time of 0.1 s to 4s, as a matter of optimization through routine experimentation, in the absence of any unexpected results of the particular time of preforming. MEP 2144.05 II. A. and B. The particular time of preforming does not patentably distinguish Applicant’s claimed method form the prior art where the only difference between the prior art and the claims is a recitation of the preforming time, and a preform having the claimed preforming time would not perform differently than the prior art connection. MPEP 2144.04 IV. A.
With respect to claim 33, de la Poype fails to disclose welding the connection section to the flat film is carried out for a time period of 1.5 s to 3.5 s and a pressure of 0.1 N/mm2 to 2 N/mm2.
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 to modify the de la Poype method to include preforming the connection in a period of time of 1.5 s to 3.5 s, as a matter of optimization through routine experimentation, in the absence of any unexpected results of the particular time of preforming. MEP 2144.05 II. A. and B. The particular time of preforming does not patentably distinguish Applicant’s claimed method form the prior art where the only difference between the prior art and the claims is a recitation of the preforming time, and a preform having the claimed preforming time would not perform differently than the prior art connection. MPEP 2144.04 IV. A.
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 to modify the de la Poype method to include preforming the connection at a pressure of 0.1 N/mm2 to 2 N/mm2, as a matter of optimization through routine experimentation, in the absence of any unexpected results of the particular pressure of preforming. MEP 2144.05 II. A. and B. The particular pressure of preforming does not patentably distinguish Applicant’s claimed method from the prior art where the only difference between the prior art and the claims is a recitation of the preforming pressure, and a preform having the claimed preforming pressure would not perform differently than the prior art connection. MPEP 2144.04 IV. A.
With respect to claim 34, de la Poype fail to disclose welding the connection section to the flat film is carried out at a pressure of 0.3 N/mm2 to 0.5 N/mm2.
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 to modify the de la Poype method to include preforming the connection at a pressure of 0.3 N/mm2 to 0.5 N/mm2, as a matter of optimization through routine experimentation, in the absence of any unexpected results of the particular pressure of preforming. MEP 2144.05 II. A. and B. The particular pressure of preforming does not patentably distinguish Applicant’s claimed method from the prior art where the only difference between the prior art and the claims is a recitation of the preforming pressure, and a preform having the claimed preforming pressure would not perform differently than the prior art connection. MPEP 2144.04 IV. A.
Claims 36 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over de la Poype (US Patent No. 4,603,536) in view of Berlich et al. (WO 2020/011751).
With respect to claim 36, de la Poype fail to disclose a peel seam extending in the longitudinal direction is produced in the film tube; the peel seam detachably connects two layers of the film tube to one another; and two adjacent receiving pockets are produced and separated by the peel seam.
Berlich et al. disclose in a similar type of system that it is old and well known to provide a bag for medical contents with at least two chambers, which are separated from each other by an openable peel seam (separable peel seal pg. 2, para. 4).
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 to modify the de la Poype method to include providing a peel seam and two adjacent pockets, as taught by Berlich et al., to maintain contents separate to preserve freshness until use. In this instance, a skilled artisan would have recognized that the provision of two chambers separated by a peel seal as suggested by Berlich et al. to the de la Poype bag involves no more than the predictable use of prior art elements according to their established functions, and that one of ordinary skill in the art could have provided the known element and the results would have been predictable.
With respect to claim 45, de la Poype fails to disclose at least two chambers, which are separated from each other by an openable peel seam.
Berlich et al. disclose in a similar type of system that it is old and well known to provide a bag for medical contents with at least two chambers, which are separated from each other by an openable peel seam (separable peel seal pg. 2, para. 4).
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 to modify the de la Poype bag to provide two chambers separated by a peel seal, as taught by Berlich et al., to maintain contents separate to preserve freshness until use. In this instance, a skilled artisan would have recognized that the provision of two chambers separated by a peel seal as suggested by Berlich et al. to the de la Poype bag involves no more than the predictable use of prior art elements according to their established functions, and that one of ordinary skill in the art could have provided the known element and the results would have been predictable.
Claims 37 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over de la Poype (US Patent No. 4,603,536) in view of Goldberg et al. (WO 80/02706).
With respect to claim 37, de la Poype fails to disclose each of the two adjacent receiving pockets are filled by two separate filling lances with at least one of a liquid, solid, or pasty content, which is designed for producing dialysate.
Goldberg et al. disclose in a similar type of system that it is old and well known to provide a bag system for peritoneal dialysis (pg. 2, l. 1-13) with a solution bag (solution container, pg. 16, l. 27-35) and a drainage bag (figs. 1, 3), in which the solution bag and drainage bag are connected to a three-way valve (pg. 25, l. 6-24), and the drainage bag includes film and a connection fixed to the film (fig. 1).
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 to modify the de la Poype method to separately fill bag portions for dialysate, as taught by Goldberg et al., to provide a peritoneal dialysis system, especially since de la Poype teach a bag for medical purposes. In this instance, a skilled artisan would have recognized that the provision of the additional bag and three-way valve as suggested by Goldberg et al. to the de la Poype bag involves no more than the predictable use of prior art elements according to their established functions, and that one of ordinary skill in the art could have provided the known element and the results would have been predictable.
With respect to claim 47, de la Poype fails to disclose a bag system for peritoneal dialysis with a solution bag and a drainage bag, wherein the solution bag and the drainage bag are connected to a common three-way valve.
Goldberg et al. disclose in a similar type of system that it is old and well known to provide a bag system for peritoneal dialysis (pg. 2, l. 1-13) with a solution bag (solution container, pg. 16, l. 27-35) and a drainage bag (figs. 1, 3), in which the solution bag and drainage bag are connected to a three-way valve (pg. 25, l. 6-24), and the drainage bag includes film and a connection fixed to the film (fig. 1).
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 to modify the de la Poype bag to provide an additional bag and a three-way valve, as taught by Goldberg et al., to provide a peritoneal dialysis system, especially since de la Poype teach a bag for medical purposes. In this instance, a skilled artisan would have recognized that the provision of the additional bag and three-way valve as suggested by Goldberg et al. to the de la Poype bag involves no more than the predictable use of prior art elements according to their established functions, and that one of ordinary skill in the art could have provided the known element and the results would have been predictable.
Claims 38-42 are rejected under 35 U.S.C. 103 as being unpatentable over Merkus (US Patent No. 4,709,528) in view of Gerstner et al. (US Patent Publ. No. 2015/0353214).
With respect to claim 38, Merkus disclose a device for fixing at least one connection of a film using butt welding (fig. 1), the device comprising: a retaining device for holding a tube section (holder 28 that holds fitment 5 including tubes 7, fig. 2); a receiving section (tubular fitting 20, fig. 2); a movable pressure plate (heat sealing stamp 26, fig. 2); and a control unit to control the device to carry out a method (jaws 13 pull the film 1, sealing stamp 26 and holder 28 are displaced toward and away from each other by cylinder 36, figs. 1, 2) comprising: providing a flat film with two outer edges (film 1, fig. 1); fixing at least one connection to the flat film by butt welding (fitment 5 is heat sealed by butt welding to film 1, fig. 2); producing a film tube out of the flat film by a forming shoulder and by sealing the outer edges of the flat film together (film 1 is formed by forming shoulder 10 and longitudinal edges are sealed by jaws 12, fig. 1); producing a sealing seam that extends perpendicular to at least one of a longitudinal direction or extending direction of the film tube (cross-wise seals are produced by jaws 13, fig. 1), whereby a receiving pocket is produced in the film tube (pocket above heat sealed cross-wise seal, fig. 1); filling the receiving pocket along the longitudinal direction of the film tube with at least one of liquid or solid contents (pocket is filled through filling tube 40, fig. 2); and closing the receiving pocket by producing an additional sealing seam that extends perpendicular to the longitudinal direction of the film tube, whereby the receiving pocket is closed (jaws 13 seal and cut cross-wise, fig. 1), and a completely closed chamber is formed (individual packages 4 are formed, fig. 1).
Merkus fails to disclose a control unit programmed to control the device.
Gerstner et al. disclose in a similar type of system that it is old and well known to have a control unit programmed to control a device to carry out a method of attaching an element to a film, forming the film into a tube, and closing the tube to form a package with the element attached ([0060]-[0061]).
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 to modify the Merkus device to provide a control unit programmed to control a device to carry out a method, suggested by Gerstner et al., in order to allow the precise control of the packaging making method. In this instance, a skilled artisan would have recognized that the provision of a programmed control unit from the Gerstner et al. device to the Merkus device involves no more than the predictable use of prior art elements according to their established function, and that one of ordinary skill in the art could have provided the known element and the results would have been predictable.
With respect to claim 39, Merkus discloses the retaining device comprises a flange-like connection section (holder 28 is a flange on fastening device 15, fig. 2).
With respect to claim 40, Merkus discloses the receiving section is configured to receive the film and position the film in contact with a connection section (tubular fitting 20, fitments 5 are conveyed to the film 1 in tubular fitting 20, col. 2, l. 30-54, fig. 2).
With respect to claim 41, Merkus disclose the pressure plate is heatable (heat sealing stamp 26, fig. 2).
With respect to claim 42, Merkus discloses moving one of the retaining device or the pressure plate relative to each other in such a way that a connection section held in the retaining device is pressed together with a film positioned in the receiving section for a certain period of time and at a certain temperature and pressure, so that the connection section is butt-welded to the film and forms a connection (heat sealing stamp 26 and holder 28 are moved together to apply heat and pressure for a time to seal the fitment to the film, col. 1, l. 24-35).
Merkus fails to disclose a programmed control unit.
Gerstner et al. disclose in a similar type of system that it is old and well known to have a control unit programmed to control a device to carry out a method of attaching an element to a film, forming the film into a tube, and closing the tube to form a package with the element attached ([0060]-[0061]).
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 to modify the Merkus device to provide a programmed control unit, suggested by Gerstner et al., in order to allow the precise control of the packaging making method. In this instance, a skilled artisan would have recognized that the provision of a programmed control unit from the Gerstner et al. device to the Merkus device involves no more than the predictable use of prior art elements according to their established function, and that one of ordinary skill in the art could have provided the known element and the results would have been predictable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Totani (US Patent Publ. No. 2023/0089787) discloses a fitment attaching method.
Kobetsky et al. (US Patent Publ. No. 2003/0029138) discloses a fitment attaching method.
Posey (WO 86/04545) disclose a fitment attaching and bag forming method and device.
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/LINDA J. HODGE/Primary Examiner, Art Unit 3731
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