DETAILED ACTION
This Office Action is in response to Applicant’s amendment filed 15 December 2025.
Notice of 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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Arguments
In the response filed 15 December 2025, Applicant argues the rejection to claim 1 under 35 USC 112a is improper because MPEP 2163.02 states that the subject matter does not need to be described literally in order to satisfy the description requirement. Applicant further argues that Figures 4a-b and paragraphs [0049]-[0054] of the published application describes the combination of the limitations as recited in the claims. This argument is not persuasive. The previous office action rejected claim 1 for failing to meet the enablement requirement, not the written description requirement, as argued by Applicant.
In order to make and use the claimed invention, the Office maintains a person of ordinary skill in the art would need to perform undue experimentation because the limitations regarding the water solubility of the adhesive polymer and biocompatible material is highly variable based on the specific conditions (e.g. water temperature). The specification fails to provide any working examples of a combination of materials which would read on claim 1.
With respect to the rejection to claim 2 under 35 USC 112b, Applicant argues that claim 2 was amended to delete all materials which are neither water soluble or hot water soluble. This argument is not persuasive. Amended claim 2 contains at least 2 materials which are not water soluble.
For these reasons, the rejections are maintained.
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, 2, 5, 9-22 and 27 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 1 recites a tubular body comprising a wall made of a sheet of water-soluble biocompatible material in laminate structure having two or more layers, joined by a water-soluble adhesive polymer, such that the water-soluble adhesive polymer has a dissolution rate in water that is greater than the sheet of the water-soluble biocompatible material. The specification fails to teach how to make and use the claimed invention without undue experimentation.
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is "reasonable" or is "undue." These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The claim is analyzed below with respect to some of the Wands factors to show the experimentation required by make and use the claimed invention is undue.
(B) The nature of the invention – The claims are directed towards an anastomosis guide implanted into the body for connecting a two parts of a tubular body lumen, such as a severed small intestine. The claims recite the guide is in the form of a tubular element comprising a wall made of a sheet of water-soluble biocompatible material in laminate structure having two or more layers, joined by a water-soluble adhesive polymer, such that the water-soluble adhesive polymer has a dissolution rate in water that is greater than the sheet of the water-soluble biocompatible material.
(C) State of the prior art – Water solubility is a known material property. However, the water-solubility of a material may vary depending on local conditions – including, the temperature of the water.
For example, agarose – disclosed as an example of a biocompatible material for forming the wall on page 14, line 13 - is only soluble in hot water, but not cold water. Hydroxypropyl cellulose - disclosed on page 14, line 19 as an example of a water-soluble adhesive - is soluble in cold water, but not hot water. The claim does not define under what conditions the materials are water-soluble.
(D) The level of one of ordinary skill – A biomedical engineer with sufficient skill and experience working with implantable tubular implants for connecting vessels.
(E) Predictability of the prior art – Since some of the adhesive materials disclosed in the specification are soluble in cold water while some of the biocompatible materials are soluble only in hot water (see section (C) above), it is difficult to predict the conditions envisioned by the inventor to create a tubular element having a wall made of water-soluble biocompatible materials joined by a water-soluble adhesive such that the adhesive has a dissolution rate greater than the biocompatible materials.
The anastomotic guide is disclosed for implantation in the body of human or animal, which is not comprised of only water. Human or animal bodies, and in particular the small intestines, will be surrounded by blood and contain partially digested food and digestive juices so it is unclear what conditions are envisioned to define “water solubility” of a particular material. The conditions claimed by the inventor (i.e. water solubility) are not the same as the intended use conditions (i.e. implanted in the body). Further, the conditions of a human or animal body are not uniform – for example, animal and human blood has different components, pH levels, etc. and animals and humans have different average body temperatures. This leads to further uncertainty of what materials are envisioned by the inventor to make and use the claimed invention.
(F) Amount of direction provided by the inventor – The specification provides no direction what materials should be used to construct an anastomotic guide of a water-soluble biocompatible material having multiple layers are joined by a water-soluble polymer adhesive such that the water-soluble polymer adhesive has a dissolution rate greater than the water-soluble biocompatible material. The water solubility of a material is dependent on local conditions, like the temperature of the water (see section (C) above). The specification does not describe what under what conditions the materials are water-soluble.
One of ordinary skill would need to perform undue experimentation to find a combination of wall materials and adhesive materials which would create an anastomotic guide which is water-soluble. One of ordinary skill would be challenged to come up with a combination of materials to make and use the claimed invention because the water dissolution rate of a material can be different depending local conditions, such as water temperature. This variability in water dissolution rates, in combination with the many disclosed materials for both the biocompatible wall material and the adhesive polymer, would require substantial experimentation. Further, even the skilled artisan found a combination of materials that meet the claim limitations, it is unclear that the device dissolve in the body since the small intestines are not surrounded by water.
(G) Existence of working examples – The specification fails to disclose a combination of materials which will meet the limitation of a water-soluble biocompatible material and a water-soluble adhesive polymer such that the water-soluble adhesive polymer has a dissolution rate in water that is greater than the dissolution rate of the water-soluble biocompatible material. The specification does not provide working examples of a combination of materials which would meet these limitations.
Page 15, line 29+ provides an example in which the tubular wall is made of “PVP”, a water degradable polymer. The specification does not disclose what PVP stands for; however, this abbreviation is commonly used for polyvinylpyrrolidone, which is known to be water-soluble and used on page 15, line 21 of the specification as an exemplary water-soluble adhesive. The example on page 15, line 29+ does not disclose an adhesive. Therefore, this example does not provide an adhesive which has a greater water dissolution rate than Polyvinylpyrrolidone.
Page 58, line 5+ provides an example of fabricating a wall of layers of polyurethane and polyvinylpyrrolidone. Polyurethane can be formulated to be water-soluble but, by itself, is not water-soluble. The specification does not disclose the polyurethane in this example is water-soluble. This example does not mention the use of an adhesive and in particular, does not disclose the use of an adhesive which has a greater water dissolution rate than polyvinylpyrrolidone and polyurethane.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure – Making and using the claimed invention will require undue experimentation because water solubility is dependent on the local conditions. For example, agarose – disclosed as an example of a biocompatible material for forming the wall on page 14, line 13 - is only soluble in hot water, but not cold water. Further, hydroxypropyl cellulose - disclosed on page 14, line 19 as an example of a water-soluble adhesive - is soluble in cold water, but not hot water. The claim does not define what conditions materials are water-soluble. The specification does not provide further direction to the skilled artisan to create a laminate tubular element constructed of a water-soluble material and a water-soluble adhesive such that the adhesive has a dissolution rate in water greater than the material of the tubular element.
The specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’. The specification discloses a large list of biocompatible materials for forming wall of the tubular body and states these materials maybe water-soluble (page 3, lines 9-11 and page 13, lines 21-27), but does not disclose which materials are water-soluble and under what conditions they are water-soluble.
In order make or use the invention, a person of ordinary skill in the art would need to identify which materials are water-soluble and then construct a physical model using an adhesive to see which dissolves in water faster. However, because the temperature of the water affects solubility, it would be nearly impossible for the skilled artisan to determine how to make and use the invention such that the adhesive has a greater water dissolution rate than the biocompatible material forming the wall. For example, a tubular element constructed of material A and adhered with material B such that material B could dissolve faster than material at one temperature, but no longer would dissolve faster when the temperature is raised. This would require the skilled artisan to create different combinations of biocompatible wall materials and adhesives and dissolvability testing on the devices at several different water temperatures.
The disclosure, as filed, would require a person of ordinary skill in the art to perform undue experimentation to make or use the invention because it is unclear from the specification, what biocompatible materials for forming the wall are water-soluble and under which conditions they are water-soluble. And in particular, the specification does not disclose what biocompatible materials have a lower water dissolution rate than the water-soluble polymer adhesive.
In conclusion, the specification fails to teach how to make and use the invention of claim 1 without undue experimentation.
Claims 2, 5, 9-22 and 27 are rejected based on their dependency from 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 2 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 pre-AIA the applicant regards as the invention.
Claim 2 recites that the biocompatible material of claim 1 is selected from a group consisting of many specific materials. However, claim 1 requires the biocompatible materials is water-soluble and the list of materials presented in claim 2 includes materials which are not known to be water-soluble. For example, fibrin and chitin is are present on the list in claim 2, but these materials are not known to be soluble in water, as required by claim 1. Therefore, it is unclear if a layer consisting of fibrin, for example, would anticipate or render the claim obvious. There are many other examples in the list and the examples provided are not exhaustive. Clarification is required.
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 extension fee 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 date of this final action.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 16 January 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771